MPs have attacked a report into controversial hormone pregnancy tests including Primodos as “a whitewash, an injustice, a betrayal”.

Campaigners believe the drugs caused serious disabilities in babies, but a report by an expert working group set up by the Commission on Human Medicines (CHM) concluded there was no “causal association” between the disabilities and Primodos.

Campaigners said the inquiry into the use of Primodos and HPTs in the 1960s and 1970s failed to analyse all the available evidence, and dismissed the report as “a cover-up”.

Anna Soubry, the Conservative MP for Broxtowe, said her constituents were disappointed, and compared it to the contaminated blood scandal which claimed 2,400 lives.

“Knowing about contaminated blood, I am afraid to say I smell a very large rat in all of this, and there have been cover-ups in it,” said the former health minister.

Charlotte Fensome, whose brother Stephen suffers from severe epilepsy, said she had found every page of the report, which was published on Wednesday, “almost unreadable”.

“It’s beyond outrageous. There is bias and injustice on every single page,” said Fensome. “I can’t believe that the government will let this report stand. I am shocked.”

Fensome’s mother was given Primodos when she was eight weeks pregnant.

Justin Madders, the Labour MP for Ellesmere Port and Neston, said: “This decision has rightly been met with disbelief by the campaigner groups. It has been called a whitewash, an injustice, a betrayal. It is clear from the reaction to yesterday’s report that there remains real anger about the way that affected families have been treated.”

Hannah Bardell, the MP for Livingston, said she was “locked out of a press conference” held by the Medicines and Healthcare Products Regulatory Agency after the publication of the report, which in itself “smacks of a cover-up”.

“There were a number of relevant documents not included in this inquiry. It is not fair to say this report was comprehensive and independent,” said Bardell.

While speaking in parliament, the health minister Steve Brine was criticised for not having read the controversial report before appearing. Brine told the Commons that the report had assessed the “casual link” between birth defects and the drugs, instead of a “causal link”.

Campaigners have said the report is a whitewash, because instead of looking for a “possible association” between the drugs and serious disabilities in babies, the inquiry was changed to look only for a “causal link”, which is a different standard of proof.

Yasmin Qureshi, the Labour MP for Bolton South East who asked the urgent question following the report’s publication, said she was disappointed by Brine’s response: “Clearly, he is just quoting what his staff and the ministry have been telling him. I do wish the minister would actually go through the documents that were submitted to the inquiry.

“If he had read those documents, he would never have come to this dispatch box and say what he has said,” said Qureshi. “They were asked to look at a possible association – not a casual link, not a causal link, but a possible association.”

Brine said the expert working group had comprehensively analysed the effects of hormone pregnancy tests. “We recognise the review’s conclusion may be difficult to accept by the families, of course we do,” said Brine. “Birth defects occur naturally in up to four in every 100 babies and a birth defect in a baby exposed to a medicine during a pregnancy does not necessarily mean it was caused by the medicine.”

The expert group assessed a number of studies looking at a link between women given an HPT to diagnose pregnancy and congenital anomalies in babies, but concluded there was no connection.



The expert group found that “although there was never any reliable evidence that HPTs were unsafe, concern about this issue, coupled with the development of better pregnancy tests” led to the use of HPTs being restricted in the 1970s.

Primodos, which was also used to treat menstruation problems, was then withdrawn completely in 1978. “Whether these precautionary actions were sufficiently timely became a subject of controversy,” noted the report.

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.

Primodos contained synthetic versions of progesterone and oestrogen. A spokeswoman for Bayer AG, which acquired the Primodos manufacturer Schering in 2006, 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.”