Drug linked to birth defects ‘not assessed properly’ in UK reviewNachelle Geronimo
Primodos: Drug linked to birth defects ‘not assessed properly’ in UK review.
The government-commissioned review into the effect of the drug Primodos has been criticised for leaving out vital analysis.
Experts at the University of Oxford have accused a government-commissioned review team of failing to properly assess the risks of a drug that may have caused birth defects.
The pill, called Primodos, was used as a pregnancy test in the 1960s and 1970s.
Hormones in the drug would induce a period if the woman was not pregnant, but thousands who used it gave birth to children with congenital malformations.
It was removed from the market in 1977 after concerns were raised – but they were not proven.
In 2017, an expert working group (EWG) was ordered by the government to investigate the matter.
It was overseen by the medical and healthcare products regulation agency (MHRA), and concluded that a causal association could not be found between hormone pregnancy tests and birth defects.
But now a leading expert from Oxford is suggesting that a significant part of the study has either not been done or has been left out of the final report, and that – if included – it would have contradicted the findings.
Primodos was given to pregnant women in the 1960s and 1970s
Professor Carl Heneghan told Sky News: “Somebody, somewhere, has done a meta-analysis and not provided those results.”
Campaigners used a freedom of information request to get hold of the raw data used in the original study.
This was given to professors of evidence-based medicine Carl Heneghan and Jeffrey Aronson, who conducted a so-called meta-analysis.
This is where all the data from previous studies are pooled to create a more robust picture.
Previous research conducted last year at Oxford pointed to an association between the drug and malformations, but now these academics have the same data as the EWG, they believe this link is even more obvious.
Professor Heneghan said: “Their results are completely consistent with our results. They show an effect size that is completely consistent with our results on heart defects. They’re virtually identical for all malformations.
“So we are basically saying, not only does our review show an association, their review always showed an association and it strengthens our effect because it’s similar and it’s strikingly similar to our results.
“They (the EWG) said they’d done a statistical thing called a random effects analysis. To do that, that means you assign weights to the individual studies and somebody somewhere has performed a meta-analysis.
“At some point there was a decision not to include that in the EWG report.
“Why that was, I don’t know – the MHRA doesn’t want to answer that question.”
Co-chair of the group, MP Mike Penning, added: “Either they’ve done the analysis and haven’t published it, or they haven’t done the analysis, which they should have done because they’re there to protect us. So if they haven’t, it is a dereliction of duty.”
Marie Lyon, whose daughter was born with a shortened arm after she used Primodos, leads the campaign for children damaged by hormone pregnancy tests.
She told Sky News: “I would hate to think it was deliberately taken out.
“But they’ve not done the job they were tasked to do and my question is, why? They had the same data and the same opportunity. In fact they had two years to find it (the link). Carl had seven months.”
Campaigner Marie Lyon
Sky News raised questions about the MHRA report when it was released in November 2017. We obtained a draft copy which appeared to have significant elements removed on publication.
We also found evidence in archives in Germany, where the drug was manufactured, that in the 1970s UK regulators had destroyed evidence that pointed to an association.
The MHRA say they are considering Professor Heneghan’s evidence, but that they did not conduct a meta-analysis.
They said: “The EWG considered whether meta-analysis was possible and ultimately concluded that because the studies were so different such an analysis would not be informative.
“Meta-analysis was also not considered appropriate because the studies were not sufficiently robust and because the weighting system is usually based on study size which, given the extensive limitations of many of the studies, would not have been appropriate.”
Translated documents show that Primodos was used by doctors in Germany for abortions
They added: “The publication does not contain new data. It is a different approach to the analysis of existing historic observational data which was reviewed by the commission on human medicines’ expert working group on hormone pregnancy tests and has been published on the MHRA website.
“The review by the EWG was comprehensive, scientifically robust and independent.
“Based on the totality of the data, the review concluded the available scientific evidence did not support a causal association between the use of Primodos during early pregnancy and birth defects or miscarriage.”
The manufacturer of Primodos, Schering, now owned by Bayer, has always denied a link between the drug and malformations.
Creative Commons Disclosure
About The Mandatory Training Group
The Mandatory Training Group is the leading provider of accredited mandatory and statutory training programs for healthcare professionals, nurses, carers, care providers and staff in the UK.
We provide training and workshops to deliver the required workforce knowledge and skills to maintain safe, effective, and patient-centred treatment. Our course materials also help raise health awareness and medication management to prevent incorrect diagnosis and treatment. Click on the links below to learn more about our accredited e-learning and classroom-based programs.
- Dual Diagnosis Training – Level 2 Online CPD Accredited Course
- Mandatory Health Care Training Courses – 24 Online CPD Accredited Courses – Skills for Health CSTF
- Safe Handling of Medication Training – Level 2 – Online CPD Accredited Course
Contact our Support Team on 024 7610 0090 or via Email to know more about our approved online and classroom-based courses.