Politics & Policy

Drug Resistance Is Deadly

Pharmaceutical knock-offs may threaten our ability to treat malaria.

Thai government officials, led by commerce permanent secretary Siriphol Yodmuangcharoen, will meet with their Washington counterparts on June 10, hoping to persuade the U.S. Trade Representative to remove Thailand from its “Priority Watch List.” Thailand is one of nine countries listed, earning its place because of intellectual property-rights violations by the previous Bangkok government — which broke patents on AIDS and heart drugs, undermining its trade relationship with the U.S., and harming foreign investment. While the U.S. will continue to demand stronger support for patents before removing Thailand from the Watch List, the discussions this week are not just about trade: Bootleg pharmaceuticals in Southeast Asia constitute a health emergency — proliferating poor drug quality and inducing widespread drug resistance around the globe.

Thailand has made some progress recently. In the past few weeks, the entire board of the Thai national drug company, the Government Pharmaceutical Organization (GPO), was fired and replaced. The old GPO board had promoted patent breaking and produced poor quality HIV drugs, accelerating resistance to that class of drugs. GPO’s products were so bad that donor agencies, even some that are sympathetic with patent-breaking in developing countries, stopped procuring them a few years ago. Around the beginning of the year, GPO started revamping its production entirely, and hopefully quality will be much improved. And it needs to be: substandard drugs are a matter of life and death.

While Thailand has a problem with resistance to HIV drugs, countries far poorer than Thailand are facing drug resistance problems for other infectious diseases. This has fatal consequences, for resistant strains can no longer be cured by previously effective drugs.

Malaria has always been a problem in the region, with hundreds of thousands of cases and thousands of deaths annually. In 2005, there were over 100,000 cases and over 300 deaths in Cambodia and Thailand combined. But that is a great improvement on the 1990s; fatality rates have fallen recently thanks to the development of new drugs containing the compound artemisinin.

For all the principal anti-malarial pharmaceuticals developed over the past 30 years, drug resistance always seems to develop along Thailand’s borders with Cambodia and Myanmar. Those border regions were the first to note significant resistance to the last best drug, mefloquine: Between 1984 and 1989 the efficacy of the best combination treatment — of mefloquine and sulfadoxine pyrimethamine — plummeted from 97 percent to 54 percent along those Thai borders. People carrying drug-resistant parasites then traveled from the region to Africa and elsewhere, helping the resistance to spread.

From at least 2006, the latest best drug, artemisinin, is beginning to suffer the same drug-resistant fate. In the city of Pailin in Western Cambodia, close to the Thai border, failures of mefloquine/artemisinin combination therapies are now over 12 percent, and close to 10 percent elsewhere along the Thai border. Resistance has also been noticed at lower levels in China and Vietnam. Soon enough, these artemisinin treatments will become as compromised as earlier combinations are today. Experts meeting in Phnom Penh in January 2007 gave the newest combination only two years before a change would be required.

While it is possible that the people in this region were just unlucky in being the first to suffer from drug-resistant strains of malaria, an increasingly likely explanation is that the malarial parasite is being encouraged to develop resistance by the widespread prevalence of poor quality drugs.

The Mekong Delta is awash in counterfeit drugs. It is as easy to buy a fake anti-malarial at the numerous kiosks along the riverbank as it is to buy a Coca-Cola. One survey in Cambodia found that 90 percent of the malaria drugs on sale were substandard and larger assessments of the region average out at about one third. And while many of these fakes contain no active ingredients (and so cannot contribute to drug resistance), several academic studies show that many contain just enough artemisinin to build resistance, but do not contain enough (in the correct proportions) to cure the patient. Furthermore, the region receives a lot of poorly produced, if not counterfeit, drugs from China, Vietnam, and India. And Thailand’s own GPO has made many substandard drugs, as well.

There are no new drugs to replace artemisinin. All the drugs under mid- and late-stage development are combinations using artemisinin alongside another drug. In other words, for the next decade at least, artemisinin is the last defense against malaria. But thanks to counterfeit and other poor-quality pharmaceuticals, that defense that is cracking. If the resistance reaches Africa, tens of thousands more children will die every year as a result.

This failure is ultimately the responsibility of governments in the Mekong region, and of countries that allow a substantial trade in substandard drugs (notably China and India).

The June 10 meeting between the U.S. Trade Representative and the Thai commerce secretary will discuss intellectual property, patent battles, and foreign investment. It will also be the start of a crucial conversation on the problem of substandard drugs that plagues the region. Hopefully, Thailand will accept a leadership role in fighting the problem: poor communities throughout the region — and the world — are depending on them.

– Roger Bate is the author of Making a Killing: The Deadly Consequences of the Counterfeit Drug Trade.

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