Indian girl dying of TB sues to get new drug

Government restricts access to bedaquiline in a bid to retain effectiveness of the only remaining treatment against drug-resistant TB.

An Indian tuberculosis patient rests at the Rajan Babu Tuberculosis Hospital in New Delhi. Chandan Khanna / AFP / March 24, 2014

NEW DELHI // A teenage girl, caught in the crossfire of India’s war on drug-resistant superbugs, is waging a closely watched legal battle for access to a tightly regulated new medicine that her doctor says could save her life.

The father of the 18-year-old girl has filed a lawsuit to force the Indian government to lift regulatory restrictions on access to bedaquiline, the first new treatment for tuberculosis in almost 50 years. The suit, filed in a New Delhi court, comes up for hearing on Monday.

Medical experts believe the overuse of older antibiotics in India has resulted in the country having one of the highest levels of drug-resistant TB in the world. As a result, the government has placed strict controls on the use of bedaquiline to preserve the new treatment’s effectiveness. It is available only through a government programme in five of India’s 29 states, and only as a last resort.

Although the government has said it intends to gradually increase access for more patients, the teenage girl’s lawyer says her suit could become a precedent that forces it to act faster.

In court, the lawyer for the government hospital named in the suit, Saket Sikri, has argued that doctors must adhere to rules requiring that bedaquiline be administered only after a test proving there is no other option, a precaution as much for the patient’s good as the public’s. Her doctor and lawyers argue it could take six weeks to get the results of the added tests, a delay the girl, whose weight has dropped to about 24 kilograms, cannot afford. At stake is a precedent that could help shape the world’s response to the threat of superbugs, determining what takes priority: preserving long-term efficacy of the newest drugs, or acting quickly against a deadly disease.

“India is so restrictive on its policies on bedaquiline and who can get it, they turn these seemingly medical issues into bureaucratic ones,” said Jennifer Furin, a lecturer at Harvard Medical School and an expert in the treatment of drug-resistant TB.

Ms Furin reviewed the teenager’s medical records and recommended to the court that she be given urgent access to the drug.

“This young woman shouldn’t be fighting to access this drug, she should have been offered this drug when she started treatment back in October,” she said.

She called the demand for the new test “a bureaucratic requirement” given that the same type of test in 2014 already showed the patient had the type of TB bedaquiline was designed for, and five years of treatment with most other drugs had all failed.

Keeping such patients sick longer increases the odds they could infect other people with the resistant bacteria, Ms Furin wrote in her opinion.

Manisha Verma, a spokeswoman for India’s ministry of health, did not respond to calls and emails requesting comment on the case. Lawyers representing the government could not be reached for comment.

The type of TB bedaquiline is meant to treat is caused by a class of infections called superbugs that have evolved immunity to the traditional arsenal of antibiotics. The more antibiotics that are used in a general population, the more opportunities bacteria have to gradually develop resistance to them. In 2015, 480,000 people around the world developed TB resistant to multiple drugs, according to the World Health Organisation.

Indian regulators’ approval of bedaquiline was conditioned on the government having control of its distribution, in part to reduce the likelihood of the new therapy being weakened by resistance too, according to Janssen Pharmaceuticals, the pharmaceutical unit of US-based Johnson & Johnson that makes bedaquiline.

“The reason we’ve wrecked all our other drugs is that they were freely available and I think we really need to take care of this drug,” said Ramanan Laxminarayan, director of the Centre for Disease Dynamics, Economics & Policy and a professor at Princeton University. “It’s a public health issue that we get to control access to this drug, make sure someone who is absolutely dying of extensively drug resistant tuberculosis is the one who gets to have it.”

That is exactly the question the teenage girl’s lawsuit could hinge on. Though her family says they were initially told she could not access the drug because she was not from a state designated to administer it, in court the government has argued that to get the drug she must first undergo a new test showing she really needs it. In the hearing scheduled for Monday, which could be the case’s last, the judge has asked the government to defend that assertion.

Without bedaquiline the girl’s chances of survival stand at 50 per cent compared to 80 per cent with it, Ms Furin wrote in her opinion.

The patient’s father, who asked that his daughter not be named to protect her privacy, said she was realistic about her chances but felt it was important to see her legal case through. In fact, he said it was her idea to launch the suit in the first place. He says she told him: “I get better or not, there will be a lesson and other patients will be benefited in future.’”

* Bloomberg