Lack of access to unpublished clinical study reports and trial protocols at drug agencies, and lack of good arguments against access

Article type
Authors
Gøtzsche P
Abstract
Background: The secrecy at drug agencies and the preferential publication of positive results have the consequences that patients are being treated with inferior drugs and die unnecessarily, as doctors are ignorant about what the true balance is between the benefits and harms of drugs. Anti-obesity drugs have little effect and serious harms, even judged by the published trials, and it is therefore not clear whether these drugs do more good than harm. More than one-third of patients dropped out of the trials, and the imputation technique used, last observation carried forward, is likely to have biased the results. Methods: We aimed to explore the robustness of the published results by comparing them with the clinical study reports and protocols of anti-obesity drugs submitted to the Danish and the European Medicines Agency (EMEA). We plan to use various imputation techniques, guided by analysis of individual patient data from other anti-obesity trials we have obtained from an academic investigator and to check for possible reporting and publication bias. Results: We have tried to get access to these documents at the Danish Medicines Agency and EMEA since June, 2007. We have not obtained any reply from the Danish agency, despite repeated requests, and our request has been turned down twice by EMEA. The main argument has been that allowing us access would undermine the protection of commercial interests. As none of the arguments have been convincing, we have complained to the European Ombudsman. We will discuss the nature of our arguments and those of EMEA, and how we may best move forward in order to ultimately open Pandora's box for the benefit of mankind, rather than for its punishment, as in the Greek mythology, or in the current climate of secrecy where even drug deaths may be regarded as trade secrets. Conclusions: We conclude that EMEA prioritises to protect the profits of the drug companies rather than protecting the lives and welfare of the patients, as both cannot be protected at the same time. EMEA does not live up to its obligations towards the European citizens.