Senior researchers are calling for legislative change to prevent the UK’s drug regulator from destroying old evidence.
The Medicines and Healthcare products Regulatory Agency (MHRA), routinely destroys all the evidence about the benefits and harms of the products it approves after 15 years, Professor Peter Gøtzsche from the Nordic Cochrane Centre in Denmark, revealed this week in a letter in the BMJ.
This makes it impossible for treatments to continue to be assessed by the scientific community, he argues.
Gøtzsche and colleagues recently applied to the European Medicines Agency (EMA) for access to unpublished trial reports for eight antidepressant drugs approved for use in the European Union.
Some drugs, including the antidepressant drug fluoxetine, have not been approved centrally, so the EMA advised them to contact the relevant national drug agencies.
“But the MHRA informed us that it no longer holds the requested reports,” says Gøtzsche.
He explains 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.
He points out that court cases “have shown serious scientific misconduct in placebo controlled industry sponsored trials of antidepressant drugs including fluoxetine.”
Furthermore, selective serotonin reuptake inhibitors as a drug class increase the risk of suicide in children and adolescents, he adds.
“The action of the MHRA may mean that it is impossible for independent researchers to correct the seriously flawed publication record on fluoxetine, which, ironically, is the only drug approved for use in childhood depression,” he argues.
He concludes: “I have asked the UK Department of Health and the EMA how we can obtain the data the MHRA has destroyed, and I suggest legislation be introduced to prevent the MHRA from destroying the evidence in future. Lack of space is no excuse because the documents can be scanned.”