Daily Record

REVIEW NEARS END

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massive boost to our campaign. Then there needs to be redress for people who have been affected.”

Primodos was taken by an estimated 1.5million women in the UK before it was withdrawn from the market in 1978.

In 2014, a panel of independen­t experts was set up to probe links of birth defects and oral hormone pregnancy tests but was later slammed as a “whitewash” by numerous MPs and campaigner­s and a new probe was ordered. In November 2017, an expert working group set up by the Commission on Human Medicines concluded there was no “causal associatio­n” between the drug and severe disabiliti­es in babies.

In February last year, the Record reported that a study at Aberdeen University linked the drug components of Primodos to congenital malformati­ons in fish embryos. Zebrafish are a recognised method of research which can be linked to harm in humans.

Then in December, an Oxford University team reviewed all previous studies into Primodos and found a “clear associatio­n for all congenital malformati­ons”.

The developmen­ts have offered hope for thousands of families who have never been acknowledg­ed or compensate­d despite repeatedly trying to prove that Primodos affected them and their children.

In 1982, a group action against Schering Chemicals, which produced Primodos, was shelved.

Since the court case, it has emerged that 26 studies from 1960 on suggested the drug may have caused miscarriag­es and birth defects, yet it remained on the market.

A spokeswoma­n for Bayer, which acquired Schering in 2006, said: “Bayer is participat­ing in the ongoing IMMDS and has provided the required documents.

“There is no scientific evidence available which would support the existence of a causal relationsh­ip between use of Primodos and adverse outcomes to pregnancy.

“Bayer has worked together with the Medicines and Healthcare products Regulatory Agency to help inform the Commission on Human Medicines expert group’s review of the properties of the sex hormones contained in Primodos and other products.

“Bayer has given the MHRA full access to all the scientific records that it continued to hold relating to norethiste­rone acetate, ethinylest­radiol and combinatio­n products that include such active substances.

“The expert group considered all scientific evidence from all relevant discipline­s and concluded that the available evidence does not support the existence of a causal relationsh­ip between use of Primodos and adverse outcomes to pregnancy.”

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