Sidney Wolfe, a physician who co-founded the Health Research Group, and—as a pioneer of “research-based advocacy”—took pharmaceutical companies to task over bad drugs, often shaming federal regulators into changing policies for the benefit of patients, died Jan. 1 in Washington. He was 86.
He died of a brain tumor.
Wolfe had zero tolerance for bad drugs, shoddy devices, and all flavors of unethical behavior.
“What was most singular about him, professionally, was his passion for advancing health justice,” Robert Weissman, president of Public Citizen, wrote in an obituary published by Public Citizen. “There was a distinctive fierceness and fury to his work. Everyone who knew or even encountered Sid—allies and adversaries alike—experienced his intensity.”
In 1971, Wolfe, who had just completed a stint as a researcher at NIH, partnered with activist Ralph Nader to urge FDA to ban intravenous fluids produced by Abbott Laboratories. Hundreds of patients who received these fluids had developed severe bacterial infections, and dozens died.
After Wolfe and Nader sent a letter to the press and FDA about the issue, Abbott recalled the contaminated fluids.
“Sid said that he learned from that initial experience with Abbott fluids that 1) government agencies are often in possession of clear, unequivocal evidence and not using their powers to get documented serious hazards off the market,” Weissman wrote. “2) government agencies must have outside pressure to use their authority to save lives and injuries.”
Those who worked with Wolfe note his sense of outrage over betrayal of public trust.
“He was so smart and tireless—relentless really. And never afraid to speak up,” Steven Woloshin, co-director of the Center for Medicine and Media at The Dartmouth Institute, and a general internist, said to The Cancer Letter.
There was a distinctive fierceness and fury to his work. Everyone who knew or even encountered Sid—allies and adversaries alike—experienced his intensity.
Robert Weissman
Woloshin and his late wife and research partner, Lisa Schwartz, created the “drug facts box,” drug-benefit and harm-data summaries, which improve consumer decision-making. As researchers early in their careers 30 years ago, Woloshin and Shwartz met with Wolfe in Washington to discuss their ideas.
“We talked to him about our ideas about the drug box, and other ways to try to make sure that what FDA knew was communicated fairly and reliably to doctors and patients so they could make good decisions,” Woloshin said. “It was just fabulous. He was so kind and so supportive. It really made a huge difference in giving us confidence as young researchers.”
While the public-facing image of Wolfe could be gruff, Woloshin found him inspiring.
“He was fierce, where the public was involved,” he said. “I found him tough, but really kind. He was a big inspiration to me and to lots of other people. I think we’re all going to miss him.”
Wolfe also left Woloshin and Schwartz with a gift.
“He also gave us signed copies of [his book] ‘Worst Pills, Best Pills,’ which I have lugged around for the last 30 years.”
Proceeds from Wolfe’s book “Worst Pills, Best Pills,” first published in 1988, which sold nearly 2.5 million copies, helped pay for Public Citizen’s headquarters in Washington, DC. The influential book explained the side effects of certain medications and warned about drug interactions.
“When we recommend against approval of a drug, for example, it’s because the available data shows that its risks are too great,” Weissman wrote. “Sid saw that in the overwhelming number of cases when the FDA sided with a drug company against our recommendation, it was ignoring the best science, responding instead to improper influence and refusing to uphold its core public health and consumer protection mission.
“With lives and people’s well-being at stake, outrage was exactly the right response.”
Alan Blum, professor and Gerald Leon Wallace, MD, Endowed Chair in Family Medicine at the University of Alabama, and director of the Center for the Study of Tobacco and Society, worked with Wolfe and Nader to oppose a 1993 bill in Texas that would have protected tobacco and pharmaceutical groups from litigation.
“So many organizations that are two standard deviations away from even the most progressive-seeming groups, they were just light years ahead of anybody,” Blum said to The Cancer Letter. “And I think that that means that his bristly personality didn’t necessarily help sell the message, and yet, frankly, Sid was just spot-on just about everything he ever touched.”
Blum recalled Wolfe’s unique way of phone communication.
“Sid is the only guy that I’ve ever met who would call you up and say, ‘Alan, I can’t speak now. I’m too busy,’” he said. “But of course he would say something, get his point across, and then say, ‘I can’t speak now. I’m too busy.’”
It was exciting to be around Wolfe, Blum said.
“I wasn’t always going to agree with everything he said or did, and I think he just had his priorities correct overall, and he knew why medicine was losing credibility,” he said. “He knew why medicine needed to get its act together.”
Wolfe was multi-talented, too, Blum said—”he was also a gourmet.”
He was fierce, where the public was involved. I found him tough, but really kind. He was a big inspiration to me and to lots of other people. I think we’re all going to miss him.
Steven Woloshin
Wolfe was also instrumental in ensuring that physicians were held accountable for providing proper care, Michael Millenson, president of Health Quality Advisors LLC and a former journalist, said in a statement posted on Linkedin.
“In 1975, a quarter century before the Institute of Medicine picked up the torch on medical error and patient harm, he proclaimed, ‘The health care system is the leading cause of preventable deaths in this nation,’” Millenson wrote. “Wolfe made complex scientific articles understandable for health care journalists and the public, a crucial innovation of that era.”
Through Public Citizen, Wolfe filed a federal lawsuit to prevent the American Medical Association from sanctioning doctors who responded to Public Citizen’s request for information on fees, office hours, hospital privileges, and attitude about prescribing certain drugs.
“I suspect Sid was more outraged than amused at how the health policy establishment, for-profit start-ups and enormous health plans have embraced (and forgotten about) his work in opening up some kinds of data, like pricing, while mostly ignoring the need for information for consumers about the care they’re receiving in return,” Millenson wrote.
Wolfe led the Health Research Group from 1971 until 2013, when at the age of 76 he left the role. After leaving this position, Wolfe continued his work at Public Citizen, claiming that he cut back his hours to only 45 a week.
In 1990, Wolfe received a “genius grant,” or MacArthur Fellowship.
His first marriage to Ava Albert ended in divorce. He married Suzanne Goldberg, a clinical psychologist, artist, and a founder of the free speech movement, in 1978. He is survived by Goldberg and his four children from his first marriage, five grandchildren, and his sister, Janet, who is a psychologist.
“As a young reporter, I learned that when someone violated the public trust, Sid was the guy to call,” said Paul Goldberg , editor and publisher of The Cancer Letter.
“Sid had zero tolerance for bad drugs, zero tolerance for sloppy science, zero tolerance for regulators who looked the other way, zero tolerance for politicos who made false promises, zero tolerance for physicians who allowed self-interest drive treatment decisions.
“It helped that even when outraged, Sid could be self-deprecating, hilarious, and masterful at deploying Yiddishisms.”
A list of Wolfe’s achievements appears on Public Citizen’s website.
The Cancer Letter has turned to Wolfe for nearly fifty years when questions of ethics in medicine arise. Each quote of Wolfe’s featured in The Cancer Letter maintains a level of outrage and a sense of justice:
Wolfe condemned the unethical sexual relationships pursued by prominent gastrointestinal oncologist Axel Grothey.
“It should be called sexual abuse if it’s a mentor-mentee relationship,” Wolfe, who has studied sexual misconduct by physicians, said to The Cancer Letter. “The reason it has not been in the news is obvious. Women are usually ashamed, embarrassed, horrified at making any of this public—and not a lot of medical boards have a range of ways in which they can complain to the medical board without going public.”
(The Cancer Letter, May 28, 2021).
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Wolfe warned against the weakening of FDA rules on pharmaceutical companies and medical devices.
“The FDA would be reckless to weaken rules and allow the pharmaceutical and medical device industry to promote products for which they are not proven to be safe and effective,” said Wolfe, who testified at a Nov. 9 and 10, 2016 FDA hearing. “Opening the door to the promotion of potentially dangerous products undermines the entire FDA approval process. The FDA needs to slam this door shut.”
(The Cancer Letter, Nov. 18, 2016).
A study conducted by Carleton University and Public Citizen found that Medicare’s Part D program paid significantly higher prices for drugs than either Medicaid or the Veterans Health Administration.
“Medicare Part D was designed less as a system for social protection for the sick and more as a system of corporate welfare for brand-name pharmaceutical companies,” Wolfe said in a statement. “Lower prices would alleviate the current de facto rationing that occurs because so many Medicare recipients cannot afford these inordinately high prices and suffer the health consequences of cost-related non-adherence to drugs prescribed for them. That’s just wrong.”
(The Cancer Letter, Aug. 7, 2015).
Wolfe criticized President George W. Bush’s decision to appoint then-NCI-director Andrew Von Eschenbach to the position of FDA commissioner.
“Dr. Andrew von Eschenbach will become yet another Bush appointee whose main reason for being selected is that he is a family friend, someone who has been warmly embraced by the regulated industries—especially the pharmaceutical industry—and someone who has been and will continue to be loyal to the White House agenda.”
(The Cancer Letter, March 10, 2006).
The Health Research Group supported FDA’s role in regulating cancer drugs. In a letter to Rep. Paul Rogers, chairman of the House Health Subcommittee, HRG attorney Anita Jackson and Wolfe asked Rogers “to resist the claims of the cancer experimenters that they can regulate themselves in this sensitive area, and to encourage FDA to apply the same ethical standards to experimentation with cancer patients as with all other patients.”
(The Cancer Letter, Feb. 11, 1977).
