Hormone Pregnancy Tests

Emma Reynolds Excerpts

Tuesday 23rd April 2019 Westminster Hall

[Emma Reynolds (Wolverhampton North East) (Lab)]

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.

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.

[Gordon Marsden]

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.

[Emma Reynolds]

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.

--- Later in debate ---

[Emma Reynolds]

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.

[Paula Sherriff]

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.

--- Later in debate ---

[Jackie Doyle-Price]

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.

[Emma Reynolds]

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.

[Jackie Doyle-Price]

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 right hon. and 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.