Addiction refuses to allow discussion of industry ties to criticism of our “softening paper”

In June 2015 we published our paper “The smoking population in the USA and EU is softening not hardening” in the journal Tobacco Control. We showed that as smoking prevalence has declined over time, quit attempts increased in the USA and remained stable in Europe, US quit ratios increased (no data for EU), and consumption dropped in the USA and Europe. These results contradict the hardening hypothesis which is often used as part of the tobacco industry’s strategy to avoid meaningful regulation and protect its political agenda and markets, claiming that there is a need for harm reduction among those smokers who “cannot or will not quit.” Indeed, rather than “hardening” the remaining smoking population is “softening.”
 
In February 2016 we received an email from Robert West, editor of the journal Addiction, informing us that Addiction was about to publish an article by Plurphanswat and Rodu entitled “A Critique of Kulik and Glantz: Is the smoking population in the US really softening?” whose sole purpose was to critique our Tobacco Control paper, and offered to let us respond to the criticism.
 
The fact that Plurphanswat and Rodu sent their paper to Addiction was unusual because normal scientific procedure would have had them sending a letter to the editor of the journal that originally published the work (Tobacco Control).
 
As detailed below, we did respond, noting that Plurphanswat and Rodu’s paper followed the well-established pattern of tobacco industry-funded researchers trying to create controversy about research inconsistent with industry interests, the fact that Rodu had understated his financial ties to the industry, and, of course, showing how their criticism was based on statistical error that they made.
 
Addiction rejected our response because we would not delete the first two points and limit our response only to the statistical issue. 
 
This blog post includes the response that Addiction rejected so that readers of Plurphanswat and Rodu’s critique do not think we did not have a response.  We also include a summary of our interactions with the journal and the related email correspondence.
 
THE REJECTED RESPONSE
 
Consider the Source
 
“Harm reduction” is a key part of the tobacco industry’s strategy to avoid meaningful regulation and protect its political agenda and markets.[1] This agenda is premised on the existence of “hard core” smokers who “cannot or will not” quit.[2-4] Our paper, “The smoking population in the USA and EU is softening not hardening”,[5] undermined this agenda because it showed that, contrary to the hardening hypothesis, as smoking prevalence has declined over time, quit attempts increased in the USA and remained stable in Europe, US quit ratios increased (no data for EU), and consumption dropped in the USA and Europe.
 
There is a longstanding pattern of tobacco industry-funded experts writing letters criticizing work that threatens the industry’s position, first described in 1993 by then-JAMA Deputy Editor Drummond Rennie.[6] Rodu and various co-authors have written several such letters.[7-10] Another similarity to past efforts is industry-linked experts submitting critiques of a paper published in one journal to another,[11-15] which is also the case here, with this critique of our paper published in Tobacco Control being published in Addiction. One would have expected any criticism to have been published as a letter in Tobacco Control.
 
Addiction requires “full disclosure of potential conflicts of interest, including any fees, expenses, funding or other benefits received from any interested party or organisation connected with that party, whether or not connected with the letter or the article that is the subject of discussion.” As with another investigator supported by the tobacco industry,[16] the conflict of interest statement Plurphanswat and Rodu provide may not truly reflect the extent of Rodu’s involvement with the tobacco industry. For example:
 
• Rodu’s Endowed Chair in Tobacco Harm Reduction Research at the University of Louisville is funded by the U.S. Smokeless Tobacco Company (US Tobacco) and Swedish Match North America, Inc.[17]
 
• Rodu is a Senior Fellow at the Heartland Institute, which has received tobacco industry funding.[18-20]
 
• Rodu is a Member and Contributor to the R Street Institute, which has received tobacco industry funding.[19,21]
 
• Before moving to Louisville, Dr. Rodu was supported in part by an unrestricted gift from the United States Smokeless Tobacco Company to the Tobacco Research Fund of the University of Alabama at Birmingham.[8]
 
• Rodu was a keynote speaker at the 2013 Tobacco Plus Expo International, a tobacco industry trade fair to discuss “How has the tobacco retail business evolved; where was it fifteen years ago, where is it today and where is it going”.[22]
 
• Rodu has worked with RJ Reynolds executives between at least 2000 and 2009 to help promote industry positions on harm reduction, including specific products.[23-26]
 
The substance of Plurphanswat and Rodu’s criticism is that the statistically significant negative association between smoking prevalence and quit attempts and the positive association between prevalence and cigarettes smoked per day both become non-significant when more tobacco control variables are included in the model (state fixed effects, cigarette excise taxes, workplace smoking bans and home smoking bans). The problem with including all these variables is that it results in a seriously overspecified model, which splits any actual effects between so many variables that all the results become nonsignificant. The regression diagnostic for this multicollinearity is the Variance Inflation Factor (VIF); values of the VIF above 4 indicate serious multicollinearity. For the United States, adding all the other variables increases the VIF for the effect of changes in smoking prevalence from 1.8 in our model for quit attempts to 16.7, and from 1.8 in our model to 17.9 for cigarettes per day, respectively. Plurphanswat and Rodu’s model is a textbook case of why one has to be careful not to put too many variables in a multiple regression.
 
The Plurphanswat and Rodu criticism misrepresents our conclusions. We did not argue that drops in prevalence caused increased quit attempts and reduced consumption; we simply present the observation that, as prevalence falls, quit attempts increase and consumption fall or remain constant, which is the exact opposite of what the hardening hypothesis predicts.
 
Funding
         
This work was supported by National Cancer Institute Grants CA-61021 and CA-113710. The sponsor played no role in the conduct of the research or preparation of the manuscript.
 
Declaration of interests
 
Nothing to disclose.
 
[References appear at the end of this blog post]
 
CORRESPONDENCE ABOUT CONFLICT OF INTEREST
 
When Addiction invited us to respond, they informed us of the journal’s strict conflict of interest disclosure policy, which requires “a full disclosure of potential conflicts of interest, including any fees, expenses, funding or other benefits received from any interested party or organisation connected with that party, whether or not connected with the letter or the article that is the subject of discussion”.
 
Plurphanswat and Rodu’s original declaration of interest stated: “Competing interest: The authors are supported by unrestricted grants from tobacco manufacturers to the University of Louisville, and by the Kentucky Research Challenge Trust Fund. Neither has any financial or other personal relationship with regard to the sponsors.”
 
We then alerted the journal to the fact that Plurphanswat and Rodu had supplied a declaration of interest that was incomplete at best, playing down their involvement with the tobacco industry.
 
The journal contacted Plurphanswat and Rodu, who provided a revised statement that read, “Declaration of interests: Since 2005 Dr Rodu has been supported by the Kentucky Research Challenge Trust Fund and by unrestricted grants to the University of Louisville from tobacco manufacturers (Swedish Match AB, U.S. Smokeless Tobacco Company, Reynolds American Inc. Services, Altria Client Services, and British American Tobacco). Dr Plurphanswat has been supported by these grants since 2013.”   
 
As detailed in the response we submitted to Addiction, we still do not believe that this statement fully discloses their level of engagement with the industry.
 
FULL EMAIL CORRESPONDENCE WITH ADDICTION:
 
01-Feb-2016
 
Dear Prof. Glantz:
 
Re: "Reply to Rodu and Plurphanswat [draft title]"
 
I am writing to let you and Dr Kulik know that we will publish the attached article for our Journal Club series. The article has been peer reviewed. We are keen to ensure that authors of articles discussed in the Journal Club series have an opportunity to give their point of view. You are very welcome to submit a response that we would be happy to consider for publication. Obviously I cannot guarantee publication because it will have to meet the usual standards of quality required by the journal, but we will do our best to work with you to ensure that your point of view is fairly represented. The authors of the Journal Club article may then be given a chance to respond subject to the same caveats.
 
I should point out that, as with all papers, we will require a full disclosure of potential conflicts of interest, including any fees, expenses, funding or other benefits received from any interested party or organisation connected with that party, whether or not connected with the letter or the article that is the subject of discussion.
 
If you wish to write a response to appear with the Journal Club article, please would you let me know as soon as possible, and submit the response within the next three weeks. We can provide some additional time if you need it, but if you wish to respond but cannot manage it within that timescale, your response would be published as a letter as soon as possible thereafter.
 
Please try to keep your reply under 2000 words.
 
With best wishes,
 
Robert West
Editor-in-Chief, Addiction
 
 
08-Feb-2016
To Addiction:
We are preparing our scientific response to Plurphanswat and Rodu’s paper “A Critique of Kulik and Glantz: Is the smoking population in the US really softening?”  Before we submit our response, however, we wish to bring your attention to extensive undisclosed conflicts of interest.Addiction’s conflicts of interest policy states, “we require a full disclosure of potential conflicts of interest, including any fees, expenses, funding or other benefits received from any interested party or organisation connected with that party, whether or not connected with the letter or the article that is the subject of discussion.”
 
Plurphanswat and Rodu list their competing interests as follows: “The authors are supported by unrestricted grants from tobacco manufacturers to the University of Louisville, and by the Kentucky Research Challenge Trust Fund. Neither has any financial or other personal relationship with regard to the sponsors.”
 
This statement is vague about the specific “tobacco manufacturers” that have and are funding Dr. Rodu and leaves out many details of his extensive, longstanding and ongoing relationship with tobacco companies on “the subject of discussion in our paper.”
 
For example:
 
•             Rodu’s Endowed Chair in Tobacco Harm Reduction Research at the University of Louisville is funded by the U.S. Smokeless Tobacco Company (US Tobacco) and Swedish Match North America, Inc. [1]. 
 
•             Rodu is a Senior Fellow at the Heartland Institute, which has a long history of tobacco industry funding [2-4].
 
•             Rodu is a Member and Contributor to the R Street Institute, which also receives tobacco industry funding [3,5].
 
•             Before Rodu moved to Louisville, he was at the University of Alabama, Birmingham, where US Tobacco supported his work for years to promote smokeless tobacco for harm reduction [6].
 
•             Rodu was a keynote speaker at the 2013 Tobacco Plus Expo, a tobacco industry trade fair financed by major multinational tobacco companies.[7]
 
•             In an email exchange in 2000 between Rodu and RJ Reynolds Tobacco Company’s then vice president of product evaluation David Doolittle working with Targacept (Don deBethizy), Rodu wrote, “Thanks for your call. Hopefully, we will be discussing the risks of tobacco use and risk reduction in a calm, rational manner much more often in the future. Keep my name in your rolodex as a supporter of such measures” [8].  Rodu subsequently invited RJR to demo Eclipse at his Medical Center at UAB and give a seminar on harm reduction strategies for smoking  [9].  This is just one example disclosing his close cooperation and working relationship with the tobacco industry.
 
•             In the same 2000 email exchange David Doolittle wrote to Seth W. Moskowitz, then in RJR’s public relations department, regarding Rodu’s invitation to UAB and , “SETH - thanks for forwarding this [Rodu’s email], do not miss any opportunity to put us in contact with scientists who email the company! This type of professional interaction is priceless for enhancing RJR's credibility and getting our message out!!” [9].   Rodu had apparently been offering RJR consultation as to how to get their message about harm reduction out better with regard to marketing Eclipse. In that email contact which Rodu initiated, he wrote: “It seems that you have missed an opportunity to roll out this product [Eclipse] with a slightly revised message.  Such as: ‘Scientists have associated the toxins produced by burning tobacco are associated with cancers, heart diseases and emphysema. RJR is releasing Eclipse as a tobacco product which delivers only xx% of (specific toxins) when compared with currently available products because the tobacco is heated rather than burned.’ It would seem that your discussion of health risks places you in a difficult position and open to criticism” [9].  Here Rodu is talking about effective marketing claims—the type of “safer cigarette” claims disallowed by the FDA currently—backed by scientific elusiveness. Making specific rather than broad claims in their marketing, he confirmed, would cover RJR’s back should the FDA or another legal body challenge their health claims.
 
•             In 2008, Rodu was still in contact with RJR, working with them on refining their harm reduction strategies for Camel Snus and other products [10]. And in 2009, Rodu and RJR Executive Vice President of Public Affairs Tommy Payne were exchanging emails regarding harm reduction to mount scientific evidence for smokeless tobacco as a safer alternative to cigarettes [11].
 
This is only a small sample of Rodu’s extensive relationship with the tobacco industry.  A search for “Rodu” in the Truth Tobacco Documents Library produces 5349 hits (https://idl.ucsf.edu/results/#q=rodu&h={%22hideDuplicates%22%3Afalse%2C%22hideFolders%22%3Atrue}&cache=true&count=5349).
 
These kinds of incomplete misleading conflicts of interest are an ongoing pattern among academics with longstanding financial relationships with the tobacco industry [12], which makes it important that the journal vigorously implements its stated policy.
 
Please advise us whether this situation will lead you to reverse your decision to accept Rodu’s paper. 
 
At the very least the journal should require a complete and accurate description of Rodu’s” full disclosure of potential conflicts of interest, including any fees, expenses, funding or other benefits received from any interested party or organisation connected with that party, whether or not connected with the letter or the article that is the subject of discussion.” 
 
On a related issue, Plurphanswat and Rodu’s paper has an odd title focused on us as individuals rather than the scientific substance of our paper. This approach seems more designed to reinforce a public relations position (in internet searches) than a meaningful scientific discussion. 
 
Please advise us on how you plan to proceed.
 
Thank you,  
 
Margarete C. Kulik and Stanton A. Glantz
 
REFERENCES
1. University of Louisville. Available at http://louisville.edu/bucksforbrains/descriptions/tobaccoharmreduction/, accessed February 2016
 
2. The Heartland Institute. Available at https://www.heartland.org/dr-brad-rodu, accessed February 2016.
 
3. Nitzkin email string "Dialogue with Tobacco Industry re 3d Party Research". Available at https://tobacco.ucsf.edu/sites/g/files/tkssra4661/f/u9/Nitzkin-email-string.pdf, accessed February 2016.
 
4. The Center for Media and Democracy. Available at http://www.prwatch.org/news/2012/07/11671/tobacco-can-cure-smoking-and-other-highlights-alecs-annual-meeting-salt-lake, accessed February 2016.
 
5. The R Street Institute. Avaliable at http://www.rstreet.org/people/brad-rodu/, accessed February 2016.
 
6. Rodu B, Cole P (2006) A deficient study of smokeless tobacco use and cancer. Int J Cancer 118: 1585; author reply 1586-1587.
 
7. Tobacco Plus Expo 2013. Available at https://web.archive.org/web/20121219001140/http://tobaccoplusexpo.com/tpe_keynotes.html, accessed February 2016.
 
8. University of Alabama, Debethizy JD, Doolittle DJ, Rodu B. Followup from Brad Rodu. 2000 April 26. RJ Reynolds. https://industrydocuments.library.ucsf.edu/tobacco/docs/hklw0187.
 
9. RJR, University of Alabama, Burger GT, Lyalls TM, Doolittle D, Moskowitz SW, Rodu B, Smith C, Williard S. ECLIPSE and Dr. Brad Rodu. 2000 April 20; 2000 April 26. RJ Reynolds. https://industrydocuments.library.ucsf.edu/tobacco/docs/lklw0187.
 
10. Hawkins SC. TTM - Brad Rodu for 122006 (20061200).PPT. 2008 December 01. RJ Reynolds. https://industrydocuments.library.ucsf.edu/tobacco/docs/xrvm0222.
 
11. Reynolds American, Payne TJ, Rodu B. Thanks. The following studies (attached) provide almost identical evidence that appropriate marketing of smokeless products would result in a 10% drop in smoking prevalence. 2009 February 27; 2009 March 02. RJ Reynolds. https://industrydocuments.library.ucsf.edu/tobacco/docs/yjpl0222.
 
12. Bero LA, Glantz S, Hong MK (2005) The limits of competing interest disclosures. Tob Control 14: 118-126.
 
 
11-Feb-2016
Dear Prof Glantz,
 
Thank you for notifying us of this. The senior editorial team has registered your concern and is asking the authors for much fuller disclosure of their competing interests. The editorial team will also review the title of their paper to see whether it should be amended. The paper itself was considered, after substantial amendment, to make valid points following peer review, but if there are valid counter-arguments the journal would be pleased to publish these.
 
Best wishes,
Jean
 
Jean O'Reilly
Editorial Manager, Addiction
 
 
11-Feb-2016
To Addiction:
 
We will prepare our response once we see the final manuscript with the new conflict of interest disclosure and title.
 
I can tell you, however, that the results are easily dismissed on the grounds that the authors violated basic statistical methods.
 
As we noted in our original email to you, letters like this are part of a longstanding tobacco industry PR campaign to discredit bothersome research.  Given the fact that Rodu’s paper was controversial among the editors and that he violated your strong conflict of interest disclosure rules – something that you only found out about because we spent substantial time digging up some of the details, we will be discussing these issues in our response.  THAT, rather than  the statistical manipulation Rodu used, is the important thing to be learned from his letter. 
 
As we said before, you might want to reconsider publishing his piece. 
 
Let us know what you decide.
Stan Glantz
 
 
11-Feb-2016
Dear Prof Glantz and Dr Kulik,
 
The version of the paper you were sent is the one that has been accepted for publication after peer review. The title uses the names of the authors of the paper being commented on in order to identify it. It will not change substantially though we are considering how to make this clearer. 
 
The authors are being asked to respond to your allegations about undisclosed conflicts of interests, though we note that they have acknowledged involvement with the tobacco industry so the issue you raise is about the extent of their engagement. If a fuller disclosure statement is warranted, this will be published.
 
You are being given an opportunity to respond to the points they raise in their article. If you are able to respond in a timely manner and your response passes peer review, we will aim to publish it with the original. If not then your response can be published as a letter when it is available. Please restrict your arguments to the scientific issues raised. 
 
Best wishes,
Jean
 
Jean O'Reilly
Editorial Manager, Addiction
 
 
11-Feb-2016
To Addiction:
We will prepare our response after you send the final version of Rodu’s paper, including the revised conflict of interest disclosure.
 
Stan Glantz
 
 
25-Feb-2016
Dear Prof Glantz and Dr Kulik,
 
Attached you will find a revised version of Plurphanswat and Rodu's Journal Club paper, with revised title [changed to “Is the smoking population in the US really softening?”] and declaration of interests highlighted.  These changes have been approved by Addiction’s senior editorial team.  Thank you for your patience while we investigated the issues you raised over their disclosure statement.
 
I have set a deadline of 17 March (three weeks) for your response; if you think you will need more time than that, please let me know. 
 
Best wishes,
Jean
 
Jean O'Reilly
Editorial Manager, Addiction
 
04-Apr-2016

Dear Prof. Glantz:

ADD-16-0290 - "Consider the Source"

Thank you for your reply to the Rodu and Plurphanswat Journal Club article.  Ultimately, regardless of what we might perceive as potential biases in the reasons for conducting studies, or as here, follow-ups of published studies, it is the science that must either stand or fall on its technical merits. In the final section of your reply article, starting, "The substance of...," you appear to make a strong case that Rodu and Plurphanswat's science may not stand up. This is extremely important to focus on. To this end, I would like to publish this section alone, and to give the authors the opportunity to reply.  If you are willing to do this, I would also ask you to change the title of your letter to something more along the lines, "Model over-specification and the hardening hypothesis".  

If you are agreeable to this plan, please resubmit your paper as a revision, including the section I mention above and a new title….

With best wishes,

John Stapleton
Methods Editor
 
 
15-Apr-2016
Dear Dr. Stapleton,
 
We respectfully disagree that “potential biases in the reasons for conducting studies, or as here, follow-ups of published studies” is not relevant to the discussion of our Tobacco Control paper.  As indicated by the citations in our manuscript the industry strategy manifest in the Rodu manuscript has been the subject of scholarly research that is directly relevant to this exchange.  
 
We cannot help but note that this whole interchange is a bit odd, since the Rodu manuscript is a criticism of a paper we published in another journal, Tobacco Control.  Normal scientific protocol would have had him submitting a letter to the editor criticizing our paper to that journal which, if the editors found reasonable, would have been published with our response.
 
Now, Addiction has turned that process on its head, by putting us in the position of criticizing Rodu’s paper as if it was original research, then giving him the last word.
 
The Feb 1, 2016 email inviting us to respond to Rodu's paper, as part of Addiction’s “Journal Club” series inviting our submission assured us that the editors “are keen to ensure that authors of articles discussed in the Journal Club series have an opportunity to give their point of view. You are very welcome to submit a response that we would be happy to consider for publication. Obviously I cannot guarantee publication because it will have to meet the usual standards of quality required by the journal, but we will do our best to work with you to ensure that your point of view is fairly represented.”
 
Making the changes that you request will mean that the resulting manuscript would not fairly represent our point of view.
 
Therefore, we request that our comment be published as submitted.
 
Stanton Glantz, PhD
Margarete Kulik, PhD
 
27-Apr-2016
Dear Stanton and Margarete,
 
I am truly sorry that you have declined to accept the journal's invitation to publish the potentially important technical point raised in your letter in response to R & R’s article. I considered that this point had prima-facia merit and as such should be published in the journal. Normally, in a situation like this, I would simply accept your decision and move on to the many other authors and articles that are awaiting my attention. However, in this case, I would like you to re-consider my offer a little longer.
 
I must say at the outset of my plea that I do consider the R & R article as an original piece, rather than as a letter of criticism. It is a full analysis and report of the dataset which you had previously analysed and, as I’m sure you are aware, this type of approach to science is now actively encouraged by research policy makers regarding public datasets. I would also stress that unless you decide to concede any reply they make – if indeed they do reply – you are free to write a letter in response to anything they might say. There is absolutely no question of them having the last word, as you say, provided that you have something of value to add.
 
As I have previously said, no matter what the motivation of R & R, if you believe that they have made a technical error which discounts their analysis, then I urge you to allow this to be aired in the journal. If, as you suggest, the authors had a somewhat unethical motivation for writing their article, then this will surely best be exposed by exposing errors in their science. If their science can be shown to fail, this strengthens considerably your case regarding their original motivation for their analysis.
 
I very much hope that you will see the strategic merit of my suggestion and reconsider.
 
Yours,
 
John Stapleton
 
 
27-Apr-2016
 
Dear Dr. Stapleton,
 
We appreciate you wanting to give us more time, but that will not change our view that making the changes you want to our response substantially changes it in a way that will mean that it would no longer accurately represent our views.
 
In the last paragraph of your email you yourself state that "...if you believe that they have made a technical error which discounts their analysis, then I urge you to allow this to be aired in the journal. If, as you suggest, the authors had a somewhat unethical motivation for writing their article, then this will surely best be exposed by exposing errors in their science. If their science can be shown to fail, this strengthens considerably your case regarding their original motivation for their analysis."
 
It is important to emphasize that we took care in our response not to attribute motives to Rodu in his coauthor, but rather note that his article is similar to ones prepared by him and other tobacco consultant in the past.  As you note, pointing to the mistakes in the article is an integral point – but not the only point – in our response.  However, you are unfortunately not allowing us to build this case by not letting us publish information pertaining to this very point.
 
Should you maintain your position of not publishing our full response, it is important that you be clear in however you characterize our position that we have not "declined to accept the journal's invitation" to respond to the Rodu paper.  Quite the contrary, we have invested substantial effort in the research presented in the response that we submitted and that you rejected.
 
This is an important distinction, because if Addiction characterizes our response as "declining to respond" makes it sound like we did not respond or did not have a response.  That is quite different from a situation in which we have responded in a way that the journal refused to publish.
 
We again appeal to you to publish our response as written.
 
Should you stick with your decision to reject the response we have submitted, we will be publishing this entire email exchange on my blog to ensure that people know that we had a full response that Addiction rejected.
 
Please advise us of your final decision by Monday May 2, so that we will know how to proceed.
 
Margarete Kulik
Stanton A. Glantz
 
 
29-Apr-2016
Dear Professor Glantz,
 
I am truly sorry that you have declined for a second time to accept the journal’s offer to publish the key scientific part of your letter, which I believe may have had sufficient substance to not go unchallenged. I am also somewhat surprised at your decision on this occasion, because I know you to be a pre-eminent worker in this field who always tries to place scientific probity and the unbiased interpretation of data before all else.
 
I wish you every success in your future work and I hope that you will continue to consider Addiction for your articles.
 
Yours,
 
John Stapleton
 
 
29-Apr-2016
Dear Dr. Stapleton,
 
That’s' the point.
 
Again, we request that when you publish Rodu's paper you do so in a way that in no way implies that we did not have a response.
 
Stanton Glantz
Margarete Kulik
 
REFERENCES
 
1. Peeters S, Gilmore AB (2015) Understanding the emergence of the tobacco industry's use of the term tobacco harm reduction in order to inform public health policy. Tob Control 24: 182-189.
 
2. Abrams DB (2014) Promise and peril of e-cigarettes: can disruptive technology make cigarettes obsolete? JAMA 311: 135-136.
 
3. Polosa R, Rodu B, Caponnetto P, Maglia M, Raciti C (2013) A fresh look at tobacco harm reduction: the case for the electronic cigarette. Harm Reduct J 10: 19.
 
4. Nitzkin JL (2014) The case in favor of E-cigarettes for tobacco harm reduction. Int J Environ Res Public Health 11: 6459-6471.
 
5. Kulik MC, Glantz SA (2015) The smoking population in the USA and EU is softening not hardening. Tob Control doi:10.1136/tobaccocontrol-2015-052329 Published online 24 June 2015.
 
6. Rennie D (1993) Smoke and letters. JAMA 270: 1742-1743.
 
7. Rodu B, Phillips CV (2015) Letter by Rodu and Phillips regarding article, "Discontinuation of smokeless tobacco and mortality risk after myocardial infarction". Circulation 131: e422.
 
8. Rodu B, Cole P (2006) A deficient study of smokeless tobacco use and cancer. Int J Cancer 118: 1585; author reply 1586-1587.
 
9. Rodu B, Plurphanswat N, Phillips CV (2015) Discrepant results for smoking and cessation among electronic cigarette users. Cancer. 121(13):2286-7. doi: 10.1002/cncr.29307. Epub 2015 Mar 4.
 
10. Rodu B, Heavner KK (2009) Errors and omissions in the study of snuff use and hypertension. J Intern Med 265: 507-508; author reply 509-510.
 
11. Glantz SA, Parmley WW (1992) Passive smoking causes heart disease and lung cancer. J Clin
Epidemiol 45: 815-819.
 
12. Mantel N (1992) Dubious evidence of heart and cancer deaths due to passive smoking. J Clin
Epidemiol 45: 809-813.
 
13. Glantz SA, Parmley WW (1991) Passive smoking and heart disease. Epidemiology, physiology, and biochemistry. Circulation 83: 1-12.
 
14. Jensen RP, Luo W, Pankow JF, Strongin RM, Peyton DH (2015) Hidden formaldehyde in e-cigarette aerosols. N Engl J Med 372: 392-394.
 
15. Bates CD, Farsalinos KE (2015) Research letter on e-cigarette cancer risk was so misleading it should be retracted. Addiction 110: 1686-1687.
 
16. Bero LA, Glantz S, Hong MK (2005) The limits of competing interest disclosures. Tob Control 14: 118-126.
 
17. University of Louisville. Available at http://louisville.edu/bucksforbrains/descriptions/tobaccoharmreduction/, accessed February
2016.
 
18. The Heartland Institute. Available at https://www.heartland.org/dr-brad-rodu, accessed February 2016.
 
19. Nitzkin email string "Dialogue with Tobacco Industry re 3d Party Research". Available at
https://tobacco.ucsf.edu/sites/g/files/tkssra4661/f/u9/Nitzkin-email-s..., accessed
February 2016.
 
20. The Center for Media and Democracy. Available at
http://www.prwatch.org/news/2012/07/11671/tobacco-can-cure-smoking-and-o...
alecs-annual-meeting-salt-lake, accessed February 2016.
 
21. The R Street Institute. Avaliable at http://www.rstreet.org/people/brad-rodu/, accessed February 2016.
 
22. Tobacco Plus Expo 2013. Available at
https://web.archive.org/web/20121219001140/http://tobaccoplusexpo.com/tp..., accessed February 2016.
 
23. University of Alabama, Debethizy JD, Doolittle DJ, Rodu B. Followup from Brad Rodu. 2000 April 26. RJ Reynolds. https://industrydocuments.library.ucsf.edu/tobacco/docs/hklw0187.
 
24. RJR, University of Alabama, Burger GT, Lyalls TM, Doolittle D, Moskowitz SW, Rodu B, Smith C, Williard S. ECLIPSE and Dr. Brad Rodu. 2000 April 20; 2000 April 26. RJ Reynolds.
https://industrydocuments.library.ucsf.edu/tobacco/docs/lklw0187.
 
25. Hawkins SC. TTM - Brad Rodu for 122006 (20061200).PPT. 2008 December 01. RJ Reynolds.
https://industrydocuments.library.ucsf.edu/tobacco/docs/xrvm0222.
 
26. Reynolds American, Payne TJ, Rodu B. Thanks. The following studies (attached) provide almost identical evidence that appropriate marketing of smokeless products would result in a 10% drop in smoking prevalence. 2009 February 27; 2009 March 02. RJ Reynolds.
https://industrydocuments.library.ucsf.edu/tobacco/docs/yjpl0222.
 
 

Comments

Comment: 

In my view, the story here is essentially one of censorship. It is important to note that when asking authors to provide a response to criticism of their work, journals typically allow authors wide discretion to respond as they see fit. The response is not subject to the type of rigorous review that an original manuscript would receive because the authors essentially have a "right" to respond to the criticism of their article.
Of course, the journal will screen the response for any material that is inappropriate or out of line, but I have never seen a journal dictate the grounds upon which the authors can respond to the criticism. And I have never seen a journal dictate that the authors cannot use a particular line of argument in responding.
It is entirely appropriate to address conflicts of interest that are present because these conflicts may well have influenced the conduct of the research and the interpretation and reporting of the results. Addressing and considering conflicts of interest is not only a legitimate aspect of responding to a critique, but it is a "scholarly" response. Kulik and Glantz went beyond the call of duty here and provided a detailed accounting of the conflict of interest, noting and documenting the conflicts with 26 references (which is very strong documentation considering that this is merely a response to a letter to the editor).
To argue that addressing conflicts of interest is not relevant to evaluating a manuscript is to undermine the entire purpose of requiring that such conflicts be disclosed. Essentially, what the journal is saying is that while they require authors to disclose conflicts, they do not see those conflicts as having any relevance to the evaluation of the research. Well if that is the case, then why bother publishing the conflict of interest disclosures?
The very purpose of disclosing conflicts of interest is to allow readers to take that conflict into consideration <strong;in evaluating the validity</strong; of the article.
Now I firmly believe that one should never simply dismiss an article because of a conflict of interest; every article must also be evaluated in terms of its scientific content. However, it is not appropriate to go to the opposite extreme and argue that conflicts of interest must be ignored. Both are legitimate and important points to consider in evaluating a paper. And in this case, Kulik and Glantz did also address the scientific aspects of the statistical analysis conducted in the critique.
The rest of the story is that the refusal to allow the authors to address conflicts of interest present in the paper criticizing their work essentially amounts to censorship. The journal is dictating the scholarly points that can and cannot be made and not allowing the authors discretion in how they respond to criticism of their own work. Moreover, the arguments made by the journal in rejecting the authors' response undermine the entire purpose of conflict of interest disclosure.
We do not publish conflict of interest disclosures and then right after that, publish an additional disclosure which reads: "In evaluating this paper, please ignore the above conflicts of interest." But that is exactly what the journal is asking its readers to do.

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