Monday, July 30, 2012

American Legacy Foundation Takes More Money from Pfizer; Still Fails to Disclose Conflict of Interest on Electronic Cigarette Recommendations Disseminated to the Public

The American Legacy Foundation took money from Pfizer as recently as last year; this money was used to support a national survey of more than 3000 American smokers about smoking cessation.

The 2011 funding is in addition to additional funding that Legacy received from Pfizer in 2009, and further confirms that Legacy has financial ties to the pharmaceutical industry, which stands to lose severely if electronic cigarettes continue to become more and more popular.

At the same time that it accepts funding from Pfizer, Legacy continues to fail to disclose this significant conflict of interest on its web page which disseminates to the public recommendations about electronic cigarettes. Specifically, the web page recommends that the FDA take electronic cigarettes off the market until they are proven to be safe and effective: "The FDA should take electronic cigarettes off the market until it is satisfied that they are safe and effective."

According to the web page, Legacy's recommendation is as follows: "While we remain open to promising products that can help smokers quit smoking, a consideration of all of the available evidence combined with important unanswered questions strongly supports our call on the FDA to prohibit the marketing and sale of e-cigarettes unless and until the FDA is satisfied that they are safe and effective."

Importantly, nowhere on the web page does Legacy disclose that it has received funding from a pharmaceutical company which manufactures a smoking cessation product, and thus that the Foundation has a conflict of interest by virtue of this pharmaceutical company funding. The public is therefore not able to take this conflict of interest into consideration when evaluating Legacy's presentation of the scientific evidence and formulation of its recommendation.

The Rest of the Story

It is interesting that the American Legacy Foundation chooses to continue pointing readers to this recommendation to ban electronic cigarettes, even though the District Court for the District of Columbia has ruled that the FDA does not have the authority to remove electronic cigarettes from the market in the absence of therapeutic claims by manufacturers because they must be regulated under the Tobacco Act rather than under the Food, Drug, and Cosmetic Act.

It is unfortunate that the American Legacy Foundation misrepresents the findings of a 2009 FDA laboratory study on electronic cigarettes, and fails to even mention numerous studies conducting since that time which point to the relative safety of electronic cigarettes over regular cigarettes. Legacy highlights the finding that electronic cigarettes were found to contain tobacco-specific nitrosamines, without notifying readers that the levels of these TSNA's were extremely low, that these levels are comparable to those in nicotine gum and patches, and that the TSNA's are present at trace levels simply because the nicotine is derived from tobacco.

All nicotine products derived from tobacco are going to have trace levels of tobacco-specific nitrosamines so this finding is essentially meaningless. It does not indicate that electronic cigarettes are carcinogenic. Instead, it demonstrates that electronic cigarettes pose a much lower level of carcinogenic risk that tobacco cigarettes, because the levels of TSNA's in these devices are orders of magnitude lower than in regular cigarettes.

Why is the American Legacy Foundation misrepresenting the health risks of electronic cigarettes to the public?

Well, one potential explanation - only apparent to those who might somehow discover the Foundation's financial ties to Big Pharma from sources other than the recommendations themselves - is that the financial conflict of interest is contributing to this bias in the reporting of the scientific evidence.

A second factor could be the reluctance to admit that a behavior which looks like smoking might actually be significantly safer than cigarette smoking and therefore might be something which a public health organization might actually recommend as a strategy for smoking cessation. Of course, this would take sales away from pharmaceutical companies, including Pfizer, and so it also plays into the bias caused by the conflict of interest.

The failure to disclose a significant conflict of interest is unfortunate because it deprives the public the information it needs to appropriately evaluate the validity of the Foundation's presentation of the scientific facts and recommendations about electronic cigarettes. In this case, a blatant misrepresentation of the scientific evidence occurs, but readers have no way of knowing that Legacy has a financial interest in promoting the sales of smoking cessation drugs over electronic cigarettes.

Another public communication from Legacy which has the appearance of a bias potentially resulting from a conflict of interest is the Foundation's 2008 press release praising Pfizer for "proactively and voluntarily giving more prominence to its consumer warning messages specific to their popular smoking medication, Chantix." Unfortunately, and quite inexplicably, the press release fails to mention just what the adverse side effects of Chantix might be that are the subject of these warning messages.

Ironically, the press release closes by emphasizing that: "smokers therefore need to be armed with all the available information to make the best, most informed choices about the smoking cessation medications available to them." But Legacy fails to provide the very information that smokers need most: that Chantix was associated with severe psychiatric side effects - including suicide.

In the press release, Legacy appears to be intentionally hiding from the public the fact that Chantix was associated with adverse side effects as severe as death. Given the funding from Pfizer, what else are we to think, other than that this biased reporting of the science is being influenced by this financial conflict of interest, which - incidentally - is not even disclosed in the press release.

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