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Piggott: Critiques of the STAR*D study

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Here are three papers from H. Edmund Pigott, Ph.D., who has been at the forefront of critics of the STAR*D study.

 

Dr. Pigott has a blog on Robert Whitaker's site, Mad in America http://www.madinamerica.com/madinamerica.com/Pigott.html

 

Dr. Pigott has been kind enough to make his papers freely available. In his e-mail in response to my request for papers:

 

"You are doing very important work with your website."

 

J Contemp Psychother (2009) 39:93–100

Full text at http://www.karger.com/Article/FullText/318293 http://www.mediafire.com/?gl56lmnj0gmnben

Just How Effective are Antidepressants? Results of a Major New Study

John J. Boren, Allan M. Leventhal, H. Edmund Pigott

Published online: 6 September 2008

 

Abstract

The STAR*D (Sequenced Treatment Alternatives to Relieve Depression) project was the largest and most extensive trial of antidepressants ever conducted. The study used state of- the-art methods to treat real patients coming to a hospital or psychiatric clinic for relief from depression. Because the first antidepressant is often ineffective for most patients, a sequence of drug treatments targeting various brain neurochemicals was carefully planned. This article will review the complex treatments and the various outcomes, including the frequency of relapse during twelve months of follow-up care.

 

Psychother Psychosom 2010;79:267–279

Free full text at http://www.mediafire.com/?udwrmpr30u4wmi2

Efficacy and Effectiveness of Antidepressants: Current Status of Research

H. Edmund Pigott, Allan M. Leventhal, Gregory S. Alter, John J. Boren

Published online: July 9, 2010

 

Abstract

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.

 

Ethical Human Psychology and Psychiatry, Volume 13, Number 1, 2011

Free full text at http://www.mediafire.com/?33oueqhf3gwmgek

STAR*D: A Tale and Trail of Bias

H. Edmund Pigott, PhD

 

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.

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Healing

That's great that he acknowledged the site! :)

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Barbarannamated

Efficacy and Effectiveness, Pigott et al, p.276

 

"In STAR*D, failed trials had negative consequences for patients beyond not attaining remission. Such failures decreased patients' likelihood for obtaining remission in subsequent trials while increasing their likelihood for drug intolerance, relapse, or dropping out.

These negative effects lend support to the observation of Fava that successive pharmacologic manipulation 'may propel depression into a refractory phase' by fostering oppositional tolerance in which the antidepressant sensitizes some patients to depression."

REF:

Fava, GA, et al: The Road to Recovery from depression: don't drive today with yesterday's road map, Psychother Psychsom 2007;76

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Altostrata

It's unknown what this "refractory phase" is. It may be withdrawal syndrome, or symptomatic of brain changes from which it may take a long time to recover -- not unlike withdrawal syndrome.

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Barbarannamated

I had not heard of a link to diabetes before although it doesn't surprise me given that we are playing with same neurohormones. Do we have Andersohn study? I'll check and get full text if not.

 

From same Pigott paper, p. 277

 

"Besides these studies, failure to find any apparent benefit from continued antidepressant treatment, the recent finding that LONG TERM USE OF SSRIs AT MODERATE/HIGH DAILY DOSE DOUBLES THE RISK OF DIABETES (Andersohn, F) and the uncertain risk of oppositional tolerance, provides additional reasons for reexamining this all too common practice." (emphasis mine)

 

REF

Andersohn F, et al: Long term use of antidepressants and the risk of diabetes mellitus. Am J of Psychiatry 2009; 166:591-598.

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Barbarannamated

It's unknown what this "refractory phase" is. It may be withdrawal syndrome, or symptomatic of brain changes from which it may take a long time to recover -- not unlike withdrawal syndrome.

 

I love how he handles this (p.277)

 

"...it is worth reconsidering the term 'treatment resistant depression' when referring to patients who don't respond favorably to drug treatment. Should we not direct our attention to what is wrong with our treatment rather than classifying some patients as having an exotic form of depression because they fail to respond?" Our understanding is hampered by using language that wrongly implies that there is an exceptional subgroup of patients who are refractory to an otherwise effective treatment."

 

I have to read how Fava explains oppositional tolerance. Did these trials require that patients be medication-naive? I haven't seen that, but recall it was big with antipsychotics trials. Just very brief exposure to neuroleptics lessened effect of future drugs--a desensitization of sorts.

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compsports

As an FYI, on the 1Boring Old Man blog, Mickey, the psychiatrist blog owner, discusses Piggott's work and refers to the Star D studies as fraudulent. Interestingly, when I mentioned this in discussion with psychiatrists on other blogs, there was no comment or avoidance of the issue.

 

If anyone wants the direct link, I previously provided them in a post on this site. Use the "search" function or if you want, I can find the direct links.

 

CS

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Barbarannamated

Im trying to sort thru the STAR*D info. It appears to be alot of data that's been sliced and diced by many.

Just FYI, Pigott is founder of NeuroAdvantage, LLC.

Giovanna Fava is (or was) editor of Psychotherapy Psychosomatics.

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compsports

Im trying to sort thru the STAR*D info. It appears to be alot of data that's been sliced and diced by many.

Just FYI, Pigott is founder of NeuroAdvantage, LLC.

Giovanna Fava is (or was) editor of Psychotherapy Psychosomatics.

 

Hi Barb,

 

Yeah, I wasn't too happy when I found out about Pigott being the founder of NeuroAdvantage. I mean here we scream conflict of interest and this came across as one even though I was pretty convinced the data was accurate. And John Grohol, of psych central, who pointed out the conflict of interest, and who isn't exactly anti psychiatry, felt the study raised some serious issues.

 

Anyway, that is why I was so glad when Mickey on the Boring Old Man blog pretty much echoed Pigott's conclusions as a retired psychiatrist.

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Altostrata

Bar, we don't have the Andersohn study, would be a great addition to the Journals section.

 

The increase in diabetes risk alone is an excellent argument against the widespread prescription of SSRIs.

 

Great summation by Pigott on what's wrong with "treatment-resistant" label.

 

All the Fava papers on oppositional tolerance are posted in Journals.

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Barbarannamated

Trying to get link to Andersohn article in here. First attempt to post as new topic failed. Posting link. More to come...

 

Long-term use of antidepressants for depressive disorders and the risk of diabetes mellitus.Andersohn F, Schade R, Suissa S, Garbe E.

SourceBremen Institute for Prevention Research and Social Medicine, Bremen, Germany. frank.andersohn@charite.de

 

http://www.ncbi.nlm.nih.gov/pubmed/19339356

 

OR, Abstract from American Journal of Psychiatry online:

 

http://ajp.psychiatryonline.org/article.aspx?volume=166&page=591

 

Abstract Objective: Use of antidepressants has been reported to cause considerable weight gain. The aim of this study was to assess the risk of diabetes mellitus associated with antidepressant treatment and to examine whether the risk is influenced by treatment duration or daily dose. Method: This was a nested case-control study in a cohort of 165,958 patients with depression who received at least one new prescription for an antidepressant between January 1, 1990, and June 30, 2005. Data were from from the U.K. General Practice Research Database. Patients were at least 30 years of age and without diabetes at cohort entry. Results: A total of 2,243 cases of incident diabetes mellitus and 8,963 matched comparison subjects were identified. Compared with no use of antidepressants during the past 2 years, recent long-term use (>24 months) of antidepressants in moderate to high daily doses was associated with an increased risk of diabetes (incidence rate ratio=1.84, 95% CI=1.35—2.52). The magnitude of the risk was similar for long-term use of moderate to high daily doses of tricyclic antidepressants (incidence rate ratio=1.77, 95% CI=1.21—2.59) and selective serotonin reuptake inhibitors (incidence rate ratio=2.06, 95% CI=1.20—3.52). Treatment for shorter periods or with lower daily doses was not associated with an increased risk. Conclusions: Long-term use of antidepressants in at least moderate daily doses was associated with an increased risk of diabetes. This association was observed for both tricyclic antidepressants and selective serotonin reuptake inhibitors

I had not heard of a link to diabetes before although it doesn't surprise me given that we are playing with same neurohormones. Do we have Andersohn study? I'll check and get full text if not.

 

From same Pigott paper, p. 277

 

"Besides these studies, failure to find any apparent benefit from continued antidepressant treatment, the recent finding that LONG TERM USE OF SSRIs AT MODERATE/HIGH DAILY DOSE DOUBLES THE RISK OF DIABETES (Andersohn, F) and the uncertain risk of oppositional tolerance, provides additional reasons for reexamining this all too common practice." (emphasis mine)

 

REF

Andersohn F, et al: Long term use of antidepressants and the risk of diabetes mellitus. Am J of Psychiatry 2009; 166:591-598.

 

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