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Underhand About Secondhand

A Federal Judge Rules that the EPA Put Politics Before Science in their Report that Called Secondhand Smoke a Killer
Jason Sheftell
From the Print Edition:
John F. Kennedy, Nov/Dec 98

(continued from page 1)

But what is the reality? Some antitobacco advocates claim that the big tobacco companies "shopped the venue" by getting a hearing in North Carolina. Yet the simple fact is, that is where most of the tobacco companies are based, so it is no more unusual for their cases to be heard in North Carolina courts than, say, for many of the top pharmaceutical companies to turn to courts in New Jersey.

Some antismoking advocates claim that Osteen once lobbied for tobacco interests. The brief lobbying that Osteen engaged in took place in 1974, when, as a lawyer in private practice, he was hired by a group of small local tobacco growers from three North Carolina counties to plead their case in Washington, D.C., to maintain tobacco quotas that limited the size of tobacco yields, in effect protecting smaller growers. (The quotas were extended.)

Appointed to the federal court in 1991 by President Bush, Osteen was assigned the EPA case as a part of the normal judicial rotation of federal district courts. What's more, in 1997, Osteen had ruled against the cigarette companies' claims that the Food and Drug Administration had no right to regulate nicotine (a decision overturned by a federal appeals court this past August).

Well before the ruling, even EPA insiders and a research branch of Congress knew trouble was brewing. In 1990 and 1991, when the study was in its draft stages, Dr. Geoffrey Kabat, a cancer epidemiologist, a member of the EPA's Scientific Advisory Board for the report and now a professor at the State University of New York at Stony Brook, felt the sting of disagreeing with the government when he voiced his opinion that the EPA was doing a disservice by classifying ETS as a Group A carcinogen. After examining the data, Kabat concluded that the risk was too small to place ETS on the same list as arsenic, asbestos and radon. "I was hated by activists inside the EPA for saying what I believed to be true," says Kabat. "The discussion was so polarized, with the tobacco machine on one side and the EPA agenda on the other. When my comments came out, based on what I saw as the truth, the tobacco companies wanted to use me like a poster child."

The EPA Risk Criteria Office, a group of internal risk assessment experts who evaluated the study, agreed with Kabat that the report had flaws and that a Group A classification seemed severe and politically risky. Because of limited evidence, the group recommended ETS for a Group B1 classification, labeling it a "probable human carcinogen."

Shortly after the EPA report was released, the Congressional Research Service, an independent research arm of the Congress, expressed "uncertainty" about the EPA methodology and conclusions, stating, "It is unusual to return to a study after the fact, lower the required significance level, and declare its results to be supportive rather than unsupportive of the effects one's theory suggests should be present."

After combining the results of 31 leading studies on ETS (and ignoring some others), the EPA concluded that a woman who lives with a smoker is 1.19 times as likely to develop lung cancer as a woman who lives with a nonsmoker. This means, if you smoke, your wife has a 19 percent greater chance of developing lung cancer than the wife of a nonsmoking friend. Weighing the use of the 1.19 factor in relation to most other medical agencies studying causal relationships between cancer and carcinogens, the EPA risk assessment for ETS is suspect. "Relative risk of less than 2 are considered small and are usually difficult to interpret," the National Cancer Institute states in its standards for risk assessment in studies, adding, "Such cases may be due to chance, statistical bias, or the effect of confronting factors that are sometimes not evident."

Even more profound, compared to the 15 other Group A carcinogens, ETS possessed the lowest risk factor during its five-year tenure on the EPA list. In his decision, Osteen noted that other agents with relative risks of 2.6 or greater were not placed on the list by the EPA. (Diesel emissions, for example, have a 2.6 rating, yet received a B1, not A, listing. Electromagnetic fields (EMFs) emanating from everyday appliances were not included on any list of carcinogens because, according to the EPA, no studies rated the risk of EMFs above 3.0.) The EPA contends that "ETS is the only Group A for which cancer risk in humans was detected at environmental exposure levels [in the air around us], rather than occupational or pharmaceutical levels." The judge, however, found the classification exaggerated.

In spite of recent criticism, the EPA stands by its report. In a press release response to the ruling, EPA Administrator Carol M. Browner said the judge's decision was based on "procedural concerns." Yet any researcher knows that procedural concerns are a cornerstone of scientific studies. The release went on to state that "It is widely accepted in the scientific community that secondhand smoke poses significant health risks to children and adults. Further, since the EPA's 1993 study, health study after health study confirms that both children and adults are at a serious risk from exposure." Browner cited no specific studies in her release to support her sweeping statement. The EPA and the Justice Department have not yet decided whether they will appeal Osteen's ruling.

While scientists and health officials disagree on the extent of the ETS risk, most contend the evidence is minimal, but risk is plausible. Morton Lippmann, head of the EPA's Scientific Advisory Board for the 1993 report on ETS, told a Washington reporter in 1991, "Exposure to ETS represents a small added risk, probably much less than you took to get here through Washington traffic."

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