Researchers are pushing for pharmaceutical companies to make full data from their clinical trials publicly available, allowing risks and benefits of drugs to be independently analysed. Currently drug research - clinical trial data – is considered commercial confidential information, not a public, social or philanthropic interest. The researchers have documented a number of cases in which access to full trial data would “radically change public knowledge of safety and efficacy” of widely used drugs, including Vioxx and Tamiflu. The researchers point out that there is insufficient evidence that Tamiflu – stockpiled by governments around the globe in 2009, including the Australian Government, to quarantine swine flu – had any preventative effect.
REPORT:Consider the case of the influenza antiviral Tamiflu (oseltamivir). Prior to the global outbreak of H1N1 influenza in 2009, the United States alone had stockpiled nearly US$1.5 billion dollars worth of the antiviral. As the only drug in its class (neuraminidase inhibitors) available in oral form, Tamiflu was heralded as the key pharmacologic intervention for use during the early days of an influenza pandemic when a vaccine was yet to be produced. It would cut hospitalizations and save lives, said the US Department of Health and Human Services. The Advisory Committee on Immunization Practices – ACIP, the group the US Centers for Disease Control and Prevention uses to form national influenza control policy – said it would reduce the chances of developing complications from influenza. So, too, did the Australian Therapeutic Goods Administration and the European Medicines Agency. Read the full article »»»»