Tamiflu

This article is part of the Pharma_Portal project of Spinwatch.

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.

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'.

Sales in Tamiflu rose by 38 per cent in for the first quarter of 2009 following the outbreak of Swine Flu to £227 million. 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.

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.

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.

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.”

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."

In early 2007, said The Guardian article, four 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. 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.’

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.

• 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.

• Roche halved the price of Tamiflu for the world's developing countries following the swine flu pandemic.

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".

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).

"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.

WHO's lack of Transparency

In March 2010, WHO was accused of overstating the dangers of the flu pandemic in a draft report to the Council of Europe commissioned by its parliamentary assembly:

"In the United Kingdom, the Department of Health initially announced that around 65,000 deaths were to be expected. In the meantime, by the start of 2010, this estimate was downgraded to only 1,000 fatalities. By January 2010, fewer than 5,000 persons had been registered as having caught the disease and about 360 deaths had been noted."

It was noted that some advisory groups members are flu experts who've received funding from pharmaceutical companies manufacturing drugs and vaccines against flu:

"The neutrality of their advice could be contested...To date, WHO has failed to provide convincing evidence to counter these allegations and the organisation has not published the relevant declarations of interest. Taking such a reserved position, the organisation has joined other bodies, such as the European Medicines Agency EMEA, which likewise, have still not published such documents."