[House Hearing, 108 Congress]
[From the U.S. Government Publishing Office]
DIETARY SUPPLEMENTS: NATURE'S ANSWER TO COST EFFECTIVE PREVENTATIVE
MEDICINE
=======================================================================
HEARING
before the
SUBCOMMITTEE ON HUMAN RIGHTS AND WELLNESS
of the
COMMITTEE ON
GOVERNMENT REFORM
HOUSE OF REPRESENTATIVES
ONE HUNDRED EIGHTH CONGRESS
SECOND SESSION
__________
SEPTEMBER 22, 2004
__________
Serial No. 108-270
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
__________
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COMMITTEE ON GOVERNMENT REFORM
TOM DAVIS, Virginia, Chairman
DAN BURTON, Indiana HENRY A. WAXMAN, California
CHRISTOPHER SHAYS, Connecticut TOM LANTOS, California
ILEANA ROS-LEHTINEN, Florida MAJOR R. OWENS, New York
JOHN M. McHUGH, New York EDOLPHUS TOWNS, New York
JOHN L. MICA, Florida PAUL E. KANJORSKI, Pennsylvania
MARK E. SOUDER, Indiana CAROLYN B. MALONEY, New York
STEVEN C. LaTOURETTE, Ohio ELIJAH E. CUMMINGS, Maryland
DOUG OSE, California DENNIS J. KUCINICH, Ohio
RON LEWIS, Kentucky DANNY K. DAVIS, Illinois
TODD RUSSELL PLATTS, Pennsylvania JOHN F. TIERNEY, Massachusetts
CHRIS CANNON, Utah WM. LACY CLAY, Missouri
ADAM H. PUTNAM, Florida DIANE E. WATSON, California
EDWARD L. SCHROCK, Virginia STEPHEN F. LYNCH, Massachusetts
JOHN J. DUNCAN, Jr., Tennessee CHRIS VAN HOLLEN, Maryland
NATHAN DEAL, Georgia LINDA T. SANCHEZ, California
CANDICE S. MILLER, Michigan C.A. ``DUTCH'' RUPPERSBERGER,
TIM MURPHY, Pennsylvania Maryland
MICHAEL R. TURNER, Ohio ELEANOR HOLMES NORTON, District of
JOHN R. CARTER, Texas Columbia
MARSHA BLACKBURN, Tennessee JIM COOPER, Tennessee
PATRICK J. TIBERI, Ohio BETTY McCOLLUM, Minnesota
KATHERINE HARRIS, Florida ------
------ ------ BERNARD SANDERS, Vermont
(Independent)
Melissa Wojciak, Staff Director
David Marin, Deputy Staff Director/Communications Director
Rob Borden, Parliamentarian
Teresa Austin, Chief Clerk
Phil Barnet, Minority Chief of Staff/Chief Counsel
Subcommittee on Human Rights and Wellness
DAN BURTON, Indiana, Chairman
CHRIS CANNON, Utah DIANE E. WATSON, California
CHRISTOPHER SHAYS, Connecticut BERNARD SANDERS, Vermont
ILEANA ROS-LEHTINEN, Florida (Independent)
ELIJAH E. CUMMINGS, Maryland
Ex Officio
TOM DAVIS, Virginia HENRY A. WAXMAN, California
Mark Walker, Chief of Staff
Mindi Walker, Professional Staff Member
Danielle Perraut, Clerk
Richard Butcher, Minority Professional Staff Member
C O N T E N T S
----------
Page
Hearing held on September 22, 2004............................... 1
Statement of:
Coates, Paul, Ph.D., Director, Office of Dietary Supplements,
National Institutes of Health, U.S. Department of Health
and Human Services......................................... 9
Dobson, Allen, Ph.D., senior vice president, the Lewin Group;
Jeffrey Blumberg, Ph.D., professor, Friedman School of
Nutrition Science and Policy, Tufts University; Barbara
Levine, R.D, Ph.D., associate professor of nutrition in
medicine, Weill College of Medicine; Elliott Balbert,
president, Dietary Supplements Education Alliance; and
Marilu Henner, actress, nutrition and diet expert.......... 22
Letters, statements, etc., submitted for the record by:
Balbert, Elliott, president, Dietary Supplements Education
Alliance, prepared statement of............................ 59
Blumberg, Jeffrey, Ph.D., professor, Friedman School of
Nutrition Science and Policy, Tufts University, prepared
statement of............................................... 42
Burton, Hon. Dan, a Representative in Congress from the State
of Indiana, prepared statement of.......................... 4
Coates, Paul, Ph.D., Director, Office of Dietary Supplements,
National Institutes of Health, U.S. Department of Health
and Human Services, prepared statement of.................. 12
Dobson, Allen, Ph.D., senior vice president, the Lewin Group,
prepared statement of...................................... 24
Henner, Marilu, actress, nutrition and diet expert, prepared
statement of............................................... 65
Levine, Barbara, R.D, Ph.D., associate professor of nutrition
in medicine, Weill College of Medicine, prepared statement
of......................................................... 50
DIETARY SUPPLEMENTS: NATURE'S ANSWER TO COST EFFECTIVE PREVENTATIVE
MEDICINE
----------
WEDNESDAY, SEPTEMBER 22, 2004
House of Representatives,
Subcommittee on Human Rights and Wellness,
Committee on Government Reform,
Washington, DC.
The subcommittee met, pursuant to notice, at 10:10 a.m., in
room 2154, Rayburn House Office Building, Hon. Dan Burton
(chairman of the subcommittee) presiding.
Present: Representatives Burton and Watson.
Staff present: Mark Walker, chief of staff; Mindi Walker,
Brian Fauls, and Dan Getz, professional staff members; Nick
Mutton, press secretary; Danielle Perraut, clerk; Sarah
Despres, minority counsel; Richard Butcher, minority
professional staff member; and Cecelia Morton, minority office
manager.
Mr. Burton. Good morning. A quorum being present, the
Subcommittee on Human Rights and Wellness will come to order. I
ask unanimous consent that all Members and witnesses' written
and opening statements be included in the record. And without
objection, so ordered.
I ask unanimous consent that all articles, exhibits, and
extraneous or tabular materials referred to be included in the
record. Without objection, so ordered.
In the event of other Members attending the hearing, I ask
unanimous consent that they be permitted to serve as a member
of the subcommittee for today's hearing. And without objection,
so ordered.
We have other Members that will be coming very shortly, Ms.
Watson in particular. And for those who aren't here, they will
get transcripts of the hearing.
I, along with millions of Americans, firmly believe that
dietary supplements have been shown through credible scientific
research and historical use to be of immeasurable benefit to
human health.
As a regular consumer, I know firsthand the health benefits
of using dietary supplements on a daily basis. Consequently I
proudly serve as cochairman of the Congressional Complementary
and Alternative Medicine Caucus, the CAM Caucus, along with my
colleague, Representative Dennis Kucinich of Ohio, in the
House, and Senators Orrin Hatch of Utah in the Senate, and Tom
Harkin of Iowa in the Senate. They have been true champions on
these issues for some time.
Together we have worked hard, in a bipartisan fashion, for
the continued research and safety of all dietary supplements
manufactured and sold in the United States. It remains our top
priority to ensure that only the highest quality of products
are made available to the American consumers.
Given my role as cochairman of the CAM Caucus, as well as
my duties as chairman of the Subcommittee on Human Rights and
Wellness, I am particularly concerned about how these products
can be used as preventatives, and preventative measures, to
combat the multitude of life-threatening and debilitating
medical conditions like cardiovascular disease, cancer,
osteoporosis, and even preventable birth defects in infants.
The subcommittee has invited some of the foremost experts
on nutrition to discuss the proven health benefits of regular
supplement usage. Dr. Jeffrey Blumberg, professor at the
Friedman School of Nutrition Science and Policy at Tufts
University is with us today to explain the role of folic acid
and other dietary supplements in the promotion of health and
prevention of chronic diseases.
The subcommittee also has the pleasure of hearing testimony
from Dr. Barbara Levine, an associate professor of nutrition
and medicine at the Weill College of Medicine at Cornell
University, who will discuss two of the nutrients she has
studied for a majority of her career, Omega-3 fatty acids and
calcium. Dr. Levine will also explain how those two nutrients
are needed throughout the entire life cycle in the development
and growth of the human body, in addition to their use for
prevention and treatment of a variety of diseases.
In addition to the scientifically proven health benefits of
using dietary supplements correctly to promote a healthier
lifestyle and curb disease, these products can also offer
substantial cost savings for our long-term national health care
expenditures. And that is one of the things that isn't talked
about enough.
During our hearing today a new study will be released
regarding the cost savings of dietary supplements on the U.S.
health care system. Dr. Allen Dobson, senior vice president of
the Levin Group, an independent health care consulting firm, is
here with us today to discuss the conclusions of his study,
which demonstrates that certain supplements provide an
inexpensive and safe way to improve overall personal health and
reduce health care expenditures.
A recent report published by the Institute of Medicine
[IOM], estimates that American consumers spend over $18 billion
annually on the over 29,000 supplements sold in the United
States. In 1994, Congress passed, and the President signed into
law, the Dietary Supplement Health Education Act [DSHEA]. DSHEA
prescribes the framework for how the Federal Government ensures
the safety and the efficacy of dietary supplements sold in the
United States.
Prior to DSHEA, dietary supplements were treated and
regulated as traditional food products. Seeing a need for the
Federal Government to address the American consumer's growing
interest in dietary products, in conjunction with public
safety, Congress overwhelming passed this legislation to make
certain that all dietary health products sold in the United
States are held to the highest and most stringent quality
standards.
DSHEA ensures the safety of dietary supplements by
requiring manufactures to follow standards called good
manufacturing practices [GMPs]. Essentially all ingredients in
supplements sold in the United States must be previously
approved by the Food and Drug Administration and listed on the
products bottle label. In addition, distributors must follow
strict guidelines on all claims that are made in regard to a
particular product. This ensures consumers are equipped with
the most accurate information regarding their supplements.
Dr. Paul Coates, the Director of the Office of Dietary
Supplements at the National Institutes of Health [NIH], is here
to talk about the Federal Government's research into dietary
supplements and how these products have been shown to provide
for a healthier lifestyle both in children and in adults.
In addition, Mr. Elliott Balbert, the president of the
Dietary Supplement Education Alliance, will be testifying
before the subcommittee to discuss the supplement industry's
efforts and continued support for the overwhelming need to
ensure that consumers have access to balanced, science-based
facts about dietary supplements.
And, finally, we have the distinct pleasure of having a
distinguished star of the stage and screen, whom I think is
beautiful and have admired her for a long, long time,
testifying before our subcommittee today. I saw her in Taxi a
long time ago, and she looks so young, it just doesn't seem
possible. Marilu Henner is here to talk about her personal
experiences using dietary supplements in attaining and
maintaining optimal health. Ms. Henner has not only personally
benefited from supplement usage, but has also served as a
health advocate, and is the author of six books on how to live
a healthier lifestyle.
Whether taking a multivitamin, herbal product or a
specialty supplement, people can and do live healthier lives
and save money in long-term health care costs by supplementing
their diets.
I would like to thank all of our witnesses for their
participation in this hearing, and I look forward to hearing
their testimony.
[The prepared statement of Hon. Dan Burton follows:]
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Mr. Burton. With that, we will start with Dr. Coates.
Dr. Coates, if you would come forward and stand so I can
swear you in, please.
[Witness sworn.]
Mr. Burton. Do you have an opening statement, Doctor?
Mr. Coates. I do.
Mr. Burton. If we could, I would like to try to admonish
the witnesses to try to keep their statements to 5 minutes so
we would have more time for questions if possible.
STATEMENT OF PAUL COATES, Ph.D., DIRECTOR, OFFICE OF DIETARY
SUPPLEMENTS, NATIONAL INSTITUTES OF HEALTH, U.S. DEPARTMENT OF
HEALTH AND HUMAN SERVICES
Mr. Coates. Thank you very much. Mr. Chairman, I am Paul
Coates. I direct the Office of Dietary Supplements at the
National Institutes of Health. I appreciate the opportunity to
appear before you today to talk about NIH efforts and research
on dietary supplements.
I appeared before this committee 2 years ago to give you
details about some key NIH initiatives and to highlight the
opportunities as well as the challenges associated with
developing strong science in the field of dietary supplements.
These are products that are used widely by American consumers
for their potential health benefits, often in combination with
other lifestyle measures such as diet and physical activity.
Their potential to improve health and to prevent disease has
been realized when some have been put to modern scientific
testing. Clear examples of this are folic acid, in the
prevention of neural tube defects, and calcium to reduce the
risk of osteoporosis.
It is important to keep in mind, though, that others have
not undergone rigorous scientific testing to establish their
efficacy and safety. Some are currently under active
investigation at the NIH, as I will mention in a moment.
In the preamble, or in the invitation, you identified five
supplements as being of particular interest today: folate,
calcium, omega-3 fatty acids, glucosamine, and saw palmetto. I
would like to give you a snapshot of some ongoing NIH-funded
research efforts related to these ingredients.
With respect to folate, NIH has funded and continues to
fund considerable research examining its role in the prevention
of chronic diseases such as cancer and heart disease. In
addition to these many projects, which I would be pleased to
share with you in more detail, I draw your attention to another
current trial that looks at the impact of folate and other B
vitamins on slowing the rate of cognitive decline in
Alzheimer's disease.
With respect to calcium, the NIH has a considerable
investment in clinical research. In addition to the many
studies supported by NIH over the years on calcium and bone
health, one current trial that I would like to draw to your
attention is a trial called supplemental calcium in overweight
people, currently under way at the NIH to examine the effects
of calcium supplementation on weight reduction.
With respect to omega-3 fatty acids, the Office of Dietary
Supplements has sponsored a series of evidence reports in
collaboration with the Agency for Health Care Research and
Quality, on the health effects of omega-3s for a number of
conditions. One report in particular, the one on cardiovascular
disease, concluded that there was substantial evidence for
benefit of omega-3 fatty acids in the secondary prevention of
heart disease, but that there was considerably less evidence
for an effect on primary prevention; that is, in the general
population.
We view that as an opportunity, not a barrier, and as a
result of this report, the National Heart-Lung and Blood
Institute, along with the Office of Dietary Supplements,
convened a working group earlier this year to assess future
research needs related to coronary disease prevention with
omega-3s. The working group recently made its recommendations,
which are currently being pursued at the NIH.
With respect to glucosamine, a clinical trial is currently
under way looking at the effect of glucosamine and chondroitin
sulfate for knee osteoarthritis. It has now met its recruitment
goals of nearly 1,600 participants and scheduled to be
completed within a year.
Finally, a clinical trial of saw palmetto and African plum
for urinary symptoms in men was recently funded and should
provide some very informative results.
I would like to comment at this point that the evidence for
benefit is stronger for some of these supplements than it is
for others. I would also like to point out that research
efforts need to continue apace in all of these areas, and that
NIH remains committed to encouraging and supporting the best
science in this area.
Between 1999 and 2003, the years for which we have these
data, NIH invested roughly $770 million to support research
related to dietary supplements. About a quarter of that was
devoted to studies of the five supplement ingredients that I
have cited above.
Let me briefly tell you a little about the Office of
Dietary Supplements. We were authorized by the Dietary
Supplement Health and Education Act of 1994, and came into
existence at the NIH in 1995. Our mission is to identify and
foster research on the health benefits and the risks of
supplements.
We have a strategic plan in place, and I am pleased to
announce that the strategic plan for the next 5 years has now
been published, and it can be found on the Office of Dietary
Supplements' Web site.
As a result of increases in funding for the Office by
Congress, from $3.5 million in 1999 to about $26 million year,
we have expanded our role in a number of important activities.
This year we cofund 90 research grants with other institutes at
the NIH, and among those a number of dietary supplement
research centers that we fund across the country that
specialize in botanical dietary supplements.
Let me give you four brief examples of other efforts that
we do in collaboration with other agencies, both within and
outside the NIH. The National Health and Nutrition Examination
Survey looks at supplement use in a health context, and is
conducted by the CDC. We significantly support that, along with
collaborators at the FDA, the National Institute of Standards
and Technology, and a number of private sector organizations,
including the dietary supplement industry. We administer a
program to develop, validate and disseminate analytical methods
and reference materials for dietary supplements.
And, finally, I wanted to mention that as part of our
evidence-based review program, which we conduct in
collaboration with the Agency for Healthcare Research and
Quality, we have two others that are currently under way, two
evidence reports, in addition to the omega-3 ones I cited. One
is on vitamin D adequacy in health, and the other is on the
role of antioxidants and B vitamins in the age-related
neurodegenerative disorders. These are all collaborative
efforts. It is a key way in which to get research done in this
area, in my opinion.
Mr. Chairman, I thank you for the opportunity to review the
status of dietary supplement research at the NIH, and I would
be happy to answer your questions.
[The prepared statement of Mr. Coates follows:]
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Mr. Burton. Do you take supplements?
Mr. Coates. That is a personal decision, and I do. But that
doesn't extend beyond by personal decision.
Mr. Burton. What does that mean?
Mr. Coates. I am not in a position to make recommendations
to others.
Mr. Burton. I see. But you do take supplements.
Mr. Coates. I take a multivitamin.
Mr. Burton. Can you tell us a little bit about the risks
associated by using dietary supplements, from your point of
view?
Mr. Coates. I can tell you some of the issues that are
raised. One in particular is the possible interaction of
certain dietary supplement ingredients and other bioactive
ingredients that people take, either other supplements or
drugs. Occasionally there have been identified risks associated
with that. People need to know about the possible interaction
among these biologically active constituents.
Mr. Burton. But the labeling on the bottles pretty much
tells people who are taking those to be careful or consult a
physician in the event that they think that there might be some
counteractive----
Mr. Coates. Yes. That is certainly a goal for all of the
potentially harmful interactions. I venture to say that we
don't know everything that we need to know either about the
benefits or the risks of dietary supplements, and our job is to
try to identify those so that the best information can be made
available to consumers.
Mr. Burton. I see. But you don't see the need for the
health agencies to take over complete control over supplements
and all of that?
Mr. Coates. I am not sure I understand that question.
Mr. Burton. Well, there have been some people who thought
that DSHEA was something that we should not have passed in the
Congress, and some of our health agencies say that all
supplements should be regulated. You don't agree with that?
Mr. Coates. They are regulated.
Mr. Burton. No. What I mean is they are not reviewed on a
regular basis by the health agencies; i.e., Health and Human
Services and FDA.
Mr. Coates. I think it is the FDA's responsibility to
regulate dietary supplements using the existing law.
Mr. Burton. Using the existing law. But you don't think
there needs to be any changes in that?
Mr. Coates. The last time I testified here, Mr. Chairman, I
think you asked me the same question, and I said that at the
time that DSHEA was passed, that it was an effective and
appropriate way to look at dietary supplements.
Sometimes things change. I think we have learned a lot
about dietary supplements, and I am not advocating that there
be any change. But I do think that it is appropriate for people
to examine periodically what they are doing.
Mr. Burton. But you are not advocating any change right
now?
Mr. Coates. That is not my position.
Mr. Burton. Good.
In your opinion, how has the passage of the dietary
supplement--or DSHEA affected the FDA's enforcement powers over
dietary supplements?
Mr. Coates. This is a tricky question for me to answer,
since I am not in the FDA, and I am in a sister agency, and I
don't know that I have any information that I can bring to bear
on your question.
Mr. Burton. OK. Could you please inform the subcommittee
where you believe the issue of dietary supplements will be in 5
years if the funding for these research initiatives remain
consistent or constant?
Mr. Coates. Thank you for--there is a question that I am in
a much better position to be able to answer, since it relates
to the research efforts, which really is what I do.
I think we are in a position where we can provide an
enormous amount of information to American consumers about
dietary supplements. There is a lot that still needs to be
done.
What we understand about dietary supplements is quite
variable. For some, we have very clear evidence of benefits. We
also understand those circumstances in which individuals may be
at risk, given exposure to certain supplements under some
conditions. It is such a large body of knowledge that needs to
be addressed. I think you alluded to the idea that there are
29,000 or so products in the marketplace. They are not, of
course, all different from one another in terms of the
ingredients.
But there is a lot that remains to be done, and I think it
is incumbent upon us as a research agency to invest as much as
we can in developing the right data set to inform consumers.
Mr. Burton. Ms. Watson, I am sure, has questions. Would you
be willing to have her submit those to you for the record,
because she is not here. She had to go to a Democrat get-
together, I guess, and she is in the front row, and she can't
leave right now. But she will be here shortly, so we will have
her submit those to you.
Mr. Coates. Thank you. I will be here for the rest of the
hearing.
Mr. Burton. Oh, good. Thank you. I am glad you decided to
stay. I wish we had more government agencies that were willing
to do that.
Mr. Burton. OK. Our next panel is Allen Dobson, Ph.D.,
senior vice president of the Lewin Group. Would you come
forward, Mr. Dobson.
Jeffrey Blumberg, Ph.D., professor at Friedman School of
Nutrition Science and Policy at Tufts University; Barbara
Levine, R.D., Ph.D., associate professor, nutrition in
medicine, Weill College of Medicine, Cornell University;
Elliott Balbert, president of the Dietary Supplement Education
Alliance; and the ever popular Marilu Henner, TV and movie
star, actress, author, and health advocate, and author of six
books. I will have to read one of your books.
Would you all please rise so we can have you sworn.
[Witnesses sworn.]
Mr. Burton. Dr. Dobson.
STATEMENTS OF ALLEN DOBSON, Ph.D., SENIOR VICE PRESIDENT, THE
LEWIN GROUP; JEFFREY BLUMBERG, Ph.D., PROFESSOR, FRIEDMAN
SCHOOL OF NUTRITION SCIENCE AND POLICY, TUFTS UNIVERSITY;
BARBARA LEVINE, R.D, Ph.D., ASSOCIATE PROFESSOR OF NUTRITION IN
MEDICINE, WEILL COLLEGE OF MEDICINE; ELLIOTT BALBERT,
PRESIDENT, DIETARY SUPPLEMENTS EDUCATION ALLIANCE; AND MARILU
HENNER, ACTRESS, NUTRITION AND DIET EXPERT
Mr. Dobson. Mr Chairman, my name is Allen Dobson. I'm am a
senior vice president for the Lewin Group. Thank you for the
opportunity to present key findings of a study that the Lewin
Group has conducted for the Dietary Supplement Education
Alliance.
The purpose of the study was threefold: to critically
review the research evidence for five specific dietary
supplements, to estimate changes in health care utilization and
the associated health care expenditure savings that could
result from the daily use of two of these supplements, and then
for the other three supplements to recommend research that
might be done in the future.
The five supplements that were covered in this study,
calcium with vitamin D, folic acid, omega-3 fatty acids,
glucosamine and saw palmetto, the Lewin Group developed
estimates of potential cost savings that could result from the
daily use of only two of these supplements for which the higher
standard of evidence exists at this time. In effect, what we
are doing is we were moving beyond the research and the
literature, which speak to the efficacy of the supplements, and
speaking to their cost-effectiveness in society. That is to
say, if they are used appropriately, what savings might accrue
to both the individuals and society? So in that sense the study
results that we are presenting today are new.
Cost estimates were developed for calcium with vitamin D
and folic acid where in each case there is significant
scientific agreement as to the improvement in health status.
For these two supplements, conservative estimates for health
care expenditure savings were developed for specific relevant
outcomes.
Dr. Devonso, my colleague, and I were very conservative in
our approach to building the cost estimates. We only went to
those supplements that had the most strong scientific evidence,
and when we did our costing, we only looked at a few of the
possible areas where cost savings might exist.
As Dr. Coates has indicated, for instance, for calcium,
there is many areas where it will be effective, but we only
looked at a few specific areas where the evidence was
strongest. That is to say for calcium, we estimated savings for
avoided hip fractures for over age 65; and for folic acid, we
looked at avoided incidences of babies being born with neural
tube defects.
In terms of our key findings for calcium, for a daily
intake of 1,200 milligrams of calcium D, calcium with vitamin
D, could result in 734,000 fewer hip fractures for the
population aged 65 and over. We estimated that would save about
$13.9 billion over a 5-year period. We used the CBO-type
scoring procedures, which you are familiar with, because CBO
scores all of our budgetary items for you. We tried to use
their procedures because they are well known and fairly
conservative in their approach, and subject to much scrutiny,
and we feel that those kinds of procedures are the appropriate
ones to use.
We looked at net savings in hospital, nursing facility and
physician expenditures. There again, we could have added more
expenditures to the list, but we felt we would take the biggest
ones and the least controversial with respect to hip fractures.
Over one-third of adults over age 65 experience falls each
year. Hip fractures caused the most severe health problems and
the greatest number of deaths. So not only are we looking at
cost savings here, we are looking at improved health and
people's status in terms of feeling better. When you have a
broken hip and you are over 65, it is not a good condition to
be in. If we can avoid that, not only do we save money, but we
improve people's health status enormously.
In terms of folic acid, there are 64 million women of
child-bearing years in the United States. Again, we were
conservative, and we said if an additional 10.5 million, or 25
percent of those not currently taking folic acid, begin to take
400 micrograms of folic acid on a daily basis, we estimated
that 600 babies would be born without neural tube defects. Our
savings over 5 years, using the CBO estimates again, were about
$1.3 billion. Again, these are conservative, because we only
took 25 percent.
The problem here is not so much the effects of the
supplement itself, but getting people to take the supplements.
And the recommendation here, of course, would be that we do a
lot as a society, much more as a society, to get people to
understand both the benefits of taking the supplement and the
risk of not taking it, which are enormous.
For omega-3 fatty acids, we found that there was a lot of
evidence. As we heard from Dr. Coates, a lot of it is good. But
the evidence wasn't quite strong enough to do our cost
estimates. And as Dr. Coates indicated, the government is under
way taking studies where perhaps we will have stronger evidence
in the future.
Similarly with glucosamine and saw palmetto, we found that
the evidence was strong, it was encouraging, but it wasn't
quite up to the rigor that we would like before we did our cost
studies. So for those two studies, we note that the government
is undertaking again, and already under way, very large double-
blind, placebo controlled studies, which should provide us the
evidence in the future with which we can proceed with cost
studies.
In closing, I would like to note that the typical American
diet does not always provide a sufficient level of nutrients to
support optimal health, very much as you said in your
introductory comments, and then that would be the overall
conclusion of this; that is, in certain instances, supplements
are an inexpensive and safe way to improve health status and
reduce health care expenditures, and in these cases the role of
public policy to support their use is unambiguous.
I would thank you for the opportunity to present these
findings from the Lewin Group study. Thank you.
Mr. Burton. Thank you, Doctor.
[The prepared statement of Mr. Dobson follows:]
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Mr. Burton. We didn't get into any other--they only asked
you about those five products?
Mr. Dobson. Yes.
Mr. Burton. Didn't get into vitamin C or any of the others?
Mr. Dobson. No. We took the five--we knew there was a great
deal of literature out there, and we wanted to look at those
cases where we thought we had the best case to move beyond the
studies of efficacy and impact on health and move into cost
savings. So we felt that we would look at those where the
literature in come cases is 30 and 40 years in length.
Mr. Burton. OK.
Dr. Blumberg.
Mr. Blumberg. Good morning. I am a professor of nutrition
at the Friedman School of Nutrition Science and Policy, and the
associate director of the Jean Mayer USDA Human Nutrition
Research Center on Aging at Tufts University in Boston. I also
serve as a nonpaid member of the Scientific Advisory Board of
the Dietary Supplement Education Alliance. I have been
investigating the role of dietary supplements in the promotion
of health and prevention of chronic disease for almost 25
years.
It is now indisputable that nutrition is a key component of
any disease-prevention strategy, and optimal intakes of
vitamins, minerals, and other nutrients are critical to
maintaining wellness. Virtually every nutrition-monitoring
survey reveals that most Americans fail to achieve these
intakes through their usual diets. Fortunately, dietary
supplements represent an affordable, effective and practical
tool to help solve this problem, and thus ultimately reduce
health care costs.
This morning I will illustrate this principle with the
example of folic acid. Folic acid is a B vitamin essential to
the activity of more than a dozen enzymes, amino acid
metabolism, and DNA formation. Inadequate intake of folic acid
has been associated with anemia, some forms of cancer, heart
disease, poor pregnancy outcomes, and birth defects, most
notably neural tube defects, but also including cleft lip and
palate, limb deficiencies and defects of the heart.
The richest dietary sources of folic acid are liver,
mushrooms, dried beans, green leafy vegetables, and, since
1998, enriched grains fortified with this vitamin.
The recommended dietary allowance for folic acid is 400
micrograms daily. Usual intakes of folic acid before
fortification were 200 micrograms, but are now estimated to be
about 300 micrograms, with much lower intakes in people
following low-carbohydrate diets and avoiding fortified breads
and other cereals.
However, it is important to understand that many people
have a greater need for folic acid, including pregnant and
lactating women, people who consume alcoholic beverages or take
certain medications, patients with certain inflammatory
conditions of the intestines, and the elderly.
For the last 5 years, the Center for Disease Control and
Prevention and the Institute of Medicine have recommended that
all women capable of becoming pregnant should consume 400
micrograms per day of synthetic folic acid from supplements or
fortified foods, in addition to consuming food folate from a
variety of dietary sources. Nonetheless, two-thirds of American
women of child-bearing age do not follow this advice, and 1 of
every 1,000 babies in the United States is born with a neural
tube defect.
The Lewin Group analysis which you just heard about
calculated that over the next 5 years, $1.3 billion in health
care costs could be saved if these women took a daily
supplement containing 400 micrograms of folic acid, but folic
acid supplements are not just for women. Observational studies
consistently reveal that men and women taking supplements
containing folic acid have the lowest blood levels of the amino
acid homocysteine. Elevated levels of homocysteine are a
significant independent risk factor for atherosclerotic
vascular disease and for thromboembolism. Some evidence
suggests that lowering homocysteine levels could reduce the
risk of heart disease by 20 percent. Many studies reveal that
elevated homocysteine may enhance the effect of other
established vascular risk factors such as hypertension and
smoking.
Folate inadequacy also has a procarcinogenic effect by
interfering with normal DNA synthesis and regulation. An
increased risk for some forms of cancer has been associated
with poor folate status in several epidemiological studies,
with the strong evidence linked to colorectal cancer.
Studies have also suggested that the increased risk of
breast cancer associated with regular alcohol consumption may
be reduced by an increased intake of folic acid from dietary
supplements.
While many different factors contribute to the risk of poor
health and chronic disease, we know that diet and the intake of
specific nutrients play a key role in the prevention of cancer,
diabetes, heart disease, infectious diseases, macular
degeneration, osteoporosis and other conditions.
The power of nutrition to promote health is well
established. We need now to find ways to encourage Americans to
choose helpful dietary patterns and increase their intake of
key nutrients with fortified foods and dietary supplements. If
we succeed in doing so, both the personal burden of disease
carried by Americans and the associated enormous expenditure
for their health care will be substantially reduced. Thank you.
Mr. Burton. Thank you, Dr. Blumberg.
[The prepared statement of Mr. Blumberg follows:]
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Mr. Burton. Dr. Levine.
Ms. Levine. Good morning, Chairman Burton. I am Barbara
Levine, associate professor of medicine at Weill Cornell
Medical College, as well as the head of clinical nutrition at
Strang, which is part of Cornell Medical College, as well as
the Rockefeller University.
It is a great honor to be able to address you about the
importance of the nutritional health of Americans. More
specifically, I will be discussing two nutrients I have studied
for most of my career. The first nutrient is calcium, which is
found in every cell of the body. Calcium is essential for bone
development and growth, and in the protection of the human body
through all stages of life.
Prolonged low calcium intake has been linked to the
development of several chronic diseases, including colon
cancer, hypertension and osteoporosis, and we have to remember
that we reach our peak bone mass really at around age 20, and
then bone resorption will really exceed bone formation, so that
it is very important for us to get enough calcium very early on
in life, but continue to get the calcium we need throughout our
life so that we don't lose more bone than we make.
It is generally accepted that the ideal method for
obtaining calcium is through regular dietary sources.
Unfortunately, meeting the recommended daily intake of calcium
has proven to be difficult for the average American, as
evidenced by the low percentage of individuals actually meeting
recommended calcium intake levels on a continuing daily basis.
In the recent National Health and Nutrition Examination
Survey, it was reported that the average intake of calcium for
women, for example, age 40 and over, was only 698 milligrams
per day. This is well blow the 1,200-milligrams-per-day calcium
intake recommended for postmenopausal women, and illustrates
the overall need to encourage calcium supplementation.
And this is true for men as well, as we know that women
generally experience fractures earlier on because of
postmenopause, but men catch up in the sixth decade of life and
will experience hip fractures as well.
Not only can calcium supplements help to increase the
intake of calcium among our population, but also the resultant
disease prevention can help cut health care costs
substantially.
The second nutrient I will discuss today is actually part
of a group of nutritional components, the much-heralded omega-3
fatty acids. This group has a major role in the maintenance of
cardiovascular health, development of the nervous system and
other key functions. As was mentioned today, there is more
evidence in the secondary prevention of the omega-3 fatty
acids, which include DHA, docosahexaenoic acid, and
eicosapentaenoic acid.
But we just finished, and I will have the results at the
Rockefeller University, a primary prevention study with DHA in
patients that are overweight and have the syndrome called
metabolic syndrome. So they are overweight, they have high
triglycerides, they generally have insulin resistance, and we
will get you that information as soon as possible.
But the role of omega-3 fatty acids and cardiovascular
function has been studied for the last 40 years. I would like
to commend the American Heart Association for its recent
Scientific Statement on Fish Consumption, Fish Oil, Omega-3
Fatty Acids and Cardiovascular Disease. This statement confirms
the importance of long-chain omega-3 fatty acids, both DHA and
EPA, for their significant role in the reduction of cardiac
death. DHA recommends that patients with coronary disease and
hypertriglyceridemic patients, that is with the high
triglycerides, consume DHA and EPA as part of their medical
management.
As just another example of the importance of omega-3 fatty
acids, research has found that DHA is particularly vital for
pregnant and lactating women because it plays a critical role
in supporting brain and retinal development in infants. A
recent workshop supported by NIH recommends 300 milligrams of
DHA a day for pregnant and nursing women to promote optimum
neurological development and visual acuity in their babies.
As I mentioned in my discussion of calcium, despite our
best intentions, the nutritional health of our Nation remains
suboptimal. The principal dietary source of omega-3 fatty acids
is coldwater fish like salmon and trout. However, both the
United States Food and Drug Administration and the
Environmental Protection Agency has recently scrutinized
certain fish, such as shark, swordfish and fresh frozen tuna,
for having potentially high levels of methyl mercury. And the
Heart Association tempers its recommendations to increase DHA
and EPA intake by stating that the availability of high-quality
omega-3 fatty acid supplements, free of contaminants, is an
important prerequisite to their extensive use. This is even
more important for pregnant and lactating women who would
benefit from DHA. These are a clear example of the benefits of
supplementation which can provide high-quality omega-3 without
contamination.
I thank you for the opportunity to speak to you about these
important nutrition issues. Thank you, Mr. Chairman.
Mr. Burton. Thank you.
[The prepared statement of Ms. Levine follows:]
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Mr. Burton. You know, before we go to the next witness, I
always find it very interesting that the EPA is talking about
being very careful about how much fish we eat that might have
mercury in it, because the environment has been contaminated
with mercury, you know, and yet most of the adult shots that we
get, where we get a vaccination, contain mercury. They have
that in there as a preservative.
I mean, they will tell you not to eat it, but when you go
to get a tetanus shot or a flu shot, they are going to stick
mercury in your body. They say it doesn't hurt anything. And we
have a huge increase; we have gone from 1 in 10,000 children
that are autistic to 1 in 166. We have an epidemic of
Alzheimer's. And we know that mercury causes neurological
problems, and yet our health agencies--I know the gentleman is
here from a health agency. I don't know if he is going to carry
this message back, but it just seems reasonable to me that
maybe we ought to get mercury out of these shots. Just get it
out of there. Hell, if we can't eat it, we sure don't want to
have it stuck in our bodies.
Anyhow, Mr. Balbert.
Mr. Balbert. Chairman Burton and members of the committee,
thank you for the opportunity to address you as a
representative of the dietary supplement industry.
I am Elliot Balbert, CEO of Natrol, Inc. Natrol is a
diversified nutrition company and manufactures and markets
premium-branded nutritional products for a wide range of
consumer needs.
While running Natrol is obviously an important and central
role for me, I am here in another capacity, as chairman of a
not-for-profit group, the Dietary Supplement Education Alliance
[DSEA]. DSEA was created in 2001 as a way for my industry to
help ensure that the intent of the Dietary Supplement Health
and Education Act [DSHEA], is met by providing meaningful
information about the health benefits and responsible use of
dietary supplements to all Americans.
As you well know, Mr. Chairman, an important aspect of the
passage of this critical law was to ensure that all of us as
potential consumers of dietary supplements were educated about
them, the very reason for the E in DSHEA. For that reason,
those of us involved in DSEA have worked over the past 3 years
to educate the public, the media, and even Members of Congress
and their staffs through our Web site, supplementinfo.org, and
other educational activities and means.
In fact, one of our ongoing educational efforts is a
monthly mailing to Members of Congress, where we strive to
provide those of you on the Hill with essential information on
the benefits of supplements. This may be a familiar package
that you have seen.
Mr. Burton. Do those contain supplements?
Mr. Balbert. Yes, they do. I can show you that if you would
like to see those.
Mr. Burton. No, just keep sending them.
Mr. Balbert. Our pleasure.
Mr. Burton. I don't want to interrupt your testimony, but
something very humorous is I take so many supplements that I
don't eat anymore. There is no more room for food. It is
supplements and more supplements. I wish somebody would tell me
what I really--I know I need vitamin C and E and all of this,
but I wish somebody would say, Danny--that is me--this is what
you ought to take every day. But everybody that I know that
knows that I am very concerned and want to make sure that the
supplement industry does very well, because I believe very
strongly in it, as you know, as the chairman of the caucus, but
there has to be a limit to how much of this stuff I can take. I
know I am going to live to be 170, but I would like to know if
I can cut down a little bit, because I am afraid if I stop
taking this, I am making a mistake and so forth.
So somebody needs to write me a letter and say, OK, this
what you ought to take. Marilu, maybe it is you.
Ms. Henner. I have it.
Mr. Burton. I may read your book. I want you to keep me
young. I am 29 now, but I want to stay there.
Ms. Henner. You only look 27.
Mr. Burton. I love you. I love you.
Go ahead, Mr. Balbert.
Mr. Balbert. Well, before I continue, Mr. Chairman, we want
to thank you on behalf of the industry for single-handedly
supporting the ongoing efforts to help educate folks.
As a representative of DSHEA, I have three important points
to make here, and I will be brief. First, as you have heard
from Dr. Blumberg and Dr. Levine, dietary supplements have been
shown to be safe and effective aids for maintaining health and
supporting overall wellness.
Just think about the implications of this on the human
level. Dietary supplements can help prevent a life of
disability due to neural tube defects. Dietary supplements can
enable senior citizens to live fuller lives without the
disability of a broken hip. Dietary supplements can help active
adults have less discomfort from arthritic knees.
The potential goes on and on. And how do you put a dollar
and cents value on the quality of life? You simply cannot. This
isn't a matter of statistics. It is the ability to lead
healthy, happy lives.
Second, these relatively inexpensive supplements can help
our country with the critical issue of managing health care
costs. One of the most pressing problems confronting the United
States today is the spiraling cost of medical health care. That
is no mystery, and as you heard from Dr. Dobson, just two
dietary supplements examined in the study could provide--I
don't know if we fully grasped his statement--just two, just
two dietary supplements examined in this study could provide
over $15 billion in savings over the next 5 years. That is two.
We have a critical crisis going on in our health care
system, and we are talking about food supplements that can help
reduce health care costs, and we are not even talking about the
value of the quality of life.
Third, to take advantage of health-promoting and cost-
savings potential of supplements, people need accurate,
science-based information about dietary supplements and access
to them. To ensure that dietary supplements get the research
attention they deserve, ongoing support from the Office of
Dietary Supplements [ODS], Mr. Coates's office, and the
National Center for Complementary and Alternative Medicine
[NCCAM], is essential.
We would urge members of your committee to strive to find
ways to increase funding to these government bodies. We are
confident that more extensive research will only further
support the benefits, safety, effectiveness, and cost savings
we are hearing about in this panel today.
To promote education about supplements, full implementation
of the Dietary Supplement Education Act is important. Chairman
Burton, we applaud your recognition of this critical aspect; on
behalf of the industry, praise your efforts to achieve this
goal by your introduction of H.R. 4760, which I wholeheartedly
support.
I believe there is more that can and should be done to
ensure that consumers have access to balanced, science-based
facts about dietary supplements so they may make informed
decisions about achieving and maintaining optimum health. That
is really what this is all about.
To ensure even greater access to supplements, bills like
your Tax Fairness Act are critical and represent legislation we
endorse. The Tax Fairness Act would allow taxpayers to deduct
amounts paid for foods for specialty dietary uses, dietary
supplements or medical foods as medical expenses, thereby
fairly putting supplements on par with other health benefits.
Likewise, the ability of food stamp recipients to use their
benefits to purchase dietary supplements. Food stamps can be
used to buy Twinkies, but they can't be used to buy dietary
supplements.
As you and others have proposed in the past, Mr. Chairman,
this is an idea we hope you and others will pursue.
In closing, I would like to point out although many
congressional hearings focus on what is wrong, hearings like
this provide encouragement to continue doing what is not only
right, but cost-effective, too. I want to thank the chairman
and others on the subcommittee for taking the time address to
the positive aspects of dietary supplements. Thank you, sir.
Mr. Burton. Thank you.
[The prepared statement of Mr. Balbert follows:]
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Mr. Burton. And I do take a myriad of supplements, but,
like I said, I think that might be one of the problems with a
lot of people, because there are so many supplements that are
available in the marketplace to take care of a myriad of
problems that you sometimes wonder, you know, if you are--if
you are taking too many, or if you are not taking enough.
So I am going to read Ms. Henner's book, I have it right
here. She looks awful nice. Does this tell me how to do that?
Ms. Henner. Sure. If not, I will give you my e-mail
address, and I can send you a lot of information.
Mr. Burton. Gosh, that would be great. I would love just to
converse with you. You are a lovely lady. OK.
Ms. Henner. Well, thank you so much.
Well, Chairman Burton, good morning, and members of the
committee. I am Marilu Henner, actress, author, concerned
mother, and health advocate. As a consumer who recognizes the
value of dietary supplements, I thank you for the opportunity
to speak here today.
I would like to provide testimony on why I believe it is
important for consumers to have information about dietary
supplements and to have access to supplements through their
government and private health plans. The information and access
is important in order to help people make better decisions and
lead healthier lives than is possible through a healthy diet
alone. I mean, that is why I believe dietary supplements should
be part of a campaign to improve our Nation's health.
Now, I feel qualified to say that, because I am not only
the author of six best-selling books promoting health and
nutrition and a healthy lifestyle, but I am also one of the
healthiest eaters in Hollywood; that is, according to a few
magazines. Which isn't saying much, because everybody is on
that crazy low-carb phase except me.
Anyway, I believe that healthy food without dietary
supplements is not enough, because it is not always possible to
get everything we need from our food, no matter how carefully
we plan our diet. We eat in restaurants, we eat on airplanes,
we eat in school lunch programs, etc.
But before I get into my personal story, I would like to
talk first about the need for information. According to the
Centers for Disease Control, approximately 400,000 Americans a
year die as a result of an unhealthy diet and a sedentary
lifestyle. While I personally think the estimate is low, it is
high enough for us to recognize that something must be done to
get people moving and eating better.
As the waistline of the average American continues to
expand, illnesses related to obesity, such as diabetes and
heart disease, are reaching epidemic proportions. People are
stuffing themselves with processed foods and fast foods and
junk foods, while they are literally starving their bodies of
the nutrients they need.
The solution for too many people is fad diets that only
perpetuate their unhealthy eating habits. As I have described
in several of my books, I was raised on the standard American
diet and spent many years dieting as I tried to control my
weight. I actually weighed 54 pounds heavier than I do right
now. Big change. The result, of course, was that I was
consistently in bad health and never could control my weight
eating that way. Both of my parents died in their fifties of
diseases associated with poor diet. As I have since learned, my
father's heart disease could have probably been mitigated using
vitamin E and omega-3 fatty acids, and the severity of my
mother's arthritis could have been alleviated using calcium
and/or glucosamine.
I have had my own experiences with calcium. I have not had
a dairy product in 26 years. I take a calcium supplement. I had
a bone density test recently. I am the 104th percentile for a
woman my age. I am 52. I was in the 97th to 99th percentile for
a woman 18 to 25, and this is--I had a mother who died of
arthritis. So I know that a calcium supplement can definitely
help, and, you know, coupled with a very healthy diet of leafy
greens, etc., salmon.
My parents' deaths were the impetus for my never-ending
quest for better health for myself, my siblings, my children
and anyone else who would listen. My journey to good health
took many years. Mine was a story of trial and error, because
it was so difficult in the 1970's and 1980's to find
information about optimizing health through diet and
supplements. There is more information now than ever before
about health, but unfortunately the same chatter about fad
diets and miracle drugs drowns out the sound information that
people should be getting.
I believe that people are ready to take the right steps
toward becoming healthy, but without the proper guidance and
the support of their insurance providers, health organizations
and the Federal Government, they will continue to be led into
to seeking false solutions. One of my goals as an author is to
show people the way to optimize their health by encouraging
them to disregard false solutions such as drastic weight loss
with no sacrifice, or better health through miracle pills. I
really do believe it is about changing the palate of America.
Through my many personal appearances advocating good
health, my books and my Web site at marilu.com, I come into
contact with and mentor thousands or people who are on their
own quest for good health. I hear many personal accounts of how
people have turned their lives around from debilitating illness
to vibrant health when they get information needed to make
choices, to make good choices, and by good choices I mean
specifically rejecting the manufactured foods of our society
with their overreliance on sugar, meat and dairy, and the
chemical, hormones and steroids that usually accompany these
products. Instead we should be moving toward an organic, plant-
based diet that produces a sense of physical well-being, and
also a healthy diet that includes the use of appropriate
dietary supplements.
Finally, I would like to describe why I think it is
important to have access to dietary supplements. Eleven years
ago when I was pregnant with my first son, I began to take
prenatal vitamins and supplements and found that I felt better
than ever before. I continued to take dietary supplements after
my pregnancy to benefit from the essential nutrients that I
knew I couldn't get from food alone, even though I am very
committed to a healthy way of eating. But I was lucky enough to
have a doctor who not only understood the value of dietary
supplements, he also encouraged me to use them to maintain my
health. Not everyone is that lucky, however, and many doctors
have no idea what supplements are best for their patient's
individual needs.
Since then I have taken dietary supplements every day, and
I would recommend them to my family and friends as well as in
my books and classes. The general public needs more access to
dietary supplements to maintain good health. Supplements are
the result of American research and development, but for some
reason they have been stigmatized by the American Medical
Association and the drug companies, and, as a result, most
Americans do not have access to those supplements because they
are not covered by their health plans, nor recognized as
effective by the Federal Government.
I think this needs to be changed. People need to be able to
find the supplements to target their specific needs. They need
good information. They need to be able to find quality
products, and the product needs to be cost-effective. They
can't have any of these things without your help.
I have the benefits of 26 years of research and
experimentation, and I have never been afraid to think outside
the box when it comes to my health, but I only wish I had that
information when my parents were alive, because I know I could
have helped them and saved their lives.
In closing, I want to thank the committee for examining the
issue and inviting me to speak here today. I would like to
encourage you to make this information on dietary supplements
available to all Americans so that the health of the American
public can be improved. And I wish you the best of health.
[The prepared statement of Ms. Henner follows:]
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Mr. Burton. You know, I am going to use a different kind of
metaphor to make this next statement. That is, you know, when
we were attacked on September 11, we at that point didn't have
the ability to arrest and hold a suspected terrorist before the
act took place. There had to be probable cause, you know, all
of the things that you do. And we ended up passing what was
called the Patriot Act, so that if we saw a terrorist, we could
get him and hold him until we checked him out to make sure that
he didn't kill 10,000 or 12,000 people.
And that brings me to the issue we are talking about here
today, and that is health. My son-in-law is a doctor, and most
doctors are taught to take care of people who become sick. But
they don't move in advance to help them with preventive
medicine, because they are not trained that way. They are not
trained to say take these supplements, take these things, and
you probably won't have the kind of maladies that you may be
heading for.
And it seems to me in our medical schools, in addition to
what we have been talking about here today, and we talked about
this at other hearings, that the medical colleges and
universities around the country ought to be teaching diet,
supplements, nutrition and everything right along with the
medical studies so that they minimize the amount of people that
have to come to them in the first place. And I think we would
have a much healthier Nation.
Unfortunately, that's not the case. We have the cart before
the horse. You get sick, then you go to the doctor and he gives
you prescription drugs, many of which help but don't solve the
problem, because the problem started earlier. So I agree with
what you said, and that's why we are sponsoring all of the
legislation we are to try to give people the ability to get
vitamins and minerals and supplements that will help them in a
preventive way from getting these diseases.
Dr. Dobson, you provided us with some very significant cost
savings in the findings of your studies. Would you say that the
cost savings for calcium and folic acid are conservative? And
would you also agree that even more savings could be achieved
by people using them?
Mr. Dobson. Yes, they are very conservative estimates, for
two reasons, No. 1, we assumed that most people wouldn't take
either the calcium they should or the folic acid they should.
If more people took each of those supplements, our estimates
would rise.
If we had public policies that encourage people, as Marilu
has suggested, to get more people to take more folic acid, we
would reduce more neural tubes defect than we estimated in our
studies, which would increase the savings similarly with the
calcium.
Second, we only took the major healthcare savings
associated with both calcium and folic acid. And as you have
heard from your panel, there are many other potential savings
that one might have. We didn't cost those, because the research
isn't quite there yet, but it may very well be in the future.
So I think for those two reasons at least, our estimates are
very, very conservative.
Mr. Burton. You also stated that omega 3 fatty acids,
glucosamine and saw palmetto, that there's emerging evidence
that suggests there's going to be significant cost savings for
those as well. What types of research would have to be
conducted to help determine if there would be economic benefits
from those supplements?
Mr. Dobson. I think that the research already in place, the
clinical trials under way by FDA and others at other Federal
agencies, may be powerful enough in the next couple of years to
allow the cost estimates to be made. We won't know until we get
the studies, of course, but it's these very carefully
controlled studies that take time and money to put in place. We
need more of those for our supplements.
The government is, as we heard from Dr. Coates, is well on
its way to providing those types of studies. We are focusing
now in those areas where there's a long trail already of
evidence that's out there, and a few additional studies may be
what we need to take us over the top to be able to say, yes,
these are supplements that we can now have confidence that they
do improve health to the point where we can calculate cost
benefits.
Mr. Burton. Let's see, Dr. Blumberg, in your testimony, you
state that all women capable of becoming pregnant need to
consume folic acid on a daily basis. What would you recommend
is the best method of obtaining folic acid besides eating
liver, mushrooms, dried greens or green leafy vegetables. Would
just taking a folic acid pill be sufficient?
Mr. Blumberg. Well, I would point out--it's not nearly my
view, but the view of the Institutes of Medicine and the CDC--
that the most effective, reliable and practical way to insure
that enough folic acid is consumed to reduce the risk for
neural tube defects is to take a dietary supplement containing
400 micrograms of folic acid.
It's just, hands down, the most realistic way to do it. The
reason that many women don't, indeed as I stated, two-thirds of
American women in this group do not use supplements containing
folic acid, is they are not getting the recommendations from
their health care providers that this is an appropriate thing
for them to do. It's really part of the preventive nutrition
issue that you were raising. This advice, which is actually
official government advice, is still not being picked up by
health care providers by physicians, dieticians, pharmacists
and others to encourage women to do this.
Mr. Burton. Is folic acid one of the most practical ways to
insure good health?
Mr. Blumberg. Well, folic acid, I like to think, is a very
important vitamin, but it's certainly not the only one. I would
point out, for example, that folic acid works in conjunction
with other B vitamins, like vitamin B6 and vitamin B12 to lower
homocysteine, which I mentioned is an independent risk factor
for cardiovascular disease.
As Dr. Coates mentioned, there's some exciting new research
that suggests that increasing our intake of folic acid may
reduce the risk for age-related dementias like Alzheimer's
disease. Recent research studies at Tufts University have shown
that people with elevated homocysteine levels which can be
lowered by folic acid supplements, have fourfold higher rates
of Alzheimer's disease than people with low homocysteine
levels. So I think the promise of folic acid, together with
other essential vitamins and minerals, holds tremendous promise
for promoting health and reducing our risk for many chronic
diseases.
Mr. Burton. Well, I would like for all of you, as I said
before--I would like for all of you, if you would, to give me a
list of the essential vitamins that people should take so that
they--I personally would like to know.
I have drawers of items. I can't possibly take them all. I
think that's one of the shortcomings that people have when they
start deciding what is best for them. Because every article
that you read says this does this, this does this, and this
does this. And clarity in your health, I think, providing for
your health, I think is very important. So I would like some
advice from you folks, and I have been taking these things for
a long time.
Dr. Levine, as part of your both written and oral
testimony, you stated that Americans are not getting the
recommended daily intake of calcium that they need on a daily
basis, just through the foods they eat, that they are eating.
Can you tell us the benefits that we are getting as a society,
how it could reap more benefits if individuals supplemented
their diets with calcium and what kind of calcium are we
talking about, are you talking about CalMax or things like
that?
Ms. Levine. Well, they are. Well, first some people should
get some calcium from their diet. Typically they get it from
dairy foods, certain leafy vegetables like cal-fortified foods,
such as fortified orange juice. They can get it from fortified
cereals. But really most people are unwilling or unable to get
the 1,200 milligrams they need, and that's for both men and
women.
That's if you translate it into dairy products, that's four
glasses of milk a day--and most of us are saying low fat or
skim milk a day--but most of us are unwilling or unable to do
that. So you can get it from calcium carbonate, calcium
citrate. You really do not want to go to bone meal or dolomite
that are contaminated with things like lead or arsenic.
And the coral calcium issue is one that I don't even want
to go into.
Mr. Burton. Why not? Wait a minute. I want you to go into
the coral calcium issue.
Ms. Levine. Because they were advertising that as having a
high absorption rate of 69 percent. We know that most calcium,
like carbonate or citrate, according to Dr. Heeney, who is a
calcium expert, shows that most calcium is absorbed like milk
at about 30 percent. So they did not do the calcium studies on
coral calcium.
Mr. Burton. Well, you are not saying coral calcium is not
good, it is just----
Ms. Levine. There is no way that it has an absorption rate
of 69 percent.
Mr. Burton. But it's not bad?
Ms. Levine. I don't think we have the studies. We really
need good double blind placebo-controlled studies. Most of the
studies that I am involved in, either at Cornell or the
Rockefeller or Strand, are in our clinical research center
where we typically--I should say it this way--incarcerate our
patients. They stay in the hospital. We control everything that
they eat and drink.
Mr. Burton. But you haven't studied coral calcium yet?
Ms. Levine. We do. We just finished a study on calcium,
using calcium carbonate in patients that were at high risk for
colon cancer.
Mr. Burton. Uh-huh.
Ms. Levine. Those data are not quite complete yet, so we
will have----
Mr. Burton. What about the coral calcium?
Ms. Levine. We didn't use coral calcium.
Mr. Burton. You haven't studied it?
Ms. Levine. No, we haven't studied it.
Mr. Burton. All right. Could you further explain the
benefits of omega 3 fatty acids for all Americans?
Ms. Levine. Yes. As I mentioned with children, it starts at
the very beginning. Mom gives DHA by the placenta in the third
trimester of pregnancy to her baby, and then if she is nursing
her baby, she will give DHA to her baby.
However, as Americans, we have the lowest levels of DHA in
our breast milk. That's because we do not eat fish, and we
don't eat organ meats--and you mentioned you don't like liver.
Typically, we used to eat more organ meats.
It's in liver, it's in brain. Remember that brain is made
up of 60 percent fatty acids and 30 percent of which is DHA or
decosahexaenoic acid, and it's also very concentrated in the
retina. So, babies that get DHA have better cognitive function
and visual acuity. And it's also in the heart muscle. So that
we really need to have it throughout all stages of life.
And now, through the Framingham study, you mentioned that
too, it's been shown that patients that have low DHA levels in
their serum and then on autopsy in their brain have higher,
higher incidence of Alzheimer's disease or dementia. So we need
it throughout our life cycle. So it's very, very important. And
I mentioned, we soon will have results in a primary--prevention
trial with DHA. And that, again, is in a study that we gave
everything that the patients had to eat and drink in our
clinical research center.
The only thing that was different is that they were either
on placebo or on DHA supplementation while in the hospital for
6 months. So it was a long-term study, and we will have the
results shortly.
Mr. Burton. Well, if I have to choose from eating a
supplement that contains DHA or eating brains----
Ms. Levine. I'm sorry.
Mr. Burton. I said if I have to choose between eating a
supplement that has DHA or eating brains, there's not going to
be any question.
Ms. Levine. Me too.
Mr. Burton. Mr. Balbert, were you surprised by the $15
billion in cost savings and healthcare expenditures that were
derived from the results of the study conducted by the Lewin
Group?
Mr. Balbert. I was delighted with the cost savings.
Mr. Burton. Were you surprised?
Mr. Balbert. Not really. Just putting a number to something
that we have, I think, intuitively understood in the industry,
was a pleasure and a relief. The fact of the matter is that's
just a quantification of a specific ailment, and I happened to
put a great deal of value in the quality of life of dietary
supplements.
One other comment, chairman, you have expressed a number of
times in your comments about the angst that you have with the
volumes of dietary supplements that you take and the difficulty
that you have in finding out what is right for you. The
industry has a very simple guideline on that. We suggest that
everybody should take one multivitamin and mineral formula as a
base of any healthy nutritional program, and then based upon
the additional body functions that you are looking for
sufficient nutritional support from--whether it be eye health
such as lutein or insulin balance, which is chromium--you would
then build around your multivitamin formula.
That, along with a good healthy life-style with plenty of
sleep and rest, and you will live to that 170 that you were
talking about.
Ms. Levine. And laughter.
Mr. Balbert. Oh, yes, and laughter.
Mr. Burton. OK. All right.
Your organization, the Dietary Suupplements Education
Alliance, in your Web site and mailings to Capitol Hill have
helped to educate Members of Congress on the benefits of taking
dietary supplements.
Do I then assume correctly that it is critical that the
DSHEA be preserved and not amended?
Mr. Balbert. Absolutely, Mr. Chairman. We don't believe
that there needs to be any modification for DSHEA. The Federal
Food and Drug Administration has all the authority that they
need. What they need to do is to encourage and implement the
DSHEA, all the grounds that are necessary at this time. DSHEA
does not need to be modified.
Mr. Burton. Our health agencies have the tools necessary to
police that?
Mr. Balbert. By their open admission and testimony----
Mr. Burton. I think they have the tools today, yes. Well
there are those in Congress and in health agencies that want to
junk DSHEA, as you probably know. I just want to admonish those
that are interested in the health care field and the supplement
field, and that they stay vigilant in contacting their
Congressmen and Senators, not just Representative Kucinich,
myself and Hatch and others. But contacting them and telling
them how important it is, we don't tinker with DSHEA.
Ms. Henner, you stated in your testimony--you just stated
that eating healthy is not enough and that you believe that
dietary supplements need to be a part of your and everyone
else's daily regimen.
Tell us a little bit about what you take and why you think
supplements are so important to you?
Ms. Henner. I take a multivitamin called Comprehensive
Formula that I actually helped develop. I take vitamin E, I
take calcium. I do take coral calcium. And I do take a calcium
called Bone-Up and I--because it's vegetarian.
Mr. Burton. You are vegetarian?
Ms. Henner. I am what is known as pesca vegetarian. Because
I eat some fish, although I have been, I eat, you know, a
little bit of fish, but I mainly eat whole grains, fruits,
vegetables, legumes. So I have a very strong plant-based diet.
I have just a----
Mr. Burton. You don't drink a lot of milk?
Ms. Henner. No, I never drink milk. My children have never
had milk. They are 8 and 10 years old. They are both in a
gifted school. They have both skipped a grade. And they have
strong bones. They are both athletes. They are incredible. My
children have never had a dairy product in their life. And I
haven't had one for 26 years. So----
Mr. Burton. Why is that?
Ms. Henner. Because the only thing dairy is supposed to do
is turn a 50-pound calf into a 350-pound cow in 6 months. It's
true. I always tell people if those are your aspirations, knock
yourself out.
I mean, we have a 27-foot long intestinal track in a very
small stomach. A baby calf has four stomachs and 9 feet of
intestines, and they have nothing to do with each other. So we
are not even, you know, I think that dairy is one of the worst
calcium carriers ever. Now, it doesn't even, you know, resemble
the milk of old. It is really just a white bovine slime, as far
as I am concerned.
Mr. Burton. Wait a minute, I will get there. White bovine
slime.
Ms. Henner. Bovine slime, it's--you know, I read people's
faces, I go up and I can always tell somebody who has an
overconsumption of dairy products. Because that was my problem.
I always ate a lot of dairy products, and when I gave them
up, my digestion changed, my skin changed, my weight changed.
Everything changed about my body.
So I am a big advocate of people looking to alternatives to
dairy products. Because two-thirds of the country doesn't even
eat dairy.
So, anyway, the other things that I take are I take
pycnogenol, which is an antioxidant. And I also take--but I
work with a nutritionist in Los Angeles, who tests me from time
to time, and also note from, based on my schedule, and based on
if I am traveling, etc., I need to make adjustments along the
way.
So, you know, I am lucky enough to have found someone to
work with who puts me on different programs from time to time.
Excuse me. Does that answer your question?
Mr. Burton. I think so. Bovine slime.
As an author of six books promoting a healthy lifestyle,
what recommendations would you make to Americans so that they
can make better healthy choices?
Ms. Henner. You mean in terms of food or supplements or
both?
Mr. Burton. Both.
Ms. Henner. Well, I think definitely think, you know, you
are a real person, eat real food. They should start reading
labels. That's always where I start with people. Because
anything that takes a paragraph, you know, this big to
describe, or says continued on the next can, you probably
shouldn't be eating it.
With my children, I always say if you can't read it, don't
eat it. I always start there. And so I always have people start
there. I also think that you should--the American public really
needs to change their palate, because it's really not about
counting, it's not about measuring, counting, you know, it's
not about measuring, weighing, counting the points, grams,
carbs, etc., of the same old food. That is not going to make
somebody healthy or thin or fit.
And the other thing is, I think that everyone needs a good
daily multivitamin to start. And as Mr. Balbert said, you start
there and then you build from there.
And then depending on your genetic hand. I knew that my
parents--having died of arthritis and heart attack, that I had
to, I looked into those diseases thoroughly and started taking
the calcium and vitamin E and, you know, Pro-EPA is the fish
oil, the one that I take.
Mr. Burton. Besides buying your book what other things can
we do to educate the public?
Ms. Henner. Well, that's an excellent start. You know what.
I always say I educated myself. I started this in 1978 after my
mother died, and I went to medical libraries and research
departments and took human anatomy classes and went to health
food stores. And there was not a lot of information.
I think what we have to do is we have to get the
information out there to people, because once you know, you
can't choose not to know anymore. And this is why I am, you
know, an actress who goes out talking as much as I do about
health. Because I think people need to be educated.
So I think what people also need to do is also get off
their butts and stop stuffing their faces but starving their
bodies with the same old junk over and over again. Because
that's exactly what is happening. Their bodies can't even
ignore the nutrients in the food, and there's no nutrients in
the foods, they choose so they keep overeating and overeating
and overeating.
I always look at someone who has either a weight or skin
problem, and I always say that's a natural healer. Because
their body is telling them that they are doing something wrong.
So I really think that what people have to do is rediscover the
child in themselves, get out there and exercise, find a good
doctor who can work you, know enough about your body so that
you can help your doctor help you and educate yourself as much
as possible. And eat lots of fruits and vegetables.
Mr. Balbert. Mr. Chairman, the DSEA has created a very
comprehensive Web site called supplementinfo.org, which is
extremely exhaustive in providing information to the American
public and access.
Mr. Burton. Give me that again.
Mr. Balbert. Supplementinfo.org contains over 2 million
pages of information on the use of dietary supplements. It is
ad nauseam in terms of--the information is there.
Mr. Burton. I want a one-page, one pager.
Mr. Balbert. We will have it prepared for you, Mr.
Chairman. I can assure you.
Mr. Burton. I want you to write down something for me
saying Dan, you can do this, and you are going be all right.
All right?
Mr. Balbert. Mr. Chairman, consider it done.
Ms. Levine. I think other responsibilities organizations,
such as the Heart Association, American Diabetes Association,
of course the NIH Web site, they are excellent Web sites to go
to.
Mr. Burton. Sure. Do you know how many pieces of paper.
Representative Watson and I, how many documents we have to look
at a day. Do you know how many pieces of documents we get each
day and constituents asking us to pass to the White House and
people asking us to get their kids appointed to the Air Force
Academy or West Point or God only knows, Social Security,
veterans problem, we really, I am not asking for sympathy. I
asked for this darn job a long time ago, but we really don't
have time to go into a million pages here.
Mr. Balbert. Of course not.
Mr. Burton. But I will say give me the KIS principle, keep
it simple.
Mr. Balbert. I will kiss you, Mr. Chairman.
Mr. Burton. No, thank you. Maybe Marilu Henner.
I just want to say first of all, your enthusiasm, Ms.
Henner is very helpful, very nice.
Ms. Henner. Thank you, this is my true passion, I was there
yesterday at the dietary guidelines open public forum talking
about--you know.
Mr. Burton. Yes. I appreciate all of you panelists, I just
want to tell you, we had a hearing about a week ago, was it, on
obesity in America, and 31 percent of the people of this
country are overweight. No. 65, 65 percent of the people of
America are overweight and 31 percent, almost 1 out of 3
people, are considered to be obese.
I just got back from Guam and Saipan not too long ago, and
they have an absolute epidemic of diabetes over there. I think
we had a doctor before us at our last hearing and he said if we
don't change our dietary habits in this country, one out of
three children will develop diabetes in their life, newly born,
one out of three.
I mean, we are looking at an absolute epidemic if we don't
educate the public about eating habits, junk food--and then
they start saying that the average child in a year sees about
10,000 commercials--and I started watching children's
commercials and my God, Little Benny's chocolate wafers, you
know, and all the stuff you see is nothing but junk food, junk
food, junk food. And a bit of that is all right. But somehow,
we have to educate the public, that they ought to create better
food products and advertise them the way that make people want
to eat them so that they get healthy. Otherwise, we are going
to be paying so much money in health care cost, it's not even
funny.
Ms. Watson is with us, she is my ranking democrat and a
very fine lady who is really concerned about health foods.
Would you like to make a comment?
Ms. Watson. I thank you, Mr. Chairman. I am going to give
my opening statement, because I think it frames my interest and
concern. Natural foods and supplements are very important to a
healthy population. If one understands what should go into the
body, then it is possible to live a healthier and more
productive life. Breast milk nurtures an infant and promotes
accelerated learning.
Vitamins and minerals give cells and organs the proper
building block for optimal performance. There are some
supplements that have been proven to be very effective, for
example, pregnant women are advised to take folic acid to
reduce the risk of certain birth defects. And calcium
supplements have been demonstrated to reduce the risk of
osteoporosis. Certain herbs and trace elements also have
medicinal values and sickness-preventing properties.
Mr. Chairman, I am encouraged with the aggressive outreach
and research initiated by the natural food and supplemental
industry.
But there is room to do much more. The natural foods and
supplement industry can help increasing numbers of Americans to
take charge of their own health. They can assist our
constituents in adopting healthier lifestyles that include a
good diet, exercise, supplementation and becoming more educated
about all of these.
The Dietary Supplement Health and Education Act is a very
important piece of legislation, and prior to its enactment, the
FDA regulated dietary supplements as food. Because
manufacturers claims are often promising and completely
positive, Congress created guidelines to address supplement
definition, safety concerns, ingredient and nutrition labels,
supplement claims, good manufacturing practices and new dietary
ingredients. In addition, the DSHEA created a supplement
Commission and an office of dietary supplements at the National
Institutes of Health. Over the past few years, there have been
several media stories of supplements causing adverse effects.
Natural nutrients are nothing to be scared of, but they
should be respected, treated with care and used properly. Since
the enactment of DSHEA, the FDA has issued alerts on several
supplements to warn consumers of possible safety problems.
In other examples, the FDA has issued alerts about a
possible liver toxicity with kava-containing dietary
supplements, dangerous interactions between Saint John's Wort
and a number of prescription drugs and serious kidney disease
and some cancers from herbal supplements containing aristolic
acid.
Until recently, the FDA has only invoked its authority to
declare a supplement altered. In December 2003, the FDA
declared that Efedra, a dietary supplement that was marketed
for weight loss and was associated with serious adverse events,
including heart attack, stroke and death, presented an
unreasonable risk of injury. The courts are currently reviewing
this action, and courts should not decide the risks and the
efficacies of a dietary supplement at all.
On the contrary, the scientific community should reach a
well-founded conclusion.
And, Mr. Chairman, you mentioned that several of the
island, Guam and other areas of the north Pacific and South
Pacific are now seeing the rapid development of being diabetic.
Mr. Burton. Diabetes.
Ms. Watson. I am thinking of so many other things. And I
remember going to the Far East early--earlier on, and there
wasn't a dentist around, and going back decades later, now
there's a dentist on every corner. Why? Because they have
started consuming western DSHEA style foods. And I think that
is a sad commentary on how we are promoting our bad dietary
habits around the world.
And so I hope that we will have other hearings on this
issue, because I do believe that of dietary supplements have an
essential role to play in today's world. And I look forward to
other hearings. I'm sorry I am late. I am sitting in another
committee at the same time. So thank you very much, Mr.
Chairman, for this opportunity.
Mr. Burton. You are welcome. Before we adjourn, let me say
we regret Ken Venturi wasn't here with us. Ken Venturi won the
U.S. Open here at congressional under very stressful conditions
years ago, he is one of my heroes, I have had a chance to get
to know him and meet him a little bit. So I hope somebody will
convey to Mr. Venturi our sorrow that he couldn't be with us.
He has a book out, and I am hoping I get a copy of it. I would
like to read it, not only on supplements but golf. I am a golf
nut.
We have had some other people who are very interested in
health care issues and supplements. Arnold Schwarzenegger--I
talked to him on the phone--we were going to have him testify
at one time, shortly after he had open heart surgery, and I
asked him, this might be interesting to a lot of people who are
interested in the supplement field. I asked him if he thought
that supplements benefited him in the course of his surgery and
his recovery. He said that he recovered much more rapidly than
anybody anticipated, and he was absolutely certain it was
because of not only his physical conditioning, but because of
the supplements that he had been taking for years that helped
him heal quicker.
Of course, we have Ms. Henner here, another celebrity, we
appreciate you being here. You are very beautiful and useful.
Ms. Henner. Thank you very much.
Mr. Burton. Just like when I saw you on TV.
Jane Seymour is a very good friend of mine. In fact I think
I am going to have lunch with Jane and James Keach, her
husband, tomorrow. I think you know both of them. But she is a
very, very physical culturalist, if you will, and she is also
big on supplements as well as her sister, who I think teaches
supplements.
And of course, we had one lady here, who I am sure would be
recognized as a person of great physical stature, Raquel Welch,
and just thought that you might like to know that she takes
supplements as well. So this isn't just limited to the plain
people like me. I mean, you have a lot of beautiful people who
take that stuff as well.
Ms. Watson. Mr. Chairman, would you yield just 1 second?
Mr. Burton. What piqued your interest there, was it Raquel
Welch or----
Ms. Watson. This morning, on CNN, they were talking about
the Greek diet, and I was in Greece for the Olympics, and I
noted that every time you went into a restaurant, there was a
Greek salad. And I also noticed that everyone smoked there.
And I was asking, why is it that they don't develop the
kinds of cancers related to smoking? Lung cancer and etc.? And
they said because of olive oil. So there are some medicinal
properties in olive oil that we all should be looking into.
They also talked about couscous in place of white rice, and
they talked about the fresh vegetables. They have the best
tomatoes in the world. So I think there are a lot of natural
products that we get through the supplements, and they tend
to--they say they live longer because of the olive oil. So I
think we ought to try that and, you know, stop using butter,
dip our bread in olive oil. Thank you, I just had to get that
in.
Mr. Burton. Put that on my list, will you?
Ms. Henner. I am half Greek, I just want you to know. My
book has exactly what they were talking about today.
Mr. Burton. A lot of olive oil.
Ms. Henner. A lot of olive oil. I was raised on olive oil
too.
Mr. Burton. Send me your list, kid.
Ms. Henner. I will.
Mr. Burton. Thank you, this has been very, very
interesting. We will have more panels on this, health and
wellness and supplements. And you have been very helpful today.
We will send some questions to you. If you wouldn't mind
answering them and sending them back to us for our record.
Thank you very much. We stand adjourned.
[Whereupon, at 11:40 a.m., the subcommittee was adjourned.]