Rx DRUG COSTS: Drug Giant’s Marketing Practices Panned
Hepatitis C activists are battling the drug giant Schering-Plough Corp., criticizing its "despicable" marketing of Rebetron, the leading treatment for the illness, Salon.com reports. Schering-Plough charges $18,000 per year for Rebetron because it is sold in a package that includes the pill ribavirin and injectable interferon, a combination that is about 25-30% more effective than taking interferon alone. Although many patients want to add ribavirin to their regimen, Schering-Plough, which has a patent on the drug, will not sell it alone. The move forces those infected with the disease to purchase Schering-Plough's version of interferon, although other companies manufacture the same drug. Brian Klein, co-founder of the Hepatitis C Action and Advocacy Council, called Schering-Plough's marketing strategy "extortion." He said: "Schering-Plough is tying the sale of ribavirin, which they have a lock on, to the sale of interferon, which they don't. But the decision of which drugs to use should be made by patients and their doctors, not drug companies. This is holding people hostage by forcing them to buy both drugs from Schering-Plough." According to the New Jersey pharmaceutical firm, however, the company "deserves credit" for developing the combination and bringing it to the market. In addition, the FDA only examined the combination of ribavirin with Schering-Plough's interferon, Intron A. "Schering-Plough is providing the best proven treatment for hepatitis C," spokesperson Robert Consalvo said, adding, "We put these two products together and got Rebetron through (the drug approval process) very quickly. The bottom line is it's being marketed the way it was tested and approved."
Drug Giant Toppled?
Despite the company's explanation, the battle between Schering- Plough and hepatitis C activists has intensified. While the company's patent on Rebetron will expire next year, Schering-Plough will likely fight efforts by other firms to make their own versions of ribavirin. Meanwhile, the HAAC has denounced the marketing of Rebetron at professional meetings and challenged company officials in public forums. In addition, a small pharmacy in Pittsburgh has used a "legal loophole" to sell its own form of ribavirin, at about a fifth of the price charged by the Schering-Plough. The pharmacy imports ingredients from abroad and makes capsules on a custom basis, a process called "compounding." According to Consalvo, however, "This really does not comply with the spirit of the compounding regulations. You're supposed to fill an individual patient's one prescription, not say, 'Hey, I can make the same product this big guy is making and sell it for a lot less because I don't have the overhead.'" Schering-Plough has complained to the FDA, but the agency has "taken no action."
Other health care experts and advocates also weighed in on Schering-Plough's marketing of Rebetron. Stefan Loren, a pharmaceutical industry analyst at Legg Mason, defended Schering-Plough, noting that a drug firm may spend up to $500 million to develop a new product. "Rebetron is very pricey, no question, but these companies have only a few drugs to recoup all the failures ... People are saying they can make obscene profits, but the fact is they're in a very risky business." According to Alan Franciscus, founder of the Hepatitis C Support Project in San Francisco, "It's not like [Schering-Plough is] the evil empire. But their attitude is, [w]e developed this drug, we're going to do what we want with it and you should be happy. That's not reality, though." Last year, however, the AMA's Committee on Ethical and Judicial Affairs raised concerns about the drug bundling issue, and the "normally staid" American Liver Foundation has also supported efforts by hepatitis activists. "[Schering-Plough is] playing hardball," ALF President Alan Brownstein said, adding, "As far as HAAC's position, we're supportive. ... People with [h]ep[atitis] C are fighting for their lives." Even the FDA has urged the company to alter their marketing plan, but the agency has "no authority" to force Schering-Plough to unbundle the drugs (Tuller, 8/22).