6 ms·

Doesn't exactly answer your question, but here's a list of formerly approved drugs that were withdrawn due to risks to the patient (22 in the last decade). htt

Doesn't exactly answer your question, but here's a list of formerly approved drugs that were withdrawn due to risks to the patient (22 in the last decade). http://en.wikipedia.org/wiki/List_of_withdrawn_drugs http://en.wikipedia.org/wiki/List_of_withdrawn_drugs

twoodfin 13y ago
That's kind of my point. Does that mean we should ratchet up FDA's precautionary attitude dramatically further, to the point where that number is perhaps 2 instead of 22? I don't think so. There's a sensible tradeoff to be made, but tuning exactly where that tradeoff should be isn't the kind of thing you settle with dramatic examples of things gone wrong. It's difficult to measure how many lives were saved or made substantially more livable because the FDA was not more cautious than it has been. Surely that number is not zero, and perhaps it's greater than the net harm done by drugs whose effects might have been caught by more prolonged testing. I don't think we know.
- VLM 13y ago
  There's another aspect to tradeoffs where Lumiracoxib was introduced to compete with Celecoxib. Celecoxib has a known acknowledged issue where it increases the risk of heart attack although its relatively easy on the liver. Unfortunately Lumiracoxib occasionally destroys livers. So superficially you'd think having both on the market would be a great idea, because people with a personal or family history of liver disease would probably be better off with Celecoxib but people with a personal or family history of heart attack would be better off with Lumiracoxib. However, worldwide in general all the .gov disagree with me, and as the new guy on the block Lumiracoxib more or less got the boot. It never even made it to market in the USA as far as I know. Probably has something to do with relative incidence of fatality. BTW these are not made up names although they look like it. Google them for a good time if you're bored. I'm more interested in the chemistry issues than the politics or biochemisty, so I'd be more comfortable (authoritative?) talking about the location of the methyl groups than liver toxicity, but my first paragraph has no known intentional errors (although it probably has some unintentional errors LOL). I guess the point of this ramble is if a company exists to provide highly personalized customized services, then using a metric of "joe average" is probably not overly meaningful. The response of joe average to a disease percentage is maybe not relevant to the response of someone with a high percentage to the same result. We have a pretty good medical system designed for joe average, and its intersection with radically personalized services is unsurprisingly going to be an epic disaster.

twoodfin 13y ago

That's kind of my point. Does that mean we should ratchet up FDA's precautionary attitude dramatically further, to the point where that number is perhaps 2 instead of 22? I don't think so. There's a sensible tradeoff to be made, but tuning exactly where that tradeoff should be isn't the kind of thing you settle with dramatic examples of things gone wrong. It's difficult to measure how many lives were saved or made substantially more livable because the FDA was not more cautious than it has been. Surely that number is not zero, and perhaps it's greater than the net harm done by drugs whose effects might have been caught by more prolonged testing. I don't think we know.

VLM 13y ago
There's another aspect to tradeoffs where Lumiracoxib was introduced to compete with Celecoxib. Celecoxib has a known acknowledged issue where it increases the risk of heart attack although its relatively easy on the liver. Unfortunately Lumiracoxib occasionally destroys livers. So superficially you'd think having both on the market would be a great idea, because people with a personal or family history of liver disease would probably be better off with Celecoxib but people with a personal or family history of heart attack would be better off with Lumiracoxib. However, worldwide in general all the .gov disagree with me, and as the new guy on the block Lumiracoxib more or less got the boot. It never even made it to market in the USA as far as I know. Probably has something to do with relative incidence of fatality. BTW these are not made up names although they look like it. Google them for a good time if you're bored. I'm more interested in the chemistry issues than the politics or biochemisty, so I'd be more comfortable (authoritative?) talking about the location of the methyl groups than liver toxicity, but my first paragraph has no known intentional errors (although it probably has some unintentional errors LOL). I guess the point of this ramble is if a company exists to provide highly personalized customized services, then using a metric of "joe average" is probably not overly meaningful. The response of joe average to a disease percentage is maybe not relevant to the response of someone with a high percentage to the same result. We have a pretty good medical system designed for joe average, and its intersection with radically personalized services is unsurprisingly going to be an epic disaster.