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, whether a meta-analysis was carried out as part of the Commission on Human Medicines' Expert Working Group review into 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.
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 steps he has taken to ensure the (a) impartiality and (b) independence of panels members on the Commission on Human Medicines’ independent scientific review of the publication by Professor Carl Heneghan into hormone pregnancy tests.
Answered by Jackie Doyle-Price
Since publication of the report of the Commission on Human Medicines Expert Working Group on Hormone Pregnancy Tests (HPTs) the Government has committed to review any important new evidence that arises. In response to publication of the study by Heneghan et al. the Commission on Human Medicines convened an Expert Group to advise on the suitability and robustness of the methodology (including the selection and application of the data quality score) and any clinical implications.
To ensure impartiality none of the members of the Group was involved in the previous review by the Expert Working Group on HPTs. A specific conflict of interest policy was developed and all participants were required to complete and sign a declaration of interests form. Participants were asked to declare personal or non-personal interests in the companies who marketed HPTs or whose predecessors marketed them, current or previous involvement in any studies or reviews on HPTs, the expression in public of a strong opinion about HPTs or any of the companies that produced them, and direct or indirect involvement with, or peer review of, the publication by Heneghan et al. The conflict of interest policy and declarations of participants will be made public in due course.
For complete transparency the meeting was observed by the Chair of the Association for Children Damaged by HPTs, an advocate for those affected by thalidomide, a Lay representative and a representative from the Independent Medicines and Medical Devices Safety Review.
In parallel, the European Medicines Agency is conducting an independent review of the publication by Heneghan et al. Both reviews are ongoing, and we expect the conclusions to be made public within a month of their completion, likely to be May 2019.
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 timetable is for the publication of the findings of the Commission on Human Medicines’ independent scientific review of the publication by Professor Carl Heneghan into hormone pregnancy tests.
Answered by Jackie Doyle-Price
Since publication of the report of the Commission on Human Medicines Expert Working Group on Hormone Pregnancy Tests (HPTs) the Government has committed to review any important new evidence that arises. In response to publication of the study by Heneghan et al. the Commission on Human Medicines convened an Expert Group to advise on the suitability and robustness of the methodology (including the selection and application of the data quality score) and any clinical implications.
To ensure impartiality none of the members of the Group was involved in the previous review by the Expert Working Group on HPTs. A specific conflict of interest policy was developed and all participants were required to complete and sign a declaration of interests form. Participants were asked to declare personal or non-personal interests in the companies who marketed HPTs or whose predecessors marketed them, current or previous involvement in any studies or reviews on HPTs, the expression in public of a strong opinion about HPTs or any of the companies that produced them, and direct or indirect involvement with, or peer review of, the publication by Heneghan et al. The conflict of interest policy and declarations of participants will be made public in due course.
For complete transparency the meeting was observed by the Chair of the Association for Children Damaged by HPTs, an advocate for those affected by thalidomide, a Lay representative and a representative from the Independent Medicines and Medical Devices Safety Review.
In parallel, the European Medicines Agency is conducting an independent review of the publication by Heneghan et al. Both reviews are ongoing, and we expect the conclusions to be made public within a month of their completion, likely to be May 2019.
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, how much was spent from the public purse on the Commission on Human Medicines Expert Working Group on Hormone Pregnancy Tests.
Answered by Jackie Doyle-Price
The Commission on Human Medicines (CHM) advises health ministers on the safety, efficacy and quality of medicinal products. Expert Working Groups of the CHM are comprised of independent experts who work on a voluntary basis and receive reasonable expenses. The Medicines and Healthcare products Regulatory Agency provide a secretariat function to the CHM and its Expert Working Groups. This is included in Agency costs. The Agency is an Executive Agency of the Department and it is established as a Government trading fund, with its work predominantly funded by fees charged to the industry it regulates.
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, if he will make an assessment of the merits in the conclusions of the 2018 report by Professor Carl Heneghan on oral hormones pregnancy tests and the risks of congenital malformations; and if he will make a statement.
Answered by Jackie Doyle-Price
In line with the Government’s commitment to review any new evidence in relation to hormone pregnancy tests, the Commission on Human Medicines is convening a new expert group to conduct an independent scientific review of the publication by Professor Carl Heneghan. In addition, the European Medicines Agency’s Committee for Medicinal Products for Human Use is conducting a review of the paper at European Union level, at the request of the Medicines and Healthcare products Regulatory Agency. Once this paper has been fully considered the findings will be made public.
Asked by: Grant Shapps (Conservative - Welwyn Hatfield)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether his Department has (a) conducted and (b) is aware of any research into whether women and children in any (i) post code and (ii) county area were disproportionately affected by hormone pregnancy testing.
Answered by Jackie Doyle-Price
The Department has not conducted research into whether women and children in any post code or county area were disproportionately affected by hormone pregnancy testing, nor is it aware of published scientific research on this topic.
Hormone Pregnancy Tests were available from 1958-1978. The Commission on Human Medicines Expert Working Group on Hormone Pregnancy Tests reviewed all the available evidence on the possible association between exposure in pregnancy to hormone pregnancy tests and adverse outcomes in pregnancy. The Group concluded that, taking all aspects into consideration, the available evidence did not support a causal association between the use of hormone pregnancy tests during early pregnancy and birth defects or miscarriage.
The Government’s priority, as always, is the safety of patients. The Expert Working Group made a number of forward-looking recommendations to further strengthen the scientific evidence which supports safety monitoring of medicines in pregnancy and current focus is on implementing these recommendations.
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 steps he is taking to fund independent scientific research into hormone pregnancy tests.
Answered by Jackie Doyle-Price
The Commission on Human Medicines Expert Working Group on Hormone Pregnancy Tests was established in 2015 to consider all the available evidence on the possible association between exposure in pregnancy to hormone pregnancy tests and adverse outcomes in pregnancy. The Expert Working Group conducted a comprehensive, scientifically robust and independent review of all available scientific evidence relating to hormone pregnancy tests including the responses to a public call for evidence. In reaching its conclusion that, taking all aspects into consideration, the available evidence did not support a causal association between the use of hormone pregnancy tests during early pregnancy, the Expert Working Group made a number of forward-looking recommendations to further strengthen the scientific evidence which supports safety monitoring of medicines in pregnancy. The current focus of the Medicines and Healthcare products Regulatory Agency (MHRA) is on implementing these recommendations.
The Government’s priority, as always, is the safety of patients. While there are no plans to fund independent scientific research into hormone pregnancy tests (which have not been available since 1978), should any further evidence emerge of direct relevance to hormone pregnancy tests the MHRA will evaluate this. In addition, certain recommendations of the Expert Working Group’s review are anticipated to encourage relevant research into the safety of medicines in pregnancy.
Asked by: Lord Field of Birkenhead (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps he is taking to fund independent scientific research into hormone pregnancy tests.
Answered by Jackie Doyle-Price
The Commission on Human Medicines Expert Working Group on Hormone Pregnancy Tests was established in 2015 to consider all the available evidence on the possible association between exposure in pregnancy to hormone pregnancy tests and adverse outcomes in pregnancy. The Expert Working Group conducted a comprehensive, scientifically robust and independent review of all available scientific evidence relating to hormone pregnancy tests including the responses to a public call for evidence. In reaching its conclusion that, taking all aspects into consideration, the available evidence did not support a causal association between the use of hormone pregnancy tests during early pregnancy, the Expert Working Group made a number of forward-looking recommendations to further strengthen the scientific evidence which supports safety monitoring of medicines in pregnancy. The current focus of the Medicines and Healthcare products Regulatory Agency (MHRA) is on implementing these recommendations.
While there are no plans to fund independent scientific research into hormone pregnancy tests (which have not been available since 1978), should any further evidence emerge of direct relevance to hormone pregnancy tests the MHRA will evaluate this. In addition, certain of the Expert Working Group’s recommendations are anticipated to encourage relevant research into the safety of medicines in pregnancy.
The Government’s priority, as always, is the safety of patients. A comprehensive and independent review of the science has been done but the Government will continue to listen and keep all options for further investigation on the table.
Asked by: Lord Field of Birkenhead (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what plans he has to establish an independent public inquiry into hormone pregnancy tests.
Answered by Jackie Doyle-Price
The Commission on Human Medicines Expert Working Group on Hormone Pregnancy Tests was established in 2015 to consider all the available evidence on the possible association between exposure in pregnancy to hormone pregnancy tests and adverse outcomes in pregnancy. The Expert Working Group conducted a comprehensive, scientifically robust and independent review of all available scientific evidence relating to hormone pregnancy tests including the responses to a public call for evidence. In reaching its conclusion that, taking all aspects into consideration, the available evidence did not support a causal association between the use of hormone pregnancy tests during early pregnancy, the Expert Working Group made a number of forward-looking recommendations to further strengthen the scientific evidence which supports safety monitoring of medicines in pregnancy. The current focus of the Medicines and Healthcare products Regulatory Agency (MHRA) is on implementing these recommendations.
While there are no plans to fund independent scientific research into hormone pregnancy tests (which have not been available since 1978), should any further evidence emerge of direct relevance to hormone pregnancy tests the MHRA will evaluate this. In addition, certain of the Expert Working Group’s recommendations are anticipated to encourage relevant research into the safety of medicines in pregnancy.
The Government’s priority, as always, is the safety of patients. A comprehensive and independent review of the science has been done but the Government will continue to listen and keep all options for further investigation on the table.
Asked by: Louise Ellman (Independent - Liverpool, Riverside)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps he is taking to fund independent scientific research into hormone pregnancy tests; and if he will make a statement.
Answered by Jackie Doyle-Price
The Commission on Human Medicines Expert Working Group on Hormone Pregnancy Tests was established in 2015 to consider all the available evidence on the possible association between exposure in pregnancy to hormone pregnancy tests and adverse outcomes in pregnancy. The Expert Working Group conducted a comprehensive, scientifically robust and independent review of all available scientific evidence relating to hormone pregnancy tests including the responses to a public call for evidence. In reaching its conclusion that, taking all aspects into consideration, the available evidence did not support a causal association between the use of hormone pregnancy tests during early pregnancy, the Expert Working Group made a number of forward-looking recommendations to further strengthen the scientific evidence which supports safety monitoring of medicines in pregnancy. The current focus of the Medicines and Healthcare products Regulatory Agency (MHRA) is on implementing these recommendations.
The Government’s priority, as always, is the safety of patients. While there are no plans to fund independent scientific research into hormone pregnancy tests (which have not been available since 1978), should any further evidence emerge of direct relevance to hormone pregnancy tests the MHRA will evaluate this. In addition, certain of the Expert Working Group’s recommendations are anticipated to encourage relevant research into the safety of medicines in pregnancy.