Since the mid-1960s, Congress has passed a plethora of bills intended to protect Americans against addictive drugs, toxic substances, and defective consumer products. An alphabet soup of agencies with regulatory authority for health and safety has banned substances from cosmetics and food, required the repair of defective baby cribs and sport utility vehicles, restricted the exposure of workers to acrolein and carbon monoxide, and set maximal limits on arsenic in the water and nitrogen dioxide in outdoor air. Tobacco smoke contains acrolein, carbon monoxide, arsenic, nitrogen dioxide, and well over 4000 other chemicals, more than 40 of which are known carcinogens. Tobacco kills far more Americans than all the substances and products regulated by government combined. Yet, curiously, for nearly half a century after cigarettes were scientifically indicted as causing cancer, no agency responsible for health and safety ever attempted to regulate cigarettes (Figure). When a court told the Consumer Product Safety Commission to consider such regulation in the mid-1970s, Congress amended the relevant legislation to exclude tobacco and tobacco products. The Occupational Safety and Health Administration has consistently avoided regulating exposure to tobacco smoke in the workplace, while limiting exposure to at least two dozen hazardous airborne materials that are emitted in tobacco smoke. When Congress passed the Controlled Substances Act in 1970 to prevent the abuse of drugs, narcotics, and other addictive substances, the lawmakers specifically excluded the most deadly addictive substance, tobacco, from the purview of the act. Similarly, in 1976, Congress exempted tobacco and tobacco products from the definition of "chemical substance" in the Toxic Substances Control Act, which was intended to "regulate chemical substances and mixtures which present an unreasonable risk of injury to health." On several occasions, the Food and Drug Administration (FDA) declined to consider regulating tobacco products, despite the apparent relevance of its mandate and the absence of any congressional prohibition against doing so. Enter David Kessler, the new FDA director, and his colleagues in the early 1990s. Well aware of the effects of tobacco, a handful of FDA staff members wondered collectively why the agency did not regulate a product with a death toll far greater than that of all the products it did regulate. A small group began investigating the question and concluded that the agency might well possess the legal authority to do so, although the prodigious political challenge was self-evident to all. As Kessler readily acknowledges in A Question of Intent, the agency's leader retained a healthy skepticism, adopting a "show-me" attitude before he would authorize a major investigation of the industry with the possibility of ensuing regulatory policy. As evidence accrued -- staff members scoured the literature and interviewed experts on health and addiction -- the case became compelling: nicotine was a drug, consistent with the definition in the agency's authorizing legislation, and cigarettes were drug-delivery devices. The addictiveness of smoking was established beyond question, and the preliminary research by the agency indicated that the cigarette industry engaged in a number of practices to boost the effect of nicotine on smokers. The boss gave a thumbs-up to a formal investigation. A Question of Intent documents the agency's pursuit of its investigation and the development and adoption of a policy focused on reducing the use of tobacco by young persons. The book is a road map through the perilous terrain of the government policymaking process, especially as it pertains to products manufactured by large, highly profitable, and (hence) politically influential industries. Rest assured: this road is no superhighway. Rather, the journey takes the reader through much previously uncharted political and policy-related territory. Readers will find fascinating, and often appalling, the enormity of the challenges that officials confronted in trying to secure testamentary evidence and support from the administration to move the investigation forward. Kessler's need to involve armed agents of the Office of Criminal Investigations in eliciting cooperation from reluctant industry witnesses sent chills down my spine. The duplicitous behavior of scientists coopted by the industry, as recounted by Kessler, evokes disgust in anyone who pledges allegiance to the scientific method. And, of course, the ever-present political protection afforded the industry leaves the idealist with a feeling of dismay. Written with a remarkable literary flair, A Question of Intent reads like a gripping suspense story. It is a contemporary whodunit, made far more compelling by the fact that, instead of fabricating his story out of whole cloth, the author stitches together unanticipated and frequently shocking patches of the reality of our own very imperfect form of governance. The story has a happy ending, however. Or does it? Overcoming one barrier after another, Kessler and his colleagues finally convinced the administration to support the policy that the agency proposed. For the first time in history, a federal agency announced and implemented a policy to regulate cigarettes and smokeless tobacco products in order to diminish the danger they posed to the young people of the United States. Why is this not a totally salutary outcome? For two reasons. First, the policy was ultimately rejected by the Supreme Court. While acknowledging the enormity of the toll of tobacco, the majority concluded that Congress had never intended the authority of the FDA to extend to tobacco products. For tobacco to come under the watchful eye of the FDA will now require new legislation explicitly instructing the agency to exercise such authority. The second reason to bemoan the ending of the story is that, after laboring so hard and so creatively, after overcoming seemingly insurmountable political barriers, the FDA brought forth a molehill of a policy. Yes, the very existence of the policy was itself a triumph of the first order, a crucial foot in the door of a never-entered chamber. But the fact that these intrepid policy explorers ultimately nudged tobacco control far short of its frontier left many with a sense of despair. If this policy was the best that the best and the brightest could achieve, what hope was there that the federal government could tackle the leading cause of avoidable illness and premature death? It is a sobering lesson. Fortunately, it is but one of the many lessons this fine recounting offers. Any serious student of health policy will find this book essential reading. Kenneth E. Warner, Ph.D.
Copyright © 2002 Massachusetts Medical Society. All rights reserved. The New England Journal of Medicine is a registered trademark of the MMS.
