Interesting developments.
In June, I ran a post asking: “Did the FDA Just Make a Huge Mistake?” I was puzzled why approval had been granted, over the objections of the agency’s expert advisory panel, for Aduhelm (aducanumab-avwa). The drug’s efficacy was clouded, and possibly severe side effects had occurred, including brain bleeds and falls.
Aduhelm is expensive, estimated at $56,000 a year per patient, and requires infusions. Many commentators worried that with Alzheimer’s disease on the rise in our aging population, this one drug alone might impose a huge burden on Medicare.
Looks like the real-life scenario has played out differently. The manufacturer, Biogen, reported that the drug’s sales from July through September were $300,000, far below the company’s expectations—and those of Wall Street, where analysts were anticipating $12 million in sales over that three-month period. But it appears that only 100 patients were treated with the drug.
According to The New York Times,
“Uptake has been substantially slowed by concerns among insurers, physicians and families that the drug is backed by little evidence of effectiveness while coming with significant risk of potentially serious side effects.”
Biogen’s CEO said the company still has confidence in Aduhelm and expects that once payers decide to cover it, use will increase. But there hasn’t been a groundswell of enthusiasm.
The Times reported:
“Several prominent academic medical centers, including the Cleveland Clinic and Mount Sinai Health System in New York, have decided not to give the drug to patients. Several regional Blue Cross Blue Shield health plans have declined to cover it, and in August, the Department of Veterans Affairs decided not to add the drug to its formulary of available medicines.”
This is the drug whose approval led several members of the expert advisory committee to resign in protest. One of them called the FDA’s action “probably the worst drug approval decision in recent US history.”
The decision has even generated serious second thoughts within the FDA, which has called for an investigation into the approval process. Some have charged the process bypassed the agency’s independent role and resulted from a too-cozy relationship with the drug’s manufacturer.
I’m relieved this costly, unproven drug that so many knowledgeable folks said should never have been approved hasn’t sapped money out of the system and doesn’t seem to have harmed anyone thus far.
Yet I also feel a sense of sadness for those individuals and families whose faith in its therapeutic value to alter the course of this terrible disease have been dashed.
We must hope that the FDA’s examination of how Aduhelm gained the agency’s approval in the first place will yield more independent, scientifically sound decision-making that serves patients and their families far better.
One important change would be to ensure the agency has a permanent Commissioner, rather than its current Acting Commissioner. President Biden is reportedly moving in that direction: he’s been talking with a well-regarded former FDA Commissioner, Rob Califf, about resuming that role.
The President is seeking a nominee who is likely to be confirmed by the Senate—not any easy task in itself these days.
Annie
annieasksyou... 
At that price, and with the risk of side effects and limited evidence of efficacy, it will inevitably be little-used. Medicare doesn’t have unlimited money and needs to allocate it in ways that will do the most good. If it costs $560,000 a year to treat ten patients with a drug that may not even work in every case, spending the same money on education about the role of diet and exercise in preserving brain health could statistically bring more benefit to a hundred or a thousand patients instead of ten.
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All true, Infidel. But the initial hype was so dramatic that it wasn’t clear who could withstand the pressure.
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Annie, it is nice when the concerns surface above the rhetoric. This is why the pharma companies need to stay out of trying to influence the approval process. When people with a stake in the game are allowed to close to the approval process, bad things happen. Keith
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Absolutely, Keith. That’s why I’m glad the FDA is investigating why the drug was originally approved.
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The FDA approval process seems strange. They have an advisory panel and then ignore the advice? Why have a panel of experts if you are going to ignore them? Something doesn’t smell right.
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Definitely, Joseph. As I noted previously, that’s why the FDA’s decision to investigate the process is encouraging.
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Annie that’s good to know it. I suspect many patients/doctors would have done some due diligence, and I can’t see many drug plans willingly covering such an expensive drug without demonstrating significant benefits. It was certainly a bizarre situation.
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It sure was, Joni!
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Hi, Annie. Overall, in your opinion how good is the FDA?
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Hi, Neil. I don’t know enough to express a cogent opinion. Charges of politicization of the FDA go back decades. I don’t know how valid those charges are. If Biden picks Califf, and he’s confirmed, that should help. He seems to have done a good job in his earlier stint as Commissioner.
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Doctors and pharmaceutical reps are often so sure that the drugs they prescribe (or sell) are safe with minimal side effects for the vast majority people. I’ve often wished they had to use these drugs themselves for 3 months before they can push them to others.
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Ah, Carol: that might be a fine idea. The problem is that we are all so idiosyncratic that meds that may be fine for some are awful for others. Clinical trials, of course, include relatively small numbers of participants.
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Yes. My proposal isn’t completely serious. I’ve just spent too much time advocating for my parents and my children w.r.t. various medications. Doctors discount, far too often, what their patients are telling them and go with what their pharmaceutical rep assures them instead.
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Agree with those of your readers who have noted that the price is prohibitive, the possible side effects scary, and it’s a good day when common sense outweighs the rhetoric.
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