China announced the revocation of the GeneScience Pharmaceutical license to manufacturer Jintropin brand human growth hormone. This represents a major success in efforts towards the internationalization of steroid and doping law by the United States. The U.S. federal government indicted CEO Lei Jin and GeneScience Pharmaceutical Inc. last fall as part of Operation Raw Deal (”China Cracks Down on Drug Companies,” June 19).
One of the drugmakers that China named Wednesday was GeneScience Pharmaceutical, which is based in northern China and run by an American-educated executive. Last September, a federal grand jury in Rhode Island indicted the company for illegally distributing millions of dollars in human growth hormones in the United States. The company had denied the allegation, but its American agent pleaded guilty in February to conspiracy to distribute H.G.H.
Tercica announced that they just started a Phase II clinical trial examining the efficacy of IGF-1 stacked with human growth hormone (GH). Unfortunately for bodybuilders and athletes, the outcome measure in this study is not performance enhancement, increases in lean muscle mass, or loss in body fat.
The objective is to measure “height velocity” and safety in the treatment of short stature in children. The trial will examing the efficacy of three different stacks of GH + IFG-1 and compare them with GH alone (GH monotherapy).
Potential of GH/IGF-1 Combination Product: The combination product will be studied in children with short stature not associated with growth hormone deficiency, who also have low IGF-1 levels. A potential cause of short stature in this group of patients could be a suboptimal IGF-1 secretion in response to growth hormone stimulation alone. Pre-clinical studies suggest that co-administration of GH and IGF-1 may increase specific growth responses greater than growth hormone alone. Therefore, Tercica believes that treatment with a combination of both GH and IGF-1 may be superior to monotherapy of growth hormone alone in a subpopulation of children with low IGF-1 and short stature not associated with growth hormone deficiency.
Tercica is the biotechnology company that is the first to bring FDA-approved recombinant insulin-like growth factor-1 (IGF-1) to the marketplace. The brand name for IGF-1 is Increlex and the generic name is mecasermin.
It is interesting that discussion of the use of growth hormone and IGF-1 in athletes for performance enhancing purposes revolves around the extremely dangerous side effects of these drugs; efforts to prevent GH use in sports is often based on the dangers of the drugs and potential public health crisis they may cause.
Yet a news story about the therapeutic use of growth hormone and IGF-1 in children gets buried in the news.
Roger Clemens attorney should be fired. Obviously, attorney Rusty Hardin must have devised the strategy used by Roger Clemens in his interview with Mike Wallace on 60 Minutes tonight. Brian McNamee’s attorney, Richard Emery, was spot on when he identified the likely legal strategy:
I think that this is a lawyers’ game, which allows him to try and attempt to say that McNamee didn’t know what he was injecting or that at least Clemens didn’t know what he was injecting.
Conceivably, this is a crafty legal strategy to suggest that Clemens received so many injections of substances that were NOT anabolic steroids, testosterone, or growth hormone, that there is a chance that McNamee and/or Clemens simply didn’t know what was injected.
Roger took bunches of his shots over his career, much the way racehorses do, unfortunately.
But from a public relations standpoint, this strategy is stupid. It is stupid for the attorney to make an analogy to a racehorse; it is stupid to have Clemens’ publicly outline the hypocrisy of drug use in major league baseball…
Clemens’ admission to injecting several performance-enhancing substances that were to help joints and/or mask pain pointed out the hypocrisy of selectively demonizing some performance enhancers while condoning others. Drugs that allow a baseball player to “mask pain” are arguably more dangerous than growth hormone use and even steroid use. Yet Clemens is proud to use these drugs to mask pain allowing him to continue playing and performing while injured.
Clemens admitted to regularly using Toradol, which is considerably more liver toxic than most oral anabolic steroids. Yet the dangerous liver toxicity of oral androgens is unacceptable, but the even more dangerous liver toxicity of Toradol (not to mention its use to mask pain to allow players to perform while injured) is perfectly acceptable.
The regular denials by athletes accused of using anabolic steroids and growth hormone has become relatively commonplace and quite boring. So, I didn’t expect much from Mike Wallace’s 60 Minutes interview of baseball player Roger Clemens (who was accused by trainer Brian McNamee of using testosterone and growth hormone in the Mitchell Report). But I was pleasantly surprised when Clemens offered “proof” that he never used steroids or GH. If he did use the alleged performance enhancing drugs…
He would have grown a “third ear out of his head”;
He would have been able to “pull a tractor with his teeth”;
His tendons would have “turned to dust”;
His body would have experienced a “breakdown”; and
He would have lost “flexibility”
Since none of these things happened, that must be proof positive that he never used steroids or growth hormone!!
