An international health initiative has brokered a landmark accord that aims to halve the price patients pay for advanced tests for a strain of tuberculosis that is resistant to standard drugs.
The deal is between the makers of diagnostic equipment that can detect multi-drug-resistant TB and private Indian clinics that test patients. Together, they could fill a big hole in international efforts to combat more-virulent forms of the disease by creating a matchable model.
India is fighting a TB epidemic. In the past year, a Mumbai hospital has been reporting an increasing number of patients—now numbering 22, who are resistant to virtually all of the dozen treatments commonly used against the disease.
Under the accord—coordinated by the nonprofit Clinton Health Access Initiative and a McGill University professor—several diagnostics makers will give private Indian laboratories the same steep discounts offered to India and other poor governments. In return, the laboratories agreed to a top price for the tests that is about half of the current market price in India.
"We convinced the manufacturers that if they made the best diagnostics more affordable, a much larger numbers of patients would use them. That's good for the manufacturers and good for TB control," said Madhukar Pai, an associate professor at McGill University in Canada and one of the world's top TB experts, who helped organize the initiative.
The Indian government, supported by the World Health Organization, runs a national program to test and treat TB free of charge. But about half of TB patients don't use the government program because many believe they will receive poor medical care in the public-run sector.
Many TB victims instead seek care from private medical providers, who often offer cheap, inaccurate tests and inadequate treatments, fueling the spread of drug-resistant forms of the disease.
"Either a patient with no disease is put wrongly on TB treatment or a patient with disease is not treated," said Navin Dang, a New Delhi laboratory owner and an organizer of the initiative. "The poor TB patient in India suffers terribly as a result."
The potential impact of the new initiative remains uncertain due to the reluctance of India's Central TB Division to endorse it. New Delhi's support is crucial to persuade private physicians and patients to use their tests rather than the poor diagnostics, the initiative's organizers say.
Dr. Dang said the WHO has endorsed all of the discounted diagnostics and they are widely used globally. But the Indian TB officials say they haven't validated some of them. In particular, after about a year of pilot tests, the TB division hasn't adopted GeneXpert—a rapid test to detect TB and drug resistance within two hours—and the pilot studies continue.
Last week, Dr. Dang said he and other organizers visited the TB division and invited officials to endorse their efforts to bring good discounted diagnostics to private laboratories.
"I was quite disgusted" by the reaction of the officials, Dr. Dang said. "They refused to come on board. They said these are not validated tests. How can they not be validated when the WHO themselves endorsed them? They've been widely reported in publications internationally as accurate tests."
Ashok Kumar, the head of the TB division, didn't return phone calls seeking comment.
"The government welcomes all initiatives that support the fight against tuberculosis," Anshu Prakash, joint secretary of health for India, who oversees TB, told The Wall Street Journal on Friday. He said he wasn't told why the TB division didn't endorse the effort but said it might have been because a written proposal wasn't submitted. He added that he also needed to review a proposal in writing before endorsing the initiative.
Dr. Pai and Dr. Dang said they canceled plans to announce the initiative with fanfare in New Delhi on Friday because of the TB division's refusal to participate. Both men said the initiative would still go forward, but it would be less likely to be widely adopted without the government's stamp of approval. An official with the Clinton group declined to comment.
"For the uptake to be huge, we need to be able to get the word out to private sector doctors and to patients that these are the tests they should be using and that we are discounting them," Dr. Pai said. "For that, the government's help is important."
Dr. Pai said even at the discounted price of 1,700 rupees, or $35, the GeneXpert and other good TB diagnostics would still be unaffordable to many Indians. "We acknowledge that we are still a long, long way from a test that will be affordable to the masses. There needs to be a 100-rupee test. But this is a critical first step."
Under the Indian government's TB program, TB deaths have declined. But TB remains the leading cause of death by infectious disease in the country's adults.
The airborne disease, usually affecting the lungs and spread through coughing and sneezing, can be cured with a treatment of four medicines taken for six months. But patients often go undiagnosed for months, spreading the disease to others. Inadequate treatment allows the TB bacteria to mutate into a stronger form, fueling drug resistance.
India is home to the largest number of TB patients—2.2 million of the world's 8.7 million, according to the WHO's latest estimates.
Despite the decline in regular TB, drug resistant strains of the disease have worsened and spread here and globally. There hasn't been a nationwide survey of drug resistance, but India and the WHO say 2% to 3% of India's TB patients are drug resistant. However, pilot tests of a new rapid diagnostic suggest a rate of 6.7% at 18 sites around the country. The same preliminary analysis showed rates were far higher for Mumbai, where 28% of patients tested at one clinic were resistant to the most powerful TB medicine.
Mumbai made international headlines last year when a physician researcher reported several patients whose disease didn't respond to 12 of the most commonly used TB medicines.
The Clinton group and Dr. Pai began a year ago visiting manufacturers of the GeneXpert and several other diagnostics, said Dr. Pai, convincing them to extend their public sector discounts to the private sector in India because so many poor people sought care there.
"The reality in India is poor people are getting treatment in the private sector. It's not just rich people. So if you want to improve TB care, you have you make sure accurate testing is available in the private sector," Dr. Pai said. "It also makes good economic sense for the manufacturers to try to increase volumes by lower the price."
Because the best diagnostics were unaffordable to most Indians, inaccurate tests have proliferated in India, TB expert say. The Indian government last year banned one of the inaccurate diagnostics, although many are still performed by small laboratories because few other cheap alternatives are on the market.
"I realized it wasn't enough to ban bad diagnostics. You had to make sure consumers had access to affordable good diagnostics," Dr. Pai said.
Dr. Pai said he and the Clinton group canvassed the Indian laboratory industry, convincing 27 of the 400 laboratories in the country to agree to a price ceiling on the diagnostics they purchased at the steep discount.
Dr. Dang, who owns Dr. Dang's Lab Private Ltd., said he signed up for the initiative in the national interest. The agreement requires the participating labs also not to use certain inaccurate tests and to register all patients with the Indian government.
"So much manpower is wasted because of TB," he said. "India cannot advance economically if we let more than two million people a year suffer from TB."
India's own strategic plan for TB calls for improving medical care in the private sector, in addition to scaling up testing and treatment of drug resistance nationwide.
India's director general of health this year said India would improve TB treatment in the private sector by soon extending the free drug program in the public sector also to patients being treated in the private sector—provided they were under the care of qualified doctors who registered them in a government database. The government last year required all private doctors to register TB patients, but few are complying.
Source: The Wall Street Journal