India: Drug-resistant TB and a promising drug
Drug-resistant TB cases are growing. We need speedier diagnosis, treatment and care
World TB Day commemoration events for 2016 have just concluded. The Ministry of Health and Family Welfare announced that bedaquiline, the first new TB drug in over 40 years, will be now available in India. It had been given accelerated approval by the U.S. Food and Drug Administration in December 2012. Announcing its availability, the Ministry indicated it would be available only at six sites; in the first lot, only 600 doses will come.
This announcement has given the over 71,000 multidrug-resistant TB patients in India some hope, though the scramble for doses will probably cause heartburn. How would 600 be chosen from among 71,000? Who will decide? Will patients being treated in the private sector be eligible? Will politicians have a say? These are the questions facing patients.
India did take its time in approving bedaquiline. On March 6, 2015, USAID and Janssen, the manufacturer of the drug, signed an agreement to provide a substantial number of doses free of charge to countries including India, with Janssen donating 30,000 treatment courses over a four-year period. The donation is provided through USAID’s agreement with the Stop TB Partnership’s Global Drug Facility (GDF). The process time, from request to delivery, takes six to nine months. As of December 31, 2015, India was yet to make a formal request.
A second-year post graduate student in pediatrics was diagnosed with pre XDR (extremely drug-resistant TB) in May 2015. The young woman’s family members, themselves doctors, approached our network to look for the best options. After discussions with experts it was agreed that she would be a good candidate for bedaquiline under compassionate use. She used it through a private facility as it was not available in the public sector.
Less than a year later, she is doing well. She says: “I feel bedaquiline was a life-saver for me. I’m alive because I was able to have access and the means to get it. If we have a disease without a cure then one can understand and take it as fate and accept it. But if you have something like TB, even XDR-TB, and we know there is a cure but have no access to it, the frustration, pain and hunger for that is something that only someone going through it can understand….”
The questions posed by this young doctor force us to look at our slow responses and ask if the 600 doses are enough. Multidrug-resistant TB is a complex infection. Every patient may not be eligible for Bedaquiline. Even if half the MDR-TB patients in India are eligible, we are looking at over 35,000 doses. So 600 is but a drop in the ocean. Why invest in research if you cannot ensure that patients get the benefits?
India is a signatory to the Sustainable Development Goals where TB figures prominently. It plans to ‘End TB’ by 2035, and to do that it needs to accelerate rapidly. Early and easy access is key to this. If one looks at how India won the battle over HIV, the turning point came when testing, treatment and care became freely available.
Bangladesh tested an interesting model, which it called Community based programmatic Management of Drug-Resistant TB (cPMDT). This has shown good results and brought benefits to patients as it is based on patients receiving MDR-TB treatment within their own communities. Patients find treatment at home more convenient, and close daily support from family members is possible. Community-based care is more economical than hospital-based care yet it is compatible with hospital care.
Drug-resistant TB patient numbers are growing. There is only one way to fight this: accelerate access to diagnosis, treatment and care. No more pilots, no more small numbers of doses, no more red tape. The time has come to have one DRTB centre in each district. The time to scale up tested models from within India and other settings is now.
Source: The Hindu
