Last week, Pfizer held its promised "media roundtable" to address a rising chorus of concern about its anti-smoking drug Chantix. Reports from Pharmalot and the WSJ Health Blog suggest that Pfizer and its spokespeople offered exactly the kind of circle-the-wagons defense I'd predicted. From the WSJ blog, Pfizer's main talking points included:
- Smoking is a serious health problem that kills people.
- Most of the adverse events that have been reported recently are already in the Chantix label.
- Smokers who are trying to quit can be depressed and irritable.
- Paying close attention to adverse-event reports helps the FDA and Pfizer enhance drug safety.
First, even if alleged Chantix side effects such as suicidal or violent inclinations, psychosis, hallucinations and paranoia are mentioned in the drug's official warnings, the sheer number of recent reports over the space of 19 months -- while small compared to the number of people taking the drug -- is still large enough to warrant concern. Second, of course, is the fact that many reported adverse events aren't included in the drug's label, such as accidents and injuries, distorted vision, and seizures or muscle spasms.
Of course, even large numbers of self-reported side effects don't prove that Chantix is responsible for some, or even any, of them. That's what further study is for, and to its credit, Pfizer is doing just that. (Whether it would be doing so expeditiously in the absence of public outcry is another question entirely.)
Still, it's easy to see where Pfizer's interests really lie in the controversy. Look again at point three, which academic researcher David Gonzalez offered as a kind-of, sort-of explanation for some of the neuropsychiatric effects that have been reported with Chantix. Pfizer, it turns out, excluded smokers with mental problems from its original studies, and for the justifiable reason that it didn't want pre-existing issues to obscure the drug's potential benefits in healthy people.
Given that fact, however, it's wholly unreasonable for the drugmaker to insist now that Chantix remains safe for people with mental issues, as Pfizer's senior medical director Martina Flammer does. A clearer indication that Pfizer is more concerned about minimizing the threat to its moneymaker than about the possible health of its customers would be difficult to imagine.