6 ms·

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

im3w1l 6y ago
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.
chapium 6y ago
The fda does not regulate surgical procedures.
- aminozuur 6y ago
  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.
ouid 6y ago
Do you have a proposal for how? Drugs have very precise chemical formulations. Surgical techniques do not.
- aminozuur 6y ago
  "Do you have a proposal for how?" Placebo-controlled trials for surgeries, as there already is for drugs, could do the trick.
  - IMTDb 6y ago
    > 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.
    - aminozuur 6y ago
      "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.
      - rscho 6y ago
        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.
        I_AM_A_SMURF 6y ago
        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.
        bonoboTP 6y ago
        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?
        scotty79 6y ago
        Is it more unethical than performing a surgery that doesn't help?
      - 6y ago
- DanBC 6y ago
  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 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.
nradov 6y ago
The FDA lacks statutory authority to regulate surgical techniques. That mostly happens at the level of state medical boards.
epmaybe 6y ago
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?article=1467&context=cjlpp 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)
- JMTQp8lwXL 6y ago
  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?
  - jhart99 6y ago
    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.
  - phkahler 6y ago
    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.
pretendscholar 6y ago
Why does the food and drug administration only regulate food and drugs?
- busyant 6y ago
  They regulate medical devices, too, so the literal name of the fda doesn't restrict their mandate.
- detaro 6y ago
  It doesn't only regulate food and drugs.

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.

chapium 6y ago

The fda does not regulate surgical procedures.

aminozuur 6y ago
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.

ouid 6y ago

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

aminozuur 6y ago
"Do you have a proposal for how?" Placebo-controlled trials for surgeries, as there already is for drugs, could do the trick.
- IMTDb 6y ago
  > 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.
  - aminozuur 6y ago
    "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.
    - rscho 6y ago
      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.
      - I_AM_A_SMURF 6y ago
        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.
      - bonoboTP 6y ago
        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?
      - scotty79 6y ago
        Is it more unethical than performing a surgery that doesn't help?
    - 6y ago
DanBC 6y ago
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 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.

nradov 6y ago

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

epmaybe 6y ago

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?article=1467&context=cjlpp 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)

JMTQp8lwXL 6y ago
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?
- jhart99 6y ago
  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.
- phkahler 6y ago
  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.

pretendscholar 6y ago

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

busyant 6y ago
They regulate medical devices, too, so the literal name of the fda doesn't restrict their mandate.
detaro 6y ago
It doesn't only regulate food and drugs.