Oxandrolone Background

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 savings.
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 directly.

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

Back to Vancouver Index