Posted by yxibow on May 21, 2009, at 16:52:51
In reply to Re: When will Agomelatine be available in the US, posted by odon on May 21, 2009, at 12:20:41
> I was reading some fairly recent posts by Marty.He said he orders Agomelatine by mail from some other country(not sure which country).--I understand this site does not permit people to list sources where they may order medications,however if its a reliable outfit, maybe an exception should be made in this case.And this is coming from a guy(me) that never ordered any medications online,I personally am not comfortable with the idea,but that's me. A sidenote:It's absurd that this medication and certain other possibly effective proven medications are not available in the US and some other countries yet.Why wait,they have been approved in other countries?---The FDA is terrible.If a medication has proven results it should be immediately available in every country.
Oh I don't know -- is that terribly wise, I mean EMEA and Canada's Health Products and Food Branch of Health Canada approve medications; India's health ministry, Japan, etc...
But are each created alike...no. Is it suffice to say that medications that are available in first class Western democracies are likely to be safe for other individuals, probably...
....but it goes much beyond that, including litigation which would be unaffordable to people injured unjustly by medications in developing countries just because a major health organization put a stamp on something.
And just like the FDA, EMEA (or corresponding countries) have had to recall things, such as the 'first' SSRI.
A well regulated health agency collects post-marketing data to see what happens in the real patient-hours after a medication has been approved. This can't be collected reliably from other countries. This is what is known here (FDA) as "Phase IV".
-- Jaya
poster:yxibow
thread:896778
URL: http://www.dr-bob.org/babble/20090515/msgs/897017.html