Cornered (15 page)

In 1980, a young behavioral psychologist named Victor DeNoble went to work for Philip Morris at the company's research labs in Richmond, Virginia. His job was to find that analogue, and he and his coworker, Paul Mele, set up a series of experiments on rats. They linked the rats to a catheter so that if they pressed a lever they would get a shot of nicotine directly into the heart. The rats kept pressing the lever, showing that nicotine acted as a “reinforcer”; that one dose was pleasurable enough for them to want another. In fact, the rats would press the lever several times for one injection, showing how great was their need. The rats also developed the condition known as “tolerance” to the drug; as time went on, they needed more nicotine to achieve the same effect. The work was not duplicated in outside laboratories until 1989.

The implications of the study for Philip Morris were immense—even though, as DeNoble was the first to point out, it was a single observation in rats and it was not possible to project the results to humans with any scientific certainty. All one could say was that nicotine had what behaviorists like DeNoble call “an abuse liability.” But Philip Morris didn't want to take any chances. Security at DeNoble's lab was tightened. Fresh supplies of animals would be brought in at night, or early in the morning, to minimize questions about the work from other technicians. DeNoble and Mele were not allowed to discuss their work at the company's research committee meetings. In the fall of 1982, DeNoble and Mele wanted to publish their results. They submitted a paper (“Nicotine as a Positive Reinforcer in Rats”) to their superiors for permission to publish. Approval was given and they sent a draft to the journal
Psychopharmacology.
They also sent an abstract to a meeting of the American Psychological Association. At the time, Rose Cipollone had just filed her product liability suit against three cigarette makers, including Philip Morris, charging them with failing to warn her properly of the addictive nature of nicotine and other harmful effects of smoking.

Suddenly, DeNoble and Mele were summoned to Philip Morris corporate headquarters in New York to give a presentation of the results to their corporate bosses. They were met at the airport by one of the company's chauffeur-driven limousines and whisked to the Park Avenue headquarters; there they gave the presentation and had lunch in the executive dining room. It all seemed to go well and on the way back in the plane, DeNoble and Mele agreed they had done a good job. Only one of the questions asked by a senior executive had bothered them. He had asked something like, “Why should I risk a billion dollar industry on rats pressing a lever to get nicotine?”

The two researchers thought no more of the remark until a few weeks later when DeNoble was told by his superiors that his laboratory was generating information the company did not want: the results DeNoble and Mele were getting could be used against the company in lawsuits. DeNoble was told to withdraw his paper from publication, although it had already passed peer review and been accepted. He protested to no avail, and not wanting to lose his job, he complied with the company's request.

At the same time, three corporation lawyers moved into the room next door to DeNoble and Mele and started going through their files and photocopying their research papers. They also wanted certain words in the report changed. “I had said, you know, nicotine is a drug that is widely used … and they wanted the word drug changed to compound,” DeNoble would say later. “We were not allowed to refer to nicotine or anything in tobacco as a drug.”

Next, Shep Pollack, the president and chief operating officer of Philip Morris, flew down from New York with his attorney to see for himself what was going on at the lab. DeNoble set up the experiment, the rats pressed levers for nicotine, Pollack peered into the cages. So did his lawyer. The lawyer asked whether this test procedure was the same one that would be used by a government agency to demonstrate addiction, and DeNoble answered that it was. The lawyer shook his head and walked away.

A few months later, in April 1984, days before Rose Cipollone's lawyers filed a sweeping discovery request for Philip Morris research documents, DeNoble was called to the office of his superior and fired. He was told to shut down his experiments, kill the rats, and clear out his office. When he turned up at the research center the next day, he couldn't get into the building because his pass had been canceled. DeNoble and Mele were given new offices and provided with secretarial support to look for other jobs.

A week after he was fired, DeNoble returned to the lab and was astonished to find it had literally disappeared. “The equipment was gone, the cages were gone, all the data was gone. There were empty rooms.”

Both DeNoble and Mele eventually found other jobs and still wanted to publish their work. The problem was that, like all other employees at Philip Morris, they had signed confidentiality agreements covering the work they had done for the company. At the end of 1985, they decided to take the risk and resubmit their paper to
Psychopharmacology.
They also delivered a paper on rat tolerance to nicotine to the Federation of American Societies for Experimental Biology. Philip Morris found out and sent the researchers a letter warning them that they had breached their confidentiality agreement. DeNoble was told that if anything about his work at the lab was published, Philip Morris would sue.

When DeNoble's troubles became known in the antismoking movement, he was contacted by the Food and Drug Administration and asked to help with the agency's own inquiries into the tobacco industry. A copy of his and Mele's paper also found its way to Henry Waxman's subcommittee in Washington. Waxman released the paper from his office in March 1994, in effect forcing Philip Morris to release DeNoble and Mele from the confidentiality agreements. The information about the rats was now public, and DeNoble would testify before Waxman's committee. It sounded like a triumph over censorship, but in fact Philip Morris had achieved its aim in hiding his results. In the interim decade, several independent papers mimicking DeNoble's experiments, and his results, had been published in medical journals. His work was now out of date.

5

A FOOL'S MISSION

He who lives without folly isn't as wise as he thinks.

—
François, Duc de la Rochefoucauld,
Sentences et Maximes Morales,
no. 209

 

L
LOYD
V
ERNON
J
ONES
had tobacco farming in his blood. He had lived all his life on an eighteen-acre plot of land in North Carolina where he lovingly provided the care and attention needed to nurture his delicate and unpredictable tobacco plants to maturity. He sowed the seeds in late winter and transplanted the little shoots, six or so inches high, in the spring. All summer long he protected them from voracious pests and prevented them from growing too high by topping the plants as soon as they flowered, thus assuring the nutrients went into the sticky aromatic leaves. When the flowers were picked, lateral buds of “suckers” grew on the leaf axils and these, too, had to be removed.

In late summer, he picked the leaves, tied them together into “hands,” and hung them from tiered poles in the curing barn. There they stayed, turning a pale, then a golden brown, and in the fall he loaded them on his truck and drove them to the tobacco auction warehouse. Jones followed a ritual that had gone virtually unchanged for three centuries, since the English settlers first started growing tobacco in neighboring Virginia. It was time-consuming, back-breaking work but it was a good little business, much more profitable on a small farm than any other crop. He could average more than $3,000 gross income an acre, easily beating such staples as cotton and soybeans.

Local farmers acknowledged that Jones was one of the best small growers in the area, which is probably the reason he was selected in the late '70s by the tobacco giant Brown & Williamson to grow an experimental tobacco plant. The company never said why they had chosen him; their representative just turned up one day at his ranch house a few miles south of the small town of Wilson, and offered to rent his farm for several years and pay him for growing new plant varieties that had been crossbred to produce more nicotine. “His eyes were bugged out like a stomped-on toad,” recalled his widow, Martha, in the fall of 1995. I laughed at her Southern aphorism and she smiled, but only briefly. Jones died in 1993 and it was difficult for her to remember the good times.

The money the company offered for Jones's land and his labor was more than he thought it was worth. It was steady money, too, at a time when the tobacco market was becoming as fragile as the plants Jones would be asked to grow. Consumption of cigarettes was falling each year—from 630 to 540 billion during the '80s—and tobacco farmers were fearful of the future. Some had already begun to diversify into other crops, cotton and even house plants. The backing of a big corporation was attractive, and Jones had eagerly signed up.

He never knew much about the exotic new plants, or what happened to the dried leaves and the seeds once they left his farm. He did know that whatever he was doing was important. The company sent tobacco experts from Europe—from England, France, and Germany—to watch the plants grow.

He planted five new varieties of
Nicotiana tabacum,
the common tobacco plant, but only two of them lived to maturity. The company codenamed them Y1 and Y2. Y1 turned out to be the sturdier and performed better during the curing process. Y2 turned black in the drying barn and smelled like old socks. The company was very pleased with Y1 and took it away—Jones didn't know where and didn't really care. It was none of his business, except that the plant had helped him through some hard times for small growers in the South.

The mystery of Y1 began to unravel in 1994, a few months after Lloyd Jones died. The new high-nicotine plant would become a key part of the Clinton administration's unprecedented effort to regulate nicotine and a vital piece of evidence for the liability lawyers in the Third Wave of litigation in the tobacco wars. Had he lived to hear the tale, the law-abiding, churchgoing farmer would have been amazed that he had been a part of such goings-on.

The story of Y1 begins far away from tobacco country—in the dreary offices of the Food and Drug Administration in Rockville, Maryland, a featureless overspill of Washington, D.C. The agency is responsible for the licensing, manufacturing, labeling, and advertising of thousands of everyday consumer goods—from foods to drugs and cosmetics. The exceptions are meat and poultry, which are controlled by the Department of Agriculture.

In 1990, President George Bush appointed a new commissioner of the FDA. He was David Kessler, a 39-year-old pediatrician. Dr. Kessler had worked on Capitol Hill for Republican Senator Orrin Hatch, a straight-laced Mormon who is as fiercely against government regulation as Ralph Nader is for it. Kessler's association with Hatch led some to wonder whether the new FDA chief would make much of an impact. His management experience was limited to a teaching hospital in the Bronx, which seemed poor preparation for running a 4,000-person government regulatory agency in an era of deregulation. Moreover, the FDA had become a stagnant, largely ineffective bureaucracy. During the Reaganite era of “get big government off our backs,” the FDA's enforcement actions had declined sharply. Inspections of food and drug manufacturing plants had dropped by half and seizures of contaminated foods or adulterated pharmaceuticals had also fallen. The agency had been rocked by scandal: a number of drug companies had been selling adulterated and mislabeled products; others had falsified records and paid off inspectors. Four FDA employees were convicted of taking bribes to speed up drug approval. “We had become a paper tiger,” Kessler would say later. “We would write a letter, and we would write another letter. And another letter. No one in industry took us seriously.”

Certainly no one forecast that Kessler would be the first FDA commissioner to take the politically risky move of trying to regulate the big tobacco companies. Despite the harm cigarettes cause and the well-known pharmacological effects of nicotine, the industry had escaped being regulated either as a food or as a drug. The FDA had no control over the 4,000 compounds in tobacco smoke, nor any authority over how cigarettes were marketed.

In Congress, the persuasive power of the political campaign contribution had taken its toll. Tobacco industry funds had flowed into the coffers of Republicans and Democrats alike, and all but a few diehard antitobacco congressmen, like Henry Waxman of California, Ron Wyden of Oregon, and Mike Synar of Oklahoma, accepted the industry's propaganda that tobacco was an important cash crop that needed subsidizing and cigarettes should be left alone. Talk of regulation was almost un-American: the industry was older than the republic and tobacco leaves adorned the columns of the Capitol in Washington. As for nicotine, it was a mild, faintly pleasurable stimulant like the caffeine in tea and coffee.

Kessler's appearance, as it turned out—his youth, and his nerdish carrot-colored beard and spectacles—was deceptive. In fact, he was well suited to initiate a shake-up of the ailing agency and he would soon show that he had the guts and the stamina not only to reform the FDA but also to confront the tobacco companies. A Phi Beta Kappa student at Amherst, he was a graduate of Harvard Medical School and also of the University of Chicago Law School. Kessler had also received management training at New York University School of Business. He had always seemed to be juggling at least two jobs. While completing his residency in pediatrics at Johns Hopkins in Baltimore, he had combined exhausting work on the emergency ward with consulting at the U.S. Senate Health Subcommittee in Washington, an hour's drive away. By the time he took over the FDA, Kessler already knew a lot about how it worked because he had studied the agency for years. He saw reforming it as an intellectual challenge and he was quite confident he would accomplish many changes, even perhaps including the agency's relationship with the tobacco industry. His high school yearbook had said, “If you want something done, ask Kessler.”