Tamiflu
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This article is part of the Pharma_Portal project of Spinwatch. |
Contents
Treating Swine Flu with Tamiflu
Health regulators have relaxed rules for the distribution of drugs treating Swine Flu. While specialists rush to develop a vaccine for the new version of the H1N1 strain of the virus, pharmaceutical companies are cashing in on the antiviral drugs already on the market to treat it – with a little help from agencies responsible for protecting human health.
According to the World Health Organisation (WHO), Tamiflu and Relenza should be used for in the treatment of Swine Flu.[1]
The U.S. Food and Drug Administration (FDA), America’s drug regulator which is meant to assure the safety, efficacy and security of drugs, has issued Emergency Use Authorisations which allows the use of medicines that haven't been approved yet. The agency originally approved the use of Tamiflu for the prevention and treatment of flu in adults and children aged one and older. In 2006, it added a warning to its label based on several reports of delirium and suicide mostly in children under 17: “People with the flu, particularly children, may be at an increased risk of self-injury and confusion shortly after taking Tamiflu and should be closely monitored for signs of unusual behavior.”[2] Three ‘normal’ children were reported jumping or falling to their death after taking the drug.
Since the outbreak of Swine Flu in 2009, the FDA has allowed Tamiflu to be used to treat children under one.[3] They can also be given doses higher than initially approved.
The European Medicines Agency (EMEA) lists similar drug side effects and adds: ‘The appropriate use of Tamiflu for prevention of influenza should be determined on a case by case basis by the circumstances and the population requiring protection. In exceptional situations – such as a pandemic situation - seasonal prevention could be considered in individuals one year of age or older.’[4]
Extended Clinical Trials and Developments
- In July 2009, Roche announced it was to start clinical trials to see if Tamiflu was more effective when taken in higher doses over a longer period of time - up to twice the length of the recommended five day period. [5]
- The drug's shelf life was extended from five to seven years after the outbreak of the swine flu pandemic so stockpiles could be used. [6]
- Roche halved the price of Tamiflu for the world's developing countries following the swine flu pandemic. [7]
Background
Tamiflu was invented by Gilead Sciences and licensed to Roche in 1996. Donald Rumsfeld was Gilead’s chairman from 1997 until joining the Bush administration in 2001. In 2005, Mr Rumsfeld disclosed that he held a stake in Gilead valued at between $5 million and $25 million. In the same year, the Pentagon placed an order of $58 million for Tamiflu so they could treat US troops in the event of an outbreak of Bird Flu.[8]
Notes
- ↑ WHO.WHO:Swine Flu Accessed 10 May 2009.
- ↑ FDA. Tamiflu Patient Information Accessed on 10 May 2009.
- ↑ FDA. FDA Authorizes Emergency Use of Influenza Medicines, Diagnostic Test in Response to Swine Flu Outbreak in Humans Accessed on 10 May 2009.
- ↑ EMEA.Updated review of of influenza antiviral medicinal products for the potential use during pandemic during the CHMP of the EMEA. Accessed on 10 May 2009.
- ↑ Jack, A. Roche looks at extensions to Tamiflu. Accessed on 12 July 2009.
- ↑ Jack, A. Roche looks at extensions to Tamiflu. Accessed on 12 July 2009.
- ↑ Jack, A. Tamiflu price cut for poorest countries. Accessed on 12 July 2009.
- ↑ Schwartz, N.D.Rumsfeld's growing stake in Tamiflu CNN 31 October 2005. Accessed on 10 May.
