Tamiflu

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Tamiflu (generic name: Oseltamivir or Oseltamivir Phosphate) is a drug designed to block the influenza virus from spreading between cells in the body. It is an antiviral which is used in the treatment and prevention of influenza A and influenza B viruses and should be taken within 48 hours of experiencing flu-like symptoms to be effective.[1]

The drug was invented by Gilead Sciences and licensed to Roche in 1996. The two companies ended an ongoing dispute over the Development and License Agreement for Tamiflu in 2005 due to the 'threat of an influenza pandemic in particular related to the growing incidence of avian influenza' and the need 'to address public health needs'. [2]

Sales in Tamiflu rose by 38 per cent in for the first quarter of 2009 following the outbreak of Swine Flu to £227 million. [3] Previously, drug sales had peaked in 2006 due to the outbreak of avian flu. Tamiflu sales reached £1.5 billion, making the drug the fourth top-selling pharmaceutical product for Roche that year.[4]

Rumsfeld's role

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.[5]

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.[6]

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 FDA 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.”[7]

These possible side-effects of Tamiflu, according to a report in The Guardian, "first came to light in came to light in 2005, when 12 children died and 32 exhibited abnormal behaviour, including running on to the road and falling from buildings."[8]

In early 2007, said The Guardian article, four children were reported jumping or falling to their death after taking the drug.[9]

Since the outbreak of Swine Flu in 2009, the FDA has allowed Tamiflu to be used to treat children under one.[10] 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.’[11]

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. [12]
  • 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. [13]
  • Roche halved the price of Tamiflu for the world's developing countries following the swine flu pandemic. [14]

Side-effects

Common side-effects of Tamiflu listed at the internet resource Drugs.com are:

Diarrhea; nausea; stomach pain; vomiting

Severe side-effects are listed as:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal behavior; confusion; hallucinations; mood or mental changes; reddened, blistered, peeling, or swollen skin; seizures; severe or persistent nausea, vomiting, or diarrhea; symptoms of infection (eg, fever, chills, persistent sore throat).

Also mentioned among the severe side-effects is "Abnormal behavior and delirium leading to injury, with fatal outcomes in some cases".[15]

Patient feedback on the Askapatient.com database gives positive and negative experiences of the drug, including some reports of serious autoimmune and neurological side-effects. The overall patient satisfaction rating as at 15 July 2009 was 2.4, between "2-Not Satisfied: this medicine did not work to my satisfaction" and "3-Somewhat Satisfied: this medicine helped somewhat" (best rating would be 5, worst 1).[16]

"Swine flu clears old stock of Tamiflu" allegation

In April 2009 the website What Doctors Don't Tell You (WDDTY) reported that swine flu had arrived at a convenient time to enable governments to clear old stockpiles of Tamiflu left over from the avian flu epidemic:

It is almost three years since we faced the hysteria of an avian flu epidemic, when governments bought billions of dollars of Tamiflu – the same anti-viral now being promoted to combat a supposed swine flu pandemic. The shelf life of Tamiflu also happens to be three years. The World Health Organization has, at the time of writing, increased its threat level to five, which means governments can activate their pandemic plans – and start handing out Tamiflu drugs. This is extremely convenient for governments that would have very soon have to dispose of billions of dollars of Tamiflu stock, which they bought to counter avian flu, or H5N1. The US government ordered 20 million doses, costing $2bn, in October, 2005, and around that time the UK government ordered 14.6 million doses. Tamiflu’s manufacturer, Roche, has confirmed that the shelf life of its anti-viral is three years.[17]

Notes

  1. ↑ Tamiflu. Tamiflu for flu treatment Accessed 15 July 2009.
  2. ↑ Gilead Sciences. Gilead and Roche End Tamiflu® Dispute; Expanded Collaboration Includes Gilead Role in Oversight of Manufacturing and Commercialization Accessed on 14 July 2009.
  3. ↑ Ferguson, J. Pandemic Profits Gulf News Accessed on 14 July 2009.
  4. ↑ Ferguson, J. Pandemic Profits Gulf News Accessed on 14 July 2009.
  5. ↑ Schwartz, N.D.Rumsfeld's growing stake in Tamiflu CNN 31 October 2005. Accessed on 10 May.
  6. ↑ WHO.WHO:Swine Flu Accessed 10 May 2009.
  7. ↑ FDA. Tamiflu Patient Information Accessed on 10 May 2009.
  8. ↑ Justin McCurry and Sarah Boseley, Tamiflu warning in Japan after child suicides and injuries, The Guardian, 22 March 2007, accessed 13 July 2009
  9. ↑ Justin McCurry and Sarah Boseley, Tamiflu warning in Japan after child suicides and injuries, The Guardian, 22 March 2007, accessed 13 July 2009
  10. ↑ FDA. FDA Authorizes Emergency Use of Influenza Medicines, Diagnostic Test in Response to Swine Flu Outbreak in Humans, 27 April 2009, Accessed on 10 May 2009.
  11. ↑ EMEA.Updated review of of influenza antiviral medicinal products for the potential use during pandemic during the CHMP of the EMEA, 13 December 2007, Accessed on 10 May 2009.
  12. ↑ Jack, A. Roche looks at extensions to Tamiflu. Accessed on 12 July 2009.
  13. ↑ Jack, A. Roche looks at extensions to Tamiflu. Accessed on 12 July 2009.
  14. ↑ Jack, A. Tamiflu price cut for poorest countries. Accessed on 12 July 2009.
  15. ↑ Side Effects of Tamiflu - for the consumer, Drugs.com, accessed 14 July 2009
  16. ↑ Tamiflu, Askapatient.com, accessed 14 July 2009
  17. ↑ Swine flu alert clears old stock of Tamiflu (subscription req'd to see full article), 30 April 2009, WDDTY website, accessed 15 July 2009
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