Multi-drug resistant TB: Global NGO slams makers of new-age drugs over high price, opaque practices

The Médecins Sans Frontières (MSF) or Doctors Without Borders, an international NGO, has slammed makers of anti-tuberculosis drugs of adopting obscure practices. In a well-timed report – Ready, Set, Slowdown which was released on Saturday – MSF has said that while new drugs by firms like Janssen, Otsuka, Novartis and Pfizer provide hope, they remain largely out of reach of patients for reasons best known to the pharma giants. A top MSF official even  termed it a ‘scandal’. March 24 is observed as World TB Day.

What is the present line of treatment? 
Currently, four drugs – Isozianid, Rifampacin, Pyrazinamide and Ethambutol – are used to treat TB. However, things get complicated when a patient develops resistance to this first line of treatment. In India and many countries, it is nearly impossible to manage multi-drug resistant (MDR) TB cases.

Which are the new-age drugs? 
Globally, four modern drugs – Bedaquiline by Janssen, Delamanid (Otsuka), Linezolid (Pfizer) and Clofazimine by Novartis – are considered as potent weapons against MDR-TB. However, they are out of reach of Indian patients as they are either not available here or frightfully expensive. A six-month course of Bedaquiline can cost up to Rs 2 lakh. 

How many drug resistant cases are there in India?
According to the World Health Organisation, an estimated 61,000 people in India are living with MDR-TB, the highest in the world, while only half of them have been identified. Across the world, about 4.8 lakh people carry the drug-resistant strains of the bacteria, with the diagnosis rate being 30%, says the MSF report.

Has anyone in city been given these medicines?
Two weeks ago, a 39-year-old man under the care of Hinduja Hospital was declared cured after he was put under a six-month course of Bedaquiline. The medicine was made available under compassionate grounds by Janssen. Dr Zarir Udwadia, who treated the patient, said about 10-15 patients from Hinduja are currently on Bedaquiline. “Only 50% of those patients in need get the drug.” India may make Bedaquiline available under the government programme later this year or early next year. 

Why has MSF slammed the pharma firms?
The MSF report says the drug-makers were given some or the other concession while they were developing the life-savers. But they are apparently not passing on the economic benefits to the patients. For instance, the report said, US-FDA helped Janssen get approval for Bedaquiline in less than six months. While the firm and USAID have announced a donation programme, the details remain hazy. Similarly, in 2014, Otsuka had applied for registration in EU, Japan and South Korea, but its pricing structure outside of these regions is unknown, said the report. 

What do MSF officials say?
“With the TB community waiting for new drugs for 50 years and more than 200,000 patients dying from MDR-TB every year, the very slow uptake of the new TB drugs is a scandal. Only by significantly scaling up the number of people diagnosed with drug-resistant tuberculosis, with all patients receiving treatment, will we see a drastic fall in the rate of new infections and deaths,” writes Dr Jennifer Cohn, Medical Director, Médecins Sans Frontières Access Campaign, in the report.

Out of reach:

Drug                 Price (in rupees)
Bedaquiline   -   2 lakh for 6-month course (no generics till 2029)
Linezolid       -   4,000 per pill
Delamanid    -   (unavailable in India) 18-25 lakh for 6-month course (no generics can be formed till 2031)

Clofazimine is an anti-leprosy drug, but Novartis restricts its use for TB.  “It is vital that Clofazimine is registered for use in treating TB and alternative suppliers are found,” emphasises the report.