Biogen grapples with 'reckoning' over controversial Alzheimer's drug, reporters find

The Cambridge biotech company Biogen has roots in the 1970s — the dawn of biotechnology. Its big successes include developing a series of powerful and lucrative medicines that transformed the treatment of multiple sclerosis.

This year the Food and Drug Administration approved Biogen's new drug to delay the progression of Alzheimer's disease.

Biogen hoped the drug, called Aduhelm, would be transformational for people with the disease — and a lifeline for the company. But the FDA approval was mired in controversy that's now taking a toll on Biogen employees.

"It became a debacle," says STAT biotech reporter Damian Garde. He details what happened in the health and science publication's special report on Biogen, co-reported with Adam Feuerstein.

Biogen is expected to lay off 1,000 of its 9,000 workers around the globe.

WBUR's All Things Considered host Lisa Mullins talks with Garde about Biogen's upheaval and what it might mean for Alzheimer's drug development.

(Editor's Note: Biogen declined to comment on STAT's reporting. The company also declined a WBUR request for comment.)

Highlights from this interview have been lightly edited for clarity.

On Dr. Al Sandrock, a key figure in Biogen's recent history and Aduhelm development, who will leave the company at the end of this year after more than two decades:

"[Sandrock] rose to become head of the company's research, development and medicine operation. So truly — this is a science-based company, and he's the top scientist. Sandrock is widely considered within Biogen and in the industry as kind of the brains behind the best medicines the company has ever made. And he in recent years really devoted himself to developing and winning FDA approval for Aduhelm, which would become the first new treatment for Alzheimer's disease in 20 years, or roughly 20 years.

"[Sandrock] made Biogen kind of an interesting member of the biotech community — that the guy investors wanted to talk to, the guy reporters wanted to talk to you, frankly, was not the CEO ... but rather it was Al Sandrock, who was kind of this oracle of neuroscience. He's well-spoken, obviously, he has a charm to him and he became very much the face of Biogen."

On the immense interest around getting a new, potentially game-changing Alzheimer's drug on the market:

"Alzheimer's affects I think about 6 million people in the United States. You extrapolate that to their family members, it's not an abstract concept to them. And so to feel like you could put your fingerprints on this thing that could really make a difference for these millions of people in the U.S. and eventually in the world, I mean, [it's] an incredibly animating thing. We spoke to a lot of former Biogen scientists and, you know, they have diverging opinions or often quite negative opinions about the decisions the company has made. But none of them regret the work they did for this — I mean, they're well compensated — but this almost kind of holy mission to really change the lives of people with ... just a devastating disease."

"The legacy of Aduhelm may be that it did indeed open the floodgates, but that Biogen itself didn't manage to actually profit from it — and, based on what we've seen so far and will likely see in the coming months, will actually kind of be punished for this work that they've done."

STAT biotech reporter Damian Garde

On what happened during the FDA approval process:

"Things got pretty interesting. It's important to note that from ... October 2019, where Sandrock was speaking [in a WBUR interview], Aduhelm didn't exactly work in the clinical trials that Biogen ran. And the news at that time was that Biogen had taken a harder look at the data and said, 'We think we see a positive signal where we could make a compelling argument that, actually, it did work. If you look at it this way, that way, whatever.' "

On the raised hopes after Biogen pulled back from Aduhelm, then reconsidered its clinical trial data and decided to move forward after all:

"It did [raise hopes] — and it also raised a lot of hackles. I think a lot of people, especially on Wall Street, looked at that and said, 'Are we sure you guys are living in the same reality? The FDA's never gonna go for this. There's a tried-and-true way of deeming whether a clinical trial has succeeded and yours has almost unequivocally failed.'

"But they would all be proven wrong because what we didn't know at the time is that Biogen had already been in conversation with the FDA, and the FDA had already said it was amenable to Biogen's read of the data. And basically, from summer 2019 — for the next roughly two years — Biogen and the FDA were in almost constant communication about how to look at these data, what do they really mean. And then in June 2021 — I mean, I'm fast-forwarding through a lot of interesting stuff — but the world got the, I think, fairly shocking news that in fact, the FDA would approve Aduhelm. That the FDA agreed with Biogen's take, which is that, while the trials we mentioned did not succeed by the standard definition of success, there was enough of a sign there that convinced the FDA to grant an accelerated approval — which is sort of jargon for an approval in which we're assuming the drug actually works the way it's supposed to — and give Biogen the right to begin selling [Aduhelm] and doctors the right to begin prescribing it."

On reaction to Aduhelm's controversial FDA approval in June 2021:

"Scientists and people who follow regulatory science ... were very upset at the FDA for what it perceived to be an erosion of the standard. The FDA is often considered the gold standard. And this appeared to them like potentially opening the floodgates for treatments that may not work at all, and will undoubtedly be expensive, to be available to patients. There can be great consequences to that. Then you have Biogen's decision to set a price for the drug that they say would average out to about $56,000 a year per patient. This was, you can imagine, enraging to people who are already sensitive about drug prices. But likewise, investors on Wall Street were expecting Biogen to charge somewhere around $10,000 to $15,000 for the drug."

(Editor's Note: Many insurance companies say they won't reimburse for Aduhelm and some doctors are refusing to prescribe it.)

On another key Biogen figure, CEO Michel Vounatsos, and how the Aduhelm debacle changed his relationship with Sandrock:

"Just as Aduhelm proved to be a breaking point of public perception of Biogen, likewise, it ended up straining relationships inside the company. So as all of that negative press was heaped on them, all of the criticism over the price and then, maybe most importantly, the really, really disappointing financial returns of the company, there began to be sort of a game of musical chairs as to who was going to take the blame for this, is what our reporting has led us to understanding.

"Cut to November, there is the shocking announcement that Al Sandrock will be retiring effective the end of this year. What we learned is that he was pushed out, that he was kind of made to bear the brunt of this, because the reaction was so polarizing that there was a perception that someone needed to be the face of what is a PR failure on this company's behalf. The way people characterized it to us was, 'It was going to be Vounatsos or Sandrock.' And Sandrock was on the losing end."

On how Biogen's experience has affected other biotech companies working on Alzheimer's drugs:

"It's interesting because Eli Lilly — the massive pharmaceutical company — has a treatment that works somewhat similarly to Aduhelm, it's a different drug in late-stage development. And their stock price has actually gone up much, much more than Biogen's has in light of the approval of Aduhelm, because there's a perception among some people that they might be able to step in.

"Aduhelm did the blocking and tackling. Now the FDA has agreed to approve these kinds of medicines, and Eli Lilly might step in with a conceivably better, but at least a drug with less baggage than this one. And so the industry might march on and make a great deal of money, based in large part on Biogen's pioneering research and Biogen's efforts to win over hearts and minds at the FDA. And so the legacy of Aduhelm may be that it did indeed open the floodgates, but that Biogen itself didn't manage to actually profit from it — and, based on what we've seen so far and will likely see in the coming months, will actually kind of be punished for this work that they've done."