You may have seen the documentary on Sky News last week on Primodos, a drug given in the 1960s and 1970s as a pregnancy test and the cover up of its adverse affects (you can read the full Sky article here or watch it here). I thought it would be an appropriate topic for Talk About It.
The doc was presented by Jason Farrell, and from the start you could tell that this case has stuck to him. He’s invested. He and his team have been working for six years investigating Primodos, and have met with the affected families. It would be hard to not be invested.
So what is Primodos? It’s two tablets, containing the synthetic hormones norethisterone acetate and ethinyloestradiol. It was given as a pregnancy test in the UK between 1953 and 1975 – you took one tablet the first day, and another the second day. If a vaginal bleed occurred, you were not pregnant. If there was no bleed, it was considered to confirm the pregnancy.
Norethisterone is used in lower doses to treat abnormal bleeding from the uterus, endometriosis, and amenorrhea. It is also used in the contraceptive pill and the emergency contraceptive. There is speculation that it was also used as an abortive in other parts of the world – the documentary cites it being used in South Korea by prostitutes.
Primodos is reported to be 40 times the strength of the contraceptive pill. Families have been campaigning since the late 1970s, claiming that Primodos caused birth defects such as limb loss, heart defects, miscarriage, still birth and infant death. It was heart wrenching to hear the parents speak of the guilt they felt. One mother said that she blamed herself until she was given another answer, when other parents started reaching out. Campaigning seems to have begun with Dr Isabel Gal, a London paediatrician who raised alarm bells in 1967 with a study suggesting a link between the Primodos test and birth defects. There were corroborating studies, and there were also opposing studies. IFLScience states in an article that the “effect of synthetic hormones on embryonic development is not well studied and their effects can depend on timing and exposure.”
So there’s conflicting scientific information (as there pretty much always is). But after Dr Gal’s claim, a lot started to happen with the drug. In 1970, its licence as a pregnancy test was removed. In 1975, a warning was placed on the packet (above). And in 1978 it was voluntarily removed from the market, given the advent of the pregnancy test we all know and love – the pee stick. At about the same time that this was going on, an internal review was being carried out. Dr William Inman, who at the time was the principal medical officer for the UK government, conducted a study over five years. He reportedly made a finding that women who took a hormone pregnancy test like Primodos “had a five-to-one risk of giving birth to a child with malformations”.
Farrell’s documentary reveals that, bizarrely, Inman tipped off Schering (manufacturer of Primodos) and seemed to want to avoid them facing any medico-legal challenges from families. This is a part that I can’t get my head around at all. Inman is in a position where it is his function to review medications, appraise their safety and effectiveness, and recommend action to UK regulators or the government. He had pt i place earl warning systems to detect drugs exactly like Primodos, that had adverse effects. But he doesn’t do that. He destroys evidence of his study “to prevent claims.” It’s just not weird, it’s totally unethical. He went on to write to Schering, discussing Dr Gal and her study. According to Sky News, he states that “we’re defenceless” against legal action because of the delay in possible associations being reported, and the drug being withdrawn. A Schering lawyer wrote that the company was like to be found guilty in a court case due to a “breach of duty.”
But don’t they test drugs before they give them to people? Companies are absolutely supposed to, legally and ethically it falls under their duty of care (and of conscience, I would imagine). But it appears that Schering failed to carry out any kind of toxicology testing before Primodos was released in the UK and Germany. So Primodos seems to be have released to the market, and prescribed by doctors to pregnant women, with no evidence of it’s safety. After the thalidomide scandal (1961), teratogenic testing was common. So what was the reason for it not being carried out with Primodos?
To me, it’s just unbelievable. I know I’m speculating based only on what I’ve seen on the Sky documentary, and the articles I’ve since read trying to understand the situation. But there is just so much wrong with this. It’s in a way worse than the thalidomide scandal. Before thalidomide, there was no inkling that anything like this could happen. Babies were safe in wombs, regardless of the medication given by your trusted GP (who in turn trusted the charming pharmaceutical reps). But after thalidomide, there was new awareness. There was testing. There should be accountability. Let me know what you think about Primodos and about Inman’s disappearing report. I’ll leave links to the articles I used for this post below. You can read stories from the families here, on their website. ❀
SOURCES: IFLScience, the Guardian, Medicines in Pregnancy
a midwife's path ✿ 