BRITAIN’S medicines regulator has destroyed the original scientific data supporting the licensing of Prozac, the antidepressant drug that is provoking growing controversy over evidence that it is linked to suicide.
It means that scientists who have tried to re-examine the evidence justifying its release may now never be able to find out how good the science was. Patients making compensation claims will face the same problem.
The UK medicines regulator destroys detailed information on the benefits and harms of medicines it has approved after it has held it for 15 years. This means that for medicines which have been on the market for longer than 15 years, which is the majority of them, the Medicines and Healthcare Products Regulatory Agency (MHRA) no longer holds the data it based its licensing decision on.
This came to light after Professor Peter Gotzsche, co-founder of the Cochrane Collaboration, asked the European Medicines Agency for the data used to support the licensing of the antidepressant Prozac (fluoxetine). Gotzsche was referred to the MHRA as the UK is designated as the Reference Member State for Prozac meaning the MHRA is the nominated body within the EU that holds the information on the drug. Never the less, the MHRA had shredded clinical evidence about the benefits and harms of the product. It told Professor Gotzsche “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 reported yesterday that “the MHRA said it had shredded the detailed information and held only some documents that summarised the findings. Eli Lilly, the manufacturer, retains the data and the MHRA said it can order it to be submitted.”
Professor Gotzsche wrote in a letter in the BMJ in June 2011 “As citizens in the EU, we should not accept this state of affairs. … The UK government should introduce legislation that will prevent the MHRA in future from destroying the evidence in its possession.”
Dr 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. 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. Science progresses, and medicine improves, when we have many eyes on the data.”
- MHRA shreds clinical trial info after 15 years, AllTrials.net, News release, 24th March 2014
More information, letters, opinions and articles:
- Drug regulator destroys Prozac research, TheSundayTimes, 23 March 2014
- and take names… , 1boringoldman, 23 March 2014
- MHRA destroys trial data after 15 years on file, PharmaTimes, 23 March 2014
- Restoring invisible and abandoned trials: a call for people to publish the findings, BMJ 346:f2865, 13 June 2013
- UK drug regulator destroys all evidence after 15 years, BMJ 343:d4203, 5 July 2011
- Opening up data at the European Medicines Agency, BMJ rapid-response, 20 June 2011
- Opening up data at the European Medicines Agency, BMJ 342:d2686, 10 May 2011
- UK Drug Regulator Destroys All Trial Data After 15 Years, Medscape 746109, July 11, 2011