An 18-year-old girl has taken the Indian government to court after being refused access to blockbuster tuberculosis drug bedaquiline. The girl has extensively drug-resistant tuberculosis or XDR TB and her case is emblematic of the desperation of TB patients in India, as the Health Ministry has delayed the roll-out of the life-saving drug beyond six centres in the country. In an e-mail interview, Jennifer J. Furin of Harvard Medical School, who is also an expert witness in the court case, tells The Hindu that “India is clearly abdicating its responsibility on the TB front, and the international community is worried”. The case will come up for hearing on Monday, and the decision will have a far-reaching impact on India’s tuberculosis patients.
How worried are you about the Indian government’s delay in rolling out bedaquiline?
The delays are extremely worrisome on a number of levels. First of all, the delayed roll-out and restrictive criteria are resulting in the unnecessary loss of life for thousands of people living in India, and as the story of this young woman illustrates, these are people in their prime of their lives, whose only risk was breathing in the wrong place at the wrong time. Before we had limited options for them, but now with bedaquiline we do, and all citizens of India (and of the world) have a right to health and life and access to this medication. Second, the delay means that little is being done to stop the ongoing spread of MDR-TB ( multidrug-resistant tuberculosis ) within India and outside of its borders. The most effective way to stop the spread of MDR-TB is to rapidly identify people with the disease and start them on effective treatment. When they are denied access to effective treatment, they continue to be sick and spread the disease to others. India is home to more MDR-TB patients than any other country in the world, and you would think they would do everything in their power to halt the spread of this epidemic. By denying people access to this drug — which doubles the chances of cure — they are allowing MDR-TB to spread unchecked throughout the country. And this also affects the international community given that MDR-TB is an airborne disease that does not respect country boundaries.
Will improving access to bedaquiline result in antibiotic resistance, as the government fears? Is this a fair argument?
Resistance develops to any antibiotic when it is used — and this is true of all diseases and all antibiotics. And in fact, there are usually naturally occurring resistant strains that are out there even before a drug is ever used. Bacteria are perfect examples of evolution, where natural mutations provide a survival advantage in some conditions and the “strongest survive”. So the only way to make sure there is no resistance to BDQ is to never use BDQ, and when there is such a severe, deadly, and airborne disease like MDR-TB, then never using the drug is not an option. Some degree of responsible use is necessary. You don’t want BDQ available in all the drug stores or on the open market. But the severe restrictions the Indian government has placed on BDQ — with officials saying it should only be used for the worst, most resistant cases — actually increase the chance of generating BDQ resistance. Data from South Africa show that the sooner a person is offered access to BDQ, the better the outcome for the individual patient and for the community. When the drug is saved as a last resort only for the most resistant patients, those patients are usually very ill with severe lung damage and exposure to multiple drugs, and BDQ is less likely to be helpful and resistance is more likely to develop in those cases. So early access to BDQ for persons who need it is the ideal way to decrease the development of resistance, and patients should be given all the help and support they need to successfully complete treatment.
But TB is a funny field, and it is the only disease that I know of where the key treatment principles are based on a fundamental mistrust between persons living with the disease and those who are supposed to be providing service to them. This is seen in DOT (Directly Observed Treatment), mandatory hospitalisation, and the rationing of medications like BDQ. Providers and public health practitioners blame patients for causing drug resistance, when in fact it is often providers and cumbersome health systems that are really to blame. In India, one does have to think about the private sector and their contribution to MDR-TB creation. But the private sector is quite heterogeneous in India. And people go there for a reason — because they do not trust the pubic system to serve them with compassion or even competence. Denying this young woman access to BDQ weakens the public’s confidence in the public health system, and they will continue to go to private services until quality care is available to them elsewhere. So it is not a fair argument at all. Rationing the drug to the degree India has is not only unfair, but it is mean and people pay for this rationing with their lives. Meanwhile, they continue to spread MDR-TB.
What are the implications for the rest of the world if India does not show urgency in this matter?
There have been cases of persons travelling to India and becoming infected and sick with MDR-TB, so India’s refusal to scale up BDQ is really the world’s problem. India desires to be more prominent on the international stage, but their continued refusals to address the public health crisis of TB and MDR-TB really will limit such global aspirations. India is clearly abdicating its responsibility on the TB front, and other countries have noticed this and are not happy about it.
Do you think India’s TB management policies are not in sync with the country’s disease burden?
India's management policies are completely out of sync with the burden of TB and MDR-TB in the country. TB is an emergency in India and needs to be treated as such. As for their management policies, they put many things down on paper and in their guidelines, but they fail to implement them. This is true of daily TB treatment, the provision of preventive therapy, and the list goes on and on. Second, India is such a leader in health and technology, it is baffling that they continue to report the highest rates of TB and MDR-TB in the world. One would think a country like India would leap out and make a huge commitment to stopping TB in an urgent fashion — and India could be very successful at this given the wealth of talent in the country and all the human and financial resources there. But instead they go on with business as usual, countless delays, and even manifest great contempt towards people who try to make change in the country. This case is an example of India’s failure in TB policy and practice. They should have thousands of people like this brave young woman and her family on BDQ and be a guiding light to the world. Instead they make a sick girl and her family spend their days in court fighting for something she should have been offered two years ago. It must be very disheartening to be a young person in India and see these things today.
Lastly, are you hopeful that the 18-year-old girl will get access to bedaquiline in time?
I am always hopeful that we will do a better job in providing persons living with TB and MDR-TB with the care they need and deserve. A decision must be made urgently, though, because she is very sick right now. Because she has been made to wait for so long, her life really hangs in the balance, and all these delays for bureaucratic reasons have clearly increased her risk of dying. Whatever the decision is on Monday from the courts, that is a reality that we all have to live with. But this is what happens when restrictions and fear-based approaches take precedent over saving the life of a child. I hope that the TB community in India and abroad will realise that we are — that we must be — better than this. And will follow her brave example and that of her brave family’s and continue to fight for access for all persons. We can no longer be satisfied with “protecting a drug” when we should be protecting people’s lives. The fact that this case was taken to court emboldens all of us to keep fighting and to fight harder so that all people can have access to the care they need, the care they deserve. And I know we have taken another step forward now. So I remain hopeful and am inspired by people like her who are so courageous and whose hope never dies.
