On December 8, 2009 British Medical Journey published review result due efficacy of oral agent oseltamivir (Tamiflu, Roche Laboratories Inc), The evidence for drug’s efficacy in reducing complications in otherwise healthy individuals with pandemic influenza is now uncertain.

The investigator involved BMJ and Channel 4 news based in London, UK.
Tom Jefferson, MD, from the Acute Respiratory Infections Group, Cochrane Collaboration, Rome, Italy, and colleagues.

The researcher selected 20 randomized, placebo-controlled studies of neuraminidase inhibitors in otherwise healthy adults exposed to naturally occuring influenza to determine duration and incidence of symptoms, incidence of lower respiratory tract infections or their proxies, and adverse events.

Dr Jefferson and colleagues write, Of the trials, only 5 were judged adequate by usual Cochrane collaboration methods. Most of the trials were at risk for bias resulting from poor descriptions of methods, no description of losses to follow-up, and blinding.

From their analysis, the reviewers found that oseltamivir did not reduce influenza-related lower respiratory tract complications (risk ratio, 0.55; 95% confidence interval, 0.22 - 1.35), moreover, they found that oseltamivir induced nausea. That the evidence of rarer adverse events from pharmacovigilance studies was of poor quality, and that adverse events may have been underreported.

Dr. Jefferson and colleagues conclude, Neuraminidase inhibitors have modest effectiveness against the symptoms of influenza in otherwise healthy adults. The drugs are effective postexposure against laboratory confirmed influenza, but this is a small component of influenza-like illness, so for this outcome neuraminidase inhibitors are not effective.

Oseltamivir may be regarded as optional for reducing the symptoms of seasonal influenza, they add.

In related article, Peter Doshi, a doctoral student at Massachusetts Institute of Technology in Cambridge, and a coauthor updated Cochrane review.
They trying to obtain data to verify claims that oseltamivir lower serious complications of influenza since August 2009.

They write, “We failed, but in failing discovered that the public evidence base for this global public health drug is fragmented, inconsistent, and contradictory. We are no longer sure that oseltamivir offers a therapeutic and public health policy advantage over cheap, over the counter drugs such as aspirin.”

Mr. Doshi writes that the review team’s suspicions were aroused after a Japanese pediatrician, Keiji Hayashi, MD, pointed out that their previous review, which had found that oseltamivir was effective in reducing pneumonia and other important complications of influenza, was based on a single peer-reviewed study by Kaiser and colleagues.

It turns out that the Kaiser study, which was a meta-analysis of 10 manufacturer-funded trials, included just 2 studies that were published in peer-reviewed journals. When the Cochrane reviewers tried to verify the data from the 8 unpublished trials, they found inconsistencies in the evidence for oseltamivir’s effectiveness and safety.

Mr. Doshi said the Kaiser paper was dropped from their new analysis. “The previous Cochrane review placed its trust in publications and included Kaiser’s unpublished data, but to do so once again, despite our inability to obtain data sufficient to perform an independent analysis, would have shifted our position from that of trust in publication to that of trust in secrecy.”

He also called into question US Food and Drug Administration’s safety reporting rules. Manufacturers must report adverse events, but only if they occur in the United States.

Mr. Doshi writes, “In the case of oseltamivir, considering that 75% of global consumption has occurred in Japan, this has important implications for our knowledge of its safety.”

Nick Freemantle, PhD, and Melanie Calvert, MD, from the University of Birmingham, United Kingdom, were invited by BMJ to review the observational studies provided to the Cochrane reviewers by Roche. They said that in general, the studies support the conclusion that oseltamivir may reduce the incidence of complications of influenza in otherwise healthy adults, but as such events are rare, treatment with oseltamivir for most people is not likely to be clinically important.

Fiona Godlee, MD, Editor-in-Chief of BMJ, and Mike Clarke, MD, Director of the UK Cochrane Centre, say, “the updated review is important because it calls into question not only the effectiveness of oseltamivir but the whole system by which drugs are evaluated, regulated and promoted.”

In her editorial, Dr. Godlee writes that the claims of the efficacy of oseltamivir, based on an analysis of 10 drug company trials, have formed a key part of decisions to stockpile the drug and made it widely available.

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