Death by denial

TB patient-activists in India are calling the limited access to newer and more powerful drugs a ‘human rights violation’

Published - March 11, 2018 12:02 am IST

If one death counts as a tragedy, and a thousand as a statistic, then this is a story about statistics.

The World Health Organisation says that 423,000 Indians die each year of tuberculosis (TB), which is about 1,159 people a day. As standard TB-drug treatments are ineffective for nearly 1,30,000 of the 2.8 million TB patients in India, two relatively-new and powerful drugs, bedaquiline and delamanid, could benefit such patients with drug-resistant (DR) TB. With a success rate of approximately 70%, these drugs are now being called ‘magic bullets’. The Indian government says that nearly 13,000-20,000 patients qualify for treatment with these drugs.

‘Denying care’

But as of today there are 1,000 patients on bedaquiline and another 81 on delamanid in India’s national programme, which has received these drugs as a donation from the innovator pharmaceutical companies.

TB patient-activists describe such limited access as a “human rights violation”. Take for example Nandita Venkateshan, 28, who was diagnosed with abdominal TB when she was 17 and when newer therapies were not available to her. Standard treatment damaged her hearing. “I am deaf. I did not have access to these medicines and my life crumbled to pieces. People don’t know that TB treatment is as toxic as cancer treatment. How is it morally or economically justifiable to deny care to patients? We don’t refuse or ration treatment to cancer patients even though there isn’t a perfect cure. HIV treatment was experimental when patients started getting it because of the gravity of the epidemic,” says Ms. Venkateshan, who now campaigns for access to drugs.

Indian TB patients plan to submit a petition to Prime Minister Narendra Modi during a week-long ‘End TB Summit’ that begins in New Delhi on Monday. Mr. Modi will be delivering the keynote address at the convention, which aims to galvanise global action to eliminate TB.

Bedaquiline is the first new anti-TB drug to be approved by the U.S. Food and Drug Administration in 20 years (Rifampicin was approved in 1974). It is also the first to be introduced specifically for the treatment of drug-resistant TB.

While the drugs have proved their efficacy on smaller cohorts, they are yet to pass large-scale safety and efficacy tests, or phase III of clinical trials, which are necessary for India’s drug regulator approval. Between 70% and 90% of drugs that enter this stage successfully complete phase III. Going by the evidence from cohorts of patients currently on bedaquiline and delamanid, these two drugs are vastly better than standard treatment options.

Case for wider use

A study published in TheLancet Infectious Diseases last month found that 74% of the cohort ‘converted to negative’ within six months, meaning they were successfully treated which led to the researchers advocating a scale-up of both medicines. “Because of theoretical safety concerns, patients have been unable to access the two drugs in combination,” it notes. The study by humanitarian aid agency Médecins Sans Frontières (MSF) concludes that access to bedaquiline and delamanid in combination should be expanded for people with few treatment options while awaiting the results of formal clinical trials.

This opinion is also backed by independent medical experts. Dr. Jennifer J. Furin, Lecturer, Harvard Medical School, says: “Less than 10% of India’s TB patients, who qualify for these drugs are on them. Contrast this with Swaziland, where 90% of patients who needed new drugs received them. Rather than offer them the best possible therapy, TB patients in India are offered old drugs which have terrible side-effects. The newer agents are being ‘protected’ in case other people need them in the future. The older regimen has a 50% success rate and side-effects include permanent hearing loss in a significant proportion of patients (more than 25% in some settings).”

Meanwhile, as the airborne disease fells populations, the TB community has come together to make sure that the deaths of a million people do not remain a statistic. “It is a human rights violation to use just enough TB patients as laboratory rats while withholding treatment from the rest of the patients who either die or go deaf,” says Ms. Venkateshan.

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