Posted by pharmrep on September 23, 2002, at 12:51:50
In reply to Re: dont start » Alan, posted by Geezer on September 23, 2002, at 12:34:16
> Very good point. One might also consider any significant drug testing (in terms of large test populations, conducted over a long period of time) is only carried out in Europe - not in the US. The FDA will not allow European testing to be considered in qualifying a drug for safety or efficacy, prior to release in this country. The American drug companies sponsor the European testing and wisely so. The adverse drug reactions and interactions will be found in Europe first. This gives the drug company the opportunity to report to the FDA, thereby reducing legal exposure.
>
> Then we have the testing itself to consider. HAMD is a subjective, psycho-social, allegorical report with no basis in emperical medical science.
>
> Your point re: test population bias is also well taken. I am a 30%er - a member of that 30% refractory to contemporary drug treatment. I have a chronic, treatment refractory, major unipolar, atypical depression. This disease (in my case) is a genetically transferred, biochemical, physiologic, brain disorder. I am doubtful I would be recruited for any contemporary, meaningful drug study here in the US.
>
> Like you, I would like to see the Freedom of Information Act applied to drug studies but don't believe that will happen anytime soon.
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> My opinion only, no disrespect intended. I am assuming the topic is appropriate for this board.
>
> Good cheer** why dont you think the Freedom of info act is being used currently...it most definitely is...drug companies keep each other in check with it all the time and often use each others studies in the field...I agree..any one of the "scales" by itself is not very strong...but in combination...the ham-d, ham-a, madres, and cgi (cgi being not from the patient but from the doctor) can be compelling if the scores are consistent
poster:pharmrep
thread:109458
URL: http://www.dr-bob.org/babble/20020922/msgs/120821.html