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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

(II)

COMMITTEE ON GOVERNMENT REFORM

DAN BURTON, Indiana, Chairman

BENJAMIN A. GILMAN, New York

CONSTANCE A. MORELLA, Maryland

CHRISTOPHER SHAYS, Connecticut

ILEANA ROS-LEHTINEN, Florida

JOHN M. MCHUGH, New York

STEPHEN HORN, California

JOHN L. MICA, Florida

THOMAS M. DAVIS, Virginia

MARK E. SOUDER, Indiana

STEVEN C. LATOURETTE, Ohio

BOB BARR, Georgia

DAN MILLER, Florida

DOUG OSE, California

RON LEWIS, Kentucky

JO ANN DAVIS, Virginia

TODD RUSSELL PLATTS, Pennsylvania

DAVE WELDON, Florida

CHRIS CANNON, Utah

ADAM H. PUTNAM, Florida

C.L. ‘‘BUTCH’’ OTTER, Idaho

EDWARD L. SCHROCK, Virginia

JOHN J. DUNCAN, JR., Tennessee

JOHN SULLIVAN, Oklahoma

HENRY A. WAXMAN, California

TOM LANTOS, California

MAJOR R. OWENS, New York

EDOLPHUS TOWNS, New York

PAUL E. KANJORSKI, Pennsylvania

PATSY T. MINK, Hawaii

CAROLYN B. MALONEY, New York

ELEANOR HOLMES NORTON, Washington,

DC

ELIJAH E. CUMMINGS, Maryland

DENNIS J. KUCINICH, Ohio

ROD R. BLAGOJEVICH, Illinois

DANNY K. DAVIS, Illinois

JOHN F. TIERNEY, Massachusetts

JIM TURNER, Texas

THOMAS H. ALLEN, Maine

JANICE D. SCHAKOWSKY, Illinois

WM. LACY CLAY, Missouri

DIANE E. WATSON, California

STEPHEN F. LYNCH, Massachusetts

———

BERNARD SANDERS, Vermont

(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

(III)

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

(1)

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.

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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 expendi- tures 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 adVerDate 11-MAY-2000 10:08 Oct 09, 2002 Jkt 000000 PO 00000 Frm 00006 Fmt 6633 Sfmt 6633 C:\DOCS\81866.TXT HGOVREF1 PsN: HGOVREF1
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junct 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 lowfat and plant-based diet, moderate physical activity, stress management, and dietary supplements. This approach has been shown to

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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

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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:]

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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.

20

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:]

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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

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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

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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 31⁄2 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

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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 121⁄2 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 killVerDate 11-MAY-2000 10:08 Oct 09, 2002 Jkt 000000 PO 00000 Frm 00038 Fmt 6633 Sfmt 6633 C:\DOCS\81866.TXT HGOVREF1 PsN: HGOVREF1
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er. He was almost hysterical. I said, I don’t know, go take your xrays 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

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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.

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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:]

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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

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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.

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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

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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,

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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.

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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

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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

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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.

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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 auVerDate 11-MAY-2000 10:08 Oct 09, 2002 Jkt 000000 PO 00000 Frm 00064 Fmt 6633 Sfmt 6633 C:\DOCS\81866.TXT HGOVREF1 PsN: HGOVREF1
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thorized 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 in- takes 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 suppleVerDate 11-MAY-2000 10:08 Oct 09, 2002 Jkt 000000 PO 00000 Frm 00065 Fmt 6633 Sfmt 6633 C:\DOCS\81866.TXT HGOVREF1 PsN: HGOVREF1
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ments. 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:]

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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.

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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:]

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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,

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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.

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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:]

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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

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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.

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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 intraabdominal 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?

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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:]

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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.

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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

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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.

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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:]

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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

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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, twothirds 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 seVerDate 11-MAY-2000 10:08 Oct 09, 2002 Jkt 000000 PO 00000 Frm 00113 Fmt 6633 Sfmt 6633 C:\DOCS\81866.TXT HGOVREF1 PsN: HGOVREF1
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lectively 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

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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:]

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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.

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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.

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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

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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.

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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.

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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

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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

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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:]

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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

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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:]

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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

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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

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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.

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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

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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 someVerDate 11-MAY-2000 10:08 Oct 09, 2002 Jkt 000000 PO 00000 Frm 00157 Fmt 6633 Sfmt 6633 C:\DOCS\81866.TXT HGOVREF1 PsN: HGOVREF1
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what 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

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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.

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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

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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. Maloney, and additional information submitted for the hearing record follow:]

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