Elixir Sulfanilamide(en.wikipedia.org)
en.wikipedia.org
Elixir Sulfanilamide
https://en.wikipedia.org/wiki/Elixir_sulfanilamide
11 comments
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...
https://www.cnn.com/2021/08/20/us/purdue-pharma-richard-sack...
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.
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.
> 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.
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.
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.
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.
This was bad medicine, implemented by oblivious (or complicit) docs, pushed by bad practices by drug companies. Don't blame the patient.
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.
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.
> 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.
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.
>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.
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.
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?
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?
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.
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.
I'm not saying expertise == good decision making, I'm saying there's a greater chance of an expert making the correct decision than a layman. That article also only talks about how experts can "double down" on mistakes (and only overprecision) when there is negative feedback, it doesn't comment on the validity of their decisions as compared to layman.
Isn't that like the perfect example of comparing apples to oranges? Wouldn't the danger of trusting a doctor require comparing the outcome of trusting a doctor to the outcome of not trusting a doctor?
Isn't that like the perfect example of comparing apples to oranges? Wouldn't the danger of trusting a doctor require comparing the outcome of trusting a doctor to the outcome of not trusting a doctor?
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.
The rest of your follow up comment is also tangential, although much more interesting than the firearms junk.
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.
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.
expertise != good decision making
https://www.rutgers.edu/news/expertise-liability-experts-may...
https://www.rutgers.edu/news/expertise-liability-experts-may...
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.
That's a view I can't say I've been exposed to before. Thank you for the feedback.
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(1)
> 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.
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.
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/index.php?title=Oxycodone&oldid...
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/index.php?title=Oxycodone&oldid...
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.
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.
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.
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.
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.wikipedia.org/wiki/Residency_(medicine)#Adoption_...
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.wikipedia.org/wiki/Residency_(medicine)#Adoption_...
> 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.
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.
100% agreed, full stop.
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.
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.
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.
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.
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.
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.
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...
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.
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.
If that's your argument, it's a miracle these people didn't die earlier from drinking bleach, thinking it was a tasty beverage.
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.
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?
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.
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.
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.
Right, because what else goes together like "most addictive class of drugs known to man" and "unlikely to be abused"?
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.
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.
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.
Grünenthal's apology for Thalidomide in 2012, 50 years after it was removed from the market, included this statement:
“Grünenthal 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.”
“Grünenthal 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.”
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
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
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
It's this one: "Chapter 10. Take two elements, call me in the morning"
https://en.wikipedia.org/wiki/The_Disappearing_Spoon
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.
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.
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.
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.
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.
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.
Why is it better to decentralize the burden of checking the science behind efficacy claims?
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.
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.
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...
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...
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.”.
“(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.”.
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.
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.
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?
This reminded me of another story I saw, where the same chemical diethylene glycol caused another mass poisoning
https://youtu.be/qhN-o2ame-4
https://youtu.be/qhN-o2ame-4
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
> 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
“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.
If you aren't convinced that things haven't gotten better over the years, here's your proof.
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
https://www.youtube.com/c/PatrickKellyMedicalHistory
This is the video containing the story about Sulfaninamide: https://www.youtube.com/watch?v=Vuhi1SR8Zuk
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.
Those times were pretty wild. Just bottle up random chemicals and cross fingers. Boy am I glad for the FDA.
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.
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.
I was hoping for a new Elixir module or something
I had a similar reaction: "What a strange name for an Elixir library!"
What a manipulative article. All that is needed is a sob story about a dying child or something. Oh wait there it is.
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?
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 ça change.