Tuesday, December 04, 2007

Blast From the Past: Suicide Data Regarding Prozac Buried

This post will document plainly how Lilly and/or the National Institute of Mental Health and/or key opinion leader(s) made data on Prozac and suicide vanish. Poof! A study known as Study X065, published with Graham Emslie as the lead author, differs notably from the FDA report on the data from the same study. In the published paper, there is no mention of suicidal ideation whatsoever. None. However, according to the FDA report...

You can read it on page 19 of the report. It is clearly referencing the X065 study. Yet even a passing mention of suicide is not provided in the published paper. Regarding a different medication, the lead investigator for the X065 study, Graham Emslie, was asked at one point why he was not sharing data showing that Paxil/Seroxat was not an effective treatment for child/adolescent depression. He responded as follows:
I couldn’t talk about it because it was proprietary.
In other words, GSK owned the data, so he could not mention the negative information unless he had their permission. In my humble opinion, this gives the impression of Emslie not being a scientist, but rather a sock puppet for the drug industry. Back to the X065 study. Why wouldn't Emslie, lead author of the study insist that the suicide attempt data be included in the X065 study publication? NIMH theoretically owned the data, as they funded the study, so why wouldn't they make sure to publish such important information? It's one thing to exclude data from two patients on Prozac who had, say, treatment-emergent flatulence, but it is quite another to exclude data on a much more troubling treatment-emergent event such as suicide attempts.

I'm not the first to notice this issue. It was previously mentioned by Jonathan Leo in a letter to the editor in Psychiatric Times. When I see this incidence of hiding suicide data and I think about NIMH's poor attempts at journalism regarding the SSRI-suicide issue, it raises my suspicions regarding whose agenda is being served at the agency.

Whose Opinion Matters? Also of note, yet frequently not mentioned by the SSRI's are terrific for kids crowd is that depression measures completed by the children and adolescents in this study showed no significant improvement versus a placebo. This has nearly always been the case in studies examining SSRIs for child and adolescent depression. Measures rated by clinicians have occasionally found an advantage for SSRIs in youth depression, yet almost never have such effects extended to the youths' perceptions of their depression. Call me crazy, but if we're going to say a treatment is effective for depression, yet the people who are depressed say it does not relieve their depression, shouldn't that raise some suspicion? The authors, however, try to squirm out of this difficult position with the following sentences:
Furthermore, self-reported depressive symptom measurements also showed improvement in both groups, but the between-group differences were not significant. However, given the wide variability of initial child self-reports, these findings are difficult to interpret.
Oh, I get it. When a significant advantage is shown on a measure rated by clinicians, it is not difficult to interpret, but when a drug is not shown more effective than a placebo, well, who knows what that might mean? A very nice attempt at obfuscation on the part of the authors. You'd think this was a drug company funded study -- it hid negative data and obfuscated negative findings -- yet the good old NIMH, with our tax dollars, was behind this work.

But worry not, my friends, the study X065 conclusion, as published in the flagship journal of psychiatry (Archives of General Psychiatry) reads as follows:
These data indicate that fluoxetine 20 mg/d is safe and effective in children and adolescents.
Back to Graham Emslie. He admits to helping to keep GSK's secret that Paxil was not an effective treatment for youth depression and he was the lead investigator on a study in which two suicide attempts appear to have been deep-sixed. His interpretations of research regarding Effexor for (you guessed it) youth depression also seem overly positive, and it seems that he helped to keep data on Effexor for youth depression buried for several years. But, worry not, according to his website, he is "is known internationally for his work in the treatment of pediatric depression." Indeed. I'm comforted to know that we can expect this high caliber of work from high-ranking academic psychiatrists.


ladybroadoak said...

Can you leave the exact url on here, the comments?

I really can't get this to go on digg and it SHOULD.
Thanks again,


insider said...


Any thoughts/comments?

CL Psych said...

I'll try to work on the digg thing.

I have just posted regarding the "remarkable" new results regarding Seroquel. Please give it a look and let me know what you think.