I almost choked over my tea this morning when reading this The New York Times story, the gist of which was that French regulations governing conflicts of interest in medicine are considerably more lax than our own. If only that were true.
The NYT article described how a recent scandal over Mediator, a French drug belatedly withdrawn from the market after causing a number of deaths and severe heart problems, has prompted widespread calls for change in the French regulatory system. But while the piece mentioned in passing that the French have passed a package of reforms, it failed to note just what those reforms consisted of: that in response to this scandal, the French National Assembly has already passed a strict law mandating the disclosure of conflicts of interest among scientists who advise government officials about new drugs — see Pharmalot. This law requires external experts and health ministry staffers to declare all conflicts or face a $40,000 fine. The French response is far stricter than anything our own regulatory officials at the FDA or NIH have come up with so far.
The Times article points out there are no penalties for voting members of the French equivalent to the FDA who fail to disclose conflicts of interest, while it is a crime to do so here. While it may be against the law for FDA officials to have undisclosed conflicts of interest, it is not a crime for advisory members of the FDA or other researchers who fail to disclose such conflicts. Indeed, not a whole lot happens to the vast majority of academic researchers who fail to disclose the fact that they are getting payments on the side from the same drug companies whose drugs they are touting in medical journals and conferences or on FDA advisory panels. As I and others have blogged about before here and here, that’s primarily because it is left up to universities to sanction these researchers, and universities don’t want to bite the hand that feeds them. The only academic who was asked to step down because of failing to report egregious conflicts of interest was Charles Nemeroff at Emory. As we all know, Nemeroff was promptly scooped up by the University of Miami School of Medicine who was more than happy to have a pharmaceutical company rainmaker on its payroll.
What today’s Times piece also failed to note is that the FDA’s conflict of interest regulations are under attack in Congress. According to Pharmalot, several U.S. Senators has introduced a bill that would reverse FDA regulations that bar experts with financial ties to drug or device makers from serving on the committees without a waiver.
So at the very time that the French are tightening their regulations to better protect the public health, officials on this side of the Atlantic are trying to weaken U.S. consumer protections. But you wouldn’t know that from reading today’s New York Times.