MUMBAI—Debshree Lokhande recalls trying everything to get rid of her cough, including syrups, lozenges, tablets, and Ayurvedic remedies. She had just moved to a new city and started her first job, fresh out of university. But within days, she said she was vomiting up “bowlfuls” of blood, her weight was falling sharply, and she was experiencing night sweats. A chest X-ray soon revealed that she had contracted tuberculosis. In normal circumstances, TB is a treatable disease—you just need the right doctor to administer the right combination of drugs. Back then, in 2011, Lokhande would have neither.
For three years, she was prescribed varying cocktails of medicine, the combination changing every few months when the previous one didn’t work. Lokhande calls that period the years of loss—treatment did not cure her, and she lost her job; she also lost so much weight that at one point she was wheelchair-bound; one of her prescribed medicines led to a loss of hearing; she lost a lung. She lost, too, the life she had wanted for not just herself but her family—Lokhande’s doctor had not informed her and her relatives of the precautions required when living with a TB patient, so she unwittingly passed the infection to her younger sister.
Through all this, Lokhande did gain one thing: resistance. Yet this was no victory—the erratic prescription of antibiotics had made her resistant to tuberculosis drugs, and by 2014, she was diagnosed with extensively drug-resistant, or XDR, TB, a nastier version of the disease against which most powerful antibiotics do not work. Lokhande’s doctor gave up, advising her mother to take her home and pray.
Lokhande’s story illustrates that developing new treatments is only one part of the battle to combat infectious diseases—whether ancient bacteria such as tuberculosis, or COVID-19, the disease caused by the novel coronavirus. In cases such as Lokhande’s, in places such as India, poor regulation, improperly functioning medical systems, and wayward doctor training are in many ways more-difficult hurdles to scale.
“Everything that could go wrong, went wrong,” she told me.
In November 2014, Lokhande was wheeled into Zarir Udwadia’s clinic in Mumbai’s Hinduja hospital. Then 27, she weighed barely 60 pounds, and her clothes hung over her in no defined shape. Udwadia, one of India’s leading TB experts, told me he was appalled at the poor treatment Lokhande had received, and immediately recommended one of two relatively new drugs designed to treat XDR TB.
After years in which her body had been battered, her finances crippled, her life upended, Lokhande’s struggle still had far to go.
Tuberculosis is an ancient disease: In the age before modern science, it was called consumption, so named for what it did to a person’s body—consuming it. When people contract tuberculosis, they rapidly lose weight, start coughing up blood, and turn pale, as if life is being slowly sucked out of them. (One of the disease’s other historical names was the white plague, for the anemic pallor of those infected.) Today, TB, which is transmitted through the air and is easily passed between people, is the leading cause of death from infectious diseases worldwide. The World Health Organization estimates that 1.8 billion people, or about a quarter of the world’s population, are latent carriers of TB.
Like many things in India, TB exists here on an enormous scale. Of the 10.4 million new TB cases reported globally each year, 2.8 million are in India. The explosion of TB has become so grave in India’s megacities, where sneezing or coughing etiquette is not commonly practiced, that Udwadia has warned it is deadlier than Ebola. Some 480,000 Indians die of TB each year, more than 1,300 each day. During the peak of the AIDS epidemic, South Africa, the worst-affected nation in the world, reported fewer deaths per day.
Yet a crucial distinction between TB and HIV, the virus that causes AIDS, is that TB is curable. Most properly organized treatment plans for TB last at least six months, and typically result in a full recovery. A poorly designed plan, however, can be dangerous, leading to the development of long-term drug resistance.
Herein lies one of the many problems with treating TB in India. The country’s health-care system encompasses both government and private providers, and Udwadia and other leading TB researchers maintain that inappropriate prescription practices in the privatized sector—including small mom-and-pop clinics and swanky hospital chains—have amplified the spread of drug-resistant TB. As Udwadia concluded in a 2010 study, patients such as Lokhande were turning up with treatable versions of TB, only to be given inappropriate combinations of antibiotics that did not fully treat the disease, allowing it to build resistance against drugs. Indian doctors, he found, were not curing TB; they were strengthening it.
Getting access to the right doctor doesn’t mean you are in the clear, either. In recent years, two new drugs have been developed to combat drug-resistant TB. Bedaquiline and delamanid are fast-acting, effective oral therapies with fewer side effects compared with previous TB medication, and they both received accelerated approval from the United States Food and Drug Administration, in 2012 and 2014, respectively. The Indian government has, however, restricted the two drugs’ distribution here. It initially argued that the treatments were not safe, because the FDA had granted accelerated approval, and so made them available to only a small group of patients. Then, when the WHO updated its guidelines to recommend bedaquiline and delamanid as frontline medication to treat drug-resistant TB, the authorities here said the national policy was to restrict access in order to prevent misuse and overuse.
As of January 2020, the Indian government had 20,000 courses’ worth of bedaquiline and 400 of delamanid, all donations from each drug’s pharmaceutical manufacturer. But according to Indian health-ministry data obtained via a Right to Information request, only 4,227 patients were put on bedaquiline nationwide through all of 2018 and 2019, while the Indian government has nearly run out of its limited stock of delamanid, The Hindu has reported. By conservative estimates, about 150,000 people who suffer from drug-resistant TB in India are not allowed to take medication that is available to patients elsewhere in the world. Much like those who suffered from HIV/AIDS in the early years of that disease, many Indian TB patients must grapple with a difficult reality: Available drugs do not work for them, and newer medication is out of reach.
“The government is protecting the drug as opposed to protecting the patient,” Udwadia told me. “If we had free access to [both] drugs, thousands of patients would be deserving candidates.”
To critics of the Indian government’s policy, this rationing of much-needed medication is a human-rights violation, one that future generations will look back on in shock and disbelief. Indians must wade through a sea of red tape to show that they qualify for these drugs. That process involves a battery of tests with government laboratories, and recommendations not just from a doctor who has already treated the patient but also a doctor in a government hospital, both of whom must confirm that the patient is a bona fide TB sufferer. The wheels of India’s epic bureaucracy slowly turn, with little consideration of the patient’s dire need for treatment. Some have tried to sue the Indian government to access the new medication; the most well-known case involved Shreya Tripathi, a teenager who suffered from XDR TB yet was denied bedaquiline. She took her case to the Delhi High Court and won, but her victory was a Pyrrhic one: Tripathi died in October 2018 because, her doctors and relatives say, of delays in accessing treatment.
In other countries with a high burden of TB, bedaquiline and delamanid are more easily available. South Africa—which has a TB burden second only to India’s—in 2018 became the first country to make bedaquiline available for free from its government hospitals.
“Anytime someone says they need to protect the drug, I say, for whom?” Jennifer Furin, a TB specialist and a lecturer on global health at Harvard Medical School, told me. “I have patients who line up at my clinic every single day. Would you like me to tell them that I cannot give them medicine right now, because somebody else might need it in the future?” Furin appeared as an expert witness during Tripathi’s trial, arguing that the government should allow Tripathi access to bedaquiline immediately. She unequivocally maintains that India’s current policy is a gross human-rights violation. (Preeti Sudan, the top official in India’s health ministry, did not respond to an emailed list of questions.)
Lokhande initially tried another route to acquire the medication, by appealing to the companies that make bedaquiline and delamanid, as well as to nongovernmental organizations. The early returns were positive: In December 2014, after six weeks of back-and-forth with Janssen Pharmaceuticals, the Johnson & Johnson subsidiary that manufactures bedaquiline, she was given a six-month course of the medicine.
“Almost immediately, I started gaining weight, and for the first time, had hope that I might survive this thing,” Lokhande told me. Before long, she was physically able to undergo surgery for an implant that helped alleviate her hearing loss.
Yet in July 2016, when her weight began to drop again, tests showed that she was still positive for TB. Udwadia prescribed both bedaquiline and delamanid, attacking the disease with a stronger combination of drugs. For delamanid, Lokhande approached Médecins Sans Frontières and eventually began a 22-month treatment plan in February 2017. (She did not approach the drug’s Japanese manufacturer because Udwadia was able to connect her to MSF more quickly.) When they went back to Janssen for an extension to the compassionate access granted in 2014, the company told them that, in keeping with industry standards, it only granted such treatments once.
Lokhande, having avoided India’s health-care bureaucracy for so long, finally had to approach a government-run facility here in Mumbai for bedaquiline. It would take her family nearly two months to obtain the necessary paperwork required to get official approval for the drug. Her first six-month course began in late 2014. By the time everything was in order and she was granted another course, it was November 2016.
“It shouldn’t be this difficult to get access to lifesaving medicines,” she told me.
India no longer allows companies to grant compassionate access to bedaquiline. The government tried to convince Johnson & Johnson to sign a license allowing an Indian generic-drug company to manufacture the drug in exchange for paying J&J a fee, along with a royalty on sales, but the pharmaceutical firm declined. “Rather than pursue voluntary licensing,” the company said in a statement, “J&J is working diligently with [India] on its national TB program to increase patient access to bedaquiline, in a manner that is responsible, affordable and sustainable.” Otsuka, which makes delamanid, said that provisions were “under way” for the drug to be manufactured in India by a generic-drug company once a transfer agreement was completed this year.
Lokhande is now free of TB (as is her sister), but six years of poorly administered and interrupted treatment for TB damaged one of Lokhande’s lungs, and she had it removed entirely in 2017. In a way, she was lucky, initially able to avail herself of bedaquiline for a period without having to navigate the government’s restrictions. She now helps other TB patients work their way through the system, and campaigns for officials to lower the barrier to the drugs’ access.
When I saw her recently at the Union World Conference on Lung Health in Hyderabad, she had the words One Lung Club tattooed on the side of her arm in henna. Three other TB survivors alongside her had the same tattoo, and they all posed for pictures, joking about their club’s growing membership.