Tuesday, August 28, 2012

Author of Article Attacking E-Cigarettes Appears to Have Failed to Disclose Significant Financial Conflict of Interest

An article published in the March issue of the journal Nursing Clinics of North America reviews electronic cigarettes as potential harm reduction devices and makes recommendations to nurses about the advice they should give patients regarding the use of these products.

(See: Riker CA, Lee K, Darville A, Hahn EJ. E-cigarettes: Promise or peril? Nursing Clinics of North America 2012; 57:159-171.)

In this article, the authors make a shocking claim: that there is no scientific basis to argue that cigarettes are any more harmful than non-tobacco-containing electronic cigarettes that merely vaporize nicotine from a solution containing nicotine, glycerin, and propylene glycol.

These authors assert that despite the fact that electronic cigarettes contain no tobacco and involve no combustion, produce no smoke, and do not contain most of the tens of thousands of chemicals and more than 60 known carcinogens in tobacco smoke, there is no scientific basis to claim that tobacco cigarettes are any more harmful than electronic ones.

The article states that: "no scientific basis currently exists for making claims of ... reduced harm ... for e-cigarettes."

Of course, asserting that there is no scientific basis for making claims that e-cigarettes are less harmful than cigarettes is the same as asserting that there is no scientific basis for making claims that cigarettes are any more harmful than e-cigarettes.

It appears to me that an ideology - some sort of entrenched opposition to any behavior that looks like smoking - is intruding upon sound scientific reasoning. How can a device which delivers vaporized nicotine with a few other chemicals (including propylene glycol) and trace levels of carcinogens (TSNAs) possibly be more hazardous than a device that delivers nicotine plus thousands of other chemicals (including propylene glycol) and more than 60 carcinogens (including high levels of TSNAs, about a thousand times higher than in e-cigarettes)?

Can you imagine if any cigarette company made the same claim? We would be mauling them from all sides. How could this cigarette company dare to suggest to the public that smoking is no more hazardous than vaping? Anti-smoking groups would be attacking the company to no end. 

Also striking is the review article's failure to report the levels of chemicals detected in electronic cigarette cartridges and vapor. For example, the article warns about the finding of tobacco-specific nitrosamines in e-cigarettes, without informing readers that only trace levels were found, that these levels are comparable to those found in the nicotine patches and nicotine gum which the authors recommend later in the article, and that these levels are orders of magnitude lower than in tobacco cigarettes (providing direct evidence, therefore, that e-cigarettes are indeed safer than tobacco cigarettes - evidence which they later deny exists at all).

While the article expresses concern that the tobacco-specific nitrosamines, present in trace levels, in electronic cigarettes render them inappropriate for use by smokers until future research determines their long-term cancer potential, the authors do not similarly warn nurses about the fact that nicotine replacement products approved by the FDA and recommended in the article have also been found to contain carcinogens. Neither do they suggest that nurses hold off on recommending nicotine gum and patches until future research determines the long-term cancer risk associated with the use of these products.

In other words, the anti-electronic cigarette/pro-NRT and Chantix bias in this article is profound. Keep in mind that electronic cigarettes are a potential threat to the profitability of companies manufacturing and marketing nicotine replacement therapy and Chantix. Pfizer is the company that manufacturers Chantix, and it stands to lose substantially if electronic cigarettes gain significantly in the smoking cessation market. In other words, Pfizer (among other Big Pharma companies) produce a drug that is a direct competitor to the product being reviewed in this article.

The Rest of the Story

According to the conflict of interest disclosure published in the article: "The authors have nothing to disclose."

It therefore came as a surprise to me when I read the September-October 2008 issue of the University of Kentucky College of Nursing's Office of Research and Scholarship, which reported the award of a $5,000 grant to Dr. Ellen Hahn from Pfizer, entitled "Reducing Secondhand Smoke Exposure: An Innovative Approach to Promoting Cessation." This grant was announced as being awarded by Pfizer to Dr. Hahn and Dr. Karen Butler for fiscal year 2009.

It also came as a surprise to me when I read the disclosure statement for the authors of an American Heart Association working group in 2010 which disclosed that Dr. Hahn either served on a speaker's bureau for, or received an honorarium or honoraria from Pfizer.

If these disclosures are accurate - and I have no reason to believe they would not be since both seem like reliable sources of information on these facts - then it is my opinion that these financial relationships with Pfizer should have been disclosed in the article. These financial interests would certainly appear to represent conflicts of interest since the article reviews and makes national recommendations about a product which is a direct competitor to a product manufactured and marketed by Pfizer, the company with which the investigator appears to have a financial interest.

While I would argue that this financial conflict of interest should have been disclosed whether required by the journal or not, I did note that the journal asks authors to "DISCLOSE ANY RELATIONSHIP with a commercial company that has a direct financial interest in the subject matter or materials discussed in the article or with a company making a competing product."

I think it is quite clear that Pfizer has a direct financial interest in the subject matter (electronic cigarettes, a potential competing product for the smoking cessation market) and that Pfizer makes a competing product (Chantix). Thus, any relationship with Pfizer would appear to need to be disclosed. There is no time limit noted in the instructions, so it would not appear that only current financial relationships are being sought. This request for disclosure of conflicts of interest is a broad one.

There is direct evidence from the actions of pharmaceutical companies that they view alternative smoking products as direct threats to their profits. For example, according to an article in the Wall Street Journal, the pharmaceutical company GlaxoSmithKline urged the FDA to remove dissolvable tobacco products from the market.

According to the article: "GlaxoSmithKline PLC called for the U.S. government to remove so-called dissolvable smokeless-tobacco products from the market, a move that shows emerging battle lines between pharmaceutical and tobacco companies aiming to sell alternatives to cigarettes. GlaxoSmithKline, which markets quit-smoking aids such as Nicorette gum, said Monday that it urged the Food and Drug Administration to take oral dissolvable tobacco products from store shelves until companies that make such products, including tobacco giant Reynolds American Inc., 'can demonstrate to the FDA that their marketing is appropriate for the protection of public health.'"

This story demonstrates that Big Pharma views alternative tobacco products - such as dissolvable smokeless tobacco and electronic cigarettes - as a threat to its profits because such products may be used as an alternative to nicotine replacement therapy among smokers who want to quit or cut down on their smoking and reduce their health risks.

Further evidence of the degree to which electronic cigarettes represent a potential threat to the profits of pharmaceutical companies comes from financial analysts, such as Bonnie Herzog of Wells Fargo Securities.

According to a CS/P article: "Use of electronic cigarettes could overtake consumption of traditional cigarettes within 10 years, Bonnie Herzog, New York City-based managing director of beverage, tobacco and consumer research for Wells Fargo Securities LLC, speculated in a research note. "While difficult to predict, we think it is possible that consumption of e-cigarettes could outpace traditional cigarettes over the next decade, especially given the rapid pace of innovation and consumers' demand for reduced harm products," Herzog said. ... Herzog's bottom line: "We believe e-cigs are more than just a fad and most of our industry trade contacts agree. Considering both [Lorillard and Reynolds American] have dipped their toes in the e-cig waters, the next move is [Altria's], and we expect it to be big."

The rest of the story is that if the author's financial relationships with Pfizer - as reported by the University of Kentucky and by the American Heart Association - are accurate, then there is a significant conflict of interest that I believe should have been reported in the article. Given the subject matter of the article, it is important that readers be informed of these conflicts of interest so that they can make an informed judgment of the validity of the article's conclusions and recommendations.

Finally, given the unsupported claim that there is no evidence that cigarette smoking is any more harmful than vaping, as well as the biased reporting of the significance of the presence of tobacco-specific nitrosamines in electronic cigarettes, it certainly creates an appearance that the bias in this review could be related (subconsiously) to the conflict of interest. This makes it especially important that the conflict of interest be disclosed, or - if the University of Kentucky and American Heart Association have inaccuracies on their web sites - to have these mistakes corrected immediately.

(Note: Dr. Hahn is a colleague of mine. We have worked together in the past to help research and educate the public about the health effects of secondhand smoke and to promote smoke-free bars and restaurants. I have the utmost respect for Dr. Hahn's work, especially all that she has done to promote the cause of smoke-free workplaces and to promote smoking cessation. The state of Kentucky has made tremendous progress in tobacco control, in a difficult political climate, specifically because of Dr. Hahn's presence and efforts in the state. This is therefore an uncomfortable commentary for me to write. It is not intended to be personal, but to draw attention to the larger issue of conflicts of interest in tobacco control research and the importance of disclosure of these conflicts. I emphasize that there is nothing wrong with a conflict, nor is there anything wrong with a conflict that produces a bias. In fact, my argument is that these biases are automatic - arising subconsciously - and do not mean that the conflicted researcher has intentionally misrepresented information. I am merely arguing that where conflicts are present, it is important that these conflicts be disclosed. Also, out of respect to Dr. Hahn as a colleague, I wrote to her - prior to preparing this commentary - and asked her to confirm whether or not the financial interests with Pfizer reported by the University of Kentucky and the American Heart Association are accurate. I also wrote to Dr. Butler to confirm whether the University of Kentucky was accurate in reporting the grant from Pfizer. Unfortunately, neither one responded. I assume that if there were inaccuracies, they would have hastened to correct them. My readers should understand that if by some strange occurrence, both the University of Kentucky and the American Heart Association have inaccurately reported these relationships with Pfizer, then my comments above on the conflicts of interest are of course not relevant. But without having received a response, I have to assume that these reputable web sites are correct. Nor do I feel that this issue is trivial enough that I can let it rest until receiving a response, which is most likely not forthcoming).

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