Sidney Wolfe: Pharma's Unlikely Best Friend

Sidney Wolfe has been a thorn in the side of pharma and the FDA for almost 40 years, petitioning the agency repeatedly to pull unsafe drugs off the market or to strengthen their warnings, demanding access to confidential information, and publishing books on "Pills that Don't Work" and "Worst Pills, Best Pills." Last year the Health Research Group (HRG) issued a report documenting "Rapidly Increasing Criminal and Civil Monetary Penalties Against the Pharmaceutical Industry." Wolfe acknowledges that hundreds of drugs are useful, and that "the whole drug industry is not terrible." But as a physician and long-time patient advocate working with Ralph Nader, Wolfe is a widely respected and highly vocal critic of industry practices and products, and a visible influence on regulatory policies.

Sidney Wolfe

Wolfe first encountered drug safety problems as a medical student in the 1960s doing research on the antibiotic chloramphenicol and bone marrow toxicity. After a residency in internal medicine, Wolfe continued to study drug effects at the National Institutes of Health. He left the NIH in 1971 to found HRG after encountering a case about contaminated IV fluids that FDA was afraid to recall due to the risk of causing a dangerous shortage. But after the Centers for Disease Control ultimately documented some 100 deaths and thousands of blood contamination cases linked to the product, and Wolfe documented that a recall would not cause an IV shortage, the product was forced off the market. And Wolfe became a full-time watchdog of pharma, FDA, and medical practices.

Over the years, HRG has petitioned FDA about 35 times to ban medications it considered dangerous and without unique benefit. Wolfe considers his attacks on unsafe medicines very measured, noting that "of some 1,000 drugs approved during the last 40 years, we've gone after 35 of them, and the majority are now off the market."

Wolfe is critical of FDA, frequently speaking out at advisory committee meetings, and voicing protests even as an official member of the Drug Safety and Risk Management Advisory Committee for the last three years. He considers recent hints that FDA Commissioner Margaret Hamburg seeks to relax financial conflict-of-interest standards for advisory committee members "a lunatic idea," advising the agency to "just look harder" for unconflicted experts.

The most lasting policy change instigated by Wolfe may be increased transparency at FDA advisory committee meetings. An HRG lawsuit led the agency to post background information on the Internet at least two days prior to these sessions. These documents, says Wolfe, "allow anybody, including other companies, to participate more meaningfully in the meeting, and it helps the press know which meetings to cover." And, he adds, the policy provides a statement "that medical, scientific issues are too important to be considered in secret."

Looking forward, Wolfe is concerned about the extensive amount of mergers in the pharmaceutical industry, which lead to the demise of small, innovative companies that he considers the main source of new ideas and innovative research. Even worse is the rise in pharma industry criminal activity, which he fears will continue as long as penalties are a fraction of company revenues. His advice to industry: Stop the criminal violations, stop the mergers, spend less effort on me-too drugs, and invest more in innovation. – Jill Wechsler