Bharathi Ghanashyam, Founder &Editor, Journalists against TB, talks about the story of (multi-drug-resistant tuberculosis) MDR – TB control in India, which seems to be stuck at the foreword and asks when does it move forward
For the first time in over 125 years we have new diagnostics, we have two new drugs — bedaquiline, manufactured by Janssen Pharmaceutica NV, and delaminid, manufactured by Otsuka Pharmaceuticals, after a wait of 50 years (this article will talk only about bedaquiline). We finally have strong tools with which to fight a disease that has been defeating us down the centuries. And it seems like we are frittering away the opportunities, stuck as we are in red-tape and seemingly needless delays in effectively using these tools.
MDR – TB is a lethal form of TB. As defined by World Health Organisation (WHO), it does not respond to at least isoniazid and rifampicin, the two most powerful anti-TB drugs. It currently requires the patient to be on treatment for 24 months or more, with six other drugs, including injectibles for an intensive phase of six months and a continuation phase with four drugs for 18 months or more. These drugs are toxic and induce severe side-effects.
The numbers are growing
Dr Jennifer Furin, an infectious diseases specialist in Harvard Medical School has observed in one of her papers that “…unless the management of MDR TB changes radically, it will be one of the main drivers of antimicrobial resistance, which could kill more persons than cancer by 2050…”
According to WHO, about 480 000 people worldwide developed MDR-TB in 2015; nearly half of whom were in China, India, and the Russian Federation. Worldwide, only 52 per cent of MDR-TB patients and 28 per cent of XDR-TB are currently successfully treated. More alarming was the fact that about 9.5 per cent of MDR-TB cases had extremely drug-resistant TB (XDR-TB).
As per the TB India 2017 report of the Central TB Division, India is home to the highest burden of MDR – TB. An estimated 1.3 lakh MDR – TB patients emerge annually in India. Despite the grim situation, instead of waging a full-scale war, we are still making our first weak battle cries. Let’s look at the history of what has been done.
The history of inaction
January 2015: The Government of India approved the use of bedaquiline (BDQ) for about 500 patients under the national TB control programme. However, no plans were announced to make the drug available to the private sector, when in India, traditionally, more than half of those afflicted with TB, including MDR – TB seek treatment from the private sector. No data is available for how many patients actually received BDQ that year.
March 2016: On the eve of World Tuberculosis Day, Health Minister JP Nadda launched BDQ as part of the national programme for MDR – TB and XDR – TB patients. The drug was to be introduced at six tertiary care centres across India, which had advanced facilities for laboratory testing and intensive care for patients. It was to also be introduced in 104 districts across five states. There is no data available on how many patients received BDQ during the year. A year had passed with little or no progress.
March 2017: The Government of India announced that it would expand access to BDQ and make it available in 140 government-run centres by November. The Annual Status Report of RNTCP reported that till December 2016, more than 207 drug resistant TB patients had been initiated on BDQ containing treatment (BDQ is given in combination with other drugs).
Dr Sunil D Kharpade, Deputy Director General, Head, Central TB Division,Project Director RNTCP, responding to questions by e-mail responded, “The yearly estimated number of BDQ eligible patients in the public sector as per existing criteria is around 7000 – 8000.” He also revealed that 443 patients have been enrolled into the programme across the sites.
Juxtaposed against the number of people requiring the drug, what has been achieved does not even do justice to a pilot-programme. These numbers also do not take into account patients in the private sector who are eligible for the drug. A press note uploaded on the website of the Central TB Division of the Government of India on 25 May 2017 cautiously mentions, “For patients being treated outside the government system, the manufacturers are providing this drug under Compassionate Use Programme free of cost to the doctors, provided they follow the recommended guidelines for starting the drug and its close monitoring.”
A lot of time has gone by
Implementation of the plans outlined by the Central TB Division for the use of BDQ has been something of a non-starter. There has been no resolution to concerns on whether the drug stands the danger of being misused; whether it would end up being available over the counter without prescriptions and most of all whether patients would become resistant to the only really powerful weapon available for TB.
These fears might be unfounded. Prof Furin says, “While it is certainly true that many antibiotics can be purchased without prescriptions, it is highly unlikely that newer agents like BDQ and delamanid would be purchased on the open market. They have no indications for use other than in the treatment of serious mycobacterial disease, such as TB. So the risk of them being sought after for broad use is very low.”
That patients in need of the new drug are running out of patience is evident from the case that was recently filed by the father of an 18-year old patient of XDR –TB in the Delhi High Court. He demanded that his daughter be given BDQ as that was the only drug that could save her life. In counter argument, The National Institute of Tuberculosis & Respiratory Diseases (NITRD) argued that administering BDQ without testing the drug resistance of the bacteria in the patient and formulate the right bedaquiline containing regimen(emphasis by the author), might result in the bacteria becoming resistant to BDQ and spread in the community (as appeared in a leading daily).
Some experts have also remarked that the drug needs to be protected for future patients and hence rational use is advised. It is debatable whether protecting the future at the cost of the present will be good strategy, because it is the present which will infect the future. Ignoring this might result in the perpetuation of a cycle which might be difficult to retrieve from.
There appear to be more barriers than enabling factors in the bid to use promising new drugs that can save lives. The irony is that this situation exists despite Janssen Pharmaceutica having come forward to donate 600 courses of BDQ to India under their compassionate use programme. India was unable to absorb these courses for reasons known and unknown.
There seems to be movement at last. It is learnt that the Global Drug Facility (GDF) of the Stop TB partnership will be facilitating the USAID donation of 10,000 courses of BDQ to India before the end of 2018. 3,500 courses of these will be dispatched during 2017 and the balance 6,500 in 2018. RNTCP has requested 1000 courses as first tranche, 660 of which are being dispatched immediately.
While this is good news, the numbers don’t add up. If as mentioned earlier in the article, only 443 have been enrolled, who will use the rest? There are questions that the Central TB Division of the Government of India needs to answer and answer fast.
It is pertinent to end this piece by quoting excerpts from the first press briefing by Dr Tedros Adhanom Ghebreyesus, WHO Director-General elect, on 24 May 2017. “I think something that was coming very, very clearly was people identifying health as a rights issue. Health is a rights issue. All roads should lead to universal health coverage. And it should be the centre of gravity of our movement. And when you say universal health coverage, it’s addressing the financial barrier. It’s addressing the challenge we are facing with regard to access to drugs.” I rest my case.
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