Posted by jealibeanz on April 24, 2007, at 5:17:44
In reply to Re: Do any of your doctors have an opinion?, posted by notfred on April 24, 2007, at 1:19:25
Thanks for the articles!
Haha, I find some of the statements in the 2nd article a little over-zealous:
"By the time a drug reaches phase 3, it has already undergone years of scrutiny in the laboratory, animal trials, and smaller human trials and has the best chance of reaching pharmacy shelves within the next 18 months to three years."
18 months would be verrry quick! 3 years doesn't sound like the upper limit, especially with the way the FDA has been handling drugs in recent years. They are very cautious.
I'm not sure if I like that fact or not! We'll be less likely to have dangerous drugs released, or those that lack efficacy, but it definitely takes much longer than it used to.
Scientists have the ability and knowledge to make better drugs than we have now, and have had it for quite some time. A lot of the current pipeline drugs have been in the lab for 15-20 years. That's very long. I'd get frustrated if I were working on drugs that took soo long to get approved... and most get dropped before even thinking about approval. I've heard it said that the development psych drugs are not the big money makers because they fail so often. A test tube or idea of a anatomical target and chemical compound can't accurately predict a human mood response. The drugs that target functional problems may be much easier to predict.(yes, I know, psych drugs do, but the endpoint is more subjective than, for example, lower blood pressure.)
If someone looks at all the pipeline drugs they'd think there's a lot of work going on in the pharmaceutical world regarding psych drugs. Yes, there is, but that has to be compared to drugs that treat other conditions. There's been very little clinical progress in the last 20 years when treating anxiety/depression.
There's been a lot of progress in other areas, and new drugs have been released and used effectively (anti-hypertensives, anti-virals, anti-hyperlipidemia's... haha, I think I made that last one up, the one's that manipulate HDL's and LDL's).
Look at the thread from a few days ago about the trials, results, and release of Prozac. It's almost a different world now in terms in FDA policy! Haha, and who would have thought in 1988 that we'd still be living in a "Prozac Nation" in 2007. Maybe they did because it was touted as a huge break-through and cure-all for depression and other psychiatric illnesses.
I'm sure a major hinderance is recruiting trial 3 subjects, especially with alllll the drugs in the world in development and the restrictions on who can participate. Most people are too cautious to line up like lab rats (No offense to those who participate. I think it's very admirable.) I know I wouldn't qualify for many studies because they usually don't want anyone with comorbidities. For anxiety trials, some exclude anyone who's ever taken a benzodiazepine for an extended period of time... because they know what it's like to have relief and probably have a lower tolerance for anxiety than others!
poster:jealibeanz
thread:752892
URL: http://www.dr-bob.org/babble/20070419/msgs/752952.html