Cornered

by Peter Pringle

  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

  LLOYD VERNON JONES 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.”

  Although a registered Republican, he was not an ideological conservative. He considers himself basically apolitical. A student in the Vietnam War years, he was never a protester. When his fellow students took off for summer vacation, Kessler headed to New York for his summer job at the Memorial Sloan-Kettering Cancer Center. Before joining Hatch’s staff, Kessler had volunteered to s
erve without pay as a consultant on FDA-related matters for Senator Edward Kennedy, then chairman of the Senate Labor and Human Resources Committee, but he had been turned down.

  As a medical doctor, Kessler was concerned about the public health aspect of smoking, but when he first looked at the tobacco industry as FDA commissioner in 1991, he was warned off by agency veterans who told him it was a “fool’s mission,” a “crackpot crusade.” The industry was too big, too crafty, and too powerful. Moreover, it had never been clear whether the FDA could prove that it had jurisdiction over tobacco.

  Under the Food, Drug, and Cosmetic Act of 1938, the FDA has oversight over any substance for which the manufacturer has claimed a health benefit. In the 1950s, the FDA had challenged the outrageous promotional claims made for some cigarettes. Leaflets for one brand, Fairfax, claimed it prevented “the common cold, influenza, pneumonia … scarlet fever, whooping cough, measles, meningitis, tuberculosis … [and] parrot fever.” The FDA’s complaint was upheld but, as the tobacco industry pointed out, only because the promotional material made a therapeutic claim. In another case, Trim cigarettes were promoted as slimming aids or, as they put it, “reducing-aid cigarettes,” and smokers were instructed: “Smoke one cigarette shortly before meals … and whenever you are tempted to reach for a late evening snack. Trim reducing-aid cigarettes contain a patented appetite satient that takes the edge off your appetite. Clinically tested…” The court agreed that Trim cigarettes should also be considered therapeutic under the law, and thus subject to FDA regulation.

  Unless health claims were made, the FDA itself told Congress it did not have jurisdiction over cigarettes. Cigarettes were for “smoking pleasure, and not drugs within the meaning of the act unless a therapeutic purpose is claimed,” as one former commissioner described it. When the act was amended to include oversight of “medical devices,” such as syringes, as well as actual drugs, the FDA again said it did not interpret the law as covering cigarettes. They were not “medical devices,” the agency decreed.

  When, in 1966, Congress passed laws requiring that warning labels be put on cigarette packs, it stipulated that “any further regulation in this sensitive and complex area must be reserved for specific congressional action.” In three successive years, 1977, 1978, and 1979, antitobacco congressmen pushed for FDA jurisdiction over cigarettes, but each time the bill failed to pass. Mike Synar, of Oklahoma, one of the most outspoken antitobacco congressmen, observed during a 1992 effort to obtain FDA regulation, “While the FDA has jurisdiction to protect consumers from unsafe foods, drugs, cosmetics and medical devices it is powerless to do anything about one of the deadliest consumer products—tobacco.” Synar tried again in 1993, and again Congress said no.

  The key clause that triggers FDA oversight is whether the manufacturer “intended” the drug, or substance, “to affect the structure or function of the body.” Antismoking groups were constantly pressing the FDA to change its policy toward tobacco on the premise that nicotine was an addictive drug and there was evidence that the manufacturers “intended” the smoker’s bodily function to be affected. The groups also argued that, despite what the FDA might say, the cigarette was indeed “an instrument, apparatus, or contrivance”—a delivery device in other words—designed to administer controlled amounts of nicotine.

  The veteran antismoking activist John Banzhaf, of Action on Smoking and Health (ASH), had sought a judicial review from Kessler’s predecessor, but the FDA successfully defended its position. The government’s brief on behalf of the FDA stated, “In the seventy-three years since the enactment of the original Food and Drug Act, and in the forty-one years since the promulgation of the Food, Drug, and Cosmetics Act, the FDA has repeatedly informed Congress that cigarettes are beyond the scope of the statute absent health claims establishing a therapeutic intent on behalf of the manufacturer or vendor.” The courts had agreed. Changing this tradition was obviously not going to be easy, and Kessler decided to put tobacco at a lower point on his agenda.

  There were much easier targets. He started by strengthening the administration’s corps of inspectors, hoping at the very least to restore respect. In his first year, he almost doubled the number of prosecutions and injunctions against companies that had failed to apply for licenses or were selling questionable products.

  Kessler launched an offensive against food nutrition labels he considered hopelessly inadequate. One day, Kessler’s raiders threatened to seize 2,000 cases of Procter & Gamble orange juice because the containers had a misleading label claiming the juice was freshly squeezed when it was actually made from concentrate. After weeks of refusing to answer Kessler’s complaints, Procter & Gamble sent its lawyers to the FDA to straighten things out the way they always had done, by agreeing to consider the issue. But Kessler would not be intimidated. He told them he would seize the containers if the company refused to change the labels. The company lawyers, as companies had done for years, ignored the threat and walked out of the meeting. Kessler ordered his enforcers into action at dawn the next day.

  Next, Kessler forced “fresh” labels off reconstituted spaghetti sauce and banned “fat free” claims from diet products. His idea was that the FDA should, as he put it, “drive the development of new products,” not the other way around. What went into foods depended to a large extent on the type of claims allowed by the FDA. So a product labeled “low fat” was allowed only three grams of fat per serving. One labeled “light” would have to contain 33 percent fewer calories than the regular product.

  No industry was spared, but Kessler’s most controversial action was against the makers of silicone-gel breast implants. That also meant confronting the rich lobby of plastic surgeons. Breast implants made up a quarter of the work of America’s four thousand plastic surgeons. As Kessler began to show an interest in the problem, the surgeons launched a $2 million campaign to stop him taking the implants off the market.

  By 1990, implants had been on the market for nearly thirty years. But since the early ’80s, several thousand women had complained that their implants had become hard and lumpy and sometimes painful. Some implants had shifted or leaked, causing pain and disfigurement. As “medical devices,” they had come under the purview of the FDA, and manufacturers were required to submit applications for premarketing approval, including data on safety and effectiveness. When Kessler arrived at the FDA, he found that none of them had done so. Kessler told them there could be no more delay, but their response was still sluggish. At the end of 1991, a jury in San Francisco awarded $7.3 million to a woman who had complained her implant had caused a rare disorder known as mixed connective tissue disease. Evidence used in the case suggested the company, Dow Corning, had covered up possible dangers. Kessler came under pressure to ban implants.

  The liability lawyers were on the case immediately. Their professional association, ATLA, joined forces with Ralph Nader’s Public Citizen Health Research Group in urging Kessler to crack down on the devices. Kessler agreed. In April 1992, he restricted use of implants to those women who had undergone mastectomies as part of cancer treatment and who agreed to be part of a research program into silicone implants. The move effectively banned implants. Plastic surgeons called for his resignation, but Kessler defended his decision by saying that the burden of proof on implant safety rested squarely on the manufacturers. “Caveat emptor has never been—and never will be—the philosophy at the FDA.”

  The plaintiffs’ attorneys rushed into court with breast implant victims. One law firm in Virginia opened new offices devoted entirely to breast implant cases. A Florida lawyer’s toll-free number was 1-800-RUPTURE. Dow Corning, which was the biggest manufacturer, became the target of 30,000 lawsuits. Stanley Chesley of Cincinnati was the first to file a class action on behalf of women with implants, and he was joined on the all-important steering committee by his friend Wendell Gauthier. Two years later, the two sides reached an agreement. About 250,000 women claimed to have developed some illness connected to their implants and a r
ecord $4.25 billion was set aside for all women who had received breast implants of any type before the settlement date, June 1, 1993. The lawyers, in theory, were due their 25 percent, or roughly a billion dollars.

  Kessler didn’t stop to ponder the results. He had already moved to his next surprising target: the Red Cross. Kessler reproached them for not screening blood supplies more effectively for the AIDS virus. Then he attacked the American Heart Association for giving certain products a “red heart” symbol in return for a fee from the manufacturers. The opportunity for corruption was obvious, Kessler thought. The overall message from the new FDA was: the watchdog is back and it has teeth. Veteran inspectors at the agency said they hadn’t seen so much activity in years. Industry dubbed him “Eliot Knessler,” after the cop who pursued Al Capone. Newt Gingrich denounced the agency as the “leading job killer in America” and called Kessler “a bully and a thug.”

  Kessler was courting political disaster. The FDA depends on Congress for its budget, after all, and the Gingrich Republicans who came into power in 1994 talked of closing down the FDA altogether. But Kessler would not be cowed. He hadn’t come to Washington to win a popularity contest, he told those concerned for his future.

  While he was making headlines changing food labels and banning silicone implants, Kessler kept thinking about regulating cigarettes. On one of several TV appearances as the new FDA policeman, Kessler bumped into Dr. C. Everett Koop, whose bushy white beard and piercing eyes had become familiar to Americans during his term as Reagan’s Surgeon General. He took Kessler aside before the show and told him to “do anything you can” to regulate tobacco. “The country is going to be behind you,” he assured the young commissioner.