Denying access to bedaqualine in India costs lives
As physicians managing the so-called Patna patient—an 18-year-old woman who took the Indian government to court after being denied access to bedaqualine—we commend Amber Kunkel and colleagues on their forthright article.1 The woman's case is emblematic of the desperation of the many patients with advanced drug resistance and with few therapeutic options that we encounter in our clinic. India's National Tuberculosis Program's (RNTCP) insistence on reserving bedaqualine for patients who have at least three susceptible drugs in the background regimen,2 denies this drug to the very patients who would most benefit from it, especially since it doubles the chance of a cure.3 It worries us that such patients, denied access to a life-saving drug, are compelled to move the judiciary to access it. The theoretical fear of protecting a drug has sadly taken precedence over protecting lives.
We have been compelled to access the drug via an alternative route, the Compassionate Use Program, in 40 of our patients with advanced resistance (XDR and beyond), successfully procuring it for 33 of these patients. The process of application is a tedious and onerous one, and includes an online application and review of each case by the company (Janssen), application for the import permit, dispatch, shipping, and customs clearance. The mean time from application for the drug to its receipt was 49 days. For three patients, the drug was interminably held up at Indian customs. Despite these hurdles, 65% of our cohort who received bedaqualine culture converted.4, 5 Thus, easing bureaucratic delays to ensure accessibility of drugs could save lives.
We declare no competing interests.
Source:
The Lancet Infectious Diseases
