Watchdog to examine new files found by campaigners while Primodos maker Bayer denies it caused abnormalities

This article is more than 3 years old

This article is more than 3 years old

The UK drugs regulator is to examine new evidence about a pregnancy test used in the 1960s and 70s which hundreds of parents believe caused serious deformities in their children, often leading to early death.

A 7,000-page cache of files discovered by a victims’ campaign group includes papers suggesting the British government knew in 1975 that the hormonal drug Primodos increased the risk of a child being born with malformations. The drug was withdrawn in 1978.

Families have believed for decades that the drug might have been responsible for serious birth defects, including missing limbs, brain damage, heart defects and spina bifida, something that has been denied by Bayer, the German pharmaceutical company which owns the manufacturer, Schering.

The drug consisted of two hormone-based tablets that detected pregnancy by inducing menstruation in women who were not pregnant.

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Thirty-one files of documents about the drug were found in a state archive in Berlin by Marie Lyon, chair of the Association for Children Damaged by Hormone Pregnancy Tests, whose own daughter Sarah was born without a lower arm in 1970 after she had taken Primodos.

According to Sky News, which has investigated the files, one showed that in January 1975 Dr William Inman, then principal medical officer for the UK government, reported that women who took a hormone pregnancy test “had a five-to-one risk of giving birth to a child with malformations”.

Inman spoke to Schering but said he had contacted the manufacturer so that it could “take measures to avoid medico-legal problems”.

Later files reportedly claimed Inman destroyed the papers on which his assessment was based and that “he has done that to prevent individual claims being based on his material”. Inman died in 2005.

Sky also reported that documents in the Berlin archives detailing communications between the drug firm and its lawyers state that “no toxicology had been carried out before introduction either in Germany or the UK”.

A spokesperson for Bayer said: “Bayer denies that Primodos was responsible for causing any deformities in children. UK litigation in respect of Primodos, against Schering, ended in 1982 when the claimants’ legal team, with the approval of the court, decided to discontinue the litigation on the grounds that there was no realistic possibility of showing that Primodos caused the congenital abnormalities alleged.

“Since the discontinuation of legal action in the UK in 1982, no new scientific knowledge has been produced which would call into question the validity of the previous assessment of there being no link between use of Primodos and the occurrence of congenital abnormalities.”

But Lyons believes the files amount to “indisputable information that shows the manufacturers and the health authorities were aware these drugs were causing damage in babies, miscarriages and stillbirths”.

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In a statement on Sunday, the junior health minister, James O’Shaughnessy, said: “I welcome this investigation – it’s vital that we take concerns such as these seriously. That’s why we’ve asked the medicine and healthcare products regulatory agency to conduct a thorough scientific review of the evidence on the issue.”

A 2014 review by the agency of 36 existing studies on the effects of Primodos concluded: “The body of evidence for an association between hormone pregnancy tests and congenital anomalies is mixed, with some studies finding a strong association, some finding a weak association and many others finding no association.”

In 1978 Primodos was discontinued by the manufacturer.

To the affected families, the Berlin files have given hope that a legal challenge against the manufacturer and possibly the government could start again. Lyons said her campaign group was talking to lawyers about the possibility of such a lawsuit.