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FDA's counterfeit detection device takes global aim at malaria

April 24, 2013|By Melissa Healy

A device that reveals counterfeit drugs in the hands of Food & Drug Administration agents is set to become the newest weapon in the worldwide effort to eradicate malaria, and may soon be used to detect useless look-alikes of drugs that combat cancer, heart disease and viral infections.

FDA Commissioner Margaret Hamburg on Wednesday unveiled an initiative aimed at putting simple handheld versions of the FDA device into the hands of public health field workers in Ghana to help root out counterfeit malaria drugs. In sub-Saharan Africa, 20% of the drugs used to fight malaria are outright counterfeits, and 35% are "substandard"--meaning they are not potent enough to treat a patient's malaria.

See the device in use here.

The U.S. regulatory agency will work with philanthropic groups and with Corning Inc. to oversee the development and manufacture of battery-operated devices that use light waves to distinguish the real McCoy from the pharmaceutical fake. Because fake or diluted malaria drugs are a big business for counterfeiters--and because malaria continues to kill 660,000 people a year and sicken hundred of thousands more--the FDA and its partners have chosen to test its effectiveness first on these drugs.

In Southeast Asia, where malaria remains widespread, roughly 1 in 3 malaria medications is considered counterfeit. Hamburg said that the public-private partnership that has formed around the counterfeit detection gadget will choose one more site in the developing world to study its effectiveness.

The counterfeit detection device, dubbed CD-3 by FDA officials, was developed by the agency's Forensic Chemistry CenterĀ  in Cincinnati. Emitting light waves that are absorbed differently by items with different chemical make-ups, it is designed to allow easy side-by-side comparisons of authentic drugs and pills or tablets that may look like them but contain none of the disease-fighting agent they profess to contain.

One question that early tests will explore is how effectively the device can distinguish between legitimate medications and substandard copycats, said Hamburg.

In malaria, the cost of counterfeiting goes beyond the illness andĀ  the death of hundreds of thousands of people, most of them women and children. While the prevalence of malaria throughout the developing world has been declining, the widespread use of drugs that are useless against the malaria parasite has helped foster resistance to existing drugs, making eradication efforts more difficult.

If the devices are found effective, and can be mass-produced inexpensively, they could put a dent in a profitable worldwide business in counterfeit drugs. In the United States, the FDA has found evidence of counterfeit cancer drugs, antidepressants and erectile dysfunction drugs, as well as weight-loss medications and heart drugs.

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