stumbling block

Why aren't more TB patients getting the new life-saving drug? Geography is one reason

Only 30 patients in India have been given the new drug Bedaquiline in the last three months.

Sexagenarian Shekhar Verma* lives in Faridabad, Haryana which is part of National Capital Region. A general store owner, he has developed resistance to many crucial antibiotics while being treated for tuberculosis for the last couple of years. The doctor at the National Institute of Tuberculosis & Respiratory Diseases told Verma that the only antibiotic that has high success for patients like him is Bedaquiline. But he cannot get Bedaquiline under the Revised National Tuberculosis Control Programme, government’s tuberculosis control programme.

To get the drug under the RNTCP, Verma will need to show that he lives in Delhi, one of five cities in which the government is providing the drug. He does not have proof of address in Delhi. He approached a private hospital for Bedaquiline but since the medicine is not available in retail shops, no doctor will prescribe the drug.

Verma's work at his store sustained his family of four for many years. Owing to his unstable health, he stopped going to the store, which is wife now manages. The elder of his two sons works in a security firm.

Akruti Kumar’s* father too has developed extreme drug resistant tuberculosis, often abbreviated as XDR-TB, with a first line of antiobiotic treatment failing him and now relying on second-line treatment. The RNTCP cannot treat him with Bedaquiline since he is a resident of NOIDA and not Delhi.

Location, location, location

Bedaquiline was rolled out under the conditional access programme of the RNTCP in which six hospitals in five Indian cities were chosen to provide the drug under World Health Organisation guidelines. Patients needed to belong to either Delhi, Mumbai, Chennai, Ahmedabad or Guwahati. The government has received doses for 300 patients in donation from the United States Agency for International Development which administers civilan aid from the US to other countries. Three hundred more treatment doses will be donated next year.

Sunil Khaparde, head of Central TB Division of the health ministry said that geographical criterion is important to follow up with patients. “Bedaquiline is administered for six months and follow-up of patients continue for six more months," he said. "Thus, we have to be careful about patients’ proximity to the hospitals.”

“It is a new antibiotic and we need to use it judiciously,"said Delhi State TB officer Ashwani Khanna. "We do not want antibiotic resistance to develop against this medicine.”

Khanna added that superior laboratory facilities are needed to determine which patients can be given the medicine. “Very few hospitals can meet all the requirements – trained doctors and staff, laboratory with all facilities and other facilities in case of an adverse effect.”

He said that the government was being extra cautious with Bedaquiline since it had not undergone a third phase of clinical trials, which are normally large scale trials on human subjects. The USFDA had exempted Bedaquiline from third phase clinical trials on the grounds on exceptional results from the first two rounds of trials and to make the drug available to the public as soon as possible.

Moving too cautiously?

The activist speaking on condition of anonymity said that providing access to treatment is not as difficult as it is made out to be. Patients can even be monitored long-distance with new technological tools. "The main thing to be monitored while administering Bedaquiline is patient’s heart because it disturbs function of heart," he said. "Any patient who is close to ECG testing machine for electrocardiogram, can be given the medicine and monitored from long distance.”

Rational use of antibiotics does not necessitate restricting use. “A robust programme can ensure that there is no misuse of antibiotics and still all needy patients get it," said an activist on condition of anonymity. "To stop misuse, it should not be sold in open market or in private treatments. But it cannot be restricted in a government programme.”

The rigid regime has meant that only about 30 patients have been started on Bedaquiline in RNTCP in the past three months. There is fear that the available doses will go waste if the government does not ramp up its utilisation.

“Delhi has 10 patients and there is a similar number is in Mumbai," said an official who did not want to be identified. "The other cities have 4 or 5 patients each. We can treat 300 patients and the doses expire in October next year.”

Compassionate use

India’s progress is “pathetic” and “glacially slow” in providing such crucial medicine to its ailing population, said Dr Zarir F Udwadia, consultant physician and tuberculosis specialist at Hinduja Hospital in Mumbai. Udwadia is currently treating 25 patients with Bedaquiline citing compassionate use.

“This is almost half of all patients being treated in India,” he remarked. On the grounds of compassionate use, a drug manufacturer gives a medicine free-of-cost to patients if their doctor has convincing evidence that the patients will die without the medicine. Janssen Pharmaceuticals, an arm of Johnson and Johnson, is the drug-maker giving out Bedaquiline. The company has also provided the doses that USAID has donated to the Indian government.

Getting the drug on grounds of compassionate use, however, is not easy. The doctor need to fill in numerous forms based in each of the patient's test results and few practitioners are willing to spend the time. Even when the medicine is arranged through compassionate use, the cost of diagnostics borne by the patient can run into tens of thousands or rupees.

India has 71,000 multi-drug resistant tuberculosis patients. According to a World Health Organisation report, nearly 10% of all multi-drug resistant TB patients have extensively drug resistant TB or XDR-TB, for whom both the first and second lines of antibiotic treatment have failed. Thus, India is estimated to have more than 7,000 XDR-TB patients.

Bedaquiline is administered to pre-XDR-TB patients. These are patients with resistance to isoniazid and rifampicin used to treat MDR-TB and either a fluoroquinolone or a second-line injectable agent, but not both.

The rates of prevalence of XDR-TB are not uniform everywhere, doctors say. “In Delhi nearly 22% of all MDR cases are XDR and pre-XDR. In Mumbai, it is nearly 60%,” said Khanna. Taking this into account, there would be a much higher number of patients needing Bedaquiline.

“It is good that government launched the much needed drug but they are moving too slow," said Chapal Mehra, a TB activist in New Delhi. "We do not know on what basis was the figure of 300 and 600 was arrived at. The government has to estimate both in the public and private sectors who need the medicine and work towards achieving that target.”

Mehra said that the government should work with the private sector to start patients on Bedaquiline.

“There are multiple-barriers to the medicine right now," he pointed out. "Why should a patient from Jharkhand be not eligible for it? Patients from private sector also do not have access to it (through the RNTCP). The programme is structured to privilege a few.”

Learning from South Africa

“India is one of the high burden countries for DR-TB," said Jennifer J Furin, lecturer on Global Health and Social Medicine at Harvard Medical School. "A lot more patients have to be given Bedaquiline soon. The government should use the drug carefully because we cannot waste it to resistance, but the progress is too slow.”

India is lagging behind South Africa, which, through its robust TB programme, has put a large number of patients on Bedaquiline.

“South Africa launched the drug in July 2015," said Furin. "Within three months they had 200 patients on Bedaquiline. As we speak, the country is giving the medicine to 3,000 patients, which is a huge progress.”

India, on the other hand, will not be able to give Bedaquiline to more than 600 patients for the next two years. And this will only create bigger hurdles to fighting TB. Furin said the understanding is that the donors will see India’s progress with regard to the first 300 treatment doses. If this is not satisfactory, then the further donation will face impediments.

*Names changed

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“My body instantly craves chai and samosa”

German expats talk about adapting to India, and the surprising similarities between the two cultures.

The cultural similarities between Germany and India are well known, especially with regards to the language. Linguists believe that Sanskrit and German share the same Indo-Germanic heritage of languages. A quick comparison indeed holds up theory - ratha in Sanskrit (chariot) is rad in German, aksha (axle) in Sanskrit is achse in German and so on. Germans have long held a fascination for Indology and Sanskrit. While Max Müller is still admired for his translation of ancient Indian scriptures, other German intellectuals such as Goethe, Herder and Schlegel were deeply influenced by Kalidasa. His poetry is said to have informed Goethe’s plays, and inspired Schlegel to eventually introduce formal Indology in Germany. Beyond the arts and academia, Indian influences even found their way into German fast food! Indians would recognise the famous German curry powder as a modification of the Indian masala mix. It’s most popular application is the currywurst - fried sausage covered in curried ketchup.

It is no wonder then that German travellers in India find a quite a lot in common between the two cultures, even today. Some, especially those who’ve settled here, even confess to Indian culture growing on them with time. Isabelle, like most travellers, first came to India to explore the country’s rich heritage. She returned the following year as an exchange student, and a couple of years later found herself working for an Indian consultancy firm. When asked what prompted her to stay on, Isabelle said, “I love the market dynamics here, working here is so much fun. Anywhere else would seem boring compared to India.” Having cofounded a company, she eventually realised her entrepreneurial dream here and now resides in Goa with her husband.

Isabelle says there are several aspects of life in India that remind her of home. “How we interact with our everyday life is similar in both Germany and India. Separate house slippers to wear at home, the celebration of food and festivals, the importance of friendship…” She feels Germany and India share the same spirit especially in terms of festivities. “We love food and we love celebrating food. There is an entire countdown to Christmas. Every day there is some dinner or get-together,” much like how Indians excitedly countdown to Navratri or Diwali. Franziska, who was born in India to German parents, adds that both the countries exhibit the same kind of passion for their favourite sport. “In India, they support cricket like anything while in Germany it would be football.”

Having lived in India for almost a decade, Isabelle has also noticed some broad similarities in the way children are brought up in the two countries. “We have a saying in South Germany ‘Schaffe Schaffe Hausle baue’ that loosely translates to ‘work, work, work and build a house’. I found that parents here have a similar outlook…to teach their children to work hard. They feel that they’ve fulfilled their duty only once the children have moved out or gotten married. Also, my mother never let me leave the house without a big breakfast. It’s the same here.” The importance given to the care of the family is one similarity that came up again and again in conversations with all German expats.

While most people wouldn’t draw parallels between German and Indian discipline (or lack thereof), Germans married to Indians have found a way to bridge the gap. Take for example, Ilka, who thinks that the famed differences of discipline between the two cultures actually works to her marital advantage. She sees the difference as Germans being highly planning-oriented; while Indians are more flexible in their approach. Ilka and her husband balance each other out in several ways. She says, like most Germans, she too tends to get stressed when her plans don’t work out, but her husband calms her down.

Consequently, Ilka feels India is “so full of life. The social life here is more happening; people smile at you, bond over food and are much more relaxed.” Isabelle, too, can attest to Indians’ friendliness. When asked about an Indian characteristic that makes her feel most at home, she quickly answers “humour.” “Whether it’s a taxi driver or someone I’m meeting professionally, I’ve learnt that it’s easy to lighten the mood here by just cracking a few jokes. Indians love to laugh,” she adds.

Indeed, these Germans-who-never-left as just diehard Indophiles are more Indian than you’d guess at first, having even developed some classic Indian skills with time. Ilka assures us that her husband can’t bargain as well as she does, and that she can even drape a saree on her own.

Isabelle, meanwhile, feels some amount of Indianness has seeped into her because “whenever its raining, my body instantly craves chai and samosa”.

Like the long-settled German expats in India, the German airline, Lufthansa, too has incorporated some quintessential aspects of Indian culture in its service. Recognising the centuries-old cultural affinity between the two countries, Lufthansa now provides a rich experience of Indian hospitality to all flyers on board its flights to and from India. You can expect a greeting of Namaste by an all-Indian crew, Indian food, and popular Indian in-flight entertainment options. And as the video shows, India’s culture and hospitality have been internalized by Lufthansa to the extent that they are More Indian Than You Think. To experience Lufthansa’s hospitality on your next trip abroad, click here.

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This article was produced by the Scroll marketing team on behalf of Lufthansa as part of their More Indian Than You Think initiative and not by the Scroll editorial team.