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) Action for M.E. Action for Sick Children Addison’s Disease Self Help Group Adelaide Health Technology Assessment Advertising Health AEP (Spanish Evidence-based Paediatrics) AFAssociation Afiya Trust Age UK AIDS Coalition to Unleash Power Paris AIDS Treatment Activists Coalition Alkaptonuria Society All Ireland Institute of Hospice and Palliative Care Allen Carr’s Easyway Alpha 1 Awareness UK Alzheimer’s Australia Dementia Research Foundation Alzheimer’s Society American Board of Sport Psychology American Institute for Technology and Science Education American Medical Student Association amfAR The Foundation for AIDS Research Anticoagulation Europe Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesselschaften Arrhythmia Alliance Arthritis and Musculoskeletal Alliance Arthritis Care Arthritis Research UK ASH Scotland 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 Asthma UK Australasian College for Emergency Medicine Australasian College of Nutritional and Environmental Medicine Australasian Medical Writers Association Australian Medical Students’ Association Australian Pain Management Association Autism Rights Group Highland Avon Primary Care Research Collaborative Bad Science Watch Balance – Familienplanungszentrum Beat Beating Bowel Cancer Behcet’s Syndrome Society Belgian Centre for Evidence Based Medicine (cebam) Belgian Health Care Knowledge Centre (KCE) Berne Declaration BEUC The European Consumer Organisation BioMantra BioMed Central BioNorte – Basque Health Sciences Society Birmingham Skeptics in the Pub Birth Trauma Association BJOG Bladder Cancer Support UK BLISS Blood Pressure Association Bond University Bone Cancer Research Trust Bowel Cancer UK Brain and Spine Foundation UK Brains Trust BRCA Netzwerk Breakthrough Breast Cancer Breast Cancer Campaign Bristol and Avon Chinese Women’s Group British Association for Counselling and Psychotherapy British Association of Dermatologists British Dietetic Association British Dupuytren’s Society British Heart Foundation British HIV Association (BHIVA) British Institute of Radiology British Library British Liver Trust British Lung Foundation British Medical Association British Nutrition Foundation British Obesity Surgery Patients British Pharmaceutical Students’ Association British Pharmacological Society British Porphyria Association British Psychological Society British Science Association 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 Thyroid Foundation British Tinnitus Association British Veterinary Association BUKO Pharma-Kampagne Bundesverband Prostatakrebs Selbsthilfe e. V. Bury Knowle Patient Participation Group Canadian Agency for Drugs and Technologies in Health Canadian Cancer Research Alliance Canadian Cancer Society Canadian Cochrane Centre Canadian HIV Trials Network Canadian Medical Association Cancer Research UK Cancer52 Cardiff University Cardiff University Systematic Review Network (SysNet) Cardiomyopathy Association Cavernoma Alliance UK CEBM Laboratory CEMBE (Centro de Estudos de Medicina Baseada na Evidência) Center for Evidence-Based Physiotherapy Center for Information and Study on Clinical Research Participation Center for Open Science 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 Changing Faces Chemist and Druggist Magazine Children’s Liver Disease Foundation Chronic Granulomatous Disorder Society Chronic Pain Research Alliance CILIP: the Chartered Institute of Library and Information Professionals Clinical Pharmacist Clinical Trial Service Unit & Epidemiological Studies Unit, University of Oxford Cochrane Eyes and Vision Group Cochrane Skin Group College of Mental Health Pharmacists College of Optometrists College of Psychiatric and Neurologic Pharmacists Colombia Médica COMCEPT – The Portuguese Skeptics Community Committee On Publication Ethics Community Service Volunteers Consumers United for Evidence-based Healthcare CONSORT Consumers Health Forum of Australia Contact Help Advice Information Network Copenhagen Trials Unit Corporate Europe Observatory CRA School Group Critical Appraisal Skills Programme International Network Critical Appraisal Skills Programme Mexico Critical Appraisal Skills Programme Spain Critical Appraisal Skills Programme UK Cuban Journal for Information in Health Science (Revista Cubana de Información en Ciencias de la Salud) Cure Crohn’s Colitis Cystic Fibrosis Unite Dalhousie AllTrials Student Society Depression Alliance Deutsche Dupuytren-Gesellschaft Deutsche Gesellschaft für Neurologie Diabetes UK Dianthus Medical Ltd Dietitians of Canada Different Strokes DIPEx Disabilities Trust Doctors Reform Society Drug and Therapeutics Bulletin Drug Commission of the German Medical Association Drug Information Center of National University of Colombia (CIMUN) Duchenne Foundation Australia Dutch Association of Pharmaceutical Medicine DXY eCancer eLife Elsevier Empower: Access to Medicine Encaphalitis Society Epilepsy Action Epilepsy Society Epistemonikos Equator Network Ethics Committee of Provincies of Verona and Rovigo European AIDS Treatment Group 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 Patients’ Forum European Prostate Cancer Coalition (Europa UOMO) European Public Health Alliance European Public Health Association (EUPHA) European Society of Clinical Pharmacy EVALMED Evidence for Democracy Evidence-Based Veterinary Medicine Association Evidencias en Pediatria F1000 Research F1000Trials Faculty of Pharmaceutical Medicine Faculty of Public Health Faculty of Sexual and Reproductive Healthcare Failed Implant Device Alliance Farmacriticxs Farmaka Farnham Humanists Feel Yourself Campaign Fetal Anti-Convulsant Trust Figshare Genesis Research Trust Genetic Alliance UK Genetics Disorders UK 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. Gesundheit Aktiv GIMBE Foundation Global Healthcare Information Network Green Party Ireland Group B Strep Support Groupe de Recherche et d’Action pour la Santé GSK Guild of Healthcare Pharmacists Guildford Skeptics in the Pub Haematology Clinical Trials Unit Health Action International Europe Health Action International Global Health Care Without Harm Health Faculty at Universidad del Valle Health Press Health Projects for Latvia Health Research Authority Healthcare Information For All Healthtalkonline.org HealthWatch Healthy Skepticism UK Histologie Zytologie Laboratorium Nussdorf Hospital Pediatrico de Sinaloa (HSP) Hospital Pharmacists Association Ireland Hull York Medical School Hungarian League Against Cancer Hypermobility Syndromes Association i-base Iberoamerican Cochrane Centre Idea Pharma Ideal Imperial Clinical Trials Unit INC-Argentina Independent Age Independent Cancer Patients’ Voice InDependent Diabetes Trust INPUT 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 Foundation Intensive Care National Audit and Research Centre Intensive Care Society 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 Irish Cancer Society Irish Hospice Foundation Irish Medical Organisation Italian Association of Neuroepidemiology Italian Federation of Volunteer-based Cancer Organisations (FAVO) ITP Support Association ITPCru James Lind Institute James Whale Fund for Kidney Cancer Joanna Briggs Institute Joining Jack Journal of Cognitive and Behavioural Psychotherapies Journal of Kathmandu Medical College June Hancock Mesothelioma Research Fund Kidney Cancer Support Network King’s Clinical Trials Unit King’s College London La Leche League GB Laarkarin Sosiaalinen Vatsuu – Physicians for Social Responsibility Langland Leukaemia CARE 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 Lyme Disease Action Lymphoma Association Macmillan Cancer Support Macular Society Marie Curie Cancer Care Más Ciencia por México (More Science for Mexico) MDS UK Patient Support Group Medact MedBravo MedBunker medDigital Medical Journal of Australia Medical Research Council Medical Sciences Division, University of Oxford Medicos Sin Marca MedSci Medsin Medwave Mental Health Europe Mezis Mind Minervation Mission Arogya Health and Information Technology Research Foundation Mobility and Sickness Information Service Modepharma Motor Neurone Disease Association Mouth Cancer Foundation MRSA Action UK MS Discovery Forum Multiple Sclerosis Society Muscular Dystrophy Campaign Muscular Dystrophy Support Group Myeloma UK National Ankylosing Spondylitis Society National Association of Deafened People National Childbirth Trust 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 Osteoporosis Society National Physicians Alliance National Rheumatoid Arthritis Society National Union of Scientific Medical Information National Voices NEPI Foundation Netherlands Cancer Institute Netherlands Epidemiological Society NeurologyFirst Neurowikia New Zealand Medical Association NHS Blood and Transplant NHS Research & Development Forum NHS Vale of York Clinical Commissioning Group NI Chest & Stroke NISCHR Clinical Research Centre No Gracias No Grazie Pago Io No Panic North London Humanist Group North Wales Organisation for Randomised Trials in Healthcare North Yorkshire Humanist Group Northern California Regional Organization of Child and Adolescent Psychiatry Norwegian Cancer Society Norwegian Knowledge Centre for Health Services (Kunnskapssenteret) Nottingham Clinical Trials Unit OCD Action Open Knowledge Foundation OPEN Project Open Science Federation Organisation for Anti-Convulsant Syndromes Otago Medical Research Foundation Otago University Medical Students Association Ovarian Cancer Action Ovarian Cancer Alliance of San Diego Oxford Clinical Trials Research Unit Oxford Humanists Oxford Skeptics in the Pub Oxford University Hospitals NHS Trust Oxford Vaccine Group Pain UK Pancreatic Cancer UK Parkinson Society Canada Parkinsons UK Patient Coalition Switzerland Patients Association Patients Involved in NICE PeerJ Pelvic Pain Support Network PerioCourses Pharmaceutical Journal (PJ Online) Pharmaware PharmaXL PHG Foundation PhUSE Plaid Cymru PLOS Plymouth Community Healthcare Plymouth University Peninsula Clinical Trials Unit Plymouth University Peninsula Schools of Medicine & Dentistry Positive People Armenian Network Pragmatic Clinical Trials Unit Primary Care Diabetes Society Primary Care Respiratory Society UK Primary Immunodeficiency UK PRISMA Prostate Cancer UK PXE (PiXiE) Europe QResearch Radical Statistics Reconstructive Surgery Trials Network Red Whale Research Autism Research Design and Conduct Service Rethink Rett Syndrome Research Trust Royal College of General Practitioners Royal College of Obstetricians and Gynaecologists Royal College of Paediatrics and Child Health Royal College of Pathologists Royal College of Physicians Royal College of Physicians of Edinburgh Royal College of Psychiatrists Royal College of Radiologists Royal College of Veterinary Surgeons Charitable Trust Royal National Institute of Blind People Royal Pharmaceutical Society Royal Society of Medicine Royal Statistical Society Russian Society for Evidence Based Medicine SABRE Research UK Safer Medicines Campaign SAGE Sage Bionetworks Salamander Trust Salud y Fármacos Sarcoma Patients EuroNet Sarcoma UK Scientists for Global Responsibility Scleroderma Society Scottish Intercollegiate Guidelines Network Sealed Envelope SEISIDA Selling Sickness SLE Lupus Foundation Society for Clinical Trials Society for the Improvement of Science Society of Biology Sopharma South African Medical Research Council South East Wales Trials Unit Spanish Society of Medical Radiology Stichting Tekenbeetziekten Stonewall Stop AIDS Campaign Stroke Association Students 4 Best Evidence Support in Mind in Scotland Swedish College of General Practice (SFAM) Swedish Medical Association Swedish Paediatric Society Swedish Skeptics Association Swiss MS Society Swiss Multiple Sclerosis Society Syncope Trust and Reflex anoxic Seizures Target Ovarian Cancer Tatarstan Medical Students’ Association Teenage Cancer Trust Teesside Skeptics in the Pub Tenovus Cancer Care Terrence Higgins Trust Test Positive Aware Network Test-Achats, Belgian Consumer Organisation The Association for Clinical Biochemistry The Association of Democratic Pharmacists (The VdPP) The Association of Research Ethics Committees The Brain Tumour Charity The British Society for Rheumatology The Chartered Society of Physiotherapy The College of Podiatry The Dupuytren Foundation The Ear Foundation The Faculty of Intensive Care Medicine The Guidelines International Network G-I-N The Health Cloud The Information Standard The Institute of Clinical Research The Kidney Alliance The Lupus Research Institute The Lymphoedema Support Network The Migraine Trust The Open University The Pernicious Anaemia Society The Pituitary Foundation The Renal Association The Royal Institution The Swiss Skeptics (Skeptiker Schwiez) The TMJ Association The Welsh Intensive Care Society Therapeutic Guidelines Ltd Thinkwell This Theory Throat Cancer Foundation Thyroid Patient Advocacy Thyroid UK Together for short lives Transform Drug Policy Foundation Transparency International Deutschland e.V. Transparency Life Sciences Transverse Myelitis Society TREAT-NMD Alliance Treatment Action Campaign Treatment Action Group TrialReach Trip Turkish Clinical Research Association UK Clinical Pharmacy Association UK Cystic Fibrosis Gene Therapy Consortium UK Dermatology Clinical Trials Network UK Research Integrity Office UK Sepsis Trust UK Thalassaemia Society UKCRC Registered Clinical Trials Unit Network Uncover United European Gastroenterology University Hospitals Coventry and Warwickshire NHS Trust University of Edinburgh University of Lisbon Faculty of Medicine University of Oxford Diabetes Trials Unit University of York Urostomy Association Wales Cancer Trials Unit Waverley Care Well UK Wellcome Trust Western Australian Clinical Oncology Group Wiley Wilson’s Disease Support Group UK Wings for Life World Association of Medical Editors World Confederation for Physical Therapy Young Minds 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 book . 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). Bad Pharma
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:
VIDEO 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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