Paxil....by doc john
 

In a rare behind-the-scenes disclosure (due to a lawsuit), the public is seeing for one of the first times the degree and depth some pharmaceutical companies will go to in order to publish positive results about their drug. Using the same peer-review process that is supposed to prevent abuses by researchers and drug companies and provide other professionals (and the public) with objective data. And the same peer-review process that is used by the U.S. Food and Drug Administration (FDA) to approve medications as safe and effective.
CL Psych provides us with a further analysis of Paxil study 329, one where apparently the researchers went to great lengths to find efficacy. Why the re-examination of this study?

Because another study was just published in the International Jouranl of Risk and Safety in Medicine. The new study examined the internal documents, full dataset and drafts that were released related to a lawsuit against the makers of Paxil. The damning findings from the new study?

5.1. Were the results for study 329 positive or negative?

There was no significant efficacy difference between paroxetine and placebo on the two primary outcomes or six secondary outcomes in the original protocol. At least 19 additional outcomes were tested. Study 329 was positive on 4 of 27 known outcomes (15%). There was a significantly higher rate of SAEs with paroxetine than with placebo. Consequently, study 329 was negative for efficacy and positive for harm......

Yuck. Not good.

Oh boy, I take it and it's really helped me, what kind of harm was it positive for? :( I don't have a membership at wordpress and got an error page when I clicked the link. :(

Dear Pam,
When they say "harm" they mean the side effects" of Paxil.
A placebo has no side effects, I suppose.

Randomized drug trials showed that Verapamil did not work for bipolar.
And yet, my doc (with a dash of genius, luck, or faith) prescribed my Verapamil after ALL other mood stabilzers failed.

My feeling on this -- and I am not a scientist -- is that drugs can work for individuals even though they fail a study. -- just like drugs that pass a study don't work for every body.

The problem is that the drug companies are supposed to to honest the results that they report. HA!

Here's another link:
http://www.healthyskepticism.org/doc...ilStudy329.php

Mari

safety and efficacy...
 

You might find this interesting:

http://www.sfgate.com/cgi-bin/articl...BUMM10DPKD.DTL

Hiding negative studies, ghostwriting, and slanting patient choice for studies to look good (done with Concerta)...are tricks the drug companies use to give their drugs a push into approval.

Another drug that compares to placebo is Claritin, for example. (as ineffective)

Thank you both for the links, I will check them out later after I get back from shopping. I appreciate it a lot since I take paxil and it really HELPS with controlling the floating anxiety and my mood has lifted. :)

I am glad it helps you Pamster!
Many years ago they came out with a liquid polish treatment for toe nail fungus...it costs $100 for a teaspoon of the stuff. It only had a 27% effective rate...how could I recommend this to my clients? But I guess it worked for 27 out of 100 people so it is still an option.
Just like birth control being 99% effective meaning that 1 out of 100 get pregnant....:eek:
with every medication there are risks involved...we have to put alot of faith in our doctors, who have to put alot of faith in the pharmacuetical companies and in the trials etc...a domino effect...of trust.
bizi

Odd.

I just posted something similiar in the MS forum on Prozac. I'm not bipolar but if you don't mind I'll toss my 2 cents in;

I must be one of the lucky ones who Paxil works for. (Moose has the MS and depression... and a bunch of other stuff).:o

Drugs are big business. And these cats in the the tall polished buildings with shoes that cost more than all the clothes I own aren't much different from the hoods pushing on the corner.

Each of our own individual physiology will react differently to what we put in our bodies. And when it comes to dealing with depression and other issues "upstairs", we may have to keep trying different stuff to find the right fit. It is odd though that some stuff gets approved with such a minimal success rate and other things are forbidden with the same slim margin of failure.

Some people can take Prozac. Moose can't. (I get suicidal images popping in my head).
Some people are allergic to peanuts. Moose isn't.

20% payraise effective immediately for Bizi and bringing this to us!:D

And thanks for letting me ramble on.:)

Tea Tree oil works very well on toenail fungus. Deeply entrenched forms might
do better with Lotirimin liquid first.

For Pamster...more info about Paxil if you're interested.....May 2nd post on his blog