After the Khobrogade diplomatic dust up, FDA pushback on Indian generic drugs and FAA reprimand of India’s commercial airlines, the United States Government hopes Narenda Modi’s election will open the door to a relationship reset. But without more than a change at the helm of the Indian government, the relationship will continue adrift. The U.S. and India need something bigger to right their footing, and nothing brings countries together like a common, addressable humanitarian crisis that requires mutual cooperation. Stronger relations and lasting benefits would ensue for both countries if they pursued a strategic approach to combat Tuberculosis, a condition where the largest number of new cases resides in India and the highest costs of treatment for resistant cases are in the U.S.
Drug resistant tuberculosis (TB) is increasingly becoming a problem for both the U.S. and India. India is a World Health Organization (WHO)-designated “high burden” country, with an (under) estimated 2.8 million active tuberculosis cases; and at least 15 percent of its retreated cases are resistant to at least one first-line treatment. The United States has far fewer tuberculosis cases (approximately 9,500 new cases in 2013), but the cost of hospitalizing and fully treating a patient with drug resistant tuberculosis can reach an incredible $483,000 per case.
Individual organizations and entities concerned with tuberculosis—ranging from academic centers to government agencies to international organizations such as The Union Against Tuberculosis and Lung Disease (The Union)—learned long ago that when they work in silos, they work ineffectively. The most impactful advances in diagnosing and treating tuberculosis, like many other diseases, occurs through extensive and sustained collaboration. For example, Cepheid Gene Xpert system, a rapid test for detecting drug-resistant tuberculosis, was produced through collaboration between foundations, government agencies, a university, and a device company. The high sensitivity and accessibility of this diagnostic earned it an endorsement by the World Health Organization.
The U.S. and Indian governments must combine their ample resources to learn from and expand upon these collaborative efforts. The U.S. could connect its extensive clinical trial knowledge in entities such as the National Institutes of Health (NIH), the Food and Drug Administration (FDA), and many U.S.-based corporations with India’s massive pharmaceutical production capacity, burgeoning technical analysis hubs, and diverse TB patient population. Through such a collaborative effort, the two governments could not only accelerate the discovery and production of new tuberculosis therapies and diagnostics, but also use such collaboration as a broad and steady bridge to better relations.
Obtaining the necessary economic and human resources to support such an endeavor would involve U.S.-India technical exchange far beyond the current framework of FDA regulation of the manufacturing, clinical, and laboratory practices of Indian drug manufacturers exporting to the U.S. A promising framework could comprise the Indian government, providing incentives to Indian companies to conduct rigorous large-scale clinical trials in India, funding support, market exclusivities—similar to those provided by the U.S. FDA—and tax incentives that cultivate a research and development ecosystem. On the American side, executive branch agencies must be willing to work with their Indian government counterparts to provide technical assistance to Indian clinical trial organizers. Additionally, India would need to consider early stage “bench to bedside” R&D funding models such as those the NIH uses to partner with researchers in supporting, funding, and facilitating clinical trial activities.
To smooth risk for companies and investors willing to spend years and hundreds of millions of dollars on drug development, both countries could consider establishing postmarket purchasing commitments with drug and diagnostic device innovators that meet certain development milestones. A good model for such a program could borrow concepts from the U.S.’s Biomedical Advanced Research and Development Authority program, which, for nearly 10 years, has incentivized companies to design medical countermeasures against biological agents for the U.S. government.
The growing threat of multi-drug resistant tuberculosis is not limited by borders, and it follows that the efforts to seriously tackle this issue should not be limited to only domestic initiatives. The United States and India together are countries with the necessary ingredients—technological knowledge, unmet medical needs, and abundant resources—to address tuberculosis in a way that could substantially benefit them both. This challenge presents a unique opportunity for both countries to garner the political will to reach past recent differences and work together to innovate in drug, device and clinical trial design. Such an effort would have positive effects for the U.S., India, and the rest of the world.
By leveraging civil society, public, and private sector involvement, the growing problem of drug resistant tuberculosis can be addressed before it becomes an epidemic in lives lost and treatment costs. Such a solutions-oriented relationship would result in sustained and fruitful diplomatic relations that minor dust-ups are less prone to disrupt.
Acknowledgments: The authors would like to thank Dr. John A. Bartlett from the Duke Global Health Institute and Dr. Eric Houpt from the University of Virginia School of Medicine for their comments.
This article was originally published in the Diplomatic Courier's July/August print edition.
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Post-Election U.S-India Foreign Policy Strategy Should Start with Tuberculosis
July 21, 2014
After the Khobrogade diplomatic dust up, FDA pushback on Indian generic drugs and FAA reprimand of India’s commercial airlines, the United States Government hopes Narenda Modi’s election will open the door to a relationship reset. But without more than a change at the helm of the Indian government, the relationship will continue adrift. The U.S. and India need something bigger to right their footing, and nothing brings countries together like a common, addressable humanitarian crisis that requires mutual cooperation. Stronger relations and lasting benefits would ensue for both countries if they pursued a strategic approach to combat Tuberculosis, a condition where the largest number of new cases resides in India and the highest costs of treatment for resistant cases are in the U.S.
Drug resistant tuberculosis (TB) is increasingly becoming a problem for both the U.S. and India. India is a World Health Organization (WHO)-designated “high burden” country, with an (under) estimated 2.8 million active tuberculosis cases; and at least 15 percent of its retreated cases are resistant to at least one first-line treatment. The United States has far fewer tuberculosis cases (approximately 9,500 new cases in 2013), but the cost of hospitalizing and fully treating a patient with drug resistant tuberculosis can reach an incredible $483,000 per case.
Individual organizations and entities concerned with tuberculosis—ranging from academic centers to government agencies to international organizations such as The Union Against Tuberculosis and Lung Disease (The Union)—learned long ago that when they work in silos, they work ineffectively. The most impactful advances in diagnosing and treating tuberculosis, like many other diseases, occurs through extensive and sustained collaboration. For example, Cepheid Gene Xpert system, a rapid test for detecting drug-resistant tuberculosis, was produced through collaboration between foundations, government agencies, a university, and a device company. The high sensitivity and accessibility of this diagnostic earned it an endorsement by the World Health Organization.
The U.S. and Indian governments must combine their ample resources to learn from and expand upon these collaborative efforts. The U.S. could connect its extensive clinical trial knowledge in entities such as the National Institutes of Health (NIH), the Food and Drug Administration (FDA), and many U.S.-based corporations with India’s massive pharmaceutical production capacity, burgeoning technical analysis hubs, and diverse TB patient population. Through such a collaborative effort, the two governments could not only accelerate the discovery and production of new tuberculosis therapies and diagnostics, but also use such collaboration as a broad and steady bridge to better relations.
Obtaining the necessary economic and human resources to support such an endeavor would involve U.S.-India technical exchange far beyond the current framework of FDA regulation of the manufacturing, clinical, and laboratory practices of Indian drug manufacturers exporting to the U.S. A promising framework could comprise the Indian government, providing incentives to Indian companies to conduct rigorous large-scale clinical trials in India, funding support, market exclusivities—similar to those provided by the U.S. FDA—and tax incentives that cultivate a research and development ecosystem. On the American side, executive branch agencies must be willing to work with their Indian government counterparts to provide technical assistance to Indian clinical trial organizers. Additionally, India would need to consider early stage “bench to bedside” R&D funding models such as those the NIH uses to partner with researchers in supporting, funding, and facilitating clinical trial activities.
To smooth risk for companies and investors willing to spend years and hundreds of millions of dollars on drug development, both countries could consider establishing postmarket purchasing commitments with drug and diagnostic device innovators that meet certain development milestones. A good model for such a program could borrow concepts from the U.S.’s Biomedical Advanced Research and Development Authority program, which, for nearly 10 years, has incentivized companies to design medical countermeasures against biological agents for the U.S. government.
The growing threat of multi-drug resistant tuberculosis is not limited by borders, and it follows that the efforts to seriously tackle this issue should not be limited to only domestic initiatives. The United States and India together are countries with the necessary ingredients—technological knowledge, unmet medical needs, and abundant resources—to address tuberculosis in a way that could substantially benefit them both. This challenge presents a unique opportunity for both countries to garner the political will to reach past recent differences and work together to innovate in drug, device and clinical trial design. Such an effort would have positive effects for the U.S., India, and the rest of the world.
By leveraging civil society, public, and private sector involvement, the growing problem of drug resistant tuberculosis can be addressed before it becomes an epidemic in lives lost and treatment costs. Such a solutions-oriented relationship would result in sustained and fruitful diplomatic relations that minor dust-ups are less prone to disrupt.
Acknowledgments: The authors would like to thank Dr. John A. Bartlett from the Duke Global Health Institute and Dr. Eric Houpt from the University of Virginia School of Medicine for their comments.
This article was originally published in the Diplomatic Courier's July/August print edition.
