WHO decision to downgrade Tamiflu 'comes far too late' argues expert

July 13, 2017, British Medical Journal

In an editorial published today, Mark Ebell, Professor of Epidemiology at the University of Georgia, outlines important lessons from the Tamiflu story.

Tamiflu (oseltamivir) was approved by the US Food and Drug Administration (FDA) in 1999 and the European Medicines Agency (EMA) in 2002 for the treatment of uncomplicated influenza within 48 hours of the onset of symptoms, based on limited data from two randomised trials.

Concerned about a possible outbreak of avian influenza, as well as the H1N1 pandemic in 2009, governments around the world stockpiled oseltamivir. And in 2010, in the wake of the worldwide H1N1 pandemic, oseltamivir was added to the WHO's list of essential medications.

As a result, oseltamivir has generated over $18bn in sales worldwide, half of it from governments stockpiling the . Yet, the FDA had long concluded that there was no that oseltamivir reduced complications, hospital admissions, or mortality and actually prevented the manufacturer from making such claims in their promotional materials.

So, what is the truth, asks Ebell?

In 2014, an editorial in The BMJ described a "multisystem failure," which he says is an apt description for the series of decisions based on flawed evidence made by the EMA, CDC, and WHO. These include 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.

Following requests from The BMJ, data from several unpublished trials were eventually made available to researchers. Analysis of their results found only a 20 hour mean reduction in symptoms and no evidence of a reduction in the likelihood of pneumonia, hospital admission, or complications requiring an antibiotic.

A subsequent Cochrane review, led by Professor Tom Jefferson at the Centre for Evidence Based Medicine in Oxford, using an even larger set of unpublished studies, confirmed these findings and provided additional evidence of the drug's harms, such as nausea, vomiting, and psychiatric events.

Withholding these data was a serious breach of research ethics by Roche, argues Ebell: suppressing information obtained from patients enrolled in trials of a then experimental drug, who thought that they were contributing to the medical knowledge base.

He points to several important lessons, including the need for all trials be published, and individual patient data be made available for independent reanalysis, and recognition that money spent stockpiling drugs that are minimally effective is money not spent on other public health priorities. Belief in the efficacy of oseltamivir "may have led to less research to find truly effective drugs for influenza, again harming the public," he adds.

"It is appropriate that the WHO downgraded the status of this drug based on the concerted efforts of The BMJ, Jefferson and his team, and many others," concludes Ebell. "Removal of from the essential medicines list is better late than never, but still comes far too late."

Explore further: Continuing uncertainties surround anti-influenza drug

More information: Mark H Ebell. WHO downgrades status of oseltamivir, BMJ (2017). DOI: 10.1136/bmj.j3266

Related Stories

Continuing uncertainties surround anti-influenza drug

January 18, 2012
Incomplete availability of data has hampered a thorough assessment of the evidence for using the anti-influenza drug oseltamivir, a Cochrane Review has found. However, after piecing together information from over 16,000 pages ...

Tamiflu and Relenza: How effective are they?

April 11, 2014
Tamiflu (the antiviral drug oseltamivir) shortens symptoms of influenza by half a day, but there is no good evidence to support claims that it reduces admissions to hospital or complications of influenza. This is according ...

FDA approves first generic version of tamiflu

August 8, 2016
(HealthDay)—The first generic version of the flu medication Tamiflu has been approved by the U.S. Food and Drug Administration.

Study shows Tamiflu gets patients back on their feet faster, reduces flu complications

January 29, 2015
Earlier this month, the Centers for Disease Control and Prevention recommended the use of antiviral drugs to help treat influenza, in a year when the available vaccine is not a good match for the current strain.

Updated reviews issued for oseltamivir, zanamivir use in flu

April 10, 2014
(HealthDay)—Oseltamivir and zanamivir reduce the time to symptomatic improvement in influenza by about half a day, but evidence to support claims of reduced admissions to hospital or complications of influenza is lacking, ...

Recommended for you

Novel botulinum toxin compound relieves chronic pain

July 18, 2018
A modified form of botulinum toxin gives long-lasting pain relief in mice without adverse effects and, in time, could replace opioid drugs as a safe and effective way of treating chronic pain, according to research by UCL, ...

FDA recalls heart medication valsartan, citing cancer concerns

July 17, 2018
The U.S. Food and Drug Administration issued a voluntary recall of several medications that contain the active ingredient valsartan, which is used to treat high blood pressure and heart failure.

Opioids given too easily to children: study

July 16, 2018
(HealthDay)—Many children are prescribed powerful opioid painkillers they don't really need, putting them and those around them at risk, a new study shows.

Study reveals opioid patients face multiple barriers to treatment

July 12, 2018
In areas of the country disproportionately affected by the opioid crisis, treatment programs are less likely to accept patients paying through insurance of any type or accept pregnant women, a new Vanderbilt study found.

Report details possible conflict of interest issues for FDA advisors

July 6, 2018
Charles Piller, a contributing correspondent for the journal Science, has published a Feature piece in the journal detailing what he describes as possible conflicts of interest issues by people who serve as advisors to the ...

Opioid epidemic responses overlook gender

July 5, 2018
Yale health experts warn that current efforts to confront the growth of opioid addiction and overdose deaths must better incorporate an understanding of how women fit into this epidemic.

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.