# Aducanamab, FDA Approval, Patient "feelings" **URL:** \ **Category:** In My Humble Opinion\ **Created:** [June 10, 2021, 11:56am UTC](https://boards.straightdope.com/t/aducanamab-fda-approval-patient-feelings/943964 "2021-06-10T11:56:23Z")\ **Posts on this page:** 20\ **Page:** 3
**Author:** ![Qadgop\_the\_Mercotan](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/qadgop_the_mercotan/32/83_2.png) [@Qadgop\_the\_Mercotan](https://boards.straightdope.com/u/Qadgop_the_Mercotan)\ **Post date:** [June 11, 2021, 7:17pm UTC](https://boards.straightdope.com/t/aducanamab-fda-approval-patient-feelings/943964/41 "2021-06-11T19:17:22Z")
Medical practitioners have in the past relied on the FDA to ensure that approved meds have uses/situations where the benefits exceed the risks. That’s still the default assumption for typical day to day practice for most of us. But now we can’t trust the FDA to ensure drugs have clear potential benefits for the patient. A reliable partner in ensuring drug efficacy and safety has deserted us. I can no longer tell my patient “the drug is risky, but it can be beneficial, IF you choose to assume the risk”. To me that’s wrong. While it’s ultimately up to the doctor to weigh risk vs. benefit, to now task us with figuring out whether every approved drug out there actually has a potential benefit is a huge burden and a step backward. We’re used to finding out drugs we thought were helpful are not, and changing our practices as a result. But to now wonder whether any new drug is beneficial at all makes me despair for practitioner and patient, as the overall equation is now tipped even more towards the shareholder/special interest. ---
**Author:** ![JRDelirious](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/jrdelirious/32/9531_2.png) [@JRDelirious](https://boards.straightdope.com/u/JRDelirious)\ **Post date:** [June 11, 2021, 11:15pm UTC](https://boards.straightdope.com/t/aducanamab-fda-approval-patient-feelings/943964/42 "2021-06-11T23:15:03Z")
> [@mhendo](#): > > while also being subject to regulatory capture by the very industry that it’s supposed to be regulating. (reminds me of FAA/Boeing, y’know…) Basically at the approval end of the system the FDA is under an enormous pressure both from the public and self-inflicted, to “Dammit, approve _something!!!_ We need hope!” Well, the FDA is not supposed to be selling hope. They are supposed to be making sure what is sold is something that can be confidently deemed safe and effective. ---
**Author:** ![Hari\_Seldon](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/hari_seldon/32/5173_2.png) [@Hari\_Seldon](https://boards.straightdope.com/u/Hari_Seldon)\ **Post date:** [June 11, 2021, 11:27pm UTC](https://boards.straightdope.com/t/aducanamab-fda-approval-patient-feelings/943964/43 "2021-06-11T23:27:35Z")
Although this is behind a paywall, I think you get 10 free reads a month: > **[Three F.D.A. Advisers Resign Over Agency’s Approval of Alzheimer’s Drug...](https://www.nytimes.com/2021/06/10/health/aduhelm-fda-resign-alzheimers.html)** > > The drug, Aduhelm, a monthly infusion priced at $56,000 per year, was approved this week despite weak evidence that it helps patients. The main point is that three of the scientific advisors to the FDA have resigned over the issue. But there is much more to the article, for example this paragraph: > The committee had found that the evidence did not convincingly show that Aduhelm could slow cognitive decline in people in the early stages of the disease — and that the drug could cause potentially serious side effects of brain swelling and brain bleeding. None of the 11 members of the committee considered the drug ready for approval: Ten voted against and one was uncertain. But there is much much more in the article, which underlines how poor the decision was. ---
**Author:** ![BigT](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/bigt/32/12044_2.png) [@BigT](https://boards.straightdope.com/u/BigT)\ **Post date:** [June 12, 2021, 1:44am UTC](https://boards.straightdope.com/t/aducanamab-fda-approval-patient-feelings/943964/44 "2021-06-12T01:44:32Z")
> [@mhendo](#): > > And @Qadgop_the_Mercotan, your invocation of the Hippocratic Oath in this case is not especially convincing as an argument about drug approval. It is doctors, the people who actually treat patients, who take the Hippocratic Oath. And, at least as I understand it, doctors are supposed to follow the “do no harm” principle under all circumstances, whether or not the FDA has given its imprimatur to a particular drug. If the FDA approves a drug but you, as a physician believe that it has “no clear benefit while having clear risks,” then it’s your responsibility not to prescribe this drug for your patient. It seems to me that your argument here is basically blaming the FDA for the choices made by medical practitioners. And it seems to me that, if doctors treat the FDA as the arbiter and gatekeeper, not only of what drugs they can’t prescribe, but what drugs that should prescribe, then maybe that’s another problem with the regulatory structure and its relationship with the practice of medicine in the United States. Why should it be up to the doctors to be able to check if every single drug they prescribe is safe and effective? Why shouldn’t there be an organization like the FDA who can tell doctors what is safe and effective? The entire problem right now is that the FDA is approving something that has not been shown to be both safe and effective. I can’t see how letting that happen more often would make things better. Doctors rely on the actual experts in pharmacology to tell them what is and is not good. They don’t do their own drug research. Heck, sometimes they accidentally give a drug that would have an interaction with a current drug, which the pharmacist only finds. Not to mention all the doctors out there who do fall for quackery. Remember the hydroxychloroquine stuff, and how many doctors thought it worked? Imagine than multiple times 100. Without regulatory oversight by the FDA, I would very much expect more people to wind up harmed. Not because doctors aren’t trying to avoid harming their patients, but because they are fallible humans. Having a science-based regulatory system is a good thing. The problem is that it seems that science isn’t the motivating factor with this particular drug. ---
**Author:** ![Treppenwitz](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/treppenwitz/32/3445_2.png) [@Treppenwitz](https://boards.straightdope.com/u/Treppenwitz)\ **Post date:** [June 12, 2021, 8:40pm UTC](https://boards.straightdope.com/t/aducanamab-fda-approval-patient-feelings/943964/45 "2021-06-12T20:40:31Z")
> [@BigT](#): > > Why should it be up to the doctors to be able to check if every single drug they prescribe is safe and effective? Why shouldn’t there be an organization like the FDA who can tell doctors what is safe and effective? And it’s not as if the US is alone in taking this approach. Every developed country has (or has access to) a medicines agency tasked with regulating/approving drugs. > [@Qadgop\_the\_Mercotan](#): > > A reliable partner in ensuring drug efficacy and safety has deserted us. I’m retired and not as up to speed as I would like to be. May I ask, Qadgop, is this a comment provoked by the current situation with this specific drug, or do you see this as a larger problem affecting multiple recent decisions? j ---
**Author:** ![LSLGuy](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/lslguy/32/5813_2.png) [@LSLGuy](https://boards.straightdope.com/u/LSLGuy)\ **Post date:** [June 13, 2021, 1:36pm UTC](https://boards.straightdope.com/t/aducanamab-fda-approval-patient-feelings/943964/46 "2021-06-13T13:36:31Z")
My favorite pharmaceutical chemist’s take on this stuff. With cites to many earlier articles on this and other anti-AD drugs. [https://blogs.sciencemag.org/pipeline/archives/2021/06/08/the-aducanumab-approval](https://blogs.sciencemag.org/pipeline/archives/2021/06/08/the-aducanumab-approval) In fact this guy worked for over a decade on anti-AD drugs ending a few years ago. He has a very well-informed and nuanced view of the biology, the bio-science, and the chemical science. And, sadly, of the shareholder- and politics-driven nonsense the FDA has increasingly been succumbing to. Of which this latest decision is a gigantic wheelbarrow-load of shit on top of what had been a slowly accumulating shit sundae accompanied by many almost-additions that were successfully diverted at the last minute by real science overriding real greed. But not this time. ---
**Author:** ![Chronos](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/chronos/32/134_2.png) [@Chronos](https://boards.straightdope.com/u/Chronos)\ **Post date:** [June 14, 2021, 4:48pm UTC](https://boards.straightdope.com/t/aducanamab-fda-approval-patient-feelings/943964/47 "2021-06-14T16:48:50Z")
Sure, patients should be able to consent to experimental drugs… but it needs to be informed consent. And that’s really, really tricky, because most patients don’t have sufficient scientific expertise to be sufficiently informed. ---
**Author:** ![nearwildheaven](https://avatars.discourse-cdn.com/v4/letter/n/90db22/32.png) [@nearwildheaven](https://boards.straightdope.com/u/nearwildheaven)\ **Post date:** [June 14, 2021, 9:58pm UTC](https://boards.straightdope.com/t/aducanamab-fda-approval-patient-feelings/943964/48 "2021-06-14T21:58:44Z")
(Pharmacist here) I suspect the drug will die a slow death, because doctors won’t prescribe it. I could be wrong, yanno. ---
**Author:** ![OldOlds](https://avatars.discourse-cdn.com/v4/letter/o/a3d4f5/32.png) [@OldOlds](https://boards.straightdope.com/u/OldOlds)\ **Post date:** [June 15, 2021, 12:38am UTC](https://boards.straightdope.com/t/aducanamab-fda-approval-patient-feelings/943964/49 "2021-06-15T00:38:06Z")
It gets more interesting, too. Because as I alluded to upthread, throughout the studies on the drug they were using amyloid PET imaging agents (Neuraceq, Vizamyl, and Amyvid) to identify subjects with amyloid deposits and track deposits over time. Those scans cost about $5,000 all-in and as I understand it, the PI does not dictate a positive amyloid scan is required (I really do need to read the PI). So that will be another fly in the ointment for prescribing and coverage. And again, all this to address amyloid deposits, not changes in cognition. ---
**Author:** ![BigT](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/bigt/32/12044_2.png) [@BigT](https://boards.straightdope.com/u/BigT)\ **Post date:** [June 15, 2021, 1:04am UTC](https://boards.straightdope.com/t/aducanamab-fda-approval-patient-feelings/943964/50 "2021-06-15T01:04:13Z")
> [@nearwildheaven](#): > > (Pharmacist here) I suspect the drug will die a slow death, because doctors won’t prescribe it. > > I could be wrong, yanno. What happened with the hydroxychloroquine stuff? ---
**Author:** ![needscoffee](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/needscoffee/32/1076_2.png) [@needscoffee](https://boards.straightdope.com/u/needscoffee)\ **Post date:** [June 15, 2021, 1:10am UTC](https://boards.straightdope.com/t/aducanamab-fda-approval-patient-feelings/943964/51 "2021-06-15T01:10:52Z")
> [@BigT](#): > > What happened with the hydroxychloroquine stuff? - It’s a standard malaria, lupus, and arthritis drug. It’s an immunosuppressive and anti-parasitic drug. ---
**Author:** ![BigT](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/bigt/32/12044_2.png) [@BigT](https://boards.straightdope.com/u/BigT)\ **Post date:** [June 15, 2021, 1:34am UTC](https://boards.straightdope.com/t/aducanamab-fda-approval-patient-feelings/943964/52 "2021-06-15T01:34:06Z")
[quote=“needscoffee, post:51, topic:943964, full:true”] > [@BigT](#): > > It’s a standard malaria, lupus, and arthritis drug. It’s an immunosuppressive and anti-parasitic drug. I know that. I was meaning when it seemed that doctors were prescribing it for COVID-19, despite no scientific support. I was wondering how bad that increase actually was, and how you think that would compare to doctors prescribing this drug despite no data it actually works. I’m wary that people who are desperate will insist the doctors let them try it, which I believe also happened with HCQ. ---
**Author:** ![LSLGuy](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/lslguy/32/5813_2.png) [@LSLGuy](https://boards.straightdope.com/u/LSLGuy)\ **Post date:** [June 15, 2021, 12:27pm UTC](https://boards.straightdope.com/t/aducanamab-fda-approval-patient-feelings/943964/53 "2021-06-15T12:27:06Z")
As long as insurance companies and especially Medicare refuse to pay for it it will quickly die. As soon as they do start paying, this will be an unstoppable blockbuster drug for Biogen on a par with Viagra. Any doc who won’t prescribe it will quickly be supplemented by enterprising docs opening “memory care clinics” with patients lined up out the door to pay $10K cash each for their 5 minute “cognitive exam” and ensuing prescription. Just like pain meds or testosterone injections for men losing their libido and muscle tone in late middle age. Maybe after 10 or 15 years of abject futility the FDA or Medicare or the insurance companies will say “Enough!”. Or not. The public never will because there’s an fresh supply of new Alzheimers patients and rightly terrified families every single day. ---
**Author:** ![Hari\_Seldon](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/hari_seldon/32/5173_2.png) [@Hari\_Seldon](https://boards.straightdope.com/u/Hari_Seldon)\ **Post date:** [June 15, 2021, 4:33pm UTC](https://boards.straightdope.com/t/aducanamab-fda-approval-patient-feelings/943964/54 "2021-06-15T16:33:00Z")
Sigh. I am afraid you are right. And there will be enormous pressure for the insurers to approve it. The Times’ article suggested that Medicare will end up paying the most. ---
**Author:** ![MandaJo](https://avatars.discourse-cdn.com/v4/letter/m/ac91a4/32.png) [@MandaJo](https://boards.straightdope.com/u/MandaJo)\ **Post date:** [June 15, 2021, 7:06pm UTC](https://boards.straightdope.com/t/aducanamab-fda-approval-patient-feelings/943964/55 "2021-06-15T19:06:11Z")
> [@Qadgop\_the\_Mercotan](#): > > We’re used to finding out drugs we thought were helpful are not, and changing our practices as a result. But to now wonder whether any new drug is beneficial at all makes me despair for practitioner and patient, as the overall equation is now tipped even more towards the shareholder/special interest. Exactly. And from the patient side of things, this leads to horrific choices. It’s easy to imagine a patient spending money on this drug, believing it to be useful, and as a result, now unable to afford the care they need when it doesn’t work. Might as well have the FDA approve snake oil and homeopathy. ---
**Author:** ![LSLGuy](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/lslguy/32/5813_2.png) [@LSLGuy](https://boards.straightdope.com/u/LSLGuy)\ **Post date:** [June 15, 2021, 8:36pm UTC](https://boards.straightdope.com/t/aducanamab-fda-approval-patient-feelings/943964/56 "2021-06-15T20:36:29Z")
> [@MandaJo](#): > > Might as well have the FDA approve snake oil and homeopathy. Shhh! You’re giving Orrin Hatch a stiffie. Ewww!!! ---
**Author:** ![nearwildheaven](https://avatars.discourse-cdn.com/v4/letter/n/90db22/32.png) [@nearwildheaven](https://boards.straightdope.com/u/nearwildheaven)\ **Post date:** [June 16, 2021, 12:05am UTC](https://boards.straightdope.com/t/aducanamab-fda-approval-patient-feelings/943964/57 "2021-06-16T00:05:07Z")
It was thought to act on an inflammatory modulator that might make COVID symptoms worse, but studies revealed that it didn’t work for that. And that’s why people stopped using it. Plus, many boards of pharmacy instituted protocols for people who wanted to fill prescriptions despite having no evidence of an autoimmune disorder. In short, they had to document the diagnosis, and had the right to refuse to dispense it. People who NEED hydroxychloroquine for their rheumatoid arthritis were having a lot of trouble getting it for a while. ---
**Author:** ![Qadgop\_the\_Mercotan](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/qadgop_the_mercotan/32/83_2.png) [@Qadgop\_the\_Mercotan](https://boards.straightdope.com/u/Qadgop_the_Mercotan)\ **Post date:** [June 16, 2021, 3:53pm UTC](https://boards.straightdope.com/t/aducanamab-fda-approval-patient-feelings/943964/58 "2021-06-16T15:53:22Z")
[Excellent NYT opinion piece on the matter](https://www.nytimes.com/2021/06/15/opinion/alzheimers-drug-aducanumab-fda.html?referringSource=articleShare) for those who haven’t used up free articles. Brief excerpts from it are below "the F.D.A. approved aducanumab, a treatment for Alzheimer’s disease that has not been convincingly shown to work and can cause brain swelling and hemorrhage. The evidence that its manufacturer, Biogen, submitted to the F.D.A. showed no convincing effect on patients’ cognitive decline. Its two main trials were stopped early in 2019 because the company concluded its drug did not work. But the company later reanalyzed its data and concluded that some patients in one arm of one of the trials seemed to show some benefit from the drug, even though the other trials did not show any improvement . . . The aducanumab decision is the worst example yet of the F.D.A.’s movement away from its high standards. As physicians, we know well that Alzheimer’s disease is a terrible condition. But approving a drug that has such poor evidence that it works and causes such worrisome side effects is not the solution." By Aaron S. Kesselheim and Jerry Avorn Dr. Kesselheim and Dr. Avorn are professors of medicine at Harvard Medical School. Dr. Kesselheim recently resigned from an F.D.A. advisory committee over the agency’s approval of aducanumab. ---
**Author:** ![OldOlds](https://avatars.discourse-cdn.com/v4/letter/o/a3d4f5/32.png) [@OldOlds](https://boards.straightdope.com/u/OldOlds)\ **Post date:** [June 16, 2021, 5:16pm UTC](https://boards.straightdope.com/t/aducanamab-fda-approval-patient-feelings/943964/59 "2021-06-16T17:16:17Z")
The only thing I’ll say, and remember that I don’t think approving this was a great idea, is that these articles always make it sound line the trials/study arms were the same, with 1/3 showing improvement. As I understand it, the one that did show some improvement was at a higher dose and an earlier population. It’s an important point, IMO, even if it doesn’t change the final calculus much. ---
**Author:** ![Chronos](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/chronos/32/134_2.png) [@Chronos](https://boards.straightdope.com/u/Chronos)\ **Post date:** [June 16, 2021, 5:41pm UTC](https://boards.straightdope.com/t/aducanamab-fda-approval-patient-feelings/943964/60 "2021-06-16T17:41:34Z")
I think it’s a bit misleading to speak of “the FDA” approving this drug. The FDA is a whole organization, which includes (for instance) the advisory board which had a strong consensus against approving this drug. This decision wasn’t made by a nebulous organization as a whole; it was made by an individual, or some set of individuals. Who are those individuals, and how do they come to be in their positions? What qualifications do they need? And are there rules they’re required to follow in their decisions? [Previous page](https://boards.straightdope.com/t/aducanamab-fda-approval-patient-feelings/943964.md?page=2) [Next page](https://boards.straightdope.com/t/aducanamab-fda-approval-patient-feelings/943964.md?page=4)