mvmaxx
New member
I found this while doing some research on avavar. I found it interesting.
This is from the 1996 SF Act Up report. It is a note on how the US
Orphan Drug Act was used to increase the price of Oxandrolone from $.30 to $3.75 per pill.
http://www.actupgg.org/abs_reps/dpr/gouge.html
One Example of Extreme Price Gouging:
The story of little orphan Oxandrolone
Oxandrolone is one effective treatment for HIV-related wasting, a
leading killer of people with more advanced AIDS. Oxandrolone has been available by prescription for over 30 years and though it potentially could have prevent countless deaths from HIV-associated wasting, it is still rarely used for people with AIDS.
Oxandrolone is now being developed and marketed to people with HIV-related wasting, but at a wholesale price more that 1,200% higher than the price for which it was sold just 7 years ago. The story of how the drug's developer, BTG, used the U.S. Orphan Drug Act to increase the cost of oxandrolone more than 11-fold, is an example of everything that is wrong with AIDS-drug pricing in the U.S.
Oxandrolone was by the FDA in the early 1960's at a dosage of 5-10 mg per day for conditions which included weight loss "due to extensive surgery, chronic infection, severe trauma, failure to gain or maintain weight without definite pathophysiologic reasons [and] protein catabolism due to prolonged corticosteroid administration." The drug has been on the market long enough for all patents on it to expire and therefore it should be available as a generic. Until 1989, the drug was sold and manufactured by Searle Laboratories under the trade name Anavar and by SPA Labs in Europe under the names Lipidex, Antitriol, or Lonavar. The drug was used illegally by some bodybuilders to increase
muscular definition and was favored it for its low toxicity and few side effects. It's black market price was reported at $3.00 per tablet. Its regular pharmaceutical price as a generic was $0.30 per tablet.
The drug was discontinued by Searle Laboratories in 1989, partly because of bad publicity due to its illegal use by bodybuilders. The drug was picked up for marketing by New Jersey-based Bio-Technology General Corp (BTG), who negotiated an arrangement where Searle would continue to manufacture the drug and supply it to BTG. In a press release dated Dec.5, 1995, Bio-Technology General Corp. announced "its first major U.S. drug launch: Oxandrin(R) oxandrolone." The press release did not mention
oxadrolone'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 20 mg 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." This announced average wholesale price was more that 12 times higher that the wholesale price of oxandrolone in 1989, for exactly the same pills, manufactured by exactly the same company, in exactly the same factory.
BTG's press release also explained that "AIDS 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 formally inexpensively available generic drug, MORE THAN TWELVE TIMES MORE EXPENSIVE.
At the previously FDA-approved dose of 10 mg per day, oxandrolone will cost patients $15 per day or $5,475 per year. At higher doses of 40 or 80 mg per day, the annual cost would be or $21,900 or $43,800 respectively. Normally, consumers have the ability to obtain older prescription as generic equivalents. However, by exploiting orphan drug laws designed to help patients, BTG is attempting to monopolize the market for oxandrolone and thereby charge monopolist prices. This price is an unacceptable and exploitative mark-up of what should be an inexpensive drug.
BTG has responded to concerns expressed by PWAs over the cost of oxandrolone with a commitment to never charge any one patient more than $15,000 per year for the drug, even if a doctor prescribes a higher does. BTG also has committed to making Oxandrin available to people who cannot afford it with a patient assistance program. However, many PWAs report that their doctors are reluctant to prescribe Oxandrin because of its high cost when compared to other injectable anabolic steroids, and
instead prescribe other therapies for wasting that are available as
generics and that cost much less. For these PWAs, oxandrolone is not a treatment option, and they must use other drugs that may not work as well and are harder to take.
--
James Love / Director, Consumer Project on Technology
http://www.cptech.org / love@cptech.org
P.O. Box 19367, Washington, DC 20036
voice 202.387.8030 / fax 202.234.5176
This is from the 1996 SF Act Up report. It is a note on how the US
Orphan Drug Act was used to increase the price of Oxandrolone from $.30 to $3.75 per pill.
http://www.actupgg.org/abs_reps/dpr/gouge.html
One Example of Extreme Price Gouging:
The story of little orphan Oxandrolone
Oxandrolone is one effective treatment for HIV-related wasting, a
leading killer of people with more advanced AIDS. Oxandrolone has been available by prescription for over 30 years and though it potentially could have prevent countless deaths from HIV-associated wasting, it is still rarely used for people with AIDS.
Oxandrolone is now being developed and marketed to people with HIV-related wasting, but at a wholesale price more that 1,200% higher than the price for which it was sold just 7 years ago. The story of how the drug's developer, BTG, used the U.S. Orphan Drug Act to increase the cost of oxandrolone more than 11-fold, is an example of everything that is wrong with AIDS-drug pricing in the U.S.
Oxandrolone was by the FDA in the early 1960's at a dosage of 5-10 mg per day for conditions which included weight loss "due to extensive surgery, chronic infection, severe trauma, failure to gain or maintain weight without definite pathophysiologic reasons [and] protein catabolism due to prolonged corticosteroid administration." The drug has been on the market long enough for all patents on it to expire and therefore it should be available as a generic. Until 1989, the drug was sold and manufactured by Searle Laboratories under the trade name Anavar and by SPA Labs in Europe under the names Lipidex, Antitriol, or Lonavar. The drug was used illegally by some bodybuilders to increase
muscular definition and was favored it for its low toxicity and few side effects. It's black market price was reported at $3.00 per tablet. Its regular pharmaceutical price as a generic was $0.30 per tablet.
The drug was discontinued by Searle Laboratories in 1989, partly because of bad publicity due to its illegal use by bodybuilders. The drug was picked up for marketing by New Jersey-based Bio-Technology General Corp (BTG), who negotiated an arrangement where Searle would continue to manufacture the drug and supply it to BTG. In a press release dated Dec.5, 1995, Bio-Technology General Corp. announced "its first major U.S. drug launch: Oxandrin(R) oxandrolone." The press release did not mention
oxadrolone'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 20 mg 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." This announced average wholesale price was more that 12 times higher that the wholesale price of oxandrolone in 1989, for exactly the same pills, manufactured by exactly the same company, in exactly the same factory.
BTG's press release also explained that "AIDS 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 formally inexpensively available generic drug, MORE THAN TWELVE TIMES MORE EXPENSIVE.
At the previously FDA-approved dose of 10 mg per day, oxandrolone will cost patients $15 per day or $5,475 per year. At higher doses of 40 or 80 mg per day, the annual cost would be or $21,900 or $43,800 respectively. Normally, consumers have the ability to obtain older prescription as generic equivalents. However, by exploiting orphan drug laws designed to help patients, BTG is attempting to monopolize the market for oxandrolone and thereby charge monopolist prices. This price is an unacceptable and exploitative mark-up of what should be an inexpensive drug.
BTG has responded to concerns expressed by PWAs over the cost of oxandrolone with a commitment to never charge any one patient more than $15,000 per year for the drug, even if a doctor prescribes a higher does. BTG also has committed to making Oxandrin available to people who cannot afford it with a patient assistance program. However, many PWAs report that their doctors are reluctant to prescribe Oxandrin because of its high cost when compared to other injectable anabolic steroids, and
instead prescribe other therapies for wasting that are available as
generics and that cost much less. For these PWAs, oxandrolone is not a treatment option, and they must use other drugs that may not work as well and are harder to take.
--
James Love / Director, Consumer Project on Technology
http://www.cptech.org / love@cptech.org
P.O. Box 19367, Washington, DC 20036
voice 202.387.8030 / fax 202.234.5176
