Announcement Date: November 24, 2014
Public Accounts Committee on Tamiflu. Statement from Dr Fiona Godlee, Editor in Chief, The BMJ, November 24 2014.
CMO defends decision to stockpile Tamiflu and says she would do it again. BMJ 2014;349:g6386
Fellow witness Fiona Godlee, editor in chief of The BMJ, challenged this, saying, “The observational data cannot be relied upon for evidence of benefit in the same way that clinical trials could be.
“If there is a pandemic we must insist that there be a trial of Tamiflu or other more modern antivirals because not to do that would itself be unethical. The current system is insufficiently transparent and insufficiently independent for the regulation and evaluation of drugs, and that has to change.”
Carl Heneghan, director of the Centre for Evidence-Based Medicine at the University of Oxford, also giving evidence, said, “Observational data does have uses. It is important, but many people in this room know it’s subject to such bias that you would not want to use it to establish treatment effects.”
Godlee said, “The only evidence available that was publically used to support the decision [to stockpile oseltamivir] was the Kaiser systematic review, 3 which was funded by Roche, of 10 trials, of which only two had been published. That was the basis for the decision to stockpile the drug as I understand it.”
Davies said that other work done had played a part in the government’s decision to buy the drug at the time.
Will Tamiflu recommendations change this winter? BMJ 2014; 349 doi: http://dx.doi.org/10.1136/bmj.g6742 (Published 27 November 2014) Cite this as: BMJ 2014;349:g6742
Andrew Jack reports on renewed pressure to remove the antiviral drug oseltamivir from the World Health Organization’s powerful list of essential medicines
The World Health Organization is at the centre of a fresh debate on whether it should remove an antiviral drug from its influential list of recommended medicines, following a growing number of studies scrutinising the medicine’s value in treating influenza.
Members of the Cochrane collaboration have called for oseltamivir (Tamiflu) to be taken off WHO’s essential medicines list, a document of more than 300 drugs considered necessary to meet basic healthcare standards. It was first added in 2009, the year the H1N1 pandemic flu strain was identified.
Chris Del Mar, professor of public health at Bond University in Australia and one of the Cochrane authors, said: “Oseltamivir was included at a time when it looked as though it was effective and it seemed prudent to planners to stockpile.”
His comments come after the publication of an update to the Cochrane review of clinical trials of oseltamivir and another neuraminidase inhibitor, zanamivir. Their work followed more than four years of efforts by the researchers and The BMJ to obtain raw trial data from drug companies and to track down submissions to regulators made around the world (www.bmj.com/tamiflu). The Cochrane authors concluded, on the basis of a meta-analysis of 46 trials covering 24 000 patients, including data not previously made public, that the drugs shortened symptoms in seasonal influenza cases by less than a day and did not reduce the number of hospital admissions. (Read More)