Patients may ask about a widely reported call from the Cochrane Collaboration for full disclosure of information about clinical studies leading to the approval of the neuraminidase inhibitors oseltamivir (Tamiflu) and zanamivir (Relenza) used to treat influenza.
The reviewers point out that data on oseltamivir from 8 trials of a 10-trial meta-analysis remain unpublished and were not available either from the studies’ authors or the manufacturer. That meta-analysis “has been the sole publication” cited by the CDC in support of its treatment guidelines.
On the basis of drug company data submitted to government agencies, the reviewers estimate that 60% of patient data from oseltamivir’s phase III trials “have never been published.” Using such “regulatory information” rather than published journal studies, the reviewers estimate that oseltamivir showed “no evidence of effect” on hospitalization rates; there was not enough information available to assess the drug’s effects on complications or viral transmission.
Source: Cochrane Library.
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