Headliner: Public Citizen's Health Resource Group's Sidney Wolfe, MD
A January Wall Street Journal piece half-jokingly described his committee appointment as a “nightmare” for industry. Wolfe finds the notion amusing.
“I'm doing my job, raising questions about safety,” he says. “We do research and look carefully at data. Sometimes we think a drug is unduly dangerous and we try to get it off the market or get a black-box warning. I don't think all drugs are dangerous.”
The gig certainly hasn't prompted him to tone down his criticism of the agency—most recently over what he called the “unfortunate and incorrect exclusion” of Dr. Sanjay Kaul from the advisory panel. Kaul, it emerged, was kept off the panel because of concerns, fostered in part by a letter from Lilly, that he had an “intellectual bias” against the drug.
Wolfe has, in recent years, been in the public eye bashing lax enforcement by the agency under the Bush Administration, but the slide, he says, started in the Clinton years. “There was a huge decrease in FDA enforcement action against illegal ads,” Wolfe says. “In 1998, 157 illegal prescription drug ads were stopped. It started decreasing in 1999 and kept decreasing—it was down to 89 by 2000. In the last seven years, the highest it's been is 29. Last year it was 22. The FDA began deregulating DTC advertising in 1997. The amount of DTC has gone way up since, and the total amount of ads is up.”
He adds that former FDA chief counsel Dan Troy's policy requiring DDMAC to go through his office before sending out warning letters slowed enforcement of advertising violations. Troy has since joined GlaxoSmithKline as SVP, general counsel.
Wolfe suggests “better leadership” for the FDA, including a new general counsel and a commissioner “who believes in law enforcement.” Even that, he fears, might not stop Hydra-headed bad ads. “Schering-Plough ran 11 illegal ads for Claritin,” he says. “Each ad was stopped by the FDA, but there's no downside because as soon as one was stopped, they invented a new misleading campaign.”
Wolfe says medical education about drugs is “grossly inadequate.” He teaches med students “principles of prescribing drugs” and about research-based advocacy at schools including Cornell University, Johns Hopkins University and Case Western Reserve University. “I'm encouraging people not to use new drugs unless they're breakthrough drugs,” Wolfe says. “Drugs are more dangerous when they first come on market. You can't study a massive number of people prior to approval.”
Though approaching the age of 72, Wolfe shows no signs of slowing down. He keeps a grueling schedule and talks so fast it's tough to keep up with him. No wonder, then, that he's a sprinter, or that he ran competitively in 200- and 400-meter races until he was in his late 50s.
He still runs several miles each week, and enjoys cooking every night with his wife of 31 years. Music, particularly chamber music, is another passion. Wolfe has played piano since he was six, the age at which his love of chemistry also began.
He studied chemical engineering at Cornell University in the 1950s, but stopped after three years because he got tired of coming home with first-degree burns.
He went on to med school at Case Western Reserve University, where he researched drug toxicity. “Then I went to NIH to escape the Vietnam War and to do research and learn more,” Wolfe says. “I always intended to do research in medicine. I still am doing research in medicine, but from a different perspective.”