It was another headline busting study this week: Pfizer Drug Tied to Heart Risks – a provocative title no doubt fed to the media from the publisher: the Canadian Medical Association Journal. The study was yet another meta-analysis that culled the world’s literature in an attempt to determine if a trend could be found that might implicate Chantix as a causative agent for and increased incidence of heart disease in smokers.
On its surface, the study sounds authoritative, analyzing “14-double-blind randomized controlled trials involving 8216 participants” ranging in duration from “7 to 52 weeks.”
Never mind that 57% (25) of adverse events were weighted from one study and that none of the 14 studies had odds ratios that did not cross the unity line.
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Despite this, the lead author concluded:
Despite the limitations of our analysis, our findings have potential regulatory and clinical implications.
Sorry, this is not correct. There are no clinical implications of this trial. Like all meta-analyses, meta-anaylses simply cannot determine cause and effect. (Note to mainstream media: are you folks listening?!?)
That being said, there’s another concern I have with studies like this: our deficit and how we’re spending our precious research dollars.
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Westby G. Fisher, MD Website Westby G. Fisher, MD, FACC is a board certified internist, cardiologist, and cardiac electrophysiologist (doctor specializing in heart rhythm disorders) practicing at NorthShore University HealthSystem in Evanston, IL, USA and is a Clinical Associate Professor of Medicine at University of Chicago's Pritzker School of Medicine. He entered the blog-o-sphere in […]
This Chantix study’s lead author, Sonal Singh, MD MPH, was supported by a grant from the National Center for Research Resources (NCRR), a component of the US National Institutes of Health (NIH) and the NIH Roadmap for Medical Research (grant number 1KL2RR025006-03). This study came from that grant.
But so did meta-analyses on thiazolidinediones and inhaled corticosteroids and their possible risks for leg fractures or heart attacks.
With this grant, here’s all you need: pick a drug, any drug. Then go to a computer, do literature searches of other people’s work on a particular drug and side effect, then try to find a relationship to something.
That’s it. No original ideas. No original hypotheses to test. And all funded by the American taxpayer.
Is this the “roadmap” for medical research that we want for our public scientific dollars?
Certainly we want our researchers to have the freedom to chose an area of research that they feel is important, but when should we insist on some form of accountability for the quality and cost of that research?
Addendum: It should be noted that at the time of the above publication, the authors of the above study noted the FDA’s announcement of the addition of a warning to the product label for Chantix (varenicline) from the same single 700-patient randomized controlled trial that the authors weighted 57% of their opinion upon, yet the FDA admitted that “the trial was not designed to have statistical power to detect differences between the arms on the safety endpoints.”
Disclaimer: I have no financial conflicts of interest to report regarding Chantix or its manufacturer.
Westby G. Fisher, MD, FACC is a board certified internist, cardiologist, and cardiac electrophysiologist (doctor specializing in heart rhythm disorders) practicing at NorthShore University HealthSystem in Evanston, IL, USA and is a Clinical Associate Professor of Medicine at University of Chicago's Pritzker School of Medicine. He entered the blog-o-sphere in November, 2005. He writes regularly at Dr. Wes. DISCLAIMER: The opinions expressed in this blog are strictly the those of the author(s) and should not be construed as the opinion(s) or policy(ies) of NorthShore University HealthSystem, nor recommendations for your care or anyone else's. Please seek professional guidance instead.
