The strong ethical stance taken by medical journals in favour of transparency in the publication of clinical trial results runs the risk of being caught in the same net.

So it was with The New England Journal of Medicine (NEJM), which last week found itself in the uncomfortable position of having to acknowledge that a key lung cancer screening study it published in October 2006 was partly funded by the parent company of a major tobacco manufacturer.

It has also transpired that study authors Dr Claudia Henschkle and Dr David Yankelevitz of Weill Cornell Medical College in New York failed to disclose they were receiving royalties from Cornell Research Foundation as inventors of methods to assess tumour growth and regression in imaging tests, for which pending patents were held by the Foundation and licensed to General Electric (one of the study funders).

Both of these revelations were noted in a clarification and correction published in the NEJM on 2 April, although by then the story had already been extensively covered in the US national media.

The NEJM has also been criticised for its tardiness in disclosing the potential conflicts of interest in the lung cancer study. The journal’s initial reaction to reports about the royalty-bearing patents held by Drs Henschkle and Yankelevitz was to claim that the patents were not relevant to the published research.

The screening trial was controversial at the time for suggesting that computed tomographic (CT) scanning of smokers and former smokers for evidence of early-stage lung cancer could prevent as many as 80% of lung cancer deaths. The study by the Lung Cancer Screening Group was funded by 32 different entities, one of which was the Foundation for Lung Cancer: Early Detection, Prevention and Treatment.

In an editorial on Full Disclosure and the Funding of Biomedical Research, the NEJM notes that “it has not been our practice to inquire about the specific sources of funding of foundations such as this. We recently learned, however, that this foundation was headed by the principal investigator of the 2006 study [i.e., Dr Henschkle], that it was housed at her academic institution [Cornell University], and that the only contributor during most of its existence was the Vector Group, the parent company of Liggett, a major tobacco company”.

As the clarification by Dr Henschkle in the NEJM points out, the Vector Group contributed US$3.6 million to the Foundation for Lung Cancer – virtually all of its funding – as an unrestricted gift between 2000 and 2003. The original NEJM paper did include any conflict of interest disclosures.

In fact, the Vector Group issued a press release in December 2000 announcing that it was pledging $2.4 million to Weill Cornell to support Dr Henschkle’s work. Nonetheless, the relationship between Vector and the Foundation for Lung Cancer was not disclosed when the CT scanning research was published in the NEJM.

Defending its own role in the affair, the NEJM editorial comments: “Clinical studies have become very expensive to conduct, and multiple sources of funding often support a single study. Biomedical journals routinely disclose all sources of funding of the research they publish; this has been standard practice at the Journal for many years. As funding mechanisms grow increasingly complex, however, it has become ever more challenging for editors to ensure the complete reporting of all sources of financial support.”
Recent years, the editorial notes, have seen the emergence of non-profit foundations “housed at academic institutions but organised for the benefit of individual investigators and funded by industry sponsors”.

In the dark?
These bodies “may on the one hand be helpful in providing needed research funds at a time when there are constraints on funding from the National Institutes of Health, especially for clinical trials”, the NEJM says. On the other hand, they “may not be required to publicly disclose the details of their own funding sources and expenditures. Thus, editors, reviewers, and readers are left in the dark about the actual sources of support for a research project”.

While the science in a submitted manuscript should be judged on its own merits, “one cannot fully appreciate a study’s meaning without acknowledging the subtle biases in design and interpretation that may arise when a sponsor stands to gain from the report”, the editorial states.

It was therefore the responsibility of authors to disclose “fully and appropriately” the sources of study funding of their studies, particularly where a funding entity has a vested interest in the outcome. “The public’s trust in biomedical research depends on it,” the NEJM comments.