Dr. Sidney Wolfe of Public Citizen leaves a proud legacy of unearthing pharmaceutical industry dangers and corruption

The following is a news commentary.

I was a reporter at CBS News 20+ year ago when I was assigned my first stories on medical safety issues and government-pharmaceutical industry corruption for the CBS Evening News and I met Dr. Sidney Wolfe of the watchdog group Public Citizen.

The story, at the time, was controversy over the diabetes drug Rezulin. Dr. Wolfe, along with FDA insiders, helped me with a line of reporting that was credited with getting Rezulin pulled from the market. (I will mention here that David Willman of the Los Angeles Times had done the hard work of breaking news about Rezulin long before I was assigned the story).

In any event, one of my specialities is separating good sources from less accurate or bad sources, and I quickly learned Dr. Wolfe was in the former category. I turned to him for expertise many times over the years as an investigative reporter at CBS, as well as in my current position at “Full Measure with Sharyl Attkisson.” I came to rely on him as an informed, honest expert on the topic of drug safety as well as the inner-workings of a sometimes-corrupt government-pharmaceutical complex.

Dr. Wolfe has passed away. His voice will be sorely missed.

Below you an read the memoriam on Dr. Sid Wolfe from Public Citizen, as well as the transcript of the recent interview Dr. Wolfe did with me for “Full Measure with Sharyl Attkisson” on the FDA’s approval of the controversial Alzheimer’s drugs aducanumab and lecanemab.

Watch the “Full Measure with Sharyl Attkisson” video with Dr. Wolfe here.

Public Citizen Mourns Passing of Dr. Sidney Wolfe, A Towering Public Health Leader

Statement from Robert Weissman, President, Public Citizen

For Immediate Release: Jan. 1, 2024

Contact: Omar Baddar, [email protected]

Washington, D.C. — “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 earlier today. 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’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. He helped 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 bottles, 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 helped make Public Citizen into a leading consumer rights organization.

“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; and never to accept injustice.

“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.

“Public Citizen will miss the one-of-a-kind Dr. Sidney Wolfe, his fire and passion, brilliance and integrity, and determination and love.”

Read Weissman’s full remembrance here.

https://fullmeasure.news/news/shows/rx-repeat

Now an important update to our coverage of a new Alzheimer’s drug that drew so much controversy. Aducanumab was approved without one yes vote from the FDA advisory committee. In fact, several members quit over it. And critics say it offers no proof of real benefit but comes with significant health risks. Now, the FDA has given fast track approval to a similar drug made by the same company under what critics see as similar questionable circumstances.

The new drug is an injection called Lecanemab.

Dr. Sidney Wolfe is with the Health Research Group of the watchdog Public Citizen. He’s criticizing the FDA’s expedited approval, saying there’s no proof of the drug’s real benefit, but plenty of risks.

Dr. Sidney Wolfe: In the study, they showed clearly that, compared to a placebo sugar pill, that the brain swelling was much, much higher. You would get brain swelling just with Alzheimer’s Disease, but it was twice as frequently occurring in the people who got Lecanemab.

To critics like Wolfe, the FDA’s expedited approval of Lecanemab only compounds the fast-tracked approval of a similar drug by the same company, as we’ve reported here on Full Measure:

Aducanumab, sold as Aduhelm, is given as an injection every four weeks. But there’s a long shadow that’s loomed over the medicine ever since the FDA gave it the green light.

Sharyl Attkisson: They approved it even though not one of the advisors they had consulted said it should be approved.

Dr. Caleb Alexander: They did.

Dr. Caleb Alexander was one of the FDA advisors who voted against Aducanumab’s approval. He’s an epidemiologist, internist, and professor at the Johns Hopkins Bloomberg School of Public Health.

Dr. Caleb Alexander: The advisory committee — there was near consensus among the advisory panel that there just wasn’t the evidence to warrant approval.

Much of the controversy centers on the FDA’s overt advocacy of a medicine that had failed miserably during the test phase.

Drugmaker Biogen stopped its two major studies midstream, determining that Aducanumab performed so poorly, it was futile to go on. But within months, Biogen returned to the FDA, claiming to have found some evidence of benefit within the stopped studies. And the FDA enthusiastically endorsed the drug without a single of the completed, large studies normally required.

Dr. Caleb Alexander: But I do think this is really an exceptional setting, not only because of the incredible unmet demand for treatments, but because, in this instance, the FDA’s decision-making appears to have been at such odds with not just the recommendation of the advisory committee members, but also the recommendations of many other parties.

The drugmaker says Aducanumab, sold as Aduhelm, and the newer drug Lecanemab, sold as Leqembi, are effective at removing a sticky type of plaque in the brain that Alzheimer’s produces. Some theorize that plaque makes the disease advance. Critics question whether that’s the case at all, and say the modest impact of the drug shown in early studies isn’t impressive.

One of the Lecanemab study scientists agrees more research is needed, but says, “It’s very exciting because this is the first treatment in our history that shows an unequivocal slowing of decline in Alzheimer’s disease. Would I like the numbers to be higher? Of course, but I don’t think this is a small effect. These results could also indicate a starting point for bigger effects.”

Sharyl: What would be the takeaway for people who aren’t going to dig deep into this issue, but they hear there are new Alzheimer’s drugs that some say could be promising, but they know there’s some criticism?

Dr. Sidney Wolfe: Well, one of the takeaways is that there are a number of, I think, the brighter and more accomplished Alzheimer’s researchers that think that this study on Lecanemab doesn’t show that it really works enough. And the difference between how much less cognitive loss there was between the placebo and the drug is minuscule. One of these people said essentially the difference between the placebo and the drug is so small that doctors wouldn’t recognize it, patients or their families wouldn’t recognize it. It’s too small.

Sharyl (on-camera): Aducanumab’s price was $56,000 per year. The drugmaker slashed that in half when it appeared few if any doctors would prescribe it. Medicare generally won’t pay for it. The new drug, Lecanemab, is going for $26,500 a year wholesale.