Leo Lutwak, 78, FDA Whistleblower on Fen-Phen
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Leo Lutwak, a retired medical officer with the Food and Drug Administration who became a government whistleblower because of what he saw as the agency’s capitulation to the drug industry, died February 23 of pneumonia. He was 78.
Lutwak, an endocrinologist and biochemist by training, as well as a physician, was a nationally known figure in the medical, legal and pharmaceutical communities as an inside source about the process by which drug applications are evaluated by the FDA.
In interviews for television news programs, books and articles over the past 10 years, he warned about a growing symbiotic relationship between government regulators and drug manufacturers that threatened to undermine the FDA’s mission to safeguard the public’s health.
His insights were featured prominently in the 2000 Los Angeles Times Pulitzer prize-winning series “The New FDA: Partnership With Deadly Risk,” and investigative journalist Alicia Mundy’s 2001 book “Dispensing With the Truth: the Victims, the Drug Companies, and the Dramatic Story Behind the Battle Over Fen-Phen.”
Fen-phen, which included the drug Pondimin, was a controversial combination of appetite-suppressing drugs made popular in the 1990s.
Lutwak, a leading authority on obesity, helped evaluate the clinical data on fen-phen and a related drug marketed under the name Redux.
It wasn’t long before he voiced concern about the drug’s safety after analyzing reports that seemed to associate the medication with pulmonary hypertension and cardiac events.
Despite his evaluation that the potential health risks outweighed the benefits, Redux received approval from the FDA in 1996. It was withdrawn the next year after a Mayo Clinic report linked Redux and Pondimin with heart valve damage.
Lutwak was a native of the Bronx, N.Y., and graduated cum laude from the City College of New York. He received a Ph.D. in biochemistry from the University of Wisconsin, and a medical degree from Yale.
In the 1950s, Lutwak became a pioneering research biochemist in bone metabolism, nutrition, and geriatrics. He worked for Brookhaven National Laboratories, the National Institutes of Health, and NASA, where he investigated problems relating to food consumption in outer space.
