Monday, February 29, 2016

The Problem of Undisclosed Conflicts of Interest in Tobacco Control: How It Works and Why We are So Hypocritical

Recently, a debate has broken out in the tobacco control community about tobacco industry-related conflicts of interest in research. One recent commentary went as far as arguing that academic journals should not publish research on electronic cigarettes if that work is funded by the tobacco industry. While not everyone in tobacco control would go that far, pretty much all of us do agree that at very least, researchers with a history of funding from tobacco companies should disclose that information as part of their conflict of interest statements in journal articles that are relevant to tobacco.

However, it is not clear that the tobacco control movement applies that same conflict of interest disclosure policy to itself. In particular, the movement appears to view its own conflicts of interest with pharmaceutical companies as being immune from disclosure in precisely the same situations they would attack a researcher for failing to disclose a similar conflict with a tobacco company.

I have already revealed in great detail a number of recent articles in which conflicts of interest of the authors with Big Pharma were hidden from readers, all in situations in which they should have been disclosed.

Today, I demonstrate how a failed disclosure works and how it creates the perception that a conclusion in an article has been unduly influenced by a prior financial relationship with a company.

An article published last year in the journal Addiction Research and Theory discusses the problem of cigarette craving that occurs early in smoking cessation attempts due to nicotine withdrawal. This article was originally submitted for publication on January 25, 2014.

A major premise of the article is that addressing early nicotine withdrawal symptoms is critical in promoting successful smoking cessation. The article concludes that: "the neurocognitive effects of abstinence may be a target for smoking cessation."

Specifically, the article suggests that: "the smoking cessation medication, varenicline [Chantix], has been shown to alleviate cognitive deficits following 72h of abstinence (Patterson et al., 2009)."

The Patterson article demonstrated the effectiveness of varenicline [Chantix] in improving mood and cognition during smoking abstinence. It not only highlighted the usefulness of Chantix in enhancing smoking cessation but also suggested that the drug, or something similar, might be explored for the treatment of affective disorders generally.

The Rest of the Story

This article, submitted for publication in early 2014 and published in 2015, touts the benefits of Chantix in alleviating early withdrawal symptoms that could impede smoking cessation.

All would agree that this article is therefore reporting great news for Pfizer, which markets Chantix, and that the reporting of the findings of this research could easily affect the economic status of Pfizer.

But are the authors of this article providing a neutral, balanced, and unbiased analysis and unbiased conclusions?

The reader certainly has no reason to question the objectivity of the co-authors since the financial disclosure statement at the bottom of the paper reads: "The authors report no conflict of interest."

There's just one problem. Just as tobacco industry-funded scientists have historically hidden their prior corporate connections to Big Tobacco by failing to disclose those relationships in published articles, it appears that a co-author of this article also failed to disclose his prior corporate connection, in this case to Big Pharma.

In a 2012 article co-written by the relevant author, the role of Chantix in smoking cessation was examined. That study concluded that: "Varenicline ... led to reductions in nicotine metabolites and urges to smoke. Among this sample of non-treatment seeking smokers, varenicline significantly reduced smoking behavior."

But here's the rub: That study was funded, in part, by Pfizer (the company that markets varenicline)!

The funding statement at the end of the article acknowledges that: "This research was supported by Global Research Award for Nicotine Dependence (GRAND) from Pfizer (GA30523L)... ."

The relevant investigator was the recipient of Pfizer funding through a GRAND award from that company during the period 2008-2011.

So the rest of the story appears to be that this author had previously been funded by Pfizer (through 2011), but apparently failed to disclose this in an article submitted for publication three years later that touted the benefits of a Pfizer drug.

While this does not mean that the researcher was influenced by the prior financial relationship with Pfizer, it does create the appearance of a possible bias. And this is exactly what conflict of interest statements are designed to protect against. This is a perfect example of how a clear disclosure would have precluded any appearance of an undisclosed source of bias.

The question I find most interesting is why we seem to have a double standard in tobacco control. Any connection between a researcher and Big Tobacco, no matter how remote, has to be disclosed or we attack that researcher (and basically treat him or her as a "tobacco mole"). But connections between our own research and Big Pharma seem to be immune from a similar need for broad disclosure.

One reason for this double standard may be that we view the tobacco industry much differently than the pharmaceutical industry. I don't deny that there are qualitative differences, especially historically, between these two industries. But the problem is that if you do not honor the principle of conflict of interest disclosure yourself, then it seems to me that you lose credibility in holding tobacco-funded or tobacco-affiliated researchers to those same standards.

In closing, consider this scenario: A researcher receives a grant from Philip Morris to study the effectiveness of Mark Ten e-cigarettes in reducing the craving to smoke. Within 3 years of that grant ending, he submits an article to a journal, in which he touts the benefits of Mark Ten e-cigarettes for smoking cessation. However, in that paper, he fails to disclose that had received funding from Philip Morris to conduct a clinical trial involving the Mark Ten product. His disclosure statement says simply that he “has nothing to disclose.” Should this be considered appropriate?

In today's Rest of the Story, we have the exact same scenario except it involves funding from a pharmaceutical company instead of a tobacco company. Here, an investigator receives a grant from Pfizer to study varenicline. Within 3 years of that grant ending, he submits an article to a journal in which he touts the benefits of varenicline, but fails to disclose that he had been funded by Pfizer to conduct that clinical trial on varenicline. Because this is a pharmaceutical company instead of a tobacco company, why does it suddenly become OK?

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