Oxford University Study Links Primodos Pregnancy Drug to Birth Defects

Sky News may also reveal a former employee of the drug maker was advised not to use Home by a doctor who worked at the company while still being offered to the public.

The drug was composed of two pills that would induce a period in women who were not pregnant.

Sandra Malcolm got pregnant while working as receptionist for Schering in Burgess Hill. She says she was told by a company doctor: "I can not give it to you because it may not work and it can cause deformities."

This happened seven years before Primodos was withdrawn from the UK market in 1978 for fear that this could harm the fetus.

Alleged victims were never compensated and fought a campaign of decades to prove that their children were damaged or even killed by the drug.

Now they have new hope.

A team led by evidence-based medical professor Carl Heneghan conducted a systematic review of all previous human studies.

Nuffield's Department of Primary Health Services found that when data are grouped, it shows a "clear association" with various forms of malformation.

In an exclusive interview, Professor Heneghan told Sky News: "What the evidence showed was that the direction of the effect was showing there was an association with congenital malformations.

"It was a clear association for all congenital malformations, but also for more specific malformations: cardiac malformations, musculoskeletal malformations, neurological and neurogenetic, all became clear, there is a significant association."

This new publication comes almost exactly a year after a government-commissioned review suggested that the evidence was not strong enough to demonstrate a causal association.

Sky News has raised doubts about the report of the Expert Working Group (EWG), overseen by the Medicines and Health Products Regulatory Agency (MHRA). We found out what aspects of the report were removed.

Some MPs called it a "lime."

Professor Heneghan also criticizes the revision of the EWG.

He said the EWG did not gather all the data together and grouped correctly to show a general effect.

"What has clearly gone wrong here is the complete failure to make the right approach to systematic reviews.

"That was missing from the EWG report – that's why we've done this job and actually put it there so people can see it and come to their conclusions about what the balance of probabilities is."

He added, "Once you start looking at more specific malformations, you get to see the limit that is doubling the risk that the UK courts say – but to" this would not have happened " .

Sandra Malcolm, who worked as a receptionist for five years at Schering in Burgess Hill, said the manufacturer, which now belongs to Bayer, must admit its flaws.

At the company in 1971, she discovered she was pregnant and talked to her colleagues at work.

She said, "I was at the desk one day and there were two guys in there, one might have been a medical representative and he told me you want a dose of Primodos and the other said I think which was withdrawn from the market and the other said "no, you can pick it up".

"So, with that information I went up to see one of the doctors." "I said I'm a week late and can I get some Prims?" And he said, "I can not give it to you because it can not work and it can cause deformities, "so I thought it was definite no."

Mrs. Malcolm says that after the conversation, she decided not to accept it "for obvious reasons" and that she just assumed she was not on the market.

Many years later she saw a report on Primodos causing deformities and was shocked to find that he had remained on the market.

Ms. Malcolm's interview is among a compilation of evidence that Sky News this week presented the government's Independent Medicines and Medical Devices Safety Review, which is reviewing the safety and regulation of Primodos.

Sky News also gave oral tests this week.

The manufacturer, who took over Schering, Bayer, told Sky News: "Bayer is aware of the Safety Review of Drugs and Independent Medical Devices. This is followed by a review by an Independent Expert Working Group on Hormone Pregnancy Commission According to Bayer's view and based on all available data, it was found that the scientific evidence does not support a causal association between the use of hormonal pregnancy tests, such as Primos, and congenital or spontaneous abortion. "

A MHRA spokesman responded to the Oxford University study saying, "This publication, which is currently awaiting peer review, does not contain new data. It is a different approach to the analysis of historical observational data that have been reviewed by the Commission Specialist Working Group on Hormonal Pregnancy Tests.

"The review of the Expert Working Group was comprehensive, scientifically robust and independent. Based on the full data, the review concluded that the available scientific evidence did not support a causal association between the use of HPTs as Primodes during early pregnancy and birth defects or miscarriage.

"According to our commitment to review any new evidence, we will be consulting independent scientific experts for their views."