Surgery Works Well Without The FDA

The problems faced by surgery are matched and sometimes exceeded by problems faced by pharmaceuticals.

How do you know that? 

I think it's likely that surgeries produce more undetected long-term negative side effects than most pharmaceutical interventions. Surgeries leave scars while most pharmaceutical interventions don't have an equivalent.

In the US, there's a lot more "cancer detection" and then surgical intervention than in other countries and this doesn't seem to reduce death rates by cancers. That suggests that a good chunk of those operations are essentially snake oil that doesn't prevent death but does lead to amputations. 

That effect was strong enough that under the Obama administration, there was a move to reduce cancer screening because the results were just so depressing.

Spinal fusion for chronic low back pain seems to be a pretty bad surgical interventions that an FDA-like equivalent might outlaw (or severely restrict) because it often doesn't work and produces additional problems.

What do you think you would observe in a world where a good portion of surgical interventions are useless and harmful that you don't observe in our world? 

Pharmaceutical companies won't go and release hundreds of dud or dangerous drugs just because they can.

At least some of them would, because there are, in fact, companies that do this in the real world. They simply use a different brand name and call them "dietary supplements" rather than drugs.

One problem with this analysis is that the FDA actually regulates a ton of what happens in surgeries, which sharply reduces how much this example actually proves. Specifically, they approve all of the devices that get used during surgery, from the scalpels to the monitoring equipment to the surgical sponges, all the laparoscopic instruments used in modern surgeries, and all the replacement joints and implanted or assistive devices which are being put in in many surgeries. Yes, this is different than regulating the surgery itself, but it manages to cut off a huge range of surgical interventions that could be more dangerous or less reliable, while it raises costs and slows innovation. So I'm less sure how well surgery serves as an example of working well without the FDA.

A really simple example of what industry doesn't care about outcomes and pumps out product despite lack of evidence of effect and even potentially adds harm is the supplement industry. They dont care about brand reputation because they just change their name or bring another product to market eventually. If you take the FDA away you will have every major pharmaceutical just releasing garbage medications that barely improve life, yet increase cost and add side effects. They already try to do this with non-inferiority studies rather than coordinating studies that show improvement. Not to mention many currently available medications barely (and statistically suspect at times) show efficacy yet rake in serious money. This argument clearly is coming from someone outside of the medical industry with a limited understanding of mechanisms at work. It seems to be coming from someone on the early side of the Dunning-Kruger Curve. 

Regarding surgery there are immediate outcomes and they are treating a specific problem so it is easy to measure. These are absent or limited with medications. If a surgeon is consistently not taking the gallbladder out from patients but telling them they did, this will be discovered quickly and typically the surgeons will either be sued into not practicing or be removed from the surgeon pool. The same goes for a surgeon who isnt safely putting an aortic valve in. First off, they typically dont get to the point of being able to operate on people if they are terrible. If they do, patients die. Then the surgeon is removed from pool of operating surgeons. Thats not the same for a medication that reduces the risk of heart attack by 50% from 1% to 0.5% over a 5 year period. Have you ever seen marketing from industry? Its terrible and not aligned with the truth. It is aligned with selling a product and if thats all they need to give to a doctor then you are going to get offered medications you dont want to take. 

There are also methods of self-regulation by surgery departments, residency training programs, medical boards, state licensing agencies and professional associations. So, to say that surgery is not regulated is just misinformed at best. Your argument is just really empty. I understand what you wish to be the case, its just not realistic. Its the same argument that there is no need to regulate companies from dumping pollutants into the Hudson because they will avoid it due to reputation. Thats just not how real life works. 

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. 

You can buy nonworking fuses on Amazon if you simply buy those with good reviews and market mechanisms don't seem to prevent that. 

Two things that happen in the pharmaceutical industry today despite the FDA.

1. Many drug candidates (compounds with IND status sanctioned by the FDA ) are pushed into clinical investigation prematurely by venture capital funded biotech, that more established and careful pharma companies would stay away from. These have a high rate of failure in the clinic. This is not fraud, by the way, it is usually a combination of hubris, inexperience, and a response to the necessity of rapid returns.
2. Marketing wins over clinical efficacy, unless the difference is large. Tagamet was the first drug for stomach ulcers released in the late ‘70s.It was rapidly overtaken by Zantac, in the ’80s, through aggressive marketing, despite minimal clinical benefit.    Today there is a large industry of medical writers sponsored by the pharmaceutical industry, whose job it is to present and summarise the clinical findings on a new drug in the most favourable way possible without straying into actual falsehood.

The scientists working at the sharp end of drug discovery, who fervently believe that what they do benefits mankind (this is, I believe, a gratifyingly large proportion of them) generally respect the job the FDA do. This is despite the hoops they force us to go through. Without the FDA keeping us honest, the medicines market would be swimming with highly marketed but inadequately tested products with dubious medicinal value.  Investors would be less choosy about following respected well thought-out science, when placing their money. True innovation would actually be stifled because true innovation in drug  discovery only shows its value once you’ve done the hard (and expensive) yards to prove medical benefit over existing treatments. Honest and well enforced regulation forces us to do the hard yards and take no short cuts.

In 2023 55 new drugs were approved by the FDA, hardly a sign that innovation is slacking. Without regulation the figure might be ten times higher but clinicians would be left swimming in a morass of claims and counter claims without good guidance (currently generally provided by the FDA) of what treatments should be applied in which situation.

Keep quiet about it! If the FDA hears about this we won't be allowed to conduct surgeries any more!

Poorly regulated health orientated companies selling products that have little or no value? Seems unlikely.. Oh wait, what about Theranos?