Get ready to energize your life?
Top Offers Only Today
Support your health and step-up your mental focus
post in: Beauty, Health Date:12 Nov 2017, 08:01 views:2155
Two years after pharmaceutical giant Roche promised the BMJ it would release key Tamiflu trial data for independent scrutiny, the safety and effectiveness of this anti-influenza drug remains uncertain, warn experts today. A new report by the Cochrane Collaboration says Roches refusal to provide full access to all its data leaves critical questions about how well the drug works unresolved. A BMJ investigation, published to coincide with todays report, also raises serious concerns about access to drug data, the use of ghost writers in drug trials, and the drug approval process.
Meanwhile, Tamiflu has become the mainstay of influenza treatment in the. It has also made it onto the World Health Organisations list of Essential Medicines and Roches claims continue to be supported by influential health agencies. The Cochrane researchers set out to test Roches claim that antimuscarinic Tamiflu prevented complications and reduced the number of people needing hospital treatment.
But their investigation was hampered by Roches refusal to provide all of its trial data for ysis.
The team obtained some clinical study reports from the European Medicines Agency (EMA but found inconsistencies with published reports and possible under-reporting of side effects.
When previously questioned by the BMJ, Roche also admitted that some of the published papers had been ghost written.
The BMJ investigation reveals how different regulators took different approaches to the data submitted to them, leading to conflicting messages about it effectiveness. For example, the EMA released a proportion of the clinical study reports relating to the Tamiflu trials to Cochrane, but it admits that it did not ask for the remainder from the manufacturer, although it was legally entitled to. The EMA has since told the BMJ that it plans to start publishing reports for all drugs submitted for approval in the next few years.
Dr Fiona Godlee, BMJ Editor-in-Chief says: "We hope very much that the EMA will indeed take this important step in making the full study reports available. But we are still a long way away from having a full trial history for all drugs in clinical use.
Public safety and the proper use of public money demands that we should stop at nothing less than this.".
Meanwhile, the US Food and Drug Administration (FDA which has reviewed the Tamiflu trial programme in perhaps more detail than anyone outside of Roche, chose not to review the largest ever trial of Tamiflu when considering the drug for approval.