Critics Question Objectivity Of Government Lung-Scan Study

[Christine]

URL for this article:

http://online.wsj.com/article/SB119179920110451468.html

Critics Question Objectivity Of Government Lung-Scan Study. Tobacco Companies Paid Key Researchers As Expert Witnesses

By DAVID ARMSTRONG

October 8, 2007; Page B1

In a dispute with broad implications for cancer treatment, patient advocates and congressional overseers are raising questions about the objectivity of a massive federal study that is supposed to determine whether annual CT scans of smokers' lungs can save lives.

The nine-year study, called the National Lung Screening Trial, is tracking 50,000 smokers at a cost of $200 million, and is funded by the National Cancer Institute, or NCI. Due to be finished in 2009, the study is expected to have a major impact on whether regular CT scans for smokers will become a standard of care -- and whether tobacco companies could be forced to pay for them. The 90 million current and former smokers in the U.S. are all potential candidates for such screening.

Since late last year, the Lung Cancer Alliance, a Washington, D.C., nonprofit that supports screening, has asserted in letters to the NCI and its parent, the National Institutes of Health, that two of the study's key researchers have conflicts of interest because they have accepted money from tobacco companies to be expert defense witnesses in lawsuits. The suits sought to force the companies to pay for annual CT screening.

The Alliance, which is funded by individual donations and corporate grants, including $100,000 from General Electric Co., a maker of CT scanners, also charged the study has design flaws that could bias its outcome against screening.

In recent months, staffers of the U.S. House Energy and Commerce Committee, which oversees medical research issues, have also begun making inquiries about the alleged conflicts and design issues, say people familiar with the matter.

The question under consideration in the study is a complex one. CT, or computed tomography, scanning is adept at detecting abnormalities that might be cancerous. But once they are detected, potentially risky lung biopsies are usually needed to confirm the presence of cancer in the lung. Often, the biopsies turn up no cancer.

Skeptics say patients may suffer health problems as a result of universal screening -- such as complications from biopsies or needless surgery -- offsetting any gains from enhanced detection.

The researchers that the alliance and the congressional staffers are focused on are University of California Los Angeles radiologist Denise Aberle, one of the study's two national leaders; and Dartmouth College radiologist William Black, the principal investigator at one of the 30 study sites in the country.

In a 2003 trial of a lawsuit brought in state court in Louisiana, Dr. Aberle testified for the American Tobacco Co., now part of Reynolds American Inc., that "it is reckless or irresponsible to promote" CT screening. Court transcripts in the Louisiana case show that Dr. Aberle's role as co-leader of the government study was highlighted repeatedly. American Tobacco lawyer Gary Long says that what made Dr. Aberle a good witness was "the fact she could talk about the national lung cancer screening trial that is ongoing."

In a similar case in New York, Dr. Black provided an expert report for Philip Morris USA, a unit of Altria Group Inc., in which he warned that CT screening "may do more harm than good."

Smokers lost their bid for screening in the Louisiana case. The New York case is still pending, as is similar case in Massachusetts. The lawsuits haven't been closely followed by the media, and the researchers' roles in the cases weren't widely known until the alliance discovered them.

The NIH doesn't have conflict-of-interest rules for the nongovernment researchers it funds, and relies instead on the institutions where the researchers work to set guidelines. Universities generally require their faculty researchers to disclose consulting arrangements and other financial ties, and some schools ban some relationships outright.

Dr. Aberle denies any bias and says she decided to testify because the screening plan proposed by the plaintiffs in the Louisiana case was "poorly constructed" and "incompletely conceived." Among the flaws, she said, was the lack of a plan for how the patients would be treated following a screening test, or any provision to track patients to find out if screening had any impact. Dr. Aberle and UCLA say her expert work in the case was permissible under UCLA rules.

American Tobacco paid a total of $30,750 for Dr. Aberle's expert work in the Louisiana case, according to her and UCLA. The money, after taxes, was then deposited into a UCLA account. UCLA says she used the money for "academic enrichment," such as business-related travel and entertainment expenses or subscriptions to journals.

Dr. Black said he agreed to be an expert witness because he "felt an obligation that someone needed to stand up and represent the other side of the screening issue." He added, "the other side is getting away with false statements -- that it is a proven technology and saves lives." Dr. Black now says his decision to get involved in the court case was "naive." He has returned the $700 he earned from Philip Morris and stopped working for the company because of his concern the expert work "would be used against me" and the study "by patient advocacy groups on the other side." Dartmouth declined to comment, but in a letter to the Lung Cancer Alliance said the work was permissible under its rules.

In a written response to the Lung Cancer Alliance, the NCI said the expert witness work was appropriate. "Service as an expert witness, presenting independent analyses based on published medical literature, is a commonly accepted activity for physicians, researchers, and other experts and in the instance of the specific circumstances described did not violate the required disclosure guidelines of the organizations involved," NCI director John Niederhuber wrote.

In an interview, an NCI spokesman said the institute has no way of knowing whether any other investigators in the 30-center study have financial ties to tobacco or scanning companies because it does not examine such potential conflicts.

A spokeswoman for Siemens Medical Solutions, a big CT machine maker, said the company works on collaborative research projects with several research institutions but wouldn't say if it has any relationships with individual researchers working on this study. GE, another large CT vendor, declined to comment.

David Rothman, the director of the Center on Medicine as a Profession at Columbia University medical school, said he was "stunned" to learn that the researchers in the government study had testified for tobacco companies and said the NIH should overhaul its rules to prohibit such work.

The Lung Cancer Alliance and others also complain about the trial's design, in part because it compares patients receiving CT scans with those receiving X-rays. If abnormalities are detected by X-ray and a CT confirms cancer, the X-ray, not the CT, will be credited with the discovery. Critics also say that 50,000 patients are too few to detect a benefit.

In its written response to the Alliance, the NCI said that the there are enough patients in the study and that the study is scientifically "very well designed."

Write to David Armstrong at david.armstrong@wsj.com