This week sees the publication of the updated Cochrane systematic review on the neuraminidase inhibitors oseltamivir and zanamivir.1
Through their exhaustive scrutiny of the data contained in clinical study reports (the lengthy documents held by the drug’s manufacturer Roche and previously seen only in part by drug regulators), the Cochrane authors have set exacting new standards for systematic reviewers and decision makers. Their fight for the data has also shown us, in more detail than ever, that the entire ecosystem of drug evaluation and regulation is deeply flawed.
As summarised in the accompanying editorial by Harlan Krumholz,13 the complete evidence from the CSRs paints a much less positive picture of oseltamivir than was presented to regulators, policy makers, clinicians, and the public. Important benefits have been overestimated and harms under-reported. In particular, the review found no compelling evidence to support claims that oseltamivir reduces the risk of complications of influenza, such as pneumonia and hospital admission, claims that were used to justify international stockpiling of the drug.
The review’s conclusion should lead to serious soul searching among policy makers. So too should the story behind the review, illustrating as it does the entrenched flaws in the current system.14 Why did no one else demand this level of scrutiny before spending such huge sums of money on one drug? And why do we have a system of drug evaluation and regulation that is incapable of providing patients, clinicians, and policy makers with timely, reliable, and independent information. Indeed, the current system seems to be designed with the opposite end in mind.
VAN UK’s Comment: Can we expect the same degree of scrutiny over vaccines in the future? I’m guessing they will be exempt from this type of checking.
Source: BMJ 2014; 348 doi: http://dx.doi.org/10.1136/bmj.g2630 (Published 10 April 2014)