Pharmaceutical market failing pregnant women

Research from Tanaka Business School unveils a 'drug drought' with few new drugs suitable for treating women in pregnancy.

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 London’s 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 “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.

“The study demonstrates a ‘drug drought’ in maternal health,” Professor Atun 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 Atun 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 Atun 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 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 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.

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Notes to Editors

READER ACCESS TO THE PUBLISHED PAPER:

http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0050022

 1) About Imperial College

Imperial College London – rated the world’s fifth best university in the 2007 Times Higher Education Supplement University Rankings - is a s cience-based institution with a reputation for excellence in teaching and research that attracts 12,000 students and 6,000 staff of the highest international quality.

Innovative research at the College explores the interface between science, medicine, engineering and business, delivering practical solutions that improve quality of life and the environment - underpinned by a dynamic enterprise culture.

Website: www.imperial.ac.uk

2) About the Tanaka Business School

 -  Imperial College's Tanaka Business School is a world-class provider of business education and research, building on Imperial's strengths through focusing on innovation and entrepreneurship, finance and healthcare management. The School offers full-time and executive MBAs, Masters programmes in Finance, Risk Management, International Health management, Management and Actuarial Finance; and a Doctoral programme. The School's Innovation and Entrepreneurship faculty group is the leading research group of its kind in Europe, having received over £25m in funding from governmental and corporate sponsors.

www.imperial.ac.uk/tanaka

3) About PLoS Medicine

PLoS Medicine is an open access, freely available international medical journal. It publishes original research that enhances our understanding of human health and disease, together with commentary and analysis of important global health issues. For more information, visit http://www.plosmedicine.org 

Elliott White

Press Manager, Tanaka Business School

020 7594 9154

077 2515 9796