Oseltamivir (Tamiflu, Roche) has been downgraded by the World Health Organization (WHO) in the biennial review of its list of essential medicines.
A WHO expert committee removed Tamiflu from its list of “core” medicines, relegating it to the “complementary” list, a category used for drugs with consistently higher costs or less attractive cost-effectiveness.
This represents the latest blow to a drug whose sales hit $4 billion in 2009, riding on the back of worldwide stockpiling during the swine flu pandemic.
The spectacular rise and slow fall of Tamiflu is a cautionary tale worth remembering, if only to protect us from ourselves, the next time the public stampedes to pour money into the coffers of private industry.
Don’t forget; among the newspaper headlines screaming at politicians to stockpile Tamiflu in 2009, there was no shortage of doctors’ voices criticising any delay in access to the drug. Plenty of public health advocates—nearly all those with any influence—got it wrong, and we front-line clinicians were swept along.
The Tamiflu provided free to my Aboriginal health clinic provided the only opportunity in my entire career to stride out into my waiting room, spectacularly arrayed in gown, gloves and mask, to administer a drug to people who were mildly unwell with a fever. For two months I felt like I was on the set of the film, Contagion.
As it turns out, for my patients who did indeed have swine flu, the drug I so dramatically administered would have shortened their symptoms by just half a day, and not done a thing to prevent either complications or hospitalisation.
We only know of the extent of our mistake thanks to the dogged persistence of a few Cochrane reviewers, and the support of The BMJ. These folk noticed an anomaly that had eluded governments all around the globe, whose advisers were allowed to divert hundreds of millions of dollars from other public programs.
Professor Chris del Mar, one of the Cochrane reviewers, explained on ABC’s Catalyst program, “When we did the initial analysis, it was straightforward. We just looked at published data…the drug reduces complications…easy.”
But he soon became worried that the data may have been cherry-picked (the majority of trials were fully funded by Tamiflu manufacturer Roche), and that there may also be unfavourable results which hadn’t been published.
The Cochrane reviewers asked Roche for its unpublished trials, and that is where the trouble started.
BMJ Editor-in-Chief Fiona Godlee described the process as “a really lengthy cat and mouse, Alice-in-Wonderland, bizarre experience of trying to get data on a drug which governments around the world were busy buying, stockpiling and spending billions of dollars on.”
It took an extraordinary four years of legal and public pressure (and ongoing Tamiflu sales) before Roche was finally forced to release the less favourable information, which turned out to be the majority of data ever collected on the drug.
Dr Godlee was unimpressed by the effort it took. “I think it’s very hard to explain why this behaviour by the pharmaceutical industry in supressing data over many years is not considered as misconduct.”
That was the beginning of the end of Tamiflu’s golden run.
New analyses undermined the primary justification for stockpiling—a reduction in complications and hospitalisations—and the current WHO downgrading is the latest reminder of the folly of the 2009 international spending frenzy.
That money is long gone now, and the only thing it earned us was a valuable lesson.
This story is worth re-telling, so that next time the stampede begins, more of us are willing to look beyond the emotive calls to spend up big.
We must insist on close examination of the evidence, and our right to see all of it before buying the product.