On Friday, April 11, the House Committee on Energy and Commerce issued a release entitled "After Review of ENHANCE Trial Documents, Dingell, Stupak Express "Serious Concerns"" after writing to the CEOs of Merck and Schering Plough to ask for additional information from the companies about the study on Vytorin efficacy. In the release, Representative Bart Stupak (D-MI) had this to say:
“Our investigation is far from over. We began looking into the ENHANCE trial because of concerns raised about the delay in the release of the results. Our questions have led to more questions that still need to be answered. We will continue to explore Merck and Schering-Plough’s conduct of the ENHANCE trial and what happened in the 20 months between when the trial ended and when the results were released.”
As we churn through the election cycle, and with the likelihood of an increased Democratic presence on the Hill after the elections, this may be yet another area for prospective reform. It is easy to imagine that Congress may propose a time limit by which studies such as those conducted on Vytorin must be released to the public. I’m adding that possibility it to the growing list of things to watch respecting potential FDA reforms.