Posted by yxibow on September 20, 2009, at 22:44:49
In reply to sick, posted by Jeroen on September 20, 2009, at 13:52:47
> that's just sick, how people are going to react to it,
>
>
> il'l take it from here......Its just natural, Jeroen. Here in the US, medications that enter the marketing point (after Phase III) have to have had a multi-thousand (usually around 4 thousand patients) patient trial.
But 4,000 patients on a drug is not 1,000,000 patients on the same one.Someone in the population is going to have a polypharmacy (multiple medication regime) or a rare heart disorder or something that can't be seen on a smaller patient trial and that is why Phase IV (post-marketing is necessary.
It is observation in the "real world" scenario that could never predict that out of so many million patient-years (that is a standard practice of statistics, multiply the estimated number of patients by the number of years that the drug has been out or has been estimated to be in use), out of that large amount, say 60 people suffer some liver disease because they all have some enzyme deficiency.
Then black box warnings descend upon medications, lawsuits start, etc. Some of this is plenty warranted, some of it knocks a drug off the market that is beneficial to most all people with regular checkups.
-- Jay
poster:yxibow
thread:917060
URL: http://www.dr-bob.org/babble/20090912/msgs/917898.html