Pregnant women are being forced to take potentially dangerous drugs because pharmaceutical companies are not developing medications proven to be safe for unborn babies, a report warns.
A major review of international drug development penned by a leading Australian researcher has labelled pregnancy a pharma-free wasteland, with virtually
no new drugs on the horizon.
Professor Nicholas Fisk, from the University of Queensland, blames the drug dearth on the expense of reproductive trials and major disasters like thalidomide, a German drug responsible for severe deformities in 10,000 babies born in the 1950s and 1960s.
As a result, women needing drugs for pregnancy, labour, abortion or other obstetric conditions must almost routinely resort to so-called off-licence medications that have not been officially tested for this use, said Professor Fisk.
"The market has failed pregnant women," Professor Fisk and Dr Rifat Atun, from Imperial College London, wrote in the latest international journal PLoS Medicine.
"Seventy-five per cent of pregnant women are taking at least one drug for which safety data are unavailable."
The academics found that only 17 of the 37,000 drugs under development worldwide since 1981 were for maternal health indications.
This is less than 3 per cent of the 660 drugs in the pipeline in cardiovascular health and half those in development for a very rare condition called amyotrophic lateral sclerosis.
In contrast, worldwide there are over half a million maternal and seven million perinatal deaths annually, 99 per cent of which are in the developing world, said Professor Fisk, who heads the university's Centre for Clinical Research in Brisbane.
He said the problem stemmed from failures in the pharmaceutical market's push and pull mechanisms, whereby funding to encourage investment from universities and companies is balanced by funding to purchase drugs once they are on the market.
"Between the pull and the push, the international donor agencies have forgotten these women," Professor Fisk said.
"Given the unacceptably high number of maternal and perinatal deaths each year, it is time to addressthis."
Pharmaceutical companies were reluctant to test and develop drugs in pregnancy because of the risk of birth defects and litigation costs that come with it, the specialists said.
The profits were low, trials expensive and the regulatory system in countries like Australia allowed endemic off-label use of drugs in pregnancy, discouraging investment in the long term.
- AAP
