By Michael E. Miller
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By David Villano
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By Michael E. Miller
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The stoppage imperils Deca-D users because they now must get their doses from largely unregulated sources, according to Larry Sasich, the Nader pharmacist.
Sasich alleges that while compounding pharmacies, such as GulfSouth, are licensed by state boards of pharmacy, they're rarely inspected. Because of this, he says, there is no way of ensuring that the given formula for a compounded drug is equivalent to the pharmaceutical brand. Also, he says, the chances for unsanitary conditions are increased.
"Patients run a serious risk," Sasich charges. "All the things that could possibly go wrong producing a drug are [likely to happen]."
Last year a pharmacy in Walnut Creek, California was prosecuted when the steroid it compounded was found to be infected with the bacteria serratia. As a result three people died and ten others were hospitalized with a deadly form of meningitis, according to news reports of the incident.
"People are getting substandard products. To think they could make a safe and effective product in the back of a pharmacy is atrocious," Sasich alleges.
GulfSouth, however, has been licensed and inspected by the State of Alabama's Board of Pharmacy. It received its license in May. Coincidentally or not, that was the same month Organon stopped producing Deca-D.
GulfSouth's Kelly insists the company adheres to "stringent" aseptic procedures, meaning that the production area for nandrolone decanoate is always sterile. To assure this, and to maintain the correct formula, the company contracts with a lab in Oklahoma to test samples from each batch of D it produces, he says.
The dearth of "real" Deca-D among the AIDS community in body-conscious South Beach, where recent surveys by the Centers for Disease Control show the highest occurrence of AIDS and HIV in the nation, is causing PWAs to stockpile their supplies.
Dr. Jose Hernandez, medical director for the Community AIDS Clinic at South Shore Hospital, describes the situation as "grim." His patients who have come to rely on Deca-D and testosterone are now finding their doses in gyms and on the street, a dangerous proposition for people whose health is already at risk. "I'm familiar with steroids from Brazil that are illegally imported," Hernandez says. "Because we cannot regulate them, we have no quality assurance. Often the vials are full of water!"
Deca-D, he says, helps improve quality of life for his patients because they not only increase their strength, but look and feel healthy. Psychology, he suggests, impacts physical well-being to a high degree. So now that it's impossible to prescribe, he foresees some turbulent changes in the deceivingly tranquil world of "living with AIDS" in South Beach.
"We are not going to see the detrimental effects tomorrow, or next week," Hernandez suggests, "but in six months we will. We're going to feel it more than anybody."
Dr. Wohlfeiler, who is medical director of Special Immunology Services at Mercy Hospital and vice president of the Florida Academy of HIV Medicine, recently posted notices at his Miami Beach clinic alerting his patients that he will be getting the generic form of Deca-D through GulfSouth.
Wohlfeiler began prescribing Deca-D to AIDS patients in 1990. "We discovered that the patients with more muscle seemed to survive longer," he says. "Using steroids is a way for them to build up while they're still healthy. In a sense, it's like putting money in the bank."
While Wohlfeiler admits there is no proof that the use of steroids suppresses the advance of HIV, he has observed repeatedly that D keeps up the all-important lean body mass. "Treating wasting syndrome with steroids is still very unofficial," Wohlfeiler says. "More conservative physicians would say prescribing steroids is wrong. They refuse to use drugs that are not FDA-approved. But those of us that have been treating HIV for a long time can't waitfor a definitive word from the FDA."
Wohlfeiler, Hernandez, and other long-time HIV-battlers are, of course, the minority. Other prominent experts, such as Dr. Margaret Fischl, director of AIDS research at the University of Miami and one of the most respected researchers in the nation, disagrees with using steroids and testosterone to combat wasting.
Fischl says the steroid/testosterone regimen does not actively combat HIV and therefore should not be part of an AIDS drug regimen. By imposing a steroid therapy on a patient who already takes 72 pills a day, she says, doctors are unnecessarily complicating treatment. Deca does nothing to suppress the virus.
"We don't like getting caught up in [steroid use]. We do not believe it's the right way to go," Fischl says. "The objective is that patients are healthy, live healthy, and have self-assurance in the way they look. We're not here to promote body-building or muscle-building."
Instead Fischl advocates exploring the precise reasons a patient is experiencing wasting. She says there is no single cause for the condition. Often wasting is directly associated with adverse reactions to drug regimens. Using steroids, Fischl says, carries too many risks.
Still, hope springs eternal. Advocate Nelson Vergel never thought he'd become the poster boy for steroid use when he was first diagnosed with HIV. But in 1992 when his health began to crash, he dwindled from his normal 170 pounds to 120. He was desperate to stay alive. He remembers the time as "the gloomy years," when people thought that an HIV diagnosis was an immediate death sentence.