[House Hearing, 110 Congress]
[From the U.S. Government Publishing Office]
MYTHS AND FACTS ABOUT HUMAN GROWTH HORMONE, B-12, AND OTHER SUBSTANCES
=======================================================================
HEARING
before the
COMMITTEE ON OVERSIGHT
AND GOVERNMENT REFORM
HOUSE OF REPRESENTATIVES
ONE HUNDRED TENTH CONGRESS
SECOND SESSION
__________
FEBRUARY 12, 2008
__________
Serial No. 110-121
__________
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COMMITTEE ON OVERSIGHT AND GOVERNMENT REFORM
HENRY A. WAXMAN, California, Chairman
EDOLPHUS TOWNS, New York TOM DAVIS, Virginia
PAUL E. KANJORSKI, Pennsylvania DAN BURTON, Indiana
CAROLYN B. MALONEY, New York CHRISTOPHER SHAYS, Connecticut
ELIJAH E. CUMMINGS, Maryland JOHN M. McHUGH, New York
DENNIS J. KUCINICH, Ohio JOHN L. MICA, Florida
DANNY K. DAVIS, Illinois MARK E. SOUDER, Indiana
JOHN F. TIERNEY, Massachusetts TODD RUSSELL PLATTS, Pennsylvania
WM. LACY CLAY, Missouri CHRIS CANNON, Utah
DIANE E. WATSON, California JOHN J. DUNCAN, Jr., Tennessee
STEPHEN F. LYNCH, Massachusetts MICHAEL R. TURNER, Ohio
BRIAN HIGGINS, New York DARRELL E. ISSA, California
JOHN A. YARMUTH, Kentucky KENNY MARCHANT, Texas
BRUCE L. BRALEY, Iowa LYNN A. WESTMORELAND, Georgia
ELEANOR HOLMES NORTON, District of PATRICK T. McHENRY, North Carolina
Columbia VIRGINIA FOXX, North Carolina
BETTY McCOLLUM, Minnesota BRIAN P. BILBRAY, California
JIM COOPER, Tennessee BILL SALI, Idaho
CHRIS VAN HOLLEN, Maryland JIM JORDAN, Ohio
PAUL W. HODES, New Hampshire
CHRISTOPHER S. MURPHY, Connecticut
JOHN P. SARBANES, Maryland
PETER WELCH, Vermont
------ ------
Phil Schiliro, Chief of Staff
Phil Barnett, Staff Director
Earley Green, Chief Clerk
David Marin, Minority Staff Director
C O N T E N T S
----------
Page
Hearing held on February 12, 2008................................ 1
Statement of:
Shurin, Susan B., M.D., Deputy Director, National Heart, Lung
and Blood Institute, National Institutes of Health; Thomas
T. Perls, M.D., MPH, associate professor of medicine and
director, New England Centenarian Study, Boston University
School of Medicine; Alan D. Rogol, M.D., Ph.D., professor
of clinical pediatrics, University of Virginia, professor
of clinical pediatrics, Indiana University School of
Medicine, also representing the Endocrine Society; and Todd
Schlifstein, M.D., Department of Rehabilitation Medicine,
Hospital for Joint Diseases................................ 12
Perls, Thomas T., M.D.................................... 20
Rogol, Alan D., M.D...................................... 47
Schlifstein, Todd........................................ 52
Shurin, Susan B., M.D.................................... 12
Letters, statements, etc., submitted for the record by:
Cummings, Hon. Elijah E., a Representative in Congress from
the State of Maryland, prepared statement of............... 91
Davis, Hon. Tom, a Representative in Congress from the State
of Virginia, prepared statement of......................... 9
Lynch, Hon. Stephen F., a Representative in Congress from the
State of Massachusetts, letter dated February 5, 2008...... 77
Perls, Thomas T., M.D., MPH, associate professor of medicine
and director, New England Centenarian Study, Boston
University School of Medicine.............................. 22
Rogol, Alan D., M.D., Ph.D., professor of clinical
pediatrics, University of Virginia, professor of clinical
pediatrics, Indiana University School of Medicine, also
representing the Endocrine Society, prepared statement of.. 49
Schlifstein, Todd, M.D., Department of Rehabilitation
Medicine, Hospital for Joint Diseases, prepared statement
of......................................................... 55
Shurin, Susan B., M.D., Deputy Director, National Heart, Lung
and Blood Institute, National Institutes of Health,
prepared statement of...................................... 15
Waxman, Chairman Henry A., a Representative in Congress from
the State of California, prepared statement of............. 4
MYTHS AND FACTS ABOUT HUMAN GROWTH HORMONE, B-12, AND OTHER SUBSTANCES
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TUESDAY, FEBRUARY 12, 2008
House of Representatives,
Committee on Oversight and Government Reform,
Washington, DC.
The committee met, pursuant to notice, at 10 a.m., in room
2154, Rayburn House Office Building, Hon. Henry A. Waxman
(chairman of the committee) presiding.
Present: Representatives Waxman, Cummings, Tierney, Watson,
Norton, Sarbanes, Davis of Virginia, Shays, Issa, and Bilbray.
Staff present: Phil Schiliro, chief of staff; Phil Barnett,
staff director and chief counsel; Karen Lightfoot,
communications director and senior policy advisor; John
Williams, deputy chief investigative counsel; Sarah Despres,
senior health counsel; Steve Cha, professional staff member;
Earley Green, chief clerk; Teresa Coufal, deputy clerk; Caren
Auchman and Ella Hoffman, press assistants; Zhongrui ``JR''
Deng, chief information officer; Leneal Scott, information
systems manager; Miriam Edelman, staff assistant; Bret
Schothorst, special assistant; David Marin, minority staff
director; Jennifer Safavian, minority chief counsel for
oversight and investigations; Brian McNicoll, minority
communications director; Benjamin Chance, minority clerk; and
Jill Schmalz, minority professional staff member.
Chairman Waxman. Good morning. The committee will please
come to order.
For the last 3 years, our committee has been investigating
the use of performance-enhancing drugs in professional sports
and by high school children. A lot of developments have
surprised me but none more than the fact that there is a great
deal of misinformation and widespread confusion that surrounds
steroids, human growth hormone, vitamin B-12 and other
substances. Even highly paid, presumably sophisticated
professional athletes often seem to know the myths and not the
facts about these substances.
That's why we're having today's hearing. It's an
opportunity to provide essential and accurate information not
just to professional athletes, not just to high school kids but
to senior citizens, baby boomers turning 60 and everyone in
between.
In previous hearings, experts have testified about the
potentially deadly risks associated with steroid use. The side
effects range from serious damage to the heart and liver to
well-documented psychiatric problems. Steroids can be
especially dangerous for children by impeding normal
development and inflicting long-lasting harm. We will discuss
those issues again today, but we'll also focus on our long-
overdue attention on the growing use of other substances.
Senator Mitchell's report on the use of performance-
enhancing drugs in baseball found that the use of human growth
hormone by professional baseball players is rising. Just last
week, Sylvester Stallone seemed to be endorsing the use of HGH
to reverse the aging process. It's an unfortunate reality that
what professional athletes and celebrities do serves as a
health guide to millions of Americans.
Even worse, there seems to be an almost unlimited number of
unscrupulous scam artists ready to exploit this reality. Here's
an advertisement that we can see on the screen by GenF20 that
reads, HGH could actually prevent biological aging. It's like
your body is immune to the passage of time.
Here are the frequently asked questions from another
product, Growlean 15, that says, our product can be taken at
any age, safely, with no harmful side effects.
Well, if any of us search the Internet today, we would find
thousands of similar sites and a blizzard of confusing claims.
It's no wonder that so many are confused by the facts about
HGH. Today, we have a distinguished panel of experts who are
going to tell us, while there are appropriate uses for HGH,
there are also serious risks from abusing this powerful drug.
In adults, HGH is used to treat adult growth hormone
deficiency and the wasting syndrome of late-stage AIDS, both of
which are relatively rare. When HGH is used to treat these
conditions, there are extensive blood tests used to diagnose
the patient; and patients being treated with HGH are closely
monitored by physicians.
For children, HGH is approved to treat a few uncommon
conditions such as idiopathic short stature growth hormone
deficiency and chronic kidney disease. It's also used to treat
a few genetic diseases such as Turner Syndrome and Prader-Willi
Syndrome. In these cases, HGH can have a clear therapeutic
benefit.
But careful studies conclude that, when it comes to
reversing the aging process, HGH is more snake oil than cure.
In 2002, the National Institute on Aging sponsored the most
comprehensive single study of the anti-aging effects of HGH and
found marginal benefits and significant side effects. It warned
that HGH should not be widely prescribed and should be limited
to controlled research studies.
Another study, this one released in 2007 by researchers at
Stanford University, concluded that HGH cannot be recommended
as an anti-aging therapy.
Well, many athletes believe they get an edge by using HGH,
even though it is outlawed in all professional sports. They
think it can make them faster and stronger, and they also think
that it can help them heal more quickly. But there is only
limited scientific evidence to support these beliefs. In fact,
according to one expert, the best way to maximize growth
hormone production is to get 8 hours of sleep a night, not take
injections.
Today, we'll hear from our experts that the increase in
muscle mass that can result from taking HGH may actually be due
to water retention. There are real risks from the improper use
of HGH. Human growth hormone can elevate blood sugar levels and
cause diabetes. It can increase triglyceride levels in blood
which can contribute to heart disease. HGH can also result in
fluid retention, which then can cause swelling, joint and
muscle pain and carpal tunnel syndrome.
We know that HGH can cause problems, because it's actually
a disease where the body produces too much HGH. Doctors call
that disease acromegaly. It can lead to diabetes, heart
problems, liver problems, kidney problems, cancer and even
death.
It can also cause permanent changes in the face. We know
what these changes look like. The pro wrestler, Andre the
Giant, died of complications of untreated acromegaly; and
Richard Kiel, better known as Jaws from the James Bond movies,
has publicly spoken about his experience with this disease.
There are also cases where bodybuilders are injecting such
large doses of HGH that they are seeing some of these same
problems.
HGH purchased from the Internet may carry additional risks.
It may not be made in FDA-approved plants, and it may not even
be HGH. In many cases, it is contaminated with other drugs,
including steroids.
Because of these dangers, HGH is subject to special
scrutiny by the Food and Drug Administration. HGH is unique in
that doctors are actually prohibited from prescribing it for
any use that has not been specifically approved by the FDA.
This means the doctors who are prescribing the drug to enhance
performance or to reverse aging are actually breaking the law.
We will also focus today on the use of injectable vitamin
B-12. There seems to be a widespread myth that B-12 injections
can increase energy, fight off colds and generally promote good
health. The reality is that B-12 injections are useful for
those who suffer from pernicious anemia or have difficulty
absorbing B-12 from their food or B-12 tablets. For everyone
else, injectable B-12 appears to be an unnecessary needle and a
waste of money.
When we began our investigation into steroids in baseball 3
years ago, the committee's primary focus was the health of
teenagers who emulate their sports heroes. That remains our
focus, and that's why this hearing is so important. But, beyond
teenagers, we have these widespread myths that are leading
others to use these drugs and wasting their money and may be
jeopardizing their health.
I want to thank our witnesses for being here today, and I
look forward to their testimony. I will introduce them in a
minute. But I want to call on Ranking Member Tom Davis for his
opening statement.
[The prepared statement of Chairman Henry A. Waxman
follows:]
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[GRAPHIC] [TIFF OMITTED] T7428.003
Mr. Davis of Virginia. Mr. Chairman, thank you very much
and thank you for your leadership and for holding the hearing
today.
Athletes at all levels, from the sandlot to the Super Bowl,
look for an edge, that little something extra that could mean
the difference between winning and losing. Advances in training
equipment and nutrition offer modern competitive paths to
strength, skill and longevity not available to previous
generations, but that high-pressure quest for physical prowess
has also spawned a thriving subculture of claims hyping the
benefits and downplaying the risks of everything from vitamin
supplements to steroids. Today, we try to sort through some of
those claims, focusing our discussion on two substances much in
the news lately, human growth hormone [HGH], and vitamin B-12.
The committee's 3-year bipartisan investigation of
performance-enhancing substance abuse in professional sports
uncovered an industry dangerous and tolerant of pseudo-science
and medical mysteries in its locker rooms. The Mitchell Report
added to that picture, making clear that, while steroid abuse
continues to be a concern, the newest trend is HGH abuse,
alleged to speed recovery from injuries and building muscle
mass.
Without question, those attempting to market or distribute
HGH claiming it will aid, heal, slow or reverse the aging
process, assist in weight loss or cure depression are scamming
consumers and breaking the law. These crass moneymaking schemes
play on vanity and promise scientifically unproven results,
while openly promoting unapproved uses of a serious biological
therapy.
Synthetic HGH is approved by the Food and Drug
Administration for a limited number of scientifically supported
uses: children with growth hormone deficiency; wasting
associated with HIV and AIDS; and, in rare instances, adult
growth hormone deficiency. For these indications, HGH is an
important therapy for real medical needs. But even when used
appropriately, HGH is not without possible long-term side
effects, including an increased risk of diabetes, carpal tunnel
syndrome, nerve pain, hypothyroidism, arthritis and cancer.
No long-term clinical studies have been conducted on the
effects of HGH in healthy adults or in anyone with doses
exceeding the FDA approved levels, and those are only the known
risks associated with the abuse of real HGH. Even the quickest
Internet search produces countless advertisements for
nonprescription or dietary supplement HGH and pills, sprays and
topical creams. Consumers ordering these products run the risk
of putting counterfeit, contaminated or altered substances in
their bodies.
It's impossible to differentiate legitimate drugs from
fakes by just looking at them. Best case, gullable people are
only being scammed out of their money; worst case, they are
placing their health in the hands of criminals who could be
operating beyond the reach of our laws anywhere in the world.
B-12 abuse involves similar scams but admittedly fewer
risks. The vitamin is essential for normal nervous system
function and blood cell production. For most people, a balanced
diet captures adequate amounts of B-12. Injections of
additional B-12 under the supervision of a physician can be
therapeutic for patients diagnosed with a specific vitamin
deficiency or anemia. But there's no reliable evidence to prove
or even suggest B-12 injections given to healthy people produce
increased energy, aid in weight loss or improve athletic
performance. Nevertheless, Web sites, anti-aging centers and
so-called sports medicine experts continue to flout the law and
promote unproven unapproved uses for HGH, B-12 and a variety of
other products.
Hearings like this have to be but one part of a much larger
effort involving parents, coaches and health providers to
educate consumers, especially young people, about the gauzy
myths and harsher realities of HGH, B-12 and other alleged
pharmacological shortcuts to athletic success. That in the end
is what makes this oversight so important, preventing drug
abuse and other physically damaging activities by young
athletes. Even tacit acquiescence by professional sports
franchises and locker room malpractice and quackery glamorizes
harmful, even illegal practices that young impressionable
aspirants are bound to mimic. In that respect, HGH and B-12 can
be seen as gateway drugs to steroid abuse.
We have to find a way to block transmission of that false
incentive and convince young athletes there are no magic pills
or wonder drugs that will grease the path to the hall of fame.
Only hard work and the most effective antidote to illicit
drugs, the truth, should fuel the bodies and minds of those
seeking athletic excellence at any level.
Today's witnesses bring invaluable expertise to our
oversight, and we appreciate their willingness to testify. I
look forward to a frank and informative discussion of the myths
and realities of performance-enhancing drugs.
Thank you, Mr. Chairman.
[The prepared statement of Hon. Tom Davis follows:]
[GRAPHIC] [TIFF OMITTED] T7428.004
[GRAPHIC] [TIFF OMITTED] T7428.005
Chairman Waxman. Thank you very much, Mr. Davis.
Our panel of witnesses today:
Dr. Susan Shurin. Dr. Shurin is the Deputy Director of the
National Institutes of Health's National Heart, Lung and Blood
Institute. She's an expert in pediatric hematology and
oncology.
Dr. Thomas Perls is an attending physician in the
geriatrics section at Boston Medical Center. He is also a
visiting scholar at the gerontology department at Boston
University and has published a number of peer-reviewed articles
about aging and also about anti-aging medicine.
Dr. Alan Rogol is a practicing pediatric endocrinologist in
Charlottesville, VA. He is also a professor of clinical
pediatrics at the University of Virginia and a professor of
clinical pediatrics at the Indiana University School of
Medicine. Today, he's representing the Endocrine Society. Among
his patients are children who are being appropriately treated
with human growth hormone, and he is an expert on the effects
of HGH on children.
And Dr. Todd Schlifstein. Dr. Schlifstein practices sports
medicine in New York City and treats athletes, among others. He
is an attending physician at both the RUSK Institute of
Rehabilitation Medicine at New York University School of
Medicine and also at the Orthopedic Institute of New York
University School for Joint Disease. He is an assistant
professor at the New York University School of Medicine.
We're pleased to have each of you here today. It's the
practice of this committee that all witnesses testify under
oath. So if you would please rise and raise your right hands.
[Witnesses sworn.]
Chairman Waxman. Thank you.
The record will indicate that the witnesses answered in the
affirmative.
Your prepared statements will be in the record in its
entirety. What we'd like to ask each of you to do is be sure
the button of the mic is pressed so that it's on and then try
to limit your oral presentation to us to around 5 minutes.
There's a little clock sitting there; and it will be green
for 4 minutes, yellow for the last minute. And when it turns
red it will indicate to you that the 5 minutes are up, and we'd
like you to then be sure to summarize your statement.
Dr. Shurin, why don't we start with you.
STATEMENTS OF SUSAN B. SHURIN, M.D., DEPUTY DIRECTOR, NATIONAL
HEART, LUNG AND BLOOD INSTITUTE, NATIONAL INSTITUTES OF HEALTH;
THOMAS T. PERLS, M.D., MPH, ASSOCIATE PROFESSOR OF MEDICINE AND
DIRECTOR, NEW ENGLAND CENTENARIAN STUDY, BOSTON UNIVERSITY
SCHOOL OF MEDICINE; ALAN D. ROGOL, M.D., PH.D., PROFESSOR OF
CLINICAL PEDIATRICS, UNIVERSITY OF VIRGINIA, PROFESSOR OF
CLINICAL PEDIATRICS, INDIANA UNIVERSITY SCHOOL OF MEDICINE,
ALSO REPRESENTING THE ENDOCRINE SOCIETY; AND TODD SCHLIFSTEIN,
M.D., DEPARTMENT OF REHABILITATION MEDICINE, HOSPITAL FOR JOINT
DISEASES
STATEMENT OF SUSAN B. SHURIN, M.D.
Dr. Shurin. Mr. Chairman, members of the committee, thank
you for the opportunity to appear before you in my capacity as
Deputy Director of the National Heart, Lung and Blood
Institute, which is part of the National Institutes of Health,
an agency of the Department of Health and Human Services. I'm
here today to discuss the current state of the science of
vitamin B-12 and to briefly outline what we know about vitamin
B-12 deficiency and the administration of vitamin B-12 to
healthy persons.
A vitamin is a chemical substance that is required for a
particular chemical reaction in the body but is not synthesized
by the body and therefore needs to be included in the diet. The
dietary requirements for normal function are usually relatively
small. Most vitamins that are known today were recognized
because their deficiency causes recognizable diseases.
Examples, for instance, would be scurvy, caused by a deficiency
of vitamin C, which ultimately motivated British sailors to
carry limes onboard ship, and beriberi, which is caused by a
deficiency of thiamine, or vitamin B1.
Supplemental vitamins are usually not required by people
who have varied, well-balanced diets and normal metabolism.
However, supplements are often advisable for people who are on
limited diets or have increased requirements for vitamins, such
as pregnant women and growing children. Moreover, a number of
gastrointestinal diseases can interfere with absorption of
vitamins and cause deficiencies even in people who have
adequate dietary supplies.
Vitamin B-12 is required for a number of vital biologic
reactions. Two of its most important roles are in the
production of components of DNA and in the proper functioning
of different parts of the neurologic system. Tissues in which
cells are constantly dividing, such as bone marrow and the
lining of the entire gastrointestinal and respiratory tracts,
require a constant supply of vitamin B-12. Normal function of
cells throughout the nervous system and spinal cord also
requires vitamin B-12.
Vitamin B-12 comes from animal products and from bacteria.
The stomach produces a factor that binds to the vitamin in food
and allows it to be absorbed in the small intestine. Therefore,
the primary causes of vitamin B-12 deficiency are dietary
deficiency and malabsorption.
Diets that lack food from animal sources tend to be low in
vitamin B-12. Strict vegans, for instance, need a source of
vitamin B-12. However, it can take 5 years for someone with
adequate stores of vitamin B-12 to develop a deficiency after a
major change in diet.
Diseases of the stomach and small intestine can cause
problems with absorption and consequent vitamin B-12
deficiency. Some people make antibodies to the cells that
produce the stomach factor which is necessary for absorption of
B-12 and therefore cannot produce the factor. As a result, they
develop a condition called pernicious anemia, to which
Representative Waxman, referred which can cause a decrease in
the number of blood cells. Extensive bowel resections, removal
of much of the stomach or inflammatory bowel disease can also
cause vitamin B-12 deficiency. In all of these conditions, they
need to be treated with monthly B-12 injections, because the
vitamin cannot be absorbed from food or pills without the
stomach factor.
B-12 deficiency has several major manifestations. A very
characteristic anemia, in which the red blood cells are larger
than normal, may progress to include low numbers of white blood
cells and platelets. The symptoms of anemia include fatigue and
shortness of breath on exertion. The lining of the mouth and
the gastrointestinal tract can be thin and abnormal. The
neurologic symptoms are particularly serious and may be hard to
recognize.
Difficulty with position sense, nerve damage, depression,
memory loss and dementia are seen with vitamin B-12 deficiency,
even when the hematologic manifestation are not obvious.
Recent studies have highlighted the value of screening for
vitamin B-12 in older people with mild dementia. B-12
deficiency in older individuals is probably related to changes
in the GI tract with aging and fairly limited diets. Both
problems appear to be more common with advancing age. For this
reason, the 2005 Dietary Guidelines for Americans recommends
that persons over 50 consume vitamin B-12 in its crystalline
form, such as fortified pills or pills. Pernicious anemia is
most common in older women, who must receive vitamin B-12 by
injection.
Diagnosing mild cases in B-12 deficiency can be difficult.
While looking for low B-12 levels can be useful for diagnosis
of severe deficiency, serum levels of folate, homocysteine,
methylmalonic acid, 2-methylcitric acid and cystathionine can
help make the diagnosis in milder cases.
The only medical indications for administration of vitamin
B-12 are deficiency of a vitamin or risk factors for developing
such deficiency, such as stomach or bowel disease or a limited
diet.
Some manufacturers and distributors of dietary supplements
may claim that vitamin B-12 administration will improve energy
levels, memory, concentration and mood. All of these are true
when the person has vitamin B-12 deficiency and are treated
with B-12. However, there is no evidence at all that these
clinical benefits occur when the vitamin is given to people who
are not deficient.
Vitamin B-12 is not toxic when given to nondeficient
persons. It is simply excreted in the urine. So you don't
buildup your stores beyond a certain level. Administration of
vitamin B-12 does not enhance physical or cognitive function of
persons who are not B-12 deficient.
Thank you for the opportunity to provide information on
this topic. I'd be happy to answer any questions the committee
may have.
Chairman Waxman. Thank you very much, Dr. Shurin. We're
going to have questions after all the witnesses testify.
[The prepared statement of Dr. Shurin follows:]
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Chairman Waxman. Dr. Perls.
STATEMENT OF THOMAS T. PERLS, M.D.
Dr. Perls. Thank you, Chairman.
Chairman Waxman. Be sure the mic is pulled up close to you
and that it's on.
Dr. Perls. What is growth hormone? Human growth hormone
[HGH], is produced by a pea-sized endocrine gland near the base
of the brain called the pituitary gland. Its primary utility
relates to growth in the height of children.
What about deficiency in adults? Human growth hormone
levels gradually decline in adults with minimal or no negative
health consequences for the vast majority of the population
with aging. The anti-aging industry, the primary pusher and
seller of growth hormone in this country, advertises that
normal declines of growth hormone causes decreases in strength,
muscle mass, sleep and sexual performance and a long list of
other attributes. They go on to claim that replenishing growth
hormone to levels present at younger age stops or reverses
these problems as well as aging itself. This is a ruse.
There are few medical conditions in adults that merit the
use of growth hormone. Recognizing the potential for growth
hormone abuse, Congress amended the Food Drug and Cosmetic Act
in the late 1980's and the early 1990's, stipulating that
growth hormone can be distributed to adults for only three
specific indications approved by the Secretary of Health and
Human Services. These are: AIDS Wasting Syndrome, Short Bowel
Syndrome and Growth Hormone Deficiency, also called Adult
Growth Hormone Deficiency Syndrome.
Growth Hormone Deficiency is very rare, occurring at a rate
of about 1 adult per 10,000; and the legal diagnosis requires
documentation of disease, such as a cancer or trauma to the
pituitary gland and a failed stimulation test. Oftentimes,
Growth Hormone Deficiency is accompanied by deficiencies of
other pituitary gland-produced hormones.
In January 2007, the FDA released an alert reminding those
that distribute growth hormone for anti-aging body building and
athletic enhancement that they are doing so illegally. I have a
copy of that at the end of my prepared remarks.
A recent Stanford University review of 31 clinical studies
of growth hormone used among healthy, normal aging adults found
the only benefit to be a slight increase in muscle mass. The
documented negative side effects include soft tissue swelling,
joint pains, carpal tunnel-like syndrome, breast enlargement
and diabetes. Other side effects include liver and heart
enlargement, increased pressure around the brain and high blood
pressure.
In a 2002 Johns Hopkins study published in JAMA, about 50
percent of subjects experienced side effects, primarily joint
pains; and 13 percent developed elevated blood sugar levels or
even diabetes.
Recent studies demonstrate strong associations between
growth hormone and prostate, colon and breast cancers. In
another study, investigators found that growth hormone enhances
the ability of cancer to spread. It is theoretically possible
that normal declines of growth hormone with age may actually be
protective against cancer.
Ironically, there's no credible evidence that growth
hormone substantially increases muscle strength or aerobic
exercise capacity in normal individuals.
What about the illegal and medically inappropriate
distribution of growth hormone? Since 1990, a growing network
of compounding pharmacies, anti-aging clinics and physicians
have created what some within the industry estimate is a $2-
billion-a-year business for distributing growth hormone--a
distribution network involving hundreds of thousands of weight
training enthusiasts, practitioners and promoters of anti-aging
medicine and those who have fallen victim to the growth hormone
replacement scams.
I personally have found Web sites of 279 anti-aging clinics
that advertise growth hormone treatment and 26 pharmacies or
what are called ``compounding pharmacies'' that distribute the
drug to these clinics and sometimes directly to users. I
certainly discovered only a fraction of what exists out there.
There's a map at the end of my remarks that spell out the
number of some of these entities per State.
Of the seized anti-aging clinic records I have reviewed for
the DEA, the average patient that first presents to the clinic
is not a person in their 60's or 70's seeking alleviation of
their age-related problems but, rather, a male in their late
20's to mid 40's, weight training nearly daily, in otherwise
excellent health, clearly seeking anabolic steroids and growth
hormone.
In summary, one, experts in the care of patients with
growth hormone related problems clearly state that giving
growth hormone for anti-aging or age management is not
medically appropriate, particularly when weighing the potential
benefits versus risks.
In this modern day and age, we have witnessed the re-
emergence of the health and longevity salesman. Many members of
the public have been misled to believe in the magical powers of
growth hormone and, because of the associated risks and other
drugs typically sold along with growth hormone, this is a major
health problem. The cash-only business of Web sites or clinics
working closely together with compounding pharmacies to turn
huge profits, the national and international organizations
promoting the illegal use of the drug, and drug companies
turning a blind eye to how and to whom their product is
distributed bear similarity to what some investigative
reporters have likened to a narcotics trafficking ring.
Thank you.
Chairman Waxman. Thank you very much, Dr. Perls.
[The prepared statement of Dr. Perls follows:]
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Chairman Waxman. Dr. Rogol.
STATEMENT OF ALAN D. ROGOL, M.D.
Dr. Rogol. Good morning, Mr. Chairman and members of the
committee. I am pleased that the committee has taken the time
to examine this issue as hormone abuse and misuse has long been
a concern to the Endocrine Society and its membership. The
Endocrine Society's is the world's largest and most active
professional organization of endocrinologists, representing
over 14,000 members worldwide. We are dedicated to quality
research, patient care and education.
Growth hormone is a natural hormone made by the pituitary
or master gland. Once it circulates in the blood, growth
hormone travels to bone, muscle and other tissues where it has
many growth-promoting or anabolic effects and metabolic
effects. In children, for example, growth hormone stimulates
lineal growth or height. It is also important for the
development of muscle and bone and the distribution of body fat
throughout the body. In adults, growth hormone affects energy,
muscle strength, bone health and psychological well-being.
Having either too much or too little growth hormone can cause
health problems.
The most common efficacy outcome for the use of growth
hormone is an increase in linear growth. Growth hormone therapy
employing replacement doses and modestly high doses is very
safe. Very large data bases have noticed only minimal increases
in scoliosis and slipped capital femoral epiphysis, both likely
due to rapid growth and can occur in any therapy that promotes
rapid growth or just during normal puberty.
The single most serious side effect is increased
intercranial pressures and visual disturbance, which usually
occurs in the first month of therapy as the kidney is re--
learning how to handle salt and water. Stopping growth hormone
therapy for a few days and then beginning again at half dose is
usually all that is necessary to combat these side effects.
Growth hormone is also administered by physicians to
promote psychological well-being and alter body composition in
adults, as Dr. Perls has mentioned.
Now I want to address the off-label uses of growth hormone.
Off-label use usually occurs in adults in two main spheres, the
anti-aging market and the body image or athletic market.
It should be noted that off-label use comes with increased
risk. One risk factor is that most off-label users are usually
unaware of the correct doses, at least for athletes, and one
can only assume that the doses administered to athletes must be
very much greater than those used for the legitimate uses noted
above. As I am sure you are aware, increased doses often mean
increased risk.
With increased doses one might get into the range of
acromegaly, as was mentioned. In children with growth potential
this may cause gigantism, but I am unaware of anyone being able
to take these doses--and actually pay for them--in the athletic
sphere as teenagers. It should be noted that acromegaly is a
serious disease with weak muscle and very significant heart
disease.
Perhaps the most insidious off-label use is by athletes who
are told they are receiving growth hormone but may actually be
receiving a different substance or substances. Growth hormone
is an injectable medication. Magazines and the Internet are
replete with advertisements for growth hormone. Many of these
preparations are taken orally and cannot be the protein hormone
HGH, for it is not active by this route. Most likely, they
contain amino acids, which do release growth hormone but
usually only in much larger doses and given intravenously.
In fact, the amino acid arginine is administered as a test
for growth hormone sufficiency. Most of the releasers are water
soluble compounds and are excreted in the urine, with the main
side effect being expensive urine. Some of the compounds
purported to be growth hormone may have many ingredients,
including anabolic steroids or steroid precursors in unknown
quantities and the entire preparation of unknown purity and
with multiple safety concerns. Longer term use of this anabolic
agent may promote tumor growth.
In addition, the vast majority of clinically administered
growth hormone is made by recombinant DNA techniques and thus
not from human tissue. Growth hormone made from human tissue
has been largely removed from the market because of a rare but
fatal disease called Creutzfeldt-Jacob. Some of the growth
hormone now available clandestinely is of human origin and may
carry this biological agent.
Also worth noting is that, as with any injectable, one is
at risk for diseases of shared needles: Hepatitis and HIV/AIDS,
both of which are serious and may be fatal.
In summary, there are a number of FDA-approved uses of
growth hormone in children and adults. These do not include
anti-aging or improvement in athletic performance. The larger
the dose of growth hormone administered, the more likely
moderate and serious side effects may occur.
Mr. Chairman, thank you.
Chairman Waxman. Thank you very much, Dr. Rogol.
[The prepared statement of Dr. Rogol follows:]
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Chairman Waxman. Dr. Schlifstein.
STATEMENT OF TODD SCHLIFSTEIN, M.D.
Dr. Schlifstein. Good morning. Thank you.
Not to be redundant, I'm going to focus in on the efficacy
or the lack of efficacy of human growth hormone in regards to
performance-enhancing ability or as a performance-enhancing
drug.
As a performance-enhancing drug, human growth hormone is
believed to increase energy, maintain or increase lean body
mass, meaning the muscle-to-fat ratio in the body, help energy
and muscles recover and help recover from previous injuries. It
has only been shown to increase lean body mass, meaning the
muscle-to-fat ratio. Studies have shown the benefits of human
growth hormone healing from an injury have not been done or
done well, and there's no shown benefit or efficacy of it as a
healing agent for recovery from surgery and/or trauma. However,
I have seen individual case evidence of that, yes.
When human growth hormone is used in combination with
anabolic steroids, the effects of the steroids are believed to
be amplified or improved. The combined use of anabolic steroids
with human growth hormone together have shown increased muscle
mass, speed and size. However, when the human growth hormone
and the steroids combined were compared to studies were just
using the steroids alone, it was very similar improvements,
meaning, it was a questionable benefit whether the human growth
hormone added upon the anabolic steroids really didn't really
improve increased muscle mass, size and speed.
For example, test performance enhancements really typically
means a repeatable exercise activity of like a bench press
which you would do and then 6 weeks later, without practicing,
do it again, 6 weeks again, to see if there's any improvement
benefit from beginning to end without practicing, doing that
activity.
When human growth hormone was tested by itself and in that
short interval of 6 weeks, it was not shown to improve any
functional compacitants or functional benefit gained during
that time period when used alone. When used with anabolic
steroids, it was a benefit, but it was very similar to the
amount of benefit that was gained with using the anabolic
steroids by itself.
There are a lot of limitations in the medical literature
currently available looking at human growth hormone as a
performance-enhancing drug, as a healing agent. Most of these
studies were looking at it only in the short term. There's no
studies really looking at somebody using human growth hormone
in another capacity, which is looking at human growth hormone
in combination with steroids, but someone who is cycling on
steroids and then cycling off but still maintaining usually the
human growth hormone. Meaning if they're taking both together
in a cycle which could be anywhere from 6 to 12 weeks of the
anabolic steroid, when completing that cycle, in order to come
off that, cycling off that and then maintaining the use of the
human growth hormone, the believed benefit is to hopefully help
maintain or prevent loss of that muscle mass gained when using
the anabolic steroid with the human growth hormone. It may
delay loss of muscle mass or strength during that time period
but really fails to maintain them at the same level when using
the human growth with the anabolic steroid in combination.
As regards to healing from injuries, we know that it does
have a direct effect on bone tissue and case reports of faster
healing of fracture injuries with doses of human growth hormone
have been out there but no clinical evidence in a study-based
format. However, there was also a believed potential benefit in
users of it in young athletic patients that they have more
energy, which hasn't really been assessed and is difficult to
measure. Improving soreness and recuperation from a workout,
meaning are they able to work out better and harder because
they are able to recuperate faster? And no assessment of how
much soreness or prevention of lactic acid buildup and
prevention of soreness and muscle pain after a workout to allow
to work out again. There's questionable benefit from that
respect as well.
Certainly the side effects of human growth hormone are
plentiful, as previously discussed; and many of these people
who were self-treating themselves and using human growth
hormone in this manner as a performance enhancer are finding
out the side effects by titrating it and then, once they get
the side effect, backing off.
We do see acute onset of carpal tunnel, large hands,
swollen hands, numbness, tingling from acute onset, meaning
they're taking too much. We do get joint pain, muscle pain,
joint swelling, enlargement of the joints, especially the
fingers and knuckles. As the bone grows and it grows wider, as
the growth plates already--and doesn't elongate anymore, you
get excessive bone growth, which is not only causing problems
in the short term but we're seeing patients with much earlier
and much more advanced degenerative or osteoarthritis formation
in these joints. The bones are overgrowing tremendously and
can't take that strain and wear and tear.
Yes, we've seen incidences of patients with getting
elevated blood sugars and continuing elevated blood sugars from
the fact they're treating themselves with insulin in order to
get their sugars under control and, in cases, turning
themselves into diabetics. Quite often, on a lot of these Web
sites you'll see adjunct medications, meaning medications to
control side effects, sold right next to the place where
they're selling the human growth hormone, where they're selling
insulin, they're selling Lasix so you get rid of the excess
water--it's a diuretic--painkillers for joint pain and
stiffness, anti-inflammatories, pain medicine, anti-anxiety
medication, and then other medication to help them wake up
after sleeping well. Sleeping well is important for anyone who
works out regularly, because that's when your body tends to
heal more; and getting enough sleep certainly helps them
maintain muscle mass as well.
So, with anything you inject, there's a risk of skin
infection, cellulitis, abscess formation, fibrosis scar tissue,
which I have seen. I have seen a lot of it. After a while, they
start running out of places to inject themselves because
there's so much scar tissue in there. Having to have areas
resected because there's fluid collections in there, especially
with anabolic steroids that are oil based because they don't
dissolve. They really don't break down, and they tend to sit
there and get infected chronically and have to be resected.
When patients are treating themselves or self-treating
themselves, then they're usually using multiple poly pharmacy
techniques in order to control or limit some of the side
effects in order to maintain the supposed benefits of using
those drugs.
Also, with a tremendously large fraudulent market--meaning
a fake product--out there, there's a lot of other drugs that
are being used in replacement of the human growth hormone
that's very hard to distinguish between the two by looking at
it. Most of the companies--pharmaceutical companies that
produce this and legitimately produce this, you have on their
Web sites ways to detect fraudulent market or fake products,
because they're very hard to distinguish. They're very well
done, and they're changing all the time in order to keep ahead
of the market.
Quite often, it's HCG which is very inexpensive and easy to
get. HCG is sometimes used by people who are on anabolic
steroids but are tapering off a cycle. It helps simulate your
body to help produce more hormones itself. So they taper off.
They don't bottom out completely from having a low testosterone
level. So they get a little benefit in feeling like it's
working, but it's really not doing much. And then, also, it's
sometimes combined with an anabolic steroid, so they really
think they're getting a benefit where they're really not
getting a benefit from that.
Chairman Waxman. Dr. Schlifstein, let me stop you there,
because I wanted to ask some questions.
[The prepared statement of Dr. Schlifstein follows:]
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Chairman Waxman. I wanted to start the questions for the 5
minutes that each Member will have.
We pay a lot of attention on steroids because steroids does
enhance performance. Isn't that accurate?
Dr. Schlifstein. Yes, that's an accurate statement.
Chairman Waxman. But it has very dangerous side effects.
And we know that, if children use it, it can even cause
psychiatric problems as well as other medical problems. There's
also a test. So if an athlete is using a steroid, it can be
detected in the urine.
Human growth hormone, on the other hand, cannot be detected
by any tests that we know of at the present time. Isn't that
accurate?
Dr. Schlifstein. Yes. At the present time, there's pending
stuff working----
Chairman Waxman. People are working on it. But some
athletes believe that if they use human growth hormone, it's
going to increase their performance and they won't get caught.
Dr. Schlifstein. Right.
Chairman Waxman. Are they mistaken? Does it increase their
performance?
Dr. Schlifstein. Well, the reason it has that appeal that
way is because you can't detect it; and if you are on like a
steroid and you stop it, you try to falsely inflate yourself
into thinking you're going to maintain the benefits you have
gotten from the steroids and hopefully make it longer lasting.
It may help a little bit in the short term, but that effect I
think will be very short lived.
Chairman Waxman. That's a short term in conjunction with
steroids.
Dr. Schlifstein. Right. As it tapers off, you want to try
and hold onto that benefit because it's really not going to----
Chairman Waxman. A lot of them are using it instead of
steroids.
Dr. Rogol, there is this widespread belief that using human
growth hormone can increase your muscle mass. Does it make you
faster? Does it make you stronger?
Dr. Rogol. Well, this is the second time--that's two out of
three for the Olympics: ciltius, altius and fortius--higher
stronger and faster. And the answer is, probably not by itself.
So as you look at Sylvester Stallone and say that's a different
body for a 61-year-old man, he may very well have been taking
growth hormone, Jintropin, that he said he was taking. None of
us in this room knows what else he was taking; and I think it's
the ``what else,'' meaning anabolic steroids, that made the
difference.
There is, sir, no question that there is a lipolytic, that
is, fat breakdown effect and mild anabolic effect. So if you're
a bodybuilder and you want that ripped look, that might make
sense. But that's about the only place. There are no studies of
people who are honest-to-goodness growth hormone deficient
given growth hormone legitimately that shows that their
strength is very much better and certainly no performance data,
sir.
Chairman Waxman. Well, some people believe it's going to
make them more ripped and stronger and faster and more able to
perform. What risks are they taking?
Dr. Rogol. Well, if you are an adult--most of them have
been mentioned by the two gentlemen who flank me. The major
risks are, first of all, early on, the edema, muscle aches,
joint aches. And remember, sir, these are anabolic hormones.
They lead to the production of insulin-like growth factor one,
IGF-1, which is really pro growth of tumors. So the aging
population, whether it's men like we are and prostate cancer or
women with breast cancer, harbor smaller, earlier tumors than
the older people; and this may just lead to their growth.
Theoretical to be sure. But absolutely true in vitro. In
addition, can show the effects of growth hormone but especially
IGF-1 on that particular biological effect.
Chairman Waxman. Dr. Perls, you know a lot about human
growth hormone. If a young athlete were asking you whether you
should take it because he thinks it will increase his muscle
mass, lower his fat and help him be a better athlete, what
would you say?
Dr. Perls. First, it's certainly not worth the risk; and,
second, you know that I would hope that he would go about these
things in an honest way. One of the dangers of the athletes or
entertainers taking this stuff is providing a very bad example
for all these young people certainly. There are no clinical
studies showing the long-term risk in terms of cancer, but
certainly short-term studies show that there is substantial
risk.
I think kind of the bigger picture is is that we have an
anti-aging industry and other areas of the market that do an
unbelievably good job of marketing an incredible false sense of
safety and an incredible false sense of tremendous benefits
from these drugs; and out of that comes a huge amount of money,
$2 billion a year, for these hucksters.
I think that there's--you know, if you look at the
Internet, blogs where a lot of these athletes or bodybuilders
are discussing what to do in terms of the recipes and cocktails
and what have you, everybody's just kind of playing a guessing
game, saying this works, this works, this doesn't work, don't
do this because you'll get caught. It's almost like a cult-like
presence, and nobody is really like making any decisions with
the help of caring physicians like from the Endocrine Society
or elsewhere that really understand the risks and benefits.
Chairman Waxman. They're not relying on the science;
they're relying on mythology. Is that correct sir?
Dr. Perls. And it's almost how much of this is placebo.
Again, they're not just a danger to their bodies. It's a huge
danger to their pocketbook. And a lot of the people that are
taking this stuff, they're not getting the lab tests. They're
not being well followed.
So they are really in danger of developing really
significant heart disease, for example. Not so much from the
growth hormone, but I very rarely have ever saw growth hormone
taken in isolation. It's--you're almost always given it with a
lot of other drugs, anabolic steroids, HCG, Eliminex, all kinds
of drugs. So it's really amazing to me that they can take all
these things. They're not getting followed by any lab tests.
They're not really being followed by a physician. They're
really putting themselves in significant danger.
Chairman Waxman. Thank you very much.
Mr. Davis.
Mr. Issa. Thank you, Mr. Chairman.
I guess I'll start off with B-12, since that's a relatively
new part of our investigation.
Dr. Shurin, you spoke mostly on B-12. Let me ask it, if you
will, on behalf of the vitamin industry. Medical professionals
thought, by and large, will tell us that the--whatever it is--
several billion dollar industry, from One a Day to every other
vitamin, just gives you expensive urine. Is that a
generalization that it's pretty darn accurate that the medical
industry and the science industry and certainly pharma tells us
that there's very little benefit to most vitamins, particularly
oral?
Dr. Shurin. Yeah. I think the shotgun approach, in which
you just give lots of vitamins because, for the most part, more
doesn't do you any harm--there are situations in which it does.
People tend to take it rather than or figuring out how to eat a
balanced diet, how to get vitamins in the ways that are far
better for their bodies.
Mr. Issa. The medical profession tends to give antibiotics
without knowing exactly what the infection is.
Dr. Shurin. It happens all the time, yes.
Mr. Issa. The reason why I want to focus on that, from a
practical standpoint, B-12 is simply another vitamin that a
vast, vast number of people believe will help them.
Dr. Shurin. Right.
Mr. Issa. Now I happen to have a mother who, during most of
her pre-menopausal days, was getting various vitamin B-12
supplements by injections by my own first cousin who was a
family doctor who thoroughly believed that this was something
that was helpful for her persistent anemia. He may have been
right. He may have been wrong. But I grew up with those
injections.
Is there any reason for this panel to get involved in a
multibillion dollar industry and debate the merits of vitamin
supplements in general here today that would be--where we would
be effective? We have in the past weighed in, both this
committee and the chairman's other committee and my other
committee, the Energy and Commerce Committee. We have gotten
involved in the vitamin industry; and, at the end of the day,
it's still a conundrum. Would you say that is roughly correct?
Dr. Shurin. Yeah.
There are several issues here. One is that many of the
vitamins--certainly, the evolution of discovery of these
vitamins is people gave cocktails, like all the B vitamins sort
of came together, and so you could only give them together. And
then, as you've dissected out, we now have a lot more
components. So it's a common practice for many older
practitioners to give these sort of cocktails.
The biggest danger for situations in which they're given
without a clear understanding of what you are giving them for
is you may not--if you actually have a problem, is you may not
be making the underlying diagnosis.
For instance, one of the common situations as you are
describing with your mother is that the person may have a mild
hematologic disease, such as beta thalassemia minor, which is
an inherited blood disease that doesn't get better no matter
what you give. And the biggest problem is that there's an
anxiety that's associated with it because I've got anemia and
is that--does that mean that there's something serious?
The vitamins themselves generally don't hurt. Excess iron,
of course, can hurt.
I would say that the major damage that's done is the
failure to diagnosis and to treat significant problems and then
just the costs.
Mr. Issa. OK. And because so much of our hearings have
focused on athletics, I'm going to assume for today that the
taking of vitamins by athletes of all levels probably is so
benign as to not be a major part of what we should be looking
into today. Rather, steroids and human growth hormone are.
Which brings up a real point that I'd like to make in the
remaining time.
It appears as though this committee's good work under both
the chairman and ranking member have led to professional and
amateur athletics doing testings for steroids, and I think that
we should all be very proud that's happened and happened
without legislation. However, it appears that since there's no
test for human growth hormone and it appears as though there is
a legitimate--I'm going to rephrase that--there is a reason
that people would think that it works as part of an ongoing
attempt to evade detection, that we need--this committee needs
to look at the development of a test for human growth hormone,
perhaps federally funded.
And, last, if--and anyone can answer that disagrees--
whether Sylvester Stallone, Jesse Ventura, Arnold
Schwarzenegger or Hulk Hogan--two of whom became Governors. It
appears as though there is, unfortunately, a tendency for the
good-looking body on the runway to be part of both steroids and
human growth hormone; and, up until now, we really haven't, as
a committee, attacked that. Because, basically, looking good on
the runway, looking good running for--well, the chairman
looking good running for re-election in Hollywood and Los
Angeles has not--and he does look good, and he does get elected
by a wide margin with Hollywood and Beverly Hills----
Chairman Waxman. It ain't my looks.
Mr. Issa. It could just be the physique, though.
But if you would comment on the fact that, as of right now,
that has not been successfully looked at. In other words,
outside of athletics, we're not presently testing; and we do
have at least two Governors who had incredibly good-looking
bodies that may have contributed to their election.
Chairman Waxman. The gentleman's time is up, but let's see
if the panel wants to answer any of these points.
Dr. Rogol. In full disclosure, I'm working with both USADA
and WADA on the growth hormone testing. There's certain things
I can say; there's certain things I can't.
Mr. Issa. We can keep a secret.
Dr. Rogol. Yeah, right. Is this the IRS?
It is a blood test, first of all, No. 1; and, No. 2, so
there are a lot of difficulties with labor contracts, what
you're allowed to do and what you're not. There are some very
good tests in the urine that prove you can't find HGH in the
urine. So while there are no tests that are presently available
that will show HGH use beyond a couple of weeks, there indeed
are tests and they are in the mill that pass the International
Olympic Committee's standards, sir.
Chairman Waxman. Thank you very much.
Dr. Perls, you wanted to make a quick comment.
Dr. Perls. Another interesting idea would be to compel the
pharmaceutical companies to add some kind of inert marker to
the drug so that it does absolutely nothing in terms of
biological activity, but it would be easy to detect. This could
be with growth hormone. It could be with anabolic steroids and
so on. That would be a little difficult to compel Chinese
makers of the growth hormone, but, hopefully, the government
has other ways to interrupt the flow of that. But that might be
another idea to pursue.
Chairman Waxman. Thank you.
Mr. Cummings.
Mr. Cummings. Thank you very much, Mr. Chairman.
Dr. Rogol, you know, as we sit here, we have national
surveys--and I'm sure you are familiar with them--that tell us
as many as 4 percent of high schoolers are taking anabolic
steroids and as many as 5 percent, 1 out of 20, are using human
growth hormone. A recent confidential survey of kids in grades
8 to 12 is even more disturbing. Over half of the kids who have
used steroids said that pro athletes influence their decision
to use those drugs. Does that surprise you at all, any of you?
Dr. Rogol. No. I've looked at the data. The data are
anywhere from 2 to even up to 12 percent. I think the issue of
HGH is not correct, and the reason is--many kids think they're
taking HGH and, when you ask them, they're taking something by
mouth. That could not be HGH. The wallet test is probably the
most difficult test for the teenage athlete to pass. We're
talking about tens of thousands of dollars for a year. So I
think the abuse of honest-to-goodness HGH is really quite a bit
lower. The steroid numbers are exactly in the range that you
mention.
Mr. Cummings. The fact is is that those steroids are
harming our children, though.
Dr. Rogol. I believe so, yes.
Mr. Cummings. And the fact is is that I think sometimes the
media concern me because they seem to think that the committee
is just showboating. And the reason why we started these
hearings from the very beginning is because we were concerned
that young men and women were taking these substances, trying
to emulate their sports heroes. And here's the most concerning
part of the survey, it's that three of every five kids using
steroids were also willing to take it even if it shortened
their life.
Dr. Rogol. Yes.
Mr. Cummings. That's deep.
Dr. Rogol. It is. It goes back to an athlete dying young.
It's exactly the same phenomenon. If they could win a gold
medal, they didn't care what happened 10 or 20 years down the
road. Yes, sir.
Mr. Cummings. Is that, Doctor, because--when we're younger
we feel like we could do anything and we--or is it just that--
are we going for the goal, are we going for the glory, and
figure when we get the glory it's OK that we just burn out? I
mean, what is that about?
And is it something to do with a person just being young
and not understanding--as one of my people in my district once
said to me after they had used this kind of stuff, he said, I
used it; and he said, I can forgive myself, but my body won't
forgive me.
I mean, is it that kind of thing, Doctor?
Dr. Rogol. Well I'm not sure it's--that's a very telling
comment. But, remember, we're talking about adolescents. I deal
a lot with adolescents. They are invincible. We all were. Never
mind voting yes, but we all were.
But the point is, you know, the brain isn't fully
developed; and so the executive function, the frontal lobe part
that tells you, hey, you might not want to do this because of
the consequences, isn't so developed. So you have the push to
take it and you don't have the pull back. And so the immature--
even though it's an adolescent, the immature brain is a bad
thing to have, by the way.
Mr. Cummings. The immature brain says take me? Is that what
you are saying?
Dr. Rogol. Yes. This is Alice in Wonderland.
Mr. Cummings. All right. That's all right. And then the
immature brain also says, hey, you know, we're doing pretty
good, let's not go backward. Is that----
Dr. Rogol. Well, I don't know about let's not go backward.
Let's not look forwards is probably a better way of saying it,
Mr. Cummings.
Mr. Cummings. I got you. Now, let me just go to your
testimony. And I saw in your testimony that there is a long
list of legitimate uses for children. And some of these
diseases have names I'm not even sure how to pronounce. So can
we simplify this list by saying that growth hormones is used
for kids who are not growing enough? Is that----
Dr. Rogol. Well, that are not growing enough for reasons
that are stated here. Kids who are caloric deficient also don't
grow well. Growth hormone would not be an appropriate drug. So
it is not growing well or normally and having one of these
conditions. In double blind trials or at least in legitimate
trials, the FDA has approved the use of growth hormone in these
conditions, most of which are rare as can be.
Mr. Cummings. And--I mean--and when you say rare as can be,
can you give me some numbers? I'm trying to figure out if
somebody would be using these things and----
Dr. Rogol. Growth hormone deficiency is about 1 in 4,000;
chronic kidney disease is probably about the same. Turner
Syndrome is 1 in 2,500 girls. Small for gestational infants who
fail to catch up to normal growth is probably 1 in 5,000.
Prader-Willi is more like 1 in 15,000. Idiopathic short stature
is the bottom 1 percent. So it is a 1 out of every 100 of us.
SHOX haploinsufficiency is a gene problem. That is about 1 in 4
or 5,000. Noonan syndrome is about the same. On average,
between 1 in 4,000 and 1 in 10,000, sir.
Mr. Cummings. Thank you, Mr. Chairman.
Chairman Waxman. Thank you, Mr. Cummings. Mr. Bilbray.
Mr. Davis of Virginia. Let me go next. Thank you. Thank you
all for being here today. I think this sheds a lot of light on
the situation. One of the difficulties is even if you think HGH
and B-12 can do the job, with this mail order stuff, you're not
sure what you are getting. Isn't that one of the problems? It
is a huge problem, isn't it? And so contaminants get into the
system very, very quickly. I'm trying to look at this B-12
problem.
This has come up before this committee before. We had a
situation a year ago where--or a couple of years ago where one
of the ball players tested positive for steroids, and he
thought he was getting a B-12 injection. This seems to be
fairly commonplace where athletes get B-12 injections and
thinks it can do something. We talked--are there any adverse
effects of getting a B-12 shot, Dr. Shurin?
Dr. Shurin. No, there really are not.
Mr. Davis of Virginia. It is, like, drinking too much V-8
or something like that?
Dr. Shurin. Pretty much, pretty much. And there is
absolutely no interference in the assays for B-12 and steroids,
because one of the things that is implied by some of this is,
as well, if I weren't--it gave you a false positive test for
steroids or any--or other substances. That actually is not--is
not possible. Now, many of these substances are coming in
through tested and legitimate sources, and it is anybody's
guess.
Mr. Davis of Virginia. So again, the problem with B-12,
particularly through the mail is you don't know what your' e
getting. It is not FDA regulated or anything else.
Dr. Shurin. That's correct. If you're really getting B-12,
it is not--it is not harmful.
Mr. Davis of Virginia. Have any of you ever encountered a
situation or a patient or known patients who thought they were
getting one drug through the mail, particularly a B-12 or HGH,
and ended up getting something that was contaminated?
Dr. Schlifstein. Absolutely. I've tested it. It was HGC and
an anabolic steroid combined in a powder that looked identical
to the human growth hormone.
Mr. Davis of Virginia. And would it have been harmful if
somebody injected it, do you think?
Dr. Schlifstein. Well, if someone thought they were getting
human growth hormone, it would have an effect but it wouldn't
be the effect from the human growth hormone, it would be the
effect of the anabolic steroid combined with the HGC, which
would enhance it somewhat.
Dr. Rogol. And if you were a woman, it would be much worse.
Dr. Schlifstein. Absolutely, absolutely. If a woman--if she
thought she was getting that, that could have dramatic
secondary sex characteristics, deepening of her voice, facial
hair, excessive weight gain, hair loss, acne. Or--I had a woman
whose husband was buying steroids on line and didn't tell her.
They went away on vacation, he put his pills in her sleeping
pill bottle. She took them for a week thinking they were
sleeping pills and in a week she grew facial hair, a beard,
deepened voice, gained 15 pounds, acne, clitoral hypertrophy
just from 1 week; 6 months later, it still never reversed
itself; 25 years old. Just by taking it accidentally for a
week.
Mr. Davis of Virginia. So this stuff is dangerous?
Mr. Schlifstein. Yep.
Mr. Davis of Virginia. On the HGH side, we talked a little
bit about some of the side effects from using that--not just
contaminated, but using regular human growth hormone. There are
a large and a growing number of Web sites marketing HGH
injections. How do you respond to proponents of HGH that
believe it is a safe alternative to steroids? Go ahead, Dr.
Perls.
Dr. Perls. There are thousands of Web sites. You put in
human growth hormone or HGH and antiaging into Google and you
get somewhere in the range of a million, 500,000 hits. And I'm
not so sure they market it as an alternative to growth
hormones, they just--I mean, to steroids. It is just a--it is
the greatest thing since sliced bread. I mean, it is really
snake oil. It is the fountain of youth. And they push this to
the hilt.
In terms of the medical records that I reviewed for the
DEA, I almost, however, never saw a growth hormone given in
isolation. I think the reason for this is because the clients
would never see much of any benefit and they'd wonder where is
my $1,000 a month going. And so they see the growth hormone
combined with all these other drugs that we've been talking
about. Just--the other very interesting thing that I saw with
these clinics is that the compounding pharmacies were, in fact,
giving the growth hormone with B-12. They would write a
prescription that said somatropin and B-12. And the only reason
that I can think of for them doing this is trying to get around
the law a little bit because giving growth hormone for
antiaging, athletic use or bodybuilding is illegal. There is no
such thing as legal off-label use. The Secretary of Health and
Human Services says that in adults, it can only be used for
three purposes. Maybe the compounding pharmacies are trying to
skirt around the law a little bit by saying, well, we're doing
very individualized therapy, we're trying to produce something
that is individualized for that specific patient. But it does
not get around the fact that patient has requested it in the
setting of an antiaging clinic.
Mr. Davis of Virginia. Thank you.
Chairman Waxman. Thank you, Mr. Davis. Mr. Tierney.
Mr. Tierney. Thank you, Mr. Chairman. Just so I--the human
growth hormone doesn't really do anything for performance
enhancement taken alone, correct?
Dr. Rogol. As far as studies have gone, I'll let my
partners say more. As far as studies have gone, no. But
remember for those of us who do remember when the anabolic
steroids came back, we as physicians were the worst actors of
all. We said steroids did nothing and then there were some
proper double blind studies done by Dr. Baseen, who is at your
institution and they do work. So there are no studies that show
unequivocally or not even really equivocally.
Dr. Schlifstein. I think also the studies that are
available don't look at it in the way it was intended to be
used, meaning they are looking at taking that in isolation by
itself, testing before and testing after to see if there is a
change in performance. And that is not really its intended use
by its users, meaning its users in conjunction with something
else.
Mr. Tierney. Like the steroids?
Dr. Schlifstein. Right. To maintain hopefully that benefit
from that amount of steroid, to amplify the effect later on in
the steroid. And when you're off the steroid, hopefully to
maintain those benefits. And it really wasn't looked at in that
way. Also it really wasn't looked at in how it effects the
individual performance, meaning are you able to tolerate more
of a workout, are you able to tolerate more muscle recuperation
from that. Just like something like creatine, which is an acid
buffer, it allows you work out more because you can tolerate
more lactic acid buildup, that allows you to tolerate more
working out, working out sooner. That has a benefit in the
longer term, but immediately by itself nothing.
Mr. Tierney. The research on the harm that it does seems to
be a little more advance.
Dr. Schlifstein. Absolutely.
Mr. Tierney. Now, all these advertisements we've seen about
people aging, this is going to reverse the aging process, this
is the fountain of youth on that basis. Even some well-named
actors trying to indicate to people--anybody over 40 should
take it. And they indicate in those advertisements that they
believe HGH actually causes aging. It doesn't cause aging, does
it, Dr. Perls?
Dr. Perls. I can speak to that. They claim that growth
hormone levels drop with aging, which is true, and therefore
the growth hormone causes aging. Aging is caused by multiple
problems involving our--hits to our DNA, our cells, chronic
damage to many different entities of our body by free radicals
and so on. It is not caused by declines in growth hormone or
other substances.
Mr. Tierney. Does it do anything beneficial to--regarding
aging at all?
Dr. Perls. Say again?
Mr. Tierney. Does it do anything beneficial regarding
aging?
Dr. Perls. In fact, my guess is that it does bad things
with regard to aging. Studies and lower organisms in mine show
that animals that are deficient in growth hormone actually live
30 to 40 percent longer. These animals also have a marketedly
reduced rates of cancer. So it is actually--probably does the
opposite effect.
Mr. Tierney. It sounds to me from your testimony earlier
that the concerns we have with respect to women using HGH is
even more pronounced than with males using it. Is that also
correct?
Dr. Perls. I'm not so sure--there are other hormones that
some of these antiaging clinics--you know, the clinics make
their bucks on what they call hormone replacement programs. And
it is multiple hormones from steroids and--which are basically
testosterone or variations of--and growth hormone. And it is
really the anabolic steroids where we see the untoward effects
with--in women in particular.
Mr. Tierney. All right. And you announced the problems for
women using HGH earlier and I won't go over--you keep shaking
your head, Doctor. Am I getting it wrong?
Dr. Rogol. What my colleague to the left mentioned were the
problems with steroids in women, not with HGH. That is why I
was shaking my head.
Mr. Tierney. Are there any problems with women, in
particular, using HGH?
Dr. Schlifstein. As compared to men differentiating, I
haven't seen any sexual differences between one and the other.
Mr. Tierney. So whatever problems exist for men taking it,
it would be for women as well?
Dr. Schlifstein. Right. I mean, with testosterone, the
women's receptor is like 100 times more sensitive than the
males. So even a low dose of something that is testosterone can
have much amplified effects in women that may not reverse
themselves even if taken off. And that is an anabolic steroid.
That is not human growth hormone.
Dr. Perls. One concern would be the 1 out of 9 women that
go on to develop breast cancer and taking growth hormone for
any woman. When you're looking at that kind of prevalence would
probably be a very bad idea. And there are studies to show
that--particularly with a breast cancer tumor, that one of the
events to allow that breast cancer to spread is when it starts
expressing its own growth hormone. So this is just a really bad
idea.
Mr. Tierney. Well, thank you. I yield back, Mr. Chairman.
Chairman Waxman. Thank you very much, Mr. Tierney. Mr.
Bilbray.
Mr. Bilbray. Yes. Todd, in your testimony, you were talking
about taking--administering which substance after doing a bench
press?
Dr. Schlifstein. That is one of the typical tests you do
for performance enhancement. There were studies looking at the
efficacy of human growth hormone used in combination with
anabolic steroids versus anabolic steroids by themselves and
looking at that at day 1 and then day 6. There was a slight
benefit from using the human growth hormone when used with the
anabolic steroid as compared to just using the anabolic
steroid. So in that scenario, when combined with an antibiotic
steroid, it did have some performance enhancing effect. Not in
isolation, only when used with a combination with something
else.
Mr. Bilbray. The growth hormone itself, you stated that
after the workout, the administration of the substance after a
period of time, there was no net difference between the
application of the growth hormone and not--and without it?
Dr. Schlifstein. Right. When just looking at pure
performance enhancing assessment from day 1 to day--you know,
week 6, growth hormone was nothing. There was no benefit in a
test of pure performance enhancing in that timeframe.
Mr. Bilbray. Doctor, I think any, you know, sophomore in
high school would tell that you if he is an athlete, that is
not--they'd perceive that not being worth the paper it is
written on because they're exercising, working out at least 3
days a week. They are going through extensive weight training.
And the perception would be, then, do we do these tests showing
that the use of the hormone or--during regular training
sessions where at least 3 times a week there is extensive
workout, you know, strain to the muscle mass, do we do that
kind of real world testing that these kids are perceiving that
they are going to go through?
Dr. Schlifstein. That's why I said I really don't think
there is testing appropriate to what we're really looking for
the potential benefit of. It is looking at a benefit in the
short term. And anyone who takes it will tell you that is a
more longer term benefit. And even by itself or potentiated by
something else. So I don't know if that assessment tool really
applies to that by itself is really applicable. And not to draw
too many conclusions by that, just by saying in the short term.
Mr. Bilbray. I'm glad to say that you have brought that up,
because I think that is really critical. Because when we bring
data forward to persuade young people to stay off this stuff,
we need to make sure we have a credible argument that they will
accept. And I don't think any of my kids would look at this and
say, yeah, dad, of course if you're not working out, you're not
going to get any benefit from--you know, this is a supplement
to a major workout program, so it has to be real life.
So I just hope that when--we're really careful that when we
give the argument why kids should stay away from this, it is
one that is very defensible, it is not able to be assailed or
justified. I--the flip side is I kind of tell them, look,
you're working out anyways, you're going to put muscle mass on
and, yeah, there might be a placebo effect. But until we do
those kind of real world testing, our ability to sort of argue
the point is diminished to some degree. These kids are not
idiots. The fact is they may be getting into this drug and that
is stupid. But still, as I said, the--some parts of the brain
haven't developed but other parts are very well developed.
And we have to make sure that we approach this with an
intelligent argument. Because once our arguments get debunked,
then we're really in trouble trying to give science to these
kids. That is within the guy that is pushing the drugs, pushing
the substance really is saying, see, they're really not giving
the data and here is the argument. There is already enough bad
propaganda out there already. I just hope that we have the
substance--I mean, have the substance in our argument.
Do we--are we testing real life application? Do we have
that data so we can show these young people, look, here is an
athlete working out here and here is the application over here,
this is your life? Because any high school/college student is
going to tell you, you know, doing one sets of bench presses,
taking the injections and then waiting for a month is not my
world. I'm working out three times a week extensively and I'm
just looking for something that will give me that little edge.
I'm not talking about a silver bullet that is going to do it
all for me. Do we have the ability to give them that kind of
information?
Dr. Schlifstein. I mean, I think we have the ability to
give them certainly the downside, the side effects. I don't
know if we have enough ammunition to be convincing by itself. I
think that would be a little more difficult. But certainly it
makes it more difficult when you have other people endorsing it
by using it and saying they are using it. And so it makes it
that much harder for your argument to say and this doesn't
work. But someone else is saying I'm using it like that is very
hard to counterproduct, especially for a kid who is not looking
at long-term side effects, they're going to get arthritis or
diabetes later. He is looking at the short term.
Mr. Bilbray. All of us will admit that the statement, if I
knew I was going to last this long, I would have taken better
care of myself. So the universe will turn. And so, Mr.
Chairman, I just hope that we--again, the fact is that they are
not in a position to make the best judgments of anybody in the
world and then they've got the ambition of success, which we
all can suffer from. And then I just hope that we give them a
lot more data than just this could hurt you when you're an old
guy. Their attitude is I could give--I'm not looking forward to
that. That's--how many young people do we still see smoking
cigarettes. And when, you know, my God, if we can't get them
off cigarettes, this is a hard argument to make. Thank you very
much, Mr. Chairman.
Chairman Waxman. Thank you, Mr. Bilbray.
Mr. Lynch.
Mr. Lynch. Thank you, Mr. Chairman. I want to thank the
ranking member as well. Following up--and I want to thank our
panelists for helping us out with this issue. Following up on
Mr. Bilbray's line of questioning, we have a hearing tomorrow
regarding Major League Baseball, which HGH is an important
issue and a significant danger in itself. But I think the
hearing tomorrow has provided added focus. It has provided some
context, I believe. And I think in a way the problems in
baseball, are, I think, instructive as to the wider problem in
society.
In baseball, we had a situation where--let's take steroids
for example. Major League Baseball came back and they had a
greater awareness program, a greater acknowledgement that
steroids were bad. And that was--that was right up front and a
big part of their push. They came up with a very aggressive
testing program for steroids and a very thorough testing
protocol for steroids. They had much stronger penalties for
steroids. And as a result in the Mitchell Report, it reported
that steroid use in baseball was down significantly. When they
addressed the HGH or failed to address the HGH problem, Major
League Baseball, they had no--there was reluctance to put in
any testing protocol regarding HGH, there was not the same
message put out there on the street that HGH is bad. And not
surprisingly as a result, the report indicated that HGH use was
on the rise. Now, if you look at the problem that we're having
that you have described already where the message is not out
there among our young people, it is not out there in the
public. There is a very mixed message because you've got some
of these athletes and sports figures--well, Stallone, the
actor, there saying HGH is good. There is a real problem with
the--I say popular opinion regarding HGH.
And it even comes to our laws. Our laws under Title III of
the controlled substance act include steroids. It has very
strong criminal penalties for mere possession of steroids
without a position--without a prescription. We have no
prohibition for simple possession of HGH. There is no criminal
penalty for that. And that is what I'm getting at. That is
something we here in Congress can control. And since you're the
experts on this and--you know, if I could just, you know,
personally thank Dr. Perls for your good work at Boston Medical
Center and at Boston University, what do you think about the
idea of including HGH in Title III to include all of these
penalties to at least legislatively send out the signal that
this is a seriously dangerous substance?
Dr. Perls. I'm incredibly appreciative to the committee
having this hearing in the first place to start to--not to
start to, but to look at growth hormone and the public health
concern that it represents. And along with that, stiffer
penalties such as making Schedule III, I think, is an excellent
idea. Already there are very important laws on the books to go
after the distributors for illegally distributing--for
distributing growth hormone for legal uses that include
imprisonment and fines. But adding it as a Schedule III has all
kinds of great potential in terms of educating physicians as
well. Because right now I think it is a little fuzzy for a lot
of doctors out there in terms of what the law really is.
So I think that is also very important. Along with making
it a Schedule III, though, I think it is very important to also
do what Congress can to provide additional resources to the DEA
in particular, who is short on staff and already has to pay a
lot of attention to methamphetamines and heroin and other big
drugs and this will be one more on their list.
So giving them the additional resources that they need to
carry out their mission would be very important. The other
thing, I think, is while you're at it, there are other hormones
that go along with growth hormone. There is something called
growth hormone, stimulating hormone, and then there is the
already mentioned insulin growth factors. And as we've seen
with other drugs, when one becomes hard to get, everybody
starts looking out for one that is easy to get and is less
expensive. When growth hormone--when things clamp down heavy on
growth hormone, they'll start looking at growth hormone
stimulating hormone and insulin growth factor, which are all
part of the same endocrine access. And I would think it would
be good to add those to the list as well.
Mr. Lynch. Mr. Chairman, if I can ask, I have a letter to
me but it is actually testimony to me from Gary Wadler, from
the World Antidoping Agency that I would just ask to be
included in the record if I may.
Chairman Waxman. Without objection, it will be included.
[The information referred to follows:]
[GRAPHIC] [TIFF OMITTED] T7428.048
[GRAPHIC] [TIFF OMITTED] T7428.049
[GRAPHIC] [TIFF OMITTED] T7428.050
Mr. Lynch. Thank you, Mr. Chairman.
Chairman Waxman. Thank you. Mr. Sarbanes.
Mr. Sarbanes. Thank you, Mr. Chairman. I've learned a ton
here today, so I appreciate your holding the hearing. And I
thank you for your testimony. What percentage of the people
that are using HGH or B-12 would you say are using it
exclusively without it being used in combination with anything
else? Do you have any sense of what that would be?
Dr. Rogol. No, sir.
Dr. Perls. So my exposure to this comes again from
reviewing seized medical records for the DEA from three
antiaging clinics. And I can't think of any instance where the
growth hormone B-12 was used in isolation. It's--they were
always given with anabolic steroids and a number of other
substances. And while we were talking about vitamins, I must
also say that they were providing very expensive collections of
a whole bunch of different vitamins, all on the idea of just
making a lot of money.
Mr. Sarbanes. So the adults in this equation have figured
out that HGH by itself and B-12 by itself and other sort of
vitamin supplements by themselves really are pretty useless for
the goals they have it sounds like.
Dr. Perls. The adults--well, I think it is the--it is the
antiaging physicians, the owners of these clinics and the
compounding pharmacies that are selling this stuff that have
realized that selling it in isolation is going to make for some
angry clients and that it is probably best to get this stuff in
combination with other things. So that they try to see some--
whatever benefit that might be. And that is all without saying
much about the side effects I might add.
Mr. Sarbanes. Are they being explicit in the blogosphere
about the fact that the--the discussion on the blogosphere, is
it explicit about the fact that, you know, it is the
combination of steroid use with a growth hormone or vitamin
supplement----
Dr. Perls. Absolutely. Very explicit. It is amazing
following these blogs how much time everybody is spending on
what the right recipes and cocktails are and what works for
whom.
Mr. Sarbanes. So it still gets us back to the steroid use
as being--that is the driver? I mean, that is the aspiration,
is through that you enhance performance and these other things
are sort of on the margin to help boost the effects of that?
Dr. Perls. I think that is right. And I also--again, as was
just intimated, this is not any kind of standard clinical
trial. This is a bunch of nonscientists, nonclinicians just
trying to feel their way through this and saying, oh, this
worked for me and this worked--and without really any--
monitoring for any long-term side effects or benefits for that
matter.
Mr. Sarbanes. How much complicity does--without assuming
it, how much complicity would you say there has to be on the
part of medical professionals to help perception? In other
words, if all of those who have the science at their disposal
were emphatic on the point of the dangers that are involved
with steroid use or the fact that B-12 or HGH really doesn't
help you do anything, then you would imagine that would be a
significant deterrent to the use. But the high incidence of use
suggests that there is some--some complicity. And I'm
wondering----
Dr. Perls. In terms of the--in terms of the physicians who
are illegally writing prescriptions for hormone and steroids
without ever seeing the patients or the owners and the
physicians of the antiaging clinics, it is not a matter of
complicity. They are the driving force.
Mr. Sarbanes. OK. And I'm running out of time. So let me
ask you this question. I raised this in another hearing we had,
but now I've got some experts in front of me and I'd be curious
on your perspective on this. I bought my son one of these
pushup kits. OK? So it has some equipment with it and it has a
video on how to use it. And then at the end of the video, lo
and behold, it shows you two bottles of some kind of thing that
you're supposed to take in conjunction with this regimen. What
would that have been most likely do you think?
Dr. Rogol. Hell of good marketing. That is terrific
marketing. My guess would be if I had to guess would be
something like HGH, but there would be a releaser or it would
be something that you'd take by mouth that is likely something
that is relatively harmless except to your wallet.
Mr. Sarbanes. OK. Thank you.
Dr. Rogol. But that is purely a guess, Mr. Sarbanes.
Mr. Sarbanes. Understood.
Chairman Waxman. Thank you, Mr. Sarbanes.
Mr. Sarbanes. He is not going to be using it anyway.
Dr. Rogol. Is that for the record, sir?
Chairman Waxman. Ms. Watson.
Ms. Watson. Thank you so much, Mr. Chairman, for having
this hearing and to the doctors who are witnesses. We certainly
appreciate you appearing before the committee to let us know
about some of the threats to public health. I want to just
probe a little bit and I think most of you have addressed the
overuse of HGH. And I know there are a couple of conditions
that occur normally when you have too much HGH in the system.
And I think Dr.--I want to be sure I pronounce your name. Is it
Schlifstein?
Dr. Schlifstein. Schlifstein, yes.
Ms. Watson. Yes. You mentioned a woman taking her
husband's----
Dr. Schlifstein. That was anabolic steroids. It was a
steroid that she took by mistake.
Ms. Watson. Oh, I see. OK. There is something called
acromegaly. And, of course, we know about gigantism. And I
would like any of you that can, can you describe the problems
associated with acro--what is it, acromegaly? And--to us so we
can understand it? And I see these hearings, Mr. Chairman, as
very helpful to the general public and certainly helpful to us
because we live in this drug culture. You can't turn your TV
on, you can't listen to the radio--they are not pushing
something over the counter or go talk to your doctor about
this.
So I think our young people believe that the way to live
their lives and to enhance their abilities is to take some of
these drugs. Now, some of these things occur in the body
normally, so, Dr. Rogol, maybe I should start with you. Can you
describe the problems associated within acromegaly.
Dr. Rogol. I'm actually going to let Dr. Perls do it. He is
a big people's doctor. I'm a little people's doctor.
Dr. Perls. Acromegaly involves usually a tumor of the
pituitary gland where it is making too much growth hormone. And
you'll see the facial characteristics that was mentioned with
Andre the Giant, and so on where they get a bossing of the
forehead, they get an enlarged jaw, they can have an increased
incidence of certain cancerous tumors probably because of the
effect of growth hormone in the terms of the ability of a tumor
to grow and to spread. They get troubles with their heart and
liver in particular, because they get heart enlargement and
liver enlargement. And that doesn't necessarily make for a
better functioning organ.
They get what is called insulin resistance or they can have
elevated blood sugars and that can go on to develop to be
diabetes. They do have shortened life spans, not increased life
spans. And then there is all the other--you know, we had
mentioned the enlarged hands and so on.
Ms. Watson. Maybe you can tell us about if you can
extrapolate from the--from this experience and to the elderly.
What can you extrapolate from acromegaly to the elderly?
Dr. Perls. Well, I first actually got interested in growth
hormone because I run the New England centenarian study which
is a large study of people who get to 100. And I'm a
geriatrician who absolutely loves old people. And the very
first concern for me was an antiaging industry that was
portraying old people in a terrible light, saying that, you
know, do you want to be demented and frail and really scaring
the heck out of a very important population, the baby boom
population, 70 million strong individuals who are very actively
aging right now and just to scare them and then say, oh, by the
way, we have the cure.
And that would be growth hormone, books like Stop the
Clock, Reverse Aging Now, a huge number of Web sites
popularizing this. And much of this happened--it began with a
New England Journal of Medicine article in 1990 looking at
growth hormone and a very small sample of older men and
comparing the two with and without growth hormone and
basically--unfortunately a statement saying that it took 10 to
20 years of aging off of the person's life.
The New England Journal editors have since come out saying
they rued the day that they ever allowed that statement to
happen because it led in part to a blooming of this industry.
And what really surprised me was with my review of these charts
for the antiaging clinics, was that the vast majority of them
are not older people. It is again people in their late 20's,
30's and 40's who are going for the kinds of things we see the
testimonials of, these good looking, strong athletic types. And
I think unfortunately as a society we're very susceptible to
looking at testimonials and taking them hook, line and sinker.
But that is all this market is based on, is testimonials and
not real silence. And I'm hoping that the elderly population as
you mentioned are a relatively minor part of this very big
public problem.
Ms. Watson. Thank you. Mr. Chairman, can I have a few more
minutes? I wanted to ask about vitamin B-12. Before I get
there, I wanted to address this to Dr. Rogol. Sylvester
Stallone once told the Today Show that HGH was just amino
acids, just a collection of proteins. And the body--that the
body already produces. And how can 191 amino acids be all that
dangerous? And is it just amino acids?
Dr. Rogol. Ma'am, there is one problem with that. 191 amino
acids probably aren't a problem. A 191 amino acids hooked
together that form a protein called HGH, that is what the
problem is. So it is a little B&A in the middle of that to try
to take these things and make a growth hormone. And I suspect
as some of you may have read in the article in last Wednesday
in USA Today that Mr. Stallone said all of this was done by
HGH. I am sure he took HGH. We are absolutely unsure the 17 or
23 other things that he said.
And as you probably also read, I was quoted as saying
exactly that in the USA Today. So, yeah, he took HGH. But,
again, with HGH and anything else--I am a clinical scientist. I
know how to do experiments. The biggest issue in most
experiments, once they're properly designed, is what the dose
is. We know precisely what the dose is when we do an
experiment. These doses are way beyond that. They're taken in a
different way. And so we really don't have the idea of how to
go about testing or studying as Dr. Schlifstein has said. So
that is the long-winded answer to your question, ma'am.
Ms. Watson. Thank you so much. And if I can shift now to
injectable vitamin B-12. And, Dr. Shurin, can you tell us just
very briefly--I'm out of my first period of questioning and
into the second period. I'm almost out of time--but the
appropriate use of the injectable vitamin B-12?
Dr. Shurin. The appropriate use for the injectable vitamin
B-12 are for people who are unable to absorb the oral form of
B-12. Normally, if you have a perfectly normal gut, you can
absorb vitamin B-12 from your diet. Even people who are strict
vegans who don't take vitamin B-12 in their diet can take
supplemental vitamin B-12, which they usually do from yeast and
absorb it just fine. So it is people who have had--who got
pernicious anemia, people who have had bowel resections, some
people who have inflammatory bowel disease, all need to get
vitamin B-12 by injection, otherwise it is perfectly
appropriate and definitely safer to have it by mouth. It is not
dangerous by injection, but it is not helpful either. It also
means that there are syringes and needles around which--whether
it is the locker room or the home is not a small issue.
I think the potential secondary complications of having
needles and syringes around is not a trivial issue.
Chairman Waxman. Thank you, Ms. Watson. I think your time
has expired.
Ms. Watson. Fair enough.
Chairman Waxman. I want to ask--and you may want a second
round. But I want to take a second round and ask some questions
of Dr. Schlifstein. Dr. Perls treats the elderly, Dr. Rogol the
children. But you've been a sports doctor and you've dealt with
athletes. In your experience with athletes, if they use human
growth hormone, are they more likely than not to be using it in
conjunction with other drugs?
Dr. Schlifstein. They almost in every case are using it
with other drugs. There may be periods of time where they're
only taking that and cycling off something else. But certainly
it is the mainstay, is using with something else. So that is
why a lot of times these talks about human growth hormone in
isolation isn't really true or we shouldn't just be talking
about that. You have to talk in combination with some type of
anabolic steroid.
Chairman Waxman. If an athlete tells me that he is taking
human growth hormone to heal from a sports injury, how would
you react to that? Is it credible? Is it helpful?
Dr. Schlifstein. We really don't have any proof that it is
beneficial in that manner. Certainly with its effect on both
muscle and bone tissue, one could hypothesize that--like a
fracture or something else may heal slightly faster than one
without taking it. I've seen some cases where people have
fractures, young people taking human growth hormone and they
healed a lot faster than normal. Was that the only factor
involved? It was only a case report. So it is not really
scientific evidence. But possibly, yes.
Chairman Waxman. And when an athlete uses it--these are
expensive items, this human growth hormone, $1,000 a month, are
they taking very high doses do you expect from your experience?
Dr. Schlifstein. From my experience with these people,
patients, what they've been taking, the dosing that some of
them would use for an HIV wasting syndrome, it can vary between
a quarter and a half of that dosing, because sometimes they get
it from those patients as well because they know they're
getting legitimate sources of it and don't have to get a
prescription themselves and they get it and they buy it off
those people who get it----
Chairman Waxman. More than likely than not, they are people
hanging around that they tell them, just get me some human
growth hormone.
Dr. Schlifstein. Well, these people get it automatically
every month and they know they get a certain amount. That's why
I know how much they have of it based on that dose. So it is
already paid for and gotten through and gotten regularly and
they know it is a legitimate source and a real source. And
usually, it is about half that dose. But that has dramatic
effects on someone who is in their 20's and 30's, taking that
large of a dose, especially with whatever else they're taking.
Chairman Waxman. What is it that they think they're getting
when they take a vitamin B-15 shot? I mean, you can't take it
orally, so they get a shot. What do they think----
Dr. Schlifstein. You referring to a B-12 shot?
Chairman Waxman. Yeah.
Dr. Schlifstein. You know, I think a lot of that I think is
the placebo effect. If you're already doing so many injections
and you think you're going to get an energy boost from it and
you have something that looks like red syrup and you think it
is going to boost your energy, if you really believe in it,
yeah, what is another shot if you're already taking, you know,
7, 10 a week anyway?
Chairman Waxman. 10 in a week of B-12?
Dr. Schlifstein. Injections.
Chairman Waxman. Injections of other drugs?
Dr. Schlifstein. Yeah. They are using it once or twice a
day. The anabolic steroid, depending on which one, oil-based or
water-based can be daily or twice a week. I mean, insulin
growth factor is even worse because they have to inject it into
each individual muscle. So you have to do every muscle you
worked out.
Chairman Waxman. Is B-15 injected in the muscle?
Dr. Schlifstein. B-12 is. Usually it is an intramuscular
injection, yes.
Chairman Waxman. I see. How about lidocaine? Tell us about
lidocaine. And is it safe for a fitness trainer to inject
someone with lidocaine or is it a dangerous drug?
Dr. Schlifstein. Well, I don't think a fitness trainer
should be injecting anything or recommending anything either on
that behalf. But lidocaine is used as a local anesthetic. Now,
as far as injections for pain management goes or for treatment
of an injury, very specific reasons and uses for it. Now, it
only is temporary, right? A short-lived, short-acting
anesthetic. It just numbs the area temporarily, and in 2 hours
it is gone. So if someone has an inflamed, irritated joint, we
may put some corticoid steroid, an anti-inflammatory steroid
combined with some lidocaine, inject it into a joint to get
pain relief from an inflamed, irritated join. The lidocaine
gives them temporary short-term pain relief, while the anti-
inflammatory or corticoid steroid or cortisone takes time to
work its anti-inflammatory effect.
Now, that can be injected into a muscle, yes. Sometimes it
can be injected into a muscle usually with a corticoid steroid
or anti-inflammatory steroid as well for pain relief into what
we call a trigger point.
Chairman Waxman. Is this a dangerous drug?
Dr. Schlifstein. It can be, depending on dose, amount and
frequency. Now, usually a limited amount would be injected
and--with joint space, most of it tends to stay in that joint
space. Injected into a muscle, there is going to be some
systemic absorption.
Chairman Waxman. Who do you think should give this kind of
injection? You say not----
Dr. Schlifstein. I mean, only a physician and I would say
only a trained physician in that specialty.
Chairman Waxman. What specialty, sports medicine?
Dr. Schlifstein. Sports medicine or pain management,
somewhere where they know how much you're doing and where
you're doing it. You can get other effects to nerves. You can
do a nerve block by mistake, you can cause damage to that
nerve. There are a lot of other potential problems with that.
And when injecting it into a muscle, you want it just into that
muscle, you don't want to damage any other tissue. If someone
has what we call a trigger point or like back pain and you put
into the muscle spasm, it helps that muscle relax but only
temporarily.
Chairman Waxman. My last question. Is it a performance
enhancing drug, this lidocaine.
Dr. Schlifstein. It is not a performance enhancing drug. It
is purely a local anesthetic or local pain reliever? Any other
Members wish for more time? Mr. Bilbray.
Mr. Bilbray. So lidocaine really just addresses the pain.
So it doesn't----
Dr. Schlifstein. So something wouldn't hurt.
Mr. Bilbray. I guess the only way to performance
enhancement would be to eliminate the pain so you could
continue to perform without knowing that you actually have
damage going on there and probably create more damage?
Dr. Schlifstein. Right, which is a dangerous scenario
because you're going to have an anesthetic or numb area where
you inject it. So potentially, during an athletic competition
or an event, there are serious concerns about doing that kind
of injection because you're not going to have the normal
feedback.
Mr. Bilbray. Pain tends to be nature's way of telling us to
slow down?
Dr. Schlifstein. Absolutely.
Mr. Bilbray. OK. Well, those of us over 50 relate to that.
The B-12 image of enhancement, is that the increased red blood
cells thus the fact is that the blood is able to carry more
oxygen, able to do that? Is that the image that is being given
out on the B-12?
Dr. Shurin. That is exactly right. The benefits of
receiving B-12, if you're B-12 deficient, are all in exactly
the areas where people want to have enhanced performance. You
have more energy, your red count goes up, you have better
memory, you have better concentration, your nerves function
better. So all of those things are clearly benefited if you're
B-12 deficient and you get treated with vitamin B-12. And I
think what is happening is that they are extrapolating from
that kind of situation to the idea that if you're starting----
Mr. Bilbray. A little is good; a whole lot is better.
Dr. Shurin. That is exactly right. And it is very clear
that is, in fact, not the case.
Dr. Rogol. Mr. Bilbray, I think there is a little confusion
here. Most of the athletes who want that are taking
erythropoietin rather than B-12. And so EPO is another hormonal
drug of abuse, and that is where medals were lost in Salt Lake
City based on compounds like that. And so there is quite a
difference and most of the athletes are more likely to take
erythropoietin than they are to take B-12.
Dr. Shurin. B-12 use is very, very common. And I think what
they're looking for is some of the same kind of benefit that
they'd also look for from erythropoietin. The big difference is
that the use of erythropoietin is not without major side
effects. You said erythropoietin is a serious business and that
is actually--that is the Tour de France problem as well.
Mr. Bilbray. OK. Now, when we focus on the problems, the
problems, the problems and trying to grasp for the answers, one
other thing that I think that those of us here in the Federal
Government have jurisdiction specifically on and may be able to
address is this issue of the network that is distributing the
propaganda out to our young people which is not necessarily
over the traditional airwaves, but over the new vehicle of
communication for the next generation, that is the Internet.
Was it fair to say that the Internet could be, you know, a
major line of communication on not only touting this--these
substances, but also the possibility of distributing them?
Dr. Schlifstein. I think it is a dangerous combination of
both. You're getting information from the same place that is
trying to sell you something. Of course, they're going to tell
you the good sides or the potential good sides or even if
they're not even truth. But the myths of it--they're certainly
not selling you the downsides and that is the same source of
information you use in the purchase of something from--which is
a dangerous combination when you do the two together.
Dr. Perls. It goes beyond just individuals on the Internet
marketing and pushing the stuff. There is coordinated efforts
between clinicians or these clinics and the compounding
pharmacies or a number of drug busts--Raw Deal was one of them.
Another one is something called Witch Doctor--that these
operations conducted by the DEA and others that showed that
there are coordinated efforts between these entities to push
and market the stuff to go into gyms and sports spas to
actually recruit individuals to take the drug and then they get
a kickback for that.
There are much larger almost pseudo medical societies bent
around antiaging that have courses and symposia on how to
take--how to deliver the drug, how to have successful antiaging
practices. They produce books. They produce very large
conventions, both nationally and internationally where they
bring all these folks under one roof.
Mr. Bilbray. So you've got a whole network. And the
Internet, though, is a major part of that?
Dr. Perls. Sure. Well, they have their Web sites and what
have you----
Mr. Bilbray. Even among those groups?
Dr. Perls. The Internet is most dangerous because of such
easy access by the--by everyone. And then----
Mr. Bilbray. Especially at the high-risk population?
Dr. Perls. Right.
Mr. Bilbray. Young males wanting--Mr. Chairman, I just
wanted to raise that issue because I think that one of the
things that we have had a success in the past working on--and,
in fact, you and I worked on the telecommunication bill over
the energy and commerce back in the 1990's of addressing the
use of the Internet as a predatorial vehicle on young people.
I, have a feeling that we ought to be looking at the Internet
as being part of the answer to this issue of those who are
using these predatorial activities for selling these drugs and
really trying to address how we monitor and enable to regulate
the Internet to at least try to obstruct it from being a fast
track to substance abuse. Thank you very much, Mr. Chairman.
Chairman Waxman. Thank you, Mr. Bilbray. It would be Mr.
Lynch first if you want more time and Ms. Watson if she wishes
more time.
Mr. Lynch. Just briefly. On that same topic again. I do
know that the difficulty in policing some drugs, such as
OxyContin was that doctors--individual physicians had the right
to--to prescribe them so-called off--off labeled for reasons
and for situations that weren't necessarily the primary reason
for certain medications. Interestingly enough, HGH is one of a
very rare examples--I can think of no other drug that we've
investigated up here that has a prohibition that says you can't
prescribe this off label. And that is what--that is what the
FDA says about HGH.
So all of this stuff, whether it is on the Internet or
whether it is in the mail or whether it is, you know, within
these gyms, all of this stuff is right now off label. It is
prohibited flatly by the FDA.
So since--I think we already have the tools to stop this.
And I just want to know, you know, from our panelists, is it a
matter of enforcement that we're falling down on here or do you
think that there is some other, you know, prohibition maybe
regarding the Internet? And I just think that is the vehicle--
that is just one way of selling this stuff. I think that we
have the tools already to stop this if we were serious about
it. I'd just like to hear your thoughts on that.
Dr. Rogol. I presume that is correct if it really is human
growth hormone. That is precisely the drug that the FDA talked
about. But I could see the biggest amount of wiggle room with
things that aren't HGH because they--they say, well, this is
not proscribed. So that is where I think there might be a lot
of difficulty because it is my opinion--I haven't looked at the
Internet sites--but it is my opinion that the vast majority of
the hype for this are things other than the 191 amino acid
drug--HGH. So that might be another avenue to look at. It is
just a little bit different than what you said, sir.
Mr. Lynch. That is very good, Doctor. That explains a lot.
Anybody else? Dr. Perls.
Dr. Perls. I'd actually disagree. The amount of hype and
literature in marketing that I've seen around growth hormone,
the injectable is unfathomable in that it does represent a $2
billion a year market for the--what we call the off-label
indications of growth hormone or the illegal indications. The
laws are there to prevent the illegal distribution or to try
and prevent the illegal distribution, but it doesn't get to
possession as you have mentioned. And I do think that calling
something a Schedule III has a great deal of education benefit
to the people who prescribe the drug. There is--I think it
became a big problem--it's been going on for about 17 years and
it's been pretty much under the radar because it is a fairly
obscure rule.
You said it is unique and it is. So I think taking the
extra steps to bring it out of obscurity is very important and
a bill to make it Schedule III I think would very much help in
that vein. And then, of course, there is providing the
resources to go after it. I think another big problem is a very
overstretched FDA and DEA in their ability to deal with all the
things that they have to deal with.
Mr. Lynch. OK. All right. Thank you, Mr. Chairman.
Chairman Waxman. And, Ms. Watson, do you wish to ask
further questions?
Ms. Watson. Just very quickly. I wanted to raise an issue
about lidocaine. Just recently we saw a very tragic news story
about a young lady who was on her way, as we understand, to the
laser hair removal clinic and spread lidocaine cream all over
her leg, and I guess her body and she had a seizure, collapsed
and died. Can someone comment on the cream that you can get?
And should it be controlled by a professional?
Dr. Rogol. I don't know about the cream, but I was going to
mention before lidocaine is a drug that affects electrical
activity, whether it is of your heart or your brain. So when
physicians appropriately inject into a joint, shoulder, knee
are the usual ones, no problem. But when it gets systemic, that
is when you have the problems. And so cardiac and brain
arrhythmias, which is, in essence, what a seizure is, are a
known side effect of that particular drug.
Dr. Schlifstein. Right. It would have to be taken in very
large quantities through the skin to be absorbed that way. Now,
you can get it over the counter which is, like, 1 percent.
Prescription strength is 5 percent. There is also a topical
patch which is Lidoderm, which is lidocaine in a patch which is
5 percent. Now, if you keep doing that, your body is going to
absorb more and more, and eventually it will get into your
blood stream and you'll probably build it up over time.
Lidocaine is also an anti-arrhythmic. I mean, it is
usually--to prevent a heart from having arrhythmias. But like
any anti arrhythmic, it can be prorhythmic. And it also affects
the electrical conductivity of your heart, and it certainly can
affect the electrical conductivity of your brain. I think the
perception is if it is over the counter, or if it is a topical
medication, the perception is I can't take too much, it won't
get absorbed. There have been cases of people from taking the
topical aspirin creams who have died from salicylate toxicity
or aspirin toxicity just because they perceive it as benign.
They are putting the patch on, they are putting the cream on.
They don't think they're going to be affected that way.
Lidocaine would have to be taken in pretty large quantity to be
absorbed to have that effect.
If you left three patches on for 24 hours a day, you'd only
have about 1 percent absorption into your blood stream. So it
would probably have to be a large dose and a continual dose to
do that. But some patients, if they're given that, they need an
instruction on how to take it appropriately. Just because you
put more on, it doesn't mean the area is going to get more numb
or penetrate more deeper. It really only works superficially.
And I think people who are getting a procedure and want to
anesthetize and someone prescribes that, has to give
appropriation instruction on the use of that medication.
Ms. Watson. What I'd like to have clarified, how much is
too much of the cream?
Dr. Schlifstein. I mean, it really has to only go on that
area locally and it has to be on there a half hour beforehand.
So if you were just doing your head, you just need enough to
cover it. Once it is numb, it is not going to get more numb.
It's not going to go deeper. So it is really going to--it is
going to last 2 or 3 hours. That is how long it lasts. More on
is not going to make it last longer or be more numb. Either it
is anesthetized or it's not. There is no in between. Usually--I
mean, those tubes come in large amounts, which is usually
enough for weeks if not a month. At most it should be applied
twice a day because it will stay--some are absorbed in the
adipose or fat tissue on the subcutaneous tissue. I mean, just
under the skin, there will be a little residual buildup.
If you continue to use it, you'll get continual buildup of
additional lidocaine. So it probably wasn't a one time use. It
was probably a continual use and probably had to put a lot of
cream on it in order for that to occur. But, you know, if you
weren't instructed properly, you probably wouldn't know any
better. And if they had it ahead of time before a procedure,
someone is nervous, they are going to keep doing it just to
hopefully have less problems later.
Chairman Waxman. Would the gentlelady yield to me?
Ms. Watson. Yes. I'm finished. Thank you so much.
Chairman Waxman. If you heard about a professional athlete
who had a lidocaine injection, but didn't go to a physician,
what risks is that person taking?
Dr. Schlifstein. I think a lot. I think--even--a lot of
physicians wouldn't inject lidocaine without a lot of
experience in doing it, and especially depending on what part
of the body you're doing it into. Certainly there are nerves
that go all over the body. Just as we talked about absorption
from a topical, if you hit a blood vessel, it can be absorbed
and you can have an arrhythmia or a seizure if it goes into a
blood vessel because it will get absorbed really quickly.
So, I mean, I would say only a medical doctor and only one
really trained in doing those--and experienced in doing those
procedures. Otherwise, that is when something that seems like a
benign drug--but let's remember, it is a drug. So an injectable
makes a risk of anything more dramatic. Absorptions to the
blood where we can get a problem like that to occur is a real
possibility.
Chairman Waxman. Thank you. Well, this panel, I want to
thank you all very much. You've done an excellent job in
outlining the issues for us. Not just as it relates to
professional athletes, but to the whole range of the
population. And I think it has dispelled a lot of myths and it
has also been very educational for us and for the American
people. I'd like to ask unanimous consent that the record be
held open for 2 weeks. There may be additional questions that
we might ask you to respond to in writing.
Mr. Shays. Just 30 seconds.
Chairman Waxman. My colleague, Mr. Shays.
Mr. Shays. Mr. Chairman, I just wanted to thank you for
holding this hearing and thank our witnesses. I know all the
questions have been asked that needed to be. But I think it is
important that you're doing this and I think it will lead to
some insights on the part of the government and some action
both on the part of the government and the private sector and
the sports community that I think ultimately will have
significant benefits. So thank you.
Chairman Waxman. Thank you. That is certainly our hope and
we're going to work with you and others to try to achieve that
goal. Thank you very much for being here. That concludes our
hearing and we stand adjourned.
[Whereupon, at 12 p.m., the committee was adjourned.]
[The prepared statement of Hon. Elijah E. Cummings and
additional information submitted for the hearing record
follow:]
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