- Joined
- Jun 3, 2007
- Messages
- 4,693
- Reaction score
- 3,095
I am attaching an editorial "You (still) can't disprove the existence of dragons" because for me, this is one of the most shocking and interesting editorials I have ever read as a scientist.
But first a little background.
Some time before this editorial came out, the FDA put a black box warning on droperidol for no apparent reason. This shocked and angered the anesthesia world because the data to support this decision was essentially non-existant and everyone understood that this was a very shady and money driven decision influenced by big pharma. At the time 5-HT3 inhibitor drugs were much more expensive and companies could stand to make gazillions if droperidol use was somehow curtailed. Well they succeded. It is interesting to note that at the time this decision was made (and sill stands today), there wasn't a single peer-reviewed case report of problems with droperidol in anti-emetic doses that involved QTc, but there was several with Zofran and others. This highlighted the unbelievable corruptness of the FDA.
So, that is the history and subject of the editorial. However, the bigger issue...or the thing our community needs to address and understand and believe and spead - is that the FDA is corrupt and does little to REALLY help medicine on so many levels. Why is this important?
Almost daily in my anesthesia or pain world, I will hear someone say "but that is off-label" or something equally ridiculous. This is ridiculous for several reasons but I will point out a few. First off, it is extremely expensive and difficult to get a "label" of anything. A company cannot spend the time to get a label for every clinical scenario that their drug or device works for. The medical community understands this and that is why the FDA doesn't dictate practice. That is why it is completely legal, ethical, and should be encouraged, to use studies, available data, etc - to dictate practice. Second, as mentioned, the FDA should have NO CREDIBILTIY in each of your minds. This droperidol is just one OF MANY examples where they continually show they can be bought, do not follow science, are extremely shady, etc. If you don't believe me, spend an hour or two drumming up story after story of their shady practices. To me it is stunning and upsetting.
But the most upsetting thing is we - as physicians - let this idea creep in that we have to do what the FDA says. It bugs me to no end. I get it...laws suites bla bla bla. But it only is a legal issue because people say it is...maybe because it enters into our venacular about practicing "off-label". We sit on committees and maybe disallow use of off-label use - then this translates to the front lines that somehow off-label use is wrong, or should be avoided.
Please - educate yourself about the law, FDA practices, etc. Then, if you can come to this same conclusion, we need to spread the word and practice responsibly. That is, do what is right - not what is labeled by the FDA.
Back to the editorial - much better written than what I said, this summarizes the same feeling regarding droperidol.
I find it funny that everyday, we use common drugs off label and that is perfectly okay, but other drugs get totally side-lined for its off-label use. It is sadly commical.
I moonlight for an LA county surgicenter where spinals make an excellent choice for many clincial reasons - but they don't like to do them because the time it takes to recover. I suggested 2-cholorprocaine which is extremely safe and a phenomenal spinal for short cases. Guess what the answer was.....
But first a little background.
Some time before this editorial came out, the FDA put a black box warning on droperidol for no apparent reason. This shocked and angered the anesthesia world because the data to support this decision was essentially non-existant and everyone understood that this was a very shady and money driven decision influenced by big pharma. At the time 5-HT3 inhibitor drugs were much more expensive and companies could stand to make gazillions if droperidol use was somehow curtailed. Well they succeded. It is interesting to note that at the time this decision was made (and sill stands today), there wasn't a single peer-reviewed case report of problems with droperidol in anti-emetic doses that involved QTc, but there was several with Zofran and others. This highlighted the unbelievable corruptness of the FDA.
So, that is the history and subject of the editorial. However, the bigger issue...or the thing our community needs to address and understand and believe and spead - is that the FDA is corrupt and does little to REALLY help medicine on so many levels. Why is this important?
Almost daily in my anesthesia or pain world, I will hear someone say "but that is off-label" or something equally ridiculous. This is ridiculous for several reasons but I will point out a few. First off, it is extremely expensive and difficult to get a "label" of anything. A company cannot spend the time to get a label for every clinical scenario that their drug or device works for. The medical community understands this and that is why the FDA doesn't dictate practice. That is why it is completely legal, ethical, and should be encouraged, to use studies, available data, etc - to dictate practice. Second, as mentioned, the FDA should have NO CREDIBILTIY in each of your minds. This droperidol is just one OF MANY examples where they continually show they can be bought, do not follow science, are extremely shady, etc. If you don't believe me, spend an hour or two drumming up story after story of their shady practices. To me it is stunning and upsetting.
But the most upsetting thing is we - as physicians - let this idea creep in that we have to do what the FDA says. It bugs me to no end. I get it...laws suites bla bla bla. But it only is a legal issue because people say it is...maybe because it enters into our venacular about practicing "off-label". We sit on committees and maybe disallow use of off-label use - then this translates to the front lines that somehow off-label use is wrong, or should be avoided.
Please - educate yourself about the law, FDA practices, etc. Then, if you can come to this same conclusion, we need to spread the word and practice responsibly. That is, do what is right - not what is labeled by the FDA.
Back to the editorial - much better written than what I said, this summarizes the same feeling regarding droperidol.
I find it funny that everyday, we use common drugs off label and that is perfectly okay, but other drugs get totally side-lined for its off-label use. It is sadly commical.
I moonlight for an LA county surgicenter where spinals make an excellent choice for many clincial reasons - but they don't like to do them because the time it takes to recover. I suggested 2-cholorprocaine which is extremely safe and a phenomenal spinal for short cases. Guess what the answer was.....
