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Orphan in distress
Two dozen members of ACT UP disrupted a satellite symposium sponsored
by Bio-Technology (BTG) at the International AIDS Conference in
Vancouver July 10th, 1996. The demonstration included a skit featuring an ACT UP
member dressed in diapers representing the orphan drug oxandralone
asking to be adopted and the abuse he suffered at the hands of BTG.
This is the text of the press release issued at the time.
ACT UP ADOPTS ORPHAN DRUG:
1200% MARKUP FOR AIDS CALLED OBSCENE
People with AIDS at the Vancouver AIDS conference today zapped*
Bio-Technology General 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 DC 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status for AIDS-related wasting withdrawn by the U.S. Secretary of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 It was withdrawn from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 US'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
Sabados.
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 wasting."
* A zap is a demonstration or disruption of an event for a political
purpose. Note: wasting is not merely weight loss, it is loss of lean
muscle mass that may include weight loss as well.
To see photo's of this action and others during the week of the
international AIDS Conference in Vancouver go the ACT UP/NY's web site
at : www.actupny.org.