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Making Drugs that Kill

INTERNATIONAL criminal organizations are undermining a public-health campaign that was making promising inroads against a disease that kills more than one million people every year.

Researchers have found that 25 percent of antimalaria drugs given to patients in six African countries contain active ingredients prepared in violation of World Health Organization (WHO) rules intended to combat drug resistance. “The high persistence of substandard drugs and clinically inappropriate therapies risks patient safety and, through drug resistance, places the future of malaria treatment at risk globally,” says the report, published by the online scientific journal of the Public Library of Science.

The global trade in fake pharmaceuticals is worth an estimated $30 billion to $35 billion annually and is growing by more than 10 percent a year.

While illegal malaria drugs account for only about one percent of this market, they risk making the disease even harder to treat. If resistance takes hold, it could cost billions of dollars to develop replacement drugs.

Chloroquine kept malaria under control for decades, but the disease surged in sub-Saharan Africa in the 1990s, due in part to increased drug resistance that was probably exacerbated by substandard antimalarial drugs.

Artemisinin, a natural ingredient used in traditional Chinese medicines, has become the cornerstone of malaria treatment. It was adopted in the 1990s after scientists found it was effective against chloroquine-resistant malaria strains. In 2006, WHO recommended the use of artemisinin in combination with other antimalarials to delay the emergence of resistant strains.

“Mixed doses require more skill, and they are more expensive to make” than drugs produced to standard, says Roger Bate, a fellow at the American Enterprise Institute in Washington D.C., who led the research.

Providers use cheaper counterfeits instead of the legitimate combination antimalarial therapies, known as ACT, because it improves their bottom line, says David Sullivan, a malaria researcher at the Johns Hopkins Bloomberg School of Public Health.

Treatment using genuine drugs takes two to three days and requires a course of 24 ACT pills at $1.50 each. A single chloroquine pill costs about a dime.

Bate estimates that the African malaria drug market is worth about $300 million a year. It is mostly supplied by private networks, which are easily infiltrated by unscrupulous providers.

Counterfeiters tend to operate in India and China, because producers of substandard drugs in those countries, especially those made for markets in developing countries, rarely attract the attention of domestic law-enforcement agencies. Instead, police concentrate enforcement efforts on more high-profile products, such as narcotics or fake consumer goods, for example. Consequently, manufacturers can pay officials lower bribes.

A typical manufacturer of this type of antimalarial product is based in rural China. The company pays off the military and the local politicians so that the counterfeit drug can be produced in bulk there. After that, it is “exported to India, where it is formulated into pills and sold to other parts of the world,” says Bate.

“The bigger picture,” he notes, “is that unless there’s a significant effort by the international community, it will be impossible to win” the battle against malaria.