Tobacco funds helped finance I-ELCAP lung screening trial

The always-controversial International Early Lung Cancer Action Program has been struck a serious blow with news that the trial was funded in part by a cigarette manufacturer, according to an article in the New York Times (March 26, 2008).

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

According to the newspaper, Vector bestowed four grants on the foundation between 2000 and 2003. Dr. Henschke told the Times that the Vector money was a small part of the study’s overall costs and that the foundation no longer accepts 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 Dr. 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, 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 done and will do,” said Stanton Glantz, PhD, coauthor of The Cigarette Papers and a professor in the Division of Cardiology at the University of California, San Francisco.

In April 2007, Dr. Henschke’s group reported that strict adherence to a CT screening regimen caught a high proportion of early disease. In 2006, the group 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 243;1:239-249, 2007; N Engl J Med 355;17:1763-1771, 2006).

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.

Edward Patz Jr., MD, 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, said Dr. Patz, 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,” Dr. Patz said in an interview. “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.”

Dr. Henschke is not without her supporters, including Giulia Veronesi, MD, 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,” Dr. Veronesi said in an interview. “My personal opinion is that receiving funding from the tobacco industry is not scandalous per se, if the aim is noble, to improve 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.”

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

Dr. Henschke has taken steps to put the matter to rest by writing letters formally disclosing the tobacco money funding as well as her relation with the imaging industry concerning certain patents.

On March 24, JAMA published online a letter from Dr. Henschke and her coauthor David Yankelevitz, MD, disclosing that they, along with Cornell, hold a number of patents for computer-aided diagnostic methods, including measurement of lung nodules, licensed to General Electric. These relationships with industry were not reported in a 2006 JAMA article on women and their susceptibility to tobacco carcinogens that was authored by the I-ELCAP group, because Dr. Henschke did not think they were relevant. But a reply to the letter by JAMA editor in chief Catherine DeAngelis, MD, MPH, stated that the editors believe they are relevant and would have published the disclosures at the time the article appeared.

On April 2, the New England Journal of Medicine published online a letter from Dr. Henschke in which she formally disclosed that money donated by the tobacco industry helped fund I-ELCAP research.