![[dr. bob]](/dr-bob-sm.gif)
Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 3 of 3. This is the beginning of the thread.
Posted by Dr. Bob on November 26, 2003, at 21:37:19
In reply to FDA delay for new anti depressant, posted by Robert Fairburn on November 26, 2003, at 4:19:52
>
>
> Theres a new antidepressant thats in development called Nemifitide www.innapharma.com which is in stage 2/3 of trails. However this novel peptide antidepressant has been in the labs since 96. Why does its take so long for a drug to get fda approval. By the time this drug is released it will almost be 10 years from lab to pharmacy shelf. It will take even longer to reach people outside the USA. I know that the FDA needs to be careful but I can believe that its necessary for such long delays. I know thats AIDS patients have tahe the FDA to task over overtly long delays for approval. I cant see why it needs to take 3 years or more before approval is given. In the labs at the moment there are some interesting antidepressants in development however it will take 10 years before we will be able to buy them. Our present range of drugs are very poor. In terms of total response rate MAOI drugs are still best. Some of these drugs where approved in the 1950's. Yet in the year 2003 we have nothing better in regards to the percentage of people who respond to a antidepressant. We have a better selection of drugs, but in reality we just a better selection of poor to average. It looks like we have to wait a while longer before theres any improvement in the situation.
>
> Regards Robert
>
Posted by 8 Miles on December 6, 2003, at 17:50:38
In reply to FDA delay for new antidepressant « Robert Fairburn, posted by Dr. Bob on November 26, 2003, at 21:37:19
Actually, your theory that "the rest of the world" won't have access to meds may not actually be the case. If you will check, you will find that many meds have been used in Europe and elsewhere (even made by U.S. companies) for many years that are not yet available HERE. Maybe that's the way the med companies can gather data to present to the FDA that a drug does not have any terrible side effects, and is effective in treating the condition for which it was developed.
Then, of course, there are meds like Wellbutrin that were actually produced in the 1970's that were prescribed at the wrong dosage, which caused a lot of problems (seizures in this case) so they were taken away. Only years later did Wellbutrin come back out with dose reduction, and warnings about decreasing one's seizure threshold. We will have to see how this plays out, but the bottom line is profit for the companies, and safety and efficacy for the FDA.8
Posted by stjames on December 8, 2003, at 18:09:17
In reply to Re: FDA delay for new antidepressant, posted by 8 Miles on December 6, 2003, at 17:50:38
Wellby was never pulled.
The FDA tends not to listen to studies outside the states. At the least one must produce state
side testing to get a drug approved.
This is the end of the thread.
Psycho-Babble Social | Extras | FAQ
Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.org
Script revised: February 4, 2008
URL: http://www.dr-bob.org/cgi-bin/pb/mget.pl
Copyright 2006-17 Robert Hsiung.
Owned and operated by Dr. Bob LLC and not the University of Chicago.