Posted by Larry Hoover on August 28, 2004, at 11:07:43
In reply to Re: pediatric suicidality and SSRIs » Larry Hoover, posted by SLS on August 28, 2004, at 10:11:17
> Dear Larry,
>
> Thanks for taking the time to review the published material on Paxil. I never would have been able to get through it, much less interpret it. Your conclusions are reassuring.I'm thrilled that the raw data are being published. There is a new target for the anti-drug press, Cymbalta. I understand the full study data will be online by the end of the year.
> I only hope that they are to be concurred with by others and make headlines in the media to the same extent as were the alarmist accusations.
>
>
> - ScottYou're not going to see the retraction headlines, Scott. That won't sell newpapers.
I'll give you an example of an incidence of "serious emotional lability" in the pediatric Paxil arm of the study I reviewed. Using a priori reporting guidelines, it had to be reported this way.....
Each subject was given those foil-bubble packs of drugs, enough for 10 days intake, at twice-a-day dosing. This allowed for a little flexibility around the intended weekly monitoring meeting, at which a new set of drugs was dispensed. The old drug packs were returned, and counted, to ensure some measure of compliance to the protocol.
One subject took a little bit too much medication. She was supposed to take 14 capsules over the week-long period, but she three times took either 15 or 16 capsules. Under the study protocol, doing so two or more weeks in a row, was to be scored as "intentional overdose, severe emotional lability". If she had done so with a single week between each mistaken dosing pattern, it wouldn't have been scored at all.
Give me a break. The subject was warned to pay closer attention to her dosing schedule, and she then complied completely. No adverse side-effects of any sort were reported. She later went on to the long-term maintenance arm of the study, and did not ever again mistakenly take too many pills. She could have been in the placebo arm, for all anybody knew. Her blind was not broken.
The loony press reported this as a suicide attempt in the Paxil arm of the study.
Lar
poster:Larry Hoover
thread:382578
URL: http://www.dr-bob.org/babble/20040825/msgs/383314.html