Amid all the controversy over Vytorin this week, Congress's self-appointed Merck/Schering-Plough investigators upped the ante in their probe of the cholesterol drug. Reps. John Dingell and Bark Stupak, who lead the House Energy and Commerce Committee and its Subcommittee on Investigations, told Merck and Schering's CEOS that they need more--much more--info on the SEAS study and two others that documented Vytorin patients' cancers.
As you know, Vytorin got back in the news about a month ago when Schering announced preliminary results from the SEAS study, which found more cancers and deaths from cancer among the patients taking Vytorin versus those taking placebo. The company had Sir Richard Peto analyze the data, and he concluded that the apparent link between Vytorin and cancer was simply a blip, a statistical anomaly. This week, other experts said, "Not so fast." The New England Journal of Medicine said a link can't be ruled out and must be studied.
Dingell and Stupak had asked for Peto's analysis of the cancer data; what they got, they said in their letters, was a five-page document that contained little more than what Peto had announced publicly at a press conference. The lawmakers questioned whether the report had been edited and whether Peto had made any other analyses. And they suggested that the document they got wasn't as comprehensive as the data given to the FDA for analysis, even hinting that the companies might have given the agency a "secret report." The companies said there's no such thing.
Meanwhile, the New York Times joins those advocating that Vytorin be reserved as a last-resort option for patients who need help lowering cholesterol. And you can be sure that the debate over the drug's safety and efficacy will continue.