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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

Printed for the use of the Committee on Oversight and Government Reform

(

Available via the World Wide Web: http://www.gpoaccess.gov/congress/index.html

http://www.house.gov/reform

(II)

COMMITTEE ON OVERSIGHT AND GOVERNMENT REFORM

HENRY A. WAXMAN, California, Chairman

EDOLPHUS TOWNS, New York

PAUL E. KANJORSKI, Pennsylvania

CAROLYN B. MALONEY, New York

ELIJAH E. CUMMINGS, Maryland

DENNIS J. KUCINICH, Ohio

DANNY K. DAVIS, Illinois

JOHN F. TIERNEY, Massachusetts

WM. LACY CLAY, Missouri

DIANE E. WATSON, California

STEPHEN F. LYNCH, Massachusetts

BRIAN HIGGINS, New York

JOHN A. YARMUTH, Kentucky

BRUCE L. BRALEY, Iowa

ELEANOR HOLMES NORTON, District of

Columbia

BETTY MCCOLLUM, Minnesota

JIM COOPER, Tennessee

CHRIS VAN HOLLEN, Maryland

PAUL W. HODES, New Hampshire

CHRISTOPHER S. MURPHY, Connecticut

JOHN P. SARBANES, Maryland

PETER WELCH, Vermont

——— ———

TOM DAVIS, Virginia

DAN BURTON, Indiana

CHRISTOPHER SHAYS, Connecticut

JOHN M. MCHUGH, New York

JOHN L. MICA, Florida

MARK E. SOUDER, Indiana

TODD RUSSELL PLATTS, Pennsylvania

CHRIS CANNON, Utah

JOHN J. DUNCAN, JR., Tennessee

MICHAEL R. TURNER, Ohio

DARRELL E. ISSA, California

KENNY MARCHANT, Texas

LYNN A. WESTMORELAND, Georgia

PATRICK T. MCHENRY, North Carolina

VIRGINIA FOXX, North Carolina

BRIAN P. BILBRAY, California

BILL SALI, Idaho

JIM JORDAN, Ohio

PHIL SCHILIRO, Chief of Staff

PHIL BARNETT, Staff Director

EARLEY GREEN, Chief Clerk

DAVID MARIN, Minority Staff Director

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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

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MYTHS AND FACTS ABOUT HUMAN GROWTH

HORMONE, B–12, AND OTHER SUBSTANCES

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.

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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

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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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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 performanceenhancing 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

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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:]

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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 antiaging 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.

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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–

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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.

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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 glandproduced 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

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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 growthpromoting 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. Offlabel use usually occurs in adults in two main spheres, the antiaging 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 receivVerDate 11-MAY-2000 12:27 Mar 24, 2009 Jkt 000000 PO 00000 Frm 00051 Fmt 6633 Sfmt 6633 C:\DOCS\47428.TXT KATIE PsN: KATIE
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ing 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 antiaging 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

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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.

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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

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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.

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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

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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

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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-togoodness 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?

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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

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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.

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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?

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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?

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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

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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

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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

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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:]

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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——

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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.

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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

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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

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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 waterbased can be daily or twice a week. I mean, insulin growth factor

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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 antiinflammatory effect.

Now, that can be injected into a muscle, yes. Sometimes it can

be injected into a muscle usually with a corticoid steroid or antiinflammatory 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

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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.

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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

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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,

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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

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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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