The Search for the Smoking Gun
In taking on Big Tobacco as head of the FDA, David Kessler made a historic contribution to America's public health
A Question of Intent:
A Great American Battle with a Deadly Industry
by David Kessler
400 pages, $27.50
Imagine my shock on discovering that Philip Morris considered buying The Atlantic Monthly, along with several other media outlets, in order to "influence the public policy agenda and the information flow to the populace," to quote from an early 1990s in-house document. Big Tobacco was desperate to change the anti-smoking climate of opinion. And David Kessler would add a new dimension to their desperation. During his tenure as the head of the Food and Drug Administration, from 1991 to 1997, Kessler did more to advance the health of Americans than any other public servant in U.S. history. His politically courageous (but ultimately unsuccessful) campaign to have nicotine classified as a drug is the story grippingly told in his new memoir, A Question of Intent: A Great American Battle with a Deadly Industry.
That Philip Morris thought of acquiring The Atlantic illustrates one of the main points of the book: the tentacular reach of the tobacco industry. "You don't know what you are up against," an industry flack once told a would-be opponent. "We have more money than God." That money has tainted the most unlikely hands. Not just members of Congress from tobacco-growing states and white-shoe Washington law firms like Covington & Burling. Not just former officials of the FDA, including at least one former commissioner. But also the Sloan-Kettering Institute for Cancer Research, one of whose former directors "publicly expressed his doubt that smoking is implicated" in cancer, according to a Philip Morris memo. And the American Medical Association, which took money from tobacco to finance its lobbying campaign against Medicare in the 1960s. Seeking to manage "the social climate for tobacco use," the industry has contributed to the Heritage Foundation, the Manhattan Institute, the Hoover Institution, the National Association of Manufacturers, and the National Journalism Center, which Philip Morris claimed gave them access to "journalists at print and visual media throughout the country ... which has resulted in numerous pieces consistent with our point of view." Big Tobacco sought to influence Islamic mullahs to put a pro-smoking gloss on their interpretation of the Koran. They even targeted volunteer firefighting companies in small-town America. "The company claimed to have seen results," Kessler writes, in "... firefighters' willingness to say publicly that cigarettes do not cause fires."
Kessler made these and like discoveries while sifting through tobacco-company documents gathered by indefatigably dedicated FDA investigators, and the book tracks his sadness and outrage and finally cynicism as he finds name after prominent name—former Senate Majority Leader Howard Baker, Margaret Thatcher, leading cancer researchers, former lawyers for the FDA, congressmen at FDA hearings reading questions prepared for them by Big Tobacco—who have taken money from an industry that has killed 12 million Americans since 1964, when the famous Surgeon General's Report on smoking and health was released and we knew and they knew, past all but conscienceless denial, that cigarettes meant death.
Kessler was appointed to head the FDA when he was thirty-nine, by Dr. Louis Sullivan, President George Bush's Secretary of Health and Human Services. Kessler was a physician, hospital administrator, and lawyer who had taught FDA-related law. He had also briefly served on Capitol Hill as a volunteer for the Labor and Human Resources Committee working on FDA issues.
Kessler's mettle was tested early on during his tenure at the FDA. Embroiled in a controversy with the Agriculture Department over accurate food labeling, he pledged to resign on principle if the Administration did not side with the FDA. (It did.) The pledge of principled resignation is a weapon of conscience too rarely wielded in Washington. You can't measure the effects of an earthquake that did not occur, but would that Robert McNamara—the Secretary of Defense in the Kennedy-Johnson years who kept his doubts about the Vietnam War to himself even as he conducted it—had achieved the moral authority David Kessler won when he chose to put conviction not only above office but also above the competing good of loyalty to the people who put him there.
It was a former aide to Dan Quayle, Jeff Nesbit, who, after witnessing Kessler's grit in the labeling fight, challenged Kessler to take on tobacco. "I thought Jeff was crazy," Kessler writes. The federal courts had held that cigarettes could not be regulated as a drug, which the FDA's enabling statute defines as "articles (other than food) intended to affect the structure or function of the body." Nicotine might fit that definition, but the statute also requires a finding of intent—the manufacturer of the drug must intend to purvey it through his product for the FDA to exercise jurisdiction. Should the FDA attempt to regulate cigarettes by trying to establish industry intent? Soon after he was appointed, Kessler put the question to his staff. Some members feared congressional retaliation against the FDA. (Indeed, the GOP takeover of the House in 1994 would confirm their fears. In an airport interview with NBC days after the election, Newt Gingrich, the new House Speaker, called Kessler a "bully and a thug," a hint of congressional hostility to come. "When I later saw the clip of the Brokaw interview," Kessler recalls, "I watched Gingrich step from the tarmac onto a plane owned by a tobacco company.") But at Kessler's fateful staff meeting one FDA official voiced the spirit that would inform the agency's seven-year battle to prove industry intent. "This is the most important thing we can do," she said. "If we take it up, I'm willing to spend the rest of my career working on it."
In Kessler's deft telling the search for intent becomes a moral, scientific, political, and administrative detective story, a "policy thriller," Business Week calls it, with informers, false leads, threats, dead ends, and revelations—the story of a race against premature death for the 3,000 U.S. teenagers who start to smoke every day. The race ended in defeat when the Supreme Court, in December, 1999, ruled—by the same 5-4 majority that decided the presidential election in Bush v. Gore—that the FDA did not have the authority to regulate tobacco. Even though Philip Morris, in a historic reversal just weeks before the Supreme Court hearing, had publicly admitted that nicotine was a drug, and even though the FDA thickly documented its contention that "the manufacturers ... engineer their products to deliver the precise doses of nicotine that consumers need to obtain its powerful effects," the conservative justices did not get it. Chief Justice Rehnquist said that previous FDA commissioners had told Congress that the FDA did not have the statutory authority to regulate tobacco. Despite the Kessler-led FDA's new findings, he saw nothing new: the government had known since the early sixties that smoking was dangerous. Justice Sandra Day O'Connor "repeated the familiar tobacco industry charge that our theory on tobacco would permit [the FDA] to regulate horror movies," Kessler notes despairingly, "because so many people go to them to get scared and get their adrenaline pumping." Categorical conservative antipathy toward government regulation drove the ruling, Kessler believes. He writes, "I was convinced there was no evidence we could have presented to sway those five justices."
But the evidence uncovered by the FDA that cigarette companies deliberately try to addict customers has and will cost the industry billions in civil suits. "The industry that once boasted of having more money than God [is] in trouble," Kessler writes. Hoping to sway opinion, it has made a series of welcome concessions. It has even signaled that it may support raising the minimum age to buy cigarettes to twenty-one. But this is not enough for Kessler, now the Dean of the Yale Medical School, who fears concessions will breed complacency. Regulation of the existing industry always faced a conceptual ambiguity he did not—perhaps could not, politically—acknowledge while at the FDA. Sandra Day O'Connor, of all people, exposed it when she objected to FDA regulation as a form of approval. "I just don't see how anybody could stand here and say, fine, they're safe, so we'll permit them to be used," she said from the bench, prompting Kessler to whisper to his wife, "Maybe we should have banned them after all."
Kessler has moved closer to that position as the industry has moved to accommodate some regulation. He now wants tobacco companies spun off from their corporate parents and made separate entities under strict congressional scrutiny, with no promotions allowed and no profits. "[I]t's too easy to be swayed by the argument that tobacco is a legal product and should be treated like any other. But a product that kills people—when used as intended—is different. No one should be allowed to make a profit from that."