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Survival of Patients with Stage I Lung Cancer Detected on CT Screening (Abstract) 

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.

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LETTER: HENSCHKE: Clarification of Funding of Early Lung Cancer Study 

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.

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Survival of Patients with Stage I Lung Cancer Detected on CT Screening: Correction 

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."

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• EDITORIAL: Full Disclosure and the Funding of Biomedical Research 

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.

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#??? 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.

Author Clarifies Source of Funding for Cancer Study 

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.

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• Lung Cancer Screening - I-ELCAP 

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.

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• LCA Responds to New York Times Article on Tobacco Funding for Lung Cancer Screening Trial 

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

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Conflict of Interest Controversy Casts Cloud Over Research Into CT Scanning for Lung Cancer 

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?"

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Cancer-Tobacco Scandal Causes Firestorm 

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."

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• Tobacco Company Liggett Gave $3.6 Million To Henschke For CT Screening Research (PDF) 

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.

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• Cigarette Company Paid for Lung Cancer Study  

In October 2006, Dr. Claudia Henschke of Weill Cornell Medical College jolted the cancer world with a study saying that 80 percent of lung cancer deaths could be prevented through widespread use of CT scans.

Small print at the end of the study, published in The New England Journal of Medicine, noted that it had been financed in part by a little-known charity called the Foundation for Lung Cancer: Early Detection, Prevention & Treatment. A review of tax records by The New York Times shows that 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.

Dr. Jeffrey M. Drazen, editor in chief of the medical 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 . . .

most in the cancer establishment say that Dr. 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. . . .

On Monday, The Journal of the American Medical Association published corrections about unreported financial disclosures from Drs. Henschke and Yankelevitz. The patent and pending patents reported by The Cancer Letter “are relevant to these publications,” an editors’ note stated. Editors at the journal were not aware of Dr. Henschke’s association with Liggett . . .

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 Dr. Kopelow

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You have to ask yourself the question, ‘Why did the tobacco company want to support her research?’ They want to show that lung cancer is not so bad as everybody thinks because screening can save people; and that’s outrageous.
Dr. Jerome Kassirer, a former editor of The New England Journal of Medicine and the author of a book about conflicts of interest, on Liggett funding of the Weill Cornell lung cancer CT screening study.

If you’re using blood money, you need to tell people you’re using blood money.
Dr. Otis Brawley, chief medical officer of the American Cancer Society, which gave Dr. Henschke more than $100,000 in grants from 2004 to 2007, money it would not have provided had it known of Liggett’s grants.

Cigarette company paid for lung-cancer study - On Deadline  

A prominent scientist accepted money from the tobacco industry through a hastily created non-profit group that helped finance research that suggested CT scans could boost the long-term survival rates of lung cancer patients, The New York Times reports.

"Small print at the end of the study, published in The New England Journal of Medicine, noted that it had been financed in part by a little-known charity called the Foundation for Lung Cancer: Early Detection, Prevention & Treatment," the paper says. "A review of tax records by The New York Times shows that 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."

Dr. Claudia Henschke, a cancer researcher at Weill Cornell Medical College, was the beneficiary of this company's largess. She and her collaborator, Dr. David Yankelevitz, deny that they tried to hide the source of their funding.

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• Liggett Group to Make All Cigarettes Fire Standards Compliant 

Vector Group Ltd.'s (NYSE: VGR) subsidiary, Liggett Group LLC, announced today that, consistent with cigarette fire safety standards enacted by a growing number of states, it plans to voluntarily convert the production of all of its domestic cigarette brands to comply with state cigarette fire safety standards beginning January 2009. The Company will continue to meet all deadlines for fire safety standards that become effective prior to January 2009.

"We are committed to making best in class cigarettes while assuring compliance with all state and federal regulations. Converting our production to make all of our cigarette brands fire standards compliant nationwide is consistent with that commitment," said Ronald J. Bernstein, President and Chief Executive Officer of Liggett Group. "A change in cigarette paper along with our state of the art manufacturing process will enable us to provide customers with value priced brands that continue to meet the highest taste and quality standards in the industry."

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Liggett plans cigarette fire safety compliance  

Liggett Group will convert all of its domestic cigarette production standards to meet all state fire safety standards by January of next year, the company has announced.

The Mebane-based cigarette maker said in an announcement that the move is "consistent with cigarette fire safety standards enacted by a growing number of states." The company will continue to meet all deadlines for fire safety standards in individual states that become effective before January, the company added.

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Liggett follows suit with its own snus 

A North Carolina tobacco manufacturer said yesterday that it is planting seeds for a smokeless product in test markets already being plowed by larger competitors.

Liggett Group LLC, based in Mebane, will begin selling in May a snus product under its Grand Prix brand. There will be three flavors - original, spearmint and wintergreen - and it will be made through a partnership with Snusab of Stockholm, Sweden. . . .

Liggett is following closely in the footsteps of Reynolds American Inc. and Philip Morris USA in testing snus in select U.S. markets.

Grand Prix snus will be sold in seven of the eight metropolitan areas being used by Reynolds for Camel Snus - Columbus, Ohio; Dallas/Fort Worth, Texas; Indianapolis; Kansas City; Orlando, Fla.; Portland, Ore.; and Raleigh. Philip Morris is selling Marlboro Snus in Dallas and plans to begin testing it in Indianapolis in March.

Camel Snus is available at Sheetz convenience stores

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