With reports rolling in about mental and physical side effects, Pfizer’s prescription anti-smoking drug Chantix is only the latest problem facing the company, and indicative of deeper problems with our country’s drug testing and approvals system.
Pfizer Inc. has problems, and far too many of them seem to involve law suits. As one wag on the Wall Street Journal’s Health Blog commented, “No wonder they appointed a lawyer as a new CEO in 2006.”
The firm’s smoking-cessation drug Chantix is undergoing major re-evaluation following a storm of reports about adverse side effects, both physical and behavioral. The latest blow came this week when the Federal Aviation Administration (FAA) banned airline pilots and air traffic controllers from using the drug due to concerns about “adverse neuropsychiatric effects which could be detrimental to public safety.” The FAA’s action is expected to spread to all public transportation operators, such as railroad engineers, subway motormen, long-distance haulers, and even taxi drivers.
More than five million people have taken Chantix in the US, according to Pfizer. But the Chantix problems started a couple of years ago with reports of behavioral, or “psychiatric”, side effects. The FDA reported last November about numerous patients using Chantix experiencing suicidal ideation and occasional suicidal behavior, erratic behavior, and drowsiness. Then in February it issued an Alert, saying “it appears increasingly likely that there is an association between Chantix and serious neuropsychiatric symptoms.”
This week we are reading about a much wider spectrum of problems. The Institute for Safe Medication Practices analyzed adverse event reports published by the FDA for research use, and has reported that Chantix-related injuries include serious accidents and falls, potentially lethal cardiac rhythm disturbances, severe skin reactions, acute myocardial infarction, seizures, diabetes, psychosis, aggression and suicide.
Last Sunday, the LA Times reported that over two dozen traffic accidents have been linked to Chantix and reported to the FDA. Warnings were previously issued by Pfizer regarding the risks of Chantix while driving, but these warnings are largely ignored by doctors and patients, the story said.
As for Pfizer’s recent problems, development of its cholesterol-lowering drug Torcetrapib was halted in 2006 when phase III studies showed “excessive mortality” in the treatment group — in real language, real people died unnecessarily. And in 2004, Pfizer acknowledged the cardiovascular risks of painkiller Bextra, and the American Heart Association received a report showing patients recovering from heart surgery using Bextra were more than twice as likely to suffer a stroke or heart attack than those taking placebos — in other words, more people died unnecessarily.
But it wasn’t until April 2005 that Pfizer finally had to withdraw the pain-killer from the U.S. market after the FDA formally cited the increased risks of heart attack and stroke, and a serious, sometimes fatal, skin reaction.
We are reminded of the highly-publicized case of musician Carter Albrecht who was shot to death by his neighbor who was reportedly on Chantix. In the wake of this story, the FDA recommended that health care professionals and patients watch for behavioral and mood changes.
The problems with Chantix and the rest of Big Pharma’s problem drugs loudly and strongly indicate what’s wrong with America’s drug testing and approvals system. While we acknowledge that almost any drug will have side effects of some kind, and that side effects can be wildly different from person to person, it is perfectly clear that too many drugs are approved by the FDA with insufficiently comprehensive clinical trials. Warnings coming way too long after deaths and injuries. As usual, it’s just too little, too late — for Carter Albrecht and everyone else.
Millions of American patients have become the real lab rats for pharmaceutical testing. But this takes added weight considering the revelations of Big Pharma’s altering and withholding known adverse reactions — deceiving not just the FDA, but also our physicians and us, the public — all for monetary gain. This raises the problem from a technically faulty testing system to a criminal activity — with malice aforethought.