Hormone Pregnancy Tests — [Mr Philip Hollobone in the Chair]

– in Westminster Hall at 11:30 am on 23rd April 2019.

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Photo of Yasmin Qureshi Yasmin Qureshi Shadow Minister (Justice) 11:30 am, 23rd April 2019

I beg to move,

That this House
has considered the Expert Working Group report on hormone pregnancy tests.

It is a pleasure to serve under your chairmanship, Mr Hollobone. I am also pleased that the Under-Secretary of State for Health and Social Care, Jackie Doyle-Price, is here to respond to this debate.

To establish the context of the debate, I will begin by acknowledging the extraordinary hard work and determination of Marie Lyon, who is here with us in Westminster Hall today. She has led the campaign on behalf of the victims of hormone pregnancy tests, and alongside her husband has travelled the length and breadth of this country, and even been to Germany, to support victims.

It has been my pleasure to work with Marie since the beginning of this campaign, alongside others including Jason Farrell, who has pursued this story for Sky News from the start; Professor Neil Vargesson of Aberdeen University; and Professor Carl Heneghan and Dr Jeffrey Aronson, both of Oxford University, whose recent work is the basis of this debate.

By way of providing more background, I remind the House that Primodos, the hormone pregnancy test drug, was taken by approximately 1.5 million women in the 1960s and 1970s to test for pregnancy. The dosage contained in those Primodos tablets was 40 times the strength of an oral contraceptive that would be prescribed today. There is considerable evidence that many women who took this drug either gave birth to babies with serious deformities, or miscarried, or had stillbirths. Those babies are now in their 40s and 50s, and they have had to live a lifetime with serious disabilities.

To this day, not one Minister or one review has been able to answer some very simple questions. First, why were no official warnings issued about this drug until eight years after the first major report that indicated possible dangers? Why were some doctors still prescribing this drug for pregnant women after official warnings were issued by the Committee on Safety of Medicines? And why were some GPs able to pull out Primodos tablets from their desk drawers and hand them to women?

I secured this debate to seek answers in respect of the Medicines and Healthcare Products Regulatory Agency-led expert working group. That was the scientific review set up on the instruction of a former Minister, George Freeman, following my Backbench Business Debate on this issue in 2015. He had clearly stated to us that this review would “thoroughly” consider all the evidence.

Such is the depth of concern about this issue that there have already been three debates on the expert working group’s review—this is the fourth. Each and every time, Members from across the House have urged Ministers to consider our concerns about the methodology, the independence of the panel members and the conclusions of the report. On each and every occasion, however, our concerns have been dismissed.

Photo of Gordon Marsden Gordon Marsden Shadow Minister (Education)

I congratulate my hon. Friend on securing this debate and on the absolutely focused way in which she has conducted this campaign, with other Members here today and with Marie Lyon. I also pay tribute to George Freeman, the former Minister: it is not easy for Ministers to override the advice of their civil servants, but he did on that occasion. That, however, makes it all the more concerning that, on 24 October last year, Lord O’Shaughnessy wrote my hon. Friend a letter that was rather confusing and defensive, and did not make any reference to enforcing a rethink by the MHRA.

We know that there are issues about how the meta tests are done, and I am sure that my hon. Friend will come on to that. However, at this stage does she still find it very concerning that Ministers have not grasped the nettle?

Photo of Yasmin Qureshi Yasmin Qureshi Shadow Minister (Justice)

I thank my hon. Friend for that intervention and I absolutely agree with him; he can probably hear in my voice some of my frustration about the fact that this issue has not been grasped by Ministers and dealt with.

In recent months, the all-party parliamentary group on hormone pregnancy tests, of which I am the chair, has written to Ministers several times to ask for meetings so that we can discuss these concerns, but each time our request has been declined. Perhaps the Minister here today could shed some light on what exactly the Government are so intent on hiding each time they refuse the request by a group of MPs for a meeting.

Let us not forget that the review was cloaked in secrecy from the very start. As an observer, Marie Lyon was forced to sign a “gagging clause”, which, if breached, could have resulted in a prison sentence. Families who gave evidence to the panel reported being treated appallingly by the MHRA. Despite the MHRA’s insistence that the expert working group was independent, two panel members had to be removed after Marie Lyon discovered conflicts of interest.

Perhaps the most shocking fact was that this review was set up with terms of reference that stated very clearly that it would seek to find a “possible association”, but the review panel and the Commission on Human Medicines chose to ignore that and instead concluded that a

“causal association could not be found between the drug and birth defects.”

Each time that Ministers have been questioned about this review, we have been told that it was

“robust, comprehensive, independent and scientific”.

If that really is the case, I hope that the Minister can provide us with answers today as to why we now have evidence, which I will set out, that clearly proves that the expert working group review was anything but robust and comprehensive.

Last November, a team of experts led by Carl Heneghan, the Professor of Evidence-Based Medicine at Oxford University, conducted a systematic review of all previous human studies. They discovered that when the data is pooled properly it shows “a clear association” with several different forms of malformation. The results were clear that there is an association that is significant. That tells us that the expert working group’s review completely failed to adopt the right approach for a systematic review. Why did it not pool all the data together and properly collate it to show an overall effect? I should also point out that Professor Heneghan’s study has been published in a peer review journal, whereas the expert working group’s review was not even scrutinised.

However, Professor Heneghan did not stop there. Marie Lyon obtained raw data used by the expert working group via a freedom of information request. It is worth noting that despite the MHRA’s claim of “transparency”, this data was not already in the public domain. The cynical among us might ask: why was that? Why hide it?

That raw data was then assessed by Professor Heneghan and his team, who carried out a meta-analysis on it, and again they found that there is an association between the drug and birth defects. Let me just repeat that point again—raw data used by the MHRA for the expert working group review was assessed by independent experts at Oxford University and it was found that Primodos causes deformities.

Can the Minister appreciate why that has led to suspicion that key elements of the research were removed from the report in order for the expert working group to reach its conclusion, and why campaigners feel that Ministers and Parliament may have been misled, given that it appears that key information was being withheld from the report in order to suggest that there is no link between Primodos and deformities?

Photo of Gordon Marsden Gordon Marsden Shadow Minister (Education)

My hon. Friend is being gracious in allowing interventions. Does she not consider it confusing that the group, and indeed the MHRA, seem to be reluctant regarding meta-analysis, when only recently the National Institute for Health and Care Excellence used it to reinstate surgical mesh in the treatment of prolapse? It is widely understood to be a common method—the US Food and Drug Administration and the European Medicines Agency have adopted it. Why are we lagging behind? Perhaps the Minister would like to comment on that in her reply.

Photo of Yasmin Qureshi Yasmin Qureshi Shadow Minister (Justice)

My hon. Friend is absolutely right and I come on to explain how other bodies use meta-analysis to carry out assessment.

Does the Minister understand why we are asking why the data was not even properly assessed? When I tabled a parliamentary question to inquire whether the meta-analysis of the studies had been carried out, I was told that it had not. Can the Minister explain why not? One of the experts on the panel, Professor Stephen Evans, recently made a poor defence of meta-analysis not being used in the review, by relying heavily on a paper called, “Meta-analysis. Schemata analysis”, which was published 25 years ago. The expert working group seems not to have considered meta-analysis an appropriate way in which to assess the data. Why not? Why did it refuse to take an evidence-based approach?

Neither the Minister nor I is a scientist, but she is aware that meta-analysis is the statistical procedure that combines data from multiple studies. When treatment effect is consistent from one study to the next, as with Primodos, it is completely appropriate and evidence-based to use a meta-analysis to assess the data. Pharmaceutical companies use it to approve new drugs. The US Food and Drug Administration uses it. The European Medicines Agency uses it for the approval of drugs, and clinicians and researchers in medicine, education and the criminal justice system use it to determine whether a treatment works. The National Institute for Health and Care Excellence uses meta-analysis, and it is the cornerstone of Cochrane—previously known as the Cochrane Collaboration. The only group that discounts meta-analysis is the MHRA. Why? To say that meta-analysis was not the appropriate method is completely incompatible with an evidence-based approach.

Let me take up the matter of the independence of the expert working group. We have been told several times, by a number of Ministers, that the entire process was completely independent. It is my view that the Government are not well served by their current processes, the lack of independence and the lack of impartiality. What is in doubt is the question of whether the Government have the independent expertise required to hold Government bodies such as the MHRA to account and provide us with independent evidence with which to make informed decisions.

As the Minister is aware, in February 2018, Baroness Cumberlege began a joint non-scientific review into Primodos, sodium valproate and mesh implants, and we expect it to conclude in the next few months. Baroness Cumberlege invited the expert working group to give oral evidence to the review team, and this is how Ailsa Gebbie, the group’s chair, described herself at the beginning of an evidence session:

“I’m also the chair of the MHRA and the expert working group on hormones and women’s health that reviews all products and medicines and drugs related to women”.

What does independent mean if the chair describes herself in that way?

In 2015, the Commission on Human Medicines agreed to establish an expert working group to review the available data on a possible association between the hormone pregnancy test, Primodos, and adverse outcomes in pregnancy, and to make a recommendation. The commission appears to have commissioned the MHRA to do an independent review. Perhaps the independence of the MHRA can be summed up in its response to Marie Lyon, who in conversation with the agency had reminded it of its responsibility to the public interest. She was immediately corrected:

“No, the job of the MHRA is to represent Pharma”.

Of course, the agency is correct—it is substantially funded by the pharmaceutical industry and cannot be considered independent by any stretch of the imagination. Can the Minister explain why we are expected to have confidence in the independence of a review that was run by an organisation part-funded by pharma? How can we be expected to trust claims that Bayer, the manufacturer of Primodos, has no links to the MHRA? Yes, we had a review, but I am not sure we can call it independent. Will the Minister do the right thing and withdraw the expert working group report?

If the Minister needs any further evidence, perhaps I can point her to the testimony of Sandra Malcolm, a recent whistleblower. Mrs Malcolm worked for the manufacturer of Primodos, which is now owned by Bayer. While at the company in 1971, she discovered she was pregnant and spoke to colleagues:

“I was in reception one day and there were two guys there. One may have been a medical rep and he said to me ‘you want a dose of Primodos’
and the other said ‘I think it’s been taken off the market’, and the other one said ‘no, you can get it’. So with that information I went upstairs to see one of the doctors. I said ‘I’m a week overdue and can I have some Primodos?’
And he said ‘I can’t give it to you because it may not work and it may cause deformities’, so I thought that was a definite no.”

Mrs Malcolm said that after the conversation she decided not to take the drug “for obvious reasons” and that she assumed it was no longer on the market. However, many years later, when she saw a report about Primodos causing deformities, she was shocked to discover it had remained on the market for many years after problems had been listed.

Vast swathes of evidence clearly point to a cover-up by the drug company and the Government regulators at the time. It is utterly disgraceful that until this day the evidence has been ignored, as it was by the expert working group review.

Photo of George Howarth George Howarth Labour, Knowsley

I am grateful to my hon. Friend, not just for securing the debate and for the way in which she has conducted it, but for her leadership on the issue over a long period. One of the more modern—I say modern; I think it was in the 19th century —versions of the Hippocratic oath is the principle, “Do no harm”. Does she agree—and she has made a powerful case for this—that as harm has been done we should acknowledge the consequences and deal with them appropriately?

Photo of Yasmin Qureshi Yasmin Qureshi Shadow Minister (Justice)

I thank my right hon. Friend for that intervention, and I absolutely agree with him. He may have realised what the ending of my speech was going to be, because that was a point I was going to make.

Not once did the expert working group mention the historical evidence in its review; not once did it look at those documents and acknowledge that there are questions to be answered. Primodos has been the cause of devastating effects, and much of the current suffering is the result of ongoing uncertainty. We must accept that we cannot achieve certainty in all things, but we can admit our failings. Victims of Primodos need an acknowledgement of liability, and it is time that we gave them an apology. When will the Government stop wasting time and public money by setting up these so-called independent ad hoc expert working groups each time scientific evidence clearly shows that the use of Primodos caused birth defects, just so they can dismiss the evidence and continue to cover up what one lawyer has called the biggest medical and legal cover-up of the 20th century?

On behalf of my four constituents and their families, and on behalf of thousands of families across the country and over 130 members of the all-party parliamentary group on hormone pregnancy tests, I urge the Minister to listen to these concerns, as well as those of other Members present. I urge her to be brave, and to have the courage to say “Enough is enough.” From today, let us stop putting our heads in the sand. Let us look at the evidence that Professor Heneghan has presented, and give Primodos victims the justice they deserve.

Several hon. Members:

rose—

Photo of Philip Hollobone Philip Hollobone Conservative, Kettering

The debate can last until 1 pm. I am obliged to call the Front-Bench spokespeople no later than 12.27 pm, and the guideline limits are 10 minutes for the Scottish National party, 10 minutes for Her Majesty’s Opposition and 10 minutes for the Minister. Yasmin Qureshi will then have three minutes at the end to wind up the debate.

We are in Back-Bench time until 12.27 pm. Six Members are seeking to contribute, so please do not speak for more than six minutes. Unhelpfully, only one of the monitors is working—the one to my right—so to assist Members, I will gesticulate at them in a friendly way when they have a minute to go.

Photo of Bill Grant Bill Grant Conservative, Ayr, Carrick and Cumnock 11:52 am, 23rd April 2019

It is a pleasure to serve under your chairmanship, Mr Hollobone. I am grateful to Yasmin Qureshi for securing this vital debate on what, for many people, has been a long journey.

Sir William Osler, an eminent Canadian physician, once said:

“Medicine is the science of uncertainty and the art of probability.”

My constituents who took the hormone pregnancy tests of the ’60s and ’70s, including Primodos—which was removed from the market in 1977—have to date been met with uncertainty. They placed their trust in those involved in manufacturing, testing, prescribing and dispensing—trust that in their view, and in mine, was betrayed. With dogged but dignified determination, they still seek to confirm the probability of a possible connection between those drugs and birth defects and/or fatalities.

I understand that Professor Carl Heneghan carried out a meta-analysis that backs up the findings of Professor Vargesson’s zebrafish study. While I appreciate that meta-analysis is a complex and comprehensive tool, my layman’s understanding is that it may be undertaken to review and reconcile multiple research studies on the same topic with different results. In doing so, it may uncover a study that has different results due to systematic error or bias in the research process. In response to a recent question posed by the hon. Member for Bolton South East, the individual answering on behalf of the Secretary of State for Health and Social Care stated that the Commission on Human Medicines expert working group did not undertake a meta-analysis as part of its review, citing different designs, lack of robustness and the extensive limitations of studies as the reasons therefor.

Dan Mayer’s text, “Essential Evidence-Based Medicine” advises the reader:

“Some common problems with meta-analyses are that they may be comparing diverse studies with different designs or over different time periods.”

However, importantly, the author does not appear to suggest that such circumstances should automatically rule out proceeding with meta-analysis. Rather, he states that such apparent divergence may be addressed by incorporating various checks and balances as part of that analysis. It appears that professors at the University of Oxford who have had sight of data recently recovered through a freedom of information request are yet again persuaded that there is an association between hormone pregnancy tests and birth defects, thereby casting doubt on the robustness of the EWG’s work and the material that it has published to date.

I note that the Government’s response referred to the European Medicines Agency’s ongoing independent review of the publication by Professor Heneghan and others, and I await the EMA’s conclusions with interest. Hopefully, those conclusions will finally bring some comfort to my constituents and many others. I ask the Minister to provide greater clarity as to why meta-analysis was ruled out by the EWG, and to confirm whether the EMA’s conclusions will be published next month. Finally, I make a passionate plea—which I am sure many others share—on behalf of the victims of hormone pregnancy tests in the ’60s and ’70s. Let us introduce honesty, openness and, above all, humanity into the long-standing journey that those individuals have been on.

Photo of Emma Reynolds Emma Reynolds Labour, Wolverhampton North East 11:56 am, 23rd April 2019

It is a great pleasure to serve under your chairmanship, Mr Hollobone. I begin by paying tribute to my hon. Friend Yasmin Qureshi for having secured this important debate, and more widely for her leadership of the all-party parliamentary group on hormone pregnancy tests and her incredible campaigning on this issue. I pay tribute to all the families who, for many years, have been campaigning tirelessly to uncover the truth about Primodos, particularly Marie Lyon, who is an incredible campaigner. She has worked hard on this issue, and I hope we can do something to make sure we get to the truth about what happened all those years ago. I also place on record my thanks to Professors Neil Vargesson and Carl Heneghan, and to Sky News reporter Jason Farrell for his determination to get to the truth. Many of his reports have been seen by families who have come forward as a result of the testimony and campaigning of others.

One of the families affected by Primodos lives in my constituency. My constituent Steven Bagley was born severely brain-damaged after his mother was given Primodos as a hormone pregnancy test in 1967. Steven needs 24-hour care, cannot communicate, and suffers from a severe form of epilepsy, which means frequent seizures that have become steadily worse with age and happen throughout the night.

I have got to know the Bagley family over the past few years: Steven’s parents Pat and Ted, and his sister Charlotte, who has been a tireless campaigner for justice for her parents and brother. She has recently moved from Southampton back to Wolverhampton to help look after Steven. His parents have lovingly looked after him for 50 years, but are now in their 80s and 70s with their own health problems, and are finding it a real struggle. What I find particularly heartbreaking about the case of my constituents, which is similar to many others, is that like other mums affected, Pat still says, “If only I hadn’t taken those pills.” However, she was doing what we all do: trusting our GP and following their advice. Like many others affected by Primodos, Pat was not given a prescription, but was given the pills directly by her doctor.

It is thanks to the tireless campaigning of families such as my constituents, and of my hon. Friend the Member for Bolton South East, that the Government asked the Commission on Human Medicines to set up an expert working group to examine the scientific evidence linking Primodos to birth defects. However, from the start, serious concerns were raised by the families, the APPG on hormone pregnancy tests, individual MPs and scientists about how that group went about its work. Those concerns have only grown as evidence of missing analysis has come to light, and questions have been asked about the methodology used.

I will raise four particular concerns about the expert working group. First, the group reinterpreted its terms of reference. It was asked to look at a possible association between the drugs and the foetal abnormalities. Despite that, it decided to look for a higher standard of proof of a causal association between Primodos and birth defects, even though it was not asked to find a causal link. It has never been clearly explained why the group chose to interpret and change the terms of reference in that way. Perhaps the Minister will reflect on that when she winds up. If not, will she take that away, consider it and come back to us?

Secondly, the report was altered before publication in several ways. Apparently the draft report, provided to Marie Lyon, 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.”

That line was removed before the final report was published. The draft also stated that

“there is insufficient evidence to determine whether taking the medications at the doses found in Primodos tablets, for two days during the first trimester of pregnancy could have reached and had an effect on the fetus.”

However, in the final report, that was substantially changed. That uncertainty was replaced by the claim that the evidence indicated that any exposure

“was unlikely to have had an effect on the developing fetus.”

In short, the conclusion in the draft report changed from

“the evidence is insufficient to form a conclusion”,

to, in the final report,

“the evidence does not support a causal association”.

Again, there has been no satisfactory explanation for those changes. Will the Minister reflect on that in her winding-up speech or go back to the Department and convey to us why the changes were made?

Thirdly, there was no consideration of possible regulatory failures at the time Primodos was given to mothers by doctors as a hormone pregnancy test. That seems to be a huge omission. Will the Minister explain why such a vital question was excluded? It would surely help us to understand what concerns were raised or should have been raised about Primodos at the time.

Photo of Gordon Marsden Gordon Marsden Shadow Minister (Education)

My hon. Friend is making an excellent speech. She is taking us necessarily into the past. What we know about the past is that how the drugs were marketed in the 1960s and 1970s would be totally unacceptable today. Does she not find it concerning that the context of how the drugs were delivered has not been looked at properly by the report? Some of the potential consequences of that, such as what women took as gospel from doctors, have not been addressed either.

Photo of Emma Reynolds Emma Reynolds Labour, Wolverhampton North East

I agree with my hon. Friend. It is incredible that the burden of proof seems to rest on the families. That is what is being suggested in debates—not our debates, but others—but the burden of proof actually lies with the pharmaceutical company that made the products in the first place and did not do the testing required. The drugs subsequently had horrific effects on the babies who were born, yet we still have not got a Government or a Minister to accept that there is a link. We are looking for the truth to be uncovered.

I am conscious of time and your advice, Mr Hollobone, but allow me to make a fourth point about the expert working group. The credibility of the group has been further undermined in the eyes of the families and of the Members here today by its not including a meta-analysis—a pooling of all the data from previous studies. It is not clear whether such a meta-analysis was carried out and not divulged, or was just not done. Marie Lyon obtained the raw data used by the expert working group though a freedom of information request. Professor Carl Heneghan of Oxford University used the working group’s own data and found strikingly similar conclusions to his review. Both reviews showed significant associations of the use of Primodos with all congenital malformations and congenital heart defects. Both systematic reviews show that the use of Primodos in pregnancy is associated with increased risk of congenital malformations.

In conclusion, we know that Baroness Cumberlege is carrying out a wider review into independent medicines and medical devices safety. I place on record my thanks to her and her team for listening to the testimony of Pat and Ted Bagley and their daughter Charlotte. For the first time, they feel like they have been heard and listened to sympathetically. I hope that the Cumberlege review will get to the truth of what happened, but before we do that, it would be useful for the Government and the Minister to get to the truth of why the expert working group has presented the evidence in such a way and to respond to the concerns I have expressed. The sooner we get to the truth of what happened in the ’60s and ’70s with Primodos tablets—they were taken not only by expectant mums in our country, but by others in countries around the world—the better.

Photo of Mike Penning Mike Penning Conservative, Hemel Hempstead 12:05 pm, 23rd April 2019

It is a pleasure to be involved in this debate, to be part of one of the largest all-party parliamentary groups in the House, and to look after my constituents and speak for them and the others who have been so dramatically affected. They trusted the NHS and the drug company and so thought that the drug they were taking was safe. As was suggested, these ladies may went to their GP surgery perhaps because they had missed their period or had some of the other symptoms of pregnancy. It was such an important time in their lives. Often the GP just opened a drawer, gave them the tablets and said, “This will tell you whether you are pregnant or not.” There were no pamphlets and no advice, even though the risks were known to nearly everyone, apart from those ladies who took those tablets.

In this excellent debate, we have touched on a lot of the science. I am not a scientist or a lawyer; I am just a dad who is trying to help out some constituents in this area and as part of the group. In the debate that followed the publication of this so-called independent review, I said that it was a whitewash, but it was not; it was a cover-up, and we have to discover what is being covered up. Is it the legal side of the NHS giving a drug to a woman on its premises when it knew there was not only a risk, but an effect? Is it the drug company having undue influence on the report, the Medicines and Healthcare products Regulatory Agency, the Department of Health and Social Care, or a bit of everything?

I say to the Minister that this is not about this Government, but Governments. The issue was being discussed when I was the shadow public health Minister, not least by thalidomide campaigners. They were supportive of this campaign, and they had to rely extensively on evidence that was there, but that the Government and the drug companies had ignored over the years.

Photo of Hannah Bardell Hannah Bardell Shadow SNP Spokesperson (Digital, Culture, Media and Sport)

Is it not the case that we do not need to be lawyers or medical experts to realise that a drug that is 40 times the strength of the contraceptive pill—it was being given in such countries as Germany as an abortive—would surely have profound impacts on unborn foetuses, or children who were born after their mothers had taken Primodos?

Photo of Mike Penning Mike Penning Conservative, Hemel Hempstead

No one in this room or anyone listening to this debate could disagree with that, unless they were a lawyer working for the drug company, the Department of Health and Social Care, or perhaps both.

Believe it or not, Mr Hollobone, 70% of me, you and anyone else in the room is the same as a zebrafish. I swim really well, but I did not realise that until this morning. We chuckle, but the point is that the effects of an experiment on zebrafish will be similar to those on a human being. There are many studies, but the link is important. Professor Neil Vargesson’s report in 2018 supported Professor Heneghan’s report. What does that mean? We all know about the disgrace of thalidomide. Through experimentation on zebrafish, it was proven that thalidomide damaged children. We do not want to experiment on humans. It appears that that is exactly what has gone on here. It is obvious that the mechanism of the action of thalidomide is the same as that shown by the Primodos tests. Everybody can read the technical stuff. There was an effect on zebrafish, who share 70% of their genes with humans. Does that mean it could have had an effect on humans? Of course it does; it is not rocket science.

Photo of Gordon Marsden Gordon Marsden Shadow Minister (Education)

The right hon. Gentleman is taking us through the history. Does he not agree with me that it is extraordinary? We need to remember the chronology. The thalidomide episode took place in the 1960s and was exposed by The Sunday Times and Harold Evans in a great step forward, but the drugs continued to be supplied afterwards. Even now, 40 years later, there is, in the statement of Lord O’Shaughnessy, doubt about whether such things should still be used. We should surely say that they should not be used.

Photo of Mike Penning Mike Penning Conservative, Hemel Hempstead

I cannot understand how a drug company, now owned by Bayer, could know what was going on and continue to supply the drug in an underhand way to GPs. As a father—as a human being—I simply do not understand it. What on earth was going on? The MHRA, which gave evidence to us, was in complete denial. We did not ask for a cause. I was lucky enough to be a Minister in seven Departments. If I had said, “This is the review that you are going to do, and these are your terms of reference,” and those terms of reference were changed by the review group without my permission, I would have smelled a rat. I would have thought something was going wrong.

We can go through all the science, which cannot be denied. I do not blame any Minister—I can feel the special advisers’ eyes on my back—but something went dramatically wrong, and it has been covered up by several Governments. That must stop now. If compensation has to be paid, fine. Most of the families simply want an apology. Why is there no apology? Because there would then be the threat of legal action. Mistakes happen. When we make mistakes, we should admit it, no matter what Government are in power. We should sort it. We did that over Hillsborough when I was a Minister in the Home Office. It was a really difficult decision to make, but we made it, and the right conclusion was reached. That should be the case in this instance.

Photo of Philip Hollobone Philip Hollobone Conservative, Kettering

I am afraid I will have to impose a five-minute limit on speeches, or we will run out of time.

Photo of Yvonne Fovargue Yvonne Fovargue Shadow Minister (Housing, Communities and Local Government) 12:12 pm, 23rd April 2019

I congratulate my hon. Friend Yasmin Qureshi on securing this debate, and on all the work she has done on this subject.

In the small geographic area of Makerfield, I probably have the most constituents affected. There are at least eight, including Marie Lyon, who has been a wonderful chair of the Association for Children Damaged by Hormone Pregnancy Tests and a tireless campaigner. Whenever I have tried to speak to Marie about any issues, she has been restricted by an incredibly strict gagging agreement. I have asked questions and she has said, “I can’t answer that. I can’t mention that. I can’t give you any information about that.” Why can she not give me, her Member of Parliament, the information that I need?

Minutes of meetings have been recorded, but were destroyed straight after. Marie has told me that they do not reflect her notes. Positive comments have been left out, and some of the minutes have been changed after her intervention. That is surely not normal practice.

I have heard the same story as many of my hon. Friends here: constituents were given tablets from an office drawer in the doctor’s desk. The women have lived with the consequences and the guilt of taking the tablets. One mother was told that her son’s severe mental and physical disability was probably her fault, and she had no more children. That has stayed with me, because she said to me, “We have such a lot of love to give.” She and her husband, who has sadly died, dedicated their lives to looking after their son. She is now worried about what will happen when she is gone, and that is why it is so important that we get to the truth. We want proof that she has been let down by the people she trusted. The statement made on behalf of the MHRA that families could already have had previous congenital abnormalities is appalling. The statement was made by a representative who had worked with a leading member of the expert working group and who would have been aware of his conclusions. Again, it raises issues about impartiality, independence and people who all know each other working together.

Women already blame themselves, and that is simply reinforced. Throughout the whole sorry affair, attempts have been made to shift the blame to women. It has been said that they did not want to be pregnant and used the tablet as a means of aborting. That was emphatically not the case with my constituents, who were delighted to think they could be pregnant. The study clearly places the blame where it should lie: with the manufacturers and distributors of Primodos, who were aware of the potential effects of the drug long before it was withdrawn in the UK. It was not withdrawn for commercial reasons, and the withdrawal of the indication of pregnancy was strongly requested by the Standing Joint Committee, which threatened to take Primodos off the market if the indication was not removed.

Looking at the review, I believe Professor Heneghan fully answered all the questions. His persistence shows how much he believes in the conclusions in his review, and in a demonstrable link between hormone pregnancy tests and foetal abnormalities, which obviously differ depending on the stage of development at which the test was administered. The families have been failed throughout the process, right from the moment that they were given the pill, often from the doctor’s desk drawer. There is now an opportunity to give some peace of mind and redress to the families, but yet again there is a cloak of secrecy and obstruction, and they feel let down by the agencies in place to protect them.

Photo of Brendan O'Hara Brendan O'Hara Shadow SNP Spokesperson (Inclusive Society) 12:16 pm, 23rd April 2019

It is a pleasure to serve under your chairmanship, Mr Hollobone. I add my thanks to Yasmin Qureshi for securing this hugely important debate. I congratulate her not only on winning this debate, but on the way in which she forensically exposed the failings of the expert working group—how it changed the terms of reference of the inquiry; its failure to report properly, if at all, on its meta-analysis findings; and the serious questions about the independence and impartiality of the group. She finished by rightly describing the issue as the biggest legal and medical cover-up of the 20th century, but that cover-up has individual victims.

I have met Wendy Brown, a constituent from the Isle of Mull, on numerous occasions. She knows that her disability was brought on by her mother’s use of Primodos when pregnant. Wendy has been a formidable campaigner for the victims of Primodos over the years, and last week she wrote to me, saying:

“My hands and both feet are deformed, which was very hard as a child due to the constant bullying. I also had damage to my neck at birth and was baptised at home as I wasn’t expected to live. The older I am getting the more...pain I am in, especially in my feet which can really wear me down, as no matter what shoes I get they are always painful. I am now getting a very painful wrist, which is due to the way I have held my hand in order to conceal it because it has unnatural motion. This is a growing concern for me because...I work in the Post Office in Tobermory and am not sure how much longer I could keep going.”

That is the day-to-day reality of people living with the effect of Primodos.

Wendy and other members of the campaign group rightly demand justice. We owe it to Wendy and all the other victims never to abandon them in their fight for justice. It is scandalous that the people whose lives have been so badly affected and who, day in and day out, have to live with the physical, social, emotional and psychological pain are being denied natural justice. They will continue to be denied natural justice as long as the United Kingdom’s medical establishment continues to deny the link between hormone pregnancy tests and serious foetal abnormalities.

If justice is to be seen to be done, surely it is time for a statutory inquiry, similar to that for the contaminated blood scandal, in which every single piece of evidence is examined forensically and transparently. If the Government are so sure of their case, they have nothing to fear from such an inquiry. At the very least, it would restore public trust in a system in which it is lacking right now.

Photo of Mike Penning Mike Penning Conservative, Hemel Hempstead

The key is for evidence sessions to happen under oath. That is what we called for in the House, and what should happen now.

Photo of Brendan O'Hara Brendan O'Hara Shadow SNP Spokesperson (Inclusive Society)

I wholeheartedly agree; they have to be under oath. Justice would also be served if the Secretary of State were to appear before the Health and Social Care Committee to answer detailed questions about the way the inquiry was conducted, and to explain and defend its findings.

I sincerely hope that the Government are not simply playing for time with this scandal, hoping that in time it will go away. Thankfully, there are people in this House, such as Sir Mike Penning, my hon. Friend Hannah Bardell, and many others in the all-party parliamentary group on hormone pregnancy tests, who will not allow that to happen.

Finally, I put on record my thanks to the members of the APPG for their work to continue to shine a light where some vested interests would rather one not be shone, and for their tireless work in advocating strongly for justice for the victims of Primodos and other hormone pregnancy tests.

Photo of Edward Davey Edward Davey Liberal Democrat Spokesperson (Home Affairs) 12:21 pm, 23rd April 2019

I agree with all colleagues who have spoken. My friend, Sir Mike Penning, is right about a cover-up. He could have gone further; there is a danger that it is a criminal cover-up. I say that to the Minister in all gravity, because if she and her colleagues do not get on top of this issue, it will end up in the courts. The Government and the medical establishment will be defeated, and a lot of money will have to be paid. It will be a national scandal. It is one already, but it is not as well known as it ought to be. It will be on the front pages. I say to the Minister that it is time to act.

When I last spoke on this subject, on 14 December 2017, I used material from the Berlin archives, thanks to the amazing Marie Lyon and the Sky journalist Jason Farrell. I showed that lawyers and the scientific advisers from Schering knew about this in the 1960s. Minutes from meetings in ’68 and ’69 showed that they knew that there were problems, and that they would be found guilty in a court of law. I used long-standing evidence that the people involved knew there was a problem.

Today, I will focus on the science—first, on the association between HPTs and deformity, and secondly, on the issue of causal links. The 2017 expert working group report said that there was not an association. It is interesting, however, that when members of the EWG gave evidence to the review, they had a different story. The Minister needs to think about why that is. Professor Stephen Evans, for example, in evidence on 28 January 2019, at 28 minutes and 46 seconds into the video, said that

“Dr Olszynko-Gryn says this: ‘More optionally the authors’—this is Heneghan…‘the authors might consider reflecting on the extent to which the association they identify implies a causal association. An association between the use of HPTs and birth defects has long been recognised and was rarely in dispute.’
Well, we don’t dispute that;
there is an association.”

He did not say that in 2017. Ailsa Gebbie from the EWG, at the same oral hearing, said:

“But everybody admits there is a possible association, and that’s why the report was carried out in the first place.”

I think it is more than a possible association.

Let us go to the meta-analysis that has been quoted, which is where lots of studies are brought together to see whether together they tell a consistent story. I am not a scientist or a mathematician, but I have spoken to academics who really understand this. They say that when the studies are brought together, their homogeneity, and the consistency of the findings, is extraordinarily striking. They all show an association.

The EWG wants to dismiss that. Professor Evans does not want to accept that methodology. As we heard from Gordon Marsden, Professor Evans is going against the Food and Drug Administration—the US authorities—the European Medicines Agency, the National Institute for Health and Care Excellence and clinical researchers in this area across the world, who accept meta-analysis for this type of risk analysis. The Minister needs to ask her officials why the EWG refuses to accept the analysis, because it is strong, overwhelming and proves the case, I personally think, in legal terms, beyond reasonable doubt. The Minister must leave the Chamber knowing that there is an association, because that is what the science shows.

We have heard about the desire for a causal link to be shown. I urge the Minister to ask her experts and officials what is needed to prove a direct causal link. That test is very rarely met. If a recognised poison that is known to be lethal is given to someone, they will die; that is a binary issue. However, most other pharmaceuticals and drugs are not like that. The balance of probabilities is the test that is normally used. All the evidence that we have shows that, on the balance of probabilities, there is no doubt that there is a link.

It is sometimes difficult to show causalities. It has been suggested to me that I mention the Fairchild case, to show how difficult it is to establish causation. The Fairchild exception is a relaxation of normal tests for causation. A mesothelioma victim can prove that a particular exposure to asbestos caused the mesothelioma by proving that the exposure was such as to create a material increase in risk of the victim contracting the disease.

Has a material risk been proven? According to the meta-analysis, there is a 40% increase in risk of all malformations from taking HPTs. There is an 89% increase in risk of congenital heart malformations—more than a doubling. I say that because a doubling of a risk is material in court. There is nearly three times the risk of nervous system malformation. There is a 224% increase in risk of musculoskeletal malformation, and a 747% risk of vertical defects. That is what the evidence shows. I bring that to the Minister’s attention. She must know that. She should go back to the Department and challenge her officials, because they are getting this wrong and letting people down.

Photo of Hannah Bardell Hannah Bardell Shadow SNP Spokesperson (Digital, Culture, Media and Sport) 12:27 pm, 23rd April 2019

It is a pleasure to serve under your chairmanship, Mr Hollobone. I give huge credit to Marie Lyon and all the campaigners from the Primodos group; I have got to know them very well in the four years since I was elected in 2015. I have rarely met a more tireless and dedicated group. The same goes for Yasmin Qureshi. She, with her staff, has run the all-party parliamentary group with incredible veracity and determination, and it is a pleasure to be part of that. I also give credit to Jason Farrell of Sky, who recently did a documentary on the impacts of Primodos, shining a light where no one else, frankly, has gone.

I have campaigned for my constituent Wilma Ord and her daughter Kirsteen, who was born deaf and with cerebral palsy. Like so many women, as many Members have mentioned, Wilma believed that the deformities that her child was born with were her own fault. Let us call it out for what it is. As Sir Edward Davey said, there was a criminal cover-up. Some 1.5 million women were treated as human guinea pigs for the pursuit of profit by the company Schering, now Bayer. I hope that it is listening today.

I know that the Minister and the Government are listening. There is clearly consensus, the likes of which few of us will have seen, across the House on this issue. We are not going away, the campaigners are not going away, and this issue is not going away. Until I am no longer the elected Member of Parliament for Livingston, I will campaign on this issue and pursue it, as I know everybody in the Chamber will.

Photo of Jonathan Reynolds Jonathan Reynolds Shadow Economic Secretary (Treasury)

I, too, am pleased that this debate is happening, but I am really sad and frustrated to be here. I have re-read my speech from our October 2016 debate, at which I think all hon. Members in this Chamber were present. I spoke about two constituents who had been affected.

Most of the speeches in that debate articulately raised such cases, but basically they were asking for a process to find answers. Three years later, we have fewer answers and most of us are more suspicious and angry. On that basis alone, this cannot be the end of the matter. I thoroughly agree with the hon. Lady’s comments.

Photo of Hannah Bardell Hannah Bardell Shadow SNP Spokesperson (Digital, Culture, Media and Sport)

I absolutely agree. I share the hon. Gentleman’s despair and sadness that we are in this position so many years after the group was set up—a process into which the Government put public money and in which medical experts took part. As I have said, we are not necessarily criticising the people in the expert working group, who are medical professionals, but they have fallen victim to a process that was at best opaque and at worst corrupt, given the influence of the companies involved.

Who knows why we ended up in this mess? On the day the report was due to be published, the hon. Member for Bolton South East and I went to an event that we thought was supposed to be public—or at least open to Members of Parliament. We were stopped at the door; some of the press were allowed in, but we were not. We know that there was due to be a press conference and a public event, but they were both cancelled.

Members have spoken passionately about the lack of independence and impartiality, the gagging clause that Marie Lyon had to sign and the heavy-handed approach taken, all of which have caused serious concerns. What does it say to those in the medical community who may be invited to be part of future Government working groups that a group that was supposed to be open and transparent and get to the truth of an issue has turned out to be a cover-up? It raises serious concerns that their credibility will be called into question. That is a very dangerous situation.

As well as looking at the wider issue, we need to look at the mess that the expert group became, so that we can give confidence not only to the families and to our constituents, but to medical professionals.

Photo of Gordon Marsden Gordon Marsden Shadow Minister (Education)

The hon. Lady points out precisely the contextual things that we need to learn. Does she agree that there seems to have been an element of Jekyll and Hyde in the Government’s approach over the past three years? On the positive side, I have confidence that Baroness Cumberlege—with whom I have served on another all-party group—and her team are moving in the right direction. However, everything in the statement that the then Secretary of State made in February 2018 was about the future:

“drive forward…the recommendations of the expert working group…offering the families…a full and up-to-date genetic clinical evaluation…better training and support for obstetricians”.—[Official Report, 21 February 2018;
Vol. 636, c. 165-166.]

Those are all good things, but they do not address the past 40 years, offer an apology or express any sense of regret, nor do they address any of the issues raised in this debate. Would it not be a good idea for the Minister to go back to the Secretary of State and say that we need to look again at that 2018 statement, go back to that context and make the necessary decisions? People will not put up with just a broad range of recommendations —we need to get to the heart of the matter.

Photo of Hannah Bardell Hannah Bardell Shadow SNP Spokesperson (Digital, Culture, Media and Sport)

The hon. Gentleman is absolutely correct. How many times must the families and the victims of Primodos have their hopes built up and then completely dashed? Is it not bad enough that they have gone through the trauma, the blame and having their children live with deformities and disabilities—as my hon. Friend Brendan O’Hara so precisely and devastatingly highlighted in the case of his constituent—without also having their hopes built up for a review that turns out to be a whitewash? That gives people no confidence at a time when, let’s be honest, confidence in politicians and the political process is not particularly good. We have an opportunity here to do something good, to do it well and to do it properly.

I have to say that my exchanges with the Medicines and Healthcare Products Regulatory Agency and with the expert working group have not been good. I wrote directly to the chair of the expert working group about people’s feelings and concerns, but the response that I received did not fill me with hope.

I am pleased that Baroness Cumberlege has taken on her new role of looking at hormone pregnancy tests, sodium valproate and medical mesh, but when she sought evidence, she did not include Scotland. I have now written to her, and that issue has been rectified, but it is important to remember all the devolved nations of the UK and ensure that they are appropriately included. We know what the academic studies have shown—the work of Carl Heneghan and Neil Vargesson has been exceptional—but there is now new evidence and we should ensure that it is included in any future plans or reviews.

What we need from the Minister is an acknowledgment of the power of the views across this Chamber and across both Houses, and of the serious impact of this issue on people’s lives. How many parents need to die without knowing what happened to their children because of a pill that they took? As Sir Mike Penning said, these were women who believed that they were in the care of the NHS, that they were being given something that had been properly medically checked, and that they were not being put in danger. However, their health and the health of their unborn children were put in danger. Let us not forget that many women miscarried—there are many children who were not born because their mothers took this pill. This drug was used in Germany as an abortive and in another country as a pregnancy test. It does not take an expert to work out that that was absolutely wrong.

We have a choice, and we have an opportunity. There is a very powerful body of medical evidence that needs to be properly looked at. The Government also need to take a long, hard look in the mirror and think very carefully about why the expert working group failed so badly and why its terms of reference changed part of the way through. They need to make sure that that never happens again; that the victims of Primodos, including my constituent and all the constituents mentioned today, never have to go through any more pain and suffering; and that those victims will get truth, justice and answers to their questions. Do they need compensation? Yes, absolutely, but what they really want is an apology and an acknowledgment.

As the right hon. Member for Hemel Hempstead said, when something goes wrong, the right thing to do is put your hands up and say, “Do you know what? We got this wrong.” It is about time that that happened. I hope that now the Minister and her Government will finally do the right thing.

Photo of Paula Sherriff Paula Sherriff Shadow Minister (Mental Health and Social Care), Shadow Minister (Mental Health) 12:37 pm, 23rd April 2019

It is a pleasure to serve under your chairmanship, Mr Hollobone. Like other hon. Members, I sincerely thank my hon. Friend Yasmin Qureshi for securing this debate. I also thank Marie Lyon, chair of the Association for Children Damaged by Hormone Pregnancy Tests. Without those two strong, brave women and their pursuit of justice, truth and answers, we would probably not be having this debate. I think we can all agree that the personal stories that we have heard today are very powerful indeed, and that these people and their families deserve definitive answers to their questions, especially after so many years.

Although I am pleased that the Government have committed to the ongoing review, I hope that on this occasion all available data will be analysed and all research will be taken into account, so that the review’s conclusion can satisfy those who have campaigned so vociferously for so many years. It is alarming to read the report from experts at Oxford University, led by Carl Heneghan, Professor of Evidence-Based Medicine. The report appears to identify huge gaps in the expert working group’s 2017 study.

To find that huge areas of research were left untouched is nothing short of an insult to the campaigners who have devoted their lives to seeking justice. Some reports suggest that key elements of research were removed on purpose to support the conclusion and mislead Government and Parliament. If so, we as parliamentarians must do our utmost to right those wrongs; I hope that today the Minister will pledge to do just that. Indeed, the Prime Minister herself said in January that she would

“listen very carefully to any recommendations that come out of the review”.—[Official Report, 16 January 2019;
Vol. 652, c. 1160.]

The results of animal testing from a 1979 study released by the pharmaceutical manufacturer Schering, now owned by Bayer, found strong links between the drugs and malformations, as well as the death of embryos, and yet the expert working group in 2017 declared that those results provided insufficient evidence. The expert working group examined human studies, and the majority similarly favoured an association between Primodos and deformity, but still the working group felt that the evidence was not strong enough. Was the evidence not properly assessed, or was it simply omitted? Either way, that conclusion has undoubtedly prolonged the agony of those who have lived for 50 years without answers.

There has been much talk about whether meta-analysis should have been used by the expert working group in 2017. When Professor Heneghan carried out a random-effects meta-analysis, the results were opposite to that of the expert working group report and found that there was an association between the drug and the malformations, which was consistent with his own study.

Photo of Edward Davey Edward Davey Liberal Democrat Spokesperson (Home Affairs)

I think I am right in saying that when the raw data that the expert working group had used was rerun by Professor Heneghan, it showed that if the expert working group had done that, it would have reached similar conclusions. That makes the group’s conclusions even more worrying.

Photo of Paula Sherriff Paula Sherriff Shadow Minister (Mental Health and Social Care), Shadow Minister (Mental Health)

The right hon. Gentleman makes a very important point, which gives further credibility to the view that the review by the expert working group was completely insufficient.

One thing that I have been utterly appalled about during my research on this subject is the inhumane and patronising way in which women were treated and spoken about during the period that Primodos and other hormone pregnancy tests were available, and subsequently, when a possible link between the drugs, early abortions and birth defects was identified. As the chair and founder of the APPG on women’s health, I am often asked why I feel it necessary to have a group that looks exclusively at women’s health. This is a prime example of the inequality that women have faced over the years when they have sought help on major health issues.

One senior medical officer from the Committee on Safety of Medicines said in 1969:

“It is somewhat difficult to summon up enough enthusiasm to place a high priority on this, when so much other and possibly more important work is pressing.”

In 1968, Dr N.M.B. Dean, of the Royal College of General Practitioners, stated:

“With regard to the rather high incidence of abortions in the Primodos group, I think it must be borne in mind that women going to their doctor for this type of test often hope that they are not pregnant and it is not impossible that these women took other steps to terminate their pregnancies”.

Photo of Emma Reynolds Emma Reynolds Labour, Wolverhampton North East

Those quotes are breathtakingly horrific. My constituent gave birth in the late 1960s to Steven, who had severe abnormalities thanks to Primodos, and she then went on to conceive two healthy daughters. My constituent wanted to be pregnant, and she wanted a family.

Photo of Paula Sherriff Paula Sherriff Shadow Minister (Mental Health and Social Care), Shadow Minister (Mental Health)

My hon. Friend makes an excellent point. Time has not been a healer in this case. We need to understand what has happened and we need to get answers for the affected groups.

The quote from Dr Dean goes on:

“In view of these findings tentative though they are, it would be my own view that, since there is in any event no very sound medical reason (in my opinion) for the use of such hormonal preparations, Primodos should be withdrawn from use.”

To suggest that women going through the pain of dealing with a miscarriage had perhaps taken steps to terminate their pregnancies is nothing short of abhorrent, especially given that Dr Dean went on to suggest that Primodos should be withdrawn from use. That indicates that he did see a link between the drug and the miscarriages. Sadly, the suggestion was completely ignored.

Then there are the poor women whose babies had such severe health issues that they did not survive. Reports from those women include the following:

“1971: the words ‘Monster child’
were written on my medical notes. My baby was born alive. I was not allowed to see her. I was drugged. My baby was taken away. I never saw her again.

1971: Anencephaly. Stillborn 2 weeks early. No funeral allowed. Not allowed to name her. My daughter was put in a coffin with a stranger. Searched for 18 years to find where her remains had been left.

1973: I was 16. Just married and excited about my first baby. Just before my baby was born the doctor said my baby did not have a properly formed head. She had no skull and no brain and would die at birth. I was then heavily sedated and my waters broken. I tried to wake up when my baby was born and begged to see her. They refused as her birth defects were too distressing to see.”

I am sure we all agree that those reports are nothing short of heartbreaking. They are incredibly demeaning for the women involved.

To be put through the most horrendous of situations and made to suffer for all these years without answers has been like a life sentence for some, and those living with complex disabilities face an uncertain future without carers or financial support, should their loved ones die before them. If Primodos and other pregnancy hormone tests were to blame, the answers need to come now, and financial support needs to be given before it really is too late to help those living day to day with the effects of innocently taking a drug after putting their trust in clinicians and drug companies all those years ago.

On listening to stories from those affected and researching the issue, the greatest point that sticks with me is the uncertainty that surrounds all the reports that have been published—the lack of evidence used, the lack of research analysed, the lack of questions answered. I think 50 years is long enough for campaigners to wait. I hope that the Minister will today pledge that she will ensure an end to that wait, and that she will make sure that the findings of the latest review, when published, are acted on thoroughly and comprehensively.

Photo of Jackie Doyle-Price Jackie Doyle-Price The Parliamentary Under-Secretary for Health and Social Care 12:45 pm, 23rd April 2019

I thank all hon. Members who have participated in the debate, with real passion and determination to get to the truth. I fully accept the perception held by all Members present that we have waited a long time for answers.

One of the reasons I have pushed so hard for the Cumberlege review is exactly because of those arguments that have been made here this morning. It is important that everybody who has been affected is able to get answers. We have heard lots of talk today about a cover-up, and there clearly needs to be confidence in the review’s outcome. That is why I wanted Baroness Cumberlege to take an objective look at exactly what has happened, as well as recognising that the way in which the regulatory system has dealt with concerns has seemed very inhumane, process-driven and extremely insensitive to patients. The response on issues of patient safety must be improved. I am really looking forward to receiving Baroness Cumberlege’s recommendation in that regard, because so many people’s experiences have been entirely unsatisfactory. I know that she has considered the evidence brought to her by Marie Lyon and Jason Farrell. I will be taking the recommendations extremely seriously and I hope that she can draw some conclusions on where everything has gone wrong.

Yasmin Qureshi and others raised the issue of the independence of the Medicines and Healthcare Products Regulatory Agency. It is entirely appropriate that regulators are funded by the community that they regulate, through fees. That in itself does not lead to questions on the regulator’s independence, but we need to offer some challenge in order to see whether the processes have sufficient integrity in terms of the response on issues of patient safety. I do not think we tackle the question of independence solely by shifting the funding on to taxpayers. It is entirely appropriate that the industry should meet the cost of regulation, but the review will bring some conclusions on whether that medical regulation is operating properly.

While we await the review’s conclusions, we have had the expert working group. It is clear that hon. Members are not entirely confident in the processes and conclusions of that group. To put the work in context, the group gathered evidence from around the world and met seven times over an 18-month period. It concluded unanimously that the totality of the data reviewed did not support a causal association between Primodos and adverse pregnancy outcomes. It also did not conclude that there was not, and we clearly need to consider any further evidence when it is brought forward.

Photo of Hannah Bardell Hannah Bardell Shadow SNP Spokesperson (Digital, Culture, Media and Sport)

I appreciate the comments that the Minister is making. She must recognise that the MHRA had ultimate control over what the expert working group saw, and that many documents that Sky’s Jason Farrell had uncovered in Berlin and which Members have cited were not included in the work of the EWG. We need a fully transparent review—as Sir Mike Penning said—under oath. Does she agree that that would be sensible?

Photo of Jackie Doyle-Price Jackie Doyle-Price The Parliamentary Under-Secretary for Health and Social Care

I come back to my opening comments: we brought forward the Cumberlege review to give an independent challenge to what is currently being done by a regulatory system. We need to look at whether that system is appropriate, given the concerns.

Photo of Gordon Marsden Gordon Marsden Shadow Minister (Education)

The Minister is being very generous with her time. She is seeking to persuade us, perfectly reasonably, that she and the Government have been acting in a measured way to try to look into all these things. As I have said, we welcome Baroness Cumberlege’s report. Has the Minister at any time asked the members of the expert working group why they changed the definition that they were given?

Photo of Jackie Doyle-Price Jackie Doyle-Price The Parliamentary Under-Secretary for Health and Social Care

I am not satisfied that that is actually what happened. When we receive drafts of reports that are circulated to committees, they often go through amendment.

Let me continue going through the chronology of events. As I said, the evidence did not support a causal association, nor did it disprove one. We will of course continue to review evidence as it arises.

Photo of Mike Penning Mike Penning Conservative, Hemel Hempstead

I think this is a really fundamental point. I apologise if it seems like I am going to give the Minister a hard time, but I am. They were not asked to look for a causal link; they were asked to look for an association, and we have now seen evidence that they knew it was there. I know what happens when the notes are written for the Minister. They were not asked to look for a causal link, but for an association. They decided among themselves to change what they were supposed to look at, which is why they came out with the results that they did. That is a really fundamental point.

Photo of Jackie Doyle-Price Jackie Doyle-Price The Parliamentary Under-Secretary for Health and Social Care

I hear what my right hon. Friend says. There has to be some element of cause, otherwise there is no scientific basis for a judgment. I will have to agree to disagree with him on that point.

Photo of Edward Davey Edward Davey Liberal Democrat Spokesperson (Home Affairs)

I have to intervene on the Minister on that point. In many cases, drugs are looked at on the probability of risk, not on causality. Causality is a much stronger test. In science, it is very difficult to prove. If her officials are telling her that about a causal link, they are wrong. I urge her to get separate independent advice on that.

Photo of Jackie Doyle-Price Jackie Doyle-Price The Parliamentary Under-Secretary for Health and Social Care

The drugs are no longer available because of association, due precisely to that balance of risk. The issue that we are looking at now is to what extent that was understood at the time, and to what extent there is a liability. That is what the group is ready to look at.

Photo of Edward Davey Edward Davey Liberal Democrat Spokesperson (Home Affairs)

The Minister is being very generous with her time. I refer her to the evidence that was in the Berlin archives, which goes back to 1968 and 1969, and to the meta-analysis, which proves that on the balance of probabilities there is no doubt. That became known not this year, but years ago.

Photo of Jackie Doyle-Price Jackie Doyle-Price The Parliamentary Under-Secretary for Health and Social Care

I am answering on behalf of the working group. That is an independent process and I will try to do my best. The right hon. Gentleman raises the issue of the meta-analysis and the suggestion that Parliament has been misled about why that was not done. The expert working group discussed the merits of doing a meta-analysis at its fifth meeting. In its view, the studies were very different, not sufficiently robust and suffered from extensive limitations. The group concluded that conducting a meta-analysis was not the most appropriate way to analyse this type of study. Instead, the group developed a set of quality criteria and presented its assessment of each study in a series of plots. To reconfirm, the data was not considered sufficiently robust for meta-analysis to be used. One of the real problems we have is that we are talking about data that, as we have mentioned, is 50 years old and not sufficiently robust.

There have been some suggestions that the expert working group has been less than transparent. In line with the Government’s commitment to publish the report of the review and all the evidence considered by the group, all documents have been available for public scrutiny since November 2017. We have been very grateful for the involvement of Marie Lyon throughout that process.

There has been some criticism of the lack of an external peer review of the expert working group report. The Government’s independent scientific advisory body on the safety of medicines, the Commission on Human Medicines, acts as the peer reviewer for all expert working groups. It reviewed the draft report on two occasions before it was published. I know that Baroness Cumberlege will be looking at whether there has been sufficient peer review of that report, and I look forward to receiving her recommendations. As with any issue, new evidence can emerge in the meantime. I reassure the House that the Government have made a commitment to review any important new evidence, and we have honoured that commitment.

Photo of Emma Reynolds Emma Reynolds Labour, Wolverhampton North East

The Minister said a moment ago that the crux of the matter is what was known at the time about the balance of risks. Will she look at international comparisons? In other countries, this hormone pregnancy test was banned much earlier than it was in the UK.

Photo of Jackie Doyle-Price Jackie Doyle-Price The Parliamentary Under-Secretary for Health and Social Care

I hear what the hon. Lady says. We have taken this work forward with the working group and have been looking at the totality of evidence around the world, particularly in Europe. Last year, Ministers asked the MHRA to convene a group of experts who have been completely without any agenda on this issue in the past, to consider the work by Professor Vargesson and ensure that it was sufficiently independent. That work, which has been referred to, concluded that Primodos caused malformations in zebrafish embryos. We have also asked for an independent European-level review of that evidence to be undertaken, so that everyone can have more confidence in the outcome. Both the UK and European reviews concluded that the results of the zebrafish study had no implications for the conclusions of the expert working group’s report, and the findings of both reviews have been published.

I turn finally to the data published by Professor Heneghan. Although this analysis does not contain any new data, it found the use of hormone pregnancy tests in pregnancy is associated with a small increased risk of certain congenital malformations. The Government have therefore asked for a completely new expert group to be convened in order to consider Professor Heneghan’s work, and for a review to be conducted in parallel with the European review. Those reviews are ongoing, and I look forward to receiving that advice.

I appreciate that I have not been able to satisfy all the representations made by hon. and right hon. Members this morning. As I said, the Government will continue to review evidence in this area. We are still considering the evidence from Professor Heneghan, and we look forward to implementing any recommendations that Baroness Cumberlege brings forward in this regard.

Photo of Yasmin Qureshi Yasmin Qureshi Shadow Minister (Justice) 12:58 pm, 23rd April 2019

I thank the hon. Members for Ayr, Carrick and Cumnock (Bill Grant), for Argyll and Bute (Brendan O'Hara) and for Livingston (Hannah Bardell), my hon. Friends the Members for Wolverhampton North East (Emma Reynolds) and for Makerfield (Yvonne Fovargue), and the right hon. Members for Hemel Hempstead (Sir Mike Penning) and for Kingston and Surbiton (Sir Edward Davey). I thank my hon. Friend Gordon Marsden for his helpful interventions.

I am very disappointed with the response the Minister has given. The questions and interventions that my colleagues have voiced suggest their disappointment as well. She has said what all the Ministers have been saying, which is basically reading out the civil service line—Sir Humphrey speak. We have raised a number of serious questions. We raised the constitution of the expert working group—the people who sat on the panel. In meetings I had with the then Minister—Norman Lamb—and civil servants, we sat and discussed what they would to be looking at. They assured us that all the documents and available evidence would be looked at. Clearly, some of it has not been looked at, yet there is no promise to look at all the evidence in this case.

The scientific studies by Professor Vargesson have been mentioned. As the right hon. Member for Hemel Hempstead said, the human body shares about 70% of the genetic code of the zebrafish. They were found to be damaged. Most of us listening to the Minister are just gobsmacked by what we are being told. None of the issues that have been raised today has really been taken on board.

Motion lapsed (Standing Order No. 10(6)).