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Sidney Wolfe, MD – His Legacy Will Live On As America’s Hero

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In my 21 plus years of exposing and reporting on the criminal activities of the FDA, pharma and politicians, I knew I would never “win the war.”  What I never expected was to have an association with and mentioned in the “Legacy of a Medical Crusader: Sidney Wolfe, MD in “Medscape Medical News.”  It was my privilege to be involved in some of the “battles” with Dr. Wolfe.  The last time we talked by phone, Dr. Wolfe said to me “stay healthy — we need you.”  I will miss you Dr. Wolfe but will continue fighting the battles.  Rest in Peace, my hero.

Legacy of a Medical Crusader: Sidney Wolfe, MD

A pediatrician warns parents not to give aspirin to their sick baby and points to the warning on the label. Silicone breast implants are heavily restricted. Medical residents now get a small break in their long hours.
The above scenarios are spokes in a wheel of public service. The hub of that wheel was Sidney M. Wolfe, MD, who died of brain cancer on January 1, 2024, at age 86. Along with his friend Ralph Nader, Wolfe cofounded Public Citizen’s Health Research Group (HRG), a job that had him touching the lives of millions of Americans whether they realized it or not.
When HRG began in 1971, there were “a slew of these public interest lawyers,” said Peter Lurie, MD, MPH, president of the Center for Science in the Public Interest and a longtime friend and colleague of Wolfe. “What there wasn’t was a public interest doctor. That was Sid. He created this job title. He created the mold.”
Wolfe’s main sparring partner was the US Food and Drug Administration (FDA), which he felt was a frequently imperfect defender of the public welfare.
He described himself as, “depending on the project, an ally or an adversary of the FDA and the regulated industries.” One former FDA administrator, Frank Young, MD, who led the agency between 1984 and 1989, called him “the high priest of demagoguery.” He was widely recognized — and often feared by his detractors — for being thorough.
“One of the qualities of people who get stuff done by swimming against the tide is that sense of stubbornness,” said Vikas Saini, MD, president of the Lown Institute, a think tank in Needham, Massachusetts, dedicated to equitable healthcare. “That can be a pain in the ass when you’re dealing with somebody, but that is almost necessary.”
His widow, the psychotherapist and artist Suzanne Goldberg, said he was determined to hold the powerful accountable. “He just felt he was doing his job,” she told Medscape Medical News in a recent interview. “If somebody was lying, he’d say, ‘You are lying.'”
Wolfe worked the Beltway as well as anyone, but at bottom, he was a physician. “He didn’t have a clinical practice, but if you had a medical problem, everyone would go to Sid first,” said Robert Weissman, president of Public Citizen. “He understood that there were real people who were affected by action or inaction.”
Wolfe pioneered the concept of research-based advocacy. “He would make people listen,” said Michael Cohen, RPh, president emeritus of the Institute for Safe Medication Practices. “He came over as very authoritative when he was talking. He was a no-nonsense type of guy. He didn’t smile a lot, either, and he was kind of scary with some of the information he came up with. He would go public. He would have his facts in place, and he’d keep pounding.”Wolfe was a gadfly who established HRG’s credibility by publishing its research and other articles in peer-reviewed publications like the New England Journal of Medicine. “It showed that the quality of the work being done was on a par of that being done at academic centers,” Lurie said. In 1980, he published Worst Pills, Best Pills, a book that Lurie said sold 2.5 million copies before HRG put it online with a searchable database.
Wolfe and HRG knew from the start how to use the media to alert the public of its activities. Its first major case involved intravenous fluids from Abbott Laboratories that were contaminated with bacteria. He and Nader wrote a letter to the FDA demanding that they be withdrawn. The letter was sent to the media at the same time, and within days, the company pulled the fluids from the market.
Vikas Saini, MD, president of the Lown Institute, a think tank in Needham, Massachusetts

He became the model for how clinical people who have an understanding of what happens could put their experience and expertise to use outside the clinic.

Wolfe came to believe the FDA, founded to safeguard the public, got caught up in the “medical-industrial complex” and sometimes lost its way to the point where “the citizen didn’t have a chance on their own,” Saini said. “The system was failing.” To correct it, “he became the model for how clinical people who have an understanding of what happens could put their experience and expertise to use outside the clinic.”

Wolfe’s list of notable successes — some of which took decades before the government acted — include the eventual ban of dozens of drugs and additives. Among them are the food coloring Red Dye No. 2, powdered latex gloves, and the arthritis pill Vioxx. He campaigned for years to get a warning on aspirin for children after it was associated with Reye syndrome, a rare but fatal complication. Thanks to his advocacy, the government monitors the amount of the carcinogenic mold aflatoxin in peanut products.

Lurie, who attended medical school at Western Reserve (now Case Western) with Wolfe, said Wolfe was less well-known for his efforts on behalf of workers. He successfully sued to force the Occupational Safety and Health Administration (OSHA) to curtail the number of hours of workplace exposure to hexavalent chromium, which was tied to an elevated risk for lung cancer in shipbuilders, welders, and miners. When he felt OSHA was delaying, he sued again. Wolfe also petitioned the agency to cut the number of hours medical residents had to work in a week. His efforts with OSHA failed. But, facing regulation from Congress, the Accreditation Council for Graduate Medical Education in 2003 limited to 80 hours per week with 1 day free of all medical duties, a 10-hour rest period between shifts, and no more than 24 hours straight.
A stickler for transparency, Wolfe was an expert practitioner of the Freedom of Information Act (FOIA). Lurie said Wolfe used the law to compile — against the wishes of the American Medical Association — a public, nationwide list of questionable doctors. He also leveraged FOIA to get information 48 hours before public hearings, a practice that spread beyond government agencies dealing with public health. His goal, Lurie said, was to get “a nose under the tent.”

He made a point of making his findings public. “Things happened in the medical environment that were a result of Sid’s actions that clearly never would have happened,” Lurie said. “Doctors would experience them and never know why. It was this doctor [Wolfe] in Washington.”

“Many — not all — of his concerns were legitimate and resulted in FDA action,” conceded Wayne Pines, an associate FDA commissioner from 1978 to 1982.

Wolfe was as skeptical of sources as he was of the FDA. “If you called him up as a whistleblower, you could expect a barrage of questions,” Lurie said. FDA officials had grudging respect for him when he got his teeth into an issue, but he “had the ability to say no.”

A Legacy of Skepticism

“What he taught doctors was that you’ve got to be critical,” Saini said. “You’ve got to be skeptical when drugs and devices are released into the marketplace.”

Marianne Perez, whose daughter died of an overdose of OxyContin, saw Wolfe’s tender side. When she testified before a US Senate committee in 2006 on the perils of the painkiller, Wolfe was seated beside her. “He reached over and patted the top of my hand,” she recalled. “I was just impressed with his conscience. He knew what these pharmaceutical companies were getting away with. He was a hero to me.”

John Dillon is a journalist in Boston, Massachusetts.


Marianne Perez

Marianne Perez, Salem-News.com Investigative Reporter, is an Activist for Victims of OxyContin and Purdue Pharma throughout the United States and Canada. In July 2007, she testified against Purdue Pharma in Federal Court in Virginia at the sentencing of their three CEO's - Michael Friedman, Howard Udell and Paul Goldenheim - who pleaded guilty to charges of marketing OxyContin as less likely to be addictive or abused to physicians and patients. She also testified against Purdue Pharma at a Judiciary Hearing of the U.S. Senate in July 2007. Marianne works with government agencies and private attorneys in having a voice for her daughter Jill, who died in 2002 after being prescribed OxyContin, as well as the voice for scores of victims of OxyContin. She is currently working on a book that exposes Purdue Pharma for their continued criminal marketing of OxyContin. Marianne is a nurse, graduated in 1991 as president of her class, and also has a Paralegal certification. Marianne served on a Community Service Board for the Courier News, a Gannet newspaper in NJ, writing articles predominantly regarding AIDS patients and their emotional issues. She was awarded a Community Service Award in 1993 by the Hunterdon County, NJ HIV/AIDS Task Force in recognition of and appreciation for the donated time, energy and love in facilitating a Support Group for persons with HIV/AIDS.
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