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Dietary Guidelines Advisory Committee

Third Meeting

June 16-18, 1999
1800 M Street, NW, Washington, DC

In the Matter of:

Dietary Guidelines Advisory Committee Meeting Transcript

Wednesday, June 16, 1999

Economic Research Service
1800 M Street, N.W.
Waugh Auditorium
Washington, D.C.

Pages: 1 through 317

Official Reporters
1220 L. Street, NW, Suite 600
Washington, D.C.
(202) 628-4888

The meeting in the above-entitled matter was convened, pursuant to Notice, at 9:11 a.m.


Vice Provost and Professor, Cornell University
Associate Director, Food and Nutrition
Programme, United Nations University


Researcher, Cancer Research Center of Hawaii
University of Hawaii



Chair, Department of Clinical Nutrition
Director, Center for Human Nutrition
University of Texas Southwestern Medical Center at Dallas

Associate Dean for Health Promotion and Disease Prevention
University of Pennsylvania School of Medicine
Center for Clinical Epidemiology and Biostatistics

Chair and Professor, Departments of Nutrition Sciences and Medicine
School of Medicine
University of Alabama at Birmingham

Assistant Member, Fred Hutchinson Cancer Research Center
Affiliate Assistant Professor
Department of Health Sciences
University of Washington



USDA, Agricultural Research Service


Interim Associate Dean, College of Agriculture and Life Sciences
Associate Professor, Nutrition Food Sciences
University of Vermont

Director, Frances Stern Nutrition Center
New England Medical Center
Professor of Medicine (Nutrition) and Community Health
Tufts University School of Nutrition

Director, Institute of Human Nutrition
Columbia University College of Physicians and Surgeons

Professor, Tufts University School of Nutrition Science and Policy
Senior Scientist, Jean Mayer USDA
Human Nutrition Research Center on Aging
Tufts University

Professor of Epidemiology and Nutrition
Harvard School of Public Health
Associate Professor of Medicine
Harvard Medical School


Cooper Institute for Aerobic Research
Dallas, Texas

University of South Carolina
Columbia, South Carolina




DR. GARZA: Good morning. I want to welcome everyone, especially the committee members who have a busy three days ahead of them. And also, Dr. Lesley Tinker, welcome to the committee. Dr. Tinker was appointed at the beginning of the process, but was on sabbatical leave and chose to respect that. I don't understand why. But obviously she is bright and we're -- we're always happy to see bright people in this group. So welcome.

We also have three guests that I want to welcome, Dr. Blair, Dr. Pate and Dr. Ludwig today. And they are going to be presenting some information for the committee in terms -- that -- that should help our deliberations. I also want to thank both Dr. Meyers and Kennedy for taking time out of their busy schedules to join the committee.

And with those very brief introductions and welcomes, I would like to -- to get started because we do have a busy three days ahead of us. And judging from our last committee meeting, we likely will be working until the very last moment. So that -- to help assure ourselves that we're going to give as much attention to the beginning items as to those at the end of the agenda, I would like to get started.

And so with that, let me welcome Dr. Steve Blair from the Cooper Institute for Aerobic Research from Dallas. Dr. Blair was asked to come and discuss the issue of physical activity and weight loss and weight maintenance for adults as the committee considers separating the weight gain or weight maintenance guideline from its physical activity components and developing two guidelines instead of one.

Dr. Blair, thank you for joining us.

DR. BLAIR: Thank you, Dr. Garza. Well, Dr. Garza, committee members, colleagues, it is a pleasure to come to the committee this morning. Obviously, I'm very excited about the possibility that you will consider having a separate guideline for physical activity. It obviously is the single most important risk factor for all kinds of diseases and the biggest public health problem in the United States. No reaction.


Either stunned, disbelief or complete agreement, I don't know which.

DR. GARZA: We are very well trained not to be responsive.


DR. BLAIR: I would like to discuss the four points on the slide with you this morning. First of all, I will review some of the evidence actually on cardiorespiratory fitness and health. And as you will see as I get into it, the large cohort that I follow, we have the I think good fortune of having data from a maximal exercise test on a treadmill as part of the baseline examination which I think the value of that is that it is an objective laboratory measure albeit of a physiologic parameter, cardiorespiratory fitness, the way you get to be fit or to be unfit by and large is to be active or sedentary.

So I think it is a marker for habitual physical activity. And, of course, habitual physical activity, just as habitual diet, is very difficult to assess with a lot of misclassification and so forth.

But as I present these data on fitness and health, I want to underscore or make clear that I think this is an indication of the association of -- of physical activity patterns to health factors. I will focus this specifically on how fitness might fit into the picture of overweight or obesity and health; give a very brief summary of what I think are the current consensus public health recommendations for physical activity; and conclude very briefly with a discussion of physical activity interventions.

This last point, kind of added after talking with Dr. Garza, the physical activity intervention area is a very new one. And I find health professionals and members of the public tend to have the view, you can't get people to be physical active. This is a research area that is really less than ten years old. So we haven't solved all the problems yet. But a lot of progress has been made. And I will review just a little bit of that for you.

I did send along several reprints that are included in the orange folder that the committee members have before them.

As I said, I'm going to start reviewing the association of cardiorespiratory fitness to various health outcomes. And these data do come from our own follow-up studies of a large cohort of men and women who have been examined at the Cooper Clinic in Dallas at least once during 1970 to 1989. These are men and women on the average in what I would call early middle age, although the age range spans essentially the adult years from about 20 to about 90.

I make no claim that this is a representative population sample. It's an opportunistic sample of people who have elected to come to this clinic for an examination. They are predominantly white. They come from mid -- middle to upper socioeconomic strata. Seventy-five or 80 percent of them are college graduates.

However, on some key risk factor indicators such as triceps skin fold, BMI, cholesterol, triglyceride levels, even physical activity patterns, they are very similar to other large North American cohorts such as in Hanes Surveys, the Canada Fitness Survey and the like. But certainly I recognize we cannot generalize from this one sample.

The first bit of data I will show you come from a paper published in the JAMA in 1996 which is in your folder. It's for mortality follow-up in this cohort through December 31st, 1989. Note that we have a reasonably large number of deaths in the men. Of course, we have a smaller number of women in the cohort and death rates in any cohort are always lower in women. So we only have 89 deaths in the women. And some of the analyses that we've done, some of the papers we've published, at this point we've had to limit to men simply because of not having enough power to look at the data in the women.

But as I will show you and in other analyses, whenever we have done similar analyses in men and women, we see virtually identical patterns, dose response pattern, between cardiorespiratory fitness and health outcomes.

As I said, all of these individuals had a maximal exercise test at baseline. We take the treadmill time from this standard protocol, put that in age and sex-specific distributions. And we have typically called the least fit 20 percent of the population as the low-fit or unfit group. When we look at three categories, the next 40 percent we've called moderately fit.

And I often wonder if high fit is the correct adjective to use for this top group because it's 40 percent of the distribution. So high fit doesn't mean three percent who are marathon runners or are triathletes. And as you'll see for some analyses, we simply compare the unfit or the low fit with the fit which is everybody else.

Here are the cardiovascular disease death rates by these three fitness groups for men and women. And as you can see, there is a fairly steep inverse gradient across fitness categories in both women and men. And one of the striking things that we first observed, oh, nearly a decade ago is the very large difference in death rates that we see between the low and moderately fit groups which has led us to believe that people at the lower end of the activity or fitness spectrum can actually get a fair bit of health benefit, a good bit of protection from going from doing nothing to doing a little bit. And you'll see some of that thinking reflected later in the consensus public health guidelines.

Now, this paper that Ming Wei published in January of this year in the Annals of Internal Medicine was dealing with the issue of physical fitness as it might relate to the development of Type II diabetes. In the last five or six years, it has been concluded -- was concluded in the Surgeon General's report on physical activity and health that a sedentary way of life does lead to the development of Type II diabetes.

The studies available at that time had used self- report of physical activity as the exposure and self-report of a clinical diagnosis of diabetes as the outcome. Since we know that it's very difficult to measure activity by a questionnaire, we also know that about half the prevalent cases of Type II diabetes are unknown. That leads to tremendous rates of misclassification for both exposure and outcome, and led us to believe that the current studies, although showing an association, probably were under- estimating the magnitude of the association.

In this report, we have about 8,600 men with two examinations. So we have objective measures of fitness at both exams. And for the definition of diabetes, we use the American Diabetes WHO criteria that you see on the slide so that we could screen out all people at the beginning who had diabetes and then at follow-up use fasting plasma glucose criteria as the indicator of diabetes which at least is an objective marker, whether or not you agree specifically with these cut points.

During the six-year follow-up, 149 new cases of diabetes developed in these men. Again, we saw a very steep inverse gradient across low, moderate to high fitness groups. The low-fit men had relative risk for developing diabetes, about 3.2 times higher than the fit men. And this is a much stronger association than had been reported in the physical activity diabetes studies. And that's after adjustment for kind of all of the confounders that you think might influence the relationship.

And I show you just one slide from this study. Again, you do have the full paper in your handout, but showing that this association is similar across overweight men. At the time we wrote this before the NIH treatment guidelines came out, we used the BMI cut point of 27.

But you see a similar pattern of results in the lighter men and in the heavier men. And in fact, the lighter men who were -- or the heavy men who were high fit actually had about the same if not a little lower rate of diabetes development than the unfit men who were in fact normal weight.

I want to follow up then on that suggestion of the data from the last slide and go a little more into the fitness, overweight or obesity, and health area. Certainly, we have enormous -- an enormous database indicating that as one moves up the BMI scale, we see higher rates of many different chronic diseases, higher death rates, especially from cardiovascular disease.

But much of that work has not really taken into account the physical activity status of individuals in the studies. And I don't think any of them had objective measures of fitness. So this is a line of work we've been pursuing in recent years. This reprint, published in the AJCN in March of this year, is also included in your packet.

In a cohort of about 22,000 of our men, we have measure or estimates of body composition and fat distribution from hydrostatic weighings on the seven skin folds and waste circumference and, again, cardiorespiratory fitness as assessed by a maximal exercise test. In this subgroup of the total cohort, 428 deaths.

Now, what we did in this analysis or the analysis shown on this slide is to sort the men into three categories of percent body fat as you see on the slide: less than 16, 16 to 25, and more than 25 percent.

And in each body fat in a stratum, further divided them into the fit and unfit men. And as you can see for all cause mortality, we really don't see higher mortality rates in the men who were fit, whether they were lean and a normal body fat or in fact obese. It's the unfit individuals in each stratum who had the higher mortality rates. In fact, the fit obese men had much lower mortality during this follow-up than did the lean men who were unfit.

Cardiovascular disease mortality, we do now see that there is a progression even in the fit men across fat in this category. So I'm not here to claim that body fatness makes no difference in terms of health. But certainly, these data do suggest that at least activity and fitness seem to ameliorate the effects of -- although these data aren't on BMI, we've looked at that, as well -- but BMI body composition and mortality.

And in this analysis, we actually tried to focus a little more on kind of a pure fitness measure. So we look at the bottom 25 percent of the estimated VO2 max. per -- in ml per kg of fat-free mass. And here you see that in the fit men, there is quite a strong trend upward with the fit obese men having nearly three-times higher risk of dying from cardiovascular disease.

But again, in every stratum, the fit men do much better than the unfit men. So I think these data strongly suggest -- and actually, I think we're the only group that has looked at this specific issue in this way, although you can ferret out from other reports analyses that looked at state of BMI by levels of physical activity, and those results are consistent with what I am showing you here.

The differences in most of those other reports is they didn't set out to do this kind of analysis. The top stratum of BMI in virtually all the reports tended to be 25 or greater, 26 or greater. So overweight, mild overweight perhaps and low levels of obesity. Whereas we go on up. In fact, the BMIs in our group range on up to about 35 or so.

But let me say also, I don't think the pattern of results that I've shown you are likely to apply in Class II or Class III obesity. They do apply in Class I obesity, at least in this set of observations.

And now some new work that is not past peer review. We have a paper currently out for review. We've extended the mortality surveillance in our cohort through 1994. And I'll show you in this analysis data from 25,000 men that have been followed for about ten years used and about 1,000 deaths in the cohort, more than 400 from cardiovascular disease using now the NIH guidelines BMI categories for those definitions, and has -- no surprise to anyone in the room, of course -- as we look across the BMI categories with the normal weight as the reference category for cardiovascular death or for all-cause deaths, we see the sort of progression that many others have reported.

So I show you this just to indicate we see the same pattern in our men as the Physicians Health Study or the Nurses Health Study or in any number of other recent reports.

Now, what we were trying to look at in this set of analyses was whether or not inactivity should be considered as a more important co-morbidities perhaps of obesity. The treatment guidelines of course say that you stratify a person by BMI, by waste circumference, and then you look for co-morbidities.

And diabetes is usually the first thing that the obesity experts mention, that obese -- overweight or obesity individuals with diabetes have very high rates of cardiovascular and all-cause mortality, and of course hypertension, cholesterol, smoking and so forth -- high cholesterol, smoking and the like are other risk factors. Physical activity is only mentioned kind of as an after- thought later. So that prompted me to take a look at this issue, again, in our cohort with the objective measure of fitness.

So what I've done in this analysis for these five risk predictors, high cholesterol, diabetes, hypertension, smoking and low fitness, we show the -- in this slide, the relative risk for all-cause mortality with the orange bars, the reference category, being the normal weight men in that analysis who do not have that specific risk factor, so these normal weight men who have cholesterol 239 or less.

This then is the relative risk for men who are normal weight, but have high cholesterol, maybe a little increase in mortality. The overweight men with high cholesterol and the obese men with high cholesterol. So then the same for each of the other analyses.

Normal weight men with diabetes, normal weight men -- or overweight men with diabetes, obese men with diabetes, hypertension, cigarette smoking, low fitness. Now, even with my biases that I bring to this from studying physical activity, frankly I was a little surprised that in obese men, low fitness is just as important a predictor of mortality as is actually having diabetes.

We see a very similar pattern of results, only with higher relative risk, when we look at cardiovascular disease mortality. So, again, keep in mind, these are preliminary. They've not undergone peer review. I'm surprised the journal didn't write back immediately and accept this paper. But they've had it now for a couple of months.

But it seems to me that for overweight and obese individuals, low fitness which you get by being sedentary is an important determinant of mortality risk. And therefore, it deserves to be considered anytime one is interested in the public health problem of overweight and obesity.

Now, if one takes the view of the Surgeon General or the State Health Officer -- of course, epidemiologists, as you know, like to go on and look at population attributable risk -- let's just look at the population attributable risk for all cause mortality. And this is in the 3,300 men in our cohort who were obese, BMI of 30 or greater.

Granted the relative risk for fitness is -- it's one of the higher ones. It's almost as high as actually having cardiovascular disease at baseline. And all of these relative risks are adjusted for all the items in the table, age, examination, year and family history of CVD. The relative risks I suppose don't differ all that much, except maybe for hypertension. But the prevalence of the condition does.

Diabetes is a bad thing to have. And obese people are more likely to have diabetes than those who are not obese. But still, only ten -- ten percent of our obese men have diabetes. Fifty percent of them are low fit. So from a population attributable risk perspective, I would put forth the argument that low fitness is a very important item to consider in the context of the public health problem of overweight and obesity.

We've just recently -- and these -- this isn't even out for review yet. So it's even more preliminary. We're still working on this paper and I'll just show you one data slide from it. But it's a group of 1,200 of our men who had diabetes at baseline, either by a clinical history - - a physician diagnosed diabetes -- or elevated fasting plasma glucose or they're taking anti-diabetic medicine.

We looked at the low fit group. Again, that's the least fit, 20 percent of the total population. But in these diabetic men, 42 percent of them actually were low fit. Followed them for about 12 years, 180 deaths --heavy touch on the button -- with 180 deaths in the cohort.

And what I'm showing in this slide is the relative risk for cardiovascular disease mortality adjusted for age and examination year across the low, moderate and high fit categories. And again, you see this very steep inverse gradient in this group of men who already had diabetes at the start of follow-up. So high fitness appears to provide some protection against mortality and in men who have diabetes.

Here is the relative risk for cardiovascular mortality across the BMI categories, normal weight, overweight and obese; the sort of upward progression that you would expect. But again, I would argue it seems to me that low fitness is as important a predictor of mortality in diabetic men as is obesity.

And this is not to diminish the importance of obesity, but I am trying to elevate the importance of physical fitness and physical activity in healthy people, in unhealthy people.

We've just been looking at this same kind of analysis in hypertensive men. We see the same thing. The hypertensive men who are low fit, much more likely to die of cardiovascular disease and all cause mortality than those who are fit.

So there is a large database. And I didn't come preparing to do a meta analysis and report all the data. The Surgeon General's report on physical activity and health published in 1996 did that. And certainly conclusions, conservative conclusions drawn from that were that sedentary living habits and low fitness are associated with the kinds of disease outcomes that I have been talking about this morning.

Further, since the prevalence of inactivity and, therefore, I suspect the prevalence of low fitness, although we don't know that yet, is on the order of 20 to 25 percent of the population. So we have a huge group of people exposed to this hazard of being sedentary and unfit.

We do have pretty good consensus on the public health recommendations for physical activity. The first kind of major report on this -- the next speaker, Russ Pate, led a group; Centers for Disease Control and the American College of Sports Medicine published a report in JAMA in '95. And the main recommendation for sedentary individuals -- this is not the recommendation for marathon runners. This is the recommendation for the 25 percent who are totally sedentary. That if you get up and move around a little bit and accumulate 30 minutes of at least moderate intensity physical activity on most, preferably all days of the week, you will be getting enough exercise to get some health benefits.

Now, the two relatively new elements of this recommendation was the word, "accumulate". I know exercise scientists for years preached that exercise needed to be aerobic and large muscle and continuous to the point that people were afraid to stop and tie their shoe. And I think we now know that you can accumulate the dose. It's really -- and those of you in the dietary community can certainly think of, you know, it's the total calories spent over the day, over the week that is probably important.

I don't think we can make a strong case that intensity of exercise matters very much. There may be some minimal intensity below which there is no benefit. But if there is, no one has yet, at least to me, has presented compelling evidence that that's true. It's kind of how much do you do, keeping in mind the high death rates in our low fit men and the much lower death rates in the moderately fit men.

You get up and move around a little bit, take three ten-minute walks a day meeting this criterion, you will move into our moderate fitness category.

Now, this same recommendation was repeated almost word-for-word in the -- also in 1996, the -- first of all, the National Institutes of Health Consensus Development Conference on Physical Activity and Cardiovascular Health, and was essentially repeated, not word-for-word, but conceptually repeated by the Surgeon General's report also in 1996.

The American Heart statements on exercise that in '92 labeled inactivity as the fourth risk factor and then their revised statement in '96 also embraced this concept. So the important public health advice is you don't have to go through marathon training to get benefit from activity.

And finally, can we get people to follow this recommendation? I'll show you data from one of our clinical trials recently published. And again, you have the reprint of that published in January in the JAMA. It was a two-year randomized trial which we recruited 235 very sedentary and unfit middle-aged men and women in -- in the Dallas community.

Now, this clinical trials cohort was very diverse. We had 25 to 30 percent minorities across a fairly wide age range. We were interested in comparing in this study the established exercise treatment advice, that is the structured advice -- go to the gym; join a fitness class; run on the treadmill; run around the block, etcetera -- with what we've called lifestyle physical activity.

It was a two-year trial, but there was six months of intensive intervention and then 18 months of follow-up with fairly minor intensity of intervention.

The goal was to increase energy expenditure in these sedentary individuals on the order of three kilocalories per kilogram per day which if accomplished would achieve comfortably, more than achieve the CDC/ACSM public health recommendation that I mentioned a moment ago.

The structured intervention group in this study was given a free membership to a state of the art fitness center for the six months of intensive intervention. And they followed the traditional kind of American College of Sports Medicine exercise prescription model that you see on the slide.

The lifestyle intervention group came to the institute for an hour a week for the first four months, and then every other week for the next two months. But they came not to exercise. They came to sit in the room like this around a table and talk about exercise. So it was pretty non-threatening. You know, don't even have to come and exercise. We come and talk about it.

Now, obviously, it was a little more complicated than that. The goal of the intervention was to help people develop the behavioral lifestyle skills to integrate more physical activity into their daily lives. We tried to take them where they were.

We tried to move them along a motivational readiness spectrum. We tried to get them to use the behavioral skills of goals setting -- or self-monitoring, goals setting, evaluating progress, finding and using social support, positive reinforcement, etcetera, etcetera.

Here are the results in terms of their energy expenditure obtained from a carefully structured and validated seven-day physical activity recall. You can see both groups increased their physical activity at six months during the intensive intervention. There was some slight decay over the 18 months following, but no difference between groups at either time point, and both groups being more active at 24 months.

I'm not taking the time to show the data. Both groups were also more fit at 24 months by VO2 max. criteria. They lowered their blood pressure -- I didn't put in -- they also lost body fat. And again, no difference between the two groups. So these two approaches appear to work which give us encouragement that this lifestyle recommendations, lifestyle advice can appeal to a segment of the population that will never join a fitness center, take up jogging, join aerobics class and -- and so forth.

We have a paper coming out in preventive medicine on the cost effectiveness of these analyses. And you can see kind of for any of the outcomes we looked at per unit change in these outcomes, the lifestyle intervention was a good deal less expensive.

So we think we're accumulating evidence that these sort of behavioral skills training sort of intervention does work for physical activity just as it has worked in smoking cessation and diet intervention programs. Don't have all the answers but, as I said, this is a very new area of research. I think we have made some progress.

So just to summarize, I think we can certainly say that sedentary habits are an important determinant of chronic disease. I didn't show any data on loss of function, but that, too. Decreased longevity.

I think physical activity and certainly fitness in our analyses seems to attenuate the force of the other well established risk factors including overweight and obesity on mortality, both all cause and cardiovascular disease mortality.

Now, physical activity doesn't contribute a lot to weight loss. I mean, just the thermodynamics of it make the situation -- you can't lose a lot of weight by activity. You certainly can't do it quickly. I mean, it takes a long time. You just can't spend that many calories, and especially if you take an overweight, sedentary, unfit person. They don't have the engine to spin the calories. So you can't lose a lot of weight certainly quickly by physical activity.

It does, however, in meta analyses appear to add a couple of kilograms of weight loss in dietary intervention programs or even pharmacologic interventions over weeks or months. But it does appear to be critical, maybe almost essential to maintain weight loss. We don't have all the randomized trials and maintenance that we would like. But it appears that people who lose weight by whatever means and then manage to keep it off are the people who take up physical activity.

So I think inactivity is a major public health problem. We have some good consensus recommendations that I've reviewed. And I would hope that your committee would -- if you decide to issue guidelines on physical activity, I hope you will consider it carefully and make it consistent with the NIH/CDC/ACSM/Surgeon General's recommendation so we don't confuse the public.

I think -- I think we are learning how to amount the effect of physical activity interventions. And we've never had a large-scale, nationwide coordinated physical activity intervention ala National Cholesterol Education Campaign and the like. It is time that we begin to organize ourselves for such an effort.

Thank you. And I intend to address questions, Dr. Garza, if you have time and if -- if the committee has questions.

DR. GARZA: We saved some time for questions. Roland?

DR. WEINSIER: Steve, I really appreciate your overview and an excellent summary in such a short period of time. A couple of questions, if I may. Why do you think there is a difference in the effectiveness of --

DR. GARZA: Roland, can you please use your mike? Otherwise, they're going to --

DR. WEINSIER: Yes. Why do you think there is a difference between the effectiveness of physical activity or exercise to sustain weight loss, but not to induce weight loss. What are the proposed different mechanisms by which this occurs?

DR. BLAIR: Well, I'm not sure it is different mechanisms. I think it's largely -- and it's the same kind of dose of exercise. It's just that in the shorter term weight loss studies that people -- I mean, some of them short, ten, 12, 14 weeks. And again, with unfit, sedentary, obese individuals, they just can't do enough exercise.

But if they begin to exercise, begin to develop a little bit of fitness and they lose some weight which makes it easier to do exercise, the if they can sustain according to the data 45 to 60 minutes a day of just moderate intensity, walking activity, that that does of exercise then seems to prevent the weight regain. And some data would even suggest slight further weight loss.

I don't know that it's a different mechanism. It's just a different set of circumstances I would say. Now, there are -- if I can interrupt -- some of the psychologists like Kelly Brownell would say that actually exercise increases self-efficacy and has psychological benefits and makes it easier for the person to deal with staying with a diet and so forth. It's a nice hypothesis and I hope it's true. It could be true. But I don't think there is a lot of data to support it at this point.

DR. WEINSIER: Yes, I guess it's an unfair question because I don't think there are any data to indicate that there is a mechanism the same or different. But it's an interesting combination.

Let me ask you, in -- in the beginning you probably defined physical fitness, but I missed it. I heard the VO2 max. But it's a VO2 max. relative to what? Is it - - is it --

DR. BLAIR: Well, the definition --

DR. WEINSIER: -- divided by weight?

DR. BLAIR: Well, the definition of fitness in our studies is the bottom 20 percent in each age-sex group --

DR. WEINSIER: Yes, but the --

DR. BLAIR: -- on this maximal exercise test. So it's time on treadmill in this protocol which correlates 0.92 with measured VO2 max. ml per kg per minute. So this really would be analogous to VO2 max. and ml per kg per minute.

DR. WEINSIER: So it's -- basically, is it function then as a ratio of VO2 max. relative to body weight?


DR. WEINSIER: If -- let me see if this makes sense. I'm thinking back to the decades of time when we looked at resting metabolic rate relative to fat-free mass in obese versus lean people. And we were convinced the obese people have a lower resting metabolic rate relative to body size. But it was an artifact of the ratio effect.

If -- if I have -- if I want to change my fitness, it looks like I can do it in two ways. I can either keep my weight the same and be more physically active and increase my VO2 and, therefore, keep the denominator the same and I increase my fitness. Alternatively, could I not decrease my weight with keeping the VO2 max. the same and look like I'm becoming more fit?

DR. BLAIR: Yes, you can at least theoretically. But you have to lose an awful lot of weight to kind of get any kind of clinically significant --


DR. BLAIR: -- change in fitness. It's just going through the math --


DR. BLAIR: -- through the mathematics of it. Theoretically, that is possible. We have done some analyses, particularly in the -- in the area of fitness, fatness and mortality in which we estimated VO2 in liters where we take out body weight, carry out the analyses. And we see about the same kind of thing, trying to get at a pure and a cardiovascular power function, if you will, by looking at it in liters.

DR. WEINSIER: Within an individual -- yes, your point is well taken. I may not change my weight that much. But here we're crossing over groups of BMI -- I mean, percent body fat. It's gone from less than 16 and 25 percent. So we're getting pretty significant comparisons. And I wonder if this has been looked at in an analysis of variance rather than a ratio effect to make sure that --


DR. WEINSIER: -- this is not an appearance of decreased fitness and obese people --

DR. BLAIR: Yes, we've --

DR. WEINSIER: -- rather than the truth.

DR. BLAIR: -- we've done a lot of that over the years, just looking -- not looking at BMI categories, but looking at fitness in these kinds of outcomes and in multi- variant models including BMI, including percent fat. And it changes -- it rarely changes the relative risk much at all.

DR. WEINSIER: And can I ask one last question, or am I taking up too much of my time?

DR. GARZA: Well, let me go to others and then we'll come back to you, Roland.


DR. GARZA: Scott?

DR. GRUNDY: There were questions that I had in these impressive results. One is it always helps your case if you can tell me why it provides benefit, what is the mechanisms. And, you know, even if you had a list of three or four most important, it would be more convincing to me that, you know, what does exercise do.

The other question I have is how do you know that the patients or people who entered this study weren't already ill when they entered this study and that impaired their ability to exercise or be in shape?

DR. BLAIR: I'll take the second question first. The epidemiologists, the ones on the committee, now we always worry about subclinical disease at baseline in these populations. However, in our study, these patients have -- have gone through a five or six-hour intensive physical examination. Each physician at the Cooper Clinic sees four or five patients a day.

Now, that's not to say that people couldn't get through that screening and still have subclinical disease. I think it's much less likely that they do than if we did a questionnaire survey and asked them about their health status. So we certainly try to take that into account.

And further, when we look at patients that we know have disease, hypertension, diabetes and the like, we see the same pattern. Now, you could say, "Well, yes, but the most sick diabetics are the ones who don't exercise as much." And, you know, we try to control for that by the biochemical measures we have and blood pressure and other risk factors. And we never make this association go away. We attenuate it a little bit.

What are the mechanisms? Certainly, the conventional risk factors explain a little bit of this, but not a whole lot of this because when we adjust for lipids and blood pressure and smoking status, it only attenuates the association between fitness and mortality by some relatively small amount. But there are newer mechanisms under investigation in clinical studies for which we and other large cohort studies just don't have the data such as immune function.

Now, I don't know how those of you on the committee feel about is atherosclerosis partly an infectious disease. I mean, there are people who believe that it is and there are some data that support that.

We do have good data from clinical studies that the proper dose of exercise seems to enhance immune function. You can do too much and drive it down. But that takes an awful lot of exercise. And that's -- an awful lot of exercise is not a public health problem in the U.S. So immune function could be one.

Exercise affects clotting mechanisms, lipolytic mechanisms. And it's certainly possible that that is part of the overall picture. We just don't have those data in the epidemiological studies.

And finally I'm just a -- you know, a simple Kansas farm boy epidemiologist. It seems to me that -- we know that exercise increases the strength of the heart. It gives you bigger LV mass and increases cardiac output and stroke volume. If you've got a bigger, stronger pump and then even if you have an infarct and you lose X grams of tissue, the fit person has more tissue left over. And we do have data from epidemiology that fit people -- active people I should say are less likely to die if they have a heart attack.

So, you know, maybe you've just got a better pump, Scott, is part of it. But certainly we don't know all we would like to know about mechanisms.

DR. GARZA: Shiriki?

DR. KUMANYIKA: Steve, this may not be a fair question for you. But let's get it on the table. Can you help us relate physical activity to dietary intake?

DR. BLAIR: There is not much of an association between activity and dietary intake as -- as I understand it. We've looked at this in our randomized clinical trials. Where we're intervening on physical activity, we're not intervening on diet. We measure diet, three-day diet records, and we give the participants feedback kind of as a customer service. And they're very interested in it. They want to know about a healthful diet.

But intervening on physical activity does not in our studies cause a spontaneous change in diet. We haven't been able to find it. And some of the dieticians working with us have looked for it. And we just can't find any evidence that your diet changes.

At a consensus conference on physical activity and obesity where Scott chaired the consensus panel, we heard a report on this topic by Dr. Blundale from the U.K. And Scott, if you can help me remember, I -- I think the bottom line of his presentation was really not a lot of evidence that people have been able to identify direct links between activity and diet pattern.

Now, obviously total calories -- I mean, over time if you exercise a lot, your total caloric intake is going to go up. And to some extent, if you become more and more sedentary, it's going to go down. It probably doesn't keep up. It probably doesn't go down enough which frankly may be a major cause of the overweight and obesity. But there doesn't appear to be a very tight coupling as far as I understand it.

DR. GARZA: Dr. Tinker?

DR. TINKER: I have two questions about the CDC recommendation. And the first one is, let me just make sure I understand, the 30 minutes of physical activity, that is not in any way related to anything related to weight loss. So that's just the physical activity without any --

DR. BLAIR: For health.

DR. TINKER: Basically for health.

DR. BLAIR: Physical activity for health in general. It's a broad stroke recommendation. You can ask Russ when he gets up here. I certainly believe and think many people on the committee believe that if you want to focus on weight loss, that's probably not enough. You probably ought to be recommending more. And the follow-up studies on weight maintenance suggest 45 minutes to moderate -- moderately vigorous activity is probably a better target to aim for.

So if the sole focus is on weight loss, weight control, I'm not sure that's the optimal. But it's enough to get health benefits. And if our data are correct, even if you stay fat, stay overweight, if you're exercising at that level, you're probably better off than if you weren't exercising.

DR. TINKER: And then have you considered moderate intensive exercise?

DR. BLAIR: Yes. Moderate intensity exercise in these various guidelines has been defined somewhat differently. But as I boil it down, what it -- what it amounts to is brisk walking which three to four miles an hour; not race walking, just striding along three to four miles an hour, 15 to 20 minutes per mile.

DR. GARZA: Meir?

DR. BLAIR: Oh, can I say just one more thing about that? We received a lot of criticism from some quarters when the Surgeon General's report came out. And I think the thing you have in your packet talks about washing the car and washing windows. And I can't tell you how many drive-time VJs would call and say, "Oh, Dr. Blair, should I wash my car every day for 30 minutes?". And I would say, "Well, no, you dummy, you wash your car today and rake the leaves tomorrow."


But actually just in the last year, there have been three laboratories looking at -- with measured oxygen uptake with portable metabolic cards, measuring the energy costs of these kinds of activities, of weeding and raking and vacuuming and washing windows and dusting. And all of those fall in the three to four met. category. And there is remarkable consistence across laboratories.

I was a little surprised. Dusting I think in the one laboratory that studied dusting was 3.1 mets., in that range. Patty Feregson says she now has 15 coats of wax on her tables, but --

DR. GARZA: We've just discovered why men die so young.


DR. GARZA: On that happy note, Meir?

DR. STAMPFER: Just to follow up on that, is there -- is there -- what's your take on any further benefit of more vigorous activity?

DR. BLAIR: Thank you, Meir. Good question. I think there is more benefit. Certainly our data suggests additional benefit in the high fit group. And as I look across all of our studies and I look at Pattenbarter studies and so forth, if you go from -- say in our studies, from moderate fit to high fit, the risk drops another ten to 15 percent. We've actually published on fitness change, also. I don't think I included that paper, 1995 in the JAMA.

The big drop going from low fit to moderate fit, the risk dropped by about 50 percent. Going from moderate to high, it dropped another ten to 15 percent. So some of you know, I'm a runner of 30 years. I ran this morning. I run every day. I'm proof positive. Running 100,000 miles does not make you skinny. But I hope that there is benefit to more vigorous exercise. And the data certainly suggests that.

So I think we need to always mention that so as not to discourage the people who are runners and cyclists and go to aerobics class every week. I think they probably do get a little additional benefit.

DR. GARZA: Johanna?

DR. DWYER: Thank you for a wonderful presentation, Steve. One question about sources and the second one about the message we might want to convey. On sources, it would seem to me that one of the biggest couch potato processing companies in the United States is the U.S. military because they're taking fairly sedentary people and putting them through basic training. And I wondered if there were any data that you were aware of that might -- might be useful for us in our deliberations.

The second is the focus. And should we be focusing on an active and healthy lifestyle to avoid this inactivity crisis that Surgeon General Coop referred to a couple of weeks ago rather than achieving and maintaining healthy weight? What is your take on that or are both messages -- certainly, the latter is important. It was in the guidelines. But what about the first?

DR. BLAIR: There certainly are some military studies not with health outcomes. There are studies with what happens to injury rates as these recruits go through basic training; some studies on changes and fitness. But another nature of the military is that basically young people and basically leave early. So you can't study the chronic diseases in that population.

DR. DWYER: Fair enough.

DR. BLAIR: I would say one of the people who knows the most about this if you want to contact is Colonel Bruce Jones, retired, now at CDC. Bruce Jones at CDC in the injury branch has over a career of 15 or 20 years conducted studies of that type. So he would be a good source of information.

And your second -- what should the focus be? Well, I'm certainly not going to come here and say let's ignore overweight and obesity. I do think that the pendulum has maybe swung too far to the side of focusing on overweight and obesity as just the problem.

And I know the old guidelines mention physical activity. And to me, we -- I think we need to come to an energy balance discussion. I think it makes no sense to talk about energy intake and not talk about energy expenditure. It makes no sense to talk about diet and not talk about physical activity.

And I say that to people in both camps. I do not say that if you're active, you can ignore diet and forget about your weight. I only say that when I'm trying to annoy the speaker you have tomorrow, Claude Bouchard, or someone of that sort. But, no, I think we need to focus on both. But certainly, you can see a passionate believer. We need to have more emphasis in this country on organized programs to promote activity. And it's going down. I mean, the estimates show the U.S. and the U.K. -- of course, a lot of assumptions go into these -- but the average daily energy expenditure of Americans has probably declined 200 or 300 kilocalories a day, not since 1900; probably since 1980, 1975.

Why is that? Just think of your own life. How many of you order Christmas presents now over the internet or Father's Day present which we -- some of us just did this week over the internet? Now, shopping is not your basic aerobic training activity. But it does spend more calories than sitting at your computer shopping over the internet. So 10,000 examples we can all come up with of how we've engineered activity out of daily life. It would be difficult to overcome that in this larger context of an evermore sedentary kind of energy expenditure-free society.

DR. GARZA: Rachel?

DR. JOHNSON: Thank you, as well, Steve. As you probably know, the dietary guidelines are designed to apply to all Americans over the age of two. And all of your data that you presented on was adults. I wanted to know if you think there is any special caveats for the pediatric population, if the CDC guidelines of 30 minutes per day are applicable to children, and if you have any comments achieving fitness -- you know, appropriate fitness levels in children and prevention of obesity, the role of physical activity.

DR. BLAIR: My work, as you point out, is with adults, both in epidemiological studies and clinical trials. And I might have some opinions. But your next speaker is an authority --


DR. BLAIR: -- on that issue. So I'm sure he'll be addressing it.

DR. JOHNSON: Thanks.

DR. GARZA: Steve, I, too, want to thank you for an excellent presentation. I have three -- three brief questions. On the slides where you had body fat, how was that mentioned?

DR. BLAIR: In -- in those 22,000 men, it was either by hydrostatic weighing or by sum of skin folds, or both. There was some -- some group that had only the sum of skin folds. In that group, we used the data on the men that had both to develop a regression equation to standardize an estimate of percent fat from the skin fold measures. And then actually, it appeared to work pretty well. So it -- there were different measures, but we tried to put them together in a coherent way and didn't -- well, I have confidence that it's a reasonable estimate.

DR. GARZA: Okay. Is there a -- is there a benefit from the cumulative duration of physical fitness, or is -- is -- are the benefits available to the individual the moment he or she becomes more physically fit? Do you see a risk -- an immediate risk reduction or does it take time?

DR. BLAIR: There is an immediate effect. There is an acute effect of physical activity that has been overlooked for too long. We are accustomed to thinking of exercise as something you train and weeks and months later, you've had some changes and you get benefit.

But actually, we know one bout of exercise improves insulin sensitivity. One bout of exercise effects fibrinolytic activity. One bout of exercise typically makes you feel better. And if you doubt that, when it comes time for your break, get up and walk five minutes down the hall. You'll feel better.

So there are acute benefits of exercise as well as chronic benefits from training. And Bill Haskell has suggested there is kind of an augmented acute effect that as you progress along over weeks and months being more active, improving fitness, you get a little bit of an augmentation to some of these acute effects. But there are some immediate effects.

DR. GARZA: So you would expect that the risk to chronic disease would fall in someone over 50 that decided to -- to adopt either a lifestyle or a structure type of program and, therefore, become more physically fit?

DR. BLAIR: Well, our data show that. We looked at men who were unfit at the first exam, fit at the second exam, and just moderately fit, just getting out of the low fit category. Their risk of all cause mortality was 50 percent lower than the unfit men who stayed unfit.

Now, I don't think I can answer the question of acute benefits and reduction in mortality. I mean, nobody has any data that would really address that. So we're kind of looking at habitual activity or an attained level of fitness which get by habitual activity.

So how quickly the results would come, you know, we said over the years for smoking cessation, within a year risk begins to return. We don't have the data to really know how quickly that risk returns.

DR. GARZA: You don't have any data that suggests it's too late to begin exercising at any particular age? I mean --

DR. BLAIR: It's never too late according to our data and according to other date; for example, on musculoskeletal fitness and function. We see this 50 percent reduction in mortality in men 40 to 49 who improved from low fit to moderately fit. We also see it in the men 60 and older who improved from low fit to moderately fit.

And with our new mortality data -- I haven't yet looked at change in that group, but we see this same inverse gradient of fitness, much higher death rates, but same inverse gradient in men and women 80 -- 80 years of age and older at baseline. Never too late to get the benefits of exercise according to our data.

DR. GARZA: And lastly, what do the -- what is the body of evidence that you find most convincing that goes counter to what you've told us for the last 45 minutes?

DR. BLAIR: There is essentially no reasonable study over the last ten or 15 years, epidemiological study as far as I know, that has shown sizeable increases in mortality, for example, or increases in some of these other end points in people who are active or fit compared with not.

So there is -- I don't think there is any reasonable evidence on the other side of that issue. Another issue, however, is what about the costs of exercise; what about the sudden deaths. Well, these epidemiological studies, when we look at death rates at the end, we're really looking at a net effect.

So if the exercisers -- if some of them are more likely to drop dead while they're out there exercising, I mean, that -- their death gets counted in the active and fit group. So we're looking at net effects.

Another issue of course is injury, musculoskeletal injury. I attended last weekend an NIAMS Academy of Orthopedic Surgeons meeting. And they're very interested in the injury issue. Certainly, if you go out and move around or if you take up competitive sports, you're more likely to develop a musculoskeletal injury than if you stay home in bed all day. So that there is that. And frankly, that hasn't been studied enough.

But I think we could expect that if all the sedentary Americans started exercising, there would be some increase in, you know, musculoskeletal injuries of one type or another. However, we do have data to suggest that the injury rates in people who are walking is just not very high. It's if you take up running, aerobic dance or more vigorous activities and sports where the injury rates will go up.

But the ACSM/CDC recommendation has been looked at in some controlled -- or activity of that type looked at in controlled studies. Injuries don't seem to go up very much. There will be some. I think the benefits outweigh the risks clearly.

DR. GARZA: We're going to have to move on to our next speaker unless your questions are very brief and Steve promises to answer them within the ten -- a

ten-second --

DR. BLAIR: All right. I'll promise.

DR. GARZA: Roland?

DR. WEINSIER: Yes. Real quick. What was the data on anaerobic fitness? Are there -- is it absence of data or that the data are negative regarding anaerobic resistance fitness to increase strength, therefore, being able to climb stairs, stand from a chair, carry a load, etcetera?

DR. BLAIR: We have data from both epidemiologic studies -- we've been looking at this -- and from training studies, especially in elderly individuals, that musculoskeletal fitness delays the development of functional limitations. And that's so logical, it has to be true. I mean, the 80-year-old who can't get out of the chair can't get out of the chair because they have no muscle left in their quadriceps and other places.

So, I mean, it's clear that there are those benefits. There is a suggestion that musculoskeletal fitness-type training, strength training benefits insulin sensitivity. But we have no studies of disease outcome with musculoskeletal fitness that I am aware of.

DR. GARZA: Okay. Alice?

DR. LICHTENSTEIN: Just there are some data on the very old and increased physical activity and being able to maintain activities of daily life. Fiaderoni has published that.


DR. LICHTENSTEIN: But very briefly, do you collect any data on prior participation or exposure to activity, let's say, during childhood in your subjects and is there any relationship?

DR. BLAIR: We looked at that in a paper ten years ago or so. And just a bottom line, I can't find evidence that participation in activity or sports, I should say, in that study early in life has anything to do with health and function later on life. And Pattenbarter's data tends to show the same thing. It's the activity you're getting in middle age and older that gives you the benefit.

DR. LICHTENSTEIN: But would a relationship with whether when they come in to your study they are active or inactive?

DR. BLAIR: I included that in my comment actually, not specifically. But we saw that -- again, these data were limited to men. Men who were athletes in high school or college were no more likely to be physically active and fit when they came in average age 45 to the clinic. And, yes, I was actually referring to Fiaderoni's data and our epidemiological data that suggests that strength training, musculoskeletal fitness does indeed benefit function.

DR. GARZA: Thank you very much. We're going to move on then to our -- out next speaker, Dr. Russ Pate from the University of South Carolina in Columbia. He is going to address the appropriate physical activity level for children. Dr. Pate, thank you very much for joining us this morning.

DR. PATE: I apologize for dashing out. I had a -- have a committing British Columbia night.

DR. GARZA: The door is locked. Don't worry about it.


DR. PATE: Well, I'm relieved. Well, I have followed Steve many times over the years including on to the faculty of the University of South Carolina where he used to work. And it's never an easy assignment. But I'm very pleased to have the opportunity, glad to be here, and I am, too, very pleased that consideration is being given to including an independent guideline on physical activity in -- in the next set of dietary guidelines.

So that there will be no confusion about where I'm heading, I do intend to encourage you to proceed with -- with a development of an independent guideline on physical activity.

But I will also be cautioning you that I think if that guideline is to apply to young people, children and adolescents, that consideration should, in fact, must be given to the fact that children and youths are not the same as adults when it comes to physical activity. Their physical activity behaviors, as I will be showing you, are -- are different.

And, unfortunately, I will have to admit to you right up front that the knowledge base that links physical activity to chronic disease health outcomes is orders of magnitude less voluminous in young people than is the case with -- with adults. And Steve, of course, has done a very nice job here this morning, of over-viewing that evidence in -- in adults.

My primary objective, as per the title of my presentation, is going to be to overview for you the current thinking on guidelines for physical activity in children and youths. I am going to begin by addressing a couple of secondary objectives which get at why I think it would be appropriate to be concerned about physical activity in young people in the context of the dietary guidelines that are being developed.

The major reasons are, again, so that you will know where I'm heading, that obesity is an increasing problem in young Americans. And it is my view and I think a view that is increasingly accepted that lower levels and/or decreasing levels of physical activity is probably a major, if not the exclusive, reason for that trend.

And I, like Steve, understand that I am amongst a group of people who focus largely on diet. So that you will know where my biases are, I am a traditionally trained exercise physiologist. I work in a department of exercise science which is in a school of public health.

And I'll -- I'll tell you right now that I don't think we're going to effectively address the growing obesity problem that we confront in this country if we don't deal with physical activity.

And that certainly is not to say that dietary considerations are -- are unimportant or less important. But I think there are some fairly profound physiologic reasons why diet won't be the whole answer to the problem and that physical activity will have to be addressed.

So with that as introduction, many of you in the room are as or more familiar with these data than I. This is -- is simply to make the point that the obesity rates in young people in the United States are clearly growing. And Rick Troiano's paper from a year or so ago based on the National Health Survey data collected since the '60s indicates this.

In this analysis, they looked at obesity rates from the '60s to the '90s based on the National Health Examination Survey data and then subsequent NHANES data, and defined overweight in these analyses as the age and sex- specific ninety-fifth percentile for -- for BMI from the first two surveys in the '60s.

And I suspect you are well aware, these are data for kids in the six to 11-year age range working from left to right, black males, black females, white males, white females. Again, the bars go from the initial National Health Examination Survey data on up to NHANES III.

And as I'm sure you all know and appreciate, the prevalence rates in all groups -- prevalence of obesity rates in all groups have gone up and are very alarming in particularly black females. Similar pattern in older kids. These are the data for ages 12 to 17. And, again, the prevalence rates are very alarming, particularly in black females, but apparently have increased in -- in all of the demographic groups, and perhaps most rapidly in the most recent surveys.

And this is just a capsulization of that trend across the various groups showing perhaps a disproportionate and alarming great increase in the prevalence of obesity in young people just in -- in recent decades.

Now, the issue is what, if anything, does this have to do with physical activity and what might physical activity do in -- in addressing this -- this alarming trend. I think there are, at least in my mind, four areas in which we would like to know a lot. And frankly in some of these areas, we know something, probably not as much as we would like to. And in a couple of areas, I think the science is - - is really just beginning.

The four areas that come to my mind that would potentially link physical activity to this obesity problem are, first of all, cross-sectional epidemiologic studies looking at associations between activity and body fatness. These studies exist. There are a fairly large number of them. I don't intend to talk about them today. I have reviewed this literature in the past. I can tell you the conclusion that I draw.

I think that those studies, if you look across them, generally show that the more active kids tend to be leaner or vice versa, less active kids tend to be fatter. Now, we all understand the limitations of these cross- sectional surveys and they certainly do not establish causality.

And you can make the argument that the causality could be and may in fact even operate in both directions: Fatter kids less likely to opt for activity and, therefore, are found to be less active; and, of course, inactivity also could be causally related to the development of obesity.

Now, where it gets a little murkier though is in the context that we're all here considering today which is the body composition fatness issue. And based on my review of those cross-sectional studies, it's not nearly as clear that heavier kids or fatter kids expend less energy in activity. They be less active in terms of gross movement, but, of course, they're heavier. And so when they move, they expend more energy in the process.

And that's where the whole relationship becomes a little less clear. And I think that at this point, or at least based on my last review of that literature, it is not as clear as we might like that -- that heavier kids expend less energy and activity, though they are probably less active.

Now, second issue is probably the one that we most likely -- would most like to be able to present compelling data concerning. And that is that we would like to know based on longitudinal -- prospective longitudinal observational studies, that kids that are more active are perhaps less likely to develop obesity in the future; or conversely, that -- that -- that may not happen, I mean, not to bias ourselves of what the outcome of those observations would be.

There are very few studies, unfortunately, in the literature at this point that address this critical issue. And I'm going to overview a couple of them for you because I think they really are most germane. So that the consideration here is if kids are more or less active, are they more or less likely to develop obesity in the future.

And with the credit to Ivo Brisanic at NHLDI who kind of lives in this world and helped me identify a few of these papers, I'll mention a couple of them.

One is Bob Clujis' paper from '95 in Pediatrics, presenting a longitudinal analysis here. They looked about 150 healthy pre-school kids; followed them from age three to five up to the point where they were in the first grade. And they did have an over-sampling of kids that were considered to be obese. Physical activity was rated by both parents. They looked at it at baseline and with two years of follow-up.

And the significant predictors of change in BMI over the two-year follow-up period in addition to age included baseline aerobic activity and change in what was called leisure time activity between years two and -- two and three. So this study did provide some evidence that activity-related variables measured in a limited way, which is often true in these studies, that those activity markers were associated with -- with weight gain in pre-school kids.

Another study in -- in young children based on the Framingham offspring study and again looked at pre-schoolers physical activity level and change in body fatness. They had better measures of activity in this study. And here they had about 100 kids, initially three to five years old; followed them through the first grade and assessed activity in this case by Caltrack.

Many of you know, but for those that don't, the -- the technology in this area is developing rapidly. And many of us are now using objective motion sensors, accelerometers, which can be attached to the belt and if appropriately calibrated are indicative of movement and -- and energy expenditure.

So they used one of the earlier versions of these accelerometers. The Caltrack in this particular study observed these kids twice a year for five-day periods. They also had some diet data. And they looked at triceps and BMI.

There was evidence in this study that activity associated with weight gain and that the active kids were observed to gain less weight. These are the data for triceps skin fold, less fat than was the case in the inactive kids. These differences were significant. And it was interesting that in -- after controlling for age, TV viewing, energy expenditure, baseline fatness and parental BMI, the inactive kids were almost four-times as likely as the -- as the active kids to show increasing triceps slope over the period of observation.

One more, and this is a study that I like a lot. And I wish there were more studies like this in the literature. This is called the Young Finns Study by Dakari and others, have published several papers based on this study. And what they did was, again, a longitudinal observation of -- of activity and looked at changes in fatness and other chronic -- physiological risk factors for chronic disease in Finland who were --

DR. WEINSIER: Excuse me. What was the journal on that, if I may ask?

DR. PATE: I think it's American Journal of Epidemiology, but I'll have to check. Methods in this study were that they drew the sample from a national population registry in Finland. They had about 1,000 kids who were 12, 15 and 18 years of age at baseline, and then they followed them up about -- over a period of three years. Activity was assessed by questionnaire.

Two groups were formed at baseline, based on their activity status. At that time, they were labeled active and sedentary, though I'll say now and have more to say about it in a minute, sedentary is rarely an accurate label in -- in kids. It's often an accurate label in adults, but rarely is that literally an appropriate label in young people. But that was the label that was used here.

And they did look at BMI and subscapular skin fold thickness as well as some other physiologic markers. And to sort of cut to the main conclusion here that bears on the issues today, data for males and females, sedentary versus active groups, and controlling for lots of things. Basically what they see is lower subscapular skin fold, lower triglycerides and a higher HDL to try to total cholesterol ratio.

In the males who tracked in the active group versus those that tracked in the sedentary group, females, some of the same relationships were observed, lower subscapular skin folds and lower triglycerides, although the HDL to total cholesterol ratio was not different across those two.

Now, I've just shown you what to my knowledge are most of the papers -- not all of them; there are a handful more -- that really have taken this prospective longitudinal approach to examining the issue of whether or not higher levels of activity prevent the development of obesity and some of the physiologic risk factors for chronic disease that are often associated with obesity.

Clearly, the available data are at least suggestive and encouraging, but the number of studies is clearly very limited.

Now, another area in which the literature though is a bit deeper has to do with small group experimental observations of the effects of exercise training on fatness and physiologic risk factors for chronic disease in overweight kids. Again, I'm not going to show data on this. I'll simply tell you what I think that literature shows.

It is that if you take kids who are overweight and systematically expose them to substantial increases in activity, there will be the expected changes in body fatness. And based on Bob Gootin's fairly recent studies in -- at Augusta Medical College of Georgia, I think there is reasonable expectation that physiologic risk factors, some of them, will get better when that happens.

Now, again, we don't have nearly as much evidence on all of this as we would like. Lynn Epstein has shown on multiple occasions that you can work closely with kids in a counseling session -- setting that includes their parents and produce increases in activity that appear to last for a period of some years.

But I think based on what we do know in this area, there is some experimental evidence that -- that in overweight kids, activity can -- can be somewhat effective.

Now, what I guess we would like to know, again, most from the standpoint of interventions is from the perspective public health interventions, can we be successful. And here I think, as Steve indicated, not only are we -- are we really beginning a new line of work -- he said it's about ten years old. It's probably ten years old in adults. It's from a public health intervention standpoint maybe not even that old in kids. So our knowledge is pretty limited.

But I'll mention one paper which suggests that maybe there is -- there is hope. And this is the Planet Health Project. Steve Gortmaker and colleagues published it just earlier this year. Looking at a school-based intervention, they had five intervention and five control schools. And it was a sizeable and ethnically diverse group of sixth and seventh graders.

And it was -- it was intervention that was implemented in the school setting, but it was focused on making changes in kids' behavior outside the school setting. And there was a substantial emphasis on decreasing TV viewing, as well as modifying dietary behaviors and generally increasing moderate and vigorous physical activity.

And the findings were encouraging in that the -- and they -- the outcome measure here was prevalence of obesity and -- and then remission of obesity. And essentially what you see is adjusted odds ratios indicating that in girls in particular, but also boys, to a not significant extent in the boys, that the intervention -- kids in the intervention group were less likely to be obese at the end of the project and that they were more likely to move from an obese to a non-obese status.

Now, why? And this is probably the most interesting finding in this study. And it really came down to reductions in TV viewing appeared to be the most salient intermediate change that was associated with change in body fatness.

Now, there are other school-based studies looking at promotion of activity in kids. I work in that area and I can tell you that the success stories are few. Probably the one area where we -- where we know we can be successful is in increasing physical activity in physical education classes.

And even getting that done is not easy. It takes, you know, a couple of years of working with school personnel and -- and teachers to make changes in the curriculum. But from an intervention standpoint, this -- this literature is pretty young.

Now, what do the experts think about physical activity behavior in kids; how active do we think kids should be; and what forms of activity should they engage in? Well, there are a number of documents which have addressed this issue. One of them would be Healthy People 2000 where objectives 1.3 and 1.4 both include -- both include young people. And 1.3 is the sort of moderate intensity guideline which says increase to 30 percent for the young people at age six and older; engaging regularly, preferably daily, in light and moderate physical activity for 30 minutes.

So if you took the word, "light", out of there, you would have something that's very similar to the CDC/ACSM recommendation which I'll have more to say about in a minute.

Now, the second guideline here that -- that also applies to younger people is the more traditional vigorous physical activity guideline calling for performance of activities that would develop and/or maintain cardiorespiratory fitness, three or more days per week for 20 or more minutes. Healthy People 2000 included two guidelines which have some considerable currency, though tweaking has gone on here in the last decade.

Steve mentioned the CDC/ACSM guideline which has been essentially gratified by the NIH consensus conference and the -- and the Surgeon General's report, as well as other documents, not only in our country, but in a number of countries around the world.

I would -- I put this up this morning only to point out that when -- when we developed this guideline, it -- it was very intentional that the word, "adult", was included in it because that project really was not intended to consider what may be the special needs of young people.

But there have bene productive studies that have been designed to address what that -- those specific needs of young people. One was organized by Jim Salis and colleagues in San Diego, and was focused on adolescents. It produced two guidelines or recommendations.

The first one was rather nonspecific and it essentially said that adolescents should be active daily or nearly every day as a part of their lifestyle. And then there was sort of along trail of settings in which kids could be active: transportation, sport, PE classes, after- school jobs and so on. But no specific number of minutes was included.

Now, when this guideline has been operationalized in subsequent studies, it has often been operationalized as a 30-minute guideline. But the consensus group didn't actually specify that.

The second guideline is a lot like Healthy People 2000, objective 1.4. And it says that adolescents should engage in three or more sessions of exercise per week that lasts for 20 or more minutes and that require moderate to vigorous levels of exertion. That's pretty much the traditional exercise prescription recommendation.

Now, a fair amount of though has gone on though in the -- in the interim. And the Health Education Authority in England convened about two years ago a conference. And a number of us from the U.S. were involved in this. And I'm going to tell you that I think this is the approach that lot of consideration should be given to.

It is that the guideline might reference the fact that all young people should participate in physical activity of at least moderate intensity of one hour per day. Now, let me tell you were that came from. There is -- there is a concern that 30 minutes is just not enough in kids. And I'll show you part of the reason why in just a minute.

Not that 30 minutes wouldn't be fine, and the next guideline addresses that. It basically says for kids that are currently doing little, 30 minutes is recommended; but that it would preferable that a standard of one hour per day be met.

And then the third guideline is intended to address the fact that cardiorespiratory or aerobic-type activity, as important as it is, is likely not the only form of activity that is important for young people. And of course, there are increasing concerns about bone health and the fact that we have an enormous osteoporosis problem on our hands, and that -- that early in life is when we lay down bone; so that maybe we need to be focusing on musculoskeletal health in our guidelines for young people.

And so this -- this additional component was added. And it says that at least twice a week, some of the activities performed that meet these standards should help to enhance and maintain muscular strength and flexibility.

Now, where are our kids? Well, I wish -- I wish we knew more about this than we do. But we do know something. The YRBS, the Youth Risk Behavior Surveillance System, which involves completion of a self-report survey by high school kids, a national probability sample of high school kids in the United States on odd-numbered years does survey physical activity.

Frankly, the moderate -- the question that is intended to get at moderate intensity activity I think does not do that very well. And so I am not going to show you those data. It's not an easy thing to do. I'm not being critical of the folks that put these surveys together. And I've participated in some of those conversations.

But it probably is a little easier to get at vigorous activity. And so I'll show you what these data show. And these are data for ninth through twelfth graders. The darker bars are -- are for the girls and the lighter bars are for boys. And this is the percent needing a vigorous physical activity, 20 minutes or more, three or more days per week standard.

And what you can see is there is a rather consistent gender difference and decline in the percentage meeting the standard across those high school grades; but that quite a sizeable percentage of particularly boys and in the younger ages, girls report meeting that standard.

Do they really? I don't think so. And it's not that I think they're lying to us. It's that I think that the way maybe people in general, but kids specifically process questions of this sort, that I think there is reason to question whether literally the self-reported data that we get in surveys like YRBS is accurate.

And I have been involved the last few years with a collaborative group that has been using objective activity monitors on -- on larger groups of kids than have been studied previously. And in this study where -- well, it's a hundred kids in each of these four grade categories, going from first in the primary grades on up to the high school grades, equally split between boys and girls in Amherst, Massachusetts were activity monitors for a week.

And what's reported here is the median number of activity minutes. And this is anything above three mets., moderate intensity activity, on up looking at minutes per day. And what you see is a precipitous decline across those -- across that age.

A lot of kids, a lot of young kids would probably meet about any reasonable standard. But when you get out here to the high school age and middle school and high school age, very sizeable percentages of them do not meet it, certainly in our standard if we went with the 60 minute standard and significant percentages of them don't meet a 30-minute standard either.

I'm not going to show you this morning, but we also have -- have examined those data for bouts of activity. And all I can tell you is it's a myth. Kids, particularly in the older age groups, just do not spontaneously perform 20 minutes of vigorous activity. I mean, we've scanned these one-week accelerometer data every way there is to scan them. And it's -- it's just not there. I mean, the -- the percentage of kids that do that sort of thing with any frequency is -- is just dramatically low.

Now, I'll finish by saying that I have on more than one occasion tried to pull all this together and in the context of that San Diego conference that I mentioned a bit ago did do that, trying to look at those two guidelines from that meeting, one which was operationalized as 30 minutes of moderate to vigorous physical activity; went back to the National Children and Young Fitness Study from the mid-'80s which is a study that, since I have an important group of people here today, I'll say I think we need to replicate about once a decade. And we missed it in the '90s. So I hope we'll -- I hope we'll come back and try to get this done again before too long.

But based on the activity reports in the National Children and Youth Fitness Study from the -- from the mid- '80s, about 84 percent would have met a 30-minute standard, but it would be a considerably smaller percentage that would meet a 60-minute standard.

And Guideline 2 from the San Diego recommendation was the more structured, vigorous approach. And there, depending on age, about 62 to 70 percent of the males based on YRBS reports would have made it. A considerably smaller percentage, probably less than 50 percent of girls would meet that standard.

So where does that bring us? Well, I think that with all acknowledgement of the fact that our knowledge base concerning physical activity and its relationship to obesity and associated physiologic risk factors for chronic disease being less extensive than we would like it to be, I would nonetheless encourage you to -- to proceed with the development of a physical activity guideline, to include young people in that guideline, and to consider an application of that guideline to young people that would acknowledge the fact that they probably need more activity than is -- is currently being recommended in public health guidelines for adults in the United States. And I will be happy to try and respond to questions.

DR. GARZA: Any questions? Rachel?

DR. JOHNSON: Thank you very much for a great presentation. One quick question. Could you make sure we get the citation for those recommendations from the England --

DR. PATE: Yes, I will.

DR. JOHNSON: -- conference that you talked about?

DR. PATE: Yes.

DR. JOHNSON: And my other question is, as -- as you well know and showed, most of the research when you look at sedentary activity emphasizes television watching. And there is some supposition that it's more than just the TV watching. It's the ads for various types of food products. It's the fact that kids might be eating while they're watching television.

DR. PATE: Yes.

DR. JOHNSON: That even worsens that effect of television watching. We've sort of had the issue about whether we can extend the findings from television watching to time that children are spending in other very sedentary activities like computer games or video games. Are you comfortable with us making that connection because I'm not sure that the research has really kept up with the technology of how kids are spending their time?

DR. PATE: Yes, it hasn't. Yes, I have tried to keep up with that literature concerning TV watching, physical activity, and -- and body fatness measures. And my reading of that literature is that the associations between TV watching and fatness are tighter than the associations between physical activity and fatness. And of course the point you raise is often drawn in, and that is that TV watching may not only be an inactive pursuit, but one which either directly or indirectly impacts eating behavior, as well. And that's -- strikes me as a rational thought.

However, I think part of the problem with this may be that our measures of physical activity have traditionally been quite limited. And I'm not quite ready to conclude that in fact the TV watching fatness association is more powerful than the physical activity fatness association. I think we've got to do the studies using the more objective measures of activity before we firm that conclusion up.

Now --

DR. JOHNSON: I guess, you know, to ask you to bottom line it, would you feel comfortable with the recommendations that said limit the amount of time you spend watching TV, playing computer games, video games? I mean, would you feel comfortable --

DR. PATE: Yes.

DR. JOHNSON: -- linking those?

DR. PATE: Yes, I would.


DR. PATE: And I would suggest that we do that. The rationale for that is probably not as -- something that we can document as extensively as we would like to. But, yes. And I think that the literature is growing. And of course the study that I cited here, the Gortmaker paper, is -- is the most encouraging one from an intervention standpoint that -- that's -- that's come into the literature so far.

DR. JOHNSON: Thank you.

DR. GARZA: Alice?

DR. LICHTENSTEIN: I'm interested in what your thoughts are on the determinants of activity. And is inactivity sort of the default mechanism? Because, you know, you showed a relationship between activity, let's say, and age, that it goes down with age. Well, if you think of an elementary school, recess time comes and there is suddenly a burst of activity when those kids are out. There is an opportunity for them to engage in active play.

You know, you presented data on level of activity among children, but we know that there are a lot of subgroups. If you live in a community where there is a girls soccer program starting in first grade, there is going to be a lot more physical activity associated with that group.

So, a) do you think that inactivity is sort of the default mechanism when there aren't other opportunities? And what are the major determinants that we should really be focusing on or maybe encouraging the development of in the guideline?

DR. PATE: Yes. The strongest predictors of activity in kids are -- are the demographic variables, age and gender, ethnicity, at least in some data sets. There has been a lot of focus over the last decade on psychosocial variables. Sort of health behavior models have been applied to these studies.

The -- I think the bottom line is there are a number of these variables that with some considerable consistency across studies do either cross-sectionally associate with or predict future physical activity variable -- behavior. Of all of those variables, the one that I believe most consistently and powerfully associates with and/or predicts activity is something that we call physical activity self-efficacy which basically comes down to a person's sense of confidence or competence in their ability to enjoyably engage in physical activity.

And a number of the intervention studies including those that we're working on now are focusing on trying to enhance physical activity self-efficacy on the premise that that's an important intermediate to behavior.

Now, having said that, I believe that -- that this work is now moving on from largely a focus on -- on this set of psychosocial variables that we think are important to social and environmental interventions. My personal belief is that kids -- not only kids probably -- but kids in particular are very reactive, responsive to the environment in which they find themselves, both from a social and physical environmental perspective.

Tom Verinowski's studies on young kids show, from the SCAN study some years, show that the strongest predictor of activity in that group of young kids was whether they were inside or outside. If they were outside, they were much more likely to be active than if they were inside.

So I think we -- we -- we now need a round of studies that really are carefully looking at social and physical environmental factors. I'm interested in day care centers and after-care centers; and is there a TV; is it turned on, you know, that -- that sort of thing as -- as potentially associated with activity. Not many of those studies have been done yet.

Jim Salis in San Diego has done some of that showing that the proximity of green spaces and parks and so on does -- does seem to have an impact on activity.

DR. LICHTENSTEIN: But is there enough data in the guideline to say that there should be more opportunity for children to engage in physical activity because that is a determinant of physical activity, I mean, you know, for the guideline now as opposed to what data is going to be collected in the future?

DR. PATE: I think there is sufficient data in the literature to -- to support the -- a comment on the self- efficacy piece. I think that's reasonably consistent and I think most that work in this area would be comfortable with that.

I don't think so yet on the -- on the physical and social environmental factors. I think that that's where this work is heading. But I wish we --

DR. GARZA: It's 10:45. I'm going to ask for you to please focus your questions. Otherwise, we're going to fall behind as we did at our last committee meeting. I - - I don't know whether it was -- Johanna, do you have a question before I move?


DR. DECKELBAUM: Just one quick question. The issue about whether this is -- we're putting this in because it's linked to nutrition and weight reduction versus the benefits of exercise as Steve pointed out in his previous presentation. What is your view on that? And then maybe I could comment on my view just briefly? Well, maybe I'll just say that real quickly.

DR. PATE: I'm not sure I understand the question.

DR. DECKELBAUM: Okay. Well, whether we would put in a recommendation about exercise because it is a way to control obesity or whether there is a health benefit from it that's for all people unrelated to obesity. I guess that's --

DR. PATE: And, of course, in my case here, the issue is kids. And, of course, it's even more complicated. I -- I agree with something that Steve said. And that is the long-term tracking data are not terribly impressive; meaning if you look at activity behavior performed early in life, to the extent that this has been studied, it's not yet very clear that that impacts health outcomes later in life.

And the chronic disease outcomes that we're perhaps most concerned about don't manifest in childhood from a clinical perspective. And so it's difficult to -- to address these issues. We don't have the long-term prospective studies that would allow you to follow this from childhood on into adulthood to really nail that question down.

However, I will say that those of us that work with -- with kids and think about these kinds of things a lot -- this may -- this may be circular reasoning, but it goes like this. If -- if kids are this active -- and I've shown you some of the data that we have on how active they tend to be. And it's highly variable, a lot of -- a lot of variability.

And if, however, the -- the obesity rates are on the increase, and if you believe that activity almost has to be a factor in this -- in this increasing prevalence of obesity, then it would appear important to -- to consider activity in young people in the context of developing guidelines that would be intended to address this obesity problem.

DR. GARZA: Roland?

DR. WEINSIER: Yes, in trying to develop this guideline and think through the description of the type of activity, going back to the resistance/restraint training versus the aerobic, it seems to me that since 1965, there are about 33 national recommendations of which less than about 16 percent even address, you know, us making a recommendation with regard to strength or resistance training.

You're saying here that Jim Salis made a recommendation that it should include at least twice a week musculoskeletal strength and flexibility activities. So is this important that it should be included or we don't have enough data and that's why other recommendations don't include it?

DR. PATE: The experimental literature in young people looking at the effects of controlled exercise do provide some support for that recommendation. But I cannot tell you that at this point, we have compelling evidence to link performance of resistance exercise during childhood or adolescents to, let's say, bone health, you know, decades later. I'm not aware of evidence to support that.

Now, at this point, given the limitations in the literature, the thought process has been we certainly know from other studies that the development of bone and bone density and so on occurs early in life and that because bone density declines more or less steadily beyond early -- the ages of early adulthood, and since there is some evidence from the experimental literature that activity performed early in life can impact skeletal development, that it's early but may not too early to be saying something about the performance of resistance activity and the kinds of activity which are most likely to impact the development of bone.

DR. GARZA: Please, Dr. Pate, setting aside then the osteoporosis and obesity issues --

DR. PATE: Yes.

DR. GARZA: -- the other health benefits that we learned about in terms of physical activity in adults suggests that physical activity may also be important in children, but only if there is a significant behavioral carry-over.

Am I correct in concluding that in fact there is preliminary data that relates to self-efficacy, but no strong data that links physical activity patterns in children to sustained behaviors in adulthood that relate to physical activity?

DR. PATE: Yes.

DR. GARZA: But that's in absence of data. There's not -- or is it actually data that supports the idea that there is no connection? I mean, that was the sense that I got from Dr. Blair; that when people had looked at this, they had not found it.

DR. PATE: No. The -- the data sets that are available in which you might look at this are very limited. And, no, it's -- it's not that we know that those associations don't exist. It's that they have not been demonstrated at this point.

Now, I'm not -- I'm not here to argue that I'm absolutely positive that there is a powerful tracking of activity behavior early in life to activity behavior later in life. But I think it's too early to reject the hypothesis that that tracking may exist.

DR. GARZA: Okay. Then we're going to take a break. We'll be back by 11:00. How is that for optimism, all right?

(Whereupon, a brief recess was taken.)

DR. GARZA: Okay. We have a few committee members missing, but we're going to get started without them. Otherwise, we won't -- we won't get through the material we need to get through by 12:00 on Friday.

We're very pleased to have Dr. Ludwig, our next speaker, from Harvard University in Cambridge. He is going to help the committee wrestle with some of the issues on glycemic indexes and health disease relationships related to the glycemic index. We have another speaker tomorrow who will be addressing similar problems. We couldn't schedule them both on the same day. So this is the first half of a two-part presentation, one by Dr. Ludwig and the second by Dr. Sunyer from Colombia.

Dr. Ludwig, thank you very much for joining us.

DR. LUDWIG: Thank you, Dr. Garza and committee members, for inviting me to speak about glycemic index and human nutrition. It's a -- a great pleasure to be here today.

I would like to begin by discussing issues regarding the background of glycemic index, what is it, how is it defined, what studies have been done in general; and then focus on how glycemic index may affect obesity, cardiovascular disease and diabetes mellitus; and then conclude by a consideration of the significance of this to current nutritional recommendations.

As far back as the early 1900s, carbohydrate was thought to differ primarily according to chain length based on some classic studies of Allen involving dogs. Official recognition for this, the distinction between simple sugars and complex carbohydrate, was given in 1977. And current nutritional guidelines provide at least tacit endorsement for this distinction between simple sugars and complex carbohydrates.

Recently, however, the biologic significance of saccharide chain length has been questioned. Wahlquist and colleagues showed that consumption of glucose as a monosaccharide, oligosaccharide or polysaccharide -- in other words, starch -- produced similar changes in blood glucose and insulin levels.

Bantle in the New England Journal of Medicine in a classic paper 15 years ago showed no significant differences in blood glucose response to meals with sucrose, compared to meals with wheat among normal and diabetic subjects.

And in a recent rather provocative study, Rickard and colleagues demonstrated actually improved glycemic control in subjects with Type I diabetes after iso-caloric substitution of sucrose for starch.

A potentially more physiologic basis for characterizing carbohydrate is the glycemic index. Glycemic index was proposed by Jenkins and colleagues in 1981 as a measure of the rate of absorption of carbohydrate after a meal. It's affected by a variety of dietary factors that in any way alter gastric emptying, intestinal tract activity, or the rates of nutrient digestion and absorption.

It's affected by, for example, macronutrient composition in that protein and fat delay gastric emptying. Fiber content, fiber has a very important role in forming an emulsion in the small intestines, particularly soluble fiber, that serves as a mechanical barrier for the diffusion of glucose through the intestinal wall, and therefore delaying rise in blood sugar. And food form and method of food preparation also affect digestion, primarily through mechanical properties.

There are currently over 200 scientific articles on the subject in the world's literature. And the glycemic index of most commonly consumed carbohydrate-containing foods have been determined and reported.

Glycemic index is actually defined as the area under the glucose response curve after 50 grams carbohydrate consumption from a test food, divided by the area under the curve after 50 grams carbohydrate from a controlled food, generally white bread or glucose.

We find grain products in potato are very rapidly hydrolyzed into glucose in the digestive tract. In fact, in the refined form, there is essentially no rate limitation to this process. And, therefore, these substances have a very high glycemic index.

As suggested by the study by Rickard, many refined grain products, especially white bread and others, have a higher glycemic index than table sugar because sucrose is -- 50 percent of its constitute of saccharide structure is fructose. Fructose needs to go to the liver and -- to be metabolically transformed into glucose through a rather slow process. Fruits, vegetables and legumes, by contrast, have a low glycemic index.

Glycemic index has previously been shown to affect appetite in a number of single-meal studies. For example, addition in this Appetite 1988 paper -- addition of a low glycemic index, starch, bean flakes to a test meal delayed return of hunger and request for food in comparison to addition to -- addition of a glycemic index starch, potato, to the same meal.

In fact, 15 of 16 studies published to date show beneficial effects of glycemic index on either appetite, hunger or voluntary food intake, though it should be pointed out -- and I would like to emphasize -- that some of these studies do not control for macronutrient ratio, energy density, palatability or other potentially confounding dietary properties.

To further explore the issue of glycemic index and appetite regulation, we conducted a cross-over study looking at the effects of three different meals containing identical energy, but differing in glycemic index. The low glycemic index meal was a vegetable omelette with fruit. The high glycemic index meal, instant oatmeal with milk and sugar. And for the medium glycemic index meal, we used steel cut oats, a -- an old-fashion preparatory method that maintains the structure of the oat kernel intact, thereby lowering the -- slowing the rates of digestion and lowering glycemic index.

I would like to point out that the medium and high glycemic index meals were controlled for macronutrient composition, energy density, and in fact contained virtually identical foods, whereas the low glycemic index meal differed in many ways and was there to demonstrate the maximum effect that could be attained by using all dietary properties available to modify glycemic index.

And all meals -- just to emphasize, all meals for all subjects were isocaloric and determined as 18.5 percent of resting metabolic rate.

The subjects for the study were obese teenage boys, at least 120 percent of ideal body weight, but otherwise in good health. Each subject was studied three times in this cross-over design in the Clinical Research Center according to this protocol, admitted to the CRC in the evening, given a standard dinner, bedtime snack.

And then in the morning, an intravenous line was placed and one of these three meals was administered. For the next five hours, blood was obtained every 30 minutes for determination of hormones and metabolic fuels.

At lunch, the intravenous line was removed. A second meal identical to the breakfast meal was given. And then the subjects were told to request a large ad-lib test meal platter if and when they got very hungry.

They were encouraged to eat as much or as little as they wanted from these platters to feel satisfied. At the end of the afternoon, the amount of food remaining on the platters were quantitated for assessment of voluntary energy intake.

This slide depicts the change in blood glucose and fatty acids after the three test breakfasts. As expected, blood glucose was highest after the high glycemic index meal compared to the medium or the low. The ratio of areas under the curve here was four to two to one.

Note that at four and five hours after the high glycemic index meal, there was a relative hypoglycemia which amounted to ten milligrams per deciliter and significant at the 0.02 level in comparison with the other two meals.

Fatty acids were suppressed to a greater degree after the high glycemic index meal than after the other two meals. And thus the concentration of the two major metabolic fuels, glucose and fatty acids, were lowest after the high glycemic index meal, even though all three meals provided identical amounts of energy at T equals zero.

These changes in blood glucose and fatty acids can be understood by considering the secretion dynamics of insulin and glucagon. Insulin levels were highest after the high glycemic index meal owing to the rapid influx of glucose. And glucagon was suppressed after this meal.

The combination of high insulin and low glucagon would together promote uptake of glucose in muscle and in liver, suppress or inhibit release of glucose from the liver, and also inhibit the release of fatty acids from fat cells.

So after the nutrients of a high glycemic index meal have been absorbed from the gastrointestinal tract, glucose and fatty acids are low because the body has difficulty accessing its stored fuels under these hormonal influences.

The physiologic significance of these biochemical changes can be seen by examining the counter-regulatory hormones, epinephrine and growth hormone. After the low and medium glycemic index meal, epinephrine remained essentially flat for five hours, but surged after the high glycemic index meal, indicating that the body is truly under a metabolic stress. And similar changes were found with growth hormone.

This slide depicts the voluntary food intake after the three test meals in the afternoon. Subjects ate 53 percent more after the high compared to the medium glycemic index meal, and 81 percent more after the high compared to the low glycemic index meal, both comparisons statistically significant.

So in summary, from this first study, high glycemic index meals are associated with elevated insulin and suppressed glucagon levels, lower post-absorptive blood glucose and fatty acids; and a stress response in the post- absorptive period. There was also increased hunger. I didn't show you the hunger scale, but I did show you increased voluntary food intake.

Now, this study and others that I described at the beginning of the talk examine the short-term effects of glycemic index on energy balance. However, in the field of obesity, a central concept is that body weight may be regulated around a -- at least a set point or if not a set point, a set range, a concept that is based on several observations.

First and importantly, the very poor long-term outcome of conventional energy-restricted diets according to this NIH consensus statement several years ago, and also that under and over-feeding induce a sequence of metabolic adaptations that defend against further weight loss.

In a classic article by Leibel in the New England Journal of Medicine a few years ago, the team underfed either lean or obese subjects to obtain a ten percent decrease in baseline weight. And they found that as a result of that underfeeding, resting metabolic rate was suppressed by ten to 15 percent.

This body weight set point or set range is believed to have substantial genetic contributions, as evidenced by concordance in BMI among identical twins raised apart, and also the fact that many genes have recently been identified that affect body weight on a chronic basis.

Nevertheless,l environmental factors must also affect body weight regulation as simply demonstrated by the rising prevalence rates of obesity amongst genetically stable populations. This line of argument leads to the hypothesis that dietary composition influences the physiologic adaptations to energy restriction.

To test the study, we conducted a randomized cross-over study looking at the effects of high and low glycemic index energy-restricted diets. The diets were 50 percent of total -- predicted total energy expenditure, controlled for energy density and fiber content. However, they did differ in macronutrient composition -- we'll come back to this point -- in order to achieve maximal differences in glycemic index. And that will affect to some degree the interpretations we can make from this.

Outcomes were arresting energy expenditure, fasting serum leptin levels, nitrogen balance and voluntary food intake. And this is just to summarize the protocol. The subjects were admitted for a brief baseline evaluation and then randomized to receive one of the two energy- restricted diets for six days; and then were allowed to -- to eat ad-lib and at the end of the energy restriction, but re-examined on the high or low glycemic index diets.

As expected from the fact that the two diets provided identical amounts of energy, weight loss did not differ significantly over the six days of energy deprivation between the dietary treatments. However, serum leptin level was significantly different between the two treatments from day two onward.

Resting energy expenditure decreased by the expected ten percent on the high glycemic index diet, but decreased by less than half as much, 4.5 percent, on the low glycemic index diet, a difference which achieved statistical significance at the end of the evaluation.

Nitrogen balance was negative on the high glycemic index diet, but positive on the low glycemic index diet, approaching statistical significance. And this should actually read, "Nitrogen balance in milligrams per kilogram per day." Consistent with the single day studies, voluntary energy intake after energy restriction was higher after the high compared to the low glycemic index diets.

And in conclusion from this study, diets with identical energy content may affect leptin levels differently compared to a high glycemic index diet in accord with current nutritional guidelines in that it was a low fat, grain-based diet. The low glycemic index diet employed here showed beneficial effects on energy expenditure, nitrogen balance and voluntary food intake.

Now, because the diets differed in macronutrient composition in order to achieve substantial differences in glycemic index, the effects seen cannot be definitively attributed to glycemic index alone.

Nevertheless, the study I believe argues that the physiologic adaptations to energy restriction can be influenced by dietary composition. And these results are potentially also attributable to glycemic index, as well require further investigation.

This brings us to I think the central question which is does glycemic index affect body weight regulation over the long-term. To date there are, unfortunately, no randomized controlled perspective clinical trials of a low glycemic index diet and the treatment of or prevention of obesity.

Nevertheless, I believe that there is substantial theoretic basis for believing such an effect may exist. High glycemic index diets, as has been demonstrated here and is quite clear that this happens, elicits higher insulin levels than low glycemic index diets. This relative hyperinsulinemia on a high glycemic index diet may predispose to weight gain. This contention is supported by a variety of lines of investigation.

Amongst animal studies, prior insulin treatment of normal rats stimulates glucose uptake in the fat, but not i the muscle; increases food intake; and promotes weight gain. Turning now to human studies, individuals with the greatest intravenous -- with the greatest insulin response to IV glucose prospectively gain the most weight.

Fasting hyperinsulinemia also predicts weight gain in Pima Indian children. And as is becoming I think abundantly clear in the literature in the last few years, excessive weight gain is a complication of insulin treatment of Type II diabetes and also, for that matter, intensive insulin treatment for Type I diabetes as seen in the DCCT.

And then finally, returning to animal studies and looking specifically at glycemic index -- high glycemic index starch consumption compared to low glycemic index starch consumption resulted in increased fatty acid synthase activity, increased adipocyte size, and increased glucose incorporation in total lipids in rats.

Several studies suggest that glycemic index -- low glycemic index diet may be beneficial for certain cardiovascular disease risk factors and perhaps myocardial infarction rate itself.

The first study in this area was published by Jenkins and colleagues in 1987. They conducted a two-week cross-over study involving six healthy men. The diets were higher low glycemic index, identical in energy, macronutrients and fiber. The meals were prepared in a dietary kitchen. And importantly, there was no change in body weight during either treatment.

They found that C-peptide excretion, a measure of integrated insulin levels, was lower on the low glycemic index diet than on the high glycemic index diet, quite a -- I think an impressive difference.

Total cholesterol and fructosamine -- fructosamine being an integrated measure of blood glucose levels -- decreased significantly only on the low glycemic index diet, not on the high glycemic index diet.

And the effects of glycemic index in subjects with hyperlipidemia were examined in a one-month uncontrolled study with 30 subjects. The intervention consisted of substitution of low glycemic index for high glycemic index foods without change in energy content, macronutrients or fiber. The meals were prepared at home according to standard recipes. And I think it would be very important to note that in this uncontrolled study, body weight change during treatment was minimal -- was minimal.

They found that total cholesterol decreased by 7.7 percent, LDL cholesterol by 8.5 percent and triglycerides by 15.3 percent, whereas there was no deterioration in HDL cholesterol.

Recently, Jarvy examined 20 patients with Type II diabetes in a one-month cross-over study. The diets were similar in energy, macronutrients and fiber, but differed in glycemic index. The meals were prepared in a diet kitchen and there was some weight change on treatments, about 1.5 kilograms over the month. But the change happened to be identical between treatment groups allowing for a fair comparison.

They found that plasminogen activator inhibitor 1 activity decreased by over 50 percent on the low glycemic index diet, but did not change on the high glycemic index diet. PI-1 is a newly identified cardiovascular disease risk factor that may relate to abnormal fibrinolysis and atheroma formation.

They also note that total cholesterol, HDL cholesterol and fructosamine were significantly lower on the low compared to the high glycemic index diet.

Two large epidemiologic studies have examined the relationship between glycemic index and cardiovascular disease. In a survey of British adults initially performed in '86 and '87, 1,420 adults were examined in a cross- sectional analysis. Their diets were determined by a seven- day food diary. The data were controlled for age, sex, BMI and a variety of other cardiovascular disease risk factors.

They found that glycemic index was the only dietary component associated with HDL cholesterol in both men and in women. No other dietary factor including total or saturated fat was seen in this epidemiologic analysis to have any predictive effect.

In the Nurses Health Study, 75,000 women were examined prospectively over ten years. Diet was assessed by a food frequency questionnaire. Data again were controlled for age, smoking and other coronary risk factors. They found that individuals in the highest quintile of glycemic load, here defined as glycemic index times the amount of carbohydrate in the diet in percent -- individuals in this highest quintile of glycemic load had a two-fold higher greater relative risk of myocardial infarction compared to those in the lowest quintile.

Now, this result certainly seems quite intriguing. But I will point out that it's present only in abstract form. The full report has yet to be published and is subject to the attendant peer review process.

Two epidemiologic studies suggest a connection between glycemic index and risk for Type II diabetes mellitus. In the Nurses Health Study, 65,000 women were followed prospectively over six years; diet again assessed by a food frequency questionnaire. And in light of earlier presentations, it's important to note that the data were controlled not only for BMI, but also for physical activity and other risk factors for diabetes.

They found a 37 percent increased risk of Type II diabetes in the highest quintile of glycemic index, here glycemic index rather than glycemic load, compared to those in the lowest quintile. And virtually identical results were found in the Health Professionals Follow-up Study.

Use of glycemic index in the treatment of diabetes has been very controversial. A number of studies over the past two decades have shown improvements in blood glucose, glycosylated hemoglobin, fructosamine and C-peptide excretion on low compared to high glycemic index diets.

Nevertheless, the clinical significance and practical applicability of these findings have been hotly contended by other authors. And I just point out the titles of some of these articles to indicate the ardor with which this argument has been waged in the literature.

Currently, the American Diabetes Association does not recognize a role for glycemic index in the treatment of diabetes mellitus. However, a number of diabetes organizations outside the United States do recognize a role for this factor.

In summary, a substantial body of research suggests that glycemic index may affect several chronic diseases in the United States, though I think I would have to say that the data to date falls short of proof. Regarding obesity and body weight regulation, possible mechanisms may include decrease in the insulin to glucagon ratio, increase in the concentration of metabolic fuels, and thus better control of hunger and appetite.

Fifteen of 16 short-term studies show beneficial effects of glycemic index in this regard. Nevertheless, these studies can have difficulty in controlling for other dietary factors such as macronutrients, fiber and -- and food form and the like because many of these factors are intimately related to the determination of glycemic index.

And most importantly, there are currently no long- term randomized control prospective clinical trials of a low glycemic index diet and the treatment or prevention of obesity.

Regarding cardiovascular disease, possible mechanisms I think importantly include reductions in hyperinsulinemia which I think is becoming increasingly well documented to be an independent risk factor for cardiovascular disease thought central in the etiology of the metabolic syndrome, or syndrome X.

A handful of studies have demonstrated beneficial effects on lipids, fibrinolysis and possibly risk factor for myocardial infarction itself -- possibly for myocardial infarction itself, though the total study number is small. Some of these studies have few subjects. And again, there were no long-term clinical intervention studies.

Diabetes prevention, glycemic -- low glycemic index diets may operate by a -- in effect, a beta cell rest mechanism and increased insulin sensitivity. Blood sugar -- blood sugar rises markedly less high after a low glycemic index diet. Therefore, there is less secretory demand placed on the beta cells. And there -- there are in fact some clinical trials designed to prevent the progression of Type I diabetes through this similar sort of mechanism, by providing insulin and helping to allow the beta cells to rest.

Two major epidemiologic analyses show protection by low glycemic index diets. These studies being epidemiologic in nature may be confounded by uncontrolled variables and, importantly again, no long-term interventional studies have bene conducted.

Finally, regarding diabetes treatment, protective mechanisms may involve decreased glycemic excursion around the meals and increased insulin sensitivity. A majority of the studies show some sort of clinical benefit. But the area is hotly contended.

So finally, I would like to consider the implications of glycemic index to nutritional policy. Current dietary guidelines recommend the consumption of a grain-based, low fat diet. And in fact, dietary fat has decreased, at least in percentage of total energy, from 42 percent to 34 percent since the 1960s. And because these two macronutrients are so intimately linked, there has been a well documented compensatory increase in dietary carbohydrate during this time.

Unfortunately, most of the carbohydrate that is being consumed in increasing amounts are very high in glycemic index. According to data from the continuing survey of food intake by individuals, these are the top 20 sources of dietary carbohydrate for children ages two to 18 in the United States.

Actually, perhaps ice cream here should be in -- in red here. But most of these items in white have a glycemic index equal to or greater than table sugar. Perhaps an over-emphasis on dietary fat without sufficient attention to the quality of carbohydrate in the American diet may have paradoxically contributed to the rising prevalence rates of obesity, Type II diabetes, and certain cardiovascular disease risk factors in the United States.

And in my last slide, I would like to present what might be an alternative low glycemic index pyramid that would include fruits and vegetables at the base, consumed in abundant quantities. These foods are not only low glycemic index, with a few exceptions. Banana is a notable exception here. Corn, beets and carrots are exceptions here; and of course, potatoes.

But most of these are quite -- not only quite low in glycemic index, but they also have the added benefit of being very low in energy density compared to the current pyramid base.

There would also be moderate intake of protein and healthful oils. These items would help lower the glycemic index of the diet. There would be moderate -- modest intake of unrefined grain products and pasta. Pasta is unique amongst the refined grain products in having a -- a relatively lower reduced glycemic index. And there would be also substantial reductions in the intake of refined grains, potato and concentrated sugars. Thank you very much for your attention.

DR. GARZA: Thank you very much. I have difficulty getting this thing on.

DR. MURPHY: Thank you for a very interesting presentation. Can you help me understand a little bit better the role of macronutrients on glycemic index? For example, are -- if all else is equal, are higher fat foods lower glycemic index than low fat foods?

DR. LUDWIG: I want to preface my remark by saying I'm not encouraging a very high fat diet. But, yes, glycemic index is -- or the glycemic load, which I think is a useful concept that actually Walter Roet proposes, really represents the primary stimulus for raising insulin levels. And insulin is this extraordinarily potent substance that can probably shift the metabolism toward anabolism.

So glycemic load is a product of the glycemic index of the individual foods times the total amount of carbohydrate. So as dietary fat -- dietary fat decreases, all things being equal, glycemic load will increase. And as is not necessarily the case, but unfortunately the case, as dietary fat intake is reduced, those calories are replaced not with fruits and vegetables, but refined starchy foods and sugars. And so there is a pretty good relationship between -- an inverse relationship between dietary fat and glycemic load.

DR. MURPHY: And so, for example, are french fries compared to plain potatoes a more desirable food if you're looking at glycemic index?

DR. LUDWIG: The presence of fat in the french fry would tend to lower the glycemic index a bit, yes.

DR. MURPHY: Thank you.

DR. LUDWIG: It would still be a high glycemic index food probably.

DR. GARZA: Scott?

DR. GRUNDY: What is your major -- what are the major dangers of this having a hyperglycemic, hyperinsulinemic excursion after glycemic -- glycemic index? Do you think that that is on a long-term basis sustained over a period of time where it has a detrimental effect on development of diabetes or cardiovascular disease? Is that your major point?

DR. LUDWIG: Well, I think a number of short-term interventional studies and long-term epidemiologic studies suggest a relationship, although I do again emphasize that the critical long-term interventional studies haven't been done. But, yes, I think that the -- if one eats a high glycemic index diet day-after-day, insulin levels will remain in an integrated fashion high day-after-day.

What are the implications of that to both weight gain, diabetes and cardiovascular disease I think is the key question. And if I may digress just slightly, hyperinsulinemia or insulin sensitivity may be one of the unifying factors between diet and exercise. Controlling for BMI, those who exercise the most have significantly lower insulin levels, higher insulin sensitivity. And that -- that may operate through similar pathways.

And maybe one final comment on the point. I think frequently people in the field of insulin and energy homeostasis look at global insulin resistance. That may be an over-simplified concept. I think what may be key, as demonstrated by the study by Cousin, and the rats were given insulin and then became not only more obese, but had differential insulin sensitivity.

The key issue may be what is the insulin sensitivity in fat versus the insulin sensitivity in muscle. When muscle is sensitive to insulin, good things happen. When fat is sensitive, then it tends to promote differentiation, increase lipoprotein like these activities, increase uptake of fatty acids and resistance to the release of fatty acids which is ultimately the final common pathway for decreasing obesity.

DR. GARZA: Any questions over here? Meir?

DR. STAMPFER: I just wanted to pursue the questions that Suzanne raised. Wouldn't it be possible though -- I mean, you noted that there is a link between the -- the amount of fat and sort of a -- perhaps a see-saw of glycemic load or glycemic index with fat. But isn't that just a reflection of behavioral choices rather than diet?

I mean, wouldn't it be -- couldn't you lower glycemic load just as readily by substituting carbohydrate sources that inherently had a lower glycemic index? For example, as steel-cut oats versus instant oats, legumes. I mean, is it -- do you feel that this see-saw is inherent in -- or is just a reflection of bad choices of diet?

DR. LUDWIG: Yes, I think it's a -- a very important point you raise, Dr. Stampfer. I think one can accomplish a significant amount by attention to the quality of the carbohydrate. As dietary fat continues to decrease - - and I -- I don't know what the magic number is -- it becomes increasingly more difficult to do so without resorting to high glycemic -- high glycemic index foods.

So I'm not suggesting that 35 percent or 30 percent or 25 percent dietary fat is optimal. And in fact, I think it's an interesting question that in my reading of the literature has never been answered. But one can accomplish a significant amount. But it becomes increasingly more difficult to do in practice as dietary fact continues to drop below 30 percent.

DR. GARZA: Dr. Tinker?

DR. LUDWIG: And that's primarily an energy density argument, as well. You know, one would have to eat vast amounts of fruits and vegetables to maintain energy intake. And I -- the traditional approach to weight loss is to restrict calories. And that typically leads to exacerbations in appetite that drive over-eating.

I think it will be difficult to get people to -- eating the requisite quantities of fruits and vegetables, you know, if their blood sugar is low and they are feeling very hungry and they are craving -- they are craving rapid access to highly dense energy.

DR. GARZA: Dr. Tinker?

DR. TINKER: This question is somewhat similar to -- to the previous two questions, or it relates to them in that with countries that have been using the glycemic index, do you have any knowledge of what pitfalls they've run into, some of -- some of the consequences like this always sounds good and, okay, so we put a --


DR. TINKER: -- put a factor in there with, you know, be cautious about the overall dietary facts and not to use ice cream because it's got a low glycemic index?

DR. LUDWIG: Right, right.

DR. TINKER: But do you know any of -- you know, what's been happening in these countries that have used it?

DR. LUDWIG: I don't -- I don't have any -- I don't have any relevant data on the point. The argument that's raised by, for example, Rivan and Colsten in California is that, yes, there is a little effect. But they feel that it is clinically insignificant, certainly for diabetes because they feel that diabetics already have to pay so much attention to their health maintenance that they shouldn't be burdened with this new construct, namely, you know, paying attention to the nature of the carbohydrate. That's -- that's their opinion that it -- yes, there is an effect, but it's not really worth the trouble.

But I -- Australia is one country. Many countries in England. Jenny Branmiller has been the champion in Australia and is coming out with a book shortly called -- she has a book called, The Glycemic Index Factor, which will be making its presentation into the United States shortly. I have no idea what the effect of this -- this work is on prevailing health in those countries.

DR. TINKER: Do you know if those other countries are using it in the general population or are they limiting it to folks that have diabetes?

DR. LUDWIG: I think the main attention to glycemic index has been around diabetes up until -- diabetes treatment up until very recently which is one of the reasons I think that glycemic index has taken on such a controversial air, and also just to acknowledge the fact that there are a number of popular books that have gone right to the public with glycemic index-related concepts without an adequate amount of scientific research.

And so it's understandable that the professional medical and nutritional community would be very ready to write off the concepts entirely. But it's only in the last I think two or three years that implications beyond diabetes treatment have -- have sprung up.

DR. GARZA: Dr. Dwyer?

DR. DWYER: Thank you for an interesting presentation. Could you speak a little more, Dr. Ludwig, to the issue of the relative importance of this concept compared to physical activity? My reading of the literature -- I just wanted to see what your's was on that.

DR. LUDWIG: My personal experience in running an obesity -- pediatric obesity program is that they're both critically important at both sides of the energy balance equation. But I think they may be interrelated in other important ways.

After a high glycemic index meal, three hours later, access to metabolic fuels will be low. I think that is pretty well documented in the study I showed you and in other studies that look at related concepts. How will someone who -- with low blood sugar and limited access to fats feel? I mean, undoubtedly they'll be hungry. They may be distractable. They may be less likely at that point to go out and want to exercise.

I think a diet that provides a steady, sustained release of nutrients over time and improved access to metabolic fuels may increase the likelihood that people will want to exercise. But I certainly couldn't say that one is absolutely more important than the other.

DR. DWYER: The -- that's an interesting hypothesis. But I was wondering -- I was just at the American College of Sports Medicine --


DR. DWYER: And, you know, saw a lot of people with a lot of low glycemic index foods who were very fit. And I wondered if -- I guess what I was trying to get at is if people are physically active --


DR. DWYER: -- is this important?

DR. LUDWIG: I think as -- as physical activity increases, insulin sensitivity improves. The adverse consequences of a high glycemic index diet decrease. And so it's going to be one of these U-shaped curves. Ideally -- I believe. I mean, that's purely hypothetical. I believe they work very well together.

DR. GARZA: Alice?

DR. LICHTENSTEIN: Going back to the intervention data, do you have any data on either remnant particles or triglyceride-rich particles after the different glycemic load meals?

DR. LUDWIG: Yes, interesting question. No data directly related to glycemic index. Nevertheless, hyperinsulinemia and through this metabolic syndrome, or syndrome X which actually Dr. Rubin -- Rubin described in the Banting Lecture in 1988 -- is a strong predictor, if not an etiologic agent in some of these novel cardiovascular disease risk factors.

So I think it stands to reason to me that diets that raise integrated insulin levels throughout the day should have adverse effects, but not documented to date directly.

DR. LICHTENSTEIN: Well, also with some of the other intervention data that you presented, the Jenkins study I think in '87 which showed a drop in LDL cholesterol levels when the people made the changes, were there changes in saturated fat intake or was that -- in those two diets?

DR. LUDWIG: I know that they controlled for total fat intake. I just -- I don't recall whether saturated fat was controlled for in that study.

DR. LICHTENSTEIN: Okay. I guess because I'm trying to just figure out whether some of the changes that you're talking about are related specifically to the glycemic index --


DR. LICHTENSTEIN: -- or other things. I mean, the same thing with the nitrogen balance. Are you suggesting that the glycemic index impacts on nitrogen balance? Because there were two different protein levels as you pointed out --

DR. LUDWIG: Right.

DR. LICHTENSTEIN: -- in those two diets. Was it the effect of protein --


DR. LICHTENSTEIN: -- or the effect of glycemic index?

DR. LUDWIG: Well, I'm sorry I didn't point out that in my -- in my study, both diets were protein sufficient. They provided --

DR. LICHTENSTEIN: Right, but one was higher than the other.

DR. LUDWIG: Well, one was higher. We took those increased -- increased dietary proteins into account in the nitrogen balance study. So --

DR. LICHTENSTEIN: You think it's an independent effect of the glycemic index then?

DR. LUDWIG: I believe it is. And, again, I can't prove it because macronutrients differ here. But I showed you in the first study that counter-regulatory hormones tend to rise four and five hours in the post-absorptive period. These counter-regulatory hormones are secreted teleologically with the expressed intent of accessing secondary metabolic fuels; in particular, protein.

When blood sugar is low, you know, epinephrine is secreted, cortisol is secreted. These have proteolytic effects used to fuel gluconeogenesis. And so I think conceptually there is a basis for understanding why iso- energetic diets with different effects on hormones could have different effects on which fuels are burned during an energy-restricted diet.disease

DR. LICHTENSTEIN: Well, that's great because that gets me to the last question I was going to ask you. And that had to do with that first study and the three different diets that -- I've been out of the sort of insulin/glucagon field for a long time.

DR. LUDWIG: That's all right. You --

DR. LICHTENSTEIN: But what I remember is that if you want to induce glucagon levels, you feed egg albumin; that that -- and I notice that your one diet had whole eggs. The other two were different versions of the oats. And I was just wondering whether the glucagon effect that you were observing had something to do with the protein amino acids?

DR. LUDWIG: Absolutely yes. I think it's a very perceptive point. And I -- I didn't take the time to discuss that. But protein is an independent secretagon for both insulin and glucagon. So both insulin and glucagon rise with protein. With glucose, insulin rises and glucagon is suppressed.

They balance -- I think the two are -- through a mixed meal which does not have a lot of high glycemic index carbohydrate, glucagon actually tends to be secreted, at least in moderate amounts. And I believe that what it's doing is preparing the liver to make a transition from the fed to the fasted state.

About three or four hours after a meal, suddenly we go from an influx -- influx of excessive numbers of caloric for immediate metabolic requirements from the gut to suddenly needing to shift to energy -- energy catabolism. And that shift can require the presence of the right enzymes in the right locations for gluconeogenesis and glycogenolysis. So I think that both of those hormones play key roles in modulating that smooth transition.

And glucagon also probably has a direct satiety effect when administered under controlled situations. So -- but very difficult to control for all these factors because of intimate interrelationships.

DR. GARZA: Are there other questions? Meir?

DR. STAMPFER: Two quick things. Just a quick comment on Johanna's question about the effect of modification by obesity and -- and physical activity. That's exactly what we see in our -- in our studies, in the epidemiologic studies; namely that the adverse effects of high glycemic load are really not there among people with, say, a BMI of 22 or highly active.

The only problem is there aren't that many people. Most of the people are fat, not just in our study, but in our country. And this also explains why countries with -- with glycemic load diets like in China can get away with it, because they're -- they tend to be lean and physically active.

My question though is have you been able to sort of get this message across in a simple understandable way to -- to people as to how to distinguish the quality of carbohydrates and how do you translate this concept to -- to advice?

DR. LUDWIG: It's -- it's so almost aesthetically pleasing to think that eating too much fat makes you fat. You know, and it's difficult at first to -- in my clinical experience to disassociate those two. And you'll probably be hearing lectures -- presentations from others in the next few days that will debate both sides of this issue.

But we have used a low glycemic index pyramid such as the one I showed you at Children's Hospital for the last three years and have had very good results with it. In fact, in a manuscript that's currently in preparation, we have evaluated the 18-month outcomes of individuals who were placed either on low fat, American Heart Association- recommended diets or low glycemic index diets for a period of 18 months.

And we found that there was over a three-fold increased rate of weight loss on the low glycemic index diet which was not provided in a calorie-restricted fashion. We told them to eat as much as they wanted, but to follow this -- this approach.

That study also has the limitations of a retrospective rather than a prospective analysis. But to answer your question, yes, I think that with some attention to shifting the prevailing mind-set from simple to complex carbohydrate and fat is bad, I think that the diet is fairly straight-forward and easy to follow.

DR. GARZA: And, Dr. Ludwig, I have two or three questions. I want to stress the point that Meir just made to make sure I understood it. And that is that in populations that are lean, the relationships that you describe are not necessarily observed.

So that in a Chinese population, you get fat intakes below 20 percent, a high glycemic index diet, but no -- no adverse effects, at least that we're aware of. So it is that interaction between obesity and the diet that is important. Is that true?

DR. LUDWIG: I think it's an interesting speculation. Dr. Stampfer has some preliminary data in that regard. I don't really have any direct data to bear on it. But it -- it -- if the final common pathway is hyperinsulinemia, then it would make sense that they will have a synergistic effect.

DR. GARZA: Okay. What nutrients become potentially limiting in a low glycemic index diet that will utilize foods most commonly consumed in the U.S.?

DR. LUDWIG: A little outside of my area of expertise. Certainly, grain products are fortified now, folate, etcetera. And so if consumption of grain products decreased, there would be that adverse effect. Although if fruits and vegetable consumption increased, I would think that that loss would be more than overcome.

And even if there other ways of -- and even if there were persisting inadequacies, there would be other ways of providing those micronutrients than at the same time with a high glycemic index, energy rich calories.

DR. GARZA: But you're not aware of any analysis that we could look at that have looked at different age groups? And the third is you premised your summary slide by saying that you didn't think that there was -- there was sufficient proof for any of the insertions that then followed.

In your opinion then, is -- is the fund of knowledge related to glycemic index sufficient and adequately compelling to face national policy or is it an area that we as a committee ought to continue to look at and recommend further research?

DR. LUDWIG: It's almost a philosophical question.

DR. GARZA: It's a very practical one and we're going to face it --

DR. LUDWIG: Well, yes.

DR. GARZA: -- it's not philosophical at all.

DR. LUDWIG: No, I understand. I think philosophical only in the sense that where does -- you know, in the absence of complete knowledge, you know when does one make a paradigm shift? I would encourage you to make that shift. But I do want to, you know, recognize that the gold standard is not past the RCT. But I -- I believe that there is sufficient both experimental and a theoretical basis for understanding advantages.

When -- especially in a society where the primary nutritional problems are of over-nutrition, I think there is a lot of argument for shifting diet away from the very high energy-dense refined grain products and towards fruits, vegetables and legumes anyway, independent of considerations of glycemic index.

DR. GARZA: Okay.

DR. GRUNDY: Can I follow up on one thing you said, is that you kind of said in populations that are thin, they can get away with that. But --

DR. GARZA: I was -- I was not asserting that. I was just following up to make sure I understood.

DR. GRUNDY: Well, let me just say that in those populations, there is a tendency for older people to develop hyperglycemia. And I wouldn't say that it's totally benign to have a stimulation -- continuous stimulation of insulin secretion because Oriental populations do have a high prevalence of hyperglycemia in the older populations --

DR. GARZA: But we don't know if it's --

DR. GRUNDY: -- even in the absence of obesity. So I -- you know, I wouldn't just say they get -- it's totally benign to have this continuous excessive stimulation of insulin.

DR. GARZA: That's an association. You're not asserting there is a causality there.

DR. GRUNDY: Yes, I am.

DR. GARZA: You are?

DR. GRUNDY: Yes, I'm suggesting there may be a causality that -- this idea of insulin exhaustion from continuous stimulation. I don't think that's been ruled out by any means.

DR. GARZA: And the basis for that, Scott? I mean, if --

DR. GRUNDY: High carbohydrate intakes, as was pointed out, can lead to high response -- insulin responses, post-prandial excursions of insulin being greater on the -- on diets high in carbohydrate.

DR. GARZA: And you feel there is sufficient epidemiological data around the world to link high carbohydrate diets with the prevalence of -- of either -- of Type II diabetes.

DR. GRUNDY: Well, I think one of the problems is that those populations -- well, one of the issues is they don't tend to be obese, so they don't have the insulin resistant component of that. But to say that that's not related to the beta cell component of diabetes I think may not be correct, or at least I don't think we have evidence that it's a totally benign thing as regard to beta cells. So I don't think we can base the evidence on epidemiologic data alone about the incidence of diabetes in those populations because I do think hyperglycemia is being increasingly recognized in Oriental populations that follow that kind of diet.

DR. GARZA: Okay. Dr. Ludwig, obviously you've stimulated lots of questions. Thank you very much for your presentation.

The department is to design the pyramid that it is primarily a teaching tool that the department uses with the guidelines being only one component that's used in its formulation. But yet because it comes up repeatedly in our discussions, I hope you will be able to isolate the reason why we're doing it from the presentation itself so that it's -- it's not intended to encourage you to take that on as an added task.

I think we have enough to do. It's only intended so that in fact we can understand the basis for it; not say, "Well, gee, we're about to request authorization for designing our own pyramid", at least I am. I think we have enough to do is your Chair's perception.

So with that -- with that caveat, Dr. Ann Shaw from the Center of Nutrition Policy and Promotion on the development of the food guide pyramid.

DR. SHAW: I was wondering how many of us are already hypoglycemic. I had something for breakfast. Okay, do I have a switch? All right. I'm always happy to talk about the food guide pyramid. I've been working on it -- or the food guide -- for almost all my career at USDA.

And today I want to cover about three basic areas. First, a very, very brief history of food guides at USDA so you'll see the context for this one. Second, I want to spend more time on the technical process of developing the current food guide and give you just a little bit about the consumer research that went into the graphic. And then finally I want to talk about ongoing research to update the food guide as new data on composition and food consumption and new nutrition standards become available.

Am I going backwards? Yes. Okay. Forward. There we go. As -- as most of you know and some of you have heard this presentation, maybe more than once, a science- based approach to food guidance began about a century ago with Atwater who developed databases that we use for food guides. And that's tables of food consumption and dietary standards for protein, calories and ash.

The definition of a food guide here is a tool to translate nutrient recommendations into recommendations for food intake. But we must remember that this tool is going to be used by ordinary people, that's not trained nutritionists, to choose foods for a healthy diet.

Typically, we have assumed that -- that these people have some knowledge and responsibility for food preparation and purchase. So they have some interest in it.

The first food guide is usually attributed to Carolyn Hunt. In 1916, she developed a guide for feeding young children that had five food groups. This was followed by buying guides in the 1920s. And then in the 1940s when the diet -- recommended dietary allowances were first released, we had the National Wartime Food Guide which became the National Food Guide which became the Basic 7. And I think this was the first time we had a picture of a food guide, at least one that I remember from elementary school in the '50s. This poster summarizes the emphasis of those guides at the time. And particularly it says, "The Basic 7, eat this way every day." And then at the bottom it says, "In addition to the Basic 7, eat any other foods you want."


Remember this picture. You can't see this very well, but it is a poster of a meal pattern using the Basic 7. And some of the meals on it we wouldn't exactly recommend today. They look pretty high in fat. But the -- but the idea was that people needed to be able to translate the food guide into actual foods they put on the table.

In the 1950s, work began on a simpler food guide, one which would be easier to remember than seven groups, and provide a foundation for a good diet by recommending minimum numbers of servings from four groups of foods. The documentation for this is in, "Essentials for an Adequate Diet", which was actually a very excellent document done by Paige and Fippert in 1956 or so.

And it used the 1953 edition of the RDA and the 1953 Household Food Consumption Survey, and provided food groups which emphasized short-fall nutrients at that time like vitamin A, vitamin C and iron.

This was translated into a food guide for people called the Food for Fitness; A Daily Food Guide. And it was the basic four. This was the USDA poster of it which was more like a mobile. It wasn't a circle as many people had thought. But it shows the four food groups sort of not linked together, but individually.

All right. In the late '60s and '70s, we had a growing concern about nutrients in excess, fats, saturated fat, cholesterol, sodium, and their relation to heart disease and cancer. These concerns led to the dietary goals in 1977. And USDA responded by adding a fifth food groups of fats, sweets and alcohol at the bottom to the basic four, and cautioning, "Use these in moderation."

Then in 1980 with the first edition of the guidelines, that one over on the left, we began work in earnest on a new food guide to help people actually put those dietary guidelines into practice. You can see that the first guidelines were mostly as you would call component food, component-based; like, "Eat foods with adequate starch and fiber", and, "Avoid too much sodium", and so forth. Over the years, they've gotten more food oriented.

Okay. Philosophical goals for the new food guide were the first thing we established. And these were specifically stated. And I think these are very important to review and for you to keep in mind. Our goal was to promote overall health rather than treatment or prevention of a specific disease.

At the time, in the early '80s, we were getting multitudes of guidelines from different professional organizations. The dental people were saying eat cheese. And the heart people were saying have all-day suckers because they wanted it low fat.

So we were left with, "Well, what's the average healthy American to do?". And so these -- this guide was to be directed to healthy Americans over the age of two. That would be the same target audience for our dietary guidelines for Americans.

Second, we wanted to make sure it was based on up- to-date research on nutrient data, on foods and on nutrient recommendations, and it should be perceived as up to date by the users. And keep that in mind because that's really important as you'll see later.

Next, we wanted it to address the total diet. No longer was it good enough to say eat whatever else you want. The Basic 4, as you would call, provided about 80 percent of the nutrients known at that time, and also about 1,200 calories. So since most people on average were -- the recommended level was about 2,400 calories, say, that left a lot of room for the whatever else you want.

So our new guide would have to address both adequacy and moderation issues and it would no longer be a foundation diet, but a total diet.

Next, we needed to have this food guide useful to our target audience which again was the ordinary person, the consumer. The conceptual framework of the guide, the food groups must be -- useful must be recognized.

Then the fifth objective was to make it realistic. If we were going to verify that this would indeed deliver the nutrients and the -- so forth, we should not depend on including in there infrequently consumed foods like maybe oysters for zinc or tofu or something that was not so commonly used. That doesn't mean we couldn't use -- people couldn't eat those. It means we wouldn't depend on those for nutrients.

Six, we wanted it to offer the maximum flexibility possible for consumers to eat in a way that would address their taste and lifestyle interests. This was not a prescribed diet. We should allow healthy consumers to decide which foods they wanted as their sources of fat and sugars and in keeping the total fat and calorie intake moderate.

We wanted it to be practical. That was our seventh one. We particularly had in mind feeding groups of people. The household food manager or the -- or preparer was not going to fix a different menu for each age and sex group. We wanted the food guide to sort of cover a common menu that could be eaten in varying quantities by people of different ages and activity levels and so forth.

And finally, and perhaps very important for this group, we wanted the food guide to be evolutionary. We wanted to build on previous guides, but yet accommodate the anticipated direction of changes and dietary recommendations over time without having to revise the whole food guide.

For example, if we wanted to incorporate new recommendations, say, for a phytochemical like lycopene, we could develop another subgroup or something with recommendations for that. But we wouldn't have to revise the whole food guide. That also convinces people that there is -- there is some continuity of scientific thought and that we don't just throw away something when the next new thing comes up.

Okay. So once the philosophical goals were set and were discussed among professionals, we started the steps of building our new food guide. The first step was to establish these nutritional goals which were the specific goals that the food guide would need. Then we had to define the food groups or the framework for the guide.

Next we had to define serving sizes or serving units so we would know how to evaluate whether people were getting enough of each food group. Then we had to develop nutrient profiles or expected nutrient levels of each food group. And then we had to determine what numbers of servings of each of these food groups would together allow for an adequate diet and yet be moderate in the components like fat and sugar, sodium and cholesterol.

Okay. This is a little hard to read. These were our nutritional goals. For food energy, we wanted to look at the range of 1,300 to 3,000 calories. We got these mostly from the RDA text. For vitamins and -- and for minerals, we wanted to hit the RDA if possible. This was a goal. And for fiber, we wanted to increase consumption.

For moderation concerns, we looked at the dietary guidelines, but we had also looked at recommendations of other groups. As you remember, the first dietary guidelines were not quantitative. They didn't give you a level to target for fat or saturated fat. So we looked at recommendations of other groups.

Again, now, for fat -- because these have been updated since the newer dietary guidelines -- was 30 percent of calories or less; for saturated fatty acids, it was less than ten percent of calories; cholesterol, we were targeting 300 milligrams or less; sodium, 2,400 milligrams or less; and added sugars, we wanted them to -- to balance the calories or to allow people to have added sugars in their diet.

But since they didn't produce very many nutrients, we realized they would have to be restricted more at lower calorie diets than at higher calorie ones. And we didn't want to exceed current consumption.

Okay. The next step was establishing our food groups. Our criteria for doing this -- since this was the framework of the food guide within which we would discuss food choices, one of them was common, recognizable foods; common use of foods in meals; nutrients -- similar amounts of nutrients from that food group was also a concern like the dairy group providing calcium, but also riboflavin, protein, B12. And then the ways foods had been traditionally grouped was another criteria.

The foods that -- the subgroups were established to emphasize sources of nutrients and food components of concern. We had looked at short-fall nutrients in the 1977- '78 survey to identify particular subgroups of vegetables, for example, that would contribute magnesium and B6 and folate and those sorts of nutrients, as well as vitamins A and C.

Ultimately, our food groups and subgroups in the food guide are these. Under bread and cereals/rice and pasta group, we had a whole grain subgroup and an enriched grain product subgroup. Fruits, we had two subgroups, but ultimately we -- we later just sort of pulled them all together. But there are those that are high in vitamin C like the citrus, melons and berries. And then there are other fruits.

Vegetables, there are five subgroups. These are very important and I'll talk to you later about them. The dark green, leafy vegetables like spinach and kale and -- we include broccoli in there, too. The deep yellow vegetables like carrots, pumpkin, that sort of thing. Starchy vegetables which included the potatoes, but also peas and corn and lima beans, the immature forms.

Dry beans and peas were the legumes group. And we subclassed them as vegetables because we wanted people to eat more of these and we wanted them to stop thinking about them as poor man's meat and to include them regularly in their diet because they are a very good source of nutrients.

And then the other vegetables included the lettuce and tomatoes and peppers and onions and celery and all of that sort of thing

Meat, poultry, fish and alternate -- the meat, poultry, fish are self-explanatory. The alternates were things like eggs, dried beans and peas and nuts. So our dried beans and peas group sort of overlaps two food groups. And that's caused problems for some people, but it can be counted either/or.

Then there is a milk, yogurt and cheese group. And last, the fats, oils and sweets group which we kept like in the hassle-free guide.

All right. Step three of the food guide was to establish serving sizes or serving units, amounts to count as a serving. We needed to do this to specify these amounts times the number of servings would equal a quantity of foods to eat per day from each food group.

We used typical servings or portion sizes as reported in surveys as one of our major criteria. Ease of use and household serving units were -- was also a major criteria. Similar nutrient content of key nutrients like calcium in the dairy group was important. So we had one cup of milk equivalent to one and a half ounces of cheeses.

And finally, tradition was important, the serving sizes used in previous food guides. And the issue here was a matter of perception, particularly with the grain products. Our survey suggested that people were using two slices of bread or the equivalent as a portion of grain products every time they ate grains. But nutritionists had been used to talking about one slice of bread as one serving.

Now, if we had increased the serving size to two slices, then our ultimate food guide probably would have had three to six servings from the grain products instead of six to 11. And that would look an awful lot like we were decreasing the amount of grain products we should have in the diet from the Basic 4.

So instead of four servings in the Basic 4, we suddenly had three. And it would be an artifact of the serving size. So we decided to keep the one slice of bread as the serving equivalent.

No serving sizes were specified for the fats, oils and sweets group because the amount that you can use of these pure fats and sweets depends on what else you have in your diet. And so the message there is to use sparingly those.

Okay. Step four was to establish nutrient profiles for each of these food groups and subgroups. And a nutrient profile is the expected amount of nutrients that you would get from a serving of each of these food groups or subgroups based on the current food choices in the U.S. population.

Now, these nutrient profiles represent the relative frequency of consumption of particular food items within the food group as recorded in surveys. In other words, it sort of answers the question, if you go out to choose a dark green, leafy vegetable, which one will you choose more often. And that one that you choose more often, you want to represent its nutrients in the composite in a greater percentage.

So this whole grain composite shows you the choices of whole grain type of foods that people make. Whole wheat bread is chosen more frequently than rye bread, for example. So it's represented in our composite in a greater quantity. And we do this preparation of nutrient profiles and food group composites for every -- every one of those food groups and subgroups.

So for the five nutrient -- main nutrient-bearing food groups and their subgroups, when we developed the nutrient profile, another key point was we only used the foods in their lowest fat, lowest added sugars forms. So these were stripped-down nutrient profiles; very lean, very nutrient dense.

And these composites or composite nutrient profiles were used in the last step to develop diet patterns containing the numbers of servings from each of the nutrient-bearing food groups and subgroups that would meet our established goals for protein, vitamins and minerals.

Again, we used ranges in the numbers of servings to cover the varying needs of males and females two years and older. And once the vitamin, mineral and -- and mineral objectives were met from these foods in their lowest fat form without added sugars, then we could add back discretionary fat, as we called it, up to a limit of 30 percent of calories which was our goal.

And the balancing calories at each calorie level would be provided by added sugars which would give you nutrients -- I mean give you calories, but very few nutrients. So you see that the lower calorie diets have less room for the added sugars, six teaspoons instead of 18 at the higher calorie diet.

And the spreadsheets, which I've passed out and which I'll discuss a little longer later, show you how we operationalized this.

The system here is flexible in that people can spend their fat, their available fat within the context of the total in higher fat choices from each of the food groups or in added sugars and fats from the fat, sweets and oils group.

They can -- we use skim milk as our dairy lowest fat food. But if they chose whole milk or cheese, then they would be spending some of their extra fat, discretionary fat, on the cheese. Our discretionary fat composite had included in it butter fat and vegetable oil and a variety of fats from -- based on the food supply in -- in the U.S.

Now, how good are these patterns in meeting our nutrient goals? Well, the lower calorie pattern, the 1,600 calorie, has a problem in meeting iron and zinc RDA. But once you get up to the 2,200 calories, you can generally meet all the RDA. Individuals who have high nutrient requirements like women for iron or high RDA, but eat low amounts of calories, 1,600, would need special attention to that nutrient.

These are the food components provided by those diet patterns. Protein -- total fat percent of calories was 30 because we maintained it that way. And if you do that and use our composite of dietary fat that's based on the food supply, you get about nine percent of your calories from saturated fat.

Cholesterol was kept at -- at or close to 300 milligrams per day. It's a little high on the higher calorie diet. That's a problem because you're eating fats in your discretionary fat that contain cholesterol. But we had a limit of about three eggs a week in each pattern. So that would maintain the cholesterol at approximately 300 milligrams.

Sodium is the -- the level is without added salt at the table or in preparation, although our composites included some foods that -- with sodium in it as if they had been canned. We -- in our other vegetable composite, for example, we put in a certain amount of canned string beans figuring that people would not know if they got their string beans at a restaurant whether salt had been added or not, so --

Our fiber level ranges from 17 to 27. That's over current consumption. But there wasn't any particular goal for fiber mentioned except to increase it. Others have reported somewhere around 20 to 30 grams of fiber per day is desirable.

Remember, this food guide is for healthy Americans, not those on prescribed diets. For individuals who have high blood cholesterol or something like that, you would have to give more specific guidance on limiting saturated fat sources or cholesterol, or give more guidance about the use of eggs or lower fat dairy products. But they could still eat within the general context of the food guide.

All right. This was the technical research on the development of this food guide. Most of this -- the levels and everything that I've shown on these slides are summarized in a yellow publication that I think the committee has gotten at one point or another. But we have many more copies of it.

The -- this technical research was based -- to assess the reliability of the recommended dietary patterns in meeting the nutrient objectives. Okay. This research base was peer reviewed and published in JNE in 1987, and it was used with a Red Cross course that we developed around 1984-'85 and in several USDA publications.

However, another type of research is required to assure that the guide could be understood and applied by this average consumer in constructing everyday meals or even to assure that the guide would capture their interest and attention in the first place.

As it happens, in the late '80s, the perception remained among consumers and many professionals that we were still using the Basic 4 and that we had never updated it and wouldn't -- when would we get on with the new food guide.

So -- so we undertook in the late '80s a project to develop a consumer booklet that was entirely devoted to the food guide and a graphic to help identify key concepts of the guide. And we did this with the help of a contractor. Our target audience, again, was average American adults who are household food managers who have at least a high school education.

Well, this slide shows a circle graphic which was represented by the food wheel from the American Red Cross nutrition course. And while this was well received within the context of the course, in our consumer research when people just saw it off the wall, they thought it was boring, old fashioned and, lo and behold, they thought they already knew it because they had it in 1950s in school, the Basic 7 even though it depicted actually our new food guide.

So conversely, when we tried other options, the pyramid design sparked a lot of interest, was seen as appealing and adult, and proportionality was more easily remembered. So we worked along those lines. And later phases of our research tested both the booklet and the graphic alone.

We never meant for the graphic to be used independent of the booklet, but it was to summarize some of the major concepts of the food guide. Here is the first one we developed with the first booklet in 1991. The pyramid shows variety among the food groups by the names of the food groups and the sections of the pyramid.

It shows variety within the food groups by different pictures of foods within the food groups. It shows proportion by the shape and by the idea that you need more servings from the bottom. And it shows moderation by having the small tip with the fats and added sugars symbols and "Use sparingly" text which was added later.

And also moderation related to food choices within the food groups was conceptualized by having these what we call the sprinkles within each food group to remind you that some foods you choose, like from the grain group, like a crescent, would come along with fat, would have fat already; or in the vegetable group if you bought potato salad, it comes along with its fat.

Before we could get this thing out, we had to have a national test of graphic alternatives. And this was a large-scale project which only tested the graphic, not associated booklets. And many graphics were evaluated early. And I think it's always fun just to look through some of the ones that were tried.

There were picnic table cloths with pie charts on them. There were shopping carts, which no one particularly liked. These were half circles which were a little confusing. And there were many, many, many ball designs. The ball is really popular.

Ultimately, it came down to balls and pyramids being tested in the final test. And results indicated that the pyramid was the more effective graphic, even if people happened to think the ball was prettier. The pyramid was better at conveying concepts of proportionality and moderation. But of course, these were all tested without any other booklet that went with it.

So the sprinkles of the fats and sugars symbols were a little confusing without the other booklet. But they didn't detract from the overall message of moderation and go easy on those fats and sweets and eat most of your foods from fruits, vegetables and grain products.

So this was the one that was ultimately released and -- by USDA and DHHS in 1992. And as you know, it -- the food guide pyramid, the graphic has been used in many, many, many educational pieces and on food packages and everything. We have a number of publications for consumers that use the food guide pyramid and explain it -- even others that explain it in more detail for professionals and how to use it with their clients.

But the food guide itself, the food groups and subgroups, the serving size units, the suggested numbers of servings, have been used as a basis for diet evaluation in the healthy eating index, which we have a lot of evaluations on that, and computer programs for consumers, even in nutrition objectives for the nation.

And using the new servings database that ARS has, the food choice behaviors of the population can be evaluated in terms -- in the same terms as we give the guidance, the amounts of varying types of foods to choose for a healthy diet.

So with that, I want to continue on now with the -- the discussion of our current research to update the food guide. As I mentioned before, food guides are dynamic tools that translate nutritional recommendations --

DR. GARZA: Dr. Shaw, I have to ask you to try and speed it up because --

DR. SHAW: Okay.

DR. GARZA: -- we've already used up --

DR. SHAW: Okay. It's just about five minutes.

DR. GARZA: -- the allotted time and there's no -- there's no time for questions, so --

DR. SHAW: No time for lunch, okay. The food guides are based on sets of food and nutrient recommendations like the RDA, DRI, the dietary guidelines, data on foods used by the target population and data on nutrient composition of those foods. And as the science base advances, we will need to keep reassessing the food guide to see that they meet these recommendations.

So research to update it is ongoing and especially with the food group and subgroup composites which, as I said, were key to this research. Updating these food group composites is more labor intensive than you might think. It calls for a pouring through thousands of food codes in the survey and grouping them into item groups within each -- within each food group and subgroup.

But we are working on it. We've updated it to the '89-'91, and established our procedures for doing that. And now we're working on converting it to the more complex '94 to '96 data.

We also update the nutrient profiles of these foods when new nutrient data come out, like we've put in the folic acid fortification for grain products most recently, not in the tables that I've handed out.

Okay. The spreadsheet which I handed -- which we've distributed to the committee is for discussion purposes only because it's lots and lots of raw data. It's an example of how we used these composites to -- to test our food patterns. So if you look at that spreadsheet, in the left-hand column, you see the number of servings in the pattern for each food group.

And then when the nutrients per serving that you see across the way are the nutrient profiles of those food group and subgroup servings, and then we just multiply it through to determine the -- a subtotal for the pattern which you see down there as pattern totals for the nutrients.

Okay. Then we add back the discretionary fat which is a composite, sufficient to get us 30 percent of calories. And then we add added sugars as teaspoons of sucrose to come up with the targeted calorie level.

The totals with the fat and sugar are across the bottom of the first six pages. Then we can use the same spreadsheet to look at the percent contribution by each food group to the total for that nutrient -- calories or nutrients, and also then to compare the expected totals to the whatever nutrient standard we're using. In this case, we -- we had -- used the RDA for women, 25 to 50. And again, we're using the 1989 RDAs here. We haven't updated it to any DRIs that have come out yet.

So one can see that -- two things about this, or several things about this. Under the vegetables, we included dark green, deep yellow, legumes and starchy and other as three subgroups to eat all kinds regularly. We included them in one-third/one-third/one-third. Of that, we wanted dark green, leafy vegetables to be eaten three times a week and legumes three times a week. So those values represent that.

Whole grains, we're suggesting several servings a day. And so we've included three. And we included that across all calorie levels.

So when I heard that people wanted more emphasis on fruits, vegetables and grain -- whole grain products, we already do that. So -- all right. Now that we compare to the estimated nutrient totals of the patterns to the RDA, we can look at several kinds of changes we can make --

DR. GARZA: Dr. Shaw, can you bring it -- I hate to be so insistent. But we're --

DR. SHAW: Okay. All right.

DR. GARZA: You need to conclude so we can have some time for questions.

DR. SHAW: All right. Okay. There are several kinds of changes we can make. And I'll just mention four. We can provide individualized guidance for the selected age groups that doesn't meet its nutrient standard -- to meet it, like using a fortified food; or we can change the numbers of servings; or we can develop new food groups or subgroups.

Now, one of the things that we did because the committee was interested was to look at a vegetarian food pattern. And that's in this other table that you have. I just want to highlight that. We have a vegan pattern on the right-hand side. And that compares are -- just suggested numbers of servings that we were doing on a trial basis to the food guide patterns we already recommended and to the average servings consumed.

Okay. Now, one reason we haven't done an official vegetarian food guide pattern is we don't have enough data on what vegetarians in the U.S. eat. Only 2.7 percent of adults report being vegetarians. And those that do, 75 percent use milk products and 47 percent use some kind of meat, poultry, fish. So we don't know what kind of vegetarians they are.

However, we illustrated that the food guide pyramid could be used to do a vegetarian pattern and to highlight nutrients that may be a problem in this pattern. For example, if you look at the vegan patterns in the dietary fiber, you see that it's an outrageous amount of dietary fiber in those patterns. And we feel that -- among other nutrients that aren't making the RDA.

And we feel that a lot more work would have to be done before we found a pattern that might be acceptable to a vegetarian population.

I guess I can answer questions during lunch or I can answer questions now if you have them.

DR. GARZA: No, we have to do the questions in public.

DR. SHAW: Oh, okay.

DR. GARZA: Alice?

DR. LICHTENSTEIN: From what I understand, you indicated that for the dairy grouping there, you used in your calculations levels for the fat-free and the low fat. Yet that's not indicated on the pyramid. And that's something that I've always been a bit perplexed about because in a sense, it's not really communicating what the assumptions were.

And consistent with NCEF recommendations or other recommendations with regard to saturated fat, there seems to be a discordance there.

DR. SHAW: Okay. Well, in the little pyramid booklet, which describes more sources of different kinds of fat and are some fats better than others, we indicate that fats from dairy products are more saturated and that if you choose dairy products that are higher -- I mean, you know, the higher fat dairy products, you'll have to limit your saturated fats somewhere else. I mean, like always choosing the leanest meats or not using butter maybe.

But to make it very flexible, what I was talking to you about before with using the stripped down composites was -- was a technical issue. We were trying to say, okay, what is the lowest fat, lowest calorie pattern that we can develop. And then we can add back discretionary fat that people can spend where they want.

And our discretionary fat made some assumptions that there was better fat in the discretionary fat that would account for people choosing higher fat dairy products. And it would still come out to nine percent of the calories as saturated fat if you kept the total fat to 30 percent.

But we didn't indicate on this that -- that those foods had to be the lowest fat because that's a -- a personal decision. It's part of the flexibility for the healthy person to say, "If I'm going to drink milk, by golly, it's going to be whole milk", or whatever. But then they'll have to make up their -- reduce their fat somewhere else.

DR. GARZA: Shiriki?

DR. KUMANYIKA: Given that the pyramid is being used alone, have you thought about how it could be modified to stand alone?

DR. SHAW: We thought there was only a limited amount of stuff that you could get across to people in a single graphic which is -- if they just got the impression from looking at it that they should have more grain products and less fat in their diet, or more fruits and vegetables and less fat, I think that's a good first step.

I don't know how it could be used all by itself to plan menus because of the serving size issue and the fact that people don't know -- I think we're wrestling now with the portion size issue predominantly. People will say, "Oh, I can eat all the grain products I want", and it turns out that they're portions are really extraordinarily large in many cases.

DR. GARZA: Roland?

DR. WEINSIER: Yes, is there a nutritional basis for relegating a larger number of servings from the -- the grains, basically the breads and the rice and the pasta, relative to the starchy vegetables, the legumes, the beans, the lentils, corn?

DR. SHAW: Well, partly it was usage, to get the - - to get the fat down and to maintain it low, as well as certain nutritional advantages to the grain products, particularly the whole grains. And we are pushing whole grain. It may not look like it on the -- on the pyramid. But our booklet and our -- my technical research, as you can see from that chart, is pushing whole grains in the sense that it's recommending many times more than people -- people are currently eating about one serving on the average of whole grains per day. And we're suggesting three.


DR. SHAW: Okay.

DR. WEINSIER: Yes, I wasn't getting at the whole grain issue.

DR. SHAW: Yes.

DR. WEINSIER: I was getting at the difference between grains versus legumes in the starchy vegetables.

DR. SHAW: Well, legumes have even a smaller consumption now. And we wanted people to up their consumption. And -- but we didn't think that if they were - - if you put the legumes in the base of the pyramid, they were going to choose six servings of legumes. That just seemed kind of impossible.

But I know the diabetic exchange system for many years has put all those starchy things together. And sometimes people think of -- "I'm eating my starch" when they think of rice and pasta and beans even. But -- besides, legumes had a different nutritional profile even than whole grains. They're high in protein and they are high in the -- the minerals that we depend on the meat group for. So they could also make a meat group alternate.

DR. GARZA: Johanna?

DR. DWYER: Thank you, Dr. Shaw, for a very interesting presentation, and particularly for this pyramid for vegans which I think is a useful contribution. However, it seems to me the second -- sort of, if you look at food patterns, that Hispanic Americans are one of the most rapidly growing groups. And there are certainly many more Hispanic Americans than there are vegans.

DR. SHAW: Right.

DR. DWYER: So it's of interest to me to know whether you have done similar calculations with a typical Hispanic American pattern; not only Mexican American, but also Puerto Rican American, and whether the pyramid can fit that sort of eating style, too.

DR. SHAW: I think a lot of people have pictured pyramids including Hispanic foods. But again, from our database, we don't really have enough data on Hispanics, and then which Hispanic group we're going to use. Are you going to use the Puerto Ricans or are you going to use the Tex-Mex Hispanics or what.

So we haven't done that yet because we feel that if we come out with a food guide that's for a particular population group, we have to have some data to back it up; that it will in fact deliver those nutrients to -- in that population.

I notice that on our newer composites, Hispanic foods are turning up more often. I mean, people are eating more beans that are -- have Hispanic origin, beans like they would put on tacos and things like that. People are using more tortillas in cooking. And so some of these things are coming up even for the national population in these composites. So -- but we haven't done a Hispanic food guide yet.

DR. GARZA: Scott?

DR. GRUNDY: Yes. I thought maybe you could divide that bottom big part into two parts and have more of the grains and so forth on one side, and it wouldn't make -- it almost looks like its bottom heavy with a lot of bread and things that might be rich in calories. I mean, that -- you know, there really are two different kinds of components in that bottom part, aren't there?

DR. SHAW: Right. Well, the whole grain products -- it turns out our composite for whole grain products is largely breakfast cereals that people are getting their whole grain servings is -- 25 percent of it is breakfast cereals whereas the enriched grain products, it's such a variety of things. Breakfast cereals are only about -- I think now about three and a half or four percent of the composite.

But you're right. We could emphasize whole grains more. And I would be all in favor of doing that. Again, like the thing shows, we already do emphasize whole grains. It's just people may not be aware of it.

DR. GARZA: Richard?

DR. DECKELBAUM: Right now when we look at the food pyramid on the slide, there is a blank side. And I would like to know if there has been consideration as to incorporating some kind of exercise into the pyramid to balance the foods. That's one question.

The second question is there is a number of food pyramids that are --

DR. SHAW: Yes.

DR. DECKELBAUM: -- coming out from different organizations. And how does the -- how does the USDA or how do you -- you can answer either for the USDA or for yourself -- how do you feel about the multiple choices now that you can have in food pyramids? Which one should we take and if there is one available for the elderly, will that replace the general food pyramid of the USDA?

DR. SHAW: Oh, I don't think it will replace it. We -- we even put out one for children that looks very much like this one except has different foods pictured because there are foods that children recognize and eat. We haven't put physical activity actually on our pyramid because actually when did it, we were thinking it's a picture of the food guide, okay, not of an exercise guide or anything else. We wanted to communicate food here.

So -- so we didn't put exercise. And we didn't put alcohol on it either, although our materials sort of caution people about the excessive calories that they might get from alcoholic beverages. We didn't actually put it on the pyramid.

DR. GARZA: Alice?

DR. LICHTENSTEIN: This has been very helpful because I understand now the issue of a low fat dairy product and the whole grains that were actually incorporated in. I think what has become apparent though is that -- that somehow those things haven't been communicated adequately and that's really what the challenge is.

My question has to do with something you mentioned about what the RDA is -- looking at age-sex groups. But this -- there is one period for individuals above the age of two. So how did you handle that. Did you -- is it sort of like with the labeling where you took the highest RDA or did you take mean RDAs for each nutrient?

DR. SHAW: Well, we -- using that spreadsheet, you can compare it to whatever RDA you want, you know, the nutrient totals. So we sort of said that the 1,600 calorie was a little low for adult women, but many sedentary women eat this. And if they do eat at this low calorie level, that they'll probably need extra iron or that sort of thing because you can see in that, they don't meet the iron.

Zinc is another problem that is kind of emerging because, you know, in our composite, red meats have gone down because people are using them less, and particularly beef. So our zinc levels have -- expected zinc levels from the meat, poultry, fish composite have gone down.

And that's what makes me hesitate to think that if one even cuts it further or takes out red meat completely or relegates it to a couple of times a month or something, you know, it's going to look serious and you'll have to make some decisions which our food guide can help you do.

You can see what would happen to food guidance if you said, you know, you're going to change this food group and not have any red meat or you're not going to have any milk group and you're going to substitute all calcium- fortified orange juice or something like that. What happens to other nutrients when you do that?

DR. GARZA: Dr. Meyers? Okay, then. We're going to break. We will be back by 1:30. So we'll have 35 minutes. Lunch has been brought in. So that if you can be very efficient in your consumption of lunch, we should be able to meet everybody back here at 1:30.

(Whereupon, at 12:56 p.m., the meeting was recessed to reconvene at 1:40 p.m., this same day.)

A F T E R N O O N   S E S S I O N
1:40 p.m.

DR. GARZA: We are going to move on with the agenda which is beginning a discussion of the various guidelines. As I indicated to each of you in an e-mail that we all received in the middle of last week, late last week, was we're going to try and organize our discussions around three main sections. But obviously, we won't rule you out of order if you fall out of that organization. It's just to make sure that we cover all three.

The first part will be some introductory remarks by staff that have reviewed both oral and written comments, oral testimony and written comments that the committee has received to make sure that in fact all relevant issues that was not involved with the committee have raised -- have bene considered, either by the working group in their deliberations or in the plenary sessions.

So that the chair of each of working group should be prepared to discuss how each of those issues have been taken care of or how -- or what plans are to review them.

The second is to -- is to allow time for anyone else in the committee who is not a member of the specific working group guideline that's under discussion to raise issues that they want to discuss. And then lastly is issues that the committee wants to raise -- or rather that the working group wants to raise with the full committee.

Now, the reason for those -- for that order is to make sure that in fact we -- we take up all relevant issues because I -- I hope that we can begin coming to closure in our -- in our recommendations by the next time we meet in September so that you will have a full work plan devised by the time we leave on Friday for each of the guidelines.

I also will repeat that as you think of the changes that are being recommended for any of the guidelines, that you think about the documentation that has been forwarded in support of those changes.

I mentioned one concern that I had, and that is that generally what's being done in the documentation is to list those papers that support the change. But they're listed in a rather uncritical way. And there is no listing of data or evidence that doesn't necessarily support that change.

And we need to be as objective as possible and cite both, give a brief description of the strengths and weaknesses of those in support and those not in support of the change, and then the rationale for why the committee is going to fall on one side of the debate or the other. Otherwise, it's going to be very difficult for the Secretaries to reasonably assess the basis for any of our recommendations.

So please put on a reviewer's hat. Assume that in fact you're on study section and somebody is asking you for lots of money. And so you're demanding relevant information in support of their proposal. These are proposals that are being made for the committee's consideration. And so make sure that the science is on the side of what we're -- we're recommending.

Lastly, keep in mind that one of the most -- we're entering one of the most difficult phases of this discussion because in my experience what we're doing now is entering the phase where it's going to be very tempting for us to want both language and recommendations that are personally satisfying.

And if this -- I'll pick on Dr. Tinker because she's the newest. If this was going to be Dr. Tinker's report, she could really push for wanting it to be personally satisfying. Because it's a committee process, then it has to reflect a committee consensus. It's very difficult at times to come to that consensus if the over- powering allure of wanting it to be personally satisfying overwhelms your better senses.

So I hope that all of us will keep in mind that this is a committee process and be prepared to see everyone's point of view and come up with a list of recommendations that will be supportive of good health and

-- and of the spirit of the guidelines which has been reflecting the predominance of scientific data rather than the latest scientific finding, which may turn out to be accurate, but for which there is still limited information on which to build a national consensus.

So with that in mind, let me ask if any of you have any questions or comments you wanted to make before we start with the first -- the first guideline. Shiriki?

DR. KUMANYIKA: I just have a comment about --

DR. GARZA: Speak into the microphone.

DR. KUMANYIKA: I think we should probably structure the way that opposing evidence is listed so that it's uniform across the guidelines as we think about it. For example, if we're going to present the rationale of the answer to, you know, what's the evidence supporting this guideline, then we should have a specific section saying, you know, is here any contrary evidence and why has -- and why does that not change your mind or something like that rather than necessarily blend it in or selectively pick opposing evidence. If we could get suggestions on how to standardize that, it might save Carol some time.

DR. GARZA: Well, you suggested one way to standardize it. Do people feel comfortable in -- in following the suggestion that Shiriki made which was to put the supporting evidence in one section, evidence that -- that perhaps would not be as supportive or supporting, and then the conclusion at the end? Did I understand the outline you suggested? Rachel?

DR. JOHNSON: I just want a clarification. Is that -- are you thinking about that in the written report to the Secretaries or are you thinking of that as a structure for our discussions?

DR. KUMANYIKA: In the written report for the Secretaries.

DR. GARZA: But you could always use -- I mean, you could always use the same format in your discussion here, as well. I mean, that -- that would be fine. Carol, do you have any other suggestions or requests of the group?

DR. SUITOR: Not at this point.

DR. GARZA: Okay. All right. Then let's begin with the first guideline. And I don't know whether to call it the variety guideline or the five cook guideline. And Suzanne just looked in horror and said, "Don't call it anything." So the non-referring guideline, okay. And I don't know whether you would like to start or would like to staff would like to first start with the issues that they identified. We could do it either way.

DR. MURPHY: Yes, I would like some suggestions because I'm not sure -- I came prepared mostly to talk about the issues that had been identified by the working group. And I'm not sure how these fit into the three points that we're supposed to cover. I guess those are mostly point number three, the issues we've identified. And they were driven to some extent by the issues that were discussed at our last meeting.

So since our Chair is distracted, I'm going to -- Joan just gave me the list of a -- the topic areas that are summarized from the public comments. And I assume those were driven by this document that was in our book, "Recommendations from Public Comments". All right.

But I'm not sure that's the place to start. I mean, that seems backward to me.

DR. GARZA: That's up to you.

DR. MURPHY: All right.

DR. GARZA: The reason that we chose this was that in discussions, there was some concern that we never -- that if we left the public issues for the last, that we wouldn't cover them --

DR. MURPHY: Oh, okay. I see.

DR. GARZA: Because in fact the committee would be so preoccupied with their own discussions that we would -- we would make short shrift of the others. So that's the reason for putting the public comments first, to make sure we get to them, then to the rest of the committees' concerns, and then to the working groups' concerns since the working group gets to talk among itself most often.


DR. GARZA: But --

DR. MURPHY: But if I promise we'll get to this, I don't have to do it first.

DR. GARZA: Exactly. But we will -- we will hold you -- it's off with your head or something if you don't get to the public comments, yes.

DR. MURPHY: Right. My concern is that we also don't have very much time to meet as a committee. The working groups have had ample time to do conference calls. But I feel that at least the group for the first guideline would profit substantially from feedback from the rest of the committee. So I don't want to lose that in the agenda either. And I would actually prefer to start there, and then move to the public comments.

And I have not prepared visuals and what not, although someone has prepared one for me that I may in the end use. But what I would really like to do is draw your attention to Tab 9 whcih is the working draft that Carol Suitor has so ably put together, and start really on the second page which is the text, the working draft text of what Bert called the first guideline. And that's the best term for it right now because, as you know, this was originally the variety guideline.

And I would first like to make a couple of comments about our rationale for leaving variety behind and moving on to a different concept which I would like to call nutritional adequacy. And I hope whatever version we come up with of this guideline, it will be centered at least in part around ensuring nutritional adequacy.

I presented to all of you at our last meeting some analyses that I had undertaken with the staff at CNPP that led us to believe that there were concerns about the concept of variety if it was not very well defined. Those of course were unpublished analyses and therefore difficult to cite.

However, in the interim, there has bene a paper specifically on dietary variety that was published in the American Journal of Clinical Nutrition by McCrory and her colleagues; and in addition, an editorial by Ann Colston who is the incoming President of the American Dietetic Association. So I felt we were perhaps justified, perhaps supported in our initial unpublished analyses by some of what this paper demonstrated.

And I would urge you to read the paper if you have not already. We can certainly get copies for the committee. But if you have any remaining concerns about why we might wish to move on from variety as a concept, I think those were nicely summarized in both this paper and the editorial.

My summary of the article is there is variety and there is variety. And unless you're rather specific about it, we really could be accused of misleading the American public a bit. So what is evolving and I think in the right direction is that two of the other guidelines now incorporate variety into the text of the guideline; that is, the fruit and vegetable, and the grain guideline.

And, therefore, this working group is recommending very strongly that we take the word, "variety", out of the "first guideline", and instead come up with wording that will allow us to focus more on the food guide pyramid.

And the primary issue that I think has bene identified both by our working group, as well as by the staff, is whether to focus the wording of this guideline on the pyramid per se, use the word, "pyramid", in it, or be somewhat more vague and talk about the five food groups.

So one of the issues I would like to put very high on our agenda, perhaps first on our agenda is a discussion of whether the wording as it is now, which is, "Let the five food groups be your guide", is that preferable to the wording that we discussed at our last meeting which was, "Let the pyramid be your food guide."

And there were some persuasive arguments on both sides of that issue. And in spite of two conference calls, I don't believe the working group for this guideline has really resolved that. And so my preference, Mr. Chairman, would be to take up some of these issues sequentially and discuss them, and then move on to the next one if that's all right.

DR. GARZA: Now, what Dr. Murphy has done is to put the committee's concerns up front which is precisely what we were concerned about doing. No, because that -- that then doesn't get other issues on the table. But let's go ahead and see how this works. And if -- if we get through the committees' -- the working groups', the committees' and the public issues in this hour, then I'll be flexible on the remainder of the guidelines. So the onus will be on her to make sure that we get through all of them.

DR. MURPHY: I feel we have to get the wording of the guideline as a pretty high priority. So --

DR. STAMPFER: Maybe this is a hard guideline to start with because it's very broad and over-arching and kind of serves as the basis for all the rest. But I strongly support the evolution away from variety which I -- for all the reasons that you gave.

But rather than just choose between those two, you know, pyramid versus five food group, I would just carry that evolution one step further in its logic, as I think it's heading, which is basically this -- this is a guideline of nutritional adequacy.

And why not be explicit and up front and have some kind of wording that directly reflects nutritional adequacy, which means getting -- this is the only place that we have for getting, say, adequate calcium and talking about the supplements and so on, and -- and take the other issues that are already covered in the other guidelines and let them, the grains, the fruits and vegetables -- and maybe target this explicitly; you know, some kind of wording that would be -- "Make sure you get enough essential nutrients" or something like that.

I mean, I'm not suggesting that as an explicit wording, but the concept of not being a total diet, five food groups versus pyramid, but just making sure that you get enough of what you need.

DR. MURPHY: Are you chairing this or am I? You don't trust me.

DR. GARZA: I don't trust Suzanne. Rachel?

DR. JOHNSON: I want to respond to your specific query about the controversy between the pyramid or the five food groups. And I think that moving to five food groups is a step backwards because the pyramid reflects proportionality which you lose when you just talk about the food groups.

So I think it's important to include some sense of proportionality. And I think that based on the presentation by Dr. Shaw, it's clear that adequacy was a critical component of the development of the pyramid and that it is structured to at least if not meet 100 percent of the RDA for most age and gender groups, it comes very close.

DR. GARZA: Other opinion? Alice?

DR. LICHTENSTEIN: I'm sympathetic to the suggestion to individuals that they consume adequate amount of the nutrients. However, I don't think that is something that most people can do because I don't think they have a mechanism really for doing that and don't think in terms of nutrients. I think they think in terms of food.

Therefore, I think without orienting this guideline towards food, it's going to end up being something that's not going to achieve its intended goal.

DR. GARZA: Shiriki?

DR. KUMANYIKA: I think I agree with Rachel that to reintroduce the word, "food groups", might cause problems because people see that we've moved away from food groups. And the other is when you -- once you say five food groups, it locks you in in a way that the pyramid doesn't.

On the other hand, to refer o the pyramid is a bit circular as we've been told before because the pyramid will interpret the guidelines. And so it -- it -- we weren't comfortable with that before.

The only other concept I can think of that was probably recognizable to consumers is something that has to do with a balanced diet. And I wonder if there is any wording, old as it sounds, but familiar to consumers that we could use to pick up the concept of adequacy without using the word, "variety".

DR. GARZA: And as I -- as I listen to the discussion, at least with the working group, the major issue seems to be with the word, "the", in terms of, "Let the pyramid be your guide", because in fact there are more than one --


DR. GARZA: -- pyramid. And that's the level of -- of detail that leads to an enormous amount of contentiousness. But if that's correct, if that's the concern, then we're talking about not -- you know, "Let the pyramid be your guide", and there you've got this icon that suggests a specific eating pattern. And as we've heard there are a -- multiple eating patterns. And that seems to be the principal sticking point. Is that correct or am I -- have I missed the main concern with, "Let the pyramid be your guide"?

DR. WEINSIER: Well, that was certainly a major sticking point at the last meeting.

DR. GARZA: But I mean as I heard the discussion, we still are there giving -- given the comments we just heard from Rachel and others. Johanna?

DR. DWYER: I think there are a lot of different ways of eating and there are a lot of different pyramids. But as I remember, even including some that were developed at my own institution, these have not been subjected to the rigorous testing that the -- the one that Dr. Shaw presented involves.

And, therefore, I would be in favor of including the pyramid as the food guide, along with the notion of proportionality which goes along with the pyramid. That's what I don't like and why I, too, think talking about the five food groups or five nutrient groups, which is really a step backward in terms of communication, I think we also need to keep it food-based, emphasize adequacy.

I think that's very, very important; variety, pleasure, healthfulness, safety and balance. And it seems to me, that first guideline has to do with all of those things.

DR. MURPHY: My understanding is that the USDA pyramid, although there are many, is the only one that has been analyzed to ensure nutritional adequacy.

DR. DWYER: Correct.

DR. MURPHY: I don't know if Dr. Kennedy would like to respond to what Shiriki had to say. Do you want to share your concerns, if any?

DR. KENNEDY: About one pyramid?

DR. MURPHY: Well, about the circular--

DR. KUMANYIKA: Well, about the circular because we'll have the wrong pyramid in there.

DR. KENNEDY: Shiriki, since you were involved in the 1995 dietary guidelines committee, do you remember some of the same discussions where for the first time we put the food guide pyramid actually in the bulletin. I think we have to balance pros and cons. But from our point of view, trying to translate this concept of overall diet, one of the major advantages of the pyramid is the fact that it has such wide recognition, not simply on the part of health professionals, but the American consumer.

I think that the concern, chicken-and-egg guidelines, you change the pyramid, new guidelines. And we start to have a discussion informally about when the pyramid will be revised. Clearly at some point, it will be revised. But I think we look for windows of opportunity.

It does not get revised year-to-year. We look at major new release of the DRIs. And I would see that over the next three to five years. We look at analyzing current consumption patters, be that '94, '96 or later. And then we look at -- at new dietary guidelines.

And, again, we all look, you know, into our crystal balls a bit on this. But I think it was probably at the first meeting where I talked about I thought there would be zero probability of having a new food guide pyramid released simultaneously with the guidelines. Part of it is, Shiriki, the information on the guidelines influencing a new pyramid.

But it's -- it's as you saw from Dr. Shaw's presentation much more complicated than that. So I think we realistically are probably looking at a three to five-year time frame post the committee's report before we would have a new pyramid. And Carol and others may want to jump in on this.

And I think there -- the -- when one looks at the essence of that, that even with -- if you took all the possible changes that are being contemplated, I think the essence of what we have in the pyramid, the structure of the pyramid given the consumers' understanding, I like tend to highlight the similarities of different pyramids.

All the pyramids I've seen are all based on grains, fruits and vegetables. They deviate from there, but they all have the basic structure. They all -- Rachel, your point, they all try to convey through a pyramid structure the issue of proportionality.

So, yes, there is a bit of a chicken-and-egg argument, although this chicken is probably not going to lay an egg for five years.


DR. GARZA: Eileen has been you can see totally corrupted by USDA. I don't know -- I don't know if they would appreciate you using that analogy, but at any rate --


DR. GARZA: Do you want to follow up, Shiriki, or --

DR. KUMANYIKA: I do want to make a sort of follow-up comment. I think to me there is a difference between including the food guide pyramid in that guideline and basing the guideline title on that because to me it locks -- to say, "Let the pyramid be your guide", locks you into that pyramid as the guide and opens up some cans of worms.

If you have -- if you -- if you find another way to say it, then in the text you present the pyramid and you might also talk about other versions of the same thing that get to that without creating that -- having that as the only thing that people can follow. And that's what I'm trying to get at. I think it should still appear there and pick up -- pick up on it. But I'm not sure that we want to lock into it.

DR. GARZA: Roland?

DR. WEINSIER: Yes, when Suzanne first brought up this possibility of switching to a focus on a pyramid as a graphic, I -- I was very comfortable with that. And actually, I still am. I'm trying to think.

And one suggestion that I have for trying to weave together the concern that Meir brought up about focusing on nutritional adequacy; two, having a graphic that is readily identifiable; and three, thinking about what we had so much problem with the last time, and that's the multiple eating patterns to show that people do have options without trying to indicate in any sort of graphic or text that this is only one way and one pattern that we have to follow.

And my suggestion that I sent around as an e-mail to consider to try to tie these together, at least in my mind, is the labeling of the two categories or groups, the one called the milk group, the other called the meat/beans group, to perhaps change them to -- if we call it milk group, say, "Calcium-rich (milk) group", or "Calcium-rich group". Instead of calling it the meat and beans groups, call it "Protein/iron group (meat/beans)".

But if we put the label, "calcium-rich", if we put the label, "protein/iron group", we're doing three things in my mind. We're dealing with the -- with the multiple eating patterns possibility or issue because we're now suggesting that there are many ways to make it adequate because there are lots of foods within the calcium group that are not necessarily milk or other dairy; within the protein group -- protein/iron group, there are lots of foods that are appropriate, but are not necessarily meats.

So it -- it gives more flexibility to the individual. It's less prescriptive. It doesn't indicate or imply to the population at large that all subgroups have to use milk or dairy, that all subgroups have to use dairy or possibly beans.

Secondly, I think it appropriately identifies and labels those two groups. That's the primary reason why they're there is for calcium on the one hand and the protein, possibly iron on the other hand. And third, that it makes it easier, at least for me, to cross-reference the other material in this guideline which focuses on what are good sources of calcium; what are good sources of iron.

Well, now I'm tying together. I can see the food group. It's the calcium-rich group. Well, here are good sources. That gives further information in the box. When I look under iron, it ties right back to the protein/iron group. So it seems to help me.

DR. GARZA: But, Roland, I can anticipate three questions. It would be useful if you addressed them now. One was that people that felt uneasy in moving to a nutrient base which calcium-rich, protein-rich gets us back to the food group concept.


DR. GARZA: Secondly, if you look at the dairy group, it's calcium, but it's also riboflavin. It's also vitamin A. It's also vitamin D for a significant portion of the population. If you look at meats, it's zinc in addition to iron. What do you -- what -- what would be your response to those sorts of concerns if we were to follow the suggestion that you just made?

DR. WEINSIER: Well, unless you're saying that the dairy group is created specifically to provide riboflavin and vitamin D, it isn't nutrients.

DR. GARZA: It's a nutrient adequacy issue that when they looked at it, they -- when Dr. Shaw presented her analysis, it was not only looking at calcium. It looked at all the nutrients in that -- in that food group. And I just picked those four because those are the ones that -- that come to my mind. I mean, if -- as a -- as a nutritionist, I don't know whether they would come to the public's mind.


DR. GARZA: But it's not just calcium, it's these others.

DR. WEINSIER: Well, I mean, your point -- your point is valid. But the way I think we have to look at it is, first of all, what is the message we want to convey and it's got to be appropriate in sound. And then there may have to be caveats within the text that explain that if you choose to get all of your calcium-rich foods as kale, then you will probably need additional sources of protein. I mean, there may have to be some caveats.

But this whole guideline is not prescriptive to that extent. I mean, there are lots of ways to develop an insufficient diet still following this pyramid if we use all highly refined foods, all that are high fat dairy products. I mean, we can still abuse the system.

DR. GARZA: No, I'm trying to get to the issue of nutrient adequacy which is something that I thought you all were concerned about. And if we follow -- the prescription says here are calcium-rich foods, they are going to be missing other nutrients. And how do we assure the nutrient adequacy in the way that Shaw's presentation presented the -- the issues?

DR. WEINSIER: Well, what I'm saying is I think it still can be done with the text. But right now we could argue the opposite, that having cottage cheese in the dairy group, which is one of the items, is not a calcium-rich food. So if person's chose their two to three servings, we would still run into problems.

DR. GARZA: Yes, but that's not my argument. It's not just calcium. That's -- that's the issue as I see it. But maybe I'm misunderstanding the exchange that's occurring here.

DR. LICHTENSTEIN: Well, as we started talking about this during lunch, I think there are other ways of dealing with that. I think by renaming groups, a tremendous amount of confusion is going to be created and, as brought up by Bert, that that group was not just for calcium. However, we do have the boxes.

And I think that the boxes are a real opportunity to go by nutrients. So do calcium-rich. It could be protein-rich if that's what's deemed to be necessary, or iron-rich or whatever; and in the text, state quite clearly that not everybody follows the same food pattern and there are -- if you follow different patterns, there are maybe different ways of getting certain nutrients; these are the ones that are of specific concern.

And here is a box that presents food in an alternate way without really creating a tremendous amount of confusion.

DR. GARZA: Let me go to Rachel, and then Richard, and then we'll come back to Scott.

DR. JOHNSON: I just want to emphasize that I think -- I've tried to read through, you know, most of the documentation we've been sent. And most of the consumer focus group materials that we've seen from various -- I think there have been three or four consumer focus groups that we've seen. And they pretty uniformly say that consumers want food messages. And I think it's a mistake to move to a nutrient message rather than a food message as the primary message.

DR. GARZA: Oh, I'm sorry. Richard and then Scott.

DR. DECKELBAUM: Perhaps this is a bit early in our deliberations to bring it up, but we need to decide whether we're recommending to go forward with inclusion of the existing food pyramid, because we're not going to have a new one by the time this report comes out, even if it's imperfect because if the pyramid is included, then we can put our messages according to the pyramid.

If the pyramid is not to be included, then we have to have a different approach. And in the previous guide, the 1995, the pyramid proved fairly useful and went along with the text. And I think we're having a lot of discussions without knowing where we're going in terms of inclusion or exclusion of the pyramid. And I think we need to come to some kind of consensus on that question.

DR. GARZA: Well, that --

DR. DECKELBAUM: Which guides the guide?

DR. GARZA: The choices that we seem to be discussing, Richard, are two. I don't know whether we're ready to come to a decision yet. One is its inclusion with the types of boxes that Alice alluded to, to meet the concern that Roland expressed --


DR. GARZA: -- versus its elimination and moving to a nutrient-based or five food group-based alternative. But I don't think that -- at least I hear that the group is ready to come to a decision that says, "All right. This is what we're going to do."


DR. GARZA: Now, am I reading you wrong? Are you ready to decide?

DR. MURPHY: If I could re-summarize and then maybe we should ask if people are -- I see three alternatives. One is to not use the pyramid anywhere in the guidelines. And I -- there may be some of you that favor that. But I don't think it's the majority. The second is to include it in the booklet I think as Shiriki was saying, but not necessarily in the wording of the guideline. And the third I would say is whether the pyramid appears in the wording of the guideline itself.

My belief is we could probably eliminate the first of those. I think that we are going to at least reference it in here. I'm not sure we're ready to decide on the wording of the guideline itself. But maybe after -- I know Scott was next in line. But after he gets a turn, we should address those as two specific topics: Number one, should it be in the booklet at all; and then should it be in the wording of the pyramid.

DR. GARZA: Let's hear from Scott. But I'm going to table that discussion until we go through all the other issues because --

DR. MURPHY: All right.

DR. GARZA: -- because we could get ourselves bogged down and -- much like we did the last time and go through no other -- no other concerns but this one.

DR. GRUNDY: Well, one thing it seems to me is this lead guideline sort of sets the stage for all the others to come. And what's not included in there is the anticipation or the foreshadowing of the obesity, the total control of intake and as well as physical activity.

And so I wonder if it could be broadened in some way to say like, "A healthy eating pattern", or something that would indicate that -- that it really is going to be broader than just, "You eat this", because people are over- eating this and it's -- and so it's really I think -- you know, maybe it could be a broader guideline and that might help to solve the problem.

DR. GARZA: You're saying, "Make" -- "Make" - - "Make your diet part of a healthy lifestyle" or something.

DR. GRUNDY: Something like that. And it's a thought.

DR. GARZA: Okay. There is one suggestion. Then can I suggest to the chair then that we move on to --


DR. GARZA: -- to other -- unless the committee has other concerns they want the group to -- other than the -- the ones that revolve around the pyramid.

DR. MURPHY: Okay. But I need to be reassured that there is a process for resolving these issues.

DR. GARZA: We will resolve it. We'll come back to it either today or --


DR. GARZA: -- Friday. But hopefully today. But I want to make sure we get through the other -- the other concerns that were raised. So let's --

DR. DWYER: Could we get back to it today, please, Dr. Garza?

DR. GARZA: Sure, sure. We'll come back to it.

DR. MURPHY: This is scary.

DR. GARZA: All right. Let's --

DR. MURPHY: I'm a bit scared.

DR. GARZA: Let's then go to the issues. Are you ready to do that?

DR. MURPHY: The public comments?

DR. GARZA: The public comments, yes.

DR. MURPHY: All right. And was the idea to go down this list?

DR. GARZA: Or part of the list. If you feel that they've all been covered, then to reassure the group that --

DR. MURPHY: That they have been.

DR. GARZA: -- you don't see anything that is --

DR. MURPHY: So would someone -- Joan, I don't know if you would put this up on the -- I don't particularly want to stand up there. Thank you. I believe we have each been given this list, which I appreciate the staff putting together. And I actually really appreciate whoever did all these summaries that are included in our briefing book because I know that was a lot of work.

And what I would like to suggest is that we take just a minute to remind, the topics that are covered in this first guideline, whatever -- however the guideline may be worded, I believe the topics that are covered are basically the ones we want to keep in the guideline.

And so just to remind you, the major topic headings within the guideline itself are to use plant foods as the foundation of your diet -- this is all in your Tab 9. We talk about the five food groups and choosing a variety of foods. That's in the first box.

We are focused on there being many healthful eating patterns. We have a comment about specific demographic groups that may need higher nutrients and whose diets may be harder to design.

We talk about good sources of calcium and good sources of iron. We have a section now on the food labels specifically; and finally, a concluding section on the use of supplements.

And I think if you go through the topics that are up on that list, on the overhead projector, we have indeed addressed most of those issues. And I may need some help in remembering exactly what each issue was.

But focus of the diet, this was a comment about keeping variety in the guideline. It was from someone who gave testimony at our last meeting. And I think we have adequately indicated why we did not keep variety in the title of the guideline. But indeed variety is an intrinsic part of how the guideline is discussed. So I feel that we did address that comment.

The second was on meet and eggs, to I believe in particular not eliminate them from the recommended healthful diet. And indeed they are still there. I believe balance and moderation are still the focus of this first guideline. So that has been addressed.

Nutrient density and healthful foods, again, I believe that that continues to be the theme as it was the last time, to choose diets that are not high in fat or high in -- in foods that are not nutrient dense.

We had many comments in the public comment about vegetarian diets and also about vegan diets and about decreasing the focus on animal products. And I think we've tried to be very responsive to that.

We have this new -- fairly new box on, "There are many ways to do a health diet." And we've tried to give ample guidance on what people can do who are lactose intolerant, for example. If you look through the re-wording of the guideline, there is even a comment on using lactose-free or reduced lactose foods.

We've been very careful to talk about alternatives to meat products. And so I believe that we have been very careful to indicate vegetarian diets are included in this guideline. And I believe the calcium is also well addressed because we have a box on food sources of calcium.

We have not said anything specifically about functional foods which was an issue that was brought up. But we've greatly widened our definition of supplement. And we now talk about dietary supplements as well as nutritional supplements. So the decision was not to specifically talk about functional foods, but to focus more on supplement issues.

I don't remember what minerals was. But we still have a pretty good focus on minerals. We have a box on sources of iron in the diet.

"Focus on balance rather than intake for minerals such as calcium and iron." So that particular comment was indeed related to the vegetarian diets and for there -- to there being alternative sources. And so I believe that was well covered.

Whole foods and fibers, whole grains. We've tried to include extra text on choosing whole grain products often and more often. And you'll see as you look at the bold terms, that that was added in several places in this discussion.

As I mentioned, there is a new section on dietary supplements. So I believe we've covered that even more carefully than it was in the former version of the guidelines. Somebody remind me what "wording" is.

DR. LICHTENSTEIN: It was -- the recommendation was to lessen consumer confusion, change wording to choose foods from each of the five food groups and -- it was just a --

DR. MURPHY: Oh, all right. Way back at the beginning. Thank you.

DR. LICHTENSTEIN: It was in your addendum copy.

DR. MURPHY: Okay. Well, I think we -- we have definitely discussed that in great detail. Whether we will choose that wording is -- remains to be seen. But we certainly have discussed a wording that revolves around food groups. And it has not at this point proven particularly popular. But it certainly was discussed.

"Meet alternatives again." I think this is the vegetarian concern and are we giving people adequate opportunities to make non-meat choices. And I believe we have tried very hard to keep that and to expand it in this version.

"And for all, not just healthy Americans." I'm not sure that we have been able to really talk about chronic diseases, but certainly everything we're doing as far as I can tell is focused on reducing the risk of chronic disease. And I don't believe the guidelines are ever going to be able to be a prescription for therapy. But certainly we want to make sure they are for all Americans including those that may be suffering from chronic diseases. But we're not talking about therapy for chronic diseases.

So maybe I should open it to other comments by either the working group or the rest of the -- the rest of the full committee to see if you feel we have left out any of those areas or if there are any that we should go back and look at in some more detail.

DR. KUMANYIKA: I would like to open up the -- or reopen the issue of mentioning ethnic cuisines somewhere in this guideline. Johanna brought it up before. In the way that you put it, you know, it is kind of stock because with the relatively small number of vegetarians and vegans compared to the large number who eat -- and the large number of the general public who are eating from different ethnic cuisines all the time.

We need to find a way to say something about how the food groups relate to the emphasis from different ethnic cuisines. And I don't have wording for that now. But I thought if we can agree that this will not be the, you know, sort of white bread dietary guidelines from hence forth and forever more, then we could figure out the best way to do it.

DR. GARZA: You're suggesting looking at the variety of healthy patterns section and assuring that it deal with ethnic cuisines and not just the vegan/vegetarian issue.

DR. KUMANYIKA: Right, because this heading is nice, but it doesn't cover what I thought it covered when I first saw the heading.

DR. MURPHY: Where are you?

DR. KUMANYIKA: The heading and -- I'm in Tab 9.

DR. MURPHY: Page four?

DR. KUMANYIKA: Page four where it used to say, "What about vegetarian diets?". So this is the opening now to say there are many healthful eating patterns or something like that and to find a way to embrace the fact that the food choices will vary across different cuisines.

DR. MURPHY: Yes, that's a nice idea.

DR. GARZA: Johanna?

DR. DWYER: I wanted to second your concern, Shiriki. It's just that it's very important of course to reach out to everyone. But we really need to think about the large group of eaters, Hispanics, people who have African American eating styles, Asian eating styles, as well as vegan and vegetarian. There are a whole bunch of different styles in the United States. And perhaps we can include a little bit variety ourselves in the healthy eating pattern thing, emphasizing adequacy, as well.

DR. GARZA: Scott?

DR. GRUNDY: I just wanted to ask a question about that, Shiriki. Is -- are the different eating patterns and different ethnic groups, are they -- they don't compose different food groups, do they? It's more the way the food is prepared, or is there a fundamental difference in the eating composition of the foods?

DR. KUMANYIKA: No. I mean, the same basic set of food choices is operating. But what happens when -- when Dr. Shaw was presenting, there is the -- the thing that I heard coming through is that we're basing this on commonly eaten foods. The definition of commonly eaten foods has changed. I mean, half of the committee had something wrapped up in a tortilla for lunch. I mean, commonly eaten foods have changed. So --

DR. GRUNDY: But it had the same things in it. It was just prepared a different way. That's what I'm asking.

DR. KUMANYIKA: Right, but -- no, it's the same -- it's prepared differently. And there are some foods that have become common that didn't used to be common when these things were done. It's the same category, but it's different choices within that category that are coming into prominence.

DR. GARZA: But there would be changes, Scott, though taking the Hispanic eating pattern, for example, with tortillas because you can get all the calcium you need from that particular food. And how you get your riboflavin and vitamin D and vitamin A may then change because, in fact, if you're -- if you're consuming the dairy product for calcium, then -- and you're having tortillas, you don't need the dairy food because calcium is highly bioavailable if they are prepared in the traditional way, at least.

DR. GRUNDY: That's good news.

DR. GARZA: They're very high because of the calcium in line. But that's only one example. I'm sure there may be others if we put our minds to it. Are there other suggestions from non-working group members before we return to the hippopotamus in the middle of the room?

DR. KUMANYIKA: I have one more on the term, "dietary supplements". And I -- in this version of it, I can't find it. I saw it in the report to the Secretaries part. That term doesn't mean what -- it doesn't mean vitamin and mineral supplements. And we're going to have to -- if we mean vitamin and mineral supplements, we have to say that because dietary supplements to a lot of consumers means herbal products and things, you know, the echinacea they're taking for their cold or whatever.

DR. MURPHY: Right. So you're looking at the wording on page ten, "Some people need a dietary supplement"?


DR. MURPHY: Yes, I -- I think personally that's probably incorrect. What we mean is some people need a vitamin or mineral supplement.

DR. KUMANYIKA: I think that's what you mean. And the term has been defined by the shade.

DR. MURPHY: Right.

DR. KUMANYIKA: So you can't dietary supplement --

DR. MURPHY: We have to be very careful.

DR. KUMANYIKA: -- and have it be that narrow.

DR. MURPHY: Exactly.

DR. GARZA: Because no one but you have the drafts, if you can make your comments to be more issue- related than what is the word on page eight --


DR. GARZA: -- I think it will help all of us follow the discussion a bit more easily.

DR. DWYER: Could I make a suggestion for the future? Could we have the --

DR. GARZA: Lines.

DR. DWYER: -- the lines numbered on these so that we can be more specific in our comments. My comments relate to there are many healthful eating patterns. And the part that says, "If we choose not to eat other animal foods, you can easily get enough protein", and I think that should say, "from a variety of grains, beans and other vegetables. And if you eat no animal foods at all, you will need" -- "also need a source of vitamin B12, D and iron."

DR. GARZA: We're going to come back to the specific text before this process is over. And so if it is a generic issue that is broader than wording, then I sort of want to encourage you to bring it up. If it would fall more easily under wordsmithing, then let's wait because we'll have a whole week, maybe a five-day meeting so that we can all go down word-by-word. I mean, that's -- that's what happened at the last committee meeting almost.

DR. MURPHY: That's a threat, not a promise.

DR. GARZA: That's a threat, that's right, not a promise. That's correct. Now, it's 2:30. I'm expecting that we are not going to have as long a discussion on food safety, but maybe I'm -- I'm being too optimistic. So I'm going to extend this one for 30 minutes and then be prepared to suffer the consequences if my expectation on food safety is wrong.

DR. DWYER: Just two additional generic comments. One is I don't know how to phrase this, I guess what I'm trying to do is get the idea of plant-rich diets instead of -- it doesn't seem to come through quite as much as -- as strong as it needs to. The other issue is, is it -- do we really always want to say fruits and vegetables first or vegetables and fruits?

DR. GARZA: Well, that would fall under wordsmithing. Let's hold comments like that until a later date.

DR. DWYER: It's more than wordsmithing. It's -- I think there is reason from my reading to think that maybe the vegetable part is more important.

DR. GARZA: Okay. Alice?

DR. LICHTENSTEIN: We actually do less well as far as consuming fruits than vegetables according to the Healthy Eating Index. So that's one reason to put the fruits first.

DR. GARZA: Okay. Are there other issues that you don't think are well covered in this guideline? And it would be useful to have some discussion -- I don't remember whether it was Scott or Shiriki that suggested changing the guideline to read -- to be broader than the diet and incorporate some of the -- I think it was Scott -- in terms of, you know, make the diet part of a healthy lifestyle or something along those lines. Rachel and then - - was it Johanna?

DR. JOHNSON: In the area -- in the part of the text on growing children, teenage girls need higher -- have higher needs for some nutrients. There is no mention of folate I believe. And I think that given that we fortify our food supply with folate, we probably ought to say something there.

And I just wanted to clarify that this is all fact checked at some point, is it not? Because there are some things in here that, you know, I don't know if I should go to the detail of fact-checking it all.

But, for example, like breakfast cereals -- "Some breakfast cereals contain more folic acid." I'm not sure with fortification now of breakfast cereals, I think that there probably are still some cereals that are higher than others. But based on fortification, that statement is a little misleading because most cereals would be --

DR. GARZA: You're the fact-checker.

DR. JOHNSON: We are. So the agencies don't fact- check the documents.

DR. GARZA: This is our document. No, I mean, the eventual document will be. This is our recommendation. So this is -- if there are facts you are concerned about, you should point those out. Let's check them -- let's check on them.

DR. MEYERS: You can ask staff to check facts. I mean, if it's an FDA issue, you can ask us and we'll, say, you know, check the regs.

DR. GARZA: But you shouldn't expect them to originate the question.


DR. KENNEDY: Could I just add, before we release the -- the bulletin and we talk about good source of nutrients, we actually go back to the nutrient databases and make sure that is still current.

DR. GARZA: Johanna?

DR. DWYER: I -- I just want to make sure that we convey a strong message about pleasurable and healthful eating. And what's written so far doesn't really do it as far as I'm concerned. A four-prong message I think that's related to pleasurable, healthful, safe eating in the context of physical activity, as Dr. Grundy suggested and based on the pyramid eating plan, might mean something more to consumers than what we've written so far.

And also, related to that, I think we need to get in that emphasis Dr. Grundy said about active and healthy lifestyles rather than solely the emphasis on weight.

DR. GARZA: That's the fun and frivolity part of the committee.


DR. MURPHY: May I also raise another procedural question? There is at this point -- in the last version, t here was at least -- I don't know -- three or four pages called the Introduction I guess. And I notice no one is currently rewriting or writing that. And possibly some of the issues that are currently being discussed would best go in the introduction instead of just one guideline.

UNIDENTIFIED VOICE: That's a good idea.

DR. GARZA: Carol and I will draft the introduction and bring it back to you for the next meeting. So if there are issues that you feel would be best covered there, then let us know and Carol will take notes and we'll draft it over the summer. I'm trying to find a way to get to New Hampshire anyway.

DR. KUMANYIKA: I think I would suggest that the introduction is not -- anything that is in the introduction is going to get lost because it will not appear as a bullet. And I remember working on that introduction the last time. There is a lot of -- there are a lot of things that we want to say. And some other national dietary guidelines say those things as part of the guidelines, enjoyment of meals or, you know, roles of food other than this technical version.

So it might be fine to draft it, but we should consider making that information one of the guidelines for eating. It has to do with a context for eating and lifestyle. And to put that up front as opposed to being so medicinal about what we are prescribing to people.

DR. GARZA: Any other comments? All right. Then let's return. Oh, Linda?

DR. MEYERS: Let me raise a broad question. As you're thinking through and you get back to thinking through titles, whether in fact the title as it now suggests really does cover or will relate to consumers what's actually in that guideline. Variety was a catch-all term that had a lot of failings. But it did -- you could at least rationalize supplements fit under variety somehow. I think you need to think through whether the title now does that.

DR. GARZA: And that's precisely where we're moving to unless people have other issues they want to raise other than the title. Richard?

DR. DECKELBAUM: I would like to second that concept because at the introduction in the 1995, a lot of the things that have just come up in the last six or seven minutes are actually included in the introduction. So -- and it may be lost. And if the first guideline were, following Scott's suggestion, "Make a healthful diet" -- or make some diet -- "Make your diet part of a healthy lifestyle", you could cover all those points including the points that are currently under guideline number 1. And it may be a way to go.

DR. GARZA: Okay. Then let's move on to that. We now have various options before us. And maybe Suzanne wants to go back and review them. One is broadening the guideline. Eliminating the word, "pyramid", from the guideline, but incorporating into the body of the text; using it in the guideline and including it in the text; and eliminating it completely from the text or the -- or the guideline itself. And I think those are the principal ones that have emerged. Is that right? Can we hear advocates for any of the four?

DR. STAMPFER: I'm fighting a losing battle, so I will be very brief. But I did want to go on the record --

DR. GARZA: You could join the winning side then.

DR. STAMPFER: -- that I think we should not refer to the pyramid at all. The pyramid flows from the guidelines and it's not just a theoretical issue because it does come from -- it's supposed to come from the guidelines. And just because we can't have a new pyramid to conform with the new guidelines shouldn't mean that we shouldn't change our -- our guidelines. There is a clear chicken-and-egg issue here.

And why shouldn't we refer to the pyramid? Well, I think the pyramid is -- first of all, there is no evidence that I know of that shows that adherence to the pyramid actually improves health. And it's -- far too -- provides far too much emphasis on animal foods. There is an inadequate distinction between quality of carbohydrate. There is too much emphasis on carbohydrate as a main source of calories. And there is too much restriction of polyunsaturates and mono.

So I think there is lots of reasons how -- why the pyramid can be improved. And I think we should just use our best scientific judgement to make the best guidelines we can and whatever follows will follow.

DR. GARZA: So you're -- you're recommendation is to say what is the guideline.

DR. STAMPFER: My recommendation is if this is to be an adequacy guideline, to make it an adequacy guideline based on a best scientific evidence without reference to the pyramid.

DR. GARZA: Can you suggest some wording?

DR. STAMPFER: For the bullet or --

DR. GARZA: For the bullet.

DR. STAMPFER: Well, I like that one that Richard had about -- or Scott's -- part of the healthy --

DR. GARZA: "Make a diet part of a healthy lifestyle", or something along those lines?


DR. GARZA: Any other discussion, comments? Are you all in full agreement with Meir then in everything that he said because silence is -- silence is agreement.

DR. MURPHY: Silence is not consent.

DR. GARZA: Is consent, that's right. See how we can bring people back to life?

DR. MURPHY: Yes, that's very good. A good chair here. Let me just say that after spending many years working with consumers, I feel you have to operationalize nutritional adequacy. Just telling the man or woman on the street to consume a nutritionally adequate diet isn't very helpful. And for me the pyramid is the tool that I've been able to use to communicate nutritional adequacy to consumers. And I don't know of any other tool that does that.

DR. GARZA: So are you suggesting then make the pyramid a basis for your diet as -- we should keep the bullet as it presently is?

DR. MURPHY: I would certainly go along with that, but I'm willing to hear other views, as well. I feel very strongly the pyramid should stay in the booklet.

DR. GARZA: How do you feel about that, the -- the guideline that Meir just endorsed in terms of, "Make the diet part of a healthy lifestyle", or something along those lines as an alternative to your first choice?

DR. MURPHY: I don't think that's actionable.

DR. GARZA: Okay. Johanna?

DR. DWYER: I share Dr. Murphy's views in terms of the -- I would go a little farther. And I think the pyramid should be included in a guideline. My -- I'm not sure I agree with you, Dr. Stampfer, in your view that the pyramid comes from the guidelines. I think the pyramid is based much more on the dietary reference intakes which are separate. And so I don't see the concerns quite as you do.

DR. GARZA: Well, there are three parts to the pyramid. We should be clear on that. One is the guidelines. The second is the DRIs.

DR. DWYER: Right.

DR. GARZA: And the third are eating patterns -- predominant eating patterns in the U.S. And we should keep that in mind.

DR. DWYER: Yes. And I don't see any reason why any of the things we've considered that are in this book or that have been brought up by anybody who has spoken so far can't be included in the way you adapt the pyramid to your own eating patterns, whether you be Hispanic, African American, Asian or vegan/vegetarian.

DR. GARZA: Okay. Richard?

DR. DECKELBAUM: I think a number of the points that Meir has brought up are indeed valid and are in fact being incorporated in different parts of the options that we reviewed and put into the current proposed text; so that it's already happening.

I would look -- I mentioned this at our previous meeting, that the pyramid is a tool. And when you have a visual tool with few words on it, you can adapt your text to emphasize or de-emphasize part of the picture. And since we're not going to be able to change the picture very much, I think we're making some strides forward in changing the text that goes with the pyramid.

And I think that it would be difficult to get the message across as clearly as we would like without the pyramid. So as I said, some of us feel it may not be perfect, but it's still very, very useful.

DR. GARZA: What sort of guideline would you favor as a bullet?

DR. DECKELBAUM: I would favor, "Make a healthy diet part of a healthy lifestyle."

DR. GARZA: How would you respond to Suzanne's concern that that's not actionable?

DR. DECKELBAUM: I don't know why it's not actionable.

DR. MURPHY: What is a -- what is your definition of a healthy diet?

DR. DECKELBAUM: That whole section will then describe it. And that's what the guidelines are about. That's --

DR. GARZA: It's, "Make a diet part of a healthy lifestyle." So that's -- is that -- is that the wording that you were suggesting?

DR. GRUNDY: Yes, but I've been thinking about, you know, Suzanne's comment about that. Maybe we're talking about two different things. You said that that might be included in the introduction. I think Richard pointed out that, you know, maybe people don't identify with the introduction too much.

Maybe there could be an overriding -- instead of having an introduction, maybe that could be a bullet, and then Suzanne's more specific about variety of the food groups could be the next one, because I think that's an important concept that we want to get across, is that diet is only one element. It's not the whole story for healthy living, prevention of chronic disease. And it ought to be incorporated and built in.

DR. GARZA: So are you suggesting that as part of a title for the introduction or as an eleventh guideline?

DR. GRUNDY: Well, either a title of the introduction or something so that it is highlighted and it is really brought out subsequently. And --

DR. GARZA: So you would be willing to go with either one. You don't have any strong feelings for either.

DR. GRUNDY: Yes, I don't really have any strong feelings where it could go. But I think that that is going to be an important message for our new guidelines, is that it's going to be part of a healthy lifestyle.

DR. GARZA: But you would not be in favor of making it -- replacing the variety guideline and moving information from the introduction into that first guideline --

DR. GRUNDY: Well, I think it's --

DR. GARZA: -- which is -- I think it's because Richard was --

DR. GRUNDY: -- discussing which is the most effective. I'm not sure I can --

DR. GARZA: All right. Alice?

DR. LICHTENSTEIN: I have problems with the wording, "Make the diet a part of a healthy lifestyle" because I don't understand what "the diet" or "a diet" would be. And I thought we had discussions the previous meetings about what the consumer viewed as diet and that it might be something restrictive like a weight loss diet.

So then I come back either, "Let the pyramid be your guide", or, "Let the food groups be your guide." But in reality, the food groups are the pyramid. And then thinking about what Shiriki brought up as far as flexibility to incorporate and acknowledge different ethnic cuisines. And I was, you know, thinking about the, you know, rice and beans and all those things, that it seems that there is that capacity within the -- I don't see where there isn't that capacity within the current ones and for cuisines that don't incorporate things like dairy products, t here is going to be language that can acknowledge that there are some dietary patterns that don't do that and "Refer to box X", and this is sources of high-end calcium.

DR. GARZA: So you're suggesting --

DR. LICHTENSTEIN: "Let the pyramid be your guide."

DR. GARZA: "Be your guide." So we have three, four --

DR. DWYER: May I add that that's from the author of another pyramid, the Tufts pyramid.


DR. GARZA: The floating pyramid, Alice.

DR. LICHTENSTEIN: I would just like to say that the Tufts pyramid is really just a modification of the USDA pyramid and is totally consistent with the USDA pyramid. And I would like to acknowledge that publicly.

DR. GARZA: And I was told that it was really based on ice.


DR. GARZA: This was not intended to sink on its first float. Shiriki?

DR. KUMANYIKA: Is it -- this is a question for Eileen. Is it possible that this booklet would ever come out with other pyramids, with anything other than the main pyramid in it? I was looking at the nutrition insights which is mentioning ones from -- from old ways. But I'm wondering, has the USDA -- do you have materials that translate the pyramid so that it's conceivable that if you use the pyramid as a rubric, modifications to show different emphases could appear in there?

DR. KENNEDY: Let me talk about -- I mean, potentially sure. I mean, potentially one could think about recently the department released a children's food guide pyramid which at least at first wash is very popular. And the same underlying food guidance system is there. Richard, your earlier comment about that blank side. Well, on the kid's pyramid, this is physical activity.

Another is the serving sizes. Now, when we did that particular piece, the CMPP, we had actually done Gifford and others from All Ways In to talk about the scientific basis for developing their pyramids versus ours. And some of the technical aspects that are necessary in order for us to go through clearance, through very tedious reviews, just weren't there. I mean, linking it to very specific -- by age, gender groups, DRIs, RDAs; linking it to actual consumption patterns.

Having said that, Richard Deckelbaum and I were recently together at a conference where -- and Shanthy's not here -- Shanthy and I did some analysis where we looked at consumption patterns of Hispanic women and children, African American women and children, Asian women and children. Those could be the basis of a different food guide pyramid, but you would have to think about those three linkages which Cutberto also talked about, the DRIs, the dietary guidelines and consumption patterns.

And the reaction we got as we were discussing some of the -- these are actual consumption patterns -- was a fairly lengthy discussion of whether proliferation of pyramids is more confusing or less to the consumer. And I think that was -- these were people outside of federal government. And there were a number of people who thought that in some ways, the proliferation of pyramids was confusing and it was easier to have one -- this isn't based on any -- so, I mean, I think all of us have to take this under advisement.

I think it's -- part of what I hear people here talking about is not so much the infinite number of combination of foods which are possible in our food guide pyramid, and I think the are. But I think what we're getting into is how does that get communicated.


DR. KENNEDY: And I can see, and we've -- we've actually done this in some interventions in child care programs, some WIC nutrition education where we take the USDA pyramid and in South Bronx, for example, heavy -- this particular area -- Hispanic population talking about how you translate the food guide pyramid, the one you see, into an eating pattern, what the implications are for kinds of foods you purchase, what you're eating out, etcetera.

That's more of a communication piece. So it could go in a variety of ways, Shiriki. I just think it -- we would have to be clear that what we're putting forward helps communicate to the consumer. And I think we do an awful lot of consumer testing before we went that route. So it really is what do we -- what do we want our visuals, our tools to be, our primary tools, versus what do we want some of -- and almost the many bulletins to be.

But I -- I never rule out anything. I mean, I think they are all possible. It's just a question of where we're going as far as our communication strategy.

DR. GARZA: Okay. Roland?

DR. WEINSIER: Yes, in trying to think of a compromise that will help at least Meir and me, except the fact that the pyramid in my view, and supporting Meir, it does suggest too strongly emphasis on the animal products.

If, however, we were to choose a title, something like, "Choose a healthy eating pattern", it conveys a lot of the text, "There are many ways to create a healthy eating pattern", "There are many healthful eating patterns". We then given flexibility for ethnic choices, food variety, whatever, vegetarian styles.

At least the text now -- I mean, the title is leading me into a text that's just I can choose a healthy eating pattern that I'm -- I think there are going to be options there. I'm still going to be hit with that graphic, unfortunately. But if that's the way we have to go, this would help me feel more comfortable and then give perhaps Suzanne and me some flexibility, and others on the committee.

DR. GARZA: That may be quite -- thank you, Roland. Is there -- Richard?

DR. DECKELBAUM: I would just add that if this were going to be the introduction and the first guideline, that it be, "Choose a healthy eating pattern" --

DR. WEINSIER: "Choose a healthy eating pattern".

DR. DECKELBAUM: -- "as part of a healthy lifestyle".

DR. GARZA: Johanna? We'll wordsmith it. Don't worry, Meir.

DR. DWYER: I'm concerned and I don't agree with that because I don't see the actionability of that guideline. It's so vague as to be meaningless. And it doesn't convey the adequacy concern which I'm really very much concerned about, nor the proportionality. So those are my concerns.

I should also add that at the state and local level, some groups have taken the USDA pyramid and adopted it in a number of innovative and creative ways. Ann McPhearson Vasanchez has done that in the Commonwealth of Puerto Rico. And it's -- it seems to work quite well according to her.

DR. GARZA: Okay. Are there other reactions or responses? If not, I think the working group has enough -- no? You want a decision. Well, you --

DR. MURPHY: I would be happy with a process for coming to a decision. But --

DR. GARZA: Well, a process would be that in fact you take the input we've received, draw up the text with a recommendation that will either be adopted or rejected at the next committee meeting. But in trying to come up with -- there seems to be a predominant view that the pyramid be included; that there is a sense that, gee, we ought to make the guideline actionable, but perhaps more broader -- or broader than it currently is to incorporate some of the concerns that Roland voiced in terms of -- of not directing somebody to a specific eating pattern, but something more broadly. And it could be more broadly interpreted.

But we seem to have agreed that whatever is there will incorporate the icon with the hope that in fact the chicken will soon lay an egg and we will have others to replace it with so that with the new guidelines, one can have a more consistent icon, consistent with all three parts and with changes in eating patterns in the U.S., as well.

So I -- I don't know that we can get much further than that in the full committee meeting without responding to a specific text. I think if we try to write it here, we're not going to come to any agreement. We could be here all day and we would still have some debate. But that's the Chair's sense. Maybe I'm -- I'm being too pessimistic.

DR. MURPHY: May I suggest a process?


DR. MURPHY: That doesn't involve my having to make the decision. I believe we should consider that we've gone beyond the working groups and try to use an e-mail process to poll the full group. I think what I've heard are several alternatives. And what I would like to do is summarize those, e-mail them to the rest of the committee, and ask for you to rank them or reword them. And let's -- let's get a process going whereby we can come to at least a majority decision.

DR. GARZA: My only concern with doing that is that somebody may have a much better suggestion than the majority view. As long as there is some -- some ability to respond as a group so that everybody sees everything that everybody is suggesting -- and we could either vest a group with that and then choose the three options and then send those out. But just doing it blindly and saying, well, if six vote one way and five vote the other, then the six win is -- is a bit risky as a process.

DR. MURPHY: I would see it as an iterative process.

DR. GARZA: I would feel comfortable with that. How does everybody -- say, the group feel?

DR. KUMANYIKA: Good idea.

DR. GARZA: Okay. So this is just for the bullet or all of the -- the supporting documentation? Because if you're going to make a suggestion, then you must support it with some documentation. It won't be enough to tell Suzanne, "This is what I recommend", for either text or bullet. I mean, if it -- so you remember -- remember that we have a text to forward to the Secretaries along with the recommended changes. Everybody understands that.

DR. MURPHY: And an addendum to that. There -- I know many of you, I assume, have suggested changes on specific sections within this guideline, probably within all of them that we simply haven't had the time to get to. For example, Shiriki's comment about the dietary supplements. I've -- we really haven't had time to even talk about that section.

So would it be possible in this same iterative process to address more than just the wording of the guideline, but anything else that you or I feel that we didn't get to in this discussion?

DR. LICHTENSTEIN: Having been part of that working group, what about the sub-topics? Is -- it is -- besides the text underneath it, does anyone have any concerns -- would you agree, Suzanne, that we have to --

DR. GARZA: I'm assuming that they're not because we asked if there were any other questions.

DR. LICHTENSTEIN: Okay. Great. Okay, good.

DR. GARZA: Well, maybe -- was that an assumption? Did everybody -- I mean, you were sent the -- the drafts before hand. So you -- we heard one from Shiriki that said, "Gee, the healthy pattern one is not very conclusive."


DR. GARZA: So I assume that in fact we had that discussion. You are being held accountable for raising issues. And remember, silence means that you agree.

DR. DWYER: Can we just pass in all the nickels because I've got 25 and I'll be glad to --

DR. GARZA: No, that's -- I don't want to get into the wordsmithing nickels. I mean, if we do that, we're going to be here -- just pass them on. If there are major issues, I mean like there is a heading missing, because we don't discuss botanicals and you feel that botanicals should be there; or, gee, we don't recommend that everybody have their bone density checked because you feel that's very important, then you -- this is the time to raise it because by the time we come back, through a combination of the iterative process that Suzanne suggested and the drafting that the working group may be doing, we hope to have a near- final draft for your final approval the next time we meet. So that eventually you'll be sent text before the next meeting, not only on the guideline and the supporting text for the guideline, but for the documentation that's going to the Secretaries. So make sure that you read both. And that's what I meant by having the reviewer's hat on.

DR. KUMANYIKA: Let me just raise one more issue of the group, even though it may be covered under the sugar guideline. If we could consider beverages -- given beverages more prominence, I think it would be important in the overall pattern guideline because I think consumers, from what I've seen in some food frequency data and so forth, consumers are missing the point that beverages can contribute a lot of calories and can be a part of the overall -- are a part of the overall dietary pattern because the word, "food", doesn't imply that. It's not enough to pick it up in sugar and weight. We should talk about foods and beverages more clearly than -- and not just milk and orange juice which is what we --

DR. GARZA: Rachel?

DR. JOHNSON: I would like to second that, Shiriki. And also, because of some of the work that Barbara Rose and Rick Mattus have done that says that people don't seem to be able to compensate as well for the energy that they obtain in beverages as they do in whole foods. So I would like to second that.

And also, I had -- since you challenged us to bring anything forward --

DR. GARZA: That's right.

DR. JOHNSON: I think in box two and box three in this, I really would like us to take a careful look at including -- at looking at the percent of the population that actually consumes some of the foods that are listed here and also bringing in the issues of diversity.

For example, soy-based beverage with calcium is listed twice under the milk group and then on box three as a good source of calcium. I'm not really sure that consumers even know what that is or what percent of consumers actually even consume it. So I have some concerns about putting some foods on these lists that are so rarely consumed by Americans that they're almost unidentifiable to them.

DR. GARZA: All right. So would -- who is the staff person who is helping with the variety guideline?

DR. MURPHY: Carol.

DR. GARZA: Carol, can you make sure that you look at that, see how commonly those foods are consumed? And if there are substitutes that one can use that are more commonly employed by Americans that achieve the same dietary end? Any other -- any other points? Richard?

DR. DECKELBAUM: I think we've gone through the major points relating to the former variety guideline including whether the introduction should be included under it. And I'm concerned about what process would be best because we've heard the major issues. They're really more of presentation issues than issues -- except for some of the points that have come up that are where wee need more scientific evidence.

And I'm -- I'm just wondering, if we open it up to the whole committee now to give you further input, I think we -- we've just been through that process in the last hour. And I think the approach in terms of process would be to get together with -- there already is a working group for the former variety guideline. And you would be part of that and Carol. And to take what we've heard today with the pros and cons and try to draft another -- draft another formal variety guideline and then present it to the group so we can give our comments back.

DR. GARZA: Well, I'm assuming that's what -- what Suzanne had in mind, that in fact they would take the next draft and begin that iterative process --


DR. GARZA: -- that would be -- would be concluded before September.

DR. DECKELBAUM: But do you need -- you -- were you suggesting that you would like further input from us before you drafted the next version or --

DR. MURPHY: I feel that our working group needs input from the bigger group in order to draft the guideline itself. I don't feel I have enough information, the bullet, the actual guideline. Because we've had these discussions, Richard, and we're -- I don't want to say hopelessly deadlocked, but we -- we have not been able to come to a consensus. And I don't feel that we can at this point necessarily either.

DR. DECKELBAUM: But again, as Bert said, it's not going to be determined on a vote of six to five or that kind of thing. I think that major issues have come up in the last hour.

DR. GARZA: Let me suggest this as a process then. Johanna has a lot of specific points. Others may -- may have a lot of specific points to send to the working group. Let me encourage all of you to send in both your thoughtful recommendation in terms of a bullet and your more -- more specific comments as to text, that the working group will incorporate those discussions, perhaps come up with two or three of the most popular bullets, send those back out for comment, react again and go through that iterative process in a way that will forge a consensus. Is that what you had in mind, Suzanne, or --

DR. MURPHY: Well, I was going to do the first round based on the comments I've heard today, but give people an option to say, no, that -- I have yet another option.

DR. GARZA: Right, so it's a thing basically.

DR. MURPHY: And just do it that way.

DR. GARZA: Scott?

DR. GRUNDY: One point I'm not quite clear on is how we came down on this, whether it is going to include this one and this particular point under the overall healthy lifestyle or whether that's going to be in the introduction. Did you decide on that?

DR. GARZA: Well, Carol and I will work on the introduction. And we would have to work close with the variety folks as we forge that. My sense would be that at the end of Friday, we -- when we -- we're going to have a discussion sometime tomorrow on whether we like ten guidelines or not, if that's too many or too few.

We can then decide if we just want the introduction with a subtitle that says, "Make this part of a healthy lifestyle", and then forge the introduction from that. But I don't -- I don't feel that at this point, we need to come to a decision that says, "Well, we need 11 guidelines instead of ten."

I think that the material that finally goes to the introduction may in large part depend on how inclusive we want to make the former variety guideline. Is that --

DR. MEYERS: So you've not -- you've not closed off the possibility that the introduction part is now the no variety guideline. It could be merged. That's still an option --

DR. GARZA: That's still, but it's not very likely at this point. But it's still -- it's still there. I mean, I -- I guess I want to make sure that we're responsive to the various bullets that people will be suggesting. And --

DR. LICHTENSTEIN: It seems that one fundamental issue is whether pyramid be included in the bullet.

DR. GARZA: It will be included. We did come to that decision.

DR. MURPHY: In the bullet or the --

DR. GARZA: Oh, in the bullet. I'm sorry.

DR. LICHTENSTEIN: Well, that -- I guess that hasn't become -- I know in the guideline, it -- it is. But it seems to me a very critical issue is whether the pyramid is going to be included in the bullet. And I -- I'm not real clear --

DR. GARZA: You -- you get to suggest that when you send your -- send your bullet to the committee that says pyramid if you want it or not.

DR. LICHTENSTEIN: I think I'm part of that committee.

DR. GARZA: Well, then -- then you can --


DR. GARZA: Because I don't know whether we're going to be able to come to that decision today.

DR. LICHTENSTEIN: I guess I don't see where we're going to be getting additional information to be any further along in four months from now.

DR. GARZA: Well, we hope that -- that in fact -- maybe we ought to give people deadlines so that we're not --


DR. GARZA: -- that unless you get in your comments by June 30th for the first iteration or do you want it July the 15th? What would be the --

DR. MURPHY: Well, let's all give this a little more thought. But maybe we could even do some sort of a poll while we're here. I think that might be real useful. So maybe we'll see if --

DR. GARZA: We already had that poll. Would you like me to repeat it?

DR. MURPHY: No. No, you haven't. You haven't asked everyone around this table --

DR. GARZA: Well, Meir -- Meir said no. Alice said yes. Richard said he didn't know, he wanted the broader one.

DR. DECKELBAUM: Not in the bullet itself, but in the --

DR. GARZA: Oh, I -- I thought you said you were in favor of Scott's for a bullet, something along -- something along Scott's suggestion of "Make a healthy diet part of your" --

DR. DECKELBAUM: No, no. But not the pyramid. The pyramid doesn't have to be part of this -- this list of bullets here which are now --

DR. GARZA: That's what I'm saying.

DR. DECKELBAUM: No, so the pyramid does not have to be in the guideline itself. But it should be in the text --


DR. DECKELBAUM: -- and the figure -- the picture should be there.

DR. GARZA: No, that's exactly what I'm --


DR. GARZA: Johanna I think said yes, that she wanted the pyramid in --

DR. DWYER: I do.

DR. GARZA: -- as part of the bullet and the text.

DR. DWYER: Correct. Both places.

DR. GARZA: Rachel said both.

DR. DWYER: Showing adequacy and proportionality.

DR. GARZA: So I'm sorry, I mean, that's what I heard.

DR. DECKELBAUM: No, so Rachel, what did you say?


DR. GARZA: Yes to both. Lesley actually had not.

DR. TINKER: No, I -- I hadn't - based on what we discussed so far, I'm more in favor of including the pyramid than -- than not. But I can't say I'm 100 percent --

DR. GARZA: Including in part of the bullet and the text?

DR. TINKER: Including it in the bullet. I'm more of favor of it. But my big question is still the piece about what drives the guidelines, is it the pyramid or the other. But it seems that it's got the actionable piece that the other suggestions that we've talked about haven't had.

DR. GARZA: Roland said neither. Shiriki, I don't recall.

DR. KUMANYIKA: I'm -- I'm against including it in the bullet, although I haven't ruled out there may be wording of a bullet. Not "Let the pyramid be your guide" because it's too -- it gives the pyramid too much weight. But there may be wording to refer to the pyramid that -- that I could live with. I'll have to think about it.

DR. GARZA: Yes, and you said like a healthy eating pattern or something to that --

DR. KUMANYIKA: Yes, I was into the "Choose a healthy", or, "balanced eating pattern", where Roland was, although it's maybe too vague.

DR. GARZA: And that's where I thought Scott was, as well.

DR. GRUNDY: Well, I'm not in favor -- I'm like Shiriki. I'm not in favor of having the pyramid in the guideline. I think it gives it too much weight and it's to restrictive and it's not enough --

DR. GARZA: So you've got a pretty evenly split group. I mean, that's -- that's how --

DR. MURPHY: That's the problem.

DR. GARZA: Yes, I know. But that's what I said, we're not going to get any further by -- at this round because we're four and four or five and five or whatever. And so that's why I suggested send in the text, send in your bullets, and we will start the iterative process that Suzanne wants because I didn't see us coming to resolution with that type of division within the committee in the next 15 minutes. And I wish we could, but I just don't see it happening.

Now, at the end, I think that if we can -- if you all go home, reflect on it, send in your comments by June the 15th or July the 1st. I know -- well, I know. It's --

DR. MURPHY: June 15th, today?

DR. GARZA: Go home and e-mail them.

DR. MURPHY: Today is June 15th.

DR. GARZA: Yes, that was the idea. Or do you want to -- July 1st, is that a reasonable --

DR. MURPHY: Well, now I'm not sure what people are going to mail in.

DR. GARZA: Well, maybe some of them will change their minds.

DR. MURPHY: Oh, right.

DR. LICHTENSTEIN: Does the chair have an opinion?

DR. MURPHY: Yes, you get to do the tie vote.

DR. GARZA: Well, the reason I don't want to express an opinion at this point is that I would to be able to serve as a -- a safe solution at the end if I see that people are deadlocked. And if I -- at least -- chairs forget that in fact they're supposed to try to bring consensus to the group rather than bring them to his consensus -- tend not to -- or to his point of view, tend not to be as effective. So let me punt on that, Alice, for a while.


DR. GARZA: I have no difficulty making decisions so that if the group gets deadlocked, you will hear a decision. You can check with the faculty of my university on that one if you -- if there is doubt in your mind.

DR. STAMPFER: I think it's a good idea. I think if we think about it a bit, these aren't the only two options. We're -- there are a lot of creative people around the table. And if we reflect on it, we can probably come up with something even better than what we've talked about now.

DR. GARZA: All right. So July 1st is a Wednesday? Is that correct?

DR. WEINSIER: Thursday.

DR. GARZA: Thursday. If you will send your comments in to -- to Suzanne by the 1st. If we don't hear from you by the 1st, you would have forfeited your input by then because we have to -- we have to bring this process to a closure. Otherwise, it's unfair to the committee.

DR. KUMANYIKA: Close of business on the 1st?

DR. GARZA: Close of business on the 1st, 5:00 postmarked or e-mail. I -- send the comments by then. That will give the committee two weeks or the working groups two weeks to filter through the suggestions. And we ought to expect then that iterative process that Suzanne described to begin by that point and conclude by -- before the next committee meeting. Is that a reasonable --

DR. MURPHY: Yes, that's fine. Sometimes I'm reminded that Hawaii is 2,500 miles out in the ocean. And e-mails actually get lost on a regular basis. So let's cc somebody.

DR. GARZA: Well, send them to Shanthy because --

DR. MURPHY: Yes. Would that be all right, for Shanthy to be the primary recipient and "cc" me on them?

DR. GARZA: That's a very good suggestion. So you will send all your comments to Shanthy. And she will then send them forward to either the whole committee or to - - to Suzanne. I mean, there is no reason why everybody couldn't see the e-mail exchange. That might actually be better so you could see what the whole committee was thinking.

DR. JOHNSON: Could we request a reminder e-mail from Shanthy next Friday, the 25th, to get our creative juices flowing over the weekend?

DR. GARZA: Shanthy, could you make a note to e-mail all the committee members that their recommendations on the former variety guideline need to be in by the 1st of July?

DR. ESCOBAR: No, no. Next Friday, the 25th.

DR. GARZA: Yes, by the 25th just to remind the group. All right. Now we have a process and now we're going to move on to safety. And rather than truncate the discussion, let's take a 15 minute break. And then we'll come back and discuss food safety.

(Whereupon, a brief recess was taken.)

DR. GARZA: Dr. Meyers, could you come to your seat, Dr. Kennedy? If the two leaders come forward, I'm sure everybody else will follow. We're sure that if the government acts, we will follow.

DR. KENNEDY: Okay, now we're going to be humiliated totally.

DR. GARZA: No, no. Of course not. You were called to leadership, see that? All right. I want to thank everybody for being back promptly. I just noticed the clocks.

DR. MEYERS: That never moves.

DR. GARZA: I hadn't noticed it before. I just came in from Stockholm. I said I wondered why they reminded me. It's really 9:00 at night. Okay. We're going to move on to food safety, a topic that is consuming European colleagues as we speak. The -- the headlines in the Herald Tribune, the British papers, the Swedish papers were all on food safety the last four days. And it is rumored that the government of Belgium fell on the whole business on food safety this weekend.

So on -- on you, Johanna, rests the stability of our government apparently if we take the Belgium example. So Johanna to the rescue.

DR. DWYER: Please forgive me for standing up here. I was going to do it from Powerpoint if it works.

DR. GARZA: Can you speak into the mike? Otherwise --

DR. DWYER: Thank you. The three issues -- the three issues you had asked us to address, Dr. Garza, were the public comments, the committee concerns and working group concerns as I heard you speak. Let me try to go first to the public comments.

As -- as I read them and as the committee has in its book, the first kinds of comments were not to have such a guideline. And the ARA, not the rifle, but the restaurant association was opposed to that. And another group of people said to separate food safety and nutrition, don't separate that. And then a third group of people said -- KISS, Keep It Simple Stupid -- don't do that. And I believe last time there was a comment by CSPI saying don't have a guideline.

The second set of comments that I saw were on the scope of the problem. The food industry -- there was some disagreement about the estimates of the incidence of food safety problems and whether deaths were correct.

There were also some comments that were -- let me see where the positive were at. Here we are. As I understand it, the document we received said that the American Dietetic Association opposed the food safety guideline. And I believe that's incorrect, is it not, Dr. Johnson?

DR. JOHNSON: The new testimony that I received just yesterday or the day before says they do support it. I can pull that out.

DR. DWYER: Thank you. I hadn't seen it, but I knew from oral comments that that wasn't correct. If it said to include it --

DR. JOHNSON: Do you want me to say what it says?


DR. JOHNSON: It says, "ADA supports the addition of a separate guideline to encourage safe food handling practice by consumers."

DR. DWYER: There were also some public comments about message consistency, that the public was confused about meat temperatures and cooking guidelines. And specifically, one letter said that the various branches of the government needed to get together on these particular issues.

And indeed, from reviewing the materials, our subcommittee found that there were differences from one agency to another. But we were able to get to some common ground using expert consultants from all three agencies with the fundamental responsibilities in that area. So I think the messages that are included in your book are consistent across all agencies of government.

There was another comment saying that the messages could include the fight BAC business, and then there was something on the scope of the problem. One of the comments I gather was that health care institutions and others lag behind commercial institutions. So those were the guidelines as I -- as I read them.

Now, if I can go back and just speak to a couple of those issues. The first is a study that I'm sorry I didn't circulate to anybody else because I just got it late Friday night courtesy of Dr. Anjulo who is one of the scientists at the Centers for Disease Control.

This is a new study. It's based on the Morbidity and Mortality Weekly Reports from about a year ago. But it's new data that gets an issue that the committee and also some of the public comments were directed to. And that is, well, are there really -- are people really doing anything that needs to be changed.

And this -- this was a multi-state survey of consumer food handling and food consumption practices. And just -- I think it's in galley proof right now in American Journal of Preventive Medicine.

The Behavioral Risk Factor Surveillance Survey of 1995 to '96 was used as the base for this. This consists of about 20,000 adults in eight different states. And what these investigators did was to focus on some questions to consumers on various food handling and food consumption practices.

And let me just show you a couple of the results that suggest that -- that speak to the issue that we talked a little about last time about consumer practices. And then later on, I'll try to address some of those other issues.

The first was what about adequately washing hands or cutting boards after contact with raw meat or chicken. And about 20 percent of all the people who were surveyed had not done that.

Another concern that seemed to be particularly -- a great concern in fact had to do with eating of -- over the past year of various raw animal foods. And about eight percent of the people ate raw oysters. I think about two percent of them were in Boston. And about one percent ate -- drank raw milk. Most of them were in the west coast.

About 20 percent of all of the people surveyed had eaten undercooked eggs. And about 50 percent had -- had hamburger that was pink. And these were -- these were behaviors that the BRFS declared as risky.

As you might expect in this respect, males were greater than females. They tended to eat more oysters and so forth, rawer hamburger. And also, high socioeconomic status more than low socioeconomic status. That's sort of counter-intuitive, but it's true.

In terms of the issue raised by the public comments of food -- food borne illness, this was the latest that I could find on that issue. This is from the -- from the food safety, From Farm to Table, a national food safety initiative report to the President. And what it suggests is estimates of food borne disease per year ranging someplace between 6.6 million and 33 million. And in your text and in prior discussions, we've talked about some of the issues there.

So let's -- I think that's all I've got on the public comments. Now let me turn to some other things. The first thing that I think is very important and I -- in reviewing the text that's in your books, I have some specific suggestions that we can talk about later perhaps to emphasize this issue that there is a lot of food borne illness that occurs further back in the food chain. And it's very important not to forget that.

In other words, we have to -- we have to deal with those issues, too. There are now two National Academy of Sciences reports that deal with some of those issues. Of course, Under Secretary Woteki talked about this last time. And any kind of effort in this direction is not a substitute for these other efforts. I wanted to make it very clear that this is not -- it -- these issues remain. They must be dealt with. And I think all of us can support that happening.

But there are precedence, World Health Organization and a number of other countries, other federal activities in the fact that food safety is a critical part of public health is important. So I think the remedy is to perhaps include a food safety guideline.

I think we reviewed the last time the reasons for a food safety guideline, that -- that healthy eating requires that food be safe and that -- that food borne illness is a major problem and it may be increasing; that there are more vulnerable people and perhaps more virulent pathogens. And the nature of our food supply is changing to become more global. At the same time, food reporting is -- is increasing.

So there still is a residuum of some food borne illness that consumers can control. It's just that it isn't all of it. And we have to deal with those other parts, as well; that there are some simple handling practices that we can employe and there are consumer actions that can complement these other efforts elsewhere in the food chain. And there is some legal basis for it that we also talked about last time.

The final new thing that I was able to find in terms of studies to answer the questions of the committee are certainly not as strong. This study is not anywhere near as strong as the work I just showed you from the Behavioral Risk Factor Survey. It has the advantage of being -- it has the advantage of being a study that was done actually in about 100 people's homes.

And they used institutional criteria of the NRA. And these were the criteria that were used in this particular little study. They set up -- critical violation was something that potentially led to food borne illness. And the kinds of things that would be regarded in a restaurant, for example, if you were trying to be certified as a great place would be that you did all of these things correctly and didn't have refrigerators that were too high or damaged cans or had a food handler who was sick or any of these other things, cross-contamination, handwashing, all of these various things that -- that you check and that public health authorities check when they go into kitchens and nursing homes and elsewhere.

The critical food handling violations that were found at home in this study -- it was published around March of last year in Food Technology -- were that cross- contamination and improper cooking of leftovers if you look at the bottom of the slide were by far the most common mistakes that people made in their homes during the periods of observation in this particular study.

So there are critical food handling violations at home that -- that are amenable to change and that can be changed. And the number out of this -- the number per family ranged from about three up to about eight in -- in the home study with very few having none.

So critical food handling violations at home really were quite common in this group of people who were studied. I think a lot more definitive work needs to be done in this area. But these are hints that there area some problems there.

If you look at major violations, that is things that really don't -- probably alone wouldn't cause a problem, but that would be contributory a problem; things like this: improper thawing, insufficient temperature use, dirty sponges and things like that, improper handling of leftovers, refrigerator temperatures that are too high and so forth. They're not -- consumers aren't batting a thousand there either.

So the basic point is that we really have to think of what we can do. So everybody is at risk. It's a special hazard for some people like older people and the young and so forth. But I think there is a reason to -- to have such a guideline. I can go on, but let's see what the committee has to say.

DR. GARZA: Are there any issues the committee wants to raise?

DR. KUMANYIKA: One additional question. I think this is -- I mean, it's only one or two studies. But at least it puts it on a solid footing. And I'm in agreement with having this guideline. Is the issue of handling food without food that doesn't have preservatives one that comes up anywhere in the literature because --

DR. DWYER: There is -- well, let's see, there are a couple of things in the text which I think is before you, Shiriki, or in the explanatory text that may speak to that. I think one line -- and Dr. Suitor, you'll have to correct me if I'm wrong -- talks about not using unpasteurized cider. Did that get in there in the final version?

DR. SUITOR: Yes, it did, cider.

DR. DWYER: Yes, it did. So that's one -- one thing that I can remember. In terms of the overall thrust of the guideline, I think there are many legitimate concerns with respect to food safety that we might address. The -- the overwhelming burden of disease seems to be bacterial, however.

DR. KUMANYIKA: Okay. So it's --

DR. DWYER: So it was a question of cutting to the chase, at least at the beginning. But these other concerns are all legitimate.

DR. GARZA: Johanna, how -- how -- would it - - would the committee then be well advised either in the -- in our report to the Secretaries to put the microbiological concerns in this larger context? Because there are at least three issues that need to be considered. One is the microbiological. Another is the chemical. And a third growing concern in the public, at least if we see Europe as a -- as a forerunner in this, is genetically modified foods.

If we had an appropriate database to deal with all three, then I think we could deal with them intelligently because much of this is just fear rather than fact. But it may be useful to have a preamble to the Secretaries' report that says, look, we realize that there are other issues. We're going to focus only on this one for these reasons. And then it at least helps direct their attention to -- to issues that we considered rather than thinking that we -- we left them alone because we didn't think they were important.

Also, in the research area, we've been criticized -- our food system has been criticized as not having a sufficient surveillance system and having efficient methods for detecting either pathogens or chemical contaminants in foods that are being imported. And so we probably should comment on the need for developing more effective methodologies for assuring the public's confidence. Those are the two issues that came to my mind.

DR. DWYER: We would welcome help from the Centers for Disease Control, the Food and Drug Administration and FSIS. I heard a very good talk by Dr. Anjulo last week about some of the systems that the Centers for Disease Control have begun to -- to put in place. And I know Dr. Woteki at Agriculture is very concerned about getting better monitoring systems in place. And I know the FDA people are, as well.

But we would very much appreciate the help of our colleagues within government in describing those surveillance systems appropriately. So we welcome -- the committee welcomes help from them.

DR. GARZA: And my main concern is that we not be perceived as saying that this committee feels that the onus is on the consumer alone and that this is a shared responsibility; and, yes, the consumer has a role to play, but certainly government and industry have very important roles; and that we state that up front somewhere so that it's not seen as, gee, it's -- it's as the consumer is the arbiter of safety.

DR. DWYER: I'm trying to get to the last slide which is very important. And the point is as consumers, we're over here. But if we don't have the systems at the farm and in restaurants and in all of these other places farther back along the food chain, this isn't going to work. So it shouldn't be -- it is -- it's a continuous process that goes from farm to table. But if we don't deal with things at the level of the producer, as well, this is all for naught.

DR. GARZA: Richard, do you have a comment?

DR. DECKELBAUM: Is this the time for -- to general points in the text that we have?

DR. GARZA: Yes, that's right.

DR. DECKELBAUM: So in the section on "Cooks food to a safe temperature", the recommendations there would I guess eliminate soft boiled eggs. But on top of that, the recommendation to avoid raw seafood such as sushimi, sushi from raw fish, clams and oysters has major implications on certain groups who do eat these things as an important part of their diet and also has implications in terms of industry, the shellfish industry, the oyster industry and habits.

So I'm just wondering if we have to take this into consideration. Are there other approaches besides cooking to ensure that oysters are safe and that sushi is safe? Because by definition, sushi has to be mostly -- I think it's all raw. There are a few little things that have actually cooked shrimp on them. But most of it's raw.

So it really has important implications for the segments of the population, segments of the restaurant industry and segments of the producing industry.

DR. GARZA: Rachel?

DR. JOHNSON: I would just like to ask a question about that. I know when you go to some sushi bars in England, for example, they pass the food through UV lights. If you've ever been to one of these things where it's sort of on a conveyor belt and they pass it through UV lights. Does anybody -- that would just be a question to ask, if that's some way of assuring safety or if that's -- I'm not sure, but we could find out.

DR. GARZA: Any other questions? Shiriki?

DR. KUMANYIKA: Well, I want to pick up on Richard's comments because these -- this guideline has some implications for some of the other guidelines. In other words, within fruits and vegetables, there are safety issues and within maybe some other categories. Sitting by itself, it does seem unrealistic if you say most food is safe and people are allowed to market these things on the market. And then you just tell the consumer, "Avoid whole categories of food."

Is there a way we can keep them from -- because if people go out with friends to a sushi bar, they either avoid it or they don't. I mean, they -- I think we need to give consumers a little bit more help with things that are sold. You know, what are you supposed to do about those things?

DR. JOHNSON: Right. Our food safety experts on the committee did specifically recommend that statement as I recall, Johanna.


DR. JOHNSON: About the sushi.

DR. DWYER: I went into this at some length with a colleague from CDC last week because he was in Boston. And there is risk. The question is how -- how do you put it in the context of all the risks in the world. But this is what our expert suggested, there is a risk from -- it may be an acceptable risk.

The other thing I guess Julia Child would say if she was here, and she's not -- she's someplace much nicer than this -- but I guess what she would say is that there is a whole body of other information that doesn't belong in a little booklet about sourcing, knowing your sources and so forth when it comes to seafood because in seafood, we're still in the hunting mode for a lot of fish. Basically, you hunt fish.

DR. GARZA: But perhaps you could look at wording that would convey risk without saying that, gee, total avoidance or abstinence is the only way to achieve safety I think is the point that is being made.


DR. GARZA: Okay. Roland?

DR. WEINSIER: Yes, I wonder -- Johanna, I think this is outstanding in terms of a reference guide. But unfortunately, I'm seeing it as a reference guide, even as a health professional. I think I would have to have this on my refrigerator to look up repeated. I'm trying to think. I -- I've read it over -- what message -- if I forgot most of what was here, what would you want to make sure that I did not miss? Is it a temperature? Is a length of time of handwashing? Is it -- because I'm thinking if Doris Dorilian read this, would she say this is very, very clear cut; the consumer is going to pick up on your key message?

And I'm not sure I have figured out what the key message is other than there is a lot of useful material here.

DR. DWYER: Well, we -- the subcommittee tried very hard to take to the extent that we could -- to take messages that had been tested on consumers like us to make sure they got the message. I think the most difficult, but perhaps the most useful message would be the issue of cross- contamination. But the business about raw, as distasteful as it is to some sushi lovers around the table, is another one that is probably a key issue.

DR. WEINSIER: I mean, my issue may get back to not wordsmithing at this point, but to consumer recommendations -- or make it more consumer-friendly in terms of bullets, pictures, boxes, whatever, saying --

DR. DWYER: Good idea, Roland.

DR. WEINSIER: -- it's the 40/140 rule.

DR. DWYER: Excellent. Yes.

DR. WEINSIER: If it's cold, it's less than 40; if it's hot, it's greater than --

DR. DWYER: Yes. Fair enough.

DR. WEINSIER: -- or something where I'm left with something you wanted me to know.

DR. DWYER: Excellent. Well, if you -- if you've got any wordsmithing on that, it would be most helpful. But 40 to 140. Life begins at 40 and ends at 140. If in doubt, throw it out.

DR. WEINSIER: Yes, exactly. Exactly.

DR. DWYER: I agree. Don't eat sushi.

DR. GARZA: And on that positive note --

DR. MURPHY: Just for clarification, Johanna, is this following the four key words of "fight BAC". The first two sections seem to have clean and separate, but then cook -- cook isn't there as a separate word and chill isn't there at all. Is that by design? I'm not sure.

DR. DWYER: It's the best we could get --

DR. JOHNSON: Those two sections I think could be labeled in a way that would call out those words, "cook" and "chill", using the -- because it says, "Cook food to safe temperature and refrigerator perishable foods promptly."

DR. DWYER: Right.

DR. JOHNSON: It's really those cook and chill messages that maybe --

DR. MURPHY: It's just the first two had the word followed by a period. And I thought, oh, isn't this nice; it's going to be parallel to fight BAC. And then the other two weren't there.

DR. JOHNSON: That's good.

DR. DWYER: I think and wonder if they weren't -- we kept trying to shrink it down to make it shorter. And we can certainly take that into account.

DR. MURPHY: Or you could take the first two out. But I think it should be consistent.

DR. DWYER: Fine. Any -- any text you've got, just give it to me and I'll revise it.

DR. GARZA: Any other comments? Johanna, the only other one I had was the practicality of the thermometer. Are there -- are there alternatives that we could suggest to the consumer because I don't think most are going to buy a digital thermometer? I mean, I just --

DR. WEINSIER: Buy two of them, one for the frig --

DR. GARZA: I know. I mean, I just -- and, I mean, I don't know. Maybe there are no alternatives and that's what we have to say because there are none. And I don't know the area well enough to suggest that there might be some guidelines that we could provide the average homemaker.

DR. DWYER: We -- that's a very good question, Dr. Garza. And it's a question I think a couple of us asked our panel of experts whom we polled because I certainly don't purport to be a food safety expert.

The -- the opinion we got was that this was the way that they thought things should go and that we would be well advised to include a statement to that effect, that this --

DR. GARZA: They had no alternative that we could include along with it? I mean, the best is the thermometer, but --

DR. DWYER: The alternatives and Dr. Johnson and others who were -- Dr. Suitor was on the calls, too, and you were, too, on some of them when you could get on them. One of the alternatives would be to try to describe what various meats look like or fish look like when it was cooked. And we can do that.

But the -- the task that Dr. Suitor has is to try to make it concise. And so we threw out all of these temperature guidelines, for example, that we talked about last time. And we also threw out a lot of descriptions of what various foods look like when they were cooked. So it's possible if you just give us more space, Dr. Garza.

DR. GARZA: Maybe the best thing we could do is put in a resource guide at the end to have some places where consumers could go for alternatives.

DR. DWYER: Excellent. And that's I think the -- the tact that Dr. Suitor took in this latest draft that's before you now.

DR. GARZA: Meir?

DR. STAMPFER: In the nutritional parts, we've been paying attention to what consumers actually eat as -- as part of formulating the guidelines. And, you know, I think that spirit should be present in this guideline, as well. I think some of these things are really beyond what even a small percentile of the population might do.

I'm not going to embarrass the committee by asking for a straw poll of how many people have checked their freezer and refrigerator for their temperature. I know I've never done that. I think a lot of these things are --

DR. DWYER: Could we make that a sex-specific poll, please?

DR. STAMPFER: Well, I think -- my point is that - -

DR. GARZA: Let the record show that Dr. Stampfer was the only one that --

DR. STAMPFER: A lot of these things are just -- are kind of extreme for the general population. I think if it's really going to have an impact, it should be scaled back to something where a lot of -- it's within the experience -- range of experience of at least, you know, a few percent of the population.

DR. GARZA: Shiriki?

DR. KUMANYIKA: To make this more practical, would there -- will or can there be boxes with guidelines for things like packing lunches? This is very home facet oriented.

And it doesn't necessarily -- I mean, for -- you know, there are people who put the doggie back in the trunk of the car and go to the theater. So even though it says, "Refrigerate all perishable foods properly", maybe a box that gives some common situations where you wouldn't do that. I mean, if it's winter, it's okay if we're in Chicago. But if you're in Florida and it's a two-hour play, you're in big trouble.

So -- and maybe also for children because there are people who are not sure what they should do because kids are -- you know, might dig their food around in the dirt and then eat it. Maybe some guidelines for food safety for kids would be nice, too.

DR. DWYER: If you're willing to forego your aesthetic sensibilities, we could make such a box, Dr. Kumanyika.

DR. LICHTENSTEIN: Okay. I'm wondering if maybe some reference could be given to reheating food in a microwave oven? That it talks about like bringing things to rolling boils if you're reheating. But I think more and more people are going, especially to leftovers, actually to microwaves. And there might -- I don't know what kind of criterion one could use. But it actually might be a reasonable way of making sure that foods are thoroughly heated through, something like that.

DR. GARZA: All right. Then it being 4:00, why don't we move on to the next guideline unless --

DR. DWYER: Thank you, Dr. Garza, but it sounds like you want about two or three more pages for this guideline? Is that --

DR. GARZA: No, no, no. We want --


DR. GARZA: Johanna, the difficult we expect from the rest of the world. The impossible from you. I have no doubt that you can be -- you can get every one of these suggestions in the page limits that were assigned originally. So --

DR. DWYER: Could I also thank Dr. Lyon and also Etta Saltos who is no longer with us. And who else --

DR. GARZA: She's only at another agency. It's not that she's dead. I mean, so she is with us. She's just not at the USDA.


DR. GARZA: I don't want her death to be prematurely reported. She ate sushi.


DR. GARZA: Either that or she didn't have a thermometer at home, we don't know. A cautionary tale for those of you that fall in Dr. Stampfer's camp. Okay. Let's move on then. And we are moving on to the grains guideline. And Richard Deckelbaum has assured me that we can do this in 15 minutes because it's going to be so non-controversial.

DR. DECKELBAUM: Maybe ten. So I think going in the spirit of how we're going to order things, we're going to do it along the lines of first reviewing questions that have come from the oral testimony and written submissions. And I prepared one for this and the staff has also prepared another one.

But I thought I would refer to this one first that I prepared before we got here because it covers a number of the issues that were brought up by staff, as well. And I think the -- in general, I think this is a fairly easy guideline. But I'm waiting to be proven wrong because it's associated with goodness. And the science base is getting better of this goodness of grains and fruits and vegetables.

And in the previous two meetings, we discussed the possibilities of separating grains from the fruits and vegetables guidelines into two separate guidelines. And in fact, when you look at the public comments, I would say that by and large the majority who address this issue are certainly in favor of splitting the guideline. And that's what we prepared for this meeting. Alice will be following with the fruits and vegetable guideline.

And the reason for doing it is based on responses of the focus group. And we've had some reviews of that in the public comments. Certainly the scientific literature and science base supports that in terms of strong evidence, especially for whole grains which we'll get to in a second, having independent health benefits separate from fiber and separate from fruits and vegetables so that there is no need to necessary combine -- to have them all together.

But a major point is in implementation because the messages to improve intake of fruits and vegetables has to be strengthened because in fact it falls behind grains, especially fruit intake which falls behind vegetables. And Alice will be addressing that later.

So we've reviewed the option and decided to propose that we go ahead with two separate guidelines. And that is in keeping I think with public comments.

Increased emphasis on whole grains. And actually, I don't have the wording of the proposed guideline in front of me, right here. But we've included especially whole grains in the guideline itself because we feel that there are specific benefits based on scientific evidence that are associated with whole grain intake.

That's been addressed in the guideline itself and throughout the text. So that takes care of -- oh, there's the guideline. She was -- that's it, sorry -- behind me. So that was a major change in terms of the guideline. And it's been strengthened throughout the text that the committee has in front of it.

The question of glycemic indices came up in a discussion this morning. Unfortunately, I wasn't able to be here. But I did get a summary. And, again, this is a -- an area which is of high interest, not only to this group, but I think to the nutrition community at large.

And because this -- it's really an emerging area, it's not mentioned in the text that goes along with the guideline. But it will be addressed and it is included in a couple of sentences and referred to in the green book, and perhaps will be emphasized greater -- more in future -- future committees.

But after discussions among the working group, we have decided not to address it within the text of the guideline and the book itself.

This is the -- the list of topics that I was provided with just before the beginning of the meeting. And I think we've addressed some of them. I don't know exactly what, "Maintain current recommendations", refers to. Can anyone help me on that?

DR. GARZA: Keep them together I think.


DR. GARZA: To keep them together.

DR. DECKELBAUM: Don't split them.

DR. LICHTENSTEIN: No, it's referring to the six to 11 servings.


DR. JOHNSON: Keeping them at the base of the pyramid.

DR. GARZA: That's right.

DR. DECKELBAUM: Well, we are -- we're maintaining that. The glycemic index I've just referred to, whole grains and the increased emphasis I've just discussed.

Plant-based diet. It's actually interesting, when you look at the current text, plant-based -- plant sources is not specifically emphasized now, but it is emphasized in the first former variety guideline. And whether we should re-emphasize it again, I mean, I just don't know where grains come from other than plants. But we're -- I think we would be willing to entertain emphasis of plants again here.

Enriched whole grains. There is actually a section in the new text which refers to enriched grains as a good source of folate. And I think that's taken care of. Vegetarian diets we discussed earlier. And that's going to be part of the first guideline.

And complex carbohydrates, we -- I'm not sure how to separate that out from glycemic index. And it may fall more into the discussion on fruits and vegetables and whether potatoes are a good source of complex carbohydrates. So I will leave that to Alice to address. Are there any comments on what we've reviewed so far?

DR. DWYER: Richard, on the -- the plant-based diet, is there a way to call it plant-rich instead? Is there any way we could do the wordsmithing because they are two -- what I find is people interpret that two different ways. I think what the -- what I -- what I think I'm trying to say is plant-rich.

DR. DECKELBAUM: Are you referring to grains specifically or --

DR. DWYER: Yes, well, for everything. It's the comment down there.

DR. MURPHY: It's not in here. That's someone else's comment.

DR. DWYER: Oh, okay. I see.

DR. DECKELBAUM: Yes, these are from public comments. And I think we largely address it, as I mentioned.

DR. DWYER: I thought you were saying you were going to --

DR. DECKELBAUM: No, no, no. This isn't my --

DR. GARZA: As we begin this discussion, I want to make sure the committee considers that an important context because this is the first guideline where we're going to be looking at specific health claims. And given your federal legislation, anything that you say as a committee can be used to base a health claim on.

So if we say that fiber helps diverticulosis, theoretically now, someone can take our statement of that as a scientific consensus and put it on the label. So that you have a role that's quite different from what other committees have had because of new federal legislation. So that it -- it makes it all the more important that as you go through these guidelines and you see health claims being made, that you feel comfortable that you can defend from information that's in the published literature.

DR. DECKELBAUM: Well, again, Bert, following your guidance and looking at this with a reviewer's hat on, which I think we'll all have to do very carefully, I think all the statements that are in the current text can be supported by good science.

DR. GARZA: And this doesn't apply only to this one. It's the rest of the guidelines that are coming because I think there are health claims in each of them. Keep that in mind.

DR. DECKELBAUM: But I think if anyone does have any doubts, it's probably a good time to raise it now.

DR. JOHNSON: I just think this -- we've talked a lot about servings versus portions. And what I hear constantly is this six to 11 servings thing. So this may be a good place to again re-emphasize this concern about portion sizes and people misinterpreting. So it may be a good place to put a box to really say what do we mean by a serving of a grain product, you know, half a cup of rice, one slice of break.

DR. LICHTENSTEIN: That's actually in the first guideline. But we could put a reference to that box that's in the first guideline because that comes up with fruits and vegetables, also.

DR. JOHNSON: I guess based on -- oh, I'm sorry.

DR. GARZA: Go ahead. Well, why don't you finish, Rachel.

DR. JOHNSON: I guess based on your comment, Bert, I would just like to ask the committee if everybody feels comfortable with this bold statement that, "Folate may help protect against coronary heart disease and certain cancers", because my understanding now is that that's not a recognized health claim for folate. So --

DR. GARZA: Thank you. That is. I mean, and that was one that I had in mind.

DR. WEINSIER: Yes, I would like to know how a consumer group -- focus group would respond to this guideline. My reaction is that whole grains are good for preventing hemorrhoids. But if I want to prevent the big stuff, cancer and heart disease, I'm going to use enriched grains.

DR. DECKELBAUM: You're talking in terms of folate now specifically?

DR. WEINSIER: Well, because it jumped out at me. I mean, that's -- it was a separate category. It's -- because everything that led up to it is just whole grain. All the important things of whole grain, I'm convinced so far. And all of a sudden now if I switch to enriched grain, then I get the folate. Then I protect myself from the big disease. And I forgot everything else I read because the rest of the stuff is on the hemorrhoids and stuff.

DR. LICHTENSTEIN: I was actually going to make the same point, that -- that I'm concerned that we've gone so much towards whole grain. And when you see the claim for whole -- or -- or the text for, "If you eat plenty of whole grains such as whole wheat bread or oat meal, you may reduce your risk of cardiovascular disease, certain types of cancer and bowel disease." I thought the same thing with respect to cardiovascular disease, enriched -- and the form of folate that is enriched would certainly apply.

So I think we should re-look at this and maybe we've gone a little bit too much in the whole grain direction. Whole grains, you know, as far as enrichment goes -- with the onset of enrichment in whatever it was, the '30s or whatever, suddenly all sorts of deficiency diseases essentially were decreased and you could almost make, you know, a claim for that, not that I'm suggesting it. But that I think we need to also acknowledge enrichment and fortification.

DR. DECKELBAUM: Okay. Well, we do. But just one question along with what Bert brought up in terms of what we write here will then be the basis of health claims. And the current text reads, "May help protect". Now, on the basis of -- does that warrant a health claim?

DR. GARZA: I don't know. I mean, I --

DR. DECKELBAUM: If we write, "may"?

DR. GARZA: I wasn't -- it wasn't aimed at any specific text. But I'm just saying that you need to be very careful. That was one which certainly alerted me to the care that we need to take precisely because I think -- it was Rachel or Johanna, I'm not sure whom -- I mean, current data doesn't support that folate has much of a role to play in heart disease. Now, there may -- there are a number of trials that are ongoing. And those trials may -- may prove that in fact they do. But up until now, I've not seen any data that's very convincing.

DR. STAMPFER: Maybe you can just clarify how far we can go. I mean, there certainly are data, observational data relating folate to -- to reduced risk of coronary disease. There is no randomized trial data. But if we base all of our guidelines on randomized trial data, we're going to have a very slim book. Is that -- do we need to have consistent randomized trial data for every statement?

DR. GARZA: I have to turn to the government. I'm not exactly sure how to interpret the health claim issue. But maybe you could help us, Linda.

DR. MEYERS: Eileen may want to weigh in on this one, too. Well, we're also trying to figure out. We as scientific bodies who -- who issue authoritative statements are trying to figure out what that means. And in -- in some cases, it may be a definite recommendation. You know, the committee recommends that.

But I think you -- it may not be as clear cut as a statement in a book which is meant as background. But I think you do have to think through what -- the implications of what your -- of the statements you're making in terms of that it could be -- are you -- are you very comfortable with that statement because it could be potentially taken as quite definitive. So if it's not, you may want to caveat it in some way or another.

DR. GARZA: I mean, is "May help" enough?

DR. DECKELBAUM: Well, we actually considered that when we --

DR. MEYERS: That's what the "may" is there for I assume.

DR. DECKELBAUM: Yes, that's why the "may" is there, "May help". One other point, just to address what Roland brought up, we actually had discussed in our working group discussions eliminating the detailed bowels symptomatology so that somehow that would be cut down so we don't list each of these different problems that can happen with bowels.

DR. GARZA: For example, here on the folate, what we may want to say is that epidemiological data or something that -- that shows that it's not a random clinical trial, it's not -- we don't know whether it's causative. Based on the information that we now have and making it meaningful to the consumer.

But here it sounds almost like we're saying that it may be directly causative. And it may be. But I'm not - - I don't know the data.

DR. DECKELBAUM: Scott, would you comment on that?

DR. GRUNDY: Well, I know from the -- the diet -- from the dietary reference intakes, the folate, that was not the basis for the recommendation for the current one. Now, we had a lot of discussion. It was sort of -- it was consistent with -- the recommendation was consistent with that, but was not the basis for the recommendation. And the end point for the DRI for folate was something else related to anemia. So, you know, I think that people felt comfortable because the data was consistent. But it was not a definite -- it was not the basis of the recommendation.

DR. DECKELBAUM: All right. Well, here we're not really discussing DRI. I don't think we mention folate --

DR. GRUNDY: No, but I mean it's the same concept. If there was proof that was considered strong enough for a relation, then it would have been part of the DRI. That's my point.

DR. GARZA: Shiriki and then Roland. And then we'll come to this side.

DR. KUMANYIKA: This guideline reminds me of the issue of standardization of the wording. We talked about having a parallelism between the guidelines or -- can we discuss the health effects in one place so that the language can be less conversational and more to the point about what we know about a particular thing?

Because this is the sort of bulletin conversational tone where we mention these health issues throughout as we come to them. And it -- especially if there are new regulations, it's risky to wind that information through when we're dealing with the kind of evidence that we have.

And I would rather see, you know, what are the health benefits and say it, and then the rest of it be talking about implementing -- you know, implementing it or what foods that's in it or something like that. And I may be the only one that thinks that, but I -- I would like to see these sections more consistent across guidelines with respect to how we give the health information.

DR. GARZA: Okay. Roland?

DR. WEINSIER: Rich, I'm not getting a good feel for what you want the consumer to know about the enriched grains and how you want them to use them. I'm getting the feeling that -- as I was saying before, that it -- folate jumps out. But it almost implies that the whole grains are deficient in folate; that if you use enriched product, you're getting your folate.

You do say that there are other nutrients added in the enriched foods. But I'm not getting the feeling whether half, more than half, none should be enriched, or what are the pros and cons of using enriched versus whole grains? You know, I'm not sure that has to be lengthy. But I read your justification. And it seems to -- that enriched grains are basically important because they have folate. And I wonder if that's the only message that we need to be conveying.

DR. DECKELBAUM: This was actually something that we discussed within our working group. It's a tricky subject because we did have some evidence from staff that -- that, you know, going over to whole grains would not have an effect on diminishing folate intake. But again, that's not published. And we're being advised now not to use unpublished data that's available through different surveys that the government may have.

So I don't -- you know, I would appreciate your advice on how to handle that better.

DR. GARZA: Johanna?

DR. DWYER: Maybe I'm the only one who is confused, but, you know, I think it would help me enormously if there were a box on -- three things need to be distinguished. One is fortification, is that what folic acid is when it's added to cereals or is it enrichment? I always thought it was fortification, not enrichment. And yet what -- what is written suggests that it is enrichment. The second is whether whole grains are in fact fortified. Are they or are they not? They are not.

DR. MURPHY: Some are.

DR. DWYER: Okay. Some are and some are not.

DR. MURPHY: Some are not.

DR. DWYER: It strikes me that that's very confusing, as well. The thrust of the box that I'm talking about, Richard, would be that one of the greatest public health advances in the past five years has been the fortification of grain products with folic acid.

And I'm not sure we do justice to that public health advance without having a box that really talks specifically about that. That's new news, too. Whole grains are fine, but I think that that's a very important public health measure. And it doesn't come through quite well enough yet. But otherwise, the text is great.

DR. GARZA: Alice?

DR. DECKELBAUM: Well, I'll just bring up a point that was a key point of a meeting that we were at -- I was at last week with March of Dimes, whether, you know, folate, you know, is -- should folate be the major emphasis or is it one part of a good diet and one of the messages we want to get across because I would say that the -- one of the messages that came out strongly on last week's meeting on nutrition and optimal human development was that folate is only one part of a nutrition approach to healthy infant outcomes. And, you know, are we -- and here we're getting into a similar discussion now on folate as a major part of the grain guideline. I look to your counsel on that and whether we should --

DR. DWYER: Well, you know, my own attitude is in line with what Dr. Stampfer said, believe it or not, Meir.


DR. DWYER: That there is -- there is an increasing --

DR. STAMPFER: Could we say that again just to make sure it does get into the minutes?

DR. DWYER: -- increasingly compelling data that suggests that there may in fact be some associations. I'm not sure we should put that sentence, "May help protect against coronary artery disease and certain cancers", quite yet. But the basic point is I think folate fortification of grains is new news that we do need to communicate that is a very important public health message; not for birth defects alone, but also for adults and perhaps some chronic degenerative diseases that are --

DR. DECKELBAUM: So you're seconding the concept, "May help", because there are 2,500 birth defects in the United States every year which isn't -- you know, in terms of the grand scale, it's -- it's not --

DR. DWYER: Well, I changed that, too, and specifically --

DR. DECKELBAUM: It's an effect of getting a message across, but --

DR. DWYER: -- said --

DR. DECKELBAUM: -- in terms of public health, it sort of doesn't carry the burden of heart disease and cancer.

DR. LICHTENSTEIN: Initially when I started looking at the whole issue of supplements and fortification and enrichment, I tried to sort out what the difference was. And certainly the classical, textbook definition would distinguish between folate added in amounts over and above what was original in the grains versus the classical enrichment of the thiamin, niacin and riboflavin.

However, it turns out that the products are still labeled as enriched flour. So we have to somehow address that because this would be very confusing to the consumer.

The other issue is that now there is mandatory enrichment so that people don't need to make the decision as when they -- it's not like with salt, that you buy either iodized salt or non-iodized salt. You buy refined flour, and you're going to get the folate in it. So I agree that it is certainly a public health advancement over the past five years. But I don't think it's something that is tremendously actionable by the consumer.

I think what's actionable is whether they're going to choose to use either refined grain products or whole grain products. And the new thrust of this guideline is to suggest they pay more attention to the whole grain products. And somehow I guess that needs to be conveyed. And we need to assure ourselves that if someone decides to go completely over to whole grains, that they're not missing some potential benefit from the folate that's added to the refined flour.

DR. DECKELBAUM: On that last point, I'm not sure we have proper documentation to be pro or con in that regard, especially since we just heard some whole grains now are fortified.

DR. GARZA: Linda?

DR. MEYERS: I think partly spurred by your -- your questions at the last meeting, I understand that FDA is -- is now at least at the staff level looking into the fortification of whole grains. And we could get an update on where that -- where that is and bring it back to you.

DR. DECKELBAUM: How long do you think it will be before that's looked into?

DR. MEYERS: Looked into, you mean before there is a regulation or not a regulation? I asked that question and that's what I didn't get an answer to. So that's what we're going to ask.

DR. MURPHY: Yes, just one more comment on this same issue. The data that we have on consumption of whole grains is based on what the public is currently choosing which is primarily, as was noted -- well, not primarily. But about a quarter of all the whole grains are fortified cereals. My guess is if we have a really specific guideline that's urging whole grains and it actually affects consumers, that that proportion may shift. People may go more to bread than to fortified cereals.

The point being here that it's hard to predict what mix of foods would result from this guideline. It may be very different from the mix that is currently being chosen. And therefore, it is entirely possible that folate intakes will go down as a result of this guideline.

DR. GARZA: Other questions? Lesley?

DR. TINKER: It looks like reading the guideline, that we assume that the consumer knows about enrichment or remembers about enrichment of all the other vitamins and minerals, and may be worth considering putting something along the line that folate isn't the only thing that is added; that there has been this ongoing enrichment program.

And then I have one other question about the title. I'm just wondering whether the title, "Choosing a variety of grains", reflects what we're trying to do which is to in the advice for today make a variety of grains a foundation of the diet, so maybe thinking back to the word, "plenty", that was in the 1995, "Eat plenty of grains", whether, you know, we are emphasizing the whole grains or not.

But when it says, "Choose a variety of grains every day", I'm not sure the consumer would really get at that basing the diet on grains. And this applies to the fruit and vegetable guideline as -- as well.

DR. DECKELBAUM: So what would you --

DR. TINKER: What would I specifically say for the second part would be to consider changing the bullet to, "Eat plenty of grain products daily", instead of, "Choose a variety of grain products daily".

DR. GARZA: Scott?

DR. GRUNDY: When I look at the contribution of grains total calories, it looks like it's the single largest component of total caloric intake. And I just wanted to raise the question how much is it contributing to the excess caloric intake in the population and whether there should be something said about, you know, just eating too much bread makes you fat and things like that. I mean, you know, that -- I think that's something to think about.

And, you know, when you're going to have a restriction on other components, you know, and just -- I think across the board, there ought to be some consideration or comment made about avoiding excess as well as eating the right amount. And that didn't seem to come across in this.

DR. DECKELBAUM: I would agree. And it's something we discussed and didn't quite fully handle. But it's something I did list here on issues that I bring up to the -- we're bringing up to the committee on how to better address within that guideline. And if we could get some specific suggestions, they would be welcome. And if we're not going to get some, we'll try to come up with some on our own.

DR. GRUNDY: I guess what comes across here is like eat these other things and then eat as much of this as you want. I mean, that's kind of what I get from this. You can't -- don't worry about grains; you can't hurt yourself eating grains.

DR. DECKELBAUM: Well, that's certainly not a message we want to get across. And this actually goes back to our first meeting. You will recall we had discussions on whether we were going to have 11 servings a day. And I think -- I think from what I recall, part of it is addressed in one of the boxes.

DR. JOHNSON: It is. It's under, "Advice for today: Make a variety of grains the foundation of your diet." And it says, "If your calorie needs are low, have six servings daily. Add more servings if you need more calories."

DR. DECKELBAUM: Yes. But I think we could further strengthen that so it's --

DR. GRUNDY: Yes, I think so.

DR. DECKELBAUM: -- it is in the, "Advice for today", but we might look for another place or two where we can insert it. But this isn't an open invitation to each as much grains as you want.

DR. GRUNDY: Yes. Okay.

DR. GARZA: Okay, Alice, as we get to the end. Yes.

DR. LICHTENSTEIN: Then I would like to come back to the suggestion to change the bullet to, "Eat a variety of" -- "Eat plenty of grain products daily, especially whole grains", as opposed to the variety concept. And I guess I would just like to put a word in saying I favor more the varieties so that we can catch a lot of different --

DR. GRUNDY: I agree with you.

DR. LICHTENSTEIN: Yes. And the plenty starts getting at as much as you want.

DR. TINKER: And how do you blend that with making it the foundation. So it's back to probably the portions and serving size.

DR. LICHTENSTEIN: And serving number.

DR. GARZA: Roland?

DR. WEINSIER: Variety, I don't even remember variety being addressed here. Isn't variety important to good health, to have a variety of grains? I mean, it's in the title, and yet I didn't get that feeling here at all. Options -- there are options here. But how important is it to have the variety? If I ate it all as brown rice throughout the day, that was my -- basically my grain, is that bad? Does it have to be a variety?

DR. GARZA: That gets -- that gets to a point that I would raise --

DR. DECKELBAUM: I would have to get an analysis of the nutrients in brown rice versus other whole grains.

DR. WEINSIER: Well, I'm saying if it's going to be in the title, I think it has to be supported in the document that there is evidence that variety is important.

DR. DECKELBAUM: Well, could we get that from staff because my feeling is that brown rice from other whole grain -- you know, there are differences in different whole grains. So if we can get some support on that.

DR. GARZA: But it's not going to -- I don't think that staff issues are the ones that -- that Roland is getting to. It's whether in the published epidemiological literature that relates whole grain intakes to certain beneficial health outcomes, if variety of that grain intake is a significant explanatory variable in the variance of -- so that individuals that just consume all brown rice do not get as many health benefits from their consumption of whole grains as individuals that included eight or nine different whole grains. And I don't -- I never have seen the data analyzed in that way, but maybe Meir can help us.

DR. DECKELBAUM: Generally -- we can go back and actually check the individual papers that have come out, especially the ones in the last five years. But to the best of my knowledge, they -- they are a group of whole grains and they don't distinguish a single one except for popcorn perhaps.

DR. GARZA: And we could use that as a basis for saying variety; that in fact the only data that we have is for a group. But as you go through this, I had the same sense, that we are hearing, Richard -- that we seem to be saying that the most important thing about grains are the fiber and the fact that it's enriched in certain B vitamins.

And I'm not sure that we know that. We know that the consumption of fiber -- I'm sorry, of whole grains and grain products are associated with good outcomes. But whether it's the B vitamins, the fiber or something else, I don't think we know. I mean, I'm looking to Meir because obviously he has published on this issue.

DR. STAMPFER: Yes, I agree. And I think there are -- I don't know of any data supporting variety in -- as a strong bit of data, as opposed to, you know, getting it from one source or another. But I think "plenty" also conveys that message of just go ahead and keep eating. Maybe one option would just be to say, "Choose grain products daily", and just drop that little phrase.

DR. GARZA: What about the point that in --

DR. STAMPFER: Oh, as far as what the --

DR. GARZA: -- it's been grouped as grain products. So actually in groups --

DR. STAMPFER: What the mechanism -- what aspect of whole grain is --

DR. GARZA: No, I'm looking at the -- addressing the variety issue that in fact in -- in the analyses that have been done today, it's been a group of grain products that --

DR. STAMPFER: Yes, it hasn't been -- to my knowledge, nobody has separated out, as you say, the -- you know, the analysis -- I don't know of any analysis that's done that.

DR. GARZA: So does the fact that we haven't separated them out then support variety or support -- or not. I mean, you could interpret it either way. Is that right?

DR. STAMPFER: Well, I -- yes. But I don't -- I mean, if we're going to have an evidence-based recommendation, I don't think we have evidence to -- to say you need a variety of grain products. I don't know of such evidence.

DR. LICHTENSTEIN: What would happen if the food guide pyramid, the modeling that's done with that were run with a single grain product versus what it appears to be now where there is a variety because there is some enriched and some whole grain? Would that be -- would that be admissible, useful, helpful?

DR. GARZA: I think all it would give us is nutrient intake --

DR. DECKELBAUM: Yes, and we don't know --

DR. GARZA: -- for the enriched type products.

DR. LICHTENSTEIN: Yes, so it wouldn't --

DR. DECKELBAUM: Well, so --

DR. GARZA: Do you -- do you have enough to go back and --

DR. DECKELBAUM: Yes, just one point. There is a sentence in the current text which says, "However, vitamins, minerals and other substances in whole grains also contribute", so that it wasn't based entirely on folate and fiber.

DR. GARZA: I'm just reacting to that bold type. And I had the same reaction that Roland described as if the main impetus for this guideline seemed to be the folate and enriched B vitamin content of the foods. And I don't think that's what was intended. So it may just be a packaging issue. And if you could look at that and perhaps relate that --

DR. DECKELBAUM: I would agree with that if

that's --

DR. GARZA: -- the strength of the data --

DR. DECKELBAUM: I would agree with that message, I mean, to -- to strengthen the broader approach to the benefits of whole grain.

DR. GRUNDY: Is not another benefit the fact that it tends to -- it's not sugar? I mean, it's a source of carbohydrate that it -- there is some implied benefit that it is less glycemic or has less of the adverse effects of simple sugars.

Is that correct, or why not just eat only simple sugars and forget about whole grains and take fiber pills? I mean, you know, is -- is there some other benefit from the grains that go beyond fiber and vitamins that are enriched in them?

DR. DECKELBAUM: Well, this overlaps into the fruits and vegetables guideline. It's related to the question of where we emphasize complex carbohydrates. And it's also related to the sugar guideline. So we've got really three guidelines in which what you've just brought up should be considered. And I think that's a good point, you know, how to get that message across best.

Certainly if you have a lot of your carbohydrates coming in through whole grains, you would probably need less simple sugars. But what effect might that have on fruits and vegetables?

DR. GRUNDY: But is -- but there is a lower glycemic index in -- in grains, right?


DR. GRUNDY: Okay. So isn't that one of its advantages? And that's not clearly stated here, is it?

DR. GARZA: And I think it also aids satiety, at least that's -- perhaps through the same mechanism. But --

DR. GRUNDY: Yes, right. But, I mean --

DR. GARZA: It's a satiety issue so that you can control your caloric intake. I think there are some other -- some health benefits that we might be able to allude to --

DR. DECKELBAUM: So there was a lecture this morning which included glycemic index --


DR. DECKELBAUM: -- and satiety.

DR. GRUNDY: I think this is lacking in mechanistic --

DR. DECKELBAUM: Well, but the question is, is what I referred to earlier, how big is the science base right now on satiety and glycemic index?

DR. GRUNDY: But it can be added in as one of several different things. You don't have -- it's not an overriding issue, but there -- there are additive benefits I think.

DR. DECKELBAUM: I think that's one of the questions we can also address when -- after Dr. P. Sunyer's talk.

DR. GARZA: Shiriki?

DR. KUMANYIKA: Even though we're going to have the rationale in the report to the Secretaries, I'm really wary of making a lot of vague statements of mechanisms in this forum because it will take on a life of its own.

So I think we should structure this section to say what it is we know, is that people who eat whole grains seem to be healthier. And there might be a lot of reasons for it.

But to really take control of the way we state it so that the fact that this is a recommendation based on global associations comes through because with the polyps trial coming up negative where people were kind of thinking that would nail something with cancer risk, I -- it could be displacement of other foods. We don't know what it is. So I wouldn't be too willing to list here a lot of things that are still speculative because it would come back to haunt us.

DR. GRUNDY: The only thing I can say, Shiriki, to that is if that's true, you know, how strong is the evidence for this recommendation unless you've got some specific reasons for making this recommendation. I think some global association might confound the variables.

DR. KUMANYIKA: Well, I think a lot of the rationale for it is that it's to substitute for some of the things --

DR. GRUNDY: Well, I mean, that could be --

DR. KUMANYIKA: -- that we are telling people to eat less of.

DR. GRUNDY: -- that could be -- that could be stated.

DR. DECKELBAUM: But, again, Shiriki, I think, you know, if we're talking about the text of the guideline, I think what we'll be putting in the green book will certainly be backing up the statements that are present in the guideline text. So that's the purpose of the green book. I don't think that we can go into all of the scientific details in the guideline itself. But we'll have to in the green book and we're doing so.

DR. GARZA: Johanna?

DR. DWYER: Richard, I'm sure you considered this when -- in your subgroup. But I'm concerned about the functionality issue, and also on some of the other guidelines, the functionality issue with respect to the whole grains. How do you -- it seems to me a variety is important, more whole grains is fine. But you can substitute them 100 percent in some products from the standpoint of just cooking them.

DR. DECKELBAUM: I'm not sure I --

DR. GARZA: You mean the food functionality.

DR. DWYER: You can't make 100 percent -- there are some products that you just can't make with whole grains if you've ever cooked.

DR. GRUNDY: Are you talking about recipes?

DR. DWYER: That's correct. They don't work.

DR. DECKELBAUM: But I don't think we're saying that. But -- so let me just ask, these are discussion points for the full committee. Let's just make sure we all agree before I sit down --

DR. DWYER: It just doesn't seem to be mentioned or considered. And I'm sure you did consider it. And I'm just suggesting it be more explicit, at least in the text that accompanies the guideline.

DR. DECKELBAUM: So I'm just going to go through this and -- which is there is agreement on the separation of the grain from fruits and vegetables? Is --

DR. GARZA: I have a sense, Richard, that that agreement comes from previous discussions --


DR. GARZA: -- rather than what's on -- written here, that here we haven't -- it's not clear as to why the health benefits from whole grains and grains are substantially different from fruits and vegetables to merit separating them out, whether it's quantity, health benefits, functionality of the foods in terms of satiety or other things. I mean, that's not very clear from the text.

DR. LICHTENSTEIN: Do you mean separating out from fruits and vegetables or --


DR. LICHTENSTEIN: -- separating out from --

DR. GARZA: Separating out from fruits and vegetables.

DR. LICHTENSTEIN: But what about separating them out -- separating out from enriched refined products? Is that clear?

DR. GARZA: Yes. Well --


DR. GARZA: -- because of the fiber content.

DR. DECKELBAUM: Well, the question is do we have to justify -- justify the separation in this book or in the --

DR. GRUNDY: Yes, is that what you're getting at?

DR. GARZA: I mean, the reason why we're telling consumers why this is different is not very clear, I mean, at least -- because it is going to be seen as a change. And is that because in the past, it was difficult to separate out the serving sizes or --

DR. DECKELBAUM: Because the green book -- the revised green book text in fact --

DR. GARZA: I realize that's going to be the detailed -- but we have to have some mechanism of translating that science into a way that consumers would appreciate, gee, you know, consuming grains and whole grains is really important independently of your fruit and vegetable consumption. I mean, am I the only one that's not seeing --

DR. LICHTENSTEIN: Well, but from the standpoint of nutrient intake, that there are different nutrients contributed by fruits and vegetables relative to grains --

DR. GARZA: Exactly, but this --

DR. LICHTENSTEIN: -- there are different barriers to use of grains relative to fruits and vegetables.

DR. GARZA: It's motivating the consumer to be independently concerned about grains and whole grains from fruits and vegetables. And I'm not certain that I don't see them as interchangeable based on the data -- on what I'm reading. I know why they are, but from the consumer, I'm not certain that they would see it.

DR. DECKELBAUM: Well, as we discussed at the --

DR. GARZA: Now, maybe I'm the only one that --

DR. DECKELBAUM: Well, we -- we --

DR. GARZA: -- that doesn't.

DR. DECKELBAUM: At the previously meeting, that the science base now for whole grains has certainly gotten quite a bit stronger in the past five years. So that including whole grains as an independent benefit factor, if you will, certainly is justified I think by the science that's come out.

Now, does that justify separating it from fruits and vegetables in a separate guideline? And the question I have for you is in this book for the year 2000, do we have to say why --

DR. GARZA: You have to motivate the consumer is all I'm saying that -- that science has advanced and that based on the advanced in science, we would like them to pay more attention to whole grains. And that motivation doesn't seem to be coming across is all -- I would take that as not a -- sort of as a committee member's concerns rather than as the Chair's.

I mean if none of you are concerned about that, I would -- I would shelf that comment. If I were a consumer, I wouldn't understand why the committee increased the number of guidelines, if I were an uninformed consumer I guess I should say.

DR. DECKELBAUM: That should come in the introduction then. I think --

DR. GARZA: Well, we could. I mean, if that's what you wanted, fine.

DR. LICHTENSTEIN: And there were reasons, because we found the consumer was -- there was a certain level of confusion because there was the five-a-day program and there were fruits and vegetables and grains in a guideline. And the five-a-day program doesn't really contain all of those or refer to all those foods. So that's one reason for separating, too.

DR. GARZA: All I'm suggesting is the working group think about motivating the consumer to pay more attention to grains and whole grains, and the motivation isn't very strong right now.

DR. GRUNDY: Well, don't forget that one motivation is to pay more attention to fruits and vegetables and to separate them out because they are really two different types of foods. And it's confusing to have them all together in one thing. So I think there is a conceptual reason to do it as well as a scientific reason.

DR. DECKELBAUM: I think in separating them, we don't want to give the message that, you know, whole grains are -- are, you know, so much better that we can not worry so much about fruits and vegetables. It's quite the opposite message we're trying to get across.

DR. GARZA: Motivate them to do both. I mean, we'll be asking the same questions about --

DR. JOHNSON: Yes, I agree with Scott. And I think we need to hear about fruits and vegetables because I think there are the phytochemical issues and all kinds of things about fruits and vegetables that are different from grains. And that to have this discussion without having fruit and vegetables on the table makes it a little difficult.

DR. GARZA: Shiriki?

DR. KUMANYIKA: I think, to go back to Scott's point before about the amount of whole grains you eat -- because when I look at the evidence that Richard is citing here, it's primarily observational evidence that a dietary pattern which has a lot of whole grains in it or grains is healthier and -- except for probably the oat -- oat bran and cholesterol and some of those things there.

I don't -- I'm not aware of a lot of evidence and I don't see it here that gives you the specific mechanisms for the grains. So I thought we were separating it because we were not getting enough fruit and vegetables and so it's an operational issue. And so the list of mechanisms really is speculative.

And that's why I would want to be careful with them. It's to replace -- it's to change the shape of the diet into a pyramid, and it's to replace the other foods. And I don't -- we have -- that's what we have to say because I still think that this "Plenty of grains" may be a part of the increase in obesity. People didn't get the substitution point. The word, "substitution", isn't in here anywhere. It just says eat more. It doesn't say instead of something else.

DR. GARZA: Okay.

DR. GRUNDY: That's the mechanism. That's not --

DR. GARZA: Let's go ahead. And I think we need to move on --

DR. LICHTENSTEIN: Just one quick grain issue. One thing that I -- sort of keeps coming back in my head, but it's nothing we've really talked about, is that whole grain products tend to cost more money. And what is -- do we need to consider that impact and what -- then is it -- are they considered to be a luxury food and are there certain groups that are going to be caught in a bind because we're now putting more emphasis on whole grains?

DR. GARZA: We have to give the best health advice we can give and then leave it up to the government to figure out how they can make it accessible to consumers. But I want to make sure the science base is there to both motivate and -- and -- the consumer and justify the guideline. So let's go on to fruits and vegetables. Then perhaps at the end of the discussion, come back and look at both in juxtaposition.

I would like to be able to then before we -- we adjourn for today, is then to come back to a general discussion of the guidelines because Johanna and others are going to be leaving tomorrow. And I want to make sure that we get some of that discussion in. But we still have quite a bit to do today.

DR. LICHTENSTEIN: Okay. What I'm going to do first is show the overhead that I prepared on the public comments and then go to the one that's been prepared for us with the individual -- with the additional information.

Some of the public comments centered on the strength of the advice and essentially on suggesting that we urge for even greater consumption of fruits and vegetables. And I think the reason that we had initially proposed to split fruits and vegetables from grains is that the data was suggesting that, in general, people were not consuming adequate numbers of servings of fruits and vegetables. So I think we're in sync there.

Another group of comments with respect to separating the fruits and vegetables from grains was to increase predominance of fruits and vegetables and -- and then place the plant-based foods at the base -- well, they're already there; but again, increasing predominance of fruits and vegetables was the basis for suggesting that they be split and then lastly, issues related to the phytochemical-rich foods at the base of the food pyramid, which I think nothing that we're doing would be in conflict with that.

And this is the summary of the public comments that I just received. And again, strength of the evidence - - there was strength in the advice and, again, I think that was the original reason why we proposed to change it and besides strengthening the advice, also making the advice clearer because there was some evidence that there was confusion regarding what was meant.

And then, let's see, I don't know what the comment as far as wording -- if anyone can enlighten me on that.

DR. DAVIS: "Suggest wording of" -- "suggesting wording of enjoy meals and snacks with plenty of vegetables and fruits", which communicates --

DR. LICHTENSTEIN: Okay. So increased emphasis on how to incorporate fruits and vegetables into the diet. Vegetarian diets which with respect to the former variety guideline were getting away from vegetarian diets or the specific wording, but just going to alternate dietary patterns. And I think that will be addressed more in that first guideline.

And then the phenolic contents, again the phytochemical-rich foods. So I think that most of that is addressed.

We got some new focus group data from the last -- our last meeting. And if you remember, the last focus group data that was presented was in support of why the guideline should be split. And this came from Produce for Better Health Foundation. And what they did was be in focus groups where they showed half of the individuals the combined guideline and the other half of the individuals the two separate guidelines.

And they concluded that the main idea to include fruits and vegetables in the diet was conveyed better when the guidelines were split; that 43 percent of the individuals said, well, the main idea of the guideline was to include more fruits and vegetables than when they saw it together which was 24 percent.

And then, "Have a healthy snack like fruits and vegetables", again, a higher percentage of individuals who saw the separate guidelines felt that was the message that was coming through. And lastly, when asked about what the most important foods to eat, a higher percentage of individuals mentioned fruits and vegetables when they saw the guideline split as opposed to together.

So it's a little bit of additional data to suggest that at least the reason that we're proposing to split them as far as conveying a clearer message to the consumer probably is valid, or at least we don't have any data to suggest that it would cause additional confusion to the consumer.

I had prepared overheads just sort of going through the specific text that we provided. But I think what's probably a better use of time right now would just be to discuss the comments and concerns of the committee. Actually, I could start it off with variety -- including variety actually in the bullet for fruits and vegetables. I think we do have a good scientific data to suggest that that's an important concept to include.

DR. GARZA: And it's whether we could bring the same sort of message to grains. And we have provided any content -- are there any opposite content that's different, is one greener or another, but something that would give the consumer the type of information that I think is motivating them when you read the first paragraph in terms of variety in the various nutrients you would find in different vegetables and fruits. And it comes across in a much more -- much more motivational text.

DR. DECKELBAUM: Well, I think it's clear that, you know, different grains have different vitamins and other substances that are beneficial. So we could put that in and --


DR. DECKELBAUM: -- right in that first paragraph. And so that's easy to justify.

DR. GARZA: It's that type of --

DR. DECKELBAUM: Yes, I think it's a good suggestion.

DR. GARZA: Roland?

DR. WEINSIER: Yes, I think you've justified your designation of aim for variety in your -- in your justification section if I'm interpreting correctly because you're saying here -- at least raising the concern that without variety, you may just eat -- be eating potatoes, french fries, whatever.

But if that's the reason, should it be stated clearly that not just eat variety, but go ahead and say potatoes should not constitute the bulk or reversely, more positively, say that in addition to potatoes, be sure you get lots of other things. So if this is a concern, the only way I got it was reading the justification. And the consumer will not have access to that. It should be stated.

DR. LICHTENSTEIN: So essentially -- I can see justification for putting language in to reinforce variety that all of the fruits and vegetables categories shouldn't come from one specific one as far as singling out a specific food because if you ate just all bananas, that would cause as much of a problem as eating all potatoes. I think if we start singling out one food -- my concern is that we're going to get into a good food/bad food situation.

And we do have emphasis on dark green and deep orange. And maybe we could take care of that by putting even more emphasis on that.

DR. WEINSIER: Well, how about without identifying a single food? Could it be stated that various foods have various advantages; the best way to assure good health is to get a variety? I mean, it's a little bit encountered here where you talk about when it's in season, eat lots of it for a while and skip some of the stuff that you usually have. So it's sort of -- I thought you were arguing against yourself. But I'm not sure that's a major issue. I think --

DR. LICHTENSTEIN: Carol, can you remind me, did that come from the last version of the guideline? Do you know where that came from? Okay. I think if there is concern, that's not necessary to keep in although it addresses sort of the reality to the situation.

DR. WEINSIER: Could I ask one additional question that's somewhat related? Is it important to prepare fruit and vegetables in certain ways -- prepare and serve it in different ways or is this just giving me options to making it more enjoyable?

DR. LICHTENSTEIN: I think most likely that's why that's there.

DR. WEINSIER: Okay. I wasn't sure, you know, why you were saying that I should do this.

DR. LICHTENSTEIN: I think it's getting towards overcoming some of the barriers that are perceived as far as increasing consumption of fruits and vegetables because what we saw in some of the focus group data was that there was this concept that we were just referring to fresh fruits and vegetables, and that there was a high cost associated with fresh fruits and vegetables.

So we were trying to get across the concept that fruits and vegetables can come in many different forms and that they all essentially count. Just because they're canned or frozen doesn't mean that they all necessarily have a lower nutrient content than just the fresh.

DR. GARZA: Richard and then --

DR. DECKELBAUM: I would just like to get to one point that Shiriki brought up because it applies to fruits and vegetables and it applies to grains. And that's, you know, basing some of our recommendations on some observational data. If we look -- go back in the fat field and look what Dr. Keys and Hexta did, they did their work way before the LDL receptor was uncovered. And we can consider the Hexta and Keys equations essentially as sort of observational data.

But nevertheless, the recommendations on saturated fat started to proceed the -- the absolute understanding of how it was working. And I think we're in the same kind of boat here with fruits and vegetables and with whole grains because the observational data is getting stronger and stronger. We don't know the mechanisms certainly in total. But it took a long time. There was a big lag period in the fat field, too, before we understood the mechanism. And we still don't understand all the mechanisms in terms of fat.

So that I think, you know, as a committee, you know, we can't hold back on the consumers when there is a strong body of observational evidence. I think we could state somewhere that we don't necessarily understand the mechanisms. But the evidence is out there.

DR. DWYER: I think what was disturbing me, Richard, was not quite that. Keys and Hexta both used experimental methods for their derivation of those formulas. These were not observational studies. These were experiments with -- in the case of Hexta, with people in a mental institution. So I think that's what bothering me that's a little different. The level of evidence is quite different it strikes me for some of the things we're talking about now.

I must say I was taken aback by something Dr. Kumanyika said. I guess I haven't been reading the journals about the polyps trial. And I wish she would elaborate a little on that. My question to you though, Alice, is I didn't get why it's fruits and vegetables rather than vegetables and fruits. Could you --

DR. LICHTENSTEIN: Yes, my understanding --

DR. DWYER: -- say that again?

DR. LICHTENSTEIN: -- of the data from the Healthy Eating Index is that we as a population are doing better with our vegetable consumption than our fruit consumption as far as meeting the goals. Now, part of that may be because of potatoes. It may be because of lettuce and tomato on Big Macs with cheese on top. I don't know. But my understanding of the data are that we are doing better with vegetables than fruits.

And, you know, I would actually argue to move that up as a guideline because I think, you know, when we look at these guidelines, we're trying to look at where we are and where we want people to go. And I would think that you would want to put -- give the most prominence to where we want them to go and improve. So that's the fruit and vegetable.

DR. GARZA: Richard?

DR. DECKELBAUM: Just, Johanna, I'm sure that, you know, if we asked Dr. Hexta, he could do studies now in a metabolic ward if we gave a cohort, you know, number of whole grains and certain measurements. And he would then have an end point like anti-oxidant levels or anti-oxidant vitamins that change in blood. And he would be able to give us equations.

So -- and also I'm sure if Dr. Stampfer wanted to in some of the -- he could do a meta analysis and get equations on the observational studies on whole grains and, you know, cancer risk; you know, for every gram of whole grain, you're going to get this much of a reduction.

But the point is that, you know, in the metabolic studies, what Hexta and Keys did actually, they didn't measure disease. They measured cholesterol levels which is only one way -- one part of the way to the end point of heart disease or stroke.

DR. DWYER: I agree, but I'm just saying the causal change is much less well developed for what you're talking about than for the -- the -- the hypothesis about serum cholesterol being related to coronary artery disease. I just don't see the two as being at all the same in terms of the level of the evidence.

DR. GARZA: Meir?

DR. STAMPFER: Yes, I agree with that, Johanna. But I think the wording here covers that. I think it's very -- I like the whole guideline. And I think it's very -- very well done. But the wording here, "Fruits and vegetables may help protect you", two caveat words in there, not just one.

And, you know, I think where -- where we do have, you know, proven data, I think we say so in the guidelines. For example, later on for the fat, it says, you know, "Saturated fat raises cholesterol". And we know that from experimental studies. So, you know, I think we're well protected and well within the range of evidence.

DR. DECKELBAUM: Could I ask Eileen whether this word, "May help" -- because it's here and it's in grains and it's probably in other places throughout the guidelines. Is that a problematic phrase, "May help", or, "May contribute to"?

DR. KENNEDY: It's not a problem from our center. Are you talking about the whole issue of authoritative statements as the basis of health claims?


DR. KENNEDY: I should say we are in the process of as departments resolving that. It's a rather complicated issue, driven by the FDA Modernization Act. But we are actually with legal counsel looking at procedures for coming up with a process for determining what authoritative statements are out of our department. I know HHS is going through the same. So I think the -- I think the way this is being approached, the "May help" or whatever is --

DR. GARZA: I mean, with folate, we were coming down to a specific agent.


DR. GARZA: Here we're saying these foods -- there could be anything in the food -- that you're on sounder ground because of the nature of the way that the associations are derived. Let me -- Rachel, let me go to this side because we've been dominated by this side.

DR. GRUNDY: All right. Thanks.

DR. GARZA: Scott?

DR. GRUNDY: One of the things that you've got in here about carotinoids and vitamin C and so forth, I think that we wouldn't want to imply that carotinoids are the protective factor. There has bene a lot of discussion recently about the lack of evidence that carotinoids prevent cancer. And I think that to kind of relate the specific components to the fruit or the vegetable might not be a good idea.

There has also been a lot of other -- there are a lot of other things in dark green vegetables besides carotinoids that have been more implicated as protective factors. So to sort of put these down, you know, you could just take pills and get these things from them. I mean, you could take -- they have pills with mixed carotinoids now and vitamin C. So why eat all these? Just take capsules and get that.

So I think that there -- if there is some protective factors, they may go way beyond these. So it might be not a good idea to list those as particular sources. Also, I think the evidence for the dark green vegetables is perhaps strongest among the various things that relate to prevention of cancer at least and maybe that ought to be highlighted a little bit more in the text. But --

DR. GARZA: Any other -- Shiriki?

DR. KUMANYIKA: Well, I need to at least try to clarify the statement that I made about the polyp study. I was referring to the -- and I don't have the -- the paper. But a lot of people were waiting for the polyps prevention trial to definitively show that the fiber would regress the polyps and be preventive, and it didn't show that as far as I understand.

So that the observational data are very compelling that these dietary patterns are protective. But trying to isolate the factor and nail it in the clinical trial isn't working. And that's why I think the wording should stay closer to what we actually know which is that this dietary pattern seems to be healthful and state -- back off of the agent because we would be behind the state of the science if we repeat some of these things that we were believing until we tested them, you know, as limited as our means are for testing.

DR. GARZA: Roland, did you want to say something before we --

DR. WEINSIER: No, I don't remember putting my hand up.

DR. GARZA: Rachel?

DR. JOHNSON: Well, my -- I have a very practical point on the text for the booklet. On the section where it's encouraging plenty of fruits for snacks, I'm a little reluctant to include dried fruits in there because a) they're very high in calories and b) they're sticky and very cariogenic. So I don't know that it's a good thing to be encouraging for snacks.

DR. GARZA: Okay. Johanna?

DR. DWYER: Two other very specific things is, first of all, being from Massachusetts, I object to your statement about look for 100 percent juices without added sugar if that includes cranberry juice. If you take cranberry juice without added sugar, you live to regret it.

And secondly, it seems to me that this statement, "If you buy prepared vegetables, check the nutrition label to find choices that are low in saturated fat and sodium", is really -- are you really trying to say don't eat french fries or do you want to say something like prepare or serve foods that are low on saturated fat and sodium so that you get at things like gravies and dressings that people put on vegetables, and make it more general?

DR. LICHTENSTEIN: Or what's becoming more and more available in the market which is these frozen vegetables with this packet of gravies or -- or it's soaked in gravy.

DR. GARZA: Okay.

DR. KUMANYIKA: I mean, there are a lot of very specific points. But a couple I want to bring up has to do with some of the boxes and the examples that are given for foods that are high in vitamin C or foods that are high in vitamin A and carotinoids, that do we have some criterion for how high they need to be in order to get included?

DR. GARZA: There is an FDA definition that I suspect the departments are going to be checking from what you said earlier. I think it's that you have to contribute at least ten percent of the DRI or some -- somebody help me. There is a --

DR. McMURRY: It's ten percent to be a good source and 20 to be an excellent source.

DR. LICHTENSTEIN: Okay. So then we should probably be concerned about that. I'm also a little bit concerned about reference to dried peas and beans in the text because, again, the sort of -- the barriers to consumption, the advice on use and -- as a whole group, it just -- it sort of gets -- it got put in there.

And it seems not to be consistent with how we're talking about fruits and vegetables fit into the diet and why should we increase the intake of fruits and vegetables. There is a very good reason for increasing the intake of peas and legumes. But I'm just kind of wondering how the committee feels about that. Did that stick out to anyone else or come up?

DR. KUMANYIKA: Where is it?

DR. LICHTENSTEIN: It's somewhere. I don't --

DR. DWYER: I'm not sure I understand what the concern is. I see the recommendation on page 31.

DR. LICHTENSTEIN: Right. I guess what I thought about -- think about fruits and vegetables in this -- for this guideline, I don't really think about peas and beans. And I think the average consumer doesn't think about dried peas and legumes. And it -- and a lot of the advice that we're giving doesn't really pertain to that. Certainly string beans and snow peas and those kinds of things, yes. But when we come to the dried beans and lentils, it just doesn't seem to fit --

DR. GARZA: But you can eliminate them and have other examples. I don't think that that's --

DR. LICHTENSTEIN: Okay. The other thing that Shiriki had brought up and I think perhaps we should emphasize a little bit more, and that has to do with displacement of it. And it also goes back to how to we interpret the observational data.

People that eat diets that are high in fruits and vegetables appear to have a lower incidence. Those dietary patterns are associated with a lower incidence of certain cancers and cardiovascular disease.

Is it the fruits and vegetables so that as Scott brought up, you can just take a pill, or -- or, you know, is it -- is that the displacing of other foods from the diet and perhaps we could just somehow somewhere, whether it be in the first guideline or in this guideline, and it came up with the grains, just talk a little bit about that you're going to eat.

You're going to eat a certain amount. You shouldn't eat too much. But that if you choose one thing, it means also that you're not going to be choosing something else. And I think this will probably come up again with fat.

But getting that concept across, but that you really not only should be doing all these things, but that we need to think about how that impacts on the rest of the diet.

DR. GARZA: That might be best taken up in the introduction.


DR. GARZA: Okay? And let's move on to the next item that's not on your agenda, and that is a general discussion of the direction in which the guidelines are moving. One is we're going from seven to ten if we continue on -- possibly 11 if we decide to do something different with the introduction. But certainly, it seems as though we'll have ten.

But there may be other comments in terms of the usefulness to the consumer, the format, whether we want to have all -- give all equal visibility or have a two-tier, but general issues that transcend any single guideline. I would like to ask, Johanna and Rachel especially because I think they're both going to be away the third day.

DR. JOHNSON: No, I'll be back Friday.

DR. GARZA: You'll be back Friday?

DR. JOHNSON: I'm just missing part of tomorrow afternoon.

DR. GARZA: Okay. Johanna, do you want to start?

DR. DWYER: I think one major concern is they look awfully wordy. There an awful lot of them and there are a lot of qualifiers. And that's just probably something that can be cleaned out -- cleaned up. I think the over-arching thing is, you know, how are we going to deal with this notion of adequacy, proportionality, emphasis on the pyramid; pleasure, healthful and safe eating with variety and moderation and balance, including balance in terms of physical activity and fitness, and a focus on a healthy and active lifestyle. It seems to me that's one set of concerns.

The other is -- and we'll probably deal with this more tomorrow -- but is not only achieving and maintaining a healthy weight, but also a healthy lifestyle. This notion of an inactivity crisis I think as Dr. Coop suggested last week a statement he made, a focus on active and healthy lifestyles and not just on weight I think is extremely important. And we're going to deal with it.

But how do we get it all into a sort of a bolus that's easy to understand? Considering the difficulty of losing weight, I'm not sure that achieving and maintaining a healthy weight alone is going to get at all we -- we need in that respect. Those are two main concerns.

DR. GARZA: What about the -- how do you feel about the presentation of the guidelines? Should we give them all equal weight or should we move to a two-tiered system?

DR. DWYER: I think I'm in favor of some organization, you know, a scheme that makes it a little easier to remember. I have trouble with anything over seven.

DR. GARZA: Richard?

DR. DECKELBAUM: Well, you know, certainly there is a good historical precedent for ten major guidelines. And certainly we shouldn't go above that. That's a big challenge --

DR. GARZA: Even God couldn't get away with less than ten. How could we expect more of them ourselves?

DR. DECKELBAUM: But one thing I would just bring to the floor, and we did discuss it at our previous meeting, is with these ten guidelines, if we're going to have ten, we have -- I think they are pretty evenly divided about, you know, do this, do this, do this and don't do this, don't do that and don't do that.

So that if we're going to divide them, you know, we might sort of consider in molding or what you should do and what you should do less of. If that's a two-tiered approach, I would be in favor of it.

DR. JOHNSON: I'm a little concerned about the two-tiered approach if we put the -- what you're suppose to do at the top because of all of these issues that we've talked about, you know, with proportionality and energy intake and energy balance; that there has been a lot of talk about putting the sugar guideline in the sort of second tier. And I will talk about that tomorrow. But we have consumption figures that are showing there is a clear, you know, uncontestable increase in added sugar intake. And I can easily show you the chart.

So I am concerned about relegating that to a less important guideline if we're saying, well, eat more of these things, but it's really not that important to not worry about what you're eating too much of.

DR. GARZA: As I've talked to people about the two-tiered approach, they've commented that in fact what we may be doing is promoting a cafeteria style to the guidelines that says, well, if you agree with number three but want to omit six, that's perfectly all right. And so they've been echoing pretty much what -- what Rachel has just said. Have you all -- have any of you heard similar sorts of comments or -- let me go this way and then I'll come back to Johanna. Lesley?

DR. TINKER: Well, I'm concerned with a two-tiered approach because I would be concerned that people might look at the second tier and just ignore them and just go with the first tier and use that as some way of prioritizing. It's like, well, I can't remember all ten, so I will remember the seven. And you have the other -- other three exist, but I really don't remember what they are.

And also, with seven and three, does that really help because there are still the seven that there have been.

DR. GARZA: Okay. Scott?

DR. GRUNDY: I see this in a way fitting into this healthier lifestyle. There are three major things, is what you eat, how much you eat and how much you exercise. And somehow if in the introduction or someplace, that could be put into that. And certainly the major emphasis on this is what you eat.

But that has to fit into these other things. So maybe the other two, how much you -- how much you eat and how much you exercise, could be sort of separated out a little bit. And then you could have the three different categories. But maybe those latter could come last, even though they probably ought to come first.

But you might not just have ten in a row. So you could divide in equal lines into those three major areas that they need to be concerned about.

DR. GARZA: Okay. Richard?

DR. DECKELBAUM: I just may be confused about what a two-tiered approach means. I didn't -- I wasn't thinking of it in terms of one tier being more important than another. It's just I was thinking of it in terms of just sort of different types, one is a positive and one is a less positive type of message. Is that -- so I didn't -- I wasn't voting to de-emphasize any of the moderate --

DR. JOHNSON: It's kind of like going to church now and they don't talk about sin anymore. We only want to hear the good messages. That's what -- I guess that's what I'm worried about.

DR. DECKELBAUM: That's why we're getting back to the ten guidelines.

DR. DWYER: Well, could we -- could we compromise on a seven deadly sins and --


DR. GARZA: I think only a few of us will remember those with a certain persuasion. Shiriki?

DR. KUMANYIKA: I -- I think that we have -- we need to move beyond a list of unconnected guidelines that leave some wholes in the advice. And maybe the time for us to make a conceptual -- you know, to cross some conceptual threshold because we started with a Basic 4 and Basic 5 when we were looking adequacy. Then we came from the other side with a list of specific guidelines.

I mean, we and the, you know, Diet and Health Committee and so forth, a list of specific things for which there was evidence. And now what we're trying to do is shape a dietary pattern. And we say -- we make statements about some aspects of the dietary pattern and we don't make statements about other aspects of the dietary pattern.

Like we don't say eat less of anything because we decided we didn't want to talk about sin. We only say eat more of things. So I think we really have to take a look at this and see how we can describe the dietary pattern we intend to describe which will increase the emphasis on plant foods and decrease the emphasis. And it would probably never get approved ultimately, but we could try because we've been there before.

And then these other things that are in the so- called second tier I don't see as less important. I see them as of a different type. And what I'm envisioning is that we could come up with a graphic where for each guideline we have, its relationship to some overall pattern is highlighted because we're trying this talk about salt and sugar as we run through other guidelines, but we haven't come up with the right way to do it. And so it seems to sort of stick out like a sore thumb.

So we need both types of guidelines, but we need to organize them so that it describes a dietary pattern plus some additional considerations about that pattern which includes the safety and so forth. So we're not that close, as far as I can see, to where we need to be at this point.

DR. GARZA: Suzanne?

DR. MURPHY: I was thinking along the line, Shiriki. I was wondering if there was a different set of criteria we might use. And I may -- I think I'm expanding on what you just said. But I -- we've always said the guidelines are variety, moderation and balance. I would say they are now adequacy, moderation and balance.

And I wonder if we maybe come up with some broad terms like that to actually group them into maybe just three major categories that could be sort of consumer key messages. And -- and I think, for example, we do have four guidelines which are moderation guidelines. We have three that are probably adequacy guidelines. And then the balance would be the activity and the body weight.

DR. JOHNSON: And safety would moderation -- are you thinking of food safety as moderation?

DR. MURPHY: Food safety is sort of an orphan at the moment. That might go with adequacy. It might go with moderation. Well, we'll see. I don't know.

DR. DWYER: Could you tell us how you put them down? I'm not sure --

DR. MURPHY: Well, this is the evolving thinking. But adequacy would be whatever we decide to do with the "adequacy" guideline, plus perhaps the fruits and vegetables and grains. Moderation I think would be all -- the four things that are now at the bottom of the list, the fats, sugars, sodium and alcohol. And balance would be the physical activity and the healthy weight. But, as Rachel points out, that leaves food safety as a little bit of an orphan.

DR. GARZA: We could put it under adequacy.

DR. MURPHY: I could.

DR. GARZA: Okay. Let me -- I think people are getting -- are getting tired. And I have an assignment unfortunately for you. And that is as you -- as you look at the various guidelines, especially the material that's going to the Secretaries, it would be very useful if you look at them and at least the working groups begin to assign yourselves segments of that report to the Secretaries that begins to document material along the ways that Shiriki suggested, in terms of supporting evidence, other evidence and then conclusions for each of the changes that we're going to be recommended in the guidelines.

So that it's very clear by the time we leave on Friday that for changes one, two and three in the first guideline, it will be -- on Suzanne -- on Suzanne or if -- you know, it's the five guidelines -- the same thing would apply to Scott and other members of that working group.

So that Carol and myself will have a very clear idea as to who we go to for -- for the documentation pieces. And I think that if each of us do -- does a segment of that and gets it to Carol in a reasonable amount of time to be able to put it in a similar style, then you won't be surprised in September when we come back to you and say, gee, this is -- this is just not adequate in terms of documenting the recommended changes.

So as you look at food safety, and there you've got a brand new guideline. And if you can divide it out in terms of those issues that -- that require more documentation, or if you think that they are adequately documented and that you've critically reviewed strengths and weaknesses and can reach conclusions, then obviously you have no work to do.

If in some of the guidelines there are just statements that are made without that type of review, then obviously there -- there has to be a brief synopsis of the strengths, the weaknesses of the evidence that we're marshalling in -- in support of the guidelines.

I was discussing this with Carol and she pointed out -- and I hadn't appreciated it until I stopped to think about it and she is absolutely right -- that there has been a very clear evolution in the reports to the Secretaries since these first came out with a bar for documenting the changes that are recommended having been increased with each successive iteration.

But I think that's only fair given the fact that we are working with -- with a document that's now basically, what, about 20 years old. And we should be able to document changes in a way that is transparent to the public, that is going to be -- that are going to be looking -- scientific public at least that is going to be looking at -- at the green book.

So if you can begin doing that so that by Friday, it will be very clear as to who is going to be doing what within the working groups. And you can turn in those lists to Carol because she is -- in your -- in your notebooks, you've got the changes that are being made, have been documented. So just let us know who is going to be documenting each of those changes. Is that clear or did I confuse everybody, because I'm jetlagged.

DR. DWYER: I'm a little confused about the process. And I guess it goes back to a question Dr. Murphy raised at the beginning. It seems to me that what we're into is sort of like a chariot race. And we have these working groups going along in chariots. And they've bene going along now for six or eight months. But they are the same people in the chariots. And I'm getting a little stale in my chariot. And I wonder if others aren't, too.

You know, sometimes it's hard to see -- you try to listen, but you find you're not. And at what point does this get mixed up and do people sort of go to another set of partners and have a fresh look at these things? It seems to me in the end, we will all stand or fall by all of the guidelines, not just the ones that we were on a working group on.

DR. GARZA: No, we each are responsible for all of them. But trying to now change -- to use your analogy, change chariot drivers so that somebody else has to become familiar with the literature you each have been looking at I think will be more work rather than less work for individuals.

So that if you can look at the guidelines -- I mean, I -- I haven't heard those many substantive changes to the ones that have already been incorporated. I mean, most of it has been refinement rather than, you know, we've got this major, major rationale for a change.

So I don't think that we're adding to the text of the guidelines themselves; just asking you to go back and seriously look at the case you have built for justifying the changes that each of you is recommending; and to assign yourselves specific components.

Otherwise -- unless the chairs want to take it on and be totally responsible for the guideline. That's fine. Just give -- just give us your name. But I think that would be a significant burden on --

DR. JOHNSON: Could I suggest that each group at least have one outside reviewer that takes --

DR. GARZA: Oh, we will.

DR. JOHNSON: -- a look? You know --

DR. GARZA: All of us --

DR. JOHNSON: -- really, you know, a critical, critical look that somebody has actually assigned that? Because when you say, well, review them all with a critical eye, it's a little, you know --

DR. GARZA: No, you're right.

DR. JOHNSON: -- if we had one that was --

DR. GARZA: And that's a very good suggestion. We will before the process is over, say, gee, well, you look at this one and somebody else look at another one that wasn't involved with the initial writing. And maybe that will avoid the staleness issue that Johanna was going at. Alice?

DR. LICHTENSTEIN: I'm only wondering if it might not be more efficient for the chairs of the subcommittees to actually do it because the amount of work is going to be the same whether we split ourselves up among different committees or whether we just focus on one topic. And efficiency-wise, that's a --

DR. GARZA: I will leave that up to you guys.

DR. LICHTENSTEIN: -- potential --

DR. GARZA: You know, I would be happy with either -- either approach. But I think it would be better decided within those groups than by the Chair.

DR. WEINSIER: Are there any other documents that we need to be submitting? Is there just an evidence-based document that's more global and then one that specifically relates to the changes over the last set of guidelines or is there only the one evidence-based document which is in support of the recommended changes since the last document? There is only the one?

DR. GARZA: Well, no. I mean, there -- there have been -- there are a series of documents that have been prepared for every one of those guidelines.

DR. WEINSIER: Well, I can't --

DR. GARZA: And for every one of the changes. Is that what you mean?

DR. WEINSIER: Well, like in the beginning, I've submitted, I don't know, at least two broad-based -- you know, evidence-based documents. Do we just throw those out or do we just lift out of those the very specific things that relate to the changes --


DR. WEINSIER: -- rather than the -- so --

DR. GARZA: You lift them out related to -- lift out those components that are related to specific changes. Now, if there are other topics you want to raise that didn't motivate a change but you want to call the Secretaries' attention to them, then certainly we can -- we can -- we should have a section under each of the guidelines that say, "Other research names", or, "Other issues that the committee felt the scientific data were just not sufficient to merit a change, but we were concerned about to try to motivate research or ask future committees to pay particular attention to that aspect of the science as it evolves." So you could put the -- the other pieces in there.

DR. MURPHY: I guess I'm still slightly confused. We've all been working and Carol has been helping us on a parallel document that has references in it and justification. You're just talking -- are you talking about a refinement of --

DR. GARZA: Amplifying -- yes, that's right.

DR. MURPHY: -- the existing document.

DR. GARZA: That's right.

DR. MURPHY: So we're not talking about starting all over on something.

DR. GARZA: Oh, no. It's just that in that document right now, what we've done is only to state a conclusion and then the references that support that conclusion have been -- have been cited. But there is a critical analysis of why you selected that reference in terms of its strengths and weaknesses. And that doesn't mean that we need to necessarily have a very exhaustive document.

But there should be some analysis that helps the reader understand why that particular reference supports that conclusion rather than just listing three or four references and leaving it up to the reader and try to go back and read our mind as to why we thought that it was sufficient justification.

But it's a bit more work than previous committees have done because most of the committees have used the same format that is presently in our document. I don't think that that is going to be sufficient given the present state of attention that these guidelines are getting. And I don't think that -- you know, I'm not asking for pages and pages. Just that we need to be able to identify strengths and weaknesses in a reasonably compact way.

DR. GRUNDY: One question. Is this -- are we -- you asking for references since the last document?

DR. GARZA: That's right.

DR. GRUNDY: No, you know, one of the problems that I see is that this is assumed that the previous document was based on the evidence that existed to that point. One thing I think about, the dietary fat guidelines, is it's an evolution over a period of time and that the recommendations made at the last time represent the judgement of the committee at that time.

But that doesn't mean that the changes that are made are based entirely on what's happened since that time because it's a body of evidence over a longer period of time that might be thrown in a slightly different perspective by recent findings. But you go back and look at the previous data, you might interpret it a different way now.

DR. GARZA: And if you want to bring in references that -- that help interpret recent data, I think that's certainly reasonable, from the past. I just don't want --

DR. GRUNDY: Right.

DR. GARZA: -- to have it as an onus on each of us that you have to review all of the data that's been published since 20 years ago. I mean, I just don't think we have the staff time or --


DR. GARZA: -- that you necessarily have to be brought into that process. But if you find that that would help make your case because you've got a few key articles that you want to cite that were previous to '95, I don't see any problem with that.


DR. GARZA: It's just that we can't just take data only since before '95 and use that as a sole -- as a sole basis for then recommending a change.


DR. DECKELBAUM: Again, in putting on our reviewer's caps though, I'm just counting the papers on whole grains and cancer and heart disease. So there are seven papers -- seven major papers and there are probably others. But -- and they are published in the American Journal of Clinical Nutrition, Circulation, JAMA, Nutrition and Cancer, etcetera. So they've already been peer reviewed. And so should we do a meta analysis of these, you know, combine them and --

DR. GARZA: No, but you can say, for example, we have these three -- these three publications that are all random control trials and give them -- give the strengths of that design. We have these other three that are less -- are less convincing because in fact they were observational in nature. But when we combined them with these other three, they certainly are consistent, therefore bolster the case we're trying to make.

So it's not taking each paper and dissecting it, but providing some -- some rationale that will be more user- friendly than, "Trust me, you know, I read these three papers and this is the conclusion that I reached."


DR. MURPHY: So I think it would be helpful if we made a decision about whether the chair does it or we divide it up amongst our working groups because we need to all do it the same way. I rather liked Alice's concept, that each of us chairs, a group -- and it's easier for me to sit down and do all of the adequacy guideline than it is to do part of grains and part of food safety and part of adequacy.

DR. GARZA: That would be fine. And then what we can do is those of your that are not chairs -- or those of us who are not chairs can then be the reviewers. And we can -- we can assign ourselves the task that Johanna and Rachel --

DR. LICHTENSTEIN: Just a procedural thing. I'm sure that colleagues on the staff have discs with the copy on it. It would be a great help to -- to us if we're going to be doing that in a timely fashion, if we could get it because I don't have the stuff up on disc.

DR. GARZA: Okay. We'll send you the whole report. It's on disc.

DR. GRUNDY: Well, this is not due Friday. You just want the assignments Friday.

DR. GARZA: I mean, if we --

DR. LICHTENSTEIN: So with that I'll just give you the assignments.

DR. GARZA: Exactly. And it follows as a suggestion -- and Alice's -- we've got the assignment. We don't have to -- it's the chairs of the committees that will be responsible then for fleshing those out. And obviously, you can give them to the group if you want.

DR. LICHTENSTEIN: Can we get them tomorrow?

UNIDENTIFIED VOICE: Do you want to just confirm who is responsible for what?

DR. GARZA: Well, the only two that we don't have right now are weight and physical activity. Everything else is assigned --

DR. GRUNDY: That you don't have --

DR. GARZA: -- chairs for because we may be shifting you and Lesley. WE've got to talk about that and Lesley doesn't know about it yet.

DR. MURPHY: Surprise, Lesley.

DR. GARZA: Well, that's what I mean. That's -- okay? All right. Then thank you very much. We will meet back here tomorrow morning at 9:00. And we will try to start as punctually as we did this morning.

(Whereupon, at 5:40 p.m. on Wednesday, June 16, 1999, the meeting was recessed to reconvene at 9:00 a.m. on Thursday, June 17, 1999.)


Name of Hearing or Event: Dietary Guidelines Advisory Committee

Docket No.: N/A

Place of Hearing: Washington, DC

Date of Hearing: June 16, 1999

We, the undersigned, do hereby certify that the foregoing pages, numbers 1 through 316 , inclusive, constitute the true, accurate and complete transcript prepared from the tapes and notes prepared and reported by Sharon Bellamy , who was in attendance at the above identified hearing, in accordance with the applicable provisions of the current USDA contract, and have verified the accuracy of the transcript (1) by preparing the typewritten transcript from the reporting or recording accomplished at the hearing and (2) by comparing the final proofed typewritten transcript against the recording tapes and/or notes accomplished at the hearing.

Date: 6/22/99

Name and Signature of Transcriber Heritage Reporting Corporation: Bonnie Niemann

Date: 6-23-99

Name and Signature of Proofreader Heritage Reporting Corporation: Lorenzo Jones

Date: 6-16-99

Name and Signature of Reporter Heritage Reporting Corporation: Sharon Bellamy

Last updated July 13, 1999