Hormone Pregnancy Tests

Hannah Bardell 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.

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[Hannah Bardell]

I could not agree more with my hon. Friend. Many families around the world do not have the answers. Their children have been affected and it is nothing short of a scandal that, many, many years later, they still do not know. It is therefore very important that we ensure the inquiry is effective and ask what other steps we can take.

I ask the Minister to consider whether the scope of the inquiry should be increased to look at why it was apparently hidden that the drug was known to be potentially unsafe in the 1960s or even earlier. I should mention the eight years—this has been mentioned by other hon. Members—from 1967, when the adverse reaction committee advised that there was cause for further investigation of Primodos, to 1975, when the Committee on Safety of Medicines actually issued its warning. The Minister may also be interested to know that Norway and Sweden banned hormone pregnancy test products in 1970. In Norway, it was said to be blacklisted after evidence was submitted that the test caused foetal malformations. Finland banned it in 1971. Germany issued a warning notice in 1972, the USA in 1973, Australia, Ireland and the Netherlands in early 1975, and the UK, finally, on 4 June 1975. Notably, a document shows a comment by a Dr Inman on 15 October 1975 stating that

“we are defenceless in the matter of the eight year delay”.

The families affected are now concerned about this inquiry being a whitewash. They are concerned about a Hillsborough-style situation where there have been years of cover-ups and an inability to get information they have asked for repeatedly. In early July of this year, an article in the German newspaper Der Spiegel reported from old court files that it had gained access to:

“Schering was warned in the late sixties by various animal tests. They had knowledge of possible side effects of this hormone drug.”

Tests were conducted with different dosages, with the result that some dosages resulted in disabilities and the death of foetuses. Other tests showed that animals showed weight loss. In 1971, a scientist recorded that a test dose was

“highly embryotoxic and a cause of early cell death.”

Earlier this year, a major radio station in Germany broadcast a 45-minute documentary on Primodos. Here are just some brief extracts of the stories told:

“My name is Petra Marek and my mother has taken Duogynon as a pregnancy test, but was unaware of what consequences this would have”—

[Madam Deputy Speaker (Natascha Engel)]

Order. I remind the hon. Lady that she is a Front-Bench spokesperson and this is a Back-Bench debate. I am already going to have to impose an informal time limit of 10 minutes per speaker. If she could start to get to the end of her speech, we would all be very grateful.

[Hannah Bardell]

Thank you, Madam Deputy Speaker. I will wind up my comments as quickly as I can.

Another said:

“My name is Birgit Rothlaender. I am almost 50 years old, I have a deformation of my genitals and I have a colostomy for the last 43 years. I think enough is enough, I would like to get 100% confirmation on what happened.”

Let me be clear that for the families who have suffered for decades, this is not about money. It is absolutely about unveiling the truth. The Scottish Government have raised and continue to raise the issue of the independent panel with the UK Government and the MHRA. Public money is being used for this inquiry and it would be an absolute dereliction of duty if it was misused. We must ensure that we do right by the victims of Primodos. We must have an effective inquiry and get the answers for the families which they so desperately need.

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[Seema Malhotra (Feltham and Heston) (Lab/Co-op)]

Thank you, Madam Deputy Speaker, for the opportunity to speak in this debate on this devastatingly sad topic. I also thank the Backbench Business Committee and my hon. Friend the Member for Bolton South East (Yasmin Qureshi) for securing the debate today. It is an honour to follow some passionate speeches today. I pay tribute to Marie Lyon and the hormone pregnancy test campaign for their powerful representations in telling their own stories and the story of Marie’s daughter in the media.

Much that we take for granted today, given the improvements in health care and the ease of pregnancy tests, sheds an important light on what happened 40 years ago. It is a matter of great sadness and shame that it happened in our country. Many of the tributes and stories that we have heard today show that many are still living with the consequences and that we must learn the lessons. This inquiry and our confidence in its findings is critical not only to close this chapter of our history but to ensure that lessons are learned and clear findings will be adhered to in the future when it comes to regulation and the description of how medications should be used.

When I first came to hear of this issue, I found it hard to comprehend why it seems to have taken so long for those who were prescribed Primodos to get clarity and answers about what happened to them, for the issue to be comprehensively researched, for an explanation to be given about why the drug continued to be used after concerns were raised and for families affected to be given an apology and justice. Studies in the UK and elsewhere from the late 1960s into the early 1970s suggested a link between the use of hormone pregnancy tests and a range of abnormalities including cleft lip, limb reduction and heart abnormalities.

Bethan Dickson from my constituency was affected after her mother took the drug. I want to thank her for having the courage to come and meet me about this issue and for giving me permission to share her story with the House. She says:

“My name is Bethan Dickson, I am 48 years old and work as an occupational therapist in West London. But I was born in 1968 in South Wales with heart and limb defects that have impacted on my entire life. My mother was given Primodos, an oral pregnancy test, by her doctor and I believe that this is the cause of these physical defects.

Along with members of the Association for Children Damaged by Hormone Pregnancy Tests I am supporting an inquiry into how this damaging drug could have been prescribed to mothers when there were already concerns raised about its safety.

I feel it is important that accountability is accepted by the drug company who put profit before patient safety, and for the government to acknowledge its responsibility for not ensuring that the citizens of this country were protected from harm.

I was born with a heart murmur and poorly formed bones in my feet. I experienced some shortness of breath as a child, slept poorly as a baby and was restricted in sporting activities. The heart murmur did not require a surgical intervention, but I had frequent and regular visits to cardiologists.

I suspect that many Association members can relate to waiting to see the doctor in hospital in the 1970s and '80s and knowing where you are in the queue because you can see the thickest medical record in the stack and knowing that it’s yours. Thankfully the introduction of electronic medical records means I don’t suffer that particular humiliation any more.

The defects in the bones of my toes became more obvious as I grew, and from my earliest memories (about six years old) I remember pain in both feet that prevented me from participating fully in activities in school.

When I was nine years old the orthopaedic surgeon in the local hospital recommended surgery to address the deformed joints. He felt that although I was still growing the pain I was experiencing needed to be addressed sooner. I had my first orthopaedic surgery in 1980, but the problems have persisted and I have required six further surgical interventions since then.

The pain today varies depending on the activity, but prolonged standing or walking is painful. I have been fortunate to have had excellent healthcare both in South Wales and in west London to address my physical impairments; and lucky enough to have had loving parents and a husband to give me the strength and support to deal with the emotional strain of dealing with the ongoing difficulties.

I have been able to live a full life, going to university, working full time and making a contribution to society in my capacity as an occupational therapist. Every day at work I meet people with disability and physical or cognitive impairments, but nothing prepared me for my first meeting with other Association members in June 2014.

The severity of impairments in some of my contemporaries both shocked and angered me. Some have profound disabilities that have prevented them from living a full life, and left them dependent on carers and family for care and support. This could have been avoided with responsible oversight of the drugs being given to expectant mothers, and more robust testing of drugs before they were brought to market across the world.

When I met other Association members I felt guilty that their suffering was so much worse than mine, and then felt guilty that I was relieved at that. My mother along with the mothers of many members feels guilty that she took a tablet that caused these lifelong problems to her child.

Of course logically I understand that the guilt does not lie with me or my mother, but in the absence of any form of apology or recognition of wrongdoing by the drug company or the government we do not have closure or the confidence this won’t happen again.”

[Hannah Bardell]

The hon. Lady makes the absolutely crucial point that, until the families have answers, they cannot deal with the trauma and they cannot get the proper counselling and support that they deserve.

[Seema Malhotra]

I thank the hon. Lady for her intervention. That is certainly the reason why Bethan Dickson has written to me. She said:

“That’s why I support an inquiry to establish the facts and explain to the country how this could have happened just a short while after the Thalidomide scandal.”

Bethan’s story highlights the impact of this drug and how it was prescribed and the effects that it still has to this day. I have been struck as well by the work of Marie and her campaign, their patience and their systematic and honest work. They have desired to work in partnership simply to find answers, for justice and to ensure everything is done so that this does not happen again, but I am concerned that they are not being met halfway by an inquiry that does not appear to have had effective governance while there are concerns about the constitution of the panel, the robustness of its procedures and the approach to the evidence collected and how it is analysed.

I want to close my contribution today with some questions to the Minister and some commitments that I would like to hear being made today. I believe that it is time to make sure that there is commitment today to respond to the issues raised and to do so formally in writing to my hon. Friend the Member for Bolton South East; to reconfirm the status of the inquiry, its terms of reference and its timetable for delivery; to say how quality will be ensured; to explain what action is being taken to address the concerns that have been raised by hon. Members today; and to state on the public record that Ministers will see through their commitment on this inquiry to a report and findings that will command the confidence of the House and, indeed, the families and victims who have waited so long for those answers and for justice.

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[David Mowat]

I accept that, which is why I have made the offer. I guess the caveat is that, in the end, science will play a big part in getting to where we need to be. The science will find its own path, and I want to talk a little about how we are trying to achieve that.

As hon. Members have said, two years ago my hon. Friend the Member for Mid Norfolk (George Freeman), who was then the Minister for Life Sciences, established an inquiry that, at the time, was committed to having an independent review of the evidence and to attempting to find a scientific link between the hormone pregnancy test—in particular, Primodos—and the adverse effects on pregnancy and all that goes with it. It is worth saying at this point that, as hon. Members have said, this is an international issue that has been around for 40 to 50 years. We are the only country to have set up such an inquiry, and the only one to have attempted to find a scientific route to the truth in this way.

[Hannah Bardell]

Will the Minister give way?

[David Mowat]

I will continue to make progress, but will come back to the hon. Lady.

Two years ago, the MHRA was charged with putting the inquiry in place. It worked with the Commission on Human Medicines to set up an expert group, whose job was to establish whether there was a scientific link between the drugs prescribed and the adverse effects. The first meeting was a year after that, which was a long time. I apologise for that on behalf of the Government; I think it was too long. I have inquired why that was, and I have been told that there was the election and the purdah period, but it was too long. The group has met four times, and its next meeting is on Tuesday next week. I think we can all conclude that the members of the inquiry will be watching our proceedings and listening to the points that have been made. At that time, the review’s focus was on the science to establish whether it could be shown that there was a link between the drugs prescribed and the adverse effects. The terms of reference were subsequently altered to cover going into the lessons learned.

[Hannah Bardell]

I absolutely take on board what the Minister is saying—he is being very positive, and has clearly listened to the concerns we have raised—but I have a couple of comments. First, the fact that we are the only such country is surely a good thing given how far behind we lagged. We have an opportunity to lead the world on this and to show how this can be done positively. Secondly, as he says, no Government members want the inquiry to fall down. Is it not therefore his duty to intervene to make sure that it has the right resources, the right expertise and the right processes?

[David Mowat]

There is nothing in that intervention with which I disagree. We all want the inquiry to work. The Government have not established an inquiry in order for it to fail. We have not established an inquiry for it not to have the confidence of the association. We need to get to the truth, but that is a scientific process, and because it is a scientific process, it can be frustrating and long-winded; it can take a long time.

I want to talk about some of the concerns that have been raised. There were three types of concerns. The first was that the independent group of experts is not reviewing the regulatory concerns or the delays that took place at the time, in particular the failures of the then Committee on Safety of Medicines and the five or eight-year delay, which we have heard about. The UK was not the first country to ban the drug, but it was not the last either. The second concern, which I will talk about at some length, was that members of the expert group might not be independent and might not have fully declared their conflicts of interest. We have heard words like “colluding” and “cover-up” from some Members. The third concern was that not all the available evidence is being considered by the group, and we heard about the German material not being translated. I will address all three points.

On the first issue, we have heard that there was a regulatory failure and that the inquiry should look at it. I say to the House that if, when the expert group reports next spring, it finds a clear causal link, that will be the time to take further action on issues such as regulation and liability, and everything that goes with that. The first step we are taking is to establish the science. The group that has been set up is an expert group. It is science-led. It is important to make it clear in the House that we are not criticising individual members, because they are striving to get to the truth. It is a group of eminent people.

It would be quite wrong if we conflated the possible eventual need to look at the regulatory actions that were taken, the legal liabilities and everything that goes with that, with the first step of the process, which is to establish whether the science leads us to that link. In spite of some of the comments that have been made today, that has not been done yet in any country. The first serious attempt to do it is the one that is going on now.

The second concern is that the expert working group is not impartial. The MHRA has taken a vigorous approach to evaluating and handling potential conflicts of interest. No member of the expert working group can have any interest in any of the companies that were involved or their predecessors. Members should not have publicly expressed a strong opinion, favourable or unfavourable, about the possibility of birth defects arising from these drugs. We heard that one of the members had tweeted. If there is evidence of that, we will follow it up. It is true that one member not of the expert group, but of the advisory group was removed because it was felt that he had a conflict of interest that was not properly declared. Action was taken very quickly in respect of that.

The inquiry is chaired by a consultant gynaecologist from the Chalmers centre in Edinburgh. The group has 14 scientists drawn from some of the best universities in the UK. We have no reason to believe that any of them have any more reason not to want to get to the truth than Members on both sides of this House.