Fulfilling the Promise of Medicine for the Developing World

An Interview with Dr. Raj Shankar Ghosh by Kyle Funk

The Institute for OneWorld Health develops safe, effective, and affordable new medicines for people with infectious diseases in the developing world.

What are the biggest obstacles when it comes to making visceral leishmaniasis drugs available to those in countries that need them most?
There are several levels of obstacles to access to effective treatments for visceral leishmaniasis (VL), as for most neglected diseases. Ensuring access to effective visceral leishmaniasis treatments requires political will at the national, state, and district levels; sound epidemiological data for effective planning, coordination between drug procurement agencies, manufacturers, and distributors; training and supportive supervision for doctors and paramedics in endemic areas; and effective, targeted awareness-raising social mobilization efforts among the population. Each country has its own challenges, and we strive to be able to transfer our successes in India as we move forward into Nepal and Bangladesh.

Who have been some key partners in the development of Paromomycin for visceral leishmaniasis and how specifically has their involvement been helpful?
The Bill and Melinda Gates Foundation has generously funded the majority of our work in developing Paromomycin IM Injection (PMIM) as a treatment for VL. Our success with this program could not have been achieved without their support.

Gland Pharma Limited, the India based company who manufactures PMIM, is another key partner. Gland has committed to providing PMIM for treatment of VL at cost.

International multilateral agencies like the World Bank and the World Health Organization have supported the development of Paromomycin with their commitment to funding and by providing technical input, respectively.

The Indian Council of Medical Research (ICMR) has conducted and advised the necessary studies for adoption of the drug in the public and private health systems. ICMR has also provided leadership in the dialogue with the Government to facilitate adoption of the drug in the National Visceral Elimination Program.

Individual champions of Visceral Leishmaniasis particularly from the private sector have advocated for the adoption of the drug in multiple quarters.

Once drugs are developed and approved, how does the distribution process work? How does OneWorld Health ensure that the drugs reach the people?
iOWH is working within both the public and private sector in India to ensure that Parmomycin IM Injection is available to the people who need it. Within the public system, we are working with the government of India and the manufacturer to make sure there are adequate drugs available, advocating with the government at the national and state levels, and sharing resources on treatment guidelines and training as requested. We are also working with the manufacturer on identifying distribution channels and outlets, and researching professional organizations that have a presence in the endemic regions, to facilitate training on VL diagnosis and treatment with PMIM for private sector doctors.

Is OneWorld Health interested only in exclusively third world diseases?
OneWorld Health seeks to balance the global health inequities that exist in the world today. We do this by developing safe, effective, and affordable new medicines for people with infectious diseases in the developing world.

While infectious diseases now account for only one out of 10 deaths in the world’s richest countries, among the poorest people, five in 10 still die of infectious diseases. The 10/90 gap is another statistic which demonstrates the inequity faced in the developing world. This statistic refers to the finding that just 10% of worldwide expenditure on health research and development is devoted to the problems that primarily affect the poorest 90% of the world’s population. iOWH hopes to influence these statistics by focusing on diseases that primarily affect people in the developing world.

What are your goals for the next five years, both with respect to visceral leishmaniasis and more broadly?
iOWH’s success with Paromomycin is currently being expanded into Bangladesh and Nepal in pursuit of gaining approval for PMIM in these countries. With this work iOWH, in partnership with other stakeholders, will support the South Asian effort of regional elimination of VL. We are also launching activities in India to get uptake of PMIM into the government’s public health program. This will increase access to our lifesaving drug for those suffering from VL in India.

In addition to VL, iOWH is working on developing treatments for malaria, diarrheal diseases and soil transmitted helminthes. Over the next five years, iOWH aims to build and manage a robust portfolio of projects with a primary focus in diarrheal diseases. We also hope to continue establishing partnerships to provide late-stage clinical trial services and we will work for increased global awareness of the need for increased research, programs and funding for effective treatment of neglected tropical diseases.

For more information, please visit: http://www.oneworldhealth.org/

Raj Shankar Ghosh, MD is the Regional Director for the South Asia Institute for OneWorld Health. Dr. Ghosh has worked in the field of public health for the past 15 years. In recent years he has been directing the immunization work of PATH in India. Dr Ghosh has also participated in generating several policy level decisions at the National and State level as member of several health committees including the National Technical Advisory Group on Immunization in India.

This feature also published in journal Virulence, Volume 1, Issue 5. A free PDF download is available here.

An Interview with C-PET President and CEO Nigel M. de S. Cameron by Kyle Funk

The Center for Policy on Emerging Technologies (c-pet.org) is a Washington, DC-based think tank focused on raising the profile of emerging technology policy issues and convening stakeholder discussion in areas such as GM crops, synthetic biology and vaccines. Its board includes corporate, academic, science, and NGO leaders.

How does C-PET influence science policy in America?
We host events and are developing reports. For example, we invited both the presidential candidates to be represented at a high-level invitational day conference during the campaign, with expert panels on the federal role, space policy, and bio/nano. We are also developing C-PET Global as our international partner, which has convened a transatlantic dialogue meeting in Europe and is working on an African initiative. The United States remains well in the lead in most of these technologies, but the issues are global.

How does C-PET seek to inform the debate on the issue of synthetic biology? GM crops?
C-PET’s approach is to bring parties round the table, recognizing that the issues raised by emerging technologies (of which synthetic biology is one of the more exciting and, potentially, troublesome) are of much greater significance than mainstream policy leaders tend to realize. We don’t naively believe that consensus is always possible. We do believe that identifying areas of agreement and disagreement early on in technology development, and addressing potential policy implications, is both good for technology and also for the values of civil society.

How can public policy affect the way scientific research is conducted and applied, specifically do you favor a top down approach?
I’m sure our fellows and board members take various views, but most of us would favor more federal investment in emerging technologies, and many would favor fresh approaches to research and development that encourage innovation and the work of young researchers. Governments should not dictate research - though of course they set the legal context for issues like human subject research. But they need to take more interest in the long-term implications of research. That will have the effect both of strengthening democratic participation in the shaping of the future, and underwriting the private investment dollars that will determine where research and development leads.

What are the biggest challenges when attempting to foster discussion on controversial topics such as synthetic biology?
Well, ignorance. It doesn’t worry me that political leaders are not scientists (some are, not many); it does worry me that they simply don’t see S and T issues as high on the agenda. How many speeches did the candidates make in the presidential campaign on these issues? I wonder what difference it would make if leaders in both parties took the same kind of visionary interest in S and T that President Kennedy showed in the space program. So, whether synthetic biology is wonderful or worrying (and its lead practitioners tend to agree it is both), we need a national conversation that looks seriously ahead.

What will be the goals and functions of the Commission on Biotechnology, currently in development by C-PET?
We are development three commissions to help frame our work and also to contribute to the setting of the agenda for the national debate - on artificial intelligence/robotics, on the future of the internet, and on biotechnology. They will draw together industry and policy leaders, NGOs from left and right, technology visionaries, and also science communicators - with an initial task of listing the strategic issues they see on the horizon 10 years ahead. Unless we can get deeper into that conversation, it is hard to see how we can make the best decisions for fiscal 2011.

Who supports C-PET? Is the center completely independent of the political parties?
C-PET is entirely independent, and our board and other groups include leaders known for their commitments right across the political spectrum. We have had support from individuals, foundations, universities, and the corporate world.

For more information, please visit: http://www.ritabiotech.com and http://www.c-pet.org

Nigel Cameron was most recently at the Illinois Institute of Technology, where he led a project on the societal implications of biotechnology and founded the Center on Nanotechnology and Society. His most recent book, edited with M. Ellen Mitchell, is Nanoscale: Issues and Perspectives (Wiley).

This article is also being published in the journal Human Vaccines, Volume 6, Issue 5. A free open-access .pdf of the feature is available at: http://www.landesbioscience.com/journals/vaccines/article/12218/