SEXYMAMA
New member
ANAVAR....
Stephen LeBlanc and Rob Sabados, ACT UP/Golden Gate
Writer's Pool - originally published in the issue of
the Bay Area Reporter
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 sis 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 even 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 it's 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 prevented
countless deaths from HIV-associated wasting. However,
it is rarely used for people with AIDS and has not yet
been thoroughly studied 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
expletively 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
PWAs' 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 of 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 ben diagnosed with AIDS for two years and had
wasted from an athletic 6'2" 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 rad 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 PWAs 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 si because of Anavar."
Pros and cons
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 were 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 five to ten milligrams per
day for conditions that 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, 40 to 80 mg per day."""""
Although the approved dose is only ten 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 "experimental" 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 savings.
The current cost of oxandrolone is another factor that
deserves the attention of people with AIDS. The drug
has been on the market long enough for all patients 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 December 5, 1995, Bio-Technology
General Corp. announced d"its first major U.S. drug
launch: Oxandrin oxandrolone." The press release did
not mention oxandrolone's thirty year history as a
treatment for wasting. It did state, however, that
"the recommended adult dose of Oxandrin is 2.5 mg to
20 mg per day. At an average wholesale price of $3.75
per 2.5 mg tablet, Oxandrin is a cost-effective
therapy for involuntary weigh loss. As with all
anabolic agents, Oxandrin 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 "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 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.
Stephen LeBlanc and Rob Sabados, ACT UP/Golden Gate
Writer's Pool - originally published in the issue of
the Bay Area Reporter
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 sis 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 even 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 it's 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 prevented
countless deaths from HIV-associated wasting. However,
it is rarely used for people with AIDS and has not yet
been thoroughly studied 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
expletively 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
PWAs' 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 of 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 ben diagnosed with AIDS for two years and had
wasted from an athletic 6'2" 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 rad 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 PWAs 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 si because of Anavar."
Pros and cons
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 were 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 five to ten milligrams per
day for conditions that 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, 40 to 80 mg per day."""""
Although the approved dose is only ten 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 "experimental" 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 savings.
The current cost of oxandrolone is another factor that
deserves the attention of people with AIDS. The drug
has been on the market long enough for all patients 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 December 5, 1995, Bio-Technology
General Corp. announced d"its first major U.S. drug
launch: Oxandrin oxandrolone." The press release did
not mention oxandrolone's thirty year history as a
treatment for wasting. It did state, however, that
"the recommended adult dose of Oxandrin is 2.5 mg to
20 mg per day. At an average wholesale price of $3.75
per 2.5 mg tablet, Oxandrin is a cost-effective
therapy for involuntary weigh loss. As with all
anabolic agents, Oxandrin 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 "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 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.
