I beg to move,
That this House
regrets that the terms of reference for the Commission on Human Medicines Expert Working Group on Hormone Pregnancy Tests asked the Commission to consider evidence on a possible association between exposure in pregnancy to hormone pregnancy tests and adverse outcomes in pregnancy, but the Commission’s Report concluded that there was no causal association between the use of hormone pregnancy tests and babies born with deformities between 1953 and 1975, even though it was not asked to find a causal link;
believes that the inquiry was flawed because it did not consider systematic regulatory failures of the Committee on Safety in Medicines and did not give careful consideration to the evidence presented to it;
and calls on the Government, after consultation with the families affected so they have confidence in the process, to establish a Statutory Inquiry under the Inquiries Act 2005 to review the evidence on a possible association with hormone pregnancy tests on pregnancies and to consider the regulatory failures of the Committee on Safety in Medicines.
I think we all, as constituency MPs, would have hoped that this debate was unnecessary. We all hoped that the “inquiry”—I use the word advisedly—that the Government constituted in good faith would give confidence to the families and loved ones of thousands—[Interruption.] Shall I pause while Mhairi Black stops laughing?
Thousands of people went in good faith to see their GP because they thought they might be pregnant. That is probably the most important time in any woman’s life. Certainly, as the father of two gorgeous girls, the most important time in my life was when my wife told me that she was expecting our children. It was so important to these families that often they went to their GP, which is a natural thing to do, so we had an NHS patient going to an NHS surgery to see an NHS doctor for advice about whether they were pregnant.
Look at the dates for when these potential mothers-to-be went to see their GP: between 1953 and 1975. That is quite a span of time. My mother could have gone to her GP then, because I was born in 1957. In many ways, it could easily have been me who was a victim of this—God forbid—and my mother would have been a victim as well. That is one of the reasons why I am so passionate about getting to the bottom of the disaster that happened to these ladies who went to their GPs.
These women went to their NHS GP in an NHS surgery as an NHS patient, and very often that GP would open the drawer and give them a tablet—two sometimes—with no prescription or advice, and no concern about the consequences or side effects of the drug. The GPs handed the tablets over to the ladies, and many of them took them there in the surgery. The GP simply said, “If your period starts tomorrow, you’re not pregnant. If your period doesn’t start, you are.” In good faith, which we all have for our GPs, the ladies followed that advice, even though the Department of Health and the drug companies knew that there were issues with this drug.
I am going to use a tiny bit of privilege, because every time I look around for information to do with this subject, including in the House of Commons Library debate pack “Hormone pregnancy tests” and the “Report of the Commission on Human Medicines’ Expert Working Group on Hormone Pregnancy Tests”, I see the phrase “hormone pregnancy tests”. The drug was Primodos. It was made by a drug company and often given free to GPs, who then handed it out without a prescription to determine whether a lady was pregnant.
Other companies in the world knew that there were issues. I will not go into all the evidence that was given to the so-called review, but let me just touch on some of the things that Ministers asked for when the group was set up. The first point was that the Government should set up an expert working panel “inquiry”. No such inquiry took place. At the third meeting, as I understand it, the barrister to the inquiry advised that the word “inquiry” should be changed to “review”. Under whose authority? When a Minister sets up an inquiry, should there not be an inquiry? Perhaps those people did not want an inquiry, but who cares? They should have come back to the group—the victims—and, more importantly, to the Minister. They could have spelled out their advice and the Minister could have made a decision. Some might think that this is just semantics, but it is not. If people are trying to get to the truth, it is vital that they know what a group can do. Even when the report came out—not the original report, because that was removed and draft was changed, as others will mention—it did not say “review”, because it was not a review.
There should be full disclosure and a review of all the evidence. That “review” said that it did that, but it did not. The Royal College of General Practitioners, to give just one example, informed the Department and the drug company that it had concerns way back in the 1960s, but its evidence was never sought. If Members read the report, they will find that no evidence at all from the Royal College of GPs was given to this review, which should have been an inquiry.
I thank the right hon. Gentleman for giving way. Is he aware that The BMJ reported that most of the scientific evidence considered by the working group was from the 1960s, ’70s and early ’80s. One expert in the field, Dr Neil Vargesson of Aberdeen University, told The BMJ that there were not that many scientific studies available. Does he agree that the Government should fund new research with the aim of enabling a definitive conclusion to be reached?
Yes, I do, and I will come on to that point. It is vital that we have proper evidence, not some historical evidence that was used by the report. More modern evidence was rejected because it had not yet been peer reviewed. The whole point about having all the evidence is one reason why the motion under debate today, which I hope will be passed unanimously, actually says that there should be a judge-led inquiry so that all that evidence can be considered.
I thank my right hon. Friend for giving way. I must acknowledge my constituent, Charlotte, and her family, who are here on behalf of her brother, Stephen, who has been greatly affected by this drug. One of the biggest issues is the way in which the drug was handed out with absolutely no discussion of the risks.
Jackie lost her baby, Louisa, 19 years later—in 1977. At that time, the product had been on the market for two years with Government warnings, but still GPs did not point that out to patients. There is a lot of evidence here, so why is it not in the report?
I completely agree with my hon. Friend. One thing that has surprised me is that although, on average, every single MP will have a victim of Primodos in their constituency, many of the victims think that what happened was their fault and that they are on their own. In the fantastic documentary on Sky, people came forward to say, “I have been affected by this, but I thought that I was on my own. I thought that I was the only one.”
The right hon. Gentleman is making a very powerful case. Given that the inquiry/review has now been very much discredited—it has certainly been rejected by all of those who have suffered—does he agree, as I am sure he will, that the way forward is set out in his motion, which calls for a
“Statutory Inquiry under the Inquiries Act 2005 to review the evidence on a possible association with hormone pregnancy tests on pregnancies and to consider the regulatory failures of the Committee on Safety of Medicines.”?
I praise the Clerks who helped me to draft the motion. I was very angry when we started drafting it, after reading the report, but they helped me get it into some kind of parliamentary language.
An inquiry has to be independent and judge-led, and it has be able to subpoena people to give evidence before it on oath so that we can get to the absolute truth. It also has to look at the regulatory system that was in place at the time. I am afraid that the Department of Health cannot hide behind this report. To me, that is vital.
Let us look again at the point about the inquiry being fair and independent. One of the ways we thought it could be independent and fair was to have an expert witness who was not part of the campaign, but whom everybody massively respected. For those of us who have been involved in the thalidomide campaign over the years, it was a really positive thing when we heard that Nick Dobrik’s name would be put forward.
Interestingly enough, although Nick was there as an expert witness, he was not asked to play a part in drawing up the conclusions in any shape or form. In fact, he was asked to leave the room. Nick was very surprised—actually, he was gobsmacked—when, in good faith, the Minister and then the Prime Minister said that Nick Dobrik had fully endorsed the conclusions of the report. I know now that the Minister and the Prime Minister know—I have met the Prime Minister, and Nick has done an interview with Sky today—that he categorically does not endorse the conclusions of the report. It was fundamentally wrong for anyone to advise the Prime Minister or the Minister that he did. He does not blame the Prime Minister; I do not think I blame the Prime Minister. As a former Minister—I know that there are former Ministers on the Opposition Benches—I know that we take advice from our officials and they tell us what the situation is. In good faith, the Minister at the urgent question, and the Prime Minister at Prime Minister’s questions, said that Nick endorsed the conclusions.
On behalf of Nick, who cannot defend himself in this Chamber, I would like whoever gave that advice to the Minister and the Prime Minister to formally apologise to Nick Dobrik. He is a fantastic campaigner not only for the Thalidomide Trust, but for all injustices, especially within the pharmaceutical area. The victims do not feel that the inquiry was fair and independent at all. They should have trust and confidence.
The most important thing is that the inquiry was asked to find a “possible” association—not “causal”, but “possible”. I and other members of the all-party group asked the experts from the panel why, after taking the word “inquiry” out, the remit was changed again, because “causal” is very difficult to prove. They said that they followed the science, but they were supposed to follow their remit and do what they were told. If they felt that they could not do that based on the evidence in front of them, fine. They could have gone back to the Minister and the victims and explained that. Instead, we had the farcical situation of the group looking for something when they knew full well—it is clearly in the documents—that they could not reach the conclusion that there was a causal link.
Interestingly enough, the group also could not come to the conclusion that there was not a causal link, because the evidence was not there for either conclusion. As I said during the exchanges on the urgent question, an injustice has taken place. Natural justice is the reason we are sent here. We defend our constituents when the system has come down against them and caused such horrific, horrible things to happen to them, so we need to address that injustice.
I am exceptionally grateful to the right hon. Gentleman. He says that everyone has constituents who have been affected. Two of my constituents have told me that they believe that they lost their children as a result of the drug. It is even more severe than losing a baby; one of them lost several children by taking the advice of their GP. This is a fundamental issue of trust—trusting the GP, trusting the NHS and trusting the inquiry. All those things have failed. Both my constituents told me over and over, “We no longer have any faith in the system.” They believe that the report is a whitewash, which is why I wholeheartedly agree that there should be a full and frank inquiry.
I thank the hon. Gentleman for his support for the victims.
As I said earlier, there is no constituency in this country that does not have someone who lost their baby due to stillbirth or dying shortly after birth, or whose life was transformed—for those who survived. However, many people were advised to have an abortion, and the figures on that are not available to us. Reports that the inquiry was not allowed to have are starting to come through.
I fully endorse the fact that we need some money so that we can ensure that we have modern reports, because the methodologies used back then would never be allowed today. We also need to see the missing reports. We need to find the stuff that has gone missing in Germany, where the drug company knew there were issues. We need to know why the drug company settled in America—it was using a slightly different name for the product, but it was the same company. What evidence was put before the legal system in America, where the company settled as fast as possible, and then gagged everybody and kept everything quiet?
We have a duty in this House to call things into question when they go wrong. These things started going wrong many years ago—before I was born. I have been a Minister, so I know that Ministers have to support their Department, but one role of a Minister is to question the advice that they get. I know that that is what the Prime Minister is going to do now, and I hope the House will support the victims so that they can have some confidence in the system and the NHS once again.
Order. We have a lot of people to get in and we have very limited time. Can I suggest six-minute speeches?
Six years ago, I met my constituent Nichola Williams, who shared with me her struggle with her health over her lifetime. Her mother had been prescribed Primodos. From there, I carried out my research, searching for answers and going through thousands and thousands of pages of documents.
One document was a 1969 study by a Dr Norman Dean, who worked with the Royal College of General Practitioners. He found that when women used this hormone pregnancy test, there was a higher incidence of malformed babies, miscarriages, stillbirths and infant deaths. He found the findings so alarming that he wrote to the manufacturers advising them that Primodos should be withdrawn. However, it took another eight years for it to be finally taken off the market, unlike in Norway and Sweden, which apparently acted very swiftly.
In the last six years, I have exchanged countless letters with Ministers and Department of Health officials, working alongside Jason Farrell from Sky News, who has dedicated an enormous amount of time to exposing this issue, and Marie Lyon, the chair of the victims association, who has tirelessly campaigned for justice. I have raised this matter on the Floor of the House many times. I raised it with the Prime Minister several weeks ago, and I also met her predecessor to discuss it.
In 2014, after a debate in this Chamber, we were informed by the then Minister that an inquiry would be carried out, and we were very excited about that. We were promised that the inquiry would be fair, open and transparent, would have the trust and confidence of all the victims, and would look at all evidence. Instead, we found that some experts on the panel had conflicts of interest and close ties with the manufacturer, which is now Bayer.
The victims who were invited to give evidence were treated appallingly and were given a very short period—I think it was two hours—to explain what had happened to them. Ms Lyon, who had been appointed as an observer to the panel, was forced to sign a gagging clause, which meant she could not raise with us any of the concerns she had about how the inquiry was going.
I thank the hon. Lady for mentioning the interest our Prime Minister has shown. She met Conservative Members recently, and she is watching with interest. However, the issue I would like to reiterate on behalf of my constituents and many other MPs is the treatment of the campaigners during this process. We had unacceptable timescales, and some of these people were caring for very ill children. The treatment of the campaigners, at the very least, needs some kind of apology.
I entirely agree with the hon. Lady on this matter.
The inquiry was intended to look at a possible association, not a causal link. That is very important because a different burden of proof is required for a possible association as opposed to a causal link. That was changed, and nobody can tell us who gave the authorisation to do that. The EWG was asked to look at regulatory failures. There are thousands of documents from archives in Berlin and Kew that show that there was a link between the deformities and these drugs. The Committee on Safety of Medicines looked at these documents and decided not to do anything with them. Why was that? When the report came out, the initial draft said that it was impossible to reach a definitive conclusion. However, the final document was changed to say that it could reach that conclusion. When the chair of the inquiry was asked why this happened—by Jason Farrell by me and by other colleagues in a recent discussion—she said that the Commission on Human Medicines looked at the documents very thoroughly and told the panel that
“we should strengthen the wording and put a greater clarity on it.”
It is unacceptable for the commission to have asked the panel to change its conclusion.
When I raised the report with the Prime Minister recently, one of the reasons she said that there was confidence in it was that Nick Dobrik had said that he endorsed it. However, he has said:
“I was very angry when I was informed that my name was used to endorse the conclusions of this report.”
Is the Minister aware that the EWG refused to look at the most up-to-date study on Primodos conducted this year by Dr Neil Vergesson? It said that the study had not been peer-reviewed, yet it looked at 44 other non-peer-reviewed studies, some of which had been produced by the manufacturer itself, Schering. Dr Vergesson found that Primodos deformed fish embryos, and if given in high doses actually killed them. Dr Dean apparently carried out a study and wrote to Schering telling it what his findings were. He also informed the Royal College of General Practitioners about this. That study has also been ignored, and there is no record of it at all. We know that it exists only because a letter was found showing that he had discussed this matter and told all the parties concerned what was going on, but again nothing happened.
The man in charge of the Committee on Safety of Medicines—its chief scientist, Dr Inman—also conducted a study and found that there was an adverse reaction. Instead of dealing with the issue, he contacted the manufacturer and told them to
“take measures to avoid medico-legal challenges.”
Documents from Berlin show that he later said that the documents on which he based his investigation were going to be destroyed. He made that admission at a meeting with a Schering scientist in Bermuda. A Dr Greenberg carried out a study that showed a significant twofold increase in risk of malformed babies being born to women who took this drug. Eventually, in 1977, the Committee on Safety of Medicines wrote to doctors saying that the drug should stop being given. It said that “the association is confirmed” between Primodos and deformities. It was “confirmed”, unequivocally—and that was in 1977.
Why does the EWG seem to have disregarded all these studies, not to have bothered to take any interest in what was happening and failed to look at the regulatory failures? It is vital that further scientific research is carried out not only to establish an association, but because the EWG report says that the component parts of Primodos are currently safe to be used. That is very worrying, because it is being used in many contraceptive pills. Studies and independent research should be carried out on this, because we might find that even though the drug is being used, it might be harmful to women, and we could prevent further problems from occurring. I am asking for an independent inquiry into the regulatory failures. We must put the families first.
I thank my right hon. Friend Sir Mike Penning for securing this extremely important debate. Many constituents in Ayr, Carrick and Cumnock, and throughout the UK, will have been disappointed by the recently published outcome of the review by the Commission on Human Medicines expert working group, but I have one constituent in particular who is devastated by it. It was concluded that the scientific evidence did not support a causal association between the use of hormone pregnancy tests such as Primodos in the mid to late part of the last century—roughly from 1953 to the late 1970s—and miscarriages or horrendous birth defects ranging from brain damage and heart abnormalities to transposed internal organs.
Of particular concern to my constituent is the apparent non-availability of her general practitioner records for the relevant period, when she was prescribed—a better word might simply be “given”—Primodos as part of a pregnancy test. It appears that others find themselves in a similar position.
My constituent, Peggy Gedling, finds herself in precisely that situation. In 1969, when she gave birth to her son Justin, she attended a medical practice in Crawley. Many of the GP notes were handwritten, and they appear to have been lost. Her previous practice in Gloucestershire tried to obtain her medical records and found that she had ceased to exist for 12 years. It is very worrying, is it not?
I thank the hon. Lady for that intervention, which corroborates my constituent’s concerns. This may be a common thread throughout the United Kingdom. As I understand it, general practitioners’ records are normally required to be retained for the duration of a patient’s life. In the case that the hon. Lady describes, if it had been possible to recover the GP records, it might have been interesting to establish whether there was a cluster pattern for such cases.
My constituent advises me that in June 1975, only months after she was prescribed or supplied with Primodos in the January, a warning was added to the packaging, stating that the drug should not be given to pregnant women. My constituent perceives that to be a response to a realisation that a risk had been identified, at least by that point. Her child was born in August 1975 with serious birth defects, which required major surgery. That child, in adulthood, still has to contend with the associated medical complications. Credit to both mother and child, however—despite the trauma and hardship that they have endured, they contribute positively to society and champion the care of others.
One has to ask, if Primodos is not linked to birth deformities in children whose mothers took the drug, what is the common denominator for the tragic outcomes of those pregnancies? It has, as I understand it, sadly been mooted that such women should consider genetic tests to identify other potential causes. In other words, the suggestion seems to be that all who took Primodos might coincidentally also have a defective gene—I do not think so—and that that defective gene was supposedly passed to their child and formed the root cause of miscarriage or deformity. I very much doubt that, although I might not be qualified to comment.
My constituent does not consider that she has received justice for herself or—more importantly, in her eyes—justice for her child. She feels let down by the outcome and the process followed by the EWG. She had high hopes for that outcome, but it brings us nowhere nearer to the truth or to justice for those who might have fallen foul of a drug that might not have been fit for purpose when it was prescribed, or simply given, to the patients.
For the families involved, I would welcome a broad-based and—as has been said—independent inquiry to review the evidence, of which there is a great deal. Yasmin Qureshi alluded to the fact that the journey has been long, and many pieces of the jigsaw are missing. Those should be secured to enable the independent inquiry to find the truth. There might have been a regulatory failure; we need to find out. Outcomes for the people who were subjected to hormone pregnancy testing between 1953 and 1975 have been devastating. The families deserve both truth and justice, and it is the role of parliamentarians relentlessly to pursue the truth about Primodos and other such drugs.
I raise this important issue on behalf of my constituent, Anne Darracot, and other affected constituents, and because it is a national scandal—the tragedy of babies being stillborn or born with severe foetal abnormalities after their mothers were given the hormone Primodos as a pregnancy test between 1953 and 1975. In many cases, Primodos was handed out in the GP surgery.
There has been a double failure: inadequate regulation and the failure of successive Governments to investigate what happened in an open, comprehensive and acceptable way. Hon. Members have highlighted the flaws in the findings of the expert working group set up by the Commission on Human Medicines, which reported in November this year. Those concerns include the unexplained change in the group’s terms of reference, from assessing the possible association between Primodos and foetal abnormalities to establishing a much-harder-to-prove causal link. They include the questions raised by the group’s selective use of research and the limited evidence that it considered. Nick Dobrik’s categorical denial of the Government’s claim that he, a trustee of the Thalidomide Trust, has approved the report damages confidence in the process.
The significant changes made between the production of the inquiry’s draft report and of its final conclusion undermine trust in the findings. Indeed, the draft conclusion stated that due to scarcity of evidence
“it is not possible to reach a definitive conclusion”.
By contrast, the final published conclusion was that the evidence did not support “a causal association” between the use of Primodos and birth defects or miscarriages. In short, there is no confidence in the working group’s findings.
What is required now? First, we need an admission that the current situation is unacceptable and that the working group’s report is inadequate. Above all, there must now be a judge-led public inquiry to consider all the available evidence. That was first called for by the late, lamented Jack Ashley MP as far back as
A wide range of witnesses should be called under oath. All research—whether conducted here in the UK, in Europe or internationally—should be considered. More research may be required, but that should not unduly delay the findings and conclusions of the inquiry. Regulatory failure should be part of the investigation. All research must be considered and evidence must be collected and assessed from a wide range of sources. There must be no cover-ups. That is the only way forward. The women and families affected by Primodos are still suffering from their loss. They are still grieving and will not give up. They and all of us deserve no less than the truth.
I congratulate my right hon. Friend Sir Mike Penning on securing this debate under the auspices of the Backbench Business Committee. This was one of the very first issues brought to me by a constituent following my election as the Member for North Devon two and a half years ago, and I want to raise her case again.
The people affected—the families, children, mothers and babies—should be at the very centre of our thinking. I will give one example. I was contacted by my constituent Diane Surmon from Barnstaple. She gave birth to her daughter Helen Jean Marie Barham on
Diane told me that Helen does have a quality of life. She can walk, albeit short distances. She needs a wheelchair for longer distances, or when she goes shopping or goes out with friends for a meal, for instance. She is able to feed herself, but help with her daily needs is required and she will always need 24-hour care because of her seizures.
That is one example of the extraordinary impact this has had on one family and one individual and one mother, but that can be multiplied so many times, and that is why it is absolutely right that my right hon. Friend the Member for Hemel Hempstead and others on both sides of the House—this is not a party political issue—seek to ensure this issue is kept in the spotlight. It is right that it is.
Therefore, there are many others in situations like that of Mrs Surmon. Over the years, there have been many attempts by Governments of all colours to get to the bottom of this. I know the Minister is sincere in trying to do that and to find a way forward that will help us get to the bottom of what has happened. There has also been a whole range of studies over the years. The difficulty is—this is the nub of the point I want to get across—that there is so much contradiction between all those studies; there is no agreement yet. Yasmin Qureshi delivered a good speech and rightly made the point that in the 1970s there was a report that showed, apparently clearly, evidence of a causal link. However, in 2016, the report from the Commission on Human Medicines said that there was no such evidence. Now we have had this report from the expert working group, which has come up with a similar finding. As we have so many contradictions and differences of opinion, how do we get to the bottom of this?
The report by the Commission on Human Medicines was a result of a letter I wrote to the Medicines and Healthcare products Regulatory Agency. The report was not a study into the drug itself; the commission just looked at documents that were in existence, conducted a review on the basis of those documents and gave an opinion. It was not a study.
I thank the hon. Lady for that clarification. Many of these studies have been into the historical evidence and the paperwork, which have been sifted through over and again— she is right to make that point—but there are still differences of opinion between what was said in the 1970s, in 2016 and in 2017, and that is the difficulty.
I have asked the House of Commons Library for quite a lot of background information, which I was going to try to get into, but in the six minutes allowed to me I cannot do too much. What I will say, however, is that, having read the latest report by the expert working group, it is clear that there is a concern, highlighted by my right hon. Friend the Member for Hemel Hempstead and others, about the contradiction between what it was asked to do and what it then actually found out. The question is whether there is a causal link or an association. We need to explore that: were the terms of reference of this expert working group followed in the way it carried out its investigation? On that, I absolutely agree: we need to look further into what exactly has been done here.
Further evidence from the expert working group is due to be published in the new year. That will be important.
It is not coming from the expert working group; it is coming from a professor. The expert working group rejected the evidence because it had not been peer-reviewed, but it will be in the next few days.
My point is that there is more information to come and I thank my right hon. Friend for that clarification on its source. It is really important that we keep looking for this information and that we gather everything we possibly can to help the people affected.
Many other right hon. and hon. Members wish to speak, so I shall not continue for too long. The Government and previous Administrations have consistently tried to look for answers and I know the Minister is sincere in seeking to do that. To support the Government and the people affected, I would like to work together to find a way forward to find the answers they seek. Let us get together and everyone be experts—the Department of Health, Members on both sides of the House and, crucially, the families—to try to get the answers.
I would like to end by referring back to my constituent Diane Surmon, because those affected must be at the centre of our work. In a further letter to me, she wrote:
“In my heart, I feel positive it was the drug Primodos which caused Helen’s injuries. After I took those tablets I was in and out of hospital. I carried a lot of fluid, which I have since been told is a sign of an abnormal foetus. I had had two normal pregnancies before Helen.”
She ends with these words, which I think are extraordinarily powerful:
“I feel very angry. I feel we were used as guinea pigs.”
For the sake of Diane Surmon and all the others whom we on both sides of the House represent, let us focus on the effect the drug has had on them and their families. Let us all work together. I know the Minister is sincere in wishing to do that. Let us all work together to find the answers they seek, while keeping them and their suffering at the centre of our work at all times.
I am going to have to drop the time limit to five minutes. If Members keep intervening it will go even lower.
I pay tribute to Sir Mike Penning and my hon. Friend Yasmin Qureshi for securing the debate and for their work on this issue over the years. I pay tribute to other hon. Members who have doggedly pursued justice for the victims of Primodos over a long period.
I have come relatively late to this issue, but it is very clear to me that, as my hon. Friend Mrs Ellman said recently at the all-party group, the lesson we have to learn from previous scandals is that any inquiry must have the confidence of the victims. The report of the expert working group has already failed that test.
I am speaking today because constituents of mine have been affected by the tragic events relating to hormone pregnancy tests. They have contacted me to say that they have no confidence in the process or in the conclusions of the report. The Pierce family and the McLellan family have had their lives changed by Primodos. They are convinced that their family’s issues are as a direct result of Primodos use. Louise, the daughter of my constituent Edward, suffered life-changing multiple health issues. They are just one of many thousands of families who need to see justice for the harm caused by this drug. The announcement of the review gave them some hope, but, having been in contact with them in recent weeks, I know they share the disappointment and anger experienced by many following the publication of the report.
There are too many question marks over the process and over the conclusions of the report of the expert working group. The report itself flags up the difficulty of drawing robust conclusions on the analysis of the studies available. It admits that the available evidence was very limited. It then concludes that the body of evidence did not “on balance”—key phrase—support an association between the use of HPTs and congenital anomalies. We need more explanation and more justification of what is meant by the words “on balance” in the light of such limited evidence.
In 1977, the medical regulator wrote that there was an association between the tests and birth defects. We must therefore ask what new study or evidence is available to dispute that conclusion. It strikes me that, without new research that tries to establish a new body of evidence, it is not possible to determine whether Primodos is safe. I agree with the suggestion that the Government create a ring-fenced fund to enable new studies, perhaps using imaging analysis and molecular study to try to get to the truth. Even new studies are unlikely to resolve the issue definitively—it is likely to come down to a Government judgment on where the responsibility lies—but they may at least give comfort to the victims that the whole process has been carried out thoroughly.
As we have heard, there are questions about the regulatory regime surrounding hormone pregnancy tests—I do not have the time to get into the details—but the biggest question is surely over whether this product should have been allowed on the market at all without proper testing.
My hon. Friend is making an excellent speech. I commend Sir Mike Penning for bringing forward the motion, and other hon. Members. I particularly commend my hon. Friend Yasmin Qureshi for all her work over the years. I think that my hon. Friend Jeff Smith will be aware that countries such as Finland, Sweden, Holland and Norway actually banned the use of hormone pregnancy tests between 1970 and 1971. Does he agree that the warning signs were clearly indicated at the time, so action should have been taken then to prevent foetal malformations and all the ensuing heartache?
My hon. Friend is right and makes an excellent point. We must ask why there was so little regulation for so long, given that it is possible to regulate on a precautionary basis, and whether there is a Government liability under general product law that is meant to protect citizens. Those questions need to be considered in detail.
We heard other questions about the transparency of the report, including that the published report is not the original report that was first presented. A number of inaccuracies were identified and key wording was changed, including the word “definitive”, which was removed. So is this a definitive report? If not, we clearly need a new inquiry. I am running out of time and other people have covered transparency, so I am not going to talk in great detail about it.
There are too many question marks over this issue. In order to regain the trust of the victims, the Government must commit to a judge-led independent public inquiry under the Inquiries Act 2005 to look at the issue again. The inquiry must have all the powers needed to bring to light all available evidence relating to the scandal, including the ability to compel witnesses to give oral evidence. The inquiry must be broad enough to look at the scientific and legal issues in the case, including the allegations of liability. Finally, the victims and their families must be involved in the design and implementation of the inquiry following the Hillsborough inquiry’s families first approach.
As we have heard, there are concerns across the House about this matter. It is not a party political issue. Something is not right and we need to get to the truth. We owe it to the victims and to people who may still be taking products related to these drugs. The only way we will get to the truth is with a judge-led inquiry.
I congratulate my right hon. Friend Sir Mike Penning on securing this debate. I add my weight and support to his call for a statutory inquiry into the scandal of the supply of Primodos as a pregnancy test. He drew attention to the years that the product was in use. Like him, I am a product of 1957, and it could just as easily have been my mother taking this drug. Hon. Members across the Chamber have mentioned their constituents, and it is contact with one of my constituents that brings me to contribute to today’s debate.
The resident who came to see me and who has contacted me on many occasions is Irene Creed, who lives in Long Lawford in my constituency. I owe Mrs Creed something of an apology because I am afraid that I gave a rather standard reply at our first point of contact. I did not really know or understand enough about the issues that were affecting Mrs Creed. However, she continued to write to me and to draw my attention to the issue. We eventually met in June 2014 and then again at my surgery in August 2015, when she brought along her daughter, Tamara. Tamara was born in February 1973, which means that she is now 44. Like the constituent of my hon. Friend Peter Heaton-Jones, Mrs Creed was able to tell me the very date on which she was first given Primodos. It was
When we met, Mrs Creed asked me to meet Marie Lyon, who runs the Association for Children Damaged by Hormone Pregnancy Tests. I think we should pay tribute to the association for the work that it has done in drawing attention to the issue, and for ensuring that the Members who are present today were informed and knew exactly what had happened.
The other key point made by Mrs Creed was that she was given no advice whatsoever about any side-effects of the drug. She drew my attention to the many meetings of the all-party parliamentary group on oral hormone pregnancy tests. I know that Yasmin Qureshi has done a tremendous amount of work in bringing together the members of the APPG and adding to the lobbying on this issue.
The most recent contact that I have had about the issue was with Tamara herself, who began her letter of
I pay tribute to Marie Lyon. She is an indefatigable campaigner, the mother of a child damaged by Primodos, and my constituent. Families pinned their hopes on this report, but those families, who had been let down by their doctors and by regulators, now feel let down by the report. They deserved a transparent process, but it was shrouded in secrecy. The Observer was bound by the most severe confidentiality order that can be imposed.
I am talking about not just one constituent but nine, in a relatively small geographical area, who have children born with defects. I do not know how many women who were given Primodos suffered miscarriages or stillbirths, and I think that we should try to obtain those figures. I would also like to know whether if, as is claimed, this was a naturally occurring event, nine babies were born in a similar timescale and with similar defects to women in my area who had not taken Primodos. As we have heard, many women were not given a prescription, but were given a pill, along with the little joke that “We do not have to kill the rabbit now: this is the new way.” We may never know the true figures.
Let me return to the subject of the inquiry. We believed that it had been agreed that the group would look into a possible link, not a causal link—which is not just semantics, because looking for a causal link lowers the burden of proof. That was the first major failing. The second was the existence of conflicts of interest, which was raised by Marie Lyon at the time. Many of the experts had worked for Bayer or Schering. Thirdly, the victims who were invited to give evidence were treated appallingly. Fourthly, there was a selective use of studies: the majority favoured the link. Fifthly, there was the speedy withdrawal of the draft report.
The group had taken two years to reach a conclusion, but all the advice was cancelled very quickly after Marie Lyon gave a presentation. The first draft that she saw had stated that it was not possible to reach a definitive conclusion, and contained many inconsistencies. When the final report was published four weeks later, the paragraph containing the phrase had been removed, along with many of the inconsistencies highlighted by Marie Lyon. I have read the report. I am not a scientist, but if ever there was a report that reads as though the conclusion had been written first and the data had been made to fit, this one ticks all the boxes.
I am particularly incensed, on behalf of my constituents, by the offer of genetic testing. A constituent who came to see me has a severely disabled son. She had taken Primodos. She went to the doctor for answers, because she wanted a big family. She said to me that she had a lot of love to give. However, she was told that it was probably “her fault”, so she never had any more children. To have that suggested again in the report is beyond devastating for her.
The report relies on a lot of old studies, and I believe that research funds should now be ring-fenced for new studies. We must also check whether the current regulators are fit for purpose. We cannot allow our children and grandchildren to be put in such a position again. We cannot go back and make things right for these families, but we can give them answers about what went wrong, and how it went wrong, through a fully independent public inquiry. That means full disclosure of all documents through a process managed by the victims—I assure all hon. Members that Marie is quite capable of managing that process.
People need the opportunity to scrutinise written and oral evidence, by compulsion if necessary. The inquiry must be wide ranging and broad, and it must investigate not just a possible association but why the regulatory bodies failed to withdraw the drug, despite being aware of the dangers. Warnings were first given in 1958, but the medical profession was not alerted until 1975, and Primodos was still being prescribed even in 1977.
We must look into allegations of criminal conduct: why was there no intervention by Government bodies, why were the risks hidden from the victims, and what was the role of the manufacturer? Most importantly, families must be front and centre of this inquiry. They must have a role in deciding the panel and the terms of reference, and they must believe that a true light has been shone on what has been a very dark period. There should also be compensation. Nothing can compensate for 40 years of injustice, but financial security would ease some of their worries. This issue will not go away. The families will not go away, and as they age their sense of injustice and the need for answers grow more urgent. I therefore urge the Government to accept this motion and act on it speedily, and to give those families some peace and restore some of their trust in justice.
I congratulate Sir Mike Penning on securing this debate. Like many Members, I represent families who strongly believe that their lives were forever changed because of the drug Primodos.
Today I speak on behalf of my constituents Chris Gooch and her daughter Emma Gooch. They have given me permission to share their story about how hard life has been over the past four decades, their criticisms of the expert working group’s report, and why they will continue to fight for justice, and they are with us here today.
In June 1970, Chris Gooch was prescribed Primodos by her GP to find out whether or not she was pregnant. Like any of us, Chris trusted the words of her GP and had no idea that the drug might be unsafe, or that it had been linked to deformities. It was only when Chris’s daughter, Emma, was born seven months later on
“There are many things that Emma would have liked to have done, like playing the piano or guitar, but she has been unable to do so because of limited mobility in her hands. This also came to impact her education and at secondary school she became school-phobic and was physically sick every morning before going to school. Emma has always suffered from severe back problems and has to live in intense pain all the time. She has sought treatment and scans confirmed that she has spinal deterioration, for which she was offered a spinal fusion. This only had a limited chance of success and risked making her condition worse. Emma refused this and is trying to come to terms with her long-term prognosis. She can’t work full time, has to pay for all her medications and has even been refused a blue badge, despite having to use a stick to walk and having no proper fingers or toes. Emma will be 47 next month and can now only manage to work for three days a week and even this she finds extremely draining. She is worried about her ability to keep working in the future, and the implications this has for her financially and socially.”
When I met Emma she told me:
“Myself and many others have to live with the devastating results of our mothers being given hormone pregnancy tests like Primodos. Whilst the effects on me were much less severe than on some victims, I was born with very specific deformities which I have only ever seen shared by fellow Primodos victims, so in my mind this can be the only possible cause.”
The right hon. Lady is speaking very powerfully. Does she agree that there are many who are not as severely affected as her constituent, about whom she speaks so courageously, but who are similarly affected and nevertheless feel great pain? I speak of people I have the privilege to represent.
I absolutely agree. Members across the Chamber today have given examples, but there are many victims with different levels of disability, illness and deformity as a result of this drug.
When I asked Chris and Emma what they thought about the expert working group’s report and how the inquiry process had been handled over the past three years, their criticisms could not have been clearer. Chris told me:
“I feel angry that they treated us like idiots. We have been treated appallingly. The Expert Working Group produced a report in October and then, following a meeting with our Chair, Marie Lyon, they removed some material and re-issued it a month later. They said it was to make it more readable. They found no causal link, which they weren’t even requested to look for. They only gave us a day’s notice to organise a visit to hear the report’s findings and I am sure that is because they hoped no one would turn up to hear them. Now nearly 50 years on, our children, the ones who are still alive, are still suffering. I am angry that for Emma, and for many other members of the Association for Children Damaged by Hormone Pregnancy Tests, life is a constant struggle and we still haven’t really been heard.”
Emma herself told me that she
“cannot help but feel angry that for decades we have waited for an independent and unbiased enquiry, but the Expert Working Group’s obviously flawed report feels like an attempt to discredit us and instead protect the powerful companies and authorities that were at fault.”
Since I was first made aware of the issues surrounding the drug Primodos, I have been reminded of the thalidomide and contaminated blood scandals. I am reminded of the fact that it took decades of tireless campaigning before the truth and natural justice were reached. The inquiry has been accused of failing to consider all the evidence fairly, failing to have the trust and confidence of the victims for whom it was set up, and failing to be transparent and open in its due process. The inquiry failed to consider any evidence regarding systematic regulatory failures of Government bodies at the time. Campaigners have widely dismissed the inquiry as “seriously flawed”. I therefore join the cross-party calls for a public inquiry into the use of Primodos and its connection to deformities and other birth defects. I shall end by once again quoting the words of my constituent Emma Gooch, as I believe that her determination will be shared by Members on both sides of the House. She said:
“Sadly it is too late for some, but the victims and parents still deserve justice and we will continue to fight for it.”
I join other hon. Members in thanking Sir Mike Penning and my hon. Friend Yasmin Qureshi, but I hope they will forgive me if I say that even more thanks are due to Marie Lyon and the other people who have been campaigning, some for many decades, to get justice and to discover the truth about Primodos.
I have been struck by the consistency of the stories that we have heard today, but there is one detail that I do not think the Minister will be able to help us with—that is not a challenge to him, by the way. We will probably never know how many women were given Primodos, and some of the victims will probably never be in a position to know whether they were victims of it. I have a constituent who used Primodos for a pregnancy test many years back. She lost her child a month after he was born with a blocked oesophagus and other physical difficulties.
Another of my constituents, Adele Stretch, was born with only one finger on each hand, reduced thumbs and only eight toes. Despite her disabilities, she has tried to live a full life. She is the mother of a healthy child, she works, and she does all those things that we would applaud her for doing. She began to realise that Primodos might have been the cause of her disabilities only when, in a casual conversation with her mother, she was told about the test that her mother had taken all those years ago, before she was born. A little later on, having found no one else with similar disabilities, they linked the disabilities as remarkably similar to those of Primodos victims elsewhere. That is why I say that we may never properly know the number of victims.
Our society—not just the victims—should be able to establish the real truth. That matters, because there is a stench in this case—a stench that vested interests have for 40 years been able to obfuscate and obscure, as they cynically and deliberately prevent the truth from coming out. If the truth does comes out, there will of course be consequences. It might be that scientifically provable causality will be difficult to establish over such a period of time—the drug is of course no longer inflicted on women for its original purpose—so it may be difficult to achieve the scientific veracity that would let scientists prove a causal link. That does not mean to say that the statistical consistency of victims relative to the use of the drug is insufficient to give us a genuine belief that there is enough correlation to draw our own conclusion.
That is important, however, because the victims of course want the truth, and they want the scientific and medical communities to accept and own up to the faults. That is important for another reason, because we have to say that this kind of obfuscation can never happen again. We cannot have a medical community and a drug industry that are driven by money—I know why that is the case—and unwilling to let the sun shine into their practices. We cannot have such a regime any more. Primodos matters to the victims, but it matters even more because of what it means.
If we can move the debate forward, have a judge-led inquiry and get some final reports with genuinely believable credibility, that will lead to the demand for compensation, so I understand why the Government might be reluctant. My constituent Adele Stretch says that she is leading a full life at the moment despite her disability, but she is now 51 and says that she can feel the future beginning to impose on her. She would like to believe that as she gets older, when her single fingers will find it even more difficult to carry her shopping, there will be some recognition of that and, where appropriate, some compensation.
I am here because of my constituent Sue Illsley, who took this drug when she was a teenager. She believes that her daughter has suffered disabilities as a result, and that has obviously affected her whole life. I pay tribute to Sir Mike Penning and Yasmin Qureshi, and I hope that the Minister will read their speeches, because they made some powerful points about the evidence, and he needs to ensure that his officials look into that in detail.
I want to use some evidence given to me by Jason Farrell, an investigative news reporter at Sky News who has done a fantastic job over many years to bring this matter to light. I particularly want to refer to documents that he found in the national archives in Berlin, which include minutes of meetings between the company, Schering Chemicals Ltd, its lawyer, and a scientific adviser. I will read extracts from the minutes of meetings held on 20 and
“Mr Clothier then went on to the letter written by Dr. Pitchford and Dr. Bye to Dr. Friebel in Germany (6th June 1968) requesting that… it was important that something more must be done. Mr Clothier went into this letter in some detail and suggested that it would be dynamite in the hands of the claimants.”
Another memo from Dr Pitchford to Dr Friebel, dated
Mr Clothier felt, if the case were tried to the end by a judge, the chances were that the company would be found to be in neglect of its duty. Clothier stated that there seemed to be a 5:1 chance that, if there were a malformation in a child and the mother took Primodos while pregnant, it was the fault of the drug.
Page 7 of the memo states that Mr Clothier told Schering
“there were 2 alternatives open to us—one is to establish a voluntary scheme of compensation in which a justifiable claim will be given compensation without proof of liability but simply accepting moral responsibility.”
The other alternative was to take such claims to court.
Dr Detering of Schering said he was
“hesitant in establishing a scheme as the product is marketed world-wide. If we introduce this scheme in one country, we should introduce it in other countries.”
Back in 1977, people were trying to escape their moral responsibilities.
Other prime issues were raised in this minute but, because of the time, I will go on to the other minute, which is the report of a meeting with Professor Tuchmann-Duplessis, a scientist from Paris, on
“The meeting…was arranged by Dr. Detering in Berlin in order to determine Professor Tuchmann’s general opinion on the validity and quality of the work that had been carried out on Primodos.”
According to this minute, the first question posed was:
“Did we, as a Company, carry out all the studies that we were supposed to?”
The answer was:
“In Professor Tuchmann’s opinion we should have done much more. He expressed the view that after discovering that a certain dose was embryolethal in rabbits and in rats, we should have certainly carried out teratological studies in primates in 1968.”
This is a scandal. They knew. The lawyers were saying that the company would be liable, and that it would be found guilty in a court and would have to pay.
Why does this continue? We have heard from many hon. Members today about constituents across our country whose lives have been blighted by this. Why continue? The Minister has to stand up to the official briefings he is getting. He has to stand up to the nonsense of continued obfuscation and cover-up. Surely he must stand up and say at the Dispatch Box that he will support the motion, and that the Government will set up a judicial inquiry as soon as possible.
It is such an honour to sum up this humbling and moving debate. I commend all Members who have contributed, particularly Sir Mike Penning, and the Clerks, to whom he rightly paid tribute, who drafted the motion. I also commend Yasmin Qureshi, who has fought tooth and nail for the victims of Primodos, as has Marie Lyon—she is a modern-day hero as far as I am concerned.
Like other Members, this case was one of the first that came to me after I was elected in 2015. My constituent Wilma Ord, who took Primodos in 1970, is in the Public Gallery with her daughter. Kirsteen was born with a range of birth defects, including profound deafness, cerebral palsy, an underactive thyroid that was diagnosed at age 11, and labyrinthitis. Her mobility is getting worse. I will briefly repeat some of their comments.
This is how Wilma describes what her life has been like:
“Our lives have been turned upside down, are we going to see justice for our kids? It is now that we need it, because every day we see the difference in mobility and it is real. These people need to be taken care of and it is the opportunities that have been taken from them since the day they were born”.
I asked Kirsteen if she would like anything passed on, and she said:
“I don’t see why there was a cover up in the first place. They should fix it now.”
We can never say it often enough, but this place is at its best when we are in agreement, and today we have had cross-party agreement. I am sure the Minister is aware of the strength of feeling. It is also at its best when we are representing and speaking up for our constituents, as everyone has done here today.
Another lady, who did not want to be named, contacted me this week to say:
“I was wondering if I can count on your support on Thursday. My daughter died at birth after I took The Primodos drug, she was born without the top of her brain and skull.
This week would have been her birthday, December 13th.”
So her birthday would have been yesterday. That is harrowing, as it is harrowing to hear about the deformities and disabilities that hon. Members have spoken of.
I must draw on some of the comments that really struck me. Peter Heaton-Jones talked about our constituents being treated as guinea pigs, and that is, in essence, what they were treated as—human guinea pigs. Let us not forget that this drug was on the market unregulated and untested for five years before any proper research was done on it. Sir Edward Davey spoke about the research and the information that came from Germany and some of the vast number of documents that were not looked at by the expert working group. My hon. Friend Carol Monaghan could not be with us today, but she has spoken about her constituent Russell Kelly, who has also been affected and wanted to share his experience. Russell is the youngest of four children, the other three having all been born healthy. His mother was prescribed a similar drug to Primodos and he has been left with significant disabilities, which has been devastating.
Since the release of the report on hormone pregnancy tests produced by the Commission on Human Medicines, our constituents have been further let down. I was there, as I know other Members were, at the press conference—indeed, the hon. Member for Bolton South East and I were walked out of it. Some of the women who took Primodos told me at the launch of the report that they had been told that they should now be happy and take comfort from knowing that it was not taking Primodos that caused their babies to be born with defects or malformations. How offensive and insulting is it to say something like that to victims who have experienced so much trauma? None of these women is happy or comforted, and many were absolutely shocked, particularly at the fact that the expert working group did not want to watch the Sky documentary that we had spoken about. That seems utterly incredible, but the group said it did not want to be prejudiced.
As we have heard, the report, which was produced by the expert working group, was changed between the draft and final stages. Given the process and the amount of public money committed to it, it is shocking that such a situation has been uncovered. I hope the Government will reflect on everything that has been asked on the judge-led inquiry moving forward, and on how a process can fall down and become so bad. We know that Marie Lyon, who was mentioned by Yvonne Fovargue, was restricted by the most serious and difficult circumstances as a result of the legal document she had to sign. Marie Lyon wanted to help; she wanted to make the process better. She had information that she could have passed on, but she was not able to do that—because of the document she had to sign, she was not able to do the job she wanted to do. I hope the Minister considers that as well.
I was deeply concerned that what was described as a “scientific process” by the expert working group was not just about the science. Many Members have talked about the concern that arose recently when Dr Gebbie, the chair of the expert working group, was asked about the change from the draft report not being able to reach a conclusion to the final report being able to reach one. Her reply was:
“The CHM all commented very fully and said we should make it more conclusive.”
When it was put to her as a follow-up question that those people are not scientists, she said, “Yes they are.” The point is that those people did not sit through the expert working group for all those months going through the information, so how could they possibly have that information to reach that conclusion?
I know we are pressed for time, so I shall conclude by quoting my constituent once again. She says:
“We need help now, not in 5 or 6 years’ time.”
She says that she does not really want a public inquiry; she wants something to compensate for what has happened to her and Kirsteen. She says that she wants her daughter
“to have a house where there are no stairs, but no one is prepared to give her it.”
She also says:
“We need to have trust in the people who are governing us—we look back at all these years ago and we look at what is happening now and they are still failing us. They let drugs go out that should never have gone out and they were negligent. The same people are not around now so why can’t someone now just do the right thing and say we were wronged?”
I congratulate Sir Mike Penning, who opened the debate so powerfully, and my hon. Friend Yasmin Qureshi, who has been a strident campaigner on this issue for more than six years and knew all about it before it had even reached my consciousness. She gave an excellent, if rather too short, speech. I thank all other Members for their passionate and thoughtful contributions; because of the time constraints, I hope they will please forgive me for not naming them all. Ultimately, thanks must go, as others have said, to Marie Lyon, the chair of the Association for Children Damaged by Hormone Pregnancy Tests. I am sure that I speak for all of us in the House today when I say that she has the utmost respect and admiration of Members from across the House.
I want to touch on not only the science that was used to come to the conclusions in the review, but what is missing and what should have been considered before any conclusions were drawn. I will then highlight why this is a matter of injustice and why it is important that answers are found so that we can finally conclude this sad chapter.
The main sticking point of the review’s conclusions is that the expert working group found that the science did not support a causal association between HPTs during pregnancy and adverse outcomes. My focus will be on the science used and the historical documentation that we are aware of, but which seems not to have been considered—we heard about some of it in the excellent speech by Sir Edward Davey. I will not deviate into the important argument about “possible” and “causal”, as that was covered comprehensively by other Members, including the right hon. Member for Hemel Hempstead.
I must make it clear from the outset that I am no scientist—I am sure that Members are aware of that—and my speech is not a critique of the integrity and expertise of the specialists involved. However, the conclusions arrived at in the report and the conversations I have had with many of those who have been involved in the campaign show a need for us to be critical of what was concluded by the expert working group. That is our duty as Members of Parliament, especially when it comes to what is such an important matter for so many women and their families, and also because a great deal of public funds were invested in the review over the past few years.
In the report’s consideration of the scientific detail regarding HPTs, it is argued that there are inconsistencies in the conclusions drawn from the evidence used. Take, for example, the fact that of the 15 studies that looked at heart defects, 11 favoured a link, and of five studies into limb reduction, all found a link, yet those studies were deemed to show “insufficient evidence” of the drug’s harm. Even information I requested recently and got just this week from the Medicines and Healthcare Products Regulatory Agency in the lead up to this debate is at odds with the conclusions of the review, including graphs that plot birth defects against the availability of HPTs. Even to my untrained eye, they show a possible link. In one graph on all malformations, it is clear that birth defects increased during the period in which HPTs were on the market, and shortly afterwards. They began to decrease soon after HPTs were taken off the market.
Further, in the briefing I received, the MHRA said that for every 100 babies born in the general population, around two to four are expected to have a birth defect, which means that 14,000 babies a year would be expected to be born with a birth defect. That is just generally. Using those figures, the MHRA concluded that for the more than 1 million women who took HPTs, as many as 19,000 babies would be born with a birth defect, irrespective of any additional risk from HPTs. Yet let us compare Primodos to thalidomide, for instance. More than 30 million thalidomide prescriptions saw 600 children affected in the UK, which is a rate—I have had help with these numbers —of 0.002%. Some 1.2 million Primodos prescriptions were sold and 800 children were affected, which is a rate of 0.06%. That shows a much higher prevalence caused by Primodos compared with thalidomide. It also shows how little meaning a comparison of HPT adverse reactions has against today’s prevalence of birth defects in the general population, and it is hardly a defence of disproving a link.
As I have said, I am no scientific professional, but I believe that the red flags that arise when reading what the evidence says and what conclusions were drawn from it are not ones that only an expert in this field would see. This reflects the arguments that were raised last week by Dr Neil Vargesson—that the report does not provide definitive evidence that the drug was safe. As others have said, the only conclusion that can be drawn is that a link cannot be ruled out.
That leads me on to my next point, which is to touch briefly on the historical perspective and cover-up of the evidence. We have got to use that word—it is the only word we can use—as this is something that should have been considered by the expert working group.
One such example was in 1975, when the UK regulator knew of a potential five-to-one risk that the drug could cause deformities, but that evidence was apparently later destroyed. This is a running theme—I do not have time to go into it all—through the chronology of this scandal. We see multiple examples of suppressed information regarding the adverse effects and delayed notification of those effects to medical professionals who administered the drugs.
It is also deeply concerning that this drug came into the market in 1958, with no studies on its effects at all until 1963. Five years passed before it even underwent teratogenic testing. It was still officially in circulation until 1975, but we are aware of cases of its use up until 1978. All the evidence uncovered should have been considered as part of the review. The question is: why was it not?
With any scandal such as this, it is important that those affected have the trust and confidence of any review or inquiry undertaken. In this instance, that has not been the case. The victims feel that the review has muddied the waters even more and that their views have been ignored. I have been told many harrowing stories, many of which we have heard today, and how, time and again, they have been ignored. These women did not ask to be given HPTs. Nor were they ever made aware of the effects that they could have on them or their unborn baby. They were just given them—sometimes out of a supply in a drawer on the doctor’s desk. There were no warnings, no explanations, no discussions.
A great injustice has been inflicted on these women. It is up to this House to put pressure on the Government of the day, here and now, in a fully cross-party, non-partisan way, to make things right. It is paramount that a judge-led public inquiry be conducted—one that is independent and can fully examine all the materials and documentation available and insist that all information be made public, including that which has been withheld so far. I hope that this debate helps us to take that one step further to achieving that.
“shed light on the issue and bring the all-important closure in an era of transparency”.—[Official Report,
Vol. 586, c. 1143.]
Let this debate and the following actions by the Minister ensure that what was promised in 2014 is actually achieved.
Let me start by saying that this debate has been carried out with a tone and style that do great credit to this House and to the families who have campaigned so hard for so long. The shadow Minister, Mrs Hodgson, and I are becoming known for the non-partisan way in which we approach some of the issues in our portfolio, and long may that continue.
Let me congratulate my right hon. Friend— I also congratulate him on his elevation last week—Sir Mike Penning on securing a further debate on this important issue. I pay tribute to the Members who continue to campaign tirelessly on behalf of those who were given hormone pregnancy tests. I was struck by what Mrs Ellman said—she mentioned that this was first raised in the House in 1978, when I was four. I hope that we can achieve closure before it is that long again.
Let me be crystal clear from the very start. The Government’s utmost priority is and always will be—my right hon. Friend the Secretary of State has done more than most—the safety of NHS patients. We have listened to the concerns of patients and their families. We have certainly listened to parliamentarians on the matter of hormone pregnancy tests over many years, and we will continue to do so over the coming weeks and months.
Time and again during today’s debate we have heard that there is a lack of trust and a lack of faith in this process—Jeff Smith said this clearly; I thought he made a very good speech—contrary to the words of my hon. Friend George Freeman that the shadow Minister quoted. That troubles me, so let me be clear. We have ruled out no options at this time.
The report of the group published on
“Today, there are strict requirements for the supply of free samples of medicines to prescribers, as set out in section 6.12 of the MHRA Blue Guide”.
That is why I say that medicine, science and regulation of prescribing have changed hugely in the past 50 years. It is imperative for me that we continue to seek improvement in this area. That is why we have tasked the Medicines and Healthcare Products Regulatory Agency with implementing the recommendations of the expert group. They are quite wide. They are not just nice to haves; they are valuable initiatives that should permanently benefit the millions of women who use medicines in pregnancy.
Several themes came up in the debate. My right hon. Friend the Member for Hemel Hempstead mentioned Mr Dobrik. I apologise if Mr Dobrik feels that his name has been used inappropriately; I think that is the right thing to do. He was invited, as an advocate for families facing these issues, and made a strong contribution throughout. Let me be clear as the Minister. We thank him for his contribution. He is a campaigner who rightly has wide respect across our country and the world, and I know that that will continue to be the case.
My right hon. Friend spoke about the name of the inquiry. I am told that the group was reminded from the start that it had been set up not as a statutory inquiry but as an expert group of the Commission on Human Medicines. It was important to be clear on that at the start because formal inquiries have a very different structure and statutory powers. I do not think that there was an inconsistency there, but we can continue that debate. Almost all those who spoke mentioned the terms of reference—“causal” versus “possible”. The terms of reference set out the scope of the review, and I do not believe that they changed. They were endorsed by the CHM in December 2014 a few weeks after the previous debate, and confirmed by the then Minister, my hon. Friend the Member for Mid Norfolk, in a letter to the all-party group in September 2015. In the same letter, the all-party group was informed:
“it is important to review the scientific evidence to establish whether there is any causal association between use of HPTs and subsequent birth defects in the child.”
It is implicit and integral to any scientific assessment of evidence on medicines and associated harms to see whether the medicine is actually responsible for causing the harm rather than simply being associated with it.
The hon. Member for Manchester, Withington and others mentioned changes to the expert group report. I know that many Members are concerned about differences in the draft and final reports, and especially over the removal of the sentence that said:
“limitations of the methodology of the time and the relative scarcity of the evidence means it is not possible to reach a definitive conclusion.”
That sentence in the draft report was followed immediately by the group’s overall finding
“that the available scientific evidence does not support a causal association between the use of HPTs such as Primodos, during early pregnancy and adverse outcomes.”
The CHM quite rightly considered the two sentences together to be misleading, and advised that the report should be revised to better reflect the scientific—I stress, scientific—conclusion of the group, and that is set out on page 100 of the final report.
The hon. Members for Bolton South East, for Manchester, Withington and for Makerfield (Yvonne Fovargue) and others spoke about historic actions. Ministers have always been clear that issues of historic regulatory process were outside the scope of this review because there first needed to be clarity on whether there might be a link between HPTs and birth defects. That point was made by the much-mentioned former Minister for Life Sciences—my hon. Friend the Member for Mid Norfolk—in his letter to the all-party group in September 2015, when he said:
“the review will include a chronology of events, but the EWG”— the expert working group—
“will not be asked for its advice on systemic or regulatory failures”.
The hon. Member for Washington and Sunderland West and a number of other Members said that that should have been different. As I said to the hon. Member for Bolton South East, I am listening, but the report that I inherited on my desk this summer had that as its guidance. The group was not set up to look at those historic actions. Whether or not it should have is a matter of debate.
The hon. Member for Bolton South East—while we are talking about her—and the hon. Member for Makerfield mentioned the transparency issue and the “gagging order”. As I said during the urgent question, I can assure the House that, in being asked to sign a confidentiality undertaking, Mrs Lyon, who is here today—and I pay great tribute to her for her work—was not in any way treated differently from other panel members. This is standard procedure so that discussions can be held freely and openly in the group without external interference or a running commentary in, God forbid, the media. Despite being an observer throughout the review, Mrs Lyon was invited to speak after every agenda item and asked to give a presentation to the group on the evidence she had provided for the review.
The hon. Member for Bolton South East mentioned the evidence from Dr Dean and the Royal College of General Practitioners that was ignored. The interactions between Dr Dean and the RCGP are fully described in the annexes to the report, and I will come back to that in just a second before I close.
My hon. Friend Mims Davies and the hon. Members for Livingston (Hannah Bardell) and for Bolton South East mentioned the interactions with the families. I was clear the last time I was at the Dispatch Box on this subject that the families were not treated with the respect and the dignity that I would expect as the Minister from a body that I am responsible for. I have made that very clear to the members of the group, and I have asked them to report back to me as to how they will do things better next time. I look forward to seeing that, and they know that I mean it when I say that.
I mentioned the transparency issue. Minutes of the meetings and declarations of interest were published last week. I can update the House that annexes to the report, all documents from the national archive and studies conducted by Schering have been published today. The remaining documents, including those from the German archive, will be published sooner than originally agreed, once they have been checked for any personal data that needs to be removed due to confidentiality owed.
I am going to close there and give the sponsor of the debate a chance to close. I thank Members for their contributions. Nothing is off the table, and I am listening.
I thank everybody for giving up their Thursday in their constituencies to be here. I have been praised extensively for securing the debate, but I would not have been able to do it without the all-party group—we had 57 signatures.
I have constituents whose lives were changed—blighted, completely wrecked—by Primodos, and we have heard of others on both sides of the House today. I heard the Minister say, “Nothing is ruled out. I am willing to listen.” I am really pleased, because he is going to have to listen an awful lot. If this report is still on his desk and being used as a way to go forward, I am afraid that that is an insult to the victims.
This document was described to me in a way that I cannot repeat in the House today, but a better way of describing it is that it was crap. It is fundamentally flawed and does not do what it said on the tin when the Minister asked for it to be done. The Department can talk and move on, and talk and move on, but there has to be an independent public inquiry. If that inquiry decides it needs further evidence, it needs the finance to get that, and it needs to suspend while we find further evidence—and there will be evidence coming forward in the next couple of days.
That is because the victims are the most important people in what we have been discussing today. If we forget that, we forget why we are here and why the NHS has the greatest reputation in the world. Schering is a great brand—we need its drugs—but its reputation has been damaged, and so has the national health—
Motion lapsed (