Apr 4, 2013
BMJ: Roche will release all trial reports on oseltamivir
After 3 years of talks, Roche has agreed to release all of its 74 sponsored clinical studies of the antiviral oseltamivir (Tamiflu) to the Cochrane Collaboration, a Rome-based research group that examines the evidence for medical treatments, BMJ announced in an e-mailed press release today. Roche officials promised in an Apr 2 e-mail to the Cochrane group that they would provide all the reports over the next few months, but they would be edited to ensure patient privacy and protect "legitimate commercial interests," according to BMJ (formerly the British Medical Journal). In 2009 BMJ published a review by Cochrane researchers that said they found inadequate evidence that oseltamivir reduces the risk of influenza complications like pneumonia. The authors said that 8 of 10 trials examining the issue were never published and that Roche refused to supply the full data from the trials. BMJ and the Cochrane group have been at odds with Roche over access to the data since then. Today's BMJ statement said the Cochrane researchers have cautiously welcomed the Roche announcement but are concerned that redaction and other problems may make analysis and interpretation of the data impossible. Last month, according to BMJ, Roche said it had appointed a set of third parties, including the Cochrane Collaboration, to review the data on oseltamivir and identify any gaps. The Cochrane researchers have asked for further clarification before deciding if they will participate, BMJ reported.
Apr 4 BMJ press release
Related Nov 2, 2012, CIDRAP News story
HHS awards contract for test to detect drug-resistant flu
The Department of Health and Human Services (HHS) has awarded a New Jersey company a $1.8 million contract to develop a diagnostic test to detect antiviral resistance in influenza, the agency said in a news release yesterday. The test, to be produced by Becton, Dickinson and Co., of Franklin Lakes, N.J., will both detect influenza virus and identify antiviral resistance in clinical respiratory samples. The flu-detection part of the platform has already been approved by the Food and Drug Administration for detecting influenza A and B strains. The test will be developed over 2 years at BD Technologies, the development arm of the company, in Research Triangle Park, N.C. "This type of test, which could be performed easily in local laboratories, holds the potential to guide treatment options, helping to provide the best care to patients," said Robin Robinson, PhD, director of the Biomedical Advanced Research and Development Authority (BARDA), which is supporting the contract.
Apr 3 HHS news release