Tobacco money financed CT lung cancer screening trial

The always-controversial International Early Lung Cancer Action Program has been struck a serious blow with news that the trial was funded by a cigarette manufacturer, according to an article in Wednesday's New York Times.

The Foundation for Lung Cancer: Early Detection, Prevention & Treatment received $3.6 million from the Vector Group, parent company of Liggett Group, which manufactures a number of cigarette brands, the New York Times article said. The foundation was founded in 2001 with Dr. Claudia Henschke, I-ELCAP's principal investigator, serving as president.

According to the newspaper, Vector bestowed four grants on the foundation between 2000 and 2003. Henschke told the Times that the Vector money was a small part of the study's overall costs and that the foundation no longer accepted support from tobacco companies.

A Vector spokesperson told the newspaper that the donation to the Weill Medical College of Cornell University in New York City - where Henschke is chief of the divisions of chest imaging and healthcare policy and technology assessment - was made public in 2000 and that the company had no influence on the I-ELCAP research. In a written statement issued Wednesday afternoon, Weill Medical College of Cornell University reiterated that Vector's funding for I-ELCAP had been publicly disclosed by the foundation. In addition, the university maintained that Vector's gift was unrestricted, which allowed for completely independent research.

But others in the field of cancer research remain unconvinced.

"I think that Henschke and Cornell's behavior has undermined the credibility of everything that she has and will do," said Stanton Glantz, Ph.D., coauthor of The Cigarette Papers and a professor in the division of cardiology at the University of California, San Francisco.

In April 2007, Henschke's group reported that strict adherence to a CT screening regimen caught a high proportion of early disease. In 2006, Henschke published a computer modeling study that predicted that 80% of people whose lung cancer was caught early with CT screening could expect to live at least another decade (Radiology 2007;243;1:239-249; NEJM 2006;355;17:1763-1771).

Other imaging experts have repeatedly taken issue with the I-ELCAP results. Questions have centered on the effect of lead time bias, the risks of false-positive results, and the lack of data on overall mortality.

Dr. Edward Patz Jr. has been an outspoken critic of I-ELCAP in the past. CT still has to prove itself as a valid screening tool regardless of any ancillary controversy, according to Patz, a professor of radiology, pharmacology, cancer, biology and pathology at Duke University Medical Center.

"The (NYT) article raises a number of issues concerning conflict of interest, which need to be resolved through appropriate channels," Patz said in an e-mail to Diagnostic Imaging. "The fundamental question of CT screening for early detection of lung cancer, and (whether) it reduces mortality, remains unknown. The appropriate randomized trials still need to be complete before we can determine if CT screening will be beneficial."

Henschke is not without her supporters. Dr. Giulia Veronesi is deputy director of the division of thoracic surgery at the European Institute of Oncology in Milan, Italy.

"The source of the funding ... does not affect the validity of the research (or) the commitment that Claudia and her group have demonstrated in this field," Veronesi said to Diagnostic Imaging. "My personal opinion is that receiving funding from the tobacco industry is not scandalous per se, if the aim is noble, to improve the knowledge about lung cancer detection and to reduce lung cancer mortality. I hope this controversy won't set back the knowledge obtained in lung cancer screening."

Veronesi recently authored a paper on low-dose CT for diagnosing baseline lung nodules (Lung Cancer online, Feb. 26, 2008).

The Times article is the second publication this week to claim a lack of full disclosure on the part of Henschke and her coinvestigators. On Monday, the Journal of the American Medical Association published a number of financial relationships that Henschke and her coauthor Dr. David Yankelevitz have with advanced visualization software companies. These relationships, mostly pending patents, were not reported in a 2006 JAMA article on women and their susceptibility to tobacco carcinogens that was authored by the I-ELCAP group.

As of Wednesday morning, Henschke was not granting interviews, according to a representative at her New York-based office.

For more information from the Diagnostic Imaging archives:

New CT lung screening study continues to skirt mortality issues

New data inflame debate over lung cancer screening