35% of antimalarial drugs sold in six major African cities failed basic quality tests according to a study published last week in PLoS ONE , a peer-reviewed open-access journal. The study further found that artemisinin monotherapies, which the World Health Organisation explicitly rejects as substandard, remain common in Africa. Substandard antimalarial drugs cause an estimated 200,000 avoidable deaths each year.
“Our study shows that efforts to increase access to quality antimalarial drugs in Africa are increasingly important,” said Dr. Roger Bate, Resident Fellow at the American Enterprise Institute and lead author on the study. “Substandard drugs not only endanger lives today, but also jeopardize future malaria treatment strategies by accelerating parasite resistance.”
Artemisinin combination therapies, or ACTs, lower the chances of developing parasite resistance and reducing treatment efficacy. Yet a third of the drugs collected in the study were artemisinin monotherapies. 42% of them failed and 78% were manufactured after the World Health Organisation proscribed them in January 2006.
“Malaria surged through Africa in the 1990s, fueled by resistance to chloroquine and other historically effective drugs,” said Richard Tren, Director of Africa Fighting Malaria , (www.fightingmalaria.org) a non-profit advocacy group. “Because regulation and post-market surveillance of drugs is so poor in most malarial countries, ACTs now risk the same fate.”
The World Health Assembly resolved in May 2007 to stop the production and marketing of artemisinin monotherapies. But according to the World Health Organisation, only 40 of 74 global manufacturers have agreed in principle to stop production, and 42 countries – 18 of them in sub-Saharan Africa – still allow companies to market these drugs.
Africa Fighting Malaria also released a report on malaria treatment policy in Africa, examining the challenges of pharmaceutical regulation and production in Africa, and calling for stronger global leadership from donors on drug procurement standards.
“Under the Global Fund’s ‘Option C’, (see CFD bulletin March 10th for more information) poor countries can use taxpayer funds to buy untested drugs of uncertain quality,” said Richard Tren. “Option C was intended to increase incentives for nascent ACT producers to enter the market and foster competition. It has accomplished this, but it has not provided any incentives for these companies to go the extra step and submit to bioequivalence testing by a stringent regulatory authority.”
Post-market surveillance and pharmacovigilance are severely limited in Africa, yet crucial to detecting bad drugs and the inevitable development of parasite resistance for an at-risk population of 700 million. As the PLoS ONE study argues, a fraction of the current global budget for malaria control could support a decentralized network for basic drug quality testing in Africa using Minilabs, portable chemistry sets, or equivalent technologies.
Download the study here.