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New hurdle for HGH detection
Anti-doping researchers worked the better part of a decade to find a way to identify athletes who augment their body's normal level of human growth hormone by using a synthetic form of the substance.
Now the sports world's fight against illicit HGH use may have a new venue — the pursuit of a way to detect an emerging slate of compounds called HGH releasers.
HGH releasers stimulate the pituitary gland into overproducing the natural form of the hormone, which influences the body's growth, cell production and metabolism. This potentially gives users the same physiological advantages they could get by using synthetic HGH.
The synthetic form can boost muscle growth, decrease body fat and aid in recovery from strenuous workouts. So world drug-testing authorities again will be using a blood test for synthetic HGH at this summer's Beijing Olympics.
However, anti-doping experts say the current HGH test cannot detect HGH releasers.
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HGH releasers come in two forms. There's an easily obtainable sports supplement taken orally that, according to some studies, has questionable value. Then, there's a pharmaceutical version that's injected daily.
No athletes are known to have used it, but it worries anti-doping experts and federal drug enforcement officials because its impact is unquestioned, the government's regulations don't cover it and testing for it is beyond researchers' present reach.
Meantime, a pharmaceutical manufacturer in Canada is working on a new HGH releaser. The company is touting potential use — beyond its designed use for AIDS/HIV patients — as a treatment for abdominal obesity.
In either form, HGH releasers "could be more difficult to detect than (synthetic) human growth hormone," said Anthony Butch, director of UCLA's Olympic Analytical Laboratory, one of two U.S. drug-testing labs accredited by the World Anti-Doping Agency (WADA).
Limitations of testing
Synthetic growth hormone injections are notoriously tough to identify. The current state-of-the-art test can't detect HGH more than 48 hours after the last injection and isn't effective at all in detecting pharmaceutical HGH releasers, according to HGH expert Peter Sonksen, a professor of endocrinology — the study of hormones in the body — at St Thomas' Hospital and King's College in London. (Sonksen received a grant from the IOC in 1999 to develop a test for synthetic HGH; the test he formulated is not being used by the WADA or the IOC.)
Since HGH-releasing drugs don't contain growth hormone, but instead spur the body's production of it, there's no way to identify them through the current testing method, Sonksen said.
The current HGH test's limitations mean that even though pharmaceutical HGH releasers are on the WADA's list of banned substances, the designation is almost moot. Gary Wadler, chairman of WADA's Prohibited List and Methods Subcommittee, says athletes probably know that.
"We know that there are athletes out there that follow these things closely. The first question they'll ask is if there's a test for it," said Wadler, an associate professor at New York University medical school who maintains a private practice in internal and sports medicine in Manhasset, N.Y.
The current HGH test, introduced before the 2004 Summer Games, has yet to turn up a positive result for the substance in an athlete. And no U.S. pro sports league uses blood testing or tests for HGH.
Sonksen, who says his HGH test could be more effective against synthetic HGH and the use of HGH releasers, said "only the world's dumbest athlete" would be caught by the current test because of its known time limitations.
Pharmaceutical releaser
A handful of Internet sites tout the effectiveness of the only pharmaceutical HGH releaser currently on the market, a compound called Sermorelin.
Sermorelin is a counterfeit version of Geref, a drug from the Swiss pharmaceutical company EMD Serono which had been approved by the U.S. Food and Drug Administration more than a decade ago to treat children with growth problems.
Geref has been cloned by labs in China, sold as Sermorelin, and has gained popularity in the anti-aging market.
Renee Connolly, EMD Serono's vice president of U.S. communications, declined to comment.
Since 1990, it has been against federal law to prescribe HGH for a reason other than the treatment of a disease or a recognized medical condition. Too much growth hormone in the body can lead to excess bone growth, pituitary tumors and cardiac disease. The list of circumstances under which HGH can be prescribed legally includes children with growth deficiencies; adults who have a deficiency of the hormone, most of whom are cancer survivors; and HIV patients. The Food and Drug Administration and the Drug Enforcement Administration work together on enforcement.
Pharmaceutical HGH releasers, while requiring a prescription, aren't regulated in the same manner that HGH is, according to FDA spokeswoman Susan Cruzan.
Joseph Rannazzisi, deputy assistant administrator for the DEA, said the agency knows about Sermorelin, but "we have no statutory authority (concerning its misuse), and that's frustrating sometimes. You see drugs out there that are being misused, and there's not a lot we can do about it."
Cheaper than synthetic HGH
Sermorelin can be obtained for a fraction of the cost of synthetic HGH, which can cost more than $1,000 a month.
Lifetime Wellness, an anti-aging firm based in Prairie Village, Kan., offers customers the possibility of what it calls "Sermorelin therapy" through its website, pending a phone consultation, blood testing and a physical examination. The site, as of Tuesday, stated Sermorelin's "use in anti-aging medicine is not prohibited (as is HGH)."
"Yes, Sermorelin is a bit slower acting — it'll take 3 to 4 weeks before the effects are felt," the site stated. "But this is actually another advantage. … Previous therapies worked well — but unleashed like a flash flood in your body. Sermorelin slowly builds up in strength, allowing your body to adjust to this new vigor and vitality."
Lifetime Wellness president Scott Lofquist referred questions to Miami attorney Christopher Wadsworth, who didn't return messages.
For as little as $300 a month, Karlis Ullis said he prescribes Sermorelin to about 20 of his patients out of his private practice in sports medicine and anti-aging in Santa Monica, Calif. Ullis says the drug is imported from China into the United States and dispensed by a handful of pharmacies.
"You're not going to get the huge effects like growth hormone" injections, said Ullis, who also is an associate professor of sports medicine and rehabilitation at UCLA. "These drugs are intended for older people, not the super athlete who is already producing enough HGH. It could augment what they're already making and could have a modest to moderate effect."
Montreal-based pharmaceutical manufacturer Theratechnologies is conducting human trials for an HGH releaser that could even be more effective than Sermorelin, according to George Merriam, an endocrine researcher at the U.S. Veterans Affairs hospital in Seattle who serves on an advisory board for Theratechnologies. The company is seeking FDA approval of a drug it calls Tesamorelin to treat lipodystrophy, a side effect of HIV treatment which results in changes to the face and in fat accumulation in the abdomen.
With Tesamorelin, "you can get all the effects of human growth hormone without some of the side effects," said Merriam, also a professor of medicine at the University of Washington.
A presentation on Theratechnologies' website said Tesamorelin also could be used to treat abdominal obesity in the general population. For that use of the drug, there's a market potential in the United States of as much as $1.8 billion annually, according to the slideshow.
http://www.usatoday.com/sports/2008-...gh-cover_N.htm
