World Health Organization, FDA question efficacy of Tamiflu



In this flu season many people, when struck with the onset of the flu, take the drug Tamiflu (Oseltamivir) which is supposed to reduce the harshness and length of the flu's effect on the body.

But recently the World Health Organization and the FDA have questioned the effectiveness of Tamiflu. According to Mark Ebell, an epidemiologist:

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

Following requests from The BMJ, data from several unpublished trials were eventually made available to researchers.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review, led by Professor Tom Jefferson at the Centre for Evidence Based Medicine in Oxford, using an even larger set of unpublished studies, confirmed these findings and provided additional evidence of the drug's harms, such as nausea, vomiting, and psychiatric events.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.

It is especially troubling that the manufacturer has withheld information from researchers

Cochrane researchers, joined by the BMJ(formerly the British Medical Journal), complained that Tamiflu maker Roche is keeping important data from the public. They note that despite requests dating back to 2009, Roche refuses to release crucial data from eight of 10 Tamiflu clinical trials.

Last year I caught the flu and I took Tamiflu for the first time. I felt better in about a week. Did Tamiflu reduce the length of my sickness? It's impossible to tell, and anecdotes can't conclusively answer this question.

Like any drug, Tamiflu can have side effects. The FDA allows the sale of this drug but limits the claims of what it can do; and the WHO's downgrading of Tamiflu, and the withholding of research data, raises a question mark about it. The efficacy of this drug should be researched further in rigorous double-blind studies with control groups, not funded by the manufacturer, to establish whether it really reduces the severity of the flu and whether it is being prescribed under the proper circumstances.

[originally in AT]



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