title: The Tamiflu fiasco and lessons learnt.
abstract: Oseltamivir (Tamiflu), a neuraminidase inhibitor, was approved for seasonal flu by US Food and Drug Administration in 1999. A number of randomized controlled trials, systematic reviews, and meta-analysis emphasized a favorable efficacy and safety profile. Majority of them were funded by Roche, which also first marketed and promoted this drug. In 2005 and 2009, the looming fear of pandemic flu led to recommendation by prominent regulatory bodies such as World Health Organization (WHO), Centers for Disease Control and Prevention, European Medicines Agency and others for its use in treatment and prophylaxis of influenza, and it's stockpiling as a measure to tide over the crisis. Serious Adverse Events, especially neuropsychiatric events associated with Tamiflu started getting reported leading to a cascade of questions on clinical utility of this drug. A recent Cochrane review and related articles have questioned the risk-benefit ratio of the drug, besides raising doubts about the regulatory decision of approving it. The recommendations for stockpiling the said drug as given by various international organizations viz WHO have also been put to scrutiny. Although many reviewers have labeled the Tamiflu saga as a "costly mistake," the episode leaves us with some important lessons. This article takes a comprehensive relook on the subject, and we proceed to suggest some ways and means to avoid a similar situation in the future.
authors.affiliation: Department of Pharmacology, AIIMS, Ansari Nagar, New Delhi, India.
authors.forename: Yogendra Kumar
authors.initials: YK
authors.lastname: Gupta
authors.affiliation: Department of Pharmacology, AIIMS, Ansari Nagar, New Delhi, India.
authors.forename: Meenakshi
authors.initials: M
authors.lastname: Meenu
authors.affiliation: Department of Pharmacology, AIIMS, Ansari Nagar, New Delhi, India.
authors.forename: Prafull
authors.initials: P
authors.lastname: Mohan
mesh_terms: D000998:Antiviral Agents / Q000009:adverse effects / Q000191:economics / Q000600:supply & distribution*; D003362:Cost-Benefit Analysis; D017277:Drug Approval; D016527:Drug Costs; D006297:Health Services Accessibility / Q000191:economics / Q000458:organization & administration*; D006801:Humans; D007251:Influenza, Human / Q000191:economics / Q000453:epidemiology / Q000517:prevention & control* / Q000821:virology; D017146:Models, Organizational; D053139:Oseltamivir / Q000009:adverse effects / Q000191:economics / Q000600:supply & distribution*; D058873:Pandemics / Q000191:economics / Q000517:prevention & control*; D011639:Public Opinion; D018570:Risk Assessment; D012307:Risk Factors; D015871:Scientific Misconduct; D062205:Strategic Stockpile / Q000191:economics / Q000458:organization & administration*
chemical_list: D000998:Antiviral Agents; D053139:Oseltamivir
keywords: Cochrane review; H1N1; Tamiflu; flu pandemic; roche; stockpiling
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