Much chatter about David Graham and his leaked Avandia report. It’s turning into a real whodunit. And it’s more complicated than it looks.
First, it’s important to understand that the FDA had already approved Dr. Graham’s request to submit his manuscript to JAMA. So the report (in the Wall Street Journal) that, “… Dr. Graham complained that senior FDA officials were holding up his efforts to publish his work,” is just completely wrong.
So why would Graham leak the report and torpedo his chances of getting it peer-reviewed and published? A few theories are being floated:
(1) The manuscript had been submitted and rejected by JAMA. So spurned, Dr. Graham took the next most expedient step and leaked his report.
(2) Same as above, except the leak came from a supporter inside JAMA either with or without the knowledge of Dr. Graham.
(3) JAMA accepted the paper but determined that it would also offer the FDA or GSK or both a chance for rebuttal. Dr. Graham or a JAMA editor felt this wasn’t fair and leaked the document.
(4) The report was leaked by some else inside the FDA.
Or, in the words of Sherlock Holmes, “When you have eliminated the impossible, whatever remains, however improbable, must be the truth.”...
Whatever the truth, “leaking” a confidential FDA report is not the act of a whistle-blower. Whistle-blowers have the courage of their convictions and are (appropriately) protected. Leakers, on the other hand, are just cowards with an agenda.
At the end of the day, the only thing that counts is that the FDA reach its conclusions based on sound science and not on media leaks – or politics.
