Flawed e-cigarette formaldehyde paper should be retracted – formal complaint and supporting letter published

Remember this? Our complaint to NEJM and case for retraction is published.

Background: Flawed paper on e-cigarettes and formaldehyde published in New England Journal of Medicine

On 22nd January 2015 the New England Journal of Medicine published a paper: Jensen et al, Hidden Formaldehyde in E-cigarette Aerosol . It contains the following sensational claim (emphasis added, cross references omitted for clarity)

If we assume that inhaling formaldehyde-releasing agents carries the same risk per unit of formaldehyde as the risk associated with inhaling gaseous formaldehyde, then long-term vaping is associated with an incremental lifetime cancer risk of 4.2×10−3. This risk is 5 times as high (…), or even 15 times as high (…) as the risk associated with long-term smoking.

Unsurprisingly with a claim like that, it gained huge worldwide publicity. The trouble is that this conclusion is completely unreliable and is based on measurements made in ‘dry puff’ conditions which no vaper will tolerate for more than an instant.  The calculated cancer risk is therefore a work of fiction. This paper and its flawed methodology attracted a barrage of criticism documented here by me:  Spreading fear and confusion with misleading formaldehyde studies and notably in technical posts by Konstantinos Farsalinos: here and here.

The next stage was to organise a proper complaint – this is now published.

Complaint to the New England Journal of Medicine calling for retraction

On 20th April 2015, Dr Farsalinos and I made a formal complaint to the NEJM calling for the paper to be retracted under guidelines published by the Committee on Publication Ethics (COPE).  40 experts in the field wrote a supporting letter to NEJM backing the complaint.

On 9th September 2015, the complaint was made public and published in the journal Addiction, along with a letter summarising the case for retraction, a reply from the authors of the NEJM paper, and a response from Bates/Farsalinos to their reply. It is now on the record and at the links below as published in Addiction, October 2015 online version.

  1. Letter from Bates/Farsalinos to Addiction outlining the basis of the case for retraction from NEJM. Research letter on e-cigarette cancer risk was so misleading it should be retracted
  2. Reply from some of the original authors of the paper published in NEJM (Pankow et al): Formaldehyde from e-cigarettes—it’s not as simple as some suggest.  This fails to address or acknowledge the weakness in their method…
  3. Further response to Pankow et al, by Bates/Farsalinos reiterating the central flaw in their work. E-cigarettes need to be tested for safety under realistic conditions
  4. Addiction includes as Supplementary material the Bates/Farsalinos April 2015 detailed complaint to NEJM and April 2015 supporting letter to NEJM from 40 experts – this is the first public visibility of these documents.

Guide to the case for retraction so far

The editors of the New England Journal of Medicine declined to withdraw the paper – we were not surprised by this. But neither do we think they mounted a credible argument of defence of the paper.

I have documented the case for retraction and all the exchanges relevant to this case.   It meets the criteria for retraction under the COPE Retractions Guidelines – the findings are completely unreliable and the “integrity of the academic record” is compromised. The worldwide publicity generated was based on a wholly flawed methodology and the paper continues to be cited in formal literature and by activists as if it is is meaningful for human exposure.

  1. A short guide to why the Hidden Formaldehyde paper should be retracted under COPE guidelines: Hidden formaldehyde in e-cigarette aerosol: summarising the case for retraction
  2. A full account of all the exchanges related to this case: E-cigarettes and formaldehyde – anatomy of a flawed study– including the exchanges the editor of the NEJM.

Updates

My comment for media

Clive Bates said:

The paper on e-cigarettes and formaldehyde published in the New England Journal of Medicine created worldwide alarming media headlines suggesting e-cigarettes could create certain cancer risks that would be five to fifteen times higher than for cigarette smoking. But it turns out this was based on completely unrealistic e-cigarette measurements using a flawed methodology that should not have been used to characterise human exposure or cancer risk. The findings are unreliable, the publicity unjustified and, under ethical guidelines designed to protect the integrity of the academic record, it follows that the paper should be retracted.  We will continue to press the authors and the journal to do the right thing with this paper, which is to pull it.  

24 thoughts on “Flawed e-cigarette formaldehyde paper should be retracted – formal complaint and supporting letter published”

  1. Thanks Clive and Dr F, for your usual, diligent efforts on correcting the misinformation. Thank you both for committing the time to this, it can’t be easy, we all have jobs, family etc., I really appreciate the extra yards that you two and others put in towards promoting vaping :)

  2. Thank you so much for this. I am an ex cigarette smoker of 30 years and have done hours of research on the effects of vaping. It is extremely close to harmless.
    I am very concerned with the level of fear mongering that is all over the press and in the media in regards to vaping. I even saw a report where the journalist compared “FDA approved cigarette additives” with non-approved vaping, and clearly favored cigarettes. Just wow. Hundreds of thousands of people could be spared slow, painful deaths and certain deterioration of health/quality of life from smoking cigarettes if they were properly informed of the benefits of vaping.
    I am extremely grateful to you and your colleagues for trying to combat this very real problem, which is big tobacco and government denying human beings a safer alternative to cigarettes and/or an incredible cessation tool.
    Thank you!!

  3. Thank you so much for your efforts to try to get this publication revoked. My 23 year old son has some serious mental health issues and when he saw the media coverage on this paper he decided that vaping is much worse than vaping and is still smoking. Publishing this poorly designed research will cost many lives. It makes me unbelievably angry. I just hope my son isn’t one of them.

  4. If I was to endanger a life by any other means, I would expect to be hauled before the courts. Isn’t it about time someone brought these shisters to book?

  5. Thank you Clive Bates and Dr. Farsilinos for your hard work on our behalf. This is another so called health related organization that I will no longer believe. If they will lie about this, what else do they lie about? So many are shooting themselves in the foot and becoming known for their unreliable information.

    Annette Huppatz, have your son visit CASAA.org and E-Cigarette-Forum.com. He will have a wealth of information to study, and all his questions will be answered by friendly knowledgeable people. Media coverage is rarely truthful about vaping. Media is another organization that has sadly given up research for screaming headlines instead.

  6. Thank you Clive Bates and Dr.Farsalinos,for keeping up the fight against these

    shysters.They care more for the Big Tobacco Bucks than saving lives.I saw my

    husband’s aunt die from lung cancer,and let me tell you,she was in terrible and

    agonizing pain,but God’s Grace took her fast and we’re all so grateful.Watching

    her coughing up black fleme and struggling to breath was painful to watch.

    I am forever grateful that I was able to be free of cigarettes the very first

    time I tried vaping.I no longer vape with nicotine but still enjoy vaping with

    flavors.

  7. Nice work, as usual, Clive.

    Have you contacted Portland about this? Another route for COPE is via the authors’ institution(s). Farsalinos has just published this http://www.ecigarette-research.org/research/index.php/whats-new/whatsnew-2015/231-form4revealing that they’ve now been given an obscene amount of money to investigate further. This could be useful leverage. It’s very embarrassing for a university when a huge grant is wasted on poor quality research. At the very least they should ensure that these individuals convene a properly expert steering group and demonstrate that they understand the technology properly.

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