Researchers and advocates are calling for the retraction of a 2015 letter in the New England Journal of Medicine that suggested that e-cigarettes are as harmful – if not more than – traditional cigarettes.
The NEJM paper reported that e-cigarettes expose smokers to significant amounts of formaldehyde, which the authors calculated could raise lifetime cancer risk by 5-15 fold compared to the risk for regular smokers. Critics, however, have claimed that to obtain such high levels of formaldehyde, the NEJM authors superheated the vapor from the e-cigs to levels that would create a well-known, acrid puff called a “dry puff.” This sensation, they say, is so terrible that no self-respecting “vaper” would consider repeating it. In other words, allege the e-cigarette supporters, the conditions described in the Letter—which was widely reported—were not relevant to human health.
This week, Addiction published a letter from critics of the NEJM paper, along with extensive supplementary materials, a reply from some of the NEJM Letter authors, and a response letter from the critics.
There is a clear risk that extensive and alarming reporting will have persuaded many smokers that there is little to be gained by switching to e-cigarettes, despite the emerging expert consensus that vaping is likely to be at least 20 times lower risk than smoking.
We have documented the flaws in the experiment and cancer risk calculations and in the authors’ reply to criticisms of their work, and written to the editor of NEJM requesting the retraction of the letter.
NEJM editors have declined these requests. NEJM executive editor Edward W. Campion told Retraction Watch:
The research letter reported data on an important issue, namely the presence of a known carcinogen, at least at some device settings, in the vapor from e-cigarettes. We have seen no evidence of scientific misconduct, and we see no grounds for retraction. Disagreements about interpretation of data are not grounds for retraction. If disagreements about interpretation become a reason for retraction, the scientific community will be headed for real trouble.
Indeed, retraction guidelines from the Committee on Publication Ethics (COPE), of which NEJM is a member, lay out specific conditions under which papers should be retracted:
Journal editors should consider retracting a publication if:
• they have clear evidence that the findings are unreliable, either as a result of misconduct (e.g. data fabrication) or honest error (e.g. miscalculation or experimental error)
• the findings have previously been published elsewhere without proper crossreferencing, permission or justification (i.e. cases of redundant publication)
• it constitutes plagiarism
• it reports unethical research
In May, Farsalinos published an additional study in Addiction involving “seven experienced vapers,” with results suggesting that only “dry puff” conditions—i.e., overheated liquid—produced high levels of aldehydes, including formaldehyde.
As part of their latest commentary in Addiction, Farsalinos and Bates include supplementary information that describes earlier requests for a retraction of the NEJM paper “Hidden formaldehyde in e-cigarette aerosols,” including a list of signatories to a letter sent to NEJM.
In April, NEJM published three letters to the editor critiquing the original letter, along with a response from the original authors.
David H. Peyton, professor of chemistry at Portland State University and one of authors on the original NEJM letter, told Retraction Watch:
Bates & Farsalinos requested a retraction after their NEJM correspondence and our reply, and since that quickly failed they got Addiction to accept their request.
No one seems to be arguing with the science; they just seem very much to want the shading of the interpretation to match certain agendas.
E-cig proponents argue on behalf of public health, pointing to suggestions that because e-cigs are less dangerous than regular cigarettes, they should be welcomed. Indeed, proponents add, anyone who opposes e-cigarettes is simply playing into the hands—and marketing plans—of traditional cigarette makers by doing so.
And on the other side are those who see inherent health harms in e-cigarettes, with some data suggesting that while they might not be as bad as traditional smokes, they also aren’t anything to offer to the kiddies at Christmas.
We first learned about this spirited exchange around nicotine-carrying vapors from Michelle Ertischek, director of pharmaceutical risk management at PinneyAssociates, a health consulting firm that provides marketing support for pharmaceutical and healthcare products, among other services.
Ertischek said that PinneyAssociates does
currently provide consulting services to subsidiaries of Reynolds American, Inc., on products related to smoking cessation and tobacco harm minimization and one subsidiary, Niconovum, has purchased an option from JSR, LLC (an LLC consisting of key individuals from PinneyAssociates) for patented nicotine replacement therapy product technology.
As RAI’s subsidiary, RJ Reynolds Vapor Company, markets digital vapor products, we thus would have a legitimate basis and interest in these issues…
One of the company’s vice presidents, Jack Henningfield, and a senior scientific advisor with the company, Saul Shiffman, are among the signatories of the supporting letter that Bates sent to NEJM requesting a retraction.
In the April exchange of critical letters and the author reply in NEJM, only one letter included declarations:
Dr. Nitzkin reports receiving partial funding for some of his tobacco policy work from the R Street Institute. Dr. Farsalinos reports that some of his studies on electronic cigarettes were performed with unrestricted funds provided to the Onassis Cardiac Surgery Center by FlavourArt and Nobacco.
Farsalinos also runs a site called “E-cigarette Research.”
When asked about conflicts of interest, Bates (who did not write any of the April letters published in the NEJM) said that he does “sustainability consultancy,” most recently on opencast coal mining. His work, he said, is “not in this field at all, and I have no conflicts of interest with respect to tobacco, nicotine or pharma industries and have made these disclosure statements to Addiction and to NEJM when I complained to them.”
Bates and Farsalinos are currently listed as a volunteer “advisor to the grants committee” for the E-Research Foundation, whose website says that
The E-Research Foundation is a not for profit organization formed to further advance the scientific study of electronic cigarettes, related products and their use.
In their April letter responding to critiques, the authors of the original NEJM paper said they had no additional conflicts than those declared on the COI form published with the original letter. This form lists funding from, among other sources, Regina M. Dowd and Michael J. Dowd and from Patrick J. Coughlin. Michael Dowd, a former U.S. states attorney, is the founding partner of a law firm that has “led the fight against Big Tobacco since 1991,” according to the firm’s website.
Coughlin is also associated with the firm, and according to his biography on the firm’s website, he was involved in a
a large private RICO trial against the major tobacco companies on behalf of hundreds of thousands of Ohio Taft-Hartley health and welfare fund participants. Mr. Coughlin also helped end the Joe Camel ad campaign, a cartoon ad campaign that targeted children and secured a $12.5 billion recovery for the cities and counties of California in the landmark 1998 state settlement with the tobacco companies.
Also this week in Addiction, Peyton and two of his co-authors provide specific responses to science-related assertions Bates and Farsalinos made about the original NEJM study. They don’t address the retraction question.
Addiction’s editor-in-chief Robert West told Retraction Watch that the rationale for publishing this latest series of Letters was
that science should operate with maximum transparency and it is important for these kinds of discussions to be open to scrutiny by the research community and the public.
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