(8 years ago)
Commons ChamberRead Hansard Text Read Debate Ministerial Extracts
Yasmin Qureshi (Bolton South East) (Lab)
I beg to move,
That this House notes that an Expert Working Panel Group Inquiry was set up by the Government to investigate and assess evidence on children born with serious deformities due to hormone pregnancy test drugs taken by expectant mothers between 1953 and 1975; further notes with concern that the terms of reference as set out by the Medicines and Healthcare Products Regulatory Agency do not clearly allow for an investigation into the systematic regulatory failures of government bodies at the time; notes the conflict of interest of some panel members; further notes that all evidence must be presented to expert panel members as set out in the term of reference; calls on the Inquiry to ensure that all evidence is presented to the expert panel with sufficient time for due consideration; further calls on the inquiry to guarantee thorough background checks on all panel members; calls for the terms of reference to be amended to include an investigation into the conduct of the Committee on Safety of Medicines; further calls on the Government to ensure that the inquiry has the trust and confidence of the victims for whom it was set up; and believes that, unless these changes are made, the ability of the Inquiry to achieve a fair outcome will be significantly compromised.
I thank the Backbench Business Committee for granting this debate—the second on this issue, which I started to campaign on five years ago. Just under two years ago, I asked the Backbench Business Committee for a debate about a drug called Primodos, which was prescribed to pregnant women in the 1960s and 1970s. It had 40 times the strength of oral contraceptives prescribed today, and we know what they were devised for. It is estimated that at least 1.5 million women may have taken this drug, and thousands of families suffered. In answer to a written parliamentary question, the then Minister assessed that 3,540 women may have suffered effects. We think that the actual figure is much higher.
This all started in 2011, when I met my constituent Nichola at her home. She was born with life-threatening internal congenital deformities to her stomach, spine, heart and womb. She had her first operation was when she was seven days old. Since then, her life has consisted of visiting hospital, as an in-patient and an out-patient, and going through various procedures. Another of my constituents is Bridget Olive.
When I met Nichola at her home, I saw boxes and boxes of documents, some of which had been leaked by various pharmaceutical companies and other bodies. I had a brief look through some of those documents, and it was at that point that I decided that the issue needed more than mentioning, or raising; we needed a real investigation and an inquiry on what happened. I am not exaggerating or being over-emotional, but, applying my legal knowledge in my capacity as a barrister, I am prepared to say that there was deliberate criminal, negligent oversight by the then Committee on Safety of Medicines as regards this drug and its usage, and the fact that it continued to be prescribed for years, despite most of the medical community knowing that it had caused adverse consequences for the women who took it.
At the end of the first debate on this subject, the Minister agreed that there would be an expert panel inquiry on the issue. He agreed, in and outside Parliament, that the inquiry would look at all the available documents, including those that we would provide, or had come across, and those in the archives. The Minister went further and ordered that all the documents held by the current equivalent body, the Medicines and Healthcare Products Regulatory Agency, should be revealed. The inquiry was to look at all the documents and assess what had happened. I will come on to what the inquiry has produced, but this debate is more about how the inquiry has progressed. An inquiry that becomes a whitewash is pointless and a waste of time and money.
Mr Jacob Rees-Mogg (North East Somerset) (Con)
I congratulate the hon. Lady on securing this incredibly important debate, and I reiterate and agree with what she says. When at the heart of the matter there is a regulator who took eight years to act between 1967 and 1975, and many years later is investigating what it had done, it is crucial that that inquiry is seen to be independent and full.
Yasmin Qureshi
I thank the hon. Gentleman. I shall come on to the issue of the independence of the inquiry and the members of the panel.
The Minister indicated that the inquiry would be carried out by an independent panel of experts and said that it would look at everything that had happened and the lessons to be learned. Our present concern is about what happened, who did what and who failed to do what, and what compensation and apology victims will receive.
I shall briefly highlight some of the evidence that we have uncovered, which shows what happened in the 1960s and 1970s.
Mr George Howarth (Knowsley) (Lab)
My hon. Friend will be aware that between 1970 and 1971 Finland, Sweden and Norway all banned the use of such treatments. Does she think that there was plenty of indication at that time to give people reason to believe that there was a real problem that needed to be addressed, and is it not timely—I congratulate her—that we are now starting to get the evidence out and have it discussed?
Yasmin Qureshi
My right hon. Friend is right. It is amazing how other countries reacted to the evidence. The medical association in the UK was first alerted by Dr Isabel Gal in 1967, a paediatrician who said that her research showed that there was a link between women who had taken the drug and deformities in babies. Her letters and her research were dismissed out of hand by Dr Inman, who headed the regulatory authority. In a letter the authority referred to her in a derogatory manner as a “pathetic eastern European woman”, completely ignoring what she had to say.
We know that other information was available. For example, in February 1969 a committee received a letter from a Dr Dean of the Royal College of General Practitioners, who stated that
“Primodos should be withdrawn from use”.
However, the chief scientist of that committee, Dr Inman, refused to support that and instead wrote to the manufacturer of the drug, Schering, stating that
“the opinion expressed by Dr Dean that Primodos should be withdrawn should not be taken into account. Some women deliberately use excessive doses of Primodos with the intention of ridding themselves of an unwanted pregnancy”.
We have heard that Norway and Sweden banned the drug in 1970.
Again the Committee on Safety of Medicines took no action. Similar notices were issued in Finland, Germany, the USA, Australia, Ireland and the Netherlands, but again the committee took no action. In fact, in 1974 a letter from Schering—from PGT Bye—stated that
“after discussion with the Committee on Safety of Medicines we agreed some time ago not to recommend for the use of pregnancy diagnosis. It is not recommended for early pregnancy since the possibility of virilisation of the female foetus cannot be excluded with certainty”.
Yet still the committee issued no warning.
A further letter stated that
“side effects cannot be reliably excluded”
and that
“Primodos should no longer be recommended for the diagnosis of pregnancy.”
Again the committee said nothing. There are countless such documents. One of our concerns is that panels should have sight of those documents and be given sufficient time to read them, because they must be looked at properly and not ignored.
In 1975 the Committee on Safety of Medicines issued its first warning, stating:
“A number of studies have shown a possible association between Hormone Pregnancy Tests and an increased incidence of congenital abnormalities.”
On 15 October 1975, 41 years ago, Dr Inman wrote:
“We are defenceless in the matter of the eight-year delay”.
In November 1977, eight years after the committee had first been alerted, an adverse reaction leaflet was issued to the medical profession, stating:
“Further results have now been published and the association is confirmed.”
I want to refer briefly to some of the documents, many of which were archived in Berlin and at Kew. Marie Lyon, who chairs the victims association, has painstakingly gathered the documents, and the panel has been informed of them. I want to pay particular tribute to Marie Lyon, who has been doing a considerable amount of work over the past five years. She has spent months and months working on the documents, travelling the length and breadth of the United Kingdom and visiting Germany. She has effectively been working alone, with no support from Government bodies or local authorities. She and the victims association have been on their own. The only support they have had has been from members of the all-party parliamentary group and the Members in the Chamber today who have been fighting their cause. I also want to thank Jason Farrell of Sky News, who has been instrumental in getting some of the documents from Berlin and having them translated.
Translation of the documents is another issue, because many of those that came from Berlin are in German, as is to be expected. I want to know whether all those documents will be translated into English for the panel, because clearly it cannot carry out the inquiry if they are in a different language. We need to know whether all the documents that the victims association has gathered will be looked at and presented to the panel and, if so, in what format? When I used to prepare a large case with thousands of pages, there was a way of presenting the evidence so that the jury could understand it. Will that be done for the inquiry? If not, why not?
The reason we are asking these questions is that I have tried to contact the chair of the panel, Dr Ailsa Gebbie, and written letters to her, asking her to answer numerous questions, and, to be honest, we have not received a satisfactory answer to any of them. If anything, Marie Lyon, who has observer status on the panel, has been put under what I would call a gagging clause, which means she cannot talk about anything, because if she did she would be criminally prosecuted.
One of the things I remember from our discussion with the Minister was that the purpose of the inquiry was to have transparency and openness. We accept that there is obviously a need for a degree of confidentiality when evidence is presented, but we need to know what is going on. We need transparency, because without it, what is the purpose of this?
One thing the Minister promised was that the inquiry would have the victims at its heart. Yet, how have the victims been treated in this inquiry, which has been going for over a year now? I got a letter from one of the victims who turned up, and it is so distressing. The victims were told they could come and speak for a few minutes. Some travelled for five or six hours across the country to get to the hearing. They were promised at least 15-minute slots, but some were given three minutes or five minutes. Nobody even spoke to them properly; they were just asked to get on with it and to say what they had to say.
Fortunately, the victims who gave evidence were not subject to the gagging clause, so we were able to find out a little about what happened on the one day that seems to have been allocated for the victims. The panel heard from a few of them, but it did not ask them any questions. They were not cross-examined; they were not asked for anything—they just had three minutes. One lady said she was devastated; it had taken her five hours to drive there, and she was given three minutes. The victims said they were sitting so far from the panel, where the microphones were, that they were not even sure the panel was hearing what they had to say.
How can an inquiry that has victims at its heart not take more than a day to listen to them and, when they turn up, give them just three minutes? That is why we are having this debate. Given the way this inquiry is going, I do not think that any of the Members of Parliament who are supporting and assisting the victims have any confidence in it. As in the Hillsborough inquiry and the sexual abuse inquiry, everybody accepts that it is all about the victims; it is not about protecting regulatory bodies or the scientific community—it is about the people who have been affected.
There is another thing the Minister said. Obviously, it goes without saying that any inquiry must be independent—the panel members must be independent. When I raised that in a letter to Dr Ailsa Gebbie, the chair, she said, “Well, we got the expert panel members just to declare that they had nothing to declare.” There was no independent vetting or investigation into the background of any of these people. We have to understand this: people in the medical community, scientists and people in the pharmaceutical companies often work with each other. People have been advisers or consultants to somebody, or they have gone from the pharmaceutical companies into medicine or hospitals. There is a community of people who are linked.
We do not have the resources, but our basic research has shown that one of the panel members, Laura Yates, put on her social media that she does not think that Primodos caused any defect. How can this person be part of the panel? Then we have information about Doctor Schaefer. This man has worked with the company concerned, so he is directly linked with Schering—and he is still on the panel. That is two people, just from our basic inquiry. We want to know from the Minister whether the panel members will be properly vetted to see whether they are really independent and to find out about their connections. Again, without that, we will not have any faith in the inquiry.
We have asked the inquiry how long it will go on and how many sessions it will hold. There has been no response—nothing. We have tried to find out for well over a year, but nobody knows what on earth is going on with this inquiry. That leads to another question for the Minister. How long is the inquiry going to carry on? How many days have been set aside for it? How many hours have been spent on the inquiry to date?
In addition, how have the experts been chosen? We do not even know by what methodology they have been chosen. There are about 15 people on the panel, but does it need that many? Who are they, and how relevant is their experience to what they are looking at?
Madam Deputy Speaker (Mrs Eleanor Laing)
Order. I am sure the hon. Lady will soon be drawing her remarks to a close, in the knowledge that many other Members wish to speak this afternoon. She has vastly exceeded the guideline length of time, but I will allow her a peroration.
Yasmin Qureshi
I was just coming to the end of my speech, Madam Deputy Speaker.
Lastly, we are very grateful that the inquiry has been set up, but we have genuine concerns about what is happening with it and where it is going. As has been said, at the end of the day, there is no point in having the inquiry if it does not look at the things that matter, one of which must be to provide an explanation of the regulatory failures and the cover-ups in the 1960s and 1970s.
Yvonne Fovargue (Makerfield) (Lab)
I congratulate my hon. Friend the Member for Bolton South East (Yasmin Qureshi) on securing this debate. I am pleased to be called to speak, not least to pay tribute to my wonderful constituent Marie Lyon, whom my hon. Friend has mentioned. She has worked absolutely indefatigably to pursue justice for the families affected by the hormone pregnancy test drugs. In large part, it is her persistence that has led to this inquiry, on which she sits as an observer representing the Association for Children Damaged by Hormone Pregnancy Tests.
Marie Lyon is bound by confidentiality and prohibited from discussing the process, but I know from my own observation that she has been swamped by a deluge of paper, with 36 large files in the past two weeks alone. She has two weeks to read and research those more than 3,000 pages of densely written and complex information, which is often in a foreign language, as we have heard. If I were a cynic, I would suspect that those involved were trying to deter her from continuing, but it is obvious that they do not know Marie. If all the group members have been given the same timescale, I wonder at the ability of any of them to assimilate that amount of information, however much support they have.
Marie has a daughter who was born with her left arm missing below the elbow joint. Marie took Primodos on the advice of her doctor, whose words were, “We’ve got this great new pill to find out if you’re pregnant—we’ve no longer got to kill the rabbit.” She was excited and eager to find out whether she was pregnant, and of course she took her doctor’s advice, as did a number of women in my constituency. I have the highest concentration of constituents affected by thalidomide and the highest concentration of families affected by Primodos, and there is a cluster in certain practices. To me, as a lay person, that demonstrates beyond doubt the link between the drug and the birth defects, and I question the reasonableness of placing the burden of proof on those affected. Surely the key test should be to prove that the tablets were safe to take and that there were no contraindications. We must also find out whether, when it became apparent that there were contraindications, the tablets were withdrawn speedily and in time to stop any further birth defects.
These women, whose stories I will mention, were all advised to take the drug by their GPs. They took it to find out whether they were pregnant, not for any other reason—shamefully, that has been suggested—and they are still living with the consequences. Wendy’s son has badly deformed feet; June’s son has congenital heart problems; Elsie’s daughter has severe learning difficulties and epilepsy; Anita’s son died five minutes before he was born, and had a large lump on the back of his neck; Tom lives with a club foot, and has many serious health problems; and Mike has severe problems swallowing and eating. Those are all different defects, but people would have thought that they were pregnant and would have taken the pill at different times throughout the gestation period, so of course the problems will be different. All of those are personal tragedies.
The story that has remained with me the longest is that of a constituent who does not want to be named. She came to me with her husband. They had looked forward to having a large family. She said to me, “I have a lot of love to share.” She was excited about her first pregnancy, which was confirmed after she took Primodos. Her son was born with learning difficulties and feeding problems. When they asked the doctor what the reason for this was, he said it could be hereditary, passed down from her husband. In fact, he said to her husband, “It could be your fault.” They decided not to have any more children because of that risk, so this drug not only affected their child, but cheated them out of having the other children they so desperately wanted. My constituent’s husband died earlier this year, worn out by the strain of looking after the son and of thinking for years that it could be his fault.
It is for those families that justice needs to be done, and that it needs to be seen to be done. I therefore support the motion fully. Marie Lyon and the other members of the association have done sterling work in bringing this issue forward. They have achieved great things with little money and support. It is now up to us to ensure that their voice is heard loud and clear, and that the expert working group operates without bias and undue influence. Only through lifting the veil of secrecy can we be sure of that. Only then can there be full confidence in the conclusion. We cannot give these families back what they have lost, but we can at least give them that.
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.
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.
Jonathan Reynolds (Stalybridge and Hyde) (Lab/Co-op)
I, too, thank my hon. Friend the Member for Bolton South East (Yasmin Qureshi) for securing today’s debate. It is a privilege to follow the fine speeches from my hon. Friend the Member for Makerfield (Yvonne Fovargue) and the hon. Member for Livingston (Hannah Bardell).
I rise today at the request of my constituent Susan, who is from Stalybridge. It was in the early ’70s that Susan suspected and hoped that she was pregnant. With no home urine stream pregnancy testing yet available, Susan did what any woman of her generation would do—and will do for years to come—and visited her local GP. Yet that simple visit, that routine appointment, was to haunt her with the need for answers for the rest of her life. As with 1.5 million others of her generation, several of whose stories we have learnt about today, Susan’s GP prescribed her with a couple of pills, to be taken a day apart, to determine whether she was indeed pregnant. If she was not, she would bleed, and if she was, she would not.
The pills were handed over without lengthy explanation, detailed precautions or any warning. These pills Susan now knows to be Primodos. The Primodos she took contained a now unfathomably strong cocktail of hormones: 10 mg of norethisterone and 0.2 mg of ethinyl estradiol—I ask the House to forgive my poor pronunciation. Those hormones, in those doses, equate to 13 morning-after pills or 157 contraceptive pills. Yet many patients, like Susan, at that most optimistic moment in their lives, had no inkling of what the pills contained. They simply trusted their doctor.
In 1972, Susan’s beautiful baby daughter Sarah was born. As time would tell, Sarah had severe learning difficulties. Now 44, Sarah will never enjoy her life independently. She relies on others for her care. She will never work, marry or have her own children. Her family face the challenges that all families with a loved one with additional needs face—the limitations, obstacles and “what ifs”.
In 1978, six years after Sarah was born, Primodos was withdrawn from the medical market amid fears it prompted instant miscarriage. For many women, its stated purpose of indicating whether they were pregnant or not may, sadly, have been more like “pregnant or not any more”. For those women fortunate enough to carry their babies to term, thousands may never know whether the wide-ranging disabilities their children share, from brain damage to heart defects and sensory impairments to undeveloped limbs, may have been caused or worsened by hormone pregnancy testing, or those allegedly harmless little pills—pills whose use many doctors and researchers queried at the time; pills that were to be decisively discontinued.
I do not rise today to suggest that every single disability or birth defect originating from the period of its use was caused by Primodos. That would of course be speculative. I do not rise to say that any specific reparations from Bayer, the manufacturer, should be made or to ask the Government, the NHS or the pharmaceutical industry to take speculation as fact. I rise to say that we need to give women such as Susan the opportunity to examine whether that speculation is indeed fact—whether suspicion could give way to transparency and whether peace of mind is a price worthy of investigation. I believe it is time for a thorough public inquiry into the safety of Primodos, its passage on to GPs’ shelves and its effects on both the babies who survived and those that did not. I fully accept that it may not be possible to identify all the answers, but it is none the less time to ask the right questions.
I myself am the father of four beautiful children. My eldest son has significant learning difficulties, including pronounced autism. He is absolutely wonderful and I love him and always will, yet I cannot pretend that, through the initial years of his diagnosis and in the many challenging situations that have followed, any parent would not be in a position of asking themselves “Why? Why my child? What has caused his condition? It is something that we did?” Listening to this debate, I am glad that my son is a millennial baby and not a child of the ’60s or ’70s, because if there were the slightest hint that his life chances might have been robbed by something wholly preventable and unnecessary, I confess that I would find that very difficult indeed to deal with.
Yet the importance of a rigorous investigation into this drug goes beyond the need to examine the past. We must call for this investigation because failure to do so may jeopardise something so important and fundamental to our treasured NHS, and that is the implicit trust that our doctors know what is best for us. If we allow potentially harmful drugs to ease in and out of widespread use without robust examination, that will chip away at the assurance that trained professionals are sure that they know what is best for us.
Another of my constituents was the notorious, late Dr Harold Shipman. I have close friends who had a parent among his victims. Indeed, almost everyone in the town of Hyde knows someone affected by the crimes of Harold Shipman. I have therefore experienced the most extreme example of how abuse of the fundamental trust between doctor and patient can rock a community to its core. Our NHS doctors are among the best in the world and each of us owes the whole UK medical profession our gratitude for the tireless public service they give. A GP is more than a stranger in a room; they are a friend, a confidante, an advocate and a signpost to further help.
I am sure no GP wants to find themselves in the awful position of wondering whether they have dispensed prescriptions without being fully aware of the risks to the patients who took the medication. Let us not undermine this most important of relationships by failing to look closely enough at the drugs that we have asked doctors in the past to distribute. Let us put Primodos under the microscope—for Susan, for Sarah and for continued trust in our NHS.
Maria Eagle (Garston and Halewood) (Lab)
I congratulate my hon. Friend the Member for Bolton South East (Yasmin Qureshi) on her work in this area and on securing today’s debate. I am here to speak on behalf of my constituents: Pamela Mawdsley from Garston and her daughter Louise; a constituent who lost a baby son; and Sonia Fitzpatrick from Halewood. All of them believe—I think correctly—that the disabilities with which they or their children live and the losses they have had to face were caused by Primodos being administered in pregnancy. This was not for any therapeutic reason, but simply as a test to determine whether or not there was a pregnancy.
Pamela’s daughter, Louise, is now 42. In 1973, Pamela visited her doctor to find out whether she was pregnant, and she was given Primodos. Her daughter was born in November that year with many severe disabilities. She has extensive brain damage, cerebral palsy, a right leg two inches shorter than the left and a right foot four sizes smaller than her left foot, spina bifida, scoliosis, partial deafness and significant special needs. She nevertheless lives a good life with her family at the age of 42, and her family obviously value her tremendously, but she has ongoing medical problems. My constituent Pamela had her medical records go missing when she became one of the people who tried, with other families, to sue in the early 1980s. The hon. Member for Livingston (Hannah Bardell) also raised that issue in respect of her constituent.
Sonia Fitzpatrick from Halewood is also 42, and in common with Louise Mawdsley, she believes—again, I think, correctly—that the disabilities with which she was born that affect her every day were caused by the Primodos given to her mother to see whether or not she was pregnant. She has spina bifida and other significant medical problems. Since being a young child, she has had a colostomy and a urostomy. She has significant ongoing difficulties with her feet, her hands and other joints. She, too, has lived for 42 years with the effects of that day when her mother went to find out whether she was pregnant.
I first met Pamela Mawdsley in 2011, and I had never heard of Primodos at that time. As a former lawyer who used to conduct product liability litigation and medical negligence cases, however, I rather wondered why I had not. I practised from 1990 to 1996, specialising in this field among others. Products that cause harm, especially medical products, were one of my focuses at that time; and seeking the truth and, where appropriate, compensation for those adversely affected was what I sought to achieve. Yet I had still never heard of Primodos, which is why I am participating in today’s debate.
The stories my constituents and others tell me are familiar to anyone who has practised as a lawyer in product liability litigation. From Thalidomide to Primodos and vaccine damage, there are some common themes: a lack of warnings about possible side-effects; being called a fussy mother when disabilities of a young baby are first noticed and raised with medical practitioners; denial of causality when there are reports of adverse effects; the sudden and inexplicable loss of medical records that indicated what was prescribed and when—often “just for the week” or “just for the month”. I have come across that many times in litigation. Then there are overt hostility and lack of transparency when doubts are finally expressed; no acceptance of liability by drug company or regulatory agency or prescriber, even after the withdrawal of the product in question; and a legal battle—it also happened in this case—usually with gross inequality of arms, when those at fault are utterly unwilling to concede any kind of liability or causation or to co-operate at all in finding some way through the difficulties that the victims have to suffer for many years.
The results are always the same. There are years of denial and agony for those affected, and a subsequent failure to help to alleviate the consequences or to understand the motives of the people who come forward. There is agony for parents, who invariably blame themselves for what has happened to their children, particularly in cases such as these in which there is no therapeutic reason for taking the drug. There are also extremely long, frustrating and often fruitless campaigns for truth and justice, many of which involve failed litigation, as in this case. The litigation usually fails on the basis of causation, or, effectively, because there is no real co-operation or willingness to discover the truth but merely a defensive attitude on the part of medical authorities, scientists, and frequently—I hesitate to say it—Governments. That is what I see going on here.
I think there is little doubt that hormonal pregnancy tests caused the birth defects about which many of the families affected have complained. There was significant disquiet, and evidence from the 1960s, that there were adverse effects that led to the kind of disabilities that Louise and Sonia now live with, but there were no warnings. Obviously proving causation in individual cases is difficult, particularly when the medical records have gone missing, but why should these families have to prove it? Drugs containing such hormones in such doses were banned elsewhere. The fact that existing drugs contain them in much smaller doses does not mean that the large-dose versions could not cause the problems that we are discussing now.
Survivors such as Louise and Sonia have significant and ongoing serious health problems, and they and their families deserve the truth about what happened, in addition to the further help that they need. We have the so-called independent review that the Government established in October 2014, and I think that they were right to establish it, but it does not seem to be going well. I am not sure that it has the confidence of the families, or the confidence of those who have been fighting for so long to get to the bottom of what happened. There seems to be a failure to work with the families who are affected by this scandal.
I have seen independent reviews that work. The Hillsborough independent panel springs to mind: I had a long association with that campaign, and I know what works and what does not. Independent reviews that work are not based on expecting campaigners to sign confidentiality agreements before they can even observe proceedings. They are not based on appointing experts who are suspected by some families—rightly or wrongly—to have a conflict of interests. They are not based on proceedings being so slow and opaque, with so little information emerging, that those affected become suspicious, or do not know what is going on behind the closed doors of the review. They are based on proper consultation and obtaining the full confidence of those affected.
If that does not happen, the end result, whatever it is, will make matters worse. It will make the affected families feel that there has been another establishment whitewash, that their hopes have been raised only to be dashed, that things have been swept under the carpet, and that the authorities, whoever they are, do not really want to find out what happened because it is inconvenient.
In view of the debate and in view of the concern that many of the families are expressing, the Minister must get a grip on the process and ensure that it works. He must take steps to secure the confidence of the families. He must be much more transparent about what is going on, and he must have a proper understanding of what the process is seeking to achieve. I can tell him that if there is another whitewash—if the review does not work—those families and their Members of Parliament, whether that means us or our successors, will not go away. We will be coming back to the Minister and to the Government, and we will make sure that our constituents— those families—are given the truth, the information, and the acknowledgement and help that they deserve.
Peter Dowd (Bootle) (Lab)
It was fantastic to hear that compelling speech by my hon. Friend the Member for Garston and Halewood (Maria Eagle). A theme is developing. One thing we have learned in this country time and again from many public inquiries into various issues is the need to ensure that the victims of injustice, the survivors and their families have an opportunity to have their say, in whatever format, in as transparent and open a way as possible, with no regulatory or industry cosying-up.
The second thing we have learned is that we need to bend over backwards and go the extra mile to ensure that the victims, or those speaking on their behalf, have full confidence in the mechanism set up to seek out the truth behind what has occurred. How many times have we in this country failed to investigate such matters properly, only to have to revisit them and reach the conclusion that those seeking justice were right in the first place? It often seems as though a blanket is deliberately drawn over difficult and challenging issues, to prevaricate and procrastinate until those affected are worn out, worn down or die. Institutions live on; people do not. It is a cynical game of cat and mouse. The victim is the mouse, but often it is the mouse that roars. In this case, it roars “No cover-up!”
After all the miscarriages of justice that have occurred in this country over the years, do we really have to drag institutions and organisations kicking into the light of an examination? How has it come to this? Have we learned no lessons from the history of all those inquiries? Are our institutions so arrogant that they feel immune to the democratic process, to scrutiny and to accountability? What has it come to when this House has to consider such a motion from my hon. Friend the Member for Bolton South East (Yasmin Qureshi)? We should not have to be here doing this today.
My hon. Friend has done a remarkable job on behalf of the people affected by this scandal. That is what it is—a scandal, pure and simple. She has been tenacious in pursuing the matter on behalf of the families affected by this sorry tale of incompetence and deficiency and a lack of will to put it to the test. In her, those families have a doughty champion. She and my hon. Friends the Members for Garston and Halewood, for Makerfield (Yvonne Fovargue) and for Stalybridge and Hyde (Jonathan Reynolds), and the hon. Member for Livingston (Hannah Bardell), have today laid out the inadequacies of the process so far. I do not want to repeat what they have said. They could not have been any clearer, any more forensic or any more passionate. However, I will make just two brief points.
First, I want to express my continued support for my hon. Friend the Member for Bolton South East and for the families affected, some of whom are my constituents. I am grateful for the work that she has done on their behalf so far. There is no time for subtlety in this regard, so secondly, I want to say that if the people in the institutions who have been given the task of getting to the bottom of this issue, paid for by the taxpayer—and, yes, by the families who are here today—are not prepared to carry out that task to the full satisfaction of the thousands of people affected, namely the victims, they should move aside and let others, who want to expose the inadequacies of a system that has left those people adrift for decades, get on with the job.
Enough is enough. I hope and trust that the Minister will hear the just and reasonable pleas of our constituents, and that he will take this motion and away and put it into effect, to the letter and in spirit. This injustice has gone on for 40 years, and it is time to draw a line under it. It is time to give closure and peace to the victims and their families. Anything less would be a betrayal of our duty and of our constituents.
Liz McInnes (Heywood and Middleton) (Lab)
I want to thank my hon. Friend the Member for Bolton South East (Yasmin Qureshi) for bringing this debate to the Chamber. I congratulate her on her work on this matter, on continuing to put pressure on the Government to hold an inquiry and now on working to ensure that they are held accountable following their promise. I also wish to express my support and admiration for the campaigners, particularly Marie Lyon, whom it has been my pleasure to meet over the past couple of years since I became an MP. The campaigners have pursued justice on this issue over decades to have their voices heard and their questions answered. They have shown resilience and fortitude in their search for clarification on the possible association between the prescription of hormone pregnancy tests having adverse effects in pregnancy and subsequent birth defects in their children.
My predecessor in Heywood and Middleton, Jim Dobbin, was working with constituents, trying to get some answers to their strongly held beliefs that the prescription of hormone pregnancy tests had led to birth defects in their children. After Jim’s sad death in 2014, I have carried on his work. No one was more pleased than me when, finally in 2015—40 years after hormone pregnancy tests were banned—an independent inquiry was finally set up. The families, the children and the campaigning group, the Association of Children Damaged by Hormone Pregnancy Tests, would finally receive the answers that they had sought for so long.
Hormone pregnancy tests were banned in 1975 following advice from the former Committee on Safety of Medicines that they should not be used and that a warning about a possible hazard in pregnancy should be inserted in all promotional literature. Let us consider that for a moment: this was a pregnancy test, and yet it was suggested that a warning should be inserted that it should not be used in pregnancy. The Committee on Safety of Medicines wanted a clear statement that pregnant women should not use these products. Clearly, there had been sufficient adverse reactions reported for the committee to reach those conclusions.
I can remember how jubilant we were last year when the inquiry was finally agreed to. We thought that, finally, the evidence and the causal relationships would be examined. We even thought that we might get an explanation of why the medical notes had mysteriously gone missing. We felt that we had achieved something and that we would get answers to the questions that had tormented affected families for decades.
The Government had promised in good faith that the inquiry would be transparent and in good time, but, disappointingly, the inquiry has delivered on neither transparency nor timeliness so far. Questions need to be answered. Why did it take more than a year to set up the expert working group? Why has the working group met only three times? We have no idea at what stage the inquiry is now. The Government must now provide reassurances and clarity.
The expert working group has to be more accountable and more open to scrutiny. It has to engage and work with the Association of Children Damaged by Hormone Pregnancy Tests to address its concerns on the current progress, or lack of it, of the inquiry process. A key concern, which has been voiced by many Members, is that the expert working group has also signed a confidentiality clause. It is felt that that compromises the possibility of a fair and just outcome.
The former Minister for Life Sciences, the hon. Member for Mid Norfolk (George Freeman) set out quite clearly to the families that his Government would establish a means to closure and justice, while alleviating their fears that past failings would not be investigated. The delays and deliberation on following through on those promises should now be over. The Government must now give answers and make sure that they deliver on that deal to the thousands of affected families.
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.
Emma Reynolds (Wolverhampton North East) (Lab)
I pay tribute to my hon. Friend the Member for Bolton South East (Yasmin Qureshi) for securing this debate, and for championing in Parliament the concerns of families who have been affected by hormone pregnancy tests. I also pay tribute to all those families who have for years been involved in the Association for Children Damaged by Hormone Pregnancy Tests.
One such family lives in my constituency. Stephen Fensome is a constituent of mine. His mother went to the GP early on in her pregnancy to see if she was pregnant, as any woman would. She was given Primodos. Like any of us, she trusted her doctor, and her doctor, in turn, trusted the advice he had been given. It was only months later when Stephen was born, in 1967, that his parents discovered that he was severely brain-damaged, would suffer a severe form of epilepsy all his life, which would get worse with age, and that he would suffer from daily seizures, often in the middle of the night.
I have met Stephen. He came to my surgery with his parents. He requires 24-hour care. His parents, now in their mid and late 70s, have cared for him all his life, and they love him, just as they love their two healthy daughters, but they struggle to find respite because of the severity of his seizures. It was years before the family discovered that the medication that Pat had been given was equivalent to taking 40 contraceptive pills in one dosage. One does not have to be a medical professional for that to ring alarm bells.
It also became apparent that, as early as the 1960s, and into the 1970s, research carried out warned of the toxic and, in some cases, lethal impact of the drug. Indeed, in 1975, GPs were sent advice not to prescribe it any more, but it was several more years before the drug was withdrawn from the market. Research suggests that it is likely that many women who took the medication suffered miscarriage or stillbirth. Babies who survived this toxic medication were severely affected by abnormalities or disabilities.
I was pleased to learn, as was the Fensome family, that the Minister’s predecessor, the hon. Member for Mid Norfolk (George Freeman), agreed to the establishment of an inquiry. However, as the Minister has heard from all the speakers in this debate, the families have serious, deep and genuine concerns, and I understand that they do not have confidence in this inquiry.
Mims Davies (Eastleigh) (Con)
I would like to put on record my thanks to Stephen’s family, including Charlotte, who lives in West End in my constituency. She came to see me to thank the all-party parliamentary group on oral hormone pregnancy tests for its work on the issue, and to explain how her care for Stephen carries on, as her parents age.
Emma Reynolds
I thank the hon. Lady for that intervention. Charlotte has been a tireless campaigner for the truth of what happened in the 1960s and 1970s.
I hope that when the Minister winds up, he will answer a number of questions about the inquiry. As my hon. Friend the Member for Garston and Halewood (Maria Eagle) said, we want him to get a grip on the inquiry. Will he guarantee that all the relevant evidence will be put before the inquiry? As the hon. Member for Livingston (Hannah Bardell) suggested, there is great concern that evidence is being cherry-picked. Will he guarantee that the inquiry is independent, full and transparent, and will he give a commitment today, to the House and the families present, that he will do everything in his power to ensure that the inquiry gets to the bottom of what happened, including: why evidence in the 1960s of the harmful—indeed devastating—impact of the drug was ignored for so long; why it continued to be prescribed; why there seemed to be a medical cover-up; why it took so long to be banned; and what was behind the continuous regulatory failure?
The family whom I represent would, although they might not admit it, of course like more help caring for Stephen, as any family would, but they are not driven by a desire for compensation. They are driven by a long and anguished search for truth and justice. They do not want a whitewash. They want to have confidence in the inquiry, but regrettably they do not have it. I urge the Minister to ensure that they get the truth, and justice. Surely they deserve nothing less.
Mr Jacob Rees-Mogg (North East Somerset) (Con)
Along with other Members, I want to pay great tribute to the hon. Member for Bolton South East (Yasmin Qureshi), who has run a terrific campaign on this issue, worked tirelessly, set up the APPG and raised an issue that ought to be of the greatest concern to all Members because it goes, in a way, to the heart of how Governments behave. I want to focus on the inquiry and the need to establish faith with the families who have been involved with what has happened in relation to Primodos.
It seems to me that there is a strong prima facie case that something was wrong with this drug, that it was known to the authorities and that they failed to act on it for an extended period. The first warning about it was on 11 July 1967 and the adverse reaction committee felt that there were grounds for further investigation, yet it was eight years later in 1975 when it was said that Primodos was not to be prescribed for women who were pregnant. That seems to me so irresponsible, when the risks of prescribing drugs to pregnant women are so particularly high.
Governments are amazingly good at apologising for things that happened so long ago that there is nothing that can be done about them. I seem to remember that one Government apologised for the Irish potato famine 150 years after it had happened. That does no good to anybody. What Governments need to do is to put things right when people are still alive and affected by the failings that took place. But when they have not acted, when time has gone by, the onus of proof shifts to them.
It is for Governments at that point to show how well they are behaving and how properly they are going through the process. It is for them to rebuild the trust with the families, not for the families to accept guarantees from the Government without any depth to them. Therefore, with the appointments to this inquiry, the information that is being made available to it and the investigations that are taking place, the Government have a long way to go to re-establish a trust that was probably lost as long ago as 1975. It is in that context that I hope the Minister will respond to make it clear that the Government understand the strength of the case that has been made, will be looking at it with a genuinely open mind, and will see not that things can be put right, but at least that some amelioration should be made if it is found in the end that there was fault in what the Government did, what the regulator did and, of course, what the drug company did.
There are so many bits and pieces that cause suspicion—the disappearance of records is a particularly important one. Where did those records go, as the hon. Member for Bolton South East asked? A lot of the information is in German and there is a question over whether it is being translated even for the committee. When such issues hang over an inquiry, the Government have a lot of work to do to re-establish trust so that Members of this House and, more importantly, the people affected can believe that the inquiry is fair.
Once again, I congratulate the hon. Lady on what she has done. I do not want to go into specific cases because I think those will be judged by the inquiry and that it will be a proper process to investigate whether the evidence is there on a widespread scale, but with such a strong base case, as we already know, we must have an inquiry that people can trust.
Justin Madders (Ellesmere Port and Neston) (Lab)
I congratulate my hon. Friend the Member for Bolton South East (Yasmin Qureshi) and the hon. Member for Livingston (Hannah Bardell) on securing this debate, and I welcome the well-informed and passionate nature of the contributions that we have heard from across the House. I take this opportunity to pay tribute to Marie Lyon, chair of the Association for Children Damaged by Hormone Pregnancy Tests, who has never given up in her fight to ensure that parents like her get to the bottom of exactly what happened to their children and why.
I also pay tribute to the all-party parliamentary group on oral hormone pregnancy tests, ably chaired by my hon. Friend the Member for Bolton South East, which has offered the campaigners a huge amount of support. It was its campaigning, alongside the Association for Children Damaged by Hormone Pregnancy Tests, that led to the expert working panel group being set up.
There are serious concerns about the process that clearly need to be addressed. We welcome the fact that the former Minister for Life Sciences has sought to set up an independent investigation into the issues. Unfortunately, as we have heard, there appears to be a divergence between the type of process that the Minister sought to establish and the way it is currently operating. I will address that point later in my remarks.
As we have heard, hundreds, if not thousands, of families have been affected by this issue and have suffered not only debilitating physical conditions but, in some cases, sadly, premature death. Alongside that, they have experienced a sense of injustice and the pain of more than 40 years of questions being left unanswered. My hon. Friend the Member for Bolton South East, in setting out the history so well, made the crucial point that the victims should be at the heart of the process. The testimony she gave on their behalf clearly showed that that is not currently the case.
My hon. Friend the Member for Makerfield (Yvonne Fovargue) spoke about her constituent Marie Lyon, who is on the panel, and gave the specific example of her being required to read 36 files in two weeks, which she cannot talk to anyone about. That is a patently absurd way to go about this business, and a stark example of what is going wrong.
The hon. Member for Livingston (Hannah Bardell) spoke forcefully about her legitimate concerns about the impartiality of the working group and, disappointingly, a lack of any substantive response when those concerns were raised.
We also heard from my hon. Friends the Members for Stalybridge and Hyde (Jonathan Reynolds), for Garston and Halewood (Maria Eagle)—she made a particularly powerful speech—for Bootle (Peter Dowd), for Heywood and Middleton (Liz McInnes), for Feltham and Heston (Seema Malhotra) and for Wolverhampton North East (Emma Reynolds), and from the hon. Member for North East Somerset (Mr Rees-Mogg). Time prevents me from going into much detail, but all those Members spoke passionately on behalf of their constituents and clearly identified the issues that we need to address in the current process.
As we now know, from the late 1960s warnings began to emerge about adverse reactions to the drug Primodos, including birth defects and miscarriage. A wide range of studies prompting warnings continued, and by the early 1970s it was declared that Primodos should not be used as a pregnancy test. However, despite this and a warning issued in 1975 by the Committee on Safety of Medicines about an association between hormone pregnancy tests and an increased incidence of congenital abnormalities, Primodos continued to be provided to women until its withdrawal from the market by Schering in 1978. In 1977 there were still, unbelievably, 7,038 prescriptions of Primodos to pregnant women.
That really is the crux of the issue: the delay between warnings emerging and any action being taken to stop the drug being offered to women. As we have heard today, steps were taken in Sweden, Finland, Germany, the USA, Australia and Ireland up to five years before any warnings were issued in the UK. It was that delay that led to thousands more women taking the drug than would have done so had it been withdrawn from the market when the warnings became clear in 1970. It is a scandal that families are still waiting for answers about why that was allowed to happen. There is a duty on all of us to ensure that is put right.
When the issue was last debated, in October 2014, the families were very pleased when the previous Minister for Life Sciences agreed to set up what he termed
“an independent panel of inquiry”
and committed to
“the release of all information that is held by the Department”.
He also promised that the committee would be comprised of “independent members” and that he would ensure that
“the association is properly represented and has a chance to give evidence.”
Finally, he stated that he wanted to
“shed light on the issue and bring the all-important closure in an era of transparency, so that lessons can be learned and this never happens again.”—[Official Report, 23 October 2014; Vol. 586, c. 1139-1143.]
As I said earlier, the Opposition welcomed the establishment of that process and the assurances offered by the Minister at the time. However, as we have heard today, there is now a gaping chasm between those assurances and the current process. I therefore hope that following this debate the Minister will take some urgent steps to ensure that the families, who have already been through so much, can regain confidence in the process.
With regard to independence, we have already heard that the selection process for members of the panel can at best be described as opaque. Serious concerns have been raised about conflicts of interest, and they need to be answered. Can the Minister tell us whether he is absolutely satisfied with the transparency arrangements for the selection process and with the independence of the panel? With regard to the promise to release all information, it is vital that the panel, in addition to being provided with absolutely every piece of relevant evidence, is afforded sufficient time to consider it. The evidence must also be presented in an accessible format, as is good practice in a process of this nature. Is the Minister satisfied with the way the information is being presented to members of the panel, and can he now confirm that every piece of information held by the Department has in fact been released?
In terms of the association being properly represented, we have heard that just one member of the association is entitled to attend meetings as an observer and that they have been required to sign a confidentiality clause. I understand that the clause applies both during and after the inquiry, and not only to the panel’s discussions but to the documents that are presented. How can that person raise concerns about the process if they are prevented from talking about it? Can the Minister explain why such a high level of secrecy is being applied to a process, the primary purpose of which was originally to
“bring the all-important closure in an era of transparency”?—[Official Report, 23 October 2014; Vol. 586, c. 1143.]
Justice must not only be done but be seen to be done, and there is a danger that this inquiry is failing properly to serve the people it was set up for. Given the public interest and the cost of this process, the Minister simply must address these issues now if the inquiry is to bring closure and the correct lessons are to be learned. Can he see how some of these issues will look if the families and victims of this scandal do not get the correct answers? Does he not agree that we owe them a process that is fair and transparent and, most importantly, that has their trust and confidence? Victims and their families have fought for 40 years to get answers, and during that time they have experienced grief, anger, a sense of injustice and, sadly, in some cases, even guilt, but despite all that their determination has never waned.
I am incredibly proud that, after 30 years, justice was finally served for three of my constituents and 93 other people who were tragically killed when they attended a football match at Hillsborough. That justice was achieved only because the families refused to give up, and, as the Minister will no doubt be aware, the families of the children harmed and killed by hormone pregnancy tests will not give up either. Why should the injustice that those people have suffered be compounded by further injustice and the sham of an inquiry that is patently not fit for purpose? Transparency, impartiality and completeness are not unreasonable demands; they are the basic ingredients for justice to be done. So, I ask the Minister, please to listen to the words he has heard today and act on them.
The Parliamentary Under-Secretary of State for Health (David Mowat)
May I just say at the outset that nobody in the Government has any interest other than in getting to the truth in this matter? We are as keen as the people who have spoken today, and indeed the families that are watching us, to make sure that we do that, and there is a process that is to be followed to make that happen. We have heard some strong words today: “establishment whitewash”, “sham inquiry” and “a blanket over the issues”. I say again: nobody on the Government side of the House has any interest in anything other than getting to the truth, and the process that was put in place two years ago had that at its heart.
Let me join others in congratulating the hon. Members for Bolton South East (Yasmin Qureshi) and for Livingston (Hannah Bardell) on leading the charge on this, not just today, but in terms of the APPG and making sure that this issue is very high on the Government’s agenda. It is massively important that those who feel their lives have been adversely affected by drugs, albeit 40 or 50 years ago, see that processes are in place to make sure that we do what we can.
I would also like to pay tribute from the Government side to the Association for Children Damaged by Hormone Pregnancy Tests, and particularly to Marie Lyon for the work that she has done and continues to do—and should continue to do until we get to the truth of this matter.
I am going to talk in some detail about the progress on the inquiry, but it was very clear, as I listened to the debate, that, at the very least, the association does not have confidence in the work of the inquiry, and that is unsatisfactory. I have heard people talking about letters being unanswered and all that goes with that, and that is unacceptable. I make a commitment at the start to the association, or the APPG, that one of the things that should come right out of what we are talking about today is a letter from them, in as much detail as they want it to be, raising as many concerns as they feel they have about the details of the inquiry—a lot of detailed points have been made, which I will not be able to answer today. That letter will be answered in detail, and after that we should have a meeting to make sure that everyone is content with the direction in which we are going.
Mr George Howarth
I am grateful to the Minister for his offer. Does he accept that part of the problem is that if people do not have confidence in the process and do not feel that it is being conducted in a transparent way— there is evidence that that is the case—they will say that the inquiry is likely to be a whitewash? He needs to reassure not just the families and my hon. Friends, but everybody concerned with the inquiry that the process will be transparent and open. In those circumstances, people would have more confidence in it.
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.
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.
Maria Eagle
Does the Minister not realise how important it is that, whatever the rights and wrongs of this and whatever the qualities of the members of the panel, the families need to have confidence in it? There is no point in saying that they are all wonderful people. The families have concerns and if they are not assuaged, in one way or another, the outcome will not have their confidence.
David Mowat
I said at the start of my remarks that the learning point I have taken from this debate is that, whatever we think about the truth, the science and whether we are doing the right thing, the families are not happy. I also said that we will do what we can to amend that.
As well as that, Members on both sides of the House need to accept that we need to get to the scientific truth. In order to do that, there needs to be a scientific process. That has to happen and that is why some of this is time-consuming and difficult, even though we wish that it was not.
Mr George Howarth
The Minister is being generous in giving way. I am not sure that the terminology he is using is necessarily suitable. I do not understand this to be a scientific process per se. I understand it to be an informed judgment about the available evidence and, understandably, that is best conducted by scientists. I think he was a lawyer in a previous existence, so he will understand the difference between the two approaches.
David Mowat
I am guilty of many things, but I have never been a lawyer. However, in case I was not clear, I understand the difference between the two processes and accept the distinction that the right hon. Gentleman makes. The point I would make again, however, is that the panel has 14 members who have been chosen for particular skills in the issues involved, plus lay members who are not scientists.
David Mowat
I will not, as there are only a couple of minutes left and the hon. Member for Bolton South East needs to sum up.
I will now address the third point that arose in the debate, namely whether all the available evidence will be reviewed by the expert group. The answer is yes. That is one reason why the process is taking so long. A specific question was raised about a great deal of evidence that has recently come to light which is in German. All that evidence will be translated, and all the translations will be put before the group. The chairman will be responsible for ensuring that that evidence is looked at and reviewed properly. There is absolutely no intention that the inquiry be anything other than a properly resourced attempt to get to the truth. That is difficult for something that happened 40 or 50 years ago. We all need to accept that point.
I finish by making the same point that I made at the start of my remarks. The Government are responsible for the efficacy of this inquiry, and we need to get to the right answer. It is important, and I accept, that the inquiry clearly does not have the confidence of some of the stakeholders. That is not acceptable or satisfactory. I will make the same undertaking as was made by the then Minister for Life Sciences two years ago when putting the inquiry in place, namely that we will try to put things right. I make the offer again: if there is a letter giving the detail of the points that have been made, that letter will be answered and we will hold a meeting to discuss it subsequently.
Yasmin Qureshi
I am conscious of the time. First, I thank all Members who have attended the debate. I thank the victims, some of whom are in the Gallery today, and Marie Lyon. I know we do not often refer to our staff, but I thank my researcher Sadia Ali, who has done incredible work on this issue with me for the past couple of years.
I am glad that the Minister has said that he will meet us, and we will happily write with detailed information about our concerns, but we need to emphasise again that, as my right hon. Friend the Member for Knowsley (Mr Howarth) mentioned just a minute ago, the inquiry is not so much about the medical evidence. It is not carrying out experiments to ascertain whether there is a scientific link. The crux is that a lot of evidence was available at the time and the regulator failed to do anything. Also, the victims have not been heard properly so far. The inquiry needs to do that.
I accept the Minister’s assurances and will wait to see what happens.
Question put and agreed to.
Resolved,
That this House notes that an Expert Working Panel Group Inquiry was set up by the Government to investigate and assess evidence on children born with serious deformities due to hormone pregnancy test drugs taken by expectant mothers between 1953 and 1975; further notes with concern that the terms of reference as set out by the Medicines and Healthcare Products Regulatory Agency do not clearly allow for an investigation into the systematic regulatory failures of government bodies at the time; notes the conflict of interest of some panel members; further notes that all evidence must be presented to expert panel members as set out in the term of reference; calls on the Inquiry to ensure that all evidence is presented to the expert panel with sufficient time for due consideration; further calls on the inquiry to guarantee thorough background checks on all panel members; calls for the terms of reference to be amended to include an investigation into the conduct of the Committee on Safety of Medicines; further calls on the Government to ensure that the inquiry has the trust and confidence of the victims for whom it was set up; and believes that, unless these changes are made, the ability of the Inquiry to achieve a fair outcome will be significantly compromised.