The need for disclosure

Tuberculosis patients in India are frequently ignorant of drug side-effects Last June, Sunil Kumar, 28, a Delhi-based vegetable vendor, was diagnosed with drug-resistant tuberculosis (DRTB). 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 effects. There was no Phase 3 data, which is mandatory under the Indian regulatory regime for establishing a drug’s safety. The only large randomised trial data on the drug came from a limited 161-patient Phase 2b study, which threw up paradoxical results. While on the one hand patients on bedaquiline had shown TB-negative sputum more often compared 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 find any link between the deaths and bedaquiline, the U.S. Food and Drug Administration fast-tracked the drug’s approval on the condition that the drugmaker, Janssen Pharmaceuticals Inc, provide Phase 3 data by 2022. Given this, the World Health Organisation 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 patient-information booklet (designed by India’s Central TB division) for bedaquiline, he may not have learnt about the mortality risk. “While the patient information booklet mentions side-effects such as dizziness, it does not disclose the Phase 2b results. Such a lack of disclosure is egregious,” says Jennifer J. Furin, an infectious diseases clinician at Harvard Medical School. When questioned about the inadequacy of the patient booklet, V.S. Salhotra, the additional deputy director general (TB) at Delhi’s Directorate General of Health Services, says the booklet mentions all risks. He did not respond to a follow-up question about the phase 2b results.

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