WHO spokesman Gregory Hartl said the agency recommended the drug be used to treat unusual influenza viruses like bird flu. "We do have substantive evidence it can stop or hinder progression to severe disease like pneumonia," he said.
In 2009, the BMJ and researchers at the Nordic Cochrane Centre asked Roche to make all its Tamiflu data available. At the time, Cochrane Centre scientists were commissioned by Britain to evaluate flu drugs. They found no proof that Tamiflu reduced the number of complications in people with influenza.
"Despite a public promise to release [internal company reports] for each [Tamiflu] trial... Roche has stonewalled," BMJ editor Fiona Godlee wrote in an editorial last month.
In a statement, Roche said it had complied with all legal requirements on publishing data and provided Gotzsche and his colleagues with 3,200 pages of information to answer their questions.
"Roche has made full clinical study data... available to national health authorities according to their various requirements, so they can conduct their own analyses," the company said.
Roche says it doesn't usually release patient-level data available due to legal or confidentiality constraints. It said it did not provide the requested data to the scientists because they refused to sign a confidentiality agreement.
Roche is also being investigated by the European Medicines Agency for not properly reporting side effects, including possible deaths, for 19 drugs including Tamiflu that were used in about 80,000 patients in the US.