Big Tobacco-Funded Study Raises Concerns

Hubertus, Prince of Saxony Coburg and Gotha, right, leads his American wife Kelly Rondestvedt out of St. Moriz church in Coburg, Germany, following their church wedding ceremony, Saturday, May 23, 2009. About 400 guests attended the wedding of the hereditary prince and the 34-year-old Kelly from Pensacola, Fla. (AP Photo/Eckehard Schulz) AP Photo/Eckehard Schulz

The disclosure of hidden tobacco money behind a big study suggesting that lung scans might help save smokers from cancer has shocked the research community and raised fresh concern about industry influence in important science.

Two medical journals that published studies by Weill Cornell Medical College researchers in 2006 are looking into tobacco cash and other financial ties that weren't revealed. The studies reported benefits from lung scans, which the Cornell team has long touted.

It's a crucial public health issue: Dozens of groups, including such anti-smoking crusaders as the American Cancer Society, have given the Cornell team money to see if routinely screening smokers with CT scans can spot the world's most lethal cancer in time to prevent deaths.

The study claimed that an annual CT scan could detect lung cancer early enough to extend a patient's life by at least 10 years, a remarkable survival rate for such a deadly disease, reports CBS News' The Early Show.

The federal government also has given money even though scientists have criticized the Cornell study's design and the government has its own more rigorous study under way.

Many were stunned to learn that a foundation Cornell set up and listed in the New England Journal of Medicine in October 2006 as a sponsor of the study actually got $3.6 million from a parent company of cigarette maker Liggett Group Inc. The tobacco source was reported in a New York Times story Wednesday.

Liggett, whose owner was the first to break with other tobacco companies and say that tobacco was addictive and deadly, announced its donation to the Cornell foundation in 2000 in a press release. But the foundation's funding source wasn't disclosed to the journal.

On Wednesday, company spokeswoman Carrie Bloom noted in a statement that the company "had no control or influence over the research."

Scientists must maintain the trust of patients in research studies, and "any breach of that trust is not simply disappointing but, I believe, unacceptable," Dr. John Niederhuber, director of the National Cancer Institute, said in a statement.

Any findings from a study tainted by hidden industry ties "will be much less believable," said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group. The problem is avoidable, he added. "There are plenty of people around who are bright and knowledgeable and don't have conflicts of interest. We need to look harder to find these people."

"It's important for everyone to understand why the medical community is so upset and outraged about this. We must tell the public and our colleagues what the sources of funding for the research we do," Dr. Steven Nissen, chairman of cardiovascular medicine at Cleveland Clinic in Chicago told The Early Show. "Medical research is a special trust. Patients' lives depend on what we do."

While Dr. Nissen wouldn't say whether he believed Weill Cornell deliberately concealed where they got the money, he did say that it appeared as though a foundation was set up and money was funded for the study from the tobacco company into this foundation that funded the research.

"So when it was disclosed, you couldn't tell that the money actually came from the tobacco companies," Nissen told the The Early Show. "That's a problem."

The cancer society's chief medical officer, Dr. Otis Brawley, said the society would not have contributed to the study if it knew "Big Tobacco" was co-funding the work. Still, there is no sign that the study's findings are tainted, and "it is my belief that something can be learned that can be useful," he said.

The chief Cornell researcher, Dr. Claudia Henschke, did not respond to an e-mail requesting comment. Cornell's dean, Dr. Antonio Gotto, said: "The claim that we set this foundation up in order to cover up the money just isn't true. We made a public announcement that we were taking the money from the tobacco company."

In retrospect, Gotto said perhaps the tobacco cash and patents that Cornell researchers hold on related technology should have been disclosed in Henschke's journal articles. Instead, one listed only the Cornell foundation.

Dr. Catherine DeAngelis, editor in chief of JAMA, the Journal of the American Medical Association, said she contacted Henschke months ago after others pointed out patents not disclosed in a July 2006 study. DeAngelis said Henschke didn't believe the patents were relevant to the research and resisted disclosing them.

"We'd been working with Dr. Henschke trying to get her to write a letter of apology - which is our policy - and to take responsibility," DeAngelis said. "It was not easy to get her to do anything."

Asked whether she would have published the research if the tobacco funding had been known, DeAngelis said: Absolutely not. I would have turned down the paper."

A spokeswoman for the New England Journal, which published the Henschke paper listing the Cornell foundation as a sponsor, one of about 30, said only that the journal was investigating the matter.

Smokers are in dire need of good science on the risk and benefits of lung scans, which are being marketed directly to the public in shopping centers and similar settings. About 1 million people worldwide will be diagnosed with lung cancer this year, and most will die because it is found too late for treatment to do much good.

Advanced X-rays called spiral CT scans have been touted as a way to find tumors earlier. But doctors fear that screening could lead to too many false alarms and unnecessary biopsies without saving lives. The cancer society does not currently recommend them, and most insurers don't pay for them.

Interest in the scans soared after Henschke published a key study in 1999 saying they found more tumors than conventional X-rays. Her ongoing study aims to prove the value of these scans but has been criticized because it lacks a comparison group.

The National Cancer Institute's study now under way has several comparison groups. It, too, has been criticized because two of its leaders were paid by tobacco companies as expert witnesses in lawsuits. Brawley says these were small amounts and one researcher gave the money back. Results of the federal study are expected in 2009 or 2010.

Laurie Fenton Ambrose, president of the patient advocacy group, the Lung Cancer Alliance, has complained about the government study conflicts, and says attacks on Henschke are "mudslinging."

"There is a difference between money that is provided independent of any tobacco control that would help fund research that would advance better patient outcomes and money that tobacco (companies) pay researchers for their testimony against screening in class action lawsuits," she said.

However, her group has taken industry money, too - from a maker of CT scanning equipment.

Niederhuber said the government "takes conflict of interest very seriously" and is committed to finishing its study with integrity.

An independent safety monitoring board is in place, and "investigators involved in the study do not have access to the data collected and cannot influence the data in any way that might affect the outcome of the trial," he added.
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