Via America’s Lawyer: Pharmaceutical giant Biogen is in the hot seat as lawmakers investigate concerns of drug safety and possible price gouging related to its Alzheimer’s drug Aduhelm, which may cause fatal brain swelling. Attorney Madeline Pendley joins Mike Papantonio to break down the medication’s questionable approval, despite failure to prove the drug’s efficacy.

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Transcript:

*This transcript was generated by a third-party transcription software company, so please excuse any typos.

Mike Papantonio:             Biogen is in the hot seat as lawmakers investigate concerns over drug safety and possible price gouging related to its Alzheimer’s drug that have already killed users. Attorney Madeline Pendley joins me to talk about it. Maddie, first of all, this is not, this is not the first time with Biogen. They’ve got a really checkered history, but this is just a new story, isn’t it?

Madeline Pendley:        Right. Biogen has a history of developing what’s called niche drugs, you know, used to treat very specific things like Alzheimer’s, like multiple sclerosis, putting it at an incredibly high price point and then not being forthcoming about the adverse event data that’s associated with the drug. They’ve done it with other drugs in the past and they’re doing it here. So Aduhelm is actually to treat Alzheimer’s. But what it does is it clears plaque buildup in the brain, which may or may not have anything to do with the cognitive decline of Alzheimer’s, that’s the first issue here.

Mike Papantonio:             Okay. Well let me ask you that. So, so this got put on a fast track.

Madeline Pendley:        Right.

Mike Papantonio:             And with the fast track, you don’t really have clinical data to prove that it works.

Madeline Pendley:        Right.

Mike Papantonio:             So the first time the FDA says, hell no, you can’t sell this drug.

Madeline Pendley:        Right.

Mike Papantonio:             You may not sell the drug.

Madeline Pendley:        Right.

Mike Papantonio:             They come back again and they said, oh, well how about if we fast track it? It sounds so crazy.

Madeline Pendley:        It, it’s really frustrating because like you mentioned, it, it was approved under the accelerated approval program, which is supposed to be just as thorough as the traditional approval program. But, here it seems like it’s just a plan B to get this otherwise failing drug pushed through. So a couple things to note. One, in 2019 these manufacturers Biogen and Eisai had to stop clinical tests because they could already see they would not be able to prove that this drug slowed cognitive decline of Alzheimer’s.

Mike Papantonio:             There was no proof of efficacy at all.

Madeline Pendley:        Right. So they stopped it because they didn’t want the actual result. They said, that, that we’ve seen enough. This drug doesn’t work. FDA agreed. For some reason in 2021, Aduhelm gets put back on the table in front of the FDA for review with basically the same information they’ve always had and this time it gets approved.

Mike Papantonio:             Well, we know why, because the same boneheads that have been appointed by this administration were the same boneheads in place from the last administration.

Madeline Pendley:        Right.

Mike Papantonio:             And they work for the, mostly for the pharmaceutical industry. The FDA doesn’t work, I don’t know why people have this in their head.

Madeline Pendley:        Right.

Mike Papantonio:             That the FDA protects them. But here, okay. So what, what’s really bothersome is they say, no, we don’t have any clinical showing.

Madeline Pendley:        Right.

Mike Papantonio:             That this actually works.

Madeline Pendley:        Right.

Mike Papantonio:             There’s no clinical showing that it works. But we have a guess and the guess is that if we remove the plaques from the brain, it’s going to cure the problem. Isn’t that what they’re saying here?

Madeline Pendley:        It, it is. And like you said, there’s not enough data to show that that’s the case. So what’s happening is elderly people are being put on the medication in the hope that it will one, clear plaques from the brain. We don’t even even know that it does that. And two, if it does, that they will, their Alzheimer’s symptoms will be reduced. So they’re using these older people as Guinea pigs and what’s happening is they’re suffering from brain bleeding, brain swelling and they’re dying. So, so a couple things that have been going on in getting this drug approved is the FDA actually made it easier to get the drug pushed through. The original question was, does this decrease cognitive decline? No. So they changed the question to just, does it reduce plaques? But I think the, the main question is why did they do that? And they’re actually being investigated by Congress right now, both Biogen and the FDA.

Mike Papantonio:             And again, this isn’t their first time.

Madeline Pendley:        Right.

Mike Papantonio:             This, this company’s been caught up in fraud before.

Madeline Pendley:        Right.

Mike Papantonio:             And, and, and so the, the people who were, some of the folks that were doing the review, my memory is they actually resigned from the committee because they said that this is such a bunch of BS.

Madeline Pendley:        Yes.

Mike Papantonio:             And people are gonna die because of it.

Madeline Pendley:        They said, this is the worst drug approval in US history, Aduhelm. And so interestingly, because the drug was priced so high at $56,000 a year when it first came out, thankfully not many people have taken it. But two things to be watching for is the drug to be covered by Medicare so it opens it up to more patients. And also we’ll be watching for a second attempt at Medicare fraud by Biogen, as they’ve done it in the past, very similar, Pap.

Mike Papantonio:             Okay. So $56,000 a year just for the drug.

Madeline Pendley:        Right.

Mike Papantonio:             You have to monitor with an MRI to say, yeah, I can see the bleeding coming out of your brain.

Madeline Pendley:        Right.

Mike Papantonio:             And then, so that’s an added cost.

Madeline Pendley:        Right.

Mike Papantonio:             So now the company now wants to say, well, let’s let Medicaid and Medicare pay for this.

Madeline Pendley:        Right.

Mike Papantonio:             And taxpayers have to pay for something that has been shown not to work. And oh, by the way, it’ll kill the patient.

Madeline Pendley:        Exactly.

Mike Papantonio:             Is that kind of where we are with this?

Madeline Pendley:        If covered by Medicare next year and the amount of people take it that we think are gonna take it, it will cost Medicare between 29 and $37 billion next year alone, just for Aduhelm.

Mike Papantonio:             For a drug that doesn’t, that doesn’t work.

Madeline Pendley:        Right.

Mike Papantonio:             Now, the, the idea of the plaque, the idea is if we remove the plaque, this is going to, and it’s a guess, I mean, at this point it’s purely a guess, guesswork.

Madeline Pendley:        Right.

Mike Papantonio:             We’re gonna remove the plaque and then that’s gonna cure the disease or slow it down. Most of the time you have to say, we know this.

Madeline Pendley:        Right.

Mike Papantonio:             Because we tested it clinically in little clinical steps over a long period of time.

Madeline Pendley:        Exactly.

Mike Papantonio:             Not here though, right?

Madeline Pendley:        No, what they did is they did the accelerated approval, allowed them to put the drug on the market and now they’re supposed to be conducting clinical tests in the hopes that it will support what the drug is already on the market for.

Mike Papantonio:             But the clinical tests are, are being done by, by elderly who are becoming guinea pigs. I mean.

Madeline Pendley:        Exactly.

Mike Papantonio:             Rather than using the regular clinicals process, we now have all these old folks who have Alzheimer’s disease that we can experiment on.

Madeline Pendley:        Exactly.

Mike Papantonio:             And that’s what Biogen is doing here.

Madeline Pendley:        And that’s the problem.

Mike Papantonio:             Maddie, I hope you’ll go after ’em and have some impact on stopping some of this. Thank you for joining me.

Madeline Pendley:        Thank you.

Mike Papantonio is an American attorney and television and radio talk show host. He is past president of The National Trial Lawyers, the most prestigious trial lawyer association in America; and is one of the few living attorneys inducted into the Trial Lawyer Hall of Fame. He hosts the international television show "America's Lawyer"; and co-hosts Ring of Fire Radio, a nationally syndicated weekly radio program, with Robert F. Kennedy, Jr. and Sam Seder.