Oral Hormone Pregnancy Tests

Pamela Nash Excerpts

Thursday 23rd October 2014 Commons Chamber

[Pamela Nash (Airdrie and Shotts) (Lab)]

I add my congratulations to my hon. Friend the Member for Bolton South East (Yasmin Qureshi) not just on securing this debate along with the hon. Members for Enfield North (Nick de Bois) and for North East Somerset (Jacob Rees-Mogg), but on her determined campaign on behalf of her constituent Nichola Williams. It is a measure of the success of this recent campaign that we are talking about this matter in the House and that there is rapidly increasing public awareness. Marie Lyons has also contributed to the campaign. In Scotland, my constituent Rose Stallard has been campaigning on the matter. Recently, she featured in an article in the Daily Record talking about her family and their experience.

Long before today’s commonly used urine-based pregnancy test, women were reliant on their doctors and the Government to prescribe what they believed to be safe oral pregnancy tests. One such test was primodos, which came in a small green packet of two small pills containing hormones. Patients were advised to take one tablet and then, if they did not bleed, a second 12 hours later. But in the 1960s and 1970s, the concentration of those strong hormones was extremely high. One dose of primodos equates to 13 morning-after pills or 157 oral contraceptive pills, which seems unbelievable given our increased knowledge now.

It is not yet clear how many people have suffered as a result of this drug, but at least one family in my constituency has been affected, and I suspect that there are many more. Mrs Stallard was one of the 1.5 million women who were prescribed primodos, which we now believe had such terrible consequences for their children, which included being born with under-developed limbs and facial deformities and many other medical problems, some of which we have heard about today.

Members are here today to represent their constituents and highlight the impact on their lives of the disabilities that resulted from their mothers being given that tablet, but we must remember that the drug is also suspected to have caused many miscarriages. I hope that that will be included in any review or inquiry resulting from the campaign and, indeed, from today’s debate.

Mrs Stallard told me that she was offered primodos by her GP when she thought that she was pregnant back in 1969. Having taken the test and bled, she thought that she was not pregnant after all, but she soon realised that she was indeed pregnant. She had a very normal pregnancy and gave birth to her third child—her first and only daughter—to her delight and that of her husband, Bobby. Unlike other cases we have heard about today, it was not until Elizabeth was over a year old that Rose noticed something was wrong, as Elizabeth was not developing at the same rate as her niece, who was the same age, and indeed her other children. Despite that, the family were advised that there was nothing wrong with her.

Eventually, when Elizabeth was three, the family were told by their doctor that she had “slight retardation”. That is the only diagnosis she has ever received, and she is now 44 years of age. She went to mainstream primary school, but it soon became apparent that she needed specialist help and she was transferred to a school that could provide it. At 15 she began to experience physical impairments. Only recently was she eventually given a brain scan, which showed that parts of her brain are now shrinking.

I want to highlight the fact that Elizabeth is now 44, so she has lived for more than four decades without any diagnosis, treatment or support. I also want to highlight that that is the age of the people affected. I agree with my hon. Friend the Member for Coventry North West (Mr Robinson), who highlighted the fact that one of the main purposes of the campaign is to gain closure for the families affected. It is also about getting support for those men and women. They are now in their 40s and 50s and really need the care and support that can be provided by a full inquiry and compensation. Their parents, who are providing their care needs, are also getting older and are increasingly concerned about the future for their children. For more than four decades Rose has had to live with the aftermath of having been prescribed those pills.

What angers me most is the fact that the evidence now available suggests that serious concerns about the safety of primodos were already being expressed years before Rose, and thousands of other women, took the test. It should have been taken off the market when those concerns were first expressed, and doctors should not have been prescribing it after the warnings were given. All those affected deserve to know exactly why that was not the case. Why was it not taken off the market and why did it continue to be prescribed in our NHS?

Back in 1968, Schering’s lead scientist wrote to the company’s headquarters in Berlin and made it clear that he was deeply disturbed by the evidence he was seeing of the impact the drug was having on children. Indeed, it is deeply disturbing not only that those effects were apparent, but that they were not acted upon immediately. If that research had been published then, rather than only recently, Rose and thousands of other women might not have given birth to children with life-limiting disabilities or might not have miscarried.

Let us be clear—this point has not yet been made—that primodos was not a necessary medication. The risks and benefits of new medications have to be weighed up, and there can be debate over whether the benefits outweigh the risks. Although knowing for certain whether a woman is pregnant is helpful, and for some it is definitely medically helpful, it is not essential. I suspect that most women, if not all, presented with the risks of that test would rather wait a few weeks to know for certain whether they were pregnant. These women did not get the opportunity to make an informed decision, because they did not know about the risks at the time, even though they were known to others.

The hon. Member for Enfield North mentioned the work done in this place by the late Jack Ashley, who was the Member of Parliament for Stoke-on-Trent South. When I was doing my research before the debate, I read a response that he had received to a written question in 1977. He was told by the then Secretary of State for Social Services:

“In 1975 the Committee of Safety of Medicines advised the Health Departments that hormonal preparations, including Primodos, should not be indicated for pregnancy testing and that a warning about a possible hazard in pregnancy should be inserted in all promotional literature.”—[Official Report, 13 December 1977; Vol. 941, c. 152W.]

More than 30 years ago, in the House of Commons, this drug was declared to be hazardous. I find it hard to understand why the need for an investigation of something that was deemed hazardous, and was taken by many women on whose pregnancies it had hazardous effects, is still being debated in the House. Furthermore, it was revealed over the summer, in response to freedom of information requests to the Medicines and Healthcare Products Regulatory Agency, that letters had been written to GPs warning them about

“an increased incidence of congenital abnormalities”

in babies born to women who took the drug. Yet it was not until 1975 that the drug company finally placed a simple warning on the packaging.

Let me put to the Minister some of the questions that have been raised by me, by other Members who are present, and by our constituents. Mrs Stallard and the many families who have been affected are very clear about their need for answers to these questions. Why were papers not published when research was being conducted in the 1960s that would have shown the dangers of primodos at the time? Why did it take until this year to publish the documents? What other related documents are being held by the Government, and indeed by Bayer, and are yet to be published? Will the Government undertake to publish immediately every single document that is available to them? Why was primodos not removed completely from use until 1975—or, according to some reports, 1978—years after the dangers were known? Most important, why was it still being prescribed after the Committee on Safety of Medicines had issued official warnings?

I ask the Government to commit themselves today to establishing an independent panel to examine those documents. I also ask them to acknowledge the need for an independent inquiry if a review by the panel reveals that it is required.

This morning I was visited by my aunt, who asked what the day held for me. I told her about the debate and about primodos, its suspected impact, and the fact that we were campaigning for and requesting an independent panel review. She simply looked at me and said, “I do not understand. Why does this require a debate? Why will the Government not agree to it immediately?” I could not agree with her more, and I hope that the Minister agrees with her too.

--- Later in debate ---

[The Parliamentary Under-Secretary of State for Health (George Freeman)]

I congratulate the hon. Member for Bolton South East (Yasmin Qureshi)—I pay tribute to her work—and my hon. Friend the Member for Enfield North (Nick de Bois) on securing the debate. I also congratulate the Backbench Business Committee. I did not rebel very often during my first four years in Parliament, but I am proud that one of my rebellions was in support of the Committee. The debates it brings to the House are often of the very highest quality, as today’s has again illustrated. I am delighted to have the chance to come to the Dispatch Box and speak on this important subject. I pay tribute to the victims’ association for its work, as well as to Marie Lyon, Jack Ashley and the many hon. Members who cannot be here today but take a very close interest in this issue.

I welcome the opportunity to update the House on the Department’s view of this important issue. I first want to assure all hon. Members that the current Government take very seriously the concerns that have been expressed. I want to take this opportunity to express my and other Ministers’ deepest sympathy to those who believe they have been affected by these products. I absolutely commit that this matter will receive the highest attention that it deserves, although hon. Members will appreciate that this is not an easy issue, given the many years—40-odd years—that have passed since the tests were first used.

We have heard some very powerful speeches from hon. Members on both sides of the House, and I want to highlight some of the points made. The hon. Member for Bolton South East spoke powerfully about the era of cover-ups. We have heard a lot in recent years about the cover-up of medical and sexual scandals—in Rotherham, Sheffield, Mid Staffs and, frankly, other areas—which have not been given the attention that they deserve. I suggest that we now need, and we are seeing, a new era of transparency, and that is all to the good. Medical professionals in the NHS and across the system have a duty of care and, like them, Ministers have a duty of care to the people we represent, and a duty of transparency as part of that.

My hon. Friend the Member for Aberconwy (Guto Bebb) spoke powerfully about his constituent Mrs Roberts and his experience of premature births in his family, and the hon. Member for Coventry North West (Mr Robinson) also spoke powerfully. My hon. Friend the Member for Enfield North made an important point about the trust that citizens and patients place in the medical profession and the health system. In return, we owe them a duty of trust and transparency. The hon. Member for City of Durham (Roberta Blackman-Woods) made an important point about how those involved in these cases need to receive some degree of closure and to know that the issue has been looked at properly.

My hon. Friend the Member for Romsey and Southampton North (Caroline Nokes) spoke powerfully about her constituents. The hon. Member for Hayes and Harlington (John McDonnell) made an important point about the historical relationship between the pharmaceutical industry and the medical profession. Let me make this point very clearly: this Minister and this Front-Bench team are here to represent only one special interest group, and that is the patients whom the NHS, the health system and the Department are here to serve. I say that as someone who has come from the industry. We also heard powerful contributions from the right hon. Member for Sutton and Cheam (Paul Burstow) and the hon. Member for Airdrie and Shotts (Pamela Nash).

I want to deal with some of the key points made in those speeches. In particular, several hon. Members mentioned the difficulty caused by the lack of retention of medical records. I have personal experience of that. My father died when I was 19—a year after I had met him—and I was not able to get to the hospital or, later, to find out exactly how he died and what he died of. These days, our system is much better at recording information. This problem is one of the reasons why I believe we should support electronic patient records. Once records are recorded electronically, they are much easier to keep and track, so we would not have many of the difficulties that we face today. The Department is not aware of any documents requesting the destruction of papers or records. I am happy to make the commitment to review and action any papers that come to light.

I should point out for the benefit of the House that Dr Briggs, who is deceased, did not confess to falsifying any studies on hormone pregnancy tests.

It has been said that thousands of children were affected. The evidence on that is not clear and it is difficult to find accurate information. There have been various estimates at different times and the best estimate seems to come from the victims’ association. In 2009, it said that by October 1978 it had gathered information on more than 700 children who might have been affected, and that it had received additional responses and inquiries from other parents every time the topic received publicity. Despite the references to thousands of children, it is unclear how many we are dealing with.

I want to highlight an important quote from Dr Sarah- Jane Richards, who is a senior solicitor in medical negligence at Secure Law in Cardiff, that demonstrates that there is still a lack of clarity and no definitive proof of causality. She said that primodos patients need more definitive data, namely medical notes from several hundred subjects, to strengthen their case. She said:

“The facts are compelling… There are snippets of information which are extremely insightful—but at present, there is an abundance of circumstantial evidence and a great insufficiency of scientific evidence. That is a real hurdle when we see a health issue such as handicap, which happens to an unfortunate two per cent of the population anyway.”

Hon. Members would expect the Government to be guided by the best scientific advice, so I wanted to share that with the House.

I want to address a number of points that have been raised in this debate, in earlier debates and in the work of the all-party group, including the eight-year gap between the first reports of a possible danger and the circulation of an official warning; the continued prescribing of the pregnancy tests by doctors in the 1970s; the need for full disclosure of the documents held by the Department; and the need for an independent panel to examine those documents. I confirm that I will be happy to instruct the release of all information that is held by the Department on this case, and the setting up of an independent panel of inquiry. I will say more about that at the end of my remarks.

First, I want to set the scene, because it is complex and difficult. I know that Members will be interested. As Members are aware, we have in the United Kingdom an agency whose sole responsibility is to ensure that all medicines in the UK work and are acceptably safe. That role is underpinned by robust legislation and guidance. In fact, we lead the world in medical regulation. However, we were not always this fortunate. In the late 1950s, when this story has its roots and hormone pregnancy tests were introduced, there was no legislation on the use of medicines in the UK, believe it or not. Unfortunately, it took the thalidomide tragedy in the early ’60s to highlight that serious deficiency, which now seems extraordinary to everyone in the House. Although sweeping changes to the legislation were made as a result, culminating in the Medicines Act 1971, by that time, hormone pregnancy tests were widely used.

The Committee on Safety of Medicines, to which my hon. Friend the Member for Enfield North referred, was first established as the Committee on Safety of Drugs in 1963 and took on its later incarnation in 1971. I will refer to it henceforth as the committee. Not long after the committee was established, a study was published by Dr Gal that suggested that there was a link between the use of oral hormone pregnancy tests and birth defects. The study was reviewed by the committee, but considered to be methodologically flawed. At that time, the committee was not aware of other evidence to support such an effect. Nevertheless, the committee undertook its own study to investigate the matter further. Over the next few years, a number of studies were published, but the evidence for an association remained limited and the findings inconsistent. The committee carefully evaluated all new evidence as it emerged and, in 1978, concluded that

“to date there is no proof of the existence of a causal relationship between the use of hormonal pregnancy tests and congenital abnormalities”.

As a result of the campaigning of my hon. Friend the Member for Enfield North and other hon. Members, earlier this year the Under-Secretary of State for Health, my hon. Friend the Member for Central Suffolk and North Ipswich (Dr Poulter) commissioned the Medicines and Healthcare Products Regulatory Agency—the lead regulator—to review all the key evidence on this issue and produce a report on its findings, which I believe hon. Members have been sent. The report has also been posted on the MHRA’s website.

Based on studies published between 1960 and 2013, the MHRA’s view is that the results are inconsistent, with some finding no association, some a weak association, and some a strong association. Its conclusion is that the data do not provide conclusive evidence of an association between hormone pregnancy tests and birth defects. As hon. Members will appreciate, the Government have a duty to ensure that they are acting at all times on the best advice available from specialist agencies set up to advise them, which in this case is the MHRA. I believe that in commissioning the report, the Government have listened to and acted on the concerns that have been raised about this drug.

What I believe makes the conclusion difficult to accept is that several studies did show an association that was statistically significant and, of course, many people have visible defects and feel that their lives have been damaged by these drugs. However, there are good reasons why both those observations do not yet constitute the proof that a causal association exists—proof that hon. Members and citizens would expect the Government to acquire before taking action.

As hon. Members will know, it is always exceptionally difficult to know for sure that a medicine taken by a mother during pregnancy is responsible for a defect in the child. It is almost impossible to know whether the condition would have developed regardless of whether the medicine had been taken, and that is especially true for birth defects, which are relatively common and occur in up to four in every 100 live births.

With the studies there is an added complexity in that a statistically significant association is not necessarily the same as a causal association, because limitations in the design of the studies may mean that the results are not reliable. Examples of that include poor recording of what was prescribed by doctors—that, I am afraid, has been all too common; another reason for the digitalisation of health records—as well as biased recall of what was taken by sufferers, the preferential prescribing of pregnancy tests for women who were at higher risk of a difficult pregnancy in the first place, and a number of other complicating factors.

One of the key concerns of the hon. Member for Bolton South East related to the eight-year gap between the publication of the first study finding a link and the committee alerting doctors to a potential risk. Although I appreciate that that may seem an unacceptable delay, it is worth remembering that such a charge assumes that the committee believed there was a causal association. However, the report that I referred to previously suggests that that is not the case, and that the committee at no time considered those pregnancy tests to be responsible for the observed birth defects.

Despite that, in 1969, just two years after Dr Gal’s study was published, the committee took the precaution of asking companies to stop promoting the tests to doctors. As more evidence was published and alternative methods of diagnosing pregnancy became available, the committee considered there to be no reason to use the hormonal methods anymore, and advised doctors of that in 1975. As Members may know, despite the committee’s warnings it became apparent that doctors were still using those outmoded tests, so it issued a further alert in 1977.

At this point I remind the House that guidance provided by the General Medical Council gives doctors in the United Kingdom the freedom to prescribe any medicine if they judge it to be in the best interests of their patient, and they take responsibility for their prescribing decisions. In that respect, I believe the evidence suggests that the committee acted in a proportionate and responsible way given the evidence before it—that is the only test that we can apply at this point.

[Pamela Nash]

The Minister said that the committee had to issue a further warning in 1977. I appreciate what he says about responsibility being with the GP, but why would a GP prescribe those pregnancy tests if they knew and were clear that they were dangerous? Is it the responsibility of the committee that it did not communicate that danger aptly enough?

[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.