Doctors Under the Influence?
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Chris Crisman
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The UMDNJ tobacco experts are not alone in their call for long-term drug treatment of smokers, nor are they the only such advocates with industry ties that aren't fully transparent. A new version of the U.S. Public Health Service guidelines for treating tobacco dependence, released on May 7, urges physicians to consider prescribing drugs, including Chantix. Prepared by a panel of 24 experts, it is capped off by a five-page list of those panelists' potential conflicts. The disclosures are less than entirely forthcoming, however. The report reveals that the panel's chairman received research funds from four drug companies, but it doesn't name them. Some panelists are listed as having minimal or no conflicts even though they have acknowledged more extensive industry ties elsewhere. "Conflicts are in the eye of the beholder," says Jean Slutsky, director of the federal Center for Outcomes & Evidence, which prepared the report. "All of us come to the table with conflicts."
UMDNJ patient Cynthia Bruning says she wishes she had known that the men who run the smoking clinic had ties to Pfizer. After two years of attempting to quit with nicotine gum and patches, she tried Chantix twice, for a month at a time, with Steinberg's counsel. She had severe stomach pain, vivid dreams, and insomnia. She dropped the drug and resumed smoking. Chantix affects the same brain pathways as nicotine, damping the euphoria people feel when they take a drag. That curbs cravings but might also disturb normal brain activity.
Bruning, desperate to quit, just started Chantix for a third time. Learning that her doctors are paid by Pfizer hasn't changed her mind. But in general she believes patients should be in the loop: "I don't agree with that policy [of nondisclosure]."
Steinberg sees no need to be more forthcoming. His passion for helping people quit is fueled by treating numerous cases of high blood pressure and other problems precipitated by smoking. He emphasizes, "We've had a lot of people being very successful with Chantix."
Foulds is more reflective about the issue. His posts about Chantix on Healthline have generated a flurry of anonymous complaints, one of which described a relative's suicide after taking the drug. Foulds continues to speak to groups of doctors on behalf of Pfizer, but lately he has been pressing the company to share more information about potential side effects. "I'd like the company to take another look at the data," he says. Dr. Douglas G. Vanderburg, a senior medical director at the company, says Pfizer is reexamining nine trials of the drug and plans to publish the results in 2009.
In January and then again in May 2008, Pfizer added warnings to Chantix's label saying patients should be watched for unusual psychiatric symptoms such as suicidal thoughts. The company says in an e-mail that it sought to give doctors "more direct guidance" on using the drug.
On May 21, the Institute for Safe Medication Practices, a nonprofit group in Horsham, Pa., released a paper based on 3,063 reports of "adverse events" submitted to the FDA by people taking Chantix. Among the findings: 227 had suicidal thoughts or behaviors, and 525 said they had acted with hostility or aggression. Pfizer has sent a Chantix team on the road to speak to financial analysts and journalists. Still, some Wall Street analysts fear that the FDA will require Pfizer to add a "black box"—one of the strictest warnings that can appear on a label—to draw more attention to side effects.
Steinberg says he might revert to prescribing more patches and gum if Chantix acquires a black box. But for now he adds: "If someone is doing well for six months, and they say, 'I think if I stop [taking Chantix] I might relapse to smoking,' I would feel comfortable continuing that medication."
Pfizer Responds
"Doctors Under the Influence?" (In Depth, July 7) relies on innuendo and distortion to support empty charges of lack of disclosure about interactions between pharmaceutical companies and physicians. Pfizer (PFE) has a strong record of support for greater transparency. We find BusinessWeek's omissions about this odd and troubling.
As you reported, Dr. Michael B. Steinberg and Dr. Jonathan Foulds, whom you featured in your story, published an opinion in the Annals of Internal Medicine advocating study of longer-term use of smoking-cessation products [such as Pfizer's Chantix] to see if such use might help relapsing nicotine addicts quit smoking for good. Such queries are vital--they advance our understanding of the safe use of medicines and provide new ideas for combating disease.
As you also reported, at the end of their article the authors "disclosed that they are paid by manufacturers of smoking-cessation products for speaking and consulting." There is no failure of transparency here, only a cynical attempt by your magazine to portray it as such.
Pfizer registers all clinical trials on a public database (ClinicalTrials.gov) and reports all U.S. political contributions. We also post information about grants and charitable contributions to medical, scientific, and patient groups.
In addition, though you failed to report it, Pfizer supports the initiative of Senator Charles Grassley (R-Iowa) to improve the transparency of relationships between pharmaceutical companies and physicians. We have urged legislators to adopt a uniform national reporting standard for this, arguing that the information should be presented in a way that is easy for patients to understand.
As they should, pharmaceutical companies consult with experts in the field when developing a drug and evaluating it for ongoing efficacy and safety. By implying that any paid relationship with an expert is inappropriate, you betray a fundamental lack of understanding of that process.
The many competing pressures--including conflicts of interest--buffeting the health-care system should be subject to in-depth examination. Instead, your magazine published a story reflecting a pronounced anti-industry, anti-physician bias. Your readers deserve better.
Ray Kerins
Vice-President
Worldwide Communications
Pfizer
New York
Join a debate about whether physicians should accept gifts from drugmakers.
With John Cady.
Weintraub is a senior writer for BusinessWeek's science and technology department.
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