ACT UP ADOPTS ORPHAN DRUG:
1200% MARKUP FOR AIDS CALLED OBSCENE
People with AIDS at the Vancouver AIDS conference today zapped
Bio-Technology General (BTG) Pharmaceuticals Company for its 1200% price
markup of oxandralone, a drug used to treat AIDS-related wasting. A coalition
of ACT UP groups, including chapters Golden Gate, New York, Philadelphia,
Paris, Atlanta, and D.C. announced a national U.S. campaign beginning today
to adopt oxandrolone and have its orphan drug status for AIDS-related wasting
withdrawn by the U.S. Secretary of Health and Human Services.
Oxandralone is a thirty year old anabolic steroid that has long been known
to be an effective wasting treatment and that shows great promise in treating
AIDS-related wasting, which is a contributing cause of death in up to 2/3rds
of AIDS deaths in the U.S. Oxandralone was approved by the U.S. Food and
Drug Administration (FDA) in 1963 for use in wasting due to chronic infection.
It also shows promise for women with AIDS-wasting, as it does not have the
masculinizing side effects of other hormonal wasting treatments.
According to the activist group, during most of the time that Oxandralone
was on the market, it was sold very cheaply, at a cost of $0.26 to $0.37
U.S. for a 2.5 milligram pill. It was withdrawn from the U.S. market in
1989 because its manufacturer feared bad publicity due to its occasional
non-prescription use by athletes. In December of 1995, BTG began marketing
Oxandrolone for use in AIDS-associated wasting, but at a cost of $3.75 for
the same 2.5 milligram pill, or $10,950 US per year at the lowest recommended
dose for AIDS (20 mg per day).
"Something is terribly wrong when a formerly inexpensive drug is marked
up more than 1200% to be sold to people with AIDS," said Lisa Penyak
of ACT UP Philadelphia. This the clearest example of price gouging. We know
what the drug's price was before it was marketed for AIDS, and we know its
price now, and the markup is unconscionable.
Rob Sabados of ACT UP Golden Gate explained the high price of Oxandralone
in the U.S. as a result of an abuse of the U.S.s Orphan Drug Program, a
set of regulations designed to encourage non-commercially viable drug development
for rare or under-served diseases. Winning orphan drug status, allows a
drug marketer to have exclusive marketing for a drug for seven years even
if there are no patents on the drug. "BTG is grotesquely misusing the
Orphan Drug regulations to create a monopoly in the marketing of a 30 year
old drug which should be available cheaply as a generic, and the U.S. FDA
and the National Institutes of Health are encouraging it," charged
ACT UP chapters from across the U.S. pledged to adopt the drug and have
its orphan status withdrawn by the FDA so that the drug would be available
as a generic.
"Starting today," declared David Mahon of ACT UP/Golden Gate,
we are launching a campaign to make sure that Oxandrolone is an orphan no
longer. We call on Donna Shalala to withdraw oxandrolones orphan drug status
and we call on the N.I.H. to study oxandrolone as a generic drug for AIDS
For more background info.