Thursday, March 10, 2011

Dishonest Disclosures? Six Articles on Health Effects of Hookah Use Fail to Mention that Research Sponsor Was Directed by a Tobacco Industry Executive

Six different papers on hookah (also called waterpipe, shisha, or narghile) use, published between 2008 and 2010 and funded by the International Development Research Centre, failed to report any conflicts of interest. The papers, their funding sources, and their conflict of interest statements, are as follows:

1. Al Rashidi M, Shihadeh A, Saliba NA. Volatile aldehydes in the mainstream smoke of the narghile waterpipe. Food and Chemical Toxicology. 2008 Nov;46(11):3546-9.

Funding source: International Development Research Centre and National Cancer Institute

Conflict of interest statement: "The authors declare that there are no conflicts of interest."

2. Monzer B, Sepetdjian E, Saliba N, Shihadeh A. Charcoal emissions as a source of CO and carcinogenic PAH in mainstream narghile waterpipe smoke. Food and Chemical Toxicology. 2008 Sep;46(9):2991-5.

Funding source: International Development Research Centre and University Research Board at the American University of Beirut

Conflict of interest statement: "The authors declare that there are no conflicts of interest."

3. Saleh R, Shihadeh A. Elevated toxicant yields with narghile waterpipes smoked using a plastic hose. Food and Chemical Toxicology. 2008 May;46(5):1461-6.

Funding source: International Development Research Centre and University Research Board at the American University of Beirut

Conflict of interest statement: "We have no conflict of interest in connection with the
research reported in this manuscript."

4. Sepetdjian E, Shihadeh A, Saliba NA. Measurement of 16 polycyclic aromatic hydrocarbons in narghile waterpipe tobacco smoke. Food and Chemical Toxicology. 2008 May;46(5):1582-90.

Funding source: International Development Research Centre and University Research Board at the American University of Beirut

Conflict of interest statement: "Nothing to declare."

5. Daher N, Saleh R, Jaroudi E, Sheheitli H, Badr T, Sepetdjian E, Al-Rashidi M, Saliba N, Shihadeh A. Comparison of carcinogen, carbon monoxide, and ultrafine particle emissions from narghile waterpipe and cigarette smoking: Sidestream smoke measurements and assessment of second-hand smoke emission factors. Atmospheric Environment 2010; 44(1): 8-14.

Funding source: International Development Research Centre and U.S. Public Health Service.

Conflict of interest statement: None.

6. Khalil J, Heath RL, Nakkash RT, Afifi RA. The tobacco health nexus? Health messages in narghile advertisements. Tobacco Control. 2009 Oct;18(5):420-1.

Funding source: International Development Research Centre

Conflict of interest statement: "None."

The Rest of the Story

What none of these papers disclose is that there is a significant conflict of interest:

The work was funded by an organization that is directed by a Chair who, at the time of the research and publications, was a tobacco industry executive.

The Chair of the International Development Research Centre is Barbara McDougall. Mrs. McDougall joined the Board in January 2007 and since December 2007 has directed the organization, serving as its Chairman.

Although her biography on the IDRC web site does not mention it, McDougall was, until last March, a tobacco industry executive.

From October 2004 to March 2010, McDougall was on the Board of Directors of Imperial Tobacco Company, which is owned by British American Tobacco. She served as the Chair of the Imperial Tobacco Canada Corporate Social Responsibility Committee, whose job it was to make it look like Imperial Tobacco is a socially responsible company, when in fact the company is the leading cause of cancer and heart disease in Canada.

Her 2006-2007 report starts by pretending that: "Being a socially responsible company is a top priority at Imperial Tobacco Canada." Obviously, that's a big lie, as Imperial continued to sell deadly tobacco products which serve as the leading cause of preventable deaths in all of Canada. In many respects, I view the insincere and fake efforts to make Imperial Tobacco to look socially responsible to be even more reprehensible than the actual production of cigarettes.

At any rate, the rest of the story is that despite the lack of any disclosed conflicts of interest, all of the above research was funded by an organization directed by a tobacco industry executive.

I therefore view these disclosures as being inaccurate and untruthful. Wouldn't it be important for the public to know that an article which compares the risks of hookah use with the use of cigarettes and other tobacco products was funded by an organization run by a tobacco industry executive? And not just any tobacco executive, but someone on the Board of Directors of the leading tobacco company in all of Canada.

I think it is shameful not to have such an important piece of information disclosed in these research articles. This is especially true since the conflict of interest could easily be perceived as affecting the conduct and reporting of the research findings. After all, hookah use is a potential competitor to the use of cigarettes and other tobacco products and Imperial Tobacco has a direct financial interest in the results of this research on the relative health effects of hookah use compared to the products which Imperial produces, markets, sells, and relies upon for its profits.

To not let readers of these articles know that the research sponsor was (at the time) run by a tobacco industry executive is irresponsible and undermines the purpose of conflict of interest disclosures.

Apparently, some or all of the researchers were not aware of this conflict of interest at the time they submitted their papers to the journals. A more recent article published by many of the same authors does disclose that the International Development Research Centre was chaired by a tobacco industry executive: "Revelations regarding IDRC Chairperson Barbara McDougall’s unfortunate ties to the tobacco industry were not known to the authors of this study at the time it was funded and executed". Strangely, however, the papers still state: "All other authors declare that they have no conflicts of interest."

I don't understand how they can make this statement. It can't be both ways. If the research sponsor was directed by a tobacco industry executive, then the researchers are conflicted, and that conflict needs to be disclosed. The fact that they did not know who the Chair of the Board was does not remove the conflict. Nor does the conflict mean that the researchers were biased. But the bias may come in at a higher level. For example, in the very decisions about what research to fund in the first place, having a tobacco industry executive as the Chair of the Board may influence those decisions. Studying hookah use seems to be a wise decision for a tobacco company Chair because it would help deflect attention of her products and put them onto hookah, a potential competitor.

Many researchers do not understand that a financial conflict of interest is not assessed by whether the researcher is biased or not. A researcher can be biased without any conflict of interest and a researcher could be unbiased with a serious conflict of interest. The presence of a conflict is assessed objectively by the financial relationships of the researcher and research sponsor. In this case, it is clear that there is an important conflict of interest. It doesn't mean the investigators were biased. It simply means that there is a financial conflict of interest which is relevant, and ethical considerations require that the conflict be disclosed to readers.

I want to make two other important points. First, although the investigators cannot be blamed, in some sense, for not disclosing the conflict because they apparently did not know about it, I would argue that there is some responsibility on their part because they should have known about it. I believe that when a researcher accepts funding from an organization, it is incumbent upon the researcher to understand who he or she is taking money from.

Second, these failed disclosures are not all in the past. While the PDF versions of the article can perhaps not be changed, the HTML versions of these articles certainly can be changed, and the conflict of interest statements could easily be updated, revised, or replaced. An erratum statement could easily be published noting the new information and the presence of a conflict. In other words, this is not just a mistake that happened in the past. It is, in a sense, an ongoing one.

It is important to point out that conflicts of interest are important not only in research that denies the health effects of tobacco products. Conflicts of interest are important in all research, even if it is reporting that tobacco use is harmful.

Finally, I should make it absolutely clear that I am making no statement about the merits of the findings of these articles. In no way should this commentary be construed as defending or supporting hookah use. In fact, this commentary is not about hookah use, it is about conflict of interest and the revelation of what appears to be a widespread failure on the part of six articles to disclose an important conflict in the research.

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