Pfizer has launched a campaign to control negative publicity about its anti-smoking drug, Chantix. Bad news has come steadily since last November with an FDA advisory about dangerous side effects; it accelerated after a Public Health Advisory in February. And last month the Federal Aviation Administration (FAA) announced pilots should not take the drug with side effects including seizures, dizziness, anxiety, insomnia and depression, abnormal muscle spasms, tremors, visual disturbances, suicide, heart attacks, paranoia and psychosis. Quite a list.

Then came a report two weeks ago "raising immediate safety concerns" for those operating any kind of machinery while taking Chantix, issued by the Institute for Safe Medication Practices (ISMP).

Authors say their interest was peaked as a result of tracking FDA reports about adverse events. In the two years the drug had been on the market, it not only raked up sales but also climbed to the top of the list of reported side effects. In the last quarter of 2007, it ranked first in this category.

They also questioned whether clinical studies might have been biased. People were excluded if they had a history of drug or alcohol dependence, or had been treated for "depression, bipolar disorder, psychosis or panic disorder." Given the rates of smoking for people with a mental illness, it is not a surprise many who were takig the drug, and many of the complaints, came from those on psychoactive medications.

As if this were not enough to upset Pfizer about the future of its two-year old drug which has been prescribed about 6 billion times (mostly in the United States), ethical questions dog a report issued by the federal Agency for Healthcare Research and Quality (AHRQ). Nine of the 24 panelists assessing smoking cessation techniques, recommending medications, had received fees, or had other financial arrangements with pharmaceuticals whose products they were evaluating.

You guessed it. Pfizer was one of them.

Elastic ethics
Dr. Michael Siegel, Boston University School of Public Health, lambasted the AHRQ and the Department of Health and Human Services which is supposed to protect against "conflicts of interest among America's medical researchers."

Far from being an objective review and assessment of the best possible strategy to enhance smoking cessation among smokers in the United States, the guideline is a heavily biased analysis that is plagued by the presence of severe financial conflicts of interests among the panel's chair and at least 8 of its other members.

The conflict was not just hypothetical, says Siegel. The report “over-estimates the benefit of drugs in smoking cessation and overlooks population-based evidence showing that most people who quit smoking do so without pharmaceutical aids.” WhyQuit, devoted to behavior treatments for smoking cessation, raises similar questions.

Pfizer responds
Whether it’s called a “readjustment,” a “full-court press,” or panic to halt losses for the $1.1 billion product, Pfizer put together a blitz including ”dear doctor” letters to 300,000 physicians, full page ads in newspapers including the Wall Street Journal, and unbranded TV commercials celebrating the virtues of a smoke-free life. Round table discussions with key opinion makers took place at company headquarters in New York City to abate the criticism.

According to the Wall Street Journal, Pfizer's response to the criticism was

#1 Smoking is a serious health problem that kills people.
#2 Most of the adverse events that have been reported recently are already in the Chantix label.
#3 Smokers who are trying to quit can be depressed
and irritable.
#4 Paying close attention to adverse-event reports helps the FDA and Pfizer enhance drug safety.

Nice try and a classic move to blame the victim who should have read the Chantix label. As I said in my last editorial, there are times when disclosure is not enough. And I'm not sure the insert, which has been revised a couple of times to meet the FDA's grave concern, qualifies in the real world even if it's a legal shield.

Some media markets have been sucked into the public relations machine. San Antonio’s television EyeWitness News and print Express News repeated the company's claims featuring a doctor on the panel in question. It’s an example of how the consolidation of media enables enables direct-to-consumer advertising.

We've probably not seen the the marketing techniques to gain public confidence in Chantix. In addition to standard ads in which it brands itself as slow but steady oon the way to the finish line, it has been marketed directly to consumers through a web-site offering toll free telephone support for up to one year and a structured personalized web site. You don't end up on the top of the list by hiding under a shell.

MIWatch Related Entries

• Chantix again: VA experiments with vets (Jun 19, 2008)
• Chantix warnings from FDA (Nov 23, 2007)
• Smoking, dopamine and mental illness (Oct 26, 2007)