Dear Colleague:

This is the third issue of CGD's monthly e-newsletter devoted to news and information about the global problem of drug resistance, with special attention to resistance in the developing world. In this issue, we focus on the growing appearance of poor quality drugs and their contribution to resistance. Recent evidence from Africa on the quality of malaria treatment reveals high levels of substandard drugs in pharmacies, as well as widespread availability of monotherapies that violate WHO guidelines. I discuss these findings and related efforts to combat poor quality drugs in the feature column below, along with my own interpretation of the relevance for the development of drug resistance.

For resources on the broader resistance challenge, we invite you to visit our new Drug Resistance and Global Health website. This site allows you to access newsletter archives, drug-resistance related blog posts, forthcoming research papers, and other resources related to the Working Group's activities. As our work progresses, we will use this site to share our emerging recommendations. We welcome your feedback!

Thank you for subscribing to this e-newsletter. As always, we welcome your comments and suggestions on our program of work.

Regards,

Rachel Nugent
Senior Program Associate for Global Health
Center for Global Development

Feature Column

Good Drugs are Hard to Come By*

The global health community has long worried about counterfeit, substandard and fake drugs. Everyone from pharmaceutical CEOs to national regulators to local pharmacists and, of course, patients themselves, have something at stake. As developing country markets have grown, substandard products have increasingly gained a firm foothold. Indeed, according to WHO, about a quarter of the drugs consumed in developing countries are counterfeits; in some countries, this estimate approaches 50%. Drugs may be substandard because they contain insufficient active ingredients (sometimes due to poor manufacturing, and sometimes because they are deliberate fakes) or because they have degraded due to inappropriate packaging, transportation or storage. And even quality-assured products might not have been designed for resource-constrained settings. Many (though not all) of these drugs offer limited or no therapeutic value to the sick patient. Those that contain sub-therapeutic levels of active ingredients may accelerate the evolution of resistant pathogens, in addition to reducing the likelihood of treatment success.

This has received particular attention in the malaria field, where the international community has been active in trying to reduce the resistance risks from poor-quality and inappropriate products. But better data on the true nature and extent of poor quality drugs is also needed in order to understand the contribution to drug resistance, and by extension, how to reduce it. Researchers from Africa Fighting Malaria shed new light on the drug quality issue in last month's PLoS ONE and at a recent Congressional briefing. The team went around to private pharmacies in six African countries and bought samples of all the different malaria drugs on the shelves except chloroquine. They purchased a total of 195 drug packages, and tested them through chromatography and dissolution. They found that about one-third of the drugs contained insufficient quantities of active ingredients and thus were of sub-standard quality. An additional one-third contained sufficiently high artemisinin levels, but are produced and sold as monotherapies in violation of WHO standards, including by manufacturers that had agreed to withdraw them.

The authors point out the staggering public health ramifications of these findings; and I agree that the sheer magnitude of ineffective drug treatment this implies is shocking. However, the study doesn't go far enough in helping us shape an effective policy response. The authors tell us only what percent of the drugs purchased from these pharmacies were substandard - they can't tell us why. From a resistance perspective in particular, we'd like to know more about the specific drug samples that were purchased and analyzed. Were they poorly manufactured drugs (as the PLoS study strongly suggests)? Were they originally good quality drugs that deteriorated due to poor storage and handling? And, most importantly, what was the distribution of products that still had enough active ingredient to be beneficial from a therapeutic perspective (made by manufacturers who were "trying" to play the game) even while being harmful from a resistance perspective, versus the products with little to no active ingredient, hence bringing no benefit and possibly even harm to the patient, but not contributing to resistance? Both are suboptimal from a public health perspective, but for different reasons and with different policy solutions. In the former case, the solution might be working collaboratively with the manufacturers to bring their products up to quality standards and avoid the very real risk of resistance that they are currently posing; in the latter, the solution is to crack down on the products and drive them out of the market completely.

The PLoS study provides some suggestions about policy needs, particularly emphasizing the authors' distrust of locally manufactured drugs and calling for stronger regulation in developing countries and more post-market surveillance. However, these are only one component of a broader strategy that must be developed to combat resistance to ACTs. As The Economist argued in response to the AFM findings, in addition to restricting the "bad" products that are currently on the market, the global community should leverage its protocols and resources to make sure that there are more "good" ones out there - and to use them carefully.

Ultimately, though, this is something that must be addressed by national drug regulatory authorities (albeit with international support). Since the study was published, both Kenya and Rwanda have cracked down on substandard manufacturers and complicit pharmacies. Even more encouraging, the Indian Government has launched a new study that sends disguised inspectors to 500 drug outlets around the country precisely to determine what proportion are substandard. The Indian study is spurred by worries about counterfeit drugs in particular, but is equally likely to reveal the multiple other problems with drug quality that contribute to resistance.

*This article expands upon an earlier post at the Global Health Policy blog, Good Drugs are Hard to Come By (Rachel Nugent; May 19, 2008) where we invite you to contribute your own comments to the conversation.

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