GlaxoSmithKline (GSK) Clashes With Pharmaceutical Research and Manufacturers of America (PhRMA) Over Data Disclosure
2/5/2013 8:03:58 AM
Just how heated can the controversy over disclosing clinical trial get? One day after the US pharmaceutical industry trade group bashed the cry to release patient-level data, GlaxoSmithKline has come out in support of the notion. The support by the drugmaker comes four months after the drugmaker declared a new openness in the wake of a huge scandal over data disclosure that contributed to a $3 billion settlement with the US government last year. The ideological clash between the Pharmaceutcial Research and Manufacturers of America and one of the world’s largest drugmakers centers on a petition drive called AllTrials that was recently spearheaded by Sense About Sciences, a charitable trust in the UK, and BMJ, a leading medical journal that recently vowed to no longer publish studies unless relevant patient level data available. So far, more than 20,000 people have signed. Specifically, the AllTrials campaign calls for registering clinical trials, disclosing trial results and clinical study reports. The notion was essentially endorsed last week by the lead legislator Environment, Public Health and Food Safety Committee in the European Parliament, who wants to toughen proposed legislation that is designed to bolster clinical trial practices and activities. “We are committed to being transparent with our clinical trial data to help advance scientific understanding and inform medical judgment.. All those involved in the conduct and publication of clinical research, whether healthcare companies like GSK, academia or research organisations, have a role to play in ensuring that the data they generate are made publicly available to help bring patient benefit,” says Glaxo R&D president Patrick Vallance, in a statement. Just yesterday, though, the PhRMA trade group lambasted the call for releasing patient-level data and singled out BMJ and Ben Goldacre, a physician and industry provacateur who recently wrote a book called ‘Bad Pharma,’ and has been agitating for the AllTrials campaign. Interestingly, but not surprisingly, there was no mention of Glaxo, which is a member.