Oral Hormone Pregnancy Tests
(10 years, 1 month ago)
Commons ChamberRead Hansard Text Read Debate Ministerial Extracts
Yvonne Fovargue (Makerfield) (Lab)
My constituent, the wonderful campaigner Marie Lyon, has doggedly pursued this issue, and I think we can fairly say that that has led to my hon. Friend getting this excellent debate. I am aware of two constituents who have been affected by this drug. Mr and Mrs Tilley’s son Stephen was born with brain damage, and when they asked for Mrs Tilley’s medical records, they found they were missing. This is not the first case I have heard about of records being lost or destroyed in this regard. Is my hon. Friend as concerned as I am about this apparent cover-up?
Yasmin Qureshi
I entirely agree with my hon. Friend about the cover-up.
We have recently discovered another document in the Kew archive: a letter from the 1960s about the minutes of a meeting of the General Medical Services Committee, in which Dr Inman was involved. It says that there was worry about a request by the Committee on Safety of Medicines that doctors should be monitoring adverse reactions to medication. Doctors were a bit concerned about that in case they might be liable for negligence actions. The minutes say that doctors should stop recording adverse reactions, and, even more significantly, that those who have recorded any such evidence should have it destroyed. That fits in with the constituents, including mine, who have said that when they, as parents, have gone to their doctors to get their records, they are somehow mysteriously missing.
A British medical director of British-based Schering Chemicals, which is a subsidiary of Bayer Schering in Berlin, urged the withdrawal of the hormone pregnancy drug primodos in 1969, but his plea was rejected by the company. In the same year, the author of a survey for the Royal College of General Practitioners also recommended the withdrawal of the drug, but he, too, was turned down. Until this day, Bayer has refused to take any responsibility.
Jason Farrell, the Sky News reporter I mentioned, has met the statistician, Dennis Cooke, who was contracted by Schering in the ’60s. In a report, of which he still has copies, he compared the increase in the sales of primodos with the number of recorded deformities in newborns, which, he says,
“show a rather alarming direct and strong correlation.”
Schering stopped promoting primodos in 1970, and prescriptions fell from 120,000 in that year to 7,000 by 1977, when it was withdrawn. National statistics show that birth deformities declined during that period as well.
Another person I want to allude to is Professor Briggs. Many times, whenever it has been contacted about this, Bayer has referred to the court case of 1982. It is important to explain to the House that the damage claims brought by the victims were discontinued in the 1980s because some of the medical witnesses defected to the defendants, Schering Chemicals, so the case had to be withdrawn. Some of the victims say that the so-called experts who went over to the Schering side had an interesting story. One of those was Professor Briggs. Some years after the case collapsed, The Sunday Times published an interview with Professor Briggs by Brian Deer, a journalist, in which he accepts that he had in the past “fabricated” studies and carried out
“scientific fraud on a large scale”.
That is on the internet and can be read by anyone.
On a CD that has been kept under lock and key—there is an injunction on it—Professor Briggs is heard confessing:
“Difficulties would be encountered if doubts expressed about hormone pregnancy tests were made public. These were exactly the same hormones as the contraceptive pill and would have cast doubt on the safety of hormones which would extend doubt on the safety of the Pill. This would have a major influence on worldwide family planning which could be a real human disaster. It could cause panic among millions of women worldwide which could result in thousands of pregnancies.”
Later he claims:
“Drugs such as these would never be allowed to be on the Market today, given what we ‘now know’ and following what we know about Potential Hazards to the developing Foetus.”
Those comments were made in a documentary called “The Primodos Affair”, which has never been aired because Schering took out an injunction. Why did it do that? What did it have to hide?
There is further curious evidence regarding other witnesses. Dr Smithills approached a drug company for which he was doing research work on the drug Debendox. He suggested that he would approve the drug and that a funded research project would be an appropriate reward. Dr Inman opened a research centre soon after the case, after he left the Committee on Safety of Medicines. And guess what? Professor Briggs also opened a research centre in Australia soon after the case.
I have no hesitation in saying that those witnesses were bought off by Schering. It is amazing how all of them ended up opening research centres, which, as everybody knows, costs money.
Obviously, the situation is not this Government’s fault, but no Government have taken action over the years. Given the weight of evidence, why did the regulators not warn the doctors? According to internal correspondence from the Committee on Safety of Medicines, it admits that it has
“no defence for the 8 year delay”.
Interestingly, the authorities in Sweden, Finland, Germany, the USA, Australia, Ireland and Holland issued warnings and took action on the drug as early as 1970, five years before any warning was issued in the UK, despite the fact that the first group that knew about the problem was the Committee on Safety of Medicines.
One of the things thrown at the victims is the claim that there is no link, but there is a link: so many statistics show a correlation and so many doctors saw what happened. There seems to have been a complete failure on the part of the body appointed to monitor medication. It could have taken action but failed to do so, so the Government of the day were culpable.
Interestingly, Schering discontinued the product and stopped using it for pregnancy tests. Surely that suggests that something was wrong with the drug; otherwise, it would not have been taken off the market.
It is said that justice delayed is justice denied. We have found out in recent years about cover-ups in relation to so many tragedies, including thalidomide, Hillsborough and the sexual abuse of children in care homes and institutions. The 1960s and ’70s seem to have been an era of cover-ups, wherever we look, and victims in those cases campaigned for years and years to get an inquiry. The case under discussion has been going on for 30 to 40 years. Is it not about time for the victims—there are thousands of them—to get the justice they deserve?
Nick de Bois (Enfield North) (Con)
I congratulate the hon. Lady on the work she has done to secure this debate and her work with campaigners. She is drawing a contrast between this and previous cover-ups. To support her point, I should like to point out that, in this new age of transparency, we seek not a public inquiry but an independent panel, which should be well within the Government’s gift.
Yasmin Qureshi
I entirely agree with the hon. Gentleman. I thank him for all the support that he has given me and all the work that he has carried out in the campaign on behalf of his constituents.
I want to end by paying tribute to Marie Lyon, who has already been mentioned, and the victims association for all its work, as well as hon. Members who have given their help and assistance. I want to name-check two hon. Members who, because of their positions, are not able to speak in the debate: one is my hon. Friend the Member for Garston and Halewood (Maria Eagle), who is in the Chamber; and the other is the Minister for Government Policy and Chancellor of the Duchy of Lancaster, the right hon. Member for West Dorset (Mr Letwin), who is not here today.
Guto Bebb (Aberconwy) (Con)
It is a privilege to follow the hon. Member for Bolton South East (Yasmin Qureshi). I pay tribute to her for her work on the all-party group on oral hormone pregnancy tests, and for securing this debate. I thank the Backbench Business Committee for making time to debate such an issue in the Chamber. Once again, the Committee has highlighted the House’s ability to work on a cross-party basis. I was particularly impressed by the fact that the hon. Lady’s speech was non-partisan in condemning all previous Governments, rather than just one Government; that has been much appreciated.
I have come to this debate late in the day, but after a constituent of mine informed me about the impact of the issue on her life and her family, I was lucky enough to be briefed by the campaign. The campaign should be congratulated on the work that it has done in talking to Back-Bench MPs to ensure that we are willing to speak on the issue.
It is important to point out that my constituent Mrs Margaret Roberts has provided a fantastic example of why lobbying your MP does make a difference. To be perfectly frank, if it had not been for her persistence and the fact that she came forward to explain the impact of what happened to her family, I might not have spoken in this debate. People complain that MPs are too easily lobbied, but I argue that when constituents lobby their MP, it is often an essential part of our democratic process. I am very pleased that Mrs Roberts made the effort to come to talk to me.
Having read Mrs Roberts’s testimony and listened to her talk about her experiences, it is difficult not to be moved. As a parent, I found it difficult not to be moved when I heard about the joy, grief and guilt she has felt because of the impact of the drug on her son Garry. It is worth touching on such issues because, ultimately, we need to try to shine a light on what actually happened. Nothing can change the impact of what has been done, but it is important to recognise that people want to understand exactly what happened.
In speaking to Mrs Roberts about her son Garry, it was very apparent that he brought immense joy to the family. Despite the fact that he had severe disabilities from birth, he battled on for 37 years. He was born in 1964, but passed away in 2001. What is remarkable in Mrs Roberts’s testimony is that somebody with such significant disabilities should live such a fulfilling life. Wherever he went, he clearly touched the lives of other people, not least those of his three siblings and his parents, and he had a significant impact on his carers, whether they were care in the community support staff or hospital staff. It was difficult to listen to all her testimony without feeling moved by the impact that somebody with such severe disabilities can have on others for the greater good.
What also came through was the grief of a family who expected their first-born to be healthy, but who knew within a few hours that something was wrong. I could not help but feel very affected by that. As a father who had twin boys born at 30 weeks, I know what it feels like to see one’s children taken away to be given special care. I am lucky that they came back and that they are healthy and fit.
It was hard to hear the testimony of somebody who knew that something was wrong for months and years. They have never been given a full explanation of what exactly did occur. The joy that Garry brought to their lives is clear from Mrs Roberts’s testimony, but so is the grief of knowing that they were the parents of somebody who suffered the constant visits to the hospital and the constant need to talk to the medical establishment. Throughout all that, no explanation was given of the cause of the significant health problems that he faced.
Finally, I want to touch on the issue of guilt. That is the reason why this debate is so important to people such as Mrs Roberts. She went on to have three healthy children, so she constantly asks herself whether her decision to take the tablets back in 1964 was the cause of the suffering of her son Garry. Does she need to blame herself or was it beyond her control? She needs an explanation of exactly what happened. That is why this debate is important.
We have an obligation to highlight the information that is available to Government, and to ensure that it has been looked at carefully and taken into account. We must also have the ability to look at that information afresh to see whether mistakes were made, where they were made, why they were made and how we can avoid them in future. That is the key point that comes across from the campaign group. Of course they want answers, but they want answers to ensure that such a situation does not happen in the future.
Having spoken about the issues that my constituent and her son have faced, I think it is important to associate myself with the cause made by the hon. Member for Bolton South East. We need to ask why the evidence that was collated was not acted on at an earlier date. We have heard testimony that the authorities in the United Kingdom were aware of the issues before the authorities in other countries, yet it appears that other countries acted to ban the substance before the United Kingdom. We need to know why that was.
Now that so much information has come to light from documents that have been released under the 30-year rule, why can we not instigate an inquiry with a panel of experts to evaluate what went wrong and how it can be rectified for the future? It would not have to be a far-reaching inquiry. Most important, an expert panel of the nature envisaged by the hon. Member for Bolton South East and the all-party parliamentary group would be able to tell people whether they were in any way responsible for what happened. I suspect the answer is that they were clearly not, but if that information was provided by reputable experts who had looked at the information afresh, it would give people like Mrs Roberts a degree of closure. People who are suffering the effects of what they believe to have been the ill-advised use of the hormones would also be able to understand what happened and why they have suffered.
I call on the Government to make good the mistakes of previous Administrations by taking seriously and giving due consideration to the simple request that an expert panel be put together. I am hopeful that the Minister will say that the Government will, in the interests of transparency and honesty, appoint such a committee.
Mr Geoffrey Robinson (Coventry North West) (Lab)
It is a pleasure to succeed the hon. Member for Aberconwy (Guto Bebb). I think that the whole House would like to congratulate my hon. Friend the Member for Bolton South East (Yasmin Qureshi) on securing this debate and to commend the work that she and the hon. Member for Enfield North (Nick de Bois) have done.
I thank the Backbench Business Committee for granting the debate. It is a demonstration of the work of that Committee and of committed MPs at its very best. I had the opportunity to lead a debate early on in the activities of the Backbench Business Committee on contaminated blood, which is not a million miles from this issue, although it is bigger in many ways. More people were affected and a clear link has been established between the mistaken use of contaminated blood and the terrible suffering that it caused. It is still a running sore because people cannot get closure.
I will come in a moment to the limited and modest nature of the request in the motion. I think it is contained and measured appropriately because the Government are still denying any causal link between the drugs and congenital abnormalities. First, however, let me say why I am taking part in this debate—indeed, a similar individual case sparked my deep interest in the issue of contaminated blood.
I have a constituent who suffered from the problem under discussion, and with your indulgence, Mr Deputy Speaker, I will read briefly from a letter she wrote to me. Her name is Mrs Christine Pettifer of Ladbrook road in Coventry North West, and she has given permission for me to mention her name and cite her case in this debate. She wrote:
“I went to my GP…and he gave me Primodos—”
the hormone pregnancy testing drug in question—
“to see if I was indeed pregnant. I was a bit worried about taking the tablets, but he assured me that if I was pregnant, nothing would happen. If on the other hand I was not pregnant, it would bring on a normal period.”
We can all guess the terrible consequences. In her case they were as follows:
“When my baby (Lynda) was born on 26 January 1969 the staff thought she looked a bit blue, and took her away to the nursery. I tried to breastfeed her, but she seemed sleepy all the time. At that time, all babies were put in a nursery for the night. In the early hours of the morning on 29 January, I was woken by a nurse to the terrible news that Lynda had died. I have the post mortem, which in layman’s terms stated that her heart was the wrong way round.”
I cannot claim that there is a direct cause between that and primodos, but we hope that the Minister will address the modest nature of the request we are making to the Government.
Let us be clear. As late as July this year, a Minister from the Department of Heath stated:
“The MHRA has considered the key evidence and concluded that the data are not sufficient to support a causal association between the use of hormonal pregnancy tests and congenital abnormalities.”—[Official Report, 15 July 2014; Vol. 584, c. 668W.]
The MHRA assessment was published on its website in 2014, and that remains the Government’s position.
We have raised this issue because of the situation of my constituent and that of the hon. Member for Aberconwy, but why are we pushing for an inquiry? It is because people want closure on this issue—it is like relatives of those who have died in an air crash or at sea. People want closure; they want to find the evidence and a reason for what happened, just as with all issues that involve the public sector in one way or another, as clearly this one does. As far as I am aware—nothing has come to me—these people want no apology or financial compensation such as that appropriate in the case of contaminated blood, but they want closure in their own minds. They cannot get that until they have a statement from the Government, which must follow a proper inquiry, and that is what we are asking of the Government today.
Let us be precise about what is being asked of the Government. We are all aware of the great pressures on Government time, particularly specialist time. They may look back and say, “This affects a relatively few number of people.” Indeed, this is not the fullest debate we have had in this House, but for those affected it is of deep concern, and they cannot rest until they know what happened. That is why I am so pleased to support the motion of my hon. Friend the Member for Bolton South East.
The motion is to the point. It simply
“calls on the Secretary of State for Health to fully disclose all documents relating to the use of Hormone Pregnancy Tests held by the Department from the period between 1953 and 1978”.
Members will remember that the case I cited came right in the middle of that period, when already some indications—no more than that—had been raised by Dr Gal. They had been dismissed and there was no clear, massive statistical correlation between what was happening in a certain number of cases and the use of the drug. Fair enough—but the issue was not being taken as seriously as we would have liked, and it went on far too long.
My hon. Friend indicated how lax and slow the predecessor agencies to the MHRA and the Government were in reacting to the situation. As late as July this year, the Secretary of State for Health said that there was no evidence for these claims. If so, let us have the documents. The motion also
“calls on the Secretary of State to set up an independent panel to examine these documents.”
Nothing more, nothing less. It is as simple as that—a limited request to the Minister on an important topic to bring closure to certain individuals. If the will is there, Ministers can find the resources. I urge the Minister, as do other hon. Members, to accede to our requests in the name of our constituents who cannot otherwise reach closure, and to announce that he will set up that panel as soon as possible.
Nick de Bois (Enfield North) (Con)
It is a pleasure to follow the hon. Member for Coventry North West (Mr Robinson). He may be troubled—or pleased—to know that I have spoken after him on more occasions than I have any other Member, which means that I have probably listened to more of his speeches, and he has had to listen to more of mine, than absolutely necessary.
It is a pleasure to support this debate and the case made by the hon. Member for Bolton South East (Yasmin Qureshi). I know that she has made considerable efforts in this very distressing matter. With all the cynicism about politics today, if we ever need a reminder of how active constituency MPs can play a positive role for their constituents, the evidence of this debate makes the case better than anything else I could say.
A constituent of mine, Chris Gooch, approached me some time ago about this issue and her daughter, Emma-Victoria. I echo what my hon. Friend the Member for Aberconwy (Guto Bebb) said—that the sense of responsibility that parents feel in such circumstances is magnified by the fact that they cannot as yet even be certain that the decision that they took in good faith, fully trusting the medical authorities and the drugs manufacturers and confident that regulation would protect them, has had such a dramatic effect on them and, more importantly, their offspring.
Chris Gooch made this point to me: “When I went to the GP, I did not ask for medication. I went to get confirmation of pregnancy. I knew nothing of what tests were available, but have since found out that a totally safe urine test was already available. So why was I given something that had been raising concern among professionals for many years and with no warnings given to GPs?” That sums it up. How is it possible that people can have gone with confidence to a GP they trusted, hoping for confirmation of a joyous event in their lives, and been handed two pills, without prescription, that had a legacy that will live for ever? I hope that the House will be able to make a contribution to lifting the veil of secrecy over this issue by persuading the Government to hold an inquiry.
Let us remind ourselves about that drug. One dose of primodos equates to 13 morning-after pills or 157 oral contraceptive pills. I am no medical expert, as many will testify, but it strikes me as somewhat perverse that a pill with such high levels of medication should be used as a pregnancy test. Surely that is a cause for concern.
Our motion is very simple and the hon. Member for Coventry North West has been kind enough to spell it out. We understand the constraints on government but we hope, particularly as this Government have been determined to shed transparency on so many issues that have been clouded for decades, that this relatively simple and reasonable request for an independent panel to look into the paperwork, history and documentation not in the public light will be accepted. Let me try to anticipate some of the points that might be raised in objection.
The question of causal link, which I am told scientifically may be the case, should not be a barrier to an independent panel. Many scientists and experts have raised the possibility of a large question of doubt. Let us face it: in this place we have made policy on the basis of less evidence than that which has been put forward by panels of experts who raised significant doubts about the treatment that was available and freely given to unknowing patients.
Without running through the whole list, two or three striking pieces of evidence have stuck with me. On 4 November 1966, a consultant pathologist from Sheffield said
“The test is unreliable. It may well have been dangerous”.
On 23 June 1967, the Medical Research Council said:
“It looks like it could be another thalidomide story.”
Schering’s own specialist advice in the UK raised doubts.
Our job in this House is to reflect the wishes, concerns and priorities of our constituents. I find myself at one in asking the Government’s help to navigate through these documents and this history. It becomes very complex for all but the most persistent. It is with that in mind that I pay tribute to the campaigners, because they have not been daunted by that task. They have not been daunted by the conflicting evidence. They have not been daunted by the lack of funding, or the availability and sudden loss of witnesses to legal cases in the past. They have persevered ruthlessly to try to obtain documentation, despite having the full weight of the establishment against them so frequently and so often, that I feel the time is right for us to champion transparency. Let transparency be championed across the House, albeit that we need the Executive branch of government to implement it.
Mr Robinson
I have been briefed fully by campaigners outside this House. Marie Lyon, whose daughter was born with a very foreshortened arm, came to see me with her husband yesterday. She has been indefatigable in her briefing of MPs and we should pay tribute to her for that.
Nick de Bois
Indeed we should. I echo and support those sentiments, as I am sure we all do across the Chamber. They reflect the courage and determination of every sufferer in every family. Their bravery in confronting this and in facing the future should be honoured by the setting up of the independent panel that they rightly seek.
I want briefly to press three issues: the conduct of the manufacturer; the conduct of previous Governments; and the conduct of the profession. I believe they build a compelling case for uniting behind the motion.
In 1978, when this issue was first raised, a former Labour Member, Jack Ashley, championed the cause in Parliament. It was reported in The Times that he pressed the then Health Minister to hold a public inquiry—this was after an intolerable eight-year gap between the first doubts being raised and a warning being issued by the Committee on Safety of Medicines—but unfortunately his response set the tone for the future. He said that nothing new would learned from holding an inquiry—as we now know, thanks to the diligent work of campaigners, there was lots more to be learned, and there probably still is—and that it was not worth following up because most cases would have been dealt with. I submit that this approach—expediency over justice for victims of primodos—was not necessarily the right one to take. His tone was reflected in later ministerial statements, but Jack Ashley pressed on, and I am sure he would have been proud of the hon. Member for Bolton South East for showing the same diligence.
We need to explore what the committee did between 1967 and 1975, and it is right that we now give members of the action group the opportunity to understand what happened. What government records are lurking about? It is right that we finally establish how many people were put at risk. Where was the duty of care in government, the profession and the regulatory body? In 2014, we can at least make a modest effort to make up for the then Government’s failure to consider those points.
What of the profession? In 1967, the Medical Research Council made it clear that primodos could have been another Thalidomide—so far, so good—and warnings were expressed about the high proportion of pregnancies in 1968 following use of the drug. This should have been sufficient for the profession to press for more to be done. We know that the committee was prepared to publish information letting the profession know of its concerns, and it even concluded in a letter in 1967 that if its concerns were made known, it could reduce its use by GPs, and that this would have been no bad thing. But nothing happened. In fact, the committee referred it to a GP survey for two years, until 1969, despite being fully aware of the warnings, and nothing happened until the matter was exposed by the media in 1975. This led to warnings, and subsequently the manufacturer put a warning on the box.
In 1975, the World Health Organisation asked why nothing had been done for so long. I cannot judge what was going on at the time, but I think we will be judged on how we deal with this issue in this present time, and I hope that will be sufficient to drive the Government towards the independent panel. The company was completely aware of warnings—not just from the profession and the regulatory body with which it was in communication, but from its own staff.
I freely refer Members to my declaration on the Register of Members’ Financial Interests because I worked with medical companies before coming here. I am aware of much of the excellent research and development that has come from within this sector, but let that not cloud our judgment on this issue. We must hope that it is not just our Government and our NHS who buy into transparency; it must be the role and responsibility of our pharmaceutical companies to do so wherever they may be. We are not selling a consumer good here; we are selling a product that must secure the absolute trust and absolute faith of both the profession and the users. We should never be in the position of having to say that there has been the potential for deliberate mismanagement of information from, in my opinion, right across Government, manufacturers and regulatory bodies, leading to this most distressful and distasteful situation for people who are suffering now as a result of some of that conduct.
I hope that Schering, now Bayer, will embrace the mood of this House and voluntarily come forward with as much information as possible. In this age, that would bring more benefit than harm to corporations that are understandably concerned with their image; above all else, however, such action would enable them to fulfil a moral responsibility that has clearly been lacking in this case.
I would be grateful to know that today, notwithstanding all the other issues we can argue about and the things we could do, we can take a moral and justifiable stance to help secure justice for campaigners who have been worried, troubled and wronged for far too long. I hope that the Minister will listen favourably to that request.
Madam Deputy Speaker (Dame Dawn Primarolo)
Order. I suggest to remaining speakers that in order to ensure that everyone gets into this important debate in the time we have left, each speaker should take no more, which means less, than 10 minutes. That will share the time fairly and enable us to hear what the Minister has to say at the end.
Roberta Blackman-Woods (City of Durham) (Lab)
I congratulate my hon. Friend the Member for Bolton South East (Yasmin Qureshi) on securing this important debate and thank the Backbench Business Committee for granting it. I would like to thank, too, my hon. Friends for setting up the all-party group, which has been so helpful in supporting campaigners on this issue.
In common with my hon. Friend the Member for Coventry North West (Mr Robinson) and the hon. Member for Enfield North (Nick de Bois), I have come to this issue via my constituents, and I shall talk in greater detail about the experience of Mr and Mrs Chapman in a few moments. When they came to see me at a surgery a few months ago, I approached the issue, as have most hon. Members, with a certain degree of incredulity that a situation such as that experienced by that family could have gone on for so long without any action being taken, particularly without any serious examination of why so many babies were born with serious deformities between 1953 and 1975 or of the relation between those deformities and the hormone pregnancy drug that so many of the women had taken.
We know that the most common abnormalities identified include neural tube defects, cleft lip and palate, limb reduction defects, general cardiovascular defects as well as many more. It is believed that 1.5 million women took primodos and the effect of the drug much depended on the stage of pregnancy, but in addition to many women having children with defects, it is thought that in many more women the drug caused miscarriage.
In a written parliamentary answer in the previous Parliament, the number of those affected in the longer term by primodos was assessed at about 3,500. Most campaigners think that that figure is too low and that the real figure is much higher. We know that the drug company simply discontinued primodos and never looked back, but the victims, their parents and their wider families continue to live not only with the birth defects, but with uncertainty over what has caused them. Mothers are unable to forget the guilt for using the drug. Their children, now grown up, continue to look for answers as to why they were born with abnormalities. It is up to us in the House today to try to ensure that those people get the answers they have been seeking for many decades.
We know from sales statistics that many thousands of women used primodos as a pregnancy test between 1970 and 1977 even though it was not licensed for use in that way. We know that there was a huge delay in putting information into the public domain about the possible dangers of using the drug; indeed, information did not appear in the public realm until eight years after the first reports indicated possible dangers. That seems to be an extraordinary delay and, again, one for which no real explanation has been given.
Similarly, and despite the weight of evidence, regulators did not warn doctors and patients about the possible dangers of using the drug until much later than in other countries. Authorities in Sweden, Finland, Germany, USA, Australia, Ireland and Holland issued warnings on the drug as early as 1970 to 1975. That was many years before any warning was issued in the UK, despite the fact that the Committee on Safety of Medicines was the first medical authority to know of the hazard, as other Members have said. We know that some doctors continued to prescribe the drug to pregnant women even after official warnings from the Committee on Safety of Medicines had been given. We need some answers as to why doctors kept on prescribing the drug even when it was known that there were some dangerous consequences of using it.
We also need to ask why the medical community and indeed the committee that was licensing medicine did not take on board much earlier information, especially in the academic medical community, about the potential harm that could be caused by taking the drug. As early as 1967, as Dr Isabel Gal discovered, there were warnings that primodos potentially caused spinal congenital malformations in newborns. The Medical Research Council picked up on that the next year and said that it could be another thalidomide story. Yet no real action was taken to remove the drug until 1978. Some explanation for that delay would be very helpful.
We know that the drug companies and the MHRA are now saying that it is very difficult, given the passage of time, to do anything about this dreadful situation. We have to reject that notion very strongly. There are data available. They may not be in the public domain at the moment, but those data need to be examined and that is the purpose of the motion. The issue needs to be examined very carefully to provide some answers and to see whether a causal link can be confirmed. If not, other answers must be given to the people who have for many years considered primodos to have been the cause of the birth defects they experienced.
I will try to stick to the 10-minute ruling on speech length, so finally I will talk about the case of Mr and Mrs Chapman. I have their full permission to talk about their situation. It is truly heart-wrenching. Their daughter, Margaret, was prescribed primodos—two tablets were the instructions—simply to confirm a pregnancy. It was not her first pregnancy. She was surprised that she was being given medication to assess whether she was pregnant, and queried it, but the doctor said there would be no side effects, so she trusted the doctor and took the tablets. After her baby was born in March 1975, she noticed that her baby was blue, called the midwife and the baby was rushed to Newcastle general hospital. The baby was diagnosed as having a deformed heart and they were told she would probably not live very long. She was given emergency surgery in a specialist heart unit and, despite dedicated nursing at home by her mother and wider family, lived only for 18 months. That dreadful situation has stayed with that family for many years. It is heart-wrenching, and they desperately want some answers.
My hon. Friend the Member for Coventry North West said that these families desperately need closure. I agree, and I hope we make a decision today to set up an independent panel, and to have all the relevant documentation put in the public domain. These families have been extraordinarily patient—we must pay tribute to how they have kept campaigning year after year, despite not really being listened to—and I hope today we listen to them and start the process that will perhaps give them some answers.
Caroline Nokes (Romsey and Southampton North) (Con)
I, too, congratulate the hon. Member for Bolton South East (Yasmin Qureshi) on having secured this important debate. I will keep my comments brief because, unlike many other Members present, I come to this subject quite late, and solely through a constituency interest; one of my constituents contacted me. I congratulate the hon. Member for City of Durham (Roberta Blackman-Woods) on her in-depth knowledge; sadly, I will not be able to add much to that.
I simply want to comment on the contact I have had from my constituent, who first approached me on this issue back in the summer. He desperately wanted to come to the launch of the all-party parliamentary group—I congratulate those Members who have set it up, perhaps particularly my hon. Friend the Member for Enfield North (Nick de Bois), who has worked tirelessly on this issue—but could not attend because his daughter, Vicky, was in hospital. She remained in hospital for 11 weeks. She underwent three major operations, and very nearly died during one of them. All that was entirely due to the fact that her mother had taken an oral hormone pregnancy test some 42 years ago. I know it is 42 years ago, because it particularly struck me that Vicky was born in the same year as me, 1972, which is well after it was known that there were problems with oral hormone pregnancy tests. That information had not been communicated to GPs.
We all know how quickly information now spreads, particularly via the internet, so if there are ever any concerns about medication or medical treatment, we very quickly learn about them. It seems incredible that in 1970 there were known to be problems, yet that information was not communicated to GPs until 1975. Vicky was born during the five-year window when the problems were well known and the drug had had its licence removed but it was still being prescribed by practitioners.
Vicky has a phenomenal raft of problems that were caused by the drug. She was born with an ectopic bladder and malformations of her feet and legs. She also has an incomplete pelvis and significant spinal problems. She is doubly incontinent, and for the past 24 years she has been confined to a wheelchair. She is unable to walk at all. I have met her several times, and when I first met her I had no idea what had caused her disability. I just knew her as a really lively, bubbly, enthusiastic member of the Romsey disability forum. It was not until her father contacted me and explained how her problems had come about that I began to appreciate what had caused her disability and how preventable it was. She could have been born completely healthy, had her mother not been given those drugs.
Vicky’s family have been quite amazing. They are really courageous and brave, and they were determined to hear the issue debated on the Floor of the House of Commons. They are pleased that it is being discussed today. What they and many other families want is the transparency that other Members have been calling for. They want to know what is in the documents that have not yet been made publicly available, and they would like me to urge the Minister—as many other colleagues have done today—to ensure that they are made available.
The family also want closure, and I do not think that that is unreasonable. We have heard from other Members that closure is critical to these families. The family support the calls for an independent panel to examine the documents, to come to an understanding of what went wrong and to give them the answers that they so desperately seek. I do not think those are big asks. In fact, they are really very modest and reasonable, and I sincerely hope that the Minister will be able to grant the wishes of the many families who have campaigned for so long, and give them the answers they are looking for.
John McDonnell (Hayes and Harlington) (Lab)
People often ask what an MP does. I think that my hon. Friend the Member for Bolton South East (Yasmin Qureshi) and the hon. Member for Enfield North (Nick de Bois) have demonstrated what a good MP does. They have taken an issue that has been brought to them by their constituents and pursued it until they achieve an end result. I hope that we will see such an end result today. I congratulate them on what they have done.
I was contacted by my constituent, Mr Kulvinder Sidhu, who asked me to attend and participate in today’s debate in order to secure the establishment of the panel and the full release of all the documentation. I do a radio show each week on Hayes FM, our local community radio, and I recently interviewed Mrs Valerie Williams, the former chair of the Association for Children Damaged by Hormone Pregnancy Testing. She succinctly explained the background to this scandal, and it was an extremely moving interview. She described some of the appalling human suffering that has taken place, and it was really shocking.
This seems to be a worrying hangover from the past. We thought, after the thalidomide inquiry, that we had put issues such as this behind us. We thought that in such issues, there would subsequently be full transparency, openness and decisive action by Governments. Today will test whether that is the case, and whether we will see decisive action. I do not think the general public would understand if there were a continued refusal to release all the papers, or if there were resistance to the establishment of an independent panel inquiry. My hon. Friend the Member for Bolton South East has already said that we are mopping up the scandals of the past, including Hillsborough and Bloody Sunday. The hon. Member for Enfield North said that we are now living in a different era, with more openness and transparency. This debate will test whether that is really the case.
It is difficult to understand how we have arrived at this situation. We have to address the issue of the pharmaceutical industry’s relationship with the medical profession and with the Government. Big pharma, as it is now called, has insinuated itself into the decision-making and policy-making processes of successive Governments for the past few generations, and I believe that it has had an undue influence not only on Government decision making but on some of the professional institutions that regulate the medical sector. Big pharma is one of the most powerful lobbies in government of any industrial sector. This case is another example of where one company has used the clout of its financial resources, through the legal system, to silence critics and even those who have researched the information and tried to publicise it. That was demonstrated by my hon. Friend the Member for Bolton South East in respect of the denial of not only access to information, but of someone even being able to publish or to produce a film that would have demonstrated to the wider general public exactly the scandal that is taking place. For too long, the pharmaceutical industry has dominated Government policy in a number of areas, including this one.
So I say to the Minister that this is a test case about who governs this country in the area of drugs safety and about the medical safety and security that we offer our constituents. I see no reason for the Government to deny the full publication of all the documentation and I also see no reason why we cannot have an independent panel inquiry. If such a panel is set up, I hope that not only will it be fully resourced, but those who will want to provide information to it will also be resourced, and that includes the campaigning organisation that has been fundamental to delivering today’s debate. Anything less than that will compound the scandal, because we now know much more than we did in the past about the cover-ups that have gone on, the sacrifices that have been made by individual families and the need for Government action today.
Paul Burstow (Sutton and Cheam) (LD)
I congratulate the hon. Member for Bolton South East (Yasmin Qureshi) on securing this Back-Bench business debate, which is a great example of such debates being used purposefully to pursue a passionate commitment of a Back Bencher. I also congratulate all the hon. Members who have applied for this debate and participated in it on the basis of constituency experience. What has emerged palpably is a deep sense of injustice, and Nichola’s story, mentioned by the hon. Lady, is telling in that sense. These families’ lives have been marred by a sense of not knowing, of grief and, in some cases, of guilt, as was mentioned by the hon. Member for Aberconwy (Guto Bebb). Clearly, there is a strong belief that oral hormone pregnancy tests—primodos and others—taken between 1953 and 1975 did lead to children born with serious deformities.
It has been interesting to hear the evidence that has been gradually ferreted out of the system. It has been reluctantly given but persistently chased by those who believe that a deep injustice has been done. Some of the material that has come to light from the national archive as the relevant periods of time have elapsed demonstrates that. The hon. Member for Enfield North (Nick de Bois) and others have cited it, but it is worth saying that the director of the Medical Research Council—that is who this person was, so we are not talking about a small, insignificant organisation—said in June 1967:
“It looks as if this could be another thalidomide story”.
That should have rung alarm bells at the time, and it raises questions as to why if the bells did ring, they did not get heard and why the necessary steps were not taken for a considerable time after that.
It is interesting to look at this April’s report by the Medicines and Healthcare Products Regulatory Agency. Although it acknowledges that a number of the studies do identify concerns about an association between hormone pregnancy tests and abnormalities in children, it goes on to dismiss them, and that is a cause for concern. I was struck by the fact that the Committee on Safety of Medicines in the 1970s—the independent body that advised at the time—did advise on the safety of these drugs, albeit slower than many others when it did so. It advised that pregnant women should not be using these drugs. We have heard compellingly about how other countries acted sooner, presumably on the basis of the same evidence, and it behoves us to try to understand why we did not act sooner. We know from freedom of information requests that the MHRA did write to doctors in the 1970s—in 1975—warning GPs of its concerns about the congenital defects.
The MHRA made it clear that primodos was not licensed as a pregnancy drug from the early 1970s, so it was being prescribed off licence. If we look at the current codes of conduct within the General Medical Council about prescribing off-licence drugs, it is very clear what needs to be done. Extra obligations are placed on those prescribing, and I cannot believe that those obligations did not and should not have applied in the 1970s. That alone warrants this panel having a chance to ask questions. Thousands of prescriptions were still issued right through to 1977 despite the warnings and those extra obligations on doctors when they prescribed off-licence drugs.
In April, the review of the 36 studies that have been undertaken concluded, rather disappointingly, that the evidence was inconsistent and not sufficient to reach a conclusion. I cannot help feeling that there is something missing from the MHRA’s work. Indeed it says itself that something was missing. All it could rely on was the available published evidence. My question today is: what about the unpublished evidence—the evidence that sits in the vaults of the companies that manufactured the drug? I hope that, as an act of good faith, those companies that protest their innocence in all of this are now prepared to put into the public domain and fully disclose all of their information about trials, so that that can be taken into account as well.
The motion that has been tabled today is perfectly reasonable—some might say almost too reasonable—in what it is asking for. It is not an unreasonable request of the Government to have a panel to examine the evidence and to look at what is in the national archives, the MHRA files and the Department. I hope that Bayer, the pharmaceutical company that owns Schering, which manufactured the drug, co-operates as well. This is about learning lessons, ensuring that these things cannot possibly happen again and shining a light on to a very dark period in our medical history and understanding that even things that happened a long time ago continue to have real consequences in people’s lives today. Although I fear that action will not bring closure, we should at least take it because it might, and I hope that the Government will listen to the representations that have been made today, because the case for a review is compelling.
Pamela Nash (Airdrie and Shotts) (Lab)
I add my congratulations to my hon. Friend the Member for Bolton South East (Yasmin Qureshi) not just on securing this debate along with the hon. Members for Enfield North (Nick de Bois) and for North East Somerset (Jacob Rees-Mogg), but on her determined campaign on behalf of her constituent Nichola Williams. It is a measure of the success of this recent campaign that we are talking about this matter in the House and that there is rapidly increasing public awareness. Marie Lyons has also contributed to the campaign. In Scotland, my constituent Rose Stallard has been campaigning on the matter. Recently, she featured in an article in the Daily Record talking about her family and their experience.
Long before today’s commonly used urine-based pregnancy test, women were reliant on their doctors and the Government to prescribe what they believed to be safe oral pregnancy tests. One such test was primodos, which came in a small green packet of two small pills containing hormones. Patients were advised to take one tablet and then, if they did not bleed, a second 12 hours later. But in the 1960s and 1970s, the concentration of those strong hormones was extremely high. One dose of primodos equates to 13 morning-after pills or 157 oral contraceptive pills, which seems unbelievable given our increased knowledge now.
It is not yet clear how many people have suffered as a result of this drug, but at least one family in my constituency has been affected, and I suspect that there are many more. Mrs Stallard was one of the 1.5 million women who were prescribed primodos, which we now believe had such terrible consequences for their children, which included being born with under-developed limbs and facial deformities and many other medical problems, some of which we have heard about today.
Members are here today to represent their constituents and highlight the impact on their lives of the disabilities that resulted from their mothers being given that tablet, but we must remember that the drug is also suspected to have caused many miscarriages. I hope that that will be included in any review or inquiry resulting from the campaign and, indeed, from today’s debate.
Mrs Stallard told me that she was offered primodos by her GP when she thought that she was pregnant back in 1969. Having taken the test and bled, she thought that she was not pregnant after all, but she soon realised that she was indeed pregnant. She had a very normal pregnancy and gave birth to her third child—her first and only daughter—to her delight and that of her husband, Bobby. Unlike other cases we have heard about today, it was not until Elizabeth was over a year old that Rose noticed something was wrong, as Elizabeth was not developing at the same rate as her niece, who was the same age, and indeed her other children. Despite that, the family were advised that there was nothing wrong with her.
Eventually, when Elizabeth was three, the family were told by their doctor that she had “slight retardation”. That is the only diagnosis she has ever received, and she is now 44 years of age. She went to mainstream primary school, but it soon became apparent that she needed specialist help and she was transferred to a school that could provide it. At 15 she began to experience physical impairments. Only recently was she eventually given a brain scan, which showed that parts of her brain are now shrinking.
I want to highlight the fact that Elizabeth is now 44, so she has lived for more than four decades without any diagnosis, treatment or support. I also want to highlight that that is the age of the people affected. I agree with my hon. Friend the Member for Coventry North West (Mr Robinson), who highlighted the fact that one of the main purposes of the campaign is to gain closure for the families affected. It is also about getting support for those men and women. They are now in their 40s and 50s and really need the care and support that can be provided by a full inquiry and compensation. Their parents, who are providing their care needs, are also getting older and are increasingly concerned about the future for their children. For more than four decades Rose has had to live with the aftermath of having been prescribed those pills.
What angers me most is the fact that the evidence now available suggests that serious concerns about the safety of primodos were already being expressed years before Rose, and thousands of other women, took the test. It should have been taken off the market when those concerns were first expressed, and doctors should not have been prescribing it after the warnings were given. All those affected deserve to know exactly why that was not the case. Why was it not taken off the market and why did it continue to be prescribed in our NHS?
Back in 1968, Schering’s lead scientist wrote to the company’s headquarters in Berlin and made it clear that he was deeply disturbed by the evidence he was seeing of the impact the drug was having on children. Indeed, it is deeply disturbing not only that those effects were apparent, but that they were not acted upon immediately. If that research had been published then, rather than only recently, Rose and thousands of other women might not have given birth to children with life-limiting disabilities or might not have miscarried.
Let us be clear—this point has not yet been made—that primodos was not a necessary medication. The risks and benefits of new medications have to be weighed up, and there can be debate over whether the benefits outweigh the risks. Although knowing for certain whether a woman is pregnant is helpful, and for some it is definitely medically helpful, it is not essential. I suspect that most women, if not all, presented with the risks of that test would rather wait a few weeks to know for certain whether they were pregnant. These women did not get the opportunity to make an informed decision, because they did not know about the risks at the time, even though they were known to others.
The hon. Member for Enfield North mentioned the work done in this place by the late Jack Ashley, who was the Member of Parliament for Stoke-on-Trent South. When I was doing my research before the debate, I read a response that he had received to a written question in 1977. He was told by the then Secretary of State for Social Services:
“In 1975 the Committee of Safety of Medicines advised the Health Departments that hormonal preparations, including Primodos, should not be indicated for pregnancy testing and that a warning about a possible hazard in pregnancy should be inserted in all promotional literature.”—[Official Report, 13 December 1977; Vol. 941, c. 152W.]
More than 30 years ago, in the House of Commons, this drug was declared to be hazardous. I find it hard to understand why the need for an investigation of something that was deemed hazardous, and was taken by many women on whose pregnancies it had hazardous effects, is still being debated in the House. Furthermore, it was revealed over the summer, in response to freedom of information requests to the Medicines and Healthcare Products Regulatory Agency, that letters had been written to GPs warning them about
“an increased incidence of congenital abnormalities”
in babies born to women who took the drug. Yet it was not until 1975 that the drug company finally placed a simple warning on the packaging.
Let me put to the Minister some of the questions that have been raised by me, by other Members who are present, and by our constituents. Mrs Stallard and the many families who have been affected are very clear about their need for answers to these questions. Why were papers not published when research was being conducted in the 1960s that would have shown the dangers of primodos at the time? Why did it take until this year to publish the documents? What other related documents are being held by the Government, and indeed by Bayer, and are yet to be published? Will the Government undertake to publish immediately every single document that is available to them? Why was primodos not removed completely from use until 1975—or, according to some reports, 1978—years after the dangers were known? Most important, why was it still being prescribed after the Committee on Safety of Medicines had issued official warnings?
I ask the Government to commit themselves today to establishing an independent panel to examine those documents. I also ask them to acknowledge the need for an independent inquiry if a review by the panel reveals that it is required.
This morning I was visited by my aunt, who asked what the day held for me. I told her about the debate and about primodos, its suspected impact, and the fact that we were campaigning for and requesting an independent panel review. She simply looked at me and said, “I do not understand. Why does this require a debate? Why will the Government not agree to it immediately?” I could not agree with her more, and I hope that the Minister agrees with her too.
Luciana Berger (Liverpool, Wavertree) (Lab/Co-op)
I thank my hon. Friend the Member for Bolton South East (Yasmin Qureshi) and the other sponsors of the debate for ensuring that the House discusses an issue that has been ongoing and unresolved for 40 years. I greatly admire my hon. Friend for her tireless campaigning on behalf of the families, who have never received the answers they deserve. I thank other Members for their thoughtful contributions, which are testimony to how much the issue has moved those in all parts of the House. I also pay tribute to Marie Lyon, chair of the Association for Children Damaged by Hormone Pregnancy Testing, who has never given up what has been a real struggle to get to the bottom of what happened and why. I had the privilege of meeting Marie and hearing her own story.
Today I speak not just on behalf of my party’s Front Bench and as a member of the shadow health team, but in my role as a local constituency MP. I was visited in Liverpool by my constituents Pat and Terry Hughes, who told me their story, which I have their permission to share with the House. Pat had taken the oral hormone pregnancy test, primodos, in 1971, and her daughter Katherine was born by caesarean in October of that year. When Pat came round from the operation, she was told that something had gone horribly wrong. Katherine had been born with no gullet and no back passage. She had kidney problems and disfigured feet. Very tragically, Katherine survived for just two hours. Pat and Terry never had the opportunity to see their baby. I was incredibly moved to hear that story about Pat, Terry and Katherine’s experience, and about Pat and Terry’s immense bravery, but also about their determination to find out why Katherine was born the way she was.
As we have heard, Pat and Terry Hughes are not alone. Many hon. Members in all parts of the House have shared their constituents’ stories. It is worth reminding the House of how many stories we have heard. We heard from my hon. Friend the Member for Bolton South East about Nichola Williams. The hon. Member for Aberconwy (Guto Bebb) told us about his constituent Mrs Roberts and her son Garry. My hon. Friend the Member for Makerfield (Yvonne Fovargue) shared the story of Mr and Mrs Tilly and their son Stephen. My hon. Friend the Member for Coventry North West (Mr Robinson) talked about Christine Pettifer. The hon. Member for Enfield North (Nick de Bois) spoke on behalf of his constituents, Chris Gooch and her daughter Emma-Victoria. My hon. Friend the Member for City of Durham (Roberta Blackman-Woods) spoke on behalf of Mr and Mrs Chapman and their daughter Margaret. The hon. Member for Romsey and Southampton North (Caroline Nokes) talked about her constituent Vicky. My hon. Friend the Member for Hayes and Harlington (John McDonnell) spoke on behalf of his constituent Kulvinder Sidhu. My hon. Friend the Member for Airdrie and Shotts (Pamela Nash) spoke on behalf of her constituent Mrs Rose Stallard and her daughter Elizabeth.
Those are just some of the many hundreds of individuals and families who have endured for more than 40 years not just the disabling physical conditions but an overriding sense of injustice. We are here today to determine whether there is a case to answer, whether there are unanswered questions, and whether there is information out there that might help fill in the gaps. I think that the case is clear.
Let me summarise the points we have heard. We have heard about the drug itself. Like the hon. Member for Enfield North, I am not a medical professional, but we do not need to be doctors or scientists for alarm bells to ring when we hear that a drug that was approximately 40 times the dosage of a contraceptive pill prescribed today was then prescribed to be taken by pregnant women twice within the course of 12 hours.
We have heard about the many women who took the pill at the time and who went on to suffer instant miscarriages. Thousands more gave birth to babies with missing limbs, abnormalities in their internal organs, brain damage, and heart defects. Many of those children died before reaching adulthood. Of course, many mothers who have not taken this pill also gave birth to babies with disabling conditions such as these, but the scale of the proportion of women who had taken the drug and who experienced complications gives rise to some serious questions. There were between 500 and 700 UK members of the Association for Children Damaged by Oral Hormone Pregnancy Tests, although it is thought that the true number of alleged victims may be in the thousands. The Government have estimated the number to be 3,500. In Germany, where a primodos equivalent was distributed, another 500 families are fighting for their claims to be heard.
We have heard about the studies on the drug that were undertaken at the time. In 1968, the Royal College of General Practitioners sent a letter to Dr Inman of the Committee on Safety of Medicines stating that 10% of abortions recorded after primodos were unlikely to be due to chance. The committee received a letter from the Usher Institute of Public Health in Edinburgh, which had concerns about its study on rats and abortions. It stated:
“Primodos should be withdrawn from use.”
In 1968, the drug company’s lead UK scientist wrote to the parent company in Berlin:
“it is extremely disturbing that the results of statistics, human studies and other studies all point clearly to the possibility that Primodos may interfere with a pregnancy.”
Those are just some of the studies and warnings that were received throughout the 1960s and early ’70s, and we have heard from many hon. Members on both sides of the House about further representations and studies that were done at the time.
That takes us to the crux of the debate: the significant delays in communicating those warnings. By the early 1970s, primodos was no longer authorised as a pregnancy test. In fact, it contraindicated for use in pregnancy, meaning it was declared that it should not be taken during pregnancy. Despite that fact, primodos continued to be used as a pregnancy test until 1975, when the Committee on Safety of Medicines finally wrote to doctors to warn them that the drug “may cause congenital abnormalities”. A warning was placed on the packet, saying it was
“not to be used during pregnancy...may cause congenital abnormalities”,
but it was not until two years later, in 1977, that the committee wrote to GPs stating that the “association has been confirmed”. In 1977, there were 7,038 prescriptions of primodos to pregnant women. A 1975 paper for the World Health Organisation questioned why research on such a critical issue, published in the late 1960s, was not followed up for many years.
It is worth reiterating that the authorities in Sweden, Finland, Germany, the USA, Australia, Ireland and Holland issued warnings and took action on hormone pregnancy tests as early as 1970, five years before any warning was issued in the UK, despite the fact that the Committee on Safety of Medicine was the first medical authority to know of the hazard.
Let me be clear: the point today is not why this drug was ever allowed to be prescribed in the first place, although there are some very serious questions hanging over that. No one is questioning the GPs who prescribed the drug. Why would they question the safety of the medicines and drugs approved by the Committee on Safety of Medicines? The problem is why, after so many warnings, and after it lost its licence to be given to pregnant women, there were so many delays in communicating that information to GPs. It was that delay that meant that so many women continued to take the drug long after it was known to be unsafe. Had the drug been withdrawn when the warnings become clear in 1970, my constituent Pat Hughes would not have taken it in 1971.
Why are we here? Why has this case not been resolved before now? We have heard from many Members that an opportunity the group had to mount legal action—which was supported by Lord Ashley, the then Labour MP for Stoke-on-Trent South—against the pharmaceutical company Schering had to be abandoned before it got going, when the Legal Aid Board said it could not continue to provide public funding because it felt the weight of the argument was in favour of Schering.
That case, however, was more than 30 years ago. Just because the evidence we have knowledge of is insufficient does not mean there is not a case for investigating the issue further and trying to find out more. That is why we are here: to call for the full disclosure of all the documents held by the Government relating to this drug.
There are real challenges in obtaining scientific proof of a causal link, but the facts that we do have are incredibly compelling. The drug has been withdrawn, so it cannot be tested on women, and those women who were affected have gone back to their doctors for their records, only to find that they are no longer there, as my hon. Friend the Member for Makerfield has said. I will not speculate on why the records are not there any more—I will leave it to Members to draw their own conclusions—but I understand that the BBC has made a documentary to expose that particular issue.
The situation leaves us with a real problem, and not just for those families affected: this is a matter of principle about the integrity of how we do things in this country. Marie, the chair of the Association for Children Damaged by Hormone Pregnancy Testing, explained to me that whenever she visits a doctor now, she questions everything that is prescribed to her. She has lost trust. These families want to prevent this from ever happening again.
The primodos case also raises wider questions about the safety of medicines. It is not acceptable to have such a shadow of doubt hanging over the impact of a drug that was licensed, prescribed and taken by women without due and proper process. If there are documents relating to this drug, it cannot be right that they are not made publicly available.
I want to finish by coming back to Marie Lyon, my constituents Pat and Terry Hughes, and all the other families who are still looking for answers. Feelings of guilt and injustice have followed them throughout their lives. They had 40 years of grieving for the children they lost, or of caring for those who survived. As my hon. Friend the Member for Airdrie and Shotts said, these families are getting older. The parents are now heading into their 70s, and they are worrying about who will take care of their children when they are no longer here.
The families still do not have any answers. This cannot be right. They need answers not just for themselves, but to ensure that this can never happen again. The petition signed by hundreds of people, which has been handed in to No. 10 Downing street, shows that that goal is supported by people across the country. Today’s debate has demonstrated that Members from both sides of the House are clear about what needs to be done to achieve it. It is a very reasonable request. It is important that the documents are released and that they are reviewed by an independent panel. I wholeheartedly urge the Minister to commit to making that happen. I look forward to his response.
The Parliamentary Under-Secretary of State for Health (George Freeman)
I congratulate the hon. Member for Bolton South East (Yasmin Qureshi)—I pay tribute to her work—and my hon. Friend the Member for Enfield North (Nick de Bois) on securing the debate. I also congratulate the Backbench Business Committee. I did not rebel very often during my first four years in Parliament, but I am proud that one of my rebellions was in support of the Committee. The debates it brings to the House are often of the very highest quality, as today’s has again illustrated. I am delighted to have the chance to come to the Dispatch Box and speak on this important subject. I pay tribute to the victims’ association for its work, as well as to Marie Lyon, Jack Ashley and the many hon. Members who cannot be here today but take a very close interest in this issue.
I welcome the opportunity to update the House on the Department’s view of this important issue. I first want to assure all hon. Members that the current Government take very seriously the concerns that have been expressed. I want to take this opportunity to express my and other Ministers’ deepest sympathy to those who believe they have been affected by these products. I absolutely commit that this matter will receive the highest attention that it deserves, although hon. Members will appreciate that this is not an easy issue, given the many years—40-odd years—that have passed since the tests were first used.
We have heard some very powerful speeches from hon. Members on both sides of the House, and I want to highlight some of the points made. The hon. Member for Bolton South East spoke powerfully about the era of cover-ups. We have heard a lot in recent years about the cover-up of medical and sexual scandals—in Rotherham, Sheffield, Mid Staffs and, frankly, other areas—which have not been given the attention that they deserve. I suggest that we now need, and we are seeing, a new era of transparency, and that is all to the good. Medical professionals in the NHS and across the system have a duty of care and, like them, Ministers have a duty of care to the people we represent, and a duty of transparency as part of that.
My hon. Friend the Member for Aberconwy (Guto Bebb) spoke powerfully about his constituent Mrs Roberts and his experience of premature births in his family, and the hon. Member for Coventry North West (Mr Robinson) also spoke powerfully. My hon. Friend the Member for Enfield North made an important point about the trust that citizens and patients place in the medical profession and the health system. In return, we owe them a duty of trust and transparency. The hon. Member for City of Durham (Roberta Blackman-Woods) made an important point about how those involved in these cases need to receive some degree of closure and to know that the issue has been looked at properly.
My hon. Friend the Member for Romsey and Southampton North (Caroline Nokes) spoke powerfully about her constituents. The hon. Member for Hayes and Harlington (John McDonnell) made an important point about the historical relationship between the pharmaceutical industry and the medical profession. Let me make this point very clearly: this Minister and this Front-Bench team are here to represent only one special interest group, and that is the patients whom the NHS, the health system and the Department are here to serve. I say that as someone who has come from the industry. We also heard powerful contributions from the right hon. Member for Sutton and Cheam (Paul Burstow) and the hon. Member for Airdrie and Shotts (Pamela Nash).
I want to deal with some of the key points made in those speeches. In particular, several hon. Members mentioned the difficulty caused by the lack of retention of medical records. I have personal experience of that. My father died when I was 19—a year after I had met him—and I was not able to get to the hospital or, later, to find out exactly how he died and what he died of. These days, our system is much better at recording information. This problem is one of the reasons why I believe we should support electronic patient records. Once records are recorded electronically, they are much easier to keep and track, so we would not have many of the difficulties that we face today. The Department is not aware of any documents requesting the destruction of papers or records. I am happy to make the commitment to review and action any papers that come to light.
I should point out for the benefit of the House that Dr Briggs, who is deceased, did not confess to falsifying any studies on hormone pregnancy tests.
It has been said that thousands of children were affected. The evidence on that is not clear and it is difficult to find accurate information. There have been various estimates at different times and the best estimate seems to come from the victims’ association. In 2009, it said that by October 1978 it had gathered information on more than 700 children who might have been affected, and that it had received additional responses and inquiries from other parents every time the topic received publicity. Despite the references to thousands of children, it is unclear how many we are dealing with.
I want to highlight an important quote from Dr Sarah- Jane Richards, who is a senior solicitor in medical negligence at Secure Law in Cardiff, that demonstrates that there is still a lack of clarity and no definitive proof of causality. She said that primodos patients need more definitive data, namely medical notes from several hundred subjects, to strengthen their case. She said:
“The facts are compelling… There are snippets of information which are extremely insightful—but at present, there is an abundance of circumstantial evidence and a great insufficiency of scientific evidence. That is a real hurdle when we see a health issue such as handicap, which happens to an unfortunate two per cent of the population anyway.”
Hon. Members would expect the Government to be guided by the best scientific advice, so I wanted to share that with the House.
I want to address a number of points that have been raised in this debate, in earlier debates and in the work of the all-party group, including the eight-year gap between the first reports of a possible danger and the circulation of an official warning; the continued prescribing of the pregnancy tests by doctors in the 1970s; the need for full disclosure of the documents held by the Department; and the need for an independent panel to examine those documents. I confirm that I will be happy to instruct the release of all information that is held by the Department on this case, and the setting up of an independent panel of inquiry. I will say more about that at the end of my remarks.
First, I want to set the scene, because it is complex and difficult. I know that Members will be interested. As Members are aware, we have in the United Kingdom an agency whose sole responsibility is to ensure that all medicines in the UK work and are acceptably safe. That role is underpinned by robust legislation and guidance. In fact, we lead the world in medical regulation. However, we were not always this fortunate. In the late 1950s, when this story has its roots and hormone pregnancy tests were introduced, there was no legislation on the use of medicines in the UK, believe it or not. Unfortunately, it took the thalidomide tragedy in the early ’60s to highlight that serious deficiency, which now seems extraordinary to everyone in the House. Although sweeping changes to the legislation were made as a result, culminating in the Medicines Act 1971, by that time, hormone pregnancy tests were widely used.
The Committee on Safety of Medicines, to which my hon. Friend the Member for Enfield North referred, was first established as the Committee on Safety of Drugs in 1963 and took on its later incarnation in 1971. I will refer to it henceforth as the committee. Not long after the committee was established, a study was published by Dr Gal that suggested that there was a link between the use of oral hormone pregnancy tests and birth defects. The study was reviewed by the committee, but considered to be methodologically flawed. At that time, the committee was not aware of other evidence to support such an effect. Nevertheless, the committee undertook its own study to investigate the matter further. Over the next few years, a number of studies were published, but the evidence for an association remained limited and the findings inconsistent. The committee carefully evaluated all new evidence as it emerged and, in 1978, concluded that
“to date there is no proof of the existence of a causal relationship between the use of hormonal pregnancy tests and congenital abnormalities”.
As a result of the campaigning of my hon. Friend the Member for Enfield North and other hon. Members, earlier this year the Under-Secretary of State for Health, my hon. Friend the Member for Central Suffolk and North Ipswich (Dr Poulter) commissioned the Medicines and Healthcare Products Regulatory Agency—the lead regulator—to review all the key evidence on this issue and produce a report on its findings, which I believe hon. Members have been sent. The report has also been posted on the MHRA’s website.
Based on studies published between 1960 and 2013, the MHRA’s view is that the results are inconsistent, with some finding no association, some a weak association, and some a strong association. Its conclusion is that the data do not provide conclusive evidence of an association between hormone pregnancy tests and birth defects. As hon. Members will appreciate, the Government have a duty to ensure that they are acting at all times on the best advice available from specialist agencies set up to advise them, which in this case is the MHRA. I believe that in commissioning the report, the Government have listened to and acted on the concerns that have been raised about this drug.
What I believe makes the conclusion difficult to accept is that several studies did show an association that was statistically significant and, of course, many people have visible defects and feel that their lives have been damaged by these drugs. However, there are good reasons why both those observations do not yet constitute the proof that a causal association exists—proof that hon. Members and citizens would expect the Government to acquire before taking action.
As hon. Members will know, it is always exceptionally difficult to know for sure that a medicine taken by a mother during pregnancy is responsible for a defect in the child. It is almost impossible to know whether the condition would have developed regardless of whether the medicine had been taken, and that is especially true for birth defects, which are relatively common and occur in up to four in every 100 live births.
With the studies there is an added complexity in that a statistically significant association is not necessarily the same as a causal association, because limitations in the design of the studies may mean that the results are not reliable. Examples of that include poor recording of what was prescribed by doctors—that, I am afraid, has been all too common; another reason for the digitalisation of health records—as well as biased recall of what was taken by sufferers, the preferential prescribing of pregnancy tests for women who were at higher risk of a difficult pregnancy in the first place, and a number of other complicating factors.
One of the key concerns of the hon. Member for Bolton South East related to the eight-year gap between the publication of the first study finding a link and the committee alerting doctors to a potential risk. Although I appreciate that that may seem an unacceptable delay, it is worth remembering that such a charge assumes that the committee believed there was a causal association. However, the report that I referred to previously suggests that that is not the case, and that the committee at no time considered those pregnancy tests to be responsible for the observed birth defects.
Despite that, in 1969, just two years after Dr Gal’s study was published, the committee took the precaution of asking companies to stop promoting the tests to doctors. As more evidence was published and alternative methods of diagnosing pregnancy became available, the committee considered there to be no reason to use the hormonal methods anymore, and advised doctors of that in 1975. As Members may know, despite the committee’s warnings it became apparent that doctors were still using those outmoded tests, so it issued a further alert in 1977.
At this point I remind the House that guidance provided by the General Medical Council gives doctors in the United Kingdom the freedom to prescribe any medicine if they judge it to be in the best interests of their patient, and they take responsibility for their prescribing decisions. In that respect, I believe the evidence suggests that the committee acted in a proportionate and responsible way given the evidence before it—that is the only test that we can apply at this point.
Pamela Nash
The Minister said that the committee had to issue a further warning in 1977. I appreciate what he says about responsibility being with the GP, but why would a GP prescribe those pregnancy tests if they knew and were clear that they were dangerous? Is it the responsibility of the committee that it did not communicate that danger aptly enough?
George Freeman
Unfortunately, as I have been trying to explain, in our system the sovereignty for prescribing lies with clinicians. Guidance can be issued and we would expect GPs to comply with it. Today that is more often the case, but we are dealing with a period when things were different. I cannot at this point tell the hon. Lady why a number of GPs did not comply with the guidance provided, but it was given very clearly.
Hon. Members have asked that the Department fully disclose all documents on hormone pregnancy tests held between 1953 and 1978. While I support that request, I remind the House that we are talking about an era that mostly predated medicines legislation and companies were not required even to submit evidence to support the efficacy, quality and safety of their products—extraordinary though that may seem to us today. As a result of that, and the fact that the pregnancy tests were withdrawn from use more than 35 years ago, the Department holds very limited information and what it does hold is already in the public domain. That said, I am happy to confirm to the House this afternoon that I will instruct that all relevant documents held by the Department be released.
The MHRA will of course review any new data that emerge as a matter of priority and seek independent expert advice as needed. I am happy to go further and confirm to the House that I will instruct an independent review of the papers and all the evidence. I suggest that that be carried out by the Medicines for Women’s Health Expert Advisory Group, which exists to advise the Department on such matters. It comprises independent members who are experts in their field, and I am happy to take submissions from colleagues to ensure that the association is properly represented and has a chance to give evidence.
Mr Robinson
I apologise for not being in my place for the Minister’s opening remarks. The news that the Minister has just announced is very encouraging and will help to bring closure and reassurance. I am sure that no Member, including my hon. Friend the Member for Bolton South East (Yasmin Qureshi), will want to press the motion to a Division now. I thank the Minister for his reply and the positive note that he has struck.
George Freeman
I am grateful for the hon. Gentleman’s comments and I hope that the House has taken what I have said this afternoon in the spirit in which it is intended. I am open to representations from the victims’ association and to ensure that the inquiry panel addresses all its concerns.
I assure hon. Members that Ministers in the Department will continue to monitor the evidence closely and to work with hon. Members and the victims’ association, so that if there is any reason to believe in a causal link, appropriate steps can be taken quickly. I pay tribute to the hon. Member for Bolton South East for initiating this debate, and I thank the Backbench Business Committee for providing the time. I am grateful for the tenacious advocacy of Members and many people outside, including many who cannot be with us today. We stand on the shoulders of others. Whatever the cause of the appalling disabilities that some people have suffered, their suffering still exists, and I look forward to co-operating in any way I can to try 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.
Yasmin Qureshi
I thank all the hon. Members who have spoken in the debate today. I particularly thank all the members of the all-party parliamentary group on primodos, all those who signed my early-day motion and everybody who participated in the petition that was presented to No. 10 Downing street. I also thank the association.
I should also mention a couple of other people. My hon. Friend the Member for Hayes and Harlington (John McDonnell) mentioned Valerie Williams, who campaigned on this issue many years ago. When my constituent Nichola Williams first contacted me I went to see her at her home. At first glance, she appeared to have nothing wrong with her. It was only on talking to her that I found out about all the internal damage that she has.
The campaigners have found a raft of documents that I went through with my researcher and my office. We thought that something was very wrong and that there had been a miscarriage of justice, and that is why we started the campaign. I am glad that after two years we have finally received an undertaking from the Government that they will appoint an independent panel to look not only at the documents held by the Department, but all the documents that we have. We have a lot of information that we think shows a medical and legal cover-up.
On the causal link, the Minister said that the victims’ association will be consulted. Every lady who took primodos said that it was the pregnancy during which they had taken that drug that resulted in abnormalities in children. Other children those same ladies went on to have were perfectly healthy—in those pregnancies, no primodos had been taken. This is important research and it needs to be looked at.
The Minister said that the numbers of victims may not be in the thousands. It is fair to say that as the campaign has gone on over the past two years, with limited coverage and publicity in my local newspaper and in the national media, I have received letters and e-mails from more and more people coming forward and saying, “This is what happened to us.” I think there are a lot more people out there. Perhaps this is something the independent panel can look at, because we think there are many more people who are unaware of what is happening.
I thank the Minister for what he has said at the Dispatch Box, which is that he will release and look at the documents, set up an independent panel, work with the victims’ association and also look at our documents.
George Freeman
What we might do is set up an expert working group and invite one or two patients’ representatives from the victims’ association to sit on it. If hon. Members are happy, I will write around with a suggestion for how we might do that. I want to just remind the House that those from the Medicines for Women's Health Expert Advisory Group are independent experts in their field. They currently advise the Commission on Human Medicines on issues relating to medicines for women’s health. All members must fully disclose any conflicts of interest and are disbarred from any discussions of issues where they hold a personal interest. I think the House can therefore be confident that these are independent experts. If we set up an expert working group and have patients on it, that should give the House confidence that victims’ and patients’ voices will be properly heard.
Yasmin Qureshi
I thank the Minister for that reassurance. I am sure that those from the victims’ association who are watching the debate will be reassured too.
I thank the Minister again for what the Department has offered to do. We hope it will be done speedily and that there will be a resolution. As we know, many of the victims are now approaching their 40s and 50s. Their medical conditions are worsening and some have died. It is important that they understand what has been happening. They have never, ever asked for this—they have never even suggested it—but perhaps after the investigation we could think about some kind of financial settlement or compensation. As I have said, this is something that I am saying. I think that that would be only fair after all their suffering.
Finally, I have spoken in the Chamber from time to time, but today is the first time that, when I came into the Chamber, I got a little butterfly in my stomach. It reminded me of when I was a barrister before I became a Member of Parliament. I would have that feeling when going into court for a special case of particular significance. When I came in I almost felt that I was going to present a legal case to ask for—
Madam Deputy Speaker (Dame Dawn Primarolo)
Order. Does the hon. Lady intend to talk her own proposal out? If not, perhaps she should allow me to put the question now.
Question put and agreed to.
Resolved,
That this House notes that children were born with serious deformities due to hormone pregnancy test drugs taken by expectant mothers between 1953 and 1975; also notes with concern that as the surviving victims enter their forties and fifties many of them face a host of new problems as their bodies continue to suffer; further notes that no official warnings were issued about these drugs until eight years after the first reports indicated possible dangers; further notes that some doctors continued to prescribe the drugs for pregnant women after official warnings from the Committee on Safety of Medicines; calls on the Secretary of State for Health to fully disclose all documents relating to the use of Hormone Pregnancy Tests held by the Department from the period between 1953 and 1978; and also calls on the Secretary of State to set up an independent panel to examine these documents.