Primodos survivors take on drugs firm

Primodos: Firms and govt face legal action over claims pregnancy drug ‘damaged babies’, Sky News, Aug 2019

“Parents who say their babies were damaged by a pregnancy test drug have warned manufacturers and the government that they are preparing to take legal action.”

Primodos, a pregnancy test drug, has led to a decades-long campaign by parents and children who claim it has caused a range of devastating birth defects.

In 2017, Sky News revealed how documents were destroyed and information withheld about the drug that may have deformed and killed babies in the womb.

Now, parents who say their babies were damaged by the drug have warned manufacturers and the government they are preparing to take legal action.

Lawyers representing more than 200 claimants accuse two drug companies and UK regulators of putting patients at risk.

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The Primodos Issue ; debated by Lord Alton of Liverpool

UK Parliament, House of Lords Hansard, 28 February 2019

“They have faced the implacable determination of regulatory bodies spending huge amounts of public money on ad hoc scientific reviews to cast doubt on the work of highly reputable scientists. Those who have suffered so grievously deserve much better than this.”

Safety of Medicines and Medical Devices, House of Lords Hansard Debate, 28 February 2019.

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Primodos, Sodium Valproate, Surgical Mesh : Baroness Cumberlege Talks

UK Parliament, House of Lords Hansard, 28 February 2019

“For the families involved, it is life-changing and extremely distressing. For those women who took Primodos and sodium valproate, there is an intense feeling of guilt. They took the medication and they blame themselves. However hard one tries to persuade them that it was not their fault, the guilt remains.”

“That tells me something is seriously wrong; the system is not working as it should. People who have been harmed should not have to fight to be heard or to access the care they need.”

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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 reasonsReference.

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