AIDS activists are mobilizing after Watson Pharmaceuticals last month dropped a common off-label drug used to assist patients with combating wasting and picked up a generic brand of an approved AIDS-related wasting medication that they maintain is not as effective.
"Taking this drug away from people with wasting syndrome is like taking insulin away from diabetics," said Jason Riggs, deputy director of the Stop AIDS Project. "Thousands of people with HIV depend on this drug to reverse wasting syndrome, a life-threatening illness." Patricia Eisenhaur, director of investor relations for Watson Pharmaceuticals, confirmed that Deca-Durabolin, also known as nandrolone decanoate, an anabolic steroid prescribed by physicians to combat AIDS wasting, was discontinued on March 20.
According to Eisenhaur, the active ingredient to manufacture the drug was no longer available from the Food and Drug Administration-approved supplier. Eisenhaur was unable to provide the name of the supplier, which was the only approved manufacturer of the active ingredient. She told the Bay Area Reporter that the supplier did not provide Watson with a particular reason for not being able to provide the ingredient for the medication. "We depleted all of our existing inventory and we've done everything we can to keep the product on the market," said Eisenhaur. "But without access to the active ingredient we obviously can no longer manufacture and distribute this product." Eisenhaur told the B.A.R. that Watson notified its customers – mainly hospitals, wholesalers, and those who purchase products directly from the company – about the discontinuation of the medication through its normal communications process. Watson did not issue a news release regarding its decision and the company does not plan on making any further public announcements, according to Eisenhaur. AIDS activists upset On April 4, Sanford Gross, an associate professor at Illinois College of Optometry, posted on the Yahoo Group PozHealth his discovery that Deca-Durabolin was discontinued by Watson. AIDS physicians and activists don't believe that the raw ingredient used to make the medication isn't available. During an AIDS Treatment Activist Coalition phone conference on April 13 to discuss actions to mobilize to have the medication returned to the market, there was speculation about Watson's decision. Their suspicions grew through this week as they learned that Savient Pharmaceuticals canceled its patient assistance program for Oxandrin, the second most prescribed drug to combat wasting. Savient made that decision soon after Watson was approved to manufacture a generic brand of Oxandrin in December 2006. "The company has always been pleased to provide the patient assistant programs over the past several years," said Anne Marie Fields, investor relations of Savient. "That's pretty common to cancel patient assistant program for a drug when it goes generic. It just makes sense. The increase of the introduction of the generic and reduction of the price makes the product more accessible for the patients that need them." "We are one of the broadest distributors of generic products of the United States," said Watson's Eisenhaur. "So having an opportunity to offer new products to our customers is important to us." Eisenhaur told the B.A.R. that the decisions for both drugs were unrelated. According to Eisenhaur, Deca-Durabolin "in terms of Watson's overall revenues, it is a small product." AIDS doctors and activists aren't satisfied with responses from Watson and Savient. "I think it's important for citizens to realize that our health care system for the last 30 years has slowly been hijacked by corporations," said Dr. Richard Loftus of California Pacific Medical Center, Davis Campus. But not all activists were quick to blame Watson. "I'm reluctant to put this squarely on the shoulders of Watson Pharmaceuticals," wrote Tim Horn, senior writer and editor for http://www.AIDSmeds.com, in a e-mail. "The fact is, we – treatment activists – dropped the ball. We should have been pushing for the approval of nandrolone as a bona fide treatment for HIV/AIDS-related wasting 10 years ago ... I just don't see how we're to be at all effective in terms of pushing a company to continue manufacturing a drug for an indication it doesn't even have." Which can possibly explain some of AIDS physicians' complaints that Watson didn't notify them. Deca-Durabolin isn't approved by the FDA for doctors to prescribe to their HIV-positive and AIDS patients to treat AIDS-related wasting. It was approved for treating anemia, according to Horn. According to the FDA's Web site, Deca-Durabolin is an anabolic steroid that was first approved by the FDA in 1962. The Web site also stated that there is no alternative therapy. This wasn't news to physicians treating AIDS patients and activists who are troubled by the changes. The medication was highly successful with low side effects, was cost effective, and was included in the AIDS Drug Assistance Program. According to Loftus and AIDS activists, there aren't very many viable options available on the market to assist patients with combating AIDS-related wasting. What is also troublesome to them is that the options aren't as effective treating the condition. AIDS physicians and activists repeatedly cited the fact that Deca-Durobolin was studied thoroughly, including for AIDS-related wasting. The studies showed that the medication has many benefits, according to Loftus and those that participated in the conference call. One of the benefits is that it has few side effects compared to alternative steroids, such as Oxandrin, Loftus noted. He said that the problem with Oxandrin is that it has common side effects, but more important, it damages the liver. Deca-Durabolin did not. Oxandrin, the second most prescribed anabolic steroid, is also more expensive. According to Nelson Vergel, founder of the Program for Wellness Restoration in Houston, Texas, who coordinated the conference call, AIDS-related wasting isn't the "number two HIV killer anymore in the United States, it is now number eight." He believes this is due to life-expanding medications, such as protease inhibitors, commonly referred to as "cocktails." That doesn't make a difference to Loftus, who prescribes the medication, or patients who depend on the medication to help them continue living healthy lives. "We have a real urgent need to treat weight loss in these patients for the sake of survival," said Loftus. This isn't the first time Deca-Durabolin was removed from the market. Organon International, a New Jersey pharmaceutical company, dropped the drug from distribution in 2002 with no plans to return it to the market. AIDS activists mobilized at that time as well. Eventually, Watson picked up the medication. ATAC is hoping this will happen again. "This is a decision that effects many people's health that was made by a corporation that did not even have the courteousness to consult patient groups about this decision," said Loftus. "This goes back to an old adage that we used to say in ACT UP 15 years ago, 'Their right to own the drug is more important than our right to have access to it to save our lives.'" Loftus said about 90 percent of his patients with full-blown AIDS and 40 percent of his HIV-positive patients are on Deca-Durabolin. He sees about 300 AIDS and 1,700 HIV-positive patients. He found out about Deca-Durabolin's discontinuation from Gross's posting on PozHealth, but he never received a notification from Watson. According to Loftus, Walgreens pharmacy confirmed Watson's decision on April 17. For more information on the campaign to put Deca-Durabolin, back on the market, visit http://watsonboycott.blogspot.com/. 04/19/2007