Cornered (16 page)

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 serve 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 record $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.

Meanwhile, smoking-related deaths increased each year. The Centers for Disease Control in Atlanta said the figure was now more than 420,000. That is more than the combined deaths from homicide, suicide, AIDS, automobile accidents, and alcohol and drug abuse. And it is more each year than U.S. military deaths during the entire Second World War, which numbered 292,131 from all services. Antitobacco forces liked to point out that the 420,000 figure was the equivalent of two-and-a-half jumbo jets crashing each day of the year.

*   *   *

S
TILL, REGULATION OF TOBACCO
looked like a fool's mission, as the FDA veterans had warned the newcomer. Government efforts to control smoking had always been singularly unsuccessful. When the English monarch, James I, wrote “A Counterblaste of Tobacco,” calling the custom “loathsome to the eye, hateful to the nose, harmful to the brain, dangerous to the lungs, and in the black stinking fume thereof, nearest resembling the horrible Stygian smoke of the pit that is bottomless,” his diatribe had no effect whatever on his subjects. The bloodthirsty Turkish sultan, Murad the Cruel, tortured, multilated, and hanged smokers. Still his people smoked. The Russian Tsar Michael, grandfather to Peter the Great, slit the nostrils of any citizen found indulging in the novelty of smoking tobacco. Smoking continued. When the royal households of Europe discovered they could finance wars from tobacco taxes, they imposed such heavy burdens on tobacco merchants that for a while it seemed the industry might be taxed out of business. In the 1660s, tobacco duties from the Virginia colonies accounted for roughly one quarter of total English customs revenues, and as much as 5 percent of total government income. As for religious and temperance groups, tobacco has been under permanent attack from them and, since the end of World War II, their numbers have been joined by medical researchers. Over time no barbaric ruler, no tax burden, no medical statistics, no admonishments from doctors, schoolteachers, or parents, no government health warnings on cigarettes packs have been even remotely successful in parting people from their tobacco.

The original 1906 Food and Drugs Act was designed to put a stop to quackery and the sale of impure foods. The law set up the FDA and gave the agency powers to regulate any drug that appeared in the U.S. Pharmacopoeia, a national list of substances that affect the functioning of the human body in some fashion, the modern equivalent of the apothecaries' recipe books of the Middle Ages. Tobacco, under its Latin name,
tabacum,
had been widely used as a medicine during the colonial period in America because of the properties of nicotine. “Nicotian therapy” was used as an analgesic, an expectorant, a laxative, a salve, and it was also meant to help keep the body's “humors” in balance. During the nineteenth century its medical use declined, along with many other herbal remedies, but it remained in the edition of the Pharmacopoeia as late as 1905. In 1906, it was suddenly dropped from the eighth edition, the same year the Food and Drugs Act became law. Legend has it that the tobacco companies arranged for
tabacum
to be dropped from the national drug list, thus avoiding FDA regulation, in exchange for the votes of tobacco state congressmen for the 1906 act. There is no hint, however, of such a deal in the
Congressional Record,
nor in the papers of Dr. Harvey Washington Wiley, a physician and pharmacist who had been in charge of the precursor to the FDA, the Agriculture Department's Division of Chemistry.
Tabacum
was dropped, it seems, because its properties as a cure had been superceded by other substances.