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Just days before the dawn of 2013, the US regulator approved a new drug to treat tuberculosis, a first in 40 years.
Bedaquiline, developed by Johnson & Johnson company Janssen Therapeutics, received a fast-track approval for the treatment of multi-drug resistant tuberculosis (MDR-TB), as part of a combination therapy in adults.
But healthcare experts are tempering their applause for the new drug with caution.
Later this month, the World Health Organisation is organising a meeting of experts to review the available evidence on the safety and effectiveness of bedaquiline, besides advising on the use of the drug to treat MDR-TB.
In India, already dealing with TB and resistance that develops in patients against TB medicines – the new drug, when it is brought in, will have to be introduced with great clarity regarding its use and toxicity, say experts and health workers interacting with TB patients.
“We desperately need new TB drugs and therefore the FDA approval of Sirturo is great news. But I am concerned about introducing any new TB drug in the Indian market,” says Dr Madhukar Pai, Associate Professor (Department of Epidemiology and Biostatistics) with McGill University, Canada.
And here’s why. “The (Indian) market is completely unregulated and anyone can purchase any drug over the counter. Also, several studies have shown irrational and irresponsible antibiotic use in India, including for TB.
“So, if the new drug is abused widely, then we will rapidly lose the drug to drug resistance, and that will be a big setback in the race to develop better TB drugs.
“So, new TB drugs must be introduced very carefully and regulated. Doctors must be educated on how to use them as combinations, rather than single drugs.”
From a medical research perspective, it is shameful that a new TB drug has not emerged for so long, says Dr Petros Isaakidis, a Mumbai-based epidemiologist with international humanitarian organisation Médecins Sans Frontières.
“The new drug is great news, bring it on, but bring more,” he says, underlining the need for a clear regimen on how to use the medicine. Reckless use could result in the new drug getting wasted, as resistance would develop against the medicine, he explains.
The drug is not a game-changer, and needs to be supported by a pipeline of new drugs to be effective, he points out. Research should be fast-tracked, so more medicines that are less toxic are developed and it should be targeted at people who need the medicine the most, he says.
In fact, with its robust pharmaceutical industry, India and China (with high disease burdens) should lead the research in TB drugs, he adds.
jyothi.datta@thehindu.co.in
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