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"When Government Propaganda Masquerades as Science" (on an antidepressants study)

Dolphin

Senior Member
Messages
17,567
I thought this was interesting for a few reasons including what happened with the PACE Trial with the differences between the outcome measures in the (published) PACE Trial protocol and what was published in the Lancet.

Maybe it's no co-incidence that both studies are both in the field of psychiatry (and psychology)? (In the PACE, two of the three Principal Investigators (Peter White and Michael Sharpe) are psychiatrists, Trudie Chalder is a psychiatric nurse by profession as I understand it (she's not an MD anyway).

Blogs
Mad in America
History, Science, and the Treatment of Psychiatric Disorders by Robert Whitaker
When Government Propaganda Masquerades as Science
The latest on the STAR*D scandal

Published on March 25, 2011

Five years ago, Maryland psychologist Ed Pigott read the first published results of the NIMH's large STAR*D study of antidepressants and depression.
However, even as he read that first article, he got the sense that "significant researcher trickery was afoot." Since then he has systematically exposed the trickery, piece by piece.

His latest article on the study, "STAR*D: A Tale and Trail of Bias," has just been published in Ethical Human Psychology and Psychiatry. He is also now blogging about his findings on madinamerica.com, and has posted documents there that he relied upon in his "deconstruction" of the $35 million study.
Continued at:
http://www.psychologytoday.com/node/57641
 

Dolphin

Senior Member
Messages
17,567
STAR*D: A Tale and Trail of Bias

Here's the abstract of the study. The link above expands on it. I don't have the full text of the paper itself

STAR*D: A Tale and Trail of Bias

Author: Pigott, H. Edmund

Source: Ethical Human Psychology and Psychiatry, Volume 13, Number 1, 2011 , pp. 6-28(23)

Publisher: Springer Publishing Company

(I've made each line a paragraph)
Abstract:

The 35-million-dollar Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study is the largest antidepressant effectiveness study ever conducted.

STAR*D enrolled 4,041 depressed patients and provided them with exemplary free acute and continuing antidepressant care to maximize their likelihood of achieving and maintaining remission.

Patients who failed to get adequate relief from their first antidepressant were provided with up to three additional trials of pharmacologically distinct treatments.

This article identifies numerous instances of apparent bias in the conduct and reporting of outcomes from this study.

In contrast to STAR*D's report of positive findings supporting antidepressants' effectiveness, only 108 of its 4,041 patients (2.7%) had an acute-care remission, and during the 12 months of continuing care, these patients neither relapsed nor dropped out.

This article also discusses the roles of the American Journal of Psychiatry (AJP) and the National Institute of Mental Health (NIMH) in promoting the biased reporting of STAR*D's results.

Keywords: MAJOR DEPRESSION; ANTIDEPRESSANTS; RESEARCHER BIAS; STAR*D

Document Type: Research article

DOI: 10.1891/1559-4343.13.1.6

Publication date: 2011-04-01
 

Dolphin

Senior Member
Messages
17,567
One can get the full text for free

Ed Pigott has a comment under the Psychology Today article that via his blog (he gives a link), one can request the paper.

When one gets there, one sees there is a slight catch:
My only request is that you give feedback by posting on the blog, anonymously if preferred.
However, I don't mind if several people mention the PACE Trial (for example).
 

Dolphin

Senior Member
Messages
17,567
A related paper can be got for free: http://content.karger.com/ProdukteD...ikelNr=318293&Ausgabe=254424&ProduktNr=223864

However, I imagine some people find reading full papers quite a bit of work. The original link I gave http://www.psychologytoday.com/node/57641 is for a piece that is much easier to read.

Efficacy and effectiveness of antidepressants: current status of research.

Pigott HE, Leventhal AM, Alter GS, Boren JJ.

Psychother Psychosom. 2010;79(5):267-79. Epub 2010 Jul 9.

NeuroAdvantage, LLC, Clarksville, Md., USA. pathware@erols.com

Abstract
(I've given each line its own paragraph)

BACKGROUND: This paper examines the current status of research on the efficacy and effectiveness of antidepressants.

METHODS: This paper reviews four meta-analyses of efficacy trials submitted to America's Food and Drug Administration (FDA) and analyzes STAR*D (Sequenced Treatment Alternatives to Relieve Depression), the largest antidepressant effectiveness trial ever conducted.

RESULTS:
Meta-analyses of FDA trials suggest that antidepressants are only marginally efficacious compared to placebos and document profound publication bias that inflates their apparent efficacy.

These meta-analyses also document a second form of bias in which researchers fail to report the negative results for the pre-specified primary outcome measure submitted to the FDA, while highlighting in published studies positive results from a secondary or even a new measure as though it was their primary measure of interest.

The STAR*D analysis found that the effectiveness of antidepressant therapies was probably even lower than the modest one reported by the study authors with an apparent progressively increasing dropout rate across each study phase.

CONCLUSIONS: The reviewed findings argue for a reappraisal of the current recommended standard of care of depression.

Copyright 2010 S. Karger AG, Basel.
PMID: 20616621 [PubMed - indexed for MEDLINE]