/publications/issue/2003/2003-08/2003-08-7321

Lilly Leads Global Assault on Mutated TB

Author: David Vaczek

With elements including the transfer of drug manufacturing technology and training for medical personal, Eli Lilly is heading an innovative public/private project to help developing countries to be more self-sufficient in combating a global threat of tuberculosis (TB) strains resistant to first-line drug therapies. Partners in this comprehensive initiative include the World Health Organization (WHO), the Department of Health and Human Services? Centers for Disease Control and Prevention (CDC), Harvard University School of Medicine, and Purdue University.

Purdue University will manufacture drugs for the US marketplace and, through new certificate and master of science degree programs, train health professionals from countries receiving Lilly technology in good manufacturing practices (GMP). Purdue?s department of industrial and physical pharmacy has also begun training employees at US drug companies and pharmacy students in manufacturing principles and quality standards using the new courses.

Lilly is initially providing Purdue with the technology to produce cyclo-serine, which, along with capreomycin, is used in treating multidrug-resistant TB (MDR-TB). The drug will be made at a GMP facility in the Purdue Research park, which the school began planning last year at the behest of Lilly and Abbott, to provide graduates with a better grasp of regulatory affairs fundamentals. Health personnel from India, China, and South Africa, the first countries receiving Lilly?s technology for making cycloserine and capreomycin, will take the courses and be trained at the GMP plant set to open next year. It is hoped that Russia will be added in the future.

"This a paradigm shift bringing the public and private sectors together to address a major health threat," said Dr. Charles Rutledge, interim vice provost for research, and executive director of the Discovery Park at Purdue, of the Lilly project. "More than a collaboration between academia and corporations, it includes WHO, the CDC, and 2 educational institutions, helping countries to help themselves rather than giving out handouts, contributions, and advice," he adds.

Concurrently, Dr. Rutledge noted, Purdue?s expanded industrial pharmacy program will "engage students in educational learning experiences that will let them see what life is like in the real world with regard to drug manufacturing so that they can add value right away when they go to work." The course tracks are a 9-hour certificate program in regulatory affairs and a master of science in regulatory and quality compliance, comprising 30 hours of course work and a 6-hour project. Purdue has 60 students enrolled in the courses. Students will have the chance to work as interns in the GMP facility, said Steve Byrn, Purdue department of industrial and physical pharmacy head.

"The people in the developing countries will have to be able to make the drugs following GMPs. These courses will provide the foundations of GMP, without which they would fall out of compliance pretty quickly," he said. A comprehensive global program with health organizations working with "high-burden" countries in the areas of drug supply, training, and surveillance is necessary because the characteristics of the MDR-TB epidemic are complex. MDR-TB develops when first-line therapy is administered incorrectly or when patients fall out of compliance with drugs that are expensive and in short supply. Many countries lack the staff and coordination among health agencies and government to prosecute programs to identify and treat TB and MDR-TB effectively. The first beneficiaries of the program will be 11 countries, including Russia, Peru, Mexico, and India, that WHO has identified as areas with moderate-to-high levels of MDR-TB. The project is promoting WHO?s Directly Observed Treatment, Short Course (DOTS-Plus) comprehensive management strategy for curing MDR-TB, an offshoot of its TB program, DOTS.

Here are some of the components of the program:

? With assistance from the Lilly staff, facilities in Russia will be converted to make the 2 MDR-TB drugs. Russia may also be converting former biowarfare facilities to peacetime uses under its education ministry, a prospect that has interested the US State Department in the TB project, said Rutledge.

? Harvard Medical School?s Brig-ham and Women?s Hospital, with Lilly funding, will develop a center of excellence for training health care workers in diagnosis, treatment, and management of MDR-TB, and Harvard will develop training centers at "hot spots" such as in Tomsk, Russia.

? Lilly, with WHO, the CDC, Harvard, and Purdue, will develop a laboratory-based surveillance program in Tomsk, Moscow, and Novosibirsk.

? Lilly will fund the International Council of Nurses to develop and spread best practice guidelines.

? Lilly will contract with countries including Greece and Hungary for the production of MDR-TB drugs and double its production of capreomycin at its Liverpool, England, facility to provide drugs at a fraction of their cost to WHO DOTS-Plus programs, ensuring that drugs remain affordable through negotiation of controlled prices with the partners that are receiving its technology.

WHO has said that the help is essential if it is to improve cure rates and expand its DOTS program to other countries to meet a goal of 70% TB case detection and 85% treatment success by 2005. It hopes to treat 20,000 patients with MDR-TB annually by 2010.