Dogged Drug Company and FDA Critic Delivers UCSF Health Policy Talk

By Robin Hindery

Sidney Wolfe

Over the course of his career, Sidney Wolfe, MD, has helped save the lives of many individuals facing serious health hazards – a laudable, but somewhat commonplace achievement in his line of work. But unlike most other doctors, Wolfe has never laid eyes on the vast majority of his patients; he doesn’t even know their names. That’s because Wolfe, the founder and director of the Health Research Group (HRG) at the nonprofit Public Citizen in Washington, DC, has devoted the past four decades to taking on government agencies, hospitals, drug companies and medical device manufacturers whose practices or products are putting people in harm’s way. In introducing Wolfe as the featured speaker at the UCSF Chancellor’s Health Policy Lecture on Feb. 24, Chancellor Mike Bishop, MD, described the public health champion as “an essential gadfly to the biomedical community and pharmaceutical industry.” Wolfe began his career as an internist and took a research position at the National Institutes of Health in 1966. A few years later, the United States was struck by an epidemic of septicemia, a life-threatening infection caused by the presence of bacteria in the blood. Wolfe received a call from a physician friend, alerting him that although the contamination was traced back to IV fluids produced by Abbott Laboratories, hospitals were being told to continue using the products. Wolfe contacted another friend, outspoken consumer safety advocate Ralph Nader – the founder of Public Citizen — and the two drafted a letter to the Food and Drug Administration (FDA), demanding a nationwide recall of all Abbott IV fluids. “The letter was delivered on a Friday, and we didn’t hear anything back,” Wolfe recalled. “But then the story hit the evening news and the front page of every newspaper that weekend, and [the following] Monday, all the fluids were recalled.” Once the activist bug bit him, there was no going back, Wolfe said. The HRG has since tackled issues such as unethical clinical trials in developing countries, deliberately misleading reports by drug companies seeking FDA approval, and workplace exposure to dangerous chemicals.

Picking Battles

Wolfe and his colleagues pick their battles, based on several criteria: the severity of the problem, the number of people affected, the availability and reliability of supporting data, and the chance of achieving meaningful results. HRG takes its fights to the courtroom, when necessary, but also works to effect change through research and education, Wolfe said. If Wolfe comes across as a bit cynical when it comes to the drug industry and even the FDA – which appointed him to its Drug Safety and Risk Management Advisory Committee in 2008 – his attitude is one that is widely shared. A 2008 Harris Poll measuring public attitudes toward various industries found that 41 percent of respondents thought the pharmaceutical industry was doing a bad job of serving its consumers. In addition, Wolfe said he has watched congressional oversight of the FDA grow increasingly lax over the past two decades – yet another reason for him and his colleagues at the HRG to remain vigilant. The inclusion of such an outspoken critic on the FDA’s drug safety committee has raised more than a few eyebrows and could produce some fireworks, Bishop said at Wolfe’s recent talk. “The FDA sort of let the fox into the henhouse,” Bishop said, laughing. In addition to his work with the HRG and the FDA panel, Wolfe is an adjunct professor of medicine at Case Western Reserve University School of Medicine. The Chancellor’s Health Policy Lecture series at UCSF was initiated by Bishop in 2006 to increase awareness of important health policy issues. Past speakers include Jeffrey M. Drazen, MD, editor in chief of the New England Journal of Medicine; global tobacco control advocate Judith Mackay, MD; and Julie Gerberding, MD, MPH, then director of the federal Centers for Disease Control and Prevention.

Related Links:

Public Citizen’s Health Research Group

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