[House Hearing, 110 Congress]
[From the U.S. Government Publishing Office]




 
 MYTHS AND FACTS ABOUT HUMAN GROWTH HORMONE, B-12, AND OTHER SUBSTANCES

=======================================================================

                                HEARING

                               before the

                         COMMITTEE ON OVERSIGHT
                         AND GOVERNMENT REFORM

                        HOUSE OF REPRESENTATIVES

                       ONE HUNDRED TENTH CONGRESS

                             SECOND SESSION

                               __________

                           FEBRUARY 12, 2008

                               __________

                           Serial No. 110-121

                               __________

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


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              COMMITTEE ON OVERSIGHT AND GOVERNMENT REFORM

                 HENRY A. WAXMAN, California, Chairman
EDOLPHUS TOWNS, New York             TOM DAVIS, Virginia
PAUL E. KANJORSKI, Pennsylvania      DAN BURTON, Indiana
CAROLYN B. MALONEY, New York         CHRISTOPHER SHAYS, Connecticut
ELIJAH E. CUMMINGS, Maryland         JOHN M. McHUGH, New York
DENNIS J. KUCINICH, Ohio             JOHN L. MICA, Florida
DANNY K. DAVIS, Illinois             MARK E. SOUDER, Indiana
JOHN F. TIERNEY, Massachusetts       TODD RUSSELL PLATTS, Pennsylvania
WM. LACY CLAY, Missouri              CHRIS CANNON, Utah
DIANE E. WATSON, California          JOHN J. DUNCAN, Jr., Tennessee
STEPHEN F. LYNCH, Massachusetts      MICHAEL R. TURNER, Ohio
BRIAN HIGGINS, New York              DARRELL E. ISSA, California
JOHN A. YARMUTH, Kentucky            KENNY MARCHANT, Texas
BRUCE L. BRALEY, Iowa                LYNN A. WESTMORELAND, Georgia
ELEANOR HOLMES NORTON, District of   PATRICK T. McHENRY, North Carolina
    Columbia                         VIRGINIA FOXX, North Carolina
BETTY McCOLLUM, Minnesota            BRIAN P. BILBRAY, California
JIM COOPER, Tennessee                BILL SALI, Idaho
CHRIS VAN HOLLEN, Maryland           JIM JORDAN, Ohio
PAUL W. HODES, New Hampshire
CHRISTOPHER S. MURPHY, Connecticut
JOHN P. SARBANES, Maryland
PETER WELCH, Vermont
------ ------

                     Phil Schiliro, Chief of Staff
                      Phil Barnett, Staff Director
                       Earley Green, Chief Clerk
                  David Marin, Minority Staff Director


                            C O N T E N T S

                              ----------                              
                                                                   Page
Hearing held on February 12, 2008................................     1
Statement of:
    Shurin, Susan B., M.D., Deputy Director, National Heart, Lung 
      and Blood Institute, National Institutes of Health; Thomas 
      T. Perls, M.D., MPH, associate professor of medicine and 
      director, New England Centenarian Study, Boston University 
      School of Medicine; Alan D. Rogol, M.D., Ph.D., professor 
      of clinical pediatrics, University of Virginia, professor 
      of clinical pediatrics, Indiana University School of 
      Medicine, also representing the Endocrine Society; and Todd 
      Schlifstein, M.D., Department of Rehabilitation Medicine, 
      Hospital for Joint Diseases................................    12
        Perls, Thomas T., M.D....................................    20
        Rogol, Alan D., M.D......................................    47
        Schlifstein, Todd........................................    52
        Shurin, Susan B., M.D....................................    12
Letters, statements, etc., submitted for the record by:
    Cummings, Hon. Elijah E., a Representative in Congress from 
      the State of Maryland, prepared statement of...............    91
    Davis, Hon. Tom, a Representative in Congress from the State 
      of Virginia, prepared statement of.........................     9
    Lynch, Hon. Stephen F., a Representative in Congress from the 
      State of Massachusetts, letter dated February 5, 2008......    77
    Perls, Thomas T., M.D., MPH, associate professor of medicine 
      and director, New England Centenarian Study, Boston 
      University School of Medicine..............................    22
    Rogol, Alan D., M.D., Ph.D., professor of clinical 
      pediatrics, University of Virginia, professor of clinical 
      pediatrics, Indiana University School of Medicine, also 
      representing the Endocrine Society, prepared statement of..    49
    Schlifstein, Todd, M.D., Department of Rehabilitation 
      Medicine, Hospital for Joint Diseases, prepared statement 
      of.........................................................    55
    Shurin, Susan B., M.D., Deputy Director, National Heart, Lung 
      and Blood Institute, National Institutes of Health, 
      prepared statement of......................................    15
    Waxman, Chairman Henry A., a Representative in Congress from 
      the State of California, prepared statement of.............     4


 MYTHS AND FACTS ABOUT HUMAN GROWTH HORMONE, B-12, AND OTHER SUBSTANCES

                              ----------                              


                       TUESDAY, FEBRUARY 12, 2008

                          House of Representatives,
              Committee on Oversight and Government Reform,
                                                    Washington, DC.
    The committee met, pursuant to notice, at 10 a.m., in room 
2154, Rayburn House Office Building, Hon. Henry A. Waxman 
(chairman of the committee) presiding.
    Present: Representatives Waxman, Cummings, Tierney, Watson, 
Norton, Sarbanes, Davis of Virginia, Shays, Issa, and Bilbray.
    Staff present: Phil Schiliro, chief of staff; Phil Barnett, 
staff director and chief counsel; Karen Lightfoot, 
communications director and senior policy advisor; John 
Williams, deputy chief investigative counsel; Sarah Despres, 
senior health counsel; Steve Cha, professional staff member; 
Earley Green, chief clerk; Teresa Coufal, deputy clerk; Caren 
Auchman and Ella Hoffman, press assistants; Zhongrui ``JR'' 
Deng, chief information officer; Leneal Scott, information 
systems manager; Miriam Edelman, staff assistant; Bret 
Schothorst, special assistant; David Marin, minority staff 
director; Jennifer Safavian, minority chief counsel for 
oversight and investigations; Brian McNicoll, minority 
communications director; Benjamin Chance, minority clerk; and 
Jill Schmalz, minority professional staff member.
    Chairman Waxman. Good morning. The committee will please 
come to order.
    For the last 3 years, our committee has been investigating 
the use of performance-enhancing drugs in professional sports 
and by high school children. A lot of developments have 
surprised me but none more than the fact that there is a great 
deal of misinformation and widespread confusion that surrounds 
steroids, human growth hormone, vitamin B-12 and other 
substances. Even highly paid, presumably sophisticated 
professional athletes often seem to know the myths and not the 
facts about these substances.
    That's why we're having today's hearing. It's an 
opportunity to provide essential and accurate information not 
just to professional athletes, not just to high school kids but 
to senior citizens, baby boomers turning 60 and everyone in 
between.
    In previous hearings, experts have testified about the 
potentially deadly risks associated with steroid use. The side 
effects range from serious damage to the heart and liver to 
well-documented psychiatric problems. Steroids can be 
especially dangerous for children by impeding normal 
development and inflicting long-lasting harm. We will discuss 
those issues again today, but we'll also focus on our long-
overdue attention on the growing use of other substances.
    Senator Mitchell's report on the use of performance-
enhancing drugs in baseball found that the use of human growth 
hormone by professional baseball players is rising. Just last 
week, Sylvester Stallone seemed to be endorsing the use of HGH 
to reverse the aging process. It's an unfortunate reality that 
what professional athletes and celebrities do serves as a 
health guide to millions of Americans.
    Even worse, there seems to be an almost unlimited number of 
unscrupulous scam artists ready to exploit this reality. Here's 
an advertisement that we can see on the screen by GenF20 that 
reads, HGH could actually prevent biological aging. It's like 
your body is immune to the passage of time.
    Here are the frequently asked questions from another 
product, Growlean 15, that says, our product can be taken at 
any age, safely, with no harmful side effects.
    Well, if any of us search the Internet today, we would find 
thousands of similar sites and a blizzard of confusing claims. 
It's no wonder that so many are confused by the facts about 
HGH. Today, we have a distinguished panel of experts who are 
going to tell us, while there are appropriate uses for HGH, 
there are also serious risks from abusing this powerful drug.
    In adults, HGH is used to treat adult growth hormone 
deficiency and the wasting syndrome of late-stage AIDS, both of 
which are relatively rare. When HGH is used to treat these 
conditions, there are extensive blood tests used to diagnose 
the patient; and patients being treated with HGH are closely 
monitored by physicians.
    For children, HGH is approved to treat a few uncommon 
conditions such as idiopathic short stature growth hormone 
deficiency and chronic kidney disease. It's also used to treat 
a few genetic diseases such as Turner Syndrome and Prader-Willi 
Syndrome. In these cases, HGH can have a clear therapeutic 
benefit.
    But careful studies conclude that, when it comes to 
reversing the aging process, HGH is more snake oil than cure.
    In 2002, the National Institute on Aging sponsored the most 
comprehensive single study of the anti-aging effects of HGH and 
found marginal benefits and significant side effects. It warned 
that HGH should not be widely prescribed and should be limited 
to controlled research studies.
    Another study, this one released in 2007 by researchers at 
Stanford University, concluded that HGH cannot be recommended 
as an anti-aging therapy.
    Well, many athletes believe they get an edge by using HGH, 
even though it is outlawed in all professional sports. They 
think it can make them faster and stronger, and they also think 
that it can help them heal more quickly. But there is only 
limited scientific evidence to support these beliefs. In fact, 
according to one expert, the best way to maximize growth 
hormone production is to get 8 hours of sleep a night, not take 
injections.
    Today, we'll hear from our experts that the increase in 
muscle mass that can result from taking HGH may actually be due 
to water retention. There are real risks from the improper use 
of HGH. Human growth hormone can elevate blood sugar levels and 
cause diabetes. It can increase triglyceride levels in blood 
which can contribute to heart disease. HGH can also result in 
fluid retention, which then can cause swelling, joint and 
muscle pain and carpal tunnel syndrome.
    We know that HGH can cause problems, because it's actually 
a disease where the body produces too much HGH. Doctors call 
that disease acromegaly. It can lead to diabetes, heart 
problems, liver problems, kidney problems, cancer and even 
death.
    It can also cause permanent changes in the face. We know 
what these changes look like. The pro wrestler, Andre the 
Giant, died of complications of untreated acromegaly; and 
Richard Kiel, better known as Jaws from the James Bond movies, 
has publicly spoken about his experience with this disease. 
There are also cases where bodybuilders are injecting such 
large doses of HGH that they are seeing some of these same 
problems.
    HGH purchased from the Internet may carry additional risks. 
It may not be made in FDA-approved plants, and it may not even 
be HGH. In many cases, it is contaminated with other drugs, 
including steroids.
    Because of these dangers, HGH is subject to special 
scrutiny by the Food and Drug Administration. HGH is unique in 
that doctors are actually prohibited from prescribing it for 
any use that has not been specifically approved by the FDA. 
This means the doctors who are prescribing the drug to enhance 
performance or to reverse aging are actually breaking the law.
    We will also focus today on the use of injectable vitamin 
B-12. There seems to be a widespread myth that B-12 injections 
can increase energy, fight off colds and generally promote good 
health. The reality is that B-12 injections are useful for 
those who suffer from pernicious anemia or have difficulty 
absorbing B-12 from their food or B-12 tablets. For everyone 
else, injectable B-12 appears to be an unnecessary needle and a 
waste of money.
    When we began our investigation into steroids in baseball 3 
years ago, the committee's primary focus was the health of 
teenagers who emulate their sports heroes. That remains our 
focus, and that's why this hearing is so important. But, beyond 
teenagers, we have these widespread myths that are leading 
others to use these drugs and wasting their money and may be 
jeopardizing their health.
    I want to thank our witnesses for being here today, and I 
look forward to their testimony. I will introduce them in a 
minute. But I want to call on Ranking Member Tom Davis for his 
opening statement.
    [The prepared statement of Chairman Henry A. Waxman 
follows:]

[GRAPHIC] [TIFF OMITTED] T7428.001

[GRAPHIC] [TIFF OMITTED] T7428.002

[GRAPHIC] [TIFF OMITTED] T7428.003

    Mr. Davis of Virginia. Mr. Chairman, thank you very much 
and thank you for your leadership and for holding the hearing 
today.
    Athletes at all levels, from the sandlot to the Super Bowl, 
look for an edge, that little something extra that could mean 
the difference between winning and losing. Advances in training 
equipment and nutrition offer modern competitive paths to 
strength, skill and longevity not available to previous 
generations, but that high-pressure quest for physical prowess 
has also spawned a thriving subculture of claims hyping the 
benefits and downplaying the risks of everything from vitamin 
supplements to steroids. Today, we try to sort through some of 
those claims, focusing our discussion on two substances much in 
the news lately, human growth hormone [HGH], and vitamin B-12.
    The committee's 3-year bipartisan investigation of 
performance-enhancing substance abuse in professional sports 
uncovered an industry dangerous and tolerant of pseudo-science 
and medical mysteries in its locker rooms. The Mitchell Report 
added to that picture, making clear that, while steroid abuse 
continues to be a concern, the newest trend is HGH abuse, 
alleged to speed recovery from injuries and building muscle 
mass.
    Without question, those attempting to market or distribute 
HGH claiming it will aid, heal, slow or reverse the aging 
process, assist in weight loss or cure depression are scamming 
consumers and breaking the law. These crass moneymaking schemes 
play on vanity and promise scientifically unproven results, 
while openly promoting unapproved uses of a serious biological 
therapy.
    Synthetic HGH is approved by the Food and Drug 
Administration for a limited number of scientifically supported 
uses: children with growth hormone deficiency; wasting 
associated with HIV and AIDS; and, in rare instances, adult 
growth hormone deficiency. For these indications, HGH is an 
important therapy for real medical needs. But even when used 
appropriately, HGH is not without possible long-term side 
effects, including an increased risk of diabetes, carpal tunnel 
syndrome, nerve pain, hypothyroidism, arthritis and cancer.
    No long-term clinical studies have been conducted on the 
effects of HGH in healthy adults or in anyone with doses 
exceeding the FDA approved levels, and those are only the known 
risks associated with the abuse of real HGH. Even the quickest 
Internet search produces countless advertisements for 
nonprescription or dietary supplement HGH and pills, sprays and 
topical creams. Consumers ordering these products run the risk 
of putting counterfeit, contaminated or altered substances in 
their bodies.
    It's impossible to differentiate legitimate drugs from 
fakes by just looking at them. Best case, gullable people are 
only being scammed out of their money; worst case, they are 
placing their health in the hands of criminals who could be 
operating beyond the reach of our laws anywhere in the world.
    B-12 abuse involves similar scams but admittedly fewer 
risks. The vitamin is essential for normal nervous system 
function and blood cell production. For most people, a balanced 
diet captures adequate amounts of B-12. Injections of 
additional B-12 under the supervision of a physician can be 
therapeutic for patients diagnosed with a specific vitamin 
deficiency or anemia. But there's no reliable evidence to prove 
or even suggest B-12 injections given to healthy people produce 
increased energy, aid in weight loss or improve athletic 
performance. Nevertheless, Web sites, anti-aging centers and 
so-called sports medicine experts continue to flout the law and 
promote unproven unapproved uses for HGH, B-12 and a variety of 
other products.
    Hearings like this have to be but one part of a much larger 
effort involving parents, coaches and health providers to 
educate consumers, especially young people, about the gauzy 
myths and harsher realities of HGH, B-12 and other alleged 
pharmacological shortcuts to athletic success. That in the end 
is what makes this oversight so important, preventing drug 
abuse and other physically damaging activities by young 
athletes. Even tacit acquiescence by professional sports 
franchises and locker room malpractice and quackery glamorizes 
harmful, even illegal practices that young impressionable 
aspirants are bound to mimic. In that respect, HGH and B-12 can 
be seen as gateway drugs to steroid abuse.
    We have to find a way to block transmission of that false 
incentive and convince young athletes there are no magic pills 
or wonder drugs that will grease the path to the hall of fame. 
Only hard work and the most effective antidote to illicit 
drugs, the truth, should fuel the bodies and minds of those 
seeking athletic excellence at any level.
    Today's witnesses bring invaluable expertise to our 
oversight, and we appreciate their willingness to testify. I 
look forward to a frank and informative discussion of the myths 
and realities of performance-enhancing drugs.
    Thank you, Mr. Chairman.
    [The prepared statement of Hon. Tom Davis follows:]

    [GRAPHIC] [TIFF OMITTED] T7428.004
    
    [GRAPHIC] [TIFF OMITTED] T7428.005
    
    Chairman Waxman. Thank you very much, Mr. Davis.
    Our panel of witnesses today:
    Dr. Susan Shurin. Dr. Shurin is the Deputy Director of the 
National Institutes of Health's National Heart, Lung and Blood 
Institute. She's an expert in pediatric hematology and 
oncology.
    Dr. Thomas Perls is an attending physician in the 
geriatrics section at Boston Medical Center. He is also a 
visiting scholar at the gerontology department at Boston 
University and has published a number of peer-reviewed articles 
about aging and also about anti-aging medicine.
    Dr. Alan Rogol is a practicing pediatric endocrinologist in 
Charlottesville, VA. He is also a professor of clinical 
pediatrics at the University of Virginia and a professor of 
clinical pediatrics at the Indiana University School of 
Medicine. Today, he's representing the Endocrine Society. Among 
his patients are children who are being appropriately treated 
with human growth hormone, and he is an expert on the effects 
of HGH on children.
    And Dr. Todd Schlifstein. Dr. Schlifstein practices sports 
medicine in New York City and treats athletes, among others. He 
is an attending physician at both the RUSK Institute of 
Rehabilitation Medicine at New York University School of 
Medicine and also at the Orthopedic Institute of New York 
University School for Joint Disease. He is an assistant 
professor at the New York University School of Medicine.
    We're pleased to have each of you here today. It's the 
practice of this committee that all witnesses testify under 
oath. So if you would please rise and raise your right hands.
    [Witnesses sworn.]
    Chairman Waxman. Thank you.
    The record will indicate that the witnesses answered in the 
affirmative.
    Your prepared statements will be in the record in its 
entirety. What we'd like to ask each of you to do is be sure 
the button of the mic is pressed so that it's on and then try 
to limit your oral presentation to us to around 5 minutes.
    There's a little clock sitting there; and it will be green 
for 4 minutes, yellow for the last minute. And when it turns 
red it will indicate to you that the 5 minutes are up, and we'd 
like you to then be sure to summarize your statement.
    Dr. Shurin, why don't we start with you.

STATEMENTS OF SUSAN B. SHURIN, M.D., DEPUTY DIRECTOR, NATIONAL 
HEART, LUNG AND BLOOD INSTITUTE, NATIONAL INSTITUTES OF HEALTH; 
THOMAS T. PERLS, M.D., MPH, ASSOCIATE PROFESSOR OF MEDICINE AND 
  DIRECTOR, NEW ENGLAND CENTENARIAN STUDY, BOSTON UNIVERSITY 
 SCHOOL OF MEDICINE; ALAN D. ROGOL, M.D., PH.D., PROFESSOR OF 
   CLINICAL PEDIATRICS, UNIVERSITY OF VIRGINIA, PROFESSOR OF 
  CLINICAL PEDIATRICS, INDIANA UNIVERSITY SCHOOL OF MEDICINE, 
ALSO REPRESENTING THE ENDOCRINE SOCIETY; AND TODD SCHLIFSTEIN, 
M.D., DEPARTMENT OF REHABILITATION MEDICINE, HOSPITAL FOR JOINT 
                            DISEASES

               STATEMENT OF SUSAN B. SHURIN, M.D.

    Dr. Shurin. Mr. Chairman, members of the committee, thank 
you for the opportunity to appear before you in my capacity as 
Deputy Director of the National Heart, Lung and Blood 
Institute, which is part of the National Institutes of Health, 
an agency of the Department of Health and Human Services. I'm 
here today to discuss the current state of the science of 
vitamin B-12 and to briefly outline what we know about vitamin 
B-12 deficiency and the administration of vitamin B-12 to 
healthy persons.
    A vitamin is a chemical substance that is required for a 
particular chemical reaction in the body but is not synthesized 
by the body and therefore needs to be included in the diet. The 
dietary requirements for normal function are usually relatively 
small. Most vitamins that are known today were recognized 
because their deficiency causes recognizable diseases. 
Examples, for instance, would be scurvy, caused by a deficiency 
of vitamin C, which ultimately motivated British sailors to 
carry limes onboard ship, and beriberi, which is caused by a 
deficiency of thiamine, or vitamin B1.
    Supplemental vitamins are usually not required by people 
who have varied, well-balanced diets and normal metabolism. 
However, supplements are often advisable for people who are on 
limited diets or have increased requirements for vitamins, such 
as pregnant women and growing children. Moreover, a number of 
gastrointestinal diseases can interfere with absorption of 
vitamins and cause deficiencies even in people who have 
adequate dietary supplies.
    Vitamin B-12 is required for a number of vital biologic 
reactions. Two of its most important roles are in the 
production of components of DNA and in the proper functioning 
of different parts of the neurologic system. Tissues in which 
cells are constantly dividing, such as bone marrow and the 
lining of the entire gastrointestinal and respiratory tracts, 
require a constant supply of vitamin B-12. Normal function of 
cells throughout the nervous system and spinal cord also 
requires vitamin B-12.
    Vitamin B-12 comes from animal products and from bacteria. 
The stomach produces a factor that binds to the vitamin in food 
and allows it to be absorbed in the small intestine. Therefore, 
the primary causes of vitamin B-12 deficiency are dietary 
deficiency and malabsorption.
    Diets that lack food from animal sources tend to be low in 
vitamin B-12. Strict vegans, for instance, need a source of 
vitamin B-12. However, it can take 5 years for someone with 
adequate stores of vitamin B-12 to develop a deficiency after a 
major change in diet.
    Diseases of the stomach and small intestine can cause 
problems with absorption and consequent vitamin B-12 
deficiency. Some people make antibodies to the cells that 
produce the stomach factor which is necessary for absorption of 
B-12 and therefore cannot produce the factor. As a result, they 
develop a condition called pernicious anemia, to which 
Representative Waxman, referred which can cause a decrease in 
the number of blood cells. Extensive bowel resections, removal 
of much of the stomach or inflammatory bowel disease can also 
cause vitamin B-12 deficiency. In all of these conditions, they 
need to be treated with monthly B-12 injections, because the 
vitamin cannot be absorbed from food or pills without the 
stomach factor.
    B-12 deficiency has several major manifestations. A very 
characteristic anemia, in which the red blood cells are larger 
than normal, may progress to include low numbers of white blood 
cells and platelets. The symptoms of anemia include fatigue and 
shortness of breath on exertion. The lining of the mouth and 
the gastrointestinal tract can be thin and abnormal. The 
neurologic symptoms are particularly serious and may be hard to 
recognize.
    Difficulty with position sense, nerve damage, depression, 
memory loss and dementia are seen with vitamin B-12 deficiency, 
even when the hematologic manifestation are not obvious.
    Recent studies have highlighted the value of screening for 
vitamin B-12 in older people with mild dementia. B-12 
deficiency in older individuals is probably related to changes 
in the GI tract with aging and fairly limited diets. Both 
problems appear to be more common with advancing age. For this 
reason, the 2005 Dietary Guidelines for Americans recommends 
that persons over 50 consume vitamin B-12 in its crystalline 
form, such as fortified pills or pills. Pernicious anemia is 
most common in older women, who must receive vitamin B-12 by 
injection.
    Diagnosing mild cases in B-12 deficiency can be difficult. 
While looking for low B-12 levels can be useful for diagnosis 
of severe deficiency, serum levels of folate, homocysteine, 
methylmalonic acid, 2-methylcitric acid and cystathionine can 
help make the diagnosis in milder cases.
    The only medical indications for administration of vitamin 
B-12 are deficiency of a vitamin or risk factors for developing 
such deficiency, such as stomach or bowel disease or a limited 
diet.
    Some manufacturers and distributors of dietary supplements 
may claim that vitamin B-12 administration will improve energy 
levels, memory, concentration and mood. All of these are true 
when the person has vitamin B-12 deficiency and are treated 
with B-12. However, there is no evidence at all that these 
clinical benefits occur when the vitamin is given to people who 
are not deficient.
    Vitamin B-12 is not toxic when given to nondeficient 
persons. It is simply excreted in the urine. So you don't 
buildup your stores beyond a certain level. Administration of 
vitamin B-12 does not enhance physical or cognitive function of 
persons who are not B-12 deficient.
    Thank you for the opportunity to provide information on 
this topic. I'd be happy to answer any questions the committee 
may have.
    Chairman Waxman. Thank you very much, Dr. Shurin. We're 
going to have questions after all the witnesses testify.
    [The prepared statement of Dr. Shurin follows:]

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    [GRAPHIC] [TIFF OMITTED] T7428.010
    
    Chairman Waxman. Dr. Perls.

               STATEMENT OF THOMAS T. PERLS, M.D.

    Dr. Perls. Thank you, Chairman.
    Chairman Waxman. Be sure the mic is pulled up close to you 
and that it's on.
    Dr. Perls. What is growth hormone? Human growth hormone 
[HGH], is produced by a pea-sized endocrine gland near the base 
of the brain called the pituitary gland. Its primary utility 
relates to growth in the height of children.
    What about deficiency in adults? Human growth hormone 
levels gradually decline in adults with minimal or no negative 
health consequences for the vast majority of the population 
with aging. The anti-aging industry, the primary pusher and 
seller of growth hormone in this country, advertises that 
normal declines of growth hormone causes decreases in strength, 
muscle mass, sleep and sexual performance and a long list of 
other attributes. They go on to claim that replenishing growth 
hormone to levels present at younger age stops or reverses 
these problems as well as aging itself. This is a ruse.
    There are few medical conditions in adults that merit the 
use of growth hormone. Recognizing the potential for growth 
hormone abuse, Congress amended the Food Drug and Cosmetic Act 
in the late 1980's and the early 1990's, stipulating that 
growth hormone can be distributed to adults for only three 
specific indications approved by the Secretary of Health and 
Human Services. These are: AIDS Wasting Syndrome, Short Bowel 
Syndrome and Growth Hormone Deficiency, also called Adult 
Growth Hormone Deficiency Syndrome.
    Growth Hormone Deficiency is very rare, occurring at a rate 
of about 1 adult per 10,000; and the legal diagnosis requires 
documentation of disease, such as a cancer or trauma to the 
pituitary gland and a failed stimulation test. Oftentimes, 
Growth Hormone Deficiency is accompanied by deficiencies of 
other pituitary gland-produced hormones.
    In January 2007, the FDA released an alert reminding those 
that distribute growth hormone for anti-aging body building and 
athletic enhancement that they are doing so illegally. I have a 
copy of that at the end of my prepared remarks.
    A recent Stanford University review of 31 clinical studies 
of growth hormone used among healthy, normal aging adults found 
the only benefit to be a slight increase in muscle mass. The 
documented negative side effects include soft tissue swelling, 
joint pains, carpal tunnel-like syndrome, breast enlargement 
and diabetes. Other side effects include liver and heart 
enlargement, increased pressure around the brain and high blood 
pressure.
    In a 2002 Johns Hopkins study published in JAMA, about 50 
percent of subjects experienced side effects, primarily joint 
pains; and 13 percent developed elevated blood sugar levels or 
even diabetes.
    Recent studies demonstrate strong associations between 
growth hormone and prostate, colon and breast cancers. In 
another study, investigators found that growth hormone enhances 
the ability of cancer to spread. It is theoretically possible 
that normal declines of growth hormone with age may actually be 
protective against cancer.
    Ironically, there's no credible evidence that growth 
hormone substantially increases muscle strength or aerobic 
exercise capacity in normal individuals.
    What about the illegal and medically inappropriate 
distribution of growth hormone? Since 1990, a growing network 
of compounding pharmacies, anti-aging clinics and physicians 
have created what some within the industry estimate is a $2-
billion-a-year business for distributing growth hormone--a 
distribution network involving hundreds of thousands of weight 
training enthusiasts, practitioners and promoters of anti-aging 
medicine and those who have fallen victim to the growth hormone 
replacement scams.
    I personally have found Web sites of 279 anti-aging clinics 
that advertise growth hormone treatment and 26 pharmacies or 
what are called ``compounding pharmacies'' that distribute the 
drug to these clinics and sometimes directly to users. I 
certainly discovered only a fraction of what exists out there. 
There's a map at the end of my remarks that spell out the 
number of some of these entities per State.
    Of the seized anti-aging clinic records I have reviewed for 
the DEA, the average patient that first presents to the clinic 
is not a person in their 60's or 70's seeking alleviation of 
their age-related problems but, rather, a male in their late 
20's to mid 40's, weight training nearly daily, in otherwise 
excellent health, clearly seeking anabolic steroids and growth 
hormone.
    In summary, one, experts in the care of patients with 
growth hormone related problems clearly state that giving 
growth hormone for anti-aging or age management is not 
medically appropriate, particularly when weighing the potential 
benefits versus risks.
    In this modern day and age, we have witnessed the re-
emergence of the health and longevity salesman. Many members of 
the public have been misled to believe in the magical powers of 
growth hormone and, because of the associated risks and other 
drugs typically sold along with growth hormone, this is a major 
health problem. The cash-only business of Web sites or clinics 
working closely together with compounding pharmacies to turn 
huge profits, the national and international organizations 
promoting the illegal use of the drug, and drug companies 
turning a blind eye to how and to whom their product is 
distributed bear similarity to what some investigative 
reporters have likened to a narcotics trafficking ring.
    Thank you.
    Chairman Waxman. Thank you very much, Dr. Perls.
    [The prepared statement of Dr. Perls follows:]

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    Chairman Waxman. Dr. Rogol.

                STATEMENT OF ALAN D. ROGOL, M.D.

    Dr. Rogol. Good morning, Mr. Chairman and members of the 
committee. I am pleased that the committee has taken the time 
to examine this issue as hormone abuse and misuse has long been 
a concern to the Endocrine Society and its membership. The 
Endocrine Society's is the world's largest and most active 
professional organization of endocrinologists, representing 
over 14,000 members worldwide. We are dedicated to quality 
research, patient care and education.
    Growth hormone is a natural hormone made by the pituitary 
or master gland. Once it circulates in the blood, growth 
hormone travels to bone, muscle and other tissues where it has 
many growth-promoting or anabolic effects and metabolic 
effects. In children, for example, growth hormone stimulates 
lineal growth or height. It is also important for the 
development of muscle and bone and the distribution of body fat 
throughout the body. In adults, growth hormone affects energy, 
muscle strength, bone health and psychological well-being. 
Having either too much or too little growth hormone can cause 
health problems.
    The most common efficacy outcome for the use of growth 
hormone is an increase in linear growth. Growth hormone therapy 
employing replacement doses and modestly high doses is very 
safe. Very large data bases have noticed only minimal increases 
in scoliosis and slipped capital femoral epiphysis, both likely 
due to rapid growth and can occur in any therapy that promotes 
rapid growth or just during normal puberty.
    The single most serious side effect is increased 
intercranial pressures and visual disturbance, which usually 
occurs in the first month of therapy as the kidney is re--
learning how to handle salt and water. Stopping growth hormone 
therapy for a few days and then beginning again at half dose is 
usually all that is necessary to combat these side effects.
    Growth hormone is also administered by physicians to 
promote psychological well-being and alter body composition in 
adults, as Dr. Perls has mentioned.
    Now I want to address the off-label uses of growth hormone. 
Off-label use usually occurs in adults in two main spheres, the 
anti-aging market and the body image or athletic market.
    It should be noted that off-label use comes with increased 
risk. One risk factor is that most off-label users are usually 
unaware of the correct doses, at least for athletes, and one 
can only assume that the doses administered to athletes must be 
very much greater than those used for the legitimate uses noted 
above. As I am sure you are aware, increased doses often mean 
increased risk.
    With increased doses one might get into the range of 
acromegaly, as was mentioned. In children with growth potential 
this may cause gigantism, but I am unaware of anyone being able 
to take these doses--and actually pay for them--in the athletic 
sphere as teenagers. It should be noted that acromegaly is a 
serious disease with weak muscle and very significant heart 
disease.
    Perhaps the most insidious off-label use is by athletes who 
are told they are receiving growth hormone but may actually be 
receiving a different substance or substances. Growth hormone 
is an injectable medication. Magazines and the Internet are 
replete with advertisements for growth hormone. Many of these 
preparations are taken orally and cannot be the protein hormone 
HGH, for it is not active by this route. Most likely, they 
contain amino acids, which do release growth hormone but 
usually only in much larger doses and given intravenously.
    In fact, the amino acid arginine is administered as a test 
for growth hormone sufficiency. Most of the releasers are water 
soluble compounds and are excreted in the urine, with the main 
side effect being expensive urine. Some of the compounds 
purported to be growth hormone may have many ingredients, 
including anabolic steroids or steroid precursors in unknown 
quantities and the entire preparation of unknown purity and 
with multiple safety concerns. Longer term use of this anabolic 
agent may promote tumor growth.
    In addition, the vast majority of clinically administered 
growth hormone is made by recombinant DNA techniques and thus 
not from human tissue. Growth hormone made from human tissue 
has been largely removed from the market because of a rare but 
fatal disease called Creutzfeldt-Jacob. Some of the growth 
hormone now available clandestinely is of human origin and may 
carry this biological agent.
    Also worth noting is that, as with any injectable, one is 
at risk for diseases of shared needles: Hepatitis and HIV/AIDS, 
both of which are serious and may be fatal.
    In summary, there are a number of FDA-approved uses of 
growth hormone in children and adults. These do not include 
anti-aging or improvement in athletic performance. The larger 
the dose of growth hormone administered, the more likely 
moderate and serious side effects may occur.
    Mr. Chairman, thank you.
    Chairman Waxman. Thank you very much, Dr. Rogol.
    [The prepared statement of Dr. Rogol follows:]

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    Chairman Waxman. Dr. Schlifstein.

              STATEMENT OF TODD SCHLIFSTEIN, M.D.

    Dr. Schlifstein. Good morning. Thank you.
    Not to be redundant, I'm going to focus in on the efficacy 
or the lack of efficacy of human growth hormone in regards to 
performance-enhancing ability or as a performance-enhancing 
drug.
    As a performance-enhancing drug, human growth hormone is 
believed to increase energy, maintain or increase lean body 
mass, meaning the muscle-to-fat ratio in the body, help energy 
and muscles recover and help recover from previous injuries. It 
has only been shown to increase lean body mass, meaning the 
muscle-to-fat ratio. Studies have shown the benefits of human 
growth hormone healing from an injury have not been done or 
done well, and there's no shown benefit or efficacy of it as a 
healing agent for recovery from surgery and/or trauma. However, 
I have seen individual case evidence of that, yes.
    When human growth hormone is used in combination with 
anabolic steroids, the effects of the steroids are believed to 
be amplified or improved. The combined use of anabolic steroids 
with human growth hormone together have shown increased muscle 
mass, speed and size. However, when the human growth hormone 
and the steroids combined were compared to studies were just 
using the steroids alone, it was very similar improvements, 
meaning, it was a questionable benefit whether the human growth 
hormone added upon the anabolic steroids really didn't really 
improve increased muscle mass, size and speed.
    For example, test performance enhancements really typically 
means a repeatable exercise activity of like a bench press 
which you would do and then 6 weeks later, without practicing, 
do it again, 6 weeks again, to see if there's any improvement 
benefit from beginning to end without practicing, doing that 
activity.
    When human growth hormone was tested by itself and in that 
short interval of 6 weeks, it was not shown to improve any 
functional compacitants or functional benefit gained during 
that time period when used alone. When used with anabolic 
steroids, it was a benefit, but it was very similar to the 
amount of benefit that was gained with using the anabolic 
steroids by itself.
    There are a lot of limitations in the medical literature 
currently available looking at human growth hormone as a 
performance-enhancing drug, as a healing agent. Most of these 
studies were looking at it only in the short term. There's no 
studies really looking at somebody using human growth hormone 
in another capacity, which is looking at human growth hormone 
in combination with steroids, but someone who is cycling on 
steroids and then cycling off but still maintaining usually the 
human growth hormone. Meaning if they're taking both together 
in a cycle which could be anywhere from 6 to 12 weeks of the 
anabolic steroid, when completing that cycle, in order to come 
off that, cycling off that and then maintaining the use of the 
human growth hormone, the believed benefit is to hopefully help 
maintain or prevent loss of that muscle mass gained when using 
the anabolic steroid with the human growth hormone. It may 
delay loss of muscle mass or strength during that time period 
but really fails to maintain them at the same level when using 
the human growth with the anabolic steroid in combination.
    As regards to healing from injuries, we know that it does 
have a direct effect on bone tissue and case reports of faster 
healing of fracture injuries with doses of human growth hormone 
have been out there but no clinical evidence in a study-based 
format. However, there was also a believed potential benefit in 
users of it in young athletic patients that they have more 
energy, which hasn't really been assessed and is difficult to 
measure. Improving soreness and recuperation from a workout, 
meaning are they able to work out better and harder because 
they are able to recuperate faster? And no assessment of how 
much soreness or prevention of lactic acid buildup and 
prevention of soreness and muscle pain after a workout to allow 
to work out again. There's questionable benefit from that 
respect as well.
    Certainly the side effects of human growth hormone are 
plentiful, as previously discussed; and many of these people 
who were self-treating themselves and using human growth 
hormone in this manner as a performance enhancer are finding 
out the side effects by titrating it and then, once they get 
the side effect, backing off.
    We do see acute onset of carpal tunnel, large hands, 
swollen hands, numbness, tingling from acute onset, meaning 
they're taking too much. We do get joint pain, muscle pain, 
joint swelling, enlargement of the joints, especially the 
fingers and knuckles. As the bone grows and it grows wider, as 
the growth plates already--and doesn't elongate anymore, you 
get excessive bone growth, which is not only causing problems 
in the short term but we're seeing patients with much earlier 
and much more advanced degenerative or osteoarthritis formation 
in these joints. The bones are overgrowing tremendously and 
can't take that strain and wear and tear.
    Yes, we've seen incidences of patients with getting 
elevated blood sugars and continuing elevated blood sugars from 
the fact they're treating themselves with insulin in order to 
get their sugars under control and, in cases, turning 
themselves into diabetics. Quite often, on a lot of these Web 
sites you'll see adjunct medications, meaning medications to 
control side effects, sold right next to the place where 
they're selling the human growth hormone, where they're selling 
insulin, they're selling Lasix so you get rid of the excess 
water--it's a diuretic--painkillers for joint pain and 
stiffness, anti-inflammatories, pain medicine, anti-anxiety 
medication, and then other medication to help them wake up 
after sleeping well. Sleeping well is important for anyone who 
works out regularly, because that's when your body tends to 
heal more; and getting enough sleep certainly helps them 
maintain muscle mass as well.
    So, with anything you inject, there's a risk of skin 
infection, cellulitis, abscess formation, fibrosis scar tissue, 
which I have seen. I have seen a lot of it. After a while, they 
start running out of places to inject themselves because 
there's so much scar tissue in there. Having to have areas 
resected because there's fluid collections in there, especially 
with anabolic steroids that are oil based because they don't 
dissolve. They really don't break down, and they tend to sit 
there and get infected chronically and have to be resected.
    When patients are treating themselves or self-treating 
themselves, then they're usually using multiple poly pharmacy 
techniques in order to control or limit some of the side 
effects in order to maintain the supposed benefits of using 
those drugs.
    Also, with a tremendously large fraudulent market--meaning 
a fake product--out there, there's a lot of other drugs that 
are being used in replacement of the human growth hormone 
that's very hard to distinguish between the two by looking at 
it. Most of the companies--pharmaceutical companies that 
produce this and legitimately produce this, you have on their 
Web sites ways to detect fraudulent market or fake products, 
because they're very hard to distinguish. They're very well 
done, and they're changing all the time in order to keep ahead 
of the market.
    Quite often, it's HCG which is very inexpensive and easy to 
get. HCG is sometimes used by people who are on anabolic 
steroids but are tapering off a cycle. It helps simulate your 
body to help produce more hormones itself. So they taper off. 
They don't bottom out completely from having a low testosterone 
level. So they get a little benefit in feeling like it's 
working, but it's really not doing much. And then, also, it's 
sometimes combined with an anabolic steroid, so they really 
think they're getting a benefit where they're really not 
getting a benefit from that.
    Chairman Waxman. Dr. Schlifstein, let me stop you there, 
because I wanted to ask some questions.
    [The prepared statement of Dr. Schlifstein follows:]

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    Chairman Waxman. I wanted to start the questions for the 5 
minutes that each Member will have.
    We pay a lot of attention on steroids because steroids does 
enhance performance. Isn't that accurate?
    Dr. Schlifstein. Yes, that's an accurate statement.
    Chairman Waxman. But it has very dangerous side effects. 
And we know that, if children use it, it can even cause 
psychiatric problems as well as other medical problems. There's 
also a test. So if an athlete is using a steroid, it can be 
detected in the urine.
    Human growth hormone, on the other hand, cannot be detected 
by any tests that we know of at the present time. Isn't that 
accurate?
    Dr. Schlifstein. Yes. At the present time, there's pending 
stuff working----
    Chairman Waxman. People are working on it. But some 
athletes believe that if they use human growth hormone, it's 
going to increase their performance and they won't get caught.
    Dr. Schlifstein. Right.
    Chairman Waxman. Are they mistaken? Does it increase their 
performance?
    Dr. Schlifstein. Well, the reason it has that appeal that 
way is because you can't detect it; and if you are on like a 
steroid and you stop it, you try to falsely inflate yourself 
into thinking you're going to maintain the benefits you have 
gotten from the steroids and hopefully make it longer lasting. 
It may help a little bit in the short term, but that effect I 
think will be very short lived.
    Chairman Waxman. That's a short term in conjunction with 
steroids.
    Dr. Schlifstein. Right. As it tapers off, you want to try 
and hold onto that benefit because it's really not going to----
    Chairman Waxman. A lot of them are using it instead of 
steroids.
    Dr. Rogol, there is this widespread belief that using human 
growth hormone can increase your muscle mass. Does it make you 
faster? Does it make you stronger?
    Dr. Rogol. Well, this is the second time--that's two out of 
three for the Olympics: ciltius, altius and fortius--higher 
stronger and faster. And the answer is, probably not by itself. 
So as you look at Sylvester Stallone and say that's a different 
body for a 61-year-old man, he may very well have been taking 
growth hormone, Jintropin, that he said he was taking. None of 
us in this room knows what else he was taking; and I think it's 
the ``what else,'' meaning anabolic steroids, that made the 
difference.
    There is, sir, no question that there is a lipolytic, that 
is, fat breakdown effect and mild anabolic effect. So if you're 
a bodybuilder and you want that ripped look, that might make 
sense. But that's about the only place. There are no studies of 
people who are honest-to-goodness growth hormone deficient 
given growth hormone legitimately that shows that their 
strength is very much better and certainly no performance data, 
sir.
    Chairman Waxman. Well, some people believe it's going to 
make them more ripped and stronger and faster and more able to 
perform. What risks are they taking?
    Dr. Rogol. Well, if you are an adult--most of them have 
been mentioned by the two gentlemen who flank me. The major 
risks are, first of all, early on, the edema, muscle aches, 
joint aches. And remember, sir, these are anabolic hormones. 
They lead to the production of insulin-like growth factor one, 
IGF-1, which is really pro growth of tumors. So the aging 
population, whether it's men like we are and prostate cancer or 
women with breast cancer, harbor smaller, earlier tumors than 
the older people; and this may just lead to their growth. 
Theoretical to be sure. But absolutely true in vitro. In 
addition, can show the effects of growth hormone but especially 
IGF-1 on that particular biological effect.
    Chairman Waxman. Dr. Perls, you know a lot about human 
growth hormone. If a young athlete were asking you whether you 
should take it because he thinks it will increase his muscle 
mass, lower his fat and help him be a better athlete, what 
would you say?
    Dr. Perls. First, it's certainly not worth the risk; and, 
second, you know that I would hope that he would go about these 
things in an honest way. One of the dangers of the athletes or 
entertainers taking this stuff is providing a very bad example 
for all these young people certainly. There are no clinical 
studies showing the long-term risk in terms of cancer, but 
certainly short-term studies show that there is substantial 
risk.
    I think kind of the bigger picture is is that we have an 
anti-aging industry and other areas of the market that do an 
unbelievably good job of marketing an incredible false sense of 
safety and an incredible false sense of tremendous benefits 
from these drugs; and out of that comes a huge amount of money, 
$2 billion a year, for these hucksters.
    I think that there's--you know, if you look at the 
Internet, blogs where a lot of these athletes or bodybuilders 
are discussing what to do in terms of the recipes and cocktails 
and what have you, everybody's just kind of playing a guessing 
game, saying this works, this works, this doesn't work, don't 
do this because you'll get caught. It's almost like a cult-like 
presence, and nobody is really like making any decisions with 
the help of caring physicians like from the Endocrine Society 
or elsewhere that really understand the risks and benefits.
    Chairman Waxman. They're not relying on the science; 
they're relying on mythology. Is that correct sir?
    Dr. Perls. And it's almost how much of this is placebo. 
Again, they're not just a danger to their bodies. It's a huge 
danger to their pocketbook. And a lot of the people that are 
taking this stuff, they're not getting the lab tests. They're 
not being well followed.
    So they are really in danger of developing really 
significant heart disease, for example. Not so much from the 
growth hormone, but I very rarely have ever saw growth hormone 
taken in isolation. It's--you're almost always given it with a 
lot of other drugs, anabolic steroids, HCG, Eliminex, all kinds 
of drugs. So it's really amazing to me that they can take all 
these things. They're not getting followed by any lab tests. 
They're not really being followed by a physician. They're 
really putting themselves in significant danger.
    Chairman Waxman. Thank you very much.
    Mr. Davis.
    Mr. Issa. Thank you, Mr. Chairman.
    I guess I'll start off with B-12, since that's a relatively 
new part of our investigation.
    Dr. Shurin, you spoke mostly on B-12. Let me ask it, if you 
will, on behalf of the vitamin industry. Medical professionals 
thought, by and large, will tell us that the--whatever it is--
several billion dollar industry, from One a Day to every other 
vitamin, just gives you expensive urine. Is that a 
generalization that it's pretty darn accurate that the medical 
industry and the science industry and certainly pharma tells us 
that there's very little benefit to most vitamins, particularly 
oral?
    Dr. Shurin. Yeah. I think the shotgun approach, in which 
you just give lots of vitamins because, for the most part, more 
doesn't do you any harm--there are situations in which it does. 
People tend to take it rather than or figuring out how to eat a 
balanced diet, how to get vitamins in the ways that are far 
better for their bodies.
    Mr. Issa. The medical profession tends to give antibiotics 
without knowing exactly what the infection is.
    Dr. Shurin. It happens all the time, yes.
    Mr. Issa. The reason why I want to focus on that, from a 
practical standpoint, B-12 is simply another vitamin that a 
vast, vast number of people believe will help them.
    Dr. Shurin. Right.
    Mr. Issa. Now I happen to have a mother who, during most of 
her pre-menopausal days, was getting various vitamin B-12 
supplements by injections by my own first cousin who was a 
family doctor who thoroughly believed that this was something 
that was helpful for her persistent anemia. He may have been 
right. He may have been wrong. But I grew up with those 
injections.
    Is there any reason for this panel to get involved in a 
multibillion dollar industry and debate the merits of vitamin 
supplements in general here today that would be--where we would 
be effective? We have in the past weighed in, both this 
committee and the chairman's other committee and my other 
committee, the Energy and Commerce Committee. We have gotten 
involved in the vitamin industry; and, at the end of the day, 
it's still a conundrum. Would you say that is roughly correct?
    Dr. Shurin. Yeah.
    There are several issues here. One is that many of the 
vitamins--certainly, the evolution of discovery of these 
vitamins is people gave cocktails, like all the B vitamins sort 
of came together, and so you could only give them together. And 
then, as you've dissected out, we now have a lot more 
components. So it's a common practice for many older 
practitioners to give these sort of cocktails.
    The biggest danger for situations in which they're given 
without a clear understanding of what you are giving them for 
is you may not--if you actually have a problem, is you may not 
be making the underlying diagnosis.
    For instance, one of the common situations as you are 
describing with your mother is that the person may have a mild 
hematologic disease, such as beta thalassemia minor, which is 
an inherited blood disease that doesn't get better no matter 
what you give. And the biggest problem is that there's an 
anxiety that's associated with it because I've got anemia and 
is that--does that mean that there's something serious?
    The vitamins themselves generally don't hurt. Excess iron, 
of course, can hurt.
    I would say that the major damage that's done is the 
failure to diagnosis and to treat significant problems and then 
just the costs.
    Mr. Issa. OK. And because so much of our hearings have 
focused on athletics, I'm going to assume for today that the 
taking of vitamins by athletes of all levels probably is so 
benign as to not be a major part of what we should be looking 
into today. Rather, steroids and human growth hormone are. 
Which brings up a real point that I'd like to make in the 
remaining time.
    It appears as though this committee's good work under both 
the chairman and ranking member have led to professional and 
amateur athletics doing testings for steroids, and I think that 
we should all be very proud that's happened and happened 
without legislation. However, it appears that since there's no 
test for human growth hormone and it appears as though there is 
a legitimate--I'm going to rephrase that--there is a reason 
that people would think that it works as part of an ongoing 
attempt to evade detection, that we need--this committee needs 
to look at the development of a test for human growth hormone, 
perhaps federally funded.
    And, last, if--and anyone can answer that disagrees--
whether Sylvester Stallone, Jesse Ventura, Arnold 
Schwarzenegger or Hulk Hogan--two of whom became Governors. It 
appears as though there is, unfortunately, a tendency for the 
good-looking body on the runway to be part of both steroids and 
human growth hormone; and, up until now, we really haven't, as 
a committee, attacked that. Because, basically, looking good on 
the runway, looking good running for--well, the chairman 
looking good running for re-election in Hollywood and Los 
Angeles has not--and he does look good, and he does get elected 
by a wide margin with Hollywood and Beverly Hills----
    Chairman Waxman. It ain't my looks.
    Mr. Issa. It could just be the physique, though.
    But if you would comment on the fact that, as of right now, 
that has not been successfully looked at. In other words, 
outside of athletics, we're not presently testing; and we do 
have at least two Governors who had incredibly good-looking 
bodies that may have contributed to their election.
    Chairman Waxman. The gentleman's time is up, but let's see 
if the panel wants to answer any of these points.
    Dr. Rogol. In full disclosure, I'm working with both USADA 
and WADA on the growth hormone testing. There's certain things 
I can say; there's certain things I can't.
    Mr. Issa. We can keep a secret.
    Dr. Rogol. Yeah, right. Is this the IRS?
    It is a blood test, first of all, No. 1; and, No. 2, so 
there are a lot of difficulties with labor contracts, what 
you're allowed to do and what you're not. There are some very 
good tests in the urine that prove you can't find HGH in the 
urine. So while there are no tests that are presently available 
that will show HGH use beyond a couple of weeks, there indeed 
are tests and they are in the mill that pass the International 
Olympic Committee's standards, sir.
    Chairman Waxman. Thank you very much.
    Dr. Perls, you wanted to make a quick comment.
    Dr. Perls. Another interesting idea would be to compel the 
pharmaceutical companies to add some kind of inert marker to 
the drug so that it does absolutely nothing in terms of 
biological activity, but it would be easy to detect. This could 
be with growth hormone. It could be with anabolic steroids and 
so on. That would be a little difficult to compel Chinese 
makers of the growth hormone, but, hopefully, the government 
has other ways to interrupt the flow of that. But that might be 
another idea to pursue.
    Chairman Waxman. Thank you.
    Mr. Cummings.
    Mr. Cummings. Thank you very much, Mr. Chairman.
    Dr. Rogol, you know, as we sit here, we have national 
surveys--and I'm sure you are familiar with them--that tell us 
as many as 4 percent of high schoolers are taking anabolic 
steroids and as many as 5 percent, 1 out of 20, are using human 
growth hormone. A recent confidential survey of kids in grades 
8 to 12 is even more disturbing. Over half of the kids who have 
used steroids said that pro athletes influence their decision 
to use those drugs. Does that surprise you at all, any of you?
    Dr. Rogol. No. I've looked at the data. The data are 
anywhere from 2 to even up to 12 percent. I think the issue of 
HGH is not correct, and the reason is--many kids think they're 
taking HGH and, when you ask them, they're taking something by 
mouth. That could not be HGH. The wallet test is probably the 
most difficult test for the teenage athlete to pass. We're 
talking about tens of thousands of dollars for a year. So I 
think the abuse of honest-to-goodness HGH is really quite a bit 
lower. The steroid numbers are exactly in the range that you 
mention.
    Mr. Cummings. The fact is is that those steroids are 
harming our children, though.
    Dr. Rogol. I believe so, yes.
    Mr. Cummings. And the fact is is that I think sometimes the 
media concern me because they seem to think that the committee 
is just showboating. And the reason why we started these 
hearings from the very beginning is because we were concerned 
that young men and women were taking these substances, trying 
to emulate their sports heroes. And here's the most concerning 
part of the survey, it's that three of every five kids using 
steroids were also willing to take it even if it shortened 
their life.
    Dr. Rogol. Yes.
    Mr. Cummings. That's deep.
    Dr. Rogol. It is. It goes back to an athlete dying young. 
It's exactly the same phenomenon. If they could win a gold 
medal, they didn't care what happened 10 or 20 years down the 
road. Yes, sir.
    Mr. Cummings. Is that, Doctor, because--when we're younger 
we feel like we could do anything and we--or is it just that--
are we going for the goal, are we going for the glory, and 
figure when we get the glory it's OK that we just burn out? I 
mean, what is that about?
    And is it something to do with a person just being young 
and not understanding--as one of my people in my district once 
said to me after they had used this kind of stuff, he said, I 
used it; and he said, I can forgive myself, but my body won't 
forgive me.
    I mean, is it that kind of thing, Doctor?
    Dr. Rogol. Well I'm not sure it's--that's a very telling 
comment. But, remember, we're talking about adolescents. I deal 
a lot with adolescents. They are invincible. We all were. Never 
mind voting yes, but we all were.
    But the point is, you know, the brain isn't fully 
developed; and so the executive function, the frontal lobe part 
that tells you, hey, you might not want to do this because of 
the consequences, isn't so developed. So you have the push to 
take it and you don't have the pull back. And so the immature--
even though it's an adolescent, the immature brain is a bad 
thing to have, by the way.
    Mr. Cummings. The immature brain says take me? Is that what 
you are saying?
    Dr. Rogol. Yes. This is Alice in Wonderland.
    Mr. Cummings. All right. That's all right. And then the 
immature brain also says, hey, you know, we're doing pretty 
good, let's not go backward. Is that----
    Dr. Rogol. Well, I don't know about let's not go backward. 
Let's not look forwards is probably a better way of saying it, 
Mr. Cummings.
    Mr. Cummings. I got you. Now, let me just go to your 
testimony. And I saw in your testimony that there is a long 
list of legitimate uses for children. And some of these 
diseases have names I'm not even sure how to pronounce. So can 
we simplify this list by saying that growth hormones is used 
for kids who are not growing enough? Is that----
    Dr. Rogol. Well, that are not growing enough for reasons 
that are stated here. Kids who are caloric deficient also don't 
grow well. Growth hormone would not be an appropriate drug. So 
it is not growing well or normally and having one of these 
conditions. In double blind trials or at least in legitimate 
trials, the FDA has approved the use of growth hormone in these 
conditions, most of which are rare as can be.
    Mr. Cummings. And--I mean--and when you say rare as can be, 
can you give me some numbers? I'm trying to figure out if 
somebody would be using these things and----
    Dr. Rogol. Growth hormone deficiency is about 1 in 4,000; 
chronic kidney disease is probably about the same. Turner 
Syndrome is 1 in 2,500 girls. Small for gestational infants who 
fail to catch up to normal growth is probably 1 in 5,000. 
Prader-Willi is more like 1 in 15,000. Idiopathic short stature 
is the bottom 1 percent. So it is a 1 out of every 100 of us. 
SHOX haploinsufficiency is a gene problem. That is about 1 in 4 
or 5,000. Noonan syndrome is about the same. On average, 
between 1 in 4,000 and 1 in 10,000, sir.
    Mr. Cummings. Thank you, Mr. Chairman.
    Chairman Waxman. Thank you, Mr. Cummings. Mr. Bilbray.
    Mr. Davis of Virginia. Let me go next. Thank you. Thank you 
all for being here today. I think this sheds a lot of light on 
the situation. One of the difficulties is even if you think HGH 
and B-12 can do the job, with this mail order stuff, you're not 
sure what you are getting. Isn't that one of the problems? It 
is a huge problem, isn't it? And so contaminants get into the 
system very, very quickly. I'm trying to look at this B-12 
problem.
    This has come up before this committee before. We had a 
situation a year ago where--or a couple of years ago where one 
of the ball players tested positive for steroids, and he 
thought he was getting a B-12 injection. This seems to be 
fairly commonplace where athletes get B-12 injections and 
thinks it can do something. We talked--are there any adverse 
effects of getting a B-12 shot, Dr. Shurin?
    Dr. Shurin. No, there really are not.
    Mr. Davis of Virginia. It is, like, drinking too much V-8 
or something like that?
    Dr. Shurin. Pretty much, pretty much. And there is 
absolutely no interference in the assays for B-12 and steroids, 
because one of the things that is implied by some of this is, 
as well, if I weren't--it gave you a false positive test for 
steroids or any--or other substances. That actually is not--is 
not possible. Now, many of these substances are coming in 
through tested and legitimate sources, and it is anybody's 
guess.
    Mr. Davis of Virginia. So again, the problem with B-12, 
particularly through the mail is you don't know what your' e 
getting. It is not FDA regulated or anything else.
    Dr. Shurin. That's correct. If you're really getting B-12, 
it is not--it is not harmful.
    Mr. Davis of Virginia. Have any of you ever encountered a 
situation or a patient or known patients who thought they were 
getting one drug through the mail, particularly a B-12 or HGH, 
and ended up getting something that was contaminated?
    Dr. Schlifstein. Absolutely. I've tested it. It was HGC and 
an anabolic steroid combined in a powder that looked identical 
to the human growth hormone.
    Mr. Davis of Virginia. And would it have been harmful if 
somebody injected it, do you think?
    Dr. Schlifstein. Well, if someone thought they were getting 
human growth hormone, it would have an effect but it wouldn't 
be the effect from the human growth hormone, it would be the 
effect of the anabolic steroid combined with the HGC, which 
would enhance it somewhat.
    Dr. Rogol. And if you were a woman, it would be much worse.
    Dr. Schlifstein. Absolutely, absolutely. If a woman--if she 
thought she was getting that, that could have dramatic 
secondary sex characteristics, deepening of her voice, facial 
hair, excessive weight gain, hair loss, acne. Or--I had a woman 
whose husband was buying steroids on line and didn't tell her. 
They went away on vacation, he put his pills in her sleeping 
pill bottle. She took them for a week thinking they were 
sleeping pills and in a week she grew facial hair, a beard, 
deepened voice, gained 15 pounds, acne, clitoral hypertrophy 
just from 1 week; 6 months later, it still never reversed 
itself; 25 years old. Just by taking it accidentally for a 
week.
    Mr. Davis of Virginia. So this stuff is dangerous?
    Mr. Schlifstein. Yep.
    Mr. Davis of Virginia. On the HGH side, we talked a little 
bit about some of the side effects from using that--not just 
contaminated, but using regular human growth hormone. There are 
a large and a growing number of Web sites marketing HGH 
injections. How do you respond to proponents of HGH that 
believe it is a safe alternative to steroids? Go ahead, Dr. 
Perls.
    Dr. Perls. There are thousands of Web sites. You put in 
human growth hormone or HGH and antiaging into Google and you 
get somewhere in the range of a million, 500,000 hits. And I'm 
not so sure they market it as an alternative to growth 
hormones, they just--I mean, to steroids. It is just a--it is 
the greatest thing since sliced bread. I mean, it is really 
snake oil. It is the fountain of youth. And they push this to 
the hilt.
    In terms of the medical records that I reviewed for the 
DEA, I almost, however, never saw a growth hormone given in 
isolation. I think the reason for this is because the clients 
would never see much of any benefit and they'd wonder where is 
my $1,000 a month going. And so they see the growth hormone 
combined with all these other drugs that we've been talking 
about. Just--the other very interesting thing that I saw with 
these clinics is that the compounding pharmacies were, in fact, 
giving the growth hormone with B-12. They would write a 
prescription that said somatropin and B-12. And the only reason 
that I can think of for them doing this is trying to get around 
the law a little bit because giving growth hormone for 
antiaging, athletic use or bodybuilding is illegal. There is no 
such thing as legal off-label use. The Secretary of Health and 
Human Services says that in adults, it can only be used for 
three purposes. Maybe the compounding pharmacies are trying to 
skirt around the law a little bit by saying, well, we're doing 
very individualized therapy, we're trying to produce something 
that is individualized for that specific patient. But it does 
not get around the fact that patient has requested it in the 
setting of an antiaging clinic.
    Mr. Davis of Virginia. Thank you.
    Chairman Waxman. Thank you, Mr. Davis. Mr. Tierney.
    Mr. Tierney. Thank you, Mr. Chairman. Just so I--the human 
growth hormone doesn't really do anything for performance 
enhancement taken alone, correct?
    Dr. Rogol. As far as studies have gone, I'll let my 
partners say more. As far as studies have gone, no. But 
remember for those of us who do remember when the anabolic 
steroids came back, we as physicians were the worst actors of 
all. We said steroids did nothing and then there were some 
proper double blind studies done by Dr. Baseen, who is at your 
institution and they do work. So there are no studies that show 
unequivocally or not even really equivocally.
    Dr. Schlifstein. I think also the studies that are 
available don't look at it in the way it was intended to be 
used, meaning they are looking at taking that in isolation by 
itself, testing before and testing after to see if there is a 
change in performance. And that is not really its intended use 
by its users, meaning its users in conjunction with something 
else.
    Mr. Tierney. Like the steroids?
    Dr. Schlifstein. Right. To maintain hopefully that benefit 
from that amount of steroid, to amplify the effect later on in 
the steroid. And when you're off the steroid, hopefully to 
maintain those benefits. And it really wasn't looked at in that 
way. Also it really wasn't looked at in how it effects the 
individual performance, meaning are you able to tolerate more 
of a workout, are you able to tolerate more muscle recuperation 
from that. Just like something like creatine, which is an acid 
buffer, it allows you work out more because you can tolerate 
more lactic acid buildup, that allows you to tolerate more 
working out, working out sooner. That has a benefit in the 
longer term, but immediately by itself nothing.
    Mr. Tierney. The research on the harm that it does seems to 
be a little more advance.
    Dr. Schlifstein. Absolutely.
    Mr. Tierney. Now, all these advertisements we've seen about 
people aging, this is going to reverse the aging process, this 
is the fountain of youth on that basis. Even some well-named 
actors trying to indicate to people--anybody over 40 should 
take it. And they indicate in those advertisements that they 
believe HGH actually causes aging. It doesn't cause aging, does 
it, Dr. Perls?
    Dr. Perls. I can speak to that. They claim that growth 
hormone levels drop with aging, which is true, and therefore 
the growth hormone causes aging. Aging is caused by multiple 
problems involving our--hits to our DNA, our cells, chronic 
damage to many different entities of our body by free radicals 
and so on. It is not caused by declines in growth hormone or 
other substances.
    Mr. Tierney. Does it do anything beneficial to--regarding 
aging at all?
    Dr. Perls. Say again?
    Mr. Tierney. Does it do anything beneficial regarding 
aging?
    Dr. Perls. In fact, my guess is that it does bad things 
with regard to aging. Studies and lower organisms in mine show 
that animals that are deficient in growth hormone actually live 
30 to 40 percent longer. These animals also have a marketedly 
reduced rates of cancer. So it is actually--probably does the 
opposite effect.
    Mr. Tierney. It sounds to me from your testimony earlier 
that the concerns we have with respect to women using HGH is 
even more pronounced than with males using it. Is that also 
correct?
    Dr. Perls. I'm not so sure--there are other hormones that 
some of these antiaging clinics--you know, the clinics make 
their bucks on what they call hormone replacement programs. And 
it is multiple hormones from steroids and--which are basically 
testosterone or variations of--and growth hormone. And it is 
really the anabolic steroids where we see the untoward effects 
with--in women in particular.
    Mr. Tierney. All right. And you announced the problems for 
women using HGH earlier and I won't go over--you keep shaking 
your head, Doctor. Am I getting it wrong?
    Dr. Rogol. What my colleague to the left mentioned were the 
problems with steroids in women, not with HGH. That is why I 
was shaking my head.
    Mr. Tierney. Are there any problems with women, in 
particular, using HGH?
    Dr. Schlifstein. As compared to men differentiating, I 
haven't seen any sexual differences between one and the other.
    Mr. Tierney. So whatever problems exist for men taking it, 
it would be for women as well?
    Dr. Schlifstein. Right. I mean, with testosterone, the 
women's receptor is like 100 times more sensitive than the 
males. So even a low dose of something that is testosterone can 
have much amplified effects in women that may not reverse 
themselves even if taken off. And that is an anabolic steroid. 
That is not human growth hormone.
    Dr. Perls. One concern would be the 1 out of 9 women that 
go on to develop breast cancer and taking growth hormone for 
any woman. When you're looking at that kind of prevalence would 
probably be a very bad idea. And there are studies to show 
that--particularly with a breast cancer tumor, that one of the 
events to allow that breast cancer to spread is when it starts 
expressing its own growth hormone. So this is just a really bad 
idea.
    Mr. Tierney. Well, thank you. I yield back, Mr. Chairman.
    Chairman Waxman. Thank you very much, Mr. Tierney. Mr. 
Bilbray.
    Mr. Bilbray. Yes. Todd, in your testimony, you were talking 
about taking--administering which substance after doing a bench 
press?
    Dr. Schlifstein. That is one of the typical tests you do 
for performance enhancement. There were studies looking at the 
efficacy of human growth hormone used in combination with 
anabolic steroids versus anabolic steroids by themselves and 
looking at that at day 1 and then day 6. There was a slight 
benefit from using the human growth hormone when used with the 
anabolic steroid as compared to just using the anabolic 
steroid. So in that scenario, when combined with an antibiotic 
steroid, it did have some performance enhancing effect. Not in 
isolation, only when used with a combination with something 
else.
    Mr. Bilbray. The growth hormone itself, you stated that 
after the workout, the administration of the substance after a 
period of time, there was no net difference between the 
application of the growth hormone and not--and without it?
    Dr. Schlifstein. Right. When just looking at pure 
performance enhancing assessment from day 1 to day--you know, 
week 6, growth hormone was nothing. There was no benefit in a 
test of pure performance enhancing in that timeframe.
    Mr. Bilbray. Doctor, I think any, you know, sophomore in 
high school would tell that you if he is an athlete, that is 
not--they'd perceive that not being worth the paper it is 
written on because they're exercising, working out at least 3 
days a week. They are going through extensive weight training. 
And the perception would be, then, do we do these tests showing 
that the use of the hormone or--during regular training 
sessions where at least 3 times a week there is extensive 
workout, you know, strain to the muscle mass, do we do that 
kind of real world testing that these kids are perceiving that 
they are going to go through?
    Dr. Schlifstein. That's why I said I really don't think 
there is testing appropriate to what we're really looking for 
the potential benefit of. It is looking at a benefit in the 
short term. And anyone who takes it will tell you that is a 
more longer term benefit. And even by itself or potentiated by 
something else. So I don't know if that assessment tool really 
applies to that by itself is really applicable. And not to draw 
too many conclusions by that, just by saying in the short term.
    Mr. Bilbray. I'm glad to say that you have brought that up, 
because I think that is really critical. Because when we bring 
data forward to persuade young people to stay off this stuff, 
we need to make sure we have a credible argument that they will 
accept. And I don't think any of my kids would look at this and 
say, yeah, dad, of course if you're not working out, you're not 
going to get any benefit from--you know, this is a supplement 
to a major workout program, so it has to be real life.
    So I just hope that when--we're really careful that when we 
give the argument why kids should stay away from this, it is 
one that is very defensible, it is not able to be assailed or 
justified. I--the flip side is I kind of tell them, look, 
you're working out anyways, you're going to put muscle mass on 
and, yeah, there might be a placebo effect. But until we do 
those kind of real world testing, our ability to sort of argue 
the point is diminished to some degree. These kids are not 
idiots. The fact is they may be getting into this drug and that 
is stupid. But still, as I said, the--some parts of the brain 
haven't developed but other parts are very well developed.
    And we have to make sure that we approach this with an 
intelligent argument. Because once our arguments get debunked, 
then we're really in trouble trying to give science to these 
kids. That is within the guy that is pushing the drugs, pushing 
the substance really is saying, see, they're really not giving 
the data and here is the argument. There is already enough bad 
propaganda out there already. I just hope that we have the 
substance--I mean, have the substance in our argument.
    Do we--are we testing real life application? Do we have 
that data so we can show these young people, look, here is an 
athlete working out here and here is the application over here, 
this is your life? Because any high school/college student is 
going to tell you, you know, doing one sets of bench presses, 
taking the injections and then waiting for a month is not my 
world. I'm working out three times a week extensively and I'm 
just looking for something that will give me that little edge. 
I'm not talking about a silver bullet that is going to do it 
all for me. Do we have the ability to give them that kind of 
information?
    Dr. Schlifstein. I mean, I think we have the ability to 
give them certainly the downside, the side effects. I don't 
know if we have enough ammunition to be convincing by itself. I 
think that would be a little more difficult. But certainly it 
makes it more difficult when you have other people endorsing it 
by using it and saying they are using it. And so it makes it 
that much harder for your argument to say and this doesn't 
work. But someone else is saying I'm using it like that is very 
hard to counterproduct, especially for a kid who is not looking 
at long-term side effects, they're going to get arthritis or 
diabetes later. He is looking at the short term.
    Mr. Bilbray. All of us will admit that the statement, if I 
knew I was going to last this long, I would have taken better 
care of myself. So the universe will turn. And so, Mr. 
Chairman, I just hope that we--again, the fact is that they are 
not in a position to make the best judgments of anybody in the 
world and then they've got the ambition of success, which we 
all can suffer from. And then I just hope that we give them a 
lot more data than just this could hurt you when you're an old 
guy. Their attitude is I could give--I'm not looking forward to 
that. That's--how many young people do we still see smoking 
cigarettes. And when, you know, my God, if we can't get them 
off cigarettes, this is a hard argument to make. Thank you very 
much, Mr. Chairman.
    Chairman Waxman. Thank you, Mr. Bilbray.
    Mr. Lynch.
    Mr. Lynch. Thank you, Mr. Chairman. I want to thank the 
ranking member as well. Following up--and I want to thank our 
panelists for helping us out with this issue. Following up on 
Mr. Bilbray's line of questioning, we have a hearing tomorrow 
regarding Major League Baseball, which HGH is an important 
issue and a significant danger in itself. But I think the 
hearing tomorrow has provided added focus. It has provided some 
context, I believe. And I think in a way the problems in 
baseball, are, I think, instructive as to the wider problem in 
society.
    In baseball, we had a situation where--let's take steroids 
for example. Major League Baseball came back and they had a 
greater awareness program, a greater acknowledgement that 
steroids were bad. And that was--that was right up front and a 
big part of their push. They came up with a very aggressive 
testing program for steroids and a very thorough testing 
protocol for steroids. They had much stronger penalties for 
steroids. And as a result in the Mitchell Report, it reported 
that steroid use in baseball was down significantly. When they 
addressed the HGH or failed to address the HGH problem, Major 
League Baseball, they had no--there was reluctance to put in 
any testing protocol regarding HGH, there was not the same 
message put out there on the street that HGH is bad. And not 
surprisingly as a result, the report indicated that HGH use was 
on the rise. Now, if you look at the problem that we're having 
that you have described already where the message is not out 
there among our young people, it is not out there in the 
public. There is a very mixed message because you've got some 
of these athletes and sports figures--well, Stallone, the 
actor, there saying HGH is good. There is a real problem with 
the--I say popular opinion regarding HGH.
    And it even comes to our laws. Our laws under Title III of 
the controlled substance act include steroids. It has very 
strong criminal penalties for mere possession of steroids 
without a position--without a prescription. We have no 
prohibition for simple possession of HGH. There is no criminal 
penalty for that. And that is what I'm getting at. That is 
something we here in Congress can control. And since you're the 
experts on this and--you know, if I could just, you know, 
personally thank Dr. Perls for your good work at Boston Medical 
Center and at Boston University, what do you think about the 
idea of including HGH in Title III to include all of these 
penalties to at least legislatively send out the signal that 
this is a seriously dangerous substance?
    Dr. Perls. I'm incredibly appreciative to the committee 
having this hearing in the first place to start to--not to 
start to, but to look at growth hormone and the public health 
concern that it represents. And along with that, stiffer 
penalties such as making Schedule III, I think, is an excellent 
idea. Already there are very important laws on the books to go 
after the distributors for illegally distributing--for 
distributing growth hormone for legal uses that include 
imprisonment and fines. But adding it as a Schedule III has all 
kinds of great potential in terms of educating physicians as 
well. Because right now I think it is a little fuzzy for a lot 
of doctors out there in terms of what the law really is.
    So I think that is also very important. Along with making 
it a Schedule III, though, I think it is very important to also 
do what Congress can to provide additional resources to the DEA 
in particular, who is short on staff and already has to pay a 
lot of attention to methamphetamines and heroin and other big 
drugs and this will be one more on their list.
    So giving them the additional resources that they need to 
carry out their mission would be very important. The other 
thing, I think, is while you're at it, there are other hormones 
that go along with growth hormone. There is something called 
growth hormone, stimulating hormone, and then there is the 
already mentioned insulin growth factors. And as we've seen 
with other drugs, when one becomes hard to get, everybody 
starts looking out for one that is easy to get and is less 
expensive. When growth hormone--when things clamp down heavy on 
growth hormone, they'll start looking at growth hormone 
stimulating hormone and insulin growth factor, which are all 
part of the same endocrine access. And I would think it would 
be good to add those to the list as well.
    Mr. Lynch. Mr. Chairman, if I can ask, I have a letter to 
me but it is actually testimony to me from Gary Wadler, from 
the World Antidoping Agency that I would just ask to be 
included in the record if I may.
    Chairman Waxman. Without objection, it will be included.
    [The information referred to follows:]

    [GRAPHIC] [TIFF OMITTED] T7428.048
    
    [GRAPHIC] [TIFF OMITTED] T7428.049
    
    [GRAPHIC] [TIFF OMITTED] T7428.050
    
    Mr. Lynch. Thank you, Mr. Chairman.
    Chairman Waxman. Thank you. Mr. Sarbanes.
    Mr. Sarbanes. Thank you, Mr. Chairman. I've learned a ton 
here today, so I appreciate your holding the hearing. And I 
thank you for your testimony. What percentage of the people 
that are using HGH or B-12 would you say are using it 
exclusively without it being used in combination with anything 
else? Do you have any sense of what that would be?
    Dr. Rogol. No, sir.
    Dr. Perls. So my exposure to this comes again from 
reviewing seized medical records for the DEA from three 
antiaging clinics. And I can't think of any instance where the 
growth hormone B-12 was used in isolation. It's--they were 
always given with anabolic steroids and a number of other 
substances. And while we were talking about vitamins, I must 
also say that they were providing very expensive collections of 
a whole bunch of different vitamins, all on the idea of just 
making a lot of money.
    Mr. Sarbanes. So the adults in this equation have figured 
out that HGH by itself and B-12 by itself and other sort of 
vitamin supplements by themselves really are pretty useless for 
the goals they have it sounds like.
    Dr. Perls. The adults--well, I think it is the--it is the 
antiaging physicians, the owners of these clinics and the 
compounding pharmacies that are selling this stuff that have 
realized that selling it in isolation is going to make for some 
angry clients and that it is probably best to get this stuff in 
combination with other things. So that they try to see some--
whatever benefit that might be. And that is all without saying 
much about the side effects I might add.
    Mr. Sarbanes. Are they being explicit in the blogosphere 
about the fact that the--the discussion on the blogosphere, is 
it explicit about the fact that, you know, it is the 
combination of steroid use with a growth hormone or vitamin 
supplement----
    Dr. Perls. Absolutely. Very explicit. It is amazing 
following these blogs how much time everybody is spending on 
what the right recipes and cocktails are and what works for 
whom.
    Mr. Sarbanes. So it still gets us back to the steroid use 
as being--that is the driver? I mean, that is the aspiration, 
is through that you enhance performance and these other things 
are sort of on the margin to help boost the effects of that?
    Dr. Perls. I think that is right. And I also--again, as was 
just intimated, this is not any kind of standard clinical 
trial. This is a bunch of nonscientists, nonclinicians just 
trying to feel their way through this and saying, oh, this 
worked for me and this worked--and without really any--
monitoring for any long-term side effects or benefits for that 
matter.
    Mr. Sarbanes. How much complicity does--without assuming 
it, how much complicity would you say there has to be on the 
part of medical professionals to help perception? In other 
words, if all of those who have the science at their disposal 
were emphatic on the point of the dangers that are involved 
with steroid use or the fact that B-12 or HGH really doesn't 
help you do anything, then you would imagine that would be a 
significant deterrent to the use. But the high incidence of use 
suggests that there is some--some complicity. And I'm 
wondering----
    Dr. Perls. In terms of the--in terms of the physicians who 
are illegally writing prescriptions for hormone and steroids 
without ever seeing the patients or the owners and the 
physicians of the antiaging clinics, it is not a matter of 
complicity. They are the driving force.
    Mr. Sarbanes. OK. And I'm running out of time. So let me 
ask you this question. I raised this in another hearing we had, 
but now I've got some experts in front of me and I'd be curious 
on your perspective on this. I bought my son one of these 
pushup kits. OK? So it has some equipment with it and it has a 
video on how to use it. And then at the end of the video, lo 
and behold, it shows you two bottles of some kind of thing that 
you're supposed to take in conjunction with this regimen. What 
would that have been most likely do you think?
    Dr. Rogol. Hell of good marketing. That is terrific 
marketing. My guess would be if I had to guess would be 
something like HGH, but there would be a releaser or it would 
be something that you'd take by mouth that is likely something 
that is relatively harmless except to your wallet.
    Mr. Sarbanes. OK. Thank you.
    Dr. Rogol. But that is purely a guess, Mr. Sarbanes.
    Mr. Sarbanes. Understood.
    Chairman Waxman. Thank you, Mr. Sarbanes.
    Mr. Sarbanes. He is not going to be using it anyway.
    Dr. Rogol. Is that for the record, sir?
    Chairman Waxman. Ms. Watson.
    Ms. Watson. Thank you so much, Mr. Chairman, for having 
this hearing and to the doctors who are witnesses. We certainly 
appreciate you appearing before the committee to let us know 
about some of the threats to public health. I want to just 
probe a little bit and I think most of you have addressed the 
overuse of HGH. And I know there are a couple of conditions 
that occur normally when you have too much HGH in the system. 
And I think Dr.--I want to be sure I pronounce your name. Is it 
Schlifstein?
    Dr. Schlifstein. Schlifstein, yes.
    Ms. Watson. Yes. You mentioned a woman taking her 
husband's----
    Dr. Schlifstein. That was anabolic steroids. It was a 
steroid that she took by mistake.
    Ms. Watson. Oh, I see. OK. There is something called 
acromegaly. And, of course, we know about gigantism. And I 
would like any of you that can, can you describe the problems 
associated with acro--what is it, acromegaly? And--to us so we 
can understand it? And I see these hearings, Mr. Chairman, as 
very helpful to the general public and certainly helpful to us 
because we live in this drug culture. You can't turn your TV 
on, you can't listen to the radio--they are not pushing 
something over the counter or go talk to your doctor about 
this.
    So I think our young people believe that the way to live 
their lives and to enhance their abilities is to take some of 
these drugs. Now, some of these things occur in the body 
normally, so, Dr. Rogol, maybe I should start with you. Can you 
describe the problems associated within acromegaly.
    Dr. Rogol. I'm actually going to let Dr. Perls do it. He is 
a big people's doctor. I'm a little people's doctor.
    Dr. Perls. Acromegaly involves usually a tumor of the 
pituitary gland where it is making too much growth hormone. And 
you'll see the facial characteristics that was mentioned with 
Andre the Giant, and so on where they get a bossing of the 
forehead, they get an enlarged jaw, they can have an increased 
incidence of certain cancerous tumors probably because of the 
effect of growth hormone in the terms of the ability of a tumor 
to grow and to spread. They get troubles with their heart and 
liver in particular, because they get heart enlargement and 
liver enlargement. And that doesn't necessarily make for a 
better functioning organ.
    They get what is called insulin resistance or they can have 
elevated blood sugars and that can go on to develop to be 
diabetes. They do have shortened life spans, not increased life 
spans. And then there is all the other--you know, we had 
mentioned the enlarged hands and so on.
    Ms. Watson. Maybe you can tell us about if you can 
extrapolate from the--from this experience and to the elderly. 
What can you extrapolate from acromegaly to the elderly?
    Dr. Perls. Well, I first actually got interested in growth 
hormone because I run the New England centenarian study which 
is a large study of people who get to 100. And I'm a 
geriatrician who absolutely loves old people. And the very 
first concern for me was an antiaging industry that was 
portraying old people in a terrible light, saying that, you 
know, do you want to be demented and frail and really scaring 
the heck out of a very important population, the baby boom 
population, 70 million strong individuals who are very actively 
aging right now and just to scare them and then say, oh, by the 
way, we have the cure.
    And that would be growth hormone, books like Stop the 
Clock, Reverse Aging Now, a huge number of Web sites 
popularizing this. And much of this happened--it began with a 
New England Journal of Medicine article in 1990 looking at 
growth hormone and a very small sample of older men and 
comparing the two with and without growth hormone and 
basically--unfortunately a statement saying that it took 10 to 
20 years of aging off of the person's life.
    The New England Journal editors have since come out saying 
they rued the day that they ever allowed that statement to 
happen because it led in part to a blooming of this industry. 
And what really surprised me was with my review of these charts 
for the antiaging clinics, was that the vast majority of them 
are not older people. It is again people in their late 20's, 
30's and 40's who are going for the kinds of things we see the 
testimonials of, these good looking, strong athletic types. And 
I think unfortunately as a society we're very susceptible to 
looking at testimonials and taking them hook, line and sinker. 
But that is all this market is based on, is testimonials and 
not real silence. And I'm hoping that the elderly population as 
you mentioned are a relatively minor part of this very big 
public problem.
    Ms. Watson. Thank you. Mr. Chairman, can I have a few more 
minutes? I wanted to ask about vitamin B-12. Before I get 
there, I wanted to address this to Dr. Rogol. Sylvester 
Stallone once told the Today Show that HGH was just amino 
acids, just a collection of proteins. And the body--that the 
body already produces. And how can 191 amino acids be all that 
dangerous? And is it just amino acids?
    Dr. Rogol. Ma'am, there is one problem with that. 191 amino 
acids probably aren't a problem. A 191 amino acids hooked 
together that form a protein called HGH, that is what the 
problem is. So it is a little B&A in the middle of that to try 
to take these things and make a growth hormone. And I suspect 
as some of you may have read in the article in last Wednesday 
in USA Today that Mr. Stallone said all of this was done by 
HGH. I am sure he took HGH. We are absolutely unsure the 17 or 
23 other things that he said.
    And as you probably also read, I was quoted as saying 
exactly that in the USA Today. So, yeah, he took HGH. But, 
again, with HGH and anything else--I am a clinical scientist. I 
know how to do experiments. The biggest issue in most 
experiments, once they're properly designed, is what the dose 
is. We know precisely what the dose is when we do an 
experiment. These doses are way beyond that. They're taken in a 
different way. And so we really don't have the idea of how to 
go about testing or studying as Dr. Schlifstein has said. So 
that is the long-winded answer to your question, ma'am.
    Ms. Watson. Thank you so much. And if I can shift now to 
injectable vitamin B-12. And, Dr. Shurin, can you tell us just 
very briefly--I'm out of my first period of questioning and 
into the second period. I'm almost out of time--but the 
appropriate use of the injectable vitamin B-12?
    Dr. Shurin. The appropriate use for the injectable vitamin 
B-12 are for people who are unable to absorb the oral form of 
B-12. Normally, if you have a perfectly normal gut, you can 
absorb vitamin B-12 from your diet. Even people who are strict 
vegans who don't take vitamin B-12 in their diet can take 
supplemental vitamin B-12, which they usually do from yeast and 
absorb it just fine. So it is people who have had--who got 
pernicious anemia, people who have had bowel resections, some 
people who have inflammatory bowel disease, all need to get 
vitamin B-12 by injection, otherwise it is perfectly 
appropriate and definitely safer to have it by mouth. It is not 
dangerous by injection, but it is not helpful either. It also 
means that there are syringes and needles around which--whether 
it is the locker room or the home is not a small issue.
    I think the potential secondary complications of having 
needles and syringes around is not a trivial issue.
    Chairman Waxman. Thank you, Ms. Watson. I think your time 
has expired.
    Ms. Watson. Fair enough.
    Chairman Waxman. I want to ask--and you may want a second 
round. But I want to take a second round and ask some questions 
of Dr. Schlifstein. Dr. Perls treats the elderly, Dr. Rogol the 
children. But you've been a sports doctor and you've dealt with 
athletes. In your experience with athletes, if they use human 
growth hormone, are they more likely than not to be using it in 
conjunction with other drugs?
    Dr. Schlifstein. They almost in every case are using it 
with other drugs. There may be periods of time where they're 
only taking that and cycling off something else. But certainly 
it is the mainstay, is using with something else. So that is 
why a lot of times these talks about human growth hormone in 
isolation isn't really true or we shouldn't just be talking 
about that. You have to talk in combination with some type of 
anabolic steroid.
    Chairman Waxman. If an athlete tells me that he is taking 
human growth hormone to heal from a sports injury, how would 
you react to that? Is it credible? Is it helpful?
    Dr. Schlifstein. We really don't have any proof that it is 
beneficial in that manner. Certainly with its effect on both 
muscle and bone tissue, one could hypothesize that--like a 
fracture or something else may heal slightly faster than one 
without taking it. I've seen some cases where people have 
fractures, young people taking human growth hormone and they 
healed a lot faster than normal. Was that the only factor 
involved? It was only a case report. So it is not really 
scientific evidence. But possibly, yes.
    Chairman Waxman. And when an athlete uses it--these are 
expensive items, this human growth hormone, $1,000 a month, are 
they taking very high doses do you expect from your experience?
    Dr. Schlifstein. From my experience with these people, 
patients, what they've been taking, the dosing that some of 
them would use for an HIV wasting syndrome, it can vary between 
a quarter and a half of that dosing, because sometimes they get 
it from those patients as well because they know they're 
getting legitimate sources of it and don't have to get a 
prescription themselves and they get it and they buy it off 
those people who get it----
    Chairman Waxman. More than likely than not, they are people 
hanging around that they tell them, just get me some human 
growth hormone.
    Dr. Schlifstein. Well, these people get it automatically 
every month and they know they get a certain amount. That's why 
I know how much they have of it based on that dose. So it is 
already paid for and gotten through and gotten regularly and 
they know it is a legitimate source and a real source. And 
usually, it is about half that dose. But that has dramatic 
effects on someone who is in their 20's and 30's, taking that 
large of a dose, especially with whatever else they're taking.
    Chairman Waxman. What is it that they think they're getting 
when they take a vitamin B-15 shot? I mean, you can't take it 
orally, so they get a shot. What do they think----
    Dr. Schlifstein. You referring to a B-12 shot?
    Chairman Waxman. Yeah.
    Dr. Schlifstein. You know, I think a lot of that I think is 
the placebo effect. If you're already doing so many injections 
and you think you're going to get an energy boost from it and 
you have something that looks like red syrup and you think it 
is going to boost your energy, if you really believe in it, 
yeah, what is another shot if you're already taking, you know, 
7, 10 a week anyway?
    Chairman Waxman. 10 in a week of B-12?
    Dr. Schlifstein. Injections.
    Chairman Waxman. Injections of other drugs?
    Dr. Schlifstein. Yeah. They are using it once or twice a 
day. The anabolic steroid, depending on which one, oil-based or 
water-based can be daily or twice a week. I mean, insulin 
growth factor is even worse because they have to inject it into 
each individual muscle. So you have to do every muscle you 
worked out.
    Chairman Waxman. Is B-15 injected in the muscle?
    Dr. Schlifstein. B-12 is. Usually it is an intramuscular 
injection, yes.
    Chairman Waxman. I see. How about lidocaine? Tell us about 
lidocaine. And is it safe for a fitness trainer to inject 
someone with lidocaine or is it a dangerous drug?
    Dr. Schlifstein. Well, I don't think a fitness trainer 
should be injecting anything or recommending anything either on 
that behalf. But lidocaine is used as a local anesthetic. Now, 
as far as injections for pain management goes or for treatment 
of an injury, very specific reasons and uses for it. Now, it 
only is temporary, right? A short-lived, short-acting 
anesthetic. It just numbs the area temporarily, and in 2 hours 
it is gone. So if someone has an inflamed, irritated joint, we 
may put some corticoid steroid, an anti-inflammatory steroid 
combined with some lidocaine, inject it into a joint to get 
pain relief from an inflamed, irritated join. The lidocaine 
gives them temporary short-term pain relief, while the anti-
inflammatory or corticoid steroid or cortisone takes time to 
work its anti-inflammatory effect.
    Now, that can be injected into a muscle, yes. Sometimes it 
can be injected into a muscle usually with a corticoid steroid 
or anti-inflammatory steroid as well for pain relief into what 
we call a trigger point.
    Chairman Waxman. Is this a dangerous drug?
    Dr. Schlifstein. It can be, depending on dose, amount and 
frequency. Now, usually a limited amount would be injected 
and--with joint space, most of it tends to stay in that joint 
space. Injected into a muscle, there is going to be some 
systemic absorption.
    Chairman Waxman. Who do you think should give this kind of 
injection? You say not----
    Dr. Schlifstein. I mean, only a physician and I would say 
only a trained physician in that specialty.
    Chairman Waxman. What specialty, sports medicine?
    Dr. Schlifstein. Sports medicine or pain management, 
somewhere where they know how much you're doing and where 
you're doing it. You can get other effects to nerves. You can 
do a nerve block by mistake, you can cause damage to that 
nerve. There are a lot of other potential problems with that. 
And when injecting it into a muscle, you want it just into that 
muscle, you don't want to damage any other tissue. If someone 
has what we call a trigger point or like back pain and you put 
into the muscle spasm, it helps that muscle relax but only 
temporarily.
    Chairman Waxman. My last question. Is it a performance 
enhancing drug, this lidocaine.
    Dr. Schlifstein. It is not a performance enhancing drug. It 
is purely a local anesthetic or local pain reliever? Any other 
Members wish for more time? Mr. Bilbray.
    Mr. Bilbray. So lidocaine really just addresses the pain. 
So it doesn't----
    Dr. Schlifstein. So something wouldn't hurt.
    Mr. Bilbray. I guess the only way to performance 
enhancement would be to eliminate the pain so you could 
continue to perform without knowing that you actually have 
damage going on there and probably create more damage?
    Dr. Schlifstein. Right, which is a dangerous scenario 
because you're going to have an anesthetic or numb area where 
you inject it. So potentially, during an athletic competition 
or an event, there are serious concerns about doing that kind 
of injection because you're not going to have the normal 
feedback.
    Mr. Bilbray. Pain tends to be nature's way of telling us to 
slow down?
    Dr. Schlifstein. Absolutely.
    Mr. Bilbray. OK. Well, those of us over 50 relate to that. 
The B-12 image of enhancement, is that the increased red blood 
cells thus the fact is that the blood is able to carry more 
oxygen, able to do that? Is that the image that is being given 
out on the B-12?
    Dr. Shurin. That is exactly right. The benefits of 
receiving B-12, if you're B-12 deficient, are all in exactly 
the areas where people want to have enhanced performance. You 
have more energy, your red count goes up, you have better 
memory, you have better concentration, your nerves function 
better. So all of those things are clearly benefited if you're 
B-12 deficient and you get treated with vitamin B-12. And I 
think what is happening is that they are extrapolating from 
that kind of situation to the idea that if you're starting----
    Mr. Bilbray. A little is good; a whole lot is better.
    Dr. Shurin. That is exactly right. And it is very clear 
that is, in fact, not the case.
    Dr. Rogol. Mr. Bilbray, I think there is a little confusion 
here. Most of the athletes who want that are taking 
erythropoietin rather than B-12. And so EPO is another hormonal 
drug of abuse, and that is where medals were lost in Salt Lake 
City based on compounds like that. And so there is quite a 
difference and most of the athletes are more likely to take 
erythropoietin than they are to take B-12.
    Dr. Shurin. B-12 use is very, very common. And I think what 
they're looking for is some of the same kind of benefit that 
they'd also look for from erythropoietin. The big difference is 
that the use of erythropoietin is not without major side 
effects. You said erythropoietin is a serious business and that 
is actually--that is the Tour de France problem as well.
    Mr. Bilbray. OK. Now, when we focus on the problems, the 
problems, the problems and trying to grasp for the answers, one 
other thing that I think that those of us here in the Federal 
Government have jurisdiction specifically on and may be able to 
address is this issue of the network that is distributing the 
propaganda out to our young people which is not necessarily 
over the traditional airwaves, but over the new vehicle of 
communication for the next generation, that is the Internet. 
Was it fair to say that the Internet could be, you know, a 
major line of communication on not only touting this--these 
substances, but also the possibility of distributing them?
    Dr. Schlifstein. I think it is a dangerous combination of 
both. You're getting information from the same place that is 
trying to sell you something. Of course, they're going to tell 
you the good sides or the potential good sides or even if 
they're not even truth. But the myths of it--they're certainly 
not selling you the downsides and that is the same source of 
information you use in the purchase of something from--which is 
a dangerous combination when you do the two together.
    Dr. Perls. It goes beyond just individuals on the Internet 
marketing and pushing the stuff. There is coordinated efforts 
between clinicians or these clinics and the compounding 
pharmacies or a number of drug busts--Raw Deal was one of them. 
Another one is something called Witch Doctor--that these 
operations conducted by the DEA and others that showed that 
there are coordinated efforts between these entities to push 
and market the stuff to go into gyms and sports spas to 
actually recruit individuals to take the drug and then they get 
a kickback for that.
    There are much larger almost pseudo medical societies bent 
around antiaging that have courses and symposia on how to 
take--how to deliver the drug, how to have successful antiaging 
practices. They produce books. They produce very large 
conventions, both nationally and internationally where they 
bring all these folks under one roof.
    Mr. Bilbray. So you've got a whole network. And the 
Internet, though, is a major part of that?
    Dr. Perls. Sure. Well, they have their Web sites and what 
have you----
    Mr. Bilbray. Even among those groups?
    Dr. Perls. The Internet is most dangerous because of such 
easy access by the--by everyone. And then----
    Mr. Bilbray. Especially at the high-risk population?
    Dr. Perls. Right.
    Mr. Bilbray. Young males wanting--Mr. Chairman, I just 
wanted to raise that issue because I think that one of the 
things that we have had a success in the past working on--and, 
in fact, you and I worked on the telecommunication bill over 
the energy and commerce back in the 1990's of addressing the 
use of the Internet as a predatorial vehicle on young people. 
I, have a feeling that we ought to be looking at the Internet 
as being part of the answer to this issue of those who are 
using these predatorial activities for selling these drugs and 
really trying to address how we monitor and enable to regulate 
the Internet to at least try to obstruct it from being a fast 
track to substance abuse. Thank you very much, Mr. Chairman.
    Chairman Waxman. Thank you, Mr. Bilbray. It would be Mr. 
Lynch first if you want more time and Ms. Watson if she wishes 
more time.
    Mr. Lynch. Just briefly. On that same topic again. I do 
know that the difficulty in policing some drugs, such as 
OxyContin was that doctors--individual physicians had the right 
to--to prescribe them so-called off--off labeled for reasons 
and for situations that weren't necessarily the primary reason 
for certain medications. Interestingly enough, HGH is one of a 
very rare examples--I can think of no other drug that we've 
investigated up here that has a prohibition that says you can't 
prescribe this off label. And that is what--that is what the 
FDA says about HGH.
    So all of this stuff, whether it is on the Internet or 
whether it is in the mail or whether it is, you know, within 
these gyms, all of this stuff is right now off label. It is 
prohibited flatly by the FDA.
    So since--I think we already have the tools to stop this. 
And I just want to know, you know, from our panelists, is it a 
matter of enforcement that we're falling down on here or do you 
think that there is some other, you know, prohibition maybe 
regarding the Internet? And I just think that is the vehicle--
that is just one way of selling this stuff. I think that we 
have the tools already to stop this if we were serious about 
it. I'd just like to hear your thoughts on that.
    Dr. Rogol. I presume that is correct if it really is human 
growth hormone. That is precisely the drug that the FDA talked 
about. But I could see the biggest amount of wiggle room with 
things that aren't HGH because they--they say, well, this is 
not proscribed. So that is where I think there might be a lot 
of difficulty because it is my opinion--I haven't looked at the 
Internet sites--but it is my opinion that the vast majority of 
the hype for this are things other than the 191 amino acid 
drug--HGH. So that might be another avenue to look at. It is 
just a little bit different than what you said, sir.
    Mr. Lynch. That is very good, Doctor. That explains a lot. 
Anybody else? Dr. Perls.
    Dr. Perls. I'd actually disagree. The amount of hype and 
literature in marketing that I've seen around growth hormone, 
the injectable is unfathomable in that it does represent a $2 
billion a year market for the--what we call the off-label 
indications of growth hormone or the illegal indications. The 
laws are there to prevent the illegal distribution or to try 
and prevent the illegal distribution, but it doesn't get to 
possession as you have mentioned. And I do think that calling 
something a Schedule III has a great deal of education benefit 
to the people who prescribe the drug. There is--I think it 
became a big problem--it's been going on for about 17 years and 
it's been pretty much under the radar because it is a fairly 
obscure rule.
    You said it is unique and it is. So I think taking the 
extra steps to bring it out of obscurity is very important and 
a bill to make it Schedule III I think would very much help in 
that vein. And then, of course, there is providing the 
resources to go after it. I think another big problem is a very 
overstretched FDA and DEA in their ability to deal with all the 
things that they have to deal with.
    Mr. Lynch. OK. All right. Thank you, Mr. Chairman.
    Chairman Waxman. And, Ms. Watson, do you wish to ask 
further questions?
    Ms. Watson. Just very quickly. I wanted to raise an issue 
about lidocaine. Just recently we saw a very tragic news story 
about a young lady who was on her way, as we understand, to the 
laser hair removal clinic and spread lidocaine cream all over 
her leg, and I guess her body and she had a seizure, collapsed 
and died. Can someone comment on the cream that you can get? 
And should it be controlled by a professional?
    Dr. Rogol. I don't know about the cream, but I was going to 
mention before lidocaine is a drug that affects electrical 
activity, whether it is of your heart or your brain. So when 
physicians appropriately inject into a joint, shoulder, knee 
are the usual ones, no problem. But when it gets systemic, that 
is when you have the problems. And so cardiac and brain 
arrhythmias, which is, in essence, what a seizure is, are a 
known side effect of that particular drug.
    Dr. Schlifstein. Right. It would have to be taken in very 
large quantities through the skin to be absorbed that way. Now, 
you can get it over the counter which is, like, 1 percent. 
Prescription strength is 5 percent. There is also a topical 
patch which is Lidoderm, which is lidocaine in a patch which is 
5 percent. Now, if you keep doing that, your body is going to 
absorb more and more, and eventually it will get into your 
blood stream and you'll probably build it up over time.
    Lidocaine is also an anti-arrhythmic. I mean, it is 
usually--to prevent a heart from having arrhythmias. But like 
any anti arrhythmic, it can be prorhythmic. And it also affects 
the electrical conductivity of your heart, and it certainly can 
affect the electrical conductivity of your brain. I think the 
perception is if it is over the counter, or if it is a topical 
medication, the perception is I can't take too much, it won't 
get absorbed. There have been cases of people from taking the 
topical aspirin creams who have died from salicylate toxicity 
or aspirin toxicity just because they perceive it as benign. 
They are putting the patch on, they are putting the cream on. 
They don't think they're going to be affected that way. 
Lidocaine would have to be taken in pretty large quantity to be 
absorbed to have that effect.
    If you left three patches on for 24 hours a day, you'd only 
have about 1 percent absorption into your blood stream. So it 
would probably have to be a large dose and a continual dose to 
do that. But some patients, if they're given that, they need an 
instruction on how to take it appropriately. Just because you 
put more on, it doesn't mean the area is going to get more numb 
or penetrate more deeper. It really only works superficially. 
And I think people who are getting a procedure and want to 
anesthetize and someone prescribes that, has to give 
appropriation instruction on the use of that medication.
    Ms. Watson. What I'd like to have clarified, how much is 
too much of the cream?
    Dr. Schlifstein. I mean, it really has to only go on that 
area locally and it has to be on there a half hour beforehand. 
So if you were just doing your head, you just need enough to 
cover it. Once it is numb, it is not going to get more numb. 
It's not going to go deeper. So it is really going to--it is 
going to last 2 or 3 hours. That is how long it lasts. More on 
is not going to make it last longer or be more numb. Either it 
is anesthetized or it's not. There is no in between. Usually--I 
mean, those tubes come in large amounts, which is usually 
enough for weeks if not a month. At most it should be applied 
twice a day because it will stay--some are absorbed in the 
adipose or fat tissue on the subcutaneous tissue. I mean, just 
under the skin, there will be a little residual buildup.
    If you continue to use it, you'll get continual buildup of 
additional lidocaine. So it probably wasn't a one time use. It 
was probably a continual use and probably had to put a lot of 
cream on it in order for that to occur. But, you know, if you 
weren't instructed properly, you probably wouldn't know any 
better. And if they had it ahead of time before a procedure, 
someone is nervous, they are going to keep doing it just to 
hopefully have less problems later.
    Chairman Waxman. Would the gentlelady yield to me?
    Ms. Watson. Yes. I'm finished. Thank you so much.
    Chairman Waxman. If you heard about a professional athlete 
who had a lidocaine injection, but didn't go to a physician, 
what risks is that person taking?
    Dr. Schlifstein. I think a lot. I think--even--a lot of 
physicians wouldn't inject lidocaine without a lot of 
experience in doing it, and especially depending on what part 
of the body you're doing it into. Certainly there are nerves 
that go all over the body. Just as we talked about absorption 
from a topical, if you hit a blood vessel, it can be absorbed 
and you can have an arrhythmia or a seizure if it goes into a 
blood vessel because it will get absorbed really quickly.
    So, I mean, I would say only a medical doctor and only one 
really trained in doing those--and experienced in doing those 
procedures. Otherwise, that is when something that seems like a 
benign drug--but let's remember, it is a drug. So an injectable 
makes a risk of anything more dramatic. Absorptions to the 
blood where we can get a problem like that to occur is a real 
possibility.
    Chairman Waxman. Thank you. Well, this panel, I want to 
thank you all very much. You've done an excellent job in 
outlining the issues for us. Not just as it relates to 
professional athletes, but to the whole range of the 
population. And I think it has dispelled a lot of myths and it 
has also been very educational for us and for the American 
people. I'd like to ask unanimous consent that the record be 
held open for 2 weeks. There may be additional questions that 
we might ask you to respond to in writing.
    Mr. Shays. Just 30 seconds.
    Chairman Waxman. My colleague, Mr. Shays.
    Mr. Shays. Mr. Chairman, I just wanted to thank you for 
holding this hearing and thank our witnesses. I know all the 
questions have been asked that needed to be. But I think it is 
important that you're doing this and I think it will lead to 
some insights on the part of the government and some action 
both on the part of the government and the private sector and 
the sports community that I think ultimately will have 
significant benefits. So thank you.
    Chairman Waxman. Thank you. That is certainly our hope and 
we're going to work with you and others to try to achieve that 
goal. Thank you very much for being here. That concludes our 
hearing and we stand adjourned.
    [Whereupon, at 12 p.m., the committee was adjourned.]
    [The prepared statement of Hon. Elijah E. Cummings and 
additional information submitted for the hearing record 
follow:]

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