Posted by Larry Hoover on April 22, 2007, at 16:15:32
In reply to Re: More on Prozac Approval » Jedi, posted by Klavot on April 22, 2007, at 14:00:50
> > By 1992 Prozac has had 28,600 adverse reactions reported to the FDA. Plus an additional 1,700 deaths.
>
> I find it hard to believe that Prozac could have caused 1700 deaths in the US and still be FDA approved. And that's only up to 1992. If that statistic were true, by now there would be many thousands more who have also died from Prozac.
>
> KlavotOf course, your analysis has hit it right on the head. There is no way this drug would still be available, anywhere in the world, if mortality was even a fraction of those numbers. Let's not forget that the extraordinarily conservative British analysis of pediatric data gave Prozac the only approval for child and adolescent use, based on both efficacy *and* safety.
I am amazed at how much credibility these unreferenced reports receive. The history of antidepressant drug development parallels the development of pharmacological vigilance.
Throughout the 80's, and into the 90's, there was no formal ADR (adverse drug reaction) reporting system in North America. It was done on an ad hoc basis, by doctors on their own initiative.
In early 1990, Dr. M. Teicher published the first case reports of suicidality in inpatients treated with Prozac. But prior to this article, the incidence of reports of suicidality associated with Prozac submitted to the FDA (as percentage of prescriptions written) was the same as that for Desyrel (trazodone), also then a relatively new antidepressant. Following a huge amount of publicity on the subject, reports of similar Prozac-related reactions began to flow into the FDA in larger numbers. Therefore, a special sitting of the FDA's Psychopharmacological Drugs Advisory Committee was convened to study the matter.
All told, through August 1991, the FDA had received 14,100 reports of adverse reactions occurring in connection with Prozac since the drug's approval in l987. Of those, there were only 880 reports of suicide attempts associated with Prozac use, while three million Americans had been given or were taking Prozac. That's an incidence of less than .03% I have no idea where that figure of 1700 deaths came from, but I have it on good authority that 76.8% of statistics are made up on the spot. In any case, using NIMH population data also presented to the Committee, 73,000 suicide attempts would have been expected from that population.
Anyway, the Committee concluded that the spike in reporting represented a change in vigilance, rather than a change in incidence, because the ad hoc reporting up until 1990 had not shown any difference between Desyrel and Prozac. Well, actually Desyrel was worse, but let's not split hairs.
Here's a transcript of the entire hearing:
http://www.fda.gov/ohrms/dockets/ac/prozac/2443T1.PDFFormal ADR reporting was not even instituted until 1993, and it was not mandatory, even then. This is an evolving process. Clinical trial protocols themselves were still under development, in this era. *No* drug was then properly tested, according to current criteria.
One more point. There is one drug that is profoundly and significantly associated with suicide, both when used alone or in combination with other drugs. Ethanol. Booze. Just for the record.
You have to consider the context, to understand any numbers being tossed around.
Lar
poster:Larry Hoover
thread:752317
URL: http://www.dr-bob.org/babble/20070419/msgs/752466.html