The Imperative to Share Clinical Study Reports: Recommendations from the Tamiflu Experience
by Peter Doshi, Tom Jefferson, and Chris Del Mar
April 10, 2012
[full text on-line]
Systematic reviews of published randomized clinical trials (RCTs) are considered the gold standard source of synthesized evidence for interventions, but their conclusions are vulnerable to distortion when trial sponsors have strong interests that might benefit from suppressing or promoting selected data.
More reliable evidence synthesis would result from systematic reviewing of clinical study reports—standardized documents representing the most complete record of the planning, execution, and results of clinical trials, which are submitted by industry to government drug regulators.
Unfortunately, industry and regulators have historically treated clinical study reports as confidential documents, impeding additional scrutiny by independent researchers.
We propose clinical study reports become available to such scrutiny, and describe one manufacturer’s unconvincing reasons for refusing to provide us access to full clinical study reports. We challenge industry to either provide open access to clinical study reports or publically defend their current position of RCT data secrecy.
Re: Open letter to Roche about oseltamivir trial data
British Medical Journal
by Peter C Gøtzsche:
Nordic Cochrane Centre, Rigshospitalet
8 November 2012
At an open seminar arranged by Health Action International (Europe) on 12 October about access to medical research data, I asked why European governments had not sued Roche to get the money back they had spent on needlessly stockpiling Tamiflu. Roche has withheld data that purports to show that Tamiflu has dramatic effects. We all wonder why it is so difficult to get these data from Roche and why Roche has not published them, if it is really true that they show these effects.
None of those present at the seminar could explain why our governments have not sued Roche but another speaker told me in private that the likely reason is that they don’t want to lose face. Well, it’s better to lose face than lose billions of taxpayers’ money I think. As far as I can work out, Tamiflu is likely not any better than paracetamol. The FDA required Roche to print a disclaimer on the lables: "Tamiflu has not been proven to have a positive impact on the potential consequences (such as hospitalizations, mortality, or economic impact) of seasonal, avian, or pandemic influenza". When the FDA first reviewed a similar drug, zanamivir (Relenza) from GlaxoSmithKline, the advisory committee recommended that the drug should not be approved. Zanamivir was no better than placebo when the patients were taking other drugs such as paracetamol. However, FDA overruled the committee, probably for political reasons. When that was done, FDA also had to approve oseltamivir later the same year.European governments should sue Roche, which might also have the effect that the hidden trial results come out in the open. Furthermore, I suggest we boycott Roche’s products until they publish the missing Tamiflu data.