April 4, 2008

Weill Cornell Medical College refutes New York Times article on cancer research

Weill Cornell Medical College today issued the following statement refuting a recent article in The New York Times:

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.

These issues raised in the article deserve and require a full explanation.

The Foundation for Lung Cancer: Early Detection, Prevention and Treatment received an unrestricted gift of $3.6 million from the Vector Group, the holding company for Liggett Tobacco, in a series of payments, from July 2000 to June 2003. The gift was used appropriately and responsibly for the public good -- to support Weill Cornell Medical College's highly regarded, multi-institutional, international I-ELCAP [International-Early Lung Cancer Action Program], and to support the institutions that make up I-ELCAP. The objective of I-ELCAP is to perform CT screening research for lung cancer in order to determine whether such screening improves cure rates for persons at risk

Specifically, the gift was used to support the I-ELCAP lung cancer screening project to develop the WCMC Coordinating Center, and to help other institutions to develop screening programs as part of the international screening collaboration.

The original $2.4 million pledge to the Foundation -- and the work funded by the Foundation at Weill Cornell -- was publicly disclosed at the time through a press release, and was covered in the lay media, including USA Today. It was discussed and disclosed in the academic community at I-ELCAP conferences, which were attended by advocacy groups, agencies, and by investigators from around the world interested in lung cancer screening. The gift from Vector/Liggett was also disclosed to foundations wishing to contribute funds to I-ELCAP, and who asked whether WCMC had ever accepted any funding from a tobacco company.

The gift was unrestricted, which means that, unlike industry-funded research agreements, it allowed for research to be conducted independently and without restriction in areas of significant but uncertain promise, without the gift-recipient being held accountable in any way to the gift-giver. Significantly, there were no restrictions on publication of results or data; WCMC was not required to keep the donor informed of how the funds were used; and the donor was not entitled to have access to any of the research results.

It is very important to note that the I-ELCAP project -- which comprises more than 50 institutions in nine countries and in 26 states -- has been funded only, in part, by this Vector/Liggett unrestricted gift. The basic research concepts behind the screening project have been developed by Dr. Henschke and Dr. Yankelevitz since the early 1990's, long before the Vector/Liggett gift. I-ELCAP has obtained considerable funding from other sources, and has been able to recruit additional screening centers which, in turn, have developed their own funding resources.

The gift was originally made as part of a grand plan and vision on the part of public health and lung cancer advocacy groups and Vector/Liggett to provide screening research centers throughout the country. The Foundation was organized by Dr. Claudia Henschke and Dr. David Yankelevitz and other advocacy-individuals associated with the I-ELCAP program, with the expectation that other major tobacco companies, in addition to Vector/Liggett, would contribute to this national effort. The initial decision to establish a foundation was thought by them to be the most appropriate and effective fundraising vehicle to achieve such a national research plan. It was expected that, if the additional fundraising were successful, representatives of other institutions would be invited to join the Foundation's board.

Dr. Antonio M. Gotto Jr., Dean of Weill Cornell Medical College, and Arthur Mahon, Vice Chair of Weill Cornell's Board of Overseers, were invited to join the Foundation's board because the project was centered at Weill Cornell.

It is noteworthy that, like Weill Cornell, many of our peer institutions and medical schools do accept funding from tobacco companies and from institutions that manage funds from tobacco settlements for responsible research, and do establish legitimate foundations to manage the administrative and financial aspects of grants and gifts. We recognize, due to the extreme concern about tobacco companies'attempts to misuse research to the detriment of public health, that broader and continuing disclosures could and should have been made. But Weill Cornell strongly rejects the thesis of The New York Times article that any omission was deliberate.

Regarding the matter of allegedly undisclosed patents and patent applications by Dr. Henschke and Dr. Yankelevitz, Cornell Research Foundation, Inc., a subsidiary of Cornell University, licensed technology to General Electric (some of which is now patented) related to detection and measurement of nodules developed by Henschke, Yankelevitz and others. As is generally required at academic medical centers, the royalties were distributed to Cornell, which, in turn, provided a share to the inventors under Cornell's intellectual property policy, which is based on the Bayh-Dole Act. NIH Conflict of Interest regulations currently do not require individual disclosure of royalties paid to them by the employer institutions. Nonetheless, the royalties from the GE licensing agreement, the issued patent, and the patent applications were typically disclosed to journals and at CME meetings, when such disclosures were deemed relevant by Dr. Henschke and Dr. Yankelevitz.

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. Most importantly, and again omitted in the NYT article, 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.

Weill Cornell Medical College takes seriously the need for transparency and integrity in research and the protection of patients who participate in research studies, and has policies and procedures in place to ensure the highest degree of integrity in the research conducted at WCMC. WCMC continually reviews and updates its policies, as necessary and as required, to effectively oversee and monitor the activities of all researchers and to maintain compliance with all regulatory and ethical standards.