This post first appeared on Nottingham Post. Read the original article.
A couple whose daughter was born with her brain outside her head have welcomed a study supporting their belief that a hormone pregnancy test had the potential to cause the defect.
Jill and Robert Coulling have been seeking answers ever since their daughter Joanna was born on November 10, 1973.
The couple, who lived in Wollaton at the time, have always believed the pregnancy test drug Primodos, which a GP gave to Jill to determine whether she was pregnant, led to Joanna's deformity.
Jilli was given the drug - two tables which were taken orally - instead of a urine pregnancy test.
She had a relatively smooth pregnancy but Joanna, now 44, was born five weeks early, weighing 4lbs 7oz, with her brain outside her head.
At just a few hours old, she underwent an emergency operation at Nottingham Women's Hospital, in Peel Street, and was cut from one ear to the other before her brain was relocated and attached.
(Image: Angela Ward)
The Coullings, along with other families, took their case to the Royal Courts of Justice in 1982, and a judge said it could not be proven if there was a causal link, but added that if new information came to light, then the cases may be reopened.
But research by Dr Neil Vargesson, from the University of Aberdeen, published in The Scientific Reports on Tuesday (February 13) claims that the hormone pregnancy tests had the potential to deform embryos in the womb.
The study used zebrafish embryos and claims to have found that components of the drug caused deformities to their eyes, fins and spine.
Primodos hasn't been used since 1978 but Dr Vargesson said its components - Norethisterone acetate and Ethinyl estradiol 1 are used in medications such as contraceptives and treatments for endometriosis.
Dr Vargesson said: "Our experiments with the zebrafish embryos shows quite clearly the effects the Primodos components have.
"This does not mean it would do the same in humans of course, we are a long way from saying that but we need to carry out more research into these components because they are still in drugs today and in some cases in much higher doses than those found in Primodos."
The Coullings, who now live in Wellow and are both 64, told the Post they are relieved by the findings of the study.
Jill said: "At the end of the day it's a relief that something has come to this point.
"We've been waiting nearly 45 years and it's just unreal.
"I still can't believe what I've just heard. It's been a struggle."
Robert added: "This is great news for us."
Dr June Raine, director of vigilance and risk management of medicines at the Medicines and Healthcare products Regulatory Agency, said: "The Expert Working Group of the Commission on Human Medicines conducted a comprehensive independent scientific review of all available evidence including this then-unpublished scientific study and their overall conclusion was that the available scientific evidence, taking all aspects into consideration, did not support a causal association between the use of hormone pregnancy tests such as Primodos during early pregnancy and birth defects or miscarriage.
"The Expert Working Group made a number of future-facing recommendations and our focus is now on implementing these.
"While the review cannot take away from the very real suffering experienced by the families involved, it helps shape the path to further strengthen the scientific evidence which supports safety monitoring of medicines in pregnancy."
Pharmaceutical giant Bayer, which acquired Primodos manufacturer Schering Healthcare in 2006, has previously said there is no link between the drug and birth defects.
A spokesman for Bayer 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 the legal action 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 the use of Primodos and the occurrence of such congenital abnormalities.
"Recently, the UK health secretary commissioned an expert working group, supported by the Medicines and Healthcare Products Regulatory Agency, to review the medical and scientific evidence of a link between the use of Primodos and similar products and the embryonic defects discussed at that time.
"The Committee has reviewed all available evidence on a possible link between the use of hormone pregnancy testing during pregnancy (for all products and not just Primodos) and an allegedly increased rate of congenital malformations in the child (including consideration of potential mechanisms of action).
"As a result of its review, which included a summary of the findings of Dr Neil Vargesson’s work, the Committee found no causal link between the use of such hormonal pregnancy tests and embryonic defects.
This result was also confirmed by the Commission on Human Medicines in the UK.”