I think you make some good points but you kinda overplay your hand in a number of places -- and while I ultimately tend to agree with you it's for the opposite reason.
1) Good point about surgeons being regulated by licenscing boards etc...but the fact that surgeons use anaesthetics or implant devices approved by the FDA is kinda besides the point (lots of variation in surgical technique besides the drugs and devices). So kinda weird to make it the title.
2) Is it really true that the effects of drugs are harder to measure of do we just hold them to a higher standard?
I mean, given that surgery is regulated as you describe if it is so much easier to determine its efficacy then how can it be that often it doesn't work that well?
More specifically, most drugs actually also so something pretty clear cut (put you to sleep, reduce cholesterol, kill bacteria, inhibit virus replication, reduce pain etc). They all do something clear cut if you include descriptions like: inhibit the blah protein or bind to the blah receptor.
Most of the expense and difficulty getting most drugs approved isn't in showing some efficicacy against **some** endpoint but showing that the drug isn't too harmful and is net beneficial (not phrased this way but that's essentially what's behind debates about using intermediate endpoints like cholesterol rather than reduction in heart attacks). There are plenty of surgeries that we've found out would fail those standards.
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Ultimately, while I believe the FDA imposes far too high a barrier on approving new medications (just require it to what it claims to do at the rate and side effects claimed not that it improve on existing meds) I think it's justifed for medications but not surgery exactly because it is soo much harder to figure out what surgeries are worthwhile.
There are just too many variables and the initial attempts are often failures. Transplants were death sentences ... until they weren't. Drugs are a single item that can be evaluated in it's complete form before approval. Surgery would never develop vital new techniques if it had to pass some general test of side effects vs benefits to be approved because surgeons would never learn until approval and absent training the method would languish.
Luckily, you are correct that the risks with surgery are lower. People are much less likely to undergo surgery, particularly a novel one, unless they have no other option. They might decide to take thalidomide just because they feel a bit nauseous.
Maxwell was arguing that surgery is unregulated, if you just ignore all the hoops and regulations.
Your debate is converging on the conclusions that the FDA must exist and that it also must become less bloated. Unrestrained regulatory agencies will always overreach - it’s in their nature. The onus is on us (the royal “Us”) to recognize this truism and build in constant trimming and leaning-down, lest we end up with unnavigable frigates.
Also, the main regulation of surgery in day-to-day practice in via the peer review committees of hospital medical staffs. It’s a slow and painful process, but it generally bends toward quality.
I'm new to what seems like an ongoing debate between the two of you, but it seems you are arguing past each other. From reading Maxwell's linked post I don't think they are arguing that removing the FDA will result in no scams/harm. I think they are arguing that while scams/harm exists and will continue to exist at a potentially higher rate without the FDA, the benefits provided by an unregulated pharmaceutical market outweigh those costs.
There is the heavily regulated world we currently live in, where it is extremely hard/expensive to create therapies, and many potentially good therapies never make it to market or do only after many decades of unnecessary suffering and death have occurred. There is a hypothetical unregulated world where some people fall victim to marketing, scammers, and sometimes dangerous products. In the regulated world, we still have some scammers and dangerous products, it is just less common (in principal). In the unregulated world we would still have good therapies not making it to market, it just happens less (in principal).
I don't think the point of contention is around either of these world descriptions (which is what it seems both of you are arguing about) or any hypothetical in-between world (e.g., regulated, but less so), it is instead around exactly how much harm is done (e.g., lost QALY) by the regulators/bureaucracies vs how much harm is done by scammers and profit seekers. In other words, you both agree harm occurs in both the regulated world and the unregulated world, you just disagree on how those two volumes of harm compare.
A point that I think favor's Maxwell here is your example of the supplement market. There are certainly a lot of low quality products out there, and even a handful of actively harmful ones, but I don't think human society is losing a significant amount of QALY because some Vitamin D tablets are garbage, and I think making it hard/expensive to produce/acquire Vitamin D would likely negatively impact QALY significantly. The same goes for the supplement industry as a whole, D is just meant as an illustrative example here.
Surgery has a natural control - in many places cosmetic procedures like liposuction, breast implant, etc aren't covered under general medical surgery, and they're usually less regulated. There's also issues with marketing dangerous procedures like the Brazilian Butt Lift (BBL).
You could compare post-op infection rates between the more regulated and less regulated surgery sub-fields.
"Until they were stamped out by regulators in the early 20th century, patent medicine hucksters sold ineffective, and sometimes literally poisonous, nostrums to desperate patients. We still use “snake oil” today as shorthand from a scam product."
Except that these are unrelated points. Snake oil salesmen were scammers because their products didn't contain snake oil. *actual* snake oil is very high in omega-3 fatty acids, its benefits are similar to fish oil, and fish oil has had an FDA-approved version since 2019.
Similar, any argument that post-thalidomide expansions of FDA authority has to contend with the fact the the FDA rejected thalidomide. Yes, you can argue it was too close a call, but the thalidomide birth defects happened in Europe, not here.
You can very consistently argue that requiring that products contain what they claim, as the original creation of the FDA did, was good, without thinking that requiring prescriptions, or requiring proof of efficacy, or requiring proof of not-actually-defined-but-left-to-FDA-discretion levels of safety are good,
I think you make some good points but you kinda overplay your hand in a number of places -- and while I ultimately tend to agree with you it's for the opposite reason.
1) Good point about surgeons being regulated by licenscing boards etc...but the fact that surgeons use anaesthetics or implant devices approved by the FDA is kinda besides the point (lots of variation in surgical technique besides the drugs and devices). So kinda weird to make it the title.
2) Is it really true that the effects of drugs are harder to measure of do we just hold them to a higher standard?
I mean, given that surgery is regulated as you describe if it is so much easier to determine its efficacy then how can it be that often it doesn't work that well?
More specifically, most drugs actually also so something pretty clear cut (put you to sleep, reduce cholesterol, kill bacteria, inhibit virus replication, reduce pain etc). They all do something clear cut if you include descriptions like: inhibit the blah protein or bind to the blah receptor.
Most of the expense and difficulty getting most drugs approved isn't in showing some efficicacy against **some** endpoint but showing that the drug isn't too harmful and is net beneficial (not phrased this way but that's essentially what's behind debates about using intermediate endpoints like cholesterol rather than reduction in heart attacks). There are plenty of surgeries that we've found out would fail those standards.
---
Ultimately, while I believe the FDA imposes far too high a barrier on approving new medications (just require it to what it claims to do at the rate and side effects claimed not that it improve on existing meds) I think it's justifed for medications but not surgery exactly because it is soo much harder to figure out what surgeries are worthwhile.
There are just too many variables and the initial attempts are often failures. Transplants were death sentences ... until they weren't. Drugs are a single item that can be evaluated in it's complete form before approval. Surgery would never develop vital new techniques if it had to pass some general test of side effects vs benefits to be approved because surgeons would never learn until approval and absent training the method would languish.
Luckily, you are correct that the risks with surgery are lower. People are much less likely to undergo surgery, particularly a novel one, unless they have no other option. They might decide to take thalidomide just because they feel a bit nauseous.
Drug development for fatal diseases works poorly with the FDA: https://jakeseliger.com/2024/01/29/the-dead-and-dying-at-the-gates-of-oncology-clinical-trials/
Maxwell was arguing that surgery is unregulated, if you just ignore all the hoops and regulations.
Your debate is converging on the conclusions that the FDA must exist and that it also must become less bloated. Unrestrained regulatory agencies will always overreach - it’s in their nature. The onus is on us (the royal “Us”) to recognize this truism and build in constant trimming and leaning-down, lest we end up with unnavigable frigates.
Also, the main regulation of surgery in day-to-day practice in via the peer review committees of hospital medical staffs. It’s a slow and painful process, but it generally bends toward quality.
I'm new to what seems like an ongoing debate between the two of you, but it seems you are arguing past each other. From reading Maxwell's linked post I don't think they are arguing that removing the FDA will result in no scams/harm. I think they are arguing that while scams/harm exists and will continue to exist at a potentially higher rate without the FDA, the benefits provided by an unregulated pharmaceutical market outweigh those costs.
There is the heavily regulated world we currently live in, where it is extremely hard/expensive to create therapies, and many potentially good therapies never make it to market or do only after many decades of unnecessary suffering and death have occurred. There is a hypothetical unregulated world where some people fall victim to marketing, scammers, and sometimes dangerous products. In the regulated world, we still have some scammers and dangerous products, it is just less common (in principal). In the unregulated world we would still have good therapies not making it to market, it just happens less (in principal).
I don't think the point of contention is around either of these world descriptions (which is what it seems both of you are arguing about) or any hypothetical in-between world (e.g., regulated, but less so), it is instead around exactly how much harm is done (e.g., lost QALY) by the regulators/bureaucracies vs how much harm is done by scammers and profit seekers. In other words, you both agree harm occurs in both the regulated world and the unregulated world, you just disagree on how those two volumes of harm compare.
A point that I think favor's Maxwell here is your example of the supplement market. There are certainly a lot of low quality products out there, and even a handful of actively harmful ones, but I don't think human society is losing a significant amount of QALY because some Vitamin D tablets are garbage, and I think making it hard/expensive to produce/acquire Vitamin D would likely negatively impact QALY significantly. The same goes for the supplement industry as a whole, D is just meant as an illustrative example here.
Surgery has a natural control - in many places cosmetic procedures like liposuction, breast implant, etc aren't covered under general medical surgery, and they're usually less regulated. There's also issues with marketing dangerous procedures like the Brazilian Butt Lift (BBL).
You could compare post-op infection rates between the more regulated and less regulated surgery sub-fields.
"Until they were stamped out by regulators in the early 20th century, patent medicine hucksters sold ineffective, and sometimes literally poisonous, nostrums to desperate patients. We still use “snake oil” today as shorthand from a scam product."
Except that these are unrelated points. Snake oil salesmen were scammers because their products didn't contain snake oil. *actual* snake oil is very high in omega-3 fatty acids, its benefits are similar to fish oil, and fish oil has had an FDA-approved version since 2019.
Similar, any argument that post-thalidomide expansions of FDA authority has to contend with the fact the the FDA rejected thalidomide. Yes, you can argue it was too close a call, but the thalidomide birth defects happened in Europe, not here.
You can very consistently argue that requiring that products contain what they claim, as the original creation of the FDA did, was good, without thinking that requiring prescriptions, or requiring proof of efficacy, or requiring proof of not-actually-defined-but-left-to-FDA-discretion levels of safety are good,