Thursday, February 08, 2007

Wall Street Journal Article Highlights Financial Conflicts of Interest of Chair of Federal Smoking Cessation Guidelines Panel

Two weeks after I revealed the extensive pharmaceutical company financial conflicts of interest among the chair and other scientists on panels that promulgated federal recommendations on treatment for smoking cessation and national smoking cessation policy (post 1; post 2), the Wall Street Journal today features an article that exposes and discusses these conflicts.

In an article entitled "Nicotine Fix: Behind Antismoking Policy, Influence of Drug Industry; Government Guidelines Don't Push Cold Turkey; Advisers' Company Ties," Kevin Helliker reveals the extensive pharmaceutical company financial conflicts of interest of Dr. Michael Fiore, chair of the national panel that developed guidelines for smoking cessation treatment as well as the panel that produced a national smoking cessation action plan that played a key role in the government's proposed remedies in the DOJ tobacco case.

According to the article, Dr. Fiore "holds a chair at Wisconsin that is funded by GlaxoSmithKline. He directs a tobacco research center that received nearly $1 million in funding from makers of quit-smoking medicine in 2004 and $400,000 in 2005. Between 1999 and 2004, Dr. Fiore personally pocketed $10,000 to $40,000 a year from the quitting-aid industry for honorariums and consulting work. He says he stopped such work in 2005."

Apparently, Dr. Fiore denied to Helliker that he has a conflict of interest. Helliker wrote: "Michael Fiore is in charge of revising federal guidelines on how to get smokers to quit. He also runs an academic research center funded in part by drug companies that make quit-smoking aids, and he personally has received tens of thousands of dollars in speaking and consulting fees from those companies. Conflict of interest? No, says Dr. Fiore, who has consistently declared that doctors ought to use stop-smoking medicine. He says his opinion -- reflected in current federal guidelines -- is based on scientific evidence from hundreds of studies."

The article reveals that the panels chaired by Fiore failed to give appropriate weight to the use of the cold turkey method of cessation, which population studies confirm to be the most effective, and instead, focused almost exclusively on the use of pharmaceutical aids.

A new panel is currently revising the smoking cessation guidelines, and the chair of that panel is none other than Dr. Fiore (plus, 7 of the panel's members have pharmaceutical company financial conflicts of interest). Despite the conflicts of interest, Fiore apparently denied that the pharmaceutical ties of himself and a number of other panel members represent a source of bias: "Dr. Fiore says his panel will give a fair hearing to all points of view on smoking cessation. He says the process is sufficiently collaborative to prevent bias, his or anyone else's, from creeping into the final product. He notes that many of the studies questioning the effectiveness of stop-smoking medication arose after the publication of the 2000 guidelines. The panel will scrutinize them closely before reaching any conclusions, he says."

Not so, said David Blumenthal, director of the Institute for Health Policy at Massachusetts General Hospital, who criticized the choice of Fiore as panel chair: "'The chairman of the committee should be unquestionably impartial,' says Dr. Blumenthal, who has published extensively on conflicts of interest."

The article also revealed that in at least two cases, Dr. Fiore's conflicts of interest were not disclosed in journal articles he wrote about smoking cessation methods and that Fiore admitted that the lack of disclosure may have been his fault: "In at least two medical-journal articles that Dr. Fiore wrote or co-wrote promoting the use of stop-smoking medicine, no mention was made of his financial ties to the makers of those treatments. Dr. Fiore says the editors of those journals may have ignored his disclosure or he may have failed to provide it."

The article also reveals an undisclosed conflict of interest of another smoking cessation researcher - Dr. Jack Henningfield - who, according to the article, "is a principal of Pinney Associates, a consulting firm whose largest client is GlaxoSmithKline, operator of the site. Other articles citing Dr. Henningfield's views on smoking have identified him as a professor at Johns Hopkins School of Medicine without mentioning the GlaxoSmithKline connection. ... Dr. Henningfield says he always tells journalists about his financial ties to industry. But in an interview with The Wall Street Journal last summer, Dr. Henningfield promoted the use of stop-smoking medicine without volunteering any information about those ties."

The article cites a number of independent (non-pharmaceutical company funded) scientific experts who believe that the near-exclusive focus on pharmaceutical methods for smoking cessation is undermining smoking cessation efforts by discouraging potential quitters who don't want to treat nicotine addiction with more nicotine.

The Rest of the Story

There is nothing ethically wrong with having a conflict of interest. Many researchers do. However, there is something wrong with failing to acknowledge or disclose that conflict of interest. I don't know exactly what Dr. Fiore told the reporter, but it is quite clear that the reporter got the impression that Fiore does not see any conflict of interest in his participation on the national smoking cessation guideline panel and does not see any potential for this conflict to create bias in the panel's deliberations.

That, and not the conflict itself, is what the rest of the story is all about. That, and not the conflict, is what represents a deterioration of the scientific integrity in a major segment of the tobacco control movement.

How can someone possibly deny that having a pharmaceutical company endowed chair and receiving $1.4 million from manufacturers of smoking cessation drugs in 2004 and 2005 represents a conflict of interest in chairing a national panel that is supposed to make unbiased recommendations about the appropriate course of treatment to recommend for smokers who wish to quit throughout the nation?

How can someone who has a million dollar plus conflict of interest deny that this conflict represents a source of bias when it comes to making those recommendations?

How could someone with a million dollar plus conflict of interest fail to make sure that the conflict was disclosed in two prominent journal articles?

Let me make one thing clear. There is no question that a conflict of interest exists.

The question is not whether a conflict exists, it is whether that conflict should disqualify a person from participating on, or chairing a panel that is supposed to make recommendations for the nation regarding a smoking cessation treatment strategy.

Given the fact that Dr. Fiore is defending the conflict, apparently denying that there is a conflict to the reporter, and denying that it will introduce bias, I don't think there is any doubt that the conflict is one that cannot and should not be tolerated. I agree with Dr. Blumenthal that the chair of the panel should be unquestionably impartial.

It's not like we don't have enough problems with scientific integrity without this scandal. Regular readers of this blog know that there are serious problems of scientific accuracy, integrity, and ethical conduct going on regarding the communication of information to the public. It's not like we need this on top of all that.

I stand by my earlier warning that we do face a crisis of scientific integrity in the tobacco control movement. Perhaps tobacco control practitioners can ignore these premonitions when they only appear in a blog. But when you start reading about these scientific scandals in the Wall Street Journal, then I think it's time to take notice.

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