The citalopram CIT-MD-18 pediatric depression trial: Deconstruction of medical ghostwriting, data mischaracterisation and academic malfeasance

Jureidini, Jon; Amsterdam, Jay D.; McHenry, Leemon B.

doi:10.3233/jrs-160671

Cited by 31 publications

(31 citation statements)

References 20 publications

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“…Yet the main journal article incorrectly included eight of these unblinded participants in the statistical analysis of the primary outcome measure, on which citalopram outperformed placebo to a statistically significant degree (p = .038) (50). However, Jureidini et al's review of internal Forest documents reveals that if protocol were followed and these eight participants would have been excluded, then the p-value on the primary outcome marginally missed the mark of statistical significance (p = .052) and citalopram was no longer statistically superior in efficacy to placebo (51). Further, the journal article a) reported positive results on some secondary outcomes that were not listed in the statistical analysis protocol and b) failed to report the negative results on some secondary outcomes which were listed in the statistical analysis protocol (51).…”

Section: Recent Clinical Trialsmentioning

confidence: 99%

“…However, Jureidini et al's review of internal Forest documents reveals that if protocol were followed and these eight participants would have been excluded, then the p-value on the primary outcome marginally missed the mark of statistical significance (p = .052) and citalopram was no longer statistically superior in efficacy to placebo (51). Further, the journal article a) reported positive results on some secondary outcomes that were not listed in the statistical analysis protocol and b) failed to report the negative results on some secondary outcomes which were listed in the statistical analysis protocol (51). Thus, our observation of incomplete data analysis on the SIQ-Jr in Findling et al's escitalopram trial (26) aligns with problematic data reporting in another paper describing clinical trial outcomes for another antidepressant sponsored by Forest (51).…”

Section: Recent Clinical Trialsmentioning

confidence: 99%

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Duty to Warn: Antidepressant Black Box Suicidality Warning Is Empirically Justified

2020

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The United States Food and Drug Administration issued a Black Box warning in October 2004 after placebo-controlled trials of antidepressant medications found an increased risk of suicidal thoughts and behaviors among children and adolescents taking antidepressant medications relative to placebo. Subsequently, some researchers have concluded that the Black Box warning caused severe unintended consequences; specifically, they have argued that the warning led to reduced use of antidepressants among youth, which led to more suicides. In this paper, we critically examine research regarding the Black Box warning's alleged deleterious consequences. One study claimed that controlled trials did not actually find an increased risk of suicidality among youth taking fluoxetine relative to those taking placebo, but its measure of suicidality is likely invalid. We found that ecological time series studies claiming that decreasing antidepressant prescriptions are linked to higher rates of suicide attempts or actual suicides among youth were methodologically weak. These studies exhibited shortcomings including: selective use of time points, use of only a short-term time series, lack of performing statistical analysis, not examining level of severity/impairment among participants, inability to control confounding variables, and/or use of questionable measures of suicide attempts. Further, while some time-series studies claim that increased antidepressant prescriptions are related to fewer youth suicides, more recent data suggests that increasing antidepressant prescriptions are related to more youth suicide attempts and more completed suicides among American children and adolescents. We also note that case-control studies show increased risk of suicide attempts and suicide among youth taking antidepressants, even after controlling for some relevant confounds. As clinical trials have the greatest ability to control relevant confounds, it is important to remember such trials demonstrated increased risk of suicidality adverse events among youth taking antidepressants. The Black Box warning is firmly rooted in solid data whereas attempts to claim the warning has caused harm are based on quite weak evidence.

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Section: Recent Clinical Trialsmentioning

confidence: 99%

Section: Recent Clinical Trialsmentioning

confidence: 99%

Duty to Warn: Antidepressant Black Box Suicidality Warning Is Empirically Justified

2020

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“…Concerns about the reliability of scientific knowledge extend beyond individual experiments to the social context in which scientific information is disseminated (Cosgrove, Vannoy, Mintzes, & Shaughnessy, ; Holman & Bruner, , ; Jureidini, Amsterdam, & McHenry, ; Sismondo, , , ; Vedula, Goldman, Rona, Greene, & Dickersin, ). Such concerns dovetail with those of philosophers of science who claim that one cannot develop an adequate understanding of scientific epistemology without focusing on the social interactions among scientists (Biddle, ; Elliott, ; Holman, , ; Intemann & de Melo‐Martín, ; Longino, ; Rolin, ; Wilholt, ).…”

Section: The Perils Of Industry‐funded Researchmentioning

confidence: 99%

The promise and perils of industry‐funded science

Holman

Elliott

2018

Philosophy Compass

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Private companies provide by far the most funding for scientific research and development. Nevertheless, relatively little attention has been paid to the dynamics of industry-funded research by philosophers of science. This paper addresses this gap by providing an overview of the major strengths and weaknesses of industry research funding, together with the existing recommendations for addressing the weaknesses. It is designed to provide a starting point for future philosophical work that explores the features of industry-funded research, avenues for addressing concerns, and strategies for making research funded by the private sector as fruitful as possible.

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“…Thirdly, antidepressants as a class deserve high degree of scrutiny. Recent critical evaluations have exposed how pharmaceutical industry‐sponsored studies have overestimated benefits and underestimated harms . This is especially true considering the potential for serious harms from antidepressants compared to psychotherapy.…”

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confidence: 99%