NEW DELHI — A woman’s court battle to gain urgent access to a new, government-controlled tuberculosis drug has become a rallying point for public health workers in India’s fight against a growing problem of drug-resistant diseases and attendant widespread health risks.
The new drug, bedaquiline, came to India last year, and it is the only hope for a frail 18-year-old woman in the northern city of Patna who has failed to respond to traditional antibiotics. She was diagnosed as suffering from “extremely drug-resistant” tuberculosis.
But the supply of bedaquiline is tightly controlled by the Indian government, which administers it sparingly to patients in only five Indian cities. Patna is not one of them, making the drug inaccessible for the woman. A hospital in New Delhi at first rejected her on the grounds that she is not a resident, then told her to take a drug-susceptibility test whose results could take several weeks.
The woman’s father, Kishore Tripathi, asked the Delhi High Court in December to direct the government to immediately administer the drug to his daughter. The court case, now being watched by public health experts worldwide, is setting a precedent for many countries that are severely restricting and rationing the rollout of the drug.
“Every day of delay in treating my daughter is critical. This medicine is her right,” Tripathi said. “She is very weak, weighs 55 pounds and is bedridden. She cannot move and can barely speak without getting breathless. She is deteriorating fast.”
Tripathi did not want his daughter’s name to be publicized to protect her privacy, and she is not named in his petition to the court.
Bedaquiline was the first new tuberculosis drug to be developed in 50 years when it was launched four years ago. Officials here say that they cannot allow it to be easily available because it may be misused and patients may develop resistance to it as well.
India has reported more than 1.7 million people with tuberculosis, the largest number of such patients in the world, according to the World Health Organization. Of these, 79,000 people were categorized as multi-drug resistant, a condition caused mostly by overuse of medicines. South Africa, by comparison, has only 10,000 patients who have developed resistance to the antimicrobial drugs.
India now wants to preserve bedaquiline’s effectiveness by controlling its supply.
“We have to follow strict protocols and guidelines in administering the medicine, otherwise it can be disastrous,” said Saket Sekri, a lawyer for the National Institute of Tuberculosis and Respiratory Diseases in New Delhi. “If it is used incorrectly without the drug-susceptibility test, patients may develop a resistance to this drug, too.”
But the government’s restrictive and slow implementation is proving to be an ethical dilemma for public health providers.
“This unfortunate girl has a highly drug-resistant strain. She is therapeutically destitute, having run out of almost all available drugs,” said Zarir F. Udwadia, a pulmonologist in Mumbai who examined the teen. “The government program has essentially given up on her and told her she can’t be helped. To say this, when there is an available new TB drug, strikes me as medically and morally wrong.”
Fewer than 200 patients have been administered the drug in India. And it is not the only country restricting the supply of bedaquiline. Countries such as Mexico and Brazil have also moved at a glacial pace, experts said.
Now, global specialists are weighing in on the young woman’s case.
“She has already been diagnosed as multi-drug-resistant; they don’t need to wait for test results to start bedaquiline,” said Jennifer Furin, a lecturer in the department of Global Health and Social Medicine at Harvard Medical School who last week gave her written opinion to the Indian court. The additional test is a “bureaucratic requirement that is not in the best interests of this patient,” she wrote. “The delay would only worsen her clinical status and put public health at risk.”
Several governments are trying to protect the drug, instead of protecting the patients’ lives, and the Indian court case will set a precedent for many nations, Furin added.
On Friday, Indian and international tuberculosis experts wrote a joint letter to Prime Minister Narendra Modi urging him to make bedaquiline available immediately to multi-drug-resistant and extremely drug-resistant patients.
Health activists said only two dozen labs in India are equipped to conduct the drug-sensitivity tests, forcing patients to travel long distances by train and posing hazards to many others along the way.
Tripathi’s daughter has traveled 15 times since 2014 to visit hospitals in New Delhi, he said.
“It was my daughter who pushed me to file a court case,” Tripathi said “She said, ‘I may not get the medicines in time, I may not get cured, but so many others will benefit from the verdict.’ ”
The court is scheduled to meet again Wednesday.