US: Cigarette Company Paid for Lung Cancer Study

Publisher Name: 
The New York Times

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, 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 was the foundation president, and her longtime collaborator,
Dr. David Yankelevitz, was its secretary-treasurer. Dr. Antonio Gotto,
dean of Weill Cornell, and Arthur J. Mahon, vice chairman of the
college 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."

Paul 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 researchers 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, "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 colleague 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 correctly, 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, Andrew Ben Ami, assistant secretary of the
foundation, said in an interview 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
foundation director, said he did not know the source of the funds.

Dr.
Robert C. Young, chancellor of the 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 the 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, 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 disclosure that Dr. Henschke's
work was in part underwritten by grants from a cigarette maker will
undercut those efforts, 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, 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 reported
that Drs. Henschke and Yankelevitz had 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.

Jonathan
Weil, a Weill Cornell spokesman, said Dr. Henschke did not disclose 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 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, said Dr. Catherine 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
were on the foundation board.

"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 police and
benefit from faculty members' financial deals.

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.

AMP Section Name:Tobacco
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