BOSTON, April 2 -- Claudia I. Henschke, M.D., Ph.D., principal investigator of the controversial 2006 I-ELCAP (International Early Lung Cancer Action Program) study, has formally disclosed to the medical community that tobacco-industry money funded the study.
In a letter published online in the New England Journal of Medicine, Dr. Henschke said "$3.6 million . . . was contributed in 2000 through 2003 as an unrestricted gift by the Vector Group, the parent company of Liggett Tobacco, which manufactures cigarettes."
The New England Journal of Medicine has also issued an online correction and a clarification regarding the once-again controversial study of spiral CT detection of lung cancer.
Last week, the New York Times reported that funding for the study by Dr. Henschke and colleagues at Weill Cornell Medical Center in New York had been channeled through a foundation set up by Dr. Henschke and officials at Weill Cornell (See: Early Lung Cancer Study Found Funded by Tobacco Money).
The foundation was named in the original NEJM paper as one of the study's funding sources, but its financial ties to the Vector Group, the parent company of cigarette maker Liggett Group, were not disclosed.
Also unreported was the fact that Dr. Henschke and co-investigator David Yankelevitz, M.D., received royalties derived from licenses on technology they had invented for tumor imaging.
The journal's correction today retroactively amends the study's disclosure statement to include the royalty arrangement.
The NEJM's editors also published an online editorial in which they expressed surprise at the tobacco link.
The editorial reiterated the journal's recent position on author disclosures. It did not indicate that any policy changes were under consideration.
The journal's editor-in-chief, Jeffrey Drazen, M.D., was not available for comment.
In response to e-mail questions from MedPage Today, a spokeswoman for the journal wrote, "We cannot police all medical research. If we confirm an undisclosed conflict, we inform readers as quickly as possible, through our Web site and in the printed journal."
As reported in the Oct. 26, 2006 issue of NEJM, I-ELCAP screened more than 31,000 persons at risk for lung cancer from smoking or environmental exposure to carcinogens.
The annual low-dose CT spiral scans picked up 484 lung cancers, 85% of which were clinical stage I, with an estimated 10-year survival rate of 88%.
Dr. Henschke said at the time that the results suggested that annual screening could prevent 80% of lung cancer deaths, an extrapolation that was disputed almost as soon as it was published.
The New York Times uncovered the tobacco link by investigating the tax records of the foundation. However, officials at Cornell Weill said the Vector Group funding (eventually totaling $3.6 million) had been announced when the foundation was established in 2000, with considerable media coverage.