Smoking Gun

As Dr. David Kessler was about to be nominated by President George H. W. Bush to head the Food and Drug Administration, he bumped into his former boss, Utah senator Orrin Hatch, at a social gathering. The senator greeted him with a bear hug and said, “Remember Uncle Orrin when you’re commissioner of the FDA.” After reading Kessler’s memoir cum indictment of the cigarette industry, one still has not much idea whether “Uncle Orrin” ever came calling, but the author’s recall of such amusing incidents at least keeps it interesting.

To hear Kessler tell it, when he assumed the post, “virtually nobody was happy with the FDA. . . . Much of its authority had been diluted by the Office of Management and Budget, which was used by the White House to pursue an aggressive and dangerous deregulatory agenda.”

Worse, the functions of the FDA were spread out in buildings all over Washington, D.C., making it a logistical nightmare to try to run. Kessler set out to bolster the agency’s image, consolidate operations and, above all, “enforce the law.” The agency’s job, as he saw it, was to regulate in the interest of public health; politics be damned.

Well, some politics. AIDS victims managed early on to impress upon Kessler the point that they didn’t like the FDA’s normal review process holding up potentially life-saving drugs.

Perhaps he tired of the picket signs labeling him a murderer, or perhaps he simply thought they had a point: One of his signature acts under Bush was the streamlining of the approval process for such emergency drugs. He also managed to force food companies to alter the packaging of store-bought foods so that they included the now ubiquitous “nutrition facts” labels.

He writes that he considered resigning if George Bush didn’t side with the FDA in the fight over the USDA. This was important to him because he “knew that diet accounted for the second largest cause of preventable death in the United States . . . and that improving how Americans ate was one of the most important public health actions we could take. My goal was not to dictate behavior but to allow people to make educated choices.”

The statement was made by Kessler, the competent Bush appointee with aspirations to make modest improvements in public health. Jeff Nesbit, an old Dan Quayle hand, did his best to keep the tobacco regulatory fires from dying, but Kessler had taken no action on the issue. Instead, he had killed it the good old-fashioned Republican way: a series of useless meandering meetings.

Shortly after Bill Clinton’s inauguration, however, Kessler confided to Harriet Rabb, counsel to the Department of Health and Human Services, that compared with all the other good things the FDA had accomplished, “stopping tobacco use would have a bigger effect on health in this country.” As it did to so many other things, the Clinton administration shifted Kessler’s focus, producing an increasingly activist agency bent on “regulating” Big Tobacco.

The problem with regulations, Kessler admitted at the time, is obvious to anybody who knows anything about the FDA. A cigarette is such a toxic substance that the moment the agency declares its principal component, nicotine, a drug, it will have to be banned. A “safer” cigarette was largely a nonstarter because by the time nicotine and the rest of the pantheon of carcinogens were removed from tobacco, nobody would want to smoke it. As one tobacco executive quipped, “A cigarette without nicotine is like sex without an orgasm.”

Another impediment would be that the FDA knew practically nothing about tobacco. But on the basis of information submitted by one informant code-named — and I am not making this up — “Deep Cough,” the agency issued a letter to anti-smoking activists that put the decision not in Congress’s tobacco-stained hands but in the FDA’s. Kessler acknowledges that “from a congressional perspective, our letter had the word ‘hearing’ written all over it.”

And so it did. Until the GOP took back Congress, hearings — under California Democrat Henry Waxman — were the order of the day. Tobacco executives were made to answer charges of nicotine manipulation, genetic engineering, and other Very Bad Things.

The remainder of the book runs along two parallel tracks: one detailing the discovery of the pharmacological process and properties of tobacco; the other rediscovering the history and ferocity of Big Tobacco to survive and expand market share against all impediments. The forensic details alternate between fascinating and tedious, with Kessler stressing all along that he did not intend to bring down Big Tobacco, but rather, to get at the truth. Shortly before the first hearing, Kessler “ticked off some of the questions we had to answer: How are cigarettes made? How is nicotine related to addiction? Are manufacturers adding nicotine to cigarettes? How does the industry set nicotine levels? Where is the nicotine coming from?”

The short-run solution was a cram session, with massive research following. Where the FDA’s own labs came up short, ex-smokers and former employees of tobacco companies — in spite of the stringent secrecy agreements they had signed — were more than willing to fill in the blanks.

Two things proved decisive in the FDA’s historic decision to take the first steps in regulating tobacco: the first was the supposed revelation that tobacco companies were targeting children, and the second was Dick Morris. The first shook the public out of its normal reflexive distrust for government intervention, while the latter wanted Bill Clinton to use it as a campaign issue to beat Bob Dole over the head with. Once Morris had polled tobacco-producing states and determined that strong majorities favored tightening the rules for teens, Joe Camel was a goner.

We know the rest of the story. Bill Clinton, stogie smoker, went up against Dole, the ex-smoker, and painted him as a pawn of Big Tobacco. Former demon-weed farmer Al Gore used his speech at the Democratic National Convention to damn the industry for killing his sister. Our children, they assured, must be protected from this noxious substance, and Republicans were complicit in this tragedy. Though a settlement was reached with all the state attorneys general, it appears that tobacco may yet be bled to death through punitive damages.

Looking back, Kessler thinks that the beast must be killed, not wounded. “If public health is to be the center of tobacco control,” he says, “the tobacco industry . . . needs to be dismantled.” Tobacco companies should be stripped of their trade, and the ability to manufacture and distribute cigarettes should be solely vested in the federal government. He deems this necessary because if the current arrangement is allowed to continue, “profits are inevitably used to create the same addictive product and to generate more sales.”

It really is quite a leap from Kessler wanting to “allow people to make educated choices” to the current call for a new near-prohibition, but perhaps we shouldn’t be too harsh. He has, after all, seen the fruits of his nutrition initiative: Americans are now better informed about tubs of lard than ever before.

But there’s one Kessler assertion card-carrying conservatives are obliged to take issue with. “To this day,” he says “the FDA has not been given some of the most basic powers a regulatory agency should have.”

Like what, summary execution?

Jeremy Lott is senior editor of Spintech Magazine.