In April, four experts on smoking cessation published a paper espousing an unconventional plan for helping hard-core nicotine addicts quit. They proposed treating smokers as if they have a chronic disease akin to diabetes. Such patients should take prescription drugs for years to curb tobacco cravings, the researchers advised.
The article, published in the prestigious Annals of Internal Medicine, might have slipped quietly into the vast body of anti-smoking literature were it not for its two closing paragraphs. There, authors Dr. Michael B. Steinberg and Dr. Jonathan Foulds disclosed that they are paid by manufacturers of smoking-cessation products for speaking and consulting.
Among those companies is Pfizer, whose controversial drug Chantix the researchers mentioned favorably, along with other treatments. Use of Chantix has led to reports of suicidal thoughts and other psychiatric symptoms.
To some, the Annals paper smelled suspiciously like disease-mongering to boost pharmaceutical sales.
"There's an advantage to the drug companies selling their products to smokers for a lifetime rather than for six weeks," says Adriane J. Fugh-Berman, a Georgetown University scholar who co-wrote a scathing online attack on the paper for The Hastings Center, a health-ethics research group in Garrison, N.Y. "Medicine can be a useful adjunct to quitting (cigarettes), but the goal should be quitting," she says.The Annals paper appeared around the same time that Pfizer, at the urging of the U.S. Food and Drug Administration, was strengthening warnings on Chantix's label. This timing has fueled concern that company-paid experts are trying to protect a drug with U.S. sales of more than $680 million in 2007.
The researchers deny that. They say they follow only their independent judgment when recommending Chantix and other drugs. They emphasize that they don't necessarily urge lifetime use of any medicine. But they don't routinely reveal their Pfizer pay to hundreds of patients they've steered to Chantix.
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Nicotrol nasal spray and inhaler
That has thrust Steinberg and Foulds into the middle of a raging debate about proselytizing by medical researchers and how corporate relationships should be disclosed to patients. "When (Chantix) goes wrong, it can go terribly wrong," says Dr. Daniel Seidman, director of the smoking cessation clinic at Columbia University. "These guys may think (industry money) doesn't affect their opinions about the drug, but it does. When someone pays you, there's a bias." (Seidman receives no pay from manufacturers.)Pfizer hasn't taken a formal position on whether doctors should disclose funding sources to patients. Cathryn M. Clary, vice-president for external medical affairs, says she fears too much transparency will create confusion.
"The more information that's out there, the more difficult it will be for patients to process," she says.
Pfizer instructs the researchers it pays to disclose their compensation when speaking at professional conferences. It also recently began disclosing grants for medical education on its Web site.