Hormone Pregnancy Tests

Yasmin Qureshi Excerpts

Thursday 14th December 2017 Commons Chamber

[Yasmin Qureshi (Bolton South East) (Lab)]

Six years ago, I met my constituent Nichola Williams, who shared with me her struggle with her health over her lifetime. Her mother had been prescribed Primodos. From there, I carried out my research, searching for answers and going through thousands and thousands of pages of documents.

One document was a 1969 study by a Dr Norman Dean, who worked with the Royal College of General Practitioners. He found that when women used this hormone pregnancy test, there was a higher incidence of malformed babies, miscarriages, stillbirths and infant deaths. He found the findings so alarming that he wrote to the manufacturers advising them that Primodos should be withdrawn. However, it took another eight years for it to be finally taken off the market, unlike in Norway and Sweden, which apparently acted very swiftly.

In the last six years, I have exchanged countless letters with Ministers and Department of Health officials, working alongside Jason Farrell from Sky News, who has dedicated an enormous amount of time to exposing this issue, and Marie Lyon, the chair of the victims association, who has tirelessly campaigned for justice. I have raised this matter on the Floor of the House many times. I raised it with the Prime Minister several weeks ago, and I also met her predecessor to discuss it.

In 2014, after a debate in this Chamber, we were informed by the then Minister that an inquiry would be carried out, and we were very excited about that. We were promised that the inquiry would be fair, open and transparent, would have the trust and confidence of all the victims and would look at all evidence. Instead, we found that some experts on the panel had conflicts of interest and close ties with the manufacturer, which is now Bayer.

The victims who were invited to give evidence were treated appallingly and were given a very short period—I think it was two hours—to explain what had happened to them. Ms Lyon, who had been appointed as an observer to the panel, was forced to sign a gagging clause, which meant she could not raise with us any of the concerns she had about how the inquiry was going.

[Mims Davies]

I thank the hon. Lady for mentioning the interest our Prime Minister has shown. She met Conservative Members recently, and she is watching with interest. However, the issue I would like to reiterate on behalf of my constituents and many other MPs is the treatment of the campaigners during this process. We had unacceptable timescales, and some of these people were caring for very ill children. The treatment of the campaigners, at the very least, needs some kind of apology.

[Yasmin Qureshi]

I entirely agree with the hon. Lady on this matter.

The inquiry was intended to look at a possible association, not a causal link. That is very important because a different burden of proof is required for a possible association as opposed to a causal link. That was changed, and nobody can tell us who gave the authorisation to do that. The EWG was asked to look at regulatory failures. There are thousands of documents from archives in Berlin and Kew that show that there was a link between the deformities and these drugs. The Committee on Safety of Medicines looked at these documents and decided not to do anything with them. Why was that? When the report came out, the initial draft said that it was impossible to reach a definitive conclusion. However, the final document was changed to say that it could reach that conclusion. When the chair of the inquiry was asked why this happened—by Jason Farrell, by me and by other colleagues in a recent discussion—she said that the Commission on Human Medicines looked at the documents very thoroughly and told the panel that

“we should strengthen the wording and put a greater clarity on it.”

It is unacceptable for the commission to have asked the panel to change its conclusion.

When I raised the report with the Prime Minister recently, one of the reasons she said that there was confidence in it was that Nick Dobrik had said that he endorsed it. However, he has said:

“I was very angry when I was informed that my name was used to endorse the conclusions of this report.”

Is the Minister aware that the EWG refused to look at the most up-to-date study on Primodos conducted this year by Dr Neil Vergesson? It said that the study had not been peer-reviewed, yet it looked at 44 other non-peer-reviewed studies, some of which had been produced by the manufacturer itself, Schering. Dr Vergesson found that Primodos deformed fish embryos, and if given in high doses actually killed them. Dr Dean apparently carried out a study and wrote to Schering telling it what his findings were. He also informed the Royal College of General Practitioners about this. That study has also been ignored, and there is no record of it at all. We know that it exists only because a letter was found showing that he had discussed this matter and told all the parties concerned what was going on, but again nothing happened.

The man in charge of the Committee on Safety of Medicines—its chief scientist, Dr Inman—also conducted a study and found that there was an adverse reaction. Instead of dealing with the issue, he contacted the manufacturer and told them to

“take measures to avoid medico-legal challenges.”

Documents from Berlin show that he later said that the documents on which he based his investigation were going to be destroyed. He made that admission at a meeting with a Schering scientist in Bermuda. A Dr Greenberg carried out a study that showed a significant twofold increase in risk of malformed babies being born to women who took this drug. Eventually, in 1977, the Committee on Safety of Medicines wrote to doctors saying that the drug should stop being given. It said that “the association is confirmed” between Primodos and deformities. It was “confirmed”, unequivocally—and that was in 1977.

Why does the EWG seem to have disregarded all these studies, not to have bothered to take any interest in what was happening and failed to look at the regulatory failures? It is vital that further scientific research is carried out not only to establish an association, but because the EWG report says that the component parts of Primodos are currently safe to be used. That is very worrying, because it is being used in many contraceptive pills. Studies and independent research should be carried out on this, because we might find that even though the drug is being used, it might be harmful to women, and we could prevent further problems from occurring. I am asking for an independent inquiry into the regulatory failures. We must put the families first.

--- Later in debate ---

[Peter Heaton-Jones (North Devon) (Con)]

I congratulate my right hon. Friend the Member for Hemel Hempstead (Sir Mike Penning) on securing this debate under the auspices of the Backbench Business Committee. This was one of the very first issues brought to me by a constituent following my election as the Member for North Devon two and a half years ago, and I want to raise her case again.

The people affected—the families, children, mothers and babies—should be at the very centre of our thinking. I will give one example. I was contacted by my constituent Diane Surmon from Barnstaple. She gave birth to her daughter Helen Jean Marie Barham on 29 November 1974. Diane wrote to me to say that she was given Primodos on 10 April that year, while she was pregnant—she remembers the date all too clearly. She was given the hormone pregnancy test. She was living in Cwmbran at the time and Helen was eventually born in the Royal Gwent Hospital in Newport. However, the baby was born with a number of conditions: Helen had hydrocephalus—a very rare disease—and suffered a brain haemorrhage at 12 weeks of age. Her seizures then started; she was treated at the Heath Hospital in Cardiff and then at a later date at Great Ormond Street Hospital. Diane has a letter from a consultant neurologist at the time, which states that in his opinion the drug Primodos had caused the difficulties to her baby.

Diane told me that Helen does have a quality of life. She can walk, albeit short distances. She needs a wheelchair for longer distances, or when she goes shopping or goes out with friends for a meal, for instance. She is able to feed herself, but help with her daily needs is required and she will always need 24-hour care because of her seizures.

That is one example of the extraordinary impact this has had on one family and one individual and one mother, but that can be multiplied so many times, and that is why it is absolutely right that my right hon. Friend the Member for Hemel Hempstead and others on both sides of the House—this is not a party political issue—seek to ensure this issue is kept in the spotlight. It is right that it is.

Therefore, there are many others in situations like that of Mrs Surmon. Over the years, there have been many attempts by Governments of all colours to get to the bottom of this. I know the Minister is sincere in trying to do that and to find a way forward that will help us get to the bottom of what has happened. There has also been a whole range of studies over the years. The difficulty is—this is the nub of the point I want to get across—that there is so much contradiction between all those studies; there is no agreement yet. The hon. Member for Bolton South East (Yasmin Qureshi) delivered a good speech and rightly made the point that in the 1970s there was a report that showed, apparently clearly, evidence of a causal link. However, in 2016, the report from the Commission on Human Medicines said that there was no such evidence. Now we have had this report from the expert working group, which has come up with a similar finding. As we have so many contradictions and differences of opinion, how do we get to the bottom of this?

[Yasmin Qureshi]

The report by the Commission on Human Medicines was a result of a letter I wrote to the Medicines and Healthcare Products Regulatory Agency. The report was not a study into the drug itself; the commission just looked at documents that were in existence, conducted a review on the basis of those documents and gave an opinion. It was not a study.

[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.