By Michael E. Miller
By Ryan Yousefi
By Kyle Munzenrieder
By Sabrina Rodriguez
By Michael E. Miller
By Carlos Suarez De Jesus
By Luther Campbell
By Kyle Munzenrieder
Sullivan is a long-term AIDS survivor, doing everything he can to stay healthy until a cure for the disease is discovered.
His image -- not all that unusual now -- transcends the old AIDS stereotypes of purple-splotched (Kaposi's sarcoma) gauntness, premature death-camp pallor. Since the introduction of protease inhibitor therapies such as Viracept, Crixivan, and Norvir in the mid-1990s, thousands of men and women wasting away from the slew of infections HIV unleashes have made similar comebacks. Traces of HIV in their bloodstreams have become virtually undetectable. Their disease is approached by health professionals as a manageable illness now, like diabetes.
But there is another, more controversial tactic that is transforming once-withered PWAs (Persons With AIDS) into muscle-bound survivors: although not recognized in official AIDS treatment lists, anabolic steroids are used in combination with testosterone to prevent "wasting." While many activists and physicians criticize anabolic therapy as a superficial "beautifying" agent in the war on AIDS, not directly affecting the retrovirus, patients such as Sullivan have come to believe their weekly injections are a lifeline that keeps them strong.
But the brand-name drugs Deca-Durabolin and Depo-Testosterone, most used by AIDS patients, were recently removed from the market by their manufacturers. While Pharmacia-Upjohn, New Jersey maker of Depo-Testosterone, promises to bring it back, the manufacturer of Deca-D, New Jersey-based Organon, Inc., says it has no intention of doing so.
AIDS patients who use Deca-D call the corporate decision another case of exploitation. They suspect Organon will reintroduce the drug under a new name and market it to HIV patients at higher prices. Organon press rep Fran DeSena denies the allegation. Deca-D was last priced at $32 for a 200-milligram dose. With once-a-week injections, this cost the average patient roughly $125 a month. Since marketing research sources estimate Organon's yearly sales of Deca at five million dollars (the company refuses to reveal sales volume or number of patients), it would seem likely that profitability was inadequate to hold Organon's interest.
The stoppage has left thousands of AIDS patients hoarding their supplies and frantic about their futures. Sullivan has enough Deca-D to last him through September. After that runs out, he admits he'll be scrambling for alternative sources.
"I don't know what I'm going to do," he says.
Since AIDS first appeared, survival in the affected groups has depended on the circulation of information -- both official and underground -- among patients and their supporters. Those affected by HIV have learned how to get drugs and treatments that aren't available in the U.S., or that aren't approved. In the desperate days before protease inhibitors, PWAs watched as much-touted therapies, like the highly toxic drug AZT, wreaked havoc on already-fragile immune systems. People were literally dying of the cure for AIDS. Soon word-of-mouth led to networks of "buyers' clubs," primarily among gay men, and patients began, often with the help of sympathetic physicians, to work out their own anti-HIV regimens.
Today one can find buyers' clubs that promote everything from marijuana use to cabbage juice to illegal medicines from Poland as remedies for AIDS-related infections. In the same manner, Deca-D users are now using the Internet to buy unapproved carbon copies of the drug, often veterinarian-grade steroids from Germany, Brazil, Mexico, and Venezuela, according to pharmaceutical researchers such as Larry Sasich, from Ralph Nader's Public Citizen, a Washington, D.C. watchdog organization.
While steroids are legally prescribed in the U.S., treating AIDS wasting with Deca-Durabolin has been an underground phenomenon since the mid-1980s. The practice commenced when Los Angeles physician Walter Jekot began treating dying patients with the drug and posting his findings on the Internet under the name "Dr. X." Thousands of PWAs across the country began using the drug to stave off wasting syndrome, in which patients lose weight at alarming rates and are unable to retain nutrients.
Lean muscle mass is an indicator of health. Muscle tissue helps maintain energy levels the body needs to convert proteins and nutrients, during metabolism, into energy. When the energy required begins to deteriorate because of lack of absorption of nutrients, healthy muscle tissue weakens and dwindles. Once you can't sustain your muscles, malnutrition, generally referred to as wasting, begins.
AIDS-related wasting is one of the facets of the disease yet to be fully understood. While the new drug therapies help patients survive longer, wasting is still a risk. Deca-Durabolin helps prevent that, its proponents say, because it develops lean muscle mass regardless of how the immune system is doing. This "artificial" bulk, in turn, helps keep energy levels -- and patients' self-confidence -- high.
Anabolic steroids, such as Deca-D, have chemical structures similar to the male hormone testosterone. While steroids are not recommended to replace testosterone, they enhance the effects of the hormone by juicing muscle growth and increasing strength. Users of other steroids often experience side effects such as increased hair production, lowering of the voice, enlarging of the Adam's apple, and acne. The drugs can inversely metabolize and increase levels of estrogen, the female hormone, leading to testicular atrophy and the growth of breasts, not muscle, in men, says Dr. Michael Wohlfeiler, a leading Miami AIDS specialist.
This doesn't happen often with Deca-D. Its users inject 100 milligrams into deep muscle -- usually the buttocks -- once a week or every other week. The steroid attaches to androgen cells, then is carried to the nucleus of a cell. There the molecule tells the DNA to convert into messenger RNA (mRNA). The mRNA next delivers its message to muscle cells, which respond by increasing protein synthesis. This is what causes cell growth and growth in muscle tissue.
Use of Deca-D, though, is not without risks. The drug increases red blood cell counts and so thickens blood to sometimes dangerous levels, Wohlfeiler explained. This condition makes the heart work harder and can lead to cardiac arrest, especially among patients on protease inhibitors, because those also build up cholesterol levels and fat in the body. So patients are usually advised to use Deca-D in twelve-week cycles, with several months' rest period in between.
Bill Sullivan began using Deca-Durabolin in 1992. He claims the drug helped save his life in the nightmarish days before protease inhibitors, when his five-feet-eight frame withered to less than 125 pounds.
"I put weight on as soon as I started using [Deca]," Sullivan says. "Back then I really thought I was dying. Now I don't look like an AIDS patient."
Deca-D, known in gyms worldwide as the king of steroids, was originally developed to treat aplastic anemia, a virulent form of the disease. The drug's positive effects are, however, offset by the bad reputation it gained as bodybuilders, Olympic athletes, and Mafia goons (Sammy "the Bull" Gravano and John Gotti Jr.) beefed up by injecting and injecting and injecting.
Although Deca-D was never officially recognized by the medical establishment as an AIDS treatment, word spread among the HIV networks mentioned above that steroid use was actually helping people to survive. Soon D use, whether prescribed by a doctor or not, surged.
"When I first began to speak about it, it was heresy," says Nelson Vergel, an anabolics advocate and chemical engineer who was first diagnosed with HIV in 1987. "It was like I was talking about using crack or crystal [meth]."
But the desperation among AIDS patients eventually overcame Deca's bad rep. This generated a new market the drug wasn't intended for. In pharmaceutical jargon, this is called "off-label" use. So HIV-positive Deca-D users were stunned when Organon stopped producing the drug in May. Getting a prescription now is virtually impossible.
"They dropped [it] without telling anybody," Vergel says. "We were pissed. They stopped without giving any reason."
Organon spokeswoman Fran DeSena says the company stopped making Deca because the product no longer fit into the company's "profile." Organon, she says, is shifting all efforts to the booming market for drugs that combat depression (Prozac, for example, sold $186 million in the first quarter of 2002 for Eli Lilly and Company).
"There are no plans in the future to make another version [of Deca-Durabolin]," DeSena declares.
According to Food and Drug Administration sources, the stoppage of Deca-D doesn't constitute an emergency because there are other steroids on the market such as oxandrolone and stanozolol, as well as an alternative form of Deca-D, nandrolone decanoate. To date, only two companies -- GulfSouth Rx, a Mobile, Alabama pharmacy that makes "generic" versions of drugs in its own lab; and Watson Pharmaceuticals in Corona, California, which has recently re-entered the market in a small way -- are known U.S. sources for the alternative. While GulfSouth sells its version of Deca-D at a lower price than Organon ($12.50 compared to Organon's $32 per dose), it does not accept medical insurance (making payment tougher on users), and its formula may be different from the original. Watson charges $38 per dose, and (according to an employee speaking anonymously) "may only manufacture the drug temporarily." That's because it's responding to a call from the FDA to fill a need, but has no real long-term interest.
GulfSouth pharmacists refute their critics, saying that while they may not know Organon's exact formula, they use the same base compound to produce their product. Sam Kelly, the pharmacy manager, says they get their nandrolone from Hawkins Pharmaceuticals, the same company that provided the compound to Organon.
"Nandrolone is nandrolone is nandrolone," Kelly says. "Clinically, it's identical."
At Watson, the quality is likely to be higher because the manufacturer is a known pharmaceutical, industry watchdogs say.
Against the evidence, Vergel and other AIDS activists remain wary of Organon's motives -- suggesting it pulled Deca only to capitalize on future off-label use dissatisfaction by patients, who might then be lured back to a different-named D at a higher price. But given the number of people -- nearly 800,000 -- living with AIDS in the U.S., and the estimated users of Deca to combat HIV wasting -- under 150,000 -- the profit motive doesn't seem a strong one.
In any case, DeSena denies the charge: "There is no further discussion," she concludes.
"This is just one more hit against the HIV-AIDS community," says Marc E. Cohen, president of the United Foundation for AIDS, a nonprofit agency with outreach programs and clinics in South Beach.
He points out that PWAs and their advocates have been battling pharmaceutical companies for increased access to effective and affordable medicines since the onset of the disease: "Alternatives to Deca-D are either risky or not available," Cohen says. "So naturally our patients are tremendously fearful of what their outcomes will be."
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 wait for 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.
"In 1992 we were scared shitless of losing weight," Vergel says. "It was a horrible time for all of us. Then I heard about boys who were doing anabolics underground."
As word spread in West Hollywood, Vergel learned of underground doctor Jekot, who was using Deca. Once they met, they became collaborators. Now Vergel tours the country with the book he co-wrote about treating HIV with anabolics, Built to Survive.
Vergel, five feet eight and a beefy 195 pounds, believes in anabolic therapy so much, he wants every HIV patient to have access to Deca-D. He reports attitudes have changed among the PWA community; though he used to be vilified for "promoting steroids," now those same vilifiers ask for advice on where to get it. A progressive doctor may prescribe a similar formula now through GulfSouth or Watson, but the old locker-room sources are drying up.
"I don't see poz boys selling their Deca-D anymore," Vergel says. "They know they'll need it up the road."