Hormone Pregnancy Tests

Carol Monaghan Excerpts

Thursday 13th October 2016 Commons Chamber

[Hannah Bardell (Livingston) (SNP)]

I speak on behalf of my constituent, Mrs Wilma Ord, her daughter Kirsteen and the many hundreds of thousands of women and families who have been affected by the drug Primodos. It is a sad and tragic irony that this debate follows another hugely important debate on baby loss, in a week when we remember parents and families who have lost their little ones.

Miscarriages, cerebral palsy, brain damage and children being born without limbs are just some of the alleged side effects that the hormone pregnancy drug Primodos can inflict. Dubbed the forgotten thalidomide, Primodos was a drug given to women in the 1950s, ’60s and ’70s to establish whether women were pregnant. Many believe that it caused damage and deformities in thousands of babies in the UK and across the world. Primodos, as prescribed, was 40 times stronger than the average oral contraceptive pill. Recorded tests undertaken by the producing drug company Schering, now known as Bayer, in 1966 found that Primodos was potentially “embryo lethal” and “embryotoxic”. The Medicines and Healthcare Products Regulatory Agency has stated:

“The regulatory and social environments have changed greatly since the 1970s and as a result no medicines are recommended for use in pregnancy unless considered essential.”

I urge the Minister to keep those points in mind throughout this debate and while considering the role he has to play in ensuring the integrity of the inquiry that was set up last year to establish whether there is a link between Primodos and the birth defects.

Before I touch on the detail of the inquiry, I want to pay tribute to my constituent, Mrs Wilma Ord and her daughter Kirsteen, who are here in the Gallery today, along with many other families whose lives have been affected by this issue. They have made long journeys from around the country at their own expense. Wilma has visited me and my staff a number of times and I will speak more about her story later. Marie Lyon, who has been mentioned, has done a power of work and is an inspiration to me and my staff on a daily basis.

I also pay tribute to my colleague and friend, the hon. Member for Bolton South East (Yasmin Qureshi). She has been fighting on this issue for many years. Sometimes we must put party politics to one side for the greater good. Today is one of those days when politicians of all colours stand together in unity to fight for justice for those who have been silenced or who cannot speak for themselves.

On the scope of the inquiry, in October 2014, the former Minister for Life Sciences, the hon. Member for Mid Norfolk (George Freeman), ordered an independent review of all papers and evidence linking hormone pregnancy tests to birth defects, following wide-scale concerns raised over many years by many Members of the House. I have been following recent developments in the progress of that inquiry and have grave concerns about its scope and the way in which it is being conducted. In summary, I am concerned about conflicts of interest, as there is a lack of clarity on the framework, including the scope of work and the decision makers; the evidence being presented to the group; the lack of focus on regulatory failures; and, finally and most importantly, transparency and openness.

On the conflicts of interest, my concerns are severe yet simple. Panel members have been asked to self-declare their interests. We know of one instance of an undeclared interest that went unnoticed until highlighted to the individual. That suggests that no proper checks are in place to ensure that declarations are made. There is no clarity on how or whether such conflicts of interests are declared or investigated, or on how it is decided whether they are conflicts of interest. There is a lack of clarity on who is responsible, if anyone.

It was thought appropriate to invite an expert panel member as a visiting expert who was later removed from the working group because of his previous associations with the drug manufacturer. I am concerned about the logic in deciding, first, to invite him as an expert and then to remove him because of a conflict of interests. Who is making those decisions and why are they being made?

I and other members of the all-party group on oral hormone pregnancy tests were told in a letter from the chair of the expert working group that

“no core members of the Expert Working Group have declared any interests in Bayer”.

What is a core member? How has the information given been verified? Is it acceptable for non-core members to be associated with Bayer? The letter also states that there are “participant categories”, but again there is no explanation available of what that means or who decided those categories. It further states that all recommendations about who ought to sit on the working group

“were considered and where appropriate, endorsed by the Chair, taking into consideration the expertise required for the Expert Working Group and following consultation with the MHRA Executive”.

What expertise does the chair consider is required? Is it up to only the chair to decide or is it decided in conjunction with the MHRA? Are they the correct people to decide, particularly in the light of what I have just said about decision making?

I know from a particularly odd experience of my own concerning a panel member —the hon. Member for Bolton South East also mentioned this situation; we are unsure whether the person in question is a core member—that there is a potential conflict of interest. Earlier this year when we convened with Marie Lyon we came across a website for something named “bumps/UKTIS”—that stands for UK Teratology Information Service. It purports to be funded by Public Health England. It was with some concern that we read an article on that site on the apparent safety of Primodos. By way of example, I quote just one section, which states:

“Although older smaller studies suggested a possible association between oral hormonal pregnancy tests and congenital malformation, subsequent larger prospective controlled studies showed no increased risk.”

That is doublespeak at its worst.

Upon noticing the article, I telephoned the number on the website to ask about its content and share my concerns. The gentleman with whom I spoke assured me that the head of UKTIS, who wrote the article and whom he named during the call, had lots of knowledge on the subject on account of her sitting on the expert working group. The content of the article has also been tweeted on numerous occasions. Members may imagine my dismay not only upon reading the article, which suggests to the public that the drugs are safe—as we all know, that at best remains uncertain—but upon then learning that a member of the working group was behind its content.

The review’s scope is to

“examine the evidence to assess whether there are grounds for accepting a link between the use of HPTs and the conditions experienced by some patients.”

Given that, will the Minister consider how independent and impartial the expert working group truly is or can be? Is the situation I have outlined not in fact a clear conflict of interests? Is that particular member of the working group a “core member”, expected to make a decision on whether there is a link between hormone pregnancy tests and birth defects in babies? I would suggest from her tweets that her decision is already clear. That would appear to undermine the whole purpose of the formation of the working group.

Given the obvious conflict of interest, I wrote to the chair of the inquiry panel, who I thought had a duty to check on such conflicts, for confirmation that that group member had declared an interest. I also asked what measures were taken to decide that no conflict existed. I suggested that, if it was not declared by the panel member, it should be investigated, and asked whether it was investigated. Given that one member had already been asked to leave the panel following an unveiled conflict, I looked for assurance that checks and balance were in place. I wrote and sent my letter at the end of August and am yet to receive a response.

Given the gravity of my concerns, combined with other alarming evidence that all hon. Members have seen, I get a sense not only that something is amiss with the inquiry, but that it smacks of a continued cover-up on a significant scale. I do not use those words lightly. My final question on conflicts is this: how can we have confidence in the membership of the working group, and have the members been carefully considered to ensure an appropriate balance and expertise while maintaining impartiality?

The letter from the chair that sought to reassure the all-party parliamentary group members about the documentation being considered by the group raised more questions than it answered. We were told that

“members, invited experts and observers were recently given access to all of the documents the MHRA had so far used in preparing the assessments…These are the documents that have been used as a basis for the MHRA papers for the first four meetings including 11th August meeting.”

In case anyone missed that, I will say it again: the documents given to the expert working group panel have been used by the MHRA to prepare assessments. What exactly does that mean? It strikes of the MHRA cherry-picking what the panel members get to see. Frankly, that is not acceptable. How can it make decisions based only on MHRA-chosen information when there is a vast amount of information available on Primodos? How does that fit with the order from the hon. Member for Mid Norfolk for a review of all of the evidence and papers?

I fully appreciate that I have delved into significant detail, which we occasionally lack in the House, but I hope the significance of it is not lost on the Minister when he considers the numerous documents found in the Germany and Kew archives, some of which I have seen and will describe later. Furthermore, articles published in Der Spiegel in July released damning information about Bayer and Primodos and Duogynon, as it is known in Germany. The article is exceptionally detailed and includes the many failings of Bayer and the deliberate suppression of evidence. I will of course be more than happy to share the documents with the Minister.

My concern with the lack of focus of the inquiry into regulatory failures relates to my concern about the evidence provided to the working group. By way of example, let me share the experience of my constituent Mrs Wilma Ord and her daughter Kirsteen. Mrs Ord came to see me when I was first elected. She had been pregnant in 1970 and gave birth to her daughter Kirsteen, who was born with multiple defects, including cerebral palsy, profound deafness, asthma and bone density issues. Mrs Ord had taken Primodos to test whether she was pregnant. Her medical records, which she brought to my office, show a gap between 27 November 1968 and 27 January 1971. In other words, there is no evidence of her ever being pregnant or being prescribed Primodos by her GP.

Having tried desperately to track down her missing medical records, my constituent received a letter from NHS Scotland, which states:

“I refer to missing notes for the period 1969 to 1970...I have done a full investigation and contacted all the previous GP practices you gave me and also checked our offsite storage...but with no success. Unfortunately we have no way of knowing when or where these notes were lost or mislaid at a practice”.

Evidence I have seen—I do not know whether it has been provided to the expert working group members—shows that Schering knew of GP concerns from the 1960s about the adverse effect of Primodos experienced by their patients. I have also seen documents showing that Schering sought legal advice, and that it was told that it would be more than likely to be found guilty of negligence by a trial judge.

I have seen a document saying that Schering should try to “buy off” a family who were attempting to take legal action against it because there was no telling how many more cases there would be. I have seen a document with my own eyes dated 13 March 1964 clearly stating that, for GP doctors worried about adverse reactions, it would be best for them to destroy any evidence or records to protect themselves “however wrong that was”. I ask the Minister to think again about where Mrs Ord’s missing medical records may have gone, and about the adequacy or relevance of the documents that are actually being shared with the expert working group.

[Carol Monaghan (Glasgow North West) (SNP)]

I am listening to my hon. Friend with great interest as a scientist who will always make decisions based on evidence. It seems there is a lot of evidence missing, both in terms of documentation and scientific research. Does she agree that one of the big issues for many people affected is that they feel responsible themselves? Some people have not done all the work her constituent has done and the burden they are carrying is really quite severe at this point.