Good Drugs are Hard to Come By

It's hard to know what to make of the news about bad malaria drugs in Africa reported in the new study from the team at Africa Fighting Malaria. 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. They found that about one-third of the drugs were sub-standard, and about one-third were artemisinin monotherapy, produced and sold in violation of WHO standards because of the risk of creating resistance.The authors sum up their results with this:

This study sheds light on the availability and relative quality of private sector antimalarials in Africa's private sector. In countries situated in the world's most intense region of holoendemic and hyperendemic P. falciparum malaria, where the difference between a proper and a bogus medicine cannot be surpassed (sic), various substandard therapies and clinically inappropriate monotherapies remain widely available, with between a quarter and over half of products sold in urban and peri-urban pharmacies failing basic quality testing. We do not quantitatively estimate the public health impact of this crisis, but it must be staggering.

I agree that the public health implications of these findings are serious. What is harder to take away from the study is how to respond to the findings. The authors tell us only what percent of the drugs purchased from these pharmacies were substandard - they can't tell us why. While I don't fault them for that, it doesn't help us much in choosing from among the many interventions for trying to address the problem.If we're interested in resistance (and we are, see our Drug Resistance Working Group), then we'd like to know more about the substandard drugs purchased by the AFm team. Were they poorly manufactured drugs (as the AFM study strongly suggests)? Were they originally good quality drugs that deteriorated due to poor storage and handling? What is the distribution of quality among those that didn't meet the standard, were they all close to "good enough" or were they all very poor quality, or in between? How much below the 80% active ingredient did they contain? After all, products without any active ingredient at all do not contribute to resistance.This was a small study with only 195 treatment packages purchased and sampled. It can't tell us everything we want to know about where resistance to anti-malarials might come from. But it is revealing and suggests a pretty big problem for malaria treatment in some African countries.More precise results and recommendations may emerge from a study just launched by the Indian Government to send disguised inspectors to 500 drug outlets around the country precisely to determine what proportion are substandard. The inspectors will purchase drug treatments for a wide range of high burden diseases, including but not limited to malaria. This pan-disease approach to understanding resistance is very welcome as there are common health system factors that can create resistance in drugs for many diseases. The Indian study is spurred by worries about counterfeit drugs, but it likely will reveal that there are multiple problems with drug quality that lead to resistance, such as those I mentioned above. This is a great opportunity for the government to put both manufacturers and sellers on notice that they cannot endanger the health of the Indian population by distributing counterfeit or poor quality drugs.At the international level, the authors of the PLoS study provide some suggestions about policy needs, particularly emphasizing their 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 points out, there are many perfectly legal - and even internationally encouraged - drivers of resistance. So 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.