Opening Pandora’s box in the UK: a hypothetical pharmacogenetic test for clozapine

Author:

Spencer Benjamin WJ1,Prainsack Barbara2,Rujescu Dan3,Giegling Ina3,Collier David A45,Gaughran Fiona64,MacCabe James H64,Barr Cathy L78,Sigurdsson Engilbert910,Stovring Henrik11,Malhotra Anil K1213,Curran Sarah R64

Affiliation:

1. South London & Maudsley NHS Foundation Trust, London, UK.

2. Department of Social Science, Health & Medicine, King’s College London, London, UK.

3. Department of Psychiatry, University of Halle, Germany.

4. Institute of Psychiatry, King’s College London, London, UK.

5. Eli Lilly & Company Ltd, Erl Wood, UK.

6. South London & Maudsley NHS Foundation Trust, London, UK

7. The Toronto Western Research Institute, Toronto, ON, Canada.

8. The Hospital for Sick Children, Toronto, ON, Canada.

9. University of Iceland, Reykjavik, Iceland.

10. Department of Psychiatry, Landspitali-University Hospital, Reykjavik, Iceland.

11. Department of Public Health, Aarhus University, Denmark.

12. The Zucker Hillside Hospital, Glen Oaks, NY, USA.

13. Hofstra North Shore-LIJ School of Medicine, Hemptead, NY, USA.

Abstract

Clozapine is a uniquely efficacious antipsychotic drug in treatment-resistant schizophrenia. Its use is restricted due to adverse effects including a rare but dangerous reduction in neutrophils (agranulocytosis) and the mandatory hematological monitoring this entails in many countries. We review the statistical, ethical and legal issues arising from a hypothetical pharmacogenetic test for clozapine, using the UK as an exemplary case for consideration. Our key findings include: a consideration of the probabilistic results that a pharmacogenetic test may return; the impact on drug licensing; and the potential for pharmacogenetic tests for clozapine being used without consent under the UK’s legal framework. We make recommendations regarding regulatory changes applicable to the special case of pharmacogenetic testing in clozapine treatment.

Publisher

Future Medicine Ltd

Subject

Pharmacology,Genetics,Molecular Medicine

Reference53 articles.

1. MelzerE, Raven A, Detmer DE, Ling T, Zimmern RL; Department of Public Health and Primary Care.My Very Own Medicine: What Must I Know?University of Cambridge, Cambridge, UK (2003).

2. Abacavir hypersensitivity: a model system for pharmacogenetic test adoption

3. American Psychiatric Association.Diagnostic and Statistical Manual Of Mental Disorders: DSM-IV (4th Edition). American Psychiatric Association, Washington, DC, USA (1994).

4. WHO. The ICD-10 classification of mental and behavioural disorders: diagnostic criteria for research. WHO, Geneva, Switzerland (1993).

5. Multiple Biomarker Prediction of Type 2 Diabetes

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3