Worthwhile, if technical, column today in the Wall Street Journal, “Smoking Has Side Effects, Too.” It’s a report by Dr. Joseph Feczko, Pfizer’s chief medical officer, on how the anti-smoking drug, Chantix, was tested and approved and how the pharmaceutical companies battle misinformation about adverse-event reports and patient safety.
Patients and physicians want breakthrough medicines, and pharmaceutical companies spend years – and billions of dollars – researching and testing such medicines. But this is all becoming increasingly difficult amid the public’s growing confusion about how drug development and safety monitoring actually work. Patients might rush to judgment, making medical decisions without consulting their doctors. We could also wind up with policies that reduce the availability of innovative new medicines in decades to come.
We should keep all that in mind following last month’s release of a collection of adverse-event reports by the Institute for Safe Medication Practices (ISMP), a nonprofit group in Horsham, Pa. The report focused on Chantix, a medicine developed by Pfizer to help people quit smoking. Both the report and the subsequent media coverage of it revealed a lack of understanding about how pharmaceutical companies and regulators monitor drug safety. Missing was important context about the dangers of smoking, and how adverse-event reports are used to improve patient safety.
OK, we’re going to do a little blogging experiment here. Your correspondent completely missed any news about Chantix and what we now assume were news stories about possible harmful side-effects. Here’s the question we aim to test: Have the reports elicited a wave of solicitations from trial lawyers, looking for a reason to sue?
Be right back ….
Well, there’s this from Legalview.com, a web portal sponsored by a group of trial-lawyer firms: “In addition to the extensive mesothelioma information portal, LegalView offers practice areas on other legal issues including Digitek’s digoxin recall, Singulair side effects and the Chantix risks.”
And there’s this news release from a “veteran pharmaceutical litigation attorney” — that’s a euphemism for personal injury lawyer – Kristian Rasmussen of Alabama, “Litigation Predicted in Wake of FAA Ban of Chantix Use by Pilots and Air Traffic Controllers: Smoking Cessation Drug Target of Controversy.” Gin up the controversy. And it looks like Mr. Rasmussen will be giving a talk later this month: “Chantix: Cases, Claims and Liability” Pharmaceutical Litigation Super Conference, June 23-25, 2008 Chicago, IL.”
It’s a wonder any new drugs ever come on the market.