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Published in the Bulletin of Experimental Treatments for AIDS 1999 Year-End issue, by the San Francisco AIDS Foundation.
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Rebetron Bundling Angers Hepatitis C AdvocatesWhen the FDA approved interferon/ribavirin combination therapy in 1998, they gave their imprimatur to a specific combination, Rebetron, produced by Schering-Plough. Rebetron consists of interferon-alpha 2b (Intron A, manufactured by Schering-Plough) plus Rebetol-brand ribavirin, which Schering-Plough licensed from ICN Pharmaceuticals. The drugs are sold together in a kit. Other forms of interferon-alpha are approved for use in the U.S., including interferon-alpha 2a (Roferon A, manufactured by Roche) and interferon-alfacon 1 (Infergen, produced by Amgen). Various studies have shown that these other brands of interferon are as or more effective than Intron A. Treatment advocates object to the fact that a single bundled combination of interferon/ribavirin was approved. The bundling means that people with hepatitis C cannot use ribavirin in combination with other brands of interferon that might work better or cause fewer side effects in some individuals. It also means that people must purchase the drugs in the doses sold in the Rebetron kit, which prevents people from using smaller or larger amounts of either drug without incurring the expense of wasted medication. A year's supply of Rebetron costs about $18,000 per year. According to the Wall Street Journal, financial analysts estimate that sales of Rebetron could generate nearly $1 billion in 1999. Activists contend that Schering-Plough is overcharging for the combination kit because it has a monopoly on ribavirin. Given the $5,000 cost of Intron A alone, ribavirin is priced about 350% higher than abacavir (Ziagen), the next most expensive nucleoside analog antiviral. The fact that Schering-Plough incurred no primary research costs to develop ribavirin (the drug was originally developed and approved for the treatment of pediatric respiratory syncytial virus) has further angered advocates. HCV advocates began meeting with Schering-Plough officials in October 1998, but made little progress. In April 1999, the Hepatitis C Action and Advocacy Coalition (HAAC), the Hepatitis C Support Project, the PWA Health Group, Project Inform, and many other groups and individuals submitted a consensus statement asking Schering-Plough to change its "monopolistic business practices." In May, the company issued a response stating that "Schering-Plough has no plans to change the packaging of Rebetron." Activists later brought their complaints to the American Medical Association's Council on Ethical and Judicial Affairs, testified before the FDA, and lobbied Congress and the Federal Trade Commission to examine Schering-Plough's marketing practices. According to the consensus statement, "Never in the history of drug development, approval, or marketing has bundling like this been forced on any patient population." Although the FDA has encouraged Schering-Plough to sell the two drugs separately, it does not have the authority to force the unbundling. Schering-Plough contends that it tested Rebetol only in combination with Intron A and did not seek FDA approval to sell the drug separately, and could thus be held legally liable for negative effects if Rebetol were used with another interferon. Nevertheless, Schering-Plough markets the two drugs separately in Europe. Moreover, Schering-Plough's bundling makes it difficult for researchers to study other interferons in combination with ribavirin. In an action that pleased activists, Fisher's Specialty Pharmacy Services, a Pittsburgh-based company that produces custom drug compounds, has decided to sell its own version of ribavirin, which persons with HCV can combine with whatever brand of interferon they choose. Fisher's announced its new product in July 1999 when the patent on ribavirin expired. Fisher's ribavirin is 80% less expensive than Schering-Plough's Rebetol. While Fisher's may face a challenge in successfully marketing and distributing its product, the move to make a more affordable alternative available to people with HCV is welcome. Fisher's Specialty Pharmacy Services3900 Perrysville Avenue Page last updated 8 January 2000 |
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