Kessler's Unlikely Page-Turner Tells How FDA Smoked Out Big Tobacco

Preparation of a case study on the FDA's decision to regulate tobacco

A Question of Intent: A Great American Battle with a Deadly Industry (Public Affairs Books, 2001) by David A. Kessler, former Food and Drug Administration (FDA) Commissioner, focuses on the FDA's decision to regulate tobacco products as drugs.

The regulation was issued in August 1996 and imposed new restrictions on the sale and promotion of cigarettes and smokeless tobacco to children and adolescents.

This grant supported the development and writing of the book by Dr. Kessler and a team of researchers. The grant was overseen by faculty at Yeshiva University, Albert Einstein College of Medicine, Bronx, N.Y.

Key Results

  • A Question of Intent was widely reviewed, including reviews in the New York Times Book Review, The New Yorker, Business Weekly, the Washington Post, and JAMA.

    In his review in The Journal of the American Medical Association (JAMA) (vol. 285, no. 13, April 4, 2001), Thomas P. Houston, M.D., writes:

    "In his new book, A Question of Intent, David Kessler weaves a richly detailed history of the FDA battle to assume authority over tobacco products and the drug nicotine."

    In the case of tobacco, the FDA was responding to a series of petitions from the health community asking that the agency regulate tobacco products. In response, a small internal work group began to look at the issue and was having difficulty finding a rationale for placing tobacco products under FDA jurisdiction.

    In the fall of 1992, one of his staff pointed out that nicotine is a constituent of cigarettes that could be manipulated. "Cigarette manufacturers can take the nicotine out, but they leave it in. That goes to the question of intent," David Kessler remarked. That insight propelled the agency to proceed with an effort that would consume Kessler, the health community, and the tobacco industry for a number of years.

    The Food, Drug and Cosmetic Act defines drugs as "articles (other than food) intended to affect the structure or any function of the body." How the tobacco industry's activities fit this definition became the central focus for the investigation.

    Some of this narrative reads like a John Le Carré novel, with FDA investigators talking to persons with code names like "Cigarette Jr.," "Saint," and "Critical" and to the subject of the movie The Insider, Jeffrey Wigand, who had been a highly placed research director at Brown and Williamson.

    Other former industry employees discussed many aspects of tobacco manufacturing, and the highly engineered product the modern cigarette has become.

    "Saint" had been a thermodynamics specialist and reported on processes such as denicotinizing tobacco and "supercritical extraction," for removing carcinogens from tobacco, which Philip Morris had investigated.

    Kessler details how he and his staff processed immense amounts of information never before studied by federal regulators, including the chemistry of tobacco smoke, the science of growing and processing tobacco, and the use of additives such as ammonia to make nicotine more available to the smoker's brain.

    Another segment of the investigation involved tracking down a genetically altered, high-nicotine tobacco called Y-1, which was secretly used in Brown and Williamson products to produce a relatively low-tar, high-nicotine cigarette.

    Industry documents played a large part in proving intent. Exhaustive review of documents obtained in lawsuits against the tobacco industry revealed that for years nicotine had been known to be addictive and to function as a tranquilizer, a stimulant, or a depressant.

    Such explicit statements, previously unknown to the health community, showed that the tobacco industry was actively designing its products to deliver, in the words of a 1963 Brown and Williamson memo, "an addictive drug effective in the release of stress mechanisms."

    RJ Reynolds memos from the early 1970s pointed out that "Nicotine is known to be a habit-forming alkaloid … the user is primarily seeking the physiological 'satisfaction' derived from nicotine and perhaps other active compounds. Thus, a tobacco product is, in essence, a vehicle for the delivery of nicotine." This played into the agency's decision to regulate cigarettes as devices that deliver the drug nicotine.

    The next step was to determine how to move forward, particularly since Congress had gone Republican in 1994, and the crusading Congressman Henry Waxman had been replaced by Virginia's Tom Bliley in the House Subcommittee on Health and the Environment.

    It was before Waxman's committee in preelection 1994 that the FDA investigation into the tobacco industry was debated, and the nation's top tobacco company executives had testified under oath that nicotine was not addictive. Congressman Bliley put an end to the industry's public embarrassment in this arena.

    Kessler used the facts that industry marketing and promotional practices were shown to be deliberately aimed at youth and that most smokers begin as teens to pursue his political strategy, an effort that turned out to be almost as difficult as investigating the industry. Tobacco use as a pediatric disease sold the White House on going forward with plans to lay out a regulatory scheme for FDA control of tobacco products.

    The July 19, 1995, issue of JAMA was devoted entirely to articles that analyzed for the first time in the medical literature internal tobacco industry documents from Brown and Williamson. Upon publication, copies were hand delivered to President Clinton, who read the issue from cover to cover.

    In late July 1995 Kessler met with the President, who said, "I just read all those documents, and I want to kill them [the tobacco companies]." The President approved the FDA proposals, which were announced at a White House ceremony on August 10, 1995.

    The balance of the book is spent exploring the legal and political challenges to the regulations, ultimately ending with the Supreme Court ruling that denied FDA claims to jurisdiction.

    Kessler gives an insightful account of the difficulty the courts had in understanding the science and health aspects of the issue and their reluctance to expand federal regulatory authority over a 'political' matter. The Supreme Court overlooked the central thesis of his argument: new knowledge of the tobacco industry's intent, proven in its own words, was now in evidence.

    He also argues that the nation's adversarial legal system allows "zealous advocacy" by attorneys, enabling the tobacco industry's lawyers to abet the manipulation of the truth in questionable, if not strictly illegal, activities.

    Writing in the National Journal about this part of Dr. Kessler's book, Stuart Taylor Jr. points out that "[t]he social costs of licensing lawyers to distort and conceal are especially great when they represent large and powerful organizations with the capacity to cause disease, death, or disinformation."

    This compelling book ends with Dr Kessler's recommendation that the tobacco industry be reorganized to remove the profit motive from supplying this addictive, deadly product, allowing only for sales of cigarettes in plain wrappers without logos through tightly controlled outlets.

    His book provides a chilling look at the tobacco wars and the tobacco industry's unabashed use of a host of weapons to thwart justice and truth. Despite the ultimate failure of the FDA to gain authority over tobacco products, the agency's effort forever changed the picture we have of tobacco use, the tobacco industry, and its intent.

    A review posted on www.cnn.com states:

    In this book, David Kessler tells for the first time the thrilling detective story of how the underdog FDA — while safeguarding the nation's food, drugs, and blood supply — finally decided to take on the tobacco industry and how it won.

    Like Civil Action or And the Band Played On, A Question of Intent weaves together science, law, and fascinating characters to tell an important and often unexpectedly moving story.

    We follow Kessler's team of investigators as they race to find the clues that will allow the FDA to assert jurisdiction over cigarettes, while the tobacco companies and their lawyers fight back — hard. Full of insider information and drama, told with wit, and animated by its author's moral passion, A Question of Intent reads like a John Grisham thriller, with one exception everything in it is true.
  • On January 23, 2001, the book received a ninth-place ranking on the United Press International Best Seller List. An article by Dr. Kessler covering some of the material in the book was published in Talk magazine.

Funding

The Robert Wood Johnson Foundation (RWJF) helped support this project with a grant of $200,000 between April 1997 and June 1999.

The California Wellness Foundation provided $75,000, and the Kaiser Family Foundation provided $44,000 for the project.

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