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Hormone Pregnancy Tests

Volume 631: debated on Thursday 16 November 2017

(Urgent Question): To ask the Secretary of State for Health to make a statement on the recently published “Report of the Commission on Human Medicines’ Expert Working Group on Hormone Pregnancy Tests”.

Yesterday, the Commission on Human Medicines published the report of its expert working group on hormone pregnancy tests. As I said at Health questions on Tuesday, this subject demands the utmost sensitivity and I will do my best.

Based on its extensive and thorough review, the group’s overall finding, endorsed by the Commission on Human Medicines, is that the available scientific evidence, taking all aspects into consideration, does not support a casual association between the use of hormone pregnancy tests, such as Primodos during early pregnancy, and adverse outcomes of pregnancy with regard to either miscarriage, stillbirth or congenital abnormalities. Ministers have accepted the advice of the Commission on Human Medicines. A written ministerial statement was published yesterday, along with a copy of the report.

In the UK, hormone pregnancy tests first became available for diagnosing pregnancy in the 1950s. Between then and 1978, when Primodos was withdrawn from the market in the UK, a number of studies that investigated a possible link between women being given a hormone pregnancy test to diagnose pregnancy and the occurrence of a range of congenital anomalies in their babies was published. Although there was never any reliable evidence that HPTs were unsafe, concern about the issue, coupled with the development of better pregnancy tests, meant that a number of precautionary actions were taken to restrict the use of HPTs. The tests were voluntarily removed from the market by the manufacturers.

The body of information subsequently accrued by the Association for Children Damaged by Hormone Pregnancy Tests and other campaigners led to a parliamentary debate in 2014, I think in Westminster Hall, during which the then Minister for life sciences, my hon. Friend the Member for Mid Norfolk (George Freeman), stated that he would instruct that all relevant documents held by the Department of Health be released. In addition, he determined that an independent review of the papers and all the available evidence was justified. The purpose of the review was to ascertain whether the totality of the available data, on balance, supported a casual association between use of a hormone pregnancy test by the mother and adverse pregnancy outcomes. It also considered whether, alternatively, the anomalies could have been due to chance alone, or other factors.

The final report summarises the scientific evidence that was considered by the expert working group, its conclusions on the evidence, and its recommendations. All the available relevant evidence on a possible association has been extensively and thoroughly reviewed with the benefit of up-to-date knowledge by experts from the relevant specialisms. The evidence reviewed by the expert working group will be published in the new year, once it has been rightly checked in line with the legal duties of data protection and confidentiality.

In addition to the overall conclusion, the expert working group has made a number of recommendations to safeguard future generations through strengthening the systems in place for detecting, evaluating, managing and communicating safety concerns about the use of medicines in early pregnancy. I recognise that the conclusion of the report will be a disappointment to some, but I hope that they will see the recommendations as positive. They are a credit to the efforts of the Association for Children Damaged by Hormone Pregnancy Tests and the all-party group on oral hormone pregnancy tests, which is chaired by the hon. Lady, and also a lasting legacy.

I am so disappointed with the Minister’s response. Clearly he is just reading what his staff and the Department have been telling him. I wish the Minister would actually go through the documents submitted to the inquiry and those documents that we had, because if he had read them, he would never have to come the Dispatch Box and said what he has said.

You will be aware, Mr Speaker, that I have raised this issue in Parliament on a number of occasions. In 2014, an expert working group was set up to look at a possible association—not a casual link or a causal link. I am sure that hon. Members agree that that means that a lesser burden of proof is required. The first thing that the commission did was to say that it had found no causal connection, but it was never asked to do that—it was asked to look for a possible association. In 2014, the then Minister made promises about statutory oversight. From the papers we had, there appeared to be a clear criminal responsibility regarding the statutory body, the Committee on the Safety of Medicines, and the people who ran it, given that so much evidence was adduced to them. They were alerted to the fact that Primodos was causing deformities and miscarriages in women, but they totally ignored that evidence. In fact, the person in charge actually said that he wanted to cover it up so that nobody could be sued. It is therefore highly surprising that the commission has come up with this recommendation.

The commission was shown evidence from many studies, the majority of which showed conclusively that when the drug was given to rabbits and rats—mammals, like ourselves—the tissues were damaged. There were—

Order. I am grateful to the hon. Lady, but I am afraid, although she is highlighting an immensely important matter, and one that she has highlighted before, she has not asked a question—[Interruption.] Order. She has reached her limit and that is it. I have told her, as I have other Members. I have lost count of the number of times Members have been told that if they have an urgent question, they can begin with a few observations—a sentence or two—in response to the Minister, and then questions must follow, but that is not what has happened. I have the highest respect for the hon. Gentleman’s knowledge of and commitment to this subject, but she cannot speak for two minutes and then indicate, “I’m about to get to my questions.” Sorry, I say to her—[Interruption.] Order. No, sorry, but you have had your time. It is up to Members to stick to the limits, so other colleagues will now have to pursue this matter. I genuinely thank her for what she has said, but Members really must observe procedures. If I may say so, there has never been a more enthusiastic friend of the House than me in the granting of urgent questions, but Members must then follow the procedure. That is the situation. I call Anna Soubry.

Order. I beg the right hon. Lady’s pardon. First, let us hear the Minister respond to the statement made by the hon. Member for Bolton South East (Yasmin Qureshi). It was an important statement; it just did not contain a question.

You are, indeed, a friend of the House, Mr Speaker.

I have the utmost respect for the hon. Member for Bolton South East (Yasmin Qureshi), with whom I have served on Select Committees, and I will try to help her out. I have seen some of her public criticisms in the past 24 hours. I know that she has been very consistent about this, but I am not just reading notes put before me; I am citing evidence from an expert working group. It really would come to something if Members suddenly started to second-guess expert, scientific and medical evidence. I am not just quoting what is before me. The review’s conclusions do not take away—I do not pretend for one minute that they do—from the very real suffering experienced by these families. This was a comprehensive, independent, scientific review of all the available evidence carried out by the best experts in a broad range of specialisms. Ministers are confident in the report and the review process, and the focus now must be on implementing the recommendations.

On Friday, two constituents came to my surgery to speak to me about exactly this. The mother had taken one of these pills and her daughter was born with deformities. This is not the Minister’s report—he is just giving his explanation and doing his job—but may I suggest that we have a proper Back-Bench debate in which we can exercise all these issues? With great respect to the working group, and having had some experience as a former public health Minister and knowing about contaminated blood, I am afraid to say that I smell something like a very large rat in all of this. I think that there have been cover-ups.

I thank my right hon. Friend—one of my predecessors in this role—for her question. I appreciate that she will have met constituents who have been affected by this in her surgeries and that that must have been very difficult. The report’s conclusions do not detract from the suffering experienced by the families, and we recognise that the families may find those conclusions hard to accept. Birth defects occur naturally in up to four in every 100 babies, and the existence of a birth defect in a baby exposed to a medicine during pregnancy does not necessarily mean that it was caused by the medicine.

As for the question of any future parliamentary discussion of this subject, I suspect—in fact, I know—that my right hon. Friend is more than capable of seeking such opportunities.

This decision has rightly been met with disbelief by campaign groups. It has been called a whitewash, an injustice and a betrayal. It is clear from the reaction to yesterday’s report that real anger remains about the way in which the affected families have been treated. Have we learnt nothing from previous scandals and cover-ups? The chair of the campaign group, Marie Lyon, has said:

“I could go to prison if I divulge what was discussed.”

Does the Minister not agree that that is as far away as possible from transparency? How can Marie Lyon or any of the other campaigners say that their views have been properly taken into account? Will the Minister tell us what conversations he has had with the affected families about the results of the report and what further action they want to take?

A draft of the report, which was published in October, stated

“Limitations of the methodology of the time and the relative scarcity of the evidence means it is not possible to reach a definitive conclusion.”

However, that sentence was removed from the final version. It is critical that the Minister answers these questions: why was the sentence removed; why was there a delay of a month; and did he speak to the authors of the report about the sentence before its removal? The inquiry has answered a question that it was not asked to answer, and it has reached a conclusion not supported by the evidence. What is the Minister’s view of the various studies that have been referred to that show a causal connection?

When he set up the inquiry, the previous Minister for life sciences, the hon. Member for Mid Norfolk (George Freeman), said that he wanted to

“shed light on the issue and bring the all-important closure in an era of transparency”. —[Official Report, 23 October 2014; Vol. 586, c. 1143.]

The reaction that we have seen will demonstrate to the current Minister that on that measure the inquiry has failed. Will he look again at holding a full, independent review, so that families can feel they have seen justice done and we can be sure that this will never happen again?

The hon. Gentleman referred to a “whitewash”. As I have said, this was a comprehensive, independent, scientific review of all available evidence by experts on a broad range of specialisms who, with respect, are far more qualified to consider the subject than either him or me. It was a rigorous, important and impartial review conducted over the best part of two years, and the experts were given access to all the available documents.

As for the families and issues relating to disclosure, yes, Mrs Lyon was on the panel. However, it is standard procedure for expert working groups to sign such an agreement, as all members of the panel did, in order to keep the process free from external influence and to prevent it from being constantly discussed in the media. The companies did meet the group and gave evidence to it. Having discussed the matter briefly with members of the Medicines and Healthcare Products Regulatory Agency this morning, I have to say that I think the families could have been treated a great deal better when they met the group. I thought that the layout of the room was intimidating. Not everyone is like a Minister or a Member of Parliament who can sit in front of a Select Committee and know how to handle it. I think that the process could have been handled better, and I made that very clear.

As for Ministers and meetings, my noble Friend Lord O'Shaughnessy, who ultimately has responsibility for the MHRA and whom I “shadow” in the House of Commons, has met the all-party group and the families group. He will meet them again on 6 December, now that the report has been published. The APPG is also meeting the chair of the expert working group.

The hon. Gentleman mentioned other research. He might have been referring to Dr Vargesson, an Aberdeen-based researcher who is, I believe, working on the components of Primodos in fish. He was invited to give evidence to the group, and he did so, but he did not want to leave his work and the evidence, which he said would shortly be published, with the expert working group. As far I am aware, that work has still not been published, but I know that the MHRA will be keen to look at any new work that is published.

I know the Minister very well. He is a passionate and caring Minister, but I am afraid that I disagree with many of the things he said this morning. The families do—I think, rightly—feel that the report is a whitewash. Material has been removed from the draft, and the group looked into matters that were not within its remit. The question of a causal link was not in its remit. The question was whether there was link with a drug that was often given to our constituents with no prescription: a drawer would be opened, and it would be handed out to them so that they could find out whether they were pregnant. An open inquiry was needed, but I am afraid that the families, and many Members who are present today, will not feel that that was what happened. Will the Minister please meet the families again, with members of the all-party group, and try to understand why they are so upset? Will the Minister please also watch last night’s report on Sky News, which exposes much of what has being going on over many Parliaments? No matter who was in government, Governments have ignored these people, and we cannot continue to do so.

My right hon. Friend and I do know each other very well, but I am afraid we will have to agree to differ on this; I do not agree that this is a whitewash. At the request of the Association for Children Damaged by Hormone Pregnancy Tests, an expert, Nick Dobrik, who the House and outside world will know well as a respected and well-known thalidomide campaigner, attended all meetings of the expert working group and was invited to give a statement to the Commission on Human Medicines. Mr Dobrik is many things, but the notion that he is some sort of Government yes-man who would have allowed a whitewash to go on does not stand up to much scrutiny, if any at all.

A constituent of mine has had one of the most traumatic experiences over the past 24 hours. She was invited to come down and hear the results of that report, and she was not able to travel. Like many other such families, they have children who, they believe as a result of taking this drug, require them being at home to care for them. Does the Minister think 24 hours is a reasonable period of time in which to ask a family to travel to London, often from quite rural parts of the country? Does he also think it appropriate that the hon. Member for Bolton South East (Yasmin Qureshi) and I were locked out of yesterday’s Medicines and Healthcare Products Regulatory Agency press conference? That in itself smacks of a cover-up.

A number of relevant documents were not included in this inquiry, so it is not fair to say that it was comprehensive and independent. Will the Minister consider looking again at the process? A significant amount of public money has been used, and we must make sure, and have confidence that, it was used appropriately.

As we know, “causal link” and “possible link” are two very different terms. Does the Minister think it appropriate that an expert working group changes the goalposts halfway through a process, when it is looking at a matter that is, as he says, so serious?

First, may I correct myself? I might have said that the expert working group met “companies”, not “families”. If I said “companies”, I wish to correct the record.

I agree with the hon. Lady that the notice the families were given was not good enough. I and my colleague in the other place have made that crystal clear. Some notice was given to Mrs Lyon on Friday last week that there was likely to be an event on Wednesday, but that was not confirmed until Monday, so that was the notice the family got, and I do not think that is good enough; I have made that very clear.

On the hon. Lady and the hon. Member for Bolton South East (Yasmin Qureshi), who chairs the all-party group, being locked out of the press conference, I cannot imagine how that happened, and again I have sympathy on that. I expect the MHRA to look into that and explain that to me, because, while we may disagree, I can see how that merely feeds the conspiracy theory that some have around this subject.

My hon. Friend is clearly struggling to defend this position. I urge him to look at the scope of this review and all the evidence that was presented to it, as all the evidence that was available should be looked at and looked at again. Without that, many people across this country will not be satisfied that justice has been done.

With respect, I do not think I am struggling at all; I am just setting out a very clear position. Ministers are confident in the report and the review process. I say again that this was a comprehensive independent scientific review of all available evidence by experts across the expert working group who have a broad range of specialisms.

It is my understanding that in the research on fish, the researcher was reluctant to submit the findings because they had not been peer-reviewed. Is the Minister confident that all the animal studies that were considered in this review were properly and adequately peer-reviewed?

I can only give the House the facts. Dr Vargesson’s research was there, and he presented it orally, and orally only, to the group. The expert group felt that it wanted more than that, and he has not been able to provide it. At some point, if he does, I am sure that the group will be more than happy to look at it.

One of the key points here is transparency. What work does the Minister think he can do to increase people’s confidence and to share more information to dispel the image that things are being kept secret?

As I have said, I think that I have been very honest about the way in which the families have been handled, about the notice that they have been given and about Members being able to attend report launches. There is no great secrecy here, but I can see how events like that merely feed that notion.

Like the right hon. Member for Broxtowe (Anna Soubry), I am reminded of the contaminated blood inquiry, which is ongoing. In 1975, the regulator knew that there was a potential 5:1 risk of the drug causing deformity. They told the manufacturers but not the patients, and papers were deliberately destroyed by the chief scientist. It is deeply worrying to the families that there is not an open and transparent investigation into this matter. Does the Minister know whether the Berlin archive papers were examined as part of this inquiry, because they demonstrate the cover-up that has happened over many years?

No, I do not. I will write to the hon. Lady about that, but I can tell her that issues relating to the historical regulatory process were outside the scope and remit of this review.

I come to this having had no constituency involvement in this issue at all, but I have been listening to the exchanges this morning and it is quite clear that the level of concern on both sides of the House is sufficient for the Government to call a debate on the matter in Government time, so that all these issues can be properly explored.

All I can say is that, right on cue, the Leader of the House has arrived and is sitting right next to me, and I suspect that she has heard my hon. Friend’s request.

Is the Minister aware of the study in 1979 from Primodos that concluded that the visceral malformations should be considered to be drug-related? The manufacturer seems to have made a link that does not appear to have been dealt with in the report. Does he acknowledge that serious concern is being expressed on both sides of the House about the transparency of this report and that it behoves us all to try to make it transparent and understandable and, above all, to get to the correct answer?

Yes, of course we all want to get to the correct answers. Science and clinical practice have moved on significantly since the 1970s. As the hon. Gentleman knows, there have been far-reaching advances in the regulation of medicines. One of the reasons that the report has been delayed is that it was felt that it needed to contain far more human-speak, rather than official-speak. That is why I said that Ministers now had confidence in the report and the review process and that we are now going to focus on implementing the report’s recommendations.

This is simply a matter of confidence. My constituent, Charlotte Fensome, her parents and her brother Steven simply do not have confidence in this report. I trust the Minister, who I know is thoughtful about these matters and wishes that all the families and parents had had their concerns properly taken into account, but the report that was brought forward yesterday falls incredibly short when it comes to inspiring confidence. That is a great shame. I am thoroughly dissatisfied with the complete lack of transparency and with the preparation of the report. We had only 24 hours’ notice of this. Will he meet me and other members of the all-party parliamentary group, so that he can hear from the campaigners and truly listen to their concerns?

I take the comments of my hon. Friend and parliamentary neighbour on board. As I have already said, my hon. Friend Lord O’Shaughnessy is meeting the all-party group on 6 December, and I am sure that she will be more than welcome to attend that meeting.

The report must be judged against the background of the fact that the thalidomide scandal involved only 20 birth defects in America and 2,000 in this country, that we are still misinforming and under-informing mothers and potential mothers about the valproate scandal and that GlaxoSmithKline was fined $3 billion for distorting the results of its research. The Minister must tell us how many members of the expert group are present or past employees of the pharmaceutical industry.

I cannot give the hon. Gentleman that information at the Dispatch Box, but he mentions the thalidomide tragedy and I have already said that Nick Dobrik attended all the meetings of the expert working group as an invited expert at the request of the Association for Children Damaged by Hormone Pregnancy Tests. Nick is most certainly not a Government placeman or yes-man.

I have a constituent who has been affected by this issue, and they want justice. Based on what I have heard today, justice has fallen short in this case. In any normal circumstances, justice must not only be done, but it must be seen to be done. If the criteria have not been applied correctly, we would in normal circumstances have a review to get the correct decision in the end. Will the Minister look at the matter and get it reviewed?

My hon. Friend is right to speak up for his constituent. At the risk of repeating myself, the patient voice was present throughout, and the members of the expert working group were deeply moved by the experiences of the families involved. However, the conclusions do not take away from the real suffering of the families and nothing can. Nothing can turn the clock back. Ministers are confident in both the report and the review process, and we now have to implement the recommendations.

I have been contacted by my constituent Adele, whose mother has suffered immense guilt over the loss of a child, which she now believes to be related to the Primodos hormone pregnancy test. To add further upset, when victims were brought to the inquiry, they were given only half a day to be interviewed. I implore the Minister to listen to individual cases, such as the one I describe, and to explain what steps the Government will take to ensure that the women get the answers they so desperately seek.

The step that we will take is to implement the report’s recommendations. As I have already said, the way the families were handled when they came down to speak to the expert working group could have been a lot better, which is the understatement of the day, and I apologise for that on behalf of the MHRA.

A constituent who took one of the Primodos tests and whose son was born deaf visited my surgery on Friday, and she is deeply disappointed with the latest outcome. The Minister said a few minutes ago that checks had to be made before the final report was published, so what hope can he offer her and other parents that the matter will not be swept aside, that work will continue to flush out the truth and that the affected families will be properly supported?

All I said is that there were checks to be made to ensure that the report was as readable and as accessible as possible. We are confident in the report, and we are not going to sweep it away and forget about it and move on to the next story; we will implement the recommendations.

Will the Minister outline what support is on offer to those who took Primodos and were traumatised by stillbirth when it was not possible to carry out genetic testing because the baby had died and the remains were gone? We understand the Minister’s compassion, but where is the redress for the still-grieving parents? Where is their support? Where is their help?

I repeat that we cannot turn the clock back. The conclusions of any review, no matter how it is done, cannot take away from the suffering of families and constituents. I repeat that the review of the evidence by the expert working group was comprehensive, independent and scientific. We are confident in the report and in the review process, and we will now get on with implementing the recommendations.

Is the Minister aware that in all the years that I have been here, I have never heard of such a decision, particularly one made by this party, presented by a Minister of Health who is constantly telling us all about the Stafford inquiry and how important the last Stafford inquiry was? It is time that he considered the possibility of having this thing reviewed, bearing in mind that we are dealing with drug firms that have millions and millions of pounds. He should start all over again from the beginning. It will otherwise be a bad day for the Government if he is allowed to say what he has without listening to the people from both sides of the House who have rubbished the report.

I could have sworn I heard the hon. Gentleman bring the word “party” into this. That is deeply unfortunate, and I do not think it is helpful to anybody. Last time I checked, there have been Governments of both colours since the 1950s.

As for bringing Stafford and patient safety into this, the Secretary of State for Health takes many criticisms but he has placed patient safety and getting to the bottom of the issues around Stafford at the heart of his agenda. It is because we do not bury our head in the sand and sweep these things under the carpet—as, I am sorry to say, happened in the past—that we are uncovering this and doing the best for the families with the report’s recommendations. Nothing can turn the clock back and nothing can undo the suffering of these families.

As has been said, this is absolutely not a party matter. Colleagues have expressed their interest in a debate on this matter, and I can simply say from the Chair that, one way or the other, through one vehicle or another, this matter will be debated if Members want it to be debated.