The drug was discontinued by Searle Laboratories in 1989, apparently in part because of bad publicity due to its illegal use by bodybuilders, and was picked up by New Jersey-based Bio-Technology General Corp. In a press release dated Dec. 5, 1995, Bio-Technology General Corp. announced ìits first major U.S. drug launch: Oxandrin(R) oxandrolone. The press release did not mention oxadralone's thirty year history as a treatment for wasting.
It did state, however, that the recommended adult dose of Oxandrin(R) is 2.5 mg to 20mg per day. At an average wholesale price of $3.75 per 2.5 mg tablet, Oxandrin(R) is a cost effective therapy for involuntary weight loss. As with all anabolic agents, Oxandrin(R) is classified as a Schedule III controlled substance and has been assigned a classic black box warning relating to liver and coronary artery disease.
BTG's press release also explained that ìAIDS wasting indications have been granted Orphan Drug designation by the FDA. This designation is granted to drugs for rare diseases or conditions with a prevalence of less than 200,000 cases in the United States and provides the manufacturer with seven years of market exclusivity post approval." At first look, this seems a grotesque misuse of the Orphan Drug designation to make a formerly inexpensively available generic drug, MORE THAN TEN TIMES MORE EXPENSIVE.
People with AIDS need to carefully examine this use of the Orphan Drug Act to give a company exclusive marketing rights (and therefore a monopoly) for a drug that has been available to treat wasting for more than 30 years.
At the present time, BTG planning further studies of oxandrolone to determine what doses most effectively treats HIV-wasting disorder. ACT UP/Golden Gate has sucessfully urged BTG to include women, hemophiliacs, and people on protease inhibitors in these studies. We continue to demand that BioTechnology General include detailed immunological monitoring of study participants.
The BTG press release also helpfully listed company contacts, should people with AIDS wish to express their opinion of BTG's price and marketing strategy directly.
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Emn - could you point me to a study to show what you are saying? i can't seem to find any...
thanks