Last month, the Delhi High Court acceded to the plea of an 18-year-old girl that she be given access to Bedaquiline, an anti-TB drug found useful in treating multi-drug or extensively drug resistant disease (abbreviated as MDR/XDR TB). The girl had to move court because Bedaquiline was recently added in the armamentarium of the Revised National Tuberculosis Control Program of India (RNTC) with significant riders. Since Bedaquiline was the first major anti-TB drug discovered in the last 40 years, the government restricted its use for fear of TB mycobacterium developing resistance to the medicine. Since February 2016, its availability is restricted to just six hospitals in five different cities (Delhi, Mumbai, Ahmedabad, Chennai and Guwahati). The complainant resided in Patna; her domicile status was held against her from being treated with Bedaquiline.
In a country which has an annual incidence of around 99,000 new cases of multi-drug resistant TB, only 164 patients have been enrolled for Bedaquiline therapy in these hospitals till date. Clearly, there is something amiss in the government’s policy in rolling out Bedaquiline for XDR and MDR tuberculosis. The rationing of Bedaquiline by the government on the fears of drug resistance is understandable. The rampant use of anti-tubercular medicines has resulted in India having 4.80 lakh new cases of MDR TB in 2015. But is there a scientific rationale for rationing the drug, of putting it beyond the reach of the patient (and the health practitioner), to prevent the development of resistance against it?
Ever since Penicillin was discovered by Alexander Fleming in 1929, an “antibiotic revolution” has been ushered in medicine with new antibiotics flooding the market every year. But there is hardly any antibiotic against which “no resistance” has been reported. The only way in which antibiotic resistance can be prevented is not to use the antibiotic, which, of course, is not possible. Preventing resistance against Bedaquiline is a must, but the manner in which this is being done is impractical and undemocratic.
A community perspective on the use of Bedaquiline is a must in a resource-challenged country like India. In fact, a Joint TB Monitoring Mission in its report in 2015 pointed out that the lacunae within the RNTC in the management of multi-drug-resistant cases. The high power committee suggested that the prime reason for the rise in drug-resistant TB is the inherent weakness of state-run TB control programmes and the lack of awareness among patients, who do not complete the recommended six-month medication. Besides, slashing the five-year budget of RNTC from Rs 6,500 crore to Rs 4,500 crore by the present government has only added to the problem of TB control in the country. Thus, it is thought-provoking whether it’s fair to “punish” the patient by denying a drug, for the wrongdoings of a system and the state?
Besides, scientific evidence suggests that a delay in the treatment of MDR/XDR cases of tuberculosis only makes the community more susceptible to the spread of infection by the multi-drug resistant TB organism. Studies on the use of drugs like Bedaquiline in the early stages of multi-drug resistant scenarios in South Africa showed better
results both in terms of disease cure and in the restriction of community spread of the disease. It is thus imperative that the use of Bedaquiline early in disease will have far better results than in denying its use through impractical statutes.
The issue of the geographical restriction of Bedaquiline may be one of its kind in this country. Restricting patients and means to treat them in specific regions is unprecedented. Other than preventing the development of resistance to the drug, I am not sure what other elements of scientific reasoning have gone into the government’s decision to geographically restrict the distribution of Bedaquiline. If the priority is prevention of drug resistance, it could be
attained by methods less draconian than controlling the availability of the drug. Strict surveillance of MDR/XDR cases, better community outreach programmes to educate the patient and the healthcare provider against treatment dropout, quality assurance on available anti-TB drugs and educating physicians against the irresponsible, injudicious use of anti-tubercular therapy are far better, though more difficult, means of preventing MDR/XDR. Restriction of treatment based on the geographical location of patients is the worst form of federal arrogance which a state can unleash on its citizens. Regional domiciles should not dilute the principles of equipoise in the eyes of the state. Some patients cannot be more equal than others.
TB is a disease of the poor. In his budget speech, the finance minister committed to the eradication of TB by 2025. A compassionate approach supplemented by scientific rationality is a must in promoting, not rationing, Bedaquiline therapy. Besides, the Delhi HC order should be an eye opener for policymakers to rethink means to roll out Bedaquiline more effectively and to introduce other drugs like Delaminate in the treatment of MDR/XDR TB in India.