Government drags feet on ‘effective’ anti-TB drug

MUMBAI: Bedaquiline, the first anti-tuberculosis drug manufactured after rifampicin almost 50 years ago, has been effective in five Indian patients, shows a new study by a city hospital. But it cannot be prescribed to other drug-resistant TB patients because the Indian government, unlike the West and the World Health Organization, has yet to approve its use.

"We got bedaquiline on 'compassionate grounds' at no cost from its Belgium-based manufacturer for 14 patients," said Dr Zarir Udwadia of Hinduja Hospital.

His study about the presence of totally drug-resistant TB, published in Clinical Infectious Diseases in January 2012, forced the Indian government to immediately introduce special treatment plans for Mumbai, considered the world's TB capital.

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Dr Udwadia told TOI that the first group of five patients with lung MDR TB — an 18-year-old girl and four men in the 22-40 age — responded well. "The results about the patients, who would have otherwise died, were published in the International Journal of Tuberculosis and Lung Disease last week,'' he added. Nine others are in various stages of the six-month-long bedaquiline treatment.

The Hinduja study is significant because patients here didn't develop any heart abnormalities (visible on ECG/electrocardiogram) as a side-effect of taking bedaquiline. "None of the 14 patients show any abnormal ECG patterns,'' said Dr Rohit Amale, who is one of the authors of the Hinduja study.

Minister Harsh Vardhan addressing during the launch of First National Anti-Tuberculosis Drug Resistance Survey, India 2014-15, in New Delhi

TB kills two Indians every three minutes, with drug-resistance growing at an alarming pace across the country (Mumbai alone has over 6,000 patients on MDR treatment). Yet, the Indian government has been reluctant to go ahead with bedaquiline. The US and 27 European nations gave accelerated approval to the drug.

Government officials say there are several reasons for this: bedaquiline is technically still in a trial phase and its cost in some high-income countries is $30,000 for a six-month course.

Dr Soumya Swaminathan of the National Institute for Research in Tuberculosis, an ICMR (Indian Council for Medical Research) lab in Chennai, said people's safety was paramount. "The drug is in trial phase. Moreover, its misuse could lead to further resistance," she added.

Chapal Mehra, an activist working with civil society groups on TB, wants the government to lay down protocols to avoid misuse. "Considering India's rising drug-resistant TB burden, access to new drugs like bedaquiline is essential," he said.

Medical students of various institutions World TB Day in Bangalore

Dr Udwadia wants the Indian government to act. "The drug was launched in December 2012. Our trails have shown that Indian patients, including an HIV-positive man, have done well. It is a tragedy that despite being available for almost 2 years, the government has no plan in place for using the drug,'' he said.

A senior government official said the drug may be introduced as part of a clinical trial or only with public health organizations. A spokesperson for J&J India (J&J owns Janssen Pharmaceuticals that manufactures bedaquiline) said the company has filed for regulatory approval in India. "A special committee has been set up to review the application,'' he added.

Patient story

Sherry (name changed) was 36 years old when she was given 24 hours notice by the Sharjah authorities to leave the country. "During a routine checkup, they found a lesion in my lung and asked me and my children to leave immediately,'' said Sherry, who worked as a schoolteacher. It took another three years before her lesion was diagnosed as extremely drug resistant TB (XDR-TB). "I was treated for allergic cough for 18 months before I crashed and needed hospitalization. That is when I was put on first-line TB drugs that didn't work,'' said the Thane resident. She then met Dr Zarir Udwadia in Hinduja Hospital, Mahim. "He diagnosed it as XDR TB case and when I was found resistant to nine drugs, he asked me to enrol for the bedaquiline treatment,'' she added. The paperwork took a month and she started treatment on August 25. "She is doing extremely well on the drug. Her sputum is already negative for the TB bacillus,'' said Dr Rohit Amale.

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