Not logged in
Log in now
Create an account
Subscribe to LWN
LWN.net Weekly Edition for December 5, 2013
Deadline scheduling: coming soon?
LWN.net Weekly Edition for November 27, 2013
ACPI for ARM?
LWN.net Weekly Edition for November 21, 2013
But that can happen only _after_ the drug approval. FDA takes a very dim view on any data manipulation in approval trials. In fact, that's the reason these trials cost hundreds of millions of dollars.
And FDA (unlike USPTO) is decidedly NOT a "rubber-stamping" agency. FDA delights in denying approval for drugs on which companies could have spent billions of dollars.
why software is different
Posted Nov 26, 2012 15:10 UTC (Mon) by etienne (subscriber, #25256)
Posted Nov 26, 2012 17:25 UTC (Mon) by bronson (subscriber, #4806)
And it very much happens pre-approval.
Posted Nov 26, 2012 17:45 UTC (Mon) by Cyberax (✭ supporter ✭, #52523)
There were even a couple cases where the company was amazed that drug don't work after the controlled first or second phases of trials.
Posted Nov 26, 2012 20:30 UTC (Mon) by bronson (subscriber, #4806)
And if that link doesn't, work, the Washington Post might as well put all its content behind a paywall because I sure can't figure it out. Maybe they need a "Send a free link" button...?
Posted Nov 27, 2012 0:45 UTC (Tue) by Cyberax (✭ supporter ✭, #52523)
But in reality similar risks are inherent in most of drug development, and there simply won't be any new drugs on the market if ALL risks were required to be zero. The additional risk of avandia is significant, but not really that great compared to risks of alternative medications (they are really not good enough), that's why the FDA let it remain on the market.
If you follow the drug industry then there are much more hilarious stories. Like finding out that your drug actually makes things worse for patients after the Phase II of clinical trials (at first company executives thought that the control group and the treatment group were mixed up).
Drug development is HARD.
Posted Nov 27, 2012 11:03 UTC (Tue) by hummassa (subscriber, #307)
Yes! and let's not forget that "no new drugs on the market" incurs in a casualty penalty also... Even if a new drug kills or maims 1% of the patients, if it also saves the lives of 10% of them, what should be the decision?
Posted Nov 27, 2012 15:11 UTC (Tue) by mathstuf (subscriber, #69389)
Posted Dec 12, 2012 10:50 UTC (Wed) by hummassa (subscriber, #307)
if you have 1000 patients, half of them sick and the other half misdiagnosed:
* with the "useless" drug: 10 of them will die (because of the side effects of the drug, will kill 1% of the patients).
* without the "useless" drug: 50 of them will die (because the drug would have saved 10% of the really sick patients).
Posted Dec 12, 2012 10:58 UTC (Wed) by hummassa (subscriber, #307)
Posted Dec 12, 2012 10:59 UTC (Wed) by hummassa (subscriber, #307)
Posted Dec 12, 2012 11:59 UTC (Wed) by mpr22 (subscriber, #60784)
Copyright © 2013, Eklektix, Inc.
Comments and public postings are copyrighted by their creators.
Linux is a registered trademark of Linus Torvalds