Oral Hormone Pregnancy Tests

Geoffrey Robinson Excerpts

Thursday 23rd October 2014 Commons Chamber

[Mr Geoffrey Robinson (Coventry North West) (Lab)]

It is a pleasure to succeed the hon. Member for Aberconwy (Guto Bebb). I think that the whole House would like to congratulate my hon. Friend the Member for Bolton South East (Yasmin Qureshi) on securing this debate and to commend the work that she and the hon. Member for Enfield North (Nick de Bois) have done.

I thank the Backbench Business Committee for granting the debate. It is a demonstration of the work of that Committee and of committed MPs at its very best. I had the opportunity to lead a debate early on in the activities of the Backbench Business Committee on contaminated blood, which is not a million miles from this issue, although it is bigger in many ways. More people were affected and a clear link has been established between the mistaken use of contaminated blood and the terrible suffering that it caused. It is still a running sore because people cannot get closure.

I will come in a moment to the limited and modest nature of the request in the motion. I think it is contained and measured appropriately because the Government are still denying any causal link between the drugs and congenital abnormalities. First, however, let me say why I am taking part in this debate—indeed, a similar individual case sparked my deep interest in the issue of contaminated blood.

I have a constituent who suffered from the problem under discussion, and with your indulgence, Mr Deputy Speaker, I will read briefly from a letter she wrote to me. Her name is Mrs Christine Pettifer of Ladbrook road in Coventry North West, and she has given permission for me to mention her name and cite her case in this debate. She wrote:

“I went to my GP…and he gave me Primodos—”

the hormone pregnancy testing drug in question—

“to see if I was indeed pregnant. I was a bit worried about taking the tablets, but he assured me that if I was pregnant, nothing would happen. If on the other hand I was not pregnant, it would bring on a normal period.”

We can all guess the terrible consequences. In her case they were as follows:

“When my baby (Lynda) was born on 26 January 1969 the staff thought she looked a bit blue, and took her away to the nursery. I tried to breastfeed her, but she seemed sleepy all the time. At that time, all babies were put in a nursery for the night. In the early hours of the morning on 29 January, I was woken by a nurse to the terrible news that Lynda had died. I have the post mortem, which in layman’s terms stated that her heart was the wrong way round.”

I cannot claim that there is a direct cause between that and primodos, but we hope that the Minister will address the modest nature of the request we are making to the Government.

Let us be clear. As late as July this year, a Minister from the Department of Heath stated:

“The MHRA has considered the key evidence and concluded that the data are not sufficient to support a causal association between the use of hormonal pregnancy tests and congenital abnormalities.”—[Official Report, 15 July 2014; Vol. 584, c. 668W.]

The MHRA assessment was published on its website in 2014, and that remains the Government’s position.

We have raised this issue because of the situation of my constituent and that of the hon. Member for Aberconwy, but why are we pushing for an inquiry? It is because people want closure on this issue—it is like relatives of those who have died in an air crash or at sea. People want closure; they want to find the evidence and a reason for what happened, just as with all issues that involve the public sector in one way or another, as clearly this one does. As far as I am aware—nothing has come to me—these people want no apology or financial compensation such as that appropriate in the case of contaminated blood, but they want closure in their own minds. They cannot get that until they have a statement from the Government, which must follow a proper inquiry, and that is what we are asking of the Government today.

Let us be precise about what is being asked of the Government. We are all aware of the great pressures on Government time, particularly specialist time. They may look back and say, “This affects a relatively few number of people.” Indeed, this is not the fullest debate we have had in this House, but for those affected it is of deep concern, and they cannot rest until they know what happened. That is why I am so pleased to support the motion of my hon. Friend the Member for Bolton South East.

The motion is to the point. It simply

“calls on the Secretary of State for Health to fully disclose all documents relating to the use of Hormone Pregnancy Tests held by the Department from the period between 1953 and 1978”.

Members will remember that the case I cited came right in the middle of that period, when already some indications—no more than that—had been raised by Dr Gal. They had been dismissed and there was no clear, massive statistical correlation between what was happening in a certain number of cases and the use of the drug. Fair enough—but the issue was not being taken as seriously as we would have liked, and it went on far too long.

My hon. Friend indicated how lax and slow the predecessor agencies to the MHRA and the Government were in reacting to the situation. As late as July this year, the Secretary of State for Health said that there was no evidence for these claims. If so, let us have the documents. The motion also

“calls on the Secretary of State to set up an independent panel to examine these documents.”

Nothing more, nothing less. It is as simple as that—a limited request to the Minister on an important topic to bring closure to certain individuals. If the will is there, Ministers can find the resources. I urge the Minister, as do other hon. Members, to accede to our requests in the name of our constituents who cannot otherwise reach closure, and to announce that he will set up that panel as soon as possible.

[Nick de Bois (Enfield North) (Con)]

It is a pleasure to follow the hon. Member for Coventry North West (Mr Robinson). He may be troubled—or pleased—to know that I have spoken after him on more occasions than I have any other Member, which means that I have probably listened to more of his speeches, and he has had to listen to more of mine, than absolutely necessary.

It is a pleasure to support this debate and the case made by the hon. Member for Bolton South East (Yasmin Qureshi). I know that she has made considerable efforts in this very distressing matter. With all the cynicism about politics today, if we ever need a reminder of how active constituency MPs can play a positive role for their constituents, the evidence of this debate makes the case better than anything else I could say.

A constituent of mine, Chris Gooch, approached me some time ago about this issue and her daughter, Emma-Victoria. I echo what my hon. Friend the Member for Aberconwy (Guto Bebb) said—that the sense of responsibility that parents feel in such circumstances is magnified by the fact that they cannot as yet even be certain that the decision that they took in good faith, fully trusting the medical authorities and the drugs manufacturers and confident that regulation would protect them, has had such a dramatic effect on them and, more importantly, their offspring.

Chris Gooch made this point to me: “When I went to the GP, I did not ask for medication. I went to get confirmation of pregnancy. I knew nothing of what tests were available, but have since found out that a totally safe urine test was already available. So why was I given something that had been raising concern among professionals for many years and with no warnings given to GPs?” That sums it up. How is it possible that people can have gone with confidence to a GP they trusted, hoping for confirmation of a joyous event in their lives, and been handed two pills, without prescription, that had a legacy that will live for ever? I hope that the House will be able to make a contribution to lifting the veil of secrecy over this issue by persuading the Government to hold an inquiry.

Let us remind ourselves about that drug. One dose of primodos equates to 13 morning-after pills or 157 oral contraceptive pills. I am no medical expert, as many will testify, but it strikes me as somewhat perverse that a pill with such high levels of medication should be used as a pregnancy test. Surely that is a cause for concern.

Our motion is very simple and the hon. Member for Coventry North West has been kind enough to spell it out. We understand the constraints on government but we hope, particularly as this Government have been determined to shed transparency on so many issues that have been clouded for decades, that this relatively simple and reasonable request for an independent panel to look into the paperwork, history and documentation not in the public light will be accepted. Let me try to anticipate some of the points that might be raised in objection.

The question of causal link, which I am told scientifically may be the case, should not be a barrier to an independent panel. Many scientists and experts have raised the possibility of a large question of doubt. Let us face it: in this place we have made policy on the basis of less evidence than that which has been put forward by panels of experts who raised significant doubts about the treatment that was available and freely given to unknowing patients.

Without running through the whole list, two or three striking pieces of evidence have stuck with me. On 4 November 1966, a consultant pathologist from Sheffield said

“The test is unreliable. It may well have been dangerous”.

On 23 June 1967, the Medical Research Council said:

“It looks like it could be another thalidomide story.”

Schering’s own specialist advice in the UK raised doubts.

Our job in this House is to reflect the wishes, concerns and priorities of our constituents. I find myself at one in asking the Government’s help to navigate through these documents and this history. It becomes very complex for all but the most persistent. It is with that in mind that I pay tribute to the campaigners, because they have not been daunted by that task. They have not been daunted by the conflicting evidence. They have not been daunted by the lack of funding, or the availability and sudden loss of witnesses to legal cases in the past. They have persevered ruthlessly to try to obtain documentation, despite having the full weight of the establishment against them so frequently and so often, that I feel the time is right for us to champion transparency. Let transparency be championed across the House, albeit that we need the Executive branch of government to implement it.

[Mr Robinson]

I have been briefed fully by campaigners outside this House. Marie Lyon, whose daughter was born with a very foreshortened arm, came to see me with her husband yesterday. She has been indefatigable in her briefing of MPs and we should pay tribute to her for that.

[Nick de Bois]

Indeed we should. I echo and support those sentiments, as I am sure we all do across the Chamber. They reflect the courage and determination of every sufferer in every family. Their bravery in confronting this and in facing the future should be honoured by the setting up of the independent panel that they rightly seek.

I want briefly to press three issues: the conduct of the manufacturer; the conduct of previous Governments; and the conduct of the profession. I believe they build a compelling case for uniting behind the motion.

In 1978, when this issue was first raised, a former Labour Member, Jack Ashley, championed the cause in Parliament. It was reported in The Times that he pressed the then Health Minister to hold a public inquiry—this was after an intolerable eight-year gap between the first doubts being raised and a warning being issued by the Committee on Safety of Medicines—but unfortunately his response set the tone for the future. He said that nothing new would learned from holding an inquiry—as we now know, thanks to the diligent work of campaigners, there was lots more to be learned, and there probably still is—and that it was not worth following up because most cases would have been dealt with. I submit that this approach—expediency over justice for victims of primodos—was not necessarily the right one to take. His tone was reflected in later ministerial statements, but Jack Ashley pressed on, and I am sure he would have been proud of the hon. Member for Bolton South East for showing the same diligence.

We need to explore what the committee did between 1967 and 1975, and it is right that we now give members of the action group the opportunity to understand what happened. What government records are lurking about? It is right that we finally establish how many people were put at risk. Where was the duty of care in government, the profession and the regulatory body? In 2014, we can at least make a modest effort to make up for the then Government’s failure to consider those points.

What of the profession? In 1967, the Medical Research Council made it clear that primodos could have been another Thalidomide—so far, so good—and warnings were expressed about the high proportion of pregnancies in 1968 following use of the drug. This should have been sufficient for the profession to press for more to be done. We know that the committee was prepared to publish information letting the profession know of its concerns, and it even concluded in a letter in 1967 that if its concerns were made known, it could reduce its use by GPs, and that this would have been no bad thing. But nothing happened. In fact, the committee referred it to a GP survey for two years, until 1969, despite being fully aware of the warnings, and nothing happened until the matter was exposed by the media in 1975. This led to warnings, and subsequently the manufacturer put a warning on the box.

In 1975, the World Health Organisation asked why nothing had been done for so long. I cannot judge what was going on at the time, but I think we will be judged on how we deal with this issue in this present time, and I hope that will be sufficient to drive the Government towards the independent panel. The company was completely aware of warnings—not just from the profession and the regulatory body with which it was in communication, but from its own staff.

I freely refer Members to my declaration on the Register of Members’ Financial Interests because I worked with medical companies before coming here. I am aware of much of the excellent research and development that has come from within this sector, but let that not cloud our judgment on this issue. We must hope that it is not just our Government and our NHS who buy into transparency; it must be the role and responsibility of our pharmaceutical companies to do so wherever they may be. We are not selling a consumer good here; we are selling a product that must secure the absolute trust and absolute faith of both the profession and the users. We should never be in the position of having to say that there has been the potential for deliberate mismanagement of information from, in my opinion, right across Government, manufacturers and regulatory bodies, leading to this most distressful and distasteful situation for people who are suffering now as a result of some of that conduct.

I hope that Schering, now Bayer, will embrace the mood of this House and voluntarily come forward with as much information as possible. In this age, that would bring more benefit than harm to corporations that are understandably concerned with their image; above all else, however, such action would enable them to fulfil a moral responsibility that has clearly been lacking in this case.

I would be grateful to know that today, notwithstanding all the other issues we can argue about and the things we could do, we can take a moral and justifiable stance to help secure justice for campaigners who have been worried, troubled and wronged for far too long. I hope that the Minister will listen favourably to that request.

--- Later in debate ---

[George Freeman]

Unfortunately, as I have been trying to explain, in our system the sovereignty for prescribing lies with clinicians. Guidance can be issued and we would expect GPs to comply with it. Today that is more often the case, but we are dealing with a period when things were different. I cannot at this point tell the hon. Lady why a number of GPs did not comply with the guidance provided, but it was given very clearly.

Hon. Members have asked that the Department fully disclose all documents on hormone pregnancy tests held between 1953 and 1978. While I support that request, I remind the House that we are talking about an era that mostly predated medicines legislation and companies were not required even to submit evidence to support the efficacy, quality and safety of their products—extraordinary though that may seem to us today. As a result of that, and the fact that the pregnancy tests were withdrawn from use more than 35 years ago, the Department holds very limited information and what it does hold is already in the public domain. That said, I am happy to confirm to the House this afternoon that I will instruct that all relevant documents held by the Department be released.

The MHRA will of course review any new data that emerge as a matter of priority and seek independent expert advice as needed. I am happy to go further and confirm to the House that I will instruct an independent review of the papers and all the evidence. I suggest that that be carried out by the Medicines for Women’s Health Expert Advisory Group, which exists to advise the Department on such matters. It comprises independent members who are experts in their field, and I am happy to take submissions from colleagues to ensure that the association is properly represented and has a chance to give evidence.

[Mr Robinson]

I apologise for not being in my place for the Minister’s opening remarks. The news that the Minister has just announced is very encouraging and will help to bring closure and reassurance. I am sure that no Member, including my hon. Friend the Member for Bolton South East (Yasmin Qureshi), will want to press the motion to a Division now. I thank the Minister for his reply and the positive note that he has struck.

[George Freeman]

I am grateful for the hon. Gentleman’s comments and I hope that the House has taken what I have said this afternoon in the spirit in which it is intended. I am open to representations from the victims’ association and to ensure that the inquiry panel addresses all its concerns.

I assure hon. Members that Ministers in the Department will continue to monitor the evidence closely and to work with hon. Members and the victims’ association, so that if there is any reason to believe in a causal link, appropriate steps can be taken quickly. I pay tribute to the hon. Member for Bolton South East for initiating this debate, and I thank the Backbench Business Committee for providing the time. I am grateful for the tenacious advocacy of Members and many people outside, including many who cannot be with us today. We stand on the shoulders of others. Whatever the cause of the appalling disabilities that some people have suffered, their suffering still exists, and I look forward to co-operating in any way I can to try to shed light on the issue and bring the all-important closure in an era of transparency, so that lessons can be learned and this never happens again.