The Republican from Iowa, who is the ranking member of the US Senate Finance Committee, is asking
Schering-Plough and Merck to explain when they first unblinded their controversial Enhance study data, and to account for sales and payments made for the cholesterol drug to Medicaid."In Iowa City, generic (Zocor) costs $54.54 for a month's supply while Vytorin costs $112.46. It's fair to assume the public would have benefited from knowing that a less expensive drug works just as well. Instead, people in Iowa and elsewhere paid more for nearly two years, while industry leaders sat on a scientific study that would have revealed this information," he says in a statement.
Like the House Energy & Commerce Committee, Grassley is responding to the scandal over the two-year delay in releasing trial data and the decision by the drugmakers to briefly change the primary endpoint with consulting the lead investigator. These activities, which drew enormous suspicion, looked still worse after the results released last week indicated Vytorin showed no statistically significant improvement in reducing plaque in the neck artery when compared with the much cheaper Zocor.
Meanwhile, Grassley has also written letters to Securities and Exchange Commission to ask the agency to examine stock sales by Carrie Smith Cox and other Schering-Plough execs. And he's sent letters to both the American Heart Association and the American College of Cardiology, both of which quickly issued statements telling docs and patients not to panic over the study results, without disclosing financial ties or support involving the drugmakers.
4 Comments
I am not a lawyer....
The Vytorin label does not promise it will decrease plaque build-up, only that it will lower cholesterol. If the companies legally marketed within the label, does Iowa have a case?
Vytorin label: http://www.fda.gov/cder/foi/label/2007/021687s021lbl.pdf
I think the big question is how well the companies adhere to complaint sales/marketing requirements in promoting their product. If they so much as imply decrease in plaques or push publications that do so, it's just as bad as coming right out and making the claim.
Wow, the AHA and ACC clearly have been bought off by SP and Merck. I imagine that if they didn't take money from either company, they would have told patients that they should panic and stop taking their medication and not consult their physician.
My prediction is that Fred hassan and Carrie Cox will get away free. They will never pay a dime out of their own pockets and will never serve a day for what they've done. This is America and corporate executives routinelt get away with this type of behavior. The bottom line is money drives everything. That's the dark side of blind capitalism without checks and balances.