Date Published: January 22, 2008
Publisher: Public Library of Science
Author(s): Nicholas M Fisk, Rifat Atun
Abstract: A new survey finds that only 17 drugs are under active development for maternal health indications, which is less than 3% of the pipeline in cardiovascular health (660 drugs).
Partial Text: The pharmaceutical industry’s business model is hefty investment in research and development (R&D), in expectation of high returns from future drug sales during the period of patent protection This model, which funds around 50% of health care R&D in the United States and a higher proportion in Europe , generates 20–25 new licensed drugs per year, but very few for use in pregnancy.
We undertook a search of the Pharmaprojects database (http://www.pharmaprojects.com/). This industry database used by over 700 pharmaceutical companies tracks all drugs identified as being under development from Web sites, conferences, PubMed, and registered clinical trials (over 37,000 listed since 1981). Although early pre-clinical capture is incomplete, late pre-clinical and clinical coverage is comprehensive, with around 10% of listed drugs eventually being licensed.
Overall, 67 drugs were listed in Pharmaprojects for maternal indications, mainly for preterm labour (45%, 30 out of 67). There were 17 drugs under active development as of November 2007. Only three were in pre-clinical studies, and 13 were in clinical trials (five in phase I, five in phase II, and three in phase III), with a further one awaiting registration. Nine of 10 drugs listed as licensed had been launched since 1981, but only three were licensed in both Europe and the US; two were formulations of dinoprostone, a prostaglandin E2 for labour induction, and the third was a prostaglandin F2a analogue for post-partum haemorrhage. Four were licensed in Japan and/or Korea only (all for labour induction: two sodium prasterone formulations, one prostaglandin E2 reformulation, and one oxytocin agonist). The only new class of drug listed (atosiban, an oxytocin receptor antagonist) was licensed in Europe but not the US. In 40 cases, drugs were listed as discontinued, suspended, or inactive.
We demonstrate significant under-investment by pharmaceutical companies in maternal health and the existence of a drug drought in obstetric therapeutics. Only one new class of drug has been licensed for obstetric conditions in the last 20 years, and the situation is set to worsen, with no new class of drug developed primarily for obstetric applications in clinical trials, and only three new chemical entities in pre-clinical. The meagre obstetric drug pipeline represents less than 3% of the activity (by number of drugs under investigation) in cardiovascular health, and considerably less than the activity for a single orphan disease. Pregnancy has become a virtual “pharma-free zone”, with a recent 137-page industry review of medicines development failing to mention any potential application in pregnancy . Our findings systematically demonstrate a “pharmaceutical gap” in medicines for women, whose needs, according to the WHO report on Priority Medicines for Europe, have often been neglected by manufacturers and regulators .