Lawyers, Congressional reps, and now Senators are circling around Merck and Schering-Plough as the Vytorin brouhaha escalates into a full-blown scandal. Less than two weeks after Merck/Schering-Plough released data from its Enhance study--which showed the brand-name and expensive Vytorin did no better against arterial plaque than did generic simvastatin--lawsuits have been filed in at least eight states on behalf of the consumers and insurers that paid more for Vytorin.
Meanwhile, Sen. Charles Grassley has jumped onto the investigatory bandwagon. Ranking Member of the Senate Finance Committee, which oversees Medicare, Grassley fired off letters to:
- the drug makers, asking when the Enhance data was unblinded and why its release was delayed for almost two years
- the SEC, asking it to probe stock sales made by Schering execs last year
- the American Heart Association and American College of Cardiologists, asking for details about their industry funding and their statements in support of Vytorin
For their part, the House Democrats looking into the Enhance study and its repercussions are asking some very detailed questions about the trial, namely whether the companies set up independent committees to monitor safety and to deal with any problems that arose. Forbes says there were no committees, and that at the very least, a steering committee might have helped keep mud off Merck and Schering when the results were delayed. One expert told the Forbes, "Every real trial should have both...You can't just have one individual to stand up to the sponsors."
Merck and Schering-Plough aren't taking all this without complaint. The companies issued a statement today saying that they'd conducted the Enhance study "with integrity and in good faith" and that they "stand behind Vytorin and Zetia and stand behind [the] science."
- here's Merck and Schering-Plough's statement
- read the release with links to the letters (.pdf)
- see more on the lawsuits
- read the Grassley item from Pharmalot
- get more on Enhance's missing committees
- and here are details on Merck and Schering's defense