Le Raison de Résistance: Substandard TB Drugs Found in South Africa

The Times of South Africa recently reported the recall of two TB drugs, manufactured by Pharmascript, after the national health department found them to be substandard. Initial tests at the local WHO laboratory found they did not contain the needed amount of active ingredients, as claimed on the label, and concluded that they "would most likely not have effectively treated 'thousands' of TB patients."The author, Yazeed Kamaldien, seems to find solace in the fact that "these drugs are used only to treat primary TB, however, and not other cases, such as multi-resistant TB." He appears to completely misunderstand a primary cause of MDR-TB (multi-drug resistant TB) and drug resistance in general. While he is correct to breathe a sigh of relief that this discovery will, hopefully, not cause any MDR-TB cases to become the virtually untreatable XDR-TB (extremely-drug resistant TB), episodes such as this undoubtedly increase the risk of resistance among uncomplicated, primary TB patients. As MDR-TB can cost up to 300 times as much (in time, money and human resources) to treat as primary TB, these errors can put incredible strain on an already weak health system.Also disturbing is the fact that this episode comes right on the heels of a recall of anti-retrovirals (ARVs), manufactured by Adcock Ingram to treat patients with HIV, after a packaging mix-up last week. At a time when news reports of substandard, counterfeit therapeutics in the developing world are dominated by stories on antimalarials, I hope that these South Africa cases do not signal a new trend.A recent study conducted in six African countries found that only around 1/3 of the antimalarials purchased in local pharmacies were of a high quality and not in violation of WHO guidelines. My colleague, Rachel Nugent, discusses these findings in a recent blog and asks some probing questions about the cause of the substandard products. Whatever the reason (and there can be many), it is vital to find out, because if poor quality drugs are still making their way to the sick, it will terribly undermine treatment efforts - not only by not curing the patient, but also by proliferating the epidemic of drug resistance.