NEJM Commentary Written by Anti-Tobacco Researchers Hides Conflicts of Interest with Big Pharma

An article published last week in the New England Journal of Medicine discusses strategies for reducing smoking, including the use of pharmaceutical products such as nicotine replacement therapy and other drugs. The article argues that every patient who wishes to quit should be provided with smoking cessation drugs, as opposed to relying upon other approaches, such as counseling or cold turkey quitting.

Because the advice given to physicians in this column conflicts with scientific evidence and undermines the principle of physician autonomy, readers may naturally be curious whether the authors of this commentary have any history of financial conflicts of interest with pharmaceutical companies that products the products discussed in the article.

Fortunately, readers can be rest assured that there were no relevant conflicts to disclose. All three of the co-authors - Dr. Michael Fiore, Dr. Steven Schroeder, and Dr. Timothy Baker - completed disclosure forms indicating that they have nothing to disclose, which implies that there is no relevant history of financial relationships of any of these authors with pharmaceutical companies.

Specifically, in completing section 5 of the form, each of the authors proclaimed that there were: "No other relationships/conditions/circumstances that present a potential conflict of interest." This section refers to financial interests that were not disclosed earlier in the form. The disclosures earlier in the form relate to financial interests present during the past 36 months. Importantly, however, the additional disclosures in section 5 do not have any stated time frame. The directions indicate that authors must "use this section to report other relationships or activities that readers could perceive to have influenced, or that give the appearance of potentially influencing, what you wrote in the submitted work."

Since all three authors indicated in section 5 that there are no other relationships or activities that readers could perceive to have influenced their work, we can conclude that none of these authors has any significant history of financial relationships with Big Pharma.

The Rest of the Story

The rest of the story is that two of the three authors are hiding relevant financial conflicts of interest with Big Pharma that I believe should have been disclosed in the paper.

Dr. Fiore

The truth is that Dr. Fiore actually has a long history of significant financial relationships with pharmaceutical companies that manufacture smoking cessation drugs, none of which are acknowledged in his disclosure. Here is what is being hidden from readers:

1. 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."

2. According to his own sworn testimony, at the time of his chairing in 2008 of an expert NIH panel to make recommendations about the recommended clinical strategies for promoting smoking cessation, Dr. Fiore received up to $50,000 in annual resources from GlaxoSmithKline to support his educational, research, and policy activities.

3. In 2006, Dr. Fiore acknowledged 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."

4. In 1998, the University of Wisconsin appointed him to a named chair, made possible by an unrestricted gift to the University from GlaxoWellcome.

5. In the past, "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."

6. Dr. Fiore 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.

7. In a recent set of two articles on treatment for smoking cessation published in the Annals of Behavioral Medicine in April 2011 (article 1; article 2), the conflict of interest statement regarding Dr. Fiore acknowledges that: "Over the last 3 years, Michael C. Fiore served as an investigator on research studies at the University of Wisconsin that were funded by Nabi Biopharmaceuticals."

8. In a December 2010 article on treatment for smoking cessation published in the Wisconsin Medical Journal, the conflict of interest statement regarding Dr. Fiore acknowledges that: "Over the last 3 years, Dr Fiore has served as an investigator in research studies at the University of Wisconsin that were funded by Pfizer and Nabi Biopharmaceuticals."

Amazingly, none of these conflicts of interest are reported in the paper and the reader has no way of knowing this long history of financial conflicts of interest with Big Pharma. I imagine that most readers would be shocked to find out about this intense and long history of financial conflict with Big Pharma, given that Dr. Fiore reported no conflicts of interest.

Dr. Baker

The truth is that Dr. Baker also has a long and significant history of financial relationships with pharmaceutical companies that manufacture smoking cessation drugs. Here is what is being hidden from readers:

1. In 2008, Dr. Baker reported that: "he has served as a co-investigator on research studies at the University of Wisconsin that were sponsored by four pharmaceutical companies."

2. In 2000, Dr. Baker disclosed as follows: "Timothy Baker has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by Elan Pharmaceutical, SmithKline Beecham, Glaxo Wellcome, and Lederle."

3. As recently as 2012, Dr. Baker disclosed in an article that his research involved financial support from GlaxoSmithKline in the form of free medication provided to study participants.

4. In another 2012 paper, Dr. Baker also acknowledged that GlaxoSmithKline provided financial support in the form of free study medication. The same disclosure was made in another 2012 paper. And in another paper as well.

5. According to a 2011 paper: "Timothy B. Baker has served as a consultant, given lectures sponsored by, or has conducted research sponsored by GlaxoSmithKline, Nabi Biopharmaceuticals, Pfizer, and Sanofi-Synthelabo."

6. In a 2010 paper, Dr. Baker acknowledged "research grants from Pfizer, GlaxoSmithKline, Nabi Biopharmaceuticals, and Sanofi."That paper itself involved research with financial support from GlaxoSmithKline in the form of free study medication.

Again, amazingly, none of these conflicts of interest are reported in the paper and the reader has no way of knowing this long history of financial conflicts of interest with Big Pharma.

Here, not only does it appear that Dr. Baker has failed to disclose conflicts that should have been revealed in section 5 of the form, but I have to question whether he has also hidden information that should have been disclosed in section 3. The instructions to that section clearly indicate that research involving drugs provided by pharmaceutical companies is to be included in this section. Since the research was ongoing in 2012 (that is the year in which papers were continuing to be published), it appears to me that this financial conflict falls within the 36 month period about which the form inquires.

Either way, Dr. Baker's participation in research that was financiallly supported by GlaxoSmithKline should have been reported in his disclosure.

3. Dr. Schroeder

Dr. Schroeder is the only one of the three authors who does not appear to be hiding a significant financial ionflict of interest. However, it is worth noting that Dr. Schroeder's center lists Pfizer as a partner. It is not clear to me what this means. If Pfizer is a financial partner, then this should have been disclosed in the article. But even if Pfizer is just a partner in terms of working together on a project, I would still view that as a conflict of interest that should have been disclosed.

Summary

For years, we in tobacco control have attacked tobacco industry-funded scientists or researchers who consulted for tobacco companies for not disclosing their conflicts of interest. It is therefore quite unfortunate, and ironic, that tobacco control researchers do not appear to take their own conflicts of interest seriously and that they, too, are hiding these conflicts from the public.

As I previously articulated, the hiding of these conflicts of interest damages public health in four ways:

1. It violates public health ethics and could be damaging to the entire field of tobacco control;
2. It degrades the research integrity of tobacco control;
3. It makes us hypocrites when we criticize failed tobacco industry disclosures; and
4. It hides the influence of Big Pharma money on the field of tobacco control and hinders smoking cessation efforts.