Archive for February 2013
It is common knowledge now that on July 20, 2011, WHO urged countries to ban inaccurate and unapproved blood tests and instead rely on accurate microbiological or molecular tests, as recommended by WHO for detection of TB. On June 6, 2012, the Government of India (probably the first and only country in the world), issued a notification banning serological tests. So far so good.
We have evidence that at least 1.5 million serological tests performed in India every year. At $10-$30 per test, the cost of testing, plus the cost of TB drugs wasted on treating hundreds of thousands of patients with false-positive results, rival the entire Indian TB control program annual budget of $65 million. Every major private laboratory in India offers TB serological tests, mostly ELISA kits imported from developed countries that do not allow these tests to be used on their own TB patients. Notwithstanding the ban, private medical practitioners still rely heavily on these tests.
According to a recent article published in BioSpectrum, this situation remains unchanged even months after the ban. The article quotes the union minister of state for health, Mr Abu Hasem Khan Choudhary, “The tests approved by the Revised National Tuberculosis Control Program (RNTCP) for diagnosis of TB include sputum microscopy, X-ray chest, solid and liquid culture methods and rapid molecular tests. Available evidence indicates that, besides the tests mentioned above, the private sector heavily depends on the serological tests for diagnosis of TB.”
Dr Madhukar Pai, associate professor, McGill University, Canada feels that there is no valid, accurate test for TB using blood as the sample. He says in the BioSpectrum article, “Nowhere in the world is active TB diagnosed using blood specimens. So, from that perspective, there is no real alternative. There is a FDA approved, acceptable blood test for latent TB infection (not active TB), which is called as QuantiFERON TB Gold (marketed in India as “TB Gold”). Some big labs have started replacing antibody serology tests with this TB Gold, but that is a big problem. TB Gold cannot separate latent infection from active TB and therefore will show “positive” results for a large number of Indians.”
Then why are doctors prescribing this test? Can one bad test be replaced by another test that does not do what it is supposed to do i.e. accurately diagnose active TB?
JATB did an email interview with L. Masae Kawamura, M.D. Senior Director, Medical and Scientific Affairs, QuantiFERON, Global, QIAGEN. The interview is reproduced below:
Q1. You have spoken to 25 TB experts and clinical microbiologists in the Delhi area to assess the use/misuse of the test. You and your team found that the test had been used inappropriately, but that it was not widespread. Do you think 25 was an adequate number for a country the size of India, in order to reach this conclusion?
A1. Yes, I do because it matches other proprietary sources of data that we have and the fact that the official ban on serologic tests was fairly recent (June 2012) and there is usually always a lag in implementation, especially when there are lingering stocks.
Q2. What was the profile of people you spoke to?
A2. Most were highly experienced clinical microbiologists from medium and large private, academic and public laboratories. Others included expert rheumatologists, a pediatrician, diabetes specialist, a well-respected IVF gynecologist, clinical researchers, Gates Foundation (consultant to RNTCP) and the RNTCP.
Q3. Will you kindly update me on what you will be doing to give them more clarity on when to use your test, as you found that this clarity was wanting when you spoke to them?
Q4. Do you plan to expand this initiative because it is important to know what is happening in other regions of India?
A3&4. Aside from the caution label on product cartons and laboratory results, in March, QIAGEN will be supporting a round table discussion in Mumbai on the appropriate QFT use and smaller forums with key opinion leaders and experts in Chennai, Bangalore, and Delhi. Dr. Tony Catanzaro, UCSD professor, TB expert and consultant to QIAGEN will also be giving a talk to the Association of Practicing Pathologists in Delhi. The emphasis will be on screening and prevention of TB, the importance of latent infection diagnosis and using QFT appropriately. I also plan to work with the RNTCP by exploring synergistic strategies using QFT screening of key at-risk populations by the private sector. Our work in India this spring will help expand our knowledge on what is going on the ground and as important, help us to develop a relationship with the private sector that will hopefully enhance RNTCP TB control efforts in India.
While JATB appreciates the prompt response and efforts of Qiagen, there was a slight sense of discomfort that there appeared to be a condoning of the fact that labs continued to use bad tests simply because they had ‘lingering stocks’. After all we know of cases where mobile phones, cars and white goods have been withdrawn from the market when they are found to have defects. Here we are talking of tests that can spell the difference between cure and possible death for people who are seeking diagnosis. To top it we have a ban on these tests. Shouldn’t they be withdrawn from the market immediately?
We also appeal to Qiagen to widen their efforts to spread awareness on when to best use the QuantiFeron TB Gold test. Even one inappropriate use will mean injustice to patients who deserve better. JATB also strongly appeals to the Government of India to strictly enforce the ban on serological tests. We have waited long enough and want to see some action now.
Why has MDR TB become such a threat to public health? Should the private sector shoulder all the blame?
This is a piece that has done the rounds of three mainstream newspapers. It was accepted by one but not published so I sent it to others. The second and third did not even acknowledge the many mails I sent enquiring about its fate. Does that make me a bad writer? Is the media my enemy? Do they have something personal against me? It’s none of these. It’s just that TB does not make news. But I want to get the messages out. So I’m using my own platform. I request all those who read this to please pass it on. That’s the best we can do under the circumstances.
The recently released WHO Global Tuberculosis Report 2012 throws up some contradictions. It claims that The Millennium Development Goal (MDG) target to halt and reverse the TB epidemic by 2015 has already been achieved. TB mortality rate has decreased 41% since 1990 and the world is on track to achieve the global target of a 50% reduction by 2015. However, it also goes on to warn that multi-drug resistant TB (MDR-TB) is a cause for concern.
In terms of numbers, according to the Stop TB Partnership there could be as many as 440000 new cases of MDR TB across the world. The Global TB report says that India, China, the Russian Federation and South Africa have almost 60% of these cases.
Closer to home, India has the highest burden of TB in the world and accounts for around one fifth of the global incidence. Out of 9.4 million new TB cases globally, 2 million are estimated to have occurred in India. Around 280,000 people succumbed to TB in 2009. It is estimated that close to 1000 people die from TB everyday in India.
India has 64000 MDR TB patients (RNTCP Annual Report 2012). Experts however opine that the figure could actually be much higher. Only 4237 cases out of these were notified and 2967 cases were put on treatment according to the Global TB report. Here is the contradiction. TB is an entirely preventable and curable disease. We have what is acknowledged to be among the best national TB control programmes in the world. If our TB control programme was really as efficient as we think it is, why would so many cases of MDR TB be amongst us? Especially considering this is a condition that arises when patients develop resistance to the basic drugs because they drop out of treatment mid-way, or contract itfrom a person already infected with MDR TB? Why is MDR TB making such bold inroads into our country? The private sector has been roundly blamed for the increase of MDR TB in India. I attempted to find out ground up, how true this was.
The TB sector in India is riddled with some problems that prevent it from being completely efficient. Despite the existence of the ambitious Revised National Tuberculosis Control Programme (RNTCP), it is an established fact that doctors in the private sector are most often the first point of contact for a person who is ill. Dr Mukund Uplekar, Medical Officer, Stop TB Department, WHO says, “The problem does not begin as TB; it begins as fever and cough and people don’t rush to the nearest TB facility when they fall ill. Therefore the private sector is the first vital touch point.”
For K (20) too, the private sector was the first point of contact when she fell ill. A diminutive figure heavily swathed in woolens, she lives in a dark, dank house in New Delhi at the end of a bylane dotted with puddles of slush and little mounds of garbage. She is on treatment for MDR TB and angrily recounts that when she suffered from frequent fevers and coughs she consulted several doctors in the private sector. Each of the doctors, in turns, prescribed tablets and syrups, which cost a lot of money but did not cure her. After a year or so she was referred to the government TB programme where she tested positive for TB. The DOTS supervisor at the TB dispensary where K is being treated, says, “We detected that she had MDR TB and changed her treatment when she continued to be sputum positive even several months after she was put on DOTS. She has completed one year of MDR TB treatment and has another year to go.” K’s case and several others like hers that this writer came across, illustrate that management of TB in the private sector leaves a lot to be desired and is also often the cause for MDR TB.
India has the largest private health sector in the world, with 60-80% of health care coming under this category. Private health care includes both qualified and unqualified practitioners.The quality of treatment provided by private healthcare providers for TB is not standardized as per international guidelines. Diagnosis is a problem. The Indian private sector is largely unregulated, and weak regulation results in rampant use of useless diagnostics, and prescriptions of incorrect TB treatment regimens. A recent study from Mumbai, by the Hinduja Hospital, published in Public Library of Science, showed 106 doctors prescribing 63 different drug combinations for TB (while there is only one recommended TB drug combination).
Cases of mismanagement of TB in the public sector too are common. Vedavalli (58), from Pondicherry, Southern India, died a few months ago after prolonged but unsuccessful treatment for TB. Her daughter Radha laments the loss of her mother, “My mother first went to a private doctor for her cough and fever. He diagnosed her with TB and sent us to the government facility, because we would get better and cheaper treatment there.” She can barely prevent herself from breaking down, “The doctors at the government chest clinic treated her for months without any success. My mother continued to get sicker and finally died because her lungs were damaged beyond repair.”
Radha, on her own volition, had sought a second opinion while her mother was on treatment and not showing any progress. Dr Sowmya Swaminathan, Director, TRC, Chennai, says, “When Radha brought her mother to us we tested her blood for levels of the anti-TB drugs Rifampicin, INH and PZA. They were all very low on the first occasion and then showed erratic levels. The drug quality was also checked and found to be alright. She was probably not absorbing the drug properly because of malnutrition or other reasons. Once we increased the dose and made it daily treatment, she responded immediately. She was doing well but suddenly died.”
Radha asks some tough questions. “Why did I have to seek a second opinion? Was it not the job of the doctors treating my mother to refer her? Is this what we get for trusting the government programme?”
Dr Ranganath, a private practitioner in Bangalore who has been practicing general medicine for over 30 years recalls the case of a patient with TB who was forced to avail treatment from the private sector because there was a price attached to every test, every drug and every visit he made to the local government TB hospital – all of which should actually have been free of cost.”
There is obviously a lot of confusion in the TB sector, both with regard to diagnosis and treatment. While the private sector needs to be brought under regulation, it is also mandatory that government facilities get their act together. Gaps in treatment and corruption in the treatment facilities need to be tackled firmly. Blessina Kumar, Vice Chair, Stop TB Partnership, and TB/HIV activist reiterates firmly, “RNTCP has a top down, and not rights based approach. We have to revisit the RNTCP and make changes if required to ensure that the last person who needs treatment gets it with the least red tape.”
Dr Madhukar Pai, a TB researcher, says, “Wherever a TB patient in India seeks care, he is not sure of getting the right diagnosis and treatment. When the patient goes to a private doctor (or unqualified practitioners), there are very good chances that there will be a wrong diagnosis, wrong medication and delays that could prove fatal.” He adds, “Patients with TB are not routinely tested for drug susceptibility by RNTCP before being started on medication. Second-line drugs for MDR-TB are not widely available. There are now excellent rapid molecular tests for MDR-TB but the RNTCP is yet to scale them up. These are very powerful causes for the spread of MDR TB.”
Dr Pai also recommends that RNTCP should feel ownership towards all patients, whether they come through the public system or not. Regulation of the private sector, enforcement of the governmental order that requires all TB cases to be notified, enforcement of the ban on serological antibody TB tests, and a business model at the grassroots level, which incentivizes private doctors for referrals – all these are urgently required for prevention of MDR TB .
TB already causes an estimated 100 million workdays loss due to illness. The country will also incur a loss of nearly US$ 3 billion in indirect costs and US$ 300 million in direct costs (source: RNTCP). MDR TB will exacerbate this problem. It’s time to stop blaming the private sector alone and to recognize that the responsibility for TB control is a collective one.
Posted below is a news report that appeared in The Times of India a few weeks ago. It talked about the shortage of drugs and sputum collection cups at several TB detection centres in the state of Andhra Pradesh. In response, JATB has learnt that civil society partners of Andhra Pradesh under the partnership of TB Care and Control in India met on 2 February 2013 in Hyderabad to discuss the issue of shortage of Streptomycin injection , sputum containers and some of the relevant issues to improve the TB situation in the state. The partners drafted a memorandum and decided to submit it to the Commissioner , Health, Principal Secretary, Health, Director Health Services, Director (NRHM) and the State TB Officer signed by all the partners. A full report from Citizen News Service (CNS) is available here.
What is noteworthy here is the momentum that is gathering around activism in TB Control – an element that was sorely lacking in the sector. The connections that are building up between the media, the activists, the system and action thereafter – these are signs that we will surely see a difference in the way TB control happens in India. And that undoubtedly can mean spell good for the multitudes suffering from TB and in need of treatment and other forms of support.
Shortage of drugs, sputum cups hit TB control
By Bushra Baseerat, TNN | Jan 24, 2013, 04.05 AM IST
HYDERABAD: Shortage of drugs and sputum collection cups at several TB detection centres in the state has led to the state tuberculosis control programme going haywire in Andhra Pradesh during the last six months, doctors said.
Shockingly, experts said there are several instances when patients were turned away due to non-availability of sputum collection cups, which is essentially a sterile specimen container.
Doctors at state-run hospitals concede during the last six months, there is acute shortage of the streptomycin injection. The drug is used for patients who are not responding to the primary drug regimen. “Around 20% patients are failing on primary drug regimen and they require these injections. In the state, around 50,000 patients would require it monthly as per rough estimates,” said a senior chest specialist.
As per available estimates, the multi-drug resistant TB cases in AP are as high as 12-17% of the total caseload. TB prevalence in the state is 258 per 1 lakh population and annually 1.2 lakh new cases are added every year in the state-run facilities alone.
While the central government claims there is no dearth of funds for TB but due to the short supply of this injection, patients can still infect others after the primary drug regimen as they develop resistance. “It is a free programme and all the drugs need to be supplied by the government,” doctors said.
At least four times, Chest Hospital supplied the sputum collection cups from funds received through donations to the DOTS Centre located on its premises but how long will the hospital do that, questioned a doctor adding that since Sepetember 2012, the post of state TB officer is lying vacant.
The headless body, doctors said is adversely impacting the TB control programme in the state.
Experts said the primary aim of the programme is to cut down the transmission rate but before diagnosis itself 8-10 people are getting infected.
The delay caused by health professionals at DOTS (Directly Observed Treatment, Short Course) Centres and hospitals due to non-availability of drugs and other needful items like sputum collection cups is further delaying the treatment leading to more people getting infected.
Every one minute, one TB patient is dying in India and now, MDR cases too are shooting up.
They attribute the rise in MDR TB cases to poor follow-up of patients. “It is due to lack of supervision that the Multi Drug Resistance (MDR) cases of TB are on the rise. If the primary treatment is appropriate, these cases will not rise,” said another specialist.
Absence of trained persons at the DOTS Centres is making matters worse, doctors say. “Without compassion, the programme will not work. When we are able to control HIV, why not TB? There have been number of complaints that DOTS Centres supervisors are demanding money. Medical officers posted at these centres are not working properly,” said a doctor.
“The thousands of crores the central government is pumping into the Revised National TB Control Programme are helping only the programmers but not the patients,” said a senior doctor. He added that there is an urgent need for an amendment that only trained medical officers with diploma in TB are posted at these centres.
State health officials when contacted said that the streptomycin injection is in short supply in the entire country and states have been asked to purchase locally. “Earlier the supply was in bulk from the central government but now, the respective district heads have been asked to purchase,” said an official.