NEJM seeks transparency following CT study funding disclosure

While recognizing the expense of conducting clinical trials, the New England Journal of Medicine (NEJM) said that its editors and reviewers need to be made aware of all sources of financial support for each study published, according to an editorial commentary from NEJM regarding the full disclosure and the funding of biomedical research.

In October 2006, NEJM published an article by the Lung Cancer Screening Group in which CT scanning was used to screen a high-risk population for evidence of early-stage lung cancer. From the data gathered, lead author Claudia Henschke, MD, and colleagues from the Weill Medical College of Cornell University in New York City, concluded that the majority of stage I lung cancers treated after their detection by CT screening had a favorable prognosis.

The Lung Cancer Screening Group's research was funded by 32 different entities, one of which was the Foundation for Lung Cancer: Early Detection, Prevention and Treatment, a foundation funded almost entirely by Vector Group, the parent company of Liggett, a tobacco company.

NEJM said it has not been its practice to inquire about the specific sources of funding of foundations such as this.

On April 2, the NEJM published a correction to the study, which said: “The disclosure statement (page 1769) should have read as follows: "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. No other potential conflict of interest relevant to this article was reported.”

“We recently learned, however, that this foundation was headed by the principal investigator of the 2006 study, that it was housed at her academic institution, and that the only contributor during most of its existence was the Vector Group, the parent company of Liggett, a major tobacco company,” NEJM editor Robert Schwartz, MD, and colleagues wrote in an accompanying editorial. “We and our readers were surprised to learn that the source of the funding of the charitable foundation was, in fact, a large corporation that could have an interest in the study results.”

According to NEJM editors and reviewers, the situation raises two concerns. First, it is important that the ultimate source of funding be made clear to NEJM’s readers. Second, it is appropriate to ask whether a study on clinical outcomes in lung cancer should be directly underwritten in part by the tobacco industry.

Given the enormous burden of smoking-related illness and the ongoing sale of cigarettes and other forms of tobacco, one might question the advisability of research entities accepting funding from tobacco companies except through the American Legacy Foundation, which distributes funds received through the Master Settlement Agreement with U.S. tobacco companies, according to NEJM.

“We believe that it is important for our readers and the entire biomedical community to be aware of this situation. Our goal is that readers be fully informed about funding sources,” NEJM said. “It is the responsibility of authors to disclose fully and appropriately [identify] the sources of funding of their studies. We expect that authors will be particularly attentive to transparency in reporting if a funding entity has a vested interest in the outcome. The public's trust in biomedical research depends on it.”

The editorial was published at on April 2 and will appear in the April 24 issue of the NEJM.