Tuesday, March 31, 2009

University of Wisconsin Online Physician Course in Smoking Cessation Therapy Promotes Chantix as First-Line Therapy But Fails to Disclose Drug Risks

Could University Funding by Pharmaceutical Company that Makes Chantix Be the Explanation?

The Milwaukee Journal-Sentinel reported this Sunday that a University of Wisconsin online course for physicians to teach them how to get their patients to quit smoking is being skewed because of the funding of the program by Pfizer, the manufacturer of Chantix. According to the article, the course promotes the use of Chantix as first-line therapy for smoking cessation, but fails to disclose the reported adverse effects associated with Chantix, including depression and suicide.

According to the article: "A Journal Sentinel investigation found that industry-funded doctor education courses offered at UW often present a slanted view by favoring prescription medications over non-drug therapies and by failing to mention important side effects. Among the findings: Pharmaceutical giant Pfizer is spending $12.3 million on an online UW course for doctors to tell them how to get their patients to quit smoking. A top priority is prescribing Pfizer's drug, Chantix, which has been linked to serious side effects, including a rash of suicides. But mention of the side effects can't be found in course materials." ...

"Some of the biggest money paid to UW has been for its smoking cessation course, part of a national campaign funded by Pfizer. Of the $12.3 million paid by the drug company to fund the course, $3.5 million is going to UW. The course materials heavily promote Pfizer's drug, Chantix, considered to be the most effective drug on the market. But the drug is under investigation by the FDA, and in its relatively short history on the market, it has been linked to serious side effects, none of which is mentioned in the course."

The Rest of the Story

I took the University of Wisconsin online course for myself to see exactly what the course is teaching and what it is disclosing or failing to disclose.

The Journal-Sentinel article is correct. The course promotes Chantix as a "first-line treatment for smoking cessation," but it fails to mention any of the serious potential side effects that have been reported with the use of the drug, and which the FDA itself has required be added to the drug's labeling (in a warning box, the highest level of such warnings).

The course also fails to mention that cold turkey quit attempts have been documented to be far more successful than planned quit attempts with the use of pharmaceutical aids. In fact, the course fails to mention that any course of action other than relying upon drugs as the primary mode of treatment should or could be considered by a physician or patient.

The newspaper article is absolutely correct, then, in concluding that the course "present[s] a slanted view by favoring prescription medications over non-drug therapies and by failing to mention important side effects."

Furthermore, I discovered that the course relies heavily upon and frequently cites as documentation the recommendations of an NIH expert panel on smoking cessation. However, nowhere is it disclosed that the chair of the panel and eight of its members had financial conflicts of interest by virtue of their financial ties to Big Pharma.

In fact, the report of the expert panel is the only evidence cited in the entire course to support its recommendations. Course participants are not informed that this sole source of information and guidance was developed by a panel with severe conflicts of interest.

Do we really want our nation's physicians to be getting their medical training from information sources that are heavily biased because they were compiled largely by individuals with financial conflicts of interest with pharmaceutical companies?

Do we really want our nations's physicians to be potentially misled about the safety of using a drug through the hiding of its reported adverse effects by educators who have financial ties to the very company that manufactures that drug?

This is a great example of how pharmaceutical funding of individuals and institutions is resulting in slanted and heavily biased physician training in a way that could potentially cause serious harm to some patients.

The University of Wisconsin should force the organizers of this course to immediately disclose the potentially severe adverse effects that have been reported with Chantix use, as required for disclosure by the FDA with regards to Chantix labeling.

The University should also force the course organizers to disclose the fact that the expert panel review which serves as the primary (if not sole) source of support for the course recommendations was a conflicted one: the chair and eight panel members had financial ties to Big Pharma.

While I think these two disclosures are essential and without them the course is violating ethical standards, I would note that this will only solve the most egregious aspects of the problem. The underlying issue of the biased recommendations (including the favoring of less effective pharmaceutical treatment compared to the more effective cold turkey quitting) on account of the pharmaceutical company funding will remain.

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