Wednesday, April 09, 2008

Weill Cornell Medical College Again Defends Researcher's Failure to Disclose Tobacco Funding and Financial Conflict of Interest

Even after being publicly scolded by the New England Journal of Medicine for her failure to disclose the tobacco industry funding of her research on the use of CT scans in lung cancer screening and her significant financial interest in a manufacturer of CT scanners, the researcher from Weill Cornell Medical College and the school itself have again defended her failure to provide these disclosures.

In a statement released by Weill Cornell Medical College on April 4, the school not only defended the researcher in failing to disclose significant financial conflicts of interest to medical journals, but it also blamed the New York Times for inaccurate reporting.

According to the statement: "As you may know, an article appeared last week in The New York Times (Mar. 26, 2008) alleging that two Weill Cornell Medical College (WCMC) researchers did not fully disclose that their research on the use of CT screening for the early detection of lung cancer was partially funded by money from a tobacco company, and did not properly disclose the existence of the Foundation that received the funds. We believe the article did not present a complete picture of the facts and that its primary conclusion -- that Weill Cornell intentionally attempted to conceal the gift in the Foundation -- is simply wrong."

The statement then goes on to argue that Liggett's gift to the Foundation which funded the research was widely publicized at the time the donation was made. It also argues that the failure to disclose the tobacco industry funding was not intentional.

In terms of the failure to disclose the researcher's financial interest in the use of CT scans for lung cancer detection (she apparently receives royalties from General Electric after the licensing of the patents to GE), Weill Cornell Medical College defends the disclosure failure on the grounds that "Henschke and Yankelevitz did not use the GE products developed under the licensing agreement as part of the I-ELCAP, and did not require participating I-ELCAP institutions to use the GE product."

The statement also contends that the researcher published a public apology in the New England Journal of Medicine. According to the statement: "Some of those publications have disagreed with Dr. Henschke and Dr. Yankelevitz's judgment on these, and corrections and apologies have been published in those journals."

The Rest of the Story

I find this to be a truly pathetic attempt to defend what was clearly an inappropriate failure to disclose two important conflicts of interest.

First, 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.

Second, whether Dr. Henschke used GE products in her research or not is immaterial to the question of whether her financial interest in General Electric represents a conflict of interest. It is not a conflict of interest because she is using GE products; it is a conflict of interest because she has a financial interest in a company which stands to gain financially from the widespread use of CT scanning for early detection of lung cancer. Thus, there would be a significant financial conflict of interest even if this research employed only CT scanners made by other manufacturers.

Again, this attempt to confuse the public and obscure the underlying issue is quite unfortunately. And again, I find this aspect of the defense to be worse than the original failure in disclosure.

To make matters even worse, it appears that the statement is dishonest in asserting that an apology was published in the New England Journal of Medicine.

Two corrections were published. In the first, the author writes: "In our article published in the October 26, 2006, issue of the Journal, one of the disclosed sources of funding was the Foundation for Lung Cancer: Early Detection, Prevention and Treatment, which provided partial support for our research. 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."

No apology is offered, nor is any wrongdoing admitted.

In the second correction, the Journal writes: "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.'"

Again, no apology is offered here.

So unless I am missing something, it appears that the Weill Cornell Medical College statement is dishonest. There is no apology that I can find in the New England Journal of Medicine for these two failures in disclosure.

I would have a lot more respect for the Weill Cornell Medical College and the involved researchers if they simply admitted that a mistake was made and apologized for it. That would be the end of the story. We all make mistakes and we can learn from them.

However, instead of admitting a mistake and apologizing, the researcher's and the school's response has instead been to deny wrongdoing, obscure the issues, hide behind immaterial points that will confuse the public, and to go so far as to attack the New York Times for its reporting of the issue.

So let's now get to that important issue. Cornell is attacking the New York Times for falsely implying that the failure to disclose the tobacco industry funding of the research was intentional. Well, if it wasn't intentional, then Cornell must be claiming that there was simply a mistake. The investigator intended to disclose the tobacco funding, but somehow forgot to do so.

Unfortunately, that is clearly not the case in this situation (at least, it's not what Cornell states is the situation). Cornell is not advancing a position that Dr. Henschke revealed the tobacco funding of the research to the Journal, but the Journal just forgot to publish it. Nor is Cornell suggesting that Dr. Henschke intended to disclose the tobacco funding but simply forgot or neglected to include it in her manuscript.

It seems quite clear that the failure to disclose the tobacco industry funding was indeed an intentional failure. There was no intent upon the part of Dr. Henschke to inform the New England Journal of Medicine and the readers of the article that this work was funded by a grant from Liggett.

Had the intent been to make readers aware of the tobacco funding, then Dr. Henschke would have revealed that funding.

So I believe that the New York Times was in fact entirely correct in asserting that the failure to disclose the tobacco funding was intentional.

In closing, I have to say that the original failures to disclose the tobacco funding and the royalties from the patents licensed to General Electric pale in comparison to Weill Cornell Medical College's attempt to defend, obscure, and apparently - to lie - about aspects of the issue at hand.

If they simply came out and said: "We made a mistake. We're sorry," that would be the end of the story and I would have great respect for them.

Instead, I think they have made a public disgrace of themselves.

No comments: