Clinical trials: NGOs request transparency
By Ophélie Spanneut | Friday 08 June 2012
As the pharmaceutical world impatiently awaits the upcoming proposal from the European Commission on clinical trials, the NGOs are sharpening their arguments to request data transparency. At a conference organised by Health Action International and Trans-Atlantic Consumer Dialogue, in attendance were NGOs, researchers, regulators and legislators. The NGOs presented their arguments on clinical trials and the potential benefits of sharing the results of this type of research.
The NGOs and researchers attending the conference consider the need for transparency to be self-evident. According to Professor Peter Gotzsche of the Nordic Cochrane Centre in Copenhagen, Denmark, the non-divulgation of clinical trials is unethical and ineffective. Worse, Gtzsche suggests that it leads to deaths that could avoided, is a waste of time because of redundant research, and wastes public funds, as in the case of the 2009 H1N1 influenza virus, with Tamiflu reimbursed although its effectiveness was doubtful.
As an example, Gotzsche cited the case of studies carried out in the 1980s in the UK into lorcainide, which led to the death of nine people, when only one person under placebo treatment died. Unfortunately, the results of this study were not published. Had the results on lorcainide been known, the death of tens of thousands of patients could have been avoided. Professor Gotzsche is calling for the same rules of sharing results to apply for research financed by the public sector, as for research financed by the private sector. Gotzsche also stresses that data must be usable and easy to read. An important challenge is to define the information that has to be communicated. In the view of the European Medicines Agency (EMA), there are two levels in terms of clinical data: abstracts, which must be available, and rough data, which include sensitive personal information on patients.
Gotzsche wants to open access to rough data. Indeed, he explains that thanks to these, he was able to analyse the negative effects of a medicine thanks to indications given by patients before it had been interpreted by a pharmaceutical laboratory. The Commission’s draft regulation is expected for 11 July. The EU executive will likely try to conciliate the need for transparecy, the need to protect personal data and the commercial interests of laboratories. On this last point, MEP Peter Liese (EPP, Germany) recalls that in most cases, competitor laboratories are the ones that request access to clinical trial results. Similarly, the EMA warns against bad usage of clinical data and suggests that it be made mandatory to reveal the reason for any request for access, prior to consultation.