WHO should have downgraded Tamiflu earlier, says expert.
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The World Health Organisation (WHO) has downgraded oseltamivir (Tamiflu) due to uncertainty surrounding its clinical trials, bringing to a head concerns about data and drug stockpiling. The British Medical Journal (BMJ) published an editorial on Wednesday examining the drug's fall from favour.
Tamiflu was first approved by the US Food and Drug Administration in 1999 to be used in the treatment of uncomplicated influenza within 48 hours of the onset of symptoms. The clinical trials saw a total of 849 patients with influenza take part and manufacturer Roche said the trials showed a 1.3 day mean reduction in the duration of symptoms.
The trials found the drug to be safe, due to less than 1% of patients discontinuing because of adverse effect. It was also approved by the European Medicines Agency in 2002. However, with hindsight the basis of these trials was found to both limited and incomplete, prompting governments to act.
The UK government was concerned about a potential breakout of avian influenza and the H1N1 pandemic in 2009. In response, the government stockpiled oseltamivir at a cost of over GBP600m (EUR680m; USD770m) from 2006 to 2014. The US government also stockpiled the drug in a move costing over USD1bn.
Following the worldwide pandemic of H1N1 influenza, the WHO added oseltamivir to its list of essential medicines. The list is supposed to only include "the most efficacious, safe and cost-effective medicines for priority conditions." Thanks to its appearance on the list, the drug generated over USD18bn in sales worldwide, with half of it from government stockpiling.
Even as recently as 2014 experts backed the drug, with the director of the CDC remarking that oseltamivir can "prevent serious complications; if you have influenza and get the medicine early, you may not need to be admitted to a hospital... Antiviral flu medicines save lives, but they're unfortunately underutilised."
He even went on to encourage its use in patients whose symptoms were older than two days. Meanwhile, the FDA still had no found conclusive evidence that oseltamivir reduced complications, hospital admissions or mortality. As a consequence, the regulatory body blocked the manufacturer from making such claims in its promotional materials.
Yet, in spite of this, the drug maintained its popularity. According to the BMJ, oseltamivir slipped through the net because of a "multisystem failure" due to incomplete - and as a consequence, misleading - data provided to the EMA, CDC and WHO.
Writing in the BMJ, Mark Ebell, Professor of Epidemiology at the University of Georgia, described some of the reasons the drug's shortcomings did not come to light. These were: "the failure to publish all available evidence, to make the data available at the individual patient level, and to recognise the limitations of observational data."
The editorial concludes with a few key lessons, namely: "it is vital that all trials be published, and that individual patient data be made available for independent reanalysis." Secondly, the paper explains, stockpiling drugs that are minimally effective is not effective at anything other than spending money, and results in money not being spent on other public health priorities. "Because diverting these funds causes direct harm to the public, we must demand better evidence to inform these decisions," Ebell says.
Thirdly, he explains, belief in the efficacy of oseltamivir may have led to less research being done to find more effective drugs for influenza, again harming the public.
Ebell goes on to quote a House of Commons report which said: "This longstanding regulatory and cultural failure impacts on all of medicine, and undermines the ability of clinicians, researchers and patients to make informed decisions about which treatment is best."
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|Date:||Jul 13, 2017|
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