The movement for more data transparency has been given a shot in the arm following a Sunday Times report which shows that the UK medicines regulator routinely destroys information on the licensing application files for drugs it has approved after 15 years.
The newspaper’s piece documents the bid by Peter Gotzsche, co-founder of the Cochrane Collaboration, to get access to the data used to support marketing approval for Eli Lilly’s now off-patent antidepressant blockbuster Prozac (fluoxetine). He approached the European Medicines Agency which referred him to the Medicines and Healthcare Products Regulatory Agency (MHRA) as the UK acted as the reference member state for Prozac approval.
However, the agency has shredded the vast majority of the clinical evidence it held on the treatment and the Prozac case is not an isolated one. Prof Gotzsche was told that “under MHRA record management policy, all application files and data for licences are held for 15 years”.
After this period, “files are destroyed unless there is a legal, regulatory, or business need to keep them, or unless they are considered to be of lasting historic interest”. The Sunday Times article noted that “the MHRA said it had shredded the detailed information and held only some documents that summarised the findings”. Lilly retains the data and the MHRA “can order it to be submitted”.
Ben Goldacre, co-founder of AllTrials, said: “The MHRA needs to recognise that the world has changed, it is no longer acceptable for decisions about medicines to be based on secret meetings, about secret information that is then shredded”. He added that “doctors, researchers and patients need access to all the evidence, to make fully informed decisions about which treatment is best, and help spot problems with treatments as quickly as possible”.
Dr Goldacre concluded by saying that “science progresses, and medicine improves, when we have many eyes on the data”.
MHRA responds
In response, an MHRA spokesperson told PharmaTimes that “we closely monitor the safety and efficacy of all medicines throughout the product lifecycle and we retain all key information relating to the agency’s assessment and decision-making processes”. He added that “we use modern adverse drug reaction reporting systems and current research studies that better reflect clinical use and build on the original licensing data”.
He also stressed that the MHRA “has the legal power to require manufacturers of medicines to share safety, efficacy and clinical trial information from any time period so we can thoroughly investigate any issues”.
Regarding the Prozac case specifically, the MHRA notes that it was “the first regulator to conduct a comprehensive safety review selective serotonin reuptake inhibitors (SSRIs) of the risks of suicidal behaviour and withdrawal reactions”. It adds that “our overriding responsibility is to ensure that medicines work, and are acceptably safe. Our role is not to protect industry interests”.
The agency concludes by saying that “we are committed to greater transparency in our activities [and] we have already shown this by publishing the minutes of our advisory committees and Public Assessment Reports, detailing the processes and decisions made when licensing a drug and disclosing the evidence underpinning our decisions in areas of public concern”.
