“Some organisations focus on their own products or research. At The Union, our commitment – our bottom line – is to serving the best interests of the programmes and patients.”
One of the most critical problems in tuberculosis control today is the unsatisfactory treatment regimen for drug-resistant TB. The internationally approved regimen is long, harsh and expensive – all factors that contribute to its shockingly low success rate of around 50% and further fuel the increase in drug-resistant cases. The validity of a promising shorter regimen has remained in question due to a lack of randomised data – and The Union is working to provide that data.
As part of The Union-managed TREAT TB Initiative, The Union and key technical partners, such as the UK’s MRC Clinical Trials Unit, are conducting a clinical trial to test a new MDR-TB regimen that has raised hopes around the world. Dr I.D. Rusen is Project Director of TREAT TB and oversees the complex and sometimes controversial process of launching and conducting a trial with the potential to improve the life expectancy and quality of life for hundreds of thousands of people with MDR-TB.
STREAM – which stands for Standardised Treatment Regimen of Anti-Tuberculosis Drugs for Patients with MDR-TB – is testing a modified version of a 9-month regimen used successfully in Bangladesh against the locally used World Health Organization-approved regimen lasting up to 24 months. Patient recruitment began in 2012, and 245 of the projected 400 patients are now enrolled in South Africa, Ethiopia and Viet Nam. Mongolia will join as the fourth country this year.
“By early 2017, we hope to have the answer – is the Bangladesh regimen effective in other settings and are the results at least as good as the WHO regimen?” says Rusen. “If the data confirm its effectiveness, the shortened regimen will then become the new control against which other new or modified regimens will be measured.”
For Rusen and The Union, the STREAM trial is the cornerstone of the US $80-million TREAT TB Initiative funded by the US Agency for International Development (USAID). TREAT TB has included innovative projects ranging from development of a software programme that can virtually test the process, cost and impact of rolling out a new diagnostic tool to virtual operational research training.
But STREAM is the most ambitious and high-profile project of all. “One of the challenges has been to manage the interest and excitement in this trial,” says Rusen. For example, The Union was approached 18 months ago about evaluating additional regimens, which could potentially increase the impact and value of the trial. As a result, the partners are considering a proposal to work with Janssen, a global pharmaceutical company, on a trial modification introducing two new regimens.
“Decisions about the design of a trial expansion are controversial. Protocols are developed over months with many reviews involving both local and global ethics committees, community advisory boards and other regulatory groups.” But, if new compounds are available – which can further simplify and shorten MDR-TB treatment, for example – Rusen feels that they should consider the change, as long as it doesn’t delay the work now underway.
Further evidence of the importance of the STREAM trial is that the need has created a demand, and some countries have already begun using the shortened regimen. In fact, The Union is working with several countries in francophone Africa that have been approved by WHO to offer it to their patients.
“These pilots are valuable,” says Rusen, “but the clinical trial is essential to provide crucial evidence and safety data.”
Leading projects such as STREAM is also the fulfillment of Rusen’s personal goals. A native of Winnipeg in Western Canada, he became aware of the devastating problem of tuberculosis early on in his medical training. The population of Winnipeg is over 10% First Nations and Metis, groups who suffer very high rates of TB.
Although he originally planned to go into family medicine, Rusen spent time in Malawi and Kenya before and during medical school at the University of Manitoba, and these experiences changed his perspective. “I decided public health would be the best way to combine my interest in both medicine and international development,” he says. He went on to complete an M.Sc. in Epidemiology, writing his thesis on tuberculosis among injecting drug users in inner city Toronto.
Rusen first came into contact with The Union when he had an abstract accepted for the 1997 World Conference in Paris. Working for Health Canada and the Canadian International Development Agency (CIDA) at the time, he also met fellow Canadian Don Enarson and other future Union colleagues.
In 2004, he joined The Union as a full-time technical consultant for FIDELIS, a landmark project funded by CIDA that provided grants for innovative TB case-finding projects. Between 2004 and 2008, 54 projects took place in 18 countries – “a huge task, administratively”, Rusen recalls. Yet FIDELIS made a powerful statement about The Union’s capacity and helped position it to become a partner in the Bloomberg Initiative to Reduce Tobacco Use, as well as to undertake TREAT TB and STREAM.
In working for The Union, Rusen says he has found an organisation that matches both his goals and his values. “Some organisations focus on their own products or research. At The Union, whether we’re working on MDR-TB, HIV or tobacco control, our commitment – our bottom line – is always to serving the best interests of the programmes and the patients.”