Hormone Pregnancy Tests

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, the hon. Member for Thurrock (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, the hon. Member for Mid Norfolk (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.

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 the hon. Member for Mid Norfolk (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?

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.

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.

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.

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?

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.

Order. 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.

It is a pleasure to serve under your chairmanship, Mr Hollobone. I am grateful to the hon. Member for Bolton South East (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.

It is a great pleasure to serve under your chairmanship, Mr Hollobone. I begin by paying tribute to my hon. Friend the Member for Bolton South East (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.

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.

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 the 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.

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 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.

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?