Hormone Pregnancy Tests

Maria Eagle Excerpts

Thursday 13th October 2016 Commons Chamber

[Maria Eagle (Garston and Halewood) (Lab)]

I congratulate my hon. Friend the Member for Bolton South East (Yasmin Qureshi) on her work in this area and on securing today’s debate. I am here to speak on behalf of my constituents: Pamela Mawdsley from Garston and her daughter Louise; a constituent who lost a baby son; and Sonia Fitzpatrick from Halewood. All of them believe—I think correctly—that the disabilities with which they or their children live and the losses they have had to face were caused by Primodos being administered in pregnancy. This was not for any therapeutic reason, but simply as a test to determine whether or not there was a pregnancy.

Pamela’s daughter, Louise, is now 42. In 1973, Pamela visited her doctor to find out whether she was pregnant, and she was given Primodos. Her daughter was born in November that year with many severe disabilities. She has extensive brain damage, cerebral palsy, a right leg two inches shorter than the left and a right foot four sizes smaller than her left foot, spina bifida, scoliosis, partial deafness and significant special needs. She nevertheless lives a good life with her family at the age of 42, and her family obviously value her tremendously, but she has ongoing medical problems. My constituent Pamela had her medical records go missing when she became one of the people who tried, with other families, to sue in the early 1980s. The hon. Member for Livingston (Hannah Bardell) also raised that issue in respect of her constituent.

Sonia Fitzpatrick from Halewood is also 42, and in common with Louise Mawdsley, she believes—again, I think, correctly—that the disabilities with which she was born that affect her every day were caused by the Primodos given to her mother to see whether or not she was pregnant. She has spina bifida and other significant medical problems. Since being a young child, she has had a colostomy and a urostomy. She has significant ongoing difficulties with her feet, her hands and other joints. She, too, has lived for 42 years with the effects of that day when her mother went to find out whether she was pregnant.

I first met Pamela Mawdsley in 2011, and I had never heard of Primodos at that time. As a former lawyer who used to conduct product liability litigation and medical negligence cases, however, I rather wondered why I had not. I practised from 1990 to 1996, specialising in this field among others. Products that cause harm, especially medical products, were one of my focuses at that time; and seeking the truth and, where appropriate, compensation for those adversely affected was what I sought to achieve. Yet I had still never heard of Primodos, which is why I am participating in today’s debate.

The stories my constituents and others tell me are familiar to anyone who has practised as a lawyer in product liability litigation. From Thalidomide to Primodos and vaccine damage, there are some common themes: a lack of warnings about possible side-effects; being called a fussy mother when disabilities of a young baby are first noticed and raised with medical practitioners; denial of causality when there are reports of adverse effects; the sudden and inexplicable loss of medical records that indicated what was prescribed and when—often “just for the week” or “just for the month”. I have come across that many times in litigation. Then there are overt hostility and lack of transparency when doubts are finally expressed; no acceptance of liability by drug company or regulatory agency or prescriber, even after the withdrawal of the product in question; and a legal battle—it also happened in this case—usually with gross inequality of arms, when those at fault are utterly unwilling to concede any kind of liability or causation or to co-operate at all in finding some way through the difficulties that the victims have to suffer for many years.

The results are always the same. There are years of denial and agony for those affected, and a subsequent failure to help to alleviate the consequences or to understand the motives of the people who come forward. There is agony for parents, who invariably blame themselves for what has happened to their children, particularly in cases such as these in which there is no therapeutic reason for taking the drug. There are also extremely long, frustrating and often fruitless campaigns for truth and justice, many of which involve failed litigation, as in this case. The litigation usually fails on the basis of causation, or, effectively, because there is no real co-operation or willingness to discover the truth but merely a defensive attitude on the part of medical authorities, scientists, and frequently—I hesitate to say it—Governments. That is what I see going on here.

I think there is little doubt that hormonal pregnancy tests caused the birth defects about which many of the families affected have complained. There was significant disquiet, and evidence from the 1960s, that there were adverse effects that led to the kind of disabilities that Louise and Sonia now live with, but there were no warnings. Obviously proving causation in individual cases is difficult, particularly when the medical records have gone missing, but why should these families have to prove it? Drugs containing such hormones in such doses were banned elsewhere. The fact that existing drugs contain them in much smaller doses does not mean that the large-dose versions could not cause the problems that we are discussing now.

Survivors such as Louise and Sonia have significant and ongoing serious health problems, and they and their families deserve the truth about what happened, in addition to the further help that they need. We have the so-called independent review that the Government established in October 2014, and I think that they were right to establish it, but it does not seem to be going well. I am not sure that it has the confidence of the families, or the confidence of those who have been fighting for so long to get to the bottom of what happened. There seems to be a failure to work with the families who are affected by this scandal.

I have seen independent reviews that work. The Hillsborough independent panel springs to mind: I had a long association with that campaign, and I know what works and what does not. Independent reviews that work are not based on expecting campaigners to sign confidentiality agreements before they can even observe proceedings. They are not based on appointing experts who are suspected by some families—rightly or wrongly—to have a conflict of interests. They are not based on proceedings being so slow and opaque, with so little information emerging, that those affected become suspicious, or do not know what is going on behind the closed doors of the review. They are based on proper consultation and obtaining the full confidence of those affected.

If that does not happen, the end result, whatever it is, will make matters worse. It will make the affected families feel that there has been another establishment whitewash, that their hopes have been raised only to be dashed, that things have been swept under the carpet, and that the authorities, whoever they are, do not really want to find out what happened because it is inconvenient.

In view of the debate and in view of the concern that many of the families are expressing, the Minister must get a grip on the process and ensure that it works. He must take steps to secure the confidence of the families. He must be much more transparent about what is going on, and he must have a proper understanding of what the process is seeking to achieve. I can tell him that if there is another whitewash—if the review does not work—those families and their Members of Parliament, whether that means us or our successors, will not go away. We will be coming back to the Minister and to the Government, and we will make sure that our constituents— those families—are given the truth, the information, and the acknowledgement and help that they deserve.

--- Later in debate ---

[David Mowat]

There is nothing in that intervention with which I disagree. We all want the inquiry to work. The Government have not established an inquiry in order for it to fail. We have not established an inquiry for it not to have the confidence of the association. We need to get to the truth, but that is a scientific process, and because it is a scientific process, it can be frustrating and long-winded; it can take a long time.

I want to talk about some of the concerns that have been raised. There were three types of concerns. The first was that the independent group of experts is not reviewing the regulatory concerns or the delays that took place at the time, in particular the failures of the then Committee on Safety of Medicines and the five or eight-year delay, which we have heard about. The UK was not the first country to ban the drug, but it was not the last either. The second concern, which I will talk about at some length, was that members of the expert group might not be independent and might not have fully declared their conflicts of interest. We have heard words like “colluding” and “cover-up” from some Members. The third concern was that not all the available evidence is being considered by the group, and we heard about the German material not being translated. I will address all three points.

On the first issue, we have heard that there was a regulatory failure and that the inquiry should look at it. I say to the House that if, when the expert group reports next spring, it finds a clear causal link, that will be the time to take further action on issues such as regulation and liability, and everything that goes with that. The first step we are taking is to establish the science. The group that has been set up is an expert group. It is science-led. It is important to make it clear in the House that we are not criticising individual members, because they are striving to get to the truth. It is a group of eminent people.

It would be quite wrong if we conflated the possible eventual need to look at the regulatory actions that were taken, the legal liabilities and everything that goes with that, with the first step of the process, which is to establish whether the science leads us to that link. In spite of some of the comments that have been made today, that has not been done yet in any country. The first serious attempt to do it is the one that is going on now.

The second concern is that the expert working group is not impartial. The MHRA has taken a vigorous approach to evaluating and handling potential conflicts of interest. No member of the expert working group can have any interest in any of the companies that were involved or their predecessors. Members should not have publicly expressed a strong opinion, favourable or unfavourable, about the possibility of birth defects arising from these drugs. We heard that one of the members had tweeted. If there is evidence of that, we will follow it up. It is true that one member not of the expert group, but of the advisory group was removed because it was felt that he had a conflict of interest that was not properly declared. Action was taken very quickly in respect of that.

The inquiry is chaired by a consultant gynaecologist from the Chalmers centre in Edinburgh. The group has 14 scientists drawn from some of the best universities in the UK. We have no reason to believe that any of them have any more reason not to want to get to the truth than Members on both sides of this House.

[Maria Eagle]

Does the Minister not realise how important it is that, whatever the rights and wrongs of this and whatever the qualities of the members of the panel, the families need to have confidence in it? There is no point in saying that they are all wonderful people. The families have concerns and if they are not assuaged, in one way or another, the outcome will not have their confidence.

[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.