Clinical judgments, not algorithms, are key to patient safety—an essay by David Healy and Dee Mangin

Healy, David; Mangin, Dee

doi:10.1136/bmj.l5777

Cited by 18 publications

(12 citation statements)

References 13 publications

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“…36 – 40 Ironically and sadly, what we see here is that the ‘evidence-based model’ of medical science has led to a culture of substantially ignoring patient experiences. 41 …”

Section: How Many Patients Suffer From Withdrawal?mentioning

confidence: 99%

How user knowledge of psychotropic drug withdrawal resulted in the development of person-specific tapering medication

Groot

2020

Therapeutic Advances in Psychopharmacology

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Coming off psychotropic drugs can cause physical as well as mental withdrawal, resulting in failed withdrawal attempts and unnecessary long-term drug use. The first reports about withdrawal appeared in the 1950s, but although patients have been complaining about psychotropic withdrawal problems for decades, the first tentative acknowledgement by psychiatry only came in 1997 with the introduction of the ‘antidepressant-discontinuation syndrome’. It was not until 2019 that the UK Royal College of Psychiatrists, for the first time, acknowledged that withdrawal can be severe and persistent. Given the lack of a systematic professional response, over the years, patients who were experiencing withdrawal started to work out practical ways to safely come off medications themselves. This resulted in an experience-based knowledge base about withdrawal which ultimately, in The Netherlands, gave rise to the development of person-specific tapering medication (so-called tapering strips). Tapering medication enables doctors, for the first time, to flexibly prescribe and adapt the medication required for responsible and person-specific tapering, based on shared decision making and in full agreement with recommendations in existing guidelines. Looking back, it is obvious that the simple practical solution of tapering strips could have been introduced much earlier, and that the traditional academic strategy of comparisons from randomised trials is not the logical first step to help individual patients. While randomised controlled trials (RCTs) are the gold standard for evaluating interventions, they are unable to accommodate the heterogeneity of individual responses. Thus, a more individualised approach, building on RCT knowledge, is required. We propose a roadmap for a more productive way forward, in which patients and academic psychiatry work together to improve the recognition and person-specific management of psychotropic drug withdrawal.

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“…36 – 40 Ironically and sadly, what we see here is that the ‘evidence-based model’ of medical science has led to a culture of substantially ignoring patient experiences. 41 …”

Section: How Many Patients Suffer From Withdrawal?mentioning

confidence: 99%

How user knowledge of psychotropic drug withdrawal resulted in the development of person-specific tapering medication

Groot

2020

Therapeutic Advances in Psychopharmacology

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“…They may not, therefore, record a problem, in particular one that can be passed off as a feature of the illness. 9…”

Section: Historymentioning

confidence: 99%

“…They may not, therefore, record a problem, in particular one that can be passed off as a feature of the illness. 9 Phase 1 trials also offer companies a clear view of a drug's adverse effects making it possible to design trials that will not find the problem. In a trial, comparing paroxetine to clomipramine in Obsessive-Compulsive Disorder (study 29060/136), for instance, the protocol had a Limited Symptoms Checklist with 8 questions centering on sexual dysfunction but investigators, like me, were told not to ask these questions.…”

Section: Historymentioning

confidence: 99%

Antidepressants and sexual dysfunction: a history

Healy

2020

J R Soc Med

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“…Second, the pharmaceutical industry dominates the testing of psychiatric drugs by funding it directly and indirectly, while controlling most distribution channels for drug information. 8,11 Calls to shift funding of clinical trials to primarily public sources have generally fallen on deaf ears, 12 despite the existence of the third context: an ever-growing proportion of adults (about 1 in 5) and children (about 1 in 10) taking, most for the long term, psychopharmaceuticals prescribed to them by physicians. 13,14 Thousands of psychopharmacology RCTs with “positive” results have been published in medical journals.…”

Section: Introductionmentioning

confidence: 99%

Withdrawal effects confounding in clinical trials: another sign of a needed paradigm shift in psychopharmacology research

Cohen

Recalt

2020

Therapeutic Advances in Psychopharmacology

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Randomized controlled trials’ ability to produce evidence useful for people to decide whether to take, continue taking, or stop taking psychotropic drugs has been intensely critiqued, along with the trials’ commercial, ideological, and regulatory contexts. This article applies the critique to the topic of withdrawal effects confounding the outcomes of relapse-prevention trials where prescribed psychotropic drugs are discontinued. Until recently, the complexity and reach of withdrawal and post-withdrawal effects were neglected by mainstream psychiatry, but not by lay users of prescribed psychotropics. This article discusses withdrawal effects as part of the pharmacology of psychotropic drugs but shaped by psychosocial factors, and possibly shaping the presentation of psychological distress generally. It outlines biases and misconceptions in assumptions, design, and reporting of general efficacy trials and findings from a recent review of 80 discontinuation trials. In theory, relapse-prevention trials are tautological and exaggerate efficacy. In publications, they pay little attention to the central feature of their design, favor abrupt or rapid discontinuations, do not attend to environmental factors, and provide insufficient data to allow re-analyses. Thus, relapse-prevention RCTs likely confound the detection of their main outcome of interest: “relapse.” Using slower tapers, active placebo controls, and specific covariates in analyses would reduce the risk of withdrawal confounding, and better reporting would reduce the opaqueness of trials. The crisis in psychopharmacology is fueled partly by the disconnect between claims of therapeutic efficacy from so-called best-evidence methods despite unchanging population-level indicators of psychiatric sickness. Only by “stacking the deck” against trial sponsors’ hoped-for outcomes can psychopharmacology trials regain scientific credibility.

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Clinical judgments, not algorithms, are key to patient safety—an essay by David Healy and Dee Mangin

Abstract: When it comes to detecting harms related to drugs, clinicians’ and patients’ judgment trumps trials, say David Healy and Dee Mangin. Failure to realise this is the greatest threat to the safety of medicines

Cited by 18 publications

References 13 publications

How user knowledge of psychotropic drug withdrawal resulted in the development of person-specific tapering medication

How user knowledge of psychotropic drug withdrawal resulted in the development of person-specific tapering medication

Antidepressants and sexual dysfunction: a history

Withdrawal effects confounding in clinical trials: another sign of a needed paradigm shift in psychopharmacology research

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