Wolfe, 75, and Public Citizen have worked to get 25 drugs off the market, pressured the Occupational Safety and Health Administration to set tougher worker health standards, banned Red Dye No. 2, got warning labels about Reye's syndrome on aspirin bottles, and got silicon breast implants restricted, according to the release.
Wolfe also oversaw Public Citizen's annual ranking of state medical boards based on data from the Federation of State Medical Boards on disciplinary actions taken against physicians.
Wolfe made Modern Healthcare/Modern Physician's 50 Most Influential Physician Executive list four times: In 2005, finishing 8th; in 2006, placing at No. 37; in 2007, at No. 30; and 2008, No. 44.
“I love my work,” Wolfe said in an interview. But he added that one frustration has been Congress “abandoning” its oversight and funding of the Food and Drug Administration, which now must rely on industry sources to pay for much of its operation.
Public Citizen petitioned the FDA to take the diabetes drug Avandia off the market in October 2008. Wolfe is scheduled to speak June 6 at an FDA advisory panel meeting discussing Avandia—which the European Medicines Agency took off the European market.
“I'm disappointed that the FDA has not treated Americans as safely as the EMA has treated Europeans,” Wolfe said, though he predicted that Avandia would eventually be taken off the market.
“We are quite persistent,” he added. “And we don't frivolously ask the FDA to take drugs off the market. We don't go after drugs where there are no other options for treating a disease.”
Dr. Steven Nissen, chairman of the Cleveland Clinic's department of cardiovascular medicine, said he agreed with Wolfe on his assessment of the FDA and added that “without Sid, it would be even worse.”
“We've been very fortunate to have someone like him watching over the safety of drugs and medical devices,” Nissen said. “He's fought these uphill battles and never lost faith.”
Nissen recalled how Wolfe and Public Citizen first petitioned the FDA to take the painkiller Darvon off the market in 1978, and kept the pressure on until it did so more than 30 years later.
Dr. Margaret Hamburg, the FDA commissioner, said, “Sid has been a tireless advocate for patients for many years and we at FDA expect that this important work will continue at Public Citizen. We wish him well as he assumes a new role within the organization.”
Wolfe's book, “Worst Pills, Best Pills,” was published in 1988 and has sold 2.5 million copies. His involvement with Public Citizen began while he was working as a researcher with the National Institutes of Health and contacted Nader about the continued use of contaminated intravenous fluids. Instead of issuing a recall, Wolfe said, the government merely issued a warning that instructed doctors to watch for infections.
After their letter to the FDA calling for a ban on the fluids was publicized, the manufacturer issued its own recall, Wolfe said. That success led to the founding of the Health Research Group. Nader left Public Citizen in 1980, but Wolfe said they are still friends and talk frequently.
Wolfe said that under Carome's leadership, the Health Research Group will continue working on the same issues as before.
Carome has served as deputy director since 2010. He was a staff nephrologist at Walter Reed Army Medical Center from 1992 to 2010. At the same time, Carome, 54, also worked with HHS' Office for Human Research Protections, where he was director of its division of compliance oversight. Both he and Wolfe earned their medical degrees at Case Western Reserve University in Cleveland.
“I love the work,” Carome said in the release. “We make a difference.”
Follow Andis Robeznieks on Twitter: @MHARobeznieks
