A slightly edited version of this article ran in the July 11, 1996 edition
of the San Francisco Bay Area Reporter.
Old drug gets new use ... and a big new price-tag
by Stephen LeBlanc and Rob Sabados,
ACT UP/Golden Gate Writers Pool
More and more People with AIDS are beginning to realize what
some activists and more aggressive HIV-doctors have been saying for years:
AIDS-associated wasting is not an irreversible consequence of AIDS, but
is an AIDS-associated condition that can be effectively treated.
People who are wasting can, with appropriate treatment, regain
and maintain their normal weight and have a good quality of life, possibly
indefinitely. Yet, in HIV-affected communities where aggressive prophylaxis
for OIs like PCP, MAC, or fungus are common, wasting is a leading cause
of death to people with AIDS and its becoming clear that many of these
deaths are preventable.
One effective treatment for HIV-related wasting, oxandrolone,
has been available by prescription for over 30 years. It potentially could
have prevent countless deaths from HIV-associated wasting. However, it
is rarely used for people with AIDS and has not yet been thoroughly studies
in that population. Oxandrolone has been found to be reasonably safe and
effective for children and for people with alcohol related liver-disease.
The drug is taken orally and has few significant side effects at dosages
effective against severe chronic wasting. It is extremely cheap to manufacture,
however its manufacturer has chosen to artificially and exploitively inflate
the price of oxandrolone.
Oxandrolone has been extensively studied in children with growth
disorders and adult men with alcoholic hepatitis, an inflammation of the
liver that is often accompanied by wasting. It has been shown very safe
and effective for treating alcoholic hepatitis related wasting and it is
believed that the metabolic problems associated with this condition are
similar to those found in HIV-wasting.
Doctors' reluctance to prescribe oxandrolone, and PWA's unawareness
of it, arise from a number of reasons that have nothing to do with good
quality health care. One important reason is that oxandrolone is in a
class of drugs known as anabolic steroids. These drugs are sometimes
used by athletes to enhance strength or performance and over the past several
decades have been unfairly demonized. In fact, oxandrolone at therapeutic
dosages is a proven safe and effective drug for treating wasting and is
not commonly associated with the dangerous side effects of other steroids,
though those warnings are required to appear on the label.
Typical of many doctors was the attitude Dr. Duane Goldberg,
reported in the spring 1996 issue of UC-Fresno's Inline Magazine. Dr. Goldberg
prescribed oxandrolone under the brand name Anavar for a patient who had
been diagnosed with AIDS for two years and had wasted from an athletic
6foot-2inch 210 pounds to 150 pounds. "To tell you the truth,"
Goldberg said, "I really didn't want to prescribe the Anavar as I
wasn't sure what would happen. The literature I had read was brand new,
only tried on a few patients back East. But I had to do something."
Goldberg's patient was a man similar to many PWA's who enter
a wasting state and often give up hope and die without ever receiving effective
anti-wasting treatment. "I was dying, fast. I didn't want to eat,
and I was extremely weak," he reports. "Now, I'm back up to 190
pounds, and my immune system is healthy. I have no doubt that this is
because of Anavar."
Unlike other anabolic steroids, such as testosterone, oxandrolone
is minimally metabolized by the liver, thereby avoiding most drug interactions
and the liver toxicity often seen with other steroids. Even people whose
livers where badly damaged by alcohol, and therefore were unable to take
many drugs, did well on oxandrolone.
Oxandrolone has been approved by the FDA since 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." Since
HIV wasting is the result of a chronic infection and is often without definite
cause, oxandrolone is clearly indicated and FDA approved for HIV-related
wasting at the dose of 5-10 mg per day.
However, based upon studies in alcoholic hepatitis patients and more
limited studies in people with AIDS, many researchers and activists believe
that the effective dose of oxandrolone may be much higher than the FDA
indicated dose, forty to eighty milligrams per day. Although the approved
dose is only 10 mg per day, many physicians have prescribed higher, "off-label"
doses of oxandrolone.
At the present time, insurance companies are in general covering the cost
of oxandrolone, but some have reportedly balked at paying for the full
effective dose because it is not "FDA approved." This, however,
is something of a misuse of an FDA approval. While many insurance policies
have exclusion clauses for ìexperimentalî treatments, using
a drug that has been approved and shown effective for its intended purpose
cannot fairly be characterized as experimental.
Like all anabolic steroids, oxandrolone is a Schedule III
controlled substance, which discourages some physicians from prescribing
it, especially at dosages higher than the norm. As a result, a patient
may need to persuade their doctor to prescribe it.
Some research in children suggests that oxandrolone increases
the efficacy of human growth hormone, which is also being studied as a
treatment for wasting. By combining oxandrolone with growth hormone, it
may be possible to reduce the amount of growth hormone needed. Since growth
hormone currently costs about $50,000 per year, a price that may double
if growth hormone is approved, a growth hormone/oxandrolone combination
may provide the same benefits at combating wasting with significant cost
The current cost of oxandrolone is another factor the deserves
the attention of people with AIDS. 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 recently, 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 favored by bodybuilders
for its low toxicity and few side effects.
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
Call Bio-Technology General Corp.'s Director of Sales Operations Peggy
Ference at (505)822-8820 or her voice-mail at (800)284-2480 extension
508, Leah Berkovits at (908)632-8800 or their investor relations representative
Don Weinberger at (516)829-7111.
Copyright (C) 1996 by ACT UP/Golden Gate