[HN Gopher] Third member of U.S. FDA advisory panel resigns over...
___________________________________________________________________
Third member of U.S. FDA advisory panel resigns over Alzheimer's
drug approval
Author : mrfusion
Score : 225 points
Date : 2021-06-11 11:58 UTC (11 hours ago)
(HTM) web link (www.reuters.com)
(TXT) w3m dump (www.reuters.com)
| cobrabyte wrote:
| > The 11-member committee voted nearly unanimously in November
| that Biogen's drug should not be approved, citing inconclusive
| evidence that the drug was effective.
|
| A near-unanimous vote against the drug, and the FDA moved forward
| with approval anyway?
|
| Like many others, I've experienced first-hand what Alzheimer's
| does to a person and the hopelessness in fighting it. Approving a
| drug that doesn't appear to do what it claims to do will provide
| false hope, and that's the worst thing you can give someone with
| Alzheimer's.
| paulpauper wrote:
| Worse than that. A drain on public resources for something that
| does not work. This drug is very expensive.
| dantheman wrote:
| We shouldn't tie approval to effectiveness, it should only be
| about harm. Effectiveness claims can be verified through other
| approaches.
| Tostino wrote:
| Why should my insurance premiums go up to pay for people
| getting ineffective treatments? These drugs aren't exactly
| charity, at $56k/year that's a good chunk of change for
| something not proven to work.
| wallacoloo wrote:
| Excellent point: why should your insurance have to cover
| every FDA-approved drug, and regardless of cost?
|
| My guess is your insurance doesn't cover every approved
| treatment. But if it does, is that a problem with the FDA
| (which regulates drugs), or with your insurance policy
| (which decides how to pay for them)? I'd suggest your
| complaints about insurance costs are more closely tied to
| the latter.
| HWR_14 wrote:
| > why should your insurance have to cover every FDA-
| approved drug, and regardless of cost?
|
| If only there was some group of experts that decided that
| some drugs were safe and effective vs. not. We could even
| make it a nonprofit group to avoid conflicts. Heck, we
| could get the federal government to fund and and even
| pass a law that gave their recommendations teeth.
| mcguire wrote:
| You have scabies? Asthma? Cancer?
|
| Well, now, have I got something for you! Just right here, in
| this bottle, I have a medication that is not only federally
| guaranteed not to hurt you, but also will fix your problem
| right up! And it's just $10,000 per bottle! Step right up!
| thesausageking wrote:
| The FDA didn't give it a full approval. It was an accelerated
| approval that basically said "This drug has been shown to help
| biomarkers that are associated with Alzheimer's, but it's
| unknown if it helps with Alzheimer's itself. While more
| evidence is collected, Biogen can distribute it."
|
| Which is reasonable to me. It takes years to test drugs like
| this and if a patient and her doctor believe this is the best
| treatment, the FDA shouldn't prevent them from getting access
| to it.
| HWR_14 wrote:
| > if a patient and her doctor believe this is the best
| treatment, the FDA shouldn't prevent them from getting access
| to it.
|
| I question whether a patient _or_ her doctor is more
| qualified to make that call than a panel of experts. But we
| already allow drug trials - those are just measured. And if
| there are no other treatments, the FDA has had a
| compassionate use protocol for a long time to let people
| attempt anything over nothing.
| treeman79 wrote:
| And if the doctor is getting kickbacks?
|
| I was prescribed a very expensive new drug that I couldn't
| tolerate. Eliquis, Xarelto.
|
| Medical office went to absurd lengths to keep me on it
| rather then switching to a cheaper alternative. Too
| multiple ER visits to get them to switch.
| Kept calling me a liar for saying it had side effects.
|
| Realized later that they probably made money off it. Would
| love to know if true.
| mikeodds wrote:
| One place to search
| https://projects.propublica.org/docdollars/.
|
| Disclaimer: not familiar with US medical industry or
| incentives schemes for docs
| HWR_14 wrote:
| > Realized later that they probably made money off it.
| Would love to know if true.
|
| They probably didn't even make a lot of money. Although
| they paid $18.3 million to doctors in 2018, only nine
| doctors got over $100k.
|
| Are you in the US? By law, there has been a public
| database of all pharama dollars to doctors for a bit over
| a decade. It covers lunches and consulting fees and such.
| For 2018, ProPublica has a searchable database. Here's
| Xarelto's results.
|
| Edit: I just realized I forgot to paste in the link. I
| hope I edit this before you see it:
| https://projects.propublica.org/docdollars/products/16510
| bananapub wrote:
| doesn't this translate into a many year long permission to
| sell a drug with no evidence that it works?
| BurningFrog wrote:
| There is _inconclusive_ evidence that it works.
|
| That's in theory a good scenario for allowing some level of
| use.
|
| If this practical level of use is good, I don't know.
| paulpauper wrote:
| Given the costs, I don't think this is good enough.
| Medicare cannot afford to subsidize things are
| inconclusive especially given how 6 million Americans
| have Alzheiemrs.
| BurningFrog wrote:
| I think a sane system would be where a drug is legal to
| use, _and_ Medicare can decide it 's not worth paying
| for.
|
| Those should be be independent decisions.
| mcguire wrote:
| The $50k/year above times 6 million is $300B. For
| $300,000,000,000, I suspect no one cares whether it
| works.
| CincinnatiMan wrote:
| What do you mean by this? That sounds like a lot of money
| and I would think taxpayers would care if such a large
| amount were to be essentially thrown away.
| Arrath wrote:
| It certainly sounds like it, yes.
| CogitoCogito wrote:
| > Which is reasonable to me. It takes years to test drugs
| like this and if a patient and her doctor believe this is the
| best treatment, the FDA shouldn't prevent them from getting
| access to it.
|
| I can understand this argument as long as Biogen isn't making
| any money off of these drugs. In fact, they should really be
| losing money if anything since they are gaining value from
| the data.
| f6v wrote:
| Big Pharma bad, but making drugs is incredibly costly.
| Especially in Alzheimers, where so many candidates failed.
| It's incredible someone is even trying after so many
| failures.
| CogitoCogito wrote:
| That's true, but I don't really see why the drug
| companies shouldn't pay those costs.
| alexslobodnik wrote:
| The second order effects _may_ be that they wouldn 't
| want to even try to develop a drug.
|
| What world do you want to live in? (Rhetorical)
| mcguire wrote:
| The third order effects may be continued erosion of
| respect for the federal government's regulatory process.
| Tread carefully. (And make lots of money while you can.)
| jhayward wrote:
| And blowing out the drug budget for medicare for a very
| expensive but futile treatment.
| thesausageking wrote:
| The big question is will insurance companies and CMS pay
| for it, and that's not up to the FDA. That debate is
| occurring right now and will likely create new precedents.
| mcguire wrote:
| And by "can distribute it", do they mean sell? 'Cause selling
| something you have no reason to believe is fit for purpose
| can cause problems.
|
| That is, unless a large government agency has you back.
| Bjartr wrote:
| They did test this drug for years, the conclusion was that
| the drug does absolutely nothing for Alzheimer's. A big part
| of what FDA approval means is that it's been confirmed that
| the drug does what the makers of the drug claim it does. If
| that weren't the case, many drugs that have not been approved
| over past decades would have been.
| shmatt wrote:
| This right here. People move cross country or even
| internationally for a chance to be in the 1 hospital who is
| running a trial for some non-proven drug for their disease
|
| Being able to get the drug wherever you are in the U.S is a
| good step, and every patient/doctor can decide if they want
| to try it
| Alex3917 wrote:
| > Being able to get the drug wherever you are in the U.S is
| a good step, and every patient/doctor can decide if they
| want to try it
|
| FDA approval is for letting companies market a drug to the
| public, it has nothing to do with whether you as a patient
| are allowed to take it.
| thesausageking wrote:
| That's incorrect. Biogen can't legally sell you the drug
| unless it's been approved by the FDA or they use one of
| the specific exemptions like doing a drug trial.
| dlp211 wrote:
| Why should Biogen be able to sell their drug? It hasn't
| been shown to work, it is for all intents and purposes at
| this point in time, snake oil.
|
| Should Biogen be able to continue research and studies,
| sure, but they shouldn't be able to sell it until they
| have proof that it actually improves someone's life
| instead of having some effects on a possible bio-marker.
| cogman10 wrote:
| That's incorrect.
|
| Doctors can (and do) prescribe drugs for off label
| usages. There's nothing "illegal" about it.
|
| The reason they don't do that more commonly is
| malpractice lawsuits and insurance companies don't like
| to cover off label prescriptions.
|
| An excellent example of this: Medical Marijuana. Not FDA
| approved for almost anything and the only reason it's
| "illegal" is because of federal DEA classification.
|
| So long as it's not listed as having any therapeutic
| effects, you can fairly freely buy any non-controlled
| substance.
|
| For example:
| https://www.amazon.com/Arsenic-99-9999-Crystalline-
| Metalloid...
| renewiltord wrote:
| Hang on, so I could totally sell off-patent insulin in
| America if I wanted to with a "not for therapeutic use"
| label? How do all those people keeping dying "because
| they couldn't afford insulin" then? Feels like someone
| would capture the cheap end.
| cogman10 wrote:
| Yes, you could.
|
| The issue is getting that off label insulin distributed.
| Insulin must be refrigerated which really makes
| distribution difficult. A pharmacy isn't going to store
| it in their refrigerators and stores aren't going to plop
| it down next to the milk.
|
| Then, of course, you run into the risk that you get sued
| anyways by current insulin manufacturers for patent
| violations (good luck with that!).
|
| Oh, and you also run the risk that someone takes your
| insulin and sues you for a bad reaction. With FDA
| approval, there's a much lower legal risk.
|
| And finally, after you setup your insulin product, you
| simply run the risk that nobody uses it because it's off
| label and their doctors didn't prescribe it.
|
| Oh, and for certain, your insurance will not cover it at
| all. So, bunch of risks with minimal rewards. Still
| completely legal. Can be done doesn't mean will be done.
| amarant wrote:
| Insulin is a FDA approved substance with therapeutic
| properties. How you label it is irrelevant.
|
| You can't sell heroin with a "nutritional
| supplement"label either.
|
| If a substance has no classification(neither controlled
| nor therapeutic) however, like water for example; you're
| free to sell it, to treat dehydration, or put a
| homeopathy label on it and sell it to cure cancer if you
| prefer.
| wyxuan wrote:
| Okay, but Biogen has 9 years to do the confirmatory study and
| they've indicated that they'll take their sweet, sweet, time
| with it. Also, it's not like we have 0 evidence: we have two,
| 4-5 year long studies that show how well it works: and the
| benefit in one was marginally positive and the effect of
| aduhelm was negative in the other.
|
| Sarepta's Eteplirsen was in a similar situation: little data
| to back it up and a very controversial decision. They also
| had to do confirmatory studies, but it took them 3 years
| after the approval was done for the study to begin.
| walugipnts wrote:
| it's also $56k per year, not including the imaging required
| vxNsr wrote:
| It doesn't, that was the suggested price. For anyone who is a
| candidate for this drug they will almost certainly be on
| Medicare or Medicaid and the gov negotiates a much lower
| price than retail.
| s1artibartfast wrote:
| This not correct. Medicare does not negotiate any drug
| prices and is explicitly banned from doing so.
|
| Instead medicaid pays the average price paid by private
| insurance, plus a flat markup % to the doctors office.
|
| https://medium.com/unraveling-healthcare/how-do-medicaid-
| and...
|
| The EU is different in that the national health services
| negotiate with companies based on patient benefit. This is
| illegal in USA
| vxNsr wrote:
| The article you link directly contradicts your claim:
|
| > _So how do Medicaid and Medicare set drug prices?
| Medicaid takes the lowest negotiated price by private
| payers. After which, states have the right to further
| negotiate price. Aetna, Express Scripts, and Oscar
| Insurance all negotiate with pharma companies for the
| best price. Perhaps Aetna and Oscar only receive 20%
| discounts while Express Scripts receives a 30% discount.
| This 30% discounted price is now the Medicaid price.
| Additional requirements ensure this price level adjusts
| to inflation. Although the federal government helps fund
| Medicaid, it's managed at the state level. At the state
| level, Medicaid can indeed negotiate further discounts
| with pharmaceutical companies. However, the federal
| government is still prohibited._
|
| While the fed might not be allowed to negotiate, states
| can and do. As can individual providers. Basically you're
| making a bad faith argument and hoping I wouldn't read
| your "source"
|
| Also Medicaid and Medicare are two different programs.
| The reason it doesn't get too involved in Medicaid is bec
| it's a state controlled program and would appear to be
| outside of their purview.
|
| EDIT::
|
| I seem to be getting rate limited by HN due to downvotes
| so I'm gonna post my reply here:
|
| That's false.
|
| Again, the amount paid is never the MSRP, not by Medicare
| and not by Medicaid. And generally not by any insurance
| company either.
|
| You're intentionally making a bad faith argument. Both
| Medicare and Medicaid use negotiated pricing whether they
| negotiated those prices or someone else did.
|
| It is absolutely _categorically_ false to state
| unequivocally or even imply that Medicare pays the MSRP.
|
| In the context of this discussion it is totally false to
| claim that any medical insurance provider (public or
| private) will be paying $56k for this drug. Not only
| because insurance companies don't pay MSRP, but also
| because that price was set before all this happened,
| under these new circumstances BioGen will absolutely be
| updating their MSRP as well to reflect the new reality
| (drug is only proven to lower an Alzheimer's marker and
| not directly treat the disease itself).
| s1artibartfast wrote:
| The part you quoted is specific to Medicaid, and what I
| said is accurate for Medicare.
|
| The greater point also stands, which is that the fed
| doesnt negotiate prices, and is not lower than retail.
|
| >Medicare or Medicaid and the gov negotiates a much lower
| price than retail
| savant_penguin wrote:
| It really depends. I think that not being able to access a drug
| because the FDA cites inconclusive research could also be
| terrible.
|
| Obviously you'd have to balance the risks of side effects with
| the chances of effectiveness.
|
| But for a drug with really rare and mild side effects by all
| means you should be able to try it if you want to without
| becoming a criminal
| steve76 wrote:
| I want to burn drug dealers at the stake. By all means, I
| should be able to try that without becoming a criminal.
| JoshTriplett wrote:
| It's entirely self-consistent to believe that the FDA
| shouldn't be a gatekeeper over what people can try, and
| _also_ belive that as long as they maintain that gatekeeper
| role and don 't just approve everything non-toxic then it's
| harmful for them to approve one specific drug that has no
| effect. If they purport to be a trusted signal of what works
| and what doesn't, then their approval is an endorsement, and
| in this case that endorsement is passing off noise as signal.
| linuxftw wrote:
| Do you feel the same about access to HCQ and Ivermectin?
| gilbetron wrote:
| No the OP, but if they were the only things around that
| showed any possibility of combating Covid, sure. But that's
| not the case. We have vaccines and other therapeutics that
| show incredible effectiveness. Approving HCQ and Ivermectin
| in this situation is wrong.
| black6 wrote:
| HCQ and ivermectin efficacy agaist SARS-CoV-2 was
| suppressed early on. If there were existing effective
| therapeutics, then emergency use authorization for the
| vaccines would not have been legally permissible (in the
| US).
| triceratops wrote:
| > Ivermectin
|
| Off-topic: Touting worm medicine (I've only heard of it
| used for heartworm in dogs, but apparently it's also for
| human worms) as a Covid cure has to be the work of some
| troll that got out of hand. I might be out of the loop but
| it seems like this came out of nowhere.
| birdyrooster wrote:
| They moved forward with a different type of approval
| specifically meant to mitigate the false hope you are speaking
| of. I don't see the mutual exclusivity here.
| jsnell wrote:
| It sounds outrageous when phrased like that. But turns out
| there's ways of describing what happened that make it sound
| like a completely reasonable decision as well. See e.g. this
| forum post:
|
| https://forum.quartertothree.com/t/wtf-is-going-on-at-the-fd...
|
| Which of the two groups of experts is right? I certainly don't
| have the experience to tell. But it seems plausible that both
| are acting in good faith, and there is no need for outrage.
| burkaman wrote:
| What is the second group of experts you're talking about?
| borski wrote:
| Those who do not believe amyloid is a cause, but rather a
| symptom.
| entee wrote:
| That linked post is fundamentally wrong because it rests on
| an assumption that has essentially zero human evidence:
| amyloid causes Alzheimer's. There have been several drugs
| that very efficiently reduce amyloid, strictly zero
| (including this one) have ever shown any benefit patient
| health even when running long trials (the Biogen trials
| started in 2015 and were halted for futility). There's reason
| to believe the amyloid hypothesis is flawed, meaning that
| approving a drug that reduce amyloid is not going to help
| anyone, and will likely hurt people (through side effects).
|
| If competing experts are the question, note that 3 actual
| experts have resigned from what are coveted positions in
| protest. Nearly every part of the pharma industry (including
| the press, investors, other companies) who doesn't stand to
| profit (I.e. not Biogen) has been up in arms saying this is
| an awful decision using words such as "horrifying". There is
| no expert disagreement.
|
| People can try to ret-con this by saying it's like HIV, but
| note that viral load is a pretty good marker for disease
| morbidity in most viral infections. Amyloid is nothing like
| that as a validated marker for disease burden.
|
| Useful sources:
|
| https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5797629/#s3titl.
| ..
|
| https://endpts.com/what-does-a-clear-majority-of-the-
| biophar...
| abadaba wrote:
| The author of that post (magnet) mentions the amyloid
| debate later in that same thread.
|
| https://forum.quartertothree.com/t/wtf-is-going-on-at-the-
| fd...
| entee wrote:
| Even if the amyloid hypothesis is true (and most
| neuroscientists I know think it's not), this is a
| terrible decision.
|
| 1.) We don't know when to give the drug. Maybe giving it
| even earlier would help, but these trials don't tell us
| that. Answer: Run a new trial.
|
| 2.) We don't know how much drug to give. The drug was
| approved on the (bad, weak) evidence that in one high
| dose arm of one of 2 trials, there might have been an
| effect. Is that the right dose? Who knows! In the other
| trial, the high dose may have actually been worse. You
| can't titrate dosage in Alzheimers like you do in cancer
| where you can just watch how the tumor is shrinking.
| Answer: Run a new trial.
|
| Giving this drug is not without downsides. You will have
| side-effects, including serious ones such as potentially
| brain swelling. Some people may be seriously injured or
| killed as a result of taking this drug. You have to make
| sure that the benefits outweigh that downside, and the
| trials show us a very dubious, weak effect.
|
| The FDA should have said, "Good work, maybe there's an
| effect with this dosage, go run a new trial with the
| revised protocol." That's the right call.
|
| Instead, they added, "Oh and you can sell the drug in the
| meantime and you don't have to tell us for 9 years."
|
| How are you going to recruit patients for the trial? "We
| could give you the drug, but might give you a placebo."
| How many patients sign up for that instead of saying, "OR
| I could go out and buy the drug (which you claim totally
| works, and the FDA agrees!) independently."?
|
| What if the trial fails in 9 years after you have tons of
| anecdotal reports (remember placebo shows an effect in
| past trials)? Now you have to take if off the market,
| imagine the loss of credibility that will entail for the
| FDA.
|
| How about other drugs that reduced amyloid but showed no
| cognitive effect? (Eli Lilly's Solazenumab among many,
| many others) Should they get approved now too?
|
| This is a mess for everyone and benefits Biogen. Everyone
| else loses, even the well-meaning patient advocates who
| created the political pressure for this decision.
|
| Additional sources:
|
| https://www.clinicaltrials.gov/ct2/show/NCT01900665
|
| https://blogs.sciencemag.org/pipeline/archives/2019/12/06
| /th...
| omgwtfbbq wrote:
| Surely it has nothing to do with the fact that the drug costs
| over $50,000 per year? Amirite?
| datastoat wrote:
| That forum post advises "new drugs aimed at preventing
| Alzheimer's should probably target surrogate markers rather
| than trying to fix the end-stage clinical problems".
|
| Here's One Weird Trick for targeting Alzheimer's, to try at
| home. Grey hair is correlated with Alzheimer's. Hair dye is a
| treatment that targets that particular biomarker, with
| remarkable efficacy. How about we all use hair dye, in the
| hope it prevents Alzheimer's! Way cheaper than $56k/year too.
| obsequiosity wrote:
| I'm wildly speculating here, but what if dying one's hair
| increases the odds of getting more romantic action (and
| thus more social relationships), which itself is associated
| with increased cognitive flexibility? If Alzheimer's is a
| lifestyle disease of an unfulfilling, unstimulating life,
| maybe the key is to seize each day?
| treeman79 wrote:
| Was showing all the symptoms of early onset Alzheimer's. I
| was even responding some to dementia drugs.
|
| Started blood thinners for unrelated reasons.
|
| My dementia was gone in a few days. Turned out it was a
| clotting disorder.
|
| Some dementia can have very different causes.
| saas_sam wrote:
| I'm close to multiple people with Alzheimer's. I think the
| worst thing you can give them is nothing as their personality
| evaporates and they become a husk of who they once were and a
| burden on everyone around them.
|
| I can walk 5 minutes down the block and buy an eight ball of
| fentanyl from a guy named TJ but I can't get Alzheimer's
| treatment made by a team of scientists in a cutting-edge lab
| because it doesn't meet some government worker's idea of "good
| enough"?
|
| I don't care what your bureaucratic panel thinks about how
| inconclusive the data is. My mother is dying.
| selectodude wrote:
| And charging your mother $90,000 for a drug that does nothing
| at all isn't a fix.
| [deleted]
| [deleted]
| saas_sam wrote:
| Mom's on social security she doesn't hasn't paid for any
| medical procedure in years. Have you heard of Medicare?
| Medicaid? You don't know what you're talking about at all
| selectodude.
| selectodude wrote:
| I hope you can find peace. I've been in your situation
| and I understand the desperate hope for anything at all
| that has even a chance of working.
|
| Be well.
| saas_sam wrote:
| Thank you <3
| [deleted]
| stordoff wrote:
| This is going to sound harsh, but the fact that other
| people (government/tax payers) are paying for it makes
| this even less defensible - wasting your own money on
| treatments that is likely to not work is one thing, but
| this risks diverting a shared resource from treatments
| that _do_ work.
|
| I recently lost my grandfather to vascular dementia, so I
| understand the feeling of hopelessness, but this is not a
| solution. I'd _perhaps_ support your right to buy the
| drug privately, but this would open others up to scams
| and treatments that have no chance of working (or are in
| fact harmful). This isn't the same as the war on drugs,
| where people wanting to buy a particular drug are stopped
| for (largely) moralistic reasons - this is about ensuring
| the drug does what the company claims and protecting
| desperate people from being ripped off.
| [deleted]
| shadowgovt wrote:
| Are Medicare or Medicaid covering Aduhelm to treat
| Alzheimer's? I don't know how the flow goes from FDA
| approval to certification for use by the government-
| administered insurance programs.
| mcguire wrote:
| That would be Biogen's next step, politically speaking:
| use public pressure ("They're preventing us from getting
| a drug that might help!") to force Medicare to cover it.
| [deleted]
| danso wrote:
| Sorry, but how does the fact that the government pays for
| your mother's healthcare make your position more
| defensible?
|
| > _I can walk 5 minutes down the block and buy an eight
| ball of fentanyl from a guy named TJ but I can 't get
| Alzheimer's treatment made by a team of scientists in a
| cutting-edge lab because it doesn't meet some government
| worker's idea of "good enough"?_
|
| You're implying that "some government worker" is too
| incompetent to have the power to regulate experimental
| drugs. And now you're arguing that it'd be cool for those
| same government workers to rubber stamp approve and _also
| pay_ for drugs that don 't have the backing of scientific
| evidence, which is the textbook archetype of "incompetent
| government worker".
|
| Not that your hypothetical question makes any sense. "TJ"
| selling fentanyl down the block is illegal. Biogen
| selling this unapproved drug is illegal. You have the
| same ability and legal issues to try to buy from them.
| [deleted]
| [deleted]
| markus92 wrote:
| And that's exactly why it should not be approved. There is no
| proof there is ANY effect on the disease outcome. The trial
| was halted prematurely for futility ffs! And now the FDA is
| giving people false hope? Letting them spend $65k/year for
| possible snake oil with no scientific evidence behind it?
|
| Alzheimer's is a terrible disease. And I get it, you're
| willing to try anything for a possible improvement. Problem
| is, there is no proof at all that aducanumab leads to any
| kind of improvement: only stuff that you might find if you do
| tons of data mining to get the result you want. If the drug
| was that good, you would find it each and every time you try
| it, not one out of a hundred times if you look at a subset of
| a subset.
|
| The only reason the Biogen wants approval of this drug, is to
| earn money out of desperate people willing to try anything.
| The FDA should be there to protect people from this. They
| have failed to do that here.
| bitshiftfaced wrote:
| The FDA doesn't prevent people from taking herbal
| supplements, given the supplement doesn't make misleading
| claims. Assuming this drug doesn't make misleading claims
| about the evidence for its effectiveness, why should the
| FDA prevent its sale?
| danso wrote:
| Herbal supplements aren't considered drugs by the FDA,
| and thus are regulated under a different set of rules.
| What you asked makes as much sense as, "Why won't my
| doctor prescribe me a breakfast of steak and eggs?"
| bitshiftfaced wrote:
| Say a breakfast of steak and eggs was classified as a
| drug, and it wasn't shown in a clinical setting to be
| effective in treating Alzheimer's. A doctor wants to
| prescribe it to a patient, even though the patient and
| doctor both know about the trials and evidence. Why
| should the FDA prevent the doctor from prescribing steak
| and eggs for breakfast?
|
| Edit: I ask this because my understanding is that the FDA
| is supposed to make sure drugs are safe and also to
| oversee drugs of abuse. If a drug is deemed safe and
| isn't one that's likely to be abused, I don't understand
| why it's within the FDA's domain to tell a doctor whether
| they can prescribe it.
| usefulcat wrote:
| And in your hypothetical example, should insurance
| companies be required to cover this treatment? In other
| words, should other insurees be required to pay for it?
| bitshiftfaced wrote:
| It depends on whether or not the insurance company
| determines it's of value enough to their customers to
| include it in their insurance package. Insurance
| companies don't insure all prescription drugs.
| markus92 wrote:
| That would be considered off-label prescription.
| bitshiftfaced wrote:
| Which is commonly done, and legal, right?
| danso wrote:
| Yes, doctors can prescribe off-label uses for basically
| any already approved drug. I'm not sure how it would
| apply to Aduhelm, which AFAICT has no indicated uses
| other than Alzheimer's.
|
| But let's assume there is no legal barrier to the doctor
| prescribing Aduhelm, and somehow you've found a doctor
| who is going to against the status quo based on
| inconclusive studies. Which insurers are covering it
| (certainly not Medicaid or Medicare)? Which pharmacy is
| stocking it? And where are they getting their supply?
| Biogen? You think Biogen's lawyers and executives are
| going to accept high legal exposure (e.g. consumer
| lawsuits) for an infinitesimally small market?
|
| FDA approval provides a legal and market framework for
| drugs to be supplied, marketed, and paid for. If your
| friend who runs Biogen has a spare box of Aduhelm and
| gifts it to you, it wouldn't be the FDAs problem.
| danso wrote:
| I think my comparison was too absurd/convoluted, because
| you're still making the same fundamental categorical
| mistake of asking "Why can't [X] be treated as [Y]?", as
| if "food" and "drugs" are just synonyms, and not separate
| categories with different rules and preconditions. But in
| any case, in a universe where "steak and eggs" were
| classified as a drug, and have also been commonly sold
| over-the-counter (i.e. at your local diner, without
| needing a doctor prescription), then nothing would
| prevent your doctor from prescribing "steak and eggs" for
| Alzheimers. And in our current universe, nothing stops
| your doctor from prescribing Viagra or Tylenol to treat
| Alzheimer's, even though none of those drugs have been
| approved by the FDA for that specific use. Doctors have a
| lot of freedom to use their judgment in prescribing off-
| label uses. So it's not a question of "Why can't doctors
| prescribe steak and eggs/Viagra/Tylenol" for my
| Alzheimer's -- it's "Why _won 't_...?", which I think the
| answer is mostly self-evident.
|
| So why can't Aduhelm be treated like an OTC herbal
| supplement? Well for starters, because Biogen didn't
| research and develop it with the intention of marketing
| it as a herbal supplement. So I think the answers to your
| question are very much related to the answer to "Why
| doesn't Biogen release Aduhelm as a herbal supplement?"
| bitshiftfaced wrote:
| Obviously we can dodge the question of "Why can't [X] be
| treated as [Y]?" by saying "X is not Y", as you've done.
| If you ignore the point behind the comparison, and we say
| that "X is X", then there is no argument. Biogen still
| has time to do the trial to show effectiveness and is
| going through a process that is governed by the set of
| rules set forth for drugs (not herbal supplements).
| danso wrote:
| Sorry, I didn't say you _can 't_ consider Aduhelm to be
| an herbal supplement, just that every premise and factor
| in the current discussion would be rendered irrelevant.
|
| So OK, let's agree that Aduhelm is now an herbal
| supplement. The FDA no longer has the authority to ban it
| from Walgreens. What's your point? The FDA's decision is
| about Aduhelm's proven effectiveness as a drug, and it
| has no bearing on whether Biogen wants to sell it as OTC
| herbal supplement. Do you believe the FDA is what's
| preventing Biogen from doing that right now?
| bitshiftfaced wrote:
| The OP was saying how by allowing the accelerated
| approval, the FDA failed to protect people from a drug
| that hasn't yet been shown to be effective. My point was
| that it's not like the FDA protects people from snake oil
| anyway. Doctors can already get their patients to spend
| tons of money on unproven treatments. As long as the
| treatment isn't lying about what the evidence has shown,
| adults and their doctors are able to make decisions based
| on available information, and generally society is ok
| with that. That sentiment conflicts with OP's sentiment.
| That is why the comparison is relevant to the discussion.
| hackinthebochs wrote:
| >Herbal supplements aren't considered drugs by the FDA
|
| And what is considered a drug or not is at the discretion
| of the FDA and other agencies. This is a choice they make
| not to regulate supplements like drugs. This fact has no
| bearing on what level of regulation is appropriate for a
| given chemical. Don't avoid the meaningful discussion by
| citing trivia.
| danso wrote:
| See my reply further down the thread:
| https://news.ycombinator.com/item?id=27475833
|
| You're right the FDA decides those categories. But Biogen
| is the one that created the compound and is pitching it
| as a drug, when they could've sold it as a nutritional
| supplement. Why exactly do you think they did that?
| usefulcat wrote:
| The difference is that insurance doesn't cover herbal
| supplements, so their cost isn't socialized. If insurance
| covers this treatment, then by extension everyone who has
| insurance has no choice but to pay for it.
| bitshiftfaced wrote:
| That's true of some drugs anyway, especially newer ones
| where the effectiveness isn't as well studied.
| hackinthebochs wrote:
| >Problem is, there is no proof at all that aducanumab leads
| to any kind of improvement
|
| Nothing you have said has any bearing on whether someone
| who is currently dying of Alzheimers should be allowed to
| try it if they or their doctors or family choose. "False
| hope" is not the most important thing at stake here, not by
| a long shot.
| paulpauper wrote:
| except that financial resources are finite . Without
| certain standards, costs would spiral out of control more
| than they already have.
| hackinthebochs wrote:
| I am sympathetic to the argument that expensive
| treatments socialized medicine pays for should be limited
| to those proven effective. What I am against are blanket
| restrictions presumably for people's own good, or to
| prevent "Big Pharma" from profiting or whatever bugaboo
| it is.
| peytn wrote:
| We can create combinatorially many drugs. There are labs
| that can screen hundreds of thousands of molecules a day.
| So approving drugs that aren't proven effective for a
| disease might reasonably lead to few or no drugs that are
| effective because it's so easy and relatively cheap to
| stuff a development pipeline with promising drugs if you
| don't need to worry about whether they work at the
| disease stage due to crowding out effective drugs.
| mcguire wrote:
| Committing fraud against the most desperate, vulnerable
| people in the country is universally regarded as
| unethical.
| hackinthebochs wrote:
| But there is no fraud. As has been stated elsewhere in
| this thread, the drug claims to remove plaque, not to
| treat Alzheimers. I personally don't have the hubris to
| think I should stand in the way of someone willing to try
| the drug on their loved one who is suffering from
| Alzheimers.
| bingidingi wrote:
| This is an incredibly expensive treatment meant for
| incredibly desperate people. If you were in a situation
| where a parent had alzheimers it would be hard not to
| feel guilty if you didn't try it, no matter the price.
|
| To approve the drug despite the lack of efficacy is
| unethical, especially considering there are potentially
| severe side effects like brain swelling.
| saas_sam wrote:
| If you are against desperate people buying drugs to solve
| their problems and as such the government should work to
| keep drugs away from people... tell me, are you an avid
| supporter of the War on Drugs as well? I hope I don't see
| any comments by markus92 on future threads advocating for
| drug legalization, or an easing of restrictions on
| recreational drugs, or an easing of punishments for drug
| abuse. Because to say that I don't have the right to try a
| drug after careful consideration with medical professionals
| -- DOCTORS -- to potentially help alleviate my dying
| mother's illness... while any junkie on the street is
| entitled to getting high on whatever pharmaceutical they
| can get their hands on. Is morally repugnant.
| bjornjajayaja wrote:
| Sorry to hear that about your close family/friends. However,
| vouching for a rushed approval based on emotions is why such
| panels exist. That quality assurance is extremely important,
| especially with respect to drugs. Keep in mind the worst case
| scenario: the drug does not work, the drug causes adverse
| side effects, AND it costs money.
| seattle_spring wrote:
| > I can walk 5 minutes down the block and buy an eight ball
| of fentanyl from a guy named TJ
|
| I think TJ might be yanking your chain. "An eight ball"
| refers explicitly to 1/8 ounce of cocaine.
|
| There would be approximately 35,000 doses of fentanyl in an
| eighth of the stuff.
| danparsonson wrote:
| I'm so sorry for your struggles and those of your family -
| Alzheimer's is a terrible disease and I too want to see it
| treatable as soon as possible, but in this case, if the data
| is inconclusive, then the drug is not actually a treatment
| for the disease, that's the point. The purpose of all the
| trials and tests is to ensure that a) the drug actually does
| what the scientists in the cutting-edge labs think it does,
| and b) that it's safe or at least has manageable side-
| effects.
|
| I have a relative with this disease so I understand the drive
| to find a cure but it helps no-one to push through a drug
| that may end up causing more damage.
| allie1 wrote:
| What could be benefited by not approving it with all the
| pertinent disclaimers about effectiveness?
|
| And to turn it around, what harm would it cause society if
| it's not approved due to inconclusive evidence and helps
| _only some people_? (Assuming no hard side effects)
|
| Keep in mind, there are already ineffective treatments that
| sell hope and don't help.
| mcguire wrote:
| " _What could be benefited by not approving it with all
| the pertinent disclaimers about effectiveness?_ "
|
| Let's say it is approved, with all pertinent disclaimers.
| And that it has no side effects (which seems unlikely).
|
| With little evidence of effectiveness, insurance, public
| or private, will not pay for it. They have every right,
| and at least a fiduciary responsibility not to.
|
| But you are desperate, and you are willing to pay
| $130/day for the drug. What happens if it doesn't work?
| (As you say, the list of things that don't work is
| extensive.) Are you going to post on the net, "Our
| mother's medication didn't work and literally bankrupted
| us, but it's our fault"?
| danparsonson wrote:
| Caveat: I'm not medically or pharmaceutically qualified
|
| > What could be benefited by not approving it with all
| the pertinent disclaimers about effectiveness?
|
| It prevents the drug being prescribed (at great cost!) to
| people who are desperate to try anything.
|
| What would be the benefit of approving such a drug? Who
| is missing out by not being able to take a drug not known
| to be effective? I would consider it malpractice to be
| prescribed something not demonstrated to have a
| measurable positive effect. The human body is vastly
| complicated - we shouldn't mess with it without good
| reason.
|
| > And to turn it around, what harm would it cause society
| if it's not approved due to inconclusive evidence and
| helps only some people? (Assuming no hard side effects)
|
| If it's not approved, then I would argue no harm comes to
| society. What harm is done if a drug that wasn't
| available before, still is not? Nothing has changed.
|
| > Keep in mind, there are already ineffective treatments
| that sell hope and don't help.
|
| Absolutely, and they are, in my opinion, a work of evil.
| But the crucial difference is that such treatments (I'm
| assuming you're referring to quackery such as homeopathy)
| contain no active ingredient. That's why they aren't
| regulated. They can't cause medical harm because they
| don't do anything.
| pwthornton wrote:
| The biggest harm is going to be people getting side
| effects with no benefits. I suppose you could argue that
| Alzheimer's is so bad that who cares about bad side
| effects, but usually you would not want a drug on the
| market with no real benefit and a bunch of potential side
| effects sitting out there.
| acdha wrote:
| The drug has significant side effects, likely with more
| to be recognized in wider use -- especially in
| combination with other people.
|
| There is a massive cost, which will be paid directly by
| patients (creating financial stress & conflicting with
| other care needs) and indirectly by insurance providers
| who will cut corners and raise costs for everyone.
|
| There is a psychological cost to telling people to take
| on all of the previous costs for something you know won't
| have any benefit. Offering false hope isn't a kindness.
| gaetgu wrote:
| Is anyone else getting some "Rise of the Planet of the Apes"
| vibes? Questionable Alzheimers drug etc. etc.
| m3kw9 wrote:
| The approval is a bet that it could work because of the status
| quo regarding beta amyloid's role in the disease. It'a also a
| sign of human desperation on the fight against this if you zoom
| out. Thy are willing to throw anything at it that even have a
| slight chance. This is what it is about in my view.
| r00fus wrote:
| The challenge is that a group of people are going to profit
| massively from this drug being approved. Some patients are
| going to pay $56K+ on this treatment, in other cases, we
| taxpayers are going to pay that (Medicare/Medicaid).
|
| Should this be approved if it's ineffective?
| papito wrote:
| I hope everyone realizes now that the FDA is not a real
| regulatory agency. Regulations are written by the _companies_. At
| this point, the entire industry is essentially self-regulated.
| FDA is just a formality.
|
| Boeing 737 MAX, anyone?
|
| Yes, this is what happens when Big Evil Government is gone.
| People die.
| brink wrote:
| Big Government != an effective FDA.
|
| Regardless of the size of the government, you're always going
| to have problems.
| AbrahamParangi wrote:
| The size of the federal government, as measured by spending, is
| larger than it has ever been. In what sense is "Big Evil
| Government" gone?
| jhayward wrote:
| The size of the federal government, as measured by employees
| per capita, is smaller than it was in 1950.
| papito wrote:
| _Which_ part of the government? Because the US is 19th, which
| is not bad at all.
|
| https://www.theglobaleconomy.com/rankings/wb_government_effe.
| ..
|
| Is it the military? Is that part of government spending, in
| your opinion? Because it's _definitely_ not the FAA, or the
| FDA, or that agency that is supposed to oversee the housing
| market, or the IRS.
|
| Any agency that is supposed to make sure that the consumers
| are not put in danger by reckless money-makers is at a
| constant risk of being castrated, especially with Republicans
| in the control room.
| fuzzer37 wrote:
| Regulatory capture, and gutting regulatory organizations of
| any teeth they may have once had. The money is going
| somewhere, and it's not to help the average people.
| schnable wrote:
| It's institutional decay. Pumping money into a decaying
| institution doesn't fix it. Other actions are needed.
| papito wrote:
| Or perhaps a concentrated effort by the donors to neuter the
| agency that is "in the way", no? This whole "the rotten
| government is so bloated and ineffectual" song is getting a
| little old.
|
| Hmm, why _doesn 't_ the IRS have the manpower to audit the
| top 1% anymore? It's the weirdest thing.
| refurb wrote:
| As someone who has actually interacted with the FDA during a
| drug approval this is actually the opposite of how it works.
|
| Going to add this comment to the pile of "written in a tone of
| absolute certainty but completely wrong".
| linuxftw wrote:
| > Yes, this is what happens when Big Evil Government is gone.
| People die.
|
| This is Big Evil Government. Governments are bigger and more
| powerful than they've ever been.
| wayoutthere wrote:
| Largely because they took the mask off and there's no
| question they serve their corporate masters first, second and
| third. Anything relevant to people's lives is considered
| culture / class warfare (surprise, the entities with money to
| achieve wide media reach are the ones saying that).
|
| We need real anti-corporate reform before the guillotines
| come out. Both the far left (which is growing rapidly; Trump
| radicalized a lot of us) and far right (which is a circular
| Venn diagram with the Republican Party at this point) are
| working toward the future with the guillotines. Unless the
| politicians can get over their greed and actually do
| something for the people, that's the future we're looking at.
|
| Lest you say this is just the US, pretty much every other
| democracy has this same problem right now. And the far left
| is often much bigger elsewhere than it is in the US.
| linuxftw wrote:
| The guillotines are never coming out. Just look at the
| Soviet era. Whenever there was a little uprising, the state
| just killed people. Then they killed some others to make an
| example. Secret police, surveillance, neighbors that snitch
| on you, we have it all now.
|
| The psychological condition has been much too strong.
| People identify with the state. It's a part of them, it's a
| part of who they are.
| wayoutthere wrote:
| That's changing; we have strong anti-government groups on
| both the right and left. People identify with the
| mythology of America, but not the state.
|
| We were literally 5 minutes from a guillotine event just
| 6 months ago. Those people didn't go away and they only
| radicalized a lot of the left to oppose them (gun sales
| have been persistently high and all indications are that
| the strong majority of purchasers over the last year have
| been on the left).
|
| The real danger is the far-right and far-left have a
| whole lot in common around economic conditions and the
| labor market. They just disagree about the cause. So the
| culture war is stoked to make sure they never find common
| ground.
| linuxftw wrote:
| > We were literally 5 minutes from a guillotine event
| just 6 months ago.
|
| I don't think that's true, despite how the media may have
| portrayed it.
|
| > So the culture war is stoked to make sure they never
| find common ground.
|
| I do agree with this. That's why we have to challenge
| each other to look past this pettiness and focus on the
| real issues.
| hobs wrote:
| Alright, then let's have regulated big government instead of
| unhinged corporatism.
| unanswered wrote:
| GGP comment literally just explained what "regulations"
| are: "corporatism", as you put it. And you want _more_ of
| them? So you want _more_ corporatism, to solve corporatism?
| [deleted]
| adamsvystun wrote:
| The reality is surely not so simple. How come the FDA
| regulations are written by the companies but then the tests for
| covid were super slow to be approved. More probable explanation
| for what is happening here is bound to be complex.
| rdtwo wrote:
| Slow regulators are pro industry They keep competition out by
| bleeding then out of cash before they can go to market
| banannaise wrote:
| Just because it is slow does not mean it is not a rubber
| stamp. Bureaucracy tends to take awhile whether it is
| effective or not.
| leetcrew wrote:
| the opposite of "big government" is not "corrupt government".
| the FDA has all the authority it needs to prevent dangerous or
| ineffective drugs from being sold. in this case, the
| individuals in charge have simply chosen not to do their jobs.
| newacct583 wrote:
| > the opposite of "big government" is not "corrupt
| government".
|
| It always has been. The point is not that it's impossible to
| imagine a libertarian utopia where lean and minimal
| regulation works for the benefit of all. It's just that
| everyone who's tried has ended up producing do-nothing
| systems like this.
|
| It's absolutely true that the FDA "has" the authority. But
| it's run by appointees from a culture where "doing stuff" is
| perceived as "big government", and therefore bad. So they
| don't.
| AbrahamParangi wrote:
| Are big governments less corrupt?
| newacct583 wrote:
| By the metric we're looking at, where a drug gets
| approved despite a unanimous thumbs down from the
| official advisory panel? Of course they're less corrupt.
| This simply doesn't happen unless the FDA is captured.
| oezi wrote:
| The FDA definitely isn't captured. The amount of fear and
| respect it commands in the industry is big even in the
| biggest medical device companies. I experienced how a
| competitor got shutdown, because they took a warning
| letter too lightly for another product in the same plant.
| The competitor lost more than 500m USD and never
| recovered in our market.
| vxNsr wrote:
| You've painted a black and white painting and are now
| trying to fit everything in the world into one side or
| the other. Read through the other comments in the top
| thread, it's not nearly as simple as you're making it
| out. And as usual the people trying to make it seem
| simple are either being naive or ignorant.
| leetcrew wrote:
| I'm really not sure I understand your argument here. the
| FDA is quite far from some libertarian ideal of minimal
| regulation. on the contrary, this news story makes a great
| example of the dangers of regulatory capture when a
| government institution literally decides on a case-by-case
| basis what products are allowed to compete in the market. I
| personally wouldn't go that far; I think it's worth having
| some oversight regarding food and drug safety.
|
| since you agree that the FDA does have the necessary legal
| authority, I'm curious what you think the fix is here. if
| we give it even more money and legal powers, would that be
| enough for it to do its job? I somehow doubt that.
| vxNsr wrote:
| > _Yes, this is what happens when Big Evil Government is gone._
|
| No this is exactly what big gov is.
|
| Every large system is corrupt.
|
| That's human nature.
|
| Don't for one second think you can create a better system that
| works around human nature. You will fail every time.
| [deleted]
| linuxftw wrote:
| What everyone's forgetting is we live in the information age. You
| think this stuff just started happening? No, you just started
| hearing about it. There have been countless whistle blowers over
| the years.
|
| What is it going to take for people to realize the entire
| industry is compromised from top to bottom? Why do you think some
| of us are refusing to take an experimental gene therapy drug?
| Nobody is ever going to tell you it was a failure, they will
| never admit they lied to you. The billionaires became
| trillionaires.
| [deleted]
| nceqs3 wrote:
| This was truly a terrible decision. Not a single member of the
| advisory committee would attach their name to this shit drug. 9
| YEARS for a phase 4 trial! This decision will go down in history
| in the same league as the Addyi approval or Oxycontin label
| approval.
| TaylorSwift wrote:
| Could someone please expand on the current outrage?
|
| Article did say "The 11-member committee voted nearly
| unanimously in November that Biogen's drug should not be
| approved, citing inconclusive evidence that the drug was
| effective.", but was wondering why the some would think
| otherwise for the approval.
| curtis3389 wrote:
| It seems that the committee is an panel of outside advisors
| for the FDA.
|
| The advisors advised that Aduhelm should not be approved
| because it only helps with a likely contributor to
| Alzheimer's, and it doesn't actually help with Alzheimer's.
|
| The FDA ignored the panel and approved the drug anyways.
|
| I wonder about the financial incentives and the corruption in
| the FDA. Every drug maker wants to be the first with an
| approved Alzheimer's drug; there's a ton of money to be made
| there.
| jhayward wrote:
| > _helps with a likely contributor to Alzheimer 's_
|
| There is no evidence, and plenty of failed trials, to
| indicate that Amyloid plaque is a cause of Alzheimers.
| Majromax wrote:
| Derek Lowe has a recent article on the subject (https://blogs
| .sciencemag.org/pipeline/archives/2021/06/08/th...) that
| covers the issue in some detail by way of criticism.
|
| In short, the medication does appear to reduce the beta-
| amyloid plaque buildup in the brains of patients with
| Alzheimer's. However, in the phase 3 study that plaque
| reduction did not appear to result in any clinical
| improvement in patients. The Phase 3 trial was "stopped for
| futility."
|
| That's why the advisory panel could recommend rejection --
| the drug did not appear to help patients. But equivalently,
| it did do the thing it set out to do, so that justified
| (ish?) the final approval.
| mumblemumble wrote:
| It's worrisome because this sort of thinking - "We don't
| have proof that it treats the actual disease, but it does
| seem to treat with this thing that we think might be (but
| have yet to prove actually is) a cause of the disease, so
| let's forge ahead anyway." - has led to so many instructive
| case studies in purported cures that ended up being worse
| than the disease. It's a complete abdication of what should
| be basic scientific and medical principles to decide that
| an un- or ill-evaluated hypothesis is good and run with it,
| on no firmer ground than the fact that you happen to be
| quite fond of this particular hypothesis.
| shadowgovt wrote:
| This has historically been a challenge regarding
| understanding the mechanisms of Alzheimer's in the first
| place, let alone treating the disease.
|
| We know the plaques and the memory dysfunction are
| correlated. But we don't know whether the plaques are
| build up of waste product from the mechanism that is
| destroying memory function or the cause of the memory
| function loss. If it's merely a waste product, clearing
| it out of the brain may not only have no effect on the
| memory loss, it could even accelerate it (if the
| chemistry of the process is such that build up of plaques
| interferes with whatever process damages memory).
| Destroying the plaques may be like picking a scab off a
| wound.
|
| Biomedicine is hard; none of the systems operate in
| isolation and everything is intertwined.
| derefr wrote:
| I don't see what's wrong with the FDA approving a drug
| only for specific niche proximate-cause X that currently
| has absolutely no reason to ever be prescribed, presuming
| it's disallowed from being marketed as being "for"
| anything other than specific niche proximate-cause X.
| Maybe someday a problem will come along that _can_ be
| solved by treating for specific niche proximate-cause X
| -- and hey, then you've already got an approved drug to
| treat that problem. (For example, maybe in this case the
| drug could also happen to treat some novel prion disease,
| where the _mechanism_ of that prion disease involves
| beta-amyloid buildup, such that this drug would actually
| _stop_ that disease's progression. Sort of the same way
| corticosterioids were already approved for other uses,
| but then happened to be able to be used in managing
| COVID, because the same mechanism they target -- systemic
| inflammation -- was being triggered by the disease.)
|
| Of course, if the marketability restrictions truly worked
| the way I'm talking about, then the drug would have zero
| sales until that real-world problem matching its niche
| use-case came along. Which means there'd be no point in
| _manufacturing_ it until then. But it'd be nice that it'd
| be "on the books" as being _allowed_ to be produced and
| sold, such that it could be later rushed to market if the
| problem it solves was ever realized as a necessary
| problem to solve.
| gambiting wrote:
| As someone else commented above - there is precendent to
| this, this is exactly how the HIV epidemic was
| approached. I was as upset about this decision as
| everyone else on this thread, then I read this[0] and now
| maybe not so much.
|
| [0] https://forum.quartertothree.com/t/wtf-is-going-on-
| at-the-fd...
| TaylorSwift wrote:
| I'm impressed with the information and detailed
| discussions about this topic from a gaming forum...
| JunkDNA wrote:
| I highly recommend the piece by Derek Lowe down thread, but
| the tldr is basically that researchers have believed amyloid
| plaques cause the symptoms of Alzheimer's and so the theory
| is that if you eliminate them, you can treat the disease.
| This drug gets rid of them. But the gold standard is whether
| or not the drug actually helps people, not whether it meets a
| technical definition of "working".
|
| This is the drug equivalent of an engineer following a
| requirements document and saying to a product manager, "Hey,
| you said the form has to be submitted through the website.
| You can see here when I hit submit, it submits! The website
| doesn't save the data anywhere because that wasn't in the
| requirements".
| whyIsItOk wrote:
| As great as the current US medical system is(ha), I'd love to see
| a near unregulated alternative that's entirely science based.
|
| We currently use Authority based medicine and that has caused
| unaffordable healthcare and the opiod crisis. If science based
| healthcare doesn't work, you'd still be able to visit a
| Physician.
|
| Feel free to argue the details, make sure you include getting
| heart transplants by a 18 year old science fan.
| epmaybe wrote:
| I'm finding it really hard to understand how this met approval to
| 'give patients an option' when the government just recently
| passed laws to expand access for unapproved drugs. We even have
| expanded access programs that have been possible for years, with
| rapid turnaround when requested.
|
| Maybe it's easy to understand and it's about money? Or is this a
| policy shift in the FDA to just approve 'safe' medications and
| not necessarily hold marketing approval for futility.
| hirundo wrote:
| My take on this is counter-consensus. I don't believe that
| screening drugs based on effectiveness is a proper role for any
| government agency. There is a role for them to guard against
| fraud and to protect rights, but not to prevent people from
| making risky choices. Adults should not be protected from the
| decision to take any drug, however harmful, even if instantly
| fatal, if fraud or force is not involved.
|
| These are extraordinarily complex choices that seldom have a
| right answer for all possible patients. Therefore they should not
| be made centrally for everyone. We will learn more and faster
| from decentralized decision makers, that is, from massively
| parallel computation from a mass population of decision makers.
|
| Better would be for the only role of the FDA in decisions like
| this to be determining if the manufacturer is making fraudulent
| claims. Even better (because of greater computational
| parallelism) would be for this to be legally decided only by
| individual states. Best would be to treat adults as adults, and
| let them and their medical providers make such choices.
| alisonkisk wrote:
| That's not really relevant here.
|
| Safe drugs can be sold OTC with all the homeopathics. FDA
| approval here is about fraudulent claims of _effectiveness_.
|
| You argue that unsafe drugs should be available for sale too,
| but that's not what happened here and IMO it ignores the
| societal risks of unsafe things floating around were they can
| harm non-consenting people, as well as the rights of people who
| want to be free from transient temptation to make irrevocable
| decisions.
| Angostura wrote:
| > These are extraordinarily complex choices that seldom have a
| right answer for all possible patients.
|
| I think "is there any evidence that this drug actually works"
| can a remarkably simple decision, given the results of clinical
| trials.
|
| The fact that desperate people may be willing to blow tens of
| thousands of dollars on something that doesn't work, doesn't
| make it more complex.
| devoutsalsa wrote:
| I am a smart person, and I am not remotely qualified to make
| decisions about the risks associated with an untested drug. I'd
| like to know when I get a prescription that someone else went
| through the process of being a willing volunteer in a clinical
| trial.
| bencoder wrote:
| Your doctor should be able to help with that and provide you
| only drugs that have completed clinical trials to your
| desired standard.
| chinathrow wrote:
| Your doctor is a smart person too but they can't simply
| check every single medication single handily. What even is
| "your desired standard" here?
| greeneggs wrote:
| Sure, but the doctor doesn't have to do much research in
| this case. This is front-page news in the NY Times. And
| about "every single medication": this is the _only_
| approved medication to delay clinical decline due to
| Alzheimer 's. And there are only a few medications to
| treat symptoms.
|
| I know this isn't a perfect world, but it doesn't seem to
| be asking a lot for a doctor to know this. (Especially
| for a drug that currently costs $56K/year and presumably
| will cost more next year.)
| setpatchaddress wrote:
| You seem to have an incredibly optimistic view of the
| both the medical profession and human attention span.
| kvathupo wrote:
| Frankly, I think most doctors aren't qualified to make such
| a decision by virtue of lacking PhDs: their expertise is in
| clinical care, not in evaluating research.
| kesselvon wrote:
| Doctors heavily rely on FDA to filter for effective drugs,
| they're not researchers with the skills to identify whether
| a drug has efficacy.
| galimaufry wrote:
| As I understand it the issue is
|
| * Currently the US welfare agencies will provide ~any FDA-
| approved drug for someone with the illness for which the drug
| was approved
|
| * In this case, they probably won't - in the worst case
| scenario it would double their spending on prescription drugs
| and seems unlikely to help anyone
|
| * So this is going to sever the link between FDA approval and
| medicaid spending.
|
| * Now you have an awkward situation where agencies that not
| really equipped to make judgements on dug effectiveness, and
| which are not insulated from politics, have to make those
| decisions.
|
| This could all work out for the best in the long term but may
| also be very awkward in the short term.
| burkaman wrote:
| Isn't it fraud to sell an Alzheimer's drug that doesn't prevent
| Alzheimer's?
| readams wrote:
| Only if you make untrue claims. If you claim only what is
| proven, then it is not fraud.
| danso wrote:
| So how is Biogen going to get doctors to prescribe and
| people to pay $50K for a drug with no brand recognition nor
| eligibility for insurance, and no claims of actual
| effectiveness?
| burkaman wrote:
| > ADUHELM is an amyloid beta-directed antibody indicated
| for the treatment of Alzheimer's disease.
|
| - https://www.biogencdn.com/us/aduhelm-pi.pdf
|
| I believe the advisory panel's position is that it is not
| indicated for the treatment of Alzheimer's and that Biogen
| should not be allowed to say this.
|
| In their press release (https://investors.biogen.com/news-
| releases/news-release-deta...), they explicitly describe it
| as an "Alzheimer's disease treatment". Again, I think the
| advisory panel considers this untrue, and certainly
| unproven.
|
| The FDA could have said "this drug is safe and may be sold,
| but you may not describe it as an Alzheimer's treatment,
| and you must explicitly state that it has been found to be
| ineffective as an Alzheimer's treatment in clinical
| trials".
| nabla9 wrote:
| Your argument misses some of the important reasons of the
| approval process.
|
| Firstly, approval limits the legal liability for drugmakers. If
| we adopt a policy where approval does not exist. As long as the
| government takes part in the risk so it should have a say in
| the matter.
|
| > treat adults as adults, and let them and their medical
| providers make such choices.
|
| Signing out of medicare and all government assistance in case
| of becoming invalid, so that government is not in the hook for
| personal decisions would be a huge ask.
|
| If 10 million individuals make the same decision independently,
| and it backfires, that has negative consequences for the rest
| of the country. One decision does not matter, millions of
| decisions become collective matter.
| usefulcat wrote:
| The problem is that it costs $56k/year. Most people don't have
| that kind of money, so for the most part we're talking about
| whether that cost should be socialized, either via insurance or
| the government. That's an awful lot of money that could be used
| to treat a lot of other sick people. So it's not primarily a
| question of whether people should be allowed to take risks,
| it's more a question of how best to allocate finite resources.
| barsonme wrote:
| Sure, but that is also not a question FFA should be
| answering.
| Clubber wrote:
| Wouldn't charging $56k / year for a drug that not only doesn't
| work, but has a high chance to induce brain swelling be
| considered fraud?
| mcguire wrote:
| I suppose there is some fine ethical reasoning that would
| distinguish between selling something that you know not to work
| and selling something that you don't know won't work.
|
| Of course, financially incentivizing ignorance is probably not
| the best precedent.
| jartelt wrote:
| None of this vision would work for a variety of reasons, but
| the biggest one is that insurance companies are not going to
| agree to pay for medications that are not proven effective.
|
| Your personal freedom to try whichever medications you want
| would be limited unless you are willing to pay out of pocket
| for everything.
| kesselvon wrote:
| What a terrible idea. Nobody has the knowledge base to make a
| real informed decision on the efficacy of a drug. Not filtering
| for effectiveness is to endorse fraud and blame it on consumers
| when it happens.
|
| The whole reason the FDA is set up this way was due to the
| rampant fraud that was occurring before there were standards
| for what could be sold to consumers as medicine.
| yanderekko wrote:
| >Nobody has the knowledge base to make a real informed
| decision on the efficacy of a drug.
|
| Informed decisions are not risk-free decisions. If you're
| saying that literally no one can provide informed consent to
| take a drug until years and years of trials have been
| performed, and their inability to provide informed consent
| invariably subjects them to functional degradation or death,
| then this is a perverse system, to say the least.
|
| Note that many people made the same arguments against fast-
| tracking COVID vaccines for public distribution, which
| undoubtedly saved thousands if not millions of lives.
| disgruntledphd2 wrote:
| The FDA was required to approve all new drugs because of
| this: https://en.wikipedia.org/wiki/Thalidomide
|
| I personally agree that the FDA isn't always perfect (they
| should never have approved SSRI's, for instance) but
| claiming that there's no tradeoff here is just incorrect.
| JoshuaDavid wrote:
| Yes, and the TSA is required to check the shoes of all
| passengers who want to fly because of this:
| https://en.wikipedia.org/wiki/Richard_Reid
|
| The fact the people who make a policy have a specific
| thing they want to achieve with that policy does not
| automatically make it a good policy. That remains true
| even if the thing they want to prevent is bad and could
| kill people.
| disgruntledphd2 wrote:
| I met one of the thalidomide babies once, he was a PI for
| a research project I worked on. He was a relatively tall
| man, and had tiny arms that would have looked fine on a 2
| year old.
|
| Stopping stuff like that seems like a reasonable thing
| for the FDA to do, even at the cost of it taking longer
| to approve drugs.
| JoshuaDavid wrote:
| > even at the cost of it taking longer to approve drugs.
|
| "Taking longer to approve drugs" can be restated as
| "forbidding the use of potential treatments for longer".
| To the extent that those treatments work better than the
| next-best option, delaying approval is effectively
| forcing the worse treatment on everyone who would have
| switched for the duration of the delay. If there is no
| alternative treatment, delaying approval is effectively
| equivalent to forcing the people affected by a disease to
| just live with that disease for the duration of the
| delay.
|
| Picking pretty much at random from stuff recently
| approved by the FDA, we find that Ocrelizumab, a drug to
| treat multiple sclerosis (MS), was approved in 2017.
| Patients treated with Ocrelizumab have just over half the
| chance of developing symptoms bad enough to require a
| walking aid (4.2% vs 7.3%) as compared to the next-best
| treatment (interferon beta-1a) over 96 weeks.
|
| Phase III clinical trials of Ocrelizumab started in March
| of 2011, and completed in July of 2015. In October 2015,
| Genentech presented the results of the phase III trials
| to the FDA. The FDA recognized how important this
| treatment was, and gave it breakthrough therapy
| designation, fast track designation, and priority review.
| It was approved for use in March of 2017.
|
| That is uncommonly fast for the FDA, but even so it took
| them a year and a half to "move fast" on this treatment.
| Let's be generous and say that determining that the phase
| III results were not _literally fraudulent_ takes fully 6
| months -- that means that in the case of this particular
| drug, the FDA only delayed approval for a single year.
| About 150,000 people take Ocrelizumab worldwide, most of
| which are probably in the US.
|
| As such, the FDA's (much shorter than usual) delay _for
| this particular drug_ "only" cost about 2,500 people the
| ability to walk unaided.
|
| How many delays like this does it take before we decide
| that the cure (delaying effective treatments for nasty
| diseases) is worse than the disease (occasionally letting
| through a medication with extremely nasty side effects)?
|
| This isn't a rhetorical question by the way. My personal
| answer is probably somewhere in the ballpark of "aim for
| a 1:1 ratio of QALYs lost to drugs that were approved and
| shouldn't have been : QALYs lost to drugs that should
| have been approved and weren't". Maybe 1:5, if we think
| harm from inaction isn't quite as bad as harm from
| action. But my best ballpark guess for the actual ratio
| the FDA is achieving is probably more like 1:100 or
| 1:1000, and I don't find that even remotely reasonable.
|
| (Note that this entirely ignores the question of whether
| the current FDA _does_ even have the benefit of delaying
| / not approving stuff that doesn't work, which is the
| subject of another rather active discussion on HN today:
| https://news.ycombinator.com/item?id=27472107).
| dudzik wrote:
| > Nobody has the knowledge base to make a real informed
| decision on the efficacy of a drug.
|
| This is probably true for most patients, but not doctors.
| Normally, a patient consults a doctor on what drugs to use
| for their illness and the risk of taking it.
| acdha wrote:
| This is the idealized spherical cow theory of medicine.
| Doctors have more knowledge but it's not any more
| reasonable to expect them to follow the scientific
| literature for hundreds of different topics than it is to
| expect the average HN reader to follow the standards and
| development process for every technology they use. This is
| especially true given the amount of money at stake: a
| company has enormous windfalls if they can convince doctors
| to prescribe it and there's plenty of evidence showing that
| they'll try everything to do that. The amount of money
| going into sales to doctors & advertising is similar to
| their R&D spend and there's no reason to expect the steady
| stream of ethical complaints would go down with less
| regulatory oversight.
| MauranKilom wrote:
| Isn't it more or less fact that doctors are (for obvious
| reasons) the target of marketing campaigns by the pharma
| industry to encourage prescribing certain products? Yes,
| doctors presumably have a higher degree of
| informedness/resistance to bullshit, but I think you are
| fooling yourself if you believe that everything is fine
| with doctors as the thing standing between you and the
| obvious financial incentives of the pharma world.
| pwthornton wrote:
| Doctors are doctors not research scientists. They are much
| more akin to engineers than scientists. There is also a
| massive amount of specialization in medicine (but not
| always in prescribing of medicine). Doctors absolutely rely
| on the work of scientists to help guide them. Doctors are
| not really trained in how to gauge the efficacy of
| medicines.
| big_curses wrote:
| The only two options are not either that the FDA screens and
| approves drugs or it being down to individuals (or even these
| individuals' doctors). We could have private screening and
| trials companies that the drug producers themselves would
| pay. We already see this in other industries where there are
| both public and private inspections done. I've heard in those
| cases the private inspectors are actually stricter as well,
| as they actually have more incentive to be correct.
| danso wrote:
| > _I don 't believe that screening drugs based on effectiveness
| is a proper role for any government agency...Better would be
| for the only role of the FDA in decisions like this to be
| determining if the manufacturer is making fraudulent claims._
|
| I think you come in with wrong assumptions. The FDA has little
| to no authority when it comes to off-label uses -- doctors have
| a lot of leeway to prescribe drugs for whatever non-approved
| use they judge to be effective.
|
| So the FDA's role _already_ is intertwined with marketing. A
| doctor can today prescribe Viagra as a treatment to Alzheimers,
| but it would be illegal for Pfizer to market Viagra for
| treating Alzheimers until it gets FDA approval for that
| specific use.
| deschutes wrote:
| Efficacy and safety are intertwined. Safety can sometimes only
| be evaluated in the context of efficacy. For example, you
| wouldn't amputate a healthy arm. But for a gangrenous one, it
| may be the only option.
|
| For establishing efficacy and safety, trials are the only
| process that works. Nobody can predict the effects of drugs
| because the current understanding of biology is very
| incomplete.
|
| Thalidomide [1] shows the wisdom of the current approach.
|
| [1]: https://en.m.wikipedia.org/wiki/Thalidomide
| jcranmer wrote:
| > Better would be for the only role of the FDA in decisions
| like this to be determining if the manufacturer is making
| fraudulent claims.
|
| Let us recall some of the key facts about the drug in question
| here. There were two trials. One of them showed such little
| benefit that it was halted midtrial on the basis that _it would
| be unethical to continue giving people a drug that didn 't
| work._ The second showed marginal benefit.
|
| Biogen argued that there is a rational explanation that
| explains the two trials that points to the drug working. The
| expert committee at the FDA had 10 people vote "that's bunk", 1
| person vote "unsure", and nobody vote "I agree." That's a
| pretty strong endorsement for saying "Aduhelm treats
| Alzheimer's" is a _fraudulent claim_ , and yet the FDA decided
| that the claim is merely disputed.
|
| The only way you can look on the FDA's decision favorably is if
| you know nothing about how drug development works, which is
| unfortunately true of almost the entire public. (Here's two
| facts that are important to keep in mind: _most_ drug
| candidates don 't work, and placebo effects are _very_ real and
| surprisingly powerful).
| tboyd47 wrote:
| So, do you think people should be allowed to take ivermectin
| and "that drug" (the one that rhymes with mydoxyborofin) for
| COVID-19 if they want to, given that both of those have been
| studied for years and are known to have very little side
| effects?
| swader999 wrote:
| No, the patents on these have expired and nobody will make
| any money if we promote them. Also it would have been near
| impossible to get emergency use authorisation for these
| vaccines if we had at all listened to the science on these.
| thehappypm wrote:
| You won't even say the name of the drug hydroxychloroquine?
| Trump really did a number on you!
| tboyd47 wrote:
| _head explodes_
| qudat wrote:
| I agree. The FDA should be a watch dog group that provides us
| with the knowledge to make our own decisions. How many people
| have died because a drug took too long or never made it to get
| approved?
| dcolkitt wrote:
| I agree. And regardless of where you stand on the issue, the
| current regulations with regards to off-label usage are totally
| inconsistent. Doctors are perfectly free to prescribe drugs for
| conditions that are completely unrelated to the what they were
| approved for.
|
| Drug X is proven safe but not proven effective. It's illegal to
| use to treat condition Q under any circumstances. Drug Y is
| proven safe, proven effective for condition M. It's perfectly
| legal to use for unrelated condition Q. How does this make any
| sense?
| spiorf wrote:
| Because it cuts economic incentive to produce ineffective
| (but safe) drugs on purpose.
| SpicyLemonZest wrote:
| Maybe, but it's not clear to me that the FDA is (or should
| be) experts in weighing economic incentives for good
| behavior. There's plenty of bad economic incentives created
| by the current FDA process; just ask the Lovaza guys,
| charging a 10x markup for fish oil. In an ideal world, I
| don't think the FDA should have any role in drug approvals
| other than preventing direct medical harm.
| [deleted]
| radus wrote:
| This would likely lead to a pharmaceutical landscape that is
| more like the supplements industry -- no thank you.
| mcguire wrote:
| " _The 11-member committee voted nearly unanimously in November
| that Biogen 's drug should not be approved, citing inconclusive
| evidence that the drug was effective._
|
| " _The FDA on Monday gave the drug "accelerated approval," based
| on evidence that it can reduce a likely contributor to
| Alzheimer's, rather than proof of a clear benefit against the
| disease._ "
|
| Aren't we on the third or fourth round of "likely contributor to
| Alzheimer's" that turns out not to provide significant benefits?
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