Pregnancy drug Primodos 'may have thousands of victims'

Thousands of children may have suffered deformities as a result of a pregnancy drug at the centre of a Sky investigation, an MP believes.   

Labour MP Yasmin Qureshi said evidence from a new Sky documentary about the drug Primodos supported claims of an alleged cover-up.

:: Primodos: Sky News exposes pregnancy drug cover-up

Hundreds of files relating to Primodos - prescribed to expectant mothers in the 1960s and 1970s - were uncovered by Sky News.

Among the files - at the Berlin National Archive - were findings in January 1975 by the UK's then principal medical officer Dr William Inman.

Dr Inman found that women who took the drug had a "five-to-one risk" of having a child with birth defects.

He wrote to the drug's manufacturer Schering, and warned them to "take measures to avoid medico-legal problems".

He later destroyed his research to avoid "individual claims" being made.

:: 'Taking Primodos caused me lifetime of regret': The story of mother Marie Lyon

Meanwhile, a letter from Dr Inman was published in the British Medical Journal in April of the same year.

The letter concluded the "preliminary" findings of his research meant there was "little justification" for the ongoing use of the drug.

The medical regulator was first notified about the potential link in 1967, but did not issue any warning until June 1975.

Ms Qureshi said an all-party parliamentary group had identified hundreds of potential victims but believed there could be many more.

"This is only the tip of the iceberg," she said.

"I think there's thousands out there who have disabilities as a result of this drug.

"Initially, from what I saw, the Committee on Safety of Medicines seems to have known this drug was causing problems but did nothing, completely nothing.

"It was years and years later before they said it should come off the market."

The Government set up an inquiry to look into Primodos in 2014.

Ms Qureshi, a shadow justice minister, has previously criticised a lack of progress of the independent panel's inquiry into Primodos.

Health minister Lord 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 Medicines and Healthcare products Regulatory Agency to conduct a thorough scientific review of the evidence on the issue."

Pharmaceutical giant Bayer, which acquired Schering Healthcare in 2006, said there was "no link" between Primodos and birth defects.

The German firm said: "Bayer denies that Primodos was responsible for causing any deformities in children.

"UK litigation in respect of Primodos, against Schering (which is now owned by Bayer), 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.

"Based on the facts and on the law, Bayer does not accept that Primodos was responsible for causing congenital abnormalities."

:: Sky News' hour-long documentary Primodos: The Secret Drug Scandal will be presented by senior political correspondent Jason Farrell, who has been investigating it for six years. It can be seen on Tuesday 21 March at 8pm on Sky Atlantic and on Wednesday 22 March at 9pm on Sky News.

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