107th Congress

Report: Dietary Supplements—Hearing Before the House Committee on Government Reform—July 25, 2002

Members Present

• Dan Burton (R-IN), Chair
  
• Elijah Cummings (D-MD)
  
• Eleanor Holmes Norton (D-DC)
  
• Carolyn Maloney (D-NY)
  
• Connie Morella (R-MD)
  
• Dennis Kucinich (D-OH)
  
• Edward Schrock (R-VA)
  
• John Tierney (D-MA)

Witnesses

Panel One:

Diane Ladd, Actress, Film Director, Certified Nutritional Consultant, Ojai, California.

Panel Two:

• David Seckman, Executive Director and CEO, National Nutritional Foods Association, Newport Beach, California
  
• George Bray, M.D., Boyd Professor, Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, Louisiana
  
• Larry Kushi, Sc.D., Associate Director for Etiology and Prevention Research, Division of Research, Kaiser Permanente, Oakland, California
  
• Pamela Peeke, M.D., M.P.H., Assistant Clinical Professor of Medicine, University of Maryland School of Medicine, Adjunct Senior Scientist, National Institutes of Health, Bethesda, Maryland
  
• Timothy Church, M.D., M.P.H., Ph.D., Senior Associate Director, Medical and Laboratory Director, Division of Epidemiology and Clinical Applications, the Cooper Institute, Dallas, Texas
  
• David Heber, M.D., Ph.D., F.A.C.P., F.A.C.N., Director, Division of Clinical Nutrition, University of California at Los Angeles, Los Angeles, California.

Panel Three:

• Paul Coates, Ph.D., Director, Office of Dietary Supplements, National Institutes of Health, Bethesda, Maryland
  
• William Dietz, M.D., Ph.D., Director, Division of Nutrition and Physical Activity, Centers for Disease Control and Prevention, Atlanta, Georgia

Purpose of Hearing: The purpose of this hearing was to focus on the scientific basis for Americans' decisions to use vitamins, minerals, and botanicals in combination with specific dietary and lifestyle choices as a means of improving and maintaining health.

Summary

The questions Representative Burton posed to the Government panel focused on 1) health agencies' attitude towards dietary supplements and alternative medicine; 2) what influence the pharmaceutical industry has on health agencies; and 3) studies conducted on various supplements and alternative medicine, specifically St. John's Wort and ephedra.

Representative Burton asked Dr. Coates to comment on a letter from Dr. Wayne Jonas that appeared in the Journal of the American Medical Association regarding the results of a study on St. John's Wort, whether he thought the study was flawed, and why the study was on those with major depression when it is indicated for minor depression. Dr. Coates responded that he thought Dr. Jonas' letter was a reasoned approach, explained how issues about trial design are often raised, and how others have commented that the placebo effect adds complexity to depression-oriented trials. Regarding the last question, Dr. Coates stated that the study population was called, "major depression of moderate severity." He explained that it was his understanding that the criteria used to determine whether a patient was eligible for the study was similar to that of European studies. However, there could have been differences on how European scientists and American scientists define depressive disorders. He noted that the Office of Dietary Supplements (ODS), the National Center for Complementary and Alternative Medicine (NCCAM) and the National Institute of Mental Health were mounting a followup study in a population that will carry the diagnosis of minor depression.

Representative Burton asked Dr. Coates if he knew what the Dietary Supplement Health and Education Act of 1994 (DSHEA) was, what he thought about the law, and whether he thought health agencies believed that Congress overstepped its bounds in passing the law. Dr. Coates explained how DSHEA established ODS to conduct research on the risks and benefits to provide the best information on dietary supplements. When Dr. Coates stated that he could not speak for the health agencies on whether Congress overstepped its bounds, Representative Burton asked his personal opinion. Dr. Coates answered that, at the time the bill was passed in 1994, it was an excellent piece of legislation. He added that in his personal opinion, it is a good idea to periodically reexamine statute. Representative Burton then asked what he thought about the law today, to which Dr. Coates replied that it has been demonstrated that dietary supplements could be used for a variety of conditions. He added DSHEA was intended for health promotion; however, there are sectors that go beyond this and market products for disease treatment, which was not the intent of the law.

The discussion then turned to ephedra, specifically a study known as the Boozer study and the evidence report by the RAND Corporation. Representative Burton asked Dr. Coates if he felt that the Boozer study was flawed. Dr. Coates explained that this 6-month study was conducted in a carefully monitored, well defined population, who did not have conditions that would put them at risk. Therefore, more information is needed to demonstrate that ephedra would be safe for a larger, diverse population that wouldn't necessarily be taking this supplement under the supervision of a physician. Representative Burton commented that he hoped that the RAND study would not discredit the Boozer study in order to favor pharmacological products over natural ones. Dr. Coates clarified that the RAND report is to determine what research is needed, not to discredit other ephedra studies.

Upon closing the hearing, Representative Burton stated his wish that health agencies continue to consider alternative and complementary therapies, as well as dietary supplements. He added that he would like to see DSHEA fully implemented and hoped that there would not be an attempt to circumvent or change the law, unless Congress was consulted.

Opening Statements

Representative Burton began the hearing by stating how health care oversight activities has been a high priority for the committee during his tenure as chairman. He noted the skyrocketing costs of health care; that the United States ranks 37th in health status; and that doctors are not taught preventive medicine, which includes complementary and alternative medicine. Representative Burton stated that there is an increasing body of evidence to support diet and exercise improve health. He then went on to say that the committee has been active in monitoring implementation of DSHEA. He commented that the Food and Drug Administration (FDA) has not yet published good manufacturing practice guidelines and negligible review of imported products. Noting that the National Academy of Sciences published for comment a proposed framework for evaluating the safety of dietary supplements, he commented that tracking adverse events for dietary supplements does not provide valid scientific data on which to develop policy. Representative Burton added that his wife died of colon cancer on May 10. He encouraged people over the age of 40 to get a colonoscopy, noting that his wife may have not died if she had this procedure as a regular part of her medical care.

Representative Schrock commented on the obesity epidemic in the United States and its effect on the economy. He then held up the July/August edition of Men's Magazine which contained a series of articles on obesity and challenged American men to lose one million pounds. Representative Schrock summarized some of the negative health effects of obesity and how, during his battle with cancer, he lost 142 pounds. He then said that he was going to challenge the Democrats and Republicans to each lose 5,000 pounds. He noted that he learned from his wife, who is a kindergarten teacher, that poor diet occurs in the schools. He also commented that people are overmedicated, adding that many of his wife's students are on Ritalin.

Representative Morella stated that the issues to be discussed at this hearing are common sense; and she hoped to learn something new. She commented that she was interested in the gender differences regarding obesity. She said that improved health could translate into monetary savings, noting that, "we are pouring a lot of money into the National Institutes of Health." She then acknowledged Dr. Coates and how research is reflected in knowledge, cures, and prevention of some major illnesses. She also noted how families are impacted when they care for those who are not healthy.

Statement of Witnesses

Ms. Ladd testified on how vitamins and minerals helped her conceive a baby, cure her daughter of scoliosis, and relieve her allergies.

Mr. Seckman addressed the economic opportunity for improving health through diet, physical activity and use of dietary supplements. Additionally, he addressed the importance of natural foods in the diet as a tool for disease prevention and health maintenance. He described various studies that demonstrated how various vitamins, herbs, and supplements improved health and delayed the onset of disease. He noted that ODS and NCCAM stimulate research and play vital roles in providing consumers with accurate and reliable information about alternative treatments and therapies. He added that the recent announcement regarding the risks of hormone replacement therapy underscores the need for more research and information about safe and effective alternatives.

Dr. Bray commented on obesity, its treatment, and the use of dietary supplements and other over-the-counter products. He noted how the Diabetes Prevention Program demonstrated that small reductions in weight losses significantly reduced the risk of diabetes in those who are at risk for this disease. Dr. Bray stated that improvements should be made in labeling, standardized dosing, and the use of good manufacturing practices. He said that providing financial incentives would encourage manufactures to conduct research and that pre-marketing research, in particular, should be rewarded.

Dr. Kushi described some of the scientific evidence that plant-based diets, also known as macrobiotics, are the healthiest. He then held up two articles, one supporting a vegetarian diet, the other supporting a high protein and fat diet. He noted that, although the articles seemed to contradict each other, each one had some validity. He said that the New York Times article, "What If It's All Been a Big Fat Lie?" by Gary Taubes, ignored certain fundamental truths about diet and health. He went on to state how, although there is tremendous variation in the amount of fat in Mediterranean and East Asia diets, both diets have some emphasis on plant foods and minimal use of animal foods. Dr. Kushi mentioned clinical trials of plant-based diets that demonstrated effectiveness in promoting health and preventing cardiovascular disease. He also noted that NIH funded randomized trials of plant-based diets and the recurrence of breast cancer.

Dr. Peeke informed the committee that when she reentered academia, she learned that there was no medical curriculum in nutrition. She then spoke about gender-specific medicine and its relationship to obesity, citing a 2001 Institute of Medicine report about the biology of sex and gender differences. She stated that a women's fitness will determine how well a woman copes with various diseases. She also noted that when looking at issues of obesity and unfitness, ethnic diversity and psychological issues should be considered.

Dr. Church described some of the research studies done at the Cooper Institute, adding that the Institute has produced over 650 publications, some of which have influenced major national policy initiatives from NIH, the Centers for Disease Control and Prevention (CDC), and the American Heart Association. In one of the studies he described, he noted that when individuals took a multivitamin, there was a significant decrease in LDL oxidation (less "bad" cholesterol).

Dr. Heber informed the panel that many scientists have recently raised the issue of whether the food pyramid should be remodeled. He stated that the USDA's dietary guidelines are more abstract than the food pyramid, which demonstrates a hierarchy of foods. He then explained the importance of a "colorful" diet, since these fruits and vegetables are more nutritious. He noted that both drugs and botanical supplements have a role to play in promoting health. He urged the full implementation of DSHEA and to increase fruit and vegetable intake in the American diet.

Dr. Coates discussed the activities of ODS and highlighted the directions that the office has taken in developing good science in the field of dietary supplements. He also provided comments about issues related to diet and chronic diseases, as requested by the committee.

Dr. Dietz addressed the risks of obesity and the scientific basis for diet and physical activity. He outlined four strategies to address the epidemic of obesity: physical activity, increased fruit and vegetable intake, control of time children watch TV, and breastfeeding infants.

Questions

Representative Burton:
Panel 1

• Are you aware of any research in our Government that is looking at those issues (diet, vitamins, and supplements)? Ms. Ladd recounted how she was with doctors who contacted the CDC and asked the agency to monitor their work on chelation therapy and vitamin C drips. According to Ms. Ladd, the CDC, "laughed in their faces–roared with laughter–and said, ‘We don't believe in anything holistic.' And they slammed the phone down in these famous doctors' faces. And I was there and witnessed it."
  
• Can you tell us just a little bit about your experience with some of the methods that are used in other countries and the vitamins and supplements that they use and how that might be effective?

Panel 3

• Do you find that there is a mindset in any of our agencies–FDA, CDC or the U.S. Department of Health and Human Services (DHHS)–that would indicate that complementary and alternative therapies and dietary supplements are not worth a darn? Dr. Dietz replied that his agency believes that there is a very important role for dietary and weight loss supplements. He added that he was embarrassed to hear what Ms. Ladd said about how CDC treated her and her doctors. He said that his division would not treat callers in such a manner, noting that he was proud to work at CDC.
  
• Have there been any extensive studies on how supplements affect different kinds of diseases? Have there been any double-blind studies that you know of that would say large amounts of vitamin C reduce the risk of heart attack or cancer or stroke or any of those things? Dr. Coates referred to several studies in his written testimony.
  
• Have you done any studies on any of the approaches to medicine that are age-old, like in China, where they use acupuncture and other things like that? Dr. Coates responded that NCCAM is actively pursuing these areas and evaluating them in the context in which they are being used in the United States.
  
• Do you ever feel that sometimes our health agencies are in some way being manipulated or controlled by the pharmaceutical industry? Dr. Coates stated he did not have an opinion and that he did not observe this phenomenon as a part of his work. Representative Burton then stated that people who work in health agencies leave work for the pharmaceutical companies and vice versa, and that he believed this could be an influence. Dr. Coates acknowledged that it could, but restated that he had no opinion.
  
• Staff says that the St. John's Wort study was for major depression when St. John's Wort was never supposed to have been used for that–only mild and minor depression. Can you explain why they did that? Because I think right on the bottle, it says it's not for major depression, does it not? And yet, they did include that in the study.
  
• Do you know what the DSHEA law is? What do you think about that? Do you think that people at our health agencies feel like Congress overstepped its bounds in passing the DSHEA law? What do you think about the law today?
  
• Non-synthetic ephedra has, when used in proper doses as shown on the bottle and the inserts, has minimal side effects. Do you remember who did a study on this?
  
• Our health agencies are doing another study. Who is doing this?
  
• Does the RAND report discredit the Boozer report?

Representative Maloney:
Panel 1

• Are you aware of any research in our Government that is looking at those issues (diet, vitamins, and supplements)? Ms. Ladd recounted how she was with doctors who contacted the CDC and asked the agency to monitor their work on chelation therapy and vitamin C drips. According to Ms. Ladd, the CDC, "laughed in their faces–roared with laughter–and said, ‘We don't believe in anything holistic.' And they slammed the phone down in these famous doctors' faces. And I was there and witnessed it."
  
• Can you tell us just a little bit about your experience with some of the methods that are used in other countries and the vitamins and supplements that they use and how that might be effective?

Panel 3

• Do you find that there is a mindset in any of our agencies–FDA, CDC or the U.S. Department of Health and Human Services (DHHS)–that would indicate that complementary and alternative therapies and dietary supplements are not worth a darn? Dr. Dietz replied that his agency believes that there is a very important role for dietary and weight loss supplements. He added that he was embarrassed to hear what Ms. Ladd said about how CDC treated her and her doctors. He said that his division would not treat callers in such a manner, noting that he was proud to work at CDC.
  
• Have there been any extensive studies on how supplements affect different kinds of diseases? Have there been any double-blind studies that you know of that would say large amounts of vitamin C reduce the risk of heart attack or cancer or stroke or any of those things? Dr. Coates referred to several studies in his written testimony.
  
• Have you done any studies on any of the approaches to medicine that are age-old, like in China, where they use acupuncture and other things like that? Dr. Coates responded that NCCAM is actively pursuing these areas and evaluating them in the context in which they are being used in the United States.
  
• Do you ever feel that sometimes our health agencies are in some way being manipulated or controlled by the pharmaceutical industry? Dr. Coates stated he did not have an opinion and that he did not observe this phenomenon as a part of his work. Representative Burton then stated that people who work in health agencies leave work for the pharmaceutical companies and vice versa, and that he believed this could be an influence. Dr. Coates acknowledged that it could, but restated that he had no opinion.
  
• Staff says that the St. John's Wort study was for major depression when St. John's Wort was never supposed to have been used for that–only mild and minor depression. Can you explain why they did that? Because I think right on the bottle, it says it's not for major depression, does it not? And yet, they did include that in the study.
  
• Do you know what the DSHEA law is? What do you think about that? Do you think that people at our health agencies feel like Congress overstepped its bounds in passing the DSHEA law? What do you think about the law today?
  
• Non-synthetic ephedra has, when used in proper doses as shown on the bottle and the inserts, has minimal side effects. Do you remember who did a study on this?
  
• Our health agencies are doing another study. Who is doing this?
  
• Does the RAND report discredit the Boozer report?

Representative Maloney:
Panel 1

• Do you agree that complementary and alternative treatments need to be proven safe and effective before patients decide not to have traditional treatment and follow a holistic method? What do you think we should be doing in Government to advance this?
  
• When would you recommend a holistic method, and when do you recommend the traditional method?

Representative Schrock:
Panel 2

• How does a consumer decide what dietary supplements to use, not just the brands, but specific substances like vitamin C, Ginseng, vitamin E, and others?
  
• I have been advised not to use Hydroxycut because it makes you depressed and has other side effects. How do you know it is safe to use since that information is not on the bottles. How much weight can one expect to lose from some of the products?
  
• What is the right amount of fat? Is it okay for the average American to include plant products that contain fat, such as avocados, nuts and olives?
  
• How do you explain stress and weight gain?
  
• Dr. Church, in some of the examples you gave, you had the two test groups, and you said there was no change in the plasma glucose. My guess is that is what you were looking for; and you did not find it in those two groups. Why would that be? Obviously, one was better than the other.
  
• We talk about obesity in kids. How do we turn that around–physical education programs?
  
• Dr. Heber, your book, "What Color is your diet?" Explain why that is important.

Panel 3

• What is the best kind of weight loss program? How do people really get it off and keep it off? Dr. Coates commented that weight loss programs work in the early phases, but people must be able to sustain weight management and, if necessary, to continue weight loss. He said that many programs are available, some of which have been well-designed and well-tested. Dr. Dietz also stated that sustaining the weight losses is the key. He then outlined four common strategies, uniform among people on a weight loss registry, that were successful in maintaining weight loss: eating breakfast, monitoring weight, reduced-fat diet, and physical activity.
  
• It is said that senior citizens absorb less nutrition from their food. Wouldn't supplements be a good thing for them? Dr. Coates replied that he agreed with Representative Schrock, and referred to his written testimony, where he described how vitamin B-12 is an effective strategy for the elderly, because of their decreased ability to absorb the vitamin from food. He then mentioned that ODS and the National Institute on Aging are sponsoring a conference early next year on dietary supplement use in the elderly. He also noted that Senator John Breaux (D-LA) held a hearing on this issue last year.
  
• Is not a lot of it genetics? Dr. Coates replied that it is important to look for the interactions between genes and the environment, where in this case the environment could be nutrition or dietary supplements.
  
• Dr. Dietz, all of the sudden we're really concerned about the increase in childhood diabetes. Why? Dr. Dietz described how the increase is driven by obesity.
  
• What role is the CDC playing in the President's new initiative on physical fitness? Are you integrally involved in that?
  
• Can schools have an impact on childhood obesity?
  
• Is there any role for faith-based organization in promoting physical fitness in communities, and are there funds available for that sort of thing?

Patricia Brandt Hansberger, OLPA, July 31, 2002