In May this year we mentioned that there is a battle raging in Europe over the access to clinical trials' information. While the worldwide trend seems to be increased disclosure in order to improve transparency of clinical trials and to contribute to consumer health, an opposite tendency is shown in Europe. Major pharma companies try to keep the data of their clinical trials as secret as possible, for as long as possible, claiming protection under 'commercially confidential information' laws, privacy of patients data laws, etc. (Interim injunctions to stop EMA from releasing non-clinical and clinical data) (Trying for better clinical trials)
The Guardian reported last week that pharma companies are now trying to involve their patients to support their claims on keeping clinical trials data confidential, in a battle against EMA's work to make more of these data public. (Big pharma mobilising patients in battle over drugs trials data) As we mentioned before, the whole idea about making clinical trials data public (or more public) is to allow independent scientists to replicate the results of the trials and to test health claims that are being made during them. This should increase the medicines' safety. However, as Guardian reports, currently only about half of all clinical trials are published in full, and positive results of such trials are twice as likely to be published than negative ones.
A memo that was leaked to the press by a drugs company employee shows how two large pharma trade groups (PhRMA - Pharmaceutical Research and Manufacturers of America and EFPIA - European Federation of Pharmaceutical Industries and Associations) strategized in order to influence public opinion on this subject. Under the pressure from the industry, various patients groups (who are often sponsored by the industry) were to start expressing their fears that in case clinical trials data is released it may be misinterpreted and endanger public health by scaring people to use certain drugs. Apparently, European Parliament has already witnessed such a lobbying from patients groups against the proposal on the clinical trials directive.
This leak was just what was needed, it seems, to further mobilise opposition against pharma industry. Despite attempts to rectify the situation after the leak was publicised - EU and US pharma companies pledging to share clinical trial data responsibly - the damage to their credibility has been done. As a result BEUC announced on 24 July this year that it will support EMA in its pending cases in front of the CJEU against pharma companies (read earlier posts on this).
Monique Goyens, Direction General of BEUC, said:
"The pharma industry raised concerns about the risk of trial information being misinterpreted and causing health scares. But currently, the only existing evidence points to the health risks of secrecy and non-disclosure. Several drug-related scandals could have been prevented and many lives saved
had trial data been examined by independent researchers."