Hormone Pregnancy Tests

Debate between George Howarth and Yasmin Qureshi

Tuesday 23rd April 2019 Westminster Hall

[Yasmin Qureshi]

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.

[Mr George Howarth (Knowsley) (Lab)]

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?

[Yasmin Qureshi]

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.

Hormone Pregnancy Tests

Debate between George Howarth and Yasmin Qureshi

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?