On June 22, six tobacco-oriented companies filed suit against the EPA, seeking to have its landmark 520 page report on Environmental Tobacco Smoke (ETS), released last January 7, declared "null and void". The suit, filed in a US District Court in Greensboro, NC, charges that the EPA exceeded its authority in declaring ETS a class A carcinogen, did not use proper scientific methods, manipulated data, and ignored studies that contradicted it's findings.

"The EPA, when it could not reach its predetermined conclusion with the available data, simply changed generally accepted statistical practices to achieve its findings," said Dan Donahue, an R.J. Reynolds vice president.

The companies said the report was hurting their business by increasing the movement toward indoor smoking bans.. The Fine-Cured Tobacco Cooperative Stabilization Corp. claimed it jeopardized over 500,000 tobacco growers.

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Some of the issues here are:

--The report used "meta-analysis", a technique for combining numerous small studies to reach a conclusion that may not be fully supported by any one. A "95 percent confidence level" is the standard for most individual medical studies, which means that there is no more than a 5% possibility that the study results could have occurred by chance alone. Using this confidence level, less than half the studies in the report find a link between ETS and cancer. But when the threshold is lowered to 90%, many more studies confirm the link.

The technique was used when the EPA evaluated the connection between radon gas and lung cancer. (The radon gas industry didn't carry on like this.) The EPA said the unquestionable link between smoking and lung cancer (as between cancer and massive radon exposure in uranium miners) makes it reasonable to accept this level of proof with regards to ETS.

As William H. Farland, director of the EPA's office of health and environmental assessment said, "If you have a body of evidence that is pointing you toward a conclusion, and the question is do you need to be 90 percent sure or 95 percent sure that the effects you are seeing aren't just due to chance, then we think it is reasonable to accept 90 percent certainty."

(The tobacco industry previously has claimed that the EPA did not account for epidemiologically confounding factors of income-level (smokers tend to have low incomes, low-income people tend to have unhealthier life-styles and diet) and did not account properly for "secret smoking" in the studies of spouses of smokers.)

--The tobacco companies pointed to two studies that were left out of the report that they claimed showed ETS risks as "insignificant," one by Heather Stockwell of the University of South Florida and one by Ross Brownson, of the Missouri Department of Health. Brownson, however, concludes in his report that "recent studies suggest a small but consistent elevation in the risk of lung cancer in non-smokers due to passive smoking, " and that "the proliferation of federal, state, and local regulations that restrict smoking in public places and work sites is well-founded."

--The suit claims the EPA report carries the weight of a governmental directive, and that the EPA exceeded its authority in releasing it.

--The plaintiffs must prove financial damage due to an increase in smoking bans, a tricky proposition with the current state of research, which does not establish that smoking restrictions cause people to smoke less. Smoking as a whole continues to drop at about the 2% a year rate at which it has dropped since 1982. (In 1965, the year after the Surgeon General's landmark1964 Report on Smoking and Health, consumption increased 3.4%) Cancer risks of ETS were identified in 1986 by the National Academy of Sciences' National Research Council, and in 1991 by the National Institute for Occupational Safety and Health. These reports also have had a great influence in smoking bans in public areas.

--Strange omissions:

As much as the tobacco companies have objected to the chapter on heart disease (37,000 est. dead a year) in previous drafts of the report, the focus of this suit appears to be the establishment of a link between lung cancer and ETS (3,000 est. dead a year).

Another noteworthy fact is that the suit does not object to the part of the report finding that ETS exposure causes 150,000 to 300,000 cases of pneumonia, bronchitis and other respiratory illnesses among young children, and is an aggravating factor in up to 1 million cases of childhood asthma per year. Steve Parrish, counsel for Philip Morris said, "I'm not saying people should blow smoke in the faces of their children. People should use some common sense."

--The companies and organizations filing the suit were Philip Morris Inc., R.J. Reynolds Tobacco Co., Flue-Cured Tobacco Cooperative Stabilization Corp., The Council for Burley Tobacco, Inc., Universal Leaf Tobacco Company, Inc., and Gallins Vending Company.

Responses to the suit:

EPA spokeswoman Lauren Mical said, "EPA's environmental tobacco smoke report has gone through extensive scientific review by scientists inside and outside the EPA."

Surgeon General Antonia Novello accused the tobacco industry of using the suit to delay further curbs on smoking.

Lonnie Bristow, chairman of the board of trustees of the American Medical Association, said "This lawsuit is just another example of the tobacco conglomerates blowing smoke in the faces of Americans. An industry that kills 450,000 citizens every year cannot be trusted." He said the AMA fully supports the report, and would testify in court if need be.

At the Advocacy Institute in Washington, DC, Michael Pertschuk said, "This shows the willingness of this industry to pervert law and science to whatever their business ends are with no thought to the harm it might cause people."

Cliff Douglas said, "It's like the Flat Earth Society suing NASA for publishing photographs showing that the Earth is round."

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Let's review a bit of history on this report. Begun in 1988, and based in part on the Surgeon General's report on smoking of 1986, bitter infighting has surrounded each preliminary draft, not to mention the selection of members of the scientific advisory board impaneled to review the report.

--In the summer of 1990 the EPA, recognizing the weight such a report could carry, decided to expand its 7 member advisory board on indoor air pollution by 9 members. Anti-smoking groups criticized the resulting panel for the fact that 6 of the 16 panelists had ties to the Center for Indoor Air Research, an organization mostly funded and run by the tobacco industry.

One such was Morton Lippmann, chairman of EPA's indoor air quality committee and professor of environmental medicine at New York University Medical Center, who serves on the CIAR's advisory board, helping to evaluate which projects should be funded.

Another panelist with perceived conflicts was James E. Woods Jr., of the Virginia Polytechnic Institute and State University in Blacksburg, VA. Woods, a mechanical engineer and specialist in "sick buildings", was not only a reviewer of grant proposals for CIAR, but was in negotiations with Philip Morris for a $1.2 million grant himself.

The tobacco industry, on the other hand, objected to the inclusion of David Burns, associate professor of medicine at the University of California's San Diego Medical Center, the editor of previous Surgeon General reports on smoking, and an outspoken opponent of smoking. Burns was at first dismissed in response to tobacco industry objections, then reinstated due to the resulting furor.

According to Robert Flaak, who was directly responsible for putting together the group, the best guarantee of objectivity was peer pressure.

"We like to think of this as the intellectual marketplace," he said. "This is a situation of experts sitting on a panel of peers who are knowledgeable in these issues. They're hurting themselves professionally if they don't call it the way it is."

---In April of 1991, The executive committee of the advisory board voted unanimously to endorse the draft study, with some revisions (mainly in regards to the study's estimate of 3700 lung cancer deaths a year due to ETS.)

The committee wrote in a letter to the EPA, "The committee concurs with the judgment of the EPA that environmental tobacco smoke should be classified as a . . .carcinogen,"

"We're not saying the risk is enormous. We're saying there is a risk," said Morton Lippmann, chairman of the reviewing panel.

Robert Axelrad, director of the EPA's indoor air program, characterized the report as a broad review of existing research on the hazards of second-hand tobacco smoke. He said that each chapter was reviewed and evaluated by at least two other outside scientists.

The tobacco companies were particularly distressed by the chapter dealing with heart disease deaths (37,000 a year) attributed to second-hand smoke.

--In May, just one month later, it became apparent that the report might never be released. Axelrad said the report was meant to be an informational document for the use of professionals in the fields concerned, and might never get EPA approval for public release. Anti-smoking groups accused the EPA of caving in to tobacco company pressure.

--In July 1992: the panel met for a final time.

Axelrad said the report had been extensively rewritten and strengthened over the preceding year and a half.

Stanton Glantz, one of the authors of the chapter on heart disease, said, "I think the report is both stronger, as well as more solid scientifically," He said the EPA's scientists took tobacco industry criticisms seriously. "They've really taken every single criticism that the tobacco companies have dreamed up, however flaky, and dealt with them. The document is a superb scientific document that the EPA can be proud of."

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Tobacco industry spokespeople at the press conference made comments which seemed to indicate for the first time the tobacco industry's acknowledgment of the harmfulness of primary smoking.

Steve Parrish, senior vice president and general counsel of Philip-Morris USA, while answering questions said:

"I would agree that smoking is a major risk factor for lung cancer, that it's a risk factor for heart disease and chronic obstructive lung disease. So that's our position."

"Let me just go ahead and say, though, that this law suit is not saying, and we are not saying, that smokers should smoke anywhere, any time they choose. . . We recognize that smoke in the air is a concern to people, and we think that this can be dealt with some common sense, some courtesy, and, where it's appropriate, separation of smokers and nonsmokers in restaurants, for example, and in the workplace, smoking lounges, or whatever."

"I am not saying therefore that people should smoke, blow smoke in the faces of their children. People should use some common sense."

And Dr. Gio Gori, the industry's scientist, said in response to a question about potential harm from inhaled cigarette smoke, "It certainly is a risk factor for lung cancer and cardiovascular diseases."

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Note: Unfortunately, data on this subject is difficult to find, and this report is necessarily sketchy. I welcome anyone's clarifications, corrections or amendments on these events.

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