Will the lights go out across America?

Where there's smoke there's a fiery zealot, namely the head of the FDA. Peter Pringle reports

Dr David Kessler has the most unfashionable job in the Clinton administration. He is the regulator of food and drugs in an era of constant demand for government deregulation. Naturally, he has been called all kinds of names.

At first, they referred to the youthful paediatrician as "David Howser MD", after a precocious teenage doctor in a TV sitcom, Doogie Howser MD. Then, after Kessler began bossing big industry about, telling its masters what they could and could not sell and how to label their products, he became known as Eliot Knessler, after Eliot Ness, the cop who pursued Al Capone. And then Newt Gingrich, the Speaker of the House of Representatives, branded him a "thug and a bully".

The names can only get worse. For two years Kessler has made it his mission to prescribe more, not less government control for one of America's most powerful industries - tobacco. Kessler views smoking as the priority preventable disease in the United States. In the next few weeks, possibly even days, he is expected to become the first head of the 90-year-old Food and Drug Administration to declare tobacco a drug that needs to be regulated, just like heroin or cocaine.

Kessler's priority case in the last two years has been tobacco, but before he could regulate cigarettes he had to establish two things. The first was to declare nicotine an addictive drug - something the tobacco companies, against the evidence of mainstream medical science, still deny. Second, US law defines a drug as "an article (other than food) intended to affect the structure or function of the body". The fact that the cigarette makers have the ability to alter nicotine content is enough for Kessler to satisfy the issue of intent to get people hooked on their product.

After months of scientific review, Kessler's FDA has not only declared nicotine addictive, but also unearthed evidence in the Patents Office and court documents that the tobacco companies have developed the ability to manipulate the levels of nicotine in their cigarettes. Kessler's sleuths even found a patent for a tobacco plant that produces twice the normal amount of nicotine and discovered the British-owned company Brown & Williamson had grown the plant in Brazil and shipped back tons of nicotine-rich tobacco into the US.

"The public may think of cigarettes as no more than blended tobacco rolled in paper," Kessler told Congress in hearings last year. "But they are more than that. Some of today's cigarettes may, in fact, qualify as high- technology delivery systems that deliver nicotine in quantities sufficient to create and to sustain addiction in the vast majority of individuals who smoke regularly."

This week in a speech to the US House of Representatives, Henry Waxman, a California Democrat and a leading opponent of the tobacco industry, charged Philip Morris with deliberately increasing nicotine levels in low-tar cigarettes in the Seventies and early Eighties. The company immediately responded with a statement saying that Mr Waxman was "misleading the American people; and Mr Waxman knows it". What has long been a simmering feud between pro- and anti-smoking camps now looks set for a bloody showdown.

Kessler's decision to regulate cigarettes could be as important in the debate on the health effects of smoking as the Surgeon General's 1964 declaration that smoking causes cancer. It would signal a possible end to the longstanding government compact that allows the tobacco companies freedom to sell the addictive drug nicotine and make billions in operating profits, and government - federal and state - to collect billions in excise taxes. Regulating tobacco would certainly make Kessler the darling of the anti-smoking movement, in the US and abroad; equally, he would be strongly opposed by conservative Republicans in Congress who who have been talking about abolishing the FDA because they think it is already too intrusive.

Precisely what long-term plans Kessler has in mind is not clear. And he's tight-lipped - except to acknowledge he cannot ban tobacco; too many people smoke. Apparently, he would like to force the tobacco companies to wean smokers off cigarettes by a gradual reduction of their nicotine content, although medical scientists have yet to agree on the level that would not cause addiction. He is also looking at ways to curb, possibly even end, tobacco advertising, especially any form of it that portrays smoking as romantic or hip and could lure youngsters to smoke.

In his office in the suburbs outside Washington DC, Dr Kessler appears confident and fully up to the task. As is his wont, he takes off his jacket and brings his chair up close to raise the intensity of the conversation. "We are very serious about this," he says, peering through his spectacles. "We are also very thorough. This is something where you make sure every 'i' gets dotted and every 't' gets crossed. It is something that we have been working very hard on." In the process, he doesn't mind what people call him. "I didn't come to this town to win a popularity contest," he says.

When Kessler took over the FDA, it was a stagnant, largely ineffective, bureaucracy that had lost the respect of the industries it regulates. During the Eighties, the FDA's enforcement actions had fallen sharply. Inspections of food products and food and drug manufacturing plants were halved - from 36,000 to 18,000 - and seizures of contaminated foods or adulterated pharmaceuticals dropped from 539 in 1980 to 142 in 1989. The agency was also rocked by scandal. A number of drug companies had been selling adulterated and mislabelled products, had falsified their records and had paid off FDA inspectors. Four FDA employees were convicted of taking bribes to speed up drug approval. "We had become a paper tiger," says Kessler. "We would write a letter, and we would write another letter. Then we'd write another letter. No one took us seriously."

His first move at the FDA was to strengthen the enforcement teams, hoping to bring back respect to the agency. Executives at Procter & Gamble, one of America's largest companies, are still reeling from the day Kessler sent out his inspectors and seized 2,000 cases of orange juice because the bottles had a misleading label. They claimed to be freshly squeezed juice when, in fact, the juice was made from concentrate.

Next, Kessler banned silicone breast implants, forced "fresh" labels off reconstituted spaghetti sauce and "fat-free" claims off diet products. He even upbraided the American Red Cross for not screening its blood supplies for the Aids virus, and stopped the American Heart Association giving certain products a red heart symbol in return for a fee from the manufacturers.

Right-wing magazines and Republican politicians still charged that Kessler's FDA let tens of thousands of Americans die each year because new drugs that could save them from fatal heart, kidney, stomach or blood ailments were being kept too long from the prescription counters. They also charged that the FDA's caution is driving good American drug companies offshore, with a consequent loss of jobs and technical expertise. Several businesses have moved to Europe and Ireland.

The FDA's - and Kessler's - stock reply is, "Remember thalidomoide". While European governments in the Sixties approved the sedative, with its tragic consequences, the FDA stubbornly kept thalidomide out of the US. "Anyone can accelerate the drug-approval process," says Kessler. "The hard part is knowing how to do it without lowering our traditional standards of safety and efficacy. Remember that the snake-oil salesmen who hawked their nostrums were within this century ... and it is still easy to sell miracles in a test tube."

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