Thursday, March 19, 2009

AstraZeneca silenced drug study, creates uproar (WashPost)

From the Alliance for Human Research Protection :

Study 15 was pivotal to AstraZeneca gaining FDA approval to market Seroquel.  The burial of negative data suggests that the approval process was tainted and the drug's license should be recalled.

A front page report by Shankar Vedantam in The Washington Post (below) about AstraZeneca's manipulation of research findings involving its antipsychotic, Seroquel (quetiapine) gets to the heart of the corrupting influence that pharmaceutical companies have on American medicine--both on its research and clinical practice guidelines--psychiatry, in particular has been compromised to its core.

Indeed, the evidence of corruption in psychiatry is so overwhelming that an editorial Robert Freedman, the editor in chief, of the American Journal of Psychiatry, the flagship journal of the American Psychiatric Association acknowledges:

    "Even if most doctors are ethical, corporate grants, gifts and underwriting have compromised psychiatry." "The subsidy that each of us has been receiving is part of what has fueled the excesses that are currently under investigation."

The Post reports:
"The saga of Study 15 (1997) has become a case study in how drug companies can control the publicly available research about their products, along with other practices that recently have prompted hand-wringing at universities and scientific journals, remonstrations by medical groups about conflicts of interest, and threats of exposure by trial lawyers and congressional watchdogs."  

Internal documents, the Post reports, show that company officials were worried because 45% of the Seroquel patients had experienced what AstraZeneca physician Lisa Arvanitis termed "clinically significant" weight gain. The documents reveal that rather than "coming clean" about the risk, the company put a "positive spin" on "this cursed study" and praised Dr. Lisa Arvanitis for having: "done a great 'smoke and mirrors' job!"

Two years after those exchanges, in 1999, the documents show that "the company presented different data at an American Psychiatric Association conference and at a European meeting. The conclusion: Seroquel helped psychotic patients lose weight."

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