Spin in RCTs of anxiety medication with a positive primary outcome: A comparison of concerns expressed by the US FDA and in the published literature

Lian Beijers, Bertus F. Jeronimus, Erick Turner, Peter De Jonge, Annelieke M. Roest

Research output: Contribution to journalReview article

1 Citation (Scopus)

Abstract

Objectives This study aimed to determine the presence of spin in papers on positive randomised clinical trials (RCTs) of antidepressant medication for anxiety disorders by comparing concerns expressed in the Food and Drug Administration (FDA) reviews with those expressed in the published paper. Methods For every positive anxiety medication trial with a matching publication (n=41), two independent reviewers identified the concerns raised in the US FDA reviews and those in the published literature. Spin was identified when concerns or limitations were expressed by the FDA (about the efficacy of the study drug) but not in the corresponding published paper. Concerns mentioned in the papers but not by the FDA were scored as â non-FDA' concerns. Findings Only six out of 35 (17%) of the FDA concerns pertaining to drug efficacy were reported in the papers. Two papers mentioned a concern that fit the FDA categories, but was not mentioned in the corresponding FDA review. Eighty-seven non-FDA concerns were counted, which often reflected general concerns or concerns related to the study design. Conclusions Results indicate the presence of substantial spin in the clinical trial literature on drugs for anxiety disorders. In papers describing RCTs on anxiety medication, the concerns raised by the authors differed from those raised by the FDA. Published papers mentioned a large number of generic concerns about RCTs, such as a lack of long-term research and limited generalisability, while they mentioned few concerns about drug efficacy. These results warrant the promotion of independent statistical review, reporting of patient-level data, more study of spin, and an increased expectation that authors report FDA concerns.

Original languageEnglish (US)
Article number012886
JournalBMJ Open
Volume7
Issue number3
DOIs
StatePublished - Mar 1 2017

Fingerprint

United States Food and Drug Administration
Anxiety
Randomized Controlled Trials
Pharmaceutical Preparations
Anxiety Disorders
Antidepressive Agents
Publications
Clinical Trials
Research

Keywords

  • Bias
  • Food Drug Administration
  • PSYCHIATRY
  • RCTs
  • Spin

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Spin in RCTs of anxiety medication with a positive primary outcome : A comparison of concerns expressed by the US FDA and in the published literature. / Beijers, Lian; Jeronimus, Bertus F.; Turner, Erick; De Jonge, Peter; Roest, Annelieke M.

In: BMJ Open, Vol. 7, No. 3, 012886, 01.03.2017.

Research output: Contribution to journalReview article

@article{a6cf64011dec4e75aea3650165bce235,
title = "Spin in RCTs of anxiety medication with a positive primary outcome: A comparison of concerns expressed by the US FDA and in the published literature",
abstract = "Objectives This study aimed to determine the presence of spin in papers on positive randomised clinical trials (RCTs) of antidepressant medication for anxiety disorders by comparing concerns expressed in the Food and Drug Administration (FDA) reviews with those expressed in the published paper. Methods For every positive anxiety medication trial with a matching publication (n=41), two independent reviewers identified the concerns raised in the US FDA reviews and those in the published literature. Spin was identified when concerns or limitations were expressed by the FDA (about the efficacy of the study drug) but not in the corresponding published paper. Concerns mentioned in the papers but not by the FDA were scored as {\^a} non-FDA' concerns. Findings Only six out of 35 (17{\%}) of the FDA concerns pertaining to drug efficacy were reported in the papers. Two papers mentioned a concern that fit the FDA categories, but was not mentioned in the corresponding FDA review. Eighty-seven non-FDA concerns were counted, which often reflected general concerns or concerns related to the study design. Conclusions Results indicate the presence of substantial spin in the clinical trial literature on drugs for anxiety disorders. In papers describing RCTs on anxiety medication, the concerns raised by the authors differed from those raised by the FDA. Published papers mentioned a large number of generic concerns about RCTs, such as a lack of long-term research and limited generalisability, while they mentioned few concerns about drug efficacy. These results warrant the promotion of independent statistical review, reporting of patient-level data, more study of spin, and an increased expectation that authors report FDA concerns.",
keywords = "Bias, Food Drug Administration, PSYCHIATRY, RCTs, Spin",
author = "Lian Beijers and Jeronimus, {Bertus F.} and Erick Turner and {De Jonge}, Peter and Roest, {Annelieke M.}",
year = "2017",
month = "3",
day = "1",
doi = "10.1136/bmjopen-2016-012886",
language = "English (US)",
volume = "7",
journal = "BMJ Open",
issn = "2044-6055",
publisher = "BMJ Publishing Group",
number = "3",

}

TY - JOUR

T1 - Spin in RCTs of anxiety medication with a positive primary outcome

T2 - A comparison of concerns expressed by the US FDA and in the published literature

AU - Beijers, Lian

AU - Jeronimus, Bertus F.

AU - Turner, Erick

AU - De Jonge, Peter

AU - Roest, Annelieke M.

PY - 2017/3/1

Y1 - 2017/3/1

N2 - Objectives This study aimed to determine the presence of spin in papers on positive randomised clinical trials (RCTs) of antidepressant medication for anxiety disorders by comparing concerns expressed in the Food and Drug Administration (FDA) reviews with those expressed in the published paper. Methods For every positive anxiety medication trial with a matching publication (n=41), two independent reviewers identified the concerns raised in the US FDA reviews and those in the published literature. Spin was identified when concerns or limitations were expressed by the FDA (about the efficacy of the study drug) but not in the corresponding published paper. Concerns mentioned in the papers but not by the FDA were scored as â non-FDA' concerns. Findings Only six out of 35 (17%) of the FDA concerns pertaining to drug efficacy were reported in the papers. Two papers mentioned a concern that fit the FDA categories, but was not mentioned in the corresponding FDA review. Eighty-seven non-FDA concerns were counted, which often reflected general concerns or concerns related to the study design. Conclusions Results indicate the presence of substantial spin in the clinical trial literature on drugs for anxiety disorders. In papers describing RCTs on anxiety medication, the concerns raised by the authors differed from those raised by the FDA. Published papers mentioned a large number of generic concerns about RCTs, such as a lack of long-term research and limited generalisability, while they mentioned few concerns about drug efficacy. These results warrant the promotion of independent statistical review, reporting of patient-level data, more study of spin, and an increased expectation that authors report FDA concerns.

AB - Objectives This study aimed to determine the presence of spin in papers on positive randomised clinical trials (RCTs) of antidepressant medication for anxiety disorders by comparing concerns expressed in the Food and Drug Administration (FDA) reviews with those expressed in the published paper. Methods For every positive anxiety medication trial with a matching publication (n=41), two independent reviewers identified the concerns raised in the US FDA reviews and those in the published literature. Spin was identified when concerns or limitations were expressed by the FDA (about the efficacy of the study drug) but not in the corresponding published paper. Concerns mentioned in the papers but not by the FDA were scored as â non-FDA' concerns. Findings Only six out of 35 (17%) of the FDA concerns pertaining to drug efficacy were reported in the papers. Two papers mentioned a concern that fit the FDA categories, but was not mentioned in the corresponding FDA review. Eighty-seven non-FDA concerns were counted, which often reflected general concerns or concerns related to the study design. Conclusions Results indicate the presence of substantial spin in the clinical trial literature on drugs for anxiety disorders. In papers describing RCTs on anxiety medication, the concerns raised by the authors differed from those raised by the FDA. Published papers mentioned a large number of generic concerns about RCTs, such as a lack of long-term research and limited generalisability, while they mentioned few concerns about drug efficacy. These results warrant the promotion of independent statistical review, reporting of patient-level data, more study of spin, and an increased expectation that authors report FDA concerns.

KW - Bias

KW - Food Drug Administration

KW - PSYCHIATRY

KW - RCTs

KW - Spin

UR - http://www.scopus.com/inward/record.url?scp=85016500130&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85016500130&partnerID=8YFLogxK

U2 - 10.1136/bmjopen-2016-012886

DO - 10.1136/bmjopen-2016-012886

M3 - Review article

C2 - 28360236

AN - SCOPUS:85016500130

VL - 7

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

IS - 3

M1 - 012886

ER -