Healthy Skepticism Library item: 12547

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Publication type: Journal Article

Fisk NM.
Market Failure and the Poverty of New Drugs in Maternal Health
PLoS Medicine 2008 Jan 22; 5:(1):22
http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0050022&ct=1

Abstract:

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 [1], generates 20–25 new licensed drugs per year, but very few for use in pregnancy.

After thalidomide and diethylstilboestrol, risk of teratogenicity has led to understandable caution in developing drugs for pregnancy and including women in clinical trials, but this has meant increased off-label use, with 75% of pregnant women taking at least one drug for which safety data are unavailable [2]. A greater problem is the dearth of drugs developed specifically for obstetric conditions. With the exception of abortifacients and reformulations, only three new drugs (atosiban, carboprost, and carbetocin) have been licensed over the last two decades in the United Kingdom for obstetric indications, two of which are only used after delivery. In the US, no licensed drug is available for use in preterm labour. No new classes of drug have been developed for the big diseases of preeclampsia, fetal growth restriction, postpartum haemorrhage, and miscarriage [3,4]. The mainstays of the 2007 obstetric formulary (magnesium sulfate, α-methyldopa, hydralazine, β-blockers, aspirin, and nifedipine) hark back to an earlier era, and give resonance to Archie Cochrane’s 1979 award of the “wooden spoon” to obstetrics as the least scientific specialty in medicine [5].

The paucity of obstetric drugs impacts not only the resource-rich countries, but also affects the far greater disease burden in resource-poor settings. Maternal and perinatal conditions are the single largest contributor to the global burden of disease, accounting for 6% of disability-adjusted life years (DALYs) [6], and would account for more if stillbirths were not excluded. Worldwide, there are 536,000 maternal deaths annually [7], while nearly half the 13.5 million under-five child deaths occur as antepartum, intrapartum, or neonatal deaths [6,8]. These are disproportionately concentrated in the developing world, where 99% of maternal deaths occur, three-quarters due to preventable or treatable conditions such as haemorrhage, hypertensive disorders of pregnancy, sepsis, obstructed labour, and unsafe abortion [9]. Two of the United Nations General Assembly’s eight Millennium Development Goals (MDGs 4 and 5) set targets for reducing maternal and under-five child mortality rates by 3/4 and 2/3 respectively between 1990–2015 [10]. However, progress in reducing maternal and perinatal mortality has been disappointing, and these targets are unlikely to be met [11].