Fighting Drug-resistant Malaria with Bad Drugs
November 22, 2013
J. Christopher Daniel
Senior Associate, Global Health Policy Center
Drug-resistant malaria is a clear and present danger. If you are unfamiliar with this threat to the impressive progress achieved in recent years against an ancient and deadly parasitic disease, I invite you to view a 3 ½ minute video: "Fighting Artemisinin-Resistant Malaria" and/or read a short CSIS report: Drug-Resistant Malaria: A Generation of Progress in Jeopardy. Both were released last Tuesday during a CSIS conference, “U.S. Health Partnerships in the Mekong.” Over 300 people participated in the conference, including Danny Russell, the Assistant Secretary of State for East Asian and Pacific Affairs, and senior health officials from the U.S., the Mekong and the international community. The conference provided an opportunity to focus on the myriad health challenges of the Mekong, as well as the unique opportunities and challenges in Myanmar, in the midst of extraordinary change (the subject of another new CSIS report, Rehabilitating Health in the Myanmar Transition).
Also last week, approximately 3500 scientists, clinicians and others involved in tropical medicine and global health gathered from 100 countries around the world for the annual meeting of the American Society of Tropical Medicine and Hygiene (ASTMH), which this year was held in Washington, D.C.
Drug resistant malaria was a major focus of attention last week at both CSIS and ASTMH. Many of the world’s leading malariologists highlighted the urgent need to avoid “business as usual.” They recommended bold action to eliminate malaria parasites from the Mekong, before drug resistance among these parasites emerges elsewhere - especially Africa where the disease’s burden is greatest - and reverses the gains of the past decade. They also emphasized the need for this to be an “all hands on deck” effort, which must include extensive cooperation across borders and sectors.
An example of where the need for multidisciplinary collaboration is great is in tackling the distribution and trade of counterfeit, falsified and substandard antimalarial drugs in the Mekong - a problem that extends to numerous other medical products and threatens the health and safety of people throughout the world, including the United States. FDA Commissioner Dr. Margaret Hamburg spoke eloquently at CSIS, both about the issue’s importance and about the need for international partnerships to address it. In a blog on FDA Voice later that day, Dr. Hamburg noted that the FDA is working with WHO and others “to build a global monitoring system to monitor substandard, falsified and counterfeit medicines, and collaborating with countries in the region to develop and test the system.” These efforts often involve the use in remote locations of an innovative tool developed by FDA - a hand-held portable device which can detect counterfeit products (not just drugs).
Two large symposia at ASTMH also highlighted the extent to which the international community has begun to work collaboratively on this issue. A prominent example is the Joint Interagency Task Force (JIATF), made up of the Global Fund’s Office of the Inspector General, the USAID Office of the Inspector General, and the United Nations Development Program’s Office of Audits and Investigations. JIATF tracks the theft, diversion, and counterfeiting of Global Fund and USAID-funded medicines. Other notable contributors to efforts to combat “bad drugs” in the Mekong include the US Pharmacopeia, NIH, the Bill and Melinda Gates Foundation, the German Pharma Health Fund, the Thailand Bureau of Drug and Narcotics, the United Nations Office on Drugs and Crime, the World Wide Artemisinin Resistance Network and INTERPOL.
An Institute of Medicine report (“Countering the Problem of Falsified and Substandard Drugs”) in February 2013 noted that the “root cause of substandard drugs is neglect of good manufacturing practices,” while “crime and corruption drive the business of falsified medicines.” The report noted that “good quality comes at a price,” a particular challenge in developing nations (though not exclusively, as exemplified by negligent production at a Massachusetts compounding pharmacy last year resulting in 44 deaths). The IOM report also referred to falsified medicines as “the perfect crime,” as they are cheap to make and since investigation and prosecution are extremely difficult.
Tackling counterfeit and substandard drugs requires a broad range of partners well beyond the health sector. These include the pharmaceutical industry, domestic and international law enforcement and regulatory authorities, and customs officials. As Alan Magill, Director of Malaria at the Bill and Melinda Gates Foundation and the President of ASTMH, said last week, drug resistance results from “too little drug meeting too many parasites.” In this regard, it is clear that “bad drugs,” which include insufficient or no active antimalarial agent, are a major obstacle to the efforts now underway to tackle drug resistant malaria. International and multidisciplinary cooperation is essential.