Between 1958 and 1978, women were given a hormone pregnancy test (HPT) called Primodos, produced by the drug company Schering.
The test consisted of two pills that contained norethisterone and ethinylestradiol, and aimed to detect pregnancy by inducing menstruation in women who were not pregnant – the presence or absence of menstrual bleeding determined whether a woman was pregnant. Around 1.5 million women in Britain were given Primodos.
In 1967 Dr Isabel Gal first raised concerns about the risks associated with taking Primodos – her research at the Queen Mary’s Hospital for Children in Carlshalton, Surrey, showed a link between the test and birth defects similar to those seen with thalidomide. However, it wasn’t withdrawn from the market until 1978.
Schering was taken over by German pharmaceutical giant Bayer in 2006.
The duty of the health service regulator was to protect patients; instead, they protected the manufacturer – and as a result thousands of women and unborn children were exposed to a risk that was widely acknowledged at the time. This should not have happened. The system failed. A great deal of anguish, suffering and ruined lives could have been avoided.
In 2020, the Independent Medicines and Medical Devices Safety Review – an independent review by Baroness Cumberlege – concluded that “avoidable harm” resulted from the use of HPTs and that Primodos should have been removed from the market when Dr Gal’s concerns were first raised in 1967. Furthermore, the review found the state and manufacturers have a moral responsibility to provide ex-gratia payments to those families who have experienced avoidable harm due to their failure to remove Primodos from the market.
The Association for Children Damaged by Hormone Pregnancy Tests (ACDHPT) is campaigning to ensure drug companies and the health care system admit mistakes were made, and that affected families will be redressed to help ensure a secure future for their children.
