Underhand About Secondhand

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

You know the look. Every cigar smoker does. It starts with a glance, moves to a grimace and settles into a scowl. People get up and move away. Then the comments start. "Could you put that out?" or "Would you mind?" Lately it's been, "You're not allowed to smoke that here." In the mid- to late-1980s, "here" meant airplanes, certain sections of restaurants and a handful of other locations. In the past five years, it's been stretched to include workplaces, public buildings, entire restaurants, bars and, in recent cases, the outdoors.

Secondhand smoke has become the antitobacco lobby's prized weapon against one's right to smoke. While it may be an annoyance to some, does secondhand smoke kill? In 1993, the Environmental Protection Agency, protector of the country's air, water and soil, released a report declaring that it did. Tobacco smoke caused some 3,000 deaths a year from lung cancer among U.S. nonsmokers, the agency concluded. Classifying secondhand smoke as a Group A carcinogen, the most lethal category of cancer-causing agents, the report, titled "Respiratory Health Effects of Passive Smoking: Lung Cancer and Other Disorders," fueled a nationwide explosion of smoking bans.

On July 17, 1998, five years and more than 750 local, city and state smoking bans later, Judge William L. Osteen Sr. of the U.S. District Court for the Middle District of North Carolina repudiated the 1993 EPA report, voiding crucial sections and suggesting that the EPA manipulated, misrepresented and exaggerated data.

Osteen's decision is one in a string of recent victories for the tobacco industry, and his language suggests a critical shift of the status quo in the war against tobacco. "In this case," the judge's decision stated, "the EPA publicly committed to a conclusion before research had begun; adjusted established procedure and scientific norms to validate the Agency's public conclusion; failed to disclose important findings and reasonings; and left significant questions without answers." Asserting that the EPA manipulated statistics to arrive at a pre-determined conclusion, the judge's ruling, in effect, shifted the blame for presenting dubious data from the cigarette conglomerates to antitobacco forces in the government.

"The EPA report was shoddy science and is a perfect example of policy and political agenda stepping on science," says Jacob Sullum, author of For Your Own Good: The Anti-Smoking Crusade and the Tyranny of Public Health, a 1998 book that explores the war on smoking from a tell-it-like-it-is perspective. A nonsmoker, Sullum sees extremists and crusaders on both the tobacco and the antitobacco sides, and he thinks the scientists, the public and the facts are caught in the middle. "This decision at least evens the score," he says, "and lets people know that the government is just as committed to preventing people from smoking as people think the tobacco companies are to getting them to smoke."

Ordinarily, EPA policy guides are written after a study has been concluded. But in 1988, the EPA began drafting a policy handbook recommending workplace smoking bans to combat the effects of secondhand smoke. Problem was, the EPA risk-assessment study on secondhand smoke was still in the preliminary, predraft stage. Even then-EPA Administrator William K. Reilly knew he was jumping the gun. In a July 1991 memorandum to Louis W. Sullivan, secretary of the U.S. Department of Health and Human Services, Reilly admitted, "Beginning the development of an Agency risk assessment after the commencement of work on the draft policy guide gave the appearance of...policy leading science."

But the policy guideline and the Group A carcinogen classification fit the overall administration policy and Surgeon General C. Everett Koop's 1984 goal of a "smoke-free society" by 2000. Both government and antitobacco advocates sought to control avenues of access to tobacco, raise taxes on smoking products, enact tougher smoking restrictions and decrease smoking through indoor bans.

Did such clear policy dictate the study's conclusion?

Yes, according to Osteen. While admittedly not a scientist, Osteen examined the procedures that the EPA used to gather and study the available information on secondhand smoke, medically referred to as environmental tobacco smoke (ETS). In addition to finding that the EPA had "publicly committed to a conclusion before research had begun," the judge declared as valid the cigarette companies' accusation that the EPA had "cherry-picked" the studies it used to find a statistical link between ETS and lung cancer, excluding those studies that were unfavorable to its premise. Further, Osteen found that the EPA report altered the relationship between "mainstream" smoke (what a smoker inhales) and ETS from chapter to chapter to reach desired conclusions, departed from its risk-assessment guidelines by shifting the statistical confidence interval from 95 percent to 90 percent to achieve a significant link between ETS and lung cancer, and violated procedural requirements set forth by Congress by excluding tobacco industry representatives from its Scientific Advisory Board. In conclusion, the judge wrote, the "EPA produced limited evidence, then claimed the weight of the Agency's research evidence demonstrated ETS causes cancer."

The report's authors disagree with Osteen's findings. "The ruling is frustrating," says Jennifer Jinot, an EPA health scientist and one of the authors of the 1993 agency report. "It wasn't a scientific ruling. He misconstrued reality," she says, claiming the judge ignored the science and focused only on the legal issues.

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."

Today, Lippmann, a professor of environmental medicine at the New York University School of Medicine, strongly believes ETS is a health hazard but admits that the EPA death count of 3,000 "wasn't said in any confidence, and the research isn't as convincing as you'd like it to be."

Back in 1993, the mainstream media jumped on the Group A rating without carefully analyzing the EPA's results--in one evening broadcast, CBS's national news led with the story. Using the EPA's Group A rating for ETS, antitobacco advocates and politicians created a propaganda campaign designed to frighten the public and push smoking bans. A 1995 New York City subway advertisement depicted an image of a dead person within the smoke being released from a cigarette. The caption read: If you can smell it, it may be killing you. A 1997 billboard in California read: Mind if I smoke? The response: Care if I die?

Politicians thought they were "doing the right thing" based on EPA conclusions. The wording in countless smoking bans implemented after the release of the 1993 report cited the EPA's findings as strong reason for passing antismoking ordinances.

It's unclear at this time whether tobacco companies will challenge existing smoking bans in light of Osteen's ruling, but pending bans that heavily cite the EPA report as legally submitted evidence are in jeopardy,

attorneys say. In New York City, where the EPA report was a factor in the drafting of a citywide smoking ban that includes most restaurants, officials are not concerned about the judge's decision. "The ruling doesn't knock out whatever action has been taken," says New York Councilman Victor Robles, chairman of the council's health committee. "But if we need to reassess what we did, we will."

In Boston, where the EPA report was less of a factor in drafting the city ordinance, city Public Health Commission Chairman Dave Mulligan, the former Commissioner of Public Health for Massachusetts, got to the heart of the issue: "It's really about secondhand smoke being a nuisance. Nonsmokers shouldn't have to smell smoke; but smokers shouldn't be punished for choosing to smoke and their right to smoke."

The tobacco industry is hopeful that the ruling sets a tone for a fact-based and democratic discussion on smoking, bridging the gap created by the "us-versus-them" mentality. "The significance of the decision is that it's a step in the right direction of permitting discourse on what kind of society we want to live in," says Ellen Merlo, a senior vice president of corporate affairs for Philip Morris, U.S.A. "It comes down to allowing people to make their own personal choices."

Jason Sheftell is the associate manager of Cigar Aficionado Online, the Cigar Aficionado Web site.