A Bitter Pill: Primodos, The Forgotten Thalidomide (APPG on Hormone Pregnancy Tests, 27 February 2024)

Summary

In 2021, the Independent Medicines and Medical Devices Safety review, led by Baroness Cumberlege, conducted a comprehensive review of historic documents and found that Hormone Pregnancy Tests had caused avoidable harm, that they should have been withdrawn by the regulator after the first warnings in 1967 and that this failure to act meant that women were exposed unnecessarily to a potential risk.

This report by the All-Party Parliamentary Group on Hormone Pregnancy Tests sets out the background to this and considers the findings in 2017 of an expert working group that was relied upon by the Government and manufacturers to strike out a claim for compensation in 2023. The report recommends that the Government sets up an independent review to examine the findings of this working group.

Content

The report calls on the Secretary of State to implement the following recommendations:

(a) To set up an independent review to examine the findings of the ‘Expert Working Group’:

• Appointed scientists must have a background in, and detailed understanding of this technical area.
• Any selection and appointment of experts must be independent and in consultation with the families affected by Primodos to ensure they have trust and confidence in the process.
• As set out in the IMMDS review, this must be independent of the MHRA which has taken a defensive approach to this issue.
• Where it is necessary to peer-review the draft report, this should be reviewed by an independent panel of experts to avoid the potential of undue influence.

(b) To review the compelling new evidence published in the ‘Reproductive Toxicology’ journal as set out in chapter 6.

Related reading

Patient Safety Spotlight interview with Marie Lyon, chair of the Association for Children Damaged by Hormone Pregnancy Tests