[HN Gopher] When dying patients want unproven drugs
___________________________________________________________________
When dying patients want unproven drugs
Author : jseliger
Score : 82 points
Date : 2023-06-19 16:52 UTC (6 hours ago)
(HTM) web link (www.newyorker.com)
(TXT) w3m dump (www.newyorker.com)
| Havoc wrote:
| Sure. If we've got to test dangerous drugs on humans (which at
| some point you must) - this is about as ethical as it gets I
| think.
| renewiltord wrote:
| We appointed gatekeepers and gave them a gate. Now they keep the
| gate, though our salvation is on the other side. It is the nature
| of gatekeepers to keep gates. So we perish, our gates well-kept.
| tdeck wrote:
| The other side of the gate is Tijuana where you can spend your
| family's life savings to die in a clinic offering some quack
| treatment.
| renewiltord wrote:
| Haha, for others. Not for me. I do not constrain myself to
| the law even here in the US, so I'm okay.
| mynonameaccount wrote:
| What else do they have to lose? The problem with the US health
| care system is that everything is reliant on a medical
| professional. Want a blood test, a medical professional has
| generate it. Want a ultrasound, go to a medical professional
| first. I am in charge of my health. I don't need no stinking
| doctor who could give a shit what happens to me. They get paid no
| matter. I should be able to schedule and pay for a full body scan
| if I want.
| pookah wrote:
| [dead]
| juve1996 wrote:
| No, the problem is cost. The medical professional part is
| secondary because no one wants to pay for hypochondriacs who
| think their cough at 25 is stage 4 lung cancer based on webMD
| research, because getting a full body scan is expensive. If it
| was cheap then it wouldn't matter.
| lacker wrote:
| It seems like there's a lot of lower hanging fruit here. For
| example, we could let people in the US take any drug that has
| been approved in any of the EU, England, Canada, or Japan. A drug
| isn't really "unproven" if one of the world's top-tier medical
| establishments approves it.
|
| The core problem is that our current drug approval process is
| slow, expensive, and risk-averse. The medical establishment seems
| very inward-focused, ignoring what happens in other countries,
| even the countries that are just about as sophisticated as we
| are.
| tdeck wrote:
| I'm not sure what the ultimate cost/benefit to this proposal
| would be, but it's worth noting that thalidomide was approved
| in many other countries but not the US.
| hinkley wrote:
| I've forgotten what drug but I recall a lot of people being
| salty about five years back because there was a much more
| effective treatment in Europe for some chronic condition and
| the ETA for FDA approval was still multiple years. It's not
| often such a large time lag that but sometimes the deck gets
| stacked against you.
| H8crilA wrote:
| While you're at it please import the European payments system.
| I was laughing when I heard that bank account number (or some
| other number associated with the account, not sure about the
| name) is secret. Switch to IBAN today! IBANs are public, and
| payments between them usually cost significantly less than $1.
| In some bad cases $5.
| richiebful1 wrote:
| Secret? Bank account numbers are written on the bottom of
| personal checks
| Spivak wrote:
| I like this a lot and it would end my importing the good
| sunscreen from Europe because the FDA is reeeeeally slow.
| H8crilA wrote:
| Are you sure it's good sunscreen, and not just a lie about
| the SPF? There have been many of those around the world,
| stuff that's N sold as 1.5*N.
| Spivak wrote:
| What I get is La Roche-Posay Anthelios UVmune 400 Invisible
| Fluid. The American version doesn't protect as much against
| UVA because the new fancy filters haven't been approved by
| the FDA yet.
| Topfi wrote:
| A great choice, my favorite for daily wear, but Anthelios
| is basically sold everywhere over here.
|
| I have no dog in this fight, especially because as
| someone who often finds themselves defending EU
| regulations to people who grew up in the States, but I
| have a hard time following why the FDA appears to drag
| their heels on approving more advanced filters, whilst
| Australian, South Korean and EU regulators are all far
| quicker. Do these three major jurisdictions with
| historically the highest standards for sunscreens have
| more streamlined processes, are they willing to take more
| risks, is the FDA simply underfunded to handle
| throughput?
|
| It's especially odd considering other parts of FDA
| approval can often feel overly fast compared to other the
| regulators jurisdictions, especially when it comes to
| approving medical devices[0].
|
| [0] https://www.tctmd.com/news/medical-devices-cleared-
| faulty-pr...
| [deleted]
| 908B64B197 wrote:
| Isn't the answer simply: My body my choice?
| paxys wrote:
| Do you agree with the existence of the FDA at all then? Their
| entire job is to tell you what you can or cannot put in your
| body.
| randyrand wrote:
| I thought it was primarily to ensure standardized testing,
| labeling, etc.
| JimtheCoder wrote:
| "Their entire job is to tell you what you can or cannot put
| in your body."
|
| Isn't their job to tell businesses what they can or cannot
| sell to you to put in your body? Sorta different...
| paxys wrote:
| And in this case they are telling a drug company that they
| cannot sell an unapproved drug. Are you okay with that?
| JimtheCoder wrote:
| I'm not a fan of the FDA at all and the current clinical
| trial process. I was just commenting that I thought your
| statement as to what their responsibility was is
| incorrect.
| hanniabu wrote:
| Offer it for free, problem solved
| JimtheCoder wrote:
| How many pages would that legal liability waiver have to
| be...
| derefr wrote:
| Technically, the FDA regulates precisely one thing:
| labelling. They regulate what can be _marketed as_ a name
| with a conventional meaning ( "cheese" or "beef") or what
| claims can be made about a product in its marketing ("treats
| headaches", etc.)
|
| The FDA audit for adulteration because e.g. "beef with high
| levels of thyroid hormone in it" isn't what people expect to
| be getting if they buy something called "beef." If you _label
| the product as_ "beef with high levels of thyroid hormone in
| it", then it's fine! (Same reason "Cheez Whiz" isn't legally
| able to market itself as "cheese" -- it doesn't contain what
| people expect "cheese" to conventionally contain.)
|
| The FDA audit for drug safety and efficacy because you can't
| say "makes your headache go away" if it actually doesn't; and
| you can't _leave out_ "causes cancer in 1/10th of people who
| take it" if it _does_. (And for a novel substance, you can 't
| know _what_ claims you 're able to make or leave out, without
| first doing a trial; so any claims you make are considered
| invalid by default without such a trial.)
|
| If you don't make any claims, you don't have to prove safety
| or efficacy. Supplements are just drugs that don't make any
| claims.
|
| This is also why there are products on the market that
| contain the active ingredients of prescription-only drugs,
| but are freely purchasable -- these aren't _marketed as
| being_ for human consumption. (GBL, a recreational drug
| related to GHB, is sold on the open market as a "brake-drum
| cleaning fluid." And it actually _does work_ as a brake-drum
| cleaning fluid, so it 's not like the FDA can challenge
| that.)
|
| If you're wondering about making drugs illegal: the FDA
| doesn't (and can't) do that. The DEA does that.
|
| If you're wondering about making drugs "controlled
| substances": Congress does that. Then the DEA and the FDA
| both enforce those rules -- the DEA by preventing
| importation; and the FDA by preventing drugs from being
| marketed for sale that contain that active ingredient --
| basically treating it as an adulterant regardless of
| labelling. (Note that these are both _commercial trade_
| activities that are being restricted. Any chemical, no matter
| its controlled status, can be created, possessed, handled,
| _and consumed_ within the confines of a secure facility --
| "secure" meaning that the facility takes measures to ensure
| that the substances won't leave the premises. This is how
| e.g. MDMA trials are able to continue at some universities,
| despite MDMA being a controlled substance.)
|
| If you're wondering about making drugs prescription-only: the
| FDA _does_ determine this, but only kinda. More like, the Act
| of Congress that defines the FDA into existence, also defines
| the rules for whether a drug should be prescription-only.
| Drug companies are aware of the rules, and so they usually
| just make the drug prescription-only when it should be. The
| FDA is charged with catching violations, where a drug that
| _should_ be prescription-only was marketed OTC. (What is the
| rule itself? It basically boils down to "if the necessary
| claims made by the drug are arcane and/or subtle enough, that
| a non-medically-trained lay-person couldn't reasonably be
| expected to evaluate their own safety in taking the drug,
| without a medical professional to act as an interpreter --
| then lay-people should only be able to access the drug
| through a scrip from such a qualified medical interpreter."
| It's still fundamentally about claims and labelling!)
| bequanna wrote:
| Right, but consider that this is a group of people that is
| vulnerable and desperate. They are ripe for being taken
| advantage of.
| pixl97 wrote:
| Hold up, you're forgetting the whole libertarian model... "My
| body, my choice, except when you take advantage of me and
| then I turn the full strength of the taxpayer funded law
| enforcement apparatus against you"
| Zigurd wrote:
| No. For the simple reason that there are both legitimate
| investigative drugs and treatments, and there are quacks and
| hucksters preying on the desperate.
|
| Your body is not your choice when it gives quacks publicity,
| never mind revenue, to victimize others and spread
| disinformation.
|
| There is a lot to be dissatisfied with re conventional pharma
| and medical practice. But opening the door to cranks is not an
| improvement. You might be asking "How can you tell which is
| which?" One of these has publications, has trials planned, etc.
| The other has the usual signs of quackery.
| nitwit005 wrote:
| The problem tends to be the giant army of people and businesses
| that will happily lie to people about medical treatments.
|
| People believe the lies, get ill or die, and the swindlers walk
| away richer. There's a long, sad history of it.
|
| If you do have a terminal illness though, the government agrees
| with your premise: https://research.uci.edu/human-research-
| protections/clinical...
| civilitty wrote:
| Your body, your cutting edge personal pharmaceutical
| manufacturing facility - then yes, your choice.
|
| The FDA regulates the manufacturing and distribution of the
| drugs, not what you put in your body.
| ilc wrote:
| If you have good information, and your facilities to make a
| good decision... yes.
|
| Alas, the FDA and friends exist for a reason. Snake Oil, or
| even things that are downright harmful are out there, that
| people will sell as cures, or great things.
|
| To strawman: People say all natural is great. I remind them
| hemlock is all natural, but you probably don't want to digest
| it.
| ChainOfFools wrote:
| cancer is all natural too, as are influenza and literally
| every biological pathogen.
| Spivak wrote:
| And if the FDA played an advisory role certifying products
| but not outlawing unapproved goods and informed consent was
| required for an MD to dispense unapproved drugs I really
| don't see how we're worse off.
| krick wrote:
| It should be. It isn't. The usual situation.
| asdfman123 wrote:
| One complexity is that patients might not be in a good place
| to evaluate whether a drug is truly viable or it's what they
| actually want, and they might face pressure from doctors or
| drug companies.
|
| But I generally agree that it should be the patient's choice.
| Spivak wrote:
| We already have a process for this called informed consent.
|
| * Medication must be prescribed by and supervised by an MD.
|
| * Doctor has to give you paperwork explaining everything
| about the drug, that it's not approved and experimental,
| what the known side effects are _and personally go through
| it with you allowing you to ask questions._
|
| It's not currently required but you could also mandate a
| short cooling off period to avoid rash decisions.
|
| In an odd twist of fate the political faction that would
| love to eliminate the FDA also wants to eliminate informed
| consent because people are getting medical care they don't
| approve of. How dare the FDA tell you what you can and
| can't do with your body -- only we should be allowed to do
| that lololol
| zhivota wrote:
| Right, also the state has a vested interest here, because
| patients bankrupting themselves on snake oil will result in
| more public money being spent on treatment.
| Jun8 wrote:
| Very interesting question, touched on famously in The
| Hitchiker's Guide
| (https://hitchhikers.fandom.com/wiki/Ameglian_Major_Cow). Some
| thoughts to consider:
|
| * the person giving consent may not be fully aware of
| consequence or may not have the faculties to make an informed
| decision
|
| * even if they are, they may be forced by circumstances, eg. a
| father selling his kidney for his son's education
|
| * even if the above two are satisfied, the act may be morally
| deplorable to (parts of) society, eg.
| https://en.m.wikipedia.org/wiki/The_Ones_Who_Walk_Away_from_...
| (however, note that society is generally Ok with bodily
| sacrifice in wars)
| hinkley wrote:
| The negative consequences of their choices impact all their
| loved ones or everyone in their social circle.
|
| Also if you work in the hospital you may have to deal with
| some very disturbing shit if things go badly. People don't
| just turn into smoke when they die, and anyone who lived
| through the Pandemic should remember what a horror show a not
| dead patient can be.
|
| I had a running argument with a friend who was terrible at
| money management who got very grumpy when anyone addressed
| the issue of money. It was his choice and none of our
| business. Except group activities are affected by one party
| being broke all the time and bringing up money problems.
| People who care about you are affected by your decisions. You
| getting defensive about it is all about you, not us. See also
| our friend with health problems who would stay up late the
| night before or not eat well/prepare for an event and result
| in us having to manage them or bail out in the middle. That
| gets old really fuckin quickly.
| jseliger wrote:
| In my view, patients should have a "right to try," which is part
| of fundamental freedom--and this is particularly true for
| palliative-stage patients without a route to a cure anyway. They
| are risking essentially nothing.
|
| The FDA is too slow and that's costing lives:
| https://marginalrevolution.com/marginalrevolution/2021/08/th....
| The issue is personal for me, too, because I have a squamous cell
| carcinoma (SCC) recurrence in the tongue, and the treatment that
| is most likely to cure it is still stuck in clinical trials. In
| other words, there's a reasonable shot I perish because the FDA
| is slow, in which case I'll wind up in the "invisible graveyard"
| that Tabarrok discusses.
| paulpauper wrote:
| _and the treatment that is most likely to cure it is still
| stuck in clinical trials._
|
| it seems like you are contradicting yourself. if it's likely to
| cure, then that would be borne out by the trial? And then it
| would be rushed for approval. The vast, vast majority of clinal
| trials for cancer are unsuccessful. A 'successful' drug may add
| a few months of life vs placebo at a cost of $10k or more per
| month.
| Mattasher wrote:
| > if it's likely to cure, then that would be borne out by the
| trial? And then it would be rushed for approval.
|
| I'm not sure you know how long these things take, even when
| they work well.
|
| Also, the failure to show a positive clinical effect in a
| trial mean one doesn't exist, especially at the individual
| level.
| nitwit005 wrote:
| > They are risking essentially nothing.
|
| In some cases this is true, but people often want to risk their
| chance of survival with conventional treatments.
| sam2426679 wrote:
| What treatment is this? Atezolizumab? (I also have recurrent
| SCC of the tongue.)
| jseliger wrote:
| Moderna mRNA-4359:
| https://clinicaltrials.gov/ct2/show/NCT05533697.
|
| BioNTech has a similar treatment that's also been apparently
| slow to launch Phase III trials.
| car wrote:
| Sorry to read about your illness. Without knowing specifics, it
| is sometimes possible to get access to trial drugs via a
| compassionate use exemption[0].
|
| You could find out which centers close to you are part of the
| trial, and contact them about getting access to treatment.
|
| I've previously contacted a drug manufacturers directly to
| inquire about access via a trial center. This was for a
| pancreatic cancer drug made by Halozyme. The trial was
| ultimately halted due to disappointing results.
|
| Please take into account that a drug still in trial may
| ultimately fail to meet its endpoints, as in the above case.
|
| [0]https://www.fda.gov/news-events/public-health-
| focus/expanded...
| treeman79 wrote:
| Went through this for an autoimmune condition with extreme
| nerve pain. Support forums are full of people that say LDN is a
| fantastic drug and works wonders. I was on opioids begging
| doctors to let me try LDN so I could get off the opids. All
| Refused since they weren't familiar with LDN.
|
| I was finally able to get it online. I no longer take pain
| medication. Life is basically back to normal.
| jahnu wrote:
| On this topic here is an excellent examination of it
|
| https://timharford.com/2020/06/cautionary-tales-the-spreadsh...
| taylodl wrote:
| I understand where you're coming from, but as the parent of
| someone in the field of pharmaceutical research they have a
| different view.
|
| First, human beings aren't Guinea pigs. Yes, the FDA is slow -
| for damn good reasons. We didn't use to do things this way and
| then we changed it to fix problems. There are reasons things
| are the way they are and it's very well-understood in the
| medical field. Medicine is not a move fast and cause pain and
| suffering kind of field or move fast and kill people kind of
| field. They're very conservative.
|
| Two, since human beings aren't Guinea pigs when we _do_ do
| experiments on them with drugs that have been through a very
| thorough and extensive pipeline already, they 're looking for
| very specific things. This tends to make a very small
| population of patients eligible for a trial.
|
| Three, trials are expensive. These aren't drugs that have been
| scaled-out in production. The costs tend to be exceedingly
| exorbitant. The medical field is very well aware of the
| inelastic demand for their services and this opens up new
| avenues for the unscrupulous to prey on people. Like the used
| to do in the "good ol' days."
|
| Finally, the fact the treatment you would like to pursue is
| still "stuck" in clinical trials is indicative they're not
| convinced of the efficacy of the treatment. I can tell you lots
| of "promising" treatments never make it out of clinical trials.
| That's the nature of the beast. Most ideas are dead-ends.
|
| My advice? Don't chase unicorns. Sadly, I've watched too many
| people in my family die while chasing unicorns and getting
| obsessed with treatments that are in trial. There are _always_
| treatments in trial. Live your life and enjoy what time you
| have to the fullest.
| WalterBright wrote:
| The counter to this is Sam Pelzmann's "Regulation of
| Pharmaceutical Innovation" https://www.amazon.com/Regulation-
| Pharmaceutical-Innovation-...
|
| where he shows, with statistics, that moving fast saves more
| lives than it costs.
| idopmstuff wrote:
| > First, human beings aren't Guinea pigs. Yes, the FDA is
| slow - for damn good reasons. We didn't use to do things this
| way and then we changed it to fix problems. There are reasons
| things are the way they are and it's very well-understood in
| the medical field. Medicine is not a move fast and cause pain
| and suffering kind of field or move fast and kill people kind
| of field. They're very conservative.
|
| The problem with this is that they don't appear to be
| optimizing for the minimization of harm, which seems very
| obviously to be what they should be optimizing for. Instead,
| they're optimizing for the minimization of harm caused by new
| drugs/treatments/etc., while ignoring the harm caused by
| disease. It's all well and good to not cause suffering
| through your actions, but suffering caused by inaction (or
| slow action) is still very much suffering that's caused by
| your decisions.
| jseliger wrote:
| My advice to you is that if that's your view, don't take
| advanced drugs, but get out of my way if I want or need to,
| and get out of the way of others. You can pursue your path
| and I will pursue mine.
| msla wrote:
| Right to try is a cruel scam:
|
| https://sciencebasedmedicine.org/the-cruel-sham-of-right-to-...
|
| > So-called "right-to-try" is a cruel sham that holds out the
| false hope of survival to terminally ill patients and their
| families. In return, all they have to give up is patient
| protections and agree to pay to be guinea pigs to test a drug
| company's product. The product of an ideology that uses the
| terminally ill as shields to hide the ideological motives
| behind the law, which are to hobble the FDA, right-to-try is a
| terrible idea.
| AbrahamParangi wrote:
| Wild to say this to someone with everything to gain and
| little to lose. What is the terrible fate you're protecting
| terminally ill patients from? Is it worse than death?
| HWR_14 wrote:
| There are things worse than death. And then there are
| things that are bad when added to deaths. In the first
| category might be "scammers who absorb so much cash that
| they prevent real cures from being researched". In the
| second might be "people who squander their family's
| financial future on magic beans in futile attempt to live,
| but die anyway".
|
| No one would opt into volunteer to be in the second group.
| But, I can see a lot of, e.g. 50-year-olds, taking a risk
| thinking they can refill the college-education funds and
| retirement funds by just working longer than they intended.
|
| I would imagine when dying one of the comforting thoughts
| is that your estate will continue being able to care for
| loved ones after you are gone.
| AbrahamParangi wrote:
| I mean, end of life medical care is already incredibly
| expensive with very, very little benefit in terms of
| QALYs saved. We do it anyway. I fail to see how this is
| different, let people fight to live.
| HWR_14 wrote:
| No one is arguing people shouldn't be able to fight to
| live. In fact, the post you are responding to was only
| talking about if things are "worse than death".
|
| But in general for the larger point, we should make sure
| that people can fight to live, but that assholes aren't
| stealing from them by selling magic beans.
| omg_ponies wrote:
| You're displaying a serious lack of reading
| comprehension. End of life care provided by palliative
| specialists is completely different to "scammers who
| absorb so much cash that they prevent real cures from
| being researched" and "people who squander their family's
| financial future on magic beans in futile attempt to
| live, but die anyway".
| shadowgovt wrote:
| Historically, the protection was against death and
| destitution of the family when it was discovered that dad
| dying of consumption had mortgaged the house to the hilt to
| afford the overpriced opium.
|
| With the modern social safety net, perhaps the traditional
| protections can be relaxed.
| juve1996 wrote:
| > Is it worse than death?
|
| Sure, why couldn't it be? Maybe it has severe, painful side
| effects. There's a reason many people with stage 4 cancer
| and low chance of survival decide not to go back on chemo.
| Maybe it kills them earlier than expected. Then what?
| msla wrote:
| It's a way for Big Pharma to get cheap research by dangling
| false hope in front of the desperate.
|
| Of course some here would view that as a positive.
| megaman821 wrote:
| Since any unproven treatment has a chance to produce immense
| suffering, you would need to pair this with a right to end your
| life too. That isn't right that exists in too many places now.
| seanmcdirmid wrote:
| They had this debate in China recently and the problem was
| conflict of interest (lots of pricey snake oil for dying
| patients who can come up with the money). The market has to be
| regulated even for dying people, if only to prevent scams.
| RobotToaster wrote:
| Which is why there needs to be a process to approve
| experimental drugs as at least scientifically plausible.
|
| There's a difference between something that works at least in
| a petri dish or mice, and something with no plausible
| mechanism of action like homoeopathy.
| akira2501 wrote:
| That seems like a claims and marketing issue, which is
| entirely separate from merely producing a drug and selling it
| when asked. I think it's fine that the FDA regulates
| advertising, I don't think it's fine that they act as
| gatekeepers to pharmaceutical products.
| sacrosancty wrote:
| [dead]
| AlexAndScripts wrote:
| Perhaps you can just restrict it to companies with a history
| of bringing drugs to market with FDA approval? A little
| regulatory-capture, but probably worth it for the greater
| good.
| varelse wrote:
| [dead]
| mitthrowaway2 wrote:
| Perhaps the patients should be allowed to use experimental
| treatments only under the condition that it is offered for
| free; the upside for the company is that if it works, they
| get the evidence of efficacy.
| rafark wrote:
| This should be the solution. If they're trials for an
| unproven solution, why should they pay anything at all. I'm
| any case, it should be the other way around; it's the
| companies who should pay the person for subjecting them to
| something very likely to be dangerous and painful.
|
| In any case, I agree with the sentiment here. People should
| have the right to choose.
| ramraj07 wrote:
| This is how it already works - this is what a clinical
| trial is. If you want to include the data point of a
| medicine working well as admissible, then you better have
| more than one patient try it at a time. Unless of course
| your drug is so good at curing patients who are absolutely
| terminal (like ibrutinib was). But most meds are not that
| much of a blockbuster. Thus you don't know if a single
| patient survived if it's because this medicine was very
| effective or if it was just as good as any other available
| treatment regimen.
| iskander wrote:
| >This is how it already works - this is what a clinical
| trial is.
|
| That's not at all how clinical trials work. If and when
| someone decides to advance a drug to the next stage of
| development, it's done because they think there's a
| sufficiently profitable market at the end of the road. So
| lots of extremely promising drugs stall out if the
| numbers don't make sense. Furthermore, the trial
| enrollment process itself is cumbersome and often your
| only entrypoint is email "trials@pharmacompany.com" and
| hope you can a response and can navigate their arbitrary
| screening process. Speaking of screening: trials are full
| of exclusion criteria. They can get copy-pasted between
| trial protocols and often have no real reason excluding
| you. What's the washout period for your last line of
| chemo? Ever had any kind of immunotherapy? &c &c From the
| point of view of whoever is trying to get a drug approved
| it's better to be safe than sorry wrt any kind of
| uncertainty in a patient's medical status or treatment
| history. But that means that there might be a drug that
| looks extremely promising from previous trials but the
| only current trial excludes you for a small reason.
| ryanwaggoner wrote:
| I assume they meant that clinical trials are already free
| for the patient, as suggested by the comment they were
| responding to.
| Freebytes wrote:
| The problem with clinical trials is that they are looking
| for specific patients, though. And they will exclude
| patients that introduce confounding variables. Some
| studies exclude patients that are closest to death
| because they will interfere with the trial as well.
| Wowfunhappy wrote:
| > the upside for the company is that if it works, they get
| the evidence of efficacy.
|
| They don't, though. They need a control group.
| farseer wrote:
| They can then apply to launch formal clinical trials with
| a control group. This initial evidence of efficacy is of-
| course anecdotal evidence with more traceability.
| threatofrain wrote:
| I think it's common practice to give life saving
| treatment to the control group after there is some
| measure of confidence that the drug works.
| seanmcdirmid wrote:
| They don't exactly need a control group if the chance of
| living N weeks is effectively zero. They would need it
| for something like living N weeks and living N+1 weeks,
| but any kind of change from an individual expected
| outcome would be useful signal for maybe more rigorous
| testing.
| caeril wrote:
| There is a standard of evidence above guesswork and below
| controlled trials, that is still useful: you accumulate
| enough survival rate data of whatever specific terminal
| condition you're hoping to treat, and compare it to the
| baseline untreated survival rate, which is already known.
|
| Any statistically significant difference there can then
| incentivize a drug research company to invest in the
| (expensive) clinical controlled trial process.
|
| It's strange that people here are actually saying it's
| better to waste perfectly good research opportunities and
| watch patients die, than to risk having anything less
| than perfect evidence of efficacy.
| mitthrowaway2 wrote:
| The people who have already died to-date of your terminal
| illness aren't a good enough control group to tell that
| your cure works? This is the absurdity of frequentist
| statistics. If you can't tell the difference between
| recovering from the treatment and recovering by natural
| luck, then either the treatment is barely effective at
| all, or the doctor had no basis to tell you in the first
| place that you had a terminal illness.
| jostmey wrote:
| That is correct, the people that have already died are
| unable to act as effective controls. To establish the
| medicine causes the disease to go away, you have to use
| something like a randomized trial. Otherwise, causation
| is not established. It's a very difficult problem and a
| lot of smart people have try to come up with better
| systems.
| mitthrowaway2 wrote:
| With all due respect, why? This seems fallaciously wrong.
|
| It is rather akin to saying that I can't tell whether
| seatbelts reduce car-crash fatalities simply by comparing
| collision fatalities from 1967 seatbelt-lacking car
| models with otherwise-identical 1968 seatbelt-equipped
| models; I would need to actually randomly and secretly
| sabotage a certain percentage of the seatbelts from
| 1968-model cars, while deliberately ignoring everything I
| know about prior fatality statistics. Even if every
| automobile collision without seatbelts was fatal, and
| every collision after seatbelts became mandatory was
| survived, even if nothing about the cars or driving
| conditions had changed, you're implying that it wouldn't
| provide any evidence of the efficacy of seatbelts, unless
| we conducted a new trial from scratch with a randomized
| control group as though we had no prior data?
|
| What is the actual difference, in terms of causal
| evidence, between someone who died of the same disease
| before the study officially begins, and someone in the
| "control group" who dies after the study begins?
| shadowgovt wrote:
| Almost nothing about medicine operates nearly as cleanly
| as that example; that's one of the major challenges with
| medical science. The seatbelt analogy breaks down in this
| context because the hypothetical of "Even if every
| automobile collision without seatbelts was fatal, and
| every collision after seatbelts became mandatory was
| survived, even if nothing about the cars or driving
| conditions had changed" doesn't reflect medical reality
| (and in the rare instances where it does, i.e. when
| improvement for the test group becomes obvious,
| immediate, and apparently side-effect free, it _can_
| become morally imperative to discontinue the control
| group).
|
| In medicine, you get confounding factors like change in
| standard of care year-to-year and facility-to-facility.
| You almost never get the kind of "clean-room" trials you
| get in mechanical engineering (and, indeed, the processes
| to create them would often themselves be unethical). So
| the best you usually get is trying to reason around (to
| torture the analogy a bit) "Well we introduced seatbelts
| three years ago and relative to the year prior to that,
| fatalities went way down... Oh wait, but COVID also
| happened the same year we introduced seatbelts and
| everyone stopped driving" if you compare a current trial
| to past non-trial standard care as the control group.
| mitthrowaway2 wrote:
| Isn't this just the standard challenge of separation of
| signal and noise that exists in all disciplines, though?
| It seems that it would be better dealt with by general
| Bayesian methods than by strict adherence to a
| controlled-trial process that requires ignoring or even
| _discarding_ large quantities of data (including every
| patient who ever had the disease prior to the start of
| the trial, which for rare diseases, might even be the
| _majority_ of the data!)
| shadowgovt wrote:
| > It seems that it would be better dealt with by general
| Bayesian methods than by strict adherence to a
| controlled-trial process that requires ignoring or even
| discarding large quantities of data
|
| What is the Bayesian prior on "After receiving the COVID
| vaccination, patient died when they were struck by
| lightning?"
|
| This is what I mean when I say the 'clean room' practices
| that are standard for most other fields of science would
| be considered unethical for medical trials. You can't,
| generally, lock people in a box for months to eliminate
| other confounding factors when trialing medicine; the
| best approach we have, therefore, is to minimize
| confounding factors by minimizing variables in space,
| time, &c. Yes, if we could lab-rat humans, keep them in
| controlled environments perpetually, we could use the
| previous in-a-box state as a comparison to the current
| state, _probably._ That 's obviously a non-starter.
|
| (There are some categories of medical research where
| time-variance has been used; it's just not generally an
| acceptable signal source, IIUC, for drug and therapy
| trials. If for no other reason than not nearly enough
| information has been captured about unrelated past
| patients to be compared to a current trial because
| relevant information to monitor was not known when
| monitoring past patients).
| mitthrowaway2 wrote:
| > What is the Bayesian prior on "After receiving the
| COVID vaccination, patient died when they were struck by
| lightning?"
|
| Mathematically not difficult to deal with, which is why
| you intuitively know the answer already, because it's
| approximately the same way your brain works naturally.
| The chance of dying when you are struck by lightning is
| about 10%,[1] which completely overwhelms the chance of
| the vaccine coincidentally killing you at the same moment
| by several orders of magnitude; while you could use the
| this datapoint if you want, Bayesian analysis will still
| confirm that it has approximately zero evidence
| supporting (or refuting) that the vaccine causes death,
| so Bayes' theorem effectively drops that patient out of
| the analysis. Which is the same thing you'd probably have
| done intuitively, unless some kind of formal controlled-
| test study rule prevented you from doing what would
| normally be the correct procedure. (Or worse, forced you
| to subject an unvaccinated control-group patient to a
| lightning strike, just to maintain control...?)
|
| But, since your patient died from the lightning strike
| rather than surviving it, there is a small signal present
| that points towards "the vaccine increased the chance of
| the lightning strike being fatal", which is a postulate
| that deserves a high initial skepticism until someone can
| propose a mechanism. But if you notice that multiple
| people die from lightning strikes after getting
| vaccinated, such that their lightning-strike survival
| rate is below the unvaccinated population's, you can
| start to update on that, and if it keeps happening, it
| becomes worth your time to investigate a potential
| mechanistic explanation. Like, the vaccination causing
| people to be less sweaty somehow.
|
| [1] https://www.britannica.com/one-good-fact/what-are-
| the-odds-o...
| shadowgovt wrote:
| ... or the unvaccinated population tends to cluster, for
| sociopolitical reasons, in a region of the country, where
| lightning strikes are unusually powerful. IRL confounding
| factors abound.
|
| Sweatiness is a good example of the sort of thing that
| would be hard to determine by comparing to past sample
| groups, since it's a rarely recorded piece of data.
| nick__m wrote:
| If a disease at a certain well defined stage has a 100%
| fatality rate after 6 months, why would you need a double
| blind trial if some patients are still alive 1 year after
| taking your drug ?
|
| The causality is pretty clear and while you might not
| claim that it double the life expectancy it would IMHO be
| immoral not to fast track the approval of that drug.
| Zak wrote:
| People who already died are _less_ effective controls
| than double-blind controls getting a placebo, but they
| 're not _ineffective_.
|
| Given a treatment with a large effect size like
| penicillin, a causal link will be very easy to establish
| even with a suboptimal control group.
| [deleted]
| londons_explore wrote:
| And that is why you shouldn't be able to ask for the
| experimental treatment... You should be able to ask to be
| part of a trial of the experimental treatment.
|
| Remember that if 10 treatments are being tried at once,
| you can divide the pool of participants so that only a
| smallish percentage are part of the control group.
| zo1 wrote:
| I have no better words: that is evil.
| [deleted]
| shadowgovt wrote:
| Can you clarify why that is evil? Are you referring to
| the use of control groups or the division of the test
| group into several overlapping trial compounds?
| captaincrisp wrote:
| I bet it's control groups.
|
| The FDA thinks similarly. In late 2021, they canceled
| trials of Paxlovid because it was immoral to have a
| control group. They did not then _waive the trial
| requirement_, meaning Paxlovid was both too proven to
| deny but too unproven to be administered.
| Wowfunhappy wrote:
| ...I think that's basically how it works? If the company
| is running a trial, you can enroll in the trial. AFAIK
| being in a trial is free for participants.
|
| Of course, there are any number of reasons someone may be
| rejected from the trial. If that happens, the company
| isn't going to just freely give them the drug anyway,
| because it wouldn't provide scientifically valid data.
| Also, no one would enroll in a trial (which carries the
| potential of getting the placebo) if they could get the
| treatment outside the trial.
| starkparker wrote:
| The drug itself might be paid for, as well as tests under
| the scope of the study (which might be narrow), but
| services to administer the drug, and tests or treatment
| for effects not in the scope of the study, aren't always
| covered. Or, in the stupidest cases, approval gets bogged
| down by the drug company, patient, or administering
| clinic/practitioner trying to get the patient's insurance
| to cover whatever's not covered by the trial for so long
| that the patient no longer qualifies (or is dead) by the
| time insurance relents and agrees to pay.
| torstenvl wrote:
| > _They don 't [get evidence of efficacy], though. They
| need a control group._
|
| This is false. Control groups, preferably in double-blind
| studies, are an essential part of best practices.
| However, the bar for what constitutes _evidence_ is much
| lower than that.
|
| Evidence is any fact that makes a relevant conclusion
| more or less likely. Evidence need not be conclusive in
| and of itself. Over time, the cumulative effects of less-
| strong evidence can form the basis for a reasonable
| inductive conclusion. Sorry to be trite, but as an
| example, a person can have evidence that their romantic
| partner loves them without the use of an identical twin.
|
| Insisting on gold standard medical evidence before
| _allowing_ someone to undergo life-saving treatment--when
| the preponderance of the evidence that does exist
| supports that treatment--is, to be blunt, the very
| definition of depraved heart murder. It demonstrates a
| wanton disregard toward human life in the face of the
| known likelihood that it will result in some number of
| deaths.
|
| More broadly, however, it is an extremely poor policy, in
| that this meme both weakens society's critical thinking
| generally and--among those who see through the elitist
| charade--significantly weakens the respect of those
| scientists who make the claim.
| A_D_E_P_T wrote:
| > Control groups, preferably in double-blind studies, are
| an essential part of best practices.
|
| I wouldn't go that far. I think that a paradigm built
| upon a broader evidence base -- e.g. with far more
| extensive postmarketing surveillance of drugs -- would be
| more ethical, of more benefit to society, and ultimately
| more effective.
|
| Double-blinded studies can miss, can be confounded by
| placebo effects, can easily be confounded by crooked
| researchers, and are frequently just plain unethical from
| first principles. I don't think that they should be
| considered "essential."
| random78965 wrote:
| I think all your criticisms of randomized controlled
| trials (apart from the ethical one) apply to your
| suggested approach, no?
|
| RCTs are the gold standard for demonstrating efficacy
| precisely because of the controls. I agree that they're
| not going to give you enough info about potential side-
| effects - a thorough monitoring program is definitely
| necessary for that.
|
| But without RCTs, showing that a drug works would be much
| harder. How would you weed out the snake oil?
| [deleted]
| TylerE wrote:
| Not always. In some cases, like rabies, the control group
| is 100% rate of death.
| londons_explore wrote:
| This sounds like the best way to do it.
|
| The company would still need a blinded control group to be
| able to demonstrate the effectiveness of any treatment.
|
| However patients should be allowed to enroll for free into
| multiple treatment trials at the same time. For a given
| number of people and treatments, enrolling in multiple
| trials simultaneously gives more science output, _and_ more
| chance of success for the participants, if you assume that
| ineffective treatments rarely are very harmful.
| hutzlibu wrote:
| "However patients should be allowed to enroll for free
| into multiple treatment trials at the same time."
|
| But this would likely mess up any data, you can get. How
| can you tie the cure or the bad sideeffects to any drug
| then?
|
| Apart from that, sure, I think patients should have the
| right to try anything.
| londons_explore wrote:
| Bad side effects caused by participating in other trials
| would happen with equal frequencies in the control group.
| mitthrowaway2 wrote:
| You just end up with a matrix of treatments. Whatever
| results you observe from someone undergoing treatments X
| & Y goes in the "X&Y" box, not the X box and the Y box.
| civilitty wrote:
| That would be the bare minimum in practice. That's already
| the case: without premarketing approval (clinical trials),
| companies are not allowed to charge anything for medicine
| or medical devices. They're not even legally allowed to
| ship them interstate until the premarketing application is
| accepted.
| citizenpaul wrote:
| I was going to make this point. People at EOL by default
| often have estates, investments, retirement accounts. In
| other words huge chunks of money/wealth that unscrupulous
| people may wish to get their hands on. Combine that with the
| desperation of a dying person and you have the perfect
| condition to create a very profitable scammer market for
| worthless treatments.
|
| This also harms eveyone because all the money pouring into a
| treatment that was a scam from day one is oppertunitu y lost.
| throwuwu wrote:
| I think the argument is to loosen the regulation on human
| trials, not to drop all regulation on drug companies. They
| should still have to prove that they're doing legitimate
| research and have had some success before opening it up to
| humans who are terminally ill. They should still be legally
| culpable for negligence and fraud.
| TeMPOraL wrote:
| Keep in mind that it's not the pharma companies that are
| the only, or even most notorious, scammers that would
| benefit. _Families_ of the dying one are a major risk
| factor. The difficult[0] truth is, plenty of families
| would accelerate the demise of a terminally ill or
| elderly[1] if it were possible. Like with euthanasia, any
| elective experimental treatment that carries increased
| risk of death, could become something the patients get
| pressured or manipulated into by their families.
|
| --
|
| [0] - The situations can be ethically and emotionally
| complex, so I'm not passing any generalized judgement,
| other that this is something a person might be concerned
| about when contemplating the possibility of ending up in
| this situation in the future.
|
| [1] - Arguably the same thing, but that's another topic.
| ChainOfFools wrote:
| As a general principle, any set of circumstances which
| results in net increased influence of people who are
| demonstrably amoral with regard to the public welfare,
| should have as many barriers as possible put up to obstruct
| the success of such people.
|
| Bad money chases out good, increasing the fraction of money
| in bad hands by billions or tens of billions is going to
| have a palpable effect on the stability of the world.
| civilitty wrote:
| _> This also harms eveyone because all the money pouring
| into a treatment that was a scam from day one is
| oppertunitu y lost._
|
| You guys remember Theranos? When Safeway announced their
| deal with Theranos in 2012, a bunch of companies working in
| blood diagnostics folded because they couldn't raise money
| or because their investors clawed back entire rounds.
|
| A couple of friends had just raised a series B round to
| commercialize their surface plasmon resonance blood testing
| device, which would have _actually done what Theranos
| promised_ with onsite blood testing (except with proper
| blood draw, not a finger prick). They were getting the
| product ready for golden standard testing with a CRO when
| investors decided it wasn't worth trying to compete with a
| Theranos already in the pocket of major pharmacies and
| pulled the series B funding.
|
| Patents ended up getting sold to some patent troll shortly
| before the news broke that Theranos was a scam.
|
| The people who funded Theranos weren't even desperate, just
| greedy. Imagine what fingers they'll put on the scales when
| they're actually staring death right in the face? It'll be
| a disaster.
| rajanaccros wrote:
| I guess it would depend on the reason for denial to a
| patient. If it is solely because it isn't regulatory approved
| _yet_ then that doesn 't seem sufficient. If the drug was
| provided for free from the pharma company it would be a
| faster path to a human trial which would be a win/win for all
| involved with the only possible negative for a person who
| doesn't have anything to lose.
| short_throw wrote:
| There are tradeoffs here, but the current approach seems to
| protect people's inheritances better than people's lives.
|
| Selling straight up snake oil is still fraud, and letting
| money be thrown at overhyped but ineffective treatments is a
| smaller tragedy than forcing people to die when treatments
| exist.
| nohuck13 wrote:
| If they can come up with the money then who cares?
|
| It would be a much better case for regulating if there were
| some external payer.
| seanmcdirmid wrote:
| Their parents and/or kids come up with money. It is
| basically theft. If you are ok with theft, fine, otherwise
| we shouldn't exempt it just because of the false hope it
| provides.
| jccalhoun wrote:
| Ahhh. This answers a question I've had: I'm in the USA and
| one of my senators has been banging the drum for allowing
| patients access to experimental drugs for a few years. I have
| wondered why this was an issue for him. Maybe I'm cynical but
| this and easy PR win for him seems like good reasons why.
| warent wrote:
| Did the Chinese government ultimately regulate the market to
| protect people and prevent this kind of corruption?
| DiscourseFan wrote:
| The regulation is approval by a governmental agency through
| clinical trials
| dspillett wrote:
| IIRC it did, though the cynic in me would suggest that by
| "this kind of corruption" what it prevents is the kind of
| corruption that government officials don't benefit from.
|
| I trust the Chinese government less than I trust my own
| with regard to doing the right thing (just because it is
| the right thing or indeed at all), and that is a pretty low
| bar...
| seanmcdirmid wrote:
| This wiki article is probably the best place to start:
|
| https://en.m.wikipedia.org/wiki/Death_of_Wei_Zexi
|
| Then there was some movement on the issue in 2019:
|
| https://www.bloomberg.com/news/features/2019-12-10/cancer-
| tr...
|
| I'm not sure where they ended up due to COVID happening
| next.
| aeternum wrote:
| This is a very weak excuse. If preventing scams is the main
| concern then old people should also be banned from purchasing
| real estate, timeshares, large donations, perhaps even
| giftcards in certain quantities.
|
| You can't have freedom without some chance of people making
| bad choices.
| seanmcdirmid wrote:
| Dad asks me for a lot of money to help him buy a time
| share, I'll feel ok saying no.
|
| Dad asks me for a lot of money for a snake oil cure that
| might prevent him from dying from bile duct cancer in a
| month or two...how am I going to say no to that?
| Veserv wrote:
| The link you posted has a addendum which links to this:
| https://astralcodexten.substack.com/p/details-of-the-infant-...
|
| In the more well researched followup by the same person, the
| author of Astral Codex, we see that the FDA did not block or
| slow the approval. It was that the manufacturer had no interest
| in even submitting a application. In fact, the FDA regularly
| granted usage exemptions, granted a broad exemption for
| research, and even directly funded one of the first trials even
| though they are not primarily a funding body.
|
| The actual moral of the story maybe is that we should let third
| partys submit applications? It seems like there would be little
| risk of bad outcomes as they still need to do the approval
| process. It aligns incentives better as the people ultimately
| at risk can deploy resources comparable to their QoL
| improvement instead of the expected increased sales volume at
| current prices. There is a obvious problem that the production
| process is inextricably linked to the final output so a non-
| manufacturer has limited control and insight into a core
| component that introduces the possibility of regression, but it
| seems relatively doable to develop protocols for handling that
| if they do not already exist.
|
| edit: To be fair, once the application was submitted it still
| took 6 years for approval. There are likely large procedural
| costs in doing the exemptions and testing that make inaction
| preferable. So, in some sense exemptions and lacking interest
| in approval may be problems of their own creation, but on net
| the overall outcome seems fairly reasonable. Actual
| improvements in procedural matters are likely too nuanced for a
| random layperson like myself to comment on.
| civilitty wrote:
| _> The actual moral of the story maybe is that we should let
| third partys submit applications?_
|
| The application isn't a single page form, it's hundreds to
| thousands of pages detailing everything about the clinical
| trials ranging from the success criteria for each phase, the
| doctors and hospitals involved in the trials, and even tiny
| details like how much blood is going to be drawn, when it
| will be drawn, and how it's going to be tested.
|
| They're impossible to write without the participation of
| almost everyone involved in the process since a significant
| part of premarketing approval is quality control of the final
| drug manufacturing process.
| Veserv wrote:
| Yes? I meant they should be allowed to run independent
| clinical trials and then submit for approval.
|
| I also did point out that the integral nature of the
| manufacturing process is a obvious potential problem. It,
| however, does not seem like a insurmountable problem. The
| specifications on sourced components and the quality
| control processes applied to them is already integral to
| the drug manufacturing process. This would just move it one
| level further up where the final drug produced by some
| existing production process is a "component". They also
| already approve drugs for different uses and evaluate
| existing drugs for new uses, so it does not seem that
| qualitatively different from some existing approval
| procedures. I am not sure of the exact details and am not
| proposing a specific solution, but it certainly does not
| seem to be a deal breaker.
| [deleted]
| Faaak wrote:
| Not at all in the field, but are there standardized
| clinical trial "frameworks" that can be used in order to
| simplify the process ?
| civilitty wrote:
| Designing clinical trials from scratch is a very
| difficult and time consuming process so almost all of
| them are modeled after previous successful trials
| targeting the same class of medicine - as specific to the
| new drug as possible.
|
| There's a lot of copy pasting followed by customization -
| often by "contract research organization" consultants who
| specialize in different types of clinical trials - but
| there are no "frameworks" as we would understand it in
| software engineering.
| BrandoElFollito wrote:
| I think that patients should be able to choose, but in reality
| the advantage will be for them only.
|
| Due to the lack of control groups them taking the pill does not
| make the science go _forward_ (in the sense that it is an
| indication for the use).
|
| I believe however that they're is a great interest in the
| _stopping_ effect: the evidence that the treatment is
| ultimately harmful.
|
| Still, this is a win-win:
|
| - if the patient gets better, good for them. Does not help the
| pharma company.
|
| - if the patient gets collateral negative effects, too bad for
| them (but they were very bad anyway). This helps the pharma
| company.
|
| Coupled with euthanasia, this would be a humanitarian solution
| for the extremely sick.
| RealityVoid wrote:
| I'm a bit puzzled why you couldn't extract useful information
| even _without_ a control group. Let's say we have a disease
| that we know that kills you. If you take the treatment and
| you don't die, we have pretty damn' positive evidence it
| works. The control group is the... You know... Many other
| people that don't take the medicine and die.
| BrandoElFollito wrote:
| This is probably a good indication, but you do not know if
| it is the pill that is making the effect. It may also be
| the placebo effect.
|
| It may also be that on day 6 you get better (no matter of
| you took the pill or not), and then worse on day 20, but
| much worse than without the pill.
|
| Still, this is a statistical wink so to speak (paraphrasing
| xkcd (https://xkcd.com/552/)).
|
| To be clear: I am all for patients experimenting on
| themselves when they do not have much to lose (and whenever
| they please, but they have to take their responsibilities
| then). Plus euthanasia if the experiment goes south.
| [deleted]
| HWR_14 wrote:
| Patients who are near the palliative-stage can try many drugs
| in the FDA approval process. The doctor has to get
| "permission", but that is granted over 99% of the time. IIRC,
| it mostly involves making sure the doctor has read up on the
| research, believes it is necessary to save the patient's life,
| and agrees to report back on the treatment to the FDA.
|
| If there really is a treatment that is significantly better
| than current treatments, have your doctors talked to you about
| this? It was codified into law about a decade ago, but that's
| not so new that they shouldn't be aware of the program.
| paxys wrote:
| Lipitor was formulated in 1985, went through an expensive and
| exhaustive trials process which concluded in 1994, and hit the
| market in 1996. Today it is one of the best selling drugs in the
| world, has revolutionized heart health, and saves tens of
| thousands of lives in the US annually.
|
| So was Lipitor's development and approval process a failure? If
| you ask some patients and their families who were stuck in the
| early 90s with hope but no access to the drug, they would
| probably say so. And I understand the emotions involved, but the
| truth is that if human civilization has existed without a
| lifesaving treatment for hundreds of thousands of years, delaying
| it for a couple more to better under its effectiveness is the
| right decision for the public good.
| chiefalchemist wrote:
| Yes, that's a great example of a success story. However, other
| drugs have gone through the same process and were eventually
| found to not be as effective as during the trial; or worse,
| they were found to be dangerous.
|
| Aside from the threat to the patients, there's the opportunity
| cost of such "misfires."
|
| In the US, we can upon death donate our organs to others in
| need. We can also, again upon death, donate our bodies to
| science. Yet while alive, we can't decide to help ourselves,
| and ideally others as well? That doesn't make sense.
| xxpor wrote:
| >dthe truth is that if human civilization has existed without a
| lifesaving treatment for hundreds of thousands of years,
| delaying it for a couple more to better under its effectiveness
| is the right decision for the public good.
|
| I don't understand how that's the counterfactual though. Let's
| say the patents we're talking about are ones that in the early
| 90s had a 90%+ chance of dying without Lipitor. Not giving them
| the drug simply to have a control group is just as morally
| fraught as giving people completely untested drugs that kills
| them. To suggest otherwise is just status quo bias.
|
| It's clearly a complex issue where you draw the line, but we
| should be able to have an intelligent conversation as a society
| about probabilities and tradeoffs.
| paxys wrote:
| People who don't get a drug while it is under development
| aren't in a control group. People in a _clinical trial_ who
| don't get the drug are in the control group. Yes it is a
| morally tricky situation, but the people who signed up are
| aware of it. Everyone else simply doesn't get the drug
| because the drug hasn't been approved yet.
| AbrahamParangi wrote:
| The point that people are making is that it's the trolley
| problem. Yes you actively kill one person by making a drug
| available prematurely but you kill 5 people through
| inaction otherwise.
| paxys wrote:
| More like - you kill 5 people through inaction or kill
| tens of thousands because the drug wasn't able to be
| studied correctly before release.
| AbrahamParangi wrote:
| You claim a specific belief here about the odds ratios,
| but hypothetically if the odds ratio were more similar to
| what I claimed than what you claimed, would you change
| your opinion?
| juve1996 wrote:
| It's not the trolley problem because in the trolley
| problem both outcomes are clear to the decider.
| Am4TIfIsER0ppos wrote:
| If it will make them better there is no problem. If it won't make
| them better it might be a scam. If it will make them worse just
| call it euthanasia.
| angry_moose wrote:
| I'm in medical and one major issue with Compassionate Use
| programs [1] is there often just isn't the supply yet to divert
| doses/devices to non-trial patients. By definition they are pre-
| release treatments, which means manufacturing is still ramping up
| and is often only available in small quantities.
|
| We would love to be able to provide access to our device to
| everyone (its quite promising), but we are barely able to meet
| demand for the clinical trial.
|
| With those restrictions, the call was made that we had to end
| compassionate use treatments for the foreseeable future - with
| limited supply they had to be devoted solely to the clinical
| trial, which is designed to give the maximum possible data about
| efficacy, not just anyone it might help.
|
| 1) https://www.fda.gov/news-events/public-health-
| focus/expanded... - The FDA is actually pretty good about
| allowing these treatments
| hinkley wrote:
| Sounds a lot like Mythical Man Month territory as well. More
| patients means more techs and more doctors to offer advice/test
| for side effects, and you can't just wave a wand and get those.
| You have to invest in people to roll out a product.
| civilitty wrote:
| Exactly. Patient selection in clinical trials is already
| _notoriously_ difficult even with phase I trials where it 's
| a few dozen healthy people at most. Finding the right
| patients so your control and test groups don't have a lot of
| confounding factors is a field unto itself. Doing so with
| terminal patients, who often have a lot of things going on
| including just the psychology of dying, is even more so.
|
| Almost everyone hires out to contract research organizations
| that have entire departments dedicated to the process with
| years long relationships with major hospitals and patient
| groups that serve as "sales funnels" for their clinical
| trials.
| hobotime wrote:
| My dad willingly tried an experimental drug. It killed him, but
| he would have died a week or two later. We now know that the drug
| doesn't work as well as we all would like.
|
| His death was valuable, and moved our scientific knowledge
| forward.
| VirusNewbie wrote:
| Sorry to hear. I do agree, that was a noble death. Respect to
| your father for the choice he made.
| Glench wrote:
| I'd also love to see psychedelic-assisted therapy approved for
| therapeutic use in dying patients. The outcome studies for
| exactly this scenario have been really good from my
| understanding.
| Simulacra wrote:
| Right to try should be absolutely fundamental. If patients want
| to try unproven drugs, give it to them, it's their body, their
| lives. Especially if they're terminal. I see absolutely no
| downside. The government really has no business telling us how to
| manage our healthcare, but dammit they try!
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