There have been many serious criticisms levelled against pharmaceutical companies for hiding negative results and promoting dubious claims of efficacy and safety of the drugs they manufacture. They have been able to get away with this at least partly because there have been no requirements for them to declare unfavourable studies as ever occurring. In the European Union, that will soon be changing, largely thanks to Dr. Ben Goldacre.
Dr. Goldacre is well known as the author of two books, Bad Science and Bad Pharma, and as a tireless campaigner for basing modern medicine on science. He has been the force behind the campaign to minimize the manipulation of studies by requiring that all clinical trials be registered before commencement and the results available to other researchers as soon as they are completed. A release from the AllTrials website reports on the result of the recent vote in the EU Parliament.
Europe votes for clinical trial transparency
2nd April 2014
It’s soon going to be the law in Europe that drug clinical trials are publicly registered and results reported. MEPs have today voted by a huge majority to adopt the Clinical Trials Regulation, 547 in favour and 17 against. This is fantastic. It will mean that researchers will in future know about trials as they are happening and will be able to scrutinize results soon after their end. This is all due to the efforts of people all over Europe, including many patients who took part in clinical trials, who have pressed their MEPs to set the future straight in this way. Now we want to see recognition and use of the contribution that they and thousands of others have made in the trials that have already been conducted.
The new Clinical Trials Regulation says that information from Clinical Study Reports of trials should not be considered commercially confidential and will:
• Require that all drug trials in Europe are registered before they begin on the publicly accessible EU clinical trials register.
• Require that a summary of the results from these trials is published on the register within a year of the trial’s end.
• Require that a summary understandable to a lay person of what was found in the trial is published on the register.
• Require Clinical Study Reports (detailed documents normally produced for regulatory processes) to be made publicly available, where they are produced.
• Establish a new publicly accessible EU clinical trials register, to be set up and run by the European Medicines Agency.
• Require that all trials used in support of an application to run a new clinical trial are registered or have published results.
• Impose financial penalties on anyone running a clinical trial who does not adhere to these new laws.
Dr Ben Goldacre, author of Bad Pharma and co-founder of AllTrials said: “This is an excellent small step forward after some really good work by MEPs. But the new EU legislation is only concerned with new trials. It does not address the far bigger problem, that we still don’t have full reporting for all trials on the medicines we are using right now, today, medicines which we will continue to use for the foreseeable future. Doctors and patients simply cannot make informed decisions about which treatment is best, when the evidence on the treatments they are using is still being routinely and legally withheld. We need all trials – on all uses of all currently prescribed treatments – to be made available, and urgently. There is no excuse for industry inflicting ongoing harm on patients, and on their own reputation, by continuing to campaign against this position. They should join their more ethical colleagues, and sign up to the AllTrials.net pledge.”
Congratulations to Glenis Willmott MEP who led the negotiations on the Regulation and fought for transparency to be at the heart of the new law. Following the positive vote in Parliament, the Regulation now has to be formally adopted by Council and published in the Official Journal. It is expected to come into effect in mid-2016 at the earliest and then all EU member states will adopt the laws into their own statutes. The European Medicines Agency can now start building the new publicly accessible online clinical trial database.
Unfortunately, this does not apply to studies outside of the European Union. Regulations similar to these are sorely needed in the rest of the world, and most specifically for us, in Canada and the US. Pharmaceutical companies are responsible for many of the developments that have helped improve health outcomes in modern medicine, however, they have abused their position and power and this has allowed drugs to be on the market for too long before negative impacts are recognized. The fines they face are often minuscule when compared to the profits they have already accrued and consumer protection must be proactive rather than reactive.
Registering all clinical trials is a major step in fixing this problem.