British Menopause Society uses Freedom of Information Act to question MHRA practices

Published: 10th September 2019

The medical advisory council of the BMS has written to ask the MHRA to address the following queries under the Freedom of Information Act:

  1. How often do the MHRA review their updates and what are the criteria for a publication to warrant an MHRA update? What timescale would this usually involve following the publication? It appears the last update prior to this current update on HRT in August 2019 was in 2007 despite a number of significant practice changing publications as the ones referred to below.
     
  2. Did the MHRA consider updating its recommendations on HRT following the publication of the NICE guidelines in 2015? If not, why did the NICE menopause guideline not meet the criteria of the MHRA to review its recommendations on HRT?
     
  3. Did the MHRA consider updating its recommendations on HRT following publication of the Cochrane review by Broadman et al. in 2015 which showed significant reduction in cardiovascular mortality and all-cause mortality in women taking HRT under the age of 60? If not, why did the Cochrane review not meet the criteria of the MHRA to review its recommendations on HRT?
     
  4. Would it be possible to provide information on who contributed as members of the MHRA Panel that reviewed the evidence on the risk of breast cancer and HRT and issued the MHRA recommendations that followed based on this?
     
  5. Would it be possible to provide information on how many members the MHRA Panel was made of in total and what was their specialist background?
     
  6. How many menopause specialists were there on the MHRA Panel?
     
  7. Did the MHRA Panel chose not to include the findings from the Lancet paper that showed no increase in risk of breast cancer with vaginal oestrogen administration in the MHRA recommendations?
     
  8. Did the MHRA Panel consider discussing the recommendations with the relevant Specialist Advisory Bodies: BMS, RCOG, RCGP, FSRH before making their recommendations? If not, what was the reason for not doing so?