30th April 2013
AllTrials campaigners condemn today’s interim court decision to order the European Medicines Agency not to release Clinical Study Reports submitted by companies as part of marketing authorisation for medicines. This ruling was made as part of court cases brought by two pharmaceutical companies, AbbVie and InterMune, who challenged the Agency’s decisions to grant access to the information.
Vitally important information about clinical trials on medicines being taken by patients all over Europe is routinely being withheld from doctors and patients. The Clinical Study Reports that were briefly made available by the European Medicines Agency (EMA) were one of the few ways that researchers could access withheld material. Clinical Study Reports released by the EMA have been instrumental in spotting serious flaws in the evidence for Roche’s drug Tamiflu, for example, which the UK government alone spent £500m on, in just one year.
Dr Ben Goldacre, author of Bad Pharma and co-founder of the AllTrials campaign: “This interim ruling is a disgrace. There is no justification for withholding information about the methods and results of clinical trials from doctors, researchers, payers and patients, who need all the information on a medicine to make truly informed decisions. The EMA is charged with protecting patients: they should be allowed to work with researchers to improve the safety and effectiveness of everyday medical decisions. Forcing them to hide this information is nothing short of absurd.”
Tracey Brown, Sense about Science, co-founder of the AllTrials campaign: “While hundreds of patient groups and research bodies fight for an open, honest system of reporting clinical trials, others are fighting hard to cling on to secrecy. In granting this injunction the European courts are indicating that they are on the wrong side of history. However as AllTrials has made clear, the interests of patients will prevail despite these attempts to subvert them.”
Michael Wing participated in a clinical trial in 2001: “I volunteered to participate in a clinical trial in the belief that the results would be used to help people and further the medical understanding in that area. If trial results aren’t released and made available how can doctors know whether the treatments they are prescribing will help their patients or not? The European Medical Agency should be allowed to share the results from clinical trials and this ruling today is a violation of patient trust.”
Richard Stephens participated in a number of clinical trials: “We expect that the results of trials will be made freely available to researchers, clinicians and administrators, in order to deliver better treatments, better services, and better outcomes for patients. So all clinical trials should be on a central accessible register, and all trials should be reporting their results, even if they do not change clinical practice. Patients who choose to take part in clinical trials believe that by doing so, we are helping other patients in the future. I believe it is immoral to recruit patients to clinical trials and then not report or share the results. We participate in order to increase knowledge and to help others. We do not expect the knowledge to be kept secret or the help for others to be denied.”
Phil Booth took part in trials of anti-epilepsy and pre-diabetes treatments, 1988-1989: “I volunteered to do clinical trials on the understanding they would help people. If the results of any trial aren’t published, how can doctors know what’ll help their patients and what might harm them? Had someone with diabetes reacted to the test drug I took in the way I did, they might have died. There’s no excuse for hiding data like that.”
The European Medicines Agency comment on this decision is here.