The potential perils of a drug protection framework in tuberculosis

Published November 2021.

When bedaquiline was approved by stringent regulatory agencies for the treatment of drug-resistant tuberculosis in 2012, it was as the first novel agent for the treatment of tuberculosis to be developed in almost 50 years. Given the gruelling therapeutic regimens being used for drug-resistant tuberculosis at the time—with success rates hovering at a dismal 50% globally—it would seem this novel medication would be embraced as a breakthrough and rapidly rolled out. However, data on bedaquiline use painted a different picture, with fewer than 20% of those in need of the medication actually receiving it by 2016. Although multiple reasons were given for this low uptake of bedaquiline—including costs, safety concerns, and limited practical experience with its use—one often cited reason for denying people access to bedaquiline was fear of generating resistance to the medication. “We have to protect the drug” was a common mantra among those working in the field. In fact, so invested was the tuberculosis community in this framework of drug protection that early WHO recommendations on the use of bedaquiline specified it should only be given to people who had limited treatment options, either because of resistance or intolerance to other second-line medications —a population vastly different from those included in the clinical trials that led to the purported evidence-based recommendations regarding how bedaquiline should be used.

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