Tuesday, October 12, 2010

Chair of NIH Smoking Cessation Panel May Have Made Incomplete Conflict of Interest Disclosures

According to his own sworn testimony, the chair of the expert panel which in 2008 released national recommendations for the use of smoking cessation medications by physicians received (at the time) up to $50,000 in annual resources from GlaxoSmithKline to support his educational, research, and policy activities.

In addition, according to his own 2008 JAMA article: "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."

The Rest of the Story

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.

But perhaps even worse, Dr. Fiore 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 asked for disclosure of all conflicts of interest in the past five years. 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.

Although the form does note that Dr. Fiore was named to an endowed Chair position made possible by an unrestricted gift from GlaxoWellcome, the disclosure fails to mention that receives up to $50,000 in annual resources from GlaxoSmithKline to support his educational, research, and policy activities.

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."

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 initial disclosure form.

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.

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.

A second apparent failed disclosure of Dr. Fiore's financial conflicts of interest is an article in a 2008 issue of the American Journal of Public Health. Dr. Fiore and co-authors examine the effect of smoking cessation media campaigns among socioeconomically advantaged and disadvantaged populations (see: Niederdeppe J., Fiore MC, Baker TB, Smith SS. Smoking-cessation media campaigns and their effectiveness among socioeconomically advantaged and disadvantaged populations. Am J Public Health 2008; 98:916-924).

In the paper, the authors make a push for increased access to pharmaceutical treatment for smoking cessation. They point out that access to these pharmaceuticals is a major barrier for less-educated populations: "Less-educated populations face more barriers in turning a quit attempt into smoking abstinence, including fewer smoking restrictions at work, greater nicotine dependence, and less access to evidence-based treatments. Future campaigns should keep these barriers in mind when developing campaigns to promote quitting among lower-SES populations."

The paper's push for greater access to pharmaceuticals does not come from authors who are objective. In fact, Dr. Fiore has a history of very close financial connections to a number of pharmaceutical companies which manufacture smoking cessation products and thus stand to gain financially if his advice is heeded. However, these financial relationships are not disclosed anywhere in the paper.

The paper does acknowledge financial support from the Robert Wood Johnson Foundation and from the National Institutes of Health. However, it does not disclose the financial conflicts of interest of Dr. Fiore. It appears that there is really no way for article readers to know that Dr. Fiore has had severe conflicts of interest which could lead them to question his objectivity in making a recommendation for the greater use of pharmaceuticals. I find this to be quite unfortunate.

Whether Dr. Fiore has important conflicts of interest that ought to be disclosed does not seem to be at issue here. Because in an article published on almost the exact same day as the AJPH article, Dr. Fiore discloses in a 2008 JAMA article that he does indeed have important conflicts of interest. That article states: "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. In 1998, the UW appointed him to a named chair, made possible by an unrestricted gift to the UW from GlaxoWellcome."

Does it not seem important for readers of his AJPH article to also know that Dr. Fiore has lectured and consulted for companies which manufacture smoking cessation products and that his chair position was endowed by one such pharmaceutical company?

In my opinion, this is unfortunate. I believe it represents a failed disclosure of an important conflict of interest. I suppose it is possible that Dr. Fiore did disclose the conflict but AJPH chose not to publish it. However, it seems to me that an author can insist that the journal include such a disclosure statement in the Acknowledgments section of the article.

To be clear, I am not suggesting that there was anything more than a mistake - a failed disclosure - made in these two situations. I'm not arguing that there was wrongdoing or violation of any policy or rule. However, the fact that the readers of the AJPH article are not immediately aware of the conflict of interest is problematic. As is the fact that the initial disclosure for the expert panel appears to be incomplete.

While I do not necessarily think there is anything wrong with accepting money from pharmaceutical companies to examine the use and effectiveness of their products, I do think it is wrong when such conflicts of interest are not disclosed to the public. And I think these conflicts need to be disclosed in all relevant publications, not just some of them.

Because of the importance of this issue, I would certainly hope that Dr. Fiore would correct these two failed or incomplete conflict of interest disclosures. Everyone makes mistakes (I have made my share) and mistakes may be particularly common with conflict of interest disclosures. However, the most important thing is that once a mistake is identified, the individual promptly corrects that mistake. I do not hold these apparent mistakes against Dr. Fiore. I do, however, think that they must be corrected. And I think that such complete transparency and honesty is necessary not because of any individual wrongdoing, but because the integrity of our national policy regarding smoking cessation depends on it.

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