The use of hormonal pregnancy tests (HPT), like Primodos, did not cause birth defects of miscarriages, a UK scientific review has found. The Commission on Human Medicines said the evidence did not support a 'causal link', but campaigners continue to claim a 'cover-up'.
The report says the inquiry was set up by the UK government amid concerns the drug Primodos may have caused defects and miscarriages. It was used in Britain between 1953 and 1975 – other countries stopped sooner.
However, the commission said that women who used the test and subsequently had babies born with defects would be offered genetic testing to see if any cause could be identified. An electronic system for reporting side-effects during pregnancy will also be introduced to help identify problems with medicines that may occur in the future.
It is estimated that over 1m women used the drug to test for pregnancies and the report says, campaigners claim it caused birth defects in their children, such as blindness, deafness, spina bifida and heart and limb defects as well as cleft palates.
A previous report by independent experts in 2014 also found inconclusive evidence of harm, but this new review was ordered by ministers after fresh concerns came to light.
Legal action against Schering – the original manufacturer of Primodos – was halted in 1982 because of a lack of evidence. Schering was subsequently taken over by Bayer.
Dr Alisa Gebbie, chair of the working group which oversaw the inquiry, said many thousands of pieces of evidence were examined during the review, and detailed testimonies had been gathered from families affected. But she said there was simply not the evidence to suggest the drug caused defects or miscarriages. She also said the findings should reassure women who still use the hormones – progestogen and oestrogen – that were used in the drug.
The report says Marie Lyon, who is chair of the Association for Children Damaged by Hormone Pregnancy Tests, was prescribed Primodos and later gave birth to a daughter whose limbs were not fully formed. She said she was very angry with the findings. "They have ignored some of the evidence. It's a cover-up. We had high hopes this inquiry would get to the truth but it hasn't."
She said she would like to see a judicial review of the whole issue.
MPs and families who have campaigned against the hormone pregnancy tests (HPTs) for more than 40 years, said the report was a whitewash. Yasmin Qureshi, the MP for Bolton South East, said in a report in The Guardian that there should be a judicial review or a separate inquiry to examine allegations of a cover-up by medical regulators at the time. The Labour MP said: “I am completely disgusted by the report. They clearly have not looked at the evidence that was presented to them. If they had looked at the evidence presented to them they could never have arrived at the conclusion they have now. This report is a complete whitewash. It is not worth the paper it has been printed on.”
Mims Davies, the Conservative MP for Eastleigh, said she was disappointed by the report and would be meeting with the prime minister to raise her concerns. Davies is quoted in the report as saying: “I was thoroughly dissatisfied by the complete lack of transparency in the creation and preparation of this report, with the only representative of campaigners against these historic injustices on the panel being gagged by a confidentiality agreement and prevented from speaking about the report’s preparation.”
Charlotte Fensome, whose brother Steven has severe epilepsy, said she was horrified by the report. “I’m obviously hugely disappointed by this report. My parents are 81 and 76, and they are struggling every day with my brother. Every victim of Primodos is a personal tragedy, and I am shocked at how this investigation has been carried out.
The report says modern pregnancy tests measure hormone levels in a woman’s urine. The older HPTs contained synthetic versions of two hormones found naturally in the body. Two pills were taken on consecutive days, with a withdrawal bleed a few days later in those who were not pregnant.
Professor Stuart Ralston, the chair of the CHM, said: “This was a comprehensive and wide-ranging scientific review of all the available evidence on the possible association between HPTs and birth defects by internationally leading experts across a broad range of specialisms.”
Dr Ailsa Gebbie, the chair of the expert working group, said: “Our recommendations will strengthen further the systems in place for detecting, evaluating and communicating risk with use of medicines in pregnancy and help safeguard future generations.”
A spokesperson for Bayer AG said: “Bayer notes that a review by an independent expert working group on hormone pregnancy tests of the Commission on Human Medicines has found, consistent with Bayer’s view, based on all available data, that the scientific evidence does not support a causal association between the use of hormone pregnancy tests, such as Primodos, and birth defects or miscarriage.”
[link url="http://www.bbc.com/news/health-41996712"]BBC News report[/link]
[link url="https://www.gov.uk/government/news/independent-expert-working-group-finds-totality-of-scientific-evidence-does-not-support-a-causal-association-between-the-use-of-hormone-pregnancy-test"]Commission on Human Medicines report[/link]
[link url="https://www.theguardian.com/society/2017/nov/15/1960s-hormone-pregnancy-test-did-not-cause-birth-defects-review-finds"]The Guardian[/link]