1 Boring Old Man

Don’t get me wrong about this. I’m very appreciative of the Drugs@FDA web site. It’s like most government sites: labyrinthine and labor intensive, yet full of information. But if you’re looking for something from the forgotten times before Tim Berners-Lee conjured up the World·Wide·Web, it’s pretty sparsely populated. What I’ve been trying to do is go back to what I consider "the source," the early days when Prozac and Paxil were first approved by the FDA. I can find abstracts in PubMed, but a lot of the articles are in a journal I can’t access. And the FDA web-site doesn’t have the medical reviews for the initial approvals. So I sent in my first ever Freedom-of-Information-Act requests. I ran across Dr. Peter Breggin’s account [The Real Story Behind Prozac’s Approval by the FDA] which is pretty horrific, so I thought I’d take a look for myself [it’s worth a read in its own right]. And I thought I’d throw in Paxil too so long as I’m in the neighborhood.

There are a couple of things that interest me. First, I’ve reviewed the studies that got Prozac an approval in adolescents and it’s a pretty thin story – two studies and there’s something awry with each one. Then there’s that annoying meta-analysis of Dr. Gibbons mentioned here ad nauseum that takes four adolescent trials that are shaky, pools them, and they turn into something he sees as definitively positive [sort of 1+1+1+1=8]. From Breggin’s analysis, it looks like they did something similar with Prozac’s original approval – pool a bunch of negative studies and they miraculously turned positive. And we just saw the same thing this week with the Alzheimer’s trials – negative studies reanalyzed into the positive column. So, I guess my curiosity is aroused – how does Eli Lilly do that?

I have another curiosity. Looking at the early studies for both drugs, John Feighner was involved in a number of the Clinical Trials for both drugs. Recall that John Feighner was the resident at Washington University in St. Louis who in 1972 devised the first set of descriptive diagnostic criteria, the ones that became the Research Diagnostic Criteria, that then became DSM-III. He went on to have a career running a Clinical Research Center in California – one that did a lot of the studies for both of these two drugs. I’m not trying to make something out of that other than it’s just interesting – that’s all.