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Geriatrics Section, and The New England Centenarian Study, Department of Medicine, Boston Medical Center, and Boston University School of Medicine, Massachusetts.
Address correspondence to Thomas T. Perls, MD, MPH, Geriatrics Section, Boston Medical Center, Robinson 2400, Albany Street, Boston, MA 02118. E-mail: thperls{at}bu.edu
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Abstract |
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 Top Abstract Few Federal Safeguards Regarding...Human Growth Hormone for...The Social Costs Exacted...The 15 Signs of...ConclusionReferences |
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Dorland's Illustrated Medical Dictionary defines a quack as "one who fraudulently misrepresents his ability and experience in the diagnosis and treatment of disease, or the effects to be achieved by the treatment he offers" (4). In the report, "Quackery: A $10 Billion Scandal," produced by the United States House of Representatives Select Committee on Aging's Subcommittee on Health and Long-Term Care, a quack is defined as "... anyone who promotes medical schemes or remedies known to be false, or that are unproven, for a profit" (5). Quackery is practically a millennium-old phenomenon. In the past 10 to 15 years though, new life has been breathed into this niche because of the convergence of the 1994 Dietary Supplements Health and Education Act (DSHEA), the aging of the 72-million-strong baby boom generation (born 1946–1964) and advertising of and accessibility to products and schemes via the Internet.
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FEW FEDERAL SAFEGUARDS REGARDING NUTRITIONAL SUPPLEMENTS |
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DSHEA also does not generally require premarket review or approval of dietary supplements. Therefore, products can be offered to the public without FDA approval, and the FDA can only take action after the fact against products that may be unsafe or that are promoted using bogus claims. Under DSHEA, manufacturers do not have to provide to the FDA any reports they receive of adverse events. For example, Metabolife International only reported to the FDA after congressional pressure and Justice Department investigations the 14,684 adverse events including 5 deaths, 18 heart attacks, 26 strokes, and 43 seizures related to its ephedra-containing product. Such pressure to disclose would never be necessary in the case of drugs. Labeling guidelines for products governed by DSHEA do not require warnings of known contraindications. In this manner, such supplements have entirely bypassed peer review and independent assessment of efficacy and safety procedures. All that the FDA is able to ask is that the manufacturer ensures that the dietary supplement is safe before it is marketed and that the product label information is truthful and not misleading. However, the label guidelines leave so much room for abuse that quackery and hucksterism thrive under these circumstances. The manufacturer can make numerous claims just as long as they do not claim that the product effectively diagnoses, prevents, treats, mitigates, or cures specific diseases. To make such claims would insinuate that the product is a drug. The FDA has published a final rule intended to clarify the distinction between structure/function claims and disease claims. This document is available on the Internet at http://vm.cfsan.fda.gov/
lrd/fr000106.html [codified at 21 C.F.R. 101.93(g)]. The FDA also has the opportunity to perform inspections to ensure products are manufactured in a responsible manner; however, the agency's limited resources only enable a fraction of the firms marketing supplements to be inspected each year.
While the FDA has been able to shut down a few web sites, many continue to operate unscathed and others have simply ignored FDA rulings. Judging from the rulings handed down thus far, the primary ability to impose some degree of oversight over industries that use the DSHEA as a loophole is through the Federal Trade Commission (FTC). The FTC regulates dietary supplement advertising. In September 2002, the FTC reported that 55% of weight loss advertisements included claims that were false or misleading. In 1998, in reaction to FTC guidelines regarding false claims and advertising, an estimated 28% of companies selling dietary and specialty supplements withdrew deceiving language. By comparison, the percentage of companies that made no changes was more than 60% (6,7). In his testimony before the Senate's Special Committee on Aging, the previous Chief Financial Officer of the Brazwell Companies stated that the advertisements in the Journal of Longevity contained..."outright false statements. The ads and articles routinely toss phrases around such as, ‘Thousands of doctors have praised,’ whatever product, and, ‘Millions of men use whatever product,’ which is blatantly false. One product claims to improve memory, sex drive, and reduces the chance of a heart attack by 83 percent" (6).
Figure 1 depicts a table appearing in multiple web sites advertising beneficial changes associated with hGH as an anti-aging treatment. The citation is both inaccurate and incomplete (8). The figure neglects to indicate that the "test results" were actually patient self-reports with a response rate to a questionnaire of 31%. The authors state "Herein, we report our clinical experiences with treating more than 2000 patients with adult growth hormone deficiency (AGHD) using our LD [low dose] hGH replacement regimen." Yet, questionnaires were sent to 1000 patients, the selection criteria of which were not stated. Of the 308 respondents, results from only 202 were reported with no reasons for the omissions reported in the paper. There is no mention of any Institutional Review Board oversight. The first author of the paper directs an anti-aging clinic in Palm Springs, California, that advertises the administration of hGH (www.totalhormonegenetherapy.com). The journal in which the paper appears is no longer in production.
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321(n); 21 C.F.R. 1.21). |
HUMAN GROWTH HORMONE FOR ANTI-AGING IS ILLEGAL |
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There are several reasons why hGH does not qualify as a dietary supplement. First, it was designated a drug by the FDA prior to the DSHEA and thus cannot be regarded as a dietary supplement. Second, substances covered by the DSHEA are meant to be ingested thus disqualifying the most widely distributed form of hGH, injectible hGH and sublingual so-called secretogues (e.g., somatostatin and growth hormone-releasing hormone). Third, hGH, along with anabolic steroids, must, according to the Federal Food, Drug, and Cosmetic Act (FDCA), be prescribed by a physician who also provides subsequent supervision of the patient (See 21 U.S.C. 353(b)(1)(B) (9). It is difficult to envision how physicians who provide hGH via the Internet are able to provide subsequent supervision of the patient. Nonphysicians distributing hGH can be prosecuted as narcotic dealers under the Controlled Substances Act. An example of direct sale of injectible hGH appears in Figure 2.
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Purveyors of hGH will often invoke what they call "the honorable tradition of off-label use" in prescribing and administering hGH as an anti-aging strategy. Such off-label use is not permissible in the case of hGH because of very narrowly defined circumstances under which its use is allowed. Section 303(f)(1) of the FDCA [otherwise known as section 333(f)(1) of Title 21 of the United States Code (21 U.S.C.)] allows physicians to distribute hGH in connection with either 1) "treatment of a disease" or 2) "other recognized medical condition," which has been authorized by the Secretary of Health and Human Services (HHS). The Secretary of HHS and thus the FDA have indicated that hGH for adults is allowed only for two conditions: wasting syndrome of AIDS and Growth Hormone Deficiency (GHD), which must meet two diagnostic criteria (10):
Note that aging and age-related diseases are not listed among the diseases, treatments, or trauma where administration of GH is legal. Also note that GHD due to pituitary tumors and their treatment is very rare at a rate of 10 cases per million people per year (11,12).
Most entrepreneurs that prescribe or administer hGH claim that their clients have low growth hormone levels relative to young adults, but this is not a legal indication for hGH administration. Determining hGH or insulin-like growth factor-1 (IGF-1) levels is neither accurate nor sufficient for the diagnosis of GHD. The diagnosis of GHD requires the documentation that the anterior pituitary gland produces less than 5 ng/ml hGH after the intravenous administration of the amino acid arginine and/or GH-releasing hormone (>10 ng/ml is normal, 5–10 ng/ml is indeterminant; in some laboratories >7 ng/ml is normal) (13). The test is usually administered to diagnose hGH deficiency as a cause of growth retardation in children. In adults, the test is used to diagnose panhypopituitarism or isolated GHD, thus it would be highly unusual that people being treated for anti-aging would have a positive hGH stimulation test.
Some anti-aging marketers sell what they call secretogues, which they claim stimulates the production of hGH. The assertion that the production of hGH can be stimulated assumes that the anterior pituitary gland produces and stores normal amounts of hGH. Thus, secretogues by definition would not be indicated or effective for the treatment of GHD.
Human growth hormone has been approved for treatment of the wasting syndrome in AIDS. Specifically the Secretary of HHS has not approved recombinant hGH products for "anti-aging" treatment. Thus, prescribing, administering, marketing, or distributing of hGH for anti-aging or age-related problems is illegal, and for good reason. Human growth hormone has been demonstrated to have high rates of adverse side effects in the short term, and nothing is known about its potential long-term adverse effects (14). Mouse studies suggest that growth hormone levels beyond what is age appropriate leads to the opposite of what quacks claim, that is, premature aging and marked reduction in life span (15,16).
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THE SOCIAL COSTS EXACTED BY THE ANTI-AGING INDUSTRY |
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Quacks first scare the unsuspecting, espousing dangerous and false myths about aging, and then convince the gullible and vulnerable that they have the cure. Advertised anecdotes by hGH users of increased energy and libido and other improvements have fueled the hopes and fears of many consumers anxious to erase or even prevent a natural life process falsely promoted as synonymous with ill health and growing dependency.
The economic harm imposed upon our older population by the anti-aging industry is particularly significant. Consumers unnecessarily spend an untold fortune each year on "anti-aging" formulations that promise to deliver just about everything on a fountain-of-youth wish list: increased muscle mass, the prevention of middle-aged spread, sharpened mental faculties, and a host of other claims. In 2002, the Washington Post cited one Las Vegas clinic that had one third of its 4000 patients spending $400 to $500 a month for growth hormone injections (17). The FTC estimated that the economic harm caused by 20 investigated companies that marketed such products to seniors was on average $1.8 million per company (7). Some products are relatively inexpensive compounds that can be bought at the neighborhood health food store, while others, such as injectible hGH, require a financial commitment of a small fortune each year for what the huckster hopes to be the rest of the user's life.
Given its prevalence, quackery has become a true public danger. Some products contain undisclosed ingredients that are either addictive or are harmful to specific individuals. One recent case was Botanic Lab, Inc., which marketed a product called PC SPES, a popular product because of published claims that one of its herbal ingredients showed promise in treating prostate cancer (18). PC SPES was found by the California Department of Health Services to contain nondisclosed warfarin and alprazolam. Other products produced by the company such as Arthrin, for joint stiffness, contained undeclared indomethacin, diethylstilbestrol, and alprazolam (19).
Numerous products have been noted to contain biologically meaningless amounts of the advertised substance, which in the case of hGH would ironically protect the buyer from their purchase. As reported in the New York Times recently, ConsumerLab, a company in White Plains, New York, tested for the content of hGH or substances claimed to cause release of hGH in a number of products advertised on the Internet to "Increase Muscle Mass" and "Look and Feel 20 Years Younger." One product, for example, a nasal spray, which ConsumerLab indicates is an ineffective delivery mode for hGH anyway, was found to have 1000th of a pharmaceutically meaningful dose of hGH and which cost $70 per bottle. The various companies and web sites mentioned in the article were, according to the reporter, unwilling to provide any comment (20). It should be noted that hGH is too large a protein to effectively cross mucous membranes, thus effectively making it biologically unavailable in a sublingual or nasal spray form. As a protein, if taken orally, it is destroyed in the stomach. Despite these inescapable biological facts, hGH is sold to the public through many web sites, clinics, and stores as pills and sublingual sprays.
Table 1 lists a number of products that have fortunately been caught by the so-far unacceptably permeable net of the DSHEA act-encumbered FDA and other watchdog organizations.
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The baby boomer generation in particular is increasingly looking for answers about what are appropriate and helpful strategies for improving how they age and for avoiding age-related illnesses—illnesses that some of them are witnessing first-hand with their parents. In this day and age of terrific technological gains and medical breakthroughs, it is understandable how one can be tempted by and fall for purported discoveries of fountains of youth and elixirs. Based upon a recent survey of 1000 people, Eisenberg estimated that nationwide, 24.2 million people used specialty supplements (21).
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THE 15 SIGNS OF QUACKERY |
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An excellent but most unfortunate recent example of going directly to the media was the announcement by a group called the Raelians claiming that its scientists at Cloneaid had successfully cloned a human being. Similar to other pseudoscientific claims, such announcements can have a profound and detrimental backlash on the scientific community.
When the media cannot be lured into promoting the huckster's claim, then many will resort to paid infomercials, perhaps claiming scientific proof while wearing white coats and stethoscopes but again doing so without any reasonable and reproducible scientific proof to back their claims. Internet and e-mail users are plagued on a daily basis with spam advertising, for example, penis enlargement pills and the fountain of youth in the form of hGH.
2. The Purveyor's Work or Message Is Being Suppressed By the Scientific Establishment
By virtue of their motivations and tactics, hucksters and quacks are constantly at odds with scientists, government regulatory and protection agencies, and consumer advocacy groups. One propaganda tool is to claim that critics professing to protect the public are just protecting their financial well-being. Another related tactic is to claim that they are a vanguard like Galileo and are being persecuted by the establishment, but in the end they will be vindicated.
3. Use Phrases Like "Scientific Breakthrough," "Exclusive Product," "Secret Ingredient," or "Ancient Remedy"
Given the many technological feats and discoveries we are exposed to nearly every day, blanket statements such as a cure for cancer or doubling of the human life span seem less preposterous these days, particularly to the gullible and desperate. Perhaps this is why people seem more prone lately to fall for claims like these. Another related strategy is to claim that a new finding will yield results for humans within the year. Such statements though, often based upon findings at the microbiological level, are both irresponsibly premature and nearly certainly unlikely to come to fruition. History clearly speaks for itself in this case.
4. Testimonials and Anecdotes Are Pervasive
People respond positively to anecdotes in part because they can relate to the person who had the positive experience. As with the lottery, "why wouldn't it work for me? I have as good a chance as the next guy."
For example, on one web site selling an hGH product: "I ordered a 3-month supply of Ultimate HGH 1000 and just finished my first bottle. I don't know if it is the product or just my head, but I have to say it is working! My muscle mass is increasing, I am sleeping better. I seem to be in a much better mood all the time, the bags under my eyes are gone and my skin is in much better condition. At 45 I feel like 30 at this point!"
Some entrepreneurs will claim that they themselves or the consumer cannot afford to wait for the conduct of responsible scientific trials of the product that might not even occur anyway because of the expense and time. Rather, the testimonials have to be enough proof of efficacy and safety. The claim might be made that "science doesn't have all the answers." On the other hand, quackery is quick to claim that it has discovered the fountain of youth, the cures to incurable diseases, and miracle answers to obesity. Frequently accompanying the testimonials are statements such as "sold to thousands of satisfied customers."
5. Centuries-Old Remedies Are Credible Because They Have Withstood the Test of Time
Examples abound of remedies where the efficacy is based upon their past use spanning centuries. This was a prevalent argument for defending the sale of ephedra, which is now banned by the FDA. People in remote Andean regions claim that the water from glacial runoffs, otherwise known as "glacial milk," is the fountain of youth. Several web sites promote the sale of glacial milk as an anti-aging treatment.
6. Attempts to Convey Credibility: White Coats, "MDs," "Academies," and "Institutes"
Because the consumer is likely to at first be at least a little skeptical, it is critical for the huckster to appear credible. It is this feigning of credibility in the health field that makes the huckster a quack. The huckster will often appear in a doctor's white coat with a stethoscope around his or her neck; so commonly seen in infomercials. Web sites will have pictures of people in lab coats looking in microscopes, or of other academic medical themes. When appearing in person, the effective quack will exude confidence, never letting up that what he or she is pushing is dishonest nonsense.
As the message becomes less believable, the attempts to convey credibility become more severe. Some organizations claim "board examinations" yet anti-aging medicine is not recognized by the American Board of Medical Specialties (ABMS). In December 2000, the founders of the American Academy of Anti-Aging Medicine, Ronald Klatz and Robert Goldman, were disciplined by the Illinois State Board of Medical Registration for adding the "MD" designation to their names (23).
7. The Absence of Adverse Reactions and the Making of Claims That Sound Too Good to Be True
The terms "all natural," "herbal," and "wholesome" may be used to intimate that the product has no associated adverse side effects. For example, many weight loss products claim to be "natural" or "herbal," but this doesn't necessarily make them safe. Such assurances, even if they are true, do not ensure their safety, as numerous adverse effects have been noted for many herbal products and for patients with specific conditions where the herb is contraindicated.
Unlike prescribed medications, under the 1996 labeling rules of the DSHEA, vendors of dietary supplements are not required to list either potential adverse reactions or potential interactions with medications. Thus, other than moral obligation, the vendor has no incentive to inform the public of these hazards. The result is that adverse reactions are rarely if ever mentioned by hucksters.
The more hucksterism required to sell a product, the greater the efforts to dispel any concerns about it. If adverse reactions are mentioned at all, it is usually in the context of criticizing studies that warn against use of the product. In the case of many products covered by the DSHEA, or hGH, the quack will indicate a vast experience with treating hundreds if not thousands of his or her patients with the elixir with nothing but positive reports.
8. Simplistic Rationales To Dupe the Lay Public
Very few medical innovations and discoveries are simple. In the face of the multitude of behavioral, environmental, and genetic interactions that determine the tremendous heterogeneity in how we all age, the anti-aging quacks claim that the answer is as simple as modulating a single hormone. They observe with their costumes, white coats and stethoscopes, that hGH, melatonin, and DHEA decline with advancing age. Exclaiming that aging is a disease, they announce that administration of one or more of these hormones while carefully monitoring levels will not only restore youth but expand life span to 150 years. However, there is no more science to choosing specific levels as there is to using the hormones to stop aging. In actuality, the decline in growth hormone may be evolutionarily adaptive to reduce cancer risk and propensity for insulin resistance (24).
9. Use Celebrities and Attempt Associations With Well-Known Legitimate Scientists
Numerous sites and infomercials solicit celebrities who themselves may be conned by the quack, or are simply out to make money. Legitimate well-known scientists might suddenly find their names on stationery or web sites by virtue of accepting a recognition award, but in the process, and perhaps unknowingly, appear to endorse the institution or product.
10. "The Esteemed Medical Tradition of Off-Label Use"
Quacks will often indicate their treatment as an "alternative" to traditional and FDA-approved uses of medications. However, alternatives in the world of quackery are unproven and often unsafe. To suggest efficacy, the quack often recommends using the product in conjunction with proven strategies such as exercise and weight loss. Of course, it is these latter behaviors that end up being responsible for any positive results sensed by the patient. In some cases, such as hGH and anabolic steroids, off-label use is illegal.
11. Products Are Sold
Anti-aging web sites and journals are rampant with conflicts of interest, with health care providers purporting to disseminate trustworthy information while using that very same information to sell their products. Simply, the marketing of products by people either pretending to be or who actually are licensed health care providers is likely the most important and reliable indicator of quackery.
12. Misleading Interpretations of Studies or Outright False Claims That Something Works
Out of necessity, by virtue of the products they are attempting to sell, quacks must deceive the public. Part of this deception entails misconstruing the results of published studies and outright fabrication of results. The publication of the Rudman article has led to hundreds of misleading quotes, misrepresentations, and summaries of the New England Journal of Medicine article (1,2).
In an unprecedented move, the journal now posts a warning on its web site (along with links to specific articles) in association with the Rudman article stating: "Editor's Note, posted February 26, 2003: This article has been cited in potentially misleading e-mail advertisements. To give readers more complete information, the full text of the article, its accompanying editorial, and more recent articles about advertising dietary supplements and the question of growth hormone's role in the aging process have been made available online at no charge."
For example, a web site hawking hGH, states: "Dr. Daniel Rudman published in the New England Journal of Medicine his clinical findings of the effects of anti-aging. The results were startling to say the least. Working with volunteers over a period of 6 months the aging process was reduced from 10 to 20 years in the patients who received HGH. In the controlled group that didn't receive HGH, the normal aging process continued. Since Dr. Rudman's initial findings, thousands of additional studies have supported the fact that HGH can and does not only retard aging, but also reverses the process as well. **Look Younger **Lose Weight **Restore Hair Growth **Regain Hair Color**Reduce Wrinkles **Improve Skin Texture **Improve Skin Elasticity **Feel Younger**Restore Sex Drive**Increase Energy (http://www.healthinternal.net/new_page_2.htm). Nowhere in the Rudman article do the authors indicate that the aging process was reduced (1).
According to Senator John Breaux, Chairman of the United States Senate's Special Committee on Aging, in his review of a 2001 issue of the Journal of Longevity, "Some of the articles and advertisements simply prey on the fears of the elderly, while others counsel the reader to take a particular supplement in place of traditional medicine" (6). Regarding the production of the Journal of Longevity, in his testimony, the Chief Financial Officer of the Brazwell Companies stated that "the magazine is presented in such a manner so as to suggest that it is a legitimate medical journal with articles written by various medical professionals." Furthermore: "The fact is that it is neither a journal, nor does it present any reviews of any preventative medicine. Every word in the magazine is composed by Braswell staff, and furthermore every word is designed to do one thing, sell Braswell products."
13. Disclaimers
Disclaimers in and of themselves are not proof of quackery. Many reputable books and other sources of health information provide disclaimers to advise the reader that when making decisions that could impact upon their health, they are well advised to consult with their health care professional.
However, for many web sites, infomercials, and other quackery sites, the fine print absolutely contradicts the intention of the huckster. For example, one site states: "This information is not medical advice or diagnosis, nor is it to be construed as medical advice, medical information, medical diagnosis, or medical prescription for curing, removing, or preventing any disease, or related symptoms. You should not use the information on this site for diagnosis or treatment of any health problem or for prescription of any medication or other treatment. You should always speak with your physician or other health care professional before taking any medication or nutritional, herbal, or homeopathic supplement, before starting any diet or exercise program or before adopting any treatment for a health problem."
Such clear contradictions and what appear to be excessive attempts to shrug responsibility should be regarded as a warning to the consumer. Some web sites have disclaimers that are multiple pages long attempting to protect the quack from any potential legal action. Rather than claim to cure, the quack might claim that the product balances the person's pH, detoxifies the body, or establishes youthfulness. Such language protects the quack, since it is impossible to prove what, if any, changes took place.
14. Money-Back Guarantee
Numerous mail order and web site hucksters offer money-back guarantees for their products. Given the disclaimers most of these sites have, it is hard to imagine the circumstances under which they would return money. The origin of a number of sites makes it clear that the entrepreneur has no intention of honoring a guarantee. Use of NetworkSolutions' WHOIS feature allows the consumer to look up the owner of a specific web site (http://www.networksolutions.com/en_US/whois). Many sites have off-shore origins, particularly Belize and China. Finding addresses such as these should give a person reason to suspect the veracity of the web site.
15. "We Are On Your Side"
In attempts to appear to be the consumer's true advocate, the huckster or quack might claim that they have information that doctors, the FDA, or the American Medical Association, for example, do not want them to know. They often claim that the consumer must have the freedom to choose, and they are there to help them make the decision. One hGH sales site attempted to convey they were the visitor's advocate by providing them the opportunity to report unwanted e-mails. However, further investigation revealed that such reports went to an Internet marketing firm that was the source of the e-mail advertising the site in the first place.
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CONCLUSION |
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While freedom of access and the freedom to choose are important rights, people also have the right to safe and reliable choices. Clearly a balance between these two rights must be achieved. However, the scales are severely tipped in favor of the quacks and hucksters, where people are steering blind, having no idea of the safety, content, contraindications, side effects, or efficacy of their purchases. Even worse, patients may believe they are being offered sincere and accurate information when in fact they are being duped.
Congress might have been attempting to achieve that balance with passage of the DSHEA in 1994. Clearly, however, the amendment did not afford citizens with even the bare minimum of protection from quackery and hucksterism that they deserved. Since the DSHEA, Congress has entertained the passage of legislation that would make such matters even worse with the provision of insurance coverage for these products and to allow entrepreneurs to make disease- and cure-related claims for their products (26,27). Alternatively, Congress is also considering House of Representatives bill 3377 and Senate bills 722 and 1538 to enhance consumer protection (http://olpa.od.nih.gov/legislation/108/pendinglegislation/dietary.asp).
Despite legislation that should keep substances such as hGH and anabolic steroids out of the hands of quacks, the FDA and other agencies are not afforded the resources they need to adequately protect citizens. Even with subpoenaed appearances before Congress, quacks and hucksters simply plead the Fifth Amendment in the face of admonishments for their unethical behavior, and continue to make millions of dollars taking advantage of the vulnerable and desperate, many of whom are older people (6). With such blatant disregard for the public good and with the tardy ban of ephedra fresh in the minds of Congress, the DSHEA and hormone pushers must be dealt with by Congress with effective legislative changes that will give the FDA, FTC, and state agencies the laws and resources they need to ensure that citizens receive the accurate information and assurances they need to make sound choices about their health.
The billions of dollars Americans are currently spending on alternative supplements mandates that resources be dedicated to conducting well-designed studies to determine the efficacy and safety of supplements that show promise or to debunk supplements that show no promise but are used by a substantial number of people. Short of such legislation and until responsibly performed studies provide the answers, health care providers and consumers would be wise to familiarize themselves with the quack's and huckster's arsenal of tricks.
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Footnotes |
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Received January 15, 2004
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This article has been cited by other articles:
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  T. T. Perls, N. R. Reisman, and S. J. Olshansky Provision or Distribution of Growth Hormone for "Antiaging": Clinical and Legal Issues JAMA, October 26, 2005; 294(16): 2086 - 2090. [Full Text] [PDF]
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