From FAIR <[email protected]>
Subject 'The FDA’s Decision Showed a Stunning Disregard for Science'
Date July 22, 2021 3:48 PM
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'The FDA’s Decision Showed a Stunning Disregard for Science' Janine Jackson ([link removed])

Janine Jackson interviewed Public Citizen's Michael Carome about the FDA's Alzheimer drug scandal for the July 16, 2021, episode ([link removed]) of CounterSpin. This is a lightly edited transcript.

[link removed]

Aduhelm (aducanumab)

Aduhelm, Biogen's brand name for aducanumab

Janine Jackson: The House Committee on Oversight and Reform announced an investigation ([link removed]) in late June. And earlier this month, the acting head of the FDA called for a probe ([link removed]) from the inspector general of the Department of Health and Human Services. The subject? The FDA’s accelerated approval of the drug aducanumab, whose maker, a company called Biogen, claims it is an effective treatment for Alzheimer's disease.

Some 6 million Americans are diagnosed with Alzheimer's, and aducanumab was the first treatment approved in nearly two decades. The problems, though, run from the drug’s price tag—an outrageous $56,000 a year—to the process by which it received FDA approval, even after being rejected by the agency's own advisors.

Our next guest has been calling for investigation for months now. Michael Carome is an M.D., as well as director of the Health Research Group ([link removed]) at Public Citizen. He joins us now by phone from Virginia. Welcome to CounterSpin, Michael Carome.

Michael Carome: Thank you for having me.

JJ: I keep seeing the word “controversial,” but really there seem to be very few people who think this story is anything but highly problematic. What are just the key elements of what went on here that merit our concern?

MC: Sure. But you know, there are so many things wrong with the FDA’s reckless decision to approve aducanumab for treatment of Alzheimer's disease, it's sometimes hard to decide where to begin. But two things: First of all, the FDA’s decision really showed a stunning disregard for science, and eviscerated the agency's standards for approving new drugs. And because of this reckless action, the agency's credibility has been irreparably damaged.

There is not evidence that this drug provides any clinically meaningful benefit. And that was clear from a review of data from the major clinical trials that was presented at a meeting of outside experts that the FDA convened, and it's called an advisory committee. And that group of experts essentially unanimously agreed that there was not evidence that this drug provides benefit to patients with Alzheimer's disease.

More troubling, it became apparent last year to us, and I think to the public, that the FDA inappropriately collaborated with the maker of the drug, Biogen, in analyzing data from the clinical trials of the drug. And those trials actually were stopped early, after an initial review of the data showed that it was unlikely that if we continued the trials to completion, we're going to find that the drug works.

And yet, FDA subsequently worked hand in hand with Biogen—in a very inappropriately close collaboration—to re-analyze data from those trials in a way that was biased and slanted in favor of Biogen’s position. And so that inappropriately close collaboration really seemed to be, to us, unprecedented. And it's fundamentally undermined the integrity and independence of the FDA’s review. Nevertheless, the FDA proceeded to approve the drug, despite that unanimous opinion from its outside experts, and the lack of data that this drug works.
Stat: Federal watchdog urged to investigate the FDA’s handling of Biogen Alzheimer’s drug

Stat (12/9/20 ([link removed]) )

JJ: Now, when you talk about “inappropriately close,” I understand—and some of this comes from the health news site Stat ([link removed]) , some of this information—there was at least one meeting that was off the record, between an FDA official and someone from Biogen. So in other words, just the type of thing people worry about when they think about regulatory capture: meeting behind closed doors. The FDA is meant to have a clear eye on this sort of thing, right? But at least one meeting happened that folks thought was beyond the pale, even.

MC: Absolutely. There were public disclosures by Biogen, in press releases and presentations, and in the briefing document from this advisory committee meeting, that clearly signaled to us an inappropriately close collaboration.

But there were new, stunning details disclosed, just a couple of weeks ago, in the Stat piece ([link removed]) you referenced. Early on, back in March 2019, that's when the trials were stopped and Biogen decided, “We're not going to pursue developing this drug.” And then just a few weeks later, the chief scientist for Biogen has an off-the-record meeting with Dr. Billy Dunn, the director of the Office of Neuroscience at the FDA that reviews Alzheimer's disease drugs.

They had an off-the-record meeting in which they came up with a plan to push forward with trying to resurrect the drug, despite the failed clinical trials. That subsequently led to a meeting between Biogen staff and FDA staff in June of 2019, which was followed, according to the Stat piece, by three months of nearly daily communications and meetings between FDA staff and Biogen staff, in which they conducted, jointly, analyses and reviews of the clinical trial data. And that's the data that was used to support approval of the drug.

And those same people at the FDA who were involved in this three-month collaboration? Those are the same people who had to turn around and then review the application with that data, and make a decision about whether the drug should be approved. And they were no longer independent. They were no longer objective reviewers; they were no longer objective regulators. And that completely undermined the review process. And that's why we called, multiple times now, for an independent investigation by the Office of the Inspector General of HHS.

JJ: That's what I wanted to draw you out on. What, more broadly, could be the impact of rushing this drug—without clear proof of benefit, but we do know of side effects ([link removed]) , for example—to market? And what could be the impact, maybe on other Alzheimer's treatments, for instance, or on, as you're saying, on the FDA and its reputation itself? It seems like investigation or no, the repercussions from this are quite serious and lasting.
Michael Carome

Michael Carome: "The FDA has lowered standards for approving drugs like this. And other companies are going to take advantage of that." (image: Public Citizen)

MC: They are. So, first, the FDA has lowered standards for approving drugs like this. And other companies are going to take advantage of that, and be able to rush other drugs to market where the evidence is lacking that they truly provide meaningful clinical benefits.

Secondly, there are millions of patients in this country potentially eligible for this drug. And we have millions of patients and families who now maybe have hope that this is sort of a cure, significant treatment for them. And it's not. So it has raised false hope for millions of patients and their families, who desperately want a treatment that works. But we don't have evidence that this is the answer to that.

And finally, Biogen has priced the drug at $56,000 per year, per course of treatment, and this treatment could go on for years. And that is going to cause significant threat to the financial stability and sustainability of the Medicare program…

JJ: Right.

MC: …which will pay—most of these people who are eligible are Medicare beneficiaries. And because of the significant copays of such an expensive drug, this is going to bankrupt patients and their families who think this is a drug they really want.

JJ: Let me just ask you, finally: I've read that it's quite rare for HHS’s IG to investigate the FDA, much less a particular decision. Are there ways forward from what are clearly systemic or structural problems here? I'm reading about HR3, for example, that would give the HHS Secretary the ability to negotiate prices; that seems like almost the smallest thing that could happen. But are there bigger things that you would like to see change as a result of this problem?
Public Citizen: Letter: Woodcock Must Be Investigated as Part of IG’s Probe Into Aducanumab’s Approval

Public Citizen (7/13/21 ([link removed]) )

MC: Sure. So what's fundamentally needed is a change in the leadership of FDA. Under Janet Woodcock, who is now the acting commissioner of the agency—and she took that position at the beginning of the Biden administration, and previous to that, she was, over a period of three decades, the director of the center of the FDA that reviews and approves new drugs—she has fostered, over her three decades, an ever-cozier relationship between her agency and pharmaceutical companies.

And that has resulted in regulatory capture of the agency by the pharmaceutical industry. She often refers to the agency as being a partner with industry. A partner. That they work collaboratively. And she actually defended the collaborations that occur between her agencies and companies like Biogen.

So she needs to be removed. We called for her resignation in a letter to the secretary of Health and Human Services last month. And we need to put in her place a leader who is more aligned and committed to protecting public health, and not the interests of the pharmaceutical industry.

JJ: All right then, we'll end on that note. We've been speaking with Michael Carome, director of the Health Research Group ([link removed]) at Public Citizen. You can find their work online at ([link removed]) . Thank you so much, Michael Carome, for joining us this week on CounterSpin.

MC: You’re welcome. Thank you for having me.
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