New Treatments Lacking For Pregnant Women
A British study released this week shows a dearth of new pharmaceutical medications for pregnant women, with only three new drug patents produced over the last 28 years. Among the few new treatments currently under development, many are merely improvements to existing treatments.
The study was performed by Imperial College London’s Nick Fisk, Professor of Fetal Medicine, and Rifat Atun, Professor of International Health Management. It is published in the journal Public Library of Science (PLoS) Medicine.
“The study demonstrates a “˜drug drought’ in maternal health, ” said Professor Atun.
The study analyzed an industry database that tracks drugs under development since 1981, and showed that pregnancy has become essentially off limits to new pharmaceutical developments.
The results of the study showed that out of the over 37,000 new drugs listed for development since 1981, only 17 were for maternal health indications, with only one new class of drug licensed in the last 20 years.
Comparatively, this represents less than 3% of the 660 drugs under development for cardiovascular indications, and about half the number of new treatments for Lou Gherig’s disease, which affects only 2 to 5 out of every 100,000 people.
“One of the reasons that pharmaceutical companies are reluctant to test and develop drugs in pregnancy is to avoid the litigation costs that come with the risk of birth defects and disfigurements. This is despite the fact that these risks are of little relevance to drug development for conditions in later pregnancy,” Professor Atun said.
The report states other reasons as well, such as the small market size for conditions affecting pregnant women, the limitations of a shareholder business model and a regulatory system that allows endemic off-label use of drugs in pregnancy, discouraging pharmaceutical investment in the long term.
Globally there are over 500,000 maternal and seven million perinatal deaths annually, 99% of which occur in developing countries.
The authors recommend alternative models to encourage investment and propose that not-for-profit options be considered to improve the number of pregnancy-related treatments being developed.
“International donor agencies have forgotten these women. Given the unacceptably high number of maternal and perinatal deaths each year, it is high time to address this failure,” Professor Atun said.
—
On the Net: