Tag: MHRA

Lords debate Safety of Medicines and Medical Devices

UK Parliament, House of Lords Hansard, 28 February 2019

Lords debates medicinal safety in ref to the public health scandals involving the hormone-based pregnancy test drug Primodos, the use of vaginal mesh implants and the anti-epilepsy drug sodium valproate.

  • Interventions from Lord O’Shaughnessy, Lord Hunt of Kings Heath, Baroness Walmsley, Baroness Masham of Ilton, Baroness Cumberlege 36:28 , Lord Brennan, Lord Carrington, Lord Bethell, Baroness Bryan of Partick, Lord Alton of Liverpool 1:17:29 , Lord Suri, Baroness Finlay of Llandaff, The Earl of Dundee, Baroness Jolly, Baroness Thornton, The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Blackwood of North Oxford).
  • Read the Lords Hansard transcript.
  • Parliamentary news, research briefing.
  • Parliament news, press release.
  • Video source, Parliament Tv.

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EWG Primodos review criticised for ‘not assessing risks properly’

Sky News’ Exclusive, 4 Apr 2019

“Somebody, somewhere, has performed a meta-analysis.
At some point, there was a decision not to include that in the EWG report.”

Oxford University professor Carl Heneghan has told Sky News the evidence against the pregnancy drug Primodos suggests a significant link between it and birth deformities (see below).

On 23 April 2019, during the Westminster Hall debate on the Expert Working Group report on hormone pregnancy tests, some MPs also questioned the methodology used and asked why not use meta-analysis to assess primodos evidence ? Some others clarified the difference between correlation vs causation (in ref to primodos link to births defects), or said : with pharma funding the MHRA, can the EWG report be fully independent ?

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  • 2018 Studies :
    • Oral hormone pregnancy tests and the risks of congenital malformations: a systematic review and meta-analysis, F1000Research, 31 Oct 2018, 7:1725, DOI:10.12688/f1000research.16758.1.
    • The Primodos components Norethisterone acetate and Ethinyl estradiol induce developmental abnormalities in zebrafsh embryos, Nature, 13 Feb 2018, DOI:10.1038/s41598-018-21318-9.
  • Westminster Hall debate pack : CDP-2019/0095, 18 April 2019.

With Pharma funding the MHRA, can the EWG Report be Fully Independent ?

Westminster Hall debate, 23 April 2019

” Yes we had a (Primodos) review, but I’m not sure we can call that ‘independant’ “

Yasmin Qureshi MP calls into question the independence of the MHRA in its central role on the expert working group (EWG), for their report on the use of hormone pregnancy tests (HPTs) and adverse effects relating to pregnancy including possible birth defects.

Westminster Hall debate, 23 April 2019. Video reference.

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Primodos Link to Births Defects : Correlation vs Causation

Westminster Hall, 23 April 2019

“There is an association. The Minister must go from this room knowing that, because that is what the science shows.”

Edward J Davey MP clarifies how to correctly interpret Carl Heneghan’s study (see below). Video (above) reference.

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Expert Working Group Methodology Used for Hormone Pregnancy Tests Report

Westminster Hall, 23 April 2019

“When the data was pooled together properly it shows a clear association with several different forms of malformations. …
…The Expert working Group completely failed to use the right approach for systematic reviews”. …

Yasmin Qureshi MP questions the technique used by the expert working group, for their review, on the use of hormone pregnancy tests (primodos drug) and adverse effects relating to pregnancy including possible birth defects. Westminster Hall debate, 23 April 2019. Video reference.

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Primodos hormone pregnancy test drug tragedy : what exactly is being covered-up ?

Westminster Hall, 23 April 2019

Is it the legal side involving the NHS, is it the pharma industry influence on the official report, on the MHRA, is it the government wrongdoing, or is it a bit of everything that is being covered-up ?

Sir Mike Penning MP argues that the Expert Working Group review on Primodos was a “cover-up”. Reference.

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Why Was the Primodos Drug Withdrawn in The UK ?

Westminster Hall, 23 April 2019

“…attempts have been made to shift the blame on to women, to say that they did not want to be pregnant and used the tablet as an attempt to abort”.

Yvonne Fovargue MP reminds us that the hormone pregnancy test drug was not withdrawn for commercial reasons… Reference.

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Did Bayer Schering use Millions of Women as Guinea Pigs for Profit ?

Westminster Hall, 23 April 2019

“1.5 million women, were treated as human guinea pigs for the pursuit of profit by the company Schering now Bayer”.

Hannah Bardell MP uses strong words such as “a criminal cover-up“, and reminds the minister and the government that the HPT drugs campaigners, MPs and primodos-victims are not going away… Reference.

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Why Not Use Meta-Analysis to Assess Primodos Evidence ?

Westminster Hall, 23 April 2019

Gordon Marsden MP calls for Expert Working Group / MHRA’s to use meta-analysis to assess evidence.

Gordon Marsden MP questions Expert Working Group / MHRA’s reluctance to use latest systematic review and meta-analysis to assess evidence, pointing out that the method is widely used by organisations including most recently by NICE and others through out the world. Reference.

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Primodos Drug and The MHRA : MP Yasmin Qureshi’s Request

Yasmin Qureshi MP asked for a fully independent assessment of Carl Heneghan’s systematic review and meta-analysis

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