Friday, September 11, 2009

Press Release Announces New Study Which Recommends Cessation Pharmacotherapy for All Smokers Being Treated for Mental Illness

A press release issued by Northwestern University this past Wednesday announced the recommendations of a new study, which concludes that all smoking patients being treated for mental illness should be treated with pharmaceuticals in an effort to help them quit smoking. The lead author of the study is Dr. Brian Hitsman with Northwestern University. The senior author is Dr. Tony George of the University of Toronto.

According to the press release: "when mental health providers insert smoking cessation treatment into the mental health treatment plan, they can help their patients quit or cut down. 'They find if you take advantage of the relationship with the counselor and insert smoking cessation counseling into treatment that you enhance quit rates,' Hitsman said. His tobacco cessation plan combines cognitive behavioral therapy, pharmacotherapy and motivational counseling to help the patient quit. Hitsman also has identified several treatment medications that may further facilitate quitting for this population. ... Tobacco dependence also needs to be treated as a chronic disease, Hitsman believes. 'We know that treatment provided for a longer duration substantially increases the abstinence rates of people without mental disorders,' he noted. 'Smokers with mental illness may be especially likely to benefit from extended or maintenance tobacco treatment.'"

The paper itself sets forward an algorithm in which nicotine replacement therapy, Zyban, or Chantix is prescribed for every patient in an effort to help them quit smoking, and even after successful cessation, pharmaceuticals are prescribed for up to an additional 12 months to prevent relapse.

The Rest of the Story

Nowhere in the press release is it revealed that the lead author and senior author of the paper have financial conflicts of interests with Big Pharma.

According to the published study:
  • Dr Hitsman has consulted for Pinney Associates, subcontracted by GlaxoSmithKline (2006); and
  • Dr George has received grant support from Pfizer, Sepracor, Targacept, and Sanofi-aventis, and is a consultant to Pfizer, Prempharm, Glaxo-SmithKline, Eli Lilly, Janssen-Ortho, and Evotec.
Pfizer is the manufacturer of Nicotrol and Chantix. GlaxoSmithKline is the manufacturer of Zyban and NiQuitin.

The rest of the story, therefore, is that two of the authors of this study have financial conflicts of interest with Big Pharma, and specifically, with companies that manufacture the very smoking cessation drugs that they are recommending be used with every patient.

There is nothing wrong with the investigators making this recommendation. However, it is incumbent upon them, I believe, to disclose their conflicts of interest in every communication that disseminates their findings to the media or the public. While the conflict was disclosed in the published article itself, it was apparently not disclosed in the press release. This means that the results of the study, with its recommendation that pharmaceuticals be used with every smoking patient, are being disseminated throughout the world without any disclosure of the relevant (and imporant) conflict of interest.

I don't understand why researchers believe that if there is a conflict of interest important enough to be disclosed in a published manuscript, it is not important enough to be disclosed in a press release about that manuscript, which is likely to be disseminated worldwide, and to be seen by far more people than the article itself.

There is little question that more people will see the press release than will see the actual study. So if anything, it seems even more important to disclose the conflict of interest in the press release.

I believe that medical journals should consider expanding their conflict of interest disclosure policies to require that authors of papers disclose their conflicts in any press releases issued regarding the article.

Similar, universities should ensure that disclosure of conflicts of interest is made not only in published articles, but in press releases issued about those articles. Since it is the university itself which is issuing these press releases, it seems it is even more incumbent upon the institution to disclose the relevant conflicts of interest.

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