Posted by bleauberry on December 21, 2009, at 17:25:08
In reply to NTY article on generics--mentions welbutrin, posted by floatingbridge on December 21, 2009, at 0:49:10
"Bioequivalence" does not equal "clinical" equivalence.
Unfortunately, the FDA method of testing generics is not based on patient trials or clinical equivalence. It is based on accepting theories and assumptions as if they were fact. It ignores obvious differences in manufacturing and ingredients. It "assumes" the "other" ingredients don't do anything, either good or bad.
Clinical testing doesn't help either, because the overall rate in a large group of people will probably be the same in a generic group or a brand group. So it will automatically be assumed that both are equal. However, to do a switchover study would be more meaningful...that is, switch stable brand users to generic blindfolded and see what happens. It is already showing itself in the real world.
This article which gently questions generics is but one of literally hundreds. The evidence is all over the place. Wellbutrin is but one of dozens of culprits that have brought on documented trouble to countless patients.
My doctor won't even prescribe generics because he has seen too many problems with them. Even if one is good, we don't know it is good...there is already too many variables and possibile contributors to med failures, and we don't need to introduce yet one more questionable variable, of any kind. Especially in mental health, the stakes are too high to even take on any additional risk than there already is.
This doctor has many patients stable and doing well on their meds...brand. They were tried to switch to generics, some continued to do well and some relapsed. But at least at this point we would now know what is doing what. Now, just imagine if they had started with generic and never tried brand? Guess what, they totally completely missed out THE med they were hoping for, even though it was so close.
poster:bleauberry
thread:930100
URL: http://www.dr-bob.org/babble/20091217/msgs/930213.html