(BALA) Treatment IND for Human Growth Hormone


(BALA) Treatment IND for Human Growth Hormone

BEING ALIVE: February 1995
Mark Katz, MD, and reported by Jim Stoecker


Serono Laboratories has developed a recombinant human growth hormone (brand name is Serostim) to treat AIDS-related wasting syndrome. Phase III studies have shown the drug to be safe and well-tolerated. The studies have also shown an average 2.9 kg increase in lean body mass for those on the drug vs a .1 kg loss for those on placebo. Although 2.9 kg or some 7 lbs is not a lot, the increase, it should be noted, is being measured in lean body or muscle mass. Current anti-wasting drugs, such as marinol.html">Marinol and Megace, increase weight, but that weight increase is more likely to be fat. Serostim's manufacturer has now set up a Treatment IND protocol to make the drug available to those suffering AIDS-related wasting for whom Marinol/Megace has not been successful therapy. Patients and physicians can call Serono at 1.800.714.AIDS for more information. The catch here is that, unlike some Treatment INDs, the FDA has allowed Serono to charge for the drug. And the cost for human growth hormone is significant; currently, the charge for a six weeks' supply is $12,600 which makes this drug accessible to only a few.


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