Feb 102012

The Cochrane Collaboration smells a rat around Pharma's handling of its data on oseltamivir (Tamiflu) and zanamivir (Relenza).

They're taking the unusual step of publicly calling for Roche (Tamiflu) and GlaxoSmithKline (Relenza) to make available their data from the original clinical studies that led to approval of the two blockbuster drugs. They point out that for oseltamivir, the data from 8 out of 10 trials included in the meta-analysis that led to oseltamivir's approval have still never actually been published. Rather, they've been closely held by the studies' authors or Roche itself, despite mulitple requests from Cochrane. The meta-analysis is the sole publication the CDC cites to support its guidelines (which unequivocally recommend use of one of the neuraminidase inhibitors for severe influenza).

Reviewing the unpublished data they could get their hands on (which the Pharmas sent to government agencies on the road to drug approval), the Cochrane folks were not impressed, saying they suggest that oseltamivir showed "no evidence of effect" on rates of hospitalization.

Jones JT et al for the Cochrane Collaboration. Neuraminidase inhibitors for preventing and treating influenza in healthy adults and children (Review). The Cochrane Library 2012, Issue 1.

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Cochrane to Pharma: stop hiding data on Relenza and Tamiflu