Doubts over drugs
May 11, 2009
Countries have to be provided with data on whether the drug Tamiflu is effective in fighting swine flu in humans before millions are spent stockpiling the anti-viral drug, according to Bernd Muehlbauer, the head of the Institute for Pharmacology at the Bremen-Mitte clinic.
"We absolutely do not know whether it helps with swine flu," Muehlbauer said in an interview with German news magazine Der Spiegel. "The efficacy has only been shown in the lab. One should first prove that this medication actually works against this new kind of pathogen before one damages the economy by shelling out millions on Tamiflu."
Muehlbauer said Tamiflu's effectiveness in fighting the normal flu had also been widely overstated, pointing out that on average the anti-viral drug reduced the length of the illness by just one day.
The expert also criticized a recent move by British authorities to administer Tamiflu to an entire school after it was discovered that five students were infected with the H1N1 virus.
"Excessive and irresponsible"
"That is not just excessive but also practically irresponsible," Muehlbauer told the magazine. "For one, such a thing can lead to the development of resistance."
Muehlbauer also criticized emergency plans by the German government to store stocks of Tamiflu to treat 20 percent of the population in case of a pandemic. Germany has so far reported 11 confirmed cases of the virus.
Muelhbauer's views are at odds with the prevailing wisdom on treating the swine flu virus that scientists say is a genetic mixture of swine, bird and human viruses that first emerged in Mexico in late April.
WHO pushes nations to stockpile Tamiflu
Both the World Health Organization and the EU's European Medicines Agency (EMA) have recommended countries to stockpile Tamiflu, known generically as oseltamivir, as confirmed cases of swine flu infections continue to climb around the world.
In its latest global tally, the WHO confirmed 4,379 infections with the new type A strain of H1N1 flu in some 29 countries. The United Nations said at least 49 people had been killed by the virus.
EU recommends extending Tamiflu shelf life
On Friday, European regulators took the rare step of extending the shelf life of a medicine when they ruled that Tamiflu could be used for up to two years beyond its current expiry date.
Once formally approved by the European Commission, the new guidelines from the EMA would apply to all newly manufactured Tamiflu capsules.
Tamiflu, manufactured by Swiss drug giant Roche, and Relenza, produced by GlaxoSmithKline and known generically as zanamivir, are the only approved drugs to which the new H1N1 strain has been found to be susceptible, the agency said.
"Patients who have Tamiflu capsules that have recently expired should not dispose of them because they might be needed during a novel influenza A/HINI pandemic," the London-based EMA said.