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Dr. Carolina Batista (DNDi)

Dr. Carolina Batista

Head of Access & Medical Affairs, DNDi

Interview by Kamran Rafiq (ISNTD)

This week, the Chagas disease drug benznidazole has been granted accelerated approval by the U.S. Food and Drug Administration for paediatric use in children aged 2 to 12 years old. This marks the first time that the United States approves a treatment for Chagas disease. In this exclusive interview, we speak to Dr. Carolina Batista, Head of Access & Medical Affairs at the Product Development Partnership DNDi about the highly underreported global burden of Chagas disease, major stakeholders’ collaborative approaches to accelerating the research and access to treatments, as well as the outstanding gaps in the understanding and advocacy for this deeply neglected disease.

How does the DNDi view its involvement with Chagas? Are you more focused on the discovery challenge or the market access challenge?

Perhaps we are viewed externally as an organization that “only” develops treatment, and we indeed put a lot of our efforts, resources, people, money and a lot of science into making new drugs for Chagas, as they are urgently needed. But also targeting access challenges, it helps to change the paradigm that less than 1% of people infected with Chagas disease have access to diagnosis & treatment. And clearly the whole process is much more effective by engaging the correct stakeholders, including patient groups, policy makers & regulatory agencies.

In many of the NTDs, we are seeing movement away from a top-down prescriptive approach (whether in discovery, developments, diagnostics & the MDAs) towards more of a grass-roots involvement of the stakeholder. In your perspective, who are the stakeholder groups that DNDi should reach out to, given that access is a major issue and stumbling block for Chagas?

We really must engage, firstly, with the affected people and work very closely with the Chagas Coalition, an international federation of clinicians, public health practitioners, civil society groups and affected individuals with Chagas disease that has representation in various endemic countries and others such as Europe, US, Japan and Australia, which is a real progress. Secondly, we need to engage with policy makers on Chagas as a public health problem that needs a collaborative approach, led by endemic countries’ patients and civil society, in partnership with non-endemic countries.

There’s been hardly any movement in Chagas in terms of policy. For example, only in 2015 was Chagas disease added to the PRV schedule in the USA to catalyze PDP activity at a discovery level. From a ‘let’s wake up the policy makers’ perspective, one of the messages we have had feedback on, is that policy makers tend to react when there is a perception of risk within blood transfusions and the blood supply in their sovereign setting. Is that a message we can put forward for Chagas disease? If so, who should spearhead that and who needs to coalesce around that message?

In Chagas, we have a specific setting because only very recently we had all the Chagas endemic countries’ blood banks having their supplies screened for the disease. The last country to adopt these measures did so in 2014/2015. So yes, there is a long way ahead. We have stepped out of that first challenge, and now look for champions in Latin America that are putting a lot of political will & resolve to address the issue of Chagas. We work with countries now, such as Colombia, who are putting a lot of effort into Chagas and also piloting initiatives. We really welcome these initiatives and are looking for the next country to engage in this fight.

Moving from the grassroots level upwards, we often hear that there can be a lack of awareness at the physician level about Chagas disease whether it’s in a North American or European setting (for instance, we have heard examples including Italy, Spain, Switzerland…). What can the DNDi do, as a part of the larger Chagas Coalition. What types of partnerships there would you look to form, to improve awareness at the physician level?

This is a very distinct piece of this puzzle. We can’t address Chagas effectively if there’s lack of awareness between health providers, as medical doctors, nurses and health promoters. Chagas needs to be managed at the primary healthcare level as opposed to specialists: they would not be able to manage the more than 6 million people infected in the world. Most of these people are in rural or areas of difficult access that don’t have the best access to secondary/tertiary level health care. As a member of the Chagas Coalition we work closely with partners such as universities and Findechagas, the International Patients’ Federation that advocates for the disease and is spreading the word that Chagas needs to evolve from being one class in a medical school curriculum into something that people know about. We need to think of Chagas as a differential diagnosis when we see a patient with a heart condition in endemic countries. We are moving slowly, but hopefully in a sustainable way.

Is this a new evolution in terms of the scope and remit of PDPs? DNDi definitely has a role to play here. We understand that to be effective in developing better drugs we must engage different stakeholder groups in adopting the medicines we deliver, and need to work together with the population affected to guarantee access for treatment and diagnosis. With the numbers that we have now, less than 1% of Chagas patients receive treatment. Where is the 99% remaining? We really need to reach those 99% and working collaboratively is the only way forward.

In terms of catalyzing the grassroots demand for treatment, is there room for an argument around the ethical right of the patient for healthcare provision?

Definitely. Think about best practices: if a patient who goes to the hospital with a cardiac arrest and the doctor neglects that patient by not offering the correct treatment available, it is a problem. So, we need to address the reasons why this situation persists.

Pr. Peter Hotez and his group at Baylor College Medicine are working on an immunological approach, i.e. the Chagas vaccine, and some of the trial work that they are doing involves combination therapy with Benznidazole at a lower dose, given in conjunction with the vaccine with some encouraging data coming through in terms of reduction in the cardiac abnormalities associated with Chagas. The ethical right to vaccination is a very important and enshrined aspect in strategies for dengue control through vaccination, for example. Could this approach provide accelerated leverage in terms of the ethical right to treatment for Chagas disease by galvanizing the immunological world?

It is definitely possible. The more roots we have evolved, the more it provides a lot of hope to the future. While we still have some years to wait for the results, it brings us a lot of possibilities also in the US. Doctors should definitely work together and bring more evidence around that. Vaccines will bring a whole new level for Chagas and a whole new perspective in putting the disease on the political agenda.


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15 Chemin Louis-Dunant 1202 Geneva Switzerland Tel: +41 22 906 9230 Fax: +41 22 906 9231 Email:

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