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Battling 'Black Fever'

SAS® helps OneWorld Health find cures for afflictions of people in the developing world

The bites from sand flies infected with the visceral leishmaniasis parasite kill as many as 200,000 people each year in developing countries. While there are drugs available to treat this disease, all of them have serious drawbacks: some are too toxic, others are too expensive, while others quickly become ineffective to resistant strains of the parasite.

For a typical pharmaceutical company, there is no incentive to find a better treatment for this disease. Marketing to countries that can't afford to treat people who live on a dollar a day isn't likely to recoup the costs of developing the drug, let alone turn a profit.

 

But for the United States' first not-for-profit pharmaceutical company, finding a cure for leishmaniasis is the perfect challenge. And with help from SAS software, the Institute for OneWorld Health is hoping to obtain regulatory approval from India in 2005 for a drug in the final phase of human trials.

"At OneWorld Health, you're constantly reminding yourself that the challenge is not making the drug but making it affordable to the poorest of the poor," says Bao Nguyen, OneWorld Health's director of systems and data management. And SAS helps him do just that.

Helping the world's poorest
Founded in 2000, OneWorld Health develops and tests drugs for tropical diseases that disproportionately plague the world's developing countries. By seeking patents for promising compounds from for-profit companies and universities that may not have the money or desire to pursue additional research, the San Francisco-based company is hoping to make a difference in the lives of millions of people in the developing world.

For visceral leishmaniasis, also known as kala-azar, OneWorld Health obtained the rights to an older antibiotic, paromomycin, which has been available in the United States for years to treat other parasites. In earlier trials, the drug showed promise in curing leishmaniasis without toxic side effects.

"It's very, very effective, and once you have been cured you are immune," says Catherine Ley, Ph.D., an epidemiologist and senior scientist with OneWorld Health. "If you save someone from dying from this disease at this point in time, you've saved him for life."

An offer OneWorld Health could refuse
To conduct trials on the drug in the remote Indian state of Bihar, where kala-azar is endemic, OneWorld Health needed a statistical tool for analyzing the findings and presenting them to regulatory authorities.

As OneWorld Health was setting up its first clinical trial, Nguyen received an offer from a software provider for a free clinical system package. There was one problem: "In order for us to implement the system, we would have to invest about $500,000 in infrastructure and manpower. We're a nonprofit group. We operate on a very, very tight budget. We can't afford to do a trial that costs the same as everyone else's because then the people we try to serve either couldn't afford the drug or would never ever have access to it."

Yet Nguyen says his group is still held to the highest standard in terms of data quality. So he turned to SAS, licensing software for a fraction of the half million it would have cost to use the "free" software package. He used SAS to develop a front end that does not require SAS programming knowledge to use. It took Nguyen about a month to set the program up, including the creation of 5,000 fields, plus data entry and data verification routines. Overall, the application allows the company to gather about 70 pages of data on each of the 667 patients in the trial, plus run data quality checks on that information and analyze the results.

The data includes measurements of everything from the patient's temperature while being treated to the results of hearing tests – since a key issue in checking this drug's toxicity is to make sure it doesn't adversely affect hearing.

"The unique thing about SAS is that you don't have to have a big infrastructure to run it and yet you can create a very complex system," Nguyen says. "A user can run SAS from a desktop. I don't have to run and buy a big server. I don't have to hire a database administrator to sit there and make sure that things run 24/7. And the thousands and thousands of procedures that are built into the language allow me to really achieve and develop the application in a very short time." Other software, Nguyen estimates, would require a week's worth of programming time for each procedure.

Nguyen runs SAS on a Windows environment and keeps the SAS data sets on a Dell file server. "We didn't have to have a database server," he says – another money saver.

Funding more trials, finding more cures
The leishmaniasis trial looks promising. It is the largest Phase 3 clinical trial ever performed for the disease, and the results are encouraging enough that the company hopes to submit an application to India in 2005 to win approval for the drug's use.

OneWorld Health will be adding more clinical trials in 2005. It is investigating promising candidates for treating infant diarrhea and Chagas disease, a parasitic illness common in Latin America that damages the heart of those afflicted with it. It is also working on a vaccine for malaria. With more trials, Nguyen says he might need to move up to SAS' software designed specifically for clinical trials. Either way, he feels confident his organization can depend on SAS.

"My role is to figure out how to best deliver the results with minimum resources or develop collaborations with like-minded organizations," Nguyen says. "SAS is a must-have tool for us."

 

Copyright © SAS Institute Inc. All Rights Reserved.

Institute for OneWorld Health

Business Issue:
Develop safe, effective, affordable treatments for diseases that afflict people in the developing world.
Solution:
SAS' ease of use and affordability allows OneWorld Health to maintain outstanding data quality and stay within a tight budget. 

SAS is a must-have tool for us. 

Bao Nguyen

Systems and Data Management Director

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