4 ms·

And why shouldn't they do a controlled FDA-approved study? Medicine is a /science/ which means we need to test things, rather than relying on "common-knowledge"

by likpok 18y ago

And why shouldn't they do a controlled FDA-approved study? Medicine is a /science/ which means we need to test things, rather than relying on "common-knowledge". If it is as effective as you say, a study should be fairly easy to set up.

dcurtis 18y ago
They did set up a study, informally, like you would do in most sciences for an exploratory experiment. But it was shut down by the FDA. And to comply with FDA rules (which are designed specifically for drug testing and exploring new surgical processes) it would have taken six years and been too expensive for their budget. So they went to the UK and completed the study in six months for free. The US lost out on that.
mhartl 18y ago
You're conflating "scientific studies" with "FDA-approved studies". The former proceed at whatever pace makes sense for medicine and for patients; the latter proceed at the speed of molasses.
xenophanes 18y ago
It's great to do a study, but in the meantime can anyone explain how a checklist could be dangerous? If you can't give any ways, then it's silly to ban it for now. This isn't a new medicine with potential unknown effects.
- dcurtis 18y ago
  They example they gave was this: Imagine you're operating on a person and you accidentally leave a sponge deep inside their abdomen. The nurse, following the checklist, tells you and you go back in and remove it. In the process, you cut an artery and kill the patient. The patient's family claims the hospital was performing an "experiment" on the patient because without the checklist they would not have gone back in to remove the sponge and the patient would have lived. Obviously, this is stupid. But cases have been won on this principle, which shows legal precedence. When the FDA came knocking, the hospitals, afraid of lawsuits, complied.

4 ms·

And why shouldn't they do a controlled FDA-approved study? Medicine is a /science/ which means we need to test things, rather than relying on "common-knowledge"

by likpok 18y ago

dcurtis 18y ago
They did set up a study, informally, like you would do in most sciences for an exploratory experiment. But it was shut down by the FDA. And to comply with FDA rules (which are designed specifically for drug testing and exploring new surgical processes) it would have taken six years and been too expensive for their budget. So they went to the UK and completed the study in six months for free. The US lost out on that.
mhartl 18y ago
You're conflating "scientific studies" with "FDA-approved studies". The former proceed at whatever pace makes sense for medicine and for patients; the latter proceed at the speed of molasses.
xenophanes 18y ago
It's great to do a study, but in the meantime can anyone explain how a checklist could be dangerous? If you can't give any ways, then it's silly to ban it for now. This isn't a new medicine with potential unknown effects.
- dcurtis 18y ago
  They example they gave was this: Imagine you're operating on a person and you accidentally leave a sponge deep inside their abdomen. The nurse, following the checklist, tells you and you go back in and remove it. In the process, you cut an artery and kill the patient. The patient's family claims the hospital was performing an "experiment" on the patient because without the checklist they would not have gone back in to remove the sponge and the patient would have lived. Obviously, this is stupid. But cases have been won on this principle, which shows legal precedence. When the FDA came knocking, the hospitals, afraid of lawsuits, complied.