Illegal sale of HGH for antiaging rakes in $2 billion a year.

WASHINGTON -- Congress is taking a tough look at the use of human growth hormone for a wide variety of conditions, which is prompting some concern that payers may react by limiting reimbursement for legitimate purposes.

Insurers are already reluctant to cover scientifically validated uses of HGH, Dr. Richard Hellman, president of the American Association of Clinical Endocrinologists, said in an interview. The drug can cost $10,000-$20,000 a year. The continuing use for purposes that have little-to-no evidence of safety and effectiveness may ultimately endanger patients who genuinely need HGH, said Dr. Hellman, a clinical professor of medicine at the University of Missouri, Kansas City.

An Internet search for "HGH" shows that the drug (or an illicit or counterfeit version) is being promoted for a large number of off-label uses.

While this has been a widely known problem, Congress is taking a closer look at HGH and other alleged performance-enhancing substances in the wake of the December report issued by former Sen. George Mitchell that exposed a culture of acceptance for off-label and unproven uses of HGH and anabolic steroids in Major League Baseball.

In mid-February, the House Committee on Oversight and Government Reform held a hearing on what it called "myths and facts" about HGH, vitamin [B.sub.12], and other substances. The hearing was "an opportunity to provide essential and accurate information not just to professional athletes, but to high school kids, senior citizens, baby boomers turning 60, and everyone in between," said Rep. Henry Waxman (D-Calif.), chairman of the committee.

HGH has been touted as an antiaging cure, and increasingly appears to be used by athletes of all ages in the belief that it helps them improve performance and recover from injuries faster. It has been legitimately studied for injury recovery in the elderly, and also is being investigated as a potential therapy for conditions such as fibromyalgia and chronic fatigue syndrome.

All of these uses are illegal. HGH is the only Food and Drug Administration (FDA) approved product that can only be prescribed for the approved indications. In children, the indications are growth hormone deficiency, chronic kidney disease, Turner syndrome, small-for-gestational-age infants who do not catch up to normal range, Prader-Willi syndrome, idiopathic short stature, SHOX gene haploinsufficiency, and Noonan syndrome. In adults, HGH is legal for AIDS-related wasting syndrome, short-bowel syndrome, and growth hormone deficiency.

"Without question, those attempting to market or distribute HGH claiming it will aid healing, slow or reverse the aging process, assist in weight loss, or cure depression are scamming consumers and breaking the law," warned Rep. Tom Davis (R-Va.), the oversight committee's ranking Republican member.

And yet, some estimate that illegal HGH sales far outweigh the sanctioned market. Dr. Thomas Perls told the House committee in February that anti-aging sales amount to $2 billion a year. "I personally have 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," said Dr. Perls of Boston University. In a JAMA article in 2005, Dr. Perls said that legal sales of HGH in 2004 amounted to about $622 million annually, for a little more than 200,000 initial and refill prescriptions, according to data from IMS Health, a market research company (JAMA 2005:294;2086-90).

Dr. Alan Rogol, professor of clinical pediatrics at the University of Virginia, Charlottesville, said that in many cases, HGH purchasers were getting something other than HGH. The prices being advertised are too low and, "many of these preparations are taken orally and cannot be the protein hormone HGH, for it is not active by this route," said Dr. Rogol, who testified on behalf of the Endocrine Society.

Another potential danger is that many of the illicit sales are of human tissue-derived pituitary growth hormone, which has been removed from the market because it has the potential to contain the pathogen that causes Creutzfeldt-Jakob disease.

"It is my opinion for an adult there are no legitimate off-label uses," Dr. Rogol emphasized in an interview.

BY ALICIA AULT

Associate Editor, Practice Trends