Mr. Herper offers a very tightly-knit narrative, tonight, to explain what he feels Chairman Waxman was driving at, with his latest document-demand letter (of last Thursday). For Herper, it all boils down to a central question -- that is, "Why did it take six months for Schering to make first mention of the SEAS cancer signal?"
Mr. Herper's is excellent, so do go read it all, and to entice, here's a juicy snippet:
. . . .The three-person DSMB for Pedersen's [SEAS] study began worrying about the increased rate of cancer among Vytorin patients in June 2007. The panel met twice more that year. When the panel met in January 2008 and saw no signs that the risk had abated, the chair of Pedersen's DSMB contacted the chairs of the two other ongoing Vytorin studies. . . .
. . . .[W]hy, Congressional investigators want to know, did Vytorin's maker. . . Schering-Plough, tell the House Committee on Energy and Commerce that safety committees overseeing the analysis had started looking into a cancer signal a full six months earlier -- in January 2008?
Because that's what happened.
In January 2008, Merck and Schering were already being enveloped in a firestorm of controversy for delaying the results of a preliminary study where Vytorin had failed to best a cheap generic. The story of how the results from Pedersen's study, known as SEAS, were handled shows medical researchers basically doing things right, but it also reveals weaknesses in the way medical studies are monitored -- an issue that threatens to become more prevalent as industry and government do more to uncover drug side effects. . . .
Indeed. This one is going to keep on making headlines -- even if Schering-Plough performs absolutely admirably, from here on out.
