Saturday, May 28, 2011

Chantix and Suicides: Accidental Reporting Failure?

As reported by JoNel Aleccia for MSNBC-- anti-smoking pill, Chantix (varenicline), manufactured by Pfizer, appears to have been responsible for many more suicides than previously reported (a total of perhaps 150, or double what had been known). But these reports were missed until recently when unearthed by the non-profit Institute for Safe Medication Practices. Thomas J. Moore, chief scientist on the ISMP review, called this a "major breakdown in safety surveillance."

There are two FDA reporting mechanisms for adverse drug reactions, one for routine and the other for more serious events. The FDA said that they became aware that Pfizer was sending its reports of suicides and other major events for Chantix through the same channel where it reported such minor side effects as nausea, meaning that the important stuff got lost among 26,000 reports of relatively minor reactions. Pfizer said that they promptly did what the FDA told them to do and so they were not at fault. Both basically said it was no big deal since, based on the earlier reports, Chantix already carries a black box warning that mentions suicide. (Critics of the drug say it is a big deal; that something about this drug seems to cause at least a few people with no history of violence to unexpectedly act in destructive ways.)

Now, I would like to give Pfizer (and the FDA) the benefit of the doubt on this one. I usually go by the adage that if conspiracy and incompetence are two possible explanations for what happened, the latter is much more likely than the former.

But something nags at the back of my mind--a story I related in HOOKED. During the mid-1990s, Wyeth-Ayerst was heavily marketing, and making huge profits from, the diet pill combo known as Fen-phen. The storm clouds gathering on their horizon were increasing reports of serious heart and lung disease among users of these drugs. When internal company documents were released as part of later lawsuits, a pattern emerged that suggested that the company had followed a deliberate policy in reporting adverse reactions to the FDA. Instead of reporting by the wrong channel, Wyeth-Ayerst set about concealing the serious reactions by seeking out any minor reaction that the same patient might have suffered. For example, if a patient with heart valve damage severe enough to require open-heart surgery also had reported some constipation, the company headed the report "Constipation" in big letters and added the heart valve issue as far lower down, in the smallest print, that they could. That way the company could claim legally that it had never failed to report a single side effect to the FDA, while assuring that overworked FDA reviewers had the least chance of picking up on the really serious stuff.

So, given that there's a history of drug companies manipulating the FDA reporting system to conceal serious adverse reactions of profitable drugs, is it completely possible to trust Pfizer's innocence in this matter? And for that matter, is it realistic to imagine that with all the technical staff, legal talent, etc. that a company as big as Pfizer has at its fingertips, that no one knew what were the proper channels for reporting serious adverse effects? I'm just asking.

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