1. The scientific feedback loop in surgery is in some important ways better than drugs, in the sense that non-randomized evidence does a lot to improve the science. When surgery goes wrong, often-enough, it goes wrong in ways that can be reliably attributed to specific process sub-components, allowing iterative improvement. Causal mechanisms of drug side effects etc. are far harder to follow and mitigate at the level of a single case
2. If you bucket dental procedures as surgeries, I think you would clearly observe large amounts of fraud, unnecessary work, and wrong practices. Is medical surgery simply different from dental? Why? In part it may be due to medical surgery's extremely selective training and high stakes; even within medicine it is an outlier and consumes high-quality human capital in a way that may be unwise to scale
3. Most new surgeries are risky to patients and expensive, and so are restricted to cases where we expect large benefits on the core concerns. But the case for FDA-style regulation is, paradoxically, best for treatments which might have small margins of harm. If net effect is big and bad, we will figure it out before many people die (and can theoretically resolve costs via lawsuits and insurance). If net effect is small and bad, lacking a regulator with an RCT requirement, we will give it to everyone and fail to figure out the story.
Trying to steelman a case against this: maybe non-FDA-regulated surgery only works because there is no such thing as Big Surgery, whereas there is Big Pharma. That is, maybe the incentives and capabilities of megacorporations make profiting from fraudulent drugs mechanically easier and more tempting than profiting from fraudulent surgical procedures. So the issue isn't just the information problem, it's the presence of a Molochian entity willing and able to hyperexploit that problem.
How might we check whether this is a plausibly salient difference? Note that even if it is, one can imagine different solutions to it than just FDA regulation. But whether it's worth fleshing out those solutions depends on whether this is actually what's going on.
> Running an RCT on a surgical technique is therefore difficult. Standardizing treatment as much as in pharmaceutical trials is basically impossible. It also isn’t clear what a surgical placebo should be. Do just put them under anesthetic for a few hours? Or do you cut people open and stitch them up without doing anything else? So surgical RCTs are rare and small when they happen.
But it is still worth discussing what we know from those RCTs when they *do* happen, one would think...
>> In 39 out of 53 (74%) trials there was improvement in the placebo arm and in 27 (51%) trials the effect of placebo did not differ from that of surgery. In 26 (49%) trials, surgery was superior to placebo but the magnitude of the effect of the surgical intervention over that of the placebo was generally small.
If we lived without the FDA we, or anyway I, would subscribe to a service that did the same testing. But because the finances would be so much more difficult the number of drugs endorsed by that service would be comparatively tiny. It would be like living with the pharmaceuticals of fifty years ago.
I am not very sure surgery is a good counterfactual to drugs. Surgery is a sort of mechanical procedure where the outcomes are much more predictable by "human intuition" - In a sense it's much more similar to tinkering with wood than it is to chemically altering human bodies. A good surgeon will often have what is called "flair" - that means they can slightly innovate at the edges because it's somewhat easy to predict the impact of a small modification to the procedure. Then, that often gets published and slowly adopted by other surgeons - it reminds me a bit of a guild-like situation where artisans better their craft progressively.
But with drugs, you do not have "talented drug makers" that simply have a good flair for predicting results of drug trials. It's not within "human intuition" realm.
So that is a fundamental difference in how these things work. But there is also the fact that surgeons do face rigorous oversight in the form of malpractice suits. If you innovate too much as a surgeon and kill your patient, you are screwed. There is also direct feedback in this case - which you do not have with drugs. So this naturally keeps them in check. I am not sure how you can have the same thing for drugs - let them be tested - and then if they do nothing or kill people sue in a few years when you can evaluate the results?
How would your system work, exactly? Here is one guess (feel free to correct it). A company's lab worker tells management they have developed a drug that cures heart disease in mice. The CEO calls a press conference and announces they have this new drug and will supply it to anyone with the cash. That the way your system would work? Have I made clear my objections to it?
My concern is not collapsing "pharma quality" but collapsing trust.
* RCT of knee surgery--no significant benefits. https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2794027 Note the literature review: "The RCT conducted by Sihvonen et al found that arthroscopic partial meniscectomy is associated with a slightly increased risk of radiographic knee OA compared with exercise therapy. The study by Katz et al found a 5 times higher risk for total knee replacement (ie, the treatment for end-stage knee OA) after surgery vs exercise-based physical therapy. However, the trials by Berg et al, Herrlin et al, and Sonesson et al that compared surgery with exercise therapy found no clinically relevant difference between the 2 treatments for OA progression."
I.e., based on 6 RCTs here, knee surgery is either the same or worse than physical therapy.
But almost no drugs are like parachutes, and when a drug actually works at an undeniable level (e.g., Gleevec, penicillin), there is almost no delay arising from the FDA. (The NDA for Gleevec was filed on Feb. 27, 2001, and was approved by the FDA on May 10, 2001! https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-335_Gleevec_Approv.pdf).
But almost no drugs are like parachutes. Drugs have mostly very small effects (if any) -- in one review of several dozen cancer drugs, the median improvement to life expectancy was a mere 2.1 months, and worse, many cancer drugs don't have any measurable benefit to life expectancy at all. See https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5695531/
Given how toxic those drugs are, it is a scandal that patients and payors (Medicare, etc.) often pay $100k or more for drugs that barely provide a benefit, if any at all.
Historically, the main oversight of surgeon quality, when it was mostly an in-patient activity, was via hospital quality review and medical staff oversight. These can be frustratingly clunky but generally bend toward ensuring quality over time. I worry that the push toward more profit-motivated/cost-saing outpatient surgery will blunt these tools and generally lower quality, although the effect will be almost imperceptibly slow. In this sense, it makes me worry that surgery will go the way of the almost totally unregulated field of dentistry.
Oh my friend, obviously you're a young-un. Let me tell you an old-timer story.
Bypass surgeries, including triple bypass surgeries used to be done left, right and center. Coronary arteries are blocked up? Let's open 'em up! It's self-evident that if you unclog them the patiens will do better, right?
Yes, well... ahem. When they finally did the RCTs, they found... most bypass surgeries were of no benefit. Nada. Zilch. There have been several other RCTs that found sham surgeries and actual surgeries perform equally well in many instances.
This is why you see so few bypass surgeries nowadays.
The bypass study is unusually, and was probably done because cardiologists were competing for a slice of the economic pie and taking patients away from the surgeons.
This is not to say surgeries typically self-regulate without the FDA. They do. Like bone fractures or reattachment of amputated limbs. But those are for surgeries where the benefits are clear and relatively rapid. In instances where the benefit is uncertain (like mortality over months or years), you need RCTs to be sure.
Surgeons don't have free entry. It takes almost of decade of training to be a surgeon. They're incentived to not fuck up because they can lose their licence and no one wants to do a career change in their 40s. Same principle applies to lawyers. To make the pharmaceutical industry comparable you would have to force every industry owner and major employee to go through the same process. Perhaps it's more effective to have a licence Raj for people rather than processes.
Without endorsing a specific position, consider:
1. The scientific feedback loop in surgery is in some important ways better than drugs, in the sense that non-randomized evidence does a lot to improve the science. When surgery goes wrong, often-enough, it goes wrong in ways that can be reliably attributed to specific process sub-components, allowing iterative improvement. Causal mechanisms of drug side effects etc. are far harder to follow and mitigate at the level of a single case
2. If you bucket dental procedures as surgeries, I think you would clearly observe large amounts of fraud, unnecessary work, and wrong practices. Is medical surgery simply different from dental? Why? In part it may be due to medical surgery's extremely selective training and high stakes; even within medicine it is an outlier and consumes high-quality human capital in a way that may be unwise to scale
3. Most new surgeries are risky to patients and expensive, and so are restricted to cases where we expect large benefits on the core concerns. But the case for FDA-style regulation is, paradoxically, best for treatments which might have small margins of harm. If net effect is big and bad, we will figure it out before many people die (and can theoretically resolve costs via lawsuits and insurance). If net effect is small and bad, lacking a regulator with an RCT requirement, we will give it to everyone and fail to figure out the story.
Trying to steelman a case against this: maybe non-FDA-regulated surgery only works because there is no such thing as Big Surgery, whereas there is Big Pharma. That is, maybe the incentives and capabilities of megacorporations make profiting from fraudulent drugs mechanically easier and more tempting than profiting from fraudulent surgical procedures. So the issue isn't just the information problem, it's the presence of a Molochian entity willing and able to hyperexploit that problem.
How might we check whether this is a plausibly salient difference? Note that even if it is, one can imagine different solutions to it than just FDA regulation. But whether it's worth fleshing out those solutions depends on whether this is actually what's going on.
> Running an RCT on a surgical technique is therefore difficult. Standardizing treatment as much as in pharmaceutical trials is basically impossible. It also isn’t clear what a surgical placebo should be. Do just put them under anesthetic for a few hours? Or do you cut people open and stitch them up without doing anything else? So surgical RCTs are rare and small when they happen.
But it is still worth discussing what we know from those RCTs when they *do* happen, one would think...
"Use of placebo controls in the evaluation of surgery: systematic review", Wartolowska et al 2014: https://www.bmj.com/content/348/bmj.g3253
>> In 39 out of 53 (74%) trials there was improvement in the placebo arm and in 27 (51%) trials the effect of placebo did not differ from that of surgery. In 26 (49%) trials, surgery was superior to placebo but the magnitude of the effect of the surgical intervention over that of the placebo was generally small.
If we lived without the FDA we, or anyway I, would subscribe to a service that did the same testing. But because the finances would be so much more difficult the number of drugs endorsed by that service would be comparatively tiny. It would be like living with the pharmaceuticals of fifty years ago.
I am not very sure surgery is a good counterfactual to drugs. Surgery is a sort of mechanical procedure where the outcomes are much more predictable by "human intuition" - In a sense it's much more similar to tinkering with wood than it is to chemically altering human bodies. A good surgeon will often have what is called "flair" - that means they can slightly innovate at the edges because it's somewhat easy to predict the impact of a small modification to the procedure. Then, that often gets published and slowly adopted by other surgeons - it reminds me a bit of a guild-like situation where artisans better their craft progressively.
But with drugs, you do not have "talented drug makers" that simply have a good flair for predicting results of drug trials. It's not within "human intuition" realm.
So that is a fundamental difference in how these things work. But there is also the fact that surgeons do face rigorous oversight in the form of malpractice suits. If you innovate too much as a surgeon and kill your patient, you are screwed. There is also direct feedback in this case - which you do not have with drugs. So this naturally keeps them in check. I am not sure how you can have the same thing for drugs - let them be tested - and then if they do nothing or kill people sue in a few years when you can evaluate the results?
How would your system work, exactly? Here is one guess (feel free to correct it). A company's lab worker tells management they have developed a drug that cures heart disease in mice. The CEO calls a press conference and announces they have this new drug and will supply it to anyone with the cash. That the way your system would work? Have I made clear my objections to it?
My concern is not collapsing "pharma quality" but collapsing trust.
There are some RCTs of surgeries, and they often find that surgery doesn't work.
* RCT of lumbar fusion surgery. No significant benefits to fusion surgery. https://pubmed.ncbi.nlm.nih.gov/27074066/ Another RCT on lumbar fusion with no significant benefit: https://pubmed.ncbi.nlm.nih.gov/12973134/ See also https://www.sciencedirect.com/science/article/abs/pii/S1529943015017738
* RCT of knee surgery--no significant benefits. https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2794027 Note the literature review: "The RCT conducted by Sihvonen et al found that arthroscopic partial meniscectomy is associated with a slightly increased risk of radiographic knee OA compared with exercise therapy. The study by Katz et al found a 5 times higher risk for total knee replacement (ie, the treatment for end-stage knee OA) after surgery vs exercise-based physical therapy. However, the trials by Berg et al, Herrlin et al, and Sonesson et al that compared surgery with exercise therapy found no clinically relevant difference between the 2 treatments for OA progression."
I.e., based on 6 RCTs here, knee surgery is either the same or worse than physical therapy.
Separately, I agree with Michael Sklar's point: Surgery is often directly life-saving, in front of your very eyes. It can be like the classic BMJ article on parachutes: https://www.bmj.com/content/327/7429/1459?ijkey=ccd0367ae81fdafe32c828281327002c657ed802&keytype2=tf_ipsecsha
But almost no drugs are like parachutes, and when a drug actually works at an undeniable level (e.g., Gleevec, penicillin), there is almost no delay arising from the FDA. (The NDA for Gleevec was filed on Feb. 27, 2001, and was approved by the FDA on May 10, 2001! https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-335_Gleevec_Approv.pdf).
But almost no drugs are like parachutes. Drugs have mostly very small effects (if any) -- in one review of several dozen cancer drugs, the median improvement to life expectancy was a mere 2.1 months, and worse, many cancer drugs don't have any measurable benefit to life expectancy at all. See https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5695531/
Given how toxic those drugs are, it is a scandal that patients and payors (Medicare, etc.) often pay $100k or more for drugs that barely provide a benefit, if any at all.
Historically, the main oversight of surgeon quality, when it was mostly an in-patient activity, was via hospital quality review and medical staff oversight. These can be frustratingly clunky but generally bend toward ensuring quality over time. I worry that the push toward more profit-motivated/cost-saing outpatient surgery will blunt these tools and generally lower quality, although the effect will be almost imperceptibly slow. In this sense, it makes me worry that surgery will go the way of the almost totally unregulated field of dentistry.
Wasn't Akerlof's Nobel prize specifically for showing how important regulation is to the used car market?
Oh my friend, obviously you're a young-un. Let me tell you an old-timer story.
Bypass surgeries, including triple bypass surgeries used to be done left, right and center. Coronary arteries are blocked up? Let's open 'em up! It's self-evident that if you unclog them the patiens will do better, right?
Yes, well... ahem. When they finally did the RCTs, they found... most bypass surgeries were of no benefit. Nada. Zilch. There have been several other RCTs that found sham surgeries and actual surgeries perform equally well in many instances.
This is why you see so few bypass surgeries nowadays.
The bypass study is unusually, and was probably done because cardiologists were competing for a slice of the economic pie and taking patients away from the surgeons.
This is not to say surgeries typically self-regulate without the FDA. They do. Like bone fractures or reattachment of amputated limbs. But those are for surgeries where the benefits are clear and relatively rapid. In instances where the benefit is uncertain (like mortality over months or years), you need RCTs to be sure.
Surgeons don't have free entry. It takes almost of decade of training to be a surgeon. They're incentived to not fuck up because they can lose their licence and no one wants to do a career change in their 40s. Same principle applies to lawyers. To make the pharmaceutical industry comparable you would have to force every industry owner and major employee to go through the same process. Perhaps it's more effective to have a licence Raj for people rather than processes.