Primodos

Gregory Abrams Davidson Solicitors have been instructed by the Chair of the Association for Children Damaged by Hormone Pregnancy Testing and its members to represent them in legal proceedings relating to this drug.

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Background

Primodos, a hormone pregnancy test, was first made available in the UK in 1959. Manufactured by Schering, now owned by Bayer, it was prescribed by GPs throughout the UK and was thought to be taken by 1.5 million British women.

Two pills were to be taken 12 hours apart. It was thought that if a woman was pregnant these large doses of progesterone would simply be absorbed into the body. If she wasn’t it would trigger menstruation.

One dose of Primodos contained the same hormones used in the contraceptive pill but in higher doses: 10mg of Norethisterone and 0.2 mg of Ethinylestradiol.

It is alleged that the taking of Primodos led to congenital anomalies. Birth defects cover a huge range of defects including, but not limited to, missing fingers and toes or limbs, heart defects, kidney defects, abnormal internal organs (affecting fertility), multiple spleens and brain damage. Some scientists believe that whatever part of the foetus that was developing at the time that the drug was taken is that part of the foetus that is damaged by the drug, hence the vast range of birth defects.

Warnings

In 1967, a Paediatrician at Queen Mary’s hospital in London, Dr Isabel Gal, contacted the then Committee on Safety of Medicines. Dr Gal claimed to have found a link between hormone pregnancy tests and spina bifida in newborn babies.

The Minister of State at the time advised that Dr Gal had “produced prima facie evidence that foetal abnormalities might be associated with the use of hormonal pregnancy testing” The same year the Medical Research Council stated “It looks like in fact this could be another thalidomide story”.

It was not until 1975, eight years after warnings were first raised, that the Committee on Safety of Medicines published an official warning confirming an “association” between Primodos and birth defects.

It was banned as a hormone pregnancy test in Sweden in 1970 and Finland in 1971 by their National Medical Boards.

Missing Records

A number of clients are concerned as there is no mention of the fact that Primodos was prescribed by their GP in their GP records. A number of clients have been told that their records have been destroyed in a fire or flood or simply mislaid whilst others have those pertinent years when the drug was prescribed missing.

A document was discovered at the National Archives in Kew. It was a letter from the 1960’s which details the Minutes of a Meeting of the General Medical Services Committee. Concern in relation to adverse reactions to medication was flagged and in particular that doctors would be liable for negligence claims. The Minutes go on to state that doctors should stop recording adverse reactions and significantly the point is mooted that those who have recorded any such evidence should “have it destroyed”

It is important to make clear that the Committee were not talking about HPTs at the time, rather they were talking more generically.

The Government

On 23rd October 2014 Yasmin Qureshi, MP, raised a debate in Parliament on the issue of Primodos1. It was agreed that the government would release information it holds on Primodos and that it would set up an independent panel to look at the evidence.

The Expert Working Group first met in October 2015 to consider the parameters for their work and agreed that the terms of reference should focus on the scientific evidence on the possible association between exposure in pregnancy to Hormone Pregnancy Tests (HPTs) and adverse effects in pregnancy, what lessons may be learned for improving existing regulatory systems in relation to medicines used in pregnancy and whether the findings have any implications for currently licensed medicines.

Sadly in October 2016 Yasmin Qureshi felt compelled to bring the issue back to Parliament for further debate as there were concerns over the progress of the review2.

The Government stated that they wanted to ensure that the Inquiry has the trust and confidence of the victims.

It was indicated by David Mowat that the inquiry was likely to conclude this Spring (2017). However on 23rd March 20173 Lord Alton of Liverpool asked Parliament what assessment that review has made of the decision by the Committee on Safety of Medicines to ask drug companies to stop promoting pregnancy test drugs to doctors in 1969 but not to advise doctors not to use such drugs until 1975 and whether that review will examine the allegations made by Sky4 in their documentary in particular;

  1. That no toxicology or testing was undertaken prior to the drug Primodos being licensed
  2. That Primodos was being used as an abortifacient in some parts of the world whilst being sold in the UK for the purposes of pregnancy testing and
  3. That there may have been collusion between the drug manufacturer and the regulatory bodies.

The response by Lord O’Shaughnessy was that at the time there were no legal requirements on companies to ensure that marketed medicines met appropriate standards of safety, quality and efficacy and a licence to market was not required.

The terms of reference of the Expert Working Group are focused on a scientific review of the strength of evidence for a possible association between exposure in pregnancy to hormonal pregnancy tests and adverse outcomes in pregnancy (birth defects, miscarriages and stillbirths). The Group’s terms of reference also include what lessons may be learnt for further improving existing regulatory systems to identify, monitor and minimise any adverse effects of medicines in pregnancy.

Gregory Abrams Davidson Solicitors

We act for around 100 victims of HPTs.

We work closely with the Association and have spoken at one of their AGM’s.

We were honoured to be invited to the Pre-screening of the Sky News documentary which was held at the House of Commons in Westminster.

We have also attended a Workshop arranged by Jesse Olszynko-Gryn, Historian of Medicine at the University of Cambridge5.

GAD are working tirelessly to establish a causal link between the drug and the damage caused to the victims. We are wholly committed to proving that causal link.

We will work hard to ensure that we get justice for the victims and that they get the answers that they deserve.

Lisa Lunt, Head of Clinical Negligence at GAD said “This is not just about litigation. It’s about the corrosive effect of injustice on people’s lives. It has impacted not only on the victims directly but it has also had life changing consequences for the families, friends and partners of the victims.”

If you or a family member have been affected by Primodos then please feel free to call and speak to one of our dedicated Primodos team on 0151 733 3353 or alternatively please complete the attached form and someone from the team will call you back.

Questions and Answers

We recommend that you contact your GP to obtain your medical records (if you are the mother of a victim) or if you are the victim that you ask your mother to obtain a copy of her GP records for the year covering the pregnancy and birth.

This is something that sadly we have come across in many cases. It is still worth getting in touch with us to discuss your case.

There will be a nominal fee to obtain a copy of the medical records, limited to a maximum of £50. If, sadly the mother has passed away, the charges can be more but if you limit your request to a specific year this will greatly reduce costs.

Each case will be individually assessed but where there is merit in the case we will consider pursuing the case on a no win, no fee basis.

If you are not a member we recommend that you contact the Association for Children Damaged by Hormone Pregnancy Testing y email on marielyon@virginmedia.com.

We would also recommend that you visit their website www.hormonepregnancytests.org.uk

References

  1. https://www.publications.parliament.uk/pa/cm201415/cmhansrd/cm141023/debtext/141023-0003.htm
  2. https://hansard.parliament.uk/commons/2016-10-13/debates/8520B85A-2A57-4CCB-ABB4-73DB74A51D27/HormonePregnancyTests .
  3. http://www.parliament.uk/business/publications/written-questions-answers-statements/written-question/Lords/2017-03-23/HL6261
  4. https://www.youtube.com/watch?v=7ZRkCNUQvBA
  5. https://www.youtube.com/results?search_query=cambridge+hormone+pregnancy+tests

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