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On the East Coast, word of this exciting technology spread quickly: At long last, lung cancer seemed to have its equivalent of a mammogram. In August 2000, then-New York City Mayor Rudy Giuliani added his voice to the growing chorus advocating further tests of CT scans' effectiveness. At a City Hall news conference to announce the city's plans to contribute $4 million of its tobacco settlement money toward the funding of the New York Early Lung Cancer Action Program, a branch of the international ELCAP group, the mayor called the scan "one of the most promising new technologies for cancer screening and diagnosis."
For a variety of complex reasons, the revolutionary promise of the technology has seemed to attract particularly vehement and, sometimes, unlikely enemies.
Last year, amid growing realization that spiral CT scans had the potential to transform the biotechnology, tobacco, insurance, and health care industries, the tests themselves were put on trial. In a class action lawsuit against Phillip Morris Inc., R.J. Reynolds Tobacco Co., Brown and Williamson Tobacco Corp., Lorillard Tobacco Co., Liggett & Myers Tobacco Co., Anchor Tobacco Co., and McClure Co. Inc., a group of healthy West Virginia smokers alleged the tobacco companies had put them at a heightened risk of future disease, and should therefore be forced to pay for spiral CT scanning for the smokers.
The lawsuit was Mr. Butts' worst nightmare. A decision in favor of the healthy-seeming smokers could set a national precedent that would cost Big Tobacco almost inestimable amounts of money.
Among a series of expert witnesses favoring the scans, the court heard from Dr. Naresh Gupta, director of nuclear medicine at the West Virginia School of Medicine. Gupta told the jury that CT scans are used every day at the school, and have detected early tumors in thousands of patients. "Your best bet in saving lives with a patient with lung cancer is to detect it very early on," Gupta said. "Because only when it is picked up very early on, you can have survival of 70 or 80 percent. But if you wait and it's not picked up very early on, survival falls down to as low as 10 to 15 percent."
Gupta added that the radiation level in the test itself is not dangerous -- roughly equivalent to the amount absorbed during a plane flight from New York to San Francisco.
Differing strongly with that opinion was Dr. Philip Goodman, chief of thoracic imaging at Duke University, who testified for the tobacco industry. ELCAP's follow-up protocols, in a worst-case scenario, could result in a patient receiving the radiation equivalent of about 2,000 chest X-rays in one year, said Goodman. Grannis dismisses Goodman's testimony as "obscene," and even Goodman added that his calculations had not appeared in any peer-reviewed publications.
"Unless it's really medically indicated, no amount of radiation is good for you," Goodman testified. "There is no lower threshold that may or may not cause harm to you. So it's always best, if you don't need radiation, don't get radiation."
Asked if he would recommend the test to his patients, Goodman said: "I would try my hardest to talk them out of it unless they wanted to join up in one of the randomized, controlled trials that might investigate the true validity and value of that test. But certainly not recommend it."
And in the end, neither did jurors, who decided unanimously in favor of the tobacco industry. Although the jury agreed the smokers were at a heightened risk for disease, they said medical screening for the entire class was unreasonable, and blamed smokers for deciding to take up a harmful habit in the first place.
"It came down to, "If you smoke, stop. If you don't smoke, don't start,'" jury foreman Mark Burris said after the trial. "The only way to stop latent disease is stop smoking. That was the bottom line for all the jurors."
In a sign of how contentious and consuming the topic of spiral CT scans has become, the July issue of Chest, the cardiopulmonary and critical care journal, carries no fewer than four articles about lung cancer screening. Grannis weighs in, along with Japanese scientists who report that "low-dose spiral CT seems to be a promising method for screening early lung cancer as a part of annual health examinations."
In the opposite corner, however, the National Cancer Institute's Pamela Marcus reiterates her concerns about the technology in an editorial called "Lung Cancer Screening, Once Again," which says it would be "unforgivable ... if a prematurely established lung cancer-screening program resulted in more harm than benefit." And Dr. Jerome Reich, a retired Kaiser physician in Portland, Ore., backs up Marcus' position with a lengthy article titled "Improved Survival and Higher Mortality: The Conundrum of Lung Cancer Screening."
In his article, Reich posits the usual arguments against CT scans: They've never been tested in a fully randomized trial; they've never shown decreased mortality; and because biopsy or surgery on the lung is especially dangerous, finding tumors early might actually result in more patient deaths.
But Reich goes a step further, making explicit the underlying argument that has driven screening opponents' concerns about false positives (i.e., scans that suggest cancer where none exists). He writes: "Whether community physicians employing [spiral CT scans] would reproduce the notable sensitivity, specificity, low morbidity, and minimization of invasive procedures (including resection) displayed by the ELCAP investigators is open to question."