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Thursday, March 2, 2006

Tuberculosis Drugs for Developing Countries Will Require Significant Resources, Cooperation
By Laura Brinn, Duke University Office of News & Communications

Natural disasters such as mudslides and tsunamis bring massive media attention to impoverished nations, but the enduring problem of public health in those countries receives much less notice yet continues to endanger millions of lives each year.

While more than 10 million people develop tuberculosis and two million die from it every year, science has been slow to produce new treatments that are simple to administer in settings where health care resources are limited.

A new Duke University analysis found that current investments and partnerships to locate new treatments for tuberculosis have a less than 5% chance of succeeding by the year 2010. The goal of the Global Alliance for TB Drug Development (TB Alliance) is to bring a new treatment to market by the year 2010.

The Duke analysis will be published in the March 3 issue of Science. The researchers received no external funding for this project.


K. Schulman, MD
In an analysis similar to those used in the private sector by large pharmaceutical firms, the Duke team developed a new drug-development portfolio simulation model to evaluate the development of tuberculosis treatments by a public-private partnership.

"Public-private partnerships have become increasingly popular and important in many areas of health care research and development," said [the DCRI's] Dr. Kevin Schulman, director of the Health Sector Management program at Duke's Fuqua School of Business and an author of the study. "However, this organizational structure alone won't guarantee the success of these efforts. We need to help understand their resource requirements and have realistic expectations for success if unmet public health needs are to be addressed."

According to the Duke calculations, TB Alliance has a 73% chance of generating at least one successful treatment by the year 2019, nine years past its 2010 goal. The Duke team also estimated the cost to bring such a treatment to market at $98 million, far in excess of the TB Alliance's estimated $36 million in funding through 2007. Because multiple treatments will be in development at once and it is likely many will not be successful, the Duke team estimates that up to $400 million will be needed to create a robust portfolio of candidate drugs from which one would eventually become an approved treatment.

"We set out to really turn this situation on its head and find out just how much funding and what types of resources would be needed to bring a new treatment to market," said Dr. Seth Glickman, a Fuqua MBA student and lead author of the study. "By using a new method, we have been able to create what we think is a very reasonable assessment of the prospects for new tuberculosis treatments."


C. Dukes Hamilton, MD
Added [the DCRI's] Dr. Carol Dukes Hamilton, an associate professor of medicine at Duke University Medical Center and an author of the study: "Tuberculosis is a devastating disease affecting the most populous countries in the world, And while our currently available treatments are very successful at treating patients with drug-susceptible TB within a sophisticated and structured health care environment, many TB patients around the world do not have access to such resources, or are dying of multidrug-resistant disease, and are in desperate need of new therapeutic options."

Schulman noted that the paper does not aim to criticize TB Alliance and its efforts.

"It is actually a recognition of the heroic role society is asking the TB Alliance to fill, and demonstrates the lack of resources they have been given to achieve this," he said. "Clearly, we are much better off using the TB Alliance structure than before, but we still have a ways to go to adequately address this critical issue of global health."

Glickman, Dukes Hamilton and Schulman were joined in their research by Emma Rasiel of Duke's Department of Economics and Arsen Kubatev, a Fuqua alumnus who works with the American International Health Alliance in Russia.

     
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