World Health Organization Demands Pharmaceutical Companies Stop Withholding Clinical Trials as Study Finds Over Half of Registered Clinical Trials Are Never Published
Shocking as it may seem, it is currently fairly standard practice for drug companies to withhold clinical trials with negative results, allowing doctors to blindly prescribe drugs that don’t work or are even dangerous. In the United States, failing to publish clinical trials is punishable by a fine of $10,000 per day, but shockingly the fine has never actually been issued as Dr. Ben Goldacre explains in his editorial in PloS Medicine. This is particularly unbelievable given that a recent study found that more than half of the clinical trials registered on clinicaltrials.gov within a given time period were never actually published (within the time period allowed by law). An earlier study, which found similar results, also demonstrated that even when the results are published, negative side effects and even serious adverse events are routinely left out of the published version.
Now, the World Health Organization (WHO) has joined in the chorus calling for the registration and publication of all clinical trials, by issuing a definitive statement. The WHO has demanded that all clinical trials are registered in a publicly available, free-to-access database before any trial is initiated and that the main findings of any study are submitted to an open-access, peer-reviewed journal within 12 months of completion, or otherwise be made publicly available within 24 months.
Sadly, the WHO’s demands are not legally binding. The WHO is merely the latest in a very long list of organizations to call for the publication of clinical trials:
Just in case you’re reading this on your mobile, here’s that list in text form. I hope you have your scrolling finger ready:
Academy of Medical Royal Colleges
ACHSE e.V. (German National Alliance for Chronic Rare Diseases)
Addison’s Disease Self Help Group
Adelaide Health Technology Assessment
AEP (Spanish Evidence-based Paediatrics)
AIDS Coalition to Unleash Power Paris
AIDS Treatment Activists Coalition
All Ireland Institute of Hospice and Palliative Care
Alzheimer’s Australia Dementia Research Foundation
American Board of Sport Psychology
American Institute for Technology and Science Education
American Medical Student Association
amfAR The Foundation for AIDS Research
Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesselschaften
Arthritis and Musculoskeletal Alliance
Asociación Española de Pediatría de Atención Primaria
Association for the Advancement of Experimental and Applied Hypnosis
Association of Medical Research Charities
Associazione Alessandro Liberati – Network Italiano Cochrane
Associazione Salute Attiva Onlus
Australasian College for Emergency Medicine
Australasian College of Nutritional and Environmental Medicine
Australasian Medical Writers Association
Australian Medical Students’ Association
Australian Pain Management Association
Avon Primary Care Research Collaborative
Balance – Familienplanungszentrum
Belgian Centre for Evidence Based Medicine (cebam)
Belgian Health Care Knowledge Centre (KCE)
BEUC The European Consumer Organisation
BioNorte – Basque Health Sciences Society
Birmingham Skeptics in the Pub
Bristol and Avon Chinese Women’s Group
British Association for Counselling and Psychotherapy
British Association of Dermatologists
British HIV Association (BHIVA)
British Institute of Radiology
British Obesity Surgery Patients
British Pharmaceutical Students’ Association
British Pharmacological Society
British Society for Gene and Cell Therapy
British Society for Immunology
British Society for Sexual Health and HIV
British Society for the Study of Vulval Diseases
British Society of Periodontology
British Veterinary Association
Bundesverband Prostatakrebs Selbsthilfe e. V.
Bury Knowle Patient Participation Group
Canadian Agency for Drugs and Technologies in Health
Canadian Cancer Research Alliance
Cardiff University Systematic Review Network (SysNet)
CEMBE (Centro de Estudos de Medicina Baseada na Evidência)
Center for Evidence-Based Physiotherapy
Center for Information and Study on Clinical Research Participation
Centre for Evidence Based Policy
Centre for Evidence-based Veterinary Medicine
Centre for Reviews and Dissemination, University of York
Centre for Statistics in Medicine
Centre for Sustainable Healthcare
Centre of Evidence Based Dermatology
Children’s Liver Disease Foundation
Chronic Granulomatous Disorder Society
Chronic Pain Research Alliance
CILIP: the Chartered Institute of Library and Information Professionals
Clinical Trial Service Unit & Epidemiological Studies Unit, University of Oxford
Cochrane Eyes and Vision Group
College of Mental Health Pharmacists
College of Psychiatric and Neurologic Pharmacists
COMCEPT – The Portuguese Skeptics Community
Committee On Publication Ethics
Consumers United for Evidence-based Healthcare
Consumers Health Forum of Australia
Contact Help Advice Information Network
Critical Appraisal Skills Programme International Network
Critical Appraisal Skills Programme Mexico
Critical Appraisal Skills Programme Spain
Critical Appraisal Skills Programme UK
Dalhousie AllTrials Student Society
Deutsche Dupuytren-Gesellschaft
Deutsche Gesellschaft für Neurologie
Drug and Therapeutics Bulletin
Drug Commission of the German Medical Association
Drug Information Center of National University of Colombia (CIMUN)
Dutch Association of Pharmaceutical Medicine
Ethics Committee of Provincies of Verona and Rovigo
European Association of Hospital Pharmacists
European Association of Science Editors
European Cancer Patient Coalition
European Central Council of Homeopaths
European Continuing Medical Education Forum
European Federation of Clinical Chemistry and Laboratory Medicine
European Federation of the Associations of Dietitians
European Journal of Hospital Pharmacy
European Prostate Cancer Coalition (Europa UOMO)
European Public Health Alliance
European Public Health Association (EUPHA)
European Society of Clinical Pharmacy
Evidence-Based Veterinary Medicine Association
Faculty of Pharmaceutical Medicine
Faculty of Sexual and Reproductive Healthcare
Failed Implant Device Alliance
German Association of Hospital Pharmacists (ADKA)
German Clinical Trials Register
German Institute for Quality and Efficiency in Health Care (IQWiG)
German League of People Against Rheumatism
German Medical Association of Applied Kinesiology DÄGAK
German Network for Evidence Based Medicine (ebm)
German Public Health Association
German Society for Health Technology Assessment (HTA.de)
German Society for Wound Healing and Wound Treatment
Gesellschaft zur wissenschatlichen Untersuchung von Parawissenschaften e.V.
Global Healthcare Information Network
Groupe de Recherche et d’Action pour la Santé
Guild of Healthcare Pharmacists
Haematology Clinical Trials Unit
Health Action International Europe
Health Action International Global
Health Faculty at Universidad del Valle
Healthcare Information For All
Histologie Zytologie Laboratorium Nussdorf
Hospital Pediatrico de Sinaloa (HSP)
Hospital Pharmacists Association Ireland
Hungarian League Against Cancer
Hypermobility Syndromes Association
Independent Cancer Patients’ Voice
Institute for Evidence Based Medicine, College of Medicine, Korea University
Institute of Physics and Engineering in Medicine
Integrative Psychological Services of New York City
Intensive Care National Audit and Research Centre
International Alliance of Patients’ Organizations
International Brain Tumour Alliance
International Coalition for treatment preparedness in Eastern Europe and Central Asia
International Federation of Anthroposophical Medical Associations
International Federation of Medical Students’ Associations
International Institute for Advanced Studies of Psychotherapy and Applied Mental Health
International Journal of Gynecology and Obstetrics
International Physicians for the Prevention of Nuclear War
International Society for Evidence Based Health Care
International Society of Drug Bulletins
International Union of Basic & Clinical Pharmacology (IUPHAR)
Iranian Food & Drug Organisation
IRCCS – Mario Negri Institute for Pharmacological Research
Italian Association of Neuroepidemiology
Italian Federation of Volunteer-based Cancer Organisations (FAVO)
James Whale Fund for Kidney Cancer
Journal of Cognitive and Behavioural Psychotherapies
Journal of Kathmandu Medical College
June Hancock Mesothelioma Research Fund
Laarkarin Sosiaalinen Vatsuu – Physicians for Social Responsibility
LILA Onlus – Lega Italiana per la Lotta contro l’Aids (Italian League for Fighting Aids)
Liverpool School of Tropical Medicine
London School of Hygiene & Tropical Medicine
Más Ciencia por México (More Science for Mexico)
Medical Sciences Division, University of Oxford
Mission Arogya Health and Information Technology Research Foundation
Mobility and Sickness Information Service
Motor Neurone Disease Association
Muscular Dystrophy Support Group
National Ankylosing Spondylitis Society
National Association of Deafened People
National Collaborating Centre for Mental Health
National Committee for Research Ethics in Norway
National Health and Medical Research Council of Australia
National Institute for Health and Care Excellence (NICE)
National Rheumatoid Arthritis Society
National Union of Scientific Medical Information
Netherlands Epidemiological Society
New Zealand Medical Association
NHS Research & Development Forum
NHS Vale of York Clinical Commissioning Group
NISCHR Clinical Research Centre
North Wales Organisation for Randomised Trials in Healthcare
North Yorkshire Humanist Group
Northern California Regional Organization of Child and Adolescent Psychiatry
Norwegian Knowledge Centre for Health Services (Kunnskapssenteret)
Nottingham Clinical Trials Unit
Organisation for Anti-Convulsant Syndromes
Otago Medical Research Foundation
Otago University Medical Students Association
Ovarian Cancer Alliance of San Diego
Oxford Clinical Trials Research Unit
Oxford University Hospitals NHS Trust
Pharmaceutical Journal (PJ Online)
Plymouth University Peninsula Clinical Trials Unit
Plymouth University Peninsula Schools of Medicine & Dentistry
Positive People Armenian Network
Pragmatic Clinical Trials Unit
Primary Care Respiratory Society UK
Reconstructive Surgery Trials Network
Research Design and Conduct Service
Royal College of General Practitioners
Royal College of Obstetricians and Gynaecologists
Royal College of Paediatrics and Child Health
Royal College of Physicians of Edinburgh
Royal College of Psychiatrists
Royal College of Veterinary Surgeons Charitable Trust
Royal National Institute of Blind People
Russian Society for Evidence Based Medicine
Scientists for Global Responsibility
Scottish Intercollegiate Guidelines Network
Society for the Improvement of Science
South African Medical Research Council
Spanish Society of Medical Radiology
Swedish College of General Practice (SFAM)
Swiss Multiple Sclerosis Society
Syncope Trust and Reflex anoxic Seizures
Tatarstan Medical Students’ Association
Test-Achats, Belgian Consumer Organisation
The Association for Clinical Biochemistry
The Association of Democratic Pharmacists (The VdPP)
The Association of Research Ethics Committees
The British Society for Rheumatology
The Chartered Society of Physiotherapy
The Faculty of Intensive Care Medicine
The Guidelines International Network G-I-N
The Institute of Clinical Research
The Lymphoedema Support Network
The Pernicious Anaemia Society
The Swiss Skeptics (Skeptiker Schwiez)
The Welsh Intensive Care Society
Transform Drug Policy Foundation
Transparency International Deutschland e.V.
Turkish Clinical Research Association
UK Clinical Pharmacy Association
UK Cystic Fibrosis Gene Therapy Consortium
UK Dermatology Clinical Trials Network
UKCRC Registered Clinical Trials Unit Network
United European Gastroenterology
University Hospitals Coventry and Warwickshire NHS Trust
University of Lisbon Faculty of Medicine
University of Oxford Diabetes Trials Unit
Western Australian Clinical Oncology Group
Wilson’s Disease Support Group UK
World Association of Medical Editors
World Confederation for Physical Therapy
ZonMw, the Netherlands Organisation for Health Research and Development
I think it is fair to say that the consensus is resounding. There is no excuse for the status quo. The surprisingly fascinating tale of how we came to be in this mess and why it matters such a great deal is told expertly by medical doctor and master storyteller Dr. Ben Goldacre, the brainchild of the All Trials campaign, in the bookBad Pharma. Don’t worry, you don’t need to be a doctor, a scientist, or an academic to understand it or find it interesting or useful, but if you do happen to be a doctor, you should certainly read it (if you haven’t already).
For the spark notes, check out Goldacre’s TED talk on the topic:
And/or his more recent and more detailed talk at the International Forum on Quality and Safety in Healthcare:
Reference:
Goldacre B. (2015). How to Get All Trials Reported: Audit, Better Data, and Individual Accountability, PLOS Medicine, 12 (4) e1001821. DOI: http://dx.doi.org/10.1371/journal.pmed.1001821
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