A domicile rule is preventing an 18-year-old girl from getting a life-saving TB drug

A case filed by a father of an 18-year old girl suffering from tuberculosis in the Delhi High Court has exposed the many holes in the government’s tuberculosis control programme.

After suffering from tuberculosis for nearly five years, Priya, whose name has been changed to protect her identity, has now shrunk to 25 kgs. She is barely able to walk a few steps without feeling breathless.

In December 2016, her father had moved the court seeking treatment for his daughter with a drug that the government provides conditional access to. The drug Bedaquiline was incorporated into the Revised National Tuberculosis Control Programme in February 2016 at six hospitals in five cities – Delhi, Mumbai, Chennai, Ahmedabad, and Guwahati. Bedaquiline has shown good results even for patients of extremely drug-resistant tuberculosis for whom all other lines of TB treatment have failed.

Priya has been denied treatment with Bedaquiline, the last form of medication that could save her life, simply because she is not a domicile of Delhi. She is resistant to all the available drugs available for TB so far.

Her father, who is the petitioner has stated that the denial of this treatment is “unconstitutional” and against the current guidelines for treatment with Bedaquiline.

The next date of hearing is on January 9 when the court may decide whether the drug will be made available to her.

Priya’s case highlights the gaping holes in the government’s TB control programme.

When all treatment fails

Priya was first detected with TB in 2011 in Patna. She was only 13 then. Her parents took her to a private doctor who treated her with the first line of TB drugs. Her condition did not improve, with the drugs failing within a few months into the treatment. The family was advised to take her to a government hospital and in 2013, they went to Patna Medical College where Priya was diagnosed with multi drug-resistant tuberculosis.

By November 2014, this treatment regimen also started failing her and the family came to Delhi for the next step. They went to Vallabhbhai Patel Chest Institute in North Campus where Priya was diagnosed as suffering from extremely resistant TB and treatment was started with a third line of drugs. By May 2015, this treatment too became ineffective.

Between 2014 and 2015, Priya had been so sick that she had to be hospitalised several times. She had complained of chest pain, fever and high grade or severe cough for several months.

“In the beginning of a new treatment, she feels better,” said her father, who was in Delhi for the court case. “Within a few months, she would start falling sick. She would start getting weak, would be breathless, and would not feel hungry. It was the same story each time.”

Unlike the conventional profile of a patient developing drug-resistant tuberculosis because of not following the full course of treatment, Priya appears to have become resistant to even the first line of TB drugs despite not having had treatment before. This is known as primary drug resistance.

“The initial resistance is initial only to the patient,” said Nerges Mistry, director of the Foundation for Medical Research that undertakes research on drug resistant tuberculosis. “But, the bug has seen the drug before.”

Many studies have now shown that even extremely drug-resistant tuberculosis can be transmitted directly from one person to another, Mistry said. In patients like Priya, particularly, it is important to get a profile of the bug to know what medicines could work.

The treatment failure, as Priya – now an avid reader of all issues related to TB – pointed out, is that she was never tested for drug susceptibility properly. “They did not know what medicines worked on me. If they had tested drug susceptibility for all drugs, probably I would be better.”

Priya makes a valid point. Government hospitals do not normally test for the entire profile of drugs that the TB bacilli could be resistant to. Patient groups and activists are asking that the complete profile of the pathogen be tested, as opposed to this limited approach. The treatment can then be tailor-made for a patient.

Clutching at straws

In September 2015, the family took Priya to the National Institute of Tuberculosis and Respiratory Diseases in Delhi, where the physician told her that her TB is incurable and that they should resort to alternate treatment such as homeopathy or ayurveda.

Health activists are shocked by the suggestion. An activist closely associated with the rollout of Bedaquiline in the country said, “What is shocking is that by 2015 the government had already known about Bedaquiline and were even talking of starting a programme here. Why was this girl not told about this drug? Why didn’t they prioritise this girl’s case?”

The family had almost given up hope when they heard of Dr Zarir Udwadia, the chest physician in Hinduja Hospital. Udwadia expressed shock about the doctor’s recommendation of homeopathy or ayurveda and wrote that the prognosis should be “guarded”. He put her on re-purposed drugs that are normally used to treat leprosy and told her family “to try hard” to get Bedaquiline. She was also advised to take Delaminate, a TB drug that is not yet available in India.

In October 2016, Priya tried to get Bedaquiline at the National Institute of Tuberculosis and Respiratory Diseases. Her father said that he knew that he had to be a Delhi resident and was willing to rent a house in Delhi for that purpose. But the doctors told him that Priya cannot avail of the treatment if Priya is not a domicile of the city.

Priya then urged him to file a legal case. Her father asked her, “Will you get better if you file a case?” Priya was adamant. “Many patients do not have the backing I have. What will they do?” she asked.

Drug rollout too slow

Bedaquiline’s rollout in India has been slow and the pace has taken a toll on TB patients who might benefit from the drug, as Scroll.in reported in September 2016.

The reason behind the slow roll out was that the government wanted to be cautious about the drug which had not been tested on Indians yet, explained Indian Council of Medical Research chief Dr Soumya Swaminathan. They wanted the patients to be close to the hospital so that they can be monitored. So far none of the patients has suffered any adverse side effect, she added/

In fact, Bedaquiline is proving to have less side effects as compared to other TB drugs, which have severe known side effects ranging from gastric to psychiatric problems. “Bedaquiline only has the problem of cardiac toxicity, which we now know is not as common,” said Swaminathan.

In an emergency meeting held on December 30, 2016 under directions from the Delhi High Court, a government committee said that Priya needed to undergo another drug-susceptibility test to determine whether she was eligible for Bedaquiline treatment. The committee also said that Priya should continue her treatment with Udwadia, who could procure the drug on the grounds of compassionate use.

Citing compassionate use, a doctor can get the medicine free-of-cost from a drug manufacturer, provided the doctor has convincing evidence that the patients will die without the medicine. This is a commonly-used method of accessing Bedaquline, despite the government stocking the drug for its TB programme.

“The government has abdicated its responsibility,” said Anand Grover, senior counsel appearing for Priya’s father. “It is very conservative and is not willing to part with the drug.”

A new test to prove Priya’s eligibility for Bedaquiline has become problematic. A sputum sample that Priya provided to the National Institute of TB and Respiratory Diseases in October 2016 became contaminated. Since then Priya has become so weak that she has been unable to produce enough sputum for a new sample. In fact, her December samples came out negative for TB on technical grounds.

Dr Jennifer Furin from the Global Health and Social Medicine at Harvard Medical School, in an affidavit submitted to the court on Wednesday, said her previous reports were indicative enough that Priya was eligible for Bedaquiline. Furin also said that the treatment would improve her chances of being cured from less than 50% to more than 80%. Also, the drug would stem the further spread of the disease to people in contact with her.

“The international community has been deeply concerned about the delayed roll out of Bedaquiline in India, the highly limiting enrollment criteria, the strict geographic limitations being placed on patients who need the drug,” Furin stated in her affidavit.

So far, only 164 patients have enrolled for the Bedaquiline programme, while the drugs lying with the government are set to expire in October 2017. Despite this, the government continues to deny treatment to Priya.

In the last hearing on Wednesday, the court has ordered a committee to look into Furin’s affidavit and make a decision on Priya’s treatment by Monday.

“I think we do need to increase the flexibility of the programme,” said Swaminathan. “We have some data and we should be able to go fast now. If the drug is available in the country, every patient should have access.”