Asked by: Lord Alton of Liverpool (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government, further to the statement by Lord Bethell on 15 July (HL Deb, col 1738) that “the Primodos case is subject to legal dispute, so I cannot comment on it from the Dispatch Box”, which aspects of that legal dispute prevent an independent re-examination of the contested conclusions of the report by the Expert Working Group of the UK’s Commission on Human Medicines Report of the Commission on Human Medicines’ Expert Working Group on Hormone Pregnancy Tests, published on 15 November 2017.
Answered by Lord Bethell
The Commission on Human Medicines Expert Working Group on Hormone Pregnancy Tests was an independent group convened to conduct a scientific review of the evidence for an association between the use of hormone pregnancy tests and adverse outcomes of pregnancy.
The report and all the evidence that was reviewed by the Group has been publicly available since November 2017. We cannot discuss specific issues regarding the litigation, but this does not prevent any re-examination of the report or evidence. Any relevant new evidence would be reviewed as it becomes available.
We are carefully considering the recommendations of the Independent Medicines and Medical Devices Safety Review and will respond in due course.
Asked by: Lord Alton of Liverpool (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government whether they will respond to the freedom of information request, made by Marie Lyon, Chair of the Association for Children Damaged by Hormone Pregnancy Tests on 13 November 2019, seeking access to data held by the Medicines and Healthcare products Regulatory Agency before 27 February 2020; and if not, why not.
Answered by Baroness Blackwood of North Oxford
The Medicines and Healthcare products Regulatory Agency aims to reply to all freedom of information requests within the 20 working-day statutory deadline set out in the Freedom of Information Act 2000. In circumstances where we need to consider whether the public interest in releasing the information is outweighed by the public interest in not giving the information (the ‘public interest test’) the Act allows us to extend the deadline for reply beyond the usual 20 working days. This was applied to Mrs Lyon’s request and we responded by the revised deadline of 13 January.
Asked by: Gordon Marsden (Labour - Blackpool South)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assessment he has made of the robustness of procedures to avoid conflicts of interest in the setting up of the Expert Working group led by the Medicines and Healthcare Products Agency on the effects of the drug primodos on pregnant women.
Answered by Jackie Doyle-Price
The Medicines and Healthcare products Regulatory Agency has a clearly defined, published policy on conflicts of interest for members of its scientific advisory committees and groups. This policy has been in place for a number of years and defines the level of participation of experts in the Commission on Human Medicines (CHM) and its Expert Groups.
Prior to being appointed to the CHM Expert Working Group (EWG) on Hormone Pregnancy Tests, all those invited to participate were required to complete and sign a declaration of interests form. At each meeting, experts were asked to declare any new interests. Experts with declared interests were precluded from participating in the EWG’s decision-making. Specific consideration was given to any concerns raised during the review and, in one case, led to one invited expert stepping down from the group before any scientific data were reviewed, even though the interest (a consultancy) had lapsed. All declared interests have been published.
In relation to the terms of reference of the EWG, an association between Hormone Pregnancy Tests and birth defects had long been the subject of debate, but the nature of any association remained uncertain. The EWG was formed specifically to review all the available evidence on the possible association between Hormone Pregnancy Tests during pregnancy and birth defects and reach a conclusion as to whether or not it supported a causal association. The terms of reference of the Expert Working Group on Hormone Pregnancy Tests defined the scope of the review, not the conclusion of the group, and did not change.
Asked by: Gordon Marsden (Labour - Blackpool South)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what discussions his (a) Ministers and (b) officials have had with the (i) Medicines and Healthcare Regulatory Agency and (ii) members of the Expert Working Group on the review of hormone pregnancy tests (primodos) on why that Working Group changed the terms for that review from looking for an association to looking for a causal link as to the effect of the drugs concerned on the women it was given to.
Answered by Jackie Doyle-Price
The Medicines and Healthcare products Regulatory Agency has a clearly defined, published policy on conflicts of interest for members of its scientific advisory committees and groups. This policy has been in place for a number of years and defines the level of participation of experts in the Commission on Human Medicines (CHM) and its Expert Groups.
Prior to being appointed to the CHM Expert Working Group (EWG) on Hormone Pregnancy Tests, all those invited to participate were required to complete and sign a declaration of interests form. At each meeting, experts were asked to declare any new interests. Experts with declared interests were precluded from participating in the EWG’s decision-making. Specific consideration was given to any concerns raised during the review and, in one case, led to one invited expert stepping down from the group before any scientific data were reviewed, even though the interest (a consultancy) had lapsed. All declared interests have been published.
In relation to the terms of reference of the EWG, an association between Hormone Pregnancy Tests and birth defects had long been the subject of debate, but the nature of any association remained uncertain. The EWG was formed specifically to review all the available evidence on the possible association between Hormone Pregnancy Tests during pregnancy and birth defects and reach a conclusion as to whether or not it supported a causal association. The terms of reference of the Expert Working Group on Hormone Pregnancy Tests defined the scope of the review, not the conclusion of the group, and did not change.
Asked by: Gordon Marsden (Labour - Blackpool South)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, for what reasons his Ministers declined to meet with members of the All Party Parliamentary Group on hormone pregnancy tests to discuss the scientific review set up to consider the effects of the drug primodos on pregnant women.
Answered by Jackie Doyle-Price
In November 2017 the Expert Working Group established by the Commission on Human Medicines to review hormone pregnancy tests concluded that the available evidence did not support a causal association with adverse pregnancy outcomes. At that time the Government made a commitment to evaluate carefully any new evidence. In February 2018 the Government asked Baroness Cumberlege to undertake a review into patients’ concerns and how these were responded to, and to advise what further action may be required.
Since then, a new ad hoc Expert Group of the Commission on Human Medicines has been convened to consider the recent meta-analysis published by Heneghan et al. of clinical studies. An independent review of this publication is also being conducted in parallel by the European Medicines Agency via a formal referral under European Union legal provisions. Both of these scientific reviews are ongoing and the conclusions will be made public when complete, likely in May.
While the review by Baroness Cumberlege into what further action may be required in the case of hormone pregnancy tests is ongoing, and pending the findings of the scientific reviews of Heneghan et al., the Government considers that it would be premature to have a further meeting with the All Party Parliamentary Group.
Asked by: Lord Alton of Liverpool (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government what assessment they have made, if any, of reports by Sky News on 5 April that UK regulators in the 1970s destroyed evidence that suggested an association between the use of Primodos and birth defects.
Answered by Baroness Blackwood of North Oxford
The review of Hormone Pregnancy Tests undertaken by the Commission on Human Medicines Expert Working Group (EWG) was comprehensive, scientifically robust and independent. All evidence considered by the EWG has been published online.
The EWG examined a large number of studies, including all those in Professor Heneghan’s published meta-analysis, and for scientific reasons considered that meta-analysis was not an appropriate way to analyse the data. The rationale of the EWG is clearly documented in the minutes of the meetings and in the final report, both of which have been available online since November 2017.
The terms of reference of the EWG did not include investigation of any historical regulatory failings. The Government awaits the outcome of the Independent Medicines and Medical Devices Safety Review led by Baroness Cumberlege, which is expected to examine the procedures followed in the case of Primodos and to make recommendations.
Asked by: Lord Alton of Liverpool (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government what assessment they have made, if any, of the accusations made by Professor Carl Heneghan of the University of Oxford and reported by Sky News on 5 April that a study on Primodos overseen by the Medical and Healthcare products Regulation Agency failed to properly assess the risks of that drug; and that meta-analysis results were left out of the final report.
Answered by Baroness Blackwood of North Oxford
The review of Hormone Pregnancy Tests undertaken by the Commission on Human Medicines Expert Working Group (EWG) was comprehensive, scientifically robust and independent. All evidence considered by the EWG has been published online.
The EWG examined a large number of studies, including all those in Professor Heneghan’s published meta-analysis, and for scientific reasons considered that meta-analysis was not an appropriate way to analyse the data. The rationale of the EWG is clearly documented in the minutes of the meetings and in the final report, both of which have been available online since November 2017.
The terms of reference of the EWG did not include investigation of any historical regulatory failings. The Government awaits the outcome of the Independent Medicines and Medical Devices Safety Review led by Baroness Cumberlege, which is expected to examine the procedures followed in the case of Primodos and to make recommendations.
Asked by: Yasmin Qureshi (Labour - Bolton South East)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what the criteria were for selecting members of the Expert Working Group for Hormone Pregnancy Tests.
Answered by Jackie Doyle-Price
The Commission on Human Medicines Expert Working Group on Hormone Pregnancy Tests considered that the key limitations of previous studies related to the accuracy of recording of what drug was taken by the women; clarity over the timing of administration during pregnancy; adjustment for confounding factors; selection of controls; and the statistical methodology.
The Expert Group used a quality scoring system to evaluate the quality of each individual study according to a set of seven pre-defined quality criteria. The criteria and score agreed by the Expert Working Group for each study are published in Annex 27 of the final report.
The criteria for selecting members of the Expert Working Group were based on the expertise needed to evaluate all aspects of the questions before the Group and the types of data that would need to be assessed. Membership included those with expertise in pharmaco-epidemiology, including perinatal and paediatric epidemiology, medical statistics, embryology, clinical genetics, gynaecology, reproductive endocrinology, toxicology and pharmacology.
The process for selecting members was in line with established policy for expert groups of the Commission on Human Medicines, with the nominations being agreed by the Commission and endorsed by Ministers.
Asked by: Yasmin Qureshi (Labour - Bolton South East)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 9 April 2019 to Question 239926 on Pregnancy Tests, for what reason previous studies were not considered robust; and what the extensive limitations were.
Answered by Jackie Doyle-Price
The Commission on Human Medicines Expert Working Group on Hormone Pregnancy Tests considered that the key limitations of previous studies related to the accuracy of recording of what drug was taken by the women; clarity over the timing of administration during pregnancy; adjustment for confounding factors; selection of controls; and the statistical methodology.
The Expert Group used a quality scoring system to evaluate the quality of each individual study according to a set of seven pre-defined quality criteria. The criteria and score agreed by the Expert Working Group for each study are published in Annex 27 of the final report.
The criteria for selecting members of the Expert Working Group were based on the expertise needed to evaluate all aspects of the questions before the Group and the types of data that would need to be assessed. Membership included those with expertise in pharmaco-epidemiology, including perinatal and paediatric epidemiology, medical statistics, embryology, clinical genetics, gynaecology, reproductive endocrinology, toxicology and pharmacology.
The process for selecting members was in line with established policy for expert groups of the Commission on Human Medicines, with the nominations being agreed by the Commission and endorsed by Ministers.
Asked by: Yasmin Qureshi (Labour - Bolton South East)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what plans his Department has for peer review the report of the Commission on Human Medicines Expert Working Group on Hormone Pregnancy Tests.
Answered by Jackie Doyle-Price
The Commission on Human Medicines’ Expert Working Group (EWG) review into Hormone Pregnancy Tests (HPTs) was comprehensive, scientifically robust and independent. Based on the totality of the data, the review concluded the available scientific evidence did not support a causal association between the use of HPTs during early pregnancy and birth defects or miscarriage. All evidence considered by the EWG has been published online.
The EWG did not undertake a meta-analysis as part of the review. The EWG examined a large number of epidemiological studies, many of which were conducted under different designs. The EWG considered whether meta-analysis was possible and ultimately concluded that because the studies were so different such an analysis would not be informative. Meta-analysis was also not considered appropriate because the studies were not sufficiently robust and suffered from extensive limitations.
The EWG comprised independent experts from a wide range of relevant specialisms and its report was further scrutinised by the Commission on Human Medicines, the Government’s independent scientific advisory body on the safety of medicines. There are no plans for further peer review of the report. The Government is committed to reviewing any important new evidence that arises.