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The BMJ Today: The Tamiflu trials

10 Apr, 14 | by BMJ

BirteToday The BMJ is all about neuraminidase inhibitors and open data. Ten articles on the subject of anti-influenza drugs try to establish what we know. In sum: perhaps not enough to justify the huge expense governments worldwide have incurred in stockpiling these drugs, but perhaps enough in terms of improving transparency and providing researchers with all available data for independent scrutiny.

A Cochrane review analysed the complete datasets for the first time and found that compared with a placebo, taking either oseltamivir or zanamivir  led to a quicker alleviation of flu-like symptoms of just half a day in adults, but the effect in children was more uncertain, as were the drugs’ effects on secondary illnesses. However, patients with severe symptoms may consider the risk of adverse effects to more than offset the prospect of shortening symptoms by half a day.

But is this just a classic story of big pharma greed? Andrew Jack finds a more nuanced reality: although the drugs were initially developed for seasonal flu, the focus and their area of application in the early noughties shifted increasingly to potentially lethal emerging diseases, such as SARS or swine flu H1N1—and the cost in human lives could certainly have been much higher, so taxpayers and patients may ultimately consider the price was worth paying.

The future may hold more transparency: Julia Belluz spoke to both researchers and pharmaceutical companies and found that they agree that the release of the oseltamivir and zanamivir files heralds a more transparent era. Editorialists Elizabeth Loder, David Tovey, and Fiona Godlee put it strongly: “This undoubted progress is, however, limited to data relating to future drugs. Access to data relating to drugs in current use will still be largely at the discretion of the drug manufacturer or through individual requests to regulators. The Cochrane reviewers’ exceptional efforts have achieved what should have been a matter of routine—the independent scrutiny of deindentified clinical trial data. They have shown with greater clarity than ever that the current system is broken. There are substantial battles still to fight before we have a system of drug evaluation and regulation that truly serves patients and the public interest.”

And Kamran Abbasi sums up in his Editor’s Choice: “Companies, regulators, politicians, and researchers might consider the lessons of Tamiflu and put patients first and marketing a nice little earner a distant second.”

For more on Tamiflu and open data, visit our campaigns page at http://www.bmj.com/tamiflu

Birte Twisselmann is web editor and obituaries editor, The BMJ.

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