Monday, March 31, 2008

Cornell Researcher Defends Failure to Disclose Tobacco Funding and Financial Interests in General Electric; Defense is Worse than Original Offense

In a response to publicity regarding her failure to disclose funding of her research on the use of CT scans for lung cancer screening and her failure to disclose potentially significant financial interests in General Electric, which stands to gain from adoption of CT screening, Dr. Claudia Henschke and her institution - the Weill Cornell Medical College - released a statement defending both of these disclosure failures.

As I discussed here on Friday, in an October 26, 2006 article in the New England Journal of Medicine, Dr. Claudia Henschke of Weill Cornell Medical College and a group of other investigators reported the results of a study of the use of low-dose spiral CT scans as a screening tool to detect lung cancer among asymptomatic individuals. The article reported that 85% of patients with lung cancer detected had stage I cancer and the estimated 10-year survival among these patients was 88%. The study concluded that: "Annual spiral CT screening can detect lung cancer that is curable" and that "such screening could prevent some 80% of deaths from lung cancer."

The paper listed its funding sources at the end, one of which was the Foundation for Lung Cancer: Early Detection, Prevention & Treatment.

The New England Journal of Medicine has a policy of not publishing any paper supported with funds from the tobacco industry. Not seeing any disclosure of funding from the industry, the Journal published the paper.

However, it turns out that the Foundation for Lung Cancer: Early Detection, Prevention, & Treatment "was, according to a New York Times article, "underwritten almost entirely by $3.6 million in grants from the parent company of the Liggett Group, maker of Liggett Select, Eve, Grand Prix, Quest and Pyramid cigarette brands. The foundation got four grants from the Vector Group, Liggett's parent, from 2000 to 2003."

According to the New York Times article and a concurrent article in The Cancer Letter, the Journal of the American Medical Association was also deceived by the absence of disclosure of Dr. Henschke's tobacco funding and would never have published her paper had they known that Henschke received tobacco industry money for her CT screening research.

To make matters worse, the Times reported that Dr. Henschke "failed to disclose in articles and educational lectures a patent and 10 pending patents related to CT screening and follow-up." By virtue of these financial interests, Dr. Henschke stands to benefit personally (financially) if her recommendations for the widespread adoption of CT scan screening for lung cancer are adopted.

Moreover, the Cancer Letter reports that "medical journals and providers and accreditors of continuing medical education are investigating her failure to disclose patents and royalties from commercial sponsors, including GE Healthcare. As the leading manufacturer of CT scanners, GE stands to benefit from Henschke's campaign to screen asymptomatic former and current smokers."

I wrote Friday that if it is true that Dr. Henschke has a significant financial interest in GE Healthcare, such as royalties, consultant fees, or licensing payments, and that financial interest was present in October 2006, then she did fail to disclose that interest in her New England Journal article as that article states: "No potential conflict of interest relevant to this article was reported."

The Rest of the Story

Unfortunately, in the March 26 statement from Dr. Henschke and Weill Cornell Medical College, they defend both of these failures in disclosure and do not accept any responsibility for misconduct or apologize for this conduct.

Regarding the failure to disclose funding of the research by a tobacco company, the statement argues that: "The original $2.4 million pledge to the Foundation -- and the work funded by the Foundation at Weill Cornell -- was fully and publicly disclosed at the time through a press release, and was substantially covered in the lay media. It was discussed and disclosed in the academic community at conferences, which were widely attended by advocacy groups, agencies, and by investigators from around the world interested in lung cancer screening. It was also fully disclosed to other foundations and groups wishing to contribute funds to I-ELCAP."

Unfortunately, that is simply not enough. The funding by the tobacco industry needs to be disclosed in the article itself, and to the journal. It is not enough to expect that the journal editors will look up the Foundation for Lung Cancer on the internet and search newspaper articles to try to find out who the Foundation's donors are.

I do not believe that Dr. Henschke can hide behind the excuse that she disclosed funding from the Foundation for Lung Cancer: Early Detection, Prevention & Treatment, and so that she did indeed disclose her funding sources. The intent of disclosure of funding is to provide editors, reviewers, and the public with relevant information about the source of funding, not merely to provide the name of the foundations or entities set up to receive that funding. Thus, I view the failure to disclose her funding from Liggett as a significant violation of ethical standards of conduct.

This defense is inadequate and it is unfortunate that the researcher is not willing to take responsibility for this failure. In many ways, I find this defense to be a worse offense than the original disclosure failure. To make a mistake is human, and perfectly acceptable if you admit your mistake, apologize, and learn from it. But to deny that there was any mistake and to worm around, trying to convince the public that you have indeed disclosed the funding when you haven't, makes the original offense even worse.

Regarding the apparent failure to disclose income paid by General Electric to the researcher through her institution from an intellectual property interest (licensing of a patent or patents), the statement defends failure to disclose this financial interest by arguing that it is not a significant financial interest as defined by federal regulations: "Cornell Research Foundation, a subsidiary of Cornell University, licensed technology (some of which is now patented) related to detection and measurement of nodules developed by Henschke, Yankelevitz and others to GE. As is typical at many institutions, the royalties were distributed to Cornell, which, in turn, provided a share to the inventors under Cornell intellectual property policy, which is in line with the Bayh-Dole Act. NIH Conflict of Interest regulations currently do not require individual disclosure of royalties paid to them by the employer institutions (see 42 CFR 50.603 -- Definition of "Significant Financial Interest")."

There are two problems with this defense.

First, I believe it is a misinterpretation of federal policy. The exception for compensation received from an institution applies, I believe, to compensation paid by the institution. I do not believe that exception was meant to apply to compensation, such as royalties for a licensed patent, paid by a corporation to an investigator through an institution. If that were the case, then any researcher could get around this problem by simply having the checks made out to the institution, and then having the institution make out a check to the researcher. Clearly, this is a circumvention of the spirit of the policy. The fact that General Electric made out checks to Cornell, which were then distributed, in part to Dr. Henschke, does not in my opinion mean that she did not have a significant financial interest under federal regulations.

Second, and more importantly, the policy of medical journals is not that investigators have to report significant financial interests as defined by federal policy. The policy of journals is that investigators have to report all significant financial interests, as defined by the journal.

The New England Journal of Medicine defines a significant financial interest as "any financial arrangement they [investigators] may have with a company whose product is pertinent to the submitted manuscript or with a company making a competing product."

Furthermore, the Journal describes the financial disclosure statement that is required of investigators as follows: "The statement should describe the authors’ relationships with companies that make products relevant to the paper. The statement should specify the type of relationships (e.g., consulting, paid speaking, grant support, equity, patents) EACH author has with EACH company."

In its published policy on conflicts of interest, the Journal even specifies that "patent royalties" are to be included as signficant financial conflicts of interest.

It is very clear, according to the Journal's policy, that investigators are to disclose all financial interests in companies whose products are pertinent to the manuscript.

No exceptions are made for royalties received from the university related to intellectual property licensed to a corporation. Given the information reported in the statement by Dr. Henschke and Cornell and the policy of the New England Journal of Medicine, I see no way one can conclude that there was not a blatant violation of the Journal's financial disclosure policy (unless the financial arrangement was not present at the time the manuscript was submitted, which does not seem to be the case).

Again, this weak attempt to defend the failure to disclose the significant financial interest appears to be an even greater offense than the original failure.

Why can't they just admit that a mistake was made, correct it, apologize, and move on?

The original failures to disclose the tobacco industry funding of this research and the existence of significant financial conflicts of interest were bad enough. But the defense of these unethical actions is an even worse offense.

No comments: