Global TB Fight Hits a Wall

India's New Strategy Actually Makes Disease More Drug-Resistant, Doctors Say

Satish Gupta, whose treatment for drug-resistant tuberculosis isn't working, outside his Mumbai home.

MUMBAI—Here on center stage in the global crisis of drug-resistant tuberculosis, top doctors are sounding a new alarm: India's emergency strategy to defeat the disease may be having the opposite effect—encouraging TB instead to mutate into more deadly and unstoppable strains.

In its new strategy, India is treating some, and perhaps many, drug-resistant TB patients with drugs that they are already resistant to. That can allow the bacteria to build resistance to new drugs as well.

On Friday, a prominent specialist described research to The Wall Street Journal showing that the government's treatment plan wouldn't work on fully two-thirds of the 300 patients analyzed at one major Mumbai hospital. The results suggest India's plan is "a futile exercise" that will "serve to amplify resistance," said the researcher, Dr. Zarir Udwadia. "It is morally and medically disastrous."

Shown the findings, Mario Raviglione, director of the World Health Organization's Stop TB Department, called India's approach to treating drug-resistant TB "complete nonsense."

Ashok Kumar, head of the Central TB Division of India's health ministry, declined several requests for comment.

India estimates it is home to 100,000 patients with drug-resistant TB—the most in the world—but for years it officially ignored them in favor of treating traditional TB, which is more common and curable. That policy left drug-resistant strains to spread and worsen. For countless thousands of people, it amounted to a death sentence.

Last year New Delhi made a historic policy reversal, scaling up a new strategy for treating drug-resistant patients. The change followed a Journal investigation in 2012 revealing that India, for years, had ignored evidence of increasing drug resistance and today likely has far higher rates of resistant TB than officially reported. The Journal also showed that the WHO's own policies inadvertently helped drug-resistant TB to flourish.

Drug-resistant strains are edging up in the U.S. and increasing in parts of Europe, though most cases are in India, China and Russia, the WHO says. In some Indian patients, TB is now all but incurable.

A half-century ago, researchers discovered that tuberculosis—a fatal disease often characterized by the coughing of blood—could be cured with a cocktail of antibiotics and chemotherapy drugs. The problem, however, is that if a patient's TB is resistant to some of those drugs, the cocktail won't work.

Instead, the bacteria can quickly mutate to become resistant to the other drugs in the cocktail. This is how a once-curable killer has, over time, become almost untreatable again. There are many strains of TB with varying resistance to the dozen or so standard drugs.

The issue with India's new program, doctors say, is that tries to be one-size-fits-all: The same six-drug cocktail is given to every drug-resistant patient, without thorough testing to see which they are resistant to.

Experts say at least four of the six drugs must work for most patients to be cured.

A top official in Mumbai's TB program said the city has greatly expanded its drug-resistance treatment this past year. She complained of a lack of accredited labs in the city for testing patients for resistance.

She said Mumbai has been "begging" the central government to change its policies so that drug-resistant patients are first tested thoroughly before being put on a particular cocktail. Despite these obstacles, she insisted Mumbai's program remained effective for many patients. "Our results are more encouraging than what we thought," she said.

The WHO's Dr. Raviglione said, "It is silly to use drugs that there is proven high resistance to, thinking they will work." The WHO recommends testing patients for drug resistance. If there aren't enough labs to do that, he said, Mumbai should conduct surveys to see which drugs its patients are most resistant to, then replace those drugs in the standard cocktail.

Dr. Alpa Dalal, a chest physician at GTB Hospital, Mumbai's main TB hospital, said she has been warning government TB officials that the standard cocktail isn't working for many of her drug-resistant cases. For these patients, time is of the essence, she said. "When you notice they are not responding, by that time you have lost the chance to treat them forever," she said. "And they have gone on spreading the disease in the community."

The world is battling an epidemic of drug-resistant TB. India has about 2.2 million of the estimated 8.7 million total TB patients world-wide, the most of any country. Last year it said it would scale up its treatment of drug-resistant TB and eventually test all TB patients for resistance at their initial diagnosis.

Several studies suggest substantial resistance here in Mumbai to many drugs in the government's treatment regimen. A preliminary analysis of one study under way showed that 28% of all TB patients tested in Mumbai were drug-resistant.

"It's a disaster on a huge magnitude," says Nerges Mistry, head of the Foundation for Medical Research, a Mumbai nonprofit that studies TB.

One basic problem: India doesn't have enough labs to test every patient for resistance, and likely won't for years. In light of that, some physicians say they are troubled by the fact that the government hasn't yet accredited one private lab in Mumbai—Hinduja Hospital, where Dr. Udwadia works—that they consider the most experienced in the country at testing patients for drug resistance.

"I don't understand why they don't accredit Hinduja," said Soumya Swaminathan, director of the National Institute for Research in Tuberculosis, part of the government's network of biomedical research institutions.

Last year Dr. Kumar, head of the health ministry's Central TB Division, publicly criticized Hinduja Hospital and its researchers, saying their findings of "total drug resistance" published in a medical journal would hurt Indian tourism and should have been reported to him first.

In recent interviews, Dr. Kumar said a government hospital in Mumbai would be accredited soon. He also said Hinduja's lack of accreditation was because the government's accreditation team is short-staffed and focused on processing applications from public hospitals first.

Because of Hinduja Hospital's reputation, patients flock there, often paying out of pocket for its tests to determine what drugs they might be resistant to.

On January 29, 17-year-old Satish Gupta, a winsome teenager limping from severe knee pain, a side-effect of one of his TB medicines, showed up with his brother at one of the Mumbai treatment centers. They carried a report from Hinduja showing Mr. Gupta is resistant to three of the six drugs on the government's regimen, including the one causing his pain.

Despite his Hinduja report—and a note from his physician suggesting his cocktail of drugs be tweaked—the government program refused to modify his regimen. "Hinduja not accredited," a government TB official wrote on official stationery.

A senior official in Mumbai's TB program said Mr. Gupta was treated according to the recommendations of the government program as well as a team of experts consulted on all cases. In the absence of any accredited labs, she said, she has urged program doctors to be flexible and change drugs if reports from any lab indicate resistance.

Mr. Gupta is lucky in one sense. His family, which runs a tiny store on a narrow alley, has enough money to try to pay out-of-pocket for the drugs that have a chance of curing him, since the government-provided ones don't seem to work for him.

"We will pay whatever it takes for Satish to get well," said his older brother, helping Satish hobble down the steps of Hinduja Hospital.