FOR IMMEDIATE RELEASE聽|聽April 07, 2008
Faster test reported for detecting fake Tamiflu in fight against counterfeit drugs
NEW ORLEANS, April 7, 2008 鈥� Chemists in Georgia are reporting development of a fast new method to detect fake Tamiflu, the mainstay medication for preventing and treating bird flu. Tamiflu has become a target for counterfeiters as recent outbreaks of bird flu have increased public demand for supplies of just-in-case antiviral drugs to use in case of an epidemic of the deadly disease.
In a report scheduled for presentation here today at the 235th national meeting of the American Chemical 中国365bet中文官网, Facundo M. Fernandez, Ph.D., and colleagues describe use of a method called Desorption Electrospray Ionization Mass Spectrometry (DESI-MS) that can determine authenticity of large batches of Tamiflu samples up to 20 times faster than conventional methods.
鈥淚t鈥檚 a one-step process that doesn鈥檛 require any extensive sample preparation,鈥� said Fernandez, of the Georgia Institute of Technology. Using DESI-MS, analysis of the Tamiflu powder yields results in less than one minute. The 鈥済old standard鈥� for gauging pharmaceutical quality control is a powerful but much slower method called high performance liquid chromatography (HPLC), he said. Analysis by HPLC could take up to an hour.
The researchers describe their study as the first successful demonstration of DESI-MS鈥檚 use for Tamiflu screening. 鈥淭his method is really targeted at screening large amounts of products鈥� that might be expected during a pandemic of influenza, Fernandez said. 鈥淚n case of a crisis, you wouldn鈥檛 be able to wait an hour per sample. You鈥檇 want to screen hundreds of samples per day.鈥�
When fears of a pandemic, a global epidemic, of avian influenza first emerged, worried consumers in the United States and other countries began to horde Tamiflu in 2005, seeking prescriptions from physicians and purchasing the medication from online pharmacies. In 2007, there were 86 confirmed human cases of bird flu in the world, according to the World Health Organization. The fatality rate was high, with 59 deaths.
Fernandez tested DESI-MS鈥檚 effectiveness by collecting different Tamiflu samples from online pharmacies and found all of them to contain the active ingredient. Customers who purchase from online pharmacies, he warns, should use extra caution when shopping. Although some online pharmacies are certified, he says people usually look for low prices instead. 鈥淲hat you get online can be pretty much anything,鈥� he said. 鈥淚t鈥檚 very easy for the counterfeiter to bypass the system that鈥檚 in place to protect the consumer. And it鈥檚 very easy for the consumer to get medications.鈥� At $6.50 per pill, Tamiflu鈥檚 high cost and demand have made it a preferred target for fakes, Fernandez noted. Counterfeits have already surfaced in Chicago, San Francisco and other areas.
International trade in counterfeits is a lucrative enterprise 鈥� and an increasingly sophisticated one, Fernandez said. According to the International Chamber of Commerce, global trade in counterfeit goods costs the U.S. economy between $200 billion and $250 billion a year in lost sales and is responsible for the loss of more than 750,000 American jobs. 鈥淭he penalties for counterfeiting pharmaceuticals are much lower than for trafficking illegal drugs like cocaine,鈥� Fernandez said. 鈥淢any of the operations focused on making illegal drugs are shifting to counterfeiting drugs because of the low penalties and high profits.鈥�
A few initiatives have surfaced to fight the presence of fakes, including ones by the U. S. Food and Drug Administration and the WHO, among others. Global awareness has increased, Fernandez said, but it鈥檚 not enough. 鈥淲hat鈥檚 the percentage of fake drugs in the marketplace? I don鈥檛 know. I don鈥檛 think anybody can give you a real number. That鈥檚 really a huge problem.鈥�
Fernandez remains optimistic about solving the problem of fake Tamiflu, however. 鈥淚 think it鈥檚 possible to shut down this traffic, but it will require new tools and new approaches,鈥� he said. 鈥淲e need to get very creative because the incentive for making fake drugs is huge. We always feel like we鈥檙e trying to catch up with the counterfeiters. Every time we get a new batch of fakes, they鈥檙e more sophisticated than the previous batch.鈥�
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鈥� John Simpson