Desigmatizing HGH

Dr. Weeks’ Comment:  Let’s be clear:  the only illegal use of HGH is giving it to competitive athletes for the purpose of performance enhancement. That is the law.  Nothing else is illegal. Giving HGH off-label to diseased patients is not only legal but good medicine. That is the legal fact.

However, bureaucrats at the FDA and state medical boards have a different opinion of the law and assert – in administrative  extra-legal proceedings – that any off-label use of HGH is illegal. Everyone should know, however, that that opinion has never been adjudicated and is NOT a legal finding. It is just their opinion – not law.

As one of the “progressive physicians” whose career has been destroyed by bureaucratic pawns of the Federation of State Medical Boards – the corrupt lobbying arm of Corporate Medicine (Big Pharma, Big Insurance, AMA) – my legal process is to appeal to superior court (a real court, as opposed to the kangaroo court of a biased administrative processing chaired by medical board agents) and we expect to be the FIRST case in the nation which results in a fair interpretation of this ambiguous law. We expect to prevail and once again allow the highly beneficial agent – natural human growth hormone to be freely prescribed to anyone diseased or injured person needing it – save competitive athletes whose sole purpose of taking HGH is for an unfair advantage – as noted below  “only as a cheater’s tool in sports”.

 

“…Cuban can also use his considerable influence to get the folks on Capitol Hill to amend the flawed HGH law, paving the way for pharmaceutical companies to join him in funding the much-needed science which might ultimately place the future of human growth hormone in the hands of responsible physicians, not FDA bureaucrats…”

 

Mark Cuban: Changing the Game on HGH?

Posted: 12/06/2013 5:09 pm
By RICK COLLINS

Dallas Mavericks owner Mark Cuban says he intends to fund research on human growth hormone (HGH) to see if it might help NBA athletes to recover more quickly from injuries. To be clear, he’s not advocating a rules change to permit HGH use in pro basketball — at least, not yet. But with a rash of NBA players on the disabled list, he proposes studies to find the truth about the restorative potential of HGH in the recovery process.

Cuban’s remarks last month at NBA’s Board of Governors meeting in New York could lead to a new way of looking at HGH in sports… and beyond. While anti-doping crusaders and some sports executives might tremble at the very notion that a banned substance might be just what the doctor ordered for injured players, some athletes, particularly in baseball, have recently begun to question the status quo. After missing a season recovering from Tommy John surgery, Los Angeles Angels reliever Ryan Madson suggested that MLB consider a rules change to allow rehabbing players to take HGH in limited cases. “If HGH were legal, just in the process of healing, under a doctor’s recommendation, in the right dosage, while you’re on the [disabled list], I don’t think that’s such a bad idea — as long as it doesn’t have any lasting side effects, negative side effects,” he told MLB.com.

While adverse side effects have been linked to high-dose, long-term HGH use, such concerns might not be relevant to the low-dose, short-term therapy proposed for healing injuries. Of course, the possible side effects — and the long-rumored potential benefits — can only be determined if controlled safety and efficacy studies are performed. If the results are favorable, Cuban believes that the stigma attached to HGH’s status as one of the banned “performance-enhancing drugs” can be overcome. “I mean, think of it this way: Any drug that’s been FDA approved that has medical benefits, there’s going to be a non-sports population that benefits from it,” Cuban said. “If you’ve got every recreational athlete using it to recover, then it’s becomes kind of the Tommy John surgery equivalent.”

But the hurdle for using HGH as a healing agent for the masses is more than stigma. A 1990 federal law, strictly construed by the FDA, blocks the use of HGH for anything other than a handful of applications authorized by the FDA. Back in 1988, the media frenzy surrounding sprinter Ben Johnson’s Olympic doping scandal provoked terror that the paying public might lose faith in the multibillion-dollar elite sports empire. Congress held hearings to find a solution to the problem of performance-enhancing drugs in sports, resulting in the addition of anabolic steroids to the federal list of controlled substances — addictive drugs like heroin and cocaine. But HGH was different from steroids, in that it lacked addictive potential and was unlinked to reports of aggressive behavior. After all, the FDA approved HGH as safe to prescribe to short kids to boost their height (more recently, HGH was found to be a wonder drug in the battle against HIV-wasting, restoring health and vitality to compromised immune systems). Congress wanted to curtail HGH as a cheating tool in sports, but viewed HGH as more benign than steroids and less deserving of controlled substance status. Importantly, there was no expressed awareness of HGH as a possible agent for injury recovery — only as a cheater’s tool in sports.

The HGH law that Congress passed — restricting distribution but not possession — was designed to regulate HGH on a much lower level than controlled substances. But the attempt at lesser regulation backfired. The problematic wording of the HGH law created a situation where HGH became more highly regulated than any other prescription drug, including steroids. The HGH law forbids doctors from prescribing HGH for any off-label use whatsoever.

(Dr. Weeks comment:  this is inaccurate. The law has NEVER been adjudcitated. It does NOT forbid off-label use of HGH – nay the administrative bureaucrats assert that restriction.)

Off-label use — prescribing a drug for a purpose other than the one for which the product is approved — is a widely accepted practice and the vehicle by which many drug uses are pioneered. But doctors who violate the HGH law by off-label prescribing, even if they have good reason to believe the drug would help a patient, and even if the patient isn’t an athlete at all, face prison terms of up to five years (10 years if to a person under 18 years). By threatening progressive physicians with imprisonment and removing any incentive for pharmaceutical companies to invest a single penny into testing off-label uses for HGH, the HGH law is a total roadblock to medical progress and a far cry from what Congress appears to have intended.

Could HGH help players heal faster? Quite possibly; we don’t know for sure. But shouldn’t we find out? If a doctor-prescribed and supervised medical tool might exist to help injured players get back to their teams safely and more quickly, isn’t it foolish not to look into it? The potential winners here aren’t just basketball players. What works for NBA athletes would work for construction workers, firefighters and those in countless other occupations outside of pro sports. Those injured in car crashes or workplace accidents could be off disability, fully rehabbed and back on the job in less time.

If the study results are positive, this could be big. Cuban’s visionary proposal could eventually lead to the dawn of a new age with faster recovery protocols for injured patients everywhere. But it will take a whole lot of positive studies, not just a couple, to move things forward. Perhaps Cuban can also use his considerable influence to get the folks on Capitol Hill to amend the flawed HGH law, paving the way for pharmaceutical companies to join him in funding the much-needed science which might ultimately place the future of human growth hormone in the hands of responsible physicians, not FDA bureaucrats.

 
AND

Cuban: NBA open-minded on HGH

Updated: November 27, 2013, 9:04 PM ET

By Tim MacMahon | ESPNDallas.com

  • DALLAS – Mavericks owner Mark Cuban intends to fund studies to determine whether human growth hormone use would be beneficial for athletes rehabilitating from injuries.

USA Today reported this week that Cuban broached the subject at NBA’s Board of Governors meetings in October, suggesting that the issue should be studied to determine whether HGH should remain on the league’s banned-substance list or be permitted for use by players recovering from injuries.

 

Cuban said Wednesday night that league officials were relatively receptive to the idea of the studies, which he is willing to fund.

“They’re open-minded,” Cuban said. “Knowing that it’ll take 10 years to get [the studies] done, it’s easy to be open-minded and say when it’s there, it’s there. But hopefully it’s something I can accelerate.

“I’ve talked to a couple of different universities about funding studies. It doesn’t happen in a year or two, though. It’ll take a long time.”

Any HGH use would have to be cleared by the Food & Drug Administration and Drug Enforcement Agency.  (Dr. Weeks comment:  This is NOT accurate.)

The FDA currently only allows HGH use for children whose growth is stunted due to various medical reasons or adults with a bowel syndrome, a hormone deficiency due to pituitary tumors or muscle-wasting diseases associated with HIV. The DEA bans use of HGH for improved athletic performance.

If HGH use is cleared by those agencies, Cuban is not concerned about the public perception of allowing NBA players to be prescribed the drug.

“That’s curable,” Cuban said. “That’s so curable it’s easy. I mean, think of it this way: Any drug that’s been FDA approved that has medical benefits, there’s going to be a non-sports population that benefits from it. If you’ve got every recreational athlete using it to recover, then it’s becomes kind of the Tommy John surgery equivalent.

“It’s like when I was a kid, I was stuck with glasses for life. Then Lasik comes along and it gets approved. Now, every player uses it and needs it. I’m not worried about the public perception. Perception is really connected to non-prescribed usage. If it’s all prescribed usage, it’s a different animal.”

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Dr. Weeks’ Comment:  Let’s be clear:  the only illegal use of HGH is giving it to competitive athletes for the purpose of performance enhancement. That is the law.  Nothing else is illegal. Giving HGH off-label to diseased patients is not only legal but good medicine. That is the legal fact. However, bureaucrats at the FDA…
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