Margaret Sparrow | ALRANZ: Abortion Law Reform Association of New Zealand

A Testing Time Part 3 – Hormone Pregnancy Tests

by admin | 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of congenital malformations associated with the administration of these hormones during early pregnancy, both HPTs were withdrawn by the NZ Department of Health in 1975.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 1: Old Fashioned Pregnancy Tests

by admin | 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.

‘Rough on Women’: Media Release, Excerpt

by admin | 4 Jul, 2014 | Media Release

ABORTION LAW REFORM ASSOCIATION OF NEW ZEALAND

1 July 2014 FOR IMMEDIATE RELEASE

Book Launch: The Untold Stories of Abortion in 19th Century New Zealand

The tragic toll of unsafe illegal abortion in 19th Century New Zealand is the focus of a powerful new book by longtime women’s health advocate Dame Margaret Sparrow that is being launched today in Wellington. (Photos of launch by Noemi.)

Dame Margaret Sparrow at the launch of ‘Rough on Women’ at Unity Books on 1 July 2014. (Unity’s Jacqui Brokenshaw, right, also spoke at the launch.)

The book Rough on Women: Abortion in 19th-Century New Zealand (Victoria University Press) tells the stories of 25 women who died at a time when choices were severely limited.

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