Pharmaceutical market fails pregnant women
The existing research and development and business model of the pharmaceutical industry is failing pregnant women, according a policy paper published this week in PLoS Medicine. In their analysis of an industry database that tracks drugs under development since 1981, Imperial College Londons Nick Fisk (Professor of Fetal Medicine, Faculty of Medicine) and Rifat, Atun (Professor of International Health Management, Tanaka Business School) show that pregnancy has become a virtual pharma-free zone with only seventeen drugs under active development for maternal health indications and only one new class of drug licensed in the last 20 years.
For their analysis, the authors searched the Pharmaprojects database, which lists all drugs identified as being under development from pharmaceutical company web sites, conferences, PubMed (a searchable database of the abstracts of published medical journal articles) and registered clinical trials. Over 37,000 drugs under development have been listed since 1981. They searched for drugs for obstetric applications and, in order to compare industry activity in maternal health relative to other areas of medicine, they also examined the database for drugs for cardiovascular indications and for a rare condition called amyotrophic lateral sclerosis - a neurodegenerative disease sometimes called Lou Gehrigs disease.
The team found only seventeen drugs under active development for maternal indications as of November 2007, less than 3% of the number in the pipeline in cardiovascular health (660 drugs) and less than those for amyotrophic lateral sclerosis (34 drugs), which only affects two to five of 100,000 people. In contrast, worldwide there are over half a million maternal deaths annually while over 7 million babies die before or shortly after birth, 99% of these in the developing world.
The authors argue that their study demonstrates a drug drought in maternal health. They outline how the push mechanisms (funding to encourage investment from universities and companies) and pull mechanisms (funding to purchase drugs once they are on the market) relevant to the United Nations Millennium Development Goal of providing affordable essential drugs in developing countries have not been effective in the area of maternal health.
One of the reasons that pharmaceutical companies are reluctant to test and develop drugs in pregnancy, say the authors, is to avoid the litigation costs that come with the risk of birth defects and disfigurements, despite the fact that these risks are of little relevance to drug development for conditions in later pregnancy. Other reasons for market failure cited by the authors are the small market size for conditions affecting pregnant women, the limitations of a shareholder model (maternal health drugs have a greater potential for revenue shocks) and a regulatory system that allows endemic off-label use of drugs in pregnancy, discouraging pharmaceutical investment in the long term.
In contrast, the authors point towards models such as the Drugs for Neglected Diseases Initiative (DNDI) as an example of a successful push mechanism that encourages investment and they suggest that not-for profit options which do not rely on profit for innovation should be considered. They conclude that between the pull and the push, the international donor agencies have also forgotten these women. Given the unacceptably high number of maternal and perinatal deaths each year, it is high time to address this failure.
Citation: Fisk NM, Atun R (2008) Market failure and the poverty of new drugs in maternal health. PLoS Med 5(1): e22.
Posted by: Emily Source