When a cash-cow drug like Pfizer's smoking-cessation treatment Chantix comes under fire for alleged side effects, the pharma response always seems to be the same -- circle the wagons and deny, deny, deny.
Pfizer's problems started late last year, after a Dallas TV station reported the violent death of a local musician who may have experienced hallucinations while taking Chantix. More than 5,000 complaints poured into the FDA over the next week, many of them concerning depression, suicide, anger, aggression and hallucinations. The FDA began reviewing safety data and in February warned that Chantix might be associated with "serious neuropsychiatric symptoms."
Last month, the Federal Aviation Administration banned use of the drug by pilots and air-traffic controllers, while a watchdog group that analyzed Chantix's reported side effects found many new ones, including heart attacks, seizures and diabetes. Pfizer's response: Last week, it began running full-page ads touting Chantix's benefits, and this week intends to host roundtable discussions for the media.
Unfortunately for Pfizer, this is all too little, too late. As the WSJ Health Blog noted on Friday, Chantix prescriptions have dropped like a rock since January (I've reproduced the WSJ's chart above). Pfizer's PR blitz seems pretty unlikely to turn things around, given the public's general distrust of drug companies -- an attitude that isn't likely to change given Pfizer's seeming nonchalance about Chantix's potential problems.
All of which suggests three important points:
- Rare but serious drug-safety problems will almost never crop up in testing prior to approval, so the FDA needs to get rigorous -- and fast -- about post-market surveillance;
- "Blockbuster" drugs intended for general use will remain acutely vulnerable to safety problems (the more people taking a drug, the more likely that rare side effects will crop up);
- Big Pharma needs to address legitimate drug-safety concerns head-on instead of spinning and obfuscating. Ramping down the PR campaigns and, you know, telling the truth might go a long way toward restoring the industry's battered reputation.