Big Tobacco Pursues Secondhand Smoke Data

Mobilizing against smoking bans and lawsuits that could cost them billions, tobacco companies are engaged in a far-reaching campaign to discredit evidence that secondhand smoke is harmful to human health.

Nowhere is the strategy more evident than in a legal battle over the evidence that has occupied at least 10 courts, including U.S. District Court in Los Angeles, where it appears likely to be resolved in the industry’s favor.

In the latest phase of the discovery battle, Philip Morris is fighting USC researchers to get access to a single computer disk containing raw data from an influential five-city study, known as the Fontham study, that found a causal link between lung cancer and secondhand smoke. The company wants to scrutinize the data in hopes of casting doubt on the evidence, which is weaker for secondhand smoke than for some other environmental hazards.

Fontham and similar studies have provided the scientific bedrock for a small but growing wave of secondhand smoke litigation that the industry aims to head off. At the same time, cigarette makers are determined to slow the spread of California-style smoking bans to less-regulated areas of the United States and to foreign markets where smokers still light up wherever they choose. Research suggests that smoking restrictions reduce cigarette sales by inducing many smokers to cut down or even quit.

Researchers from USC and other institutions involved in the Fontham study say the industry’s relentless pursuit of the data could have a chilling effect on future health research. Citing promises of confidentiality to subjects in the study, they have resisted demands to hand over the data, which cigarette makers say they need to defend themselves in court.

The industry has been largely thwarted in this long-running game of cat and mouse, obtaining but a sliver of the data. But its five-year quest may be about to pay off. In Los Angeles, U.S. District Judge Richard A. Paez will decide if USC must honor an industry subpoena, and he has already ruled for the industry once.

Although tobacco companies have their hands full with litigation over primary smoking--such as the huge case filed last month by the Justice Department--secondhand smoke is an emerging threat, in part because the industry’s standard defense that victims accepted the risk is not applicable.

Cigarette makers won the only two secondhand smoke cases to be decided by juries, but in 1997 they agreed to settle a class action by airline flight attendants for $349 million. The money was for health research and legal costs, not damages, but the agreement gave flight attendants a one-year window in which to sue once the settlement was final.

It became final last month, when lawyers opposed to the deal withdrew their challenge. As a result, a flurry of suits by flight attendants is expected over the next 12 months. A few secondhand smoke cases are pending, including class actions on behalf of casino workers.

The industry counterattack produced a big victory last year when a federal judge in North Carolina ruled that the Environmental Protection Agency had made procedural and substantive errors in a landmark report in January 1993 that concluded that secondhand smoke is a significant cause of lung cancer in nonsmokers. Federal officials have appealed the ruling.

In fighting to secure the Fontham data, the industry is taking aim at a major piece of research that helped persuade the EPA and other health organizations to declare secondhand smoke a significant hazard.

Named for Elizabeth Fontham, a principal investigator and lead author, the project teamed researchers from Louisiana State University, Emory University, the University of Texas and the California Department of Health Services, along with USC, in a study of nearly 2,000 nonsmoking women in Los Angeles, San Francisco, Houston, New Orleans and Atlanta--including 1,253 subjects who were healthy and 653 with lung cancer. Their conclusion: Exposure to secondhand smoke raised the lung cancer risk about 30%.

The data sought by cigarette makers include medical records and personal information on study subjects, such as work and marital histories, dietary habits and exposure to other toxic substances. But the researchers say that they promised never to divulge that information, and that it will be hard to gain cooperation in future studies if they go back on their word.

“We have to be able to make promises we can keep, and to me that’s really the essence of the litigation over this,” said Peggy Reynolds, chief environmental epidemiologist for the state health department and one of the Fontham investigators.

Tobacco critics such as Stanton Glantz of UC San Francisco medical school maintain that the industry effort amounts to harassment of the researchers.

But tobacco lawyers say it’s perfectly natural that they would want to examine the data. The Fontham study is “the No. 1 piece of evidence against us in any [secondhand smoke] lung cancer case,” said Barry Davidson, a lawyer for Philip Morris.

Davidson called the confidentiality issue “a total red herring,” noting that Philip Morris has sought a redacted copy of the data, with names, addresses and phone numbers deleted.

“Methinks,” said Davidson, “they [researchers] doth protest too much.”

Patricia Buffler, one of the Fontham researchers, acknowledged some anxiety over the industry’s intent to discredit the study. “If you know anything about statistics,” she said, “adjustments can be made to produce conflicting results.”

Indeed, secondhand smoke research may be uniquely vulnerable to the kind of test the industry would like to apply to the Fontham data. The reason is that even in the most incriminating studies, although the impact of secondhand smoke across the whole population may be substantial, the risk for each exposed person is low.

For a toxic agent to be deemed a proven risk to health, researchers typically insist that the rate of illness at least double, or increase 100%, for those who are exposed. Otherwise, other environmental factors or errors in classifying data might explain the difference.

The Fontham study, typical of research indicting secondhand smoke, found an added cancer risk of about 30%, well below the traditional threshold. By comparison, longtime smokers face a roughly twentyfold, or 2,000%, greater lung cancer risk than nonsmokers. Lifetime smokers have about one chance in eight of dying of lung cancer, compared with a risk of one in 200 for those who never smoked.

The industry’s quest for the Fontham data began in 1994, when cigarette makers subpoenaed it from Louisiana State University as part of their defense of a secondhand smoke case in Texas. But Louisiana law provides sweeping protections against disclosure of confidential data in health studies, and the industry was turned down by three different state and federal judges when it tried to enforce its subpoenas.

Tobacco lawyers made two trips to state court in Georgia and finally got data from Emory University, but only for the Atlanta portion of the study.

In California, the first industry subpoena was quashed in 1997 by a San Francisco Superior Court judge. In Los Angeles, cigarette makers also subpoenaed the data from USC, first for defense of the flight attendants’ class action, and then in the secondhand smoke case of a Florida woman named Roselyn Wolpin.

In September 1998, a U.S. magistrate in Los Angeles ruled that the university must honor the subpoena. That ruling was upheld by Judge Paez earlier this year.

Then the researchers won a temporary reprieve when the Wolpin case was dismissed. The industry immediately subpoenaed the data in the case of Robert Murphy, a former Nevada casino worker with lung cancer.

Now USC is fighting the Murphy subpoena. The dispute will go back to Paez after a ruling by the magistrate later this year.

Davidson, the Philip Morris lawyer, said he’s taken part in other protracted discovery battles, but has “never seen anything to approach this. . . . This has almost become a legend in its time.”