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Two years after pharmaceutical giant Roche promised the BMJ it would release key Tamiflu trial data for independent scrutiny, the safety and effectiveness of this anti-influenza drug remains uncertain, warn experts.
A BMJ investigation, published to coincide with the report, also raises serious concerns about access to drug data, the use of ghost writers in drug trials, and the drug approval process.
A new report by the Cochrane Collaboration says Roche's refusal to provide full access to all its data leaves critical questions about how well the drug works unresolved.
...Tamiflu has become the mainstay of influenza treatment in the UK. It has also made it onto the World Health Organisation's list of Essential Medicines and Roche's claims continue to be supported by influential health agencies.
The Cochrane researchers set out to test Roche's claim that Tamiflu prevented complications and reduced the number of people needing hospital treatment. But their investigation was hampered by Roche's refusal to provide all of its trial data for analysis. The team obtained some clinical study reports from the European Medicines Agency (EMA), but found inconsistencies with published reports and possible under-reporting of side effects.
When previously questioned by the BMJ, Roche also admitted that some of the published papers had been ghost written.
...Meanwhile, the US Food and Drug Administration (FDA), which has reviewed the Tamiflu trial programme in perhaps more detail than anyone outside of Roche, chose not to review the largest ever trial of Tamiflu when considering the drug for approval. It states that "Tamiflu has not been shown to prevent such complications [serious bacterial infections]."
However, the US Centers for Disease Control and Prevention (CDC) continue to cite key published trials of Tamiflu, claiming a reduced risk of influenza complications, even after Roche admitted that some of these trials have been ghost written....
Roche maintain they provided the Cochrane team with enough information to conduct their evaluation, but the Cochrane team say this is not the case. Dr Peter Doshi from Johns Hopkins University School of Medicine says: "In the BMJ in December 2009, Roche promised full study reports to any legitimate investigators. They have not provided a single full study report to Cochrane, despite our repeated requests."