[HN Gopher] FDA head asks for investigation into Aduhelm drug ap...
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FDA head asks for investigation into Aduhelm drug approval
Author : tima101
Score : 128 points
Date : 2021-07-10 15:54 UTC (7 hours ago)
(HTM) web link (www.businessinsider.com)
(TXT) w3m dump (www.businessinsider.com)
| loa_in_ wrote:
| Unfortunately the link is unavailable in Poland:
| https://imgur.com/a/48MFia6
| vmception wrote:
| Is the aduhelm company publicly traded? Seems like a lot of fun
| volatility upcoming on binary outcomes
|
| If I was a gambling man, which I am, I would add this to my paid
| newsletter and call it investing (with contradictory and
| nullifying disclaimers of course)
| [deleted]
| quickthrowman wrote:
| > Recent advances in amyloid imaging have made it possible to
| observe Ab amyloid accumulation in the patient's brain. As a
| result, it has been found that there are many normal patients
| with amyloid deposits, and also AD patients with very few amyloid
| deposits (Edison et al., 2007; Li et al., 2008). [0]
|
| How long is it going to take for the scientists who have built
| their career on the amyloid hypothesis to die out so new ideas
| can be investigated?
|
| [0]
| https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5797629/#s3titl...
| anonuser123456 wrote:
| One has to only look at the dumpster fire that is the USDA
| nutritional guidelines to know "never".
| AnimalMuppet wrote:
| "Die out". Everybody dies eventually. It's just a long
| process waiting for science to progress by funerals.
| quickthrowman wrote:
| Indeed, plate tectonics (sort of, Wegener had the idea but
| no evidence/proof) and hand washing for doctors/surgeons
| both faced widespread opposition, just off the top of my
| head.
| ficklepickle wrote:
| mRNA is another example
| heavyset_go wrote:
| Not to worry, there are plenty of opportunists who will
| line up to carry the torch once the older ones die.
| peytn wrote:
| Great. Speaking from first- and second-hand experience, the FDA
| is way more loosey-goosey than people think as long as you're
| paying the right people.
| eddynol wrote:
| Cuz it's a hard job. Try telling someone in a position of
| serious power who is going to loose his kid next year to back
| off. Who wants that job? Put your hand up.
| mperham wrote:
| What's the alternative? Allow snakeoil? Now insurance has to
| cover it, incentivizing the creation of more ineffective
| drugs? Trust in efficacy is critical.
| WarOnPrivacy wrote:
| Pharma lobbyists gained enough control over FDA oversight to
| get a failed Alzheimer's drug approved.
|
| I'll put my hand up to perform ethically at my job and not
| allow regulatory capture.
| throwawaygh wrote:
| _> Pharma lobbyists gained enough control over FDA
| oversight to get a failed Alzheimer 's drug approved._
|
| We'll see. What's playing out now is exactly how robust
| institutions work. Individual components can be corrupted,
| but the institution has a whole holds because of checks and
| balances.
|
| Here, one individual component of the FDA was compromised,
| but other checks-and-balances are coming to bear (namely,
| inclusion of Scientific Advisors in the review process,
| public records, and political accountability at the top).
|
| When an unconstitutional law is passed, it's law. Until a
| court strikes it down. If an unconstitutional law is passed
| and then struck down by a court, that's not the system
| failing. That's individuals within the institution failing
| but the institution as a whole working exactly as intended.
|
| _> I 'll put my hand up to perform ethically at my job and
| not allow regulatory capture._
|
| But that's not what he asked you to volunteer for. He
| didn't ask you to perform ethically at a job. He asked you
| to actually go get a PhD, do a post-doc or two, and then
| turn down well-paying industry jobs to work at the FDA and
| get demonized all day. Which, speaking as someone who has
| turned down similar types of government jobs because I
| could make 5x in the private sector, is quite a bit more of
| a sacrifice than I think you realize. (This isn't meant to
| excuse unethical behavior, btw, it's just that your comment
| is literally not responsive to GP's and GP is exactly right
| -- those jobs suck and if we want fewer failures like this
| one maybe we, the people, as the employer, should be at
| least paying market rate.)
| WarOnPrivacy wrote:
| > But that's not what he asked you to volunteer for. He
| didn't ask you to perform ethically at a job. He asked
| you to actually go get a PhD, do a post-doc or two, and
| then turn down well-paying industry jobs to work at the
| FDA and get demonized all day.
|
| That doesn't seem to be what he asked. He asked us to
| _Try telling someone in a position of serious power who
| is going to loose his kid next year to back off._
|
| It isn't clear what losing a kid has to do with qualified
| officials approving a failed Alzheimer drug, ostensibly
| in blatant and clear violation of their own protocols.
| Presented with that non-sequitur, I chose to restate the
| event in play.
| pfisherman wrote:
| What experience have you had? How many INDs, 510ks, etc have
| you worked on? Because this does not line up with my experience
| at all. IME FDA is very anal about even the appearance of the
| conflict of interest, and loosey-goosey is the last descriptor
| you would ever want to use for any interaction with FDA.
|
| That being said, informal interactions where FDA talks you
| through regulatory options do happen for high priority / unmet
| need diseases, but there the "friendlies" are compartmentalized
| away from the those who review the applications.
|
| My guess is that the review will show that someone from FDA met
| with the company to facilitate the application because
| Alzheimer's is a priority disease, but strict
| compartmentalization from the review process was maintained. If
| not, then someone is getting fired.
| rgrieselhuber wrote:
| What does that mean for the Covid vaccines?
| seriousquestion wrote:
| Maybe nothing, maybe a lot. Big pharma has huge influence in
| the government. The vaccines are authorized under emergency
| use, which is predicated on not having alternatives. That
| there is a campaign to discredit cheap off patent
| alternatives (Ivermectin) is at least concerning.
| pjc50 wrote:
| Ivermectin is not and cannot be a vaccine. Even the people
| promoting it only claim an improvement in symptoms. And
| I've not seen an explanation of how it's alleged to work?
| khuey wrote:
| There's a "campaign to discredit cheap off patent
| alternatives" because they don't actually work and people
| are going out and poisoning themselves with pills made for
| horses.
| seriousquestion wrote:
| Taking a horse quantity of any drug is unwise, even one
| that won the 2015 Nobel Prize (Ivermectin). It still
| needs large scale RCTs for Covid-19 use, but there are
| some small trials that at least indicate it should be
| taken seriously and not outright discredited and smeared.
|
| "Meta-analysis of randomized trials of ivermectin to
| treat SARS-CoV-2 infection" - "there was a 56% reduction
| in mortality; p=0.004 .. with favorable clinical recovery
| and reduced hospitalization."
|
| https://academic.oup.com/ofid/advance-
| article/doi/10.1093/of...
|
| "Ivermectin was associated with decreased mortality in
| patients with COVID-19... The certainty of evidence for
| mortality reduction was low."
|
| https://www.sciencedirect.com/science/article/pii/S187140
| 212...
| Mountain_Skies wrote:
| Of course. Veterinary pharmaceuticals have very different
| manufacturing standards, approvals, and dosages. It's
| unfortunate that so many have been pushed into this path
| by authoritarians who have in under a year turned the
| medical establishment's credibility into a pile of dust.
| WarOnPrivacy wrote:
| I see a choice of going down the Invermectin rabbit-hole
| where the framing and presentation feels a lot like an
| MLM campaign (except saturated w/ conspiracy) - or
| walking into a local store and getting sound ~95%
| efficacy w/ a pair of free Moderna shots.
|
| The latter really seems more compelling to me.
| seriousquestion wrote:
| These shots are not FDA approved yet. Usually that's
| compelling enough to look for and consider alternatives.
| Especially existing cheap off patent drugs that have been
| used billions of times over the course of decades and
| recently won the Nobel Prize. If that plus many doctors
| and small trials indicate promise with Covid-19, we
| should take that seriously. That's all.
|
| "The Moderna COVID-19 Vaccine is a vaccine and may
| prevent you from getting COVID-19. There is no U.S. Food
| and Drug Administration (FDA) approved vaccine to prevent
| COVID-19."
|
| https://www.fda.gov/media/144638/download
|
| None of this is to say that the vaccines aren't safe or
| shouldn't be used. They should be, especially for those
| at risk. The vaccines may well be better than Ivermectin
| and so far it appears that way. But there is some nuance
| here and it's valid if people want an alternative until
| the shots are FDA approved and have long term data. Many
| are not engaging in critical thinking when it comes to
| this issue and suddenly have complete trust of big
| pharma. Which I find bizarre.
| exmadscientist wrote:
| > Many are not engaging in critical thinking when it
| comes to this issue and suddenly have complete trust of
| big pharma.
|
| I wasn't first in line to get any of these vaccines.
| Distrust of anything new is pretty rational!
|
| But hundreds of millions of doses delivered, with a
| complication rate significantly less than the disease
| itself... that's pretty powerful evidence, no?
|
| Especially compared against drugs that have yet to
| convincingly beat placebos in any large trial?
|
| Personally, I find it bizarre that anyone can weight
| those two sets of evidence so differently.
| seriousquestion wrote:
| Yes, but you also have to weigh the fact that we don't
| know what the long term effects may be. Some people would
| rather trust their immune system, with or without drugs
| that have been in use for decades. That's not my personal
| calculation, but I can see why others would net out that
| way. Particularly women who are concerned about the
| possible effects on fertility.
| khuey wrote:
| When the FDA finally grants full approval to the vaccines
| the goalposts will just move again to something else.
| pjc50 wrote:
| The 2015 prize was for its use against worms:
| https://www.isglobal.org/en/healthisglobal/-/custom-blog-
| por...
|
| It's not clear how that relates to respiratory medicine.
| jollybean wrote:
| Folks you need to realize the difference between
| 'material discussion' within the scientific community
| etc. and 'drug populism' i.e. people making stuff up on
| Twitter and that information flowing to millions.
|
| Nobody is 'smearing' the drug or even the people talking
| abot it.
|
| They're saying 'stop telling the public about it because
| it's not approved yet and potentially dangerous'.
|
| Whatever Donald Trump says - people believe. And they
| will go out in droves, self diagnose, self medicate,
| demand doctors prescribe them the 'cure' (when the doctor
| knows they shouldn't) etc..
|
| And the amount of stupid conspiratorial memes that come
| up are pretty shocking. I avoid FB fro this reason and
| TikTok had a bunch of that for a bit, but I think they've
| shut down Ivermectin talk.
|
| I quite like Joe Rogan, but he's not a doctor, and
| neither is his partner in goofydom Brett Weinstein, they
| have zero medical credibility on the issue, they should
| straight up not be talking about the drug.
|
| If there is some kind of coverup, or there's hard
| evidence and the FDA is refusing to look at it, or if
| someone in Big Pharma bribed someone else ... then that's
| a story, but this is not that.
|
| Oxford has just launched a trial for Ivermectin, and
| there are others. When the results come in, and if it
| works and is safe, then CNN et. al. will talk about it
| and parameterize it appropriately. We'll all hear about
| it pretty quickly.
|
| The CDC can't stop Joe Rogan from talking about it and
| the haven't tried, but they can say 'STFU' until we have
| done the _actual_ science, which is reasonable.
| pumpkinandspice wrote:
| > I quite like Joe Rogan, but he's not a doctor, and
| neither is his partner in goofydom Brett Weinstein, they
| have zero medical credibility on the issue, they should
| straight up not be talking about the drug.
|
| By this logic, this applies to every single person that
| aren't doctors who shouldn't be talking about the vaccine
| or the drugs. This includes data scientists and
| politicians. I've watched Dr. Pierre Kory's full
| interview with Brett and seems clips of his testimony in
| front of the senate. He is extremely credible and should
| have a voice in this as a COVID-19 critical care doctor
| and who has done meta analysis of the drug
| (https://covid19criticalcare.com/wp-
| content/uploads/2020/11/F...). I think people like Joe
| and Brett help amplify voices of people like Dr. Pierre
| Kory similar to politicians who amplifies Dr. Fauci
| jollybean wrote:
| So I think you might be misunderstanding my point a bit.
|
| Scientists and Doctors should be talking about it in
| scientific forums and communities. Politicians should be
| reiterating the 'current consensus'.
|
| People shouldn't be talking about it in public / tabloid
| forums because the information is vague, misrepresented
| and will be taken entirely out of context.
|
| I totally support people taking contrarian positions.
|
| I think we should probably assign people towards being
| 'The Devil's Advocate'.
|
| The issue is not 'freedom of expression and open
| dialogue' - it's one of 'crude populism and
| misinformation'.
|
| It's about how information is propagated, and how people
| react to it.
| raphlinus wrote:
| It's not holding up so well in RCT's, like this one[1]
| that was just discussed on TWiV 778[2].
|
| BTW, I've joined the legions who are addicted to TWiV.
| It's a time commitment for sure, but it's fascinating how
| different the perspective is on important topics (like
| delta variant) than the mainstream press.
|
| [1]: https://bmcinfectdis.biomedcentral.com/articles/10.1
| 186/s128...
|
| [2]: https://www.microbe.tv/twiv/twiv-778/
| Mountain_Skies wrote:
| Did you have the same amount of confidence in your
| opinion when the lab leak theory was forbidden to
| discuss? If people are going to farm stores for medicine,
| that's a reflection on the absolutely deplorable state of
| credibility that the medical establishment has earned
| themselves over the past year. Doing more of the same
| isn't going to magically make trust in authority
| reappear, it's going to erode it even more.
| phonypc wrote:
| Even if ivermectin were as effective as some people would
| like to believe, and widely used for COVID, it wouldn't be
| an alternative to the vaccines in the sense of preventing
| their emergency use authorization.
| Mountain_Skies wrote:
| Perhaps but being honest instead of resorting to the
| smear tactics of the past year would help start
| rebuilding the ruins of the medical establishment's
| credibility. What good is it to keep pushing out
| disinformation "for the public's own good" when it
| results in more and more people looking to alternative
| (and often very dubious) sources of medical advice?
|
| What we need is a policy of absolute honesty with a one-
| strike-and-your-out-forever punishment for any health
| authority that engages in propaganda, even if they had
| good intentions. Credibility matters. It matters a lot.
| All of these coy little word games and character
| assassinations being conducted in the name of the common
| good is achieving the exact opposite result. As it stands
| now, the credibility of the medical community might be
| forever tarnished especially since there appears to be no
| attempt to get it back but rather endless doubling downs
| on the slime tactics that should be to exclusive province
| of political campaign directors and used car salesmen.
| wizzwizz4 wrote:
| > _What we need is a policy of absolute honesty with a
| one-strike-and-your-out-forever punishment for any health
| authority that engages in propaganda, even if they had
| good intentions._
|
| Won't work, unless there are multiple health authorities
| - but the average person isn't going to keep track of the
| reputation of multiple small health authorities, so the
| authorities will have comparatively less reputation at
| stake.
|
| You are onto something, though. Consider fleshing it out
| a bit before reading what other people are talking about.
| (ROT13: cerqvpgvba-onfrq zrqvpvar)
| jollybean wrote:
| The problem is people irrationally believe that a
| 'vaccine is unsafe' but at the same time 'some other drug
| is safe' and might therefore take the drug.
|
| My father is kind of scared of the COVID vaccine -
| understandable.
|
| But he gets his 'flu shot' (and a bunch of other things)
| by the doctor all the time.
|
| He has zero problem running all the other tests, taking
| pills and taking the 'flu shot' which is _literally a
| vaccine_!
|
| But he also reads stupid conspiracy theory stuff on
| Facebook and watches Fox News, and I believe to this day
| he has not been vaccinated.
|
| That's how powerful misinformation can be.
|
| My bet is that he'll probably take Ivermectin if he's
| heard about it on Facebook a bunch of times as being that
| 'safe drug that the government tried to hide'.
|
| My father is not a dumb man, and neither are most of the
| people involved in this - but about 40% of the population
| can't effectively deal with information. They will take
| the drug depending whether Biden or Trump told them to
| take it.
| seriousquestion wrote:
| Your father is erring toward things that have been proven
| over time. The flu shot has decades of use and data. So
| does Ivermectin (the open question is how effective it is
| wrt Covid-19). They are proven safe. They are FDA
| approved, Covid shots are not. It is perfectly rational
| to seek treatments that are FDA approved and have been
| used for decades.
| pumpkinandspice wrote:
| 100% agree that 40% or even more now can't effectively
| deal with information, nor can think critically for
| themselves. It's so politicized that you are either camp
| A or B (liberal or conservative). One side being 'vaccine
| is the only way' and the other is 'vaccine unsafe, other
| drugs are safe'. There seems to be very little people in
| the middle who can say 'vaccines are generally safe but
| we don't know the long term side effects so we must look
| at alternatives now for those that choose not to take it
| or cannot take it for medical reasons'. Also it's
| important for people to assess their own risk profile to
| make the decisions for themselves (if they decide not to
| take it).
| khuey wrote:
| > The problem is people irrationally believe that a
| 'vaccine is unsafe' but at the same time 'some other drug
| is safe' and might therefore take the drug.
|
| It's wild to see people grasping at random anti-
| parasitics as some sort of miracle cure when (if you're
| over the age of the 12 and in the US) you can literally
| walk into any pharmacy and get a real miracle cure for
| free.
| WarOnPrivacy wrote:
| Nothing, I believe. Every drug approval isn't suspect. Just
| the ones where pharma lobbyists get to spend the power they
| bought thru beefy campaign contributions.
|
| Also - Covid vaccines were under intense public and medical
| scrutiny, during every bit of their development.
|
| Good government and transparency tend to go together.
| pjc50 wrote:
| A lot of simultaneous trials have been run globally, and the
| only contra indication so far seems to be a slight clot risk
| with AstraZeneca.
|
| You might be able to buy off the FDA, but it's a lot more
| work to buy off all the regulatory authorities of the world,
| at short notice.
| dang wrote:
| If you're going to make a comment like that it would be much
| better to share some of the experiences you're talking about--
| it would add substance, and be much more interesting.
| gnicholas wrote:
| > _The drug in question, Aduhelm, was approved by the agency last
| month and has caused an uproar in the scientific community. Three
| of the agency 's scientific advisors resigned following the
| decision._
|
| Is this sort of thing common? Seems like an investigation is
| definitely warranted if this type of resignation is a rare as I
| would imagine it be.
| Exmoor wrote:
| I'm sure there have been many controversial FDA decisions
| before, but this one seems significantly different. The
| reactions from normally even-keeled medical journalists have
| been blistering [0] and it's apparently already set a precedent
| that has resulted in other similar therapies which have also
| not shown any sign of improving outcomes, starting to be
| approved as well [1].
|
| [0]
| https://blogs.sciencemag.org/pipeline/archives/2021/06/08/th...
|
| [1]
| https://blogs.sciencemag.org/pipeline/archives/2021/06/24/op...
| jrochkind1 wrote:
| I think the FDA board resignations and general scientist
| outcry is notable and not routine, but it didn't set the
| precedent on it's own, it's been a trend long in development.
|
| From January 2020 (17 months before aduhelm approved):
|
| https://www.npr.org/sections/health-
| shots/2020/01/14/7962270...
|
| FDA Approves Drugs Faster Than Ever But Relies On Weaker
| Evidence, Researchers Find
|
| > Almost half of recent new drug approvals were based on only
| one pivotal clinical trial instead of the two or more that
| used to be the norm, according to the study published Tuesday
| in JAMA, the journal of the American Medical Association. And
| the reliance on surrogate measures -- stand-ins for presumed
| patient benefits -- has increased. In the case of cancer
| drugs, a surrogate measure could be shrinkage of tumors
| instead of improvements in survival after treatment.
|
| > ...Drugmakers also began paying the FDA fees to fund the
| review process after AIDS activists protested the agency's
| sluggishness in the 1980s... "There is some concern about the
| incentives that this is created within the FDA," Darrow says.
| "And whether it has created a culture in the FDA where the
| primary client is no longer viewed as the patient, but as the
| industry."
|
| ["surrogate measures" is a complaint with aduhelm approval,
| when they say there was no "evidence showing the drug slowed
| the disease", they mean the approval was based only on
| surrogate measures.]
| wyxuan wrote:
| Nitpick, I have a great deal for respect for Derek but he
| isn't a journalist (and nor does he claim to be).
|
| It's just a column.
|
| But that's not to say the reactions from journalists weren't
| critical. Adam from Stat had some choice words about the
| decision.
| timy2shoes wrote:
| My personal opinion: I respect the opinion of a medicinal
| chemist working in the field of drug discovery more than I
| do a journalist. The insider who works in the field
| understands the issues and problems of getting drugs to
| market more than an outsider.
| mcguire wrote:
| In other words, it's a column by a guy who spent his career
| in drug discovery. Not merely a journalist.
| pjc50 wrote:
| I'm not sure that's a useful distinction, it's not a
| chartered profession. Someone who writes a weekly column
| for money is a journalist in the way that someone who
| writes software for money is a programmer.
| eli wrote:
| There's a pretty big distinction in the journalism world.
| It's more like saying anyone who uses a computer for work
| is a programmer.
| ElViajero wrote:
| I hope that the FDA has learned from the U.S. Federal
| Aviation Administration and the Boeing 737 MAX catastrophy.
| Credibility is easy to be lost and hard to be gained again.
| DubiousPusher wrote:
| It's especially conspicuous given how lucrative this specific
| drug is expected to be.
|
| The drug Humira for example is a drug with a similar cost and
| schedule that is used to treat chronic auto-immune diseases.
| Humira was similarly a first of its kind drug that for the
| disorders it is used to treat. It became perhaps the most
| lucrative drug in U.S. history eventually leading to the
| company that made it spinning it off into its own company. It
| has sent pharmas across the world scrambling to enter the
| market, with many of them doing quite well too. And dementia is
| an even bigger market than autoimmune disease.
| db48x wrote:
| 90% of all drug candidates that are brought to the FDA for
| approval fail one of the FDA's required studies. It is probable
| that some of the 10% that pass and are approved are marginal,
| and someone at the FDA has to make a judgement call. Thus it is
| likely that occasionally a drug is approved which later turns
| out to be ineffective or even dangerous. But it seems to happen
| fairly rarely, and it's quite rare that people resign in
| protest.
| hanselot wrote:
| In reality mail-in emergency authorized gene therapy related
| mortality-cases are extremely rare and the FDA and WHO are
| bastions of integrity and truth. In fact, you will find that
| all the agents at the FDA have been secretly engaged in a
| campaign to "secure" the approval process, to protect our
| democracy and society from the evils of critical thought and
| reason.
| amanaplanacanal wrote:
| It looks like in this case it was known to be ineffective
| when it was approved. I thought the FDA was supposed to
| protect us from snake oil like this?
| mcguire wrote:
| When this came up originally here on HN, the point was made
| that it was known to be effective in reducing plaques
| (IIRC; against a symptom anyway), but was not known to be
| effective or ineffective against Alzheimer's.
| lazide wrote:
| They are - it's also a thing that corruption happens. There
| has been a lot more corruption than usual the last 4+ years
| in gov't offices, and it will be a long time before it's
| all identified.
| l33t2328 wrote:
| What evidence is there that there has been an abnormal
| amount of corruption?
|
| What is the normal baseline?
| uvnq wrote:
| It may also just be that more corruption is being
| exposed.
| kbelder wrote:
| I suspect the baseline is measured in outraged Twitter
| posts per hour.
| Supermancho wrote:
| This is _some_ data about corruption over the years
|
| https://trac.syr.edu/tracreports/crim/646/
| WarOnPrivacy wrote:
| FDA's state of compromise goes a lot farther back than 4
| years.
|
| ref: https://www.forbes.com/sites/matthewherper/2016/09/2
| 0/approv...
| naasking wrote:
| Just go back to the history of anti-depressants 20+ years
| ago. Technically they don't work any better than placebo.
| db48x wrote:
| Yea, that's what I mean. If the evidence was merely
| equivocal, as in there was some evidence in favor but not
| as much as expected, then nobody would have resigned. In
| this case their last study was "halted for futility", which
| makes the approval pretty egregious.
| gnicholas wrote:
| What I couldn't tell was whether the "scientific advisors"
| are FTEs or some other role. It would take a lot for someone
| to give up a government job/pension, so three resignations of
| that nature would be incredible. But if these are just part-
| time consultants, the statement would be less notable.
| sgent wrote:
| These are outside advisors, probably about 1/2 of them or
| more are academics as well as patient advocates, etc. They
| maybe paid some amount, but its not their primary income
| source.
| wiredearp wrote:
| If it's a fake drug that's been priced at a level to break
| American health care [1], they could potentially be this
| kind of employee that actually care or perhaps they just
| considered the corruption too obvious even for the FDA and
| wanted to clear themselves of charges.
|
| [1]
| https://www.theatlantic.com/ideas/archive/2021/06/aduhelm-
| dr...
| jdavis703 wrote:
| Government STEM positions tend to be under paid vs the
| private sector. A lot of these people are taking a pay cut
| because they want to serve the greater good or work on an
| interesting problem.
| elil17 wrote:
| A government agency requesting an investigation into its own
| actions from an inspector general is not that weird. It can
| happen for a variety of reasons.
|
| Sometimes, the agency is confident that it handled things
| correctly, so they want an auditor to come in to prove it to
| the public and reassure everyone that nothing untold happened.
| Other times, the agency suspects internal wrongdoing but lack
| the resources to investigate it without disrupting their day-
| to-day operations. It can also be a political move from a
| presidential appointee when they suspect that the investigation
| will uncover that it was their predecessors fault.
|
| At the end of the day, though, inspectors general have wide
| latitude to investigate what they choose. HHSOIG would probably
| have investigated this anyway, so it's just a good PR move for
| the agency to invite the scrutiny.
| loceng wrote:
| In 2011 an ex-FDA advisor who had voted to approved LASIK eye
| surgery, published a letter to FDA asking them to immediately
| recall LASIK as there was data they were ignoring that they
| shouldn't have been ignoring;
| https://www.phillyvoice.com/former-fda-adviser-lasik-dangers...
| Exmoor wrote:
| Full headline (presumably cut for HN length restrictions) is:
|
| > The head of the FDA is calling for an investigation into her
| agency's controversial decision to approve a new Alzheimer's drug
| WarOnPrivacy wrote:
| That decision was so overtly concerning, I already knew what
| the headline was about.
|
| I'm suspect that a lot of lesser, bad behavior had to go
| unchallenged, for us to wind up with a decision that was this
| blatantly corrupt.
| dang wrote:
| The HTML doc title fits the 80 char limit so we've switched to
| that.
| fnord77 wrote:
| > _we have investigated ourselves and have found no wrong-doing!_
| lend000 wrote:
| The baseline reaction I'm seeing from commenters is appalling.
| This drug has been shown to NOT be particularly dangerous in
| clinical trials, while having a biochemical effect on amyloid
| protein buildup, which has strong correlations with degenerative
| brain diseases. It's another tool in the arsenal. There's no
| evidence that it cures one of the worst diseases around, but that
| shouldn't be the requirement for whether the public (only after
| having it prescribed by a medical doctor, mind you), has access
| to a drug.
|
| How can you be pro-Marijuana and then not trust doctors to have
| another tool in their arsenal? The FDA should exist to prevent
| fraud and monitor quality, and nothing else. In this case, it
| would be highly reasonable to restrict the claims of the drug
| based on the study. But to ban it? What gives you or them the
| right to protect people from themselves?
| burnished wrote:
| Probably the appalling upfront profit motive driving it. Yeah,
| I think thats probably it.
| lend000 wrote:
| Yes, how dare they try to sell a bioactive compound that cost
| billions to produce for... money! Especially to willing
| buyers only after prescribed by a medical doctor!
|
| In your fantasy world, I suspect there isn't a lot of
| technological progress.
| tsimionescu wrote:
| Yes, actually, how dare they sell a substance with no known
| effect on any disease as 'Alzheimer's medicine', just
| because they might lose some money if they don't? How dare
| they market this to desperate people willing to try
| anything?
| quickthrowman wrote:
| > How can you be pro-Marijuana and then not trust doctors to
| have another tool in their arsenal?
|
| It doesn't cost $55,000 a year to smoke weed, and if nothing
| else weed will get you high. Most people have a problem with
| Medicare paying for this drug, not people taking the drug
| itself.
| lend000 wrote:
| And if someone created a strain and tried to sell it for 55k
| a year, you would then support the FDA banning it, instead of
| letting people decide for themselves?
|
| You're right about Medicare, though. A socialized healthcare
| system creates negative incentives (for example, banning
| things that might be costly, instead of letting the market
| direct that item to people willing to pay more).
|
| I always struggle to relate to many people's infantilism. You
| aren't a baby, and other adults aren't babies. If people can
| vote, sign up for the military, etc., then they can make a
| decision about their own body given accurate information.
| quickthrowman wrote:
| The FDA does not regulate marijuana strains. If someone
| wants to pay $55,000 for weed so be it, but socialized
| medicine shouldn't pay for treatments with no efficacy.
| lend000 wrote:
| After accurately describing the problem, would you now
| say that the real root of the problem is our socialized
| healthcare system, or having choice in drugs?
| tsimionescu wrote:
| It's not a matter of infantilism. Calling this substance
| 'medication' when it has not been proven to have any affect
| at all on any disease is simply fraud. Marketing it as
| medication will be like marketing homeopathic junk as
| medicine.
| heavyset_go wrote:
| > _And if someone created a strain and tried to sell it for
| 55k a year, you would then support the FDA banning it,
| instead of letting people decide for themselves?_
|
| Are they making medical claims that aren't backed up by
| evidence?
| pg_bot wrote:
| The problem with this particular drug is that there is no
| evidence that it leads to longer or better lives for the
| patients who have taken it. Therefore there is no real reason
| to prescribe it for Alzheimer's, but it will be prescribed and
| it will cost American taxpayers billions.
| alasdair_ wrote:
| The solution seems to be to ban medicare/medicaid from paying
| for any treatment that isn't proven to work.
| tsimionescu wrote:
| It's not just a problem for Medicare/medicaid. BioGen will
| be allowed to push this through their marketing to
| desperate patients and caregivers, who will nag their
| doctors into prescribing it, even though they could just as
| well drink a glass of water.
| tsimionescu wrote:
| > while having a biochemical effect on amyloid protein buildup,
| which has strong correlations with degenerative brain diseases.
|
| That correlation has actually been turning out to be very weak.
| The very studies conducted to test this drug are some of the
| proof (reducing amyloid buildup doesn't affect disease
| progression), And there is also mounting proof from brain
| imaging that Amyloid buildup exists in the brains of many
| people with no mental problems.
|
| And in general, if we _know_ the drug does nothing at all, why
| allow the company to force doctors to prescribe it (by
| marketing to desperate patients)?
|
| The drug can still be used in new research. But unless and
| until research shows that it has an effect on some disease, it
| should be illegal to market it as medication. At best it could
| be sold as a supplement, for those gullible enough to try it.
| lend000 wrote:
| > it should be illegal to market it as medication
|
| That's exactly what I stated. But banning substances outright
| is anti-science and anti-freedom. Just prevent fraud, and
| make sure it isn't poison.
| tsimionescu wrote:
| FDA approval is needed to seek something as medication. If
| they want to package it as a supplement, they can sell it
| today.
| phnofive wrote:
| The risk/benefit model is broken here: Some risk and no
| benefit. I'm not going to even address the cost - the benchmark
| for benefit is incredibly low. All BioGen needed to show was
| that their drug delayed progression of cognitive impairment for
| a few months, and they couldn't do it.
|
| The FDA acknowledged as such in their conditional approval,
| weakly suggesting expanded access might allow BioGen to
| demonstrate this in a larger population. This would lead
| Medicare to pay for an extensive, unethical study fueled by
| nothing more than the hopes of desperate patients and their
| caregivers.
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