Hormone Pregnancy Tests

Ed Davey Excerpts

Tuesday 23rd April 2019 Westminster Hall

[Sir Edward Davey (Kingston and Surbiton) (LD)]

I agree with all colleagues who have spoken. My friend, the right hon. Member for Hemel Hempstead (Sir Mike Penning), is right about a cover-up. He could have gone further; there is a danger that it is a criminal cover-up. I say that to the Minister in all gravity, because if she and her colleagues do not get on top of this issue, it will end up in the courts. The Government and the medical establishment will be defeated, and a lot of money will have to be paid. It will be a national scandal. It is one already, but it is not as well known as it ought to be. It will be on the front pages. I say to the Minister that it is time to act.

When I last spoke on this subject, on 14 December 2017, I used material from the Berlin archives, thanks to the amazing Marie Lyon and the Sky journalist Jason Farrell. I showed that lawyers and the scientific advisers from Schering knew about this in the 1960s. Minutes from meetings in ’68 and ’69 showed that they knew that there were problems, and that they would be found guilty in a court of law. I used long-standing evidence that the people involved knew there was a problem.

Today, I will focus on the science—first, on the association between HPTs and deformity, and secondly, on the issue of causal links. The 2017 expert working group report said that there was not an association. It is interesting, however, that when members of the EWG gave evidence to the review, they had a different story. The Minister needs to think about why that is. Professor Stephen Evans, for example, in evidence on 28 January 2019, at 28 minutes and 46 seconds into the video, said that

“Dr Olszynko-Gryn says this: ‘More optionally the authors’—this is Heneghan…‘the authors might consider reflecting on the extent to which the association they identify implies a causal association. An association between the use of HPTs and birth defects has long been recognised and was rarely in dispute.’ Well, we don’t dispute that; there is an association.”

He did not say that in 2017. Ailsa Gebbie from the EWG, at the same oral hearing, said:

“But everybody admits there is a possible association, and that’s why the report was carried out in the first place.”

I think it is more than a possible association.

Let us go to the meta-analysis that has been quoted, which is where lots of studies are brought together to see whether together they tell a consistent story. I am not a scientist or a mathematician, but I have spoken to academics who really understand this. They say that when the studies are brought together, their homogeneity, and the consistency of the findings, is extraordinarily striking. They all show an association.

The EWG wants to dismiss that. Professor Evans does not want to accept that methodology. As we heard from the hon. Member for Blackpool South (Gordon Marsden), Professor Evans is going against the Food and Drug Administration—the US authorities—the European Medicines Agency, the National Institute for Health and Care Excellence and clinical researchers in this area across the world, who accept meta-analysis for this type of risk analysis. The Minister needs to ask her officials why the EWG refuses to accept the analysis, because it is strong, overwhelming and proves the case, I personally think, in legal terms, beyond reasonable doubt. The Minister must leave the Chamber knowing that there is an association, because that is what the science shows.

We have heard about the desire for a causal link to be shown. I urge the Minister to ask her experts and officials what is needed to prove a direct causal link. That test is very rarely met. If a recognised poison that is known to be lethal is given to someone, they will die; that is a binary issue. However, most other pharmaceuticals and drugs are not like that. The balance of probabilities is the test that is normally used. All the evidence that we have shows that, on the balance of probabilities, there is no doubt that there is a link.

It is sometimes difficult to show causalities. It has been suggested to me that I mention the Fairchild case, to show how difficult it is to establish causation. The Fairchild exception is a relaxation of normal tests for causation. A mesothelioma victim can prove that a particular exposure to asbestos caused the mesothelioma by proving that the exposure was such as to create a material increase in risk of the victim contracting the disease.

Has a material risk been proven? According to the meta-analysis, there is a 40% increase in risk of all malformations from taking HPTs. There is an 89% increase in risk of congenital heart malformations—more than a doubling. I say that because a doubling of a risk is material in court. There is nearly three times the risk of nervous system malformation. There is a 224% increase in risk of musculoskeletal malformation, and a 747% risk of vertical defects. That is what the evidence shows. I bring that to the Minister’s attention. She must know that. She should go back to the Department and challenge her officials, because they are getting this wrong and letting people down.

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[Paula Sherriff (Dewsbury) (Lab)]

It is a pleasure to serve under your chairmanship, Mr Hollobone. Like other hon. Members, I sincerely thank my hon. Friend the Member for Bolton South East (Yasmin Qureshi) for securing this debate. I also thank Marie Lyon, chair of the Association for Children Damaged by Hormone Pregnancy Tests. Without those two strong, brave women and their pursuit of justice, truth and answers, we would probably not be having this debate. I think we can all agree that the personal stories that we have heard today are very powerful indeed, and that these people and their families deserve definitive answers to their questions, especially after so many years.

Although I am pleased that the Government have committed to the ongoing review, I hope that on this occasion all available data will be analysed and all research will be taken into account, so that the review’s conclusion can satisfy those who have campaigned so vociferously for so many years. It is alarming to read the report from experts at Oxford University, led by Carl Heneghan, Professor of Evidence-Based Medicine. The report appears to identify huge gaps in the expert working group’s 2017 study.

To find that huge areas of research were left untouched is nothing short of an insult to the campaigners who have devoted their lives to seeking justice. Some reports suggest that key elements of research were removed on purpose to support the conclusion and mislead Government and Parliament. If so, we as parliamentarians must do our utmost to right those wrongs; I hope that today the Minister will pledge to do just that. Indeed, the Prime Minister herself said in January that she would

“listen very carefully to any recommendations that come out of the review”.—[Official Report, 16 January 2019; Vol. 652, c. 1160.]

The results of animal testing from a 1979 study released by the pharmaceutical manufacturer Schering, now owned by Bayer, found strong links between the drugs and malformations, as well as the death of embryos, and yet the expert working group in 2017 declared that those results provided insufficient evidence. The expert working group examined human studies, and the majority similarly favoured an association between Primodos and deformity, but still the working group felt that the evidence was not strong enough. Was the evidence not properly assessed, or was it simply omitted? Either way, that conclusion has undoubtedly prolonged the agony of those who have lived for 50 years without answers.

There has been much talk about whether meta-analysis should have been used by the expert working group in 2017. When Professor Heneghan carried out a random-effects meta-analysis, the results were opposite to that of the expert working group report and found that there was an association between the drug and the malformations, which was consistent with his own study.

[Sir Edward Davey]

I think I am right in saying that when the raw data that the expert working group had used was rerun by Professor Heneghan, it showed that if the expert working group had done that, it would have reached similar conclusions. That makes the group’s conclusions even more worrying.

[Paula Sherriff]

The right hon. Gentleman makes a very important point, which gives further credibility to the view that the review by the expert working group was completely insufficient.

One thing that I have been utterly appalled about during my research on this subject is the inhumane and patronising way in which women were treated and spoken about during the period that Primodos and other hormone pregnancy tests were available, and subsequently, when a possible link between the drugs, early abortions and birth defects was identified. As the chair and founder of the APPG on women’s health, I am often asked why I feel it necessary to have a group that looks exclusively at women’s health. This is a prime example of the inequality that women have faced over the years when they have sought help on major health issues.

One senior medical officer from the Committee on Safety of Medicines said in 1969:

“It is somewhat difficult to summon up enough enthusiasm to place a high priority on this, when so much other and possibly more important work is pressing.”

In 1968, Dr N.M.B. Dean, of the Royal College of General Practitioners, stated:

“With regard to the rather high incidence of abortions in the Primodos group, I think it must be borne in mind that women going to their doctor for this type of test often hope that they are not pregnant and it is not impossible that these women took other steps to terminate their pregnancies”.

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[Jackie Doyle-Price]

I hear what my right hon. Friend says. There has to be some element of cause, otherwise there is no scientific basis for a judgment. I will have to agree to disagree with him on that point.

[Sir Edward Davey]

I have to intervene on the Minister on that point. In many cases, drugs are looked at on the probability of risk, not on causality. Causality is a much stronger test. In science, it is very difficult to prove. If her officials are telling her that about a causal link, they are wrong. I urge her to get separate independent advice on that.

[Jackie Doyle-Price]

The drugs are no longer available because of association, due precisely to that balance of risk. The issue that we are looking at now is to what extent that was understood at the time, and to what extent there is a liability. That is what the group is ready to look at.

[Sir Edward Davey]

The Minister is being very generous with her time. I refer her to the evidence that was in the Berlin archives, which goes back to 1968 and 1969, and to the meta-analysis, which proves that on the balance of probabilities there is no doubt. That became known not this year, but years ago.

[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.