[House Hearing, 107 Congress] [From the U.S. Government Publishing Office] DIET, PHYSICAL ACTIVITY, DIETARY SUPPLEMENTS, LIFESTYLE AND HEALTH ======================================================================= HEARING before the COMMITTEE ON GOVERNMENT REFORM HOUSE OF REPRESENTATIVES ONE HUNDRED SEVENTH CONGRESS SECOND SESSION __________ JULY 25, 2002 __________ Serial No. 107-109 __________ Printed for the use of the Committee on Government Reform Available via the World Wide Web: http://www.gpo.gov/congress/house http://www.house.gov/reform U. S. GOVERNMENT PRINTING OFFICE 81-866 WASHINGTON : 2002 ___________________________________________________________________________ For Sale by the Superintendent of Documents, U.S. Government Printing Office Internet: bookstore.gpo.gov Phone: toll free (866) 512-1800; (202) 512-1800 Fax: (202) 512-2250 Mail: Stop SSOP, Washington, DC 20402-0001 COMMITTEE ON GOVERNMENT REFORM DAN BURTON, Indiana, Chairman BENJAMIN A. GILMAN, New York HENRY A. WAXMAN, California CONSTANCE A. MORELLA, Maryland TOM LANTOS, California CHRISTOPHER SHAYS, Connecticut MAJOR R. OWENS, New York ILEANA ROS-LEHTINEN, Florida EDOLPHUS TOWNS, New York JOHN M. McHUGH, New York PAUL E. KANJORSKI, Pennsylvania STEPHEN HORN, California PATSY T. MINK, Hawaii JOHN L. MICA, Florida CAROLYN B. MALONEY, New York THOMAS M. DAVIS, Virginia ELEANOR HOLMES NORTON, Washington, MARK E. SOUDER, Indiana DC STEVEN C. LaTOURETTE, Ohio ELIJAH E. CUMMINGS, Maryland BOB BARR, Georgia DENNIS J. KUCINICH, Ohio DAN MILLER, Florida ROD R. BLAGOJEVICH, Illinois DOUG OSE, California DANNY K. DAVIS, Illinois RON LEWIS, Kentucky JOHN F. TIERNEY, Massachusetts JO ANN DAVIS, Virginia JIM TURNER, Texas TODD RUSSELL PLATTS, Pennsylvania THOMAS H. ALLEN, Maine DAVE WELDON, Florida JANICE D. SCHAKOWSKY, Illinois CHRIS CANNON, Utah WM. LACY CLAY, Missouri ADAM H. PUTNAM, Florida DIANE E. WATSON, California C.L. ``BUTCH'' OTTER, Idaho STEPHEN F. LYNCH, Massachusetts EDWARD L. SCHROCK, Virginia ------ JOHN J. DUNCAN, Jr., Tennessee BERNARD SANDERS, Vermont JOHN SULLIVAN, Oklahoma (Independent) Kevin Binger, Staff Director Daniel R. Moll, Deputy Staff Director James C. Wilson, Chief Counsel Robert A. Briggs, Chief Clerk Phil Schiliro, Minority Staff Director C O N T E N T S ---------- Page Hearing held on July 25, 2002.................................... 1 Statement of: Coates, Paul M., Ph.D., Director, Office of Dietary Supplements, National Institutes of Health; and William Dietz, M.D., Director, Division of Nutrition and Physical Activity, Centers for Disease Control and Prevention....... 127 Ladd, Diane, actress, film director, certified nutritional consultant, Ojai, CA....................................... 32 Seckman, David, executive director and CEO, National Nutritional Foods Association; George Bray, M.D., Boyd professor, Pennington Biomedical Research Center, Louisiana State University; Larry Kushi, associate director for etiology and prevention research, division of research, Kaiser Permanente; Pamela Peeke, M.D., assistant clinical professor of medicine, University of Maryland School of Medicine, adjunct senior scientist, National Institutes of Health; Timothy S. Church, M.D., senior associate director, medical and laboratory director, division of epidemiology and clinical applications, the Cooper Institute; and David Heber, M.D., director, division of clinical nutrition, University of California at Los Angeles.................... 59 Letters, statements, etc., submitted for the record by: Bray, George, M.D., Boyd professor, Pennington Biomedical Research Center, Louisiana State University, prepared statement of............................................... 72 Burton, Hon. Dan, a Representative in Congress from the State of Indiana, prepared statement of.......................... 6 Church, Timothy S., M.D., senior associate director, medical and laboratory director, division of epidemiology and clinical applications, the Cooper Institute, prepared statement of............................................... 105 Coates, Paul M., Ph.D., Director, Office of Dietary Supplements, National Institutes of Health, prepared statement of............................................... 130 Dietz, William, M.D., Director, Division of Nutrition and Physical Activity, Centers for Disease Control and Prevention, prepared statement of.......................... 141 Heber, David, M.D., director, division of clinical nutrition, University of California at Los Angeles, prepared statement of......................................................... 112 Kushi, Larry, associate director for etiology and prevention research, division of research, Kaiser Permanente, prepared statement of............................................... 84 Ladd, Diane, actress, film director, certified nutritional consultant, Ojai, CA, prepared statement of................ 38 Maloney, Hon. Carolyn B., a Representative in Congress from the State of New York, prepared statement of............... 63 Peeke, Pamela, M.D., assistant clinical professor of medicine, University of Maryland School of Medicine, adjunct senior scientist, National Institutes of Health, prepared statement of...................................... 99 Schrock, Edward L., a Representative in Congress from the State of Virginia, article entitled, ``The Million Pound Challenge''................................................ 21 Seckman, David, executive director and CEO, National Nutritional Foods Association, prepared statement of....... 63 Towns, Hon. Edolphus, a Representative in Congress from the State of New York, prepared statement of................... 61 Waxman, Hon. Henry A., a Representative in Congress from the State of California, prepared statement of................. 158 DIET, PHYSICAL ACTIVITY, DIETARY SUPPLEMENTS, LIFESTYLE AND HEALTH ---------- THURSDAY, JULY 25, 2002 House of Representatives, Committee on Government Reform, Washington, DC. The committee met, pursuant to notice, at 10:29 a.m., in room 2154, Rayburn House Office Building, Hon. Dan Burton (chairman of the committee) presiding. Present: Representatives Burton, Morella, Schrock, Maloney, Norton, Cummings, Kucinich, and Tierney. Staff present: Kevin Binger, staff director; James C. Wilson, chief counsel; David A. Kass, deputy chief counsel; S. Elizabeth Clay, professional staff member; Blaine Rethmeier, communications director; Allyson Blandford, staff assistant; Robert A. Briggs, chief clerk; Joshua E. Gillespie, deputy chief clerk; Robin Butler, office manager; Elizabeth Crane, deputy communications director; Corinne Zaccagnini, systems administrator; Sarah Despres, minority counsel; Ellen Rayner, minority chief clerk; and Jean Gosa and Earley Green, minority assistant clerks. Mr. Burton. Good morning. A quorum being present, the Committee on Government Reform will come to order. I ask unanimous consent that all Members' and witnesses' written and opening statements be included in the record. Without objection, so ordered. I ask unanimous consent that all articles, exhibits and extraneous or tabular material referred to be included in the record, and without objection, so ordered. Let me start by saying we will probably have Members wandering in with their shirttails hanging out and their ties not tied because we ran until 2:30 a.m. As a matter of fact, is there anybody in the audience? I can't see yet. In any event, this is going to be a very busy day. Members are trying to get their offices all squared away so they can head for the August recess and district work period. As a result, we will have people coming in and out. We may be interrupted for several votes on the floor. We will probably have votes coming in a series of two, three or four. Representative Schrock and others probably will take the chair from time to time because I will have to go down and speak probably this afternoon on the homeland security issue since our committee had primary jurisdiction over that when we were marking up the bill. For those of you who will be wondering why we are running in and out and why we all look bloodshot eyed and tired, that is why. Health care oversight activities have been a high priority for this committee during my tenure as chairman. I firmly believe that as we enter the 21st century we have the opportunity to change the landscape of health care and delivery of services. Health care costs are skyrocketing. The national health expenditures are projected to reach $2.8 trillion in 2011. If we don't turn things around by 2011, we will be spending 17 percent of the Gross Domestic Product on health care, almost $1 out of every $5. One would think that because we spend more of our GDP on health care than any other country, that we would have the best health status. This, however, is not the case. In June 2000, the World Health Organization announced their first ever analysis of the world's health systems. They compared 191 countries and found that the United States ranked 37th out of 191. Obviously, dramatically increasing our spending on health care is not the solution. I am attaching to this statement a list of guiding principles for health care renewal in the 21st century. These principles embody what we have been working on for the last 4 years, as we have looked at the role of complementary medicine in our health care system and the importance of preserving our rights as Americans to make our own health care choices. One of the things we have noted is that doctors are taught how to deal with problems after they occur and not before they occur. That is why complementary and alternative medicine is a necessary adjunct to make sure that we do something that will prevent the onset of health care problems so that we can cut the health care costs. I am pleased that Ms. Diane Ladd is here with us today. Ms. Ladd has been called 1 of the 10 leading actresses in the world. Her film credits include ``Rambling Rose,'' ``Wild at Heart,'' ``Alice Doesn't Live Here Any More,'' and ``Christmas Vacation.'' Ms. Ladd has also appeared in numerous television shows including ``Dr. Quinn, Medicine Woman'' with my friend, Jane Seymour, and a show that everyone loves, ``Touched by An Angel.'' One of her most recent television movies was ``Talking to Heaven.'' Ms. Ladd, in addition to acting and directing, is a certified nutritional consultant. She is here today to share her personal insights on the role of nutrition in healing. It may seem like common sense that diet and exercise can improve our health. There is also an increasing body of scientific evidence that supports this. Experts tell us that about 85 percent of diseases and illnesses in this country result from lifestyle decisions. Conversely, the adoption of healthy lifestyle choices, including moderate physical activity, a sensible diet and the appropriate use of dietary supplements, can improve our health. Unfortunately, the typical medical school student will spend less time in classes learning about nutrition than we will spend in our hearing today. My son-in-law is a doctor and when I start talking to him about this stuff, he says let's talk about golf. He is a real neat guy thought. If doctors have no training in nutrition, much less dietary supplements, how are they supposed to advise their patients? One of our witnesses today is working to change that. Dr. Pamela Peeke is a Pew Scholar in nutrition and metabolism and an adjunct clinical professor at the University of Maryland. She is also the author of the book, ``Fight Fat After Forty.'' Dr. Peeke devotes her energies to the education of medical professionals in nutrition, lifestyle and fitness. She presently is teaching and devising new medical curricula in nutrition and metabolism. As part of our investigation, we have learned that naturopathic doctors who are trained at accredited naturopathic universities receive the training in nutrition that M.D.'s ought to receive. However, students may be discouraged from applying to these schools because there is an inequality in the loan programs at the Department of Education between M.D.s and N.D.s. The Department of Education needs to eliminate this discrepancy. The committee has been active in monitoring the implementation of the Dietary Supplement Health and Education Act of 1994. Previous hearings have focused primarily on the Food and Drug Administration's lack of full implementation. To date the American public has not been well served by the FDA in this respect. It has been 8 years, and still, we do not have good manufacturing practice guidelines published. There is negligible review of imported products. We must have the full implementation of DSHEA in order to assure the quality of products on the market and that information is readily available to consumers. Yesterday, the National Academy of Sciences, under contract with the FDA, published for comment a Proposed Framework for Evaluating the Safety of Dietary Supplements. This is also an important issue that the FDA needs to understand in order to fully implement DSHEA. As we have learned previously, tracking adverse events for dietary supplements does not provide valid scientific data on which to develop policy. Mr. David Seckman, the executive director and CEO of the National Nutritional Foods Association is here representing the manufacturers and retailers of dietary supplements. Mr. Seckman is appropriate to speak to these issues today not just in his role at the NNFA, but also because of his background as the former vice president for regulatory affairs of the American Health Care Association and former executive director of the Illinois Health Care Association. In addition to traditional use, there is a scientific basis for the wise use of vitamins, minerals, and botanicals to improve health. Through research, we are learning which nutritional components are best obtained through diet and which are absorbed from supplements. We already know from traditional use and research that drinking cranberry juice can help prevent certain infections. We also know the use of acidophilus, when taking antibiotics can help prevent the onset of yeast infections. Dr. Linus Pauling told me over 30 years ago that taking vitamin C every day would help prevent cancer. I am attaching a list of widely accepted nutritional connections to improving health. In a February 1999 hearing, Dr. Dean Ornish testified about his research showing that heart disease could be reversed through a comprehensive lifestyle improvement program that includes a low-fat and plant-based diet, moderate physical activity, stress management, and dietary supplements. This approach has been shown to reverse heart disease, a feat that drug and surgical approaches do not achieve. Currently the Ornish program is being evaluated in a Medicare demonstration program. Clinical trials are also under way evaluating the benefit of the Ornish program for preventing a recurrence of prostate cancer. The preliminary findings are promising. In December, I introduced H.R. 3475, the Dietary Supplement Tax Fairness Act of 2001. This bill amends the Internal Revenue Code to treat amounts paid for foods for special dietary use, dietary supplements, and medical foods as medical expenses for purposes of the medical expense deduction. This bill has also been introduced as S. 1330 in the Senate. Last month the Journal of the American Medical Association published research that recommended that all Americans take a multivitamin every day. With improved and expanded research we will learn more about how and when nutritional supplements will improve health and play a role in the healing process. It is also through research that we will learn more about safety, toxicity, and contraindications. On June 20th, in outlining his health and fitness initiative, President Bush made the following remarks: Better health is an individual responsibility, and it is an important national goal. We are making great progress in preventing, detecting and treating many chronic diseases. That is good for America. We are living longer than any generation in history. Yet we can still improve. When America and Americans are healthier, our whole society benefits. If you are interested in improving America, you can do so by taking care of your own body. This year, heart disease will cost our country at least $183 billion. If just 10 percent of adults began walking regularly, we could save billions in dollars in costs related to heart disease. Research suggests that we can reduce cancer deaths in America by one-third simply by changing our diets and getting more exercise. The evidence is clear, a healthier America is a stronger America. The President called for the adoption of four guideposts: No. 1, be physically active every day; No. 2, develop good eating habits; No. 3, take advantage of preventative screenings; and No. 4, don't smoke, don't do drugs, and don't drink excessively. Dr. Timothy Church of the Cooper Research Institute will be testifying about the important role that physical activity plays in improving and maintaining health. The Cooper Research Institute, founded by Dr. Kenneth Cooper, has long promoted improved health through aerobic exercise. Regular physical activity substantially reduces the risk of dying from coronary heart disease, the Nation's leading cause of death, and decreases the risk for colon cancer, which my wife succumbed to just recently, diabetes, and high blood pressure. It also helps to control weight; contributes to healthy bones, muscles, and joints; reduces falls among the elderly; helps to relieve the pain of arthritis; reduces symptoms of anxiety and depression; and is associated with fewer hospitalizations, physician visits, and medications. Moreover, physical activity need not be strenuous to be beneficial. People of all ages benefit from moderate physical activity, such as 30 minutes of brisk walking five or more times a week. We have a lot of other people who will testify today and I am pleased that we will hear from a variety of these people, Dr. George Bray, Boyd professor of medicine, Louisiana State University is a leading expert on obesity. Dr. Larry Kushi, associate director for etiology and prevention research, Kaiser Permanente, is an expert on macrobiotics and other plant-based diets and their role in preventing diseases such as cancer. Dr. David Heber, director, division of clinical nutrition, University of California at Los Angeles is one of the country's leading experts on the science of dietary supplements. I am also pleased that we will receive testimony from Dr. Paul Coates of the Office of Dietary Supplements at the National Institutes of Health and Dr. William Dietz, the Director of the Division of Nutrition and Physical Activity at the Centers for Disease Control and Prevention. Improving our health through diet and lifestyle is low cost and effective, and will save the taxpayers a lot of money and the individual citizen a lot of money. We need to find ways to empower Americans to take charge of their lives and improve their health, and reduce the incidence and tragedy of chronic and life-threatening medical conditions. The hearing record will remain open until August 8. Other statements? Mr. Schrock. [The prepared statement of Hon. Dan Burton follows:] [GRAPHIC] [TIFF OMITTED] 81866.001 [GRAPHIC] [TIFF OMITTED] 81866.002 [GRAPHIC] [TIFF OMITTED] 81866.003 [GRAPHIC] [TIFF OMITTED] 81866.004 [GRAPHIC] [TIFF OMITTED] 81866.005 [GRAPHIC] [TIFF OMITTED] 81866.006 [GRAPHIC] [TIFF OMITTED] 81866.007 [GRAPHIC] [TIFF OMITTED] 81866.008 [GRAPHIC] [TIFF OMITTED] 81866.009 [GRAPHIC] [TIFF OMITTED] 81866.010 [GRAPHIC] [TIFF OMITTED] 81866.011 [GRAPHIC] [TIFF OMITTED] 81866.012 [GRAPHIC] [TIFF OMITTED] 81866.013 Mr. Schrock. Thank you, Mr. Chairman. Thank you for calling this meeting today to discuss what I feel is a critical issue that is facing our Nation. It is no secret that obesity is epidemic in the United States. According to this committee's background documents, there are currently over 45 million obese adults and about 8 million obese children. These numbers, I can assure you, are on the rise. The effects of obesity in our population and on our economy is staggering. According to the Surgeon General, 300,000 Americans die prematurely each year due to their weight and obesity which costs Americans $100 billion per year. According to the RAND Corp., obesity contributes to higher cost increased for health care services and medications than do either smoking or drinking problems. The July August 2002 edition of Men's Health Magazine, and I appear on the cover. [Laughter.] Mr. Burton. Something has happened to you. [Laughter.] Mr. Schrock. There is a lot under this clothing, I can tell you. The magazine had a series of articles on this topic and they have challenged American men to lose 1 million pounds collectively. This is a great challenge that will help men feel better, live longer and save them thousands of dollars over their lifetimes. Overweight men, according to this article, are 50 percent more likely to develop heart disease, 70 percent more likely to develop high blood pressure, 58 percent more likely to have total cholesterol of 250 or greater, 16 percent more likely to die from their first heart attack, 9 percent more likely to have a stroke, and 250 percent more likely to develop diabetes. Overweight men spend 37 percent more a year at the pharmacy, make 12 percent more visits per year to their primary care doctor, spend 19 percent more days per year in the hospital, and pay $4,200 more over their lifetimes for medical care. Overweight men are 5 percent more likely to die of prostate cancer, 35 percent more likely to develop kidney cancer, 120 percent more likely to develop stomach cancer and 590 percent more likely to develop esophageal cancer. These statistics are staggering and though they are particularly for men, I am sure they could be translated to women as well. The way I see it, the Federal Government should do all it can to encourage healthier living. After all, an ounce of prevention is worth a pound of cure. Last month, President Bush outlined his health and fitness initiative. Congress should take his lead and find ways to positively encourage our society toward healthier living. Our panel of experts today will provide us with valuable information that we should use to improve Federal policies with regards to diet, physical activity and dietary supplements. I look forward to their testimony. I can tell you firsthand how important health is. On July 15, 1975, I was diagnosed with an incurable cancer and given 6 months to live. In 90 days, I lost 142 pounds and lived in a coma for 6 months and the doctors gave me absolutely no hope. During conversations the doctors had over me with my wife, they were convinced I would be dead anytime soon but I knew I was meant to be here to work on this issue. I think that is why I am here today. I worked out heavily, I weighed 240, I drank and smoked more than I should have but that was my wake-up call. I no longer do any of that and I am the biggest health advocate in the world and I think when we come back in January I am going to challenge my colleagues on both sides of the aisle to take part in this million pound loss by challenging the Democrats to lose 5,000 pounds and the Republicans to lose 5,000 pounds because folks, some of the people I see walk into that chamber need to do it because they are going to die young and that is not a good thing. This is a very important issue and I wish every Member was here to hear it. I am looking forward to hearing Ms. Ladd. Thank you for coming. I am delighted you are here and I am delighted the others are here as well. Thank you, Mr. Chairman. [The article referred to follows:] [GRAPHIC] [TIFF OMITTED] 81866.014 [GRAPHIC] [TIFF OMITTED] 81866.015 [GRAPHIC] [TIFF OMITTED] 81866.016 [GRAPHIC] [TIFF OMITTED] 81866.017 [GRAPHIC] [TIFF OMITTED] 81866.018 [GRAPHIC] [TIFF OMITTED] 81866.019 [GRAPHIC] [TIFF OMITTED] 81866.020 [GRAPHIC] [TIFF OMITTED] 81866.021 [GRAPHIC] [TIFF OMITTED] 81866.022 [GRAPHIC] [TIFF OMITTED] 81866.023 Mr. Burton. Thank you, Mr. Schrock. We do kid around a lot about some of these things, but it is very, very serious and I think you have illuminated that issue very well. Now for our 29 year old colleague. Mrs. Morella. Thank you, Mr. Chairman. I didn't prepare any remarks but I am very interested in this hearing. I thank you very much for scheduling it. I must say I was moved by my colleague, Mr. Schrock's comments and indeed, I would be very happy to help to partner with him as he pursues that tremendous goal. This is a hearing where we might sometimes find ourselves in the situation where Robert Frost defined a poem. He said, ``In the end, it tells me something I didn't know I knew'' because some of the issues that will come up are really common sense issues like diet, to find out how important diet is; nutrition; the whole concept of supplements, how important are they; and the whole issue of exercise; and I would add another ingredient and that is attitude. I have always felt that attitude is altitude, how you look at things. We have seen that with you, Mr. Chairman, as well as with Mr. Schrock, in terms of how you handle situations. Indeed, mention was made of obesity and you mentioned, Mr. Schrock, obesity in men in particular but we are going to have somebody testify today, someone who is a constituent of mine, Dr. Peeke who is going to be looking at the gender facet of that. Whereas 31 percent of men are obese, 34 percent of women are. Maybe in some way we can also look at gender nuances. Above all, we can look at our role as policymakers and think of the money we would be saving. We are pouring a lot of money into the National Institutes of Health and I also note that Paul Coates, the Director of Dietary Supplements at the National Institutes of Health, is here. We know that some of the research is being reflected in our knowledge as well as our cures, including prevention of some of the major illnesses and the money we have saved, and the impact on families. We tend to forget sometimes that when you have these health crises, the impact on families, on caregivers, on every member of the family. So I look forward to learning a great deal from the hearing today. I want to thank all the witnesses. You have assembled a very distinguished group of witnesses who will be able to share their experiences and knowledge with us. Dr. Peeke is accompanied by another constituent of mine, Irene Pollin. I am pleased she is here and Dr. Coates from NIH. I yield back time served so we can commence the hearing. Thank you, Mr. Chairman. Mr. Burton. Thank you, Mrs. Morella, and you do look very young. You obviously take very good care of yourself. Before we bring up Ms. Ladd, let me say that one of the things Katie Couric expressed when she lost her husband to colon cancer, and I lost my wife recently to colon cancer, and one of the things I try to say at every meeting, not on the subject at hand today, but anybody over 40 and surely over 50 should get a colonoscopy. My wife never was told that and because of that, when she started having stomach problems, they gave her stomach medicines and by the time we found out it was colon cancer, it had metastasized into her liver and it was too late. So I would say anybody over 40 if you haven't had it, especially if you are over 50, remember what I am telling you. It is something that can save your life. I gave a speech at a Republican get together in northern Indiana not long ago and I said this and the guy that was putting on the program wrote me a letter last week and said he had never even thought about that. He was a former State senator and they found 10 polyps in his colon and my bringing that to his attention probably saved his life because they think a couple of those were cancerous. So all I am saying to you is that this is not on this subject but in addition to good health, good diet and good exercise and all that, you need to do these other things that are important as well. With that, Ms. Ladd, you are a lovely lady. Would you please come forward so I can swear you in? [Witness sworn.] Mr. Burton. I have admired your work as have my colleagues for many years. I don't know how many movies you have appeared in but it is well over 100. We are very happy to have you as we have had other celebrities here and we are anxious to hear what you have to say, so would you make your opening statement? STATEMENT OF DIANE LADD, ACTRESS, FILM DIRECTOR, CERTIFIED NUTRITIONAL CONSULTANT, OJAI, CA Ms. Ladd. Mr. Chairman, Congressman Schrock, Congresswoman Morella, it is my privilege and pleasure to be here today. I not only talk to you as a fellow citizen and American, but as an actress, a species that lives between chance and oblivion. I am a resident of the State of California, previously a resident of New York. I have also at times in my life because of my work in the medical field been a resident of Texas and Florida but I was raised in the beautiful magnolia State of Mississippi. My name is Ladd. My real name was Lanier or Ladner. My father sold medicine for poultry and livestock, wholesale and retail throughout five States. As a child at his knee, I witnessed my father encouraging human beings who did not have proper nutrition to go beyond the norm, to reach the extra mile to save their lives, the same with my great grandmother who was a doctor who studied with the Cherokee Indians, the healing arts and herbology. As an actress, I am privileged to have represented my country and be a three time Oscar nominee and to have been honored with over 23 international awards and honors and sent telegrams by my Government, by Washington, by Mr. Jack Valenti representing my government. My advocation is health. It is my love and it is a professional hobby. I am here with you today to share with you how important I feel vitamins and minerals are and how they can be involved in miracles. I am here to testify to the art of miracles and how they can be accomplished by making changes mentally, physically and spiritually. It takes a triad and in order to have a cure, one must know the cause. As a young, young wife and mother, seems like eons ago, a young bride, my husband, actor Bruce Dern and I, two struggling actors, had a beautiful baby daughter 2 years old. Our child died in a very tragic accident. Being an emotional actress, the pain is always with me because memory is always in you as a human being but the trick in life is to use the things that we go through not only to better ourselves but to better our fellow human beings. As Congressman Schrock said, maybe he is supposed to be here today to fight for these issues. I feel the same way. After my daughter's death, my body screamed to replace that child, for God to give me another child. Indeed in a little over 8 weeks, I got pregnant again and I said, God taketh away, God giveth back but it was not to be so simple. It turned out it was a tubular pregnancy, a pregnancy in the fallopian tube. I almost died, it almost took my life. My right tube was completely removed and most of the left tube. They left me with just a little piece of a tube, probably for female functions. Five top doctors in our country told me that I, Diane Ladd, would never, never, impossible, have another child, no way. I went on my own search in 1962 and there were no health stores, no health books except for Gaylord Houser's ``Mirror, Mirror on the Wall.'' I took it to heart. I absorbed it. I spent my days not looking for acting jobs, but being in libraries, reading about the human body. What vitamins could help my body, what foods could help my body, avocado, the oils, bee pollens, the Vitamin B's, and so forth. I flew to New York to a great semiscean pellor doctor who really cared about his fellow human beings who informed me that mud baths can prevent sterility. I went over massage, chiropractory, the doctors thought I was nuts. They wouldn't talk to me about it but I continued my search. Gentlemen, after 3\1/2\ years, I walked into the office of Dr. Charles Ledagurber, one of the top gynecologists in our country, one of the five doctors chosen by my government to go to China to do research on their traditional modalic medicine which is our alternative modalities in medicine. I went in to Ledagurber, who had great empathy for me because he too had lost a child in his life but he had four other children, I had none. I had a smile and I said, Dr. Ledagurber, I think I am pregnant, go make your test. He looked at me with such a sad look and said, ``Oh, Diane, honey, you cannot be pregnant. It is impossible. Go home and cry.'' I said, ``Dr. Ledagurber, I have cried, now go make your test.'' He made the test and I was pregnant. When my daughter, Laura Elizabeth Dern, was born, they took her caesarian to prevent any possibility of complications. While I was on that operating table, after they took my child from my womb, I remained on the table for 4 solid hours while they played in my gut and removed 16 major adhesions that had been caused by tubular pregnancy. They removed them from my body. One of the other five doctors who said I could never have another child showed up to see it for himself. I was passed out on the table. They don't knock you out because the body bleeds more when it is knocked out but if you pass out, it is a little bit better. So I was passed out and they were in there doing their work when my subconscious heard the other doctor say, ``My God, my God, it is impossible that this child got through that body and that tube. This is a miracle.'' I scared him, this blond head rose up off the table and I said, ``That is right. It is a miracle and it is a hell of a lot of hard work.'' My daughter, Laura Elizabeth Dern, would not be on this planet today were it not for my own, individual vitamin and mineral program that gave my body the ability to assimilate those nutrients that I needed to rise above the negatives that had been created. Our body is a miracle machine, if we can follow our intuition. Or course actors have a seventh sense and they gave the medical profession psychodrama. Actors have been known to go into mental institutions and where doctors cannot get a patient to speak, actors have gotten a patient to speak, have opened them up to literally talk. As I said before, at one time in history in Egypt art and science was one profession. My second medical miracle came when my daughter, Laura Dern, was 12\1/2\ years old. She was discovered to have scoliosis, a disease which is a crippler and a killer. I took her to a Dr. Jack Moshime, a very famous Beverly Hills orthopedic surgeon. He has done a lot of great work in this country. On x-ray, my daughter's spine was like an ``S,'' very severe. I was pretty hysterical because having lost a child you can imagine how protective I was of this child, my little miracle. The fact that they hadn't discovered it before was unbelievable to me but it appeared that when she was 5 years old, she had been bitten by a black widow spider, and the poison from that bite had thrown the alignment of her spine out of balance so as she grew, the spine formed in a crooked manner. I asked Dr. Moshime how long have I got before I have to put my child in that back brace you are telling me to put her in from her hips to her neck, her whole teenage livelihood? He said, I will give you 9 months, Diane, and you be back in here and we are going to put that brace on her. You go do whatever you think you are going to do and I will see you here in 9 months. In those 9 months, I took my daughter through several things. One of them was a Dr. Viola Framman in San Diego who today has the Osteopathic Promise for Children. Viola Framman had lost a child when she was a young medical student and she knew and testifies that she knew then and knows today that if the doctors treating her child had gone the extra mile, that her child would have lived. So she has devoted her whole lifetime to humanity, especially to children, with the art of cranial therapy. Her mentor was Dr. Magune who was one of President Eisenhower's private physicians. He is the grandfather of the art of cranial therapy. Dr. Magune taught Viola, Dr. Magune sent me to Viola and she worked on my daughter every 2 weeks and then every month for the next 9 months. Through the art of adjustment, through cranial therapy, pictures were taken where you could see her body changing literally, photographs. I also took her to a chiropractor, I also took her to a laying on of hands healing arts, Doug Johnson, very famous all over the world. I also went on a vitamin, mineral regimen. I also rubbed peanut oil which is a healer on the bottom of her feet. I took the skin from potatoes and tied them at night on her eyes with a rag because I know it draws out poison from the body. In 9 months, I went back in to Dr. Moshime. He takes one look at Laura and says, oh, my God, she has grown 2 inches. Diane, growth is a detriment. Scoliosis is a not only a crippler, it is a killer. He was almost hysterical. I said, I don't know, go take your x-rays and tell me what to do now. I sat in his waiting room among 16 other patients, my daughter and I, waiting for the verdict, the health verdict when suddenly this doctor comes racing through that room, waving his hands over his head, ``My God, it is a miracle.'' I whispered, ``Yes, Doctor, it is a miracle and a hell of a lot of hard work.'' On x-ray, in those 9 months, my daughter's spine instead of being like this, still had a little bit of problem, but ladies and gentlemen, it was like this, you could hardly see the curve. Laura Dern did not have to wear that prescribed brace for her whole teenage lifetime. Instead of being able to share her great talent that God gave her and make movies such as ``Mask'' and help influence our teenagers in the world to fight for morality and the good in their own lives, Laura would not have been able to do anything or fulfill her destiny had I not fought and used alternative modalities. Third was allergies. I had gotten those from emotionalism, having gotten divorced and I had ragweed and pollens, dog hair and the actor's disease is dust because of our travels and old theaters. All of these, I had to get a staph shot once a month for the different cities, floating staph in the air and once a week, I had to get shots for the other allergies, and I had to give away my dogs. Virginia Capers, a Tony winning, beautiful black actress came to me and said, ``Diane Ladd, I am tired of you suffering like this, you take this book and make it your bible.'' It was a book on juices. It was a book that taught me that when the body gets uneasy, when the body gets too stressed, when it has disease, it begins to develop disease and the more it needs the vitamins and minerals, the body isn't capable of assimilating, of withdrawing from the nutrients what it needs. It must have supplementation. I took the book and I supplemented my diet four times a day with natural juices, mixtures of carrot juice, cucumber, celery, spinach and very little parsley. Too much parsley is not good and beet. I mixed these juices and supplemented my diet four times a day and in 1 month all of my allergies were totally gone and I have never had to have a shot. That was in 1976. So that was the third thing. The late Rock Hudson was a friend of mine, I had done a movie with him. They asked me to portray after his death his mother in a TV show. I hated the script, I thought it was completely a ripoff of this man's life. I took the script and threw it I was so angry. Then I said, Diane, if you don't do the movie, Hollywood is just going to do it and it is going to be terrible. At least if you get in there, you can fight, scream and try to make it better. Go do it and try to make it better and honor this man. So I did. I told the producers that I would do it for very little money, minimum, if they would contribute $25,000 to research for immune related diseases at the hospital of my choice. I chose Scottsdale, AZ where Dr. Terry Friedman was doing his work. He was one of the seven doctors who founded one of the great organizations in our country, the American Holistic Medical Association. These are AMA doctors who believe in the oath they took and they believed when you say you are going to make a human being well, you help them heal by using everything God gave you to help that person balance their body. Dr. Friedman worked with the money they gave him on cancer victims and AIDS victims and one particular young man who came from Texas had been given 3 months to live, he was dying from AIDS. You could see this was a skeleton walking around. They gave him chelation, they gave him mineral programming, they gave him a diet of vitamins and minerals and as much proper foods as they could. They did alternative modalities, massage, manipulation, detoxification. Within 3 months, that man did not look like the same man. That young boy walked out of that hospital. Maybe he carried still some of the AIDS with him but life is precious, none of us knows who will walk out of here and be hit by a car. A minute is a minute to smell a rose. If God can give it to us, we have the right to fight for it. There have been many other experiences. I have since worked with doctors, lectured all over the country. I am on the scientific board of advisors for Congressman Berkeley Bodel's organization here in Washington, the NFAM, the National Foundation for Alternative Modalities and when time permits, I work with doctors. I have a book I have written called, ``Spiraling through the School of Life,'' which is coming out sharing all of the experiences I have had. These experiences even included a sojourn to Central America where I picked up a parasite and St. John's Hospital didn't find it. Again, it was alternative modality doctor who is also an AMA medical doctor who in 2 weeks changed my body. In your packet today you have, which I asked for, approximately 20 letters from some of the top medical doctors in our country today who each has testified to the importance of vitamins and minerals. I as an actor testified that the actor's instrument is his body and today the arts are in as much trouble as medicine. There are those who would keep culture from shining and helping people. Culture is the mental part of health and if you don't believe me, go step in your Library of Congress. Take a minute and see what it does for your whole body, how it refurbishes your very soul. That is my primary way of healing through the arts. In a profession where there is 120,000 actors today, and 87,000 of them didn't work last year, they made less than a poverty wage of $7,500, and in a world where 37,000 didn't work, in a world where we are losing $150 billion this decade to Canada alone which is $30 billion of your tax money, why should we give that money away? That can build medical centers, playgrounds. Why aren't we helping medicine and why aren't we helping the arts so that we can make good films which will make people feel better and be healthy? I beg that the protection of vitamins and medicines, we have the right to choose our own vitamins. Medicines are food. Sure it can't be poisonous anymore than food should be poisonous but we have the right to choose. Nobody should give me a prescription for a vitamin or medicine. Don't they dare start to play that game. I want the right to choose my food in my country and the right to buy my own vitamins and medicines. If my poor actors, 120,000 of them, 80,000 who are probably getting pretty depressed and pretty ill by now, don't have the right to buy a vitamin or a medicine, they are going to die. So let us keep some of your artists alive, let us keep humanity alive and by the way, just so you know, the cultural business is affecting men and women across the country. They are going belly up because of a lack of the right to do independent films in this country. They have no money and we need to get on board with France, Spain, Australia and everybody else and get some work in this country for these people. We also need to have the educational committees work with Congressman Burton and you Congresspeople and let us get vitamins and minerals in the school lunches for our kids. If your own Surgeon General has said a proper diet can indeed prevent cancer, then let us help to get them a proper diet because when you go to dinner tonight, what is the proper diet? Sometimes food is like some of the people we know, pretty good on the outside, not much going on inside. So when you go to get your food tonight, I don't know what that food you eat has. Just to protect yourself, please let us get our kids some vitamins and minerals. Thank you for allowing me to speak. Any questions, please. [The prepared statement of Ms. Ladd follows:] [GRAPHIC] [TIFF OMITTED] 81866.024 [GRAPHIC] [TIFF OMITTED] 81866.025 [GRAPHIC] [TIFF OMITTED] 81866.026 [GRAPHIC] [TIFF OMITTED] 81866.027 [GRAPHIC] [TIFF OMITTED] 81866.028 [GRAPHIC] [TIFF OMITTED] 81866.029 [GRAPHIC] [TIFF OMITTED] 81866.030 [GRAPHIC] [TIFF OMITTED] 81866.031 [GRAPHIC] [TIFF OMITTED] 81866.032 [GRAPHIC] [TIFF OMITTED] 81866.033 [GRAPHIC] [TIFF OMITTED] 81866.034 [GRAPHIC] [TIFF OMITTED] 81866.035 [GRAPHIC] [TIFF OMITTED] 81866.036 [GRAPHIC] [TIFF OMITTED] 81866.037 Mr. Burton. Thank you, Ms. Ladd. You are very informative in your statement but you are also very interesting and I found it very entertaining as well. You mentioned that your daughter, Laura Dern, wouldn't have been born if you hadn't had proper diet and vitamins and supplements. Are you aware of any research in our government that is looking at those issues? Ms. Ladd. I am aware of those letters from the doctors who are AMA doctors. I was privileged in Arizona, unfortunately, to be in a room with five top doctors from this country. A hospital is a terrible place to get your karma. You had better pray to God if you are ever in a hospital that you get a doctor who believes in his work because the chips are down then. I was in a hospital with doctors who believed in their work and they called the Center for Disease Control in Atlanta, GA. Dr. Friedman had them on the speaker and he begged them to please come monitor the work they were doing. They didn't want any work from them, they just wanted them to come and monitor it so they could maybe get a grant or something to continue their work for humanity sake. They asked them, please, in God's name, come monitor what we are doing. They said, well, what are you doing to save the lives? He said, chelation, which I personally have seen do wonders; Vitamin C drips, and I have seen that do wonders, miraculous wonders; vitamins, massage, and modalities and herbology, and mental programming. The Centers for Disease Control laughed in their face, roared with laughter and said, we don't believe in anything holistic and they slammed the phone down in these famous doctors' faces. I was there and witnessed it. There is an organization called AHHA. She sent me a letter to thank me for coming to testify for you. She said she had heard me speak once in Scottsdale, AZ about 15 years ago and because of that she formed this organization to do research. She has a lot of research. You have a letter from her. Dr. Gladys McGary is one of the giants of the business and Dr. Bob Anderson. These doctors are the ones I put my faith in, the ones who working together to ask each other, tell me what you learned, I will tell you what I have learned, I will help you, you help me. We can't live alone, we are not isolated. Mr. Burton. Other cultures have embraced nutrition. I think China is a leading example of that. They have other methods of healing which are not generally recognized here in the United States. Here in America, it seems like we focus on after the fact, after the disease has taken place and trying to come up with the magic bullet. Can you tell us a bit about your experience with some of the methods used in other countries, the vitamins and supplements they use and how that might be effective? Ms. Ladd. When I mentioned my great grandmother, Prudence, she was a young doctor, had trained herself. First, she was a midwife and went to New Orleans with a horse and buggy and stole all the books from the library so she could help her patients. They didn't have any libraries in Mississippi at that time. She came back and finally got a medical degree, delivered over 3,000 babies. She was the kind of woman that once was thrown in a blizzard off a horse, broke her leg, got back on the horse and went and delivered a baby, then had her leg set. There are records of her cures of typhoid fever and diphtheria before the advent of the drugs that would cure those diseases. She used the herbs the Cherokee Indians taught her. I am also aware of an experience of my father when I was 5 years old. I was in Mobile, AL and there was an outbreak of spinal meningitis. The neighbor's son had been taken to the Mobile Infirmary and they even had beds in the halls. They told this poor farm couple take your son home, he was 17 years old, he will be dead by morning, there is nothing we can do. They came over to my daddy begging him, and my daddy said I am a doctor for chickens and cows and dogs. They said, oh, Mr. Ladd, please, you have to help us, we have nobody to turn to. I remember seeing my father's chin quiver and I saw those tears in his eyes and I heard him mutter, you don't ever give up on life while you are in life. He went out that door and found a young country doctor who had just graduated from Harvard and was in this place Chickasaw, AL. He brought him to these people. This doctor rounded up the neighbors and the neighbors held the boy's body, the legs and hands down because in spinal meningitis the body will curl until the back will snap. They held the boy down so the body wouldn't snap and he worked on that boy all night. You could hear that boy screaming all through the neighborhood. He also brought in an old man about 84 years old, a country doctor to advise him, tell me what to do, tell me what to use, what can we do. I don't know what all he used but I know he used alternative medicine just as fast as he could get his hands on it. Alternative medicine is herbs, perfecting the human body. Yes, I believe in traditional medicine but today, we are overmedicated and there are many, many side effects. If a woman takes an antibiotic, she is going to get yeast unless she takes acidophilus. Lots of time men will get it too in their gut, all through their body. Like you said earlier, Shelley Winters' daughter graduated from Harvard, she had 7 years there, she only got 2 weeks nutrition. That is impossible. That doesn't make any sense today. How can that make sense when the Surgeon General says you need a proper diet? We must have nutritional training for our doctors. This must be demanded from the universities. We must protect the old and the young. In answer to your question, I have seen with my own eyes miracles. I have seen women come into the wellness clinic there in Florida. I have seen them have breasts cutoff from cancer, and there is cancer in their body and I have seen the application of mental, physical and spiritual practices that then you couldn't find cancer in the body. This is without chemotherapy. I just lost another friend from chemotherapy. Two or three of my friends had cancer and it returned years later and took their lives. My witness to these miracles of cancer tells me that we don't have to be so arrogant to think that we know what we don't know. Yes, I bless the people who have drugs that will cure my body, I also want to know if it can hurt my body. You had better warn me and tell me what else I do to get those toxics it is creating out of my body. One of my experiences, and I am so sorry, Congressman, that you just lost your wife. Grief is an emotion that one cannot pretend does not exist. On May 23, I lost my beautiful 89 year old mother. She had a stroke 6 weeks earlier and I was in the hospital with her day and night. I know that I am still full of grief. I wake up and think, oh, I will make lamb tonight, it will be good for mother. Mother is not here, she won't eat the lamb, she is on the other side. I know that in those 6 weeks, the little hospital I was at the nurses cried and said, you and your daughter have helped someone leave in death in a manner we have never seen before. We wish that every human being could have this kind of treatment and this kind of love as they were leaving. I know the doctor said, my God, your mother is a strong woman. My mother was a strong woman because of the vitamin/mineral regime I gave her. My mother fell and broke her pelvis. She got up and healed. My mother fell and broke her arm. She got up and healed. My mother fell and cracked her hip but she got up and healed and she was looking forward to her 90th birthday, a beautiful party which she didn't get, but I know how vitamins and minerals helped her. I know many times the medicines they were giving her were the wrong medicines and they caused great side effects. We had to go back and talk to them and remove some of these medicines. I talked to my own Motion Picture Academy and they have really been having a terrible time with some of the side effects from some of our drugs. Again, I repeat, we bless the people who got us the drugs but we really need to use all of the knowledge and wisdom of the medical doctors who care about their patients and believe in medicine alternative modalities. Let us not throw out the baby with the bath water. Let us embrace their wisdom and their experience, people like Berkley Bodell who went fishing 1 day, a tick bit him and he got lyme disease. He has set up this whole organization, NFAM. My daughter did a picture one time where she played a blind girl. I remember Barbara Streisand saying to Peter Bogdanovich, where did you find a blind girl who could act? He said, that isn't a blind girl, that is Diane Ladd and Bruce Dern's daughter, she is an actress. She was 14 years old. Laura went to the Blind Institute to study, to find out. She was a method actress without even knowing it, to find out what do you need to know, what are the experiences she doesn't know because none of us knows what it is like when you are sick, none of us know what it is like when that person loses somebody they love. We forget what it is like to wear each other's shoes. When my daughter went to the ball of the blind people, it was her graduation from high school year. She went to the party where the blind kids were having their party. She went into the bathroom and there was a little girl who could see but she couldn't hear and could hardly talk. It was just a little dark room with a little ball up there with lights and when Laura went back to dance, the child looked over her shoulder and looked at Laura, isn't it good? She experienced the greatest job whereas my daughter, who was at a private school, had a big shindig for graduation, Laura said, mother, none of those kids had as much joy as that child with the joy in her heart. Why is that? I said, Laura, it is a sad thing that man has to go through hell to get to heaven, that only when his body is starving or dying does he realize his soul can starve too. Like I said the arts have times when we are in great depression. Then we had men like FDR. Let us not do that with medicine, we will all be dead. Mr. Burton. Thank you, Ms. Ladd. Mr. Kucinich. Mr. Kucinich. I just wanted to say your story is quite compelling. As someone who has a great deal of respect for complementary and alternative medicine, I think it is important that you have come before Congress to share your story and your understanding because I think a lot of Americans can identify with it. Thank you for having the courage and the wisdom to pursue the path you have. Thank you. Ms. Ladd. You have just made my day. Thank you so much. It is my privilege and pleasure to have been here. Mr. Burton. Mr. Schrock. Mr. Schrock. Thank you, Ms. Ladd. That was very interesting. This really is all about prevention. If we did more prevention, then we wouldn't have to worry about the after effects of not taking care of yourself. I told you earlier years and years ago I used to think chiropractory was hocus pocus. Believe me it is not. It is absolutely right on. I work out heavily and I got to a chiropractor at least once a week and when I am home, twice a week. It has made all the difference in the world. My wife started going 5 years ago and she had a curvature of the spine and it is now ram-rod straight. It is absolutely amazing. I am a big fan of that. Proper diet is right. Before I got sick, I would eat anything the traffic could bear and I realize now that is just not right. Diet will certainly prevent a lot of these problems. A lot of the diet problems occur right in the schools. My wife is a kindergarten teacher and you would see some of the junk these kids eat and that is provided by the school system, we are creating a generation of kids that will have all these problems. That has to stop. When they sell McDonald's in high schools, we are a junk food society. I like McDonald's like everybody else, but when I eat it I may as well get a can of Crisco and eat it. We have to stop that and that is what we are doing to our kids. We are overmedicated. When I was going through my chemotherapy, they had me on more stuff and I was a different person when they did that. My wife's kids in kindergarten are on Ritalin, she has eight or nine kids on Ritalin in kindergarten and that is a terrible, terrible thing. I think what you are doing is wonderful and everybody else's testimony will attribute to that, will agree with that and we just have to make sure we get this message out. It is very, very important because when you don't have your health, you don't have anything. I appreciate what you do. Thank you. Mr. Burton. Mr. Tierney. Mr. Tierney. I have no questions. I want to thank the witness for her testimony. Ms. Ladd. My privilege. Mr. Burton. Mrs. Maloney, any questions? Mrs. Maloney. First of all, I want to welcome you and thank you for your many contributions to New York culture, the Copacabana, our theater and some of the movies that you starred in were filmed in our great city, so I appreciate very much your professional career and also speaking out on what is a very, very important subject and one that does not get enough attention. You mentioned three miracles in your own life and I often hear miracles from others diagnosed with cancer, they are going to die, they go on a special diet, they cure themselves, they are fine now. I would like to ask do you agree complementary and alternative treatment need to be proven safe and effective before patients decide not to take say traditional treatment but to follow a holistic item? I agree with my friend, Congressman Schrock, that we don't focus enough on prevention in our medicine. We don't focus on any treatment except coming up with a pill or a manufactured way to treat something. The whole focus from the NIH is not a holistic one; even environmental medicine or how the environment impacts us ignores it. I just don't think there is that much focus on it. What do you think we should be doing in government to advance this? Second, expand on the idea of where do you recommend holistic or the traditional method? Ms. Ladd. I recommend both. I recommend respect for the medical profession so that the people get their sugar, their TLC which we all need today, that it is worthwhile for their lives. I see you Congresspeople getting up and running to that bell, I pray for your adrenalin. It is hard to be a Congressperson, it is hard to be a doctor, it is hard to be a human being and in today's society, we are all in a mechanized world. You would think the faster paced society and the mechanized world would pull us closer together. Unfortunately, it is not doing it. It is alienating us one from the other. The high cost of living is accelerating greed in many areas in medicine and in culture and we are not always getting the quality of food, the quality of medicine, the quality of culture that we need. I think we need to look at all these issues. These issues have one goal, to make the world a more balanced, humane and harmonious place to live, especially our own country and for our kids. I said quite often, and I mean this, if I win all the Oscars in the world and leave the planet as a sewer for my grandkids to roll around in, I haven't done a damned thing. When it comes to medicine, there is a threefold healing process. Many diseases are caused by free radicals and free radicals are anger. I think we have to help each other not to judge too harshly. We are all in a state of shock over being judged. At the same time, we have to apply wisdom. That means we have to have mental healing for people, physical healing for people and spiritual. Spiritual means a lack of judgment. Mental is culture. I think many of the movies today are making people angrier. I think people are alienated and that is why they are looking at all these realism type TV shows to watch somebody eat bugs on TV. I don't want my kid watching this. I don't think this is a healthy thing. Where are the good shows where you could laugh and cry and respect human beings and get angry? I am not against even violence if violence teaches me something in a film or a story, the same way a medical doctor examines the waste from your body to try to heal your body but he doesn't recommend that you go out in the middle of the street to get rid of the waste. I think we have already found safety methods. I think our alternative modalities today have as many safety methods as traditional medicine. I think traditional medicine in many instances is a lot more detrimental and harmful than our holistic methods. People are going after them. People are getting smart in some areas. Ms. Maloney. What can we do as a government to really educate people about the importance of a healthy lifestyle, good nutrition and alternative medicine? Ms. Ladd. I think as a government you need to give some support and grants to those qualified great physicians that have proven themselves in an organization so powerful like the AMA. This is not chopped liver. These are doctors who have spent their whole lifetime. I am not saying there might not be one bad apple in the barrel, but that is life, that is karma, wherever you go, whatever you are dealing with. By and large we need to promote the best. Promoting the best gives a higher rate of involvement of understanding of wisdom. It is like that at the Library of Congress. That is the best. Just stand there and you will understand exactly what I mean. If you can see the best, if you hear a great singer hit a high note, if you hear that high note, something happens literally in your body. When you read a great book, how many are reading the great books today? When our children get the best, if we can help our children have the understanding and wisdom to select the best, they will have the brains to go after the best in medicine, after the best in culture. Anytime through our history and any civilization that culture and medicine has been shot down because of greed and selfishness, the civilization has gone to decay. This has been proven. Right now, we have a tax in many areas on good medical modalities that could help our human beings. I think the government has to make sure that helpful aids to humanity, healthful aids, is not stopped. If you go to a restaurant, you get food. If you find out that somebody is selling you rotten meat, they get closed down. If there is a complaint about manufacturing vitamins, fine, if it is bad or rotten, close them down but I don't think ever in a billion years should this ever be put under pharmaceutical companies or prescriptions. That would be tantamount to greed on the highest level and that would be horrendous to those old people or poor people who can afford a vitamin, they wouldn't be able to afford it. It would be such a sin, nothing more than a mistake, to take something and miss the mark. Help people not miss the mark. Help them fight for the best. You are all such intelligent people. My heart goes out to you as much as it does to my actors to try to do culture in a commercialized world, it is not easy to fight for truth and fair play. May God help you fight for proper, medical and proper alternative modalities. Insurance companies should cover alternative modalities. Detoxification of a human being, you get new cells every day. Everyday your body does 360 something billion cells tomorrow morning. How is that possible that you have that kind of machine? If you are polluted in there when they do those billion cells, they have to fight that pollution. Alternative medicine isn't anything but good sense and detoxification and finding food and massage and things that detoxify. That is all it is. The poorest Indian of eons ago knew that in his heart and soul. We know it in ours. We know it in our wisdom. Health, wisdom. There is knowledge and there is wisdom. Knowledge changes everyday. We find out tomorrow we should have done this. Wisdom supersedes knowledge for all of us and there are those people who would keep us from using our wisdom. Don't ever let that happen to you. Please help me, don't ever let that happen to me. Go talk to the AMA people, get a Gladys McGary and a Bob Anderson in here, get Christian Northrop who wrote those books, get Cynthia Watson from Beverly Hills who is doing it all, get Berkley Bedell in here. He has gone to 83 countries. You have the best out there fighting. Encourage that kind of caring and enthusiasm. If it is shot down, it may never come again in our kids' lifetime. Don't let it die. Fight for the good. That is all you can do is fight for the good and I beg of you to do that. Mr. Schrock [presiding]. Mrs. Morella. Mrs. Morella. Thank you, Ms. Ladd. I am not going to ask you any questions in the interest of time but we are very honored that you are here and gave us such a moving presentation of personal experiences. I want to thank you for the nutrition that you provide through your acting. I think the arts do provide a tremendous amount of sustenance to life. I have a son who is an actor and I would agree with what you said about an actor lives between chance and oblivion, but it is so very necessary. I am pleased this year that on the House side we have increased the amount of money for the National Endowment for the Arts and Humanities. I also note in you a personality trait that I think is part of what you exude in terms of health and that is you have a determination and an attitude which probably, as you said in your opening statement, is a kind of linchpin, a kind of spirituality. I commend you for that and I thank you very much. Ms. Ladd. Thank you. It has been my privilege and pleasure to be here today. Mr. Schrock. Ms. Ladd, thank you very much for being here. I was privileged to be the Navy's liaison to the motion picture and television industry for 4 years. I probably should not admit that but I was, so I understand exactly where you are coming from. Really, health is the most important thing we can deal with. When you say we are under pressures up here, you can't imagine sometimes and our health is impacted by that. So what you are doing is absolutely magnificent and I am really going to try to do my part up here because I know what good health is and I know what good health is not. There is no comparison. Ms. Ladd. I would like to respond to your comment about health through the arts, helping people. It is true, it is a proven fact that when you are watching actors, especially in a theater or a great show on television, which is very rare, when you cry it releases toxins and pains from your body and those who make you laugh actually release gas from your body and it is very good for your heart. Laughter is the most important commodity to have. As I said, science and art was once one and you can look up my website, www.dianeladd.com and go to the bottom of the left side where there is a group called ACT. It is an art and cultural task force of 160 professional actors who are fighting to try to create Stay Here Productions to help culture in our country. Congressman McCarthy of Missouri, who got that motto from Truman, ``The Buck Stops Here,'' has taken over my ball and is going to run with it on behalf of art and culture to try to do something. I hope you will all give her your support while I am supporting medicine. Mr. Schrock. Great. I think they say when you smile, you burn so many calories. Smile all the time and you can be slim and trim the rest of your life. I thank you and Mr. Hunter for coming here today. We hope you will come back again soon. Ms. Ladd. Thank you. Mr. Schrock. We are now ready for our second panel. Please rise and we will swear you in. [Witnesses sworn.] Mr. Schrock. Before we hear our speakers, let me yield to the ranking member, Mr. Kucinich. Mr. Kucinich. I want to thank the gentleman and welcome the witnesses. In particular, I want to welcome David Seckman. Thank you and I appreciate the opportunity to work with you in so many areas. And also, Dr. Larry Kushi. Dr. Kushi and I have known each other, our families have known each other a long time. His father and mother are the individuals most responsible in the world for promoting macrobiotics. I have learned much from both of them in following their writings and I have to say Larry Kushi has continued on the brilliant path of his parents in his own writings and his work. I just wanted to be here for a moment particularly to welcome you and to thank you and your family for your lifetime commitment to macrobiotics and to alternative health, and to peace. Thank you. Mr. Schrock. Mr. Seckman is the executive director and CEO, National Nutritional Foods Association of Newport Beach, CA. We are happy to have you here today. You are recognized to give your opening statement. STATEMENTS OF DAVID SECKMAN, EXECUTIVE DIRECTOR AND CEO, NATIONAL NUTRITIONAL FOODS ASSOCIATION; GEORGE BRAY, M.D., BOYD PROFESSOR, PENNINGTON BIOMEDICAL RESEARCH CENTER, LOUISIANA STATE UNIVERSITY; LARRY KUSHI, ASSOCIATE DIRECTOR FOR ETIOLOGY AND PREVENTION RESEARCH, DIVISION OF RESEARCH, KAISER PERMANENTE; PAMELA PEEKE, M.D., ASSISTANT CLINICAL PROFESSOR OF MEDICINE, UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE, ADJUNCT SENIOR SCIENTIST, NATIONAL INSTITUTES OF HEALTH; TIMOTHY S. CHURCH, M.D., SENIOR ASSOCIATE DIRECTOR, MEDICAL AND LABORATORY DIRECTOR, DIVISION OF EPIDEMIOLOGY AND CLINICAL APPLICATIONS, THE COOPER INSTITUTE; AND DAVID HEBER, M.D., DIRECTOR, DIVISION OF CLINICAL NUTRITION, UNIVERSITY OF CALIFORNIA AT LOS ANGELES Mr. Seckman. Thank you for the opportunity to address the committee with respect to the dietary supplement industry. I am David Seckman, executive director and CEO of the National Nutritional Foods Association. NFA was founded in 1936 and is the oldest and largest trade association in the natural products industry. We represent the interests of more than 3,000 health food stores, thousands of manufacturer-suppliers and distributors of health foods, dietary supplements and related items. The committee has asked that I address the economic opportunity for improving health through diet, physical activity and the use of dietary supplements. In addition, I will also address the importance of natural foods and diet as a tool for disease prevention and health maintenance. First, let me say that I believe this hearing is occurring at a very fitting time, both in terms of some of the critical health issues we are facing today and emerging recent scientific research. There are probably few Americans who have not heard about our Nation's newest epidemic, obesity. Even our President has carved time from his own pressing schedule to personally address and champion physical activity and a healthy diet in combating this problem. Hopefully President Bush's involvement in this issue has served as a wake up call to all Americans. That call can't come soon enough. This year, the Centers for Disease Control estimated that approximately 47 million Americans will suffer increased risk of a whole host of serious illnesses, including heart disease and cancer due to poor nutrition and physical inactivity. As if this news weren't bad enough, the CDC also estimates that the problem increases exponentially with age. Having worked for many years in the long term care industry, I have witnessed firsthand how declining health in older Americans negatively impacts not only the patient but family members and society as well. One of the most devastating effects of a poor diet and inactivity is experienced by older Americans. This group is by no means the only population affected. The percentage of children and adolescents who are overweight has more than doubled since the 1970's. Today over 13 percent of our children and 14 percent of our teenagers are considered obese. These figures continue to rise each year, paving the way for increased health problems in adulthood. Between the ages of 40 and 60, 1 in 3 will feel the effects of a lifestyle that favors fast food and inactivity. These are prime earning years for many adults whose professional and economic contributions to society will be severely or completely curtailed. It is estimated that treating obesity related health problems in the United States exceeds $117 billion annually. Diabetes alone, which has a direct connection to obesity, accounts for more than $45 million each year. The reason my organization was formed more than 65 years ago was to support the growing number of consumers looking to make healthier choices about the foods they eat. Much of what the followers of this trend believed based on empirical evidence and common sense has been borne out by science over the years. For instance, whole, unprocessed and fortified foods has always been an important aspect of the natural or health food industry. Processing can eliminate some or all of a product's health qualities such as fiber and essential nutrients. Foods such as these that have retained their health benefits can be recognized by FDA authorized claims on the label such as fiber from whole oats can reduce the risk of coronary heart disease. It is important to keep in mind that whatever the health claim, the FDA requires substantial scientific proof that it is correct. Since I am on the subject of vitamins and minerals, let me make a transition into the more generic topic of dietary supplements and their role in human health. The term dietary supplement encompasses a wide range of products that include essential nutrients, herbal remedies and what we call specialty supplement products comprised of natural ingredients like enzymes and amino acids. When Congress unanimously passed the Dietary Self Help and Education Act in 1994, it acknowledged there may be a conection between dietary supplement use, reduced health care expenses, and disease prevention. In fact, current research is bearing out this very supposition. For example, the American Medical Association recently reversed its position on the value of taking a daily multivitamin suggesting that every adult would benefit from a daily multivitamin. This study is particularly important because our research indicates that physicians often do not discuss supplementation with their older patients. Other landmark studies include two published relating to the delay and lessening of symptoms of Alzheimer's disease by patients who took the herb ginko, Vitamin C and E. Not only has research demonstrated the health benefits of dietary supplements in foods, it has also shown they can reduce health care costs by billions of dollars. For example, a major medical journal reported that increased intakes of Vitamin E, folic acid and zinc could save $20 billion annually in hospital costs by reducing heart disease, birth defects and premature death. Alzheimer's disease costs Americans $61 billion a year in lost productivity from absenteeism of employees who care for family members and businesses that share health and long term health care costs. Even this modest reduction in symptoms and the delay of onset of this disease can save billions of dollars. Clearly dietary supplements as a whole, not just vitamins and minerals are beginning to get the research they deserve. Stimulating a good deal of this research is funding from two groups under the National Institute of Health's umbrella, the Office of Dietary Supplements and the National Center for Complementary Alternative Medicine. Both play a vital role in providing consumers with accurate and reliable information about alternative treatments and therapies. The recent questions raised about hormone replacement therapy which could affect an estimated 42 million American women underscores the need for more research and more information about safe and effective alternatives. More information about the qualities of dietary supplements is critical and so is access to them. Bills like Chairman Burton's Tax Fairness Act would allow taxpayers to deduct amounts paid for foods for dietary supplement uses, dietary supplements or medical foods as medical expenses. We also agree with Chairman Burton that food stamp recipients should be allowed to use their benefits to purchase dietary supplements. Although this amendment which was added to but ultimately removed from the most recent farm bill failed to become law, we hope this issue will be pursued in future legislation. Without question, combining a nutritional diet and an appropriate supplementation with physical activity not only reduces the risk of contracting a host of ailments, it improves quality of life for every age group. The body of research about the health benefits of a nutrient rich diet is impressive but needs to be expanded, particularly in the area of dietary supplements. While funding for research in this area has continued to grow, further investigation of the role of dietary supplements in maintaining optimum health is critical. Congressional hearings such as this one make strong impressions on the minds of Americans about the issues they cover. Often these issues are negative and the focus is on what went wrong and how can it be fixed. I want to thank the chairman and members of the committee for taking time today to examine what is right about nutritional foods and dietary supplements. [The prepared statement of Mr. Seckman follows:] [GRAPHIC] [TIFF OMITTED] 81866.038 [GRAPHIC] [TIFF OMITTED] 81866.039 [GRAPHIC] [TIFF OMITTED] 81866.040 [GRAPHIC] [TIFF OMITTED] 81866.041 [GRAPHIC] [TIFF OMITTED] 81866.042 [GRAPHIC] [TIFF OMITTED] 81866.043 [GRAPHIC] [TIFF OMITTED] 81866.044 Mr. Schrock. Thank you, Mr. Seckman. As you can hear, we have a vote. It is one vote. I think we will just recess for a few minutes. We will be back as quickly as we can and will continue then. [Recess.] Mr. Schrock. I want to recognize Dr. George Bray, a Boyd professor at the Pennington Biomedical Research Center at Louisiana State University in Baton Rouge. We are delighted to have you here and look forward to your opening statement. Dr. Bray. Thank you for the opportunity to participate in this hearing this morning. I won't read anything. I will make a few comments about the relationship of obesity and its treatment and the use of dietary supplements and over the counter products in that regard. My interest has been peaked in this area by a man named Mr. Pennington who provided the money to LSU to build the Pennington Biomedical Research Center which I directed for a decade. Mr. Pennington was, he thinks, cured of his cancer very much like your story for 25 years from taking a group of vitamins. He believes it was B12, I am not sure which one it was, but because of his belief in this area, when he was making his donations, he provided $125 million to Louisiana State University in 1980 to develop a nutrition research institute. That is the basic work that our facility has been doing since the completion of those buildings. Obesity, my area of interest, is an epidemic and I wanted to show you two figures. Dr. Dietz could do this but he said he wasn't, so I will. This is the behavioral risk factor survey data from 1989. I use it in color because it shows clearly the prevalence of obesity, less than 10 percent in yellow, 10 to 15 in green and there are no red States on this map. Ten years later, using the same survey techniques, you can see that only a handful of States are not now in this high risk category. So the epidemic as we all know, is a big and serious one. It is also an expensive one with major risks. Data from a paper in 1989 looking at attributable risk for physical inactivity and obesity are causally related to diabetes, heart disease, hypertension, gall bladder disease and osteoarthritis. In those data, obesity can account for up to 70 percent of diabetes, 40 to 50 percent of gall bladder disease, hypertension and heart disease and 7 to 27 percent of cancers and osteoarthritis. Physical inactivity on the other hand is of the order of 5 to 20 percent. So obesity is a major epidemic with major health risks and high cost associated with it. I was pleased to have Ms. Ladd's testimony earlier. She used at the end, the title of my testimony which is ``Don't throw out the Baby with the Bathwater.'' Having a major epidemic we need things to do to overcome it, to provide American citizens with ways to deal with it when they are afflicted with the problem. The broader those options, the more likely we are to be effective. When I was preparing for this testimony I went out to my health food stores to see what sorts of over the counter products there were and a number were available. I will have some suggestions about ways that might improve the public's ability to make decisions about using those supplements at the end. Two additional points. Small weight losses can be highly beneficial in reducing the risk for the diseases I described earlier. In a study of which we are a part that is funded by the National Institutes of Health, called ``The Diabetes Prevention Program,'' weight losses of 3 to 7 percent reduced by 58 percent and 31 percent the risk of people who are at high risk for diabetes from actually becoming diabetic. If you translate that into a 3-year delay in the complications of this disease, it saves billions of dollars by reducing the risk for human dialysis, for renal failure, for amputations, for blindness and other complications associated with diabetes. So modest weight losses can be highly beneficial. The dietary supplements that are available, particularly the ephedra-caffeine combinations have clear evidence from clinical trials of up to 6 months suggesting that the weight loss in the treating group is substantially larger than placebo and in the range that would be associated with these reductions in risk that were demonstrated in diabetes prevention programs. If we could get small weight losses, we would have a major improvement in the health of the American public and that would be highly beneficial. Let me read the three recommendations that came from my survey and I will finish. I want to read these so they are clear. First, provide clear and unambiguous labels on packages. All packages should be labeled so that consumers can find out what is in them. I found at least one that had no labeling information on it at all. Labeling should be improved to help consumers make choices. I found products with the same trade name having very different labeling of internal ingredients which can be confusing. It was confusing to me as a professional and certainly could be to the public. Having multiple packages with the same trade name but with different combinations makes selection difficult. Second, standard dosing and use good manufacturing practices in preparing them, providing the public with assurance that the amount of active ingredients in each package is standardized by analytical testing and comparable from lot to lot would provide them with assurance that they are getting what they think they are purchasing. Finally, encouraging research, providing financial incentives for manufacturers that conduct research to establish efficacy and safety of their products might be an important way to get this research done. Premarketing research should be particularly rewarded because knowing that the materials you are taking are safe and effective before they are available has real advantages to the public. Thank you for the opportunity to testify and I would be happy to answer questions. [The prepared statement of Dr. Bray follows:] [GRAPHIC] [TIFF OMITTED] 81866.045 [GRAPHIC] [TIFF OMITTED] 81866.046 [GRAPHIC] [TIFF OMITTED] 81866.047 [GRAPHIC] [TIFF OMITTED] 81866.048 [GRAPHIC] [TIFF OMITTED] 81866.049 [GRAPHIC] [TIFF OMITTED] 81866.050 [GRAPHIC] [TIFF OMITTED] 81866.051 [GRAPHIC] [TIFF OMITTED] 81866.052 [GRAPHIC] [TIFF OMITTED] 81866.053 Mr. Schrock. Thank you very much. We are happy today to have from California, Dr. Larry Kushi, the associate director of etiology and prevention research, division of research, Kaiser Permanente in Oakland, CA. Thanks for coming all the way from the West Coast. We look forward to your opening statement. Dr. Kushi. Thank you for the opportunity to describe to you some of the strong and consistent scientific evidence that plant based eating patterns are perhaps the most helpful way of eating. I am honored to be invited and thank the committee for its interest in how Americans can improve their health through diet and lifestyle choices. I have a degree in nutrition and training in epidemiology from the Harvard School of Public Health. As mentioned, I now work at Kaiser Permanente. As Representative Kucinich mentioned, my parents are credited with popularizing the macrobiotic way of life, the macrobiotic diet which is a central part of macrobiotics, a predominantly vegetarian diet emphasizing minimally processed whole foods. Among other things, it may be the most popular alternative comprehensive lifestyle approach to management of cancer. The central role that macrobiotics and my parents has played as a catalyst for the natural foods industry and for inspiring many people in the complementary and alternative medicine field led the Smithsonian Institution to start a collection of works related to their work. As you may recall, my father actually testified before this committee in 1999. Because of my personal and professional background, some say I have a unique perspective on what I can say on this topic. I am not sure how unique I am in that way but I will say my comments today are uniquely my own and don't necessarily reflect Kaiser Permanente's views or my parent's views. As the committee members are aware, there is a tremendous interest in diet and health in the United States. For example, I will show you a couple of publications published 2 weeks ago, one from the New York Times, ``What if fat doesn't make you fat?'' and inside it says, ``What if it has all been a big fat lie?'' The same week, Time Magazine published this cover story, ``Should you be a vegetarian?'' Clearly there seems to be a bit of contradiction here. I am going to say the answer to both of these questions is probably yes and there isn't really a contradiction. There is a contradiction probably in the way Gary Taubes talked about fat and the Atkins diet in the New York Times article. Let me make my views a little clearer. Basically, this article ignored certain fundamental truths about diet and health that can be gleaned from an epidemiologic perspective. We know, for example, there are tremendous variations in cancer and heart disease rates around the world. For example, with breast cancer, in which I have done a fair amount of work, there is a five to tenfold difference in breast cancer rates comparing countries in Asia versus the United States. We know despite NIH's emphasis on molecular biology and genetics that most of these differences are not due to fundamental differences in biology but rather to the lifestyle choices we make, the foods we eat, the physical activity we get, whether we smoke or not, the reproductive choices we make. And we know this because people who come from low incidence countries, such as Japan, and move to the United States, take on the disease experience of people in the United States rather than maintaining that in their home country. Two areas of the world that attract considerable interest regarding diet and disease relationships are the Mediterranean area and East Asia because they have both good quality disease registries as well as good documentation of eating habits. There is tremendous variation in the amount of fat in these diets. The traditional Japanese diet has about 10 percent of calories from fat whereas the traditional Mediterranean diets can range up to 40 percent of calories from fat. So the overall question, does fat make you fat, or does fat intake make a difference in overall health, perhaps is not the appropriate focus of what public health policy should have been. For comparison, in the United States our average fat intake is about 34 percent of calories and many of our recommendations have said we should be consuming 30 percent of calories from fat. This focus on fat may have been misguided public health policy. Despite fat intake differences there are tremendous commonalities between the Mediterranean and East Asian dietary patterns. There is an emphasis on plant foods in terms of what people have eaten traditionally, and there is minimal use of animal food. There is a substantial literature on this topic. I have provided some copies of a few articles that I wrote on this topic to the committee. I served as a member of the American Cancer Society's committees to develop dietary guidelines for the prevention of cancer in 1996 and again in 2001. In both cases, the committee, not just my view, but all committee members, agreed there was substantial evidence that the prevention of cancer can be helped through the adoption of plant based diets, deemphasizing meat and emphasizing whole grains, fruits and vegetables. There have been a couple of good, randomized trials of plant based diets demonstrating they really are effective in promoting health and preventing cardiovascular disease. The Ornish trial mentioned by Congressman Burton in his introduction is one example, using a very low fat diet. The Lyon Diet Heart Study is another example, using a Mediterranean type diet with about 30 percent of calories. So you have two different studies, using different dietary patterns with emphasis on plant foods but differing in fat intake, that demonstrates that these types of dietary patterns can really help in promoting health. As I mentioned, my parents have been leaders in macrobiotics. The macrobiotic diet is also characterized by an emphasis on whole, minimally processed foods. I also provided a copy of a paper to the committee we recently published last year about macrobiotics and cancer. Among the things in that paper was a picture of a pyramid which is sort of a takeoff of the USDA food guide pyramid. Unlike the USDA food guide pyramid, the macrobiotic pyramid my father drafted and promoted emphasizes plant foods and doesn't suggest that eating red meat on a regular basis is compatible with good health. We also received funding from the NIH Office of Alternative Medicine to compile and document a series of cases of individuals who had used macrobiotics for cancer and appeared to benefit from this use. While the amount of funding was extremely small, we are still in the process of completing the best case series. I should mention some of my colleagues at the University of South Carolina are helping with that as well as the Kushi Institute, an organization my parents founded. In that context, this past February 25, we presented six of these cases to the NIH Cancer Advisory Panel on Complementary and Alternative Medicine. While we are still waiting for the final report from the meeting, it did conclude that the cases we presented provided compelling rationale for further funding and research into macrobiotics and cancer care. I believe these cases we presented were quite remarkable, including a case of lung cancer which I detail in my written testimony, as well as several other cases of cancer. In the meantime, the NIH has funded a couple of randomized trials of plant based diets on the recurrence of breast cancer. There is substantial literature growing related to diet and cancer treatment and breast cancer which I reviewed in this book, ``Breast Cancer: Beyond Convention.'' I wrote one of the chapters, and it is edited by others. Basically, I would like to emphasize that current scientific evidence really does point toward plant based whole food diets for the prevention and treatment of major chronic diseases, including heart disease and cancer. The macrobiotic diet that I am familiar with for personal reasons is one example of such a diet. I thank the committee members for this opportunity. [The prepared statement of Dr. Kushi follows:] [GRAPHIC] [TIFF OMITTED] 81866.054 [GRAPHIC] [TIFF OMITTED] 81866.055 [GRAPHIC] [TIFF OMITTED] 81866.056 [GRAPHIC] [TIFF OMITTED] 81866.057 [GRAPHIC] [TIFF OMITTED] 81866.058 [GRAPHIC] [TIFF OMITTED] 81866.059 [GRAPHIC] [TIFF OMITTED] 81866.060 [GRAPHIC] [TIFF OMITTED] 81866.061 [GRAPHIC] [TIFF OMITTED] 81866.062 [GRAPHIC] [TIFF OMITTED] 81866.063 [GRAPHIC] [TIFF OMITTED] 81866.064 Mr. Schrock. We are glad to welcome Dr. Peeke here today. You have heard her mentioned a few times. Dr. Peeke is the assistant clinical professor of medicine, University of Maryland School of Medicine, and also an adjunct senior scientist, National Institutes of Health. We are delighted to have you here and look forward to your testimony. Dr. Peeke. It is an absolute delight to be here. I also wish to acknowledge my distinguished guest, Irene Pollin, who is the founder and executive director of a new national program called Sister to Sister which will acknowledge heart disease in women for education screening purposes. You read an advertisement about nutrition or dietary supplements and what does it always end with? Before doing any of this, please consult your physician, the one person who knows less than you do. The ultimate nightmare for any physician in America today is during the 8 minutes allocated for a patient visit, a patient comes in with what we now refer to as the Internet printout under the armpit sign which means they have scanned the Internet, they have many questions, most of which we can't answer because they have to do with a topic, nutrition, that is now not taught actively or a required topic in the majority of medical schools in this country. I am a bit of a mutation because after 11 years of critical care and trauma as an intensivist, I went back into academia as a Pugh scholar at the University of California at Davis where I had to, with a couple of colleagues, spend a couple of years learning nutrition and metabolism which is tough stuff, it is biochemistry. Then I came to the National Institutes of Health after that. What I found was that across America as I began to look at the medical curriculum in nutrition, there was none. As I teach at the University of Maryland, what I find is that the classes are standing room only, they are still voluntary not required and that interestingly who attends these classes are also the attendings, residents, interns and not just the medical students. There is an avid interest in this, if not just for our survival sake when our patients come in and ask these questions and we have so little information. So I speak first to the salient point of a gap and the gap in the knowledge on the part of the medical professionals nationally, clearly anything that you can do to be able to help us with that would help all of us and the consumer in the end. I will now speak to another gap, a gap that I had addressed in my testimony. What I was really trying to drive home was the issue of a brand new way of looking at this issue of obesity, nutritional deficiency, and that is looking at a new field of intellectual as well as academic concern. We now call it gender specific medicine after the work done by my colleague, Marianne Magado at Columbia University and others and clearly being put forth by the National Institutes of Health and the Office of Women's Research and Dr. Vivian Penn's excellent work as well as that of the HHS Division. Here we are looking at a very interesting question. When you look at obesity, look at the unfitness of Americans, is there something that is gender specific about that per se? We have never really looked at that in a significant way until in 2001 we published the findings of a milestone report by the Institute of Medicine, a Committee on Understanding the Biology of Sex and Gender Differences. It asked a provocative question, does sex matter? The answer? Yes. We found that scientists were able to turn their attention to issues of everything from behavior and perception to lifestyle, the metabolism of drugs, to physical activity. Women and men do things differently, both of which need to be honored. It is no longer just about women's health and men's health. It is about gender specific medicine, one learning from the other's strengths and vulnerabilities. What have we learned? During the endocrinological milestones of a woman's life which involve the onset of menstruation, pregnancy and her periomenopause, interesting things take place. What we have found in recent monographs is that during that time everything from depression to diabetes to asthma, epilepsy, migraine, are all worsened especially when a woman is unfit. We have been looking at this closer in the pre- menstrual period and now we are looking in the periomenstrual. What does this mean? This means that during this period of time when a woman is trying desperately to maintain a healthy lifestyle, it is rather difficult. These are physiologic and biologic interferences that need to be honored. Interestingly, the herbal industry has been looking at this very closely, certainly with the current evidence-based medicine that has been generated, looking at black cohosh, for instance, but there is a paucity of data in this certainly with the new evidence that has emerged over the last couple of weeks with regard to hormonal replacement therapy and there issues thereof, we now turn our attention to again a woman's fitness, mind and body, during these endocrinological milestones and during the menopause. We look at specific foods, for instance, phytoestrogens which were just mentioned. These are plant estrogens. Are they better for a woman, are they helpful? Absolutely. There is no question about that. We look at all kinds of new products like energy bars, this one in particular. What does it say? Soy, heart healthy. We never really looked at this before. Is this something that might be able to augment a woman's wellness during this time? Absolutely. No question. We look at issues of obesity and fitness. One of the things we have never really looked at in a significant way before was the whole issue of diversity, ethnic diversity. Thirty-four percent of women, as Congresswoman Morella noted, are obese 31 percent of men. Among women there are important racial differences. Blacks, 48.6 percent, Mexican-American, 47.2 percent and these women are much heavier than the Caucasian women, 33 percent, there are real differences among these ethnic groups with regard to the kind of incidence of disease, for instance, diabetes. For men, interestingly, White and Black men have almost identical numbers of incidence of obesity, 31.6 percent and 31.2 percent and yet 39.2 percent of Mexican-American men are overweight. Have we spent enough time looking at this, not just in terms of gender differences but also in terms of ethnic diversity, absolutely not. We need much more information with regard to this. Let us look at the psychological issues. You tell a man or you tell a woman, go ahead and get fit. Here is the template and you are going to hear excellent templates, everything from vegetarianism to physical fitness. What happens when a man and woman pursue this? What are the differences, the obstacles? Interestingly, it is the mind in a lot of this. For instance, in a man's mind, he could be 105 percent of ideal body weight and still look in the mirror and see himself as thin and fit. Over 43 percent of women who are absolutely of normal weight and quite fit see themselves as overweight and go out of their way to torment themselves with more what I refer to as science fair projects or every diet fad that comes down the block, interfering with one of the most important things we need to look at, new avenues of science, not just weight, not about weight, it is about fitness, about body composition, about body fat. If you look at a woman's body as she begins to evolve through her periomenopausal years after the age of 40, you will find there is a transformation. One of my female patients once told me, I am 45 years old, all of my life I have looked like an hour glass and I have looked at my body today and suddenly it is changed, I am not an hour glass anymore, I look more like a shot glass. In saying so, she noticed she was filling in. Was this more than just an aesthetic eyesore? Absolutely more. Why? Because she was adding weight to one of the most pieces of her body and that was the intra-abdominal area. We never knew this before. By placing too much weight there, depositing there through a lack of physical activity in addition to abnormal eating patterns, clearly she is increasing her morbidity and mortality risk for everything from heart disease to diabetes to cancer. You do not have to be overweight significantly or even obese for this to happen. It is no longer just what you weigh, it is where you weigh it. If you look at the current guidelines of the American Heart Association from this week, they are now asking that waist size now be looked at very closely as one of the greatest predictors and criterion for looking at disease morbidity and mortality, certainly for heart disease than just standing on a scale and looking at that specific number. Women are greatly affected by this. Women are more greatly affected by diabetes. Going back to the mind for another moment, if you look at the mind, you look at the mind of a woman who needs to go out and take care of herself, what do you see? The No. 1 stressor of a woman, globally, is caregiving. Frankly, women will caregive anything that comes within 20 feet of them and usually defer anything in their own self-care to be able to accomplish this goal which is usually lethal for them because they never get to their self care. Men are much smarter. They compartmentalize, they are highly focused, they are able to achieve that goal. Women's caregiving gets in the way. Clearly as they go through each decade of life, we just caregive different groups of people. So this must be understood. Where are the easy to access parks for women to be able to walk with their strollers? How can we make it easier for women who have to caregive sick ones to be able to get that physical activity, to be able to access that healthy food vegetarian or otherwise? Are we making that possible? Finally, in science itself, if you look at everything from a hormone called leptin and its concentrations in women, women have higher concentrations as they get more obese. Leptin is supposed to be able to regulate their appetite and ability to maintain more healthy body fat. What happens here? There is a difference. Look at some of the findings of the Institute of Medicine's report which are really quite astounding. Cigarette for cigarette, if a woman smokes exactly the same number of cigarettes as a man, she has 50 to 72 percent greater risk of lung cancer. We metabolize things like nicotine very differently. We do not do heart attacks the same as men do. We don't clutch the chest and drop to the floor. We have epigastric distress, perhaps a little stomach aid as mentioned before might be able to help. It doesn't. Usually these women will come in now sicker because they didn't know they had heart disease all along. What are we doing to be able to educate women nationally about this phenomenon? Most women don't know that. They are more terrified of breast cancer than heart disease, yet the No. 1 killer of women is heart disease. In putting together programs and services nationally, I think now we are going to have to look at the issue of gender and also racial diversity as we have never done before to be effective and to be meaningful. Thank you. [The prepared statement of Dr. Peeke follows:] [GRAPHIC] [TIFF OMITTED] 81866.065 [GRAPHIC] [TIFF OMITTED] 81866.066 [GRAPHIC] [TIFF OMITTED] 81866.067 Mr. Schrock. Dr. Church, welcome. Dr. Church is a senior associate director, medical and laboratory director, division of epidemiology and clinical applications, the Cooper Institute in Dallas. We are glad you are here today and look forward to your testimony. Dr. Church. I have some slides. First, it is an honor and privilege to be here and be a part of such an esteemed panel. The Cooper Institute was founded in 1970 by Dr. Cooper, as a non-profit research institution. Its original mission was to examine the role of exercise in the maintenance of health and function. Since that time, our mission has broadened considerably. To date there has been over 650 published works to come out of the Cooper Institute and the works have influenced major national policy initiatives from NIH, the American Heart Association, and the Centers for Disease Control and Prevention. We are probably most famous for the Aerobics Center Longitudinal Data base, a data base consisting of over 70,000 Cooper Clinic patients, some of whom have been followed up to 30 years. This data base is so unique because of the fact that nearly every one of these individuals had a fitness test. They got on a treadmill and went to exhaustion. That is the max treadmill fitness test. No other data base in the world is greater than 10,000 which has max treadmill fitness test. This is representative of some of the work that has come out of our group over the year. This slide shows CVD death rates across levels of fitness. On the left we have women and on the right we have men. You can see with increasing levels of fitness, you have dramatic dropoffs in CVD death rates. Often this is attributed to obesity. Individuals who are higher fit have lower rates of obesity. We can see in this the left set of bars is lean, the middle set of bars is normal weight and the right set of bars is overweight. The pink bars are unfit, the yellow bars are fit and you can see at every single weight, there is a great benefit to being fit as compared to unfit. Even in obese individuals there is a tremendous advantage for risk of mortality for being fit compared to unfit. We have a number of ongoing studies. We have an outstanding study going on now examining the role of exercise in the treatment of depression. We have an army looking at the role of exercise in weight loss and long term weight maintenance. We have a very exciting NIH funded study going now looking at different doses of exercise and risk factor reduction of post menopausal women. I was specifically asked to spend some time commenting on the Cooper clinical trial which has just completed, so a lot of this data is literally right out of the computer. The trial ended last week. This was a placebo controlled, double blinded study consisting of over 200 participants with a 6-month trial period. Placebo controlled means that half of the study participants received a placebo and they didn't know they were. The other half received a vitamin and they didn't know they were receiving the vitamin. They don't know what they are getting, we don't know what they are getting. It is not until the end of the study when we break the code that we find out who got what. It is very important. This was a privately funded study and it cost approximately $300,000. The primary outcomes of the study were homocystine, an amino acid found in the blood and a known risk factor for Alzheimer's disease and cardiovascular disease. Another primary outcome was oxidized LDL, a particularly bad type of cholesterol. The last primary outcome which was added during the course of the study was C reactive protein. C reactive protein is an inflammatory marker found in the blood. It has a risk factor for diabetes and cardiovascular disease. I want you to look at the highlighted number at the top and the bottom of the screen. This shows how difficult it is to run these studies. We phone screened nearly 1,300 people at this time to complete 176. It takes quite a bit of work to run one of these studies. These are the characteristics. You can see we have an even distribution of men and women, average age is 50 years, and BMI was 26. You are always going to be looking at the vitamin group on the left two bars and on the right two bars, it is always going to be the control group. In this instance, we are looking at change in Vitamin C and change in betacarotene. This is change in the blood. As you can see there was a 60 percent increase in Vitamin C and a 60 percent increase in the betacarotene in the group that received the vitamin with no changes in the control group. Same type of slide. There was a 100 percent increase in Vitamin E and a 50 percent increase in folic acid in the blood of the individuals who received the vitamins compared to the controls. There was a 273 percent increase in Vitamin B6 and a 55 percent increase in Vitamin B12. Why is this important? This shows if you take a multivitamin, it gets into our blood, not just simply going out the way it came in. Looking at our outcomes, there was a substantial decrease in homocystine in the vitamin group, nearly a 17 percent decrease. This is particularly interesting when you realize that folic acid is currently being supplemented in many of the grains we eat today. Both these slides show the same thing, just measured differently. The individuals taking the multivitamin, there was a significant decrease in LDL oxidation meaning there was less of this bad cholesterol. This is particularly provocative showing that a multivitamin lowers C reactive protein. This has never been examined before. We hope to submit this next week. C reactive protein is receiving a lot of attention because of its strong associated risk with diabetes and cardiovascular disease. This is an important point. We saw no change in plasma glucose and it is important because in our pilot data, we saw a very large drop in plasma glucose in individuals who took a multivitamin but that was simply pilot data. These things need to be tested. When we rigorously tested it we saw no change in plasma glucose. It is important that these things be tested at the right study protocols. In our findings we found that serum vitamin levels increased greatly with a multivitamin use. Individuals who took multivitamins had a decrease in homocystine, LDL oxidation and C reactive protein. Thank you for this opportunity. [The prepared statement of Dr. Church follows:] [GRAPHIC] [TIFF OMITTED] 81866.068 [GRAPHIC] [TIFF OMITTED] 81866.069 [GRAPHIC] [TIFF OMITTED] 81866.070 Mr. Schrock. Thank you very much. Dr. Heber, welcome. Dr. Heber is the director of the division of clinical nutrition at the University of California at Los Angeles. We are glad to have you and look forward to your testimony. Dr. Heber. Health has no party line identification. I want to thank Congressman Burton for his leadership role and the many conversations I have had with Beth Clay over the last few months. I want to confine my comments to a very few brief areas. In the late 1970's, the State of California passed a law providing funding for a professor of nutrition at each of the University of California Medical School campuses. I was the first appointee at UCLA in 1983. Since 1985, we have had one of two National Cancer Institute funded Centers for Nutrition and Cancer Prevention. There are only two in the country and the other is Sloan Kettering and the American Health Foundation. Those green boxes in the middle represent core laboratories of that Clinical Nutrition Research Unit. When I go back to California tomorrow, I will have my laboratory meeting with four assistant professors, two associate professors and seven research fellows, conducting research not only on nutrition and cancer prevention but also the box below the pink box is one of four nutrition obesity training programs in the United States funded by the NIDDK. This money was made specifically available in response to the earmarking by Congress of obesity as a national issue. The top box represents an additional three core laboratories which we competed for in 1999 through the Office of Dietary Supplement Research represented today by Dr. Paul Coates whose testimony you will hear later. I wanted to indicate that UCLA as far as I know is the only university that has all three of these coordinated within a center for human nutrition in a dedicated facility. The U.S. Government passed a law in 1977 called the Farm Bill, Public Law 95-113, which granted the USDA the responsibility for dietary advice as opposed to what was at that time called DHEW, now called DHHS. Many viewed this as a conflict of interest since the USDA is also dedicated to increasing food consumption, while it is clear that the over- consumption of some foods may be contributing to the health problems of obesity. Many scientists in the community, including those who work in the health nutrition information service, such as Dr. Marian Nestle, have recently raised the issue of whether we ought to revisit and remodel the USDA pyramid which developed in 1992. This pyramid you see before you shows how Americans are eating. They are eating refined carbohydrates off the bottom of the pyramid and they are eating sweets, fats and oils at the top of the pyramid which appears to be almost toppling off. The issue here with pyramids is that we recommended in 1997 that fruits and vegetables be placed at the bottom of the pyramid with whole grains above that. Dr. Alice Lichenstein at Tufts University and others, Dr. Walter Willet and others have asked that we revisit the pyramid. The USDA has held to the view we should have dietary guidelines. The difference between a dietary guideline and a pyramid is a pyramid creates a hierarchy of foods according to their health value whereas a dietary guideline allows you to talk in the abstract about fat, carbohydrate or protein. We know when we had fat free foods in the 1980's, there was a 30 percent increase in obesity as sugars were put into foods. We are having a lot of argument now which Dr. Kushi indicated and I think the answer is to go to a plant based diet. Man evolved on a plant based diet. If we look at this apple that has a red skin, there are 25,000 phytochemicals in that skin. If I take the Vitamin C from this apple and put it in with colon cancer cells, it will not inhibit their growth as well as if I take an extract of this whole apple. We have taken extracts of whole fruits and vegetables in our research and shown significant effects on cancer inhibition. This is a simple picture of visualizing your plate. I think we can get advice to the American people through pyramids and also through looking at your dinner plate and making it colorful, two-thirds full of fruits and vegetables, berries for dessert and a nice dark green salad which is full of folic acid as mentioned in the last talk, and Dr. Kushi also mentioned. These are not impossible changes. I wanted to get that across to the committee, very simple things we can educate the public to do. I wanted to indicate the botanical dietary supplements did not come from another planet. They are actually from our fruit and vegetable and traditional food sources. Chinese red yeast rice was classified by the USDA in 1920 as a food product. It was declassified as a dietary supplement in 2001 following the FDA's pursuit of a Federal Appeals Court decision in April 2001 declaring it an unapproved drug. The reason for this was that there is a part of the DSHEA legislation which says if a botanical dietary supplement contains something previously approved as a drug, it may not be classified as a dietary supplement. This shows you nine chemicals and they look like little chicken wires up there. One of them is classified as a drug but the other eight all have activities in lowering cholesterol. This is one of the nine called monocolin K, made by the red yeast when it sits on top of the rice and the rice stimulates the yeast to make this family of nine compounds. One of these was selected and classified as a drug because it was purified and crystallized. The key difference between a dietary supplement and a drug is dietary supplements are combinations of multiple compounds whereas a drug is a single purified and crystallized compound. We did the first trial of Chinese red yeast rice and published it in February 1999. In that trial, we showed that approximately 6 mg of monacolin K or lovastatin, the drug, when included in a matrix of an herb would actually lower cholesterol as effectively as 20 mg of mevacor. The yeast material cost $10 to $20 per month in your local drug store. This represents a potential significant cost savings, not just to the American public, but to the Federal Government through the Medicare and Medicaid programs who have to pay for expensive prescription drugs when these types of herbal products would do a similar job. Over 57 million Americans today have high cholesterol. Only 13 million take expensive prescription lowering drugs. The affordability of botanical supplements could help save money as well as improve the public health. Both drugs and botanical supplements have a role to play in promoting health. It is not one versus the other but the DSHEA law should be fully implemented and not selectively implemented. As I will point out in the next example, while FDA selectively implemented this provision I spoke about, they have not implemented the one you pointed out this morning, the issuance of good manufacturing practices which is almost 10 years overdue. PC-SPES is a mixture of eight Chinese herbs, has a 50 percent response rate in advanced prostate cancer. We have recently done research to show this has a response in colon cancer and leukemias and lymphomas as well. Some of that work is going to be very shortly published. I have with me the July 15 issue of Cancer Research, one of our most prestigious journals in the United States in cancer research. There is an article in there by Dr. Peter Nelson at the University of Washington funded through CAP Cure, the Association for the Cure of Prostate Cancer where Mr. Michael Milken has raised almost $200 million for prostate cancer research. This slide is fairly scientific but if you look at the line of identity in the upper two lines, that is comparing PC-SPES to itself and you get a 45 degree angle. If you look at it for a comparison for diethylstilbesterol which was said to be contaminated, you see there is no specific response comparing it. So it is totally different than diethylstilbestrol. This slide shows a gene profile. The genes in red are the ones that are up regulated and that is taken from this article. The green genes are the ones that are down regulated. The PC- SPES is a mixture of eight well known Chinese herbs and specifically down regulates the androgen receptors, specifically down regulates tubulin genes and other genes involved in the carcinogenesis process. Today using 21st century science, gene chips where we can monitor 80,000 genes from the prostate cancer cell, we see that the actions of PC-SPES which is prostate cancer has actions far beyond what can be explained by any of the putative contaminants which caused it to be removed from the market. The California version of the FDA found warfarin contamination in PC-SPES and it was voluntarily withdrawn from the market so thousands of patients were deprived of this treatment. This is something that could have been avoided with good manufacturing practices. We are currently mobilizing research at UCLA to reactivate the science foundation for PC- SPES after it is appropriately manufactured with good manufacturing practices. One of the problems here is that the FDA has not issued good manufacturing practices. The burden has been left to the industry in hard fiscal times to have to pay for these quality controls on their own rather than have this done as a government function which is how it should be done. I would urge you to have full implementation of the DSHEA legislation by asking FDA not only to fully implement the good manufacturing practices to help us with that aspect but I would also ask you to increase support efforts to increase fruit and vegetable intake in the American diet because 93 percent of Americans say they want to change their diet, 78 percent want to increase fruit and vegetable intake, only 4.5 percent of the USDA budget is currently being spent on fruit and vegetable intake promotion. Secretary Veneman is supportive of this, so we have the public and USDA both supportive. I think you could provide a very good catalytic action in moving this ahead. We do have an IND pending before FDA to research the basic metabolism of Chinese red yeast rice. I would say to bring this public health benefit to the public, we do need to continue to have pressure for full implementation of DSHEA so that when we get nutrition breakthroughs as we have in the last 20 years, they are fully benefiting the American public by coordinating the activities of USDA, NIH, CDC, FDA and the Federal Trade Commission which has a role in clearing up the labeling problems that Professor Bray has noted. Thank you for your time and your dedication. I look forward to working with you in the future. [The prepared statement of Dr. Heber follows:] [GRAPHIC] [TIFF OMITTED] 81866.071 [GRAPHIC] [TIFF OMITTED] 81866.072 [GRAPHIC] [TIFF OMITTED] 81866.073 [GRAPHIC] [TIFF OMITTED] 81866.074 [GRAPHIC] [TIFF OMITTED] 81866.075 [GRAPHIC] [TIFF OMITTED] 81866.076 [GRAPHIC] [TIFF OMITTED] 81866.077 [GRAPHIC] [TIFF OMITTED] 81866.078 [GRAPHIC] [TIFF OMITTED] 81866.079 [GRAPHIC] [TIFF OMITTED] 81866.080 Mr. Schrock. Thank you very much. Your testimony has been fascinating and I appreciate everything you have said. Mr. Seckman, you are right, our President is kind of taking a lead in this. His workout routine every morning is an inspiration to a lot of people and hopefully will get people on board. We do need to speak out up here and make sure that we are taking a lead in that. Some of us will certainly do that. You talk about obese kids who eat chips and cokes all day long. It is no wonder we have that problem. As a consumer decides what dietary supplements to use, not just the brand but specific substances like Vitamin C, ginseng, Vitamin E and others because you walk into these health food stores and there is this sea of things there and you think, what do I need and it is very, very difficult. The people behind the counter certainly don't know how to respond to you. Mr. Seckman. That is an excellent question. The local retailer is probably one of the best experts to direct you to certain areas. The NNFA has produced over the years and puts on our Web sites information for consumers written in language that consumers can understand about certain types of ingredients and products. We encourage them to go there. It is very difficult to go out to the mass market and have discussions with people in such and such a store but go to the local health food store where these people spend a vast majority of their lives, this is what they believe in, what they do. Talk to the retailers of those facilities about the different products and they can help guide you. Also look on the Internet at our Web site, www.nfa.org and get other information that is directed to consumers. Mr. Schrock. Dr. Bray, you were talking about some of the health foods. In this magazine I held up earlier, there is one product that I have thought about using. It is called hydroxycut. I don't even know if you are familiar with that. Dr. Bray. I am. Mr. Schrock. I have been advised by some not to use it because they say it makes you depressed and has other sorts of side effects. How does one know because on many of these bottles, you don't see that stuff and how much weight can one expect to lose from using some of these products? Dr. Bray. Let me take the second question first. Almost all of the data we have people will lose no matter what they do, sort of surgical approaches, less than 10 percent of where they started. The message I also delivered was that 3 to 7 percent is associated with reductions in risks for diabetes for people at high risk. So even small weight losses of 5 percent or less can be beneficial to people who are at risk for problems. The issue of how you make selections is a very difficult one. It is where the educational forces from consumers unions, from Prevention Magazine, from the television, newspaper and magazine issues really come into play. I think we have to do the best we can to make sure the science writers are as well educated as possible in the broad issues and that they write it in a way in which it is informative. The article that Dr. Kushi referred to a few moments ago in the New York Times has probably generated more letters and e- mails to them than any other thing they have had in a great while suggesting people read it, but there is controversy in this issue. This is a place where the press is particularly important where groups like yours are important but where it is difficult. Going in as I did on Saturday with my professional background but with nothing more than that, I found it a real challenge. I think one area where improvement could be made would be in the labeling strategy that we use. Putting large numbers of things on a package can be more confusing than helpful. I think that our regulatory agencies could work to improve the labeling information that consumers have so that when they go in after reading the New York Times or Prevention Magazine, they can identify what they want in an easily readable and intelligent fashion. Mr. Schrock. It seems every publication you read that each one tells you something different and that adds to the confusion when you try to decide what to take. Dr. Bray. The problem is some of the scientific articles shift back and forth. Sometimes fiber is good, sometimes it is not so good. That confuses even those of us who work in the field. Mr. Schrock. If you will excuse me, we do have a vote. I assure you I will run over there, and run back here. We should be back in just a few minutes. [Recess.] Mr. Schrock. Thank you for waiting. Dr. Kushi, thank you and your parents for what you do. You provide wonderful things for society and I really appreciate that a lot. Fat in the diet, boy is that a big issue. The males had a screening in the Capitol not long ago and my communications director had his done and I had mine done. He had 11 percent body fat and mine was 15 and I was furious because he is younger than I am but I just don't understand. My doctor says for you, that is perfect, so I am trying to figure out what is the right amount of fat, what is not and is it OK for the average American to include plant products that contain fat such as avocadoes, nuts and olives because sometimes you hear there is too much in the nuts. From a personal standpoint, I would like to get your spin on that. Dr. Kushi. As far as fat in the diet, generally, one of the points I tried to make is that it is really the type of fat not the amount that is probably more important, although certainly the amount also plays some role. Plant-based products that have fat intake, for example, nuts, can be part of a healthful diet and probably should be. We actually published a study that demonstrated that people who eat nuts on a regular basis have approximately 30 to 40 percent decreased risk of developing heart disease. So it is consumption of that type of plant-based quality, relatively high oleic acid, linoleic acid type fat. Mr. Schrock. That is good because I thought if I liked it, it was not good for me. Dr. Kushi. I think the recommendations from the Heart Association will be changing partly as a result of these types of observations. Mr. Schrock. Dr. Peeke, you made a lot of comments I want to comment on. You said nobody is teaching health anymore. When I was a kid, as I recall, we had a health class. It was Mr. Ridenhauer who was my health teacher. I don't think they have that sort of thing anymore but I remember it and I remember some of the things he taught me. I think that has carried me through to where I am right now. It seems like with budget cutbacks in school and such, they have gotten rid of that and I think that is a bad thing. I guess it is incumbent on us to try to do something about that. I certainly agree that is a problem. You are the recognized expert in understanding the relationship between stress and weight gain and those of us who work here in Washington can certainly relate to that. How do you explain that, stress and the weight gain? In my case, when I am stressed, I don't eat but most people do and I wonder in the environment we have here how that impacts us? Dr. Peeke. We go back to the issue of men and women again. As it turns out, a number of studies have now been done over the last 2 years that have shown that it is women who are the primary stress overeaters, that it is men who tend to lean to alcohol in response to stress. Your proclivity to undereating or overeating really depends on one, your genetic base upon which you usually deal with stress which is about 30 percent and also it depends on the level of stress. If you have a true tragedy, if you have something that is of monumental portions, it doesn't matter what the event was in your mind, by definition stress undereating tends to take place. When we look at what happened with September 11th in town, as a Washingtonian, we studied this rather closely and what we found in both New York and Washington almost uniformly across the board, people were stress undereating for that first week, they were not stress overeating because of the incredible tragedy and the level of pain that was ensuing. What was fascinating was there a rebound eating phenomenon that took place within the month. Once again, it was women who were the stress overeaters primarily and the men who interestingly coped with the stress much better. They tend to compartmentalize as I mentioned before, stay focused and just realize things would go on. Women are womenators, women are ponderers and we have new research that has just been published by the proceedings of the National Academy of Sciences and others over the last 2 weeks that has shown there are real changes in the brain that you can actually follow using something called a MRI, a scan of your head which has been noted in at least two different university studies in the last month. Again, you see that gender difference. The stress issue, very straightforward. We all have stress hormone and when stress hormone is utilized appropriately for your typical fight and flight, if I was running up those stairs and trying to not be late for the next meeting, that is normal. I am going to have a bit more functional elevation of that stress hormone, cortisol. The problem ensues--something studied by my mentor, Dr. George Krusos at the National Institutes of Health in our lab-- it was found when you have chronic levels of stress, and you have chronic elevations of stress hormone for long periods of time, this is abnormal and unhealthy and it leads to a number of different ramifications, everything from depressed immune function, retarded growth, dysfunctional reproduction, and through the use of new technology in molecular biology and work of others, we have found that you can actually stimulate increased amounts of fat deposition in the worst place in the human body which is deep under your abdominal muscle wall. So if you get too much of that, that lovely little apple look or in a guy it is that big waist look, that fat is basically toxic to the human body. It is highly associated with what we now call the metabolic syndrome associated with an increased risk in incidence of heart disease, high blood pressure, blood clotting problems, diabetes and cancer. If you look specifically at waist to hip ratios, rather than body mass index in women, the Iowa Women's Study, that is a greater predictor for morbidity, mortality than just scale weight alone. So you see we have come quite far. Mr. Schrock. Obviously this guy has no stress is that what you are saying? Dr. Peeke. No, he has other things going on. Mr. Schrock. 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 didn't find it in those two groups. Why would that be because obviously one was better than the other? Dr. Church. It wasn't something I was looking for, it was something somebody told me to look for. I didn't believe the pilot data to start with. I thought it was just a sample size issue. Once again, that is why it is so important to always have placebo control, appropriately powered, double blinded studies to see if there really is an effect or not. I think that glucose phenomenon we saw is an interesting issue because that is often what you see in those magazines you are holding. They will look at 10, 15 or 20 people and use a study that is a horrible study design and meant to show the results they are looking for. It is not a properly run study. If we were not who we are and don't do things the way we do, we could have made the claim that our research shows our vitamin lowers glucose but in fact now that we have done the appropriate research, it doesn't. Mr. Schrock. We talk about obesity in kids and my wife teaches kindergarten and you cannot believe how many are so badly out of shape, you would think they were 30 year olds. How do we turn that around? PE programs? They try to teach some of that and feed the kids correctly in school but you have to be able to turn that around or these kids are going to be health nightmares all their lives. Dr. Church. I think PE is a great place to start. Look at Louisiana, a State that has gotten rid of PE and when I lived there, they were starting to get rid of recess. The studies show that kids who are not active in school will not be active when they go home. PE and laws that mandate PE is a great place to start. Mr. Schrock. I agree. Dr. Heber, your book is great. I am going to read this, ``What color is your diet?'' Explain why that is important. Dr. Heber. Humans and a few primates are the only ones who have red-green color discrimination. Dogs, cats and other animals are red-green color blind. It is believed we evolved that to be able to select our food supply. These colors are not random. They represent specific families of chemicals that have been implicated in disease prevention. The red group would be tomato juice, tomatoes, tomato sauce, tomato soup and pink watermelon and pink grapefruit all have lycopene. The green-yellow group would be spinach, kale and avocado which have lutein in them. We were the ones at UCLA that showed that avocado is the richest source of lutein among fruits. These are concentrated in the back of the retina where they help prevent age related macular degeneration, the primary preventable cause of blindness in people over 65. The orange group is alpha and betacarotene, it is a cancer preventive and also contributes to night vision. Around the world most people get their Vitamin A from plant products. Here in the United States, we get it from Vitamin A and D fortified milk and from meat products. There may be biological differences of getting it in that way versus getting it from the fruits and vegetables. Garlic, onion and chives have Allyl sulfides in them which were used as antibiotics before World War II and these also inhibit cancer growth. The red-purple group are raspberries, blueberries and strawberries. If you feed blueberries to mice as they age, they don't go through a maze as quickly but if you put blueberries in their feed and change it from that brown, beige color to a purple color, they do better in performance tests. There is the green group which is broccoli, brussels sprouts, bok choy and cabbage that has isothiocanates which goes to your liver and stimulates enzymes to help you fight off pesticides and carcinogens in the environment. The yellow-orange group is citrus, pineapple, banana. Citrus fruits have preventive substances on their surface. If you squeeze an orange peel, a little bit of fluid comes out that has liminoids in it and these have also been shown to be cancer preventive. The oranges and lemons develop this to fight off fungi that would land on their surface and by an accident of nature, these substances are cancer preventive in humans. These and many other compounds are being studied by the National Cancer Institute for Cancer Prevention and seven servings a day of these different colors not only give you the diversity but there is 475 calories there, a lot of fiber and it is easier to diet when you fill up. Barbara Rolls wrote a book on that called ``Volumetrics.'' Nutrition authorities disagree a lot but we all agree that more fruits and vegetables are healthy. That is my push with this book. We are going to meet with grocers to see if we can get increased emphasis on produce sales throughout the country. The National Cancer Institute has an Office of Five a Day for Better Health that we initiated in California that is working on this in partnership with us. Mr. Schrock. All of what you said is in here? Dr. Heber. Absolutely. Mr. Schrock. I had a boss a few years ago who used to eat garlic all the time. He looked great, smelled like the dickens but he said it was a very healthy thing for him. I understand that now. Dr. Heber. There is a lot of science on that and on green tea and other things. Mr. Schrock. I thank you all. You have been wonderful. We have learned a lot and I hope we can continue this discussion. This Member wants to get involved in this subject and if there is anything I can do to help you on Capital Hill, I want to be the person to do that. I probably have a better feel for good health than most Members. I want to be a part of that to make sure nobody else has to go through what I went through. If there is anything I can do to help you all, that is what I am here for. Again, thank you for being here. We have Dr. Coates and Dr. Dietz next. We have to do the obligatory swearing. [Witnesses sworn.] Mr. Schrock. Let the record reflect the witnesses responded in the affirmative. Thank you for being here. Our first speaker is Dr. Paul Coates, Director, Office of Dietary Supplements, National Institutes of Health. We are delighted to have you here. Our second speaker is Dr. William Dietz, Director, Division of Nutrition and Physical Activity, Centers for Disease Control and Prevention. STATEMENTS OF PAUL M. COATES, Ph.D., DIRECTOR, OFFICE OF DIETARY SUPPLEMENTS, NATIONAL INSTITUTES OF HEALTH; AND WILLIAM DIETZ, M.D., DIRECTOR, DIVISION OF NUTRITION AND PHYSICAL ACTIVITY, CENTERS FOR DISEASE CONTROL AND PREVENTION Dr. Coates. I appreciate the opportunity to discuss with you the activities of the Office of Dietary Supplements and to highlight the directions we have taken in developing good science in the field of dietary supplements. At the end of my testimony, I will also provide some comments about issues related to diet and chronic diseases as requested by the committee. Dietary supplements are widely used by American consumers often in combination with other lifestyle measures such as diet and physical activity for their potential benefits in health promotion and disease prevention. This potential has been realized when some supplement ingredients have been put to a true scientific test. I have provided examples of these in my written testimony. I will give one example here, folic acid in the prevention of neural tube defects. The positive effects of other ingredients, while promising and subjected to early scientific testing, have yet to be fully proven. Some of these are under active investigation in studies funded by the National Institutes of Health such as a study of Gingko biloba to prevent decline in cognitive function in older individuals. I want to remind folks that the Office of Dietary Supplements was authorized by DSHEA in 1994 and its mission is to identify and foster research on the health benefits and the risks of supplements based on the merit of the underlying scientific evidence. To meet this goal, ODS uses a number of mechanisms. A major one is that we fund a network of multidisciplinary botanical research centers around the country. These centers at the University of Illinois, Chicago; UCLA; University of Arizona; and Purdue University are jointly funded with the National Center for Complementary and Alternative Medicine or NCCAM with additional support coming from other components of the NIH. The National Institute of Environmental Health Sciences supports the activities of a related center at the University of Missouri. I am pleased to announce that as of yesterday, we added a new center at Iowa State University funded in collaboration with the NIEHS. Examples of other ongoing activities of the ODS are research training and career development, an important component in establishing new careers in the area of dietary supplement research. We also cofund grants and conferences with other NIH institutes and among our educational activities, we create fact sheets for consumers. The budget for ODS has grown substantially from approximately $3.5 million in 1999 to $17 million this year. This has permitted us to expand our research agenda into new and important areas including evidence-based reviews of dietary supplement efficacy and safety, development of improved tools to evaluate dietary supplement use in the population, a research agenda focused on ephedra and analytical science tools relevant to botanical ingredients. We have worked with partners in both the public and the private sectors to meet these goals. In my view, these collaborations within and outside the NIH demonstrate the strength of forging partnerships and in my opinion have been crucial to the advancement of science in this area of dietary supplements. You asked me to comment on our efforts related to ephedra. ODS and NCCAM recently funded an evidence report on the efficacy and safety of ephedra containing dietary supplements for weight loss and athletic performance. Our specific goal in sponsoring this report was to help us with the appropriate next research steps on this topic, a mandate called for in recent congressional report language supporting the ODS budget. This evidence report, still in draft form and under review by content experts, was developed by the RAND Southern California Evidence Based Practice Center, one of a network of such centers supported by the Agency for Health Care Research and Quality, a sister agency in HHS. This report systematically and objective assesses and analyzes the world's literature relevant to this topic, both published and unpublished. The final version of this report is expected to be released later this year but in the meantime, ODS has already begun to develop research initiatives for ephedra including the development and validation of analytical methods and standard reference materials and the evaluation of potential ephedra toxicity using animal models. In the last part of my testimony, I wanted to comment briefly on some issues related to the role of dietary and lifestyle interventions that may be involved in the prevention of or contribution to chronic disease. While this is somewhat outside the purview of the Office of Dietary Supplements, here are some comments I was able to gather from my colleagues at the National Institutes of Health. More details are given in my written testimony. The Dietary Guidelines for Americans, issued by the Departments of Agriculture and Health and Human Services in 2000, recommend a diet low in saturated fat and cholesterol and moderate in total fat as part of an overall healthy eating pattern. This healthy eating pattern needs to consist of a variety of foods including grains, fruits and vegetables. The Guidelines also point to the critical importance of maintaining a healthy weight and a physically active lifestyle. Balancing dietary intake with energy expenditure is crucial, given concerns about the rising epidemic of obesity and the increase in sedentary lifestyles in the United States. A large body of evidence, alluded to more than once in previous testimony, indicates that avoiding overweight, obesity, and adult weight gain is linked with reduced risk of several cancers as well as heart disease, hypertension, and Type II diabetes. Finally, I wanted to comment that the Departments of Health and Human Services and Agriculture have contracted with the Institute of Medicine to prepare a report on dietary reference intakes of macronutrients, specifically carbohydrates, proteins, and fats. This report, due to be released within the next several weeks, is expected to contain recommendations regarding adequate levels of intake, levels that may exert positive health benefits, as well as levels that may be associated with adverse health outcomes. I thank you again for inviting me and I would be happy to answer questions. [The prepared statement of Dr. Coates follows:] [GRAPHIC] [TIFF OMITTED] 81866.081 [GRAPHIC] [TIFF OMITTED] 81866.082 [GRAPHIC] [TIFF OMITTED] 81866.083 [GRAPHIC] [TIFF OMITTED] 81866.084 [GRAPHIC] [TIFF OMITTED] 81866.085 [GRAPHIC] [TIFF OMITTED] 81866.086 [GRAPHIC] [TIFF OMITTED] 81866.087 [GRAPHIC] [TIFF OMITTED] 81866.088 [GRAPHIC] [TIFF OMITTED] 81866.089 Mr. Schrock. Last but certainly not least is Dr. William Dietz, the Director, Division of Nutrition and Physical Activity, Centers for Disease Control and Prevention. We are delighted to have you here and would love to hear your testimony as well. Dr. Dietz. It is a pleasure to be here and I am grateful for the opportunity to address the risks of obesity and the scientific basis for diet and physical activity. You are already very familiar with the topic which I was invited to address, the burden and the costs of this disease. With your permission, I would like to abbreviate my comments and focus on a few points which I think deserve greater emphasis. You mentioned already the prevalence of obesity has increased substantially but the increases have been even greater in children and adolescents than they have been in adults. Between 1980 and 1994, the prevalence of obesity in children doubled and in adolescents it tripled. Over that same time period it only increased by about 50 percent in adults. Second, you mentioned the burden of disease attributable to obesity. I think diabetes which has been mentioned is a very pertinent example. This used to be a disease which was limited to adults and now we are seeing it in children and adolescents for the first time and in some communities, Type II diabetes accounts for almost half of all new cases of diabetes. This is in effect a new disease and there has been a recent report which suggests the morbidity associated with Type II diabetes in adolescents is worse than we previously have seen and is associated with early death, early blindness, early kidney failure. The other point I think is worth emphasizing is the contribution of childhood onset obesity which you have been very concerned about and I think appropriately so. We know from some data we published that over 60 percent of overweight 5 to 10 year olds already have one additional complication of obesity like elevated blood pressure, elevated lipid levels or elevated insulin levels and 25 percent of those 5 to 10 year old children have two or more. This is a disaster waiting to happen. We published data last month showing that hospitalization rates for obesity and its associated diagnoses in children tripled over a 20 year period. The costs from obesity in childhood also tripled. To me the gravest concern is that although childhood onset obesity only contributes about 25 percent of adult obesity, children who are overweight in early childhood tend to be the heaviest of adults. The mean BMI for a child who is overweight before 8 years of age is over 40 which means that as an adult they are 100 pounds or more overweight and therefore, more susceptible to the complications of adult disease. You are very familiar with the deaths and disabilities attributable to this, so I won't emphasize that except to say that State Medicaid costs already account for 20 percent of the average State's budget and the epidemic of obesity and its associated illnesses are going to drive those costs further. So in an era of shrinking State budgets and increased Medicaid costs, we are going to be confronting a very serious financial crisis. Paul mentioned the collaboration of NIH with other groups and we have been pleased to assist the Office of Dietary Supplements with a survey of non-prescription weight loss products by adults in five States. According to our data, 7 percent of adults reported they used an over the counter weight loss product in the past 2 years and 2 percent reported the use of phenylproponolimine and 1 percent the use of an ephedra product. I think this reflects the high level of concern on the part of the population about the need for effective weight control strategies and emphasizes the need to provide the public with very effective and safe weight loss strategies. However, the rapidity with which obesity has increased can only be explained by substantial changes in the environment that have served to modify calorie intake and energy expenditure. Effective control of this epidemic will require more information about the opportunities and barriers to physical activity and good nutrition and most importantly, the development of effective interventions. The size of the population that we are attempting to reach, 25 percent of the adult population, 15 percent of the pediatric population, indicate that we can't rely on individual behavior changes alone, that those must be augmented with broader, coordinated policy and environmental changes across multiple sectors that affect large numbers of people. We have made efforts to develop effective prevention and treatment strategies through our State obesity programs, the State coordinated school health programs, the youth media campaign, partnerships with other organizations and applied research agenda to develop and refine new approaches. We believe there are four strategies which can be implemented today to address the epidemic of obesity and its associated chronic diseases. These include physical activity, which includes physical education programs in schools, increased fruit and vegetable intake, control of TV time watched by children and breast feeding for all infants. There is recent data which suggests that breast fed infants have a lower risk of the subsequent development of obesity. In summary, as you pointed out, obesity in the United States is epidemic. The diseases caused by obesity are already increasing and are already contributing to increased health care costs. Our programs have begun to address the problem of obesity but are small and just beginning. Nonetheless, comprehensive nutrition and physical activity programs to prevent and treat obesity appear the most logical course for us to address this widespread problem. Thank you very much for the opportunity to talk with you about it. [The prepared statement of Dr. Dietz follows:] [GRAPHIC] [TIFF OMITTED] 81866.090 [GRAPHIC] [TIFF OMITTED] 81866.091 [GRAPHIC] [TIFF OMITTED] 81866.092 [GRAPHIC] [TIFF OMITTED] 81866.093 [GRAPHIC] [TIFF OMITTED] 81866.094 [GRAPHIC] [TIFF OMITTED] 81866.095 [GRAPHIC] [TIFF OMITTED] 81866.096 [GRAPHIC] [TIFF OMITTED] 81866.097 Mr. Schrock. Thank you very much. Fascinating. Dr. Coates, first of all, thank you for what you do at NIH. I think this Federal Government is finally realizing we need to do more there and I know the budget increased last year. We need to continue doing that because what you do there has such an impact on every other segment of society that we need to continue funding that. I am not going to ask you for name brands but everybody is on a weight loss program. What is the best kind of weight loss program? My wife, who is gorgeous anyhow, is now 32 pounds lighter because she has lost 32 pounds on her way to 35 on Weight Watchers. It really does the trick but is that a permanent solution or what? How do people get it off and keep it off? Dr. Coates. I can make a couple of brief comments and perhaps Dr. Dietz would be able to expand on it. Thank you for your comments about the NIH. I wish I could take credit for the broad swath of advances made there but I am very pleased to be a part of an organization that has this kind of reputation. It is a very exciting place to work, I assure you. In terms of weight loss programs, I think it was alluded to a little earlier that a great many weight loss programs can work in the early phases. The trick is to be able to sustain the weight management and if necessary the continued weight loss, whether it is possible to continue to take off weight. There are a lot of programs out there. There are some that have been well designed, well tested. Sometimes you cannot distinguish between the ones that have been well designed and tested from the ones that might not have. I think it is fair to say that consumers are in a position where they have to make choices among a great many things. It is not always easy to do that. Do you have any further wisdom on that? Dr. Dietz. I completely agree there are a lot of approaches to taking off weight but the key is sustaining those losses. There is an interesting weight loss registry that exists in Pittsburgh, a national registry, that consists of people who have lost 60 pounds and kept it off for a year. There are four strategies that appear to be successful in maintaining weight loss. The first is eating breakfast; the second is monitoring weight at least on a weekly basis; third is a reduced fat diet; and fourth is physical activity, about a hour of moderate physical activity daily. Those strategies appear to be uniform across the people who have lost substantial amounts of weight and sustained it. Mr. Schrock. I am not so sure my wife would be happy about me talking about that but those are the four things she has done and it really does work. Dr. Coates, as I get closer to being a senior citizen, it is said that they often absorb less nutrition from their food and you kind of wonder why it wouldn't be important for seniors to do more supplemental food type things. Every time I am in one of those food supplement stores, I am the oldest guy there. They are usually young ladies trying to keep thin and guys who want to bulk up, and the young but not senior citizens. Wouldn't that be a good thing for them? Dr. Coates. I agree with you on that. Indeed, one of the items I referred in my written testimony was that supplementation with Vitamin B12 is an effective strategy, particularly among the elderly because of the decreased ability to absorb B12 from food. I think we are really just beginning to understand some of those issues. B12 is a signal example. Our colleagues in the National Institute on Aging and we are sponsoring a conference on this issue about dietary supplement use in the elderly to be held at the NIH early next year. In part, this was driven by the good sense at the NIH that this was an area that needed developing, but you probably also remember that Senator Breaux from Louisiana held a hearing last year I believe on September 10 on the issue of dietary supplement use in the elderly. So there is clearly a lot of concern and enthusiasm at the same time for the potential for dietary supplement use in the elderly. We just don't understand enough of the need there. Mr. Schrock. Isn't a lot of it genetics? My dad will be 89 in a couple of weeks and honestly I go out to California and I come back exhausted just trying to keep up with him and others half his age look like they are twice his age. Dr. Coates. You can argue if it were that genetic that you would be the same but I think there are differences among people. There is an unknown proportion of this sort of thing that is under genetic control and it is probably true for all of these issues. Maybe there are some common themes that run through them. I don't actually know that is true but we would be always looking for those interactions between genes and the environment, where in this case the environment would be nutrition or dietary supplements. Mr. Schrock. Dr. Dietz, you made a comment that was interesting. All of a sudden we are really concerned about the increase in childhood diabetes. Why? When I was a kid, I don't remember it at all. Now, it is a big deal. We have friends who have kids that have it. I never heard about that when I was growing up. Dr. Dietz. It is driven by obesity, 80 to 90 percent of the Type II diabetes in children and adolescents is attributable directly to obesity. There is a strong family history in those kids that it is the obesity which brings it on. Mr. Schrock. I never would have thought that. What role is the CDC playing in the President's new initiative on physical fitness? Are you integrally involved? Dr. Dietz. Yes, we very much are. We helped write the document that came out and in my division there is a Physical Activity and Health Branch which in the last administration helped put together the President's report on physical fitness or I think it was entitled, ``Physical Activity in Youth.'' We are part of the co-lead with the President's Council on Physical Fitness and Sports for drafting the Healthy People 2010 Guidelines and are actively pursuing revisions in the recommendations around physical activity. For example, our questions and surveillance only ask about leisuretime physical activity and neglecting the potential for physical activity at work. So we are involved both in terms of assessing the problem, developing recommendations and implementing those both within communities and within States. Mr. Schrock. It is not a bad thing to see the President in a workout environment, working with weights and things. I think that sends a strong message. Dr. Dietz. Yes. He is a wonderful model. In some respects though I think what the President is doing may have exactly the opposite effect because I think a lot of people see the President running and doing 7 minute miles which is extraordinary and just dismiss it, they say I can't do that. The message we try to send is you don't have to be a marathoner to have an improvement in your health as a result of physical fitness. Mr. Schrock. That is right. Schools, can they have an impact on this and how? Dr. Dietz. Absolutely. We recently published a chapter for a document known as the Guide to Community Preventive Services which is an evidence based document much the same type of analysis that physicians rely on when they prescribe a specific drug for a specific problem. One of the recommendations in that chapter was the importance of physical education as a documented way to increase physical activity in children and adolescents. In an era when parents are increasingly concerned about safety and neighborhoods are increasingly less safe for children and adolescents, schools represent one of the last safe places for children to be physically active, not only within school but one of the programs we are working on which is turning out to be quite popular in communities is the Kids Walk to School Program. When I was young, I walked to school regularly. In fact, 80 to 90 percent of adults today walked regularly to school. Today, less than one-third of children walk to school. In part, that is because they lack safe routes and in part, it is because communities lack sidewalks and part is the absence of neighborhood schools. Walking to school is one of the ways that children could build physical activity routinely into their day because they have to get to school. If they have a safe route to walk to school, that is a ready made opportunity for physical activity. Mr. Schrock. I walked to school. I would grouse about it and my dad would say, when I was your age I used to walk 5 miles uphill to get to school and 5 miles uphill to get home and I bought that for a long time but that is true. That is one thing my wife does, she walks several miles every day and she wears a thing on her hip and that is an incentive to see how high she can get that thing. Faith based initiatives and issues have kind of taken hold in the last few years. I am wondering if there is a role for those kinds of organizations in promoting physical fitness in communities and if there are funds available for that sort of thing? Dr. Dietz. It is a very important opportunity and churches have played a major role and there are well documented studies. For example, in North Carolina church based initiatives can change fruit and vegetable consumption and change physical activity levels. I think with appropriate funding that is an important opportunity. Mr. Schrock. Let me recognize the real chairman, Chairman Burton. Mr. Burton. I want to apologize for not being here. As I said earlier, this is the last day, today and tomorrow, of the session before the break and we have been working on homeland security. We have been down there fighting over that and what kind of amendments are going to be and so forth. I have a couple of amendments for the floor tomorrow, so I apologize for not being here. One of the things that concerns me about the first panel, Ms. Ladd, she mentioned the Food and Drug Administration about some alternative and complementary therapies that were used involving supplements and she said they literally laughed at them and said, we don't buy that supplement theory and that sort of thing, words to that effect. Do you find there is a mindset in any of our agencies, FDA, HHS, or CDC, that would indicate that complementary and alternative therapies and dietary supplements are not worth a darned? Dr. Dietz. That is certainly not true at the CDC. She mentioned the CDC as the place she called and was greeted with guffaws and laughter. I was embarrassed to hear that, first, because I think that certainly is not the way my division treats callers and second, because it is the agency I work for and I am quite proud of it. We think there is a very important role for dietary supplements and weight loss supplements. As I mentioned earlier, we have been pleased to assist the NIH in transferring funds to South Carolina to explore the frequency of usage of these products. Mr. Burton. Have any of the agencies, including CDC, had any extensive studies on how supplements affect different diseases? Have there been any double blind studies 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? Have there been double blind studies you know of that deal with that? Dr. Coates. On behalf of the NIH--because it is generally more likely that those kind of clinical trial studies would emerge from the National Institutes of Health--while I didn't go into any detail in my oral testimony, I did provide some examples in my written testimony of ongoing and some finished studies that have looked at these sorts of things where people are randomized to a treatment group and to a placebo group and the questions asked are how effective is it, how safe is it? So examples of ongoing trials using NIH funds are on Gingko biloba for the prevention of cognitive decline in older individuals, Echinacea to look at the possibility of prevention of colds in children, either prevention or the severity of colds. So there are a number of these studies. We think this is the right way to do this kind of evaluation so that we can send good messages to consumers about issues related to efficacy. Mr. Burton. Have you done any studies on any of the approaches to medicine that are age old like in China where you use acupuncture and other things? Are they doing studies on that? Dr. Coates. I won't speak for my colleagues in NCCAM or the other Institutes, but I do know because we have some areas of common interest with NCCAM that they are actively pursuing these kinds of things, addressing frontier kinds of medicine or age-old traditional medical approaches and trying to evaluate them in the context in which they are being used in the United States, which in some instances is quite different from the traditional ones. Mr. Burton. We have had a number of hearings on the health care industry and our government agencies, as well as supplements and alternative therapies and that sort of thing. One feels sometimes that the pharmaceutical industry has a tremendous amount of influence because of the grants they help with and other things they do in conjunction with our health agencies. Do you ever feel like sometimes our health agencies are in some way being manipulated or controlled by the pharmaceutical industry? Dr. Coates. I don't have an opinion on that. I don't observe it as part of my regular work. I don't know. Mr. Burton. But you do know that sometimes people come from the pharmaceutical industry and come into government work and work in the various health agencies and vice versa, people that work in the health agencies will leave and go to work for the pharmaceutical companies with very lucrative jobs. Dr. Coates. I certainly have seen people moving back and forth, yes. Mr. Burton. And that would have some influence I think on some people? Dr. Coates. It might, I don't have an opinion on that. Mr. Burton. OK. You are being very political. There was a letter published in the Journal of American Medical Association last week from Dr. Wayne Jonas about a St. John's Wort study. Are you familiar with that letter? Dr. Coates. I saw the letter, yes, I did. Mr. Burton. What did you think of that? Dr. Coates. It is a very reasoned approach. There are issues about trial design that always come up. I think he alluded in his letter to the fact that the recent funded St. John's Wort study in the population that was studied did not demonstrate any effectiveness of either St. John's Wort or the active drug in reducing the impact of depression in this population. Part of his comment was that the placebo effect is increasingly a complexity of depression oriented trials. I don't know how much weight that has but it was certainly something that others commented on. Mr. Burton. Was that study flawed, do you think? Dr. Coates. Studies, if they don't come up with the answer that a person wants, that person could think it is flawed. If they don't come up with an answer at all, you do begin to question whether there was something about the design or the followup that may have complicated the interpretation of those results. At this point, I can't say. Mr. Burton. The staff says they studied 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? I think right on the bottle it says it is not for major depression and yet they did include that in the study. Dr. Coates. The study population was called major depression of moderate severity. These are terms that I am not aware everybody can agree on. As an example, this is my understanding, I am somewhat peripheral to this argument, but in some European studies of St. John's Wort, the criteria that were used to enter patients into studies were similar to or maybe not very dissimilar from the criteria used to enter patients to this recently completed St. John's Wort study. That the populations might be called something different could be a function of how we define depressive disorders in the United States as opposed to their definition somewhere else. I am not trying to take the fifth on this, I am trying to help to understand why there might be some differences. I think it is true that this population had some measures of depression that would be considered more severe than people would have been interested in seeing. Just as an aside, we in the Office of Dietary Supplements along with NCCAM and the National Institute of Mental Health are mounting a follow-on study in a population that will be defined in a somewhat different way but will carry the diagnosis of minor depression. It is a tricky diagnosis to make and I think that may have also contributed some to the final results. Mr. Burton. You know what the DSHEA law is? Mr. Coates. Yes. Mr. Burton. What do you think about that? Dr. Coates. The law was passed in 1994, enacting among other things the Office of Dietary Supplements. It asked for us to provide a scientific basis, scientific support to better inform the American people about the benefits and the risks of dietary supplements, to give people the best information possible. That is my interpretation of DSHEA. It is how it affects me directly and my office. Mr. Burton. Do you think that the people at our health agencies, HHS and CDC and FDA, feel Congress overstepped its bounds in passing the DSHEA law? Dr. Coates. I can't speak for others. Mr. Burton. How about you? Dr. Coates. I think this is a law that presented a very worthy opportunity and in 1994, it was an excellent piece of legislation to try to deal with an emerging area of use in the population. I think--this is a personal opinion for which nobody else should take blame or credit--that it is not a bad idea periodically to reexamine where we are with a piece of legislation. I am not a legislator so I can say that. Mr. Burton. What do you think about today, 8 years later? Dr. Coates. I think we have demonstrated that there is plenty of room for the use of dietary supplements in a host of different conditions. I also think that people in some sectors have used it as an opportunity to be able to market in an area that was beyond what was intended by DSHEA. If DSHEA was intended to provide products that people could use for health promotion, then it is perhaps a stretch to market products for disease treatment. Mr. Burton. Such as obesity, like ephedra? Dr. Coates. That is a tricky one, sir. Mr. Burton. The reason I bring up ephedra is because the ephedra issue, we have had some discussions with people in our health agencies and a lot of companies have used synthetic ephedra and it has caused severe problems. Non-synthetic ephedra when used in proper doses as shown on the bottle and the inserts has minimal side effects. There was a study done by Harvard and Columbia Universities which I believe has been published now in the International Journal of Obesity and they tried to get it published in some others but they ran into some problems. That study which we have looked at pretty thoroughly showed it wasn't a big problem. I know that our health agencies are doing another study on that right now. You are managing that study now? Dr. Coates. The Office of Dietary Supplements and the National Center for Complementary and Alternative Medicine sponsored the development of an evidence report by the RAND Corp. They do that under contract to AHRQ. Mr. Burton. That is going on right now. Dr. Coates. That is going on now. Mr. Burton. Do you think the study that was done and published that came out of Columbia and Harvard was flawed? Why are we seeing another study being done? I am just curious. Dr. Coates. This was one of the very first randomized, clinical control trials of an ephedra-containing and caffeine- containing product used for weight management or weight loss, one of the very first randomized placebo-controlled trials. So it is significant that it was. As is true of most studies like this, it was done in a population of very-well defined and characterized subjects in whom potential risk factors for the development of some side effects were excluded. That is a good thing. You don't wish to embark on a clinical trial for weight loss where you put subjects at increased risk. So what I would say is, on the basis of that study, the results are promising but the results of that trial relate to a population so described, monitored carefully over 6 months. Over 6 months they experienced weight loss that was comparable to weight loss that could have been obtained through other pharmacologic means. That is encouraging. It was also encouraging that there were no evidence safety problems. I have to keep reminding myself that in the context of a randomized control trial, your job is to do the very best you can to monitor and prevent potential side effects in a population like that. Therefore, I think we have to limit our enthusiasm. I limit my enthusiasm for the results of the study to a similarly described population and would need to have more information in order to be certain that people who are using this in the context of weight loss in their communities, walk into a store and buy it, they are not being monitored by a physician. Remember this randomized control trial was done under the control of a number of physicians. It is a somewhat different circumstance. We should be encouraged but I also maintain some caution. Mr. Burton. Individuals buy aspirin and all kinds of products and if they don't read the label, and I have been guilty of that from time to time, taking more things than I should have or less and finding out they didn't work. I am talking about pharmacological products. Dr. Coates. I agree with you. Mr. Burton. So we can't control everything a human being does. They have to be responsible themselves and if there is a dietary supplement or a prescription drug, they have to read what they are supposed to do or else they put themselves at risk. That study, as you said, didn't appear to be flawed and we hope when the results of the study you are doing come out, it isn't skewed in such a way that it is designed to change the outcome specifically because they want to see us move toward pharmacological products instead of natural products like natural ephedra. Dr. Coates. I will make one reminder, sir. We commissioned that report because we wanted to determine what the next research steps needed to be in terms of ephedra. Mr. Burton. Not to discredit the other report? Dr. Coates. Not at all. In fact, the Boozer study to which you referred and published in the International Journal of Obesity is one of the studies being systematically reviewed in the report that is being developed by the RAND Corp. To clarify one thing, this is not a brand new clinical study, this is a meta-analysis of existing studies that relate to ephedra efficacy and safety. Mr. Burton. Let me end by saying I hope the health agencies continue to look at alternative and complementary therapies as well as dietary supplements as a help to people to help cut down the overall cost of medical care and the cost to the government for medical care. I hope there is not an attempt to circumvent or change the DSHEA law. If there is need to change the law, people like you who have expertise I hope will come to the U.S. Congress and talk to laymen like me who have been interested in the subject for a long time and explain why there is a need to change that so we can try to work together to get that done in a way that is very responsible. We have an awful lot of jobs and people who make their living in the private sector through the supplement industry. I believe the supplement industry has helped a great deal as far as health is concerned. So I hope we have a good working relationship and that if there is need for change, it is done in the proper way and not with our health agencies trying to circumvent what Congress decided. Dr. Coates. I would be pleased to talk with you in more detail about that at your request. We have also found that the dietary supplement industry has been a valuable partner in trying to move forward research activities, that they have not interfered with our activities, they try to be effective partners with us in some aspects of those things where they really do have expertise. Mr. Burton. Beth just told me that we have not yet fully implemented or health agencies have not yet fully implemented the DSHEA law and until that is done, we probably wouldn't be of a mind to change it anyhow but once it is completely implemented, if there is flaws, we will try to get those corrected. Mr. Schrock. Thank you, Mr. Chairman. Thank you for your testimony and the discussion. It has been very helpful. I think this whole day has been helpful because this is an issue that should be important to every single Member of Congress, every single staff member because it impacts so much of what we do up here. Mr. Burton. I don't know if you were here earlier. My wife died of metastatic colon cancer on May 10. One of the things I hope our health agencies will do has nothing to do with the present subject, is to illuminate the need for people above 40 or 50 to have colonoscopies and other preventative measures to prevent death or severe health problems. Had my wife's doctor told her to get a colonoscopy, she would be here today. I am convinced of that. They didn't. When she started having some minor symptoms, they just gave her pills. I am not so sure the medical profession, all of them, are aware of how important things like colonoscopies are. So if our health agencies could send out a circular when you do a mailing or whatever you do to inform the AMA or doctors, tell them how important some of these preventive measures are, it would be appreciated by not only me but I am sure thousands across the country that might be saved because of that. You guys can do a lot in addition to making sure we get the right prescriptions and the right drugs to make sure people are informed about how important preventive measures like colonoscopy are. Mr. Schrock. I agree with that. I wish we could somehow legislate people to get physicals every year. I hate to say it, but the male is worse than anybody else. We need to make sure we do that. You heard his story. Mine was caught early. I am blessed it was but so many times it gets so far down the pike, there is nothing you can do about it. Thank you very much for your testimony. Thank you for being here. This hearing is now adjourned. [Whereupon, at 3:09 p.m., the committee was adjourned, to reconvene at the call of the Chair.] [The prepared statements of Hon. Henry A. Waxman, Hon. Edolphus Towns, and Hon. Carolyn B. 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