The European Medicines Agency’s request to make all clinical trial data available is key to countering bias in publication, drug prescription practice and health policy.
In mid-April, a powerful group of European drug regulators called for clinical study reports—the raw data from clinical trials—to be made publicly available. Writing in the open-access journal PLoS Medicine (9, e1001202, 2012), the heads of the Dutch, French and UK drug regulators, together with the head of the European Medicines Agency (EMA), make the important positioning statement that clinical trial data should not be considered commercially confidential information. They argue that “most patients enrolling in clinical trials do so with an assumption of contributing to medical knowledge, and ‘non-disclosure of complete trial results undermines the philanthropy’.”
The regulators’ call came, at least in part, in response to another submission to PLoS Medicine (9, e1001201, 2012) from three independent researchers undertaking a Cochrane review—the gold standard reports for guiding clinical practice—of an approved drug, Hoffmann-La Roche’s influenza virus neuraminidase inhibitor, Tamiflu.
Tamiflu was heavily promoted by Roche and then broadly adopted and stockpiled by several European governments, the United States and the World Health Organization as a public health defense against the bird flu epidemic. The rationale was that it would protect influenza-infected patients from severe complications and deaths associated with disease. The rise of Tamiflu thus owes much to the endorsement of this rationale by major and influential government agencies.
The question is whether the claims that the drug can address influenza complications or suppress virus transmission are correct. And it is this question that three independent groups of researchers tried to answer by looking at the trials that Roche undertook on Tamiflu which formed the basis for the drug’s US Food and Drug Administration (FDA)’s approval in 1999, the implications of which had not been made clear in any of the many journal articles that Roche and its collaborators had published. Importantly, when it approved Tamiflu, the agency did not allow Roche to claim either effectiveness in dampening influenza complication or in blocking transmission.