Sidney Wolfe, fierce critic of drug companies and FDA, dead at 86

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By Dan Sears

Sidney M. Wolfe, an American physician turned activist who relentlessly lobbied against drug companies and the US Food and Drug Administration, died on Monday in his Washington home. He was 86.

Wolfe’s wife of nearly 50 years, Suzanna Goldberg, said that he died from a brain tumor, according to The Washington Post.

Wolfe, a Cleveland, Ohio, native who obtained his bachelor’s degree in chemical engineering from Cornell University, co-founded the Public Citizen’s Health Research Group, which “promotes research-based, system-wide changes in health-care policy and drug safety,” according to the group’s website.

He also served as the director and senior adviser of the non-profit, where he crusaded against FDA rulings on more than two dozen dangerous or ineffective drugs until they were yanked off the market.

In an op-ed published in HuffPost in 2011, Wolfe ridiculed the FDA for being “cautious on food safety — reckless on prescription drug safety.”

Sidney M. Wolfe died of a brain tumor in his Washington home on Monday. He was 86. C-SPAN

The banned medicines include the diabetes drug phenformin, which was linked to hundreds of deaths and sold under the trade names DBI and Meltrol in the US for 20 years.

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Wolfe was also responsible for the banning of the anti-inflammatory Vioxx, formally known as rofecoxib, which he warned caused serious heart damage years before it was taken off the market — as well as the anti-diarrheal alosetron, better known as Lotronex, The Washington Post reported.

His group also successfully petitioned federal regulators to include a warning on aspirin bottles about Reye’s syndrome, a rare but potentially fatal condition that causes swelling in the liver and brain.

In addition, Wolfe was a fierce foe of silicone gel-filled breast implants for breast augmentation and reconstruction surgeries, claiming in the 1980s that they cause cancer.

Wolfe relentlessly lobbied against the US Food and Drug Administration and was able to get the agency to yank more than two dozen prescription drugs off the market. REUTERS

However, the FDA moved forward in approving the implants in November 2006, which Wolfe bashed in a blog post on Public Citizen’s website as “the most defective medical device ever approved by the FDA.”

“The approval makes a mockery of the legal standard that requires ‘reasonable assurance of safety,’” he added.

Today, silicon-filled breast implants are still “approved for breast augmentation in women age 22 or older and for breast reconstruction in women of any age,” according to the FDA’s website. “They are also used in revision surgeries, which correct or improve the result of an original surgery.”

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Despite the setback, “Sid has the capacity to put things on the FDA agenda,” FDA official Robert Young told The Wall Street Journal in 1985. “When [Health Research Group] files a petition, it’s looked at very carefully.”

The government regulatory agency was even known to leak information to Wolfe under the cloak of anonymity, per The Washington Post.

Wolfe bashed the FDA for approving silicone gel-filled breast implants in 2006, calling them “the most defective medical device ever approved by the FDA.” Getty Images/Westend61

But Wolfe also mined published medical journals, scientific papers, and other research for smoking guns, then would circumvent bureaucrats and go directly to FDA leaders to enact change — then would hound reporters for coverage of his findings, The Washington Post reported.

“He spends his life systematically looking for problems, and he finds a remarkable number,” Michael Jacobson told The New York Times of Wolfe in 2005 when he worked as the executive director of the Center for Science in the Public Interest.

He is “almost unique in the world of drugs,” Jacobson added.

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Michael Gladwell, a Washington Post business and science reporter in the ’80s who was on the receiving end of many of Wolfe’s pestering phone calls, called him “the nudge of Washington.”

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