MUMBAI: Shasikala Sawant (name changed), a 22-year-old government worker, lived for barely six months after being diagnosed with drug-resistant tuberculosis (DR-TB) in a clinic near her Vasai house.
Her doctor says her death wasn't caused by a lack of medicines; for three months, a local health organization gave her tablets costing Rs 250 a day before she joined the Centre's free treatment programme in a south Mumbai hospital. The doctor recalls: "She was much worse and died shortly thereafter."
So, what went wrong with Shasikala ? The answer is improper treatment. Thousands suffer from DR-TB in Mumbai and hundreds like Shasikala face the risk of dying prematurely because of faulty treatment. Experts blame the government's one-treatment-for-all policy, called DOTS-Plus (directly observed treatment-short course for MDR-TB).
Consider a study done by pulmonologist Dr Alpa Dalal that shows that 50% of the DR-TB patients are resistant to either one, two or more drugs used in the Union government's Revised National TB Control Programme. In Mumbai, the BMC implements RNTCP.
"The government gives category IV regimen (of six drugs ) to all DR-TB patients, but this doesn't work for all. One-cap-fits-all policy won't work in Mumbai where many DR-TB patients show resistance to drugs beyond the standard rifampicin or isoniazid," said Dr Deepesh Reddy, a former consultant with RNTCP who is now attached to think-tank Observer Research Foundation.
"Shasikala was resistant to two of the drugs in the government's sixdrug policy,'' said her private doctor, who refused to be named.
City hospitals await TB test accreditation
'50% patients don't respond to known medicines'
What makes Shasikala's case worse is that she had reports from Hinduja Hospital in Mahim about this extensive drug resistance, but the BMC officials didn't accept it. The lab isn't accredited by the Centre to perform second-line (of higher resistance) tests. Accreditation was promised after the hospital in January 2012 exposed the threat of extensively drug-resistant TB in Mumbai, but there's been no development so far.
Until January 2012, BMC had only 180 MDR patients on free treatment. Since the public outcry in 2012, it is catering to almost 3,000 patients. "But the thrust should be on treating them correctly," said a senior doctor.
"Giving standardized treatment to MDR patients, the majority of whom has more extensive drug resistance, is a recipe for disaster. It is morally, medically and epidemiologically unjustifiable," said Dr Zarir Udwadia, whose work highlighted the emergence of extra extensively drug-resistance TB in the city.
Complaints against the fixed six-drug regimen are getting sharper. Pulmonologist Alpa Dalal, who is attached to Hiranandani Hospital in Powai, looked at the drug-susceptibility tests of 171 patients in Mumbai, Thane and Navi Mumbai. "50% of the patients are resistant to one, two or more drugs offered to drug-resistant TB patients under the government's DOT-Plus programme," she said.
At present, when patients don't shown any improvement for four months, their sputum is sent to the national TB laboratory in Bangalore to test for higher resistance. This takes three additional months.
"By continuing use of a drug with documented resistance, we are placing patients' lives at risk and may also be inadvertently fuelling an XDR-TB epidemic. Medical ethics demands that patients be provided the best care available," said Dr Yatin Dholakhia of the Maharashtra State Anti-Tuberculosis Association.
Dalal believes it's time all patients showing signs of drug resistance be tested for sensitivity to all TB drugs at the beginning instead of the staggered testing. "The nature of the disease in Mumbai is such that we need a patient-tailored flexible approach," she added.
The state's TB officer, Dr H H Chavan, said protocols have been drawn up by the Union government after talks with the World Health Organisation. "A lot of thought and trials have gone into deciding the six-drug regimen," he said.
BMC additional commissioner (health) Manisha Mhaiskar said: "Our doctors have highlighted the problems of a fixed regimen. We conveyed this to the central team that came to the city for a review three months ago.''
Regarding accreditation for state-run J J Hospital laboratory and Hinduja Hospital for second-line drug testing, Chavan said: "The accreditation is in process and should be cleared soon.'' Mhaiskar said the Union government had so far approved many suggestions made by Mumbai doctors. "We are sure they will listen to these suggestions as well."
Joining the dots
What is MDR TB?
TB is an infectious disease that mainly affects the lungs, but can also affect solid organs, brain and the lymphatic and circulatory systems.
Multi-drug-resistant TB (MDR TB) is defined as resistance to drugs isoniazid and rifampicin.
XDR-TB is defined as resistance to at least isoniazid and rifampicin, and to any fluoroquinolone, and to any of the three secondline injectables (amikacin, capreomycin, and kanamycin).
XXDR controversy
In Jan 2012, Hinduja Hospital found a group of patients who could not be treated with any of the known drugs. The cases were initially dubbed totally drug-resistant TB, but later called extra extensively drug-resistant TB. Of the 12 patients in the study, six are alive and still under treatment.
Government drug regimen
Government RNTCP (Revised National TB Control Programme) has a sixdrug regimen for MDR patients called DOTS Plus. The medicines used are Ethambutol, Pyrazinamide, Ethionamide, Cycloserin, Kanamycin and Levofl oxacin (a kind of fluoroquinolone).
Why it can backfire
In Mumbai, a person can directly get drug-resistant TB. In fact, almost 20% of primary cases are drug-resistant. Moreover, drug resistance is high in Mumbai because of rampant use of antibiotics. Hence, there are patients who may be resistant to medicines in the six-drug regimen.
BMC first starts treatment with DOTS Plus. When a patient doesn't respond after four month or so, his/her samples are sent to NTI Bangalore to test for drug resistance. This test takes three months and this, the patient loses precious months of right treatment.
Source: The Times of India