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Comment by jerry80 | Hacker News Reader

Why do we (the FDA) have such strict standards for drugs but not for surgeries?

There's actually a really good law review article about this that I encourage you to read:

https://scholarship.law.cornell.edu/cgi/viewcontent.cgi?arti...

It basically boils down to surgical training/procedural variance across geographic regions that make it hard to extrapolate some conclusions without multi centered trials, surgeon hubris, and self-regulation through way of surgical societies sponsoring trials and publishing guidelines. I think many also overestimate the FDAs ability to regulate "useless" medicine, so doctors that prescribe medicine also have the same problems surgeons do.

The article goes over more of this as well, but there's some regulation just not by a federal agency (unless you count CMS compensation/approval). Maybe we'll eventually have a group that specifically monitors surgical procedures.

Finally, I think it's fairly telling that the majority of these "useless" surgeries are elective procedures

(disclosure, if it matters: I'll be entering a surgical field that almost exclusively only performs elective procedures)

Does this mean that, as a consumer, if I need a specialized procedure I should be looking into regional variations, as there could be a material difference in outcomes?

Yes. You should go somewhere they do a lot of the particular surgery you are interested in.

Absolutely. If you have a disease which is uncommon or need a surgery which is uncommon, consider traveling to a center specializing in treatment. For example, while a doctor at a regional center might have a 100 breast cancer patients in a year, other cancers have only 10 patients in the whole US per year. That regional center doctor is only likely to see a single patient with that disease in his life. In that case, I would seek out those who study that disease.

As a consumer it would be nice to review a surgeon's track record in some way. Short of that - as a start - I'd say nobody should be charged for surgery if they die during the procedure. Then only the most skilled will take the riskiest cases.

This already happens in some select specialties (such as cardiothoracics) within the UK. In the UK, patients don’t directly pay for their care, but the effect of this case has (anecdotally) been that surgeons are more likely to refuse to operate riskier cases to avoid impacting on their outcomes score.

As others have noted yes, very often with dramatic differences by facility directly traceable to head surgeons within departments.

Multiple facilities sharing a common head surgeon, or the same facility after the arrival or departure of a surgeon being strongly detectable in outcomes data, from what I've heard.

this is the most important thing you can do for planned (not emergency) operations. check volume and pt outcomes.

I would assume it's because a drug is standardized but a surgery may reasonably be suspected to depend on the skill of the surgeon, so people lean more heavily on priors, on what seems reasonable, and less on statistical evidence.

The FDA lacks statutory authority to regulate surgical techniques. That mostly happens at the level of state medical boards.

Do you have a proposal for how? Drugs have very precise chemical formulations. Surgical techniques do not.

"Do you have a proposal for how?"

Placebo-controlled trials for surgeries, as there already is for drugs, could do the trick.

> Placebo-controlled trials

For surgeries ? We actually cut someone open, then don't fix him, risking all the complications associated with anesthesia, infections and so on ? For drugs it's pretty easy to just give a fake pill containing nothing at all, you don't actually decrease then chance of survival.

And how does that work when the technique significantly changes, as in "in that case, do we cut above or below the knee". Again in the case of pills/injections, it's pretty easy to give everyone the impression they got all the same treatment, while in the of surgery you are pretty limited in that fashion.

"We actually cut someone open, then don't fix him"

Yes. There have been placebo-controlled trials whereby the control-group was just cut open, and left there for an hour. The placebo-patients believed they had undergone the actual procedure, and reported the same improvement as the actual patients. This is the placebo effect.

Although such trials are harder than giving fake pills, they might still be worthy of doing more often than we do now.

Such trials are highly unethical IMO. I suspect that this opinion will be shared by most. There is a huge and obvious difference compared to a drug placebo.

Agreed. Although trials don't have to have a placebo control, e.g. drug trials for diseases that already have treatment available often use the in-use treatment as control, so what you're trying to prove is that the new drug is better than what we currently have.

Drug and vaccine trials also carry some risk, but are allowed by ethics committees.

Placebo surgery trials would also benefit humanity a lot in better focused efforts, money and saving future patients from having to undergo useless surgery and take risks.

Somehow you imply it's ethical to try and fix a patient with a potentially sham surgery and risk complications, but it's unethical to do it with placebo thereby gaining knowledge that can save lots of lives down the line.

I guess it's a kind of trolley problem but have those been "solved"? Who decides if it's ethical or not? Why are they qualified to make such a decision?

Is it more unethical than performing a surgery that doesn't help?

rats or monkeys maybe but human patients no thanks

Since most rats and monkeys don't speak English, how will you quantify whether they feel better?

See eg NICE in England who evaluate different things and then make recommendations.

Some of those are only guidance and NHS Trusts (the organisations that provide care) and CCGs (the organisations that take money from government and buy care from provider organisations) only have to consider it.

But some of them are mandatory and CCGs and trusts must follow it, unless they have very good reason not to.

Here's their guidance for "Arthroscopic knee washout, with or without debridement, for the treatment of osteoarthritis

Interventional procedures guidance [IPG230] Published date: 22 August 2007"

https://www.nice.org.uk/guidance/ipg230

And if people really want something that's been recommended against by NICE they can go private, I guess.

The fda does not regulate surgical procedures.

Since many surgeries have risks, perhaps the FDA should treat surgeries similar to drugs. Either regulate both, or deregulate both.

But heavily regulating drugs, while surgeries that could have severe risks, complications, or have no proven effect in placebo-controlled trials, go mostly unregulated, strikes me as odd.

Why does the food and drug administration only regulate food and drugs?

They regulate medical devices, too, so the literal name of the fda doesn't restrict their mandate.

It doesn't only regulate food and drugs.

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