Teenager’s legal victory exposes the struggle India’s TB patients have to get the wonder drug that might cure them
Bedaquiline is the only medication that works for people whose TB is resistant to other drugs, yet caution by the Indian government has led to delays and dilemmas in its roll-out, to the detriment of many sufferers
Speaking on the telephone from her home, Shreya Tripathi’s voice is low. She weighs only 25kg. If she speaks for more than a few minutes, she becomes breathless. Two years ago, she had to drop out of school because she was so weak. Swimming and badminton – her favourite sports – are distant memories.
But the teenager’s determination to recover from the tuberculosis that has consumed her life over the past five years has exposed the dilemmas in India’s roll-out of a new drug, Bedaquiline, which is the only medication that works for people with drug-resistant TB.
Shreya, 18, has XDR-TB, or extreme drug-resistant TB. After being diagnosed in her home town, Patna, in eastern India, she and her parents tried every doctor they could find. She proved resistant to the first and second lines of treatment.
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When a TB specialist in New Delhi turned her away last year saying the disease was incurable and suggesting that she “try homeopathy”, her father, Kaushal, was about to give up. They tried every possible avenue to get Bedaquiline but all sorts of government restrictions surrounded this new “wonder drug”, the first new TB drug to be registered in more than 40 years. It was launched four years ago but the government has been cautious about who gets it because of the fear of the bacteria mutating to become resistant to this drug, too.
“When we failed to get Bedaquiline, my daughter urged me to go to court over it,” says Kaushal. “She said that if we, an educated and middle-class family, couldn’t get this drug, then what chance did poor Indians have?”
He filed a writ, demanding access to the drug for Shreya. They began to wait, as they had waited so many times before.
A lifeline was thrown to her on January 20 when the Delhi High Court ruled in Shreya’s favour. The judges told the National Institute of Tuberculosis and Respiratory Diseases in New Delhi to make the drug available to her.
The institute had first refused on the grounds that she was not a resident of the Indian capital and then later (when Kaushal said they would move to New Delhi), on the grounds that she had to undergo a drug susceptibility test. The reason, says Saket Sikri, counsel for the National Institute, is that the hospital cannot prescribe the other drugs that must be administered with Bedaquiline until it gets the culture report of this susceptibility test.
During the trial, Sikri said the Institution was justified: “A wrong combination can kill and, since this drug is her last hope, we have to get it right. By following these rules, we are being humane, we are not being bureaucratic. Rather, we are following World Health Organisation guidelines. The institute cannot choose which parts of the WHO protocol to follow and which to ignore,” he told the court.
The court disagreed, and Shreya has started on a course of Bedaquiline under the supervision of TB specialist Dr Zarir Udwadia at Hinduja Hospital in Mumbai whom she had consulted earlier.
Shreya now stands a fighting chance of beating the disease. But what of the tens of thousands of other Indians with drug-resistant TB who do not have an educated civil servant father who can fight in the courts as Kaushal has done to get the drug? Many do not even know that Bedaquiline is available and can help them.
India has more than 1.7 million people with tuberculosis, the largest number in the world, according to the WHO. Of these, about 79,000 people are multidrug-resistant, a condition caused mostly by overuse of medicines. The WHO estimates that nearly 10 per cent of all multidrug-resistant TB patients have extreme drug resistant TB (like Shreya), for whom both the first and second lines of antibiotic treatment have failed.
The case has exposed problems with the Indian government’s approach towards using Bedaquiline. It has good reasons for being judicious in rolling out the use of Bedaquiline: the big fear is of resistance developing to it, too, if it is misused or not prescribed in the proper combination with other drugs or if the right protocol is not followed. Its effectiveness has to be preserved because it is the last resort.
For this reason, under the Revised National Tuberculosis Control Programme, launched in February 2016, the drug is available only in five government hospitals and eligible patients have to live close to the hospital so that they can be strictly monitored.
“Bedaquiline is administered for six months and follow-up of patients continues for six more months. That’s why this geographical requirement is important. We need patients to be close to hospitals,” says New Delhi government TB programme officer Ashwani Khanna.
Critics say the caution is being taken too far and that an overly controlled supply of the drug is depriving very sick people. Only 164 patients have enrolled for the Bedaquiline programme, while the drugs in government possession are set to expire this October.
When Dr Udwadia first saw Shreya last October, he knew she had to be put on Bedaquiline. But the hospital where he works is a private one and therefore cannot obtain the drug.
He told her to try to get it as quickly as possible from the National Institute of Tuberculosis and Respiratory Diseases. The Institute asked her to undergo another drug susceptibility test because they had lost the first sputum sample she had provided, weeks earlier. “The delay was unnecessary because all the previous tests had shown clearly the nature of her drug resistance,” says Dr Udwadia.
Shreya is admitted at Hinduja Hospital, under his care. Dr Udwadia had hoped the Delhi High Court ruling would have wider ramifications. “Sadly, we thought the court ruling would set a precedent and force a policy change so that others who need Bedaquiline could get it. But there has been no change in government policy,” he says.
He is aware of the risk of resistance to Bedaquiline developing but wants it to be available to everyone who needs it. “Look at South Africa. It’s a good model. Thousands are getting it there without any resistance to it. We need to strike a balance between preventing resistance developing and doing the morally right thing by giving it to people who need it. We need many more government centres offering it and we need it in private sector hospitals too where it will be used responsibly,” he says.
The longer Shreya was denied the drug, the greater the chance that the disease could spread to those in contact with her, says Dr Jennifer Furin from the Department of Global Health and Social Medicine at Harvard Medical School, who gave written testimony in favour of Shreya. “The international community has been deeply concerned about the delayed roll out of Bedaquiline in India, the highly limiting enrolment criteria and the strict geographic limitations being placed on patients who need the drug,” said Dr Furin in an affidavit.
Health activists in India say that sometimes government doctors often fail to inform drug-resistant TB patients about Bedaquiline. As to the residence requirement, it is also very difficult for migrant labourers to prove they live in one of the five cities listed by the government as they lack proof of their address.
The Indian Council of Medical Research has since conceded that the programme needs to have more flexibility so that every eligible patient gets a chance to be cured.
“The government is being too bureaucratic about it, too conservative and not willing to part with the drug even though people will die without it,” says senior lawyer Anand Grover of the Lawyers Collective in New Delhi who fought Shreya’s case.