Depressing News

Via Chris in Paris at AmericaBlog, most of the antidepressants on the market seem not to work, starting with Prozac. It's not the lack of effect so much as the way in which these drugs were presented to licensing agencies and then promoted. From The Guardian:

The review breaks new ground because Kirsch and his colleagues have obtained for the first time what they believe is a full set of trial data for four antidepressants.

They requested the full data under freedom of information rules from the Food and Drug Administration, which licenses medicines in the US and requires all data when it makes a decision.

The pattern they saw from the trial results of fluoxetine (Prozac), paroxetine (Seroxat), venlafaxine (Effexor) and nefazodone (Serzone) was consistent. "Using complete data sets (including unpublished data) and a substantially larger data set of this type than has been previously reported, we find the overall effect of new-generation antidepressant medication is below recommended criteria for clinical significance," they write.

Two more frequently prescribed antidepressants were omitted from the study because scientists were unable to obtain all the data.

I think any American has the right to ask the FDA why complete trial data is being analyzed for the first time -- why wasn't it analyzed before the drug was approved? It's much deeper than another Bush corporate hand-out -- Prozac's been around for years. This is systemic.

The FDA's always been pretty permissive toward pharmaceutical companies and food manufacturers (and where but America could you say someone "manufactures" food?), and maybe it's way past time that stopped. Not that I expect it from any administration or Congress -- the chance for profit under the present system is too high. But I honestly think that withholding trial data from applications before the FDC, rather than being permitted, should be a felony with criminal penalties. C'mon -- Eli Lilly has made billions from a drug that not only is not effective, but has killed people.

The responses from the pharmaceutical manufacturers are what might be expected, ranging from indignation to complete denial:

Eli Lilly was defiant last night. "Extensive scientific and medical experience has demonstrated that fluoxetine is an effective antidepressant," it said in a statement. "Since its discovery in 1972, fluoxetine has become one of the world's most-studied medicines. Lilly is proud of the difference fluoxetine has made to millions of people living with depression."

A spokesman for GlaxoSmithKline, which makes Seroxat, said the authors had failed to acknowledge the "very positive" benefits of the treatment and their conclusions were "at odds with what has been seen in actual clinical practice".

He added: "This analysis has only examined a small subset of the total data available while regulatory bodies around the world have conducted extensive reviews and evaluations of all the data available, and this one study should not be used to cause unnecessary alarm and concern for patients."

The holes in these responses are obvious: Lilly's bald assertion that Prozac has "proven itself" is obviously on shaky ground. Even from the summary in the article, GlaxoSmithKline's objection doesn't hold water: it's easy to see that the study did address the "benefits" demonstrated in clinical practice: placebo effect. The second part of that is a dodge: the complete data was not available to the regulatory bodies. That's the problem.

The whole damned thing's broken.