LDI Health Policy Seminar Series and
Division of General Internal Medicine

Samuel Martin III, MD, Memorial Lecture

David A. Kessler, M.D.
Dean, Yale University School of Medicine
(former Commissioner of the United States Food and Drug Administration)

"Tobacco Wars"
May 7, 2001
2:00 p.m. - 4:30 p.m.
BRB II Auditorium


Reception and a book signing will follow
(Medical School Bookstore BRB II, 421 Curie Boulevard)

Biosketch

Summary:
Using Socratic dialogue and the rhetoric of Perry Mason, David Kessler, MD, JD led his audience through an interactive tour of the FDA's efforts to regulate the cigarette industry. Dr. Kessler, former Commissioner of the FDA from 1990-1996 and now Dean of the Yale School of Medicine, spoke at LDI on May 7.

Dr. Kessler began with a question that an FDA staff member posed soon after Dr. Kessler arrived in Washington: Could the FDA regulate tobacco? He fired off questions to the audience: "What would you do?" "Do you have the authority?" "How would you investigate?"

The FDA began to investigate whether tobacco was a drug under its jurisdiction. However, it was two years before they refined the question to ask whether nicotine was a drug, using the definition the FDA currently uses: "an article other than food intended to effect the structure or function of the body." This set off a long investigation to prove the tobacco industry's "intent," replete with key informants from the industry and international patent searches.

Informants provided internal documents showing that tobacco companies understood the addictive nature of nicotine in the 1960s, and sought to manipulate levels of nicotine in their cigarettes. Patents indicated that the companies has devised ways to add nicotine to filters and wrapping paper. Finally, another informant provided information about genetically engineered tobacco with high nicotine content that was being imported from Brazil.

While building a case on the industry's intent to manipulate nicotine, the FDA also discovered documents indicating that the industry had been actively marketing its cigarettes to teenagers. That discovery, Dr. Kessler said, changed the dynamic of ongoing court cases and of the industry's fight against regulation. "We were aiming at the heart of the industry," he explained. Juries were much less inclined to accept grounds of choice and personal responsibility when they realized that children were being targeted.

Although the Supreme Court subsequently ruled 5-4 against FDA regulation of tobacco, and Congress did not pass significant anti-tobacco legislation, Dr. Kessler believes that the tide has turned against the industry. Liability concerns have prompted tobacco officials to want some government regulation, in the hope of protecting themselves against awards that could bankrupt the industry. "They need an endgame [to end liability]," he said.

Although he does not advocate prohibition of cigarettes, Dr. Kessler said that profits must be taken out of the industry. The tobacco industry, he said, "has perpetrated the longest running scheme ever to put the nation's health at risk." He predicted that cigarettes will become a tightly regulated product (although not in this Congress).

Dr. Kessler left his audience with these words of advice from his FDA experience: "Sometimes, just sometimes, with issues that seem impossible, you really can make a difference when you take them on."

Dr. Kessler's book, A Question of Intent, was published in 2001 by Public Affairs Press.



Biosketch:
David A. Kessler, M.D. has been Dean of the Yale University School of Medicine since July 1, 1997. Dr. Kessler, who served as Commissioner of the United States Food and Drug Administration from November 1990 until March 1997, was appointed by President Bush and reappointed by President Clinton.

As Commissioner of the FDA, he acted to speed approval of new drugs and placed high priority on getting promising therapies for serious and life-threatening diseases to patients as quickly as possible. He introduced changes in the device approval process to make it more efficient and ensure that it meets high standards. Under his direction, the FDA announced a number of new programs, including: the regulation of the marketing and sale of tobacco products to children; nutrition labeling for food; user fees for drugs and biologics; preventive controls to improve food safety; measures to strengthen the nation’s blood supply; and the MEDWatch program for reporting adverse events and product problems. He emphasized strong law enforcement and created an Office of Criminal Investigation within the agency. According to The New York Times (11/27/96), David Kessler “…revitalized a beleaguered agency that had become mired in bureaucratic disarray.” The Los Angeles Times (11/27/96) praised him for “…restor[ing] the Food and Drug Administration to what it was meant to be--an aggressive advocate for the public’s health.” With his departure, “[t]he American people lost one of their most effective champions…” (New York Daily News, 11/28/96).

Dr. Kessler has a wide range of experience in research, clinical medicine, education, administration, and the law. He is a 1973 magna cum laude, Phi Beta Kappa graduate of Amherst College. He received his J.D. degree from The University of Chicago Law School, where he was a member of the Law Review, in 1978, and his M.D. degree from Harvard Medical School in 1979. He did his internship and residency in pediatrics at the Johns Hopkins Hospital. In 1986, he earned an Advanced Professional Certificate from the New York University Graduate School of Business Administration.

From 1984 until his FDA appointment, he was the medical director of the Hospital of the Albert Einstein College of Medicine in the Bronx, New York, where he held teaching appointments in the Department of Pediatrics and in the Department of Epidemiology and Social Medicine. From 1986 until 1990, Dr. Kessler also taught food and drug law at the Columbia University School of Law in New York. He was a consultant to the United States Senate Labor and Human Resources Committee from 1981 until 1984.

Dr. Kessler’s book, A Question of Intent, was published by PublicAffairs in January, 2001. In addition, Dr. Kessler has published numerous articles in The New England Journal of Medicine, JAMA, and other major medical journals. He serves on the board of various organizations including the Elizabeth Glaser Pediatric AIDS Foundation, Doctors of the World, National Center for Addiction and Substance Abuse at Columbia University, and the Henry J. Kaiser Family Foundation. He is also a member of the White House Commission on Presidential Scholars. He is a member of the Institute of Medicine. His many honors have included the American Cancer Society’s Medal of Honor, the American Heart Association’s National Public Affairs Special Recognition Award, the American Federation for AIDS Research Sheldon W. Andelson Public Policy Achievement Award, the American Academy of Pediatrics Excellence in Public Service Award, and the March of Dimes Franklin Delano Roosevelt Leadership Award.



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