Primodos:Written question - HL15086

Asked on: 08 April 2019
Department of Health and Social Care
Primodos
Lords
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 on: 24 April 2019

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.

Grouped Questions: HL15087

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