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why software is differentwhy software is differentPosted Nov 25, 2012 11:53 UTC (Sun) by Cyberax (✭ supporter ✭, #52523)In reply to: why software is different by dark Parent article: Phipps: Stop patent mischief by curbing patent enforcement
That's a bit different. Companies may creatively bend post-approval trials (for new drug uses) and/or not be sufficiently transparent.
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.
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why software is different Posted Nov 26, 2012 15:10 UTC (Mon) by etienne (subscriber, #25256) [Link]
I do not know anything about this subject, but have seen not long ago on a BBC TV documentary some strange practices to approve drugs in India, and if I remember well it was not only for drugs to be sold inside India.
Only links I can find right now: http://www.bbc.co.uk/news/magazine-20136654 http://www.reuters.com/article/2012/05/10/drugs-india-bri... http://www.bbc.co.uk/news/world-asia-india-18018158
why software is different Posted Nov 26, 2012 17:25 UTC (Mon) by bronson (subscriber, #4806) [Link]
Here's a good article showing how data manipulation isn't even needed. The companies stage the tests so the desired results are just significant and any heart problems or complications are hidden in the noise.
http://www.washingtonpost.com/business/economy/as-drug-in...
And it very much happens pre-approval.
why software is different Posted Nov 26, 2012 17:45 UTC (Mon) by Cyberax (✭ supporter ✭, #52523) [Link]
Link doesn't work. But I very much doubt that wishful thinking of drug companies makes much difference in FDA approval. More likely, they just tend to overlook drug complications and exaggerate efficacy.
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.
why software is different Posted Nov 26, 2012 20:30 UTC (Mon) by bronson (subscriber, #4806) [Link]
Another attempt: http://www.washingtonpost.com/business/economy/as-drug-in... Definitely worth a read.
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...?
why software is different Posted Nov 27, 2012 0:45 UTC (Tue) by Cyberax (✭ supporter ✭, #52523) [Link]
Avandia is a very well known case. Media portrays it as if underhanded executives in GSK overlooked possible risks during its development.
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.
why software is different Posted Nov 27, 2012 11:03 UTC (Tue) by hummassa (subscriber, #307) [Link]
> 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.
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?
why software is different Posted Nov 27, 2012 15:11 UTC (Tue) by mathstuf (subscriber, #69389) [Link]
It means that it's useless for 89.1% of the patients. The target of the drug better have a high fatality rate (to justify the 1% "bad stuff" rate) and low false positive (to justify the 9.9% efficacy plus the cost) to justify its use. Numbers should always be taken in context :) .
why software is different Posted Dec 12, 2012 10:50 UTC (Wed) by hummassa (subscriber, #307) [Link]
A useless drug (as opposed to a killing drug) is a good drug.
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).
why software is different Posted Dec 12, 2012 10:58 UTC (Wed) by hummassa (subscriber, #307) [Link]
I should go without saying that I mean "N people will die" DURING the treatment. All of them will die, of course.
why software is different Posted Dec 12, 2012 10:59 UTC (Wed) by hummassa (subscriber, #307) [Link]
Again: IT should go without saying...
why software is different Posted Dec 12, 2012 11:59 UTC (Wed) by mpr22 (subscriber, #60784) [Link] We haven't in this example been told what the disease's fatality rate under the current standard-of-care treatment is, or even if there is a current standard-of-care treatment other than "nutrients, fluids, painkillers, and rest".
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