Hormone Pregnancy Tests

Mike Penning Excerpts

Thursday 14th December 2017 Commons Chamber

[Sir Mike Penning (Hemel Hempstead) (Con)]

I beg to move,

That this House regrets that the terms of reference for the Commission on Human Medicines Expert Working Group on Hormone Pregnancy Tests asked the Commission to consider evidence on a possible association between exposure in pregnancy to hormone pregnancy tests and adverse outcomes in pregnancy, but the Commission’s Report concluded that there was no causal association between the use of hormone pregnancy tests and babies born with deformities between 1953 and 1975, even though it was not asked to find a causal link; believes that the inquiry was flawed because it did not consider systematic regulatory failures of the Committee on Safety in Medicines and did not give careful consideration to the evidence presented to it; and calls on the Government, after consultation with the families affected so they have confidence in the process, to establish a Statutory Inquiry under the Inquiries Act 2005 to review the evidence on a possible association with hormone pregnancy tests on pregnancies and to consider the regulatory failures of the Committee on Safety in Medicines.

I think we all, as constituency MPs, would have hoped that this debate was unnecessary. We all hoped that the “inquiry”—I use the word advisedly—that the Government constituted in good faith would give confidence to the families and loved ones of thousands—[Interruption.] Shall I pause while the hon. Member for Paisley and Renfrewshire South (Mhairi Black) stops laughing?

[Mhairi Black (Paisley and Renfrewshire South) (SNP)]

No, I was talking to my colleagues.

[Sir Mike Penning]

Thousands of people went in good faith to see their GP because they thought they might be pregnant. That is probably the most important time in any woman’s life. Certainly, as the father of two gorgeous girls, the most important time in my life was when my wife told me that she was expecting our children. It was so important to these families that often they went to their GP, which is a natural thing to do, so we had an NHS patient going to an NHS surgery to see an NHS doctor for advice about whether they were pregnant.

Look at the dates for when these potential mothers-to-be went to see their GP: between 1953 and 1975. That is quite a span of time. My mother could have gone to her GP then, because I was born in 1957. In many ways, it could easily have been me who was a victim of this—God forbid—and my mother would have been a victim as well. That is one of the reasons why I am so passionate about getting to the bottom of the disaster that happened to these ladies who went to their GPs.

These women went to their NHS GP in an NHS surgery as an NHS patient, and very often that GP would open the drawer and give them a tablet—two sometimes—with no prescription or advice, and no concern about the consequences or side effects of the drug. The GPs handed the tablets over to the ladies, and many of them took them there in the surgery. The GP simply said, “If your period starts tomorrow, you’re not pregnant. If your period doesn’t start, you are.” In good faith, which we all have for our GPs, the ladies followed that advice, even though the Department of Health and the drug companies knew that there were issues with this drug.

I am going to use a tiny bit of privilege, because every time I look around for information to do with this subject, including in the House of Commons Library debate pack “Hormone pregnancy tests” and the “Report of the Commission on Human Medicines’ Expert Working Group on Hormone Pregnancy Tests”, I see the phrase “hormone pregnancy tests”. The drug was Primodos. It was made by a drug company and often given free to GPs, who then handed it out without a prescription to determine whether a lady was pregnant.

Other companies in the world knew that there were issues. I will not go into all the evidence that was given to the so-called review, but let me just touch on some of the things that Ministers asked for when the group was set up. The first point was that the Government should set up an expert working panel “inquiry”. No such inquiry took place. At the third meeting, as I understand it, the barrister to the inquiry advised that the word “inquiry” should be changed to “review”. Under whose authority? When a Minister sets up an inquiry, should there not be an inquiry? Perhaps those people did not want an inquiry, but who cares? They should have come back to the group—the victims—and, more importantly, to the Minister. They could have spelled out their advice and the Minister could have made a decision. Some might think that this is just semantics, but it is not. If people are trying to get to the truth, it is vital that they know what a group can do. Even when the report came out—not the original report, because that was removed and draft was changed, as others will mention—it did not say “review”, because it was not a review.

There should be full disclosure and a review of all the evidence. That “review” said that it did that, but it did not. The Royal College of General Practitioners, to give just one example, informed the Department and the drug company that it had concerns way back in the 1960s, but its evidence was never sought. If Members read the report, they will find that no evidence at all from the Royal College of GPs was given to this review, which should have been an inquiry.

[Margaret Greenwood (Wirral West) (Lab)]

rose—

[Sir Mike Penning]

I will give way, but I will only give way on a couple of occasions because I am conscious of the time and I want everybody to have the opportunity to speak.

[Margaret Greenwood]

I thank the right hon. Gentleman for giving way. Is he aware that The BMJ reported that most of the scientific evidence considered by the working group was from the 1960s, ’70s and early ’80s. One expert in the field, Dr Neil Vargesson of Aberdeen University, told The BMJ that there were not that many scientific studies available. Does he agree that the Government should fund new research with the aim of enabling a definitive conclusion to be reached?

[Sir Mike Penning]

Yes, I do, and I will come on to that point. It is vital that we have proper evidence, not some historical evidence that was used by the report. More modern evidence was rejected because it had not yet been peer reviewed. The whole point about having all the evidence is one reason why the motion under debate today, which I hope will be passed unanimously, actually says that there should be a judge-led inquiry so that all that evidence can be considered.

[Mims Davies (Eastleigh) (Con)]

rose—

[Sir Mike Penning]

I will give way to my hon. Friend and then I will make some progress.

[Mims Davies]

I thank my right hon. Friend for giving way. I must acknowledge my constituent, Charlotte, and her family, who are here on behalf of her brother, Stephen, who has been greatly affected by this drug. One of the biggest issues is the way in which the drug was handed out with absolutely no discussion of the risks.

Jackie lost her baby, Louisa, 19 years later—in 1977. At that time, the product had been on the market for two years with Government warnings, but still GPs did not point that out to patients. There is a lot of evidence here, so why is it not in the report?

[Sir Mike Penning]

I completely agree with my hon. Friend. One thing that has surprised me is that although, on average, every single MP will have a victim of Primodos in their constituency, many of the victims think that what happened was their fault and that they are on their own. In the fantastic documentary on Sky, people came forward to say, “I have been affected by this, but I thought that I was on my own. I thought that I was the only one.”

[Mr George Howarth (Knowsley) (Lab)]

rose—

[Sir Mike Penning]

Another point was that the inquiry should be conducted fairly and independently. Members should consider that for a few seconds and take a look at who was on the committee while I take an intervention from the right hon. Gentleman.

[Mr Howarth]

The right hon. Gentleman is making a very powerful case. Given that the inquiry/review has now been very much discredited—it has certainly been rejected by all of those who have suffered—does he agree, as I am sure he will, that the way forward is set out in his motion, which calls for a

“Statutory Inquiry under the Inquiries Act 2005 to review the evidence on a possible association with hormone pregnancy tests on pregnancies and to consider the regulatory failures of the Committee on Safety of Medicines.”?

[Sir Mike Penning]

I praise the Clerks who helped me to draft the motion. I was very angry when we started drafting it, after reading the report, but they helped me get it into some kind of parliamentary language.

An inquiry has to be independent and judge-led, and it has be able to subpoena people to give evidence before it on oath, so that we can get to the absolute truth. It also has to look at the regulatory system that was in place at the time. I am afraid that the Department of Health cannot hide behind this report. To me, that is vital.

Let us look again at the point about the inquiry being fair and independent. One of the ways we thought it could be independent and fair was to have an expert witness who was not part of the campaign, but whom everybody massively respected. For those of us who have been involved in the thalidomide campaign over the years, it was a really positive thing when we heard that Nick Dobrik’s name would be put forward.

Interestingly enough, although Nick was there as an expert witness, he was not asked to play a part in drawing up the conclusions in any shape or form. In fact, he was asked to leave the room. Nick was very surprised—actually, he was gobsmacked—when, in good faith, the Minister and then the Prime Minister said that Nick Dobrik had fully endorsed the conclusions of the report. I know now that the Minister and the Prime Minister know—I have met the Prime Minister, and Nick has done an interview with Sky today—that he categorically does not endorse the conclusions of the report. It was fundamentally wrong for anyone to advise the Prime Minister or the Minister that he did. He does not blame the Prime Minister; I do not think I blame the Prime Minister. As a former Minister—I know that there are former Ministers on the Opposition Benches—I know that we take advice from our officials and they tell us what the situation is. In good faith, the Minister at the urgent question, and the Prime Minister at Prime Minister’s questions, said that Nick endorsed the conclusions.

On behalf of Nick, who cannot defend himself in this Chamber, I would like whoever gave that advice to the Minister and the Prime Minister to formally apologise to Nick Dobrik. He is a fantastic campaigner not only for the Thalidomide Trust, but for all injustices, especially within the pharmaceutical area. The victims do not feel that the inquiry was fair and independent at all. They should have trust and confidence.

The most important thing is that the inquiry was asked to find a “possible” association—not “causal”, but “possible”. I and other members of the all-party group asked the experts from the panel why, after taking the word “inquiry” out, the remit was changed again, because “causal” is very difficult to prove. They said that they followed the science, but they were supposed to follow their remit and do what they were told. If they felt that they could not do that based on the evidence in front of them, fine. They could have gone back to the Minister and the victims and explained that. Instead, we had the farcical situation of the group looking for something when they knew full well—it is clearly in the documents—that they could not reach the conclusion that there was a causal link.

Interestingly enough, the group also could not come to the conclusion that there was not a causal link, because the evidence was not there for either conclusion. As I said during the exchanges on the urgent question, an injustice has taken place. Natural justice is the reason we are sent here. We defend our constituents when the system has come down against them and caused such horrific, horrible things to happen to them, so we need to address that injustice.

[Chris Elmore (Ogmore) (Lab)]

Will the right hon. Gentleman give way?

[Sir Mike Penning]

I will give way once more and then I will conclude to give other colleagues time to speak.

[Chris Elmore]

I am exceptionally grateful to the right hon. Gentleman. He says that everyone has constituents who have been affected. Two of my constituents have told me that they believe that they lost their children as a result of the drug. It is even more severe than losing a baby; one of them lost several children by taking the advice of their GP. This is a fundamental issue of trust—trusting the GP, trusting the NHS and trusting the inquiry. All those things have failed. Both my constituents told me over and over, “We no longer have any faith in the system.” They believe that the report is a whitewash, which is why I wholeheartedly agree that there should be a full and frank inquiry.

[Sir Mike Penning]

I thank the hon. Gentleman for his support for the victims.

As I said earlier, there is no constituency in this country that does not have someone who lost their baby due to stillbirth or dying shortly after birth, or whose life was transformed—for those who survived. However, many people were advised to have an abortion, and the figures on that are not available to us. Reports that the inquiry was not allowed to have are starting to come through.

I fully endorse the fact that we need some money so that we can ensure that we have modern reports, because the methodologies used back then would never be allowed today. We also need to see the missing reports. We need to find the stuff that has gone missing in Germany, where the drug company knew there were issues. We need to know why the drug company settled in America—it was using a slightly different name for the product, but it was the same company. What evidence was put before the legal system in America, where the company settled as fast as possible, and then gagged everybody and kept everything quiet?

We have a duty in this House to call things into question when they go wrong. These things started going wrong many years ago—before I was born. I have been a Minister, so I know that Ministers have to support their Department, but one role of a Minister is to question the advice that they get. I know that that is what the Prime Minister is going to do now, and I hope the House will support the victims so that they can have some confidence in the system and the NHS once again.

[Several hon. Members rose—]

--- Later in debate ---

[Peter Heaton-Jones]

I thank the hon. Lady for that clarification. Many of these studies have been into the historical evidence and the paperwork, which have been sifted through over and again—she is right to make that point—but there are still differences of opinion between what was said in the 1970s, in 2016 and in 2017, and that is the difficulty.

I have asked the House of Commons Library for quite a lot of background information, which I was going to try to get into, but in the six minutes allowed to me I cannot do too much. What I will say, however, is that, having read the latest report by the expert working group, it is clear that there is a concern, highlighted by my right hon. Friend the Member for Hemel Hempstead and others, about the contradiction between what it was asked to do and what it then actually found out. The question is whether there is a causal link or an association. We need to explore that: were the terms of reference of this expert working group followed in the way it carried out its investigation? On that, I absolutely agree: we need to look further into what exactly has been done here.

Further evidence from the expert working group is due to be published in the new year. That will be important.

[Sir Mike Penning]

It is not coming from the expert working group; it is coming from a professor. The expert working group rejected the evidence because it had not been peer-reviewed, but it will be in the next few days.

[Peter Heaton-Jones]

My point is that there is more information to come and I thank my right hon. Friend for that clarification on its source. It is really important that we keep looking for this information and that we gather everything we possibly can to help the people affected.

Many other right hon. and hon. Members wish to speak, so I shall not continue for too long. The Government and previous Administrations have consistently tried to look for answers and I know the Minister is sincere in seeking to do that. To support the Government and the people affected, I would like to work together to find a way forward to find the answers they seek. Let us get together and everyone be experts—the Department of Health, Members on both sides of the House and, crucially, the families—to try to get the answers.

I would like to end by referring back to my constituent Diane Surmon, because those affected must be at the centre of our work. In a further letter to me, she wrote:

“In my heart, I feel positive it was the drug Primodos which caused Helen’s injuries. After I took those tablets I was in and out of hospital. I carried a lot of fluid, which I have since been told is a sign of an abnormal foetus. I had had two normal pregnancies before Helen.”

She ends with these words, which I think are extraordinarily powerful:

“I feel very angry. I feel we were used as guinea pigs.”

For the sake of Diane Surmon and all the others whom we on both sides of the House represent, let us focus on the effect the drug has had on them and their families. Let us all work together. I know the Minister is sincere in wishing to do that. Let us all work together to find the answers they seek, while keeping them and their suffering at the centre of our work at all times.

--- Later in debate ---

[Sir Mike Penning]

I thank everybody for giving up their Thursday in their constituencies to be here. I have been praised extensively for securing the debate, but I would not have been able to do it without the all-party group—we had 57 signatures.

I have constituents whose lives were changed—blighted, completely wrecked—by Primodos, and we have heard of others on both sides of the House today. I heard the Minister say, “Nothing is ruled out. I am willing to listen.” I am really pleased, because he is going to have to listen an awful lot. If this report is still on his desk and being used as a way to go forward, I am afraid that that is an insult to the victims.

This document was described to me in a way that I cannot repeat in the House today, but a better way of describing it is that it was crap. It is fundamentally flawed and does not do what it said on the tin when the Minister asked for it to be done. The Department can talk and move on, and talk and move on, but there has to be an independent public inquiry. If that inquiry decides it needs further evidence, it needs the finance to get that, and it needs to suspend while we find further evidence—and there will be evidence coming forward in the next couple of days.

That is because the victims are the most important people in what we have been discussing today. If we forget that, we forget why we are here and why the NHS has the greatest reputation in the world. Schering is a great brand—we need its drugs—but its reputation has been damaged, and so has the national health—