Billions wasted on unproven flu drug, report claims

Researchers raise doubts over effectiveness of stockpiled medicine Tamiflu

File photo  of Tamiflu medication. Photograph: Rui Vieira/PA Wire

File photo of Tamiflu medication. Photograph: Rui Vieira/PA Wire

Thu, Apr 10, 2014, 07:30

Researchers who have fought for years to get full data on Roche’s flu medicine Tamiflu said today that governments who stockpile it are wasting billions of dollars on a drug whose effectiveness is in doubt.

The row has drawn in the drugmaker as well as industry regulators and independent scientists. Supporters of Tamiflu said the researchers’ conclusions were flawed and insisted the drug is both safe and effective.

The dispute over the benefits of Tamiflu, and to a lesser extent of GlaxoSmithKline’s flu drug Relenza, blew up with the joint publication by the respected Cochrane Review research network and the British Medical Journal of an analysis of trial data, which found no good evidence behind claims the drugs cut hospital admissions or reduce flu complications.

The review’s main findings were that the medicines had few if any beneficial effects, but did have adverse side effects that were previously dismissed or overlooked.

“Remember, the idea of a drug is that the benefits should exceed the harms,” said Carl Heneghan, one of the lead investigators of the Cochrane review and a professor of evidence-based medicine at Britain’s Oxford University. “So if you can’t find any benefits, that accentuates the harms.”

But Roche, which has been under fire for several years over its refusal to allow the Cochrane team unrestricted access to Tamiflu data, rejected the findings, saying it “fundamentally disagrees with the overall conclusions” of their study.

“We firmly stand by the quality and integrity of our data, reflected in decisions reached by 100 regulators across the world and subsequent real-world evidence demonstrating that Tamiflu is an effective medicine in the treatment and prevention of influenza,” it said in a statement.

Tamiflu sales hit almost $3 billion (€2.17bn) in 2009 - mostly due to its use in the H1N1 flu pandemic - but they have since declined.

The drug, one of a class of medicines known as neuraminidase inhibitors, is approved by regulators worldwide and is stockpiled in preparation for a potential global flu outbreak. It is also on the World Health Organisation’s “essential medicines” list.

The United States has spent more than $1.3 billion buying a strategic reserve of antivirals including Tamiflu, while the British government has spent almost £424 million (€513m ) on a stockpile of some 40 million Tamiflu doses.

“Down the Drain”

Mr Heneghan’s team say their analysis is the first based on full data - from 20 trials of Tamiflu, known generically as oseltamivir, and 26 trials of Relenza, also known as zanamivir.