World Health Organisation 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 drugs 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 missed out of the published version.
Now, the World Health Organisation (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 organisations 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)
No comments:
Post a Comment