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1980 Philip Morris Memo Ourlined Need to Conceal Nicotine Studies

By Saundra Torry
The Washington Post

Fifteen years before the Food and Drug Administration made its controversial move to regulate cigarettes, industry giant Philip Morris already was strategizing to hide studies that might encourage what it feared was the government's intention, according to a 1980 document introduced in Minnesota's lawsuit against the industry.

The document - one of a cache of hotly disputed papers unsealed by the Supreme Court last week - discusses a company legal strategy to conceal research that might aid efforts to transfer tobacco regulation to the FDA, which "was known to have interests and powers antithetical" to the industry's interests.

Although the document, written by a leading Philip Morris scientist to a top company executive, indicates that some of the studies would go forward, it adds, "Our attorneys, however, will likely continue to insist upon a clandestine effort in order to keep nicotine the drug in low profile."

"The psychopharmacology of nicotine is where the action is for those doing fundamental research on smoking, and from where most likely will come significant scientific developments profoundly influencing the industry. Yet it is where our attorneys least want us to be," he wrote.

Since the FDA moved in 1995 to regulate cigarettes as a combination drug and drug-delivery "device," the industry has argued that the agency does not have jurisdiction, in part because cigarettes do not fit the statutory definition of drugs or drug-delivery devices as defined by the Food, Drug and Cosmetic Act. The industry's challenge to the FDA's proposed set of regulations is pending before a federal appeals court.

Former FDA commissioner David A. Kessler, who initiated the agency's move to regulate tobacco, said the memo was "stronger than anything else I have seen," apparently indicating the industry "knew and acknowledged that nicotine was a drug long before we did."

"Here you have a memo that lays out them saying it (nicotine) is a drug" and that "they have to cover it up," Kessler said. "The hard thing to understand, in light of this memo, is how the lawyers for the industry have denied the fact that nicotine is a drug." For years, the industry has argued that nicotine as it naturally occurs in tobacco should not be regulated as a drug.

The 1980 memo to Robert B. Seligman, a former company vice president, also states that industry attorneys have advised against research into the health risks of smoking because it likely would be used against cigarette makers in lawsuits by the heirs of deceased smokers.

Philip Morris scientist William L. Dunn, the memo's author and a leading expert on the effects of nicotine, describes the industry's general legal defense strategy this way: "We within the industry are ignorant of any relationship between smoking and disease."