Awaiting a coherent approach in the battle against TB

TSHERING EDEN
The recently established ‘DOTS Plus site’ which houses MDR TB patients is located in a corner of the STNM Hospital, Gangtok, near the private ward building. A big airy room with windows stretched across one wall receives a light breeze and sunlight. There are 10 beds, of which 5 are occupied. There are few others walking about who are there to attend to the patients. Of the five patients, three are in their early twenties while the other two are middle-aged. The stillness in the room is broken by the intermittent coughs coming from the patients. What one cannot miss are the masks that cover the mouths of most of the patients and their caregivers. What one cannot also miss is what it signifies – the dread and more importantly the very nature of the disease i.e. TB is communicable and a lethal one at that.
Just 21 years old, Dawa [name changed] knows this well. He contracted MDR TB from a close friend who was suffering from it. With no history of TB, Dawa directly contracted the Multi Drug Resistant strain of TB. He is currently undergoing treatment at the DOTS Plus site here at STNM Hospital. As his sister tries to explain the process of treatment he went through, Dawa, who is weak and angry, interrupts, “It is all their fault. It is because of them that I am like this now”. What fault is he talking about and whose is it?
Dawa’s case exemplifies the myriad problems that the treatment of TB, particularly, the drug resistant strain, is faced with, not just in Sikkim but across the nation. Understanding his case would give a clearer picture of the ‘fault’ he is talking about. Dawa was first diagnosed with TB around 10 months ago when he showed symptoms of the disease. He was then put on TB treatment at STNM Hospital under the Revised National Tuberculosis Control Programme [RNTCP] which is a WHO recommended programme followed in India. Under RNTCP, there is a standard set of guidelines to be followed in the diagnosis, treatment and follow-up of the disease.
Dawa was first put on treatment for TB for 6 months and when he failed to show any improvement i.e his sputum test came ‘smear positive’, he was directed to take a culture test. A culture test normally takes around 2 months or less, but Dawa’s culture report did not arrive even after 2 months, by which time, his condition had deteriorated. It must be noted here that almost 9 months had passed since his treatment began.
His family then took him to a private doctor who confirmed he had MDR TB and prescribed MDR treatment drugs for him which were administered to him at STNM Hospital. After waiting for two and a half months for the culture test results, Dawa was informed that there was some “problem” with the sample that was sent and was asked to send another sample. However, they had already sent another sample through a private diagnostic centre here, the result for which would be delivered between 21 days to one and a half months they were told.
Dawa’s case raises some pertinent issues with regard to the culture test and role of private practitioners. Firstly, precious time was lost in getting a culture test which could have been done earlier.  According to WHO recommendations, if careful monitoring during the first 2-3 months of treatment show suspected resistance to any of the drugs, a culture test should be immediately taken. However, these are just recommendations and different countries have adapted the WHO programme to suit their conditions and logistical challenges. The RNTC programme followed in the country uses a strategy that enrols patients with a very high risk of MDR-TB into RNTCP DOTS-Plus activities and treatment with the RNTCP Category IV regimen. This is being followed because “RNTCP does not have sufficient quality assured laboratory capacity to do culture and DST in all TB patients”. Patients who are defined as an “MDR-TB suspect” should be identified and investigated further for MDR-TB.
MDR-TB Suspect can be any of the following:
- Any TB patient who fails an RNTCP Category I or III treatment regimen;
- Any RNTCP Category II patient who is sputum smear positive at the end of the fourth month of treatment or later; or
- Close contacts of MDR-TB patients who are found to have smear positive pulmonary TB (PTB) disease
Dawa, unfortunately did qualify as an MDR TB suspect on the last criteria mentioned above and should have taken a culture test much earlier. Speaking to NOW!, a doctor here informed, “After four months of treatment, if a patient’s sputum reports are still smear positive and the patient has a history of contact with MDR TB patients, the patient has to be asked to take a culture test”.
It can also not be denied that considering the sensitive nature of treatment of drug resistant TB, confirmation is absolutely necessary before starting treatment. A culture test detects the existence of Mycrobacterium tuberculosis in the body while a DST [Drug Susceptibility Test] is used to detect if this bacteria is resistant to any particular drug.
According to MDR TB Update 2011 published by WHO - Over 60% of MDR TB cases occur in China, India, the Russian Federation and South Africa alone (“RICS” countries). When compared to the number of detectable MDR-TB cases if DST was accessible to all TB cases notified in the world, the 53,000 cases reported by countries in 2010 represent less than a fifth of the estimated burden.
The report also states that coverage of DST for TB patients remains low and resultantly a minority of drug-resistant TB patients are detected and notified.  Information remains incomplete. The number of MDR and also XDR [Extensively Drug Resistant] TB patients is rapidly rising in the state. According to this doctor here, a very rough estimate of the number of MDR patients in the state is between 300 to 400. In this context, the importance of DST cannot be emphasised enough. As admitted by the RNTCP report, the lack of quality assured laboratories to carry out such testing severely handicaps treatment of drug resistant TB. This shortage means DST is advised only after careful screening by doctors based on the criteria mentioned earlier.
Currently there are 23 such functional labs in the country, these include 4 NRLs (Tuberculosis Research Centre [TRC], Chennai, National Tuberculosis Institute [NTI], Bangalore, Lala Ram Swarup Institute of Tuberculosis and Respiratory diseases [LRS], Delhi and JALMA Institute, Agra) 12 State level IRLs (Gujarat, Maharashtra, Andhra Pradesh, Kerala, Delhi, West Bengal, Tamil Nadu, Rajasthan, Orissa, Jharkhand, Haryana and Puducherry). Seven other labs (BPRC-Hyderabad, PD Hinduja-Mumbai, CMC-Vellore, SMS-Jaipur, RMRCTe [ICMR]-Jabalpur, JJ Hospital-Mumbai, DFIT Nellore) and more labs are in the process of accreditation in a phased manner. The accreditation of the IRL [Intermediate Reference Laboratory] at Gangtok is still under process.
RNTCP has established a nationwide laboratory network, encompassing over 13,000 designated sputum Microscopy Centers (DMCs), which are being supervised by Intermediate reference laboratories (IRL) at the state level, and National Reference laboratories (NRL) & Central TB division at the national level.
Another factor is the cost involved, a culture test costs normally costs Rs 8,000 but in Sikkim, a referral from STNM Hospital brings down the cost to Rs 200. This is certainly a relief for patients here but in a case like Dawa’s where patients are forced to go to private labs without the STNM Hospital referral, the cost can go even higher. At present, samples of TB patients of Sikkim are sent to a RNTCP recognised laboratory for testing in Blue Peter Health Research Centre, Hyderabad. This brings us to the other problem of not only the extra time that is added to the already lengthy procedure of culture testing, but also the problem of contamination of samples, as it occurred in Dawa’s case.
The doctor here revealed that, “Earlier, the samples were sent to a lab in Chennai but there were a lot of cases of contamination, so much so that the lab refused to take in samples from Sikkim. So, now they are being sent to another lab in Hyderabad”.
Contamination is an inherent problem with culture testing as it is and the added distance and time incurred accentuates this problem, it was informed. “Even sputum samples that are collected at local centres are not done in the proper manner. The staff is not properly trained or qualified and are not aware of the significance of the task at hand. Most times they are only worried about the numbers they need to show at the end of a day or month,” expressed another doctor. It is another thing that sputum testing itself is an outdated and questionable form of testing riddled with various weaknesses. What all of this goes to suggest is that diagnosis and testing which are crucial for a TB or MDR TB patient is a serious concern in the state.
Time doesn’t wait for anybody it is said, and for TB patients time can kill. A wait of 9 months as in Dawa’s case, is “too long a wait” for a MDR patient admitted one doctor here. Caught between the need to accurately determine the MDR strain of TB for fear of further aggravating or even giving rise to drug resistance because of faulty treatment and the lack of adequate and reliable testing facilities, it is not just the patient who suffers. In a year, a single MDR patient can infect at least 15 people with the disease. This in turn could very well mean that at least 4500 in the state are infected with the MDR strain of TB.
 A test which can determine drug resistance in a patient in the least amount of time and easily accessible is the obvious solution. Good news, however, came in February earlier this year with India clearing the proposal to set up a new diagnostic test GeneXpert that will test and confirm MDR TB within 120 minutes at 18 sites across the country. Funded by USAID Country Mission with technical assistance from WHO India, the initial results of this project will come in the next few months. This facility is being planned for Sikkim as well, but there are issues of adequate space to house the equipment, it is learnt. If successful, this would significantly increase the speed of diagnosis.
That said, it remains to be seen at which stage of diagnosis or treatment this test would be used because the problem with culture or DST test also seems to lie in when it is advised to patients.
The other issue that Dawa’s case raises is the role of private practitioners. When he went to a private doctor as his condition worsened, this doctor confirmed he had MDR TB. On what basis was this diagnosis made? At the time, all Dawa had was the sputum test result and it is difficult to comprehend how the doctor diagnosed Dawa with MDR TB on the basis of this and prescribed MDR TB treatment to top it off. If his culture test results prove otherwise, then the treatment for MDR he is getting at the moment is likely to trigger further resistance.
It is here that awareness and training figure in as extremely important. As a doctor remarked: “The RNTCP and DOTS programmes are absolutely brilliant on paper, but it is in the implementation that things don’t quite turn out as they are supposed to. Training for all medical staff, both private and government, has to be taken up in earnest in order for the programme to work effectively”.
The Government of India recently declared TB as a notifiable disease which means every case of TB diagnosed in private or government hospitals will now have to be notified to the government. This would mean information on every TB case will be recorded. It is certainly a positive step towards at least having complete information on the number of TB cases, however, it again remains to be seen how it will play out on-field. Critics point out that duplication of records, human rights aspect of the effect on the patient of revealing such data in sensitive socio-cultural conditions, implementation hurdles could weigh down what at present looks like a positive step.
Apart from private doctors, private laboratories that undertake culture testing is another serious concern. Considering the importance of correct diagnosis when it comes to TB and its drug resistant strains, laboratories without proper credentials cannot be entrusted with such testing. As informed earlier, there are only a few accredited labs in the entire country excluding some private ones recently added.
Dawa’s earlier outburst does seem to hold water as someone as young, he now lies at the DOTS plus site here unable to even speak or walk properly, hand fed by his sister, a testimony of the devastation that MDR TB brings down upon human bodies.
Sharing this space is also a middle aged woman, although with a prior history of TB and treatment, she was also advised culture testing after 6 months of initial treatment. There are two other young female patients in their early twenties also in the same room. One of them has been there since it opened its doors on 06 March earlier this year and says she does not remember how many but has seen numerous admitted and discharged from this very ward.
Reports of a new TDR [Totally Drug Resistant] form of TB in January this year in Mumbai brought to light the severity of the problem that is drug resistance together with the need to intensify efforts to tackle it. Despite the labyrinth of medical jargon and complex data that can disorient, discourage and blind, the fact of the matter is that MDR TB is here and Sikkim, like the rest of the world needs to up its ante.