In a blog entry posted yesterday (24 July), the director general of the European Federation of Pharmaceutical Industries and Associations (EFPIA), Richard Bergström, rebuffed reports that the pharmaceutical industry is trying to limit transparency as it seeks to work together with patient groups on clinical trials.
On Sunday, the British newspaper The Guardian reported that it had seen a leaked e-mail in which the two large trade groups, the Pharmaceutical Research and Manufacturers of America (PhRMA) and EFPIA, were pursuing a strategy of mobilising patient groups to back the industry's views on clinical trials.
The patient groups should raise fears that if full results from drug trials are published, the information might be misinterpreted, for example by the media, and cause a health scare.
European regulators are considering an update to the Clinical Trials Directive that could force pharmaceutical companies to publish all of the clinical study reports that they have filed.
The e-mail was sent from Bergström to directors of leading pharmaceutical companies. Bergström yesterday reacted to the story on his blog:
"I was, frankly, surprised by the reaction. Of course EFPIA would discuss the topic of clinical trials data sharing and transparency with patient groups. Of course we would share our views and put forth our perspective to these essential stakeholders. You know what? Most of them don’t even agree with us," Bergström wrote.
He added that a good number of patient groups are part of the AllTrials campaign which is aimed at getting more transparency and data public from clinical trials.
"To me, a pharmaceutical industry capable of positively impacting public health is shaped by two things – science and patients. I’ve spoken on this before: Science is what guides our industry, while our patients are what motivate its existence," EFPIA's general secretary wrote.
"When it comes to enhancing public health and improving patients’ lives, medical and scientific innovation is one of the most powerful tools we have – and must be protected accordingly," he said.
New commitment 'too late'
Meanwhile, EFPIA and PhRMA also published a press release, stating their commitment to "enhancing public health by endorsing joint principles for responsible clinical trial data sharing".
Monique Goyens, director general of the European Consumer Organisation (BEUC), reacted to the announcement by saying that such commitment, coming two days after the story in the Guardian was published, locks the door after the horse has bolted.
"The debate on data transparency has already moved on and there is no way back to their old secretive ways. It is no longer up to the industry. Their pronouncements do not cover up big pharma’s unethical attempts to mobilise patient groups solely to protect their commercial interests," Goyens said.
BEUC's secretary-general added that while the pharma industry has raised concerns about the risk of trial information being misinterpreted and causing health scares, 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,” Goyens added.
The EU's Clinical Trials Directive was adopted in 2001 with a view to improving research standards and protecting patients.
But the directive has been heavily criticised by researchers who say insurance costs and red tape has increased without bringing any major benefit to patients, researchers or industry.
The Commission has therefore proposed revamping the directive to address those challenges.
Enhancing the competitiveness of clinical research was a primary aim of the directive's revision amid claims that Europe would become an unattractive place to conduct large-scale trials on potentially lucrative new medicines.
The regulation also speeds up how researchers get ethical approval for medical trials and seeks to improve standards in how new medicines are tested and manufactured.
- 8 Oct.: Indicative plenary sitting date with first reading.
Business and Industry
- European Federation of Pharmaceutical Industries and Associations (EFPIA): EFPIA PhRMA Joint Commitment to Data Sharing: Enhancing Science for Patient Benefit