The Growth Hormone Craze: Why it Should Be Used only Rarely

The following article was contributed by Thomas Perls M.D., MPH, Boston University Medical Center and S. Jay Olshansky Ph.D., University of Illinois, Chicago.

An article on this topic by these authors has recently appeared in the June 18, 2008Journal of the American Medical Association and parts of the article were included in testimony before the U.S. Congress.

The U.S. House of Representatives’ Committee on Oversight and Government Reform’s recent hearing featuring Major League baseball pitcher Roger Clemens and his former trainer Brian McNamee brought growth hormone once again into the limelight. Were it not for the widespread marketing of growth hormone by the anti-aging industry and others, the committee might have been less inclined to hold the hearing. At present, it is clear that the deceptive marketing, distribution and medical misuse of growth hormone has become a major public health concern.

What is growth hormone?

Human growth hormone (hGH) is produced by the pituitary gland, a pea-sized endocrine gland near the base of the brain. Its primary medical use is to spur growth in children who are deficient in hGH.

Declining levels of hGH in adults normal, natural

HGH levels gradually decline in adults with minimal or no negative health consequences in the vast majority of cases. Particularly in the case of cancer risk, this decline may be protective. But the antiaging industry, the primary pusher and seller of hGH in this country, advertises that normal declines in hGH cause decreases in strength, muscle mass, sleep and sexual performance. They go on to claim, without supportive evidence, that replenishing growth hormone to levels present at younger ages stops or reverses these problems as well as aging itself. This is medical quackery that exposes patients to possible dangers.

Legal, medically appropriate uses for hGH

There are a few medical conditions in adults that merit the use of growth hormone but they probably make up only a fraction of the hGH sold in this country.

Recognizing the potential for growth hormone abuse, Congress amended the Food Drug and Cosmetic Act in the late 1980s and early 1990s stipulate that hGH can be distributed to adults for only three specific indications approved by the Secretary of Health and Human Services. They are:

1. AIDS Wasting Syndrome: This is defined as the involuntary weight loss of 10 percent of baseline body weight, and documented fever in the absence of a concurrent illness or condition (other than HIV infection) that would explain the findings, combined with either chronic diarrhea or chronic weakness.

2. Short bowel syndrome: This refers to a condition of food malabsorption related to disease or the surgical removal of a large portion of the small intestine.

3. Growth Hormone Deficiency (GHD): This is very rare, occurring at a rate of about one to three adults out of 10,000, and the legal diagnosis requires documentation of disease, such as a cancer or trauma to the pituitary gland and a standardized stimulation test that fails to stimulate growth hormone production, thereby establishing a functional problem with the gland. Often times, GHD 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.

Potential risks of hGH supplementation in healthy adults

A recent Stanford University review of 31 clinical studies of hGH use among healthy, normally aging individuals found the only benefit to be a slight increase in muscle mass. The documented side effects included 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 Journal of the American Medical Association (JAMA), about 50 percent of subjects experienced side effects – primarily joint pains. Thirteen percent developed elevated blood sugars or diabetes.

Recent studies suggest associations between elevated levels of hGH and prostate, colon and breast cancers. In an animal study, investigators found that hGH enhances the ability of cancer to spread. It is therefore theoretically possible that normal declines in hGH with age may actually be protective against cancer.

There is no credible scientific evidence that hGH substantively increases muscle strength or aerobic exercise capacity in normal individuals. More recently, researchers from the above Stanford group combined data from 27 different studies of healthy, relatively fit adult men with an average age of 27 years. They found that while muscle mass increased, perhaps because of muscle retention of fluid, strength and exercise capacity did not increase. In fact, the study suggested that exercise capacity worsened. Furthermore, adverse events such as upper extremity swelling and fatigue were more frequent among those who received the hGH.

Illegal, medically inappropriate uses of hGH

Since 1990, a growing network of compounding pharmacies, antiaging clinics and physicians have created what some within the industry estimate is a $2 billion a year business for distributing hGH — a distribution network involving hundreds of thousands of weighttraining enthusiasts, practitioners and promoters of anti-aging medicine.

Clinics generally charge about $1,000 per month for the drug. While the clinics might charge about three times what they pay for the drug, it is the pharmacies and others higher up in the distribution chain that can make profits that rival or surpass narcotics traffickers. In the case of Lowen’s Pharmacy in Brooklyn, N.Y., government investigators found that the pharmacy would purchase 25 grams of imported hGH for $75,000, convert each gram into 2,700 International Units (IU's—a standard measure of potency of growth hormone), of hGH, then sell the drug for $6 to $18 per IU, netting a profit of $375,000 to $1.34 million dollars. Law enforcement officials seized $7.2 million worth of the drug (90 grams), including a shipment from Lowen’s destined for The Health and Rejuvenation Center, an anti-aging clinic in Palm Beach Gardens, Fla.

Contributing to these huge and growing sales of hGH is the Food and Drug Administration (FDA)’s unfortunate decision to permit sales of hGH to children who are substantially below normal height for their age and yet do not demonstrate growth hormone deficiency. Public Citizen has previously stated that the known and unknown health complications and financial costs outweigh the minimal benefit realized by these children (see testimony of Public Citizen Health Research Group Director Dr. Sidney Wolfe at www.citizen.org/publications/release.cfm?ID=7440 ).

The authors of this article found Web sites of 279 anti-aging clinics that advertise hGH treatment and 26 pharmacies that distribute the drug to these clinics or sometimes directly to users. But they likely discovered only a fraction of what exists out there.

Of the seized anti-aging clinic records this article’s authors reviewed for the U.S. Drug Enforcement Administration (DEA) in research for the June 18, 2006, JAMA article "New Developments in the Illegal Provision of Growth Hormone for "Anti-Aging" and Bodybuilding," the average patient who first presents to anti-aging or age-management clinics where growth hormone is available is not a person in his or her 60s or 70s seeking alleviation of age-related problems, but a male in his late 20s to mid 40s, in otherwise excellent health who weight trains nearly daily and is clearly seeking anabolic steroids and hGH. Thus, some clinics are highly profitable providers of anabolic steroids, hGH and other drugs sought by bodybuilders or young to middle-aged adults duped into the idea that these drugs lead to bigger, healthier and stronger bodies without negative consequences.

In summary

Experts in the care of patients with hGH-related problems clearly state that giving hGH for antiaging, age management or bodybuilding is not medically appropriate particularly when weighing the potential benefits and risks.

In this modern 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.

This is a major public 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 trade organizations promoting the illegal use of the drug, and drug companies turning a blind eye to how and to whom their product is distributed have certain attributes similar to those of narcotics trafficking rings.

Do not use growth hormone unless you have one of the three medical conditions for which there is actually evidence that the benefits outweigh the risks: AIDS wasting syndrome, short bowel syndrome, and actual Growth Hormone Deficiency (GHD) — not including normal declines in growth hormone that accompany aging.