Adverse Events, 2008-Style
On Sept. 19, ABC News did a segment on the freak death of Carter Albrecht, a Dallas musician with the band Edie Brickell and
New Bohemians. After a night of drinking, Albrecht went on a tear, smacking his girlfriend around, then banging on a neighbor's
door. Suspecting an intruder, the man fired a warning shot, killing Albrecht. According to his girlfriend, Albrecht had just
started taking Chantix when his nervous system went wrong: nightmares, hallucinations, violent behavior.
The media went on a tear of its own. The Dallas medical examiner ruled that Chantix was not responsible for Albrecht's behavior—the
level of alcohol in Albrecht's blood was reportedly three times the legal limit. But this did little to put the controversy
to rest, since he had inexplicably failed to use the Chantix assay Pfizer had sent him.
Pfizer did its best to get in front of the story. The data from six studies in 5,000 people showed no incidence of violent
behavior; there was no difference between the Chantix and the placebo groups in the rate of neuropsychiatric adverse events.
But other than national newspapers, the media often showed little interest in the data—or a realistic view of smoking. That
nicotine withdrawal itself causes serious psychological effects; that smoking can mask depression, anxiety, and other symptoms
that emerge only upon quitting—facts like these were glossed over. Once again, nicotine addiction was not taken seriously.
"No-Smoke Pill on Sale Despite Death Link," read one headline.
With Chantix users approaching 5 million worldwide, reports of neuropsychiatric adverse events began piling up at FDA. In
October, a Sky TV editor killed himself a month after starting on the drug, sparking a similar news cycle in Britain. In November,
FDA warned doctors to closely monitor Chantix patients. "We're beginning to look at this as an emerging safety issue," said
FDA spokesperson Rita Chappelle.
Needless to say, the blogosphere has been ablaze with information, misinformation, and disinformation about Chantix from bloggers
and forum posters. The anti-pharma agendas were out in full force, only too eager to hail "another Vioxx" and spin conspiracy
theories about data cover-ups.
But for now, Pfizer has dodged the bullet. In January, the firm updated the label with a warning about neuropsychiatric symptoms.
And in a press release, the company had to leave the door to this controversy slightly open. "In some reports, however, an
association [between the adverse events and the drug] could not be excluded," it said. A few days later, Pfizer released its
fourth-quarter financials. Surprising analysts predicting a drop in prescriptions, Chantix sales remained on track, surging
to $280 million—just under $900 million for its first full year on the market.
For the Chantix team—whose branding strategy focused on changing patient behavior—to be hit with an unexpected controversy
about uncontrollable patient behavior may be a bitter irony. Still, their confidence in their product remains unshaken. "People
need to understand the difference between adverse events—which may have nothing to do with the drug—and side effects," said
Martina Flammer. "We're not seeing a higher rate of side effects in the postmarketing reports than in the clinical trials."
Looking ahead, she dismisses any talk of black-box warnings.
And while it is unwise to underestimate the public's capacity for irrationality about drug safety, Pfizer may know something
the bloggers don't. "Every day we get e-mails, calls, and letters from patients who have stopped smoking after taking Chantix—when
nothing else had ever worked," said Veronique Cardon. "That is a great achievement."
Finding a way to brand that message may be the Chantix team's next assignment.