When a shipment of round, white tablets of the generic drug misoprostol lands in Nigeria this week, that country will become the first ever to allow distribution of this effective, inexpensive and stable drug to prevent and treat post-partum hemorrhage, the devastating bleeding experienced by thousands of women after childbirth.
Backed by technical assistance from a team of researchers at University of California, Berkeley's School of Public Health, a group of Nigerian health professionals won approval for the drug at a January meeting of the Nigerian National Agency for Food and Drug Administration and Control. Now, the first load of the drug is on its way to Nigeria from the Chinese factory where it was manufactured.
"It's our hope to decrease maternal mortality in Africa in places where there are few resources and few facilities," said Ndola Prata, a physician from Angola who is a lecturer in the UC Berkeley School of Public Health and heads the scientific research in the school's Bixby Program in Population, Family Planning and Maternal Health. "Of each 100 women who go into labor in Nigeria, between 15 and 20 will develop post-partum hemorrhage. Although the majority will survive, most of those who do will suffer from severe anemia-related health problems for weeks or months after delivery. This drug will have a huge impact both in decreasing those problems and in preventing maternal deaths."
Misoprostol has been marketed since 1987 for treatment of gastric ulcers. Although its value for post-partum hemorrhage, or PPH, has been recognized since the early 1990s, the drug has not been distributed in most of the developing countries where maternal mortality rates are highest.
After its patent expired in 2000, interest in misoprostol as a PPH medication surged. Encouraged by initial studies indicating potential benefits in poor countries, a group of leading African obstetricians seeking to bring the drug into their own countries asked for help from obstetrician Malcolm Potts, Bixby Professor in the School of Public Health and founder of its Bixby Program, and Martha Campbell, a lecturer at the school and founder of Venture Strategies for Health and Development, a non-profit organization.
Since then, the group at Bixby has swung into action on the project: Prata has worked with doctors in Tanzania, Nigeria, Uganda, Egypt and Bangladesh providing technical assistance for trials and other studies; the group is helping to establish plans for the use and distribution of misoprostol in various countries; and several team members are developing educational materials for training traditional midwives in the use of the drug. In addition, Prata and Melodie Holden, an economist and engineer who holds a faculty position in the School of Public Health and is director of operations for Venture Strategies, constructed the technical regulatory application for misoprostol's approval in Nigeria.
Venture Strategies is also playing a central role in these efforts.
"Some of our work is best conducted through a private organization," Campbell said. "I founded Venture Strategies in 2000 to draw on the expertise of the School of Public Health to help low-income people in developing countries." With the scientific base of the technical team at the school, Venture Strategies has supported policy meetings in three African countries and is organizing arrangements with drug manufacturers and distributors to make misoprostol available.
Misoprostol is a hormone-like drug that rapidly stimulates powerful uterine contractions. In a normal labor, contractions after birth deliver the placenta in a timely fashion and start the process of reducing the uterus back to its normal size. If this process is delayed or fails, the bleeding that accompanies childbirth becomes excessive. By stimulating contractions, misoprostol can both prevent the bleeding before it starts, or stop it after it has started.