The Need For Disclosure

Last June,SunilKumar,28,a Delhibased vegetable vendor, was diagnosed with drugresistant tuberculosis (DRTB).

- Sunil Kumar

The government hospital he visited for treatment prescribed a drug called bedaquiline. That year, even though India was giving bedaquiline to patients as part of a conditional access programme, there were questions about the medicine’s toxic eects. There was no Phase 3 data, which is mandatory under the Indian regulatory re­gime for establishing a drug’s safe­ ty. The only large randomised trial data on the drug came from a limit­ ed 161­patient Phase 2b study, which threw up paradoxical re­sults.

While on the one hand patients on bedaquiline had shown TB­-ne­gative sputum more often com­ pared to controls, on the other, comparatively more patients died in the Bedaquiline arm, suggesting that the drug might be killing pa­tients. After an investigation did not nd any link between the deaths and bedaquiline, the U.S. Food and Drug Administration fast­tracked the drug’s approval on the condition that the drugmaker, Janssen Pharmaceuticals Inc, pro­ vide Phase 3 data by 2022. Given this, the World Health Organisa­ tion has suggested that all patients be told of bedaquiline’s mortality risk as seen in the Phase 2b trial.

Kumar doesn’t remember being told all this. “They didn’t tell me anything. Nor did I sign any form,” he says. Even if he had been given the patient­information booklet (designed by India’s Central TB di­ vision) for bedaquiline, he may not have learnt about the mortality risk.