Doctors Under the Influence?

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Before Chantix's launch in August 2006, Steinberg and Foulds say they didn't work closely with the drug industry. They say they collected modest fees for occasional consulting for companies such as Novartis (NVS) and GlaxoSmithKline (GSK), makers of over-the-counter nicotine patches, gum, and lozenges.

Foulds is something of a celebrity in antismoking circles. Before moving to UMDNJ in 2000, he worked with the World Health Organization and launched an extensive telephone hotline for smokers seeking to quit. He has written several journal articles on drug treatment for smokers and blogs for Healthline, a consumer Web site. In 2006, Pfizer recruited Foulds to serve on its paid national advisory board for Chantix. The company also selected Foulds and Steinberg to be "key opinion leaders," sending them to talk to doctors about Chantix over fancy dinners and paying them each $900 per presentation. Foulds and Steinberg say that between them they have made a total of about a dozen appearances.

Pfizer's aggressive promotion of Chantix helped turn the drug into a sensation. The company has directed patients to a Chantix Web site via a ubiquitous TV ad campaign called "My Time to Quit." By the end of 2007, its first full year of sales, Chantix had nearly doubled the size of the U.S. market for smoking-cessation products, to $1.3 billion. Meanwhile, Pfizer gave grants to physicians who wanted to study the drug in settings beyond those examined during the approval process. Such studies could expand the medicine's potential market. Steinberg received a $30,000 grant from Pfizer in April 2007 to study the effect of Chantix on patients forced to forgo cigarettes while hospitalized for other illnesses. He says this was his first research grant from a drug company. (The Robert Wood Johnson Foundation separately provided $300,000 for the hospital study.)

FRAMING A TREATMENT

As Chantix's popularity grew, Steinberg and Foulds encountered an obstacle that helped inspire their article advocating long-term drug use. They found many insurance companies wouldn't reimburse for Chantix, which costs about $100 a month, or for other less expensive antismoking products.

Steinberg and Foulds reasoned that if they compared nicotine use with diabetes, rather than with alcoholism or other addictions, they might help change insurers' thinking. Diabetes causes many of the long-term problems that nicotine addiction does. "We wanted to compare it to a disease that's well-covered," says Foulds, "and alcoholism isn't well-covered."

Over the past decade, financial ties between doctors and companies have proliferated, prompting concern that treatment is distorted by industry money. The solution that has been widely embraced is disclosure of funding sources. But the rules are inconsistent and mostly voluntary. Moreover, disclosures typically are made in medical journals, conferences, and other venues that patients tend not to see.

On the Web site for UMDNJ's smoking clinic, it's not easy for a layman to find disclosures. There is no clearly labeled list of companies that pay Foulds and Steinberg that is directly accessible from the home page. There are links to journal articles, some of which reveal industry ties. But getting the information takes effort. The online version of the Annals article requires a viewer to have a paid subscription for full access. Their twice-a-year newsletter, The Nicotine Challenger, doesn't disclose their work for Pfizer, even in articles that speak highly of Chantix. In last winter's issue, Steinberg wrote an article called "Chantix: Miracle Pill or Dangerous Problem?" At the time, the FDA was fielding reports of severe depression in some patients who had tried the drug. Steinberg suggested that nicotine withdrawal itself can cause depression and that it made sense to "continue to use this effective medication in our general population of smokers." Foulds includes a broadly worded disclosure on his blog, but doesn't name companies for which he consults. Telling patients more about industry ties "would just puzzle them," Foulds says.