by Alexander Gelfand
Growing up in India, a country where drug manufacturing plays a prominent role in the national economy, MPH/MBA student Gaurvika Nayyar had long been fascinated by the pharmaceutical industry. As a recent NIH research fellow, she focused on the emergence of drug-resistant malaria parasites in Southeast Asia. But it wasn’t until she read a paper about counterfeit medicines—a report that included the death of a child—that Nayyar and her NIH mentors put all of those pieces together and began investigating the devastating impact of poor-quality antimalarial drugs in the developing world.
Her Lancet paper reviewing multicountry studies on the packaging and chemical content of antimalarials in Southeast Asia and sub-Saharan Africa found more than one-third of all sampled drugs from both regions failed chemical analysis, and 36 percent of Asian drugs and 20 percent of African drugs were classified as fake.
Poor-quality medicines fall into two principal categories: substandard drugs that are manufactured legitimately but contain inferior ingredients, or too much or too little active ingredient; and counterfeit drugs that contain no active ingredient or the wrong one, according to Patrick Lukulay at the United States Pharmacopeial Convention, which sets quality and safety standards for drugs around the world,
While poor-quality medicines also plague HIV/AIDS and tuberculosis sufferers, they have been studied most extensively for malaria, which kills 660,000 people each year. Nayyar and her colleagues found that 15 percent of the antimalarials from sub-Saharan Africa that failed chemical analysis had low levels of an active ingredient, while 34 percent of those from Southeast Asia contained no active ingredient at all.
Poor-quality drugs prolong illness, cause unnecessary deaths and impose a heavy economic burden on developing countries by raising health care costs and eroding productivity. They also damage the credibility of health care systems, which can in turn compromise vital public health initiatives like vaccination programs. Moreover, by exposing parasites to inadequate doses of the drugs that are meant to kill them, poor-quality antimalarials threaten to drive selection of resistant strains. That is especially worrisome since Plasmodium falciparum, the parasite species responsible for the bulk of malaria-related deaths, has already shown resistance to artemisinin-based drugs on the Thai-Cambodia border. The WHO currently recommends artemisinin-based combination therapy for P. falciparum malaria, and there are few alternatives on the horizon.
Significant numbers of African and Asian drugs are substandard or fake, costing lives and prolonging illness.
Nayyar, who is the director of Global Network for Access to Medicines, a student group affiliated with the Bloomberg School’s Center for Drug Safety and Effectiveness and the Department of International Health, recommends a multipronged approach to the problem. It includes educating the public and identifying technologies that can help developing countries test for poor-quality medicines. Above all, she argues for a better global regulatory framework—one that would replace the existing hodgepodge of definitions and regulations that allows counterfeiters and purveyors of substandard medications to evade prosecution. She and her colleagues would like to see counterfeiting designated a crime against humanity, and they are working on a paper to promote an international treaty or convention that would crack down on poor-quality antimalarials worldwide.
Grand as those policy goals might be, however, Nayyar hasn’t lost sight of the basic human tragedy that first caught her attention. “As we’re talking about this,” she says, “people are dying.”
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