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By David Pittman, Washington Correspondent, MedPage Today WASHINGTON -- Sidney Wolfe, MD, can talk for as long as you let him about how he got his start in consumer health advocacy.
Wolfe was in his mid-30s in March 1971. He had just finished his residency and was doing hematology research at the National Institutes of Health when he received a call from a fellow resident.
The physician was concerned that the FDA and CDC weren't recalling contaminated intravenous fluids that had caused severe bacterial infections and dozens of deaths. Neither Wolfe nor his colleague considered the CDC recommendation to keep administering the fluids unless patients developed an infection to be correct.
After some research proving a direct link between the IV fluids and infections -- and verifying with some hospitals that a recall wouldn't cause a shortage -- Wolfe sent the FDA a letter demanding that the agency get the manufacturer to recall the fluids, and went on a media campaign with the evidence.
Two days later, the fluids were recalled.
The work was so fulfilling and satisfying that it made him shift career goals entirely, thus beginning the work of what he calls "research-based advocacy."
"I was just tracked to be in academic medicine, to be an internist, take care of patients," Wolfe told MedPage Today during an interview at his Washington office. "And it just changed my career."
That career took a turn -- but isn't over -- when Wolfe stepped down early last week as director of Public Citizen's Health Research Group, an organization that has been a leading public interest voice in health policy. He'll remain on board as the group's "founder and senior adviser." Wolfe's deputy of 3 years, Mike Carome, MD, will take over leadership.
'Gadfly' to Pharma, Organized Medicine
In his more than 40 years at Public Citizen, Wolfe has gone on to be a "thorn in the side of organized medicine," as some have called him. Former President George W. Bush referred to him as a "gadfly" to the pharmaceutical industry.
Public Citizen's Health Research Group -- which Wolfe formed with consumer advocate Ralph Nader -- was officially formed 8 months after the IV fluid recall, as they petitioned the FDA to ban Red Dye #2, which was believed to cause cancer.
Wolfe's group has asked the FDA to ban 35 drugs in the 40-plus years of its work, "not a whole lot," he said. But the agency has followed through on 25 of the group's requests -- about a 70% success rate.
He has questioned the FDA's ability to oversee the safety of drugs since Nixon was in the White House.
"Other people do research, and I had done plenty of research by then," Wolfe said. "But the next step is what do you do with this. In some cases, you're just learning things and there really isn't anything to do. In other cases, you're learning that there is a problem that the FDA ... isn't doing anything about, and what can you do to try to change that?"
At the end of his first year with Public Citizen, Wolfe had enjoyed his work so much that he told Nader, "This will be the last job I ever have."
He was then 36. He turned 76 this week.
But he doesn't have a single favorite piece of work. Asked what he is most proud of, he lists among his successes his warning about rofecoxib (Vioxx) years before it was taken off the market. The FDA also acted on Public Citizen's request to ban valdecoxib (Bextra). Wolfe's group got a warning against Reye's syndrome put on the side of aspirin bottles, and got silicone breast implants restricted.
"I just think about what's at the end," Wolfe said. "Are these people getting something that isn't even reasonably likely to cause any benefit beyond other things that are safe?"
Wolfe also said he has few regrets. He points to individual drugs like celecoxib (Celebrex), rosuvastatin (Crestor), or lorcaserin (Belviq) that Public Citizen pushed against approval of, but are still on the market. "There are individual regrets like that, but mainly not very much."
Aside from the drug world, Wolfe has probed state medical boards, questioning why some are slow to take action on physicians and why others give relative slaps on the wrist. His book "Questionable Doctors" listed every doctor in the U.S. who had been disciplined over 10 years.
What's Next?
While Wolfe is leaving as director and handling the day-to-day operations, he isn't stopping his work with Public Citizen. He considers himself in good health mentally and physically but wants to cut back to a 40- or 45-hour work week -- something he hasn't had in decades.
One of the projects he hopes to take on involves a deeper look at the role the Prescription Drug User Fee Act (PDUFA) has played in the agency's approving drugs with questionable safety issues.
"Too many times now, a drug comes up, there's a safety problem, and they say, 'Well, there's a safety question, but we need to make the PDUFA deadline. We'll approve it and do the study afterward,'" Wolfe told MedPage Today in a video interview. "It clearly has an impact."
He referenced a 1998 survey of FDA medical officers which found that of the nearly one-third who responded, about half had a decision not to approve a drug overturned by a higher authority at the agency. More had been told not to express very negative views about a drug at an advisory committee.
With a lighter work week, Wolfe may also have a chance to spend more time at his grand piano -- a result of his 1990 MacArthur Foundation "genius grant" of $320,000. The rest went to helping pay off debts incurred for his daughters' education.
David Pittman
David Pittman is MedPage Today’s Washington Correspondent, following the intersection of policy and healthcare. He covers Congress, FDA, and other health agencies in Washington, as well as major healthcare events. David holds bachelors’ degrees in journalism and chemistry from the University of Georgia and previously worked at the Amarillo Globe-News in Texas, Chemical & Engineering News and most recently FDAnews.
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