Experts push for trials to evaluate Roche, GSK flu drugs' pandemic potential

Tamiflu capsules--Courtesy of Roche

Critics have long questioned the effectiveness of Roche ($RHHBY) and GlaxoSmithKline's ($GSK) flu drugs, asking whether their benefits justify the estimated $2 billion spent to stockpile them for potential epidemics. Now, heading into flu season, scientists are pushing for randomized clinical trials to find out once and for all.

As Reuters reports, experts co-led by Wellcome Trust director Jeremy Farrar ran a report on using antivirals such as Roche's Tamiflu and GSK's Relenza to combat seasonal flu. They found that while the drugs were widely used and stockpiled in the 2009 H1N1 swine flu pandemic, "we have no idea whether that was right," Chris Butler, co-leader of the review and an expert on clinical trials at the University of Oxford, told the news outlet. No randomized trials were conducted, Butler points out, and no one can be sure whether the meds can quell large outbreaks.

"Until we do the trials we don't really know what we should be doing--and we've wasted huge opportunities in the past by not randomizing patients early on in pandemics," Butler said, as quoted by Reuters.

Still, the report did turn up some evidence in favor of the flu antivirals. The drugs can significantly reduce deaths in hospitalized patients, especially those who begin taking the meds within two days of becoming sick. The drugs also reduce seasonal flu symptoms by between 14 and 17 hours, but experts are cautioning against routine use because risks may outweigh benefits in some patients, according to the Reuters story.

The report adds to the growing debate over antivirals. Last year, Roche released a study showing that Tamiflu saved lives during the swine flu epidemic in 2009. Sales of the drug that year skyrocketed to 3.2 billion Swiss francs ($3.15 billion) amid increased demand, while GSK's Relenza posted sales of £720 million ($1 billion) in 2009, up from £57 million ($86 million) the year before.

But a few weeks after Roche released its study, the nonprofit Cochrane Collaboration--a vocal Tamiflu critic--published its own study in the BMJ showing that there's no evidence that Tamiflu can stop the flu from spreading or reduce its complications. The U.S. and U.K. spent a combined $2 billion stockpiling the drugs since 2009. And that money "has been thrown down the drain," study co-author Carl Heneghan, a professor of evidence-based medicine at the University of Oxford, said at the time.

Roche struck back, claiming that Cochrane researchers failed to include all the relevant data and don't really understand how Tamiflu works. The Cochrane team cherry-picked the studies to find numbers to support its findings, Daniel Thurley, Roche's medical director in the U.K., said last year. And the resulting confusion could present a risk to public health. "It is clear they made some fundamental mistakes and did not use appropriate or rational analyses," Thurley said.

But despite the lack of consensus on the drugs, sales for Tamiflu and Relenza still deliver, getting a boost during last year's particularly bad flu season. Tamiflu sales in Q3 2014 jumped 3% to 372 million Swiss francs, partly due to pandemic stockpiling in Europe. And sales for rival Relenza more than doubled during the same quarter to £41 million, a jump GSK primarily attributed to government stockpiling of the drug in Japan.

- read the Reuters story

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