BY John Toon
Georgia Tech researchers were part of a three-continent, multi-organizational effort known as "Operation Jupiter" that identified and shut down manufacturers who were flooding Southeast Asia with counterfeit — and ineffective — antimalarial drugs.
With 11 different organizations, including the Centers for Disease Control and Prevention, World Health Organization, Wellcome Trust and ultimately the international law enforcement agency INTERPOL, the global effort provided Chinese officials with enough information to shut down the drugmakers.
As their part of the investigation, Georgia Tech researchers used sensitive mass spectrometry techniques to analyze nearly 400 drug samples provided by public health authorities and developed methods to speed up analysis, including an ionization process that reduced the time required to test a drug sample from half an hour to just a few seconds.
Activities aimed at addressing the widespread problem of counterfeit antimalarial drugs were reported in February in the journal PLoS Medicine.
Malaria kills more than a million people each year worldwide and is a risk for about 40 percent of the world's population. Most victims would survive — if they had access to the proper drugs.
"About 50 percent of the samples obtained from the field in Southeast Asia were fakes," said Facundo Fernandez, an analytical chemist and assistant professor in the School of Chemistry and Biochemistry. "They look very real, even down to the hologram in the packaging. It's very difficult to tell which ones are the fakes and which ones are real."
When Fernandez began analysis of the drug samples, he assumed that they would not include any real active ingredients. But graduate students Christina Hampton and Leonard Nyadong soon discovered that the counterfeiters were making their fake antimalarials with a broad range of mostly expired pharmaceuticals.
"We found all sorts of drugs that basically have no effect on resistant malaria parasites. Acetaminophen was one of the most common chemicals we found," Fernandez said.
Fernandez speculated that the makers chose certain compounds, like acetaminophen, because they could temporarily make patients feel better by lowering the fever associated with malaria.
Mass spectrometry provides an effective means of identifying samples by determining their accurate molecular weight. But the conventional analysis can be time-consuming — especially in the preparation of samples.
Fernandez and his group developed a faster method that allows them to analyze hundreds of samples in a single day.
"These are methods that let you analyze a solid sample without any significant preparation," he said. "You can take a tablet, put it in front of the instrument with an ionization source and you get a quick snapshot of what's in the sample. It provides a very high throughput pipeline to identify samples quickly."
Fernandez hopes to help develop high-accuracy instrumental tests that could be used in the field to save the time and expense of shipping suspected fakes to labs.
Beyond the mass spectrometry, the effort also relied on analysis of pollen found in the drugs — a discipline known as forensic palynology — that was done by scientists in New Zealand who were part of Operation Jupiter. A study of calcium carbonate isotopes in the compounds, together with the pollen and active ingredients in the samples, pointed to two main groups of samples originating in different geographic regions of Asia.
"This is absolutely 'CSI' — the techniques they use on the television program really do work in real life," Fernandez said.
The Operation Jupiter team provided enough information that Chinese authorities were able to shut down the manufacturers, sophisticated operations able to accurately mimic the packaging and holographic seals of legitimate pharmaceutical companies.
"The problem is not over," Fernandez cautioned. "There are more fakes and more fake producers. But at least this is a beginning. Having an opportunity to do some good in this area is very satisfying."
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