Posted by Rick on February 3, 2004, at 19:38:32
In reply to Re: serzone banned in aust, posted by rvanson on February 2, 2004, at 0:31:18
> > Well, there ya go:
> >
> > That's the glory of socialized medicine for ya...
> >
> > Nothin' like the government tell you which medications you can and cannot have. Despite our problems, I'm glad I live here in the USA.
> >
> > TR
>
>
> The FDA has routinely not permitted safe A/D medications approved in other countries to be prescribed by US doctors.
>
> A good example is Moclobimide (Aurorix)readily available in Austrailia, the UK and Canada, but not the USA.
>
What you describe does indeed happen, but it's also partly up to the manufacturer sometimes. In some cases the manufacturer decides there's not enough economic payoff to warrant seeking U.S. approval, especially if they've failed to show efficacy (or have shown some potentially dangerous side effect) in initial U.S. tests.I recall reading that just a year or two ago Roche wanted to get approval for moclobemide in the U.S. for Social Phobia, but abandonded this effort when some placebo-controlled tests failed to demonstrate efficacy. Roche could have gone "back to the drawing board" and re-tested (as Somerset is doing with the selegiline patch) but apparently concluded that it wouldn't pay off economically.
Another drug available elsewhere but for which the manufacturer abandonded securing FDA approval was reboxetine. The circumstances were very similar to those for moclobemide, although the approval was being sought for depression rather than social phobia.
What's sad is that even a med which fails a placebo-controlled test could in reality be very helpful for *some* people. Also, a high placebo response rate screws things for some drugs which are actually quite effective. Heck, there have been some recent double-blind, placebo-controlled tests for old standby Prozac in which it failed to outperform the placebo!
I don't claim to know this for a fact, but I suspect the FDA may have a more rigorous (and expensive) new-drug approval process than other countries.
Rick
poster:Rick
thread:304517
URL: http://www.dr-bob.org/babble/20040131/msgs/309048.html