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FDA ‘abandoned its responsibility’ in approving Biogen Alzheimer’s drug: Doctor

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Dr. Reshma Ramachandran, Physician-Fellow at the Yale National Clinician Scholars Program, joins Yahoo Finance to breakdown the concerns over the FDA approval of Biogen Alzheimer’s drug.

Video Transcript

ALEXIS CHRISTOFOROUS: A pair of large hospitals are declining to administer Biogen's new Alzheimer's treatment. The Cleveland Clinic and Mount Sinai Health System in New York City say they will not administer the drug called Aduhelm to patients, and that's amid a debate about the drug's effectiveness and whether the FDA lowered its standards in approving the medicine.

Joining us now to talk about it is Dr. Reshma Ramachandran, Physician-Fellow at the Yale National Clinician Scholars Program. We also have our health reporter Anjalee Khemlani joining us.

Doctor, thanks so much for being with us. What is your response to this news that we got today that these two large hospitals are refusing to give this Alzheimer's treatment to their patients?

RESHMA RAMACHANDRAN: Honestly, this was really very welcome news I think to the clinician community as well as the scientific community given our deep concerns around this approval. I think both health systems stepped in where the FDA had really left its responsibility or abandoned its responsibility in not protecting patients in approving this drug without a proven clinical benefit and it potentially being unsafe as well. So we're very glad to kind of hear that both Cleveland Clinic and Mount Sinai have taken steps to protect their patient communities.

ANJALEE KHEMLANI: Doctor, Anjalee here. Looking at this controversy that's unfolding, it's been more than a month since the approval, and not just these health systems but we've also seen five Blue Cross Blue Shield insurers reject it, calling it, quote, "an experimental or investigational drug still." And we heard from United Healthcare CEO today saying that there is no rush to make a decision. So how significant are these moves in addition to the health systems?

RESHMA RAMACHANDRAN: These are pretty incredible moves, and I think it acknowledges kind of the resounding and almost unanimous voice that came from not only FDA's own expert advisory committee of independent clinicians and researchers saying that this drug had not shown any sort of clinical benefit and was potentially unsafe but also its own statisticians in voting against or saying that it should not be approved.

And so these payers and also health systems stepped in where really the FDA had stepped away from in terms of lowering its standards in approving this drug. This is a really, really significant move and something that we see as very positive in protecting our patients and making sure that there is some sort of safeguard for them in having access to drugs that are truly effective and safe.

ANJALEE KHEMLANI: I know that in an op-ed recently in CNN you and a colleague called for exactly this type of action, but really the major portion of this is on Medicare which is the largest patient population affected by this and could potentially see the largest charge for the $56,000 a year drug. So if Medicare does, in fact, decide to cover this, does that kind of seal the fate, not for-- not just for Biogen but also for competitors nearby?

RESHMA RAMACHANDRAN: Yeah, definitely. I think that's something that we're all kind of waiting to see what's going to happen. We know that, you know, a majority of patients that have Alzheimer's disease are covered under Medicare. And so if Medicare does make the decision to cover this drug, they would be bearing the brunt of this cost, and it's estimated to be $110 or some change billion dollars per year. And even the estimate of $56,000 per patient per year for the drug are actually expected to be higher around, $61,000, if we actually think about weight-based dosing for the drug.

So the immense costs on Medicare and our health-care system is just tremendous. And so, you know, we're hoping that with Medicare's announcement recently around having a conversation with the public regarding a national coverage determination that they will be taking in mind what the science actually shows in terms of this drug not being proven to be clinically effective or clinically beneficial or safe.

So we'll see really, you know, what's going to happen with Medicare if they do decide to take on this drug as a part of their formulary and covering it because not only is the drug going to cost a lot for our patients but there's going to be incredible other costs in terms of going to an infusion center and getting multiple MRIs in order to track any sort of side effects that we saw during the clinical trials from this drug.

On top of that, there's other costs as well in terms of the trade-offs, that our patients won't be able to access other proven, you know, treatments that are nonpharmacological that could actually help them in terms of their progression of Alzheimer's disease.

ANJALEE KHEMLANI: Recently you tweeted about a journal publication from FDA officials defending the approval as well as we saw recently acting Commissioner Janet Woodcock speak to Stat News about the approval, defending it once again but saying that maybe the pathway to approval was the problem, right? And the FDA has continued to say that it really was doing it more out of the hope that the drug brings. What have you seen in the patients that you see, and what are the concerns that you have?

RESHMA RAMACHANDRAN: Yeah, I think ultimately what happened-- you know, when the FDA did approve this drug-- and they did this with this special pathway called an accelerated approval where they said yes, you know, the trials did not show any sort of clinical benefit, but there is some suggestion with a biomarker that there could be despite, you know, over two dozen trials showing no association between this biomarker and slowing down the progression of Alzheimer's disease.

Our patients in seeing this approval are telling me, hey, the FDA put a rubber stamp on it. They just see this as an approval. They're not seeing kind of the differentiation between a standard approval and an accelerated approval and just know that the FDA as a gold-standard agency really around the world in making sure that drugs that reach the market and reach them are truly safe and effective have kind of given that green light for them to be able to access this drug.

So just even days after the drug was approved, I was getting questions in my clinic from patients asking me, you know, really because there are not a lot of, you know, medical treatment options, if at all, for Alzheimer's, when they could access this drug because they saw the signal from the FDA in approving this as being a green light to go ahead.

And unfortunately, you know, the pieces that we're seeing from both FDA officials, [? JAMA ?] Internal Medicine, and from acting Commissioner Woodcock are really just misleading, leaving out key facts in kind of their decision-making process-- the fact that there wasn't unanimous support within the agency to really go ahead with this approval, the fact that they're asking for nine years for Biogen to actually prove clinical effectiveness, which is way outside the norm and way longer than any other drug. There's just a number of things here that are troubling.

And for me as a clinician, I look to the agency as being a protector of our patients. And now they've put us in an unfortunate spot of having to have these hard discussions with our patients, really having to say that the FDA green light here might have been not a good idea.

ALEXIS CHRISTOFOROUS: All right, we're going to leave it there. Dr. Reshma Ramachandran, thanks so much for your time today. We appreciate it-- and also to our health reporter Anjalee Khemlani for joining us for that conversation.

Just want to point out shares of Biogen right now down more than 7 and 1/2% on that news.