Why we need free and easy access to all data from all clinical trials
Talk at the European Ombudsman's citizens' event, Bruxelles, 23 April 2013

by

Peter C Gøtzsche, DrMedSci, MSc
Professor and Director
Nordic Cochrane Centre
Rigshospitalet
Copenhagen

We don't know how to use our drugs safely. In Europe and in the United States, drug deaths are the third leading cause of death after heart disease and cancer.

An important reason for this is that the drug industry conceals the harms of its drugs. Only about half of all drug trials get published and what gets published, is often seriously misleading. Weight loss medications can be dangerous, and in 2007, The Nordic Cochrane Centre applied for access to the clinical study reports and corresponding protocols for two weight loss medications submitted to the European Medicines Agency to obtain marketing approval in the European Union. The EMA's director, Thomas Lönngren, refused to give us access, and we therefore complained to the European Ombudsman.

The EMA put forward four arguments to avoid disclosing the documents: protection of commercial interests, no overriding public interest in the data, the administrative burden involved, and the worthlessness of the data to us after the EMA had redacted them. We rejected these arguments and the ombudsman agreed with us. He inspected the relevant reports and protocols at the EMA and concluded that the documents did not contain commercially confidential information.

However, the EMA was completely resistant to our arguments and those from the ombudsman. Only after the ombudsman had accused the EMA of maladministration in a press release in 2010, did the EMA reverse its stance and gave us the documents. Thomas Lönngren left the agency and went directly into a consulting job for the pharmaceutical industry in clear violation of the EMA's policy that operates with a quarantine period of two years.

The EMA's new director Guido Rasi looks very differently at the issue of transparency. From January 2014, the EMA aims at providing public access via a website to study reports, protocols and the raw anonymised patient data in statistical programmes enabling anyone to check the results for themselves, for all new drugs.

This is tremendous progress for public health, but two drug companies have sued the EMA at the European Court to prevent its release of documents. If they succeed, we will continue to kill our patients on a gigantic scale because we don't know what the harms of our drugs are.

The European Commission's proposed revision of the Clinical Trials Directive states that a summary of the results shall become publicly available after completion of the trial. This is not enough. Summaries are generally misleading. We must get access also to the study reports that describe all results of all outcomes specified in the protocol. And we must get access to the raw data. This would reduce the risk of cheating, and it would avoid introducing double standards in the EU, one for the EMA and another for drug trials in general. It would also speed up innovation, as drug companies may avoid repeating other companies' mistakes when they can see the data.

There is something fundamentally wrong with our priorities in healthcare if commercial or academic success depends on withholding data that are important for rational decision making by doctors and patients. Furthermore, societies that have only one version of the truth are not societies we would like to live in.

Therefore, dear members of Parliament: Next month, please vote for access to full study reports and for the raw data, in line with what the EMA wants and what our patients and doctors need.