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$25 million per year in multicenter clinical trials to try to validate or invalidate this lipid hypothesis.

Mr. GRASSLEY. Results of those, as the previous witness indicated, will be in over a long period of time. Is that

right? Dr. Levy, The trials began in the early 1970's; they are scheduled to end between 1982 and 1985.

Mr. GRASSLEY. It remains true that science still has not, then, firmly and convincingly established as a fact that dietary change helps the heart?

Dr. Levy. It has not been conclusively demonstrated in man that lowering the concentration of LDL of plasma cholesterol will delay the progression-prevent coronary artery disease. That is correct.

Mr. GRASSLEY. Can you name any specific major scientific breakthroughs in the last 2 or 3 years in our understanding of the means of preventing heart disease ?

Dr. LEVY. Probably the most outstanding breakthrough in the last 3 years has been the results of the hypertension detection and followup program. This multicenter clinical trial now demonstrates conclusively that if one intervenes on individuals with mild hypertension, one can reduce mortality from heart attack and stroke considerably. In this study, cardiovascular death was reduced in the mild hypertensive group, as compared to a population referred to regular sources of treatment—heart attack by 46 percent, stroke by 45 percent.

There are other pieces of information that have come through, but in terms of specific clinical trial evidence in man, this is the most exciting information that has become available in the last 3 years.

Mr. GRASSLEY. There have been considerable joint efforts by the food industry, either alone or with the Government, to support excellent nutrition research. Does the fact that industry funding is available invalidate in any way the results of this research?

Dr. Levy. No, it should not, Congressman Grassley, especially if the investigator was allowed—as I would assume they usually are to do the research without intervention and to make known the facts as they find them.

Ár. GRASSLEY. Do you in any way question the personal integrity of the NAS and FNB members who issued the report, "Toward Healthful Diets ?"

Dr. LEVY. No; I do not.

Mr. GRASSLEY. Is it not true that the American Egg Board has repeatedly sought your assistance in the design and conduct of its scientific research program?

Dr. LEVY. The Egg Board has, on several occasions, discussed with me the nature of their grant support to research in this area. I have suggested reviewers of the research and the outcome of review.

Mr. GRASSLEY. Do you think the consumer would be well served if your agency, or this subcommittee, or any other Government agency were to discourage good scientists from participating in industry or other nongovernmental research programs?

Dr. LEVY. I would go even further, Mr. Grassley. Facts, evidence, and scientific information is important. If the expertise exists in Government, we must take advantage of it; if the expertise exists in the private sector, or in industry we must seek it out. There must be exchange and dialog and the use of the best available facts and the best available expertise.

Mr. GRASSLEY. My last question is in regard to a followup of the previous one I asked about the American Egg Board. Would you not agree that non-Government research programs such as the one at the Egg Board are contributing to our scientific understanding of the causes and means of preventing coronary artery disease ? Dr. Levy. The Egg Board's

funds for research on the role of cholesterol and blood lipids, like the American Heart Association's grants in this area and others, contribute to our gathering of additional information. That is essential if we are going to be able to act more knowledgeably and more aggressively in the future.

Mr. GRASSLEY. Thank you.
Mr. RICHMOND. Thank you, Mr. Grassley. Mr. Wampler ?
Mr. WAMPLER. Thank you, Mr. Chairman.

Dr. Levy, I want to thank you for your appearance here this morning. Let me apologize for not being present during the presentation of your statement; I was on the floor of the House and have not yet been able to determine how one could be two places at one time. So it is not a lack of respect for you or your statement, and I want you to be assured of that fact.

Dr. Levy, I am informed that the overall incidence of heart disease is declining in the United States. Is that a fair statement?

Dr. LEVY. That is correct-especially the major killer disease, coronary artery disease. The decline began somewhere around 1963 but has been precipitous especially in the last 10 years. As a result, cardiovascular disease, as a whole, is some 25 percent lower in terms of rates than it was a decade ago. Stroke has declined even more precipitously.

Mr. WAMPLER. Dr. Levy, in view of this, how would one reconcile the fact that the lifespan of human beings in the United States is increasing, the fact that the United States also has had an increase in humans of fat and cholesterol during this same general period? Is there a correlation, do you think?

Dr. LEVY. Congressman Wampler, I am delighted you asked me that question. We held a conference a little over a year ago to look at this decline in mortality rates. The question was, What were we doing so good and how could we do it better?

We looked at the factors that were related or possibly related to the decline of cardiovascular mortality. We did not have information that we would have liked on morbidity on the number of heart attacks and strokes. We only had solid, firm death information. So we could not be as convincing as to what role primary prevention had played as compared to the role of improved treatment.

It was, however, very impressive that data were presented which showed that one of the factors that temporally changed during this last decade was the American consumption of fat and cholesterol. The data, in fact, besides showing a change in cigarette habits and in attention to blood pressure, demonstrate to us that the average American's consumption of cholesterol and total fat has declined slightly. What we are talking about is a diet having between 40 and 41 percent of calories of fat. The USDA and NHLBI figures show fat intake is now somewhere between 38 and 39 percent of calories.

The so-called food disappearance data also changed between 1963 and 1977; the consumption of fluid milk and cream is down some 22 percent; of butter, down some 36 percent; of eggs, down some 14.5 percent; the consumption of fats and oils of animal origin is down some 48.6 percent; and the consumption of vegetable fats and oils is up some 74 percent. We have evidence that there have been changes in nutrition; we also have evidence that these changes in nutrition have led to changes in the average American cholesterol.

For example, looking at the two health and nutrition surveys done some 10 years apart, one sees on the average a 1- to 3-percent lowering in the average blood cholesterol level.

Using other studies, like the Lipid Research Clinic's prevalence studies and the ongoing studies in Chicago and Framingham, we have evidence that the average American blood cholesterol is now some 3 to 8 percent lower, depending on the decade we look at, than it was a decade

ago. We also have some other interesting evidence. We used to think about high cholesterol as a problem of the affluent; the more educated, the more well off an individual, the higher the cholesterol. The most recent data from the Lipid Research Clinic program show that this is not the case. In fact, our most affluent, our most educated, have lower cholesterol levels.

Whether these changes, Congressman Wampler, may be considered as a cause-and-effect relationship, I would not say. There are many other factors that have changed during this time. But it is evident that the American consumption of fat has changed; the American average blood cholesterol has changed in this time, in the same downward trend as coronary vessel disease.

And perhaps one last point what we were struck with at that meeting almost 11/2 years ago was that the decline we are seeing in the United States today is not occurring all over the world. The decline is occurring only in a few countries, and it appears to be occurring in those countries that are giving increased attention to prevention, increased attention to factors like smoking, blood pressure, and nutrition.

Mr. WAMPLER. I have one final question, Mr. Chairman.

Dr. Levy, I think you were in the witness room when I asked this same question of earlier witnesses about the effect of genetic differences between individuals. Would you agree that that is a fairly correct scientific assumption—that certain individuals have a genetic ability to absorb different levels or retain different levels of fats and cholesterol in their bodies ?

Dr. LEVY. Within a population, as in the United States, a major, perhaps the major, determinant of a cholesterol level is genetic. But, having said that, a major factor that affects the individuals over a wide spectrum of genetic thresholds, genetic susceptibility, is the environment, of which nutrition is a major factor.

Mr. WAMPLER. Thank you, Dr. Levy. Thank you, Mr. Chairman.

Mr. RICHMOND. Thank you, Mr. Wampler. And thank you again, Dr. Levy.

Mr. Harkin, you are recognized for 5 minutes.
Mr. HARKIN. Thank you, Mr. Chairman.

Dr. Levy, I am sorry I could not be here, due to other appointments, but I do have one question that I do want to propound, and I ask indulgence if it has already been asked.

The National Heart, Lung, and Blood Institute, recently, I guess, cooperated with a national food retail chain in the Washington, D.C. area in a foods-for-health program which was designed to promote dietary changes to control heart disease by lowering blood cholesterol

. The material made available to consumers said, “Scientists do not know yet whether you can delay or prevent coronary heart disease by lowering your blood cholesterol.” Do you know now?

Dr. LEVY. No, we do not, Congressman Harkin.

In my opening statement, I made it clear that we do not have conclusive evidence in man that lowering cholesterol—the level of LDLwill prevent heart disease. We are seeking that evidence through multicenter clinical trials that are in progress.

Mr. HARKIN. Thank you, Mr. Chairman.

Mr. RICHMOND. Of course you would like to say, "however," Dr. Levy. [Laughter.] Just to clear Mr. Harkin's mind, why do you not add to that?

Dr. Levy. Coming back to my last line in my opening statementand here is really the difference between the Academy report and other reports—we are looking at a glass that is not totally full or not totally empty. On the basis of the very strong and presumptive epidemiologic data, on the basis of the very strong animal data that relate LĎL cholesterol to coronary heart disease, while we wait for this final evidence to come in, the question is: Do Americans sit on their hands or do they do something to try to help themselves ? On the basis of the number of Americans who are at risk for high cholesterol, it certainly seems totally consistent with the facts at hand to recommend that one hedge one's bets and seek a diet lower in fats and cholesterol.

Mr. HARKIN. On page 3, you said: We can, however, modify or eliminate what are considered the three major risk factors associated with coronary heart disease-smoking, uncontrolled high blood pressure, and high levels of serum cholesterol.


You say:

You should not smoke; you should lower your blood pressure, and you should not have a high level of serum cholesterol.

Dr. Levy. That is, if one wants, in actuarial terms, to live as long as one possibly can.

Mr. HARKIN. Thank you, Mr. Chairman.
Mr. RICHMOND. Mrs. Heckler ?

Mrs. HECKLER. Dr. Levy, I would like to ask about a comment attributed to you, as I understand it, from the New York Times, in which you say that:

It is true that not all the facts are in, but to recommend doing nothing in the meantime is inappropriate. The existing information indicates Americans should hedge their bets and seek a diet lower in saturated fats and cholesterol.

And you call the Food and Nutrition Board document "another report of opinions rather than new facts. Those who wrote the report have expressed the same opinions for the last 10 years."

elaborate on that last statement? Is that an accurate quote from you?

Dr. LEVY. I think it is an accurate quote.

Could you

Mrs. HECKLER. Would you elaborate on the fact that “those who wrote the report have expressed the same opinions for the last 10 years?” Is that a matter of record ? Dr. Levy. We might argue over whether it is 10 years, 5 years, or 15

5 years. But Dr. Olson, for example, has written a chapter for a textbook I edited on nutrition and cardiovascular disease, and the opinions reflected in that chapter are reflected in the Academy's report. The book was published some 2 years ago, and, of course, the chapter was written earlier.

As with so many other fields, and there are a spectrum of views, a spectrum of opinions regarding available data. I do not think Dr. Olson or Dr. Ahrens—who did not write the report but reviewed itwould deny that their views are known to others of us in the scientific community.

Mrs. HECKLER. Doctor, do you feel that there will be a serious impact in terms of the dietary habits of individuals as a result of conflicting standards of good nutrition?

Dr. LEVY. I think the American public is confused right now, and that is unfortunate.

In prevention, which is the ultimate cost-effective way to approach disease, we have emphasized with smoking and with blood pressure control the role that the individual has to take in order to help himself. I am afraid that the recent report sort of colors the credibility of that concept and makes Americans think that change, which is difficult to make anyway, does not have that much value. It gives them an excuse for recidivism, for backing off, for doing what feels good or best at the time regardless of the risks, and that is a shame.

Mrs. HECKLER. Thank you. Thank you, Mr. Chairman.

Mr. RICHMOND. Thank you, Mrs. Heckler. Thank you again, Dr. Levy.

Our next witness is Dr. Philip Handler, president of the National Academy of Sciences.

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ACADEMY OF SCIENCES, WASHINGTON, D.C. Dr. HANDLER. Thank you, Mr. Chairman. May my colleagues on the panel accompany me?

Mr. RICHMOND. Certainly, Dr. Handler.

Dr. Handler, your testimony, which we received this morning, goes on for 17 pages.

Dr. HANDLER. Yes. I would like to submit it for the record, Mr. Chairman.

Mr. RICHMOND. Without objection, it will be included in the record and we would be grateful if you would take 10 minutes just to summarize it.

[The prepared statement of Dr. Handler may be found on p. 180.]

Dr. HANDLER. May I also submit for the record an accompanying statement which summarizes the curriculum vitae of myself and my colleagues ?

Mr. RICHMOND. Without objection, they will be included.

Dr. HANDLER. There is one article from "The Public Interest” which I thought might be of interest to the subcommittee and which I would offer for the record, if you would like it.

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