Dr. Sidney Wolfe's Towering Life of Public Service

America has lost a towering public health leader and an unparalleled consumer champion, Public Citizen has lost one of our founders and I and many others have lost a great friend. My dear friend Sid Wolfe passed away early Monday. He was 86 years old.

Dr. Sidney Wolfe founded the Health Research Group in 1971 with Ralph Nader, part of the enterprise that launched as Public Citizen that same year. Sid invented a new approach of “research-based advocacy” to get dangerous drugs and devices off the market, win new protections for worker health and safety, address doctor misconduct, challenge the Food and Drug Administration (FDA) to do its job, and hold pharmaceutical companies accountable.

Sid was brilliant (he won a MacArthur “genius” grant) and fearless in his advocacy. But what was most singular about him professionally was his passion for advancing health justice. There was a distinctive fierceness and fury to his work. Everyone who knew or even encountered Sid – allies and adversaries alike — experienced his intensity.

Sid innovated a whole new way to advocate for drug and medical device safety and public health through his approach of research-based advocacy.

Here’s why he brought that to his work for more than 50 years: Ralph Nader once coined the term “pitiless abstraction” to describe the mental gymnastics of corporate executives and lawyers who know that their decisions – for example, to allow dangerous cars on the market – would cost the lives of substantial numbers of people but who took refuge in the fact that they had no idea who those people were. They were just abstractions.

By contrast, for Sid, the victims of drug company or other corporate wrongdoing or FDA failures weren’t abstractions. Like those executives, he didn’t know the victims’ names. But he did know they were real, breathing human beings, as deserving of care and protection as our family members and those close to us.

So, when the FDA compromised its mission and permitted a dangerous drug on the market, or when a drug company concealed risks, or employers exposed workers to toxics, or when the private health insurance system deprived people of access to care, Sid was outraged. The anonymous people injured or killed by those actions or inactions were just as precious as anyone he knew.

Sid’s sense of injustice about drugs, devices, and a health system that imposed avoidable and needless suffering reflected the underlying science. Sid carried out cutting-edge research of the highest caliber. Under his leadership and the standards he established, the positions Health Research Group stakes out and advocates are rooted in science and evidence. When we recommend against approval of a drug, for example, it’s because the available data shows that its risks are too great. Sure, sometimes there are judgment calls. But 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.

“Outrage,” in fact, was Sid’s catchphrase, his cri de coeur. Every issue of Health Research Group’s Health Letter contains an “Outrage of the Month,” penned by Sid until he handed over leadership of the group about a decade ago. For Sid, outrage was a moral imperative; the only humane response to inhumane policies and practices.

If you look back over Sid’s TV appearances or review his writings, as I have been doing over the last many weeks, you see every time the intensity of his belief and commitment to advancing health.

Sid first partnered with Ralph Nader to call attention to a deadly problem with intravenous fluids. In early 1971, a doctor phoned Sid to complain about the government’s failure to ban contaminated intravenous fluids. Hundreds of patients who had received fluids from Abbott Laboratories had developed severe bacterial infections, and dozens had died.

Instead of ordering a product recall, the government merely warned doctors to watch for infections and stop using the fluids if they spotted any. Sid called his then-acquaintance Ralph, who suggested they write to the U.S. Food and Drug Administration (FDA) demanding a ban and release the letter to the press.

Within a few days of the letter hitting the news, Abbott recalled the contaminated fluids. “I was very surprised that we’d won,” Sid said. “It was very satisfying to see that if you did your homework and had the facts on your side, you could succeed.”

As the New York Times later reported: “Dr. Wolfe started getting calls on other issues. He was hooked. He proposed that he and Mr. Nader begin a health research group, the first specialty group within Public Citizen.”

During those early days at Public Citizen, Sid told Ralph that the Health Research Group job would be the last one he ever had. He was true to his word.

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; 2) “government agencies must have outside pressure to use their authority to save lives and injuries.” Generating that outside pressure became his mission.

Sid headed the Health Research Group from 1971 until 2013, when at the age of 76 he handed the reins over to Dr. Michael Carome. Sid didn’t retire. Instead, he remained at Public Citizen and continued his work, although, as he proudly said, he downgraded his hours to 45 or so a week. Mike Carome was an extraordinary director of Health Research Group until retiring earlier this year. Sid kept working. In July, Dr. Robert Steinbrook became the third director of the Health Research Group. Full of vigor until diagnosed with a brain tumor, Sid had planned on working for many years more with Robert and the team at Health Research Group.

Sid innovated a whole new way to advocate for drug and medical device safety and public health through his approach of research-based advocacy. This involved doing academic-level, independent, rigorous analysis of safety and efficacy information. But the goal wasn’t to publish in academic journals (although Sid often did); it was to deploy that analysis for advocacy campaigns to get dangerous products off the market or advance health and safety policies. That meant bringing the evidence to policy makers and pressuring them to respond to the evidence and public health, rather than corporate entreaties. It meant translating the information to easy-to-understand language for the public, so they could demand appropriate change.

And it meant sticking with issues as long as it took. In some cases, the FDA acted on safety recommendations Public Citizen made decades earlier. Sid regarded those FDA actions less as victories or as “I told you so moments,” than as failures. The agency should have acted decades earlier and many people were needlessly hurt in the interim.

Here’s what I mean: The FDA banned surgical powdered latex gloves – which pose serious risks both to patients and health workers — in 2016. We had first petitioned the agency for this action in 1998. “The fact that it took the FDA 18 years to propose banning powdered surgical gloves from the market highlights how recklessly negligent the agency is,” Sid said. “There is absolutely no new scientific information today that we didn’t have in 1998 about the dangers posed by cornstarch powder and by latex when used in surgical and patient examination gloves.”

Research-based advocacy also meant finding new ways to gather data, such as anonymously surveying FDA drug reviewers about degrading standards at their agency, or surveying county jail staff about inmates with serious mental illness, or collecting and publishing information on every doctor in the United States who had been disciplined at a time when that information was not otherwise available.

Everyone who knew or even encountered Sid – allies and adversaries alike — experienced his intensity.

Research-based advocacy meant getting information to consumers, and in this, too, Sid was endlessly creative. With his colleagues at Health Research Group, he published multiple editions of Worst Pills, Best Pills, a monumental book that provided people with information about the side effects of medications and warned of drug interactions. With the first edition in 1988, the book sold 2.5 million copies – the proceeds from those sales helped pay for Public Citizen’s headquarters building. Worst Pills, Best Pills has been supplemented by a website, WorstPills.org, which is updated regularly, and Worst Pills, Best Pills News, a monthly newsletter with a peak circulation of more than 150,000. Sid appeared regularly on the Donahue Show – Phil Donahue became a close friend of Sid’s and of Public Citizen – explaining in authoritative and easy-to-understand terms the risks of various medicines and the best available alternatives.

Research-based advocacy also meant using litigation, based on scientific evidence, to force recalcitrant agencies to act. The superb lawyers at our Litigation Group worked with Sid on countless legal actions to force government agencies to respond to our petitions and to disclose vital health information.

Sid’s body of work and his achievements – accomplished in partnership with amazing colleagues in Health Research Group, other Public Citizen staff and allies outside the organization – are jaw-dropping. Under Sid’s guidance, Public Citizen:

• Helped to force 28 dangerous medications off the market, limiting the use of 10 more and adding strong warnings to dozens of others.
• Pushed the Occupational Safety and Health Administration to set more than a dozen worker-protective health standards.
• Testified before hundreds of FDA advisory committees urging against approval of dangerous drugs and devices, and for limited use or strong warning labels of others, with substantial influence over countless decisions and helping prevent many dangerous products from ever making it to market.
• Won a ban of Red Dye No. 2, obtained warning labels about Reye’s syndrome on the side of aspirin bottle, and helped impose restrictions on silicone breast implants.
• Sold 2.5 million copies of Worst Pills, Best Pills.
• Documented weakening standards at the FDA following passage of the first Prescription Drug User Fee Act, which made drug companies a major revenue source for FDA.
• Won earlier public access to safety and efficacy information for products being considered for approval by the FDA, enabling more effective advocacy by consumer advocates.
• Advocated for decades against drug company marketing of dangerous opioids and demanded accountability for the drug companies and the corporate CEOs who fueled the deadly opioid addiction epidemic.

That mind-blowing list is very abbreviated. Sid and colleagues also did vital and path-breaking research and advocacy on doctor discipline, mental health, tobacco, pharmaceutical marketing, drug company payments to doctors, medical devices, health insurance and the imperative of Medicare for All, unnecessary Cesarean sections, unregulated supplements, medical resident work hours, and more.

Sid helped build Public Citizen into the vital and durable institution it is today. He made a name for the organization by making a difference. He inspired legions of medical students and made Public Citizen a name admired in the public health community – and feared by Big Pharma. He reached millions of consumers with his health information and literally helped enable us to buy the building where I sit writing this remembrance.

For half a century, Sid taught so much to all of us at Public Citizen, myself very much included: How to be strategically creative and innovative. How to translate expertise into policy talk and, even more importantly, public messaging. How to use the media to disseminate information and demand change. How to do research and maintain standards of excellence. The need to insist on accountability. How to operate with integrity and fearlessness. The power of persistence and never giving up. How to stay motivated for the long haul. Why passion makes a difference. Never to accept injustice. How to make a difference.

Public Citizen will miss the one-of-a-kind Dr. Sidney Wolfe and I will miss him terribly as my friend.

Sid and I grew very close in our more than a decade working together, rooted in our collaborations and also our bond as native Clevelanders. When I came to Public Citizen, Sid helped me immensely, in ways large and small, get settled in. Over the years, I came to admire him and his work all the more, to enjoy his sly and sometimes silly sense of humor, and appreciate his humanity, decency and friendship.

Public Citizen will miss the one-of-a-kind Dr. Sidney Wolfe and I will miss him terribly as my friend.

As we remember him, we know this: Sid saved the lives of tens and tens of thousands of people, almost none of whom will know the debt they owe to Sid. There’s just no way to know about the drug that might have killed you but didn’t because it was pulled from the market or never approved – due to Sid’s work. Very few of the millions of people who benefited from safety warnings that Sid and his colleagues forced onto drugs will know why they were able to avoid serious health problems. The millions and millions of workers who avoided exposure to workplace toxins and hazards because of rules that Sid and colleagues forced into place will never know how Sid protected them from dangers and disease.

None of that was of any concern to Sid. He knew that Health Research Group’s work had made (and continues to make) a difference, he knew the impact on real people, and he was proud of the work.

At age 86, he had intended to continue that work. We will honor the awesome achievements of the great Dr. Sidney Wolfe by doing exactly that.

By continuing to campaign against unsafe drugs and devices, to hold the FDA and Big Pharma accountable, to fight for Medicare for All, and more. By refusing to fall prey to the logic of “pitiless abstractions” and remembering always that the policies about which we advocate make a profound difference – often, a life-and-death difference – to real human beings. And by trying to bring to our work, in everything we do, Sid’s fire and passion, brilliance and integrity, and determination and love.