Hormone Pregnancy Tests

George Howarth Excerpts

Thursday 13th October 2016 Commons Chamber

[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“Primodos should be withdrawn from use”.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“the opinion expressed by Dr Dean that Primodos should be withdrawn should not be taken into account.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?

--- Later in debate ---

[The Parliamentary Under-Secretary of State for Health (David Mowat)]

May I just say at the outset that nobody in the Government has any interest other than in getting to the truth in this matter? We are as keen as the people who have spoken today, and indeed the families that are watching us, to make sure that we do that, and there is a process that is to be followed to make that happen. We have heard some strong words today: “establishment whitewash”, “sham inquiry” and “a blanket over the issues”. I say again: nobody on the Government side of the House has any interest in anything other than getting to the truth, and the process that was put in place two years ago had that at its heart.

Let me join others in congratulating the hon. Members for Bolton South East (Yasmin Qureshi) and for Livingston (Hannah Bardell) on leading the charge on this, not just today, but in terms of the APPG and making sure that this issue is very high on the Government’s agenda. It is massively important that those who feel their lives have been adversely affected by drugs, albeit 40 or 50 years ago, see that processes are in place to make sure that we do what we can.

I would also like to pay tribute from the Government side to the Association for Children Damaged by Hormone Pregnancy Tests, and particularly to Marie Lyon for the work that she has done and continues to do—and should continue to do until we get to the truth of this matter.

I am going to talk in some detail about the progress on the inquiry, but it was very clear, as I listened to the debate, that, at the very least, the association does not have confidence in the work of the inquiry, and that is unsatisfactory. I have heard people talking about letters being unanswered and all that goes with that, and that is unacceptable. I make a commitment at the start to the association, or the APPG, that one of the things that should come right out of what we are talking about today is a letter from them, in as much detail as they want it to be, raising as many concerns as they feel they have about the details of the inquiry—a lot of detailed points have been made, which I will not be able to answer today. That letter will be answered in detail, and after that we should have a meeting to make sure that everyone is content with the direction in which we are going.

[Mr George Howarth]

I am grateful to the Minister for his offer. Does he accept that part of the problem is that if people do not have confidence in the process and do not feel that it is being conducted in a transparent way— there is evidence that that is the case—they will say that the inquiry is likely to be a whitewash? He needs to reassure not just the families and my hon. Friends, but everybody concerned with the inquiry that the process will be transparent and open. In those circumstances, people would have more confidence in it.

[David Mowat]

I accept that, which is why I have made the offer. I guess the caveat is that, in the end, science will play a big part in getting to where we need to be. The science will find its own path, and I want to talk a little about how we are trying to achieve that.

As hon. Members have said, two years ago my hon. Friend the Member for Mid Norfolk (George Freeman), who was then the Minister for Life Sciences, established an inquiry that, at the time, was committed to having an independent review of the evidence and to attempting to find a scientific link between the hormone pregnancy test—in particular, Primodos—and the adverse effects on pregnancy and all that goes with it. It is worth saying at this point that, as hon. Members have said, this is an international issue that has been around for 40 to 50 years. We are the only country to have set up such an inquiry, and the only one to have attempted to find a scientific route to the truth in this way.

--- Later in debate ---

[David Mowat]

I said at the start of my remarks that the learning point I have taken from this debate is that, whatever we think about the truth, the science and whether we are doing the right thing, the families are not happy. I also said that we will do what we can to amend that.

As well as that, Members on both sides of the House need to accept that we need to get to the scientific truth. In order to do that, there needs to be a scientific process. That has to happen and that is why some of this is time-consuming and difficult, even though we wish that it was not.

[Mr George Howarth]

The Minister is being generous in giving way. I am not sure that the terminology he is using is necessarily suitable. I do not understand this to be a scientific process per se. I understand it to be an informed judgment about the available evidence and, understandably, that is best conducted by scientists. I think he was a lawyer in a previous existence, so he will understand the difference between the two approaches.

[David Mowat]

I am guilty of many things, but I have never been a lawyer. However, in case I was not clear, I understand the difference between the two processes and accept the distinction that the right hon. Gentleman makes. The point I would make again, however, is that the panel has 14 members who have been chosen for particular skills in the issues involved, plus lay members who are not scientists.