Hormone Pregnancy Tests

Yasmin Qureshi Excerpts

Thursday 13th October 2016 Commons Chamber

[Yasmin Qureshi (Bolton South East) (Lab)]

I beg to move,

That this House notes that an Expert Working Panel Group Inquiry was set up by the Government to investigate and assess evidence on children born with serious deformities due to hormone pregnancy test drugs taken by expectant mothers between 1953 and 1975; further notes with concern that the terms of reference as set out by the Medicines and Healthcare Products Regulatory Agency do not clearly allow for an investigation into the systematic regulatory failures of government bodies at the time; notes the conflict of interest of some panel members; further notes that all evidence must be presented to expert panel members as set out in the term of reference; calls on the Inquiry to ensure that all evidence is presented to the expert panel with sufficient time for due consideration; further calls on the inquiry to guarantee thorough background checks on all panel members; calls for the terms of reference to be amended to include an investigation into the conduct of the Committee on Safety of Medicines; further calls on the Government to ensure that the inquiry has the trust and confidence of the victims for whom it was set up; and believes that, unless these changes are made, the ability of the Inquiry to achieve a fair outcome will be significantly compromised.

I thank the Backbench Business Committee for granting this debate—the second on this issue, which I started to campaign on five years ago. Just under two years ago, I asked the Backbench Business Committee for a debate about a drug called Primodos, which was prescribed to pregnant women in the 1960s and 1970s. It had 40 times the strength of oral contraceptives prescribed today, and we know what they were devised for. It is estimated that at least 1.5 million women may have taken this drug, and thousands of families suffered. In answer to a written parliamentary question, the then Minister assessed that 3,540 women may have suffered effects. We think that the actual figure is much higher.

This all started in 2011, when I met my constituent Nichola at her home. She was born with life-threatening internal congenital deformities to her stomach, spine, heart and womb. She had her first operation was when she was seven days old. Since then, her life has consisted of visiting hospital, as an in-patient and an out-patient, and going through various procedures. Another of my constituents is Bridget Olive.

When I met Nichola at her home, I saw boxes and boxes of documents, some of which had been leaked by various pharmaceutical companies and other bodies. I had a brief look through some of those documents, and it was at that point that I decided that the issue needed more than mentioning, or raising; we needed a real investigation and an inquiry on what happened. I am not exaggerating or being over-emotional, but, applying my legal knowledge in my capacity as a barrister, I am prepared to say that there was deliberate criminal, negligent oversight by the then Committee on Safety of Medicines as regards this drug and its usage, and the fact that it continued to be prescribed for years, despite most of the medical community knowing that it had caused adverse consequences for the women who took it.

At the end of the first debate on this subject, the Minister agreed that there would be an expert panel inquiry on the issue. He agreed, in and outside Parliament, that the inquiry would look at all the available documents, including those that we would provide, or had come across, and those in the archives. The Minister went further and ordered that all the documents held by the current equivalent body, the Medicines and Healthcare Products Regulatory Agency, should be revealed. The inquiry was to look at all the documents and assess what had happened. I will come on to what the inquiry has produced, but this debate is more about how the inquiry has progressed. An inquiry that becomes a whitewash is pointless and a waste of time and money.

[Mr Jacob Rees-Mogg (North East Somerset) (Con)]

I congratulate the hon. Lady on securing this incredibly important debate, and I reiterate and agree with what she says. When at the heart of the matter there is a regulator who took eight years to act between 1967 and 1975, and many years later is investigating what it had done, it is crucial that that inquiry is seen to be independent and full.

[Yasmin Qureshi]

I thank the hon. Gentleman. I shall come on to the issue of the independence of the inquiry and the members of the panel.

The Minister indicated that the inquiry would be carried out by an independent panel of experts and said that it would look at everything that had happened and the lessons to be learned. Our present concern is about what happened, who did what and who failed to do what, and what compensation and apology victims will receive.

I shall briefly highlight some of the evidence that we have uncovered, which shows what happened in the 1960s and 1970s.

[Mr George Howarth (Knowsley) (Lab)]

My hon. Friend will be aware that between 1970 and 1971 Finland, Sweden and Norway all banned the use of such treatments. Does she think that there was plenty of indication at that time to give people reason to believe that there was a real problem that needed to be addressed, and is it not timely—I congratulate her—that we are now starting to get the evidence out and have it discussed?

[Yasmin Qureshi]

My right hon. Friend is right. It is amazing how other countries reacted to the evidence. The medical association in the UK was first alerted by Dr Isabel Gal in 1967, a paediatrician who said that her research showed that there was a link between women who had taken the drug and deformities in babies. Her letters and her research were dismissed out of hand by Dr Inman, who headed the regulatory authority. In a letter the authority referred to her in a derogatory manner as a “pathetic eastern European woman”, completely ignoring what she had to say.

We know that other information was available. For example, in February 1969 a committee received a letter from a Dr Dean of the Royal College of General Practitioners, who stated that

“Primodos should be withdrawn from use”.

However, the chief scientist of that committee, Dr Inman, refused to support that and instead wrote to the manufacturer of the drug, Schering, stating that

“the opinion expressed by Dr Dean that Primodos should be withdrawn should not be taken into account. Some women deliberately use excessive doses of Primodos with the intention of ridding themselves of an unwanted pregnancy”.

We have heard that Norway and Sweden banned the drug in 1970.

Again the Committee on Safety of Medicines took no action. Similar notices were issued in Finland, Germany, the USA, Australia, Ireland and the Netherlands, but again the committee took no action. In fact, in 1974 a letter from Schering—from PGT Bye—stated that

“after discussion with the Committee on Safety of Medicines we agreed some time ago not to recommend for the use of pregnancy diagnosis. It is not recommended for early pregnancy since the possibility of virilisation of the female foetus cannot be excluded with certainty”.

Yet still the committee issued no warning.

A further letter stated that

“side effects cannot be reliably excluded”

and that

“Primodos should no longer be recommended for the diagnosis of pregnancy.”

Again the committee said nothing. There are countless such documents. One of our concerns is that panels should have sight of those documents and be given sufficient time to read them, because they must be looked at properly and not ignored.

In 1975 the Committee on Safety of Medicines issued its first warning, stating:

“A number of studies have shown a possible association between Hormone Pregnancy Tests and an increased incidence of congenital abnormalities.”

On 15 October 1975, 41 years ago, Dr Inman wrote:

“We are defenceless in the matter of the eight-year delay”.

In November 1977, eight years after the committee had first been alerted, an adverse reaction leaflet was issued to the medical profession, stating:

“Further results have now been published and the association is confirmed.”

I want to refer briefly to some of the documents, many of which were archived in Berlin and at Kew. Marie Lyon, who chairs the victims association, has painstakingly gathered the documents, and the panel has been informed of them. I want to pay particular tribute to Marie Lyon, who has been doing a considerable amount of work over the past five years. She has spent months and months working on the documents, travelling the length and breadth of the United Kingdom and visiting Germany. She has effectively been working alone, with no support from Government bodies or local authorities. She and the victims association have been on their own. The only support they have had has been from members of the all-party parliamentary group and the Members in the Chamber today who have been fighting their cause. I also want to thank Jason Farrell of Sky News, who has been instrumental in getting some of the documents from Berlin and having them translated.

Translation of the documents is another issue, because many of those that came from Berlin are in German, as is to be expected. I want to know whether all those documents will be translated into English for the panel, because clearly it cannot carry out the inquiry if they are in a different language. We need to know whether all the documents that the victims association has gathered will be looked at and presented to the panel and, if so, in what format? When I used to prepare a large case with thousands of pages, there was a way of presenting the evidence so that the jury could understand it. Will that be done for the inquiry? If not, why not?

The reason we are asking these questions is that I have tried to contact the chair of the panel, Dr Ailsa Gebbie, and written letters to her, asking her to answer numerous questions, and, to be honest, we have not received a satisfactory answer to any of them. If anything, Marie Lyon, who has observer status on the panel, has been put under what I would call a gagging clause, which means she cannot talk about anything, because if she did she would be criminally prosecuted.

One of the things I remember from our discussion with the Minister was that the purpose of the inquiry was to have transparency and openness. We accept that there is obviously a need for a degree of confidentiality when evidence is presented, but we need to know what is going on. We need transparency, because without it, what is the purpose of this?

One thing the Minister promised was that the inquiry would have the victims at its heart. Yet, how have the victims been treated in this inquiry, which has been going for over a year now? I got a letter from one of the victims who turned up, and it is so distressing. The victims were told they could come and speak for a few minutes. Some travelled for five or six hours across the country to get to the hearing. They were promised at least 15-minute slots, but some were given three minutes or five minutes. Nobody even spoke to them properly; they were just asked to get on with it and to say what they had to say.

Fortunately, the victims who gave evidence were not subject to the gagging clause, so we were able to find out a little about what happened on the one day that seems to have been allocated for the victims. The panel heard from a few of them, but it did not ask them any questions. They were not cross-examined; they were not asked for anything—they just had three minutes. One lady said she was devastated; it had taken her five hours to drive there, and she was given three minutes. The victims said they were sitting so far from the panel, where the microphones were, that they were not even sure the panel was hearing what they had to say.

How can an inquiry that has victims at its heart not take more than a day to listen to them and, when they turn up, give them just three minutes? That is why we are having this debate. Given the way this inquiry is going, I do not think that any of the Members of Parliament who are supporting and assisting the victims have any confidence in it. As in the Hillsborough inquiry and the sexual abuse inquiry, everybody accepts that it is all about the victims; it is not about protecting regulatory bodies or the scientific community—it is about the people who have been affected.

There is another thing the Minister said. Obviously, it goes without saying that any inquiry must be independent—the panel members must be independent. When I raised that in a letter to Dr Ailsa Gebbie, the chair, she said, “Well, we got the expert panel members just to declare that they had nothing to declare.” There was no independent vetting or investigation into the background of any of these people. We have to understand this: people in the medical community, scientists and people in the pharmaceutical companies often work with each other. People have been advisers or consultants to somebody, or they have gone from the pharmaceutical companies into medicine or hospitals. There is a community of people who are linked.

We do not have the resources, but our basic research has shown that one of the panel members, Laura Yates, put on her social media that she does not think that Primodos caused any defect. How can this person be part of the panel? Then we have information about Doctor Schaefer. This man has worked with the company concerned, so he is directly linked with Schering—and he is still on the panel. That is two people, just from our basic inquiry. We want to know from the Minister whether the panel members will be properly vetted to see whether they are really independent and to find out about their connections. Again, without that, we will not have any faith in the inquiry.

We have asked the inquiry how long it will go on and how many sessions it will hold. There has been no response—nothing. We have tried to find out for well over a year, but nobody knows what on earth is going on with this inquiry. That leads to another question for the Minister. How long is the inquiry going to carry on? How many days have been set aside for it? How many hours have been spent on the inquiry to date?

In addition, how have the experts been chosen? We do not even know by what methodology they have been chosen. There are about 15 people on the panel, but does it need that many? Who are they, and how relevant is their experience to what they are looking at?

[Madam Deputy Speaker (Mrs Eleanor Laing)]

Order. I am sure the hon. Lady will soon be drawing her remarks to a close, in the knowledge that many other Members wish to speak this afternoon. She has vastly exceeded the guideline length of time, but I will allow her a peroration.

[Yasmin Qureshi]

I was just coming to the end of my speech, Madam Deputy Speaker.

Lastly, we are very grateful that the inquiry has been set up, but we have genuine concerns about what is happening with it and where it is going. As has been said, at the end of the day, there is no point in having the inquiry if it does not look at the things that matter, one of which must be to provide an explanation of the regulatory failures and the cover-ups in the 1960s and 1970s.

--- Later in debate ---

[Yasmin Qureshi]

I am conscious of the time. First, I thank all Members who have attended the debate. I thank the victims, some of whom are in the Gallery today, and Marie Lyon. I know we do not often refer to our staff, but I thank my researcher Sadia Ali, who has done incredible work on this issue with me for the past couple of years.

I am glad that the Minister has said that he will meet us, and we will happily write with detailed information about our concerns, but we need to emphasise again that, as my right hon. Friend the Member for Knowsley (Mr Howarth) mentioned just a minute ago, the inquiry is not so much about the medical evidence. It is not carrying out experiments to ascertain whether there is a scientific link. The crux is that a lot of evidence was available at the time and the regulator failed to do anything. Also, the victims have not been heard properly so far. The inquiry needs to do that.

I accept the Minister’s assurances and will wait to see what happens.

Question put and agreed to.

Resolved,

That this House notes that an Expert Working Panel Group Inquiry was set up by the Government to investigate and assess evidence on children born with serious deformities due to hormone pregnancy test drugs taken by expectant mothers between 1953 and 1975; further notes with concern that the terms of reference as set out by the Medicines and Healthcare Products Regulatory Agency do not clearly allow for an investigation into the systematic regulatory failures of government bodies at the time; notes the conflict of interest of some panel members; further notes that all evidence must be presented to expert panel members as set out in the term of reference; calls on the Inquiry to ensure that all evidence is presented to the expert panel with sufficient time for due consideration; further calls on the inquiry to guarantee thorough background checks on all panel members; calls for the terms of reference to be amended to include an investigation into the conduct of the Committee on Safety of Medicines; further calls on the Government to ensure that the inquiry has the trust and confidence of the victims for whom it was set up; and believes that, unless these changes are made, the ability of the Inquiry to achieve a fair outcome will be significantly compromised.