Tuesday, February 24, 2015

Tomorrow's SRNT Annual Meeting: Brought to You by Pfizer

Tomorrow marks the start of the annual meeting of the Society for Research on Nicotine and Tobacco (SRNT) in Philadelphia.

According to the 2015 meeting program, a  major purpose of the conference is: "Through scientific exchange, integrate current research with implications for clinical practice." Specifically, a major focus of the conference is discussing recommendations for the treatment of smoking addiction, including the use of drugs such as Chantix and newer alternatives such as electronic cigarettes.

In fact, there will be at least 12 presentations on the use of Chantix for smoking cessation. In addition, there will be one talk on the potential suicide risk that has been observed in post-marketing studies of Chantix users. However, that talk is based on a published paper which concludes that "there is consistent evidence that varenicline either does not cause increased suicide outcomes, or if it does, the effect is very small." That paper makes recommendations for the labeling of the drug.

In addition, there will be nearly 20 presentations on electronic cigarettes.

The Rest of the Story

This would be an awesome conference if it represented an objective, unbiased, and non-conflicted view of the scientific evidence regarding the benefits and risks of Chantix as well as the evidence regarding the relative safety and effectiveness of its chief competitor: electronic cigarettes.

So there's just one problem:

The conference is sponsored by ...

... you guessed it

Pfizer - the manufacturer of Chantix, the very drug whose clinical use will be discussed at the conference.

While there is nothing wrong with conducting clinical trials or other research studies funded by pharmaceutical companies, there is something wrong with having such companies sponsor scientific meetings at which clinical recommendations for the use of their very drugs are going to be discussed in what is supposed to be an objective manner.

By accepting the Pfizer sponsorship, SRNT is sacrificing the scientific integrity of the conference.

There is no way that the conference can objectively consider the role of Chantix (or electronic cigarettes, a Chantix competitor) as part of a broad, national strategy for smoking cessation when the conference is being funded by the very manufacturer of one of these products.

Can you imagine if this conference were being sponsored by independent (not related to Big Tobacco) electronic cigarette companies? There would be an outrage in the anti-smoking community. People would immediately question the objectivity of the conference, especially as it pertains to the discussion of the role of e-cigarettes in national smoking cessation strategy and in clinical recommendations.

In fact, I would agree that if the conference were sponsored by electronic cigarette companies, that would preclude the possibility of truly objective consideration of the appropriate role of electronic cigarettes in a national smoking cessation strategy as well as an objective consideration of clinical recommendations for the use of electronic cigarettes.

The bias introduced by the Big Pharma sponsorship of the conference is readily apparent. While there are multiple talks about the role of Chantix in smoking cessation, noticeably absent from the conference program are the following talks:
  1. Suicidal ideation and completed suicide as adverse side effects of Chantix: should varenicline be taken off the market or its warning label be strengthened?;
  2. Case reports of varenicline-related deaths among patients with no prior history of depression;
  3. Population-based data show that smoking cessation drugs are not effective;
  4. Population-based data show that cold turkey quitting remains the most effective strategy;
  5. Problems of blinding in clinical trials of smoking cessation drugs; and
  6. Weaknesses of the transtheoretical model in explaining the process of smoking cessation: the need for anti-smoking media campaigns rather than smoking cessation drugs as the mainstay for a national smoking cessation strategy.
In fact, the one talk that addresses the suicide risk associated with Chantix (and concludes that there may not be any risk) is being presented by a researcher who has received research funding and consulting fees from Pfizer!

Specifically, Dr. John Hughes - who will apparently tell the audience that there is no major suicide risk associated with Chantix - has conflicts of interest by virtue of his having consultancies, honoraria, and research grants/contracts with many pharmaceutical companies, including Pfizer.

It is completely inappropriate to have this conflicted scientist be the one to opine on the potentially fatal observed side effects of Chantix.

In a 2008 article published in the journal Drug and Alcohol Dependence (Volume 98, Issue 3, 1 December 2008, Pages 169-178), Dr. Hughes disclosed that: "In the last 3 years he has received research grants from the National Institute on Health and Pfizer Pharmaceuticals and Sanofi-Synthelabo Pharmaceuticals both of whom are developing smoking cessation treatments. In the last three years, he has accepted honoraria or consulting fees from the following profit or non-profit institutions regarding nicotine or other drug abuse topics: Academy for Educational Development, Acrux DDS; American College of Chest Physicians, Adelphi Consulting, Aradigm; Atrium, Baltimore Research, Campus Consulting, Cambridge Press, Cline, Davis and Mann; Concepts in HealthCare, Constella Group; Consultants in Behavior Change; Cowen Inc, Cygnus, Edelman, Fagerstrom Consulting; Free and Clear; Healthwise, Health Learning Systems, International Marketing Systems, Insyght; Johns Hopkins University; Maine Medical Center, McNeil, Medicus, Nabi, National Institutes on Health; NCI Consulting, Pfizer Pharmaceuticals; Pinney Associates; Research Triangle Institute, Shire Health London; Temple University of Health Sciences; University of Arkansas, University of Auckland; University of Cantabria; University of Greifswald; University of Kentucky, University of Memphis, Warner Pharmaceuticals, Wolters Press, Xenova, and ZS Associates."

Thus, Dr. Hughes is essentially a walking conflict of interest with Big Pharma.

More recently, in a 2015 paper, Dr. Hughes discloses as follows: "Dr Hughes reports receiving personal fees from Alere/Free and Clear, Cicatelli, DLA Piper, Dorrffermeyer, Embera, Equinox, GlaxoSmithKline, Healthwise, Nicoventures, Pfizer, Pro Ed, Publicis, Selecta, and nonfinancial support from Swedish Match." Moreover, that paper presents the results of a clinical trial that was funded by Pfizer.

The rest of the story is that although its main purpose is presumably to foster objective scientific consideration of the issues regarding nicotine and tobacco control, SRNT is apparently heavily funded by the pharmaceutical industry. This funding, in my view, creates a substantial conflict of interest that precludes the objective consideration of many important scientific issues; in particular, the role of smoking cessation drugs as part of national or international tobacco control strategies.

This is in no way to fault the individual scientists who will present on these issues at the conference. Nor is it to suggest that any wrongdoing is occurring. It is merely to point out that the pharmaceutical sponsorship creates, by its very existence, an unavoidable bias that precludes a truly objective consideration of any scientific issue that may have significant implications for the profitability of smoking cessation drugs, and therefore, for their manufacturers who are conference sponsors.

It is also important to point out that bias does not necessarily have to be conscious. In fact, the most concerning bias is that which could arise subconsciously by virtue of the sponsorship of the conference by Big Pharma.

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