Friday, May 23, 2008

Smoking Cessation Drug Banned by FAA for Pilots and Air Traffic Controllers; Same Drug Promoted by Big Pharma-Supported Expert Panel

The Federal Aviation Administration (FAA) announced yesterday that it was banning the use of the smoking cessation drug Chantix by pilots and air traffic controllers because of hundreds of reports of serious side effects of the medication - effects which could endanger the lives of flight crews and passengers.

According to a CBS News article: "Pfizer Inc.'s once promising anti-smoking drug Chantix received another blow Wednesday after a nonprofit group's report about serious physical side effects prompted the Federal Aviation Administration to ban the drug's use by pilots and air traffic controllers. The report, from the Institute for Safe Medication Practices, points out hundreds of serious problems reported since the popular drug was approved in May 2006, including dizziness, loss of consciousness, seizures, and abnormal spasms and movements. 'We have immediate safety concerns about the use of varenicline (Chantix) among persons operating aircraft, trains, buses and other vehicles, or in other settings where a lapse in alertness or motor control could lead to massive, serious injury,' the researchers said in the report. ... The Institute for Safe Medication Practices' report and Wednesday's move by the FAA come months after the FDA said the connection between Chantix and serious psychiatric problems is 'increasingly likely.' Pfizer had already added stronger warnings to the drug's label before that opinion was released in February."

A Los Angeles Times article added: "'These data provide a strong signal that the risks of [Chantix] treatment have been underestimated, and show that a wide spectrum of serious injuries are being reported in large numbers,' the report said. Prescription drugs are usually tested on a few thousand people before approval, but serious problems may not emerge until many more patients have used the medication for a sustained period. Responding to the study, FDA spokeswoman Susan Cruzan said: 'We agree that these findings are a signal that requires further investigation and confirmation, and the FDA has been conducting a review of the adverse events associated with Chantix.'"

Of note, the expert panel which recently released a clinical practice guideline for physicians treating patients who smoke recommended the use of smoking cessation drugs for every smoking patient and specifically promoted the use of Chantix.

Interestingly, nine members of the panel had financial conflicts of interest because of their having received funding from pharmaceutical companies, most of which are the manufacturers of various smoking cessation drugs.

The chair of the panel had a conflict of interest specifically with Pfizer, manufacturer of Chantix. It also appears that several members of the panel had received money for consultation on a new smoking cessation drug, which very well might have been Chantix.

The Rest of the Story

This is why financial conflicts of interest simply should not be tolerated in expert panels like the one on smoking cessation, especially when they are formulating national practice guidelines.

It is inexcusable to me that a individuals with financial conflicts of interest with Big Pharma would be allowed to serve on a panel like this, much less to serve as the chair of the panel.

In light of the report warning against the use of Chantix, the ban on Chantix by the FAA, the agreement of the FDA with the main contention of the report, and the ongoing investigation by the FDA of the potential for severe side effects of the drug, it is inappropriate for the scientific panel to have promoted its use by physicians throughout the country.

But what makes that recommendation truly problematic is that it has the appearance of being a biased recommendation because of the existence of these conflicts of interest.

It is one thing for a conflict of interest to result in bias which simply results in a flawed scientific finding. It is quite another for a conflict of interest to result in a recommendation which might very well actually kill people.

While I think there is room for debate about the costs versus benefits of recommending the use of Chantix give the existing data, I do not think there is room for debate about the appropriateness of allowing a conflicted panel with a conflicted chair to conduct such an analysis and to ask the nation to rely on that panel to formulate guidelines for clinical practice.

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