Primodos

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| name = Primodos

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| purpose = Determine if pregnancy is present

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{{multiple image

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| footer = Primodos ingredients

| image1 = Norethisterone.svg

| alt1 = Norethisterone

| caption1 = Norethisterone

| image2 = Ethinylestradiol.svg

| alt2 = Ethinylestradiol

| caption2 = Ethinylestradiol

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Primodos was a hormone-based pregnancy test, produced by Schering AG, and used in the 1960s and 1970s that consisted of two pills that contained norethisterone (as acetate) and ethinylestradiol.{{cite web|url=https://www.telegraph.co.uk/news/health/10819186/Is-this-the-forgotten-thalidomide.html |archive-url=https://web.archive.org/web/20170714232828/https://www.telegraph.co.uk/news/health/10819186/Is-this-the-forgotten-thalidomide.html |url-status=dead |archive-date=14 July 2017 |title='Is this the forgotten thalidomide?'|publisher=Daily Telegraph|date=12 May 2014|author=Sarah Rainey}}Department of Health, Hansard, HL Deb, 26 October 2010, c264W [https://publications.parliament.uk/pa/ld201011/ldhansrd/text/101026w0001.htm#10102627000615] It detected pregnancy by inducing menstruation in women who were not pregnant. The presence or absence of menstrual bleeding was then used to determine whether the user was pregnant. In South Korea it was also used, "perhaps as a double dose" to induce abortions.{{cite web|url=https://news.sky.com/story/uk-mothers-betrayed-pregnancy-drug-wasused-for-abortions-10809235|title=UK pregnancy test drug Primodos used for abortions in Germany}}

While first made available for sale in the UK in 1959, it was withdrawn from sale in the UK in 1978.{{cite web|url=http://www.mhra.gov.uk/Safetyinformation/Generalsafetyinformationandadvice/Product-specificinformationandadvice/Product-specificinformationandadvice-G-L/Hormonalcontraceptives/Hormonepregnancytests/index.htm|title=Hormone pregnancy tests|publisher=Medicines and Healthcare products Regulatory Agency|access-date=12 May 2014|archive-url=https://web.archive.org/web/20140512231057/http://www.mhra.gov.uk/Safetyinformation/Generalsafetyinformationandadvice/Product-specificinformationandadvice/Product-specificinformationandadvice-G-L/Hormonalcontraceptives/Hormonepregnancytests/index.htm|archive-date=12 May 2014|url-status=dead}}

Primodos was produced by Schering AG, a German company taken over by Bayer AG in 2006.

Another hormonal pregnancy test called Duogynon was in use in Germany during the same general time period.

History

In the 1960s, Dr. Isabel Gal conducted research at Queen Mary's Hospital for Children that showed a link between use of the drug and severe birth defects.{{Cite web|url=https://www.theguardian.com/science/2018/mar/13/isabel-gal-obituary|title=Isabel Gal obituary|last=Montuschi|first=Mike|date=2018-03-13|website=the Guardian|language=en|access-date=2018-06-21}} A review by the Committee on Safety of Medicines in the 1970s concluded that the product should not be used by pregnant women. Litigation in the 1980s regarding these claims ended inconclusively, with proceedings being discontinued, with the court's approval.[https://books.google.com/books?id=rSmlDMgAG2oC&pg=PA79 "Jury still out in pregnancy test case"]{{Dead link|date=July 2024 |bot=InternetArchiveBot |fix-attempted=yes }}, New Scientist, 8 July 1982, page 79 A review of the matter by the Medicines and Healthcare products Regulatory Agency in 2014 assessed the studies performed to date, and concluded that it found the evidence for adverse effects to be inconclusive.{{cite web |url=http://www.mhra.gov.uk/home/groups/comms-ic/documents/websiteresources/con404471.pdf |archive-url=http://webarchive.nationalarchives.gov.uk/20141204145033/http://www.mhra.gov.uk/home/groups/comms-ic/documents/websiteresources/con404471.pdf |url-status=dead |archive-date=4 December 2014 |title=Assessment of historical evidence on Primodos and congenital malformations – a synopsis |publisher=Medicines and Healthcare products Regulatory Agency |date=9 April 2014 |access-date=12 May 2014 }}

The report of an expert working group of the UK Commission on Human Medicines published in November 2017 concluded there was no "causal association" between Primodos and severe disabilities in babies. The expert group recommended that families who took a hormone pregnancy test and experienced "an adverse pregnancy outcome" should be offered genetic testing to establish whether there was a different underlying cause.{{Cite web|url=https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/659115/Report-CHM-EWG-HPTs_FINAL.pdf|title=Report of the Commission on Human Medicines Expert Working Group on Horrmone Pregnancy Tests|date=15 November 2017|website=UK Government Web site|access-date=15 November 2017}}

Independent Medicines and Medical Devices Safety Review

An independent review by Baroness Cumberlege, the Independent Medicines and Medical Devices Safety Review, reported in 2020 that "avoidable harm" resulted from the use of Primodos. It recommended that "the Government should immediately issue a fulsome apology on behalf of the healthcare system to the families affected by Primodos".{{cite web |last1=Cumberledge |first1=Baroness |title=First Do No Harm: The report of the Independent Medicines and Medical Devices Safety Review |url=https://www.immdsreview.org.uk/downloads/IMMDSReview_Web.pdf |publisher=Independent Medicines and Medical Devices Safety Review |access-date=8 July 2020}}

Dr Bill Inman, of the Committee on Safety of Medicines, who had investigated Primodos was referenced in a Schering memo stating "he has destroyed all the material on which his investigation is based, or made it unrecognizable, which makes it impossible to trace the individual cases taken into the investigation. I understood Dr. Inman that he did this to prevent individual claims from using this material."

Baroness Cumberlege said, in relation to Bayer, "I think they should not only apologise; they should recognise what has happened and give ex-gratia payments to these people who have suffered."{{cite web |last1=Farrell |first1=Jason |title=Primodos scandal: Relief for campaigners as review demands compensation for victims of hormone pregnancy test |url=https://news.sky.com/story/primodos-scandal-relief-for-campaigners-as-review-demands-compensation-for-victims-of-hormone-pregnancy-test-12023127 |website=Sky News |access-date=8 July 2020 |language=en}}

Primodos

History

Independent Medicines and Medical Devices Safety Review

References

Further reading