Tuesday, May 27, 2008

With $50,000 in Annual Resources from GlaxoSmithKline, Chair of Expert Panel on Smoking Cessation Should Have Recused Himself, or Been Removed

Panel Chair Apparently Fails to Disclose Financial Conflicts of Interest on Primary Financial Disclosure Form

According to his own sworn testimony, the chair of the expert panel which recently released national recommendations for the use of smoking cessation medications by physicians receives up to $50,000 in annual resources from GlaxoSmithKline to support his educational, research, and policy activities.

Despite this huge financial conflict of interest with Big Pharma, the panel chair - Dr. Michael Fiore - failed to recuse himself from the panel and the panel organizers failed to remove him from the panel.

According to his testimony in the Department of Justice tobacco lawsuit: "GlaxoSmithKline gave a grant to the University of Wisconsin that established a chair for the treatment of tobacco dependence. That donation by GlaxoSmithKline was to the University. Named chairs at the University of Wisconsin provide the person who sits in that chair to access to the revenue generated from the investment on the initial grant. So in this instance, I have access to up to $50,000 per year to support my University approved and sanctioned educational, research, and policy activities."

Dr. Fiore also apparently failed to disclose all of his financial conflicts of interest in his initial financial disclosure required for his participation on the panel. The disclosure form asks for "complete" disclosure of all conflicts over the past 5 years. On the form, Dr. Fiore denied any current honoraria or consulting arrangements with pharmaceutical companies, but apparently failed to disclose the fact (based on his own testimony) that: "I have done some consulting work for pharmaceutical companies over the years. Over the past five years, my outside consulting work on an annual basis has ranged between about $10,000 and $30,000 or $40,000 per year."

The financial disclosure form for the Clinical Practice Guideline was signed in 2006, meaning that Dr. Fiore should have disclosed any and all consulting work with pharmaceutical companies dating back to 2001. Dr. Fiore's testimony in the DOJ lawsuit was in 2005, meaning that he admitted doing pharmaceutical consulting work during the period 2001-2005 ranging between $10,000 and $40,000 per year. I do not find this consulting work disclosed on the primary financial disclosure form signed by Dr. Fiore on September 5, 2006.

The Rest of the Story

There are two important aspects to this story:

1. The Failure of AHRQ to disqualify Dr. Fiore from the Panel or for Dr. Fiore to Recuse Himself

Given the magnitude of the financial conflict of interest with a pharmaceutical company, and the fact that this company is the manufacturer of a number of smoking cessation drugs whose use, on a national basis, was to be considered by the panel, I find it inexcusable that Dr. Fiore failed to recuse himself from the panel and that the Agency for Healthcare Research and Quality (AHRQ) which convened the panel failed to remove him from the panel, or at very least, from its chairmanship.

The type of conflict of interest reported by Dr. Fiore is the largest possible conflict of which I am aware: an endowed professorship. This is the highest possible level of corporate support for a professor of which I am aware, and it undoubtedly makes the professor indebted to the company. The company is essentially providing direct support for the professor's career and for his academic endeavors. This creates a far greater conflict than merely providing a research grant, consultant fees, honoraria, or fees for speaking engagements or product reviews.

I would be overjoyed to obtain an endowed professorship and if a company gave me $50,000 a year to spend on my research and other academic endeavors, I most certainly would be deeply indebted to that company. It represents the highest level of financial security for a professor.

So I can't conclude anything other than that it is inexcusable both for Dr. Fiore to participate on the panel and for the Agency not to disqualify Dr. Fiore from participating.

It's not like the potential conflict is a small one. It was well known that the panel would be reviewing data and making recommendations for the national use of smoking cessation drugs manufactured by the company in question. This is a greater conflict than in most research situations, where a particular finding could have some small incremental effect on the use of a drug. Here, the express purpose of the panel was to develop recommendations that would serve as a guideline for how physicians throughout the country should or should not prescribe these medications. A decision by the panel to either recommend pharmaceuticals for all patients or to recommend a cold turkey approach would have profound financial implications for the pharmaceutical companies, and for GlaxoSmithKline in particular.

2. The Failure of the Panel Chair to Disclose Recent Conflicts of Interest on the Primary Disclosure Form
I do not understand why it appears that Dr. Fiore failed to disclose his consultant work for pharmaceutical companies on the primary disclosure form. In his testimony, he acknowledges receiving between $10,000 and $40,000 annually from pharmaceutical companies for consulting work during the period 2001-2005. However, I would interpret his primary financial disclosure form to indicate that he has not done any consultant work for the pharmaceutical companies for the past 5 years (that is, from 2002-2006). This appears to be inconsistent with the testimony, and therefore it appears to be inaccurate.

The disclosure form states: "In keeping with recent JAMA recommendations, Dr. Fiore does not accept honorarium nor do consulting work for the pharmaceutical industry."

Since the form requires disclosure of all financial interests during the past 5 years, the interpretation of this disclosure statement is that Dr. Fiore does not currently do consulting work for the pharmaceutical industry, and has not done such consulting work for the past 5 years.

Based on Dr. Fiore's testimony, this appears not to be true. Thus, this appears to be a dishonest, or at very least, a severely flawed and incomplete disclosure.

The fact that Dr. Fiore later disclosed 2005 consultant payments from one pharmaceutical company does not compensate for the failure to disclose similar conflicts during the years 2002-2006, which were specifically asked about in the primary disclosure form.

There is additional evidence that Dr. Fiore failed to disclose consultant payments from pharmaceutical companies for the five-year period prior to September 5, 2006, when he signed the primary disclosure form.

First, in a 2002 article in Chest, it discloses that: "Dr. Fiore has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by Ciba-Geigy, SmithKline Beecham, Lederle Laboratories, McNeil Consumer Products, Elan Pharmaceutical, Pharmacia, and Glaxo Wellcome."

Second, in a 2008 JAMA article, it discloses that: "In the past 5 years, Dr Fiore reports that he has lectured and consulted for Pfizer and has served as an investigator on research studies at the University of Wisconsin (UW) that were supported by GlaxoSmithKline, Nabi, Pfizer, and sanofi-aventis."

Thus, in the five-year period asked about in the primary disclosure form for the panel, it appears that Dr. Fiore should, at very least, have reported his lectures and consultation for Pfizer. In addition, it appears that he also should have reported his serving as an investigator on research grants funded by four pharmaceutical companies.

In addition, a Wall Street Journal article of February 8, 2007 reports that: "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." This article corroborates the information from other sources that Dr. Fiore had pharmaceutical-related consultancy income for the years 2002-2004 that should have been reported on the Clinical Practice Guideline disclosure form.

Perhaps the most striking aspect of this story is not the failed disclosure nor the failure to recuse himself from the panel, but instead is Dr. Fiore's apparent unawareness of (or unwillingness to admit) the fact that there is a conflict of interest. Apparently, Dr. Fiore denied to Helliker (author of the Wall Street Journal article) that there is 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."

As evidence mounts that the smoking cessation drug Chantix is associated with severe and fatal side effects, the unacceptable consequences of a conflicted expert panel making national recommendations become apparent. If these reports are true and the accidents and deaths being reported are true side effects of Chantix, then the panel's recommendations may not only be an example of highly biased science, but they might also result in the loss of lives.

Just Friday, the Los Angeles Times reported on a link between Chantix use and traffic accidents, a link which the FDA is currently investigating. And on Thursday, the Federal Motor Carrier Safety Administration banned the use of Chantix by anyone seeking a commercial motor vehicle license.

While there is room for debate about issues such as whether Chantix should still be prescribed for smoking cessation and about whether a pharmaceutical-based or a cold turkey-based approach would be more effective for smoking cessation on a population level, what I don't think there is room for debate about is whether decisions about these issues should be made for the nation by experts who have severe financial conflicts of interests with Big Pharma.

Finally, I think it is important to point out that while pharmaceutical funding of research is a necessity, having conflicted members of an expert panel is not. While the former is acceptable so long as the conflict is disclosed and the company has no control over the research, the latter is simply not acceptable.

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