Tamiflu cant keep it down11/24/2023 They, however, did not report any adverse effects associated with oseltamivir. They also noted a shortening of the duration of illness. elaborated the benefits of oseltamivir in terms of alleviation of symptoms, decreased viral load and improvement in health and activity. This study was also carried out in otherwise healthy patients. No formalized criteria were used to define secondary complications of influenza, e.g., bronchitis, sinusitis, and functional definitions based on clinical practice, were used.Īnother study, which was momentous in oseltamivir success, was published in The Lancet in the year 2000. In the same article, they accepted few limitations in their study. Authors offered no reasoning behind these promising assumptions. The authors went on to suggest the possibility that early initiation of antiviral drug might decrease the frequency of complications in high risk population and potentially cut down hospitalization rates although the study itself was not designed to address these issues. It also significantly reduced the frequency of secondary complications of influenza. In this RCT conducted on otherwise healthy patients (patients with no comorbidities), the authors concluded that early initiation (within 36 h) of treatment reduced illness duration by 30% and severity by 40%. One such trial that formed a strong argument in favor of oseltamivir was a Randomized Controlled Trial (RCT) published in the year 2000 in The Journal of the American Medical Association. There is a need to consider changes in the process of introduction of a new drug in the public health care system and to bring greater accountability and transparency in the way we practice science.ĭuring the 1990s, Roche sponsored 40 clinical trials on oseltamivir. This fiasco essentially provides us with an opportunity to articulate tangible lessons so as to guard against such scientific transgressions in the future. It is inexplicable that despite the lack of scientifically robust data on efficacy and safety of Oseltamivir, reputed organizations like World Health Organization (WHO), Centers for Disease Control and Prevention (CDC), EMA, US FDA not only recommended the drug in question for treatment and prophylaxis of influenza but its stockpiling as well. A recent Cochrane review and a series of articles in British Medical Journal (BMJ) have revealed the truth behind oseltamivir success story, which incidentally is one of the highest revenue earners for Roche. Serious adverse events were first reported during post-marketing surveillance from Japan, UK, and subsequently from other places although most of the published articles did not report them. 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. Although many reviewers have labeled the Tamiflu saga as a “costly mistake,” the episode leaves us with some important lessons. The recommendations for stockpiling the said drug as given by various international organizations viz WHO have also been put to scrutiny. 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. Serious Adverse Events, especially neuropsychiatric events associated with Tamiflu started getting reported leading to a cascade of questions on clinical utility of this drug. In 20, 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. Majority of them were funded by Roche, which also first marketed and promoted this drug. A number of randomized controlled trials, systematic reviews, and meta-analysis emphasized a favorable efficacy and safety profile. Oseltamivir (Tamiflu), a neuraminidase inhibitor, was approved for seasonal flu by US Food and Drug Administration in 1999.
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