Scientific Tools for War on Fake Drugs

by Thomas Fuller, New York Times:

"Let's use some Atlanta drug money," said Facundo M. Fernández, a chemistry professor, as he picked out a limp, ratty dollar bill from his wallet and handed it to one of his graduate students.

Minutes later, after running the bill through the laboratory's high-tech machinery, the chemists had found what they were looking for: traces of cocaine.

Dr. Fernández, a professor at the Georgia Institute of Technology, said that the demonstration, which he repeated with other bills provided by a reporter, showed both how pervasive cocaine was in the United States and how sensitive his machines were.

They can instantly identify the chemical makeup of food, drugs and just about anything placed in front of their stainless-steel aperture. The uses of the machines, known as mass spectrometers, are manifold - the federal Department of Homeland Security has commissioned Dr. Fernández to study whether the technology can help sniff for explosives at airports.

But Dr. Fernández's main focus is counterfeit pharmaceutical drugs, especially in poorer countries, where government regulation is weak. He is part of an informal group of researchers and government officials spanning Africa, Asia and the United States who have teamed up with Interpol, the international police agency, to use cutting-edge technology in tracking fake drugs that claim to treat malaria. Counterfeit malaria drugs are of particular concern because of the scale and severity of the disease - it kills more than 2,000 children a day in Africa alone - and fears that fake or substandard malaria drugs are aggravating a growing problem of drug resistance.

For years, scientists have been able to analyze the ingredients of a pill or capsule using mass spectrometers, which identify chemicals by measuring molecular weights. But the overall process was time-consuming, taking about an hour per sample.

A scientific breakthrough in 2005 added an "ion gun" to the machines and allowed Dr. Fernández to check hundreds of pills a day. A technician simply holds the sample - a pill, dog food or a dollar bill, for example - up to the machine, which emits a jet of helium gas and captures a minute amount of the material, instantly identifying its component parts.

Contrary to the common belief that counterfeit drugs are just sugar pills, Dr. Fernández said, most fakes have some level of active ingredient. Many contain the cheap and readily available pain reliever paracetamol, which might temporarily soothe some symptoms but will not fight the underlying disease.

Sometimes researchers find harmful or very unexpected chemicals. Once, when analyzing what was suspected to be a counterfeit antimalarial pill, his team discovered traces of sildenafil, the main ingredient in the anti-impotency drug Viagra.

"We feel like detectives," said Dr. Fernández, who is from Argentina. "You never know what you're going to find."

The counterfeit drug business has become increasingly attractive for criminal syndicates; the profit potential is vast, yet the punishment for those caught is typically much less severe than for illegal drugs like cocaine, law enforcement officials say.

This is especially true in Asia, where many countries impose the death penalty for trafficking heroin, Ecstasy or even marijuana but where combating counterfeit drugs is not a priority.

Three years ago, the World Health Organization estimated that as many as one in four pharmaceutical drugs sold in the developing world were counterfeit. It is impossible to know the exact level, but there is general agreement that the level of fake drugs is "unacceptably high," in the words of the organization.

"We have discovered that no class of drugs had been spared," said Aline Plançon, the head of Interpol's counterfeit drug department. "It's not just primary medicines. There's also lifestyle drugs, herbal drugs, vaccines."

Counterfeiters have become more sophisticated in recent years, churning out pills and packaging that look like the real thing.

But as the work of Dr. Fernández and others indicates, the sleuthing, too, is becoming more high-tech, relying on innovative forensic tools.

Dallas C. Mildenhall, another scientist in the anti-counterfeit network, helps track fake drugs by analyzing the microscopic pollen grains embedded in the pills or packaging. Forensic investigators have used pollen grains for decades to help solve murders and other crimes, but Dr. Mildenhall pioneered using the tiny grains, which are ubiquitous in clothing, nostrils, hair, food and nearly everything exposed to air, to help combat counterfeiters.

Because many plants are specific to certain parts of the world, pollen helps determine where the drugs were manufactured. "Pollen markers give you an idea of the environment," Dr. Mildenhall said by telephone from his office in New Zealand, where he is a researcher at GNS Science, a government organization. "Is it wet, dry, hot, cold? Are the soils acidic or not?"

Dr. Mildenhall's work has helped establish that many counterfeits come from the border area between China and Vietnam as well as the general vicinity of the Golden Triangle, the area famous for heroin production where the borders of Laos, Myanmar and Thailand meet.

Three years ago, an analysis by Dr. Mildenhall of both pollen grains and specific minerals found in counterfeits helped pinpoint production to one particular site in southern China. In what was dubbed Operation Jupiter, Interpol handed over the evidence, and the Chinese government arrested three suspects.

Dr. Mildenhall is now involved in a project led by Paul N. Newton, the head of the Oxford University Center for Tropical Medicine in Laos, to determine whether counterfeit antimalarial drugs found in Africa were imported from Asia or manufactured locally."In Africa, it's often said that fake drugs are coming from India and China," Dr. Newton said from his office in Vientiane, the capital of Laos. "We don't have any evidence ourselves at the moment to confirm or deny that."

The results of the study will be out later this year, said Dr. Newton, who has led the research on counterfeit antimalarial drugs.

Using technology to combat counterfeit drugs has been a "necessary complement" to old-fashioned police work, said Ms. Plançon of Interpol. But she said the main obstacle to cracking down on fakes was a lack of political will and cooperation between countries.

"Politicians need to understand that this problem is much more serious than they think," she said in a phone interview from her office in Geneva. "The more we work on these criminal networks, the more we see that they're interconnected across continents."

Ms. Plançon said that the police were discovering vast quantities of counterfeit drugs in Asia. Last year, in a coordinated police crackdown called Operation Storm, Interpol announced that 200 raids in Southeast Asia had yielded 16 million doses of fake drugs, with a street value of $6.6 million.

Officials from Cambodia, China, Laos, Myanmar, Singapore, Thailand and Vietnam participated in the operation, which resulted in 27 arrests.

Sabine Kopp, the acting head of anti-counterfeiting activities at the World Health Organization, said that Interpol's role had helped pressure governments into action. "There's a lot more discussion," Dr. Kopp said. "There's a lot more agreement to share information."

But there are also signs that the problem is spreading. Mrs. Plançon said the police were discovering not only counterfeit drugs but fake medical supplies like blood bags, syringes, bandages and contact lenses.

Mass spectrometers may have a role in weeding out some of these counterfeits. Dr. Fernández, of Georgia Tech, is using them to test whether mosquito nets treated with insecticide, a crucial way to combat malaria, are genuine.

One major limitation of using the technology is cost. A typical mass spectrometer goes for about $150,000, a budget-breaker for governments of poorer countries.

With time, though, Dr. Fernández hopes, costs will come down far enough that machines could be installed in local pharmacies.

"I always dream that at some point the end-consumer will be able to check," Dr. Fernández said. "You put your tablet in front of a machine and you get a red light or a green light. That would be the end of counterfeit drugs."

http://www.nytimes.com/2009/07/21/science/21coun.html?ref=science