We have just heard that the pharmaceutical company InterMune has dropped at least some of its cases against the European Medicines Agency (EMA). The general court removed the case from its register on 21st May and each party will bear its costs.
InterMune sued the EMA in 2013 to stop it releasing information from clinical trials of its drugs. At the same time, pharmaceutical company AbbVie was also suing the EMA. AbbVie dropped its case the day after the overwhelming vote in favour of the European Clinical Trials Regulation in the European Parliament.
Ben Goldacre, co-founder of the AllTrials campaign commented:
This case was a scandal. Furthermore, InterMune did not act alone: both ABPI and EFPIA, the UK and EU industry bodies, gave these shameful anti-transparency cases full support, while publicly proclaiming their support for transparency around clinical trials. It is encouraging that the case has now been dropped, but at the same time, the EMA is suddenly rolling back its transparency plans, announcing greater restrictions on access to information.
Industry and regulators must recognise that the world has changed, and transparency is unavoidable. They are undermining public trust in drug companies, regulators, and – most dangerously – medicine as a whole. Patients cannot make informed decisions about their treatment when vitally important information on clinical trials is routinely and legally withheld from doctors and researchers. We cannot prescribe medicines safely and effectively for as long as this ludicrous situation persists: we need access to the full methods and results of all trials on all uses of all currently used treatments.
The court cases against the EMA have been preventing it from releasing clinical trial information to researchers. The EMA has said that its policy is to be more transparent and to publish clinical trial information proactively. Now that these cases are being dropped, we would hope that this would begin to happen. But, the EMA seems to be about to adopt a policy that would be a huge step backwards. They have a new policy that would limit researchers’ access to clinical trial information. Please write to the head of the EC directorate that oversees the EMA to urge them not to adopt this. Write your letter now.