Important lessons on Tamiflu have been outlined in an editorial. Tamiflu (oseltamivir) is used for treating uncomplicated influenza within 48 hours of the onset of symptoms. Tamiflu (oseltamivir) was approved by the US Food and Drug Administration (FDA) in 1999 and the European Medicines Agency (EMA) in 2002, based on limited data from two randomised trials. The study was published by Mark Ebell, Professor of Epidemiology at the University of Georgia.
‘Removal of oseltamivir from the essential medicines list is better, as there is no evidence was found in reducing pneumonia, or hospital stay.’
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Concerned about a possible outbreak of avian influenza, as well as the H1N1 pandemic in 2009, governments around the world stockpiled oseltamivir. And in 2010, in the wake of the worldwide H1N1 pandemic, oseltamivir was added to the WHO's list of essential medications.As a result, oseltamivir has generated over $18bn in sales worldwide, half of it from governments stockpiling the drug. Yet, the FDA had long concluded that there was no evidence that oseltamivir reduced complications, hospital admissions, or mortality and actually prevented the manufacturer from making such claims in their promotional materials.
So, what is the truth, asks Ebell?
In 2014, an editorial in The BMJ described a "multisystem failure," which he says is an apt description for the series of decisions based on flawed evidence made by the EMA, CDC, and WHO. These include the failure to publish all available evidence, to make the data available at the individual patient level, and to recognise the limitations of observational data.
Following requests from The BMJ, data from several unpublished trials were eventually made available to researchers. Analysis of their results found only a 20 hour mean reduction in symptoms and no evidence of a reduction in the likelihood of pneumonia, hospital admission, or complications requiring an antibiotic.
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Withholding these data was a serious breach of research ethics by Roche, argues Ebell: suppressing information obtained from patients enrolled in trials of a then experimental drug, who thought that they were contributing to the medical knowledge base.
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"It is appropriate that the WHO downgraded the status of this drug based on the concerted efforts of The BMJ, Jefferson and his team, and many others," concludes Ebell. "Removal of oseltamivir from the essential medicines list is better late than never, but still comes far too late."
Source-Eurekalert