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Authors: Peter Pringle

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Lorillard, the fourth-largest cigarette company, also had concerns about the youth market, according to a 1970 letter that surfaced in one of the lawsuits. It was written by the then assistant creative director of Robert Brian Associates, a promotion agency working for the cigarette company. The letter is addressed to Charles Seide, then head of the art department at New York's Cooper Union college. The agency was preparing to market a cigarette, named “Kick,” to youth and wanted a design from his students. “We're adults. You've got a group of talented kids,” the letter began, then gave guidelines, including that the pack must contain the words, “Caution: Cigarette Smoking May Be Hazardous to Your Health.” It cautioned the art director, “While this cigarette is geared to the youth market, no attempt obviously can be made to encourage persons under twenty-one to smoke. The package design should be geared to attract the youthful eye, not the ever-watchful eye of the Federal Government.” Nothing came of the project.

Even though Philip Morris had Marlboro, the leading brand among youth in the early '70s, the company was always worried about losing its youth-market share. It hired pollsters and economists to keep a constant check on “college students living on campus, young people in the fourteen-to-seventeen age group, and men in the military services,” as one pollster's memo put it. The company commissioned a study by the Roper Organization in 1974; this was not the “usual sample of 18–24; in this study no lower age limit was set.” Other Philip Morris studies looked at the “higher Marlboro market penetration among 15–17-year-olds.”

By the 1980s, Philip Morris was worried about the effect on the youth market of raising taxes. “Unfortunately,” said a 1982 in-house report, “it is among the young that we have our greatest market penetration, and theoretically price increases should effect Philip Morris to a greater extent than the total industry.” By the end of the 1980s, Philip Morris was sufficiently worried about this decline to launch a study on smoking among high school seniors. In 1988, an in-house report suggested that the decline was caused by the sharp increase in the price of gasoline between 1976 and 1979. High school senior males in 1976 smoked about the same as they did in 1979—up to the age of sixteen. Then they got their driving licences. Smoking among the class of ‘79, and later, started to drop; the inference made was that the school children could not afford gas and cigarettes. In 1978, it was possible to buy two gallons of gasoline and a pack of cigarettes for one dollar; by 1980 one dollar would not even buy two gallons of gas. The report concluded, “When it comes to a choice between smoking cigarettes or cruising around in his car, the average red-blooded American male would probably choose the latter.” In other words, cut gas prices and youth will smoke more cigarettes. The company's “gasoline hypothesis” turned out to be credible. The end of the decline in smoking among high school males coincided with the stabilization of gasoline prices.

*   *   *

O
N THE LAST DAY
available to them, December 31, 1995, the tobacco companies sent in their comments on the FDA's proposed rules. Their response came in twelve volumes that stood more than a foot high. In it, they attacked the FDA on three fronts. First, they said that Congress had never intended the FDA to have authority over cigarettes, and it never would. Second, they said cigarettes could not be regulated as a “delivery device for nicotine” (although that's exactly how they were described in some company memos). Third, they said the FDA had no authority to restrict advertising. The companies were typically exhaustive in their arguments, covering any and all aspects of the law and delving deep into the congressional record.

The tobacco companies claimed Congress was the rightful body to deal with tobacco because it was necessary to balance three competing interests: maintaining the freedom of adults to smoke, informing the public of the risks associated with smoking, and preserving the significant economic interests involved in the manufacturing and marketing of cigarettes. Already, the companies noted, Congress delegates its authority over cigarettes to agencies other than the FDA. For example, Congress requires the department of Health and Human Services to review annual lists of cigarette ingredients and report back on any perceived health effects. The Department of Agriculture sets production quotas and price levels for tobacco leaf. The Bureau of Alcohol, Tobacco and Firearms regulates tobacco manufacturers. The Federal Trade Commission requires the tobacco companies to display government warning labels on their products.

But when Congress could have used other laws to move against the industry, it chose not to do so. In 1975, Congress had been asked to regulate cigarettes under the Federal Hazardous Substances Act, but had instead quickly amended the FHSA to exclude tobacco products. The 1976 Toxic Substances Control Act (TSCA) empowered the EPA to regulate chemical substances that might pose a threat to health. Congress included in TSCA's definition of “chemical substance” an exception for “tobacco or any tobacco product.”

The industry's main argument was that it was “preposterous” to suggest that after Congress had excluded cigarettes from other laws it now meant them to be regulated under the Medical Device Amendments to the Food, Drug, and Cosmetics Act. The companies argued that the definition of a “device intended to affect the function of the body” was limited in the act to medical products for which the manufacturers made a health claim.

The FDA might as well regulate guns and bullets as “devices” because they were “intended to affect the structure or function of the body of man or animals,” the industry claimed. In the same way, the FDA could regulate down jackets and flannel pajamas as “devices,” since temperature regulation is a “function” of the body. The agency could regulate boots and raincoats because they keep the body warm and dry. Even beach umbrellas could come under the act because they shield people from the sun's rays and prevent them from developing skin cancer. You could also say bicycles and roller skates were “devices” under the meaning of the act because exercise is, or can affect, a function of the body. But the FDA didn't regulate these products because no medical claims are made for these “devices.”

Finally, the companies claimed that the FDA could not treat nicotine as a drug at the same time that it regulated cigarettes as “devices.” If nicotine is a “drug,” a fact they disputed, then the rest of the cigarette is merely a “dosage form,” not a “device.” The FDA had long recognized the distinction, the industry argued. Nicotine patches and nicotine gum, for example, had been regulated as drugs, not as “nicotine delivery devices.” Taking the FDA's new interpretation of drug delivery “devices” literally, then tablets, capsules, suppositories, creams, gels, powders, and aerosols were also drug delivery devices.

The “orgy of buncombe” of which Senator Smoot of Utah spoke so eloquently in 1929 when he rose in Congress to denounce the tobacco companies' “unconscionable, heartless and destructive attempts to exploit the women and youth of this country” was again in full swing. It would be left to Judge William Osteen to decide whether the tobacco companies had a case, or were engaged once more in a campaign, as Smoot put it, “whose only God is profit, whose only bible is the balance sheet, whose only principle is greed.”

9

THE SCIENCE TEACHER

This guy is Jekyll and Hyde; he'll do whatever he needs to do for whoever is paying him.

—
Gordon Smith, a lawyer for Brown & Williamson

 

M
ERRELL
W
ILLIAMS CHANGED
the balance of power in the tobacco wars. For a lowly paralegal, he had managed to select such explicit and damning confidential documents of such high quality that the antitobacco forces now possessed a potent arsenal of evidence. For all his cleverness, though, Williams was still only a clerk. He had no firsthand knowledge of how decisions were made in the company; no evidence that the proposals in the documents were actually carried out. He had not met anyone who made big decisions, only supervisors at the document center in Louisville. Brown & Williamson would make much of this distinction, claiming in many cases that the documents Williams had stolen were only the random thoughts of individual scientists or lawyers, not company policy. What the antitobacco forces needed desperately was a high-level executive who had knowledge of policy making, someone who could substantiate conversations at board level about nicotine addiction and cancer of the lung or heart disease. At trial, Williams would be useless as a witness. He was just a document thief, a $9-an-hour clerk who turned against the company. The lawyers needed a tobacco executive.

As it turned out, such a person had been found at the end of 1993 but his identity was being kept secret. His FDA code name was “Research.” His real name was Jeffrey Wigand, a smart but somewhat erratic biochemist who once dreamed of being a doctor but had never made it to medical school. Instead, he worked as a scientific research manager in companies that produced health-care products. In 1989, he had just lost a job in New Jersey as a result of a company reorganization and had answered an ad in
The New York Times
for a company research director. A headhunting firm from Louisville, Kentucky, contacted him. They told him that Brown & Williamson was looking for someone to lead the company's research department.

Wigand had never thought of being employed by Big Tobacco, but he was interested in public health and knowing the problems of smoking and cancer, he thought he might be able to make a difference. In interviews he was told he would be working on the development of a “safe cigarette,” one with much reduced harmful substances and tobacco additives. Wigand was intrigued. He embarked on a tortuous journey that would earn him lots of money for doing rather little and, in the end, give him a pile of trouble.

After four and a half years, Wigand was fired. But within months he was working as a consultant on the tobacco industry for the CBS program
60 Minutes,
and as a witness in the Justice Department's investigation into fire-safe cigarettes, and then as a consultant to the FDA on its inquiry. He would become the highest-ranking defector in the history of the tobacco industry. He would be hounded by hostile company lawyers and private investigators. He had little prospect of ever resuming a career in the pharmaceutical industry to which he had been attached for almost three decades. Eventually, he would teach high school for a tenth of the salary Brown & Williamson had been paying him. He would be divorced from his second wife; his personal life was in tatters. He was, however, not without friends and admirers, especially among the antitobacco forces. He was honored for what he had done—he blew the whistle on a powerful and secretive industry—and he became a national hero, of sorts. Most important, the tobacco industry would decide it could not afford to have Jeffrey Wigand on the witness stand. His defection was clearly one of the reasons why the industry would capitulate and go to the negotiating table in the spring of 1997.

*   *   *

W
IGAND HAD JOINED
Brown & Williamson in 1989 at their headquarters in Louisville. They made him head of R&D. His name was in a box with all the other executives at the top of the company's organization chart. He had a budget of more than $20 million, a staff of 265, and a salary of $300,000 a year—more than he had ever earned before. For one who believed that his research skills were better, and certainly more important to him, than his management expertise, this was indeed a challenge. Wigand accepted it with gusto. He became a willing, even eager, participant in the strange, incestuous world of the tobacco executive. He went to the parties they held for themselves and joined the company's favored golf club. He even took up occasional smoking “to understand the science of how it made you feel.”

The big salary created a comfortable life at home, more comfortable than it had been, perhaps ever. He had grown up the oldest of five children in a strict Catholic household, first in the Bronx and then in upstate New York, near Poughkeepsie. He dropped out of Dutchess Community College to join the air force and to get away from a stifling home life. He was sent to Japan, where he ran a hospital operating room. He learned Japanese and the martial arts. He returned after one tour and went back to school. He studied biochemistry at the University of Buffalo, where he earned a doctorate and wrote a master's thesis on vitamin B
12
. When his first wife developed multiple sclerosis, the strain of caring for her began to take a toll. She left him after the birth of a daughter. He met his second wife when he was director of marketing for Johnson & Johnson. They married in 1986 and had two daughters.

Why Brown & Williamson decided to hire Wigand is a mystery because he was not their type. He cared too much about pure science to sustain the untenable public position of the industry—that smoking does not cause cancer and that nicotine is not addictive. And he grew to despise their philosophy. For example, Wigand would find repulsive the argument used by tobacco executives that an adult's right to smoke is as important as a woman's right to an abortion.

Apparently, he had not revealed his true self at the interviews. He was totally unsuited to life in the bunker of the tobacco industry where being a team player is essential. That was never his strength. He couldn't keep his own counsel when silence was required for his survival. “I have a very bad problem—saying what's on my mind. I don't take too much crap from anybody.”

On his first week at work, he was shocked to find the poor state of the company's research labs, which he said looked like “a high school chemistry lab from the '50s, filled with old-fashioned smoking machines. There was no fundamental science being done and no contemporary apparatus.” (Indeed, testimony that first surfaced in 1997 from one of Wigand's predecessor's, Dr. Irwin Tucker, would suggest that the research department had long been the company's poor cousin. And the Merrell Williams papers would show that most of the group's research was done abroad by the British parent company, BAT Industries.)

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