Talk about it: Primodos

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.

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image via Sky News

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.

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image via the Daily Mail

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.”

Image result for primodos warning label

 

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 GuardianMedicines in Pregnancy

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PINKOUT: I stand with Planned Parenthood

Today, March 29, is a Planned Parenthood day of action called #PinkOut. I actually only realised slightly late in the day (I’m researching and writing in a bit of a panic!) but it’s a great opportunity to talk about some of the reasons that Planned Parenthood is so important for women and men alike.

So let’s start with that. I think there’s an idea out there that Planned Parenthood serves women (primarily women accessing abortion services). Wrong! While 1 in 5 women visit during their lifetime (there was no similar statistic on men), PP offers a huge variety of health services to women and men – 2.5 million per year across the US according to their website.

But what are the services? It’s mainly prevention of unintended pregnancies – hormonal control like the pill or IUDs, condoms, and vasectomies. PP services prevent about 579,000 pregnancies per year. Not to mention all the STI testing and treatment they provide – 4.2 million per year. HIV tests alone account for 650,000 of that number.

And then there’s the health screenings. Planned Parenthood carries out 270,000 Pap tests a year, and 360,000 breast exams. Planned Parenthood does a lot of the work in catching cancer early. As well as this, PP carries out a lot of general health work including cholesterol tests, diabetes screening, administering flu vaccines, helping people to quit smoking, and basic physical exams.

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But what about the abortions?

Abortions come to about 3% of Planned Parenthood’s work. That little 3% might be because they do so much for education in sexual and reproductive health, reaching 1.5 million kids and adults every year. That number in particular makes me giddy with happiness. Sexual and reproductive education is SO important, and it’s something I’m passionate about. Once the eighth has been repealed here in Ireland, my activist mode does not turn off. It switches straight to clear, factual, and broad (as in not hetero-normative) education.

So what is this whole #PinkOut craic? Basically, they want the internet pinked out to show the US government that people stand with Planned Parenthood, people need Planned Parenthood, and people are better for Planned Parenthood being in the world (they actually do a lot of global good by being a member of the International Planned Parenthood Foundation, like our own lovely IFPA).

There has been a lot of talk about “defunding” PP over the years, and it’s been a real fear since Trump was elected. However an attempt to do so was blocked quite recently. But the threat to Planned Parenthood remains. Planned Parenthood want Congress to realise that defunding will never happen (75% of Americans oppose defunding), and to hear the big pink message “do not block access to care at Planned Parenthood. Not now. Not ever.” ❀

Talk about it: “What’s holding Irish women back from getting our boobs out to feed our babies?”

First of all, I should explain what this “talk about it” thing is. We all know it’s important to keep up with the newest information and evidence out there. It’s important to discuss things, exchange ideas, and listen to each other.  So I have decided to dedicate some time every week to discussing what’s new, what’s old, what’s working and what isn’t. I’d love it if you got involved, got a bit passionate about things (while being respectful of course!) and maybe inspired a few people.

 

What I’m talking about this week is an article from the Sunday Independent Life Magazine (read it here) about breastfeeding in Irish society. It was a really interesting read, a really thorough look at how we see breastfeeding and react to it. Siobhan O’Connor speaks about her own breastfeeding experiences, and talks to other mothers. Unsurprisingly they all come to the same conclusion: breastfeeding can be very difficult, requires confidence and there is not enough appropriate support available for people who choose breastfeeding.

The initial thing that really struck me about this article (apart from the beautiful photos accompanying it) was the first stand out words on the front page and on the by-line: “battle” “guilt””struggle” and “desperation.” I just felt sad that these are the words being associated with breastfeeding for so many women in Ireland, that this is how people describe their experience. It’s not fair on women, on babies, or on wider families. Or on healthcare providers, now that I think of it.

woman-breastfeeding-baby

Siobhan O’Connor puts it perfectly “On paper, it sounds so natural. It sounds like the only option any woman would choose, but that’s not always how it happens. It’s every mother’s right to feed her baby the way she chooses, be it breast, formula or pumping. And while, of course, we should be supported if we choose to breastfeed, we should not be chastised or breast-shamed if we choose not to.”

 

This is my big issue – the shaming. You get shamed for not breastfeeding. You might get shamed for pumping instead of having baby attached to you for every feed (some people actually still enjoy personal space after having kids). You are pretty likely to get shamed for breastfeeding in public (although there are laws protecting breastfeeding in public, read about them here). I hate shaming of any kind. It’s not nice, and I don’t think anyone has the right to judge another person.

However shame seems to be really ingrained in Irish culture. I was shocked to learn from the article that the HSE officially recommends discretion while breastfeeding, as in throwing a scarf around yourself and your hungry bub. But why? Why should the natural function of the breasts be covered up? Why should anyone cover their head or have to hide in a separate room to eat? If that’s what a person wants to do, that is absolutely fine, but it shouldn’t be expected.

An interviewee says “in old Catholic Ireland, we’re made to feel ashamed,” and there might be something to that. The BMJ Global Health journal is mentioned earlier in the article having stated that breastfeeding rates are higher in areas where the proportion of Roman Catholics are lower. Might there be a link between Christian views of sexuality and pleasure, and the sexualisation of women’s breasts, be what’s making people feel so awkward around breastfeeding.

 

I always knew that the rate of breastfeeding here was shockingly low here, but I never realised that 70% of babies are put straight onto formula. I respect that everyone has the right to feed however they like, but 70% just seems so high. Is every person in that 70% completely educated on breastmilk vs formula milk? If they are, that’s fine, because it means an informed decision has been made. But I’m more than a little bit dubious that our system works that well, that every single person understands the differences. We all know that the HSE is overrun with service users and dangerously understaffed, so how can every pregnant person be getting the full information and the full extent of support in that system?

The article states that in Holles Street, the National Maternity Hospital, there are one and a half lactation consultants for the 9,000 births a year when the recommendation is one full time LC per 3,000 births. To me that doesn’t sound manageable, or efficient, or even really safe. A high workload means high stress, which means mistakes are more likely. And I’m sure the NMH isn’t the only maternity hospital with those kinds of numbers.

 

So it looks like it isn’t just the exposed feeling, or the odd or rude comments from strangers that is putting new mothers off of breastfeeding. The system that is supposed to help them may be an obstacle instead. The system that is supposed to teach them, build up their confidence, and be there when help is required, doesn’t seem to do that. We all know that breastmilk is liquid gold, but do we know where to get help when there’s trouble producing it?

I am a bit worried that this comes off a bit rambling, and maybe even uninformed. If you think so, let me know! If you have an idea, or an argument, or a story to share, please do in the comments  ❀

 

*image via Getty*