BMJ and Doctor happy to be taken in by unsafe study conclusions

Yep this is another story about THAT study – you know the one – where ‘leading psychiatric researcher’ Robert D. Gibbons, linked a 2004 increase in the suicide rate for children and adolescents to a warning by the Food and Drug Administration about the use of antidepressants in minors. The F.D.A. warning, the researchers suggested, might have resulted in severely depressed teenagers going without needed treatment.

This study was published in the USA in the American Journal of Psychiatry and then featured in an article in the UK in the British Medical Journal entitled “Teen suicide rate rises as prescribing of SSRIs falls, study finds”

Oh yeah?

Anyway, the article in the BMJ gave Dr Chris Manning another chance to continue his bizarre campaign of attacking Professor David Healy whenever possible.

Manning is pro SSRI and sees no conflict of interest between his pro SSRI/anti Healy stance and the fact that for years Primhe (his organisation) has received grant funding from pharmaceutical companies that manufacture SSRIs. You can find out more here, here and here.

I think Manning ought to open his mind to the possibility that the conclusions of the study are flawed before he climbs once more onto his soapbox. The black box warning in the US was not applied to anti-depressants until Oct. 15, 2004, so it is difficult to believe that the warning could have affected suicide data for the entire year.

The New York Times reported on September 14 in fact, prescription rates had not changed much in 2004:
“While suicide rates for Americans ages 19 and under rose 14 percent in 2004, the number of prescriptions for antidepressants in that group was basically unchanged and did not drop substantially, according to data from the study. Prescription rates for minors did fall sharply a year later, but the suicide rates for 2005 are not yet available from the Centers for Disease Control and Prevention.

There doesn’t seem to be any evidence of a statistically significant association between suicide rates and prescription rates provided in the paper” for the years after the F.D.A. warnings, said Thomas R. Ten Have, a professor of biostatistics at the University of Pennsylvania.

In an interview, Robert D. Gibbons, a professor of biostatistics and psychiatry at the University of Illinois at Chicago and the lead author of the journal article, acknowledged that the data from the United States that he and his colleagues analyzed did not support a causal link between prescription rates and suicide in 2004. “We really need to see the 2005 numbers on suicide to see what happened,” he said.

But Dr. Gibbons defended the paper, saying that when taken in the context of previous studies that linked falling antidepressant use to increased suicide rates, “this study was suggestive, that’s what we’re saying.”

If we look at preliminary suicide data for 2005 (released last week) it shows a 3% drop in suicides for that year–the first full year of the black box warning and a year in which anti-depressant prescriptions actually did drop. This would seem to be the opposite of what the study’s authors argued.

This whole affair is an embarrassment for the AJP and the BMJ. Central flaws in a significant study were not caught by peer reviewers and the journal’s editors. A flawed and fundamentally incorrect paper was published to wide media attention. The world is now in essence being told that down is up and up is down by two hugely influential journals.

This situation must be remedied by the AJP and the BMJ – and quickly. The politics and emotions around the SSRI-suicide debate are too intense and divisive to permit this paper to just sit out in the public realm and be regarded by some forces, especially policy making ones, as ‘evidence.’ It doesn’t make sense for the journal to let whatever debate will erupt over this paper to take place six months from now in the letters section of the journal.

The journals either needs to ensure that a correction is promptly issued for this paper–and done so very publicly–or that the paper itself is retracted.

In addition, I have to wonder why Robert Gibbons, the study’s lead author and a very experienced statistician, could screw things up as badly as has been reported. It kind of makes you wonder how reliable his testimony as an expert witness for Wyeth, makers of Effexor, could have been.

Thanks to the New York Times and Phil Dawdy at Furious Seasons.


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