Organon International of West Orange, New Jersey, the only U.S. maker of Deca Durabolin (nandrolone decanoate), an injectable anabolic steroid used by many HIV-positive people to combat AIDS-associated weight loss, has decided to cease marketing the agent. The company informed the FDA last November that it intended to discontinue sales of the product first approved over forty years ago.
Over eight studies have shown nandrolone to be effective for increasing lean body mass (LBM) and strength in men and women with HIV. A randomized, placebo controlled trial in 38 women conducted by the AIDS Clinical Trials Group (ACTG) reported significant increases in weight and lean body mass after 12 weeks of nandrolone therapy (100 mg every two weeks). There were no differences between the groups in fat increases or in clinical or laboratory adverse events. Hoarseness, hirsutism, and clitoral enlargement were noted rarely in the treated group.
The drug is approved in the U.S. to treat anemia due to renal insufficiency, however many doctors prescribe the agent "off-label" to HIV patients to stimulate weight gain. Nelson Vergel, an advocate for HIV wellness in Houston, Texas said, "This is the safest and most cost effective anabolic steroid in the world and now we have no manufacturer in the U.S."
Besides its safety and reported efficacy, nandrolone is a relative bargain. Treatment costing $150 a month can result in 12 to 30 pound increases of LBM in a wasting patient within four months, according to Vergel. "Many people are taking this drug in a maintenance regimen to keep the LBM they have gained, and are faced with losing it -- and their weight gains -- if no other source becomes available."
"This is a disaster for many of my patients," said Howard Grossman, a New York City physician with a large HIV practice. "We use nandrolone extensively in patients who have testosterone deficiency and are also losing weight. We've seen better weight gain than with testosterone alone and more accumulation of muscle mass. People feel better. I haven't found any increase in side effects."
It's been rumored that, based on the promising U.S. studies for HIV-related wasting, Organon may have applied for FDA approval for Deca Durabolin to treat HIV wasting two years ago. Many suspect that the company intends to return the drug to market at a substantially higher price once approval has been secured for the new indication. Approval to treat HIV wasting may actually increase the utilization of the steroid as more doctors become aware of the substance and as third-party payers add the drug to their approved formularies. Ironically, as a part of their FDA submission, the company may point to many years of off-label usage in the HIV community as a testament to the safety of the product. According to Vergel, nandrolone was first prescribed for HIV wasting by a doctor in Los Angeles in the early 1980s and its use has grown steadily ever since.
A recent study by Wanke et al. reported that as many as 29 percent of people with HIV in the era of HAART are still losing weight or lean body mass, despite undetectable viral loads.
Nandrolone decanoate is especially attractive because of its benign side effects profile compared to alternative steroids. According to Vergel, unlike oral steroids such as Oxandrin and Anadrol, nandrolone does not impact liver function lab markers at the low doses used in HIV -- a crucial issue for many people with overtaxed livers from HAART or HCV. One of the FDA approved products to treat HIV-wasting, Megace (megestrol acetate), tends to produce its weight gain due to increases in fat rather than lean body mass -- and adding fat during AIDS wasting has not been shown to improve survival. Megace, a female sex hormone, has also been associated with side effects such as diabetes, blood clots, impotence and the development of female sex characteristics. Another agent approved to treat HIV wasting, Serostim (recombinant human growth hormone), lacks evidence of benefit beyond 12 weeks and can cost as much as $8,000 a month.
FDA-approved appetite stimulants such as Marinol contain the psychoactive ingredient in marijuana (THC), notes Brenda Lein of Project Inform, and "thus is not a preference for many people with HIV who are in recovery." Also, it's theorized that Marinol may simply owe its ability to increase weight to a side effect of the THC high -- that people get the munchies and tend to eat more. Unfortunately, it's usually junk food that's consumed to satiate the craving.
A compounding pharmacy, GulfSouth pharmacy, is reported willing to make nandrolone in small quantities as long as raw materials remain available, but this is expected to only provide a temporary supply to those who can benefit from the substance. Although there are other generic makers of the product internationally (easily located on the Internet), this offers little help to U.S. patients. Anabolic steroids and testosterone are designated by the Drug Enforcement Administration (DEA) as class III drugs, which are illegal to import even for personal and medical uses.
Up until four years ago, nandrolone decanoate was available from a generic manufacturer at a cost of about $16 per 200 mg dose. After generic production was halted, Deca Durobolin, the brand name product, was available from Organon at $32 per 200 mg dose. A typical low-dose regimen may prescribe 200 mg per week for twelve weeks in order to produce increased lean body mass. Some activists fear that the price could reach exorbitant levels when and if the product is reintroduced with an FDA imprimatur for HIV wasting.
Says Vergel: "An economical and safe product like Deca Durabolin needs to stay in the market at the current pricing levels. FDA approval for wasting could mean that more third party payers could cover its cost, but we should not tolerate any increase due to the 'AIDS cash cow effect'."
San Francisco AIDS activist Mike Donneley said, "Many activists will think that this isn't a fight for us, but I know I finally had the energy to go back to work when I started taking very low-dose Deca. It made all the difference in the quality of my life."
A nationwide network of activists is swinging into action around this issue. Vergel says, "I feel very strongly that "quality of life" drugs need as much advocacy efforts as antivirals, especially in this era."
Back to the GMHC Treatment Issues June 2002 contents page.