Pfizer Violated Own Rules to Hide Depression Drug Studies
Pfizer is accused of “deception through concealment” and “cheating” in failing to disclose nine of 16 trials of an antidepressant, Edronax (reboxetine), in Germany. The German Institute for Quality and Efficiency in Health Care slammed Pfizer in a press release titled:
Pfizer conceals study data; Drug manufacturer hinders the best possible treatment of patients with depression
Essex Pharma was also noted for not being completely upfront about its antidepressant, mirtazapine, and the Institute praised GlaxoSmithKline in the same set of statements for providing a full database of studies for bupropion XL.
Pfizer’s refusal to disclose its studies violates its own published policy about studies. That policy states:
In all cases, study results are reported by Pfizer in an objective, accurate, balanced, and complete manner and are reported regardless of the outcome of the study or the country in which the study was conducted.
Pfizer said this to the German press:
“Wir haben dem IQWiG ausreichend Daten zur Verfügung gestellt.”
Which means: We made sufficient data available to IQWiG.
This, if anything, is proof that transparency pays off in spades. BNET readers will remember that this site berrated GlaxoSmithKline last September for its ludicrous belief that full disclosure of drug company payments to doctors would “devalue” GSK’s assets.
In March 2009, GSK published this policy statement, indicating that all its data, positive and negative, would be publically disclosed.
Just three months later, that transparency policy hit the jackpot. The Institute recommended buproprion as showing “proof of benefit.” Pfizer’s Edronax was labelled as showing “no proof of benefit” because “there is a high risk of incorrectly estimating the benefit and harm of this agent” without the rest of the data.
I’m not alone in this conclusion. In Vivo notes:
Pfizer isn’t doing itself or the sector’s reputation any good in holding back data.
Image by Flickr user angel with horns, CC.
Jim Edwards, a former managing editor of Adweek, has covered drug marketing at Brandweek for four years, and is a former Knight-Bagehot fellow at Columbia University's business and journalism schools. Follow him on Twitter or send him an email.
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