Tobacco

A Question of Intent
A Great American Battle with a Deadly Industry

Book Review by David Kessler British Medical Journal 2001;322:1129 5may01

Public Affairs Press, £19.99, 492 pages
ISBN 1 891620 80 0
Rating: ***

David Kessler, United States Food and Drug Administration commissioner from 1990 to 1997, clearly changed the world in which the tobacco industry does business. In this timely memoir, he describes how the FDA's historic decision to move against tobacco hinged on proving that tobacco companies designed their products with the intent to get consumers addicted.

The need to demonstrate such intent, an artefact of American regulatory law, explains why the administration sought to regulate tobacco products as "nicotine delivery devices." Ultimately the Supreme Court ruled narrowly that the FDA lacked the legal authority to do so. As Kessler laments, tobacco remains largely unregulated for health and safety as the new millennium begins.

Still, the FDA's investigation, which exposed the tobacco industry's manufacturing practices and targeting of underage consumers, helped change the way in which society views cigarettes. It did so by turning public attention to the bad conduct of the industry, which marked a departure from the government's customarily narrow focus on the health effects of smoking. Kessler's investigators obtained previously secret industry documents that described ways to control nicotine delivery, which Kessler highlighted in televised congressional hearings. The administration's probe also benefited from the simultaneous pursuit by state attorneys general of legal actions against the industry, which forced disclosure of millions of pages of industry memos and reports, although Kessler's memoir downplays this.

Kessler's memoir is a well crafted work that reflects a passion for detail. Yet it contains a remarkable hidden flaw. His version of the forces that propelled him to strike at tobacco omits critically important information. Only a handful of people, including Kessler and this reviewer, know this information.

Kessler tells of "Deep Cough," a cigarette company insider who briefed the FDA on the industry's manipulation of nicotine. Yet he pointedly fails to acknowledge that without the information that Deep Cough imparted, the FDA would not have been able to launch its investigation. He also omits that this reviewer, not others, brought Deep Cough to the agency after spending three years nurturing this pioneering yet terrified informant.

As told in journalist Dan Zegart's Civil Warriors: The Legal Siege on the Tobacco Industry (Delacorte Press, 2000), which quotes internal FDA records, Deep Cough gave the FDA its first information about the tobacco industry's manipulation of nicotine. Kessler knew next to nothing about the subject until just six weeks before he announced that, on the basis of such information, the FDA would consider regulating cigarettes. Kessler does not mention that without Deep Cough and the impetus provided by an investigation into nicotine manipulation begun by the ABC News programme Day One a year earlier than the FDA's probe, he lacked the tools and resolve to act.

Perhaps he negates these central events because their inclusion would muddy a storyline that makes him the only important initiator of a great regulatory crusade against tobacco. While this shortchanges history, the greater wrong is that it annuls the role played by activism and investigative journalism in launching major social change.

Clifford Douglas, president
Tobacco Control Law and Policy Consulting, Ann Arbor, Michigan

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