Host Defense Activation

Ok, so, remember when those outrageous subway ads asking passengers to "demand a CAT scan" appeared, and prompted me to suspect, offhandedly, that the group behind the ads was receiving funding from GE or another CT-scanner manufacturer?

And when the awful truth came out, that the Lung Cancer Foundation was actually funded by a tobacco company -- a firm likely invested in the notion that smoking-related cancer is preventable and thus limits their liability -- well, I fretted that I wasn't cynical enough -- that it would be a far more straightforward and relatively benign conflict of interest if the funding just came from GE.

Well, here's some comforting news -- members of the Lung Cancer Foundation was also receiving money from GE! From WSJ comes news that the lead authors of a controversial 2006 NEJM report on CT-detection of lung CA were getting royalties from a major CT scanner manufacturer (these same authors are prominent members of the Lung Cancer Foundation, the group behind the dangerous advertisements):

In today's correction, the New England Journal acknowledges that the study's lead authors, Claudia Henschke and David Yankelevitz of Cornell University's Weill Medical College in New York City, received royalties from GE, a big maker of CT scanners, for pending patents on ways to manipulate and interpret CT scans and other medical images. The Wall Street Journal's Health Blog reported the royalty payments last October. Dr. Henschke said then that the royalties were small and declining.

A spokesman for both doctors said they had told the New England Journal that Cornell had licensed the pending patents to GE before the study was printed in 2006, but not that they were personally receiving a share of the royalties. Jeffrey Drazen, the New England Journal's chief editor, said the publication had learned of the royalties only recently.

I call this news 'comforting' because it suggests people behave predictably, that a truly disturbing action can be thwarted by the by lesser, more mundane transgressions. Al Capone getting busted for tax evasion is the first example that comes to mind, but there are probably more fitting precedents.

The NEJM article now carries a "correction" up front that addresses the GE conflict.

Cornell issued a press release clarifying the conflicts of interest:

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...

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 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...

NIH disclosure rules are surprising. Someone could patent a device or technique, and a university tech transfer office could license the idea to a big firm, which finds the idea so valuable they pay the university royalties for it. That money finds its way back to the original scientist, who can conduct research showing how great his idea is... and yet never be forced to disclose that he's making money off it, and could make a lot more if everyone believes his research.

It's got to be better to just fully disclose the potential conflict from the outset. That is, I think, what many successful scientists do, and it doesn't stop their research from being accepted.

I don't know why this process wasn't followed with the lung cancer research, and I don't know why the foundation instead chose a dangerous and misleading advertising campaign to advance their cause. These actions make the protestations about their level of disclosure being mischaracterized that much tougher to stomach.

The Lung Cancer Foundation has been mum on the entire debacle, save for two brief blog entries that, curiously, makes no mention of the fact that the 'tainted' researcher is the founding board member of the organization that produces the blog.

On the plus side, I don't recall seeing any new subway ads urging me to "demand a CAT scan," and I believe a few older ones have disappeared.