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Claudia Henschke and David Yankelevitz of Weill Cornell Medical College are key figures in a multicenter study of spiral CT screening for lung cancer and leading proponents of screening. . . .
All the scientists presumably hold their strong views without being influenced by monetary considerations. But their incautious behavior in accepting special-interest money and the failure of Weill Cornell researchers to make their royalty interests explicit have inevitably cast doubt on the research they take pride in.
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The New England Journal of Medicine yesterday caught up with a bit of full-disclosure housekeeping, publishing a correction and a clarification to describe a few funding and conflict-of-interest details from a lung cancer screening study the journal published in 2006.
A 2006 study claiming 80 percent of lung cancer deaths may be prevented with CT scans was funded by a tobacco company, the New England Journal of Medicine said in corrections and an editorial yesterday.
After embarrassing disclosures of financial links between authors of a lung-cancer study and two big corporations -- General Electric Co. and Vector Group Ltd. -- the New England Journal of Medicine published a correction, a clarification and an editorial calling for transparent disclosure of funding sources.
The lung-cancer study, which the journal published in 2006, has been controversial. It suggested that an annual screening with a CT scan could reduce the death rate from lung cancer, the top cancer killer. Critics said the study showed only that screening could detect cancers earlier -- not necessarily that it could avert deaths.
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. . . .
In its editorial, the New England Journal called for more-transparent disclosure of funding sources. Readers "cannot fully appreciate a study's meaning without acknowledging the subtle biases in design and interpretation that may arise when a sponsor stands to gain from the report," the journal's editors wrote. "We and our readers were surprised to learn that the source of the funding of the charitable foundation was, in fact, a large corporation that could have an interest in the study results."
Are these results sufficiently effective to justify screening people who are at risk of lung cancer? As compared with mammographic screening for breast cancer, for lung cancer the rates of detection among the participants in this study who were 40 years of age and older were 1.3% on baseline CT screening and 0.3% on annual screening (Table 2), values that were slightly higher than those for the detection of breast cancer (0.6 to 1.0% on baseline screening) and similar to those for annual screening (0.2 to 0.4%) among women 40 years of age and older.22 The rate of cancer detection depends on the risk profile of those undergoing screening; the higher the risk, the more productive the screening. Thus, as expected, CT screening of the original participants in ELCAP, who were former and current smokers 60 years of age and older,1,2 was more productive in detecting lung cancer (detection rates, 2.7% on baseline screening and 0.6% on annual screening) than among participants in the expanded study. The cost of low-dose CT is below $200,23,24,25,26 and surgery for stage I lung cancer is less than half the cost of late-stage treatment.26,27 Using the original ELCAP data and the actual hospital costs for the workup, we found CT screening for lung cancer to be highly cost-effective.23 Other estimates of the cost-effectiveness of CT screening for lung cancer for various risk profiles24,25,26,28 are similar to that for mammography screening.29,30
Supported in part by the National Institutes of Health (grants R01-CA-633931, to Dr. Henschke, and R01-CA-78905, to Dr. Yankelevitz); the Department of Energy (DE-FG02-96SF21260, to Dr. Markowitz); the Department of Defense to Dr. Tockman; Department of Health and Mental Hygiene of the City of New York; New York State Office of Science, Technology, and Academic Research; American Cancer Society; Israel Cancer Association; Starr Foundation; New York Community Trust; Rogers Family Fund; Foundation for Lung Cancer: Early Detection, Prevention, and Treatment; Foundation for Early Detection of Lung Cancer; Dorothy R. Cohen Foundation; Research Foundation of Clinic Hirslanden; Clinic Hirslanden; Swedish Hospital; Yad-Hanadiv Foundation; Jacob and Malka Goldfarb Charitable Foundation; Auen–Berger Foundation; Princess Margaret Foundation; Tenet Healthcare Foundation; Ernest E. Stempel Foundation, Academic Medical Development; Empire Blue Cross and Blue Shield; Eastman Kodak; General Electric; Weill Medical College of Cornell University; New York Presbyterian Hospital; Christiana Care Helen F. Graham Cancer Center; Holy Cross Hospital; Eisenhower Hospital; Jackson Memorial Hospital Health System; and Evanston Northwestern Healthcare.
Results
Screening resulted in a diagnosis of lung cancer in 484 participants. Of these participants, 412 (85%) had clinical stage I lung cancer, and the estimated 10-year survival rate was 88% in this subgroup (95% confidence interval [CI], 84 to 91). Among the 302 participants with clinical stage I cancer who underwent surgical resection within 1 month after diagnosis, the survival rate was 92% (95% CI, 88 to 95). The 8 participants with clinical stage I cancer who did not receive treatment died within 5 years after diagnosis.
Conclusions
Annual spiral CT screening can detect lung cancer that is curable.
the Editor: In our article1 published in the October 26, 2006, issue of the Journal, one of the disclosed sources of funding was the Foundation for Lung Cancer: Early Detection, Prevention and Treatment, which provided partial support for our research. For full transparency we wish to inform you that $3.6 million (virtually all of the Foundation's funding) was contributed in 2000 through 2003 as an unrestricted gift by the Vector Group, the parent company of Liggett Tobacco, which manufactures cigarettes.
Survival of Patients with Stage I Lung Cancer Detected on CT Screening (October 26, 2006;355:1763-71). The disclosure statement (page 1769) should have read as follows: "Drs. Henschke and Yankelevitz report receiving royalties from Cornell Research Foundation as inventors of methods to assess tumor growth and regression on imaging tests for which pending patents are held by Cornell Research Foundation and licensed to General Electric. No other potential conflict of interest relevant to this article was reported."
Although the science in a submitted manuscript should be judged on its merits, one cannot fully appreciate a study's meaning without acknowledging the subtle biases in design and interpretation that may arise when a sponsor stands to gain from the report. . . .
This situation raises two concerns. First, as medical journal editors, we believe that it is important that the ultimate source of funding be made clear to the Journal's readers. Second, it is appropriate to ask whether a study on clinical outcomes in lung cancer should be directly underwritten in part by the tobacco industry. Given the enormous burden of smoking-related illness and the ongoing sale of cigarettes and other forms of tobacco, one might question the advisability of research entities accepting funding from tobacco companies except through the American Legacy Foundation, which distributes funds received through the Master Settlement Agreement with U.S. tobacco companies.
We believe that it is important for our readers and the entire biomedical community to be aware of this situation. Our goal is that readers be fully informed about funding sources. It is the responsibility of authors to disclose fully and appropriately the sources of funding of their studies. We expect that authors will be particularly attentive to transparency in reporting if a funding entity has a vested interest in the outcome. The public's trust in biomedical research depends on it.
#?? ? the science in a submitted manuscript should be judged on its merits, one cannot fully appreciate a study's meaning without acknowledging the subtle biases in design and interpretation that may arise when a sponsor stands to gain from the report.After the Henschke/Liggett hurricane, an editorial from the NEJM.
A 2006 study claiming 80 percent of lung cancer deaths may be prevented with CT scans was paid for by a tobacco company, The New England Journal of Medicine said in corrections and an editorial. Vector Group, parent of Liggett Tobacco, contributed $3.6 million, or “virtually all” of the financing for the Foundation for Lung Cancer, which backed the study, the author Claudia Henschke said in a clarification published online by the journal.
The Foundation for Lung Cancer: Early Detection, Prevention and Treatment received an unrestricted gift of $3.6 million from the Vector Group, the holding company for Liggett Tobacco, in a series of payments, from July 2000 to June 2003. The gift was used appropriately for the public good -- to support Weill Cornell Medical College's highly regarded, multi-institutional, international I-ELCAP [International-Early Lung Cancer Action Program], whose objective is to perform CT screening research for lung cancer in order to determine whether such screening improves cure rates for persons at risk.
The original $2.4 million pledge to the Foundation -- and the work funded by the Foundation at Weill Cornell -- was fully and publicly disclosed at the time through a press release, and was substantially covered in the lay media. It was discussed and disclosed in the academic community at conferences, which were widely attended by advocacy groups, agencies, and by investigators from around the world interested in lung cancer screening. It was also fully disclosed to other foundations and groups wishing to contribute funds to I-ELCAP.
Specifically, the gift was used to support the I-ELCAP lung cancer screening project to develop the WCMC Coordinating Center and to help other institutions to develop screening programs as part of the international screening collaboration.
The gift was unrestricted, which means, unlike industry-funded research agreements, it allows for completely independently conducted research into 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.
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.
Today the New York Times ran an article "exposing" a donation made in 2000 by the Vector Group, which owns Liggett, to the International Early Lung Cancer Action Program (I-ELCAP) screening study and insinuated that the research and researchers were tainted.
Sadly, this is far from the truth and another attempt to discredit I-ELCAP and lung cancer screening in general. Why else raise this now? The donation was made 8 years ago, was publicly reported and was an unrestricted grant that allowed for no control by the donor. . . .
LCA President and CEO, Laurie Fenton Ambrose responded to the NY Times reporter with a written letter (below). We will not let those who want to deny the lung cancer community the benefits they deserve defeat our efforts. . . .
"I continue to be concerned that lost in these various questions and comments is any understanding of the public health epidemic upon us. Lung cancer is the most lethal of all cancers - killing more people than breast, prostate, colon, liver , kidney and melanoma cancers combined - 85% of which are current and former smokers - most of whom will die within a year of diagnosis because their cancers are found too late. We can help those at high risk for lung cancer today through the use of CT scans - and we stand proudly with those in the public health community who view lung cancer as a disease deserving of increased compassion and support."
--Laurie Fenton-Ambrose
The controversy surrounding computed tomography (CT) screening for lung cancer has reached new heights, with revelations this week that the research was funded by a tobacco company and earlier revelations that the researchers involved held patents on the technology used.
Principal proponent of the CT scanning approach for lung cancer, Claudia Henschke, MD, PhD, from the New York Presbyterian/Weill Cornell Medical Center, has claimed that her research provides compelling evidence that CT scanning saves lives, and that it can reduce mortality from lung cancer by 80%. These claims, based on data from the International Early Lung Cancer Action Project (I-ELCAP) reported in October 2006 in the New England Journal of Medicine (2006;355:1763-1771), were widely publicized in the lay media. They also led to calls from advocacy groups for widespread use of CT scanning for smokers and others at high risk for lung cancer. . . .
"LCA’s long-held position is that big tobacco's deceitful marketing and cover-up of tobacco's harms has led directly to the underfunding of lung cancer research," the letter states, adding: "Is seeking these and other penalty payments to advance research to help victims then wrong?"
Medical journals rely on researchers to voluntarily disclose who funds their work in order to account for a possible bias. NEJM included the charity Foundation for Lung Cancer: Early Detection, Prevention & Treatment, along with General Electric in its list of organizations that funded Henschke's research -- but not the tobacco company that funded the charity.
Nor did Henschke disclose the patents held by the Cornell Research Foundation on CT scan reading, two of which were licensed by General Electric, according to Paul Goldberg, a reporter with Cancer Letter who helped break the story.
"I said, 'Whoa, this is fascinating,'" Goldberg said. "There are 27 patents here and two of them were licensed ... and none of this is declared ... none of the royalties, nothing."
"I'm convinced that this whole episode represents an attempt by the cigarette companies [to show] that you can smoke with impunity," said Bruce Chabner, clinical director of the Massachusetts General Hospital Cancer Center. . . .
"These revelations show that the current voluntary system of disclosure of conflicts of interest is not working," said Jeffrey Spike, associate professor of medical humanities at Florida State University College of Medicine. "Tobacco companies and drug companies are treating it as a shell game, finding ways to avoid the intent of the policy."
"Researchers should be banned for life from journals when they don't disclose something that might be relevant," Spike said. "Someone who will take money and not reveal its source would be more honest if they simply worked for the companies paying for their research."
The press release quotes Bennett LeBow, chairman and CEO of Vector Group: . . .
The document is posted at http://www.tobacco.org/news/54637.html. . . .
Over the past four years, Henschke received over $100,000 in grants and contracts from ACS, the society said. This included several $10,000 to $15,000 contributions for the annual meeting of the I-ELCAP, and a $61,850 contract to support the I-ELCAP pathology and cytology evaluation program.
Each time she accepted ACS funds, Henschke signed a document certifying that she didn’t represent a tobacco company or subcontract work to those who do.
The ACS definition of a “tobacco company” contained in each of these documents includes “any company that manufactures tobacco products and is commonly considered to be part of the tobacco industry, including subsidiaries and parent companies, as well as philanthropic foundations and other organizations closely linked with the tobacco industry.” . . .
Though scientists who receive Legacy money are precluded from accepting concurrent funds from tobacco sources, surpluses of funds received from tobacco companies in the past are exempted from this prohibition, Cartwright said.
“The American Legacy Foundation requires grant recipients to agree not to accept tobacco funds or anything else of value from tobacco companies during the Legacy grant period,” she said in an e-mail. “It does not include a look-back provision, i.e., we do not disqualify grantees on the basis that they may have previously received tobacco support. . . .
On March 10, at a gala at the Pierre hotel, Legacy gave Henschke its “Humanitarian in Medicine and Public Health Award.”
In 2007, the Flight Attendant Medical Research Institute gave $8.7 million to Weill Cornell to set up a “multidisciplinary research and clinical program to enhance early detection and treatment of diseases related to secondhand smoke exposure-including cancer, heart disease, emphysema, asthma, chronic bronchitis and osteoporosis.”
The initiative, called the FAMRI-I-ELCAP Collaborative Network, was expected to recruit 5,000 individuals from industries associated with exposure to secondhand smoke.