A Testing Time Part 3 – Hormone Pregnancy Tests 

by | 27 Mar, 2022 | Our Blog

 

by Margaret Sparrow

From 1942 another type of pregnancy test was developed, not using hCG but two other hormones, oestrogen (or a synthetic oestrogen) and progesterone (or a synthetic progestogen). Either taken orally or injected, various combinations of these hormones induce menstruation but only if the woman is not pregnant or possibly if the pregnancy is not well established. There is limited evidence that it was used to induce an abortion.  No bleeding is a positive pregnancy test.

Two brands of Hormone Pregnancy Tests (HPTs) were available in New Zealand – Primodos by Schering from 1966 to 1975 and Amenorone Forte by Roussel from 1968 to 1975. Both were composed of the same hormones found in some contraceptive pills but the progestogen was in a much higher dose. It is not known to what extent these tests were used in NZ. The alternative, used by most doctors at that time, was to send a morning urine sample to the laboratory for one of the hCG tests, 14 days after the missed period.

Because of the reported risk from overseas of congenital malformations associated with the administration of these hormones during early pregnancy, both HPTs were withdrawn by the NZ Department of Health in 1975. Forty-seven years later, on 20 March 2017 the NZ Ministry of Health, responded to renewed concerns locally and in the UK and issued a statement confirming that Primodos had been used in NZ but that no fetal abnormalities had been notified to the NZ Centre for Adverse Reactions Monitoring (CARM). As a result of the publicity 10 historic cases were notified to CARM as possible adverse reactions but with the time lag it would be impossible to prove causation. The Ministry stated it would liaise with the British equivalent of CARM, the Medicines and Healthcare products Regulatory Agency (MHRA) for further developments.

The result, silence.

So what was the Primodos story in the UK?

1958                  

Primodos was introduced in Britain and was supplied on prescription for 20 years until 1978.

1967                  

Paediatrician Dr Isabel Gal published the first comprehensive study identifying an association between HPTs and congenital abnormalities. Dr William Inman Principal Medical Officer of the Medicine Control Agency was dismissive of her findings despite the fact that HPTs were introduced at about the same time as Thalidomide which also caused congenital abnormalities.

During the next 8 years Inman conducted his own study and during that time confidentially warned the German manufacturer, Schering, of possible legal consequences, but did not raise the issue with the public as might have been expected. Some commentators suggest that one factor may have been that these were the same hormones that were used in the contraceptive pill and publicity would have created a pill scare.

1975                  

Dr Inman published an interim report and the first public warning was announced regarding Primodos. This was heeded in NZ but not in the UK although a warning appeared on the packet.

1977                  

A second warning to doctors stated  “The association has been confirmed.” Archival documents reveal that at this time the probability of birth defects after taking Primodos was estimated to be 1 in 5. Inman’s evidence was destroyed eliminating its use in future case investigations.

1978                  

Primodos withdrawn in the UK.

The Association for Children Damaged by Hormone Pregnancy Tests (ACDHPT) was formed to advocate for some 800 affected families.

1982                  

ACDHPT, using legal aid, prepared to take a case to court but a causal link was too difficult to prove and the case was too costly to pursue. Inman gave evidence for Schering.

2006                  

Schering was sold to Bayer who then became responsible for any litigation.

2014                  

MHRA published an assessment of historical evidence on Primodos and congenital malformations and found the results inconclusive.

2017                  

An Expert Working Group commissioned by the UK Government concluded there was no association. In the opinion of ACDHPT this was a whitewash and PM Theresa May responded to the clamour by commissioning an independent review, not only of  Primodos but also the use of sodium valproate (a drug for epilepsy) in pregnancy and vaginal mesh.

2020                  

“First Do No Harm” The report of the Independent Medicines and Medical Devices Safety Review, chaired by Baroness Cumberlege, concluded that there was an association between Primodos and adverse effects and that Primodos should have been withdrawn in 1967, immediately after the publication of Dr. Gal’s Study. Recommendations were made to improve safety in the future. And so the campaign continues…

For further information see the website of ACDHPT

Dame Margaret Sparrow was a medical doctor, abortion provider, and president of ALRANZ for many years.

A Testing Time Part 2: Modern Pregnancy Tests 

A Testing Time Part 2: Modern Pregnancy Tests 

by | 16 Mar, 2022 | Our Blog

by Margaret Sparrow

Human Chorionic Gonadotropin (hCG), is a pretty special hormone excreted by the placenta to maintain a pregnancy. It can be detected in blood at low levels and also less sensitively (but more conveniently) in urine, especially that first morning sample when urine is more concentrated. There are two subunits (alpha and beta) and it is the beta subunit which is used in most pregnancy tests.

Immunologic tests are so called because hCG is an antigen which can trigger the production of antibodies. It is these antigen-antibody reactions which are the basis of various tests. Some tests depend on the detection of antigen, others the antibodies.

The door to immunologic pregnancy tests was opened in 1960 when two Swedish researchers (Wide and Gemzell), published the results of a technique called haemagglutination inhibition which detected antibodies to hCG. It was done in a test tube using red blood cells from a sheep which clumped together (agglutinated) in a special pattern when urine containing hCG was added. It took 60-90 minutes to read and was very accurate when taken one week after a missed period. Amazingly, Leif Wide made this discovery when he was a medical student studying under Dr Gemzell. As early as 1961 the method was introduced into Uppsala University Hospital. In 1962 a similar test used a drop of urine on a slide. Instead of red blood cells, latex particles were used to demonstrate the clumping pattern.

Initially tests were done in laboratories, then in doctors’ surgeries, then eventually in the privacy of home.  Organon in Holland was the first to patent a home pregnancy test kit in 1969 and during the 70s these were gradually introduced elsewhere. The first home tests were pretty unreliable and one looked more like a child’s chemistry set with its vial of purified water, an angled mirror, a test tube, an eye dropper and red blood cells taken from a sheep.  It took until 1971 to have home tests available over the counter in Britain, Europe and Canada, until 1977 in USA and later still in NZ in 1980. 

During the 70s and 80s many innovations were marketed with the aim of making the tests more user friendly – simpler, less expensive, more convenient, and more accurate earlier in the pregnancy. A giant leap forward was the use of coloured dyes which bonded to the antigen or antibody and travelled to the test and control zones which appeared like magic as coloured lines. Instead of test tubes or slides we were enticed by elegant test kits or a strip or wand to hold in the stream of urine.

Another significant advance was the introduction of quantitative tests which measure the level of hCG in International Units/ml. Quantitative tests have many other uses but as far as abortion is concerned they are very useful in determining whether the abortion has been successful.  Levels will remain higher than expected if there is an incomplete abortion with pregnancy tissue remaining or if there is a continuing pregnancy. Women are advised to have a post-abortion check in about 2 weeks. At this time a free blood test is available through a laboratory or a low sensitivity test can now be provided to do at home at a reasonable price. This test will only be positive when the level is over 1000 International Units/ml. It is very useful now that early medication abortion can be provided by telemedicine. (Thanks to the law changes!)

Compared to the rapid uptake of rapid antigen tests for Covid, why did it take so long for pregnancy self-testing to become available? The problem was not the tests but judgmental attitudes. Could women really be trusted to carry out instructions? Wasn’t it better to have the diagnosis from a doctor? What about false negatives and false positives? Women would not understand about reliability. What about counselling? What about support if the result was not the desired result? What about privacy? Who should provide the tests – doctors, laboratories, pharmacies, family planning clinics, mail order? And so on….

 It was a coincidence that the introduction of pregnancy testing came at the same time as the sexual revolution of the 60s to 80s.  This was a time of great social change which came to be associated with permissiveness (free love), women’s liberation, abortion law reform, gay rights and the erosion of medical authority. Self-testing gave women greater autonomy and contributed to a realignment of the power dynamics between doctors and patients. The humble pregnancy test sits alongside the birth control pill introduced in NZ in 1961 as a significant agent of change.

Dame Margaret Sparrow was a medical doctor, abortion provider, and president of ALRANZ for many years.

Pro-choice Motherhood

Pro-choice Motherhood

by | 13 Mar, 2022 | Our Blog

by Julie Fairey

When I first contemplated becoming a mother I worried. I worried about all sorts of things; would I be any good at it, would I hate it, would I be able to get pregnant at all. And I worried that it would change my attitude to abortion.

You see my journey to supporting the right to abortion, that essential medical care that needs to be available to anyone with a uterus, was a bit fraught. I had gone to a Catholic school where my classmates wore the little feet badges on their lapels. It wasn’t until I was about 16 that I learned anti-abortion was not a universally held view. I evolved my position quite slowly from that shocking first time overhearing some other girls talking about abortion as if it wasn’t a Big Bad Thing. By the time I was in my late twenties, looking to become pregnant myself, I had gone through “well I support it but only up to a certain point” to “I guess I support it for others but I could never do that” to “Ok this is a required medical procedure that anyone who needs it should be able to access”.

But the nagging sense from those early years remained, based on being told I’d feel differently once I had children of my own. So I worried, that the experience of pregnancy, childbirth and become a mother would unmoor me from my firmly held pro-choice views.

I could not have been more wrong.

I’ve been pregnant four times. The first ended in an early miscarriage; not physically traumatic luckily for me. When I told a colleague about it they remarked jovially that was just a missed period, and while that was a heartless way to put it, they were correct that what I miscarried did not look or feel to me like a baby at all.

My three subsequent pregnancies have resulted in three live births, three children I parent today as I write this (from Covid isolation!)

And each of those experiences, in particular the pregnancies, have made me more and more pro-choice. All three included bad morning sickness (not just in the morning) and loss of weight in the first trimester. Fair to say I am not one of those people who blooms in pregnancy, even in the second and third trimesters. I find it a great trial; one I’m prepared to undertake because of the likely outcome, but something no one should have to do unless they choose to.

And my final pregnancy produced a particular challenge that reinforced my views, as I went into early labour at 30 weeks (that’s at the three quarters mark for those who don’t think in gestational timeframes). While the outcome was positive for both of us, there was several months of hospital time for my child, which meant a lot of hospital time for me, and the first year was filled with beeping alarms and various tests. I was happy to do all of this because I chose it. I could not imagine going through all of that when I didn’t want to.

If I get pregnant again, I will need an abortion. My last experience, at 38, was much harder than the previous ones, even putting aside the early end. I’m just too old to do it again; others won’t be at this age but for me, for my body, I know that I am. So again, my experience becoming and being a mother, adding to my family, has strengthened my conviction that abortion is absolutely necessary, at the choice of the pregnant person.

Becoming a mother wasn’t the threat to my pro-choice views that I thought it might be. Instead I’ve been a mother speaking up for choice, in case others shared the same illusion I used to that motherhood and supporting abortion rights were incompatible.

Being a parent should be a choice you can make freely and joyfully, not an inevitability you begrudgingly have to accept. Long may we continue towards making that a reality for all.

This blog is part of the #40DaysForFacts campaign. Follow on social media. @alranztweets / https://www.facebook.com/ALRANZ

Missouri Says You Must Die

Missouri Says You Must Die

by | 11 Mar, 2022 | Our Blog

by Terry Bellamak

The state of Missouri says if you have an ectopic pregnancy you must die.

Missouri House Bill 2810, if it passes, would make aborting an ectopic pregnancy a felony. The health practitioners who do so would be felons after conviction. So would the pregnant person.

An ectopic pregnancy happens when an egg is fertilised outside the uterus, usually in the fallopian tube, and fails to implant in the uterus. The fetus cannot survive there, and it cannot move to the uterus.

If the patient receives treatment, usually surgery, to remove the fetus, they will survive and recover. If not, the fetus will burst the fallopian tube and the patient will haemorrhage and die.

This being Missouri, it is possible that this travesty, this death sentence for unlucky people with ectopic pregnancies, will pass and be signed into law.

Legislators are again attempting to practice medicine without a licence, and also without a clue. In the past, US anti-abortion legislators have demanded that, in case of ectopic pregnancy, doctors move the fetus to the uterus. But there is no such procedure. There is no treatment for ectopic pregnancy that saves the fetus, except in anti-abortion legislators’ imaginations. Either the fetus dies, or both fetus and pregnant person die.

How would this even work in practice? You’d get a diagnosis in Missouri and then … what? Rush to cross state lines to get treatment? That might not be completely impossible if you live near Illinois or Kansas. But what about folks in rural areas far from an interstate highway? Or folks with no car?

This is not normal behaviour for responsible adult legislators. This senseless bill demonstrates how far outside the mainstream these folks are, how the realities of science and medicine just pass them by.

If anyone doubts that the foundation of the anti-abortion movement is misogyny and the patriarchal desire to punish having sex without intending to procreate, look no farther than an anti-choice state that would pass a law requiring pregnant people to die or face prison.

A Testing Time Part 1: Old Fashioned Pregnancy Tests

A Testing Time Part 1: Old Fashioned Pregnancy Tests

by | 8 Mar, 2022 | Our Blog

by Margaret Sparrow

Last week I helped a friend do her first Rapid Antigen Test for Covid and we marvelled at the scientific progress and the rapid commercial development that made this possible. That got me thinking about the slow progress over the years that led eventually to the development of modern pregnancy tests which are now an essential component of safe abortion services.

Since antiquity the diagnosis of pregnancy has been attempted in a variety of ways. In ancient Egypt women soaked wheat or barley seeds in urine and if they germinated that indicated a pregnancy. A more dubious method was described by Hippocrates. The woman placed a small onion in her vagina overnight and if she was pregnant her breath would still smell sweet in the morning because a pregnancy would somehow stop the odour from spreading through her body. This practice, known as the garlic test was apparently widespread in France until the 18th Century.

Traditionally women have been perfectly capable of diagnosing a pregnancy without the use of any test – a missed menstrual period, a slight elevation of temperature and as the pregnancy progresses feelings of nausea and breast changes.

Pregnancy testing has evolved during the past half century from a time consuming complicated laboratory procedure using expensive test animals into a rapid, relatively inexpensive, reliable and convenient technique.

The basis for most pregnancy tests involves the detection (in either blood or urine) of human chorionic gonadotropin or hCG which is a glycoprotein hormone produced by the placenta during pregnancy. In normal pregnancy the production of hCG begins within 48 hours after implantation, ascends to a peak between 50 and 90 days then falls to a lower level throughout the pregnancy and  ceases soon after delivery.

In 1927 two German gynaecologists introduced the first biological test. They observed that urine from pregnant women injected into several immature female mice caused changes in the ovaries. After 4-5 days of repeated injections the test animals were killed and the ovaries examined for evidence of ovulation. The pregnancy hormones in the urine had stimulated the pituitary gland to produce ovulation hormones. This was even before hCG had been discovered.

Other biological tests were introduced. In 1932 Friedmann did the same thing to rabbits. “The rabbit died” became a euphemism for pregnancy.

In the 1930s and 1940s frogs became the ‘go to’ laboratory animals with the advantage that the reporting time was lessened and the frogs did not have to be killed. In some tests a male frog was injected under the skin with pregnant urine and within 18 hours a positive test was indicated by frog spawn and the presence of sperm under the microscope. In other tests a female frog was used and after an injection of pregnant urine the frog ovulated and the presence of eggs floating in the tank indicated a positive test. A disadvantage was that the woman usually had to be several weeks past the missed period for these tests to be reliable.

A refinement came with the use of toads. A small amount of urine was injected into the dorsal lymph sack of a male toad. Pregnancy hormones would cause the toad to spawn and sperm could be detected under a microscope within 3 hours. The test was not painful and the animal could be used for another test two weeks later.

A disadvantage of using frogs and toads was that they had to be kept in a temperature controlled environment and it was expensive to meet their fastidious requirements. In 1951 an enterprising scientist at the University of Kiel in Germany developed a reliable test using less demanding earthworms but somehow this never caught on. Biological tests were still being used in the 1960s but that was soon to change. And that is another story.

Oh and by the way my friend tested negative.

Dame Margaret Sparrow was a medical doctor, abortion provider, and president of ALRANZ for many years.