http://www.nytimes.com/2012/04/11/op...cret.html?_r=0

New York Times

Drug Data Shouldn’t Be Secret April 10, 2012
By PETER DOSHI and TOM JEFFERSON

IN the fall of 2009, at the height of fears over swine flu, our research group discovered that a majority of clinical trial data for the anti-influenza drug Tamiflu — data that proved, according to its manufacturer, that the drug reduced the risk of hospitalization, serious complications and transmission — were missing, unpublished and inaccessible to the research community. From what we could tell from the limited clinical data that had been published in medical journals, the country’s most widely used and heavily stockpiled influenza drug appeared no more effective than aspirin…

After we published this finding in the British Medical Journal at the end of that year, Tamiflu’s manufacturer, Roche, announced that it would release internal reports to back up its claims that the drug was effective in reducing the complications of influenza. Roche promised access to data from 10 clinical trials, 8 of which had not been published a decade after completion, representing more than 4,000 patients from every continent except Antarctica…

….In the case of Tamiflu, some of these assumed properties led to stockpiling at great taxpayer expense — more than $1.5 billion. ..

…. the data point to a drug of minimal benefit. In accordance with the F.D.A.’s findings, it appears to shave a day off the duration of influenza symptoms, but we found no decrease in risk of hospitalization and no evidence that it could stop the spread of the virus. More worrisome, we found suggestive evidence that Tamiflu interfered with the body’s ability to produce antibodies against influenza — which could affect the body’s response to influenza vaccine and its ability to fight off future influenza infections. But to do a complete analysis, including evaluating Tamiflu’s potential harms, we need the remainder of the data — the full “clinical study report” — promised by Roche, but never delivered..

We should not have to wait for patients to be hurt by the medications they take, as recently happened with the diabetes drug Avandia…

(Peter Doshi is a postdoctoral fellow in comparative effectiveness research at Johns Hopkins University School of Medicine. Tom Jefferson is an independent epidemiologist with the Cochrane Collaboration, an international nonprofit research organization.)