Drug Quality &Pharmacovigilence Bill Brieger | 29 Nov 2008 02:29 am
Can quick wins become quick losses?
A World AIDS Day approaches people in the field are giving a critical look at efforts to scale up ART. Jeremiah Norris in the Daily Times of Malawi raises the question of drug quality in the push for achieving widespread HIV/AIDS treatment goals. Could these same problems surface in the desire to scale up for impact (SUFI) that Roll Back Malaria partners are promoting? Some excerpts highlight the problem:
While activists have applauded the speed of this “scale-up,” it creates dangers. Many of the copies recommended by WHO are untested so patients cannot be certain that they act on the body in exactly the same way as the original (called bioequivalence). If the level of active ingredient is not absolutely correct, it can accelerate drug resistance and the mutation of the Aids virus. Under Indian law, drugs manufactured for export do not have to prove bioequivalence with the patented original.
Brazil is often held up as the model for universal Aids treatment. It too has based this largely on cheap, untested copy drugs. In July, the government acknowledged that one third of the 190,000 Aids patients under treatment were in what it called “a more advanced stage‖but medical studies had already shown even higher levels of drug-resistance.
 Norris worries that, “WHO, the Global Fund and the Clinton Foundation therefore sanctioned a drug that was not only unapproved and potentially sub-standard but also more expensive.” Most donors depend on WHO’s ‘prequalification’ program for ensuring drug quality, but maybe it is possible in the rush to achieve coverage some governments are buying drugs not on the prequalified list.
The pressure is on to scale up malaria treatment. The Global Fund Board has recently approved taking on management of the Affordable Medicine Facility – malaria (AMFm), which will among other things enhance the role of private sector in increasing access to malaria medicines. The Clinton Foundation has been negotiating with pharmaceutical manufacturers about making more lower coast malaria drugs available.
Norris’ concern that, “many poor countries … cannot carry out drug evaluation themselves” applies for malaria drugs as well as ARVs. Even if a drug appears on a WHO or FDA list, one cannot guarantee that the medicine that found in a district hospital pharmacy or a local medicine shop in a malaria endemic country is actually of the quality required. Quick wins in scaled up medicine distribution can ultimately result in quick loss of life if capacity is not built to monitor drug quality at the front line.