HEPATITIS C: New Drug Strategy; Infected Transplants
The FDA and the drug industry have been taken "by surprise" by a Pittsburgh, PA, pharmacy's plan to sell Ribavirin, an expensive medication for hepatitis C, far below Schering-Plough's price tag, the New York Times reports. When the Schering-Plough patent expires tomorrow, July 1, patients will be able to purchase the drug -- which retails at up to $1,440 a month, $17,300 a year -- for just $225 a month from Fisher's Specialty Pharmacy Services, a "compounding" pharmacy based in Pittsburgh.
Hepatitis C patients take Ribavirin in combination with an interferon. Schering-Plough has cashed in for years by bundling Ribavirin with its own interferon, Intron A, and selling the two drugs as a package, marketed as Rebetron. Patients who had trouble taking Intron A and "wanted to try their luck combining Ribavirin with another brand" of interferon were stuck with Rebetron. Beginning tomorrow, pharmacists at Fisher's will hand- pack imported Ribavirin powder into capsules to fill individual prescriptions, using mixtures and doses that differ from the commercially available version.
Looks Legal to Us
The plan is "carefully constructed to navigate the nation's drug approval and patent laws." Although Schering-Plough "has an agreement that bars competitors in the United states from marketing generic forms of the drug, that agreement does not apply to pharmacies like Fisher's, which merely puts the drug into capsules," the Times reports. The FDA said it is looking into the plan, "but would probably not try to stop it unless it was determined to be unsafe." Schering-Plough, which has reaped $214 million on the combination that is the "best treatment developed so far for the disease," concedes that the scheme appears to be legal (Grady, 6/30).
Fighting Sick with Sick
Hepatitis C patients who receive donor livers from people also infected with hepatitis C fare as well as those who receive uninfected livers, according to researchers from the University of Pittsburgh Medical Center. In research slated for publication in the July issue of Gastroenterology, Dr. Hugo Vargas and his colleagues found that among 200 liver transplant operations performed between 1992 and 1995, 89% of those who received infected livers were alive one year later, compared to 88% of those receiving healthy livers. The trend held steady with 72% of those receiving infected livers still alive after five years, compared to 73% of those receiving healthy livers. There is no national policy regarding the transplantation of hepatitis C-infected organs, said Brian Broznick of the Center for Organ Recovery and Education, adding that when "you consider the alternative, which is death, if you don't get transplanted, the risk factors are relatively low." Vargas said the study also offered some insight into the virus, noting that when two hepatitis C strains are introduced into the body, they "interact until one gains dominance." Patients whose donor strain of hepatitis takes over tend to do a little better, perhaps because the donor did not die of liver problems and may have a less virulent strain. "In the future, rather than working on a vaccine to create antibodies to hepatitis C, what you need to do is find a (strain) that can eradicate the bad virus but not cause liver disease," Vargas said (Srikameswaran, Pittsburgh Post-Gazette, 6/30).