Tuesday, August 06, 2013

Mayo Clinic Researchers Who Oppose Electronic Cigarettes Fail to Disclose Pharmaceutical Conflicts of Interest in Research

Yesterday, I revealed that a Mayo Clinic advice column which discourages smokers from quitting using electronic cigarettes and which contains false statements regarding the scientific evidence regarding these products failed to disclose the conflict of interest of the column's author with Big Pharma. Specifically, the author - Dr. Jon Ebbert of the Mayo Clinic's Nicotine Dependence Center - failed to disclose that he has received research funding from Pfizer, a pharmaceutical company that markets the very product (nicotine inhaler) that is being analyzed in the column. The column also failed to disclose that the Center's director - Dr. Richard Hurt - also has a conflict of interest because he served on the Advisory Board for Pfizer.

The Mayo Clinic - through its Nicotine Dependence Center - has been an outspoken opponent of electronic cigarettes. Another Mayo Clinic column that advises smokers not to quit using e-cigarettes also fails to disclose that the author has received Big Pharma research funding.

Today, I reveal that the problem is even worse than I thought because Dr. Hurt and Dr. Ebbert are apparently failing to disclose these relevant Big Pharma conflicts of interest in some of their research publications.

The Rest of the Story

Pfizer and GlaxoSmithKline (formerly Glaxo Wellcome) are pharmaceutical companies that manufacture smoking cessation drugs. Pfizer markets Chantix as well as Nicotrol, a nicotine inhaler. GlaxoSmithKline markets buproprion as well as a variety of nicotine replacement products (including the nicotine patch).

Thus, it is easy to easy that any researcher who has received grant funding from, or served on an advisory board for either of these companies has a conflict of interest in conducting or reporting the results of research on nicotine replacement products or other smoking cessation drugs.

It appears that as early as 2001, Dr. Hurt had received funding from Glaxo Wellcome for a clinical trial of buproprion. More recently, in a 2011 article, he acknowledged receiving funding from Pfizer. Furthermore, he acknowledged serving or having served on the advisory boards for both Pfizer and GlaxoSmithKline. A 2011 article states that he serves on an advisory board for GlaxoSmithKline. In another 2011 article, Dr. Hurt discloses that he served on an advisory board for Pfizer. Another 2011 article states that "Dr. Hurt is a member of the Scientific Advisory Board for GlaxoSmithKline and has received a medical education grant from Pfizer." A 2009 article states that Dr. Hurt "has received consulting fees from Pfizer." A 2009 article states that Dr. Hurt "serves on the Advisory Board for Pfizer."

It appears that more recently (within the past 2 years), Dr. Ebbert has also received funding from Pfizer. Dr. Ebbert is listed as a Principal Investigator on a clinical trial that is sponsored by Pfizer or in which Pfizer is collaborating. In a 2012 article, he acknowledges as follows: "Jon O. Ebbert has received support to conduct clinical trials with varenicline from Pfizer."

This brings us to the failed disclosure. In an article published online ahead of print in the journal Nicotine & Tobacco Research on July 19, 2013, Dr. Ebbert and Dr. Hurt are co-authors of a study which reports the results of a clinical trial of "nicotine patch therapy" for smokeless tobacco users. However, the paper fails to reveal any conflicts of interest. The "declaration of interests" disclosure statement reads: "None declared."

In my opinion, this is a failed disclosure because Dr. Hurt has apparently received funding from Pfizer and Glaxo Wellcome and has apparently served on advisory boards for Pfizer and GlaxoSmithKline. Moreover, Dr. Ebbert has apparently received research funding from Pfizer. Should not these conflicts of interest be disclosed since both of these companies market nicotine replacement products? If this does not represent a conflict of interest (on the part of both authors), then I'm not sure what a conflict of interest is.

There are a number of other articles that report the results of trials of smoking cessation medication that were co-authored by Dr. Hurt in recent years and which also fail to disclose any conflict of interest:
  • a 2012 study that involved the use of the nicotine patch;
  • a 2011 study that involved the use of methylphenidate for smoking cessation;
  • a 2010 article that reviews the use of Chantix for smoking cessation;
  • a 2010 study that involved the use of nicotine inhaler and buproprion; and
  • a 2009 study that involved the use of buproprion.
The rest of the story is that these researchers from the Mayo Clinic have not only failed to disclose relevant conflicts of interest with Big Pharma in columns opposing electronic cigarettes, but have also failed to disclose these conflicts in a recent research article on nicotine replacement therapy.

The public should take these conflicts of interest into consideration when evaluating the validity of the advice of these researchers regarding electronic cigarettes.

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