Independent 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.

Documents

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

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Referral letter for genetic testing

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Expert Working Group on Hormone Pregnancy Test - Meeting minutes and declaration of interests

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Expert Working Group on Hormone Pregnancy Test - Annexes to the report

Expert Working Group on Hormone Pregnancy Test - Schering studies

Expert Working Group on Hormone Pregnancy Test - Miscellaneous supporting evidence

Details

Following this extensive and rigorous review the overall conclusion, based on the totality of the available data, is that the scientific evidence does not support a causal association between the use of HPTs such as Primodos and birth defects or miscarriage.

For members of the Association for Children Damaged by HPTs who wish to take up the recommendation of the Expert Working Group (EWG) offer of genetic testing the above letter may be used.

This page also includes:

  • meeting minutes and declarations of interest
  • annexes to the report
  • documents from the National Archive
  • Schering studies
  • documents submitted through public calls for information
  • Landesarchiv Berlin documents

Statement concerning Landesarchiv documents

The attached documents originate from the Landesarchiv in Berlin (the Berlin State Archive). It is MHRA’s understanding that they derive from files of internal documents belonging to Schering AG that, in the late 1970s, were seized by the relevant federal authorities in Germany as part of a review which they conducted relating to hormone pregnancy tests.

The documents represent material from the archive made available to MHRA for consideration by the Expert Working Group (EWG). Documents from that archive are listed with summary descriptions in several annexes to the EWG report. Where they were in German, they have been professionally translated by MHRA for the purposes of the EWG’s review.

The documents date principally from a period after sales of Primodos and other HPTs ended in the UK. They were reviewed for any information of scientific relevance and to prepare chronologies that would provide historical context for the scientific questions that the report of the EWG addresses. MHRA has decided to place them on the Commission on Human Medicines website consistent with Ministerial commitments to make available all documents considered by the EWG.

Bayer has requested that it is made clear that neither the documents nor the information contained in them have been seen by them in advance of publication, and nor are they being reproduced with the consent of Bayer. Bayer has drawn to MHRA’s attention the fact that it has not waived any rights it may have in the UK or elsewhere relating to confidentiality and privilege should the documents, or any part of them, be reproduced for any other purpose.

Published 15 November 2017
Last updated 5 February 2018 + show all updates
  1. Updated referral letter for genetic testing added to the page.
  2. Additional files of supporting evidence added to the page.
  3. Annexes to the Report, Documents from the National Archive and Schering Studies added to the page.
  4. minutes and conflicts of interest documents of the Expert Working Group added to the page.
  5. First published.