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The existing research and development and business model of the pharmaceutical industry is failing pregnant women, according to a leading maternal-fetal medicine researcher, now based at The University of Queensland.
Professor Nicholas Fisk and Professor Rifat Atun (Imperial College London) describe pregnancy as a virtual “pharma-free zone” in a policy paper published this week in PLoS Medicine.
Their analysis of an industry database that tracks drugs under development since 1981, shows that only 17 drugs were under active development for maternal health indications and only one new class of drug has been licensed in the last 20 years. (This was not in Australia or the United States).
“The study demonstrates a ‘drug drought’ in maternal health,” Professor Fisk said.
The paper outlines how the pharmaceutical market’s “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 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 Fisk said.
The authors cite other reasons for market failure as 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.
They suggest alternative models such as the Drugs for Neglected Diseases Initiative (DNDI) as an example of a successful “push mechanism” that encourages investment and propose that not-for profit options – which do not rely on profit for innovation – should be considered.
“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,” Professor Fisk said.
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.
They found 17 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 fewer than those for amyotrophic lateral scelorsis (34 drugs), which only affects two to five of 100,000 people.
In contrast, worldwide there are over half a million maternal and seven million perinatal deaths annually, 99% of which are in the developing world.
Professor Fisk now heads the $66million UQ Centre for Clinical Research in Brisbane.
Media inquiries: Faculty Communications Officer, Marlene McKendry - 0401 99 6847.
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