The End of Nandrolone
The Current Terrain for Wasting Patients in the Era of HAART
On March 20, 2007, Watson Laboratories stopped the production of nandrolone decanoate (old brand name: Deca Durabolin), a low-cost injectable anabolic steroid used for HIV wasting, citing the lack of raw-material suppliers for the product. Patients found out when they went to their pharmacies for a prescription a week later.
Although there are other makers of generic nandrolone 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) of the U.S. Department of Justice as Class III drugs, which are illegal to import even for personal and medical uses.
Over the past 20 years, anabolic steroids have suffered from a lot of bad publicity and misconceptions due to their use in sports and bodybuilding. However, that did not stop activists in the 1990s from convincing doctors and researchers to look into these medicines to help those with HIV-related wasting syndrome. Since then, more than eight studies have been performed that showed nandrolone and oxandrolone (brand name Oxandrin, an oral anabolic steroid) to be effective and safe for increasing lean body mass (LBM) and strength in men and women with HIV. Many physicians quickly learned how to prescribe them and monitor their use for helping their HIV-positive patients to survive what used to be one of the main causes of AIDS mortality.
While Watson was abandoning nandrolone, another company was making a decision that would also limit options for HIV wasting patients. Savient Pharmaceuticals informed patients in April 2007 that it had stopped its 10-year-old patient assistance program (PAP) that gave free Oxandrin (oxandrolone) to HIV patients with no insurance or third-party payment sources. Oxandrin has been shown to be mildly effective in men, women, and children with HIV wasting. It can be taken by mouth daily, while nandrolone must be injected in the butt once a week. Whereas Oxandrin has been approved for the treatment of unintentional weight loss, nandrolone's use for HIV wasting was off-label (it was approved for the treatment of anemia in individuals with kidney problems). However, Oxandrin costs $1,300 a month for a 20 mg/day regimen, compared to around $200 a month for 200 mg/week for nandrolone.
Savient's PAP was set up by BTG Pharmaceuticals (bought out by Savient later on) in 1996 after activists pressured the company to provide the drug for free to those with no access or means. As with nandrolone, only 13 states include Oxandrin in their AIDS Drug Assistance Programs (ADAPs). The termination of Savient's PAP means many patients will have no way to afford this drug. The company informed patients that Watson would sell generic Oxandrin, thus eliminating the need for its PAP. Unfortunately, the generic price for Oxandrin sold by Watson is no different than that for the brand-name product, which will continue to be sold by Savient. Watson will not provide free Oxandrin via a PAP either. This is the first time in AIDS history that a company has stopped a PAP while still selling the drug.
Cost is not the only consideration. Unlike nandrolone, Oxadrin can increase liver enzymes and could be problematic for people with liver disease, or for people taking medications that heavily affect the liver, such as the HIV medication Reyataz, and drugs for those with hepatitis B and C. "The decisions of these two companies have a huge impact on many of my patients' health," says Dr. Richard Loftus, a San Francisco physician with a large HIV practice. "We use nandrolone extensively in patients who have problems gaining weight and who feel fatigued, even with undetectable viral loads. Many of my patients feel better and have experienced no side effects at the doses we use."
In the 1980s researcher Dr. Donald Kotler found that the loss of lean body mass can dramatically decrease survival in HIV-positive people.1 Even though the incidence of wasting syndrome has declined dramatically since protease inhibitors were introduced 10 years ago, many people still need extra help to hang on to their muscle to sustain health and productivity. A study performed at Tufts University School of Medicine reported that as many as 29% of people with HIV in the era of HAART are still losing weight or lean body mass, despite undetectable viral loads.2
Dr. Nathan Sherlock knows first hand about the importance of nandrolone for his health and that of his partner:
My partner has had a significant problem with wasting due to AIDS and the only way he has been able to stop the dangerous weight loss is to use anabolic steroids. He is also hepatitis B positive. His doctor first prescribed Oxandrin in 1998. Within a couple of weeks he had chemical induced hepatitis with the symptoms of nausea, vomiting, loss of appetite and jaundice. His liver enzymes were all elevated. He stopped Oxandrin and the symptoms promptly resolved. His doctor then prescribed nandrolone 200mg/week and he regained weight back to his norm with no side effects. When he stops taking it the wasting returns so he has been on nandrolone for close to 9 years now...I have been taking nandrolone for wasting due to AIDS for over 10 years. Every time I have stopped taking nandrolone I experience rapid weight loss that can only be reversed by resuming the use of nandrolone.
Al Benson, an HIV treatment advocate in Los Angeles concurs. "Nandrolone is truly 'the Lazarus drug'... it has brought me back from the brink, restored my health and made all the difference in the quality of my life."
Other HIV Wasting Drugs
The Food and Drug Administration (FDA) has approved other drugs for the treatment of HIV wasting or appetite loss. Megace (megestrol acetate), a female sex hormone-based product, tends to produce weight gain by increasing fat rather than lean body mass. Adding fat during AIDS wasting has not been shown to improve survival. Megace has also been associated with side effects such as diabetes, blood clots, impotence, and the development of female sex characteristics.
Serostim, a recombinant human growth hormone, requires daily injections and can cause joint aches, swelling, and diabetes. It can cost as much as $6,000 a month, so most insurance companies do not want to pay for it and many ADAPs can't. The kickback scandal Serostim's manufacturer was involved in hasn't helped matters either. FDA-approved appetite stimulants such as Marinol contain THC, the psychoactive ingredient in marijuana. This can be an issue for many people with HIV who are in recovery. It has also been suggested that Marinol may simply owe its ability to increase appetite and weight to a side effect of the THC high -- "the munchies."
Compounding Pharmacies: A Viable Option at Risk?
Many doctors and patients do not know that nandrolone and oxandrolone can also be obtained in smaller quantities legally by prescription and at a lower cost through compounding pharmacies (where drugs are not only dispensed but can be prepared according to a doctor's specifications). No one knows how much longer this option will remain available. One pharmacy owner reports that the DEA has raided several compounding pharmacies in the past few months, including his own. The Safe Compounding Drug Act of 2007, now under consideration, would place these sites under greater regulation and presumably greater surveillance. In the meantime, compounding pharmacies such as Applied Pharmacy, Kronos, the Compounding Shop, College Pharmacy, and others are still economical sources of nandrolone, oxandrolone, and testosterone gels and injections. However, they do not process insurance claims and are not equipped to supply ADAPs, insurance, Medicaid, or Medicare Part D vendors.
In this era when HIV/AIDS patients are living longer, it is just as critical to fight for safe, effective, and affordable "quality of life" drugs as it to advocate for accessible antiretrovirals. After all we have done as activists to secure antiwasting medications, we must not lose ground now and fall asleep when vital treatments such as nandrolone are dropped without notice and with little regard for patients' needs.
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Nelson Vergel is founder of the Program for Wellness Restoration.
Kotler DP, Tierney AR, Wang J, Pierson RN Jr., "Magnitude of body-cell-mass depletion and the timing of death from wasting in AIDS," Am J Clin Nutr. 1989 Sep; 50(3):444-7. "The impact of malnutrition on survival in AIDS was evaluated by examining the magnitude of body-cell-mass depletion as a function of time from death. Body cell mass was estimated as total body-potassium content and determined by whole-body counting. There was progressive depletion of body cell mass as patients neared death. The extrapolated and observed values for body cell mass at death were 54% of normal. Body weight had a similar relationship to death, with a projected body weight at death of 66% of ideal. We conclude that death from wasting in AIDS is related to the magnitude of tissue depletion and is independent of the underlying cause of wasting. The degree of wasting seen in this study is similar to historical reports of semistarvation, with or without associated infections. This observation suggests that successful attempts to maintain body mass could prolong survival in patients with AIDS."
Mangili A, Murman DH, Zampini AM, Wanke CA, "Nutrition and HIV infection: review of weight loss and wasting in the era of highly active antiretroviral therapy from the nutrition for healthy living cohort," Clin Infect Dis. 2006 Mar 15;42(6):836-42. Epub 2006 Feb 7.