The Nonlinear Library LW - Surgery Works Well Without The FDA by Maxwell Tabarrok
Jan 27, 2024
06:37
Welcome to The Nonlinear Library, where we use Text-to-Speech software to convert the best writing from the Rationalist and EA communities into audio. This is: Surgery Works Well Without The FDA, published by Maxwell Tabarrok on January 27, 2024 on LessWrong.
Here is a conversation from the comments of
my last post on the FDA with fellow
progress blogger Alex Telford that follows a pattern common to many of my conversations about the FDA:
Alex: Most drugs that go into clinical trials (90%) are less effective or safe than existing options. If you release everything onto the market you'll get many times more drugs that are net toxic (biologically or financially) than the good drugs you'd get faster. You will almost surely do net harm.
Max: Companies don't want to release products that are worse than their competitors.
Companies test lots of cars or computers or ovens which are less effective or safe than existing options but they only release the ones that are competitive. This isn't because most consumers could tell whether their car was less efficient or that their computer is less secure, and it's not because making a less efficient car or less secure computer is against the law.
Pharmaceutical companies won't go and release hundreds of dud or dangerous drugs just because they can. That would ruin their brand and shut down their business. They have to sell products that people want.
Alex: Consumer products like ovens and cars aren't comparable to drugs. The former are engineered products that can be tested according to defined performance and safety standards before they are sold to the public. The characteristics of drugs are more discovered than engineered. You can't determine their performance characteristics in a lab, they can only be determined through human testing (currently).
Alex claims that without the FDA, pharmaceutical companies would release lots of bunk drugs. I respond that we don't see this behavior in other markets. Car companies or computer manufacturers could release cheaply made, low quality products for high prices and consumers might have a tough time noticing the difference for a while. But they don't do this, they always try to release high quality products at competitive prices.
Alex responds, fairly, that car or computer markets aren't comparable to drug markets. Pharmaceuticals have stickier information problems. They are difficult for consumers to evaluate and, as Alex points out, usually require human testing.
This is usually where the conversation ends. I think that consumer product markets are informative for what free-market pharmaceuticals would look like, Alex (and lots of other reasonable people) don't and it is difficult to convince each other otherwise.
But there's a much better non-FDA counterfactual for pharmaceutical markets than consumer tech: surgery.
The FDA does not have jurisdiction over surgical practice and there is no other similar legal requirement for safety or efficacy testing of new surgical procedures. The FDA does regulate medical devices like the
da Vinci surgical robot but once they are approved surgeons can use them in new ways without consulting the FDA or any other government authority.
In addition to this lack of regulation, surgery is beset with even thornier information problems than pharmaceuticals. Evaluating the quality of surgery as a customer is difficult. You're literally unconscious as they provide the service and retrospective observation of quality is usually not possible for a layman. Assessing quality is difficult even for a regulator, however. So much of surgery hinges on the skill of a particular surgeon and varies within surgeons day to day or before and after lunch.
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 s...
Here is a conversation from the comments of
my last post on the FDA with fellow
progress blogger Alex Telford that follows a pattern common to many of my conversations about the FDA:
Alex: Most drugs that go into clinical trials (90%) are less effective or safe than existing options. If you release everything onto the market you'll get many times more drugs that are net toxic (biologically or financially) than the good drugs you'd get faster. You will almost surely do net harm.
Max: Companies don't want to release products that are worse than their competitors.
Companies test lots of cars or computers or ovens which are less effective or safe than existing options but they only release the ones that are competitive. This isn't because most consumers could tell whether their car was less efficient or that their computer is less secure, and it's not because making a less efficient car or less secure computer is against the law.
Pharmaceutical companies won't go and release hundreds of dud or dangerous drugs just because they can. That would ruin their brand and shut down their business. They have to sell products that people want.
Alex: Consumer products like ovens and cars aren't comparable to drugs. The former are engineered products that can be tested according to defined performance and safety standards before they are sold to the public. The characteristics of drugs are more discovered than engineered. You can't determine their performance characteristics in a lab, they can only be determined through human testing (currently).
Alex claims that without the FDA, pharmaceutical companies would release lots of bunk drugs. I respond that we don't see this behavior in other markets. Car companies or computer manufacturers could release cheaply made, low quality products for high prices and consumers might have a tough time noticing the difference for a while. But they don't do this, they always try to release high quality products at competitive prices.
Alex responds, fairly, that car or computer markets aren't comparable to drug markets. Pharmaceuticals have stickier information problems. They are difficult for consumers to evaluate and, as Alex points out, usually require human testing.
This is usually where the conversation ends. I think that consumer product markets are informative for what free-market pharmaceuticals would look like, Alex (and lots of other reasonable people) don't and it is difficult to convince each other otherwise.
But there's a much better non-FDA counterfactual for pharmaceutical markets than consumer tech: surgery.
The FDA does not have jurisdiction over surgical practice and there is no other similar legal requirement for safety or efficacy testing of new surgical procedures. The FDA does regulate medical devices like the
da Vinci surgical robot but once they are approved surgeons can use them in new ways without consulting the FDA or any other government authority.
In addition to this lack of regulation, surgery is beset with even thornier information problems than pharmaceuticals. Evaluating the quality of surgery as a customer is difficult. You're literally unconscious as they provide the service and retrospective observation of quality is usually not possible for a layman. Assessing quality is difficult even for a regulator, however. So much of surgery hinges on the skill of a particular surgeon and varies within surgeons day to day or before and after lunch.
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 s...