International medical community seems to feel scandalized in the wake of a report that the study suggesting CT scans to prevent lung cancer deaths was partly funded by a tobacco company.
The study by Dr. Claudia Henschke of Weill Cornell Medical College in the US was published in 2006 in the New England Journal of Medicine and asserted that as much as 80 percent of lung cancer deaths could be prevented through widespread use of CT scans.
It now turns out that the study had been financed in part by a little-known charity called the Foundation for Lung Cancer: Early Detection, Prevention & Treatment. And the foundation was underwritten almost entirely by $3.6 million in grants from the parent company of the Liggett Group, maker of Liggett Select, Eve, Grand Prix, Quest and Pyramid cigarette brands.
The foundation got four grants from the Vector Group, Liggett's parent, from 2000 to 2003.
Henschke served as the foundation's president, and her longtime collaborator, Dr. David Yankelevitz, was its secretary-treasurer. Dr. Antonio Gotto, dean of Weill Cornell, and Arthur Mahon, vice chairman of the college's board of overseers, were directors.
In an e-mail message, Drs. Henschke and Yankelevitz wrote that "it seems clear that you are trying to suggest that Cornell was trying to conceal this gift, which is entirely false."
"The gift was announced publicly, the advocacy and public health community knew about it, it is quite easy to look it up on the Internet, its board has independent Cornell faculty on it, and it was fully disclosed to grant funding organizations," they wrote, adding that the Vector grant represented a small part of the study's overall cost. The foundation no longer accepts grants from tobacco companies, they wrote.
Dr. Jeffrey Drazen, editor in chief of New England Journal said he was surprised. "In the seven years that I've been here, we have never knowingly published anything supported by" a cigarette maker, Dr. Drazen said.
An increasing number of universities do not accept grants from cigarette makers, and a growing awareness of the influence that companies can have over research outcomes, even when donations are at arm's length, has led nearly all medical journals and associations to demand that researchers accurately disclose financing sources, the New York Times reports.
Prominent cancer researchers and journal editors were stunned to learn of Henschke's association with Liggett. Cigarette makers are so reviled among cancer advocates and researchers that any association with the industry can taint a researcher and bar their work from being published.
"If you're using blood money, you need to tell people you're using blood money," said Dr. Otis Brawley, chief medical officer of the American Cancer Society. The society gave Henschke more than $100,000 in grants from 2004 to 2007, money it would not have provided had it known of Liggett's grants, Brawley said.
In the Vector press release, Henschke was quoted as saying that, thanks to the Vector grants, "we have raised the initial funding needed to support this important research and data collection on the effectiveness of spiral CT screening."
Dr. Robert Young, chancellor of Fox Chase Cancer Center in Philadelphia and chairman of the Board of Scientific Advisors of the National Cancer Institute, said he had never heard of the Vector grants. "As someone who really hung around the inner sanctum of cancer research, I have never heard anybody — anybody — ever say anything about this," Young said.
Dr. Jerome Kassirer, a former editor of The New England Journal of Medicine and author of a book about conflicts of interest, said he believed that Weill Cornell had created the foundation to hide its receipt of money from a cigarette company. "You have to ask yourself the question, 'Why did the tobacco company want to support her research?' " Kassirer said. "They want to show that lung cancer is not so bad as everybody thinks because screening can save people; and that's outrageous."
Henschke's work, while controversial among cancer researchers, has been embraced by many lung-cancer advocacy organizations, which have pushed for legislation in California, New York and Massachusetts to create trust funds to pay for lung cancer screening — often with language tailored to benefit Henschke's group.
In New York, for instance, a bill would create a $10 million fund "to carry out lung cancer early detection research using computer tomography (CT) scanning" at a place "that was established by the multi-institutional, multi-disciplinary research program that began at 22 sites in the state in the year 1991," a description that could only fit Henschke's group.
But the revelation that Henschke's work was underwritten in part by grants from a cigarette maker will undercut those efforts, several prominent cancer researchers said.
"She's the biggest advocate for widespread spiral CT screening," said Dr. Paul Bunn, a lung cancer expert and executive director of the International Association for the Study of Lung Cancer. "And now her research is tainted."
Corporate financing can have subtle effects on research and lead to unconscious bias. Studies have shown that sponsored research tends to reach conclusions that favor the sponsor, which is why disclosure is encouraged. The tobacco industry has a long history of underwriting research — sometimes through independent-sounding foundations — to make cigarettes seem less dangerous.
Since 1999, Henschke has asserted that annual CT scans of smokers and former smokers would detect lung cancer when tumors are small enough to be cured, preventing as many as 80 percent of the 160,000 deaths a year from lung cancer, by far the biggest cause of cancer deaths in the United States.
Her 2006 study said that, after screening 31,567 people from seven countries, CT scans uncovered 484 lung cancers, 412 of them at a very early stage. Three years later, most of those patients were still alive, and she projected that 80 percent would be alive after 10 years and assumed that they would have died without the screens.
Critics question both her survival projections and her assumption that all would have died without screening. Indeed, most in the cancer establishment say that Henschke has yet to prove her case. CT scans have radiation risks and sometimes detect cancers that would not have progressed, leading to risky procedures like biopsies and lung surgery when not needed.
To settle the dispute, the National Cancer Institute started in 2002 the $200 million National Lung Screening Trial comparing death rates among 55,000 people randomly assigned to have CT scans or chest X-rays. Results are not expected until 2010.
Legislation being considered in Congress would require drug and device makers to post registries of payments to doctors.
An increasing number of doctors and institutions are setting up foundations to accept money from companies without having to disclose its source, said Dr. Murray Kopelow, chief executive of the Accreditation Council for Continuing Medical Education.
"This is the third time in the past few weeks that one of these has been identified to us," said Kopelow, whose organization is investigating how widespread the practice is.