Literature DB >> 16804639

Manufacturing consensus.

David Healy1.   

Abstract

The Food and Drug Administration (FDA) has declared that it would be illegal to advertise as or in any way claim your drug to be superior to competitors on the market, which are up to 30 times cheaper. How does a pharmaceutical company market such a product? The answer is to enlist academics to form expert panels to construct guidelines and algorithms, or participate in Delphi panels and other exercises, which can be expected to prove that newer, more costly drugs produce cost savings. These academics do so on the basis of the existing clinical trial evidence--which supposedly the FDA has used to come to its verdict that the newer compound is no better than its competitors. However, where the FDA has seen the raw data, academics later see the published data. In between intervenes a medical writing exercise, which produces the first and most important piece of advertising for any pharmaceutical product--the randomized controlled trial infomercial. This paper explores how pharmaceutical companies manufacture an apparent academic consensus and, in so doing, gives a case study of the recent controversies surrounding the marketing of selective serotonin reuptake inhibitor (SSRI) drugs for adolescent depression.

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Year:  2006        PMID: 16804639     DOI: 10.1007/s11013-006-9013-3

Source DB:  PubMed          Journal:  Cult Med Psychiatry        ISSN: 0165-005X


  22 in total

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Journal:  Psychopharmacol Bull       Date:  1997

2.  Interface between authorship, industry and science in the domain of therapeutics.

Authors:  David Healy; Dinah Cattell
Journal:  Br J Psychiatry       Date:  2003-07       Impact factor: 9.319

3.  The Texas Medication Algorithm Project: development and implementation of the schizophrenia algorithm.

Authors:  J A Chiles; A L Miller; M L Crismon; A J Rush; A S Krasnoff; S S Shon
Journal:  Psychiatr Serv       Date:  1999-01       Impact factor: 3.084

4.  Texas Medication Algorithm Project: definitions, rationale, and methods to develop medication algorithms.

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Journal:  J Clin Psychiatry       Date:  1998-07       Impact factor: 4.384

5.  Consensus conferences as drug promotion.

Authors:  T A Sheldon; G D Smith
Journal:  Lancet       Date:  1993-01-09       Impact factor: 79.321

6.  Sertraline treatment of children and adolescents with obsessive-compulsive disorder or depression: pharmacokinetics, tolerability, and efficacy.

Authors:  J Alderman; R Wolkow; M Chung; H F Johnston
Journal:  J Am Acad Child Adolesc Psychiatry       Date:  1998-04       Impact factor: 8.829

7.  Symptom reduction and suicide risk among patients treated with placebo in antipsychotic clinical trials: an analysis of the food and drug administration database.

Authors:  A Khan; S R Khan; R M Leventhal; W A Brown
Journal:  Am J Psychiatry       Date:  2001-09       Impact factor: 18.112

Review 8.  ACNP Task Force report on SSRIs and suicidal behavior in youth.

Authors:  J John Mann; Graham Emslie; Ross J Baldessarini; William Beardslee; Jan A Fawcett; Frederick K Goodwin; Andrew C Leon; Herbert Y Meltzer; Neal D Ryan; David Shaffer; Karen D Wagner
Journal:  Neuropsychopharmacology       Date:  2006-03       Impact factor: 7.853

9.  The impact of the Food and Drug Administration Modernization Act on the recruitment of children for research.

Authors:  Vera Hassner Sharav
Journal:  Ethical Hum Sci Serv       Date:  2003

10.  Efficacy of sertraline in the treatment of children and adolescents with major depressive disorder: two randomized controlled trials.

Authors:  Karen Dineen Wagner; Paul Ambrosini; Moira Rynn; Christopher Wohlberg; Ruoyong Yang; Michael S Greenbaum; Ann Childress; Craig Donnelly; Deborah Deas
Journal:  JAMA       Date:  2003-08-27       Impact factor: 56.272

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  8 in total

1.  One flew over the conflict of interest nest.

Authors:  David Healy
Journal:  World Psychiatry       Date:  2007-02       Impact factor: 49.548

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Authors:  Kalman Applbaum
Journal:  Cult Med Psychiatry       Date:  2009-06

3.  Knowledge of ghostwriting and financial conflicts-of-interest reduces the perceived credibility of biomedical research.

Authors:  Jeffrey R Lacasse; Jonathan Leo
Journal:  BMC Res Notes       Date:  2011-01-31

4.  Our censored journals.

Authors:  David Healy
Journal:  Mens Sana Monogr       Date:  2008-01

5.  Regulating the relationship between physicians and pharmaceutical companies: a qualitative and descriptive analysis of the impact of Israeli legislation.

Authors:  Rachel Nissanholtz-Gannot; Ariel Yankellevich
Journal:  Isr J Health Policy Res       Date:  2017-09-26

6.  Antidepressant-induced akathisia-related homicides associated with diminishing mutations in metabolizing genes of the CYP450 family.

Authors:  Yolande Lucire; Christopher Crotty
Journal:  Pharmgenomics Pers Med       Date:  2011-08-01

7.  The social and cultural construction of psychiatric knowledge: an analysis of NICE guidelines on depression and ADHD.

Authors:  Joanna Moncrieff; Sami Timimi
Journal:  Anthropol Med       Date:  2013-03-18

8.  A Matter of Taste? Quality of Life in Day-to-Day Living with ALS and a Feeding Tube.

Authors:  Jeannette Pols; Sarah Limburg
Journal:  Cult Med Psychiatry       Date:  2016-09
  8 in total

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