[HN Gopher] Elixir Sulfanilamide
       ___________________________________________________________________
        
       Elixir Sulfanilamide
        
       Author : benbreen
       Score  : 62 points
       Date   : 2022-09-29 00:16 UTC (1 days ago)
        
 (HTM) web link (en.wikipedia.org)
 (TXT) w3m dump (en.wikipedia.org)
        
       | CompelTechnic wrote:
       | An honest analysis that seeks to understand the best level of
       | regulation for testing of new drugs must consider both the people
       | that will die due to inadequate testing and the people that will
       | die from drugs never being developed (or being developed much
       | later) due to overbearing testing requirements.
        
       | anvic wrote:
       | What a manipulative article. All that is needed is a sob story
       | about a dying child or something. Oh wait there it is.
        
         | pmarreck wrote:
         | How is an example of a child death from it, "manipulative"? Are
         | you not supposed to be moved by an example of a human death to
         | a poison marketed as a drug?
        
           | anvic wrote:
           | I am supposed to be moved by it, which is precisely why it
           | doesn't belong there.
        
       | assbuttbuttass wrote:
       | This reminded me of another story I saw, where the same chemical
       | diethylene glycol caused another mass poisoning
       | 
       | https://youtu.be/qhN-o2ame-4
        
         | pmarreck wrote:
         | "well, it's cheap wine, what did you expect?" (As if I should
         | be willing to accept a significant risk of death for a $13
         | bottle of wine!)
         | 
         | If you aren't convinced that things haven't gotten better over
         | the years, here's your proof.
        
         | amelius wrote:
         | The story is very much related to this story. From Wikipedia:
         | 
         | > In 1937, S.E. Massengill Co. (a Tennessee drug company),
         | manufactured sulfanilamide dissolved with diethylene glycol, to
         | create a liquid alternative of this drug. The company tested
         | the new product, Elixir sulfanilamide, for viscosity,
         | appearance and fragrance. At the time, the food and drug laws
         | did not require toxicological analysis before releasing for
         | sale. When 105 people died in 15 states during the months of
         | September and October, the trail led back to the elixir, and
         | the toxic potential of this chemical was revealed.
         | 
         | https://en.wikipedia.org/wiki/Diethylene_glycol#Epidemiology
        
       | chromatin wrote:
       | This is relevant in light of the US senate recently passing a
       | measure that removes the requirement for animal testing of
       | pharmaceutical products prior to commencement of phase 1 studies.
       | 
       | Note that the congress.gov link is outdated: the bill unanimously
       | passed in the senate on Sep 29.
       | 
       | https://www.congress.gov/bill/117th-congress/senate-bill/295...
        
         | refurb wrote:
         | The bill doesn't prevent the use of animal studies, it just
         | allows other studies to be used to prove pre-clinical safety.
         | The requirement to prove a basic level of safety before doing
         | human trials doesn't change.
         | 
         |  _"(1) Cell-based assays.
         | 
         | "(2) Organ chips and microphysiological systems.
         | 
         | "(3) Computer models.
         | 
         | "(4) Other non-animal or human biology-based test methods.
         | 
         | "(5) Animal tests."._
        
         | lend000 wrote:
         | This post on the eve of the animal testing requirement is
         | honestly even less compelling than the argument "what about the
         | bad guys" when politicians talk about outlawing encryption.
         | 
         | The US FDA, as it exists today, is the single biggest hurdle to
         | global medical progress (because other developed countries with
         | socialized medicine are still getting about half their new
         | drugs from the US). It costs a billion+ dollars (in FDA testing
         | alone) and many years to push a single drug into the market.
         | Even during an unprecedented pandemic where things are being
         | rushed and all the world's pharmaceutical resources are poured
         | into the drug development, it still took a solid year after
         | vaccines were developed.
         | 
         | 90 years ago, animal testing was often the best option. But in
         | this specific example, the drug manufacturer didn't do any kind
         | of testing at all, so it isn't much of a fair comparison. And
         | as a sibling commenter mentioned, there are other effective
         | tests that can be done before human trials, saving time and
         | animals.
        
         | gus_massa wrote:
         | Juts assuming that Big Pharma is greedy, isn't it cheaper to
         | kill a few mice instead of a few humans in a phase 1 study? In
         | which cases they can skip the animal tests?
        
       | gnfargbl wrote:
       | > The owner of the company, when pressed to admit some measure of
       | culpability, infamously answered, "We have been supplying a
       | legitimate professional demand and not once could have foreseen
       | the unlooked-for results. I do not feel that there was any
       | responsibility on our part."
       | 
       | Could be a statement made by a drug company owner in the late
       | 1930s, or an autocratic-government-friendly exploit broker in the
       | early 2020s. _Plus ca change._
        
         | tyingq wrote:
         | Grunenthal's apology for Thalidomide in 2012, 50 years after it
         | was removed from the market, included this statement:
         | 
         |  _"Grunenthal acted in accordance with the state of scientific
         | knowledge and all industry standards for testing new drugs that
         | were relevant and acknowledged in the 1950s and 1960s."_
        
         | mannykannot wrote:
         | Richard Sackler in 2021: his family and Purdue Pharma are not
         | to blame for US opioid crisis.
         | 
         | https://www.cnn.com/2021/08/20/us/purdue-pharma-richard-sack...
        
           | anonym29 wrote:
           | Any doctor who believed in addiction-proof opiates wasn't
           | worth their salt to begin with. Opiates are opiates.
           | 
           | Any consumer who took opiates and got addicted has exactly
           | one person to blame - themselves for being uninformed.
           | 
           | I love recreational drugs, and I've had back problems that
           | required more than NSAID's alone, but I've never taken
           | opiates, and I never will until I'm ready to die, because I
           | know just how awesome they are.
           | 
           | Blaming the manufacturer for opiate deaths is like blaming
           | manufacturers for firearm deaths, rather than the shooters.
        
             | loceng wrote:
             | If you follow Gabor Mate and his understanding, you aren't
             | prone to addiction if there isn't underlying trauma or
             | suffering, possibly that you're unaware of and haven't
             | processed yet.
             | 
             | I've had many dozens of procedures where afterward I need
             | an opiate prescription. I try to only take them for as long
             | as necessary, usually no more than 2 days, because I know
             | an extra 12-24 hours does start to get into mild withdrawal
             | for me. The fearful scenario you're painting more sounds
             | like when someone shoots up an opiate directly into their
             | veins.
             | 
             | More recently however I've had different procedures,
             | surgeries, the prior being stem cell treatments - and I've
             | needed to take opiates up to 4-5 days due to post surgery
             | pain. But these surgeries reduced my pain so much that the
             | mild withdrawal was the same or less than when I was used
             | to just taking them for 2 days.
             | 
             | What I actually wanted to is that as the pain in my body
             | reduced (from whatever procedure I was getting done), then
             | the withdrawal was easier, less present - arguably as there
             | was returning into less pain in my body as the opiates wore
             | off.
             | 
             | I'm talking about physical pain above, but physical and
             | emotional pain share the same pathways - and if someone
             | isn't actually properly grounded, connected, to their body,
             | and its sensory, they may not realize how much pain their
             | body is actually signalling, and then I imagine opiates
             | could quickly become a problem for someone.
             | 
             | TL;DR: Opiates aren't actually that great unless you're in
             | pain - though that's supposing you're taking the actual
             | medicinal use level dose - and not taking 4-10x+
             | recommended; I can't speak to that.
        
             | Gordonjcp wrote:
             | > Any consumer who took opiates and got addicted has
             | exactly one person to blame - themselves for being
             | uninformed.
             | 
             | Let's see how you feel after you've been in a serious car
             | accident, then.
             | 
             | Heaven forfend such a thing should happen, but I'm prepared
             | to bet you'd be hitting the fentanyl as hard as you
             | possibly could.
        
               | anonym29 wrote:
               | I want to thank you for helping me gain some perspective
               | here. I was thinking seriously about the hypothetical
               | scenario you described, and it occured to me that I might
               | be imposing an unrealistic standard on the typical
               | consumer, informed by my unique lived experiences, and
               | what may amount to a subject matter knowledge on opiates
               | that exceeds what the typical consumer can be reasonably
               | expected to have.
        
             | bgribble wrote:
             | There was a period of time (00's) when it was hard to get
             | out of an episode of medical treatment for any kind of
             | injury or pain complaint without a script for Vicodin in
             | your hand. You had to actively refuse them at every turn.
             | 
             | This was bad medicine, implemented by oblivious (or
             | complicit) docs, pushed by bad practices by drug companies.
             | Don't blame the patient.
        
             | pessimizer wrote:
             | > Any consumer who took opiates and got addicted has
             | exactly one person to blame - themselves for being
             | uninformed.
             | 
             | This is a reprehensible point of view. Consumers can't be
             | expected to place their personal medical judgements above
             | that of their doctors and their government's regulatory
             | agencies. We in fact attack them 24 hours a day if they do,
             | and call them stupid selfish traitors under the mind
             | control of foreign powers whose only goal is to foment
             | strife and destroy our unity and world leadership through
             | the corruption of our soul, the science, and the facts.
             | 
             | Besides that, people have to work and they don't have time
             | to independently determine if their cellphones will give
             | them brain cancer. They rely on _experts_ and _authorities_
             | to tell them, on the morning news, as they run out of the
             | door on the way to work.
        
               | anonym29 wrote:
               | Tell that to the millions of victims of medical
               | malpractice. Doctors make mistakes just like everyone
               | else.
               | 
               | You might attack people for having a healthy skepticism
               | of both doctors and deeply corrupt government regulatory
               | agencies that have a revolving door with big business - I
               | encourage it.
               | 
               | Most people work 8-10 hours and sleep about 8 hours. That
               | leaves a lot of time to perform a perfunctory reading of
               | the Wikipedia article on the drug you were just
               | prescribed before taking it.
               | 
               | Go look at the very first (2002) version of the wikipedia
               | page for Oxycodone, for crying out loud. This drug was
               | publicly known as dangerous and addictive on what is
               | probably the most accessible source of information for
               | common people since 2002 - https://en.m.wikipedia.org/w/i
               | ndex.php?title=Oxycodone&oldid...
        
               | gus_massa wrote:
               | Can I agree with both of you?
               | 
               | Reading the info from Wikipedia is difficult if you have
               | no chemistry education. For complex cases I read
               | Wikipedia and also obscures sites of Internet with a huge
               | bag of salt on the side of the screen, but it's
               | difficult.
               | 
               | My recommendation is to get a second opinion (from a real
               | medical doctor) and perhaps a third, and sometimes more.
               | 
               | For normal people a pill looks innocuous enough to take
               | the medical advice at face value. Anyway, opioids have a
               | long history to get my spider sense is tingling, even
               | before the recent 10 year events.
        
               | anonym29 wrote:
               | I have zero chemistry education and I find it completely
               | readable and easy to understand.
               | 
               | 100% agreed that people should seek second and third
               | opinions from medical "professionals" - from whom medical
               | malpractice is one of the top 10 leading causes of death
               | in the USA.
        
               | gus_massa wrote:
               | In every profession there are good, regular and bad ones.
               | The second opinion is to try to avoid the worse ones, and
               | evaluate if the first treatment is the mainstream opinion
               | or a crackpot idea.
               | 
               | Anyway, they are doing very complicated stuff, like
               | cutting people in half and messing with the internal
               | plumbing. In same cases it's hard to hide mistakes under
               | the carpet like with git --amend. It's like plane pilots,
               | any mistake can be fatal.
               | 
               | For some reason plane pilots have checklist for
               | everything, and very regulated maximal time without rest.
               | Anyway, IIRC surgeons at least count the number of gauze
               | they put and remove inside the patient, but are against
               | checklists. And they still have some weird long shifts in
               | some positions, like 12, 16 or 24 hours https://en.wikipe
               | dia.org/wiki/Residency_(medicine)#Adoption_...
        
             | jandrese wrote:
             | I can see doctors being deceived by the drug company
             | marketing. I mean how are they supposed to know that the
             | huge pharmaceutical company is outright lying to them? But
             | it should be obvious pretty quickly that their patients are
             | getting addicted to these supposedly non-addictive drugs.
             | There was a serious failure of public policy not to pull
             | those drugs once it became clear that they were causing
             | more harm than the drugs they were replacing. One suspects
             | regulatory capture delayed action on this issue. Either
             | that or there was a "well, at least it isn't Heroin"
             | mentality, but maybe that just made the problem worse since
             | doctors would have at least thought twice before
             | prescribing Heroin.
        
             | Joker_vD wrote:
             | > Blaming the manufacturer for opiate deaths is like
             | blaming manufacturers for firearm deaths, rather than the
             | shooters.
             | 
             | Columbian cartels whole-heartedly agree. They're just
             | manufacturing and shipping the stuff, they don't make you
             | buy and use it! Stop the war on drugs, legalize over-the-
             | counter opiates, inform the consumers, and in five years
             | you won't recognize the society -- that's how drastically
             | it will improve^!
             | 
             | ^ "improve" here means "change", and may include both
             | positive and negative improvement. Void where applicable.
        
               | anonym29 wrote:
               | 100% agreed, full stop.
        
               | User23 wrote:
               | Barely over a century ago you could walk into any
               | pharmacy in America and buy a vial of cocaine and some
               | heroin no problem, with a pint of whiskey to wash it
               | down. It was precisely on account of rampant drug abuse
               | and the resultant social ills that we got drug control.
               | 
               | Of course the modern regime somehow manages to combine
               | the worst outcomes of both permissiveness and
               | prohibition. We now have junkies overrunning our public
               | spaces while a draconian enforcement regime manages to
               | trample our civil rights without providing any social
               | benefit.
        
               | anonym29 wrote:
               | Ergo the need to legalize.
               | 
               | It's not that drug abuse is good or that we ought to
               | encourage it, it's that criminalizing it only makes the
               | situation worse without solving the original problem.
               | Criminalization is an entirely unnecessary added harm,
               | while simultaneously failing to deliver on the premise of
               | the justification for it.
        
               | User23 wrote:
               | I mostly agree with you, but observe that public drug
               | abuse is already de facto decriminalized in our major
               | cities. Clearly decriminalization is no magic bullet
               | either.
               | 
               | I don't propose any kind of one size fits all solution
               | because I don't think any such thing exists. I do think
               | that if there is a policy solution, it will necessarily
               | involve demand reduction[1], social services, and yes in
               | some cases putting addicts into some kind of custodial
               | managed living environment. All of that being tailored to
               | the needs and resources of each particular locale.
               | Practically speaking those treatment centers be a jail or
               | an involuntary hospital, but ideally it would look a lot
               | more like a nice rehab facility with incentives for
               | fostering recovery.
               | 
               | Edit: [1] I intentionally left out supply reduction,
               | because I think we have sufficient evidence that it is
               | impracticable.
        
               | anonym29 wrote:
               | Want to reduce demand for recreational drugs? Check out
               | this one simple trick the DEA doesn't want you to know! -
               | https://time.com/longform/portugal-drug-use-
               | decriminalizatio...
        
             | spamizbad wrote:
             | I think you overestimate doctors.
             | 
             | In the early aughts I was prescribed vicodin (which I
             | didn't take) and made a joke "I hope I don't get addicted
             | to these" and my doctor laughed and said "These aren't like
             | opium or heroin. They're non-habit forming if used as
             | directed"
             | 
             | I suspect the "if used as directed" was doing a lot of
             | work.
        
               | anonym29 wrote:
               | Right, because what else goes together like "most
               | addictive class of drugs known to man" and "unlikely to
               | be abused"?
        
             | arrosenberg wrote:
             | You think the average consumer has an education in
             | biochemistry and pharmacy science? I'd like to visit the
             | version of America you are living in.
        
               | anonym29 wrote:
               | Is the implication that one needs a postgraduate degree
               | in biochemistry to understand that "opiates are
               | addictive" - in a country where almost everyone has
               | instant 24/7 access to almost all of human knowledge ever
               | recorded?
               | 
               | If that's your argument, it's a miracle these people
               | didn't die earlier from drinking bleach, thinking it was
               | a tasty beverage.
        
               | geomark wrote:
               | Or they took the advice of an authority figure who
               | suggested drinking disinfectant to cure a certain viral
               | disease. JK
        
               | anonym29 wrote:
               | Personally, I much preferred sunlight injection therapy
               | to lung bleach therapy! ;)
        
               | arrosenberg wrote:
               | If doctors and television were promoting it as heavily as
               | they did opiates, people would absolutely die from it.
               | People got very sick during COVID from trying bleach and
               | ivermectin because a reality TV star told them to. Again,
               | your America sounds amazing, I'd love to visit someday.
        
               | anonym29 wrote:
               | Out of curiosity, do you have any sources on people
               | getting more ill from ivermectin than from COVID, or any
               | sources of anyone actually trying to consume, ingest, or
               | inject bleach?
        
               | arrosenberg wrote:
               | It is irrelevant whether or not people got _more_ ill
               | from taking Ivermectin (though many did get sicker from
               | delaying actual treatment in favor of horse dewormer).
               | Your argument was the consumers should be responsible for
               | discerning a good course of treatment from a bad one. The
               | use of Ivermectin to treat a viral disease is completely
               | inline with the assertion that the average American has
               | no education on this stuff, and will take what the TV and
               | trusted figures tell them to.
        
             | jotm wrote:
             | You... Really don't.
             | 
             | I will say that you should try some only if you're
             | desperate, but I wasted over a decade of my life suffering
             | and thinking illegal stimulants like meth and amphetamine
             | will make me a retarded addict... But they didn't.
             | 
             | I quit drinking and fixed anxiety and depression with GHB
             | and pregabalin. I can quit them in several days. Zero
             | problems Afterwards (except bring back to my old self).
             | 
             | I fixed my attention/energy problems with aPVP,
             | methamphetamine and amphetamine. Now using the latter
             | because it's super cheap and available and the former two
             | have too many side effects. But they're all useful in a
             | pinch.
             | 
             | Heroin? GHB feels better! I also hate cannabis which most
             | people love.
             | 
             | All I'm saying is the effects are actually different by
             | person and dosage. But falling into a binge is easy and I
             | know many people can't get out of it.
        
             | quesera wrote:
             | > Any consumer who took opiates and got addicted has
             | exactly one person to blame - themselves for being
             | uninformed.
             | 
             | You greatly overestimate the reasoning abilities of
             | suffering humans.
             | 
             | Manufacturer promotes, doctor prescribes, patient ingests.
             | 
             | Doctors should know better than to assume that the mfr is
             | motivated only by the patients' well-being, but the patient
             | should be able to trust their doctor.
             | 
             | In some cases, the medical team _does not ask you_ whether
             | you want opioids. Are you going to get  "NoOps" tattooed on
             | your forearms and butt where the IVs might be placed during
             | your unconsciousness?
             | 
             | This has nothing to do with firearms.
        
               | anonym29 wrote:
               | >This has nothing to do with firearms.
               | 
               | Way to completely miss the point. That's an analogy that
               | explains that manufacturers can't reasonably be held
               | responsible for the actions of independent consumers. The
               | manufacturer didn't make that decision, the consumer did.
               | 
               | Now you can argue that the manufacturer was manipulative
               | in effort to achieve greater profit, and thus has partial
               | liability, but do we collectively feel as angry at
               | Facebook for all the suicides that were influenced from
               | deliberate psychological manipulation campaigns the
               | company performed to shift people's feelings? If so,
               | where's the outrage?
               | 
               | Sacklers are an easy target because people hold bias
               | against "old rich white conservatives". I hear more
               | people complaining about this than I hear complaining
               | about 3M & DuPont, who have managed to put small amounts
               | of a known carcinogen in the bloodstream of about 99.9%
               | of the population of the entire planet with PFOA/PFOS in
               | Teflon & related chemicals, and then proceeded to
               | basically change 1 atom in the molecule and create an
               | entirely new product that thus far appears to be
               | identically harmful (GenX) after PFOA was banned - and
               | spun off a holding company to sell that product to
               | completely shield themselves from legal culpability.
               | 
               | Where's the outrage at that? Statistically speaking,
               | DuPont harmed you, the Sacklers didn't. Why the popular
               | anger at one and popular indifference towards the other?
               | 
               | Answer: people are stupid. Stupid doctors trusted an
               | untrustworthy company. Stupid patients trusted their
               | stupid doctors. They're mad at themselves for falling for
               | something that dumb. Also so stupid that many who were
               | harmed by DuPont but not harmed by the Sacklers don't
               | even realize that fact.
        
               | Tao3300 wrote:
               | Analogies get in the way too often. Especially when
               | they're bridging several politically sensitive topics.
               | They're fine for illustrating an unfamiliar idea, but as
               | soon as a conversation turns to debate or argument, the
               | rhetorical usefulness of analogies drops off hard.
        
               | anonym29 wrote:
               | That's a view I can't say I've been exposed to before.
               | Thank you for the feedback.
        
               | quesera wrote:
               | I didn't miss the point. The firearms thing was
               | tangential at best.
               | 
               | The rest of your follow up comment is also tangential,
               | although much more interesting than the firearms junk.
        
               | orangepurple wrote:
               | At what point is it useful to blame a manufacturer for
               | making a tool available which can lead to serious bodily
               | harm?
               | 
               | This is the fundamental question behind drugs and
               | firearms. It all boils down to how stupid, informed,
               | impulsive, and gullible people are at various layers of
               | the sales, distribution, and usage stack.
               | 
               | For firearms city dwellers generally believe the buck
               | stops with manufacturers because if they didn't exist
               | then nobody would shoot each other anymore (sic).
               | 
               | For drugs many believe the buck stops with doctors
               | because they are the patient's advocate and authority
               | figures perpetually repeat that doctors always know best
               | because they are educated in the matter and the average
               | person isn't. Americans have generally internalized this
               | propaganda.
        
               | anonym29 wrote:
               | expertise != good decision making
               | 
               | https://www.rutgers.edu/news/expertise-liability-experts-
               | may...
        
               | gusgus01 wrote:
               | I've seen outrage about PFAS, eg the recent rainwater
               | isn't safe to drink according to the EPA articles.
               | There's also been many campaigns over the years about
               | various chemical additives, eg BPA. You've also got lots
               | of people rallying against user/overuse of pesticides and
               | herbicides. I'd wager it's less that the Sacklers are an
               | easy target (as shown by the continued lack of any
               | consequences), but more that it's a slow build up of
               | anger over the continued abuse of people for profit.
               | 
               | Also, people are not stupid for trusting doctors. Are you
               | not supposed to listen to professionals with usually more
               | than a decade more of education in a specific field than
               | you?
        
               | anonym29 wrote:
               | expertise != good decision making
               | (https://www.rutgers.edu/news/expertise-liability-
               | experts-may...)
               | 
               | You are about eight times more likely to be killed by a
               | doctor than by an automobile accident, and only about 10%
               | of such deaths are reported
               | (https://pubmed.ncbi.nlm.nih.gov/28186008/).
               | 
               | People are, empirically, objectively, and measurably
               | stupid for trusting doctors more than they trust the
               | safety of being in an automobile.
        
             | mannykannot wrote:
             | You seem to be unaware of the lengths Perdue went to
             | obfuscate and mislead about where the line between
             | responsible and dangerous use lies. Motive matters, and
             | there is no reasonable doubt here.
        
               | anonym29 wrote:
               | Motive does matter, and Purdue is not "innocent", but
               | Purdue is not the only party for which a healthy portion
               | of the blame falls on.
               | 
               | If anyone's default position is to trust a private
               | multibillion dollar company telling them something that
               | sounds (or borders on sounding) too good to be true, I
               | question whether they're even equipped to navigate their
               | own lives responsibly, let alone make well-informed
               | medical decisions for patients.
        
               | mannykannot wrote:
               | The thing about motive is that even if it depends on
               | being able to persuade other people to act in a way that
               | is against their interests, that does nothing to mitigate
               | it.
        
               | anonym29 wrote:
               | If a person walks up to you and points a finger gun at
               | your head and demands your wallet, I'd have very little
               | sympathy for the "victim" of that robbery - they were
               | more like a victim of their own gullibility.
        
               | mannykannot wrote:
               | Putting aside what I think of those ethics, you are no
               | longer discussing anything remotely relevant to the
               | Perdue case and the role of motive in it.
        
               | anonym29 wrote:
               | If you're unable to connect the analogy to the original
               | topic, I'd encourage you to seek the opinions of as many
               | doctors as possible before making any medical decisions.
        
               | mannykannot wrote:
               | Your previous post does not even address the point of the
               | one it is nominally replying to.
               | 
               | If you are unable to follow this, I suggest you look up
               | the meaning of 'straw man' and 'relevance'.
        
       | anonym29 wrote:
       | https://en.wikipedia.org/wiki/Perfluorooctanoic_acid
        
       | jefftk wrote:
       | The FDA has a solid origin story: make sure drugs sold are safe.
       | But the 1960s expansion into regulating efficacy has not been
       | positive, and the organization today is not even clearly positive
       | on balance.
       | 
       | Today if the FDA approves a drug as safe, and effective for any
       | single specific use, doctors are allowed to prescribe it "off
       | label" for any other use. This generally works well, and
       | contributes to pharmaceutical innovation. We should expand this
       | to where doctors can prescribe anything the FDA has classified as
       | safe. Restricting advertising and other carrots to drugs that
       | have convinced that FDA of their efficacy (as we do today for off
       | label uses) is probably still good, though.
        
         | adrianN wrote:
         | Why is it better to decentralize the burden of checking the
         | science behind efficacy claims?
        
           | jefftk wrote:
           | It's primarily not centralizing checking the science I object
           | to, but the setting a single threshold for all of society.
           | People vary a lot in what level of efficacy evidence would
           | make taking a given medication worth it for them, and in
           | cases where safety evaluation has already gotten us to where
           | the downside looks like "it doesn't do much, money wasted" I
           | think making distribution of the substance illegal is much
           | too restrictive.
        
         | samatman wrote:
         | I don't think that advertising drugs to consumers should be
         | legal.
         | 
         | I'd go further, and restrict advertising to doctors to a
         | specific format, something like the Nutrition Facts label we
         | have for food. They'd be allowed the brand/trademark, but
         | everything else is specified to be in effect a data sheet.
         | 
         | The only thing allowing advertising to consumers will do is
         | result in a lot of them insisting on, or agreeing to, drugs
         | they don't actually need.
        
         | derbOac wrote:
         | In my personal opinion, medicines in the US are far too
         | regulated. I agree with what you're saying about efficacy
         | versus safety, but I'd even go further in my stance that safety
         | is really overstated. There's a huge difference between
         | something like the safety profile of elixir sulfanilamide and
         | most of the drugs on the market today. Many of them could be
         | distributed without a prescription over the counter, or
         | distributed behind counter under the regulation of pharmacists,
         | or distributed with a prescription by a wider range of
         | providers. It's absurd to me that something like alcohol is
         | something you can buy in the grocery, but something like
         | acyclovir requires a prescription.
         | 
         | I know my personal opinions about this are unusual,
         | statistically speaking, but I think the pendulum has swung far
         | too far in the other direction since the 1930s. It's
         | frustrating to me that debates in the US are often framed in
         | terms of two extremes, one resembling what we have, which is
         | broken, and another where there's no safety oversight at all,
         | as if those are the only options.
         | 
         | I personally feel like the FDA should concern itself with
         | regulating the characterization of basic safety profiles of
         | substances, and with product purity and truth in labeling.
         | Outside of that, it seems like you start getting into rent-
         | seeking.
        
       | tobyhinloopen wrote:
       | I was hoping for a new Elixir module or something
        
         | Maultasche wrote:
         | I had a similar reaction: "What a strange name for an Elixir
         | library!"
        
       | photochemsyn wrote:
       | The whole story of the development of the sulfa drugs is pretty
       | eye-opening, and is well-told in this popsci history book by
       | Thomas Hager (2006), which also covers this toxic poisoning
       | episode:
       | 
       | https://en.wikipedia.org/wiki/The_Demon_Under_the_Microscope
       | 
       | One fascinating aspect of this is that Bayer originally tried to
       | convince the world that their patented derivative of sulfonamide,
       | Prontosil (note nitrogenous ring additive) was the one that
       | worked.
       | 
       | https://en.wikipedia.org/wiki/Prontosil
       | 
       | It turned out that the non-patentable sulfanilamide was the
       | actual active species, which Bayer probably knew but kept secret
       | because, well, patents and market share and so on:
       | 
       | https://en.wikipedia.org/wiki/Sulfanilamide
        
         | chasil wrote:
         | There is a chapter about this in "The Disappearing Spoon."
         | 
         | It's this one: "Chapter 10. Take two elements, call me in the
         | morning"
         | 
         | https://en.wikipedia.org/wiki/The_Disappearing_Spoon
        
       | kristofferR wrote:
       | For people interested in this stuff, I recommend checking out
       | Patrick Kelly on YouTube, his videos about medical history are
       | amazing:
       | 
       | https://www.youtube.com/c/PatrickKellyMedicalHistory
       | 
       | This is the video containing the story about Sulfaninamide:
       | https://www.youtube.com/watch?v=Vuhi1SR8Zuk
        
       | TomMasz wrote:
       | It's not clear they even tested to see if it worked at all, they
       | just assumed it would based on the main ingredient and moved on.
        
         | gus_massa wrote:
         | It's a good assumption. If one thing is an antibiotic and the
         | other is not toxic, you can assume that the mix will be an
         | antibiotic. Perhaps the solvent will cause the antibiotic to be
         | absorbed slower or faster. Perhaps the solvent will cause the
         | antibiotic to be eliminated slower or faster. So you may need
         | to adjust the dose, or the time between takes.
         | 
         | There are cases where the solvent will react with the
         | antibiotic, and there are corner cases of weird interactions.
         | Some can be predicted from general chemical rules, but some are
         | unexpected.
         | 
         | So instead of mixing random stuff and following advice of
         | morons like me in the internet, it's better to ask a real
         | medical doctor and a pharmacologist, and make some animal and
         | clinical trial anyway.
        
           | onychomys wrote:
           | https://en.wikipedia.org/wiki/Grapefruit%E2%80%93drug_intera.
           | ..
        
         | foobarian wrote:
         | Those times were pretty wild. Just bottle up random chemicals
         | and cross fingers. Boy am I glad for the FDA.
        
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