 Hello and welcome to NewsClick. Today we would be discussing about tuberculosis, a communicable disease the incidence of which has acquired serious proportions, being one of the top 10 causes of deaths worldwide and becoming a global epidemic. The year 2018 alone saw 1.5 million TB related deaths. In the same year, 10 million people fell sick with TB and nearly half a million developed drug resistant TB. To discuss this further, we have today with us two guests, Lina from Medicine's Frontier and Gina who is with the Delhi Network of Positive People. Both of our guests have been closely following the issue and have been at the forefront of dealing with various issues pertaining to TB, be it the policy framework or access on the ground. So welcome Lina and Gina. So Lina if you could please start with taking us through the enormity of the challenge that we face at the hands of TB globally and especially the rise of drug resistant TB. Yeah you know when we had first line TB treatment, the combination of four drugs in the 90s, the world health organizations and governments like India thought that you know they've just overcome TB. And there was a complacency among governments and the WHO that we are just going to be able to treat everyone with those drugs. But you know the bacteria has been there for millions of years, it evolved and developed resistance to the drugs we were using and today it's one of the biggest public health emergencies that we have globally, particularly in India. Yeah so I mean if I can get Gina into it, I mean what are the issues that you face at the ground level when you are there providing services to the people? Some of the issues, what I can cite here is that recently, I'll just compare between some of the things we face before and some of the things we face now. Before two years back like there was no proper diagnosis of like MDR, there was no like everyone feel HIV I'm just linking my like things with the people living with HIV. CVNET was not there at that time but now the CVNET is there. Every PLHIV who are symptomatic is like written by the doctors for CVNET. But the thing is that the challenges we face here is that the basic thing we need to get tested to collect the sample, the fulcrum tube like in and out, like stalk out from the stairs clinic. This is one of the issues that we come across last two, three months back. And some of the issues we come across is the side effect management for both like first line TV or for MDR, there is no proper side effect management. And side and there is no proper counseling in the system, TV system. This is the some of the challenges we face. So I mean if I can get Lina into it, perhaps I should have asked this first. So WHO had called for a move from injectables to oral therapy. I mean why was that and what were the problems? What people didn't realize was that when drug resistance came about, there were no new drugs. So people started to scramble around and use the older antibiotics that had been actually abandoned as to toxic. So majority of the drugs that we're using for drug resistant tuberculosis are drugs that actually doctors did not want to use. So you had older antibiotics like PASS, cyclocerine, many of these drugs being brought back and used for DRTB. And extremely toxic, they caused a lot of side effects. And particularly the injectables, the class of injectables, for example, streptomycin and the other injectables also caused hearing loss. So you had a lot of people living with HIV who had psychosis, depression, extreme nausea, but they had lifelong disabilities. So they lost the hearing or partially lost the hearing. And in many ways, the life was completely changed by DRTB. And maybe the HIV positive people who are more vulnerable and more at risk, I think they face much more problems. One of the cases we closely follow is about one of our colleagues last year, back when we come to know about her, we really closely follow up all the process. Even diagnostic takes too much long time, too much long time. Before she was diagnosed with typhoid, after that, after one month of eating medicine, she suspect about TB, after that she was written for CBNET. And it takes a lot of process even to diagnose. And when she started mediciin, she just feared that six months of injecting drugs, but after that slowly she lost her strength. And she started like suffering from all the side effects like nausea, this even lost her hearing. And one this is hear me, I just want to run away from here. I just don't want to live now. This is the condition of this certain medicine, like huge side effect. This is a certain medicine which like now is going on. So this would be faced out because we have seen closely the tremendous side effect that bear by the people living with HIV from this current mediciin of the drug resistance. So there have been some improvements in the drugs and some new effective drugs like bedaquilin and the laminate have come about. So how effective they are. See, I think what is very important to understand that we were dealing with a public health emergency. We had older toxic drugs which are being used prolonged use without any clinical trials and safety trials. And then you had two new drugs bedaquilin and laminate who went through phase two B trials. So the decision had to be made by governments and WHO would we allow the use of these two new drugs without full phase three data coming in. And our decision was made whether rightly or wrongly that these two new drugs would be provided to people living with DRTB. What is very interesting is that South Africa started to collect data very systematically and they realized that mortality was down, efficacy was up to 70%. Now if you compare efficacy of the older regimens it was less than 50% for MDR and for the extremely drug resistance it was less than 30%. And then you had efficacy of you know adding bedaquilin to regimens through 70%. So South Africa actually changed the whole system by saying bedaquilin should be available to all people living with DRTB. And that's when actually governments started to move and WHO started to move saying we can remove injectables. South Africa has done it and we can put bedaquilin as a core drug in the regimen of DRTB. So that's essentially how it all happened. But we see that there are still problems in access to these medicines I mean maybe prices and so if you could tell us about this entire thing. Yeah so there are three top access barriers for people who have drug resistance tuberculosis. For children the safety data is coming in quite late. So you know one of the newer drugs delimited which is approved for children age three and above is very rarely available in the country. That is one of the reason is because the pharmaceutical company Otsuka was late in providing data. Even today they haven't provided data from three to six years to the Indian FDA. But it's also partially the government's own reticence to allow generic manufacturer of these drugs. So we have highly dependent for bedaquilin and delimited on the two big pharma companies. One is a US pharma company and one is a Japanese pharmaceutical company. So they are holding us hostage on the supply of these drugs. So what do you think that can be done? I mean the first thing that can be done easily if the access to these medicines needs to be increased as Gina has mentioned that there are a lot of problems in terms of access to these medicines on the ground. I think two issues are very very fundamental. I think community monitoring of DRTBE. You know where actually for example organizations like Delhi network of positive people ensure that all people living with HIV who have DRTBE have bedaquilin as part of the regimen. I think that's not happening. So even though the WHO said all people with DRTBE should have bedaquilin as part of the regimen. It's not happening on the ground. So I think community monitoring of the DRTBE program is essential and number two is this that you know J&J and Otsuka's donations will go only so far. At some level India plays a role in global health and the alternative suppliers have the raw materials. Why not bring them to fight this global health emergency? Absolutely. And so I was also wondering that largely the treatment is dependent upon donations and even the government doesn't do much more than receiving donations and so how is that is that sustainable at all in the coming I mean that we have the target of removing TB by 2025 in India for that matter. So I mean is it sustainable at all? No donation is not sustainable and all we like government have to look some long lasting sustainable things like to provide the medicine to the people's donation will go post-denation can be cut at every any time. Yeah absolutely. In fact you know at the beginning of the eighth response we saw some donations and charity from Pfizer and GSK and you could only treat a handful of of patients and that's why actually you know as treatment activists we've been saying that you know the first phase of rollout has been dependent on donations you know now you're tendering for these drugs. Now a tender system is dependent on multiple suppliers if you just have a single source then you're going to pay the price the company demands of you. So I think the tendering system fails when it comes to monopolies and single source suppliers you know. So this is the problem that to today we have is the government has been trying to negotiate lower prices but have been finding it very difficult because you know obviously they know that there's no competition so you know they will not lower the prices beyond what they have already decided globally. Yeah so I was also wondering I mean there was this recently concluded the executive board meeting 146th executive board meeting at the WHO and so they presented one progress report and the other was draft global strategy on TB but do you think it actually addresses the issues that are there and I mean because the issue of trips flexibilities and all use of those trips flexibilities has hardly been perhaps pointed out in these documents. You know you rightly pointed out something you know strategies are laid out at the global level and governments then tend to implement them. What happens with the global strategy is ironically it says that we need to protect IP. Now the intellectual property system for the last 50 years has failed to deliver for tuberculosis. Why will we increase intellectual property protection? It hasn't given us the antibiotics we need let alone for TB for many other infections. So I think this is where I think globally the strategy fails on that count. I think we have to recognize that the intellectual property system has its serious limitations today. It is not being able to address antibiotic resistance in TB and many other areas. So you know if we keep going back to the older intellectual property system and hope that somehow innovations will come and then you know somehow we'll manage to lower prices by negotiations. It's just too late for patients. I think we have to have a collaborative model of R&D and the collaborative model of R&D also means that actually public funded research and institutions contribute to that process and have ownership and responsibility to ensure that the end product is available to patients. So I mean in India for instance I mean we are approaching the world's TB day 24th March but we see that recently one of the parliamentarians has also written in terms of access to TB drugs that should be made available in India and it's still not on the national list of essential medicines the TB medicines. So in in that scenario I mean what would you like to send a message to the government that this should be done immediately and as a long-term strategy also maybe we can take G9. To like this as a long-term strategy like those old like fulcrum tubes stock out medicine stock out means like should not be there one of the things if like we really want to eliminate the TB by 2025 this shortage should not be there and the systems everything this side effect management even the the counseling system which is leaking in the system should like put in the guideline and should be implemented properly this is the thing. Yeah and in fact you know just highlighting by Gina's raising the point today we want to roll out injection-free regimens for children you can't do that without delimited and today we have a country wide shortage of delimited because months were spent negotiating with utsukha and myelin to provide the drug at an affordable cost so I think this is the time actually and I would say this particularly as I've seen many you know women and very young women actually have DRTB and I realize that you know our lives are so badly compromised forever because we have hearing loss we can't go to work we are we are asked to leave our families you know marital homes we lose custody of our children this is happening to women with DRTB on a daily basis and if we could provide a safer and more effective treatment we could address some of these issues that women face so I think at this point of time I think the next step is towards making sure that these are produced by and manufactured in the country and available to the TB program true I guess I mean there are lots of issues which are unadressed and as you rightly pointed that the first thing is that we start producing them and through generic coming ways and hope that some concrete steps would be taken by the government soon thank you for being with us and watching news click