Study supports Roche's disputed blockbuster flu drug Tamiflu

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[January 30, 2015]  By Kate Kelland

LONDON, Jan 30 (Reuters) - A major analysis of one of the world's most fiercely disputed medicines, Roche's Tamiflu, has found it cuts flu symptoms by a day and can help some patients avoid hospital treatment and complications.

But the drug can also have side effects, including nausea and vomiting, which should be balanced against its benefits, researchers who led the study said.

Published in The Lancet on Friday, the pooled analysis included data from all previously published and unpublished trials of Tamiflu, which has been the subject of intense scientific debate for years.

The drug, known generically as oseltamivir, is an anti-viral which was stockpiled and widely used by governments during the 2009/2010 H1N1 "swine flu" pandemic. It is approved by regulators worldwide and is on the World Health Organization's "essential medicines" list.
 


A high-profile analysis led by the Cochrane review concluded last year that Tamiflu's benefits were slim and were outweighed by adverse side effects. Researchers who led that study accused governments of throwing money "down the drain" by buying the drug for stockpiles.

The Lancet study, led by Arnold Monto of the University of Michigan School of Public Health and Stuart Pocock of the London School of Hygiene & Tropical Medicine, analysed data from nine trials comparing Tamiflu with placebo for 4,328 adults with laboratory-confirmed seasonal flu.

They found it reduced the duration of symptoms by 21 percent compared with placebo, from 123 to 98 hours, and significantly cut the risk of hospitalisations and flu complications such as pneumonia.

"The safety and effectiveness of oseltamivir has been hotly debated, with some researchers claiming there is little evidence that (it) works," Monto said in a comment about the findings.

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He said this analysis found "compelling evidence" of Tamiflu's benefits, adding: "Whether the magnitude of these benefits outweigh the harms of nausea and vomiting needs careful consideration."

Peter Openshaw, a respiratory infections expert at Imperial College London who was not involved in either analysis, said they showed Tamiflu "is not a perfect drug but does what you might expect of an antiviral given relatively late in the course of an acute infection".

Annual sales of Tamiflu, which Roche has always defended as effective, hit almost $3 billion in 2009, mainly due to use during the pandemic. They have since declined, although a bad flu season in the United States pushed sales up in the last quarter of 2014

(Editing by Ben Hirschler and Andrew Roche)

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