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Sidney Wolfe, fierce adversary of drug companies and FDA, dies at 86


Sidney M. Wolfe, a doctor turned consumer activist who battled drug companies, lobbyists and regulators during a nearly five-decade crusade against ineffective, risky and overpriced medications that made him a hero to patient advocacy groups and an implacable foe to anyone who opposed him, died Jan. 1 at his home in Washington. He was 86.

The cause was a brain tumor, said his wife, Suzanne Goldberg.

Dr. Wolfe did not practice medicine for long and instead spent most of his career with the Health Research Group, part of the Washington-based Public Citizen organization founded by consumer activist Ralph Nader.

Driven to expose drugs and medical devices that he was convinced could kill or harm patients, he searched for clues in thousands of research papers and medical journals, stacking them in fire-hazard piles around his office. Scientists at regulatory agencies, especially the Food and Drug Administration, leaked information to him, typically under cloak of anonymity. (One source called himself Dr. Doonesbury, after the comic strip that skewered politicians.)

Dr. Wolfe is “almost unique in the world of drugs,” Michael Jacobson, then the executive director of the Center for Science in the Public Interest, told the New York Times in 2005. “He spends his life systematically looking for problems, and he finds a remarkable number.”

His petitions and lawsuits helped get more than two dozen dangerous or ineffective drugs removed from the market.

The banned medicines include the diabetes drug Phenformin, which was linked to hundreds of deaths; the anti-inflammatory Vioxx, which caused serious heart damage; and the anti-diarrheal Lotronex. He also successfully petitioned federal regulators to include a warning on aspirin bottles about Reye’s syndrome, a potentially fatal condition linked to children’s use of the pain-relief drug for the flu or chickenpox.

“Sid has the capacity to put things on the FDA agenda,” Robert Young, an FDA official and rare Wolfe admirer within the agency, told the Wall Street Journal in 1985. “When [Health Research Group] files a petition, it’s looked at very carefully.”

In a statement, Nader praised Dr. Wolfe for “stressing prevention of trauma and sickness, accountability for gouging and unsafe practices by the drug companies and effective regulation by the FDA and [the Occupational Safety and Health Administration]. … Millions benefited from this work.”

Among his critics, Dr. Wolfe acquired a reputation as a regulatory Chicken Little in his early campaigns against Alka-Seltzer, cough syrup, contact lenses, food additives, toothpaste and entire professions (dentistry, psychiatry).

An official at the Pharmaceutical Manufacturers’ Association, the drug industry’s main lobbyist, told The Washington Post in 1978 that “his problem is an excess of zealotry. He tends to exploit every negative aspect of drug therapy to scare the consumer.” An FDA official once called him “adversarial, unfair and self-serving.”

These critiques were declarations of valor to Dr. Wolfe. He thought drugmakers, regulators and physician groups were too cozy with one another, leading to the approval of unsafe and ineffective treatments. He was formidable, especially when testifying to drug-approval panels or in Congress with his booming, trembling voice.

“When someone contradicts what Sid thinks is scientific truth, he goes ballistic,” Nader told the Times. “He doesn’t suffer fools gladly.”

FDA Commissioner Donald Kennedy told Time magazine in 1978, “Sometimes when I’ve been annoyed at Sid, I realized that I was really annoyed at myself for not seeing a problem to be as serious as I should have at first look. In the past, the tendency was not to question the fruits of technology.”

When Dr. Wolfe found a smoking gun in scientific papers, he often circumvented bureaucrats and went directly to agency heads to effect change, and he pestered reporters for coverage. Malcolm Gladwell, who as a Post business and science reporter in the 1980s endured many of his phone calls, anointed him “the nudge of Washington.”

“My memories of Sid is you would never know when you would get off the phone,” Gladwell said in 2022 during an episode of his podcast, “Revisionist History,” that focused on Dr. Wolfe’s early and widely ignored concerns about opioid painkillers.

“He’ll not just talk to you,” Michael Specter, another ex-Post science reporter of that era, recalled during the podcast. “Then the information starts flowing. In those days, the fax started to churn because that’s how we got stuff. I would go out to lunch, and if there was a pile of fax paper on my desk, it would be like ‘Sid struck.’”

Sidney Manuel Wolfe…



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