Cigarette Company Paid for Lung Cancer Study ... conflicts of interest ... NY Times March 26, 2008

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From a silent sister:

NY Times March

26, 2008 Cigarette

Company Paid for Lung Cancer Study By GARDINER HARRIS In

October 2006, Dr. 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. But 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. 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, 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. Dr. Henschke served as

the foundation’s president, and her longtime collaborator, Dr.

Yankelevitz, was its secretary-treasurer. Dr. Gotto, dean of Weill Cornell,

and Arthur J. Mahon, vice chairman of the college’s board of overseers,

were directors. Vector issued a press

release on Dec. 4, 2000, saying that it intended to give $2.4 million to Weill

Cornell to finance Dr. Henschke’s research. Articles in Business Week and

USA Today mentioned the gift. No mention was made of the foundation, begun so

hastily that its 2000 tax return stated “not yet organized.” Caminiti, a

Vector spokesman, confirmed that the company donated $3.6 million to the

foundation over three years. The company “had no control or influence

over the research,” he said. Prominent cancer

researchers and journal editors, told of the foundation by The Times, said they

were stunned to learn of Dr. 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

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, Dr. Brawley said. 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. In the Vector press

release, Dr. 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. Gotto said in an

interview that Dr. Henschke, Dr. Yankelevitz and another of their colleagues

set up the foundation initially without the university’s approval, which

he said faculty members are allowed to do. He and Mr. Mahon joined the board

some weeks or months after its creation to ensure that the Vector grants were

handled appropriately, he said. “If we had been

approached, we would not have set up the foundation,” Dr. Gotto said.

“We would have accepted the gift directly. We think we behaved honorably.

There was no attempt to set up a foundation to hide tobacco money.” Days earlier,

Ben Ami, assistant secretary of the foundation, said in an interview that he

would not disclose the source of the charity’s financing, at the request

of the university. In another interview before Dr. Gotto agreed to speak, Mr.

Mahon, another of the foundation’s directors, said that he did not know

the source of the funds. Dr. C. 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,” Dr. 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?’ ” Dr. 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.” Dr. 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 Dr. 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 Dr. Henschke’s group. But the revelation

that Dr. 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. 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, Dr.

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 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. 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. Dr.

Henschke has asserted that allowing hundreds of thousands of people to die in

the meantime is unethical. The Cancer Letter, a

newsletter, recently revealed that Drs. Henschke and Yankelevitz failed to

disclose in articles and educational lectures a patent and 10 pending patents

related to CT screening and follow-up. General Electric, a maker of CT

scanners, licensed the issued patent beginning in 2001. Weil, a Weill

Cornell spokesman, said Dr. Henschke did not reveal the patents in some

articles and lectures because she did not deem them relevant. 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 revealed by The Cancer Letter

“are relevant to these publications,” an editor’s note

stated. Editors at the journal were not aware of Dr. Henschke’s

association with Liggett, said Dr. D. DeAngelis, the journal’s

editor in chief. “I would never

publish a paper dealing with lung cancer from a person who had taken money from

a tobacco company,” Dr. DeAngelis said. Universities are

responsible for policing conflicts of interest and, in many cases, the required

disclosures of their faculty. But Weill Cornell shared in the proceeds of Dr.

Henschke’s patent and pending patents, and university officials served on

the board of the foundation. “We have a very

strict oversight policy” for conflicts of interest, Dr. Gotto of Weill

Cornell said. He dismissed any suggestion that the university could not both

police and benefit from the financial arrangements of faculty. But Dr. Kassirer said,

“The problem is that universities, because they’re so conflicted

themselves, ignore the conflicts of interest of their faculty.” 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 Dr. Kopelow, whose organization is investigating how widespread

the practice is. Laurie Fenton Ambrose,

president and chief executive of the Lung Cancer Alliance, a nonprofit patient

advocacy group, said she still trusted Dr. Henschke and still believed in

widespread CT scanning to prevent lung cancer deaths.

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