Monday, July 15, 2013

Anti-Smoking Researchers Still Hiding Tobacco Industry Funding, Failing to Disclose Conflict of Interest

A new study published this month in the Journal of the American College of Cardiology reports that secondhand smoke causes coronary artery calcification (an early sign of atherosclerosis) in nonsmokers.

(See: Yankelevitz DF, Henschke CI, et al. Second-hand tobacco smoke in never smokers is a significant risk factor for coronary artery calcification. JACC 2013; 6:651-657.)

The story here isn't the research itself, but the conflict of interest statement. According to the conflict of interest statement, two of the co-authors (Dr. Narula and Dr. Hecht) disclose conflicts, but "all other authors have reported that they have no relationships relevant to the contents of this paper to disclose." This means that Dr. Yankelevitz and Dr. Henschke, the two lead authors, are not revealing any conflicts of interest.

The Rest of the Story

Let's suppose for a minute that Dr. James Enstrom were to publish the same paper: a study of the effect of secondhand smoke on coronary artery calcification. Let's further suppose that Dr. Enstrom's conflict of interest disclosure were to read: "The author reports that he has no relationships relevant to the contents of this paper to disclose."

There is little question that within minutes of publication of such article, the anti-smoking groups (myself included) would be in an outrage, criticizing Dr. Enstrom for failing to reveal his past funding by the tobacco industry. Such funding is directly relevant to the study because the tobacco industry is affected financially by the results of the study. Finding increased effects of secondhand smoke could affect the public's perception of the risks of smoking and secondhand smoke and could also affect the fate of tobacco litigation. Thus, it could have a direct effect on cigarette company profits.

In fact, the anti-smoking groups attacked Dr. Enstrom anyway, even though he did reveal his tobacco industry funding, when he published an article about the effects of secondhand smoke on cardiovascular disease.

So clearly, in an article of this nature, a history of tobacco industry funding is most relevant and needs to be disclosed in the conflict of interest statement.

Readers may therefore be surprised to hear that both Dr. Yankelevitz and Dr. Henschke have a history of tobacco industry funding that is not disclosed in this article.Yet anti-smoking groups are not attacking them or this article. Why? What's the difference between Enstrom's research and this research? The difference is the findings. While Enstrom found no significant effect of secondhand smoke, this study reports "positive" findings. Thus, the deception by the authors regarding their history of tobacco funding is apparently acceptable to anti-smoking groups. It is the "results" of the research that apparently matter to the anti-smoking movement, not the ethical principles involved. Apparently, tobacco money automatically gets "cleansed" or "purified" when it is put to use in reporting "positive" rather than "negative" results.

What is the rest of the story? In 2006, Drs. Henschke and Yankelevitz were lead authors on a study of CT screening for early detection of lung cancer. In this paper, published in the prestigious New England Journal of Medicine, they disclosed funding from the "Foundation for Lung Cancer: Early Detection, Prevention, and Treatment." No tobacco industry funding was disclosed.

However, it turns out that the authors were hiding the truth and deceiving both the journal editors and the public. The truth is that the "Foundation for Lung Cancer: Early Detection, Prevention, and Treatment" was essentially a front group that was almost entirely funded by a cigarette company (Liggett). As revealed here at the Rest of the Story, in the Cancer Letter, and in the New York Times, a review of tax records showed that the Foundation for Lung Cancer: Early Detection, Prevention, and Treatment was "underwritten almost entirely by $3.6 million in grants from the parent company of the Liggett Group, maker of Liggett Select, Even, Grand Prix, Quest, and Pyramid cigarette brands."

The editors of both JAMA and the New England Journal of Medicine both stated that they had been deceived by the failed disclosure and would never have published the article had they known about the tobacco funding. (As expected, there was little criticism from anti-smoking groups, since the findings of the study were "favorable.")

According to these sources, as well as to an article at Source Watch, the front group - Foundation for Lung Cancer: Early Detection, Prevention and Treatment - was a research foundation set up by Dr. Henschke and Dr. Yankelevitz and underwritten by $3.6 million in grants from the Vector Group, parent company to Liggett. Apparently, Dr. Henschke was the president of the "foundation" and Dr. Yankelevitz was its treasurer.

Dr. Henschke was forced to publish a "correction" in the New England Journal of Medicine, in which she revealed that: "For full transparency we wish to inform you that $3.6 million (virtually all of the Foundation's funding) was contributed in 2000 through 2003 as an unrestricted gift by the Vector Group, the parent company of Liggett Tobacco, which manufactures cigarettes."

As if this weren't enough, it also turns out that Dr. Henschke and Dr. Yankelevitz hid another conflict of interest: both received royalties on patents licensed to General Electric relating to imaging techniques to detect lung cancer. Of course, the authors therefore had a financial interest in demonstrating the value of these techniques in the early detection of lung cancer.

They were forced to publish a second "correction" in the New England Journal of Medicine revealing that: "Drs. Henschke and Yankelevitz report receiving royalties from Cornell Research Foundation as inventors of methods to assess tumor growth and regression on imaging tests for which pending patents are held by Cornell Research Foundation and licensed to General Electric."

The authors, as well as Cornell Weill Medical College, denied that they were attempting to hide their tobacco company funding, although it seems quite obvious that they were indeed hiding this funding. They certainly deceived the editors of two major medical journals, who were both appalled when they found out the truth.

The rest of the story, sadly, is that rather than learn from their mistakes, these researchers (Dr. Henschke and Dr. Yankelevitz) are continuing to deceive the public by hiding their history of funding from the tobacco industry. If this funding was relevant in the New England Journal of Medicine article, then it is every bit as relevant in the JACC article. In fact, it is probably more relevant with the present article because with the earlier article, there was no clear direction that the tobacco industry conflict would bias the findings, but with the present study, there is. I have already explained why the fact that the funding occurred in the past is not a valid reason why it should not be disclosed.

I can certainly understand how researchers could make a mistake. We all make mistakes. But it is essential to learn from the mistakes and not to repeat them. The sad part of this story is that these researchers have apparently not learned from their mistakes, as they are repeating them. Once again, they have failed to disclose their tobacco industry funding (albeit in the past), which is a relevant financial conflict of interest that should have been disclosed in this article.

Even worse, it appears that this deception is not just a single episode, but it occurred in at least three other articles as well. A 2013 paper in the Annals of Internal Medicine about early detection of lung cancer using CT screening contains a disclosure in which Dr. Henschke fails to list her previous funding from Liggett as a conflict of interest. In addition, she deceives readers about her lung cancer research foundation by hiding the fact that the Foundation, or one similar to it, was essentially established from tobacco funding. Instead, she points out that the Foundation does not (currently) accept tobacco funds. But a reader could easily be deceived (and I think would be deceived) into thinking that the Foundation never took tobacco funding or that there was never a similar foundation that did take tobacco money. And I think someone reading this disclosure statement would be shocked to find out that the Foundation or one similar to it was established with tobacco industry funding.

The statement reads: "I am the President and serve on the board of the Early Diagnosis and Treatment Research Foundation.  I receive no compensation from the Foundation.  The Foundation is established to provide grants for projects, conferences, and public databases for research on early diagnosis and treatment of diseases.  Recipients include, I-ELCAP, among others.  The funding comes from a variety of sources including philanthropic donations, grants and contracts with agencies (federal and non-federal), imaging and pharmaceutical companies relating to image processing assessments.  The various sources of funding exclude any funding from tobacco companies or tobacco-related sources."

With this much detail given, including an emphasis about the lack of tobacco funding, but nothing about her tobacco funding in the past, it seems that this is an attempt to hide the truth from readers.

Dr. Yankelevich's disclosure for the same article also fails to mention anything about his history of tobacco industry funding. It fails to disclose his prior role as secretary of a foundation that was underwritten by a tobacco company.

Another example: this 2012 article about CT screening for lung cancer, which includes Drs. Henschke and Yankelevitz as co-authors, fails to provide any disclosure of these authors' development of a tobacco-funded research foundation or their history of tobacco funding.

And a third episode: this 2012 article, in which Drs. Henschke and Yankelevitz are co-authors, fails to disclose their history of tobacco industry funding.

Here are even more examples of articles in which this conflict of interest is not disclosed:

Article 1

Article 2

Article 3

Article 4

The original failures to disclose the tobacco industry funding of their research and the existence of significant financial conflicts of interest were bad enough. But their continuation to hide this conflict of interest is perhaps an even worse offense.

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