EWG Primodos review criticised for ‘not assessing risks properly’

Sky News’ Exclusive, 4 Apr 2019

“Somebody, somewhere, has performed a meta-analysis.
At some point, there was a decision not to include that in the EWG report.”

Oxford University professor Carl Heneghan has told Sky News the evidence against the pregnancy drug Primodos suggests a significant link between it and birth deformities (see below).

On 23 April 2019, during the Westminster Hall debate on the Expert Working Group report on hormone pregnancy tests, some MPs also questioned the methodology used and asked why not use meta-analysis to assess primodos evidence ? Some others clarified the difference between correlation vs causation (in ref to primodos link to births defects), or said : with pharma funding the MHRA, can the EWG report be fully independent ?

More information

  • 2018 Studies :
    • Oral hormone pregnancy tests and the risks of congenital malformations: a systematic review and meta-analysis, F1000Research, 31 Oct 2018, 7:1725, DOI:10.12688/f1000research.16758.1.
    • The Primodos components Norethisterone acetate and Ethinyl estradiol induce developmental abnormalities in zebrafsh embryos, Nature, 13 Feb 2018, DOI:10.1038/s41598-018-21318-9.
  • Westminster Hall debate pack : CDP-2019/0095, 18 April 2019.

IMMDS Review listens to Journalist Jason Farrell about Primodos

Independent Medicines and Medical Devices Safety Review Oral Hearing, 26th November 2018

The Independent Medicines and Medical Devices Safety Review is Chaired by Baroness Julia Cumberlege CBE DL.

In February 2018, the Secretary of State for Health and Social Care, the Rt Hon Jeremy Hunt MP, announced a review into how the health system responds to reports from patients about harmful side effects from medicines and medical devices. The announcement in the House of Commons follows patient-led campaigns on the use of the hormone pregnancy test Primodos, anti-epileptic drug sodium valproate and surgical mesh.

About Primodos

  • Read and/or download the full study (free access) Oral hormone pregnancy tests and the risks of congenital malformations: a systematic review and meta-analysis, F1000Research, First published 31 Oct 2018, 7:1725, DOI:10.12688/f1000research.16758.1.
  • Read and/or download the full study (free access) The Primodos components Norethisterone acetate and Ethinyl estradiol induce developmental abnormalities in zebrafsh embryos, nature, Published 13 Feb 2018, DOI:10.1038/s41598-018-21318-9.
  • To read some real stories told by the Primodos victims, go to this post comment section.  Read our posts tagged primodos.

Oxford University study links pregnancy drug Primodos to birth defects

Sky News Exclusive, 27 Nov 2018

A groundbreaking study from Oxford University has linked the pregnancy test drug Primodos to malformations in babies born to mothers who used the drug.

Read Oral hormone pregnancy tests and the risks of congenital malformations.

More information

  • Read and/or download the full study (free access) Oral hormone pregnancy tests and the risks of congenital malformations: a systematic review and meta-analysis, F1000Research, First published 31 Oct 2018, 7:1725, DOI:10.12688/f1000research.16758.1.
  • Read and/or download the full study (free access) The Primodos components Norethisterone acetate and Ethinyl estradiol induce developmental abnormalities in zebrafsh embryos, nature, Published 13 Feb 2018, DOI:10.1038/s41598-018-21318-9.
  • Read some real stories told by the Primodos victims, see this post comment section.

MPs Call for Public Inquiry into Hormone Pregnancy Tests

Judge-led inquiry into pregnancy drug Primodos not “off the table”, the Government confirmed

There have been growing calls for a public inquiry into the “Report of the Commission on Human Medicines’ Expert Working Group on Hormone Pregnancy Tests” scandal, after MPs debated the Primodos drug’s legacy.

Severals MPs have joined the Primodos campaigners to say that the Expert Working Group review was a complete whitewash.

House of Commons and House of Lords Debates

  • House of Commons’ talks ref “Hormone pregnancy tests“, 14 December 2017 – 15:20:54 parliamentlive.tv.
  • House of Commons’ talks ref “Hormone pregnancy tests“, 16 November 2017 – 10:40:26 parliamentlive.tv.
  • House of Lords’ talks ref “Hormone pregnancy tests“, 16 November 2017 – 17:53:45 parliamentlive.tv.
  • House of Commons’ talks ref “Hormone pregnancy tests“, 13 October 2016 – 15:05:52 parliamentlive.tv.
  • House of Lords’ talks ref “Hormone pregnancy tests“, 21 January 2016 – 11:06:20 parliamentlive.tv.

More About Primodos

Lower-Dose Primodos-like Contraceptives are Still being used Today : is it Safe ?

Primodos EWG Report : Marie Lyon Comments

Marie Lyon, Chair of the Association for Children Damaged by Hormone Pregnancy Tests, speaks live to Jason Farrell, Senior Political Correspondent for Sky News, about the growing anger among MPs over last month’s Government-commissioned report on the pregnancy drug Primodos.

Severals MPs have joined the Primodos campaigners to say that the Expert Working Group review was a complete whitewash.

  • To download the Report of the Commission on Human Medicines’ Expert Working Group on Hormone Pregnancy Testsgov.uk.

House of Commons and House of Lords Debates

  • House of Commons’ talks ref “Hormone pregnancy tests“, 14 December 2017 – 15:20:54 parliamentlive.tv.
  • House of Commons’ talks ref “Hormone pregnancy tests“, 16 November 2017 – 10:40:26 parliamentlive.tv.
  • House of Lords’ talks ref “Hormone pregnancy tests“, 16 November 2017 – 17:53:45 parliamentlive.tv.
  • House of Commons’ talks ref “Hormone pregnancy tests“, 13 October 2016 – 15:05:52 parliamentlive.tv.
  • House of Lords’ talks ref “Hormone pregnancy tests“, 21 January 2016 – 11:06:20 parliamentlive.tv.

More About Primodos

How responsible and valuable is the EWG report about Primodos side-effects ?

Sky’s Jason Farrell special report: Primodos revisited – the Government study

Two weeks ago, an Expert Working Group (EWG) of the UK’s Commission on Human Medicines (CHM) has published their report on the use of hormone pregnancy tests (HPTs) and adverse effects relating to pregnancy including possible birth defects.

A lecturer in medical sciences says its not possible for a Government-commissioned study to conclude that Primodos pregnancy drug was safe.

Commission on Human Medicines

  • Report of the Commission on Human Medicines’ Expert Working Group on Hormone Pregnancy Tests, gov.uk.
  • Referral letter for genetic testing, gov.uk.
  • Press coverage, news.google.

More About Primodos

Causal Association Between Primodos and Birth Defects : the EWG report

Report of the Commission on Human Medicines’ Expert Working Group on Hormone Pregnancy Tests

An Expert Working Group (EWG) of the UK’s Commission on Human Medicines (CHM) has published their report on the use of hormone pregnancy tests (HPTs) and adverse effects relating to pregnancy including possible birth defects.

Sky’s Jason Farrell confirms alleged victims of pregnancy test Primodos slam EWG report which found the drug was not responsible for serious birth defects. Campaigners say that the hormone pregnancy test review was a complete whitewash.

Commission on Human Medicines

  • Report of the Commission on Human Medicines’ Expert Working Group on Hormone Pregnancy Tests, gov.uk.
  • Referral letter for genetic testing, gov.uk.
  • Press coverage, news.google.

More About Primodos

Primodos EWG Report : Jason Farrell Reveals

Report of the Commission on Human Medicines’ Expert Working Group on Hormone Pregnancy Tests

An Expert Working Group (EWG) of the UK’s Commission on Human Medicines (CHM) has published their report on the use of hormone pregnancy tests (HPTs) and adverse effects relating to pregnancy including possible birth defects.

Sky’s Jason Farrell shares some thoughts.

Commission on Human Medicines

  • Report of the Commission on Human Medicines’ Expert Working Group on Hormone Pregnancy Tests, gov.uk.
  • Referral letter for genetic testing, gov.uk.
  • Press coverage, news.google.

More About Primodos

EMA Public Hearing about Drug Valproate Use in Pregnancy

Pregnant women still unaware of epilepsy drug risks

Was there a deliberate decision not to publish Valproate’s risks ?

The public hearing was part of a review of the safety of using valproate-containing medicines in women and girls who are pregnant or of childbearing age by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC). There is a risk of malformations and neurodevelopmental problems in babies who are exposed to valproate in the womb, and the review follows concerns that European Union (EU)-wide risk minimisation measures currently in place do not seem to be sufficiently effective.

Warnings to young women who might become pregnant that the epilepsy drug sodium valproate could cause birth defects and developmental problems in their babies could have been made public more than 40 years ago, according to campaigners.

Primodos Investigation : Jason Farrell Reveals

Jason Farrell has been investigating Primodos for six years – he talked about his experience

March 2017 : MPs have welcomed a Sky investigation, which revealed how hormone pregnancy tests may have caused malformations and even deaths.

Around 1.5 million women in Britain in the 1960s and 70s took Primodos in the early stages of pregnancy. Some say their pregnancies resulted in miscarriage or birth defects.

Sky News’ hour-long documentary Primodos: The Secret Drug Scandal is presented by senior political correspondent Jason Farrell, who has been investigating it for six years.

Sky News revealed how documents were destroyed and information withheld about a drug that may have deformed and killed babies in the womb.

More Information