One of the panel members mentioned that Dr. Scott Gottlieb’s Wall Street Journal piece is now on line (in full text) at the American Enterprise Institute web site. He writes:
NEJM said it rushed to post the study on the Web because of its medical importance, but the FDA, which would need to act on any safety issues, wasn't even given a heads up about the study's publication or its findings. Rep. Henry Waxman (D., Calif.), however, seems to have known in advance that it was coming because he issued a substantive press release immediately after the study was posted online. He was even ready with the date and location of oversight hearings aimed at probing the FDA's "handling" of the drug safety issues.
Under questioning from Congressman Waxman Dr. Nissen (author of the NEJM meta-analysis) confirmed that he had informed congress about the meta-analysis. Dr. Nissen was questioned extensively by multiple members of the committee. When asked repeatedly why he conferred with members of congress and did not notify the FDA he talked around the question with responses such as “I put people above politics”. The only reason he seemed able to give was that he wanted help in gathering data for his research.
Nissen indicated that he provided his preliminary analysis on Avandia to members of Congress in February. Why didn’t he go to the FDA? Because “that’s not how it’s done.” He also pointed out that they already had the data. True, but they didn’t have the results of the meta-analysis.
In his defense of not going to the FDA Nissen testified that the FDA already had much more data than he had access to. Well, if his purpose was to get missing data, again it begs the question, why didn’t he go to the FDA? Apparently because the FDA is not allowed to release that information. News to me, but perhaps so. But if the FDA had everything he had and more why not wait for them to release their analysis before submitting his meta-analysis to NEJM?
What bothers me more than anything is that a clinical investigator goes to politicians for help in researching for a scientific publication. I had to replay the video two or three times to be sure I heard correctly. Astounding. I’d say that fact should have been included in Dr. Nissen’s disclosure statement.