Thursday, April 14, 2016

Former Associate Dean of Continuing Medical Education at Stanford Essentially Acknowledges Undisclosed Conflict of Interest in Recent Tobacco Control Paper

Yesterday, I discussed a paper published online ahead of print in the journal Tobacco Control which blasts electronic cigarette companies and a consumer vaping advocacy organization for creating "knock-off" advertisements that urge smokers to quit by switching to vaping instead. The senior author of the paper - Dr. Robert Jackler - is a professor in the Department of Otolaryngology at the Stanford University School of Medicine.

One of my main criticisms was that in the paper, Dr. Jackler states that he has no conflicts of interest, but his curriculum vita reports having received grant funding from the Pfizer Corporation between 2010 and 2013. Assuming this is true, it represents a substantial conflict of interest because Pfizer markets a smoking cessation drug - varenicline - and therefore stands to lose potentially millions of dollars in profits if electronic cigarettes are successful and partially replace varenicline as a smoking cessation treatment approach.

In response to yesterday's blog post, Dr. Jackler argued (in the comments section of the blog) that I was categorically wrong, and that he had no conflict of interest based on the alleged association with Pfizer. He wrote the following:

"This is Robert Jackler of Stanford University writing to clear up Dr Siegal's assertion that I have a non-disclosed conflict of interest. This is categorically untrue. Between 2007 and 2011 I served as the Dean over Postgraduate Medical Education at the Stanford School of Medicine. The university received funding from Pfizer to support education programs. As the Dean overseeing these programs, i was listed on the grant. The funds were administered by the university and awarded by a faculty committee to individual course directors based upon their educational merit. The grant had nothing to do with scientific research, drug development, or anything of the sort. Stanford policy strictly prohibits commercial influence over its curriculum."

The Rest of the Story

My intention in writing about this issue is not to make this about any individual, but to shed light on the broad issue of failed conflict of interest disclosures which I am increasingly observing in the tobacco control research field. Obviously, in providing examples it is unavoidable to mention specific names of individuals. But my intent in responding here to Dr. Jackler's comments is to discuss the broader parameters of conflict of interest disclosure and to show how this concept is widely misunderstood, as evidenced by Dr. Jackler's argument.

The first criterion (of two) in judging whether a conflict of interest exists is whether or not there is a significant financial interest in a corporation. In his response, Dr. Jackler acknowledges having been the Dean overseeing education programs that were funded by Pfizer, and he acknowledges that he was listed on the grant. So in fact, the association with Pfizer was even stronger than I intimated yesterday, because Dr. Jackler was not merely a minor personnel on the grant; he apparently acknowledges that he was a Dean at the recipient institution and "overseeing" the programs funded by the grant. This, combined with the fact that Dr. Jackler lists the grant from the Pfizer Corporation on his CV, seems to dispel any doubt over whether there was a significant financial interest related to Pfizer, which is the first criterion in judging whether a conflict of interest exists. Pfizer itself has disclosed the grant, listing a payment of $1,000,000 to Stanford for the year 2011.

The second criterion in judging whether a conflict of interest exists is whether the research in question could be reasonably viewed as being related to the financial interest. In other words, does the company in question have a financial interest in the topic of the research? Here, it seems clear that Pfizer has a financial interest in an article attacking electronic cigarettes and discouraging their use for smoking cessation because Pfizer markets a smoking cessation drug (varenicline) and serves to lose financially (and substantially) if electronic cigarettes were to gain market share in the smoking cessation treatment category. In 2010, Pfizer's domestic revenues from the sale of varenicline were $252 million, and its global revenues from the sale of this drug were $755 million. Thus, there seems little doubt that the company has a substantial financial interest in research that attacks electronic cigarette companies and discourages the use of this alternative product for smoking cessation.

Based on the above two criteria, it seems clear to me that that a financial conflict of interest does exist with respect to the Tobacco Control paper and that it should have been disclosed.

Dr. Jackler's primary argument against this representing a conflict is that: "The grant had nothing to do with scientific research, drug development, or anything of the sort." However, the purpose of the funding is not relevant to the question of whether it represents a conflict. It is not only funding for scientific research or drug development that would represent a conflict. Any funding from the company in question is considered a significant financial interest. The relevant question, instead, is whether the funding company reasonably appears to be financially affected by the research article in question.

To illustrate this, suppose that I was a listed personnel on a $3 million grant from Philip Morris to support educational training of my public health students at Boston University. Would I not have to disclose that as a conflict of interest in a manuscript I publish which has potential financial implications for tobacco companies? Does the fact that the grant was for educational purposes, rather than for research, remove my duty to disclose the funding? I would argue that it certainly does not, and I have no doubt that my colleagues in tobacco control would have raked me over the coals if I had failed to disclose such a grant. The point is that receiving a grant from a corporation is considered a significant financial interest, even if the grant is not specifically for research or to study a specific product made by the company.

There are several other points worth mentioning. First, Dr. Jackler argues that "Stanford policy strictly prohibits commercial influence over its curriculum." Yet, the medical school accepted corporate funding to support its curriculum! This is about as hypocritical an assertion as I can imagine. If Stanford policy prohibits commercial influence over its curriculum, then certainly it should not allow the medical school to accept funding from a drug company to run a curricular program, and especially a program which covers the use of a drug made by that very company (according to an article in the Stanford Daily, the grant supported curricula related to smoking cessation).

There is no doubt that at least some saw the grant as violating university policy. The Stanford Daily wrote that the grant was indeed an "exception" to the policy: "Since 2008, Stanford has had a strict policy against commercial support for specific CME programming. However, this grant is an exception due to its open-ended scope."

The same article pointed out the blatant hypocrisy of the acceptance of this grant: "Stanford School of Medicine recently received a $3 million grant to eliminate corporate influence on continuing medical education (CME). The grant, however, came from an unexpected source: pharmaceutical giant Pfizer, Inc." Imagine: the way to eliminate corporate influence over continuing medical education is to fund that continuing medical education with money from a corporation! This is like arguing that the way we are going to eliminate the influence of Big Tobacco on university research is to accept money from Philip Morris! The logic of this evades me.

According to the same article, both the dean of the medical school and Dr. Jackler (then the dean of continuing medical education) acknowledged that one purpose of the grant was to improve Pfizer's image. This, in fact, is the primary purpose behind all corporate philanthropy, a fact that is widely acknowledged in the marketing literature. And we know from the example of Big Tobacco that it used precisely this type of approach to try to improve its corporate image.

Harvard Professor Emeritus Arnold Relman, a former editor of the New England Journal of Medicine, sharply criticized Stanford for accepting this grant, stating: "it's just not a good idea for a profession that says it wants to be independent and trusted, a reliable source of information to the profession and the public about drugs, to take money from the drug company under any conditions," he told the New York Times.

And Dr. Adriane Fugh-Berman, a professor of medicine at Georgetown University and an expert on corporate influence on medical education, appropriately called accepting the grant "self-satirizing."

I do have to admit that it sounds like a great Onion headline: "Stanford Seeks to Reduce Corporate Influence over Continuing Medical Education by Accepting $3 Million from Drug Corporation to Develop Continuing Medical Education Programs."

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