Hormone Pregnancy Tests

Debate between Yasmin Qureshi and Gordon Marsden

Tuesday 23rd April 2019 Westminster Hall

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

I beg to move,

That this House has considered the Expert Working Group report on hormone pregnancy tests.

It is a pleasure to serve under your chairmanship, Mr Hollobone. I am also pleased that the Under-Secretary of State for Health and Social Care, the hon. Member for Thurrock (Jackie Doyle-Price), is here to respond to this debate.

To establish the context of the debate, I will begin by acknowledging the extraordinary hard work and determination of Marie Lyon, who is here with us in Westminster Hall today. She has led the campaign on behalf of the victims of hormone pregnancy tests, and alongside her husband has travelled the length and breadth of this country, and even been to Germany, to support victims.

It has been my pleasure to work with Marie since the beginning of this campaign, alongside others including Jason Farrell, who has pursued this story for Sky News from the start; Professor Neil Vargesson of Aberdeen University; and Professor Carl Heneghan and Dr Jeffrey Aronson, both of Oxford University, whose recent work is the basis of this debate.

By way of providing more background, I remind the House that Primodos, the hormone pregnancy test drug, was taken by approximately 1.5 million women in the 1960s and 1970s to test for pregnancy. The dosage contained in those Primodos tablets was 40 times the strength of an oral contraceptive that would be prescribed today. There is considerable evidence that many women who took this drug either gave birth to babies with serious deformities, or miscarried, or had stillbirths. Those babies are now in their 40s and 50s, and they have had to live a lifetime with serious disabilities.

To this day, not one Minister or one review has been able to answer some very simple questions. First, why were no official warnings issued about this drug until eight years after the first major report that indicated possible dangers? Why were some doctors still prescribing this drug for pregnant women after official warnings were issued by the Committee on Safety of Medicines? And why were some GPs able to pull out Primodos tablets from their desk drawers and hand them to women?

I secured this debate to seek answers in respect of the Medicines and Healthcare Products Regulatory Agency-led expert working group. That was the scientific review set up on the instruction of a former Minister, the hon. Member for Mid Norfolk (George Freeman), following my Backbench Business Debate on this issue in 2015. He had clearly stated to us that this review would “thoroughly” consider all the evidence.

Such is the depth of concern about this issue that there have already been three debates on the expert working group’s review—this is the fourth. Each and every time, Members from across the House have urged Ministers to consider our concerns about the methodology, the independence of the panel members and the conclusions of the report. On each and every occasion, however, our concerns have been dismissed.

[Gordon Marsden (Blackpool South) (Lab)]

I congratulate my hon. Friend on securing this debate and on the absolutely focused way in which she has conducted this campaign, with other Members here today and with Marie Lyon. I also pay tribute to the hon. Member for Mid Norfolk (George Freeman), the former Minister: it is not easy for Ministers to override the advice of their civil servants, but he did on that occasion. That, however, makes it all the more concerning that, on 24 October last year, Lord O’Shaughnessy wrote my hon. Friend a letter that was rather confusing and defensive, and did not make any reference to enforcing a rethink by the MHRA.

We know that there are issues about how the meta tests are done, and I am sure that my hon. Friend will come on to that. However, at this stage does she still find it very concerning that Ministers have not grasped the nettle?

[Yasmin Qureshi]

I thank my hon. Friend for that intervention and I absolutely agree with him; he can probably hear in my voice some of my frustration about the fact that this issue has not been grasped by Ministers and dealt with.

In recent months, the all-party parliamentary group on hormone pregnancy tests, of which I am the chair, has written to Ministers several times to ask for meetings so that we can discuss these concerns, but each time our request has been declined. Perhaps the Minister here today could shed some light on what exactly the Government are so intent on hiding each time they refuse the request by a group of MPs for a meeting.

Let us not forget that the review was cloaked in secrecy from the very start. As an observer, Marie Lyon was forced to sign a “gagging clause”, which, if breached, could have resulted in a prison sentence. Families who gave evidence to the panel reported being treated appallingly by the MHRA. Despite the MHRA’s insistence that the expert working group was independent, two panel members had to be removed after Marie Lyon discovered conflicts of interest.

Perhaps the most shocking fact was that this review was set up with terms of reference that stated very clearly that it would seek to find a “possible association”, but the review panel and the Commission on Human Medicines chose to ignore that and instead concluded that a

“causal association could not be found between the drug and birth defects.”

Each time that Ministers have been questioned about this review, we have been told that it was

“robust, comprehensive, independent and scientific”.

If that really is the case, I hope that the Minister can provide us with answers today as to why we now have evidence, which I will set out, that clearly proves that the expert working group review was anything but robust and comprehensive.

Last November, a team of experts led by Carl Heneghan, the Professor of Evidence-Based Medicine at Oxford University, conducted a systematic review of all previous human studies. They discovered that when the data is pooled properly it shows “a clear association” with several different forms of malformation. The results were clear that there is an association that is significant. That tells us that the expert working group’s review completely failed to adopt the right approach for a systematic review. Why did it not pool all the data together and properly collate it to show an overall effect? I should also point out that Professor Heneghan’s study has been published in a peer review journal, whereas the expert working group’s review was not even scrutinised.

However, Professor Heneghan did not stop there. Marie Lyon obtained raw data used by the expert working group via a freedom of information request. It is worth noting that despite the MHRA’s claim of “transparency”, this data was not already in the public domain. The cynical among us might ask: why was that? Why hide it?

That raw data was then assessed by Professor Heneghan and his team, who carried out a meta-analysis on it, and again they found that there is an association between the drug and birth defects. Let me just repeat that point again—raw data used by the MHRA for the expert working group review was assessed by independent experts at Oxford University and it was found that Primodos causes deformities.

Can the Minister appreciate why that has led to suspicion that key elements of the research were removed from the report in order for the expert working group to reach its conclusion, and why campaigners feel that Ministers and Parliament may have been misled, given that it appears that key information was being withheld from the report in order to suggest that there is no link between Primodos and deformities?

[Gordon Marsden]

My hon. Friend is being gracious in allowing interventions. Does she not consider it confusing that the group, and indeed the MHRA, seem to be reluctant regarding meta-analysis, when only recently the National Institute for Health and Care Excellence used it to reinstate surgical mesh in the treatment of prolapse? It is widely understood to be a common method—the US Food and Drug Administration and the European Medicines Agency have adopted it. Why are we lagging behind? Perhaps the Minister would like to comment on that in her reply.

[Yasmin Qureshi]

My hon. Friend is absolutely right and I come on to explain how other bodies use meta-analysis to carry out assessment.

Does the Minister understand why we are asking why the data was not even properly assessed? When I tabled a parliamentary question to inquire whether the meta-analysis of the studies had been carried out, I was told that it had not. Can the Minister explain why not? One of the experts on the panel, Professor Stephen Evans, recently made a poor defence of meta-analysis not being used in the review, by relying heavily on a paper called, “Meta-analysis. Schemata analysis”, which was published 25 years ago. The expert working group seems not to have considered meta-analysis an appropriate way in which to assess the data. Why not? Why did it refuse to take an evidence-based approach?

Neither the Minister nor I is a scientist, but she is aware that meta-analysis is the statistical procedure that combines data from multiple studies. When treatment effect is consistent from one study to the next, as with Primodos, it is completely appropriate and evidence-based to use a meta-analysis to assess the data. Pharmaceutical companies use it to approve new drugs. The US Food and Drug Administration uses it. The European Medicines Agency uses it for the approval of drugs, and clinicians and researchers in medicine, education and the criminal justice system use it to determine whether a treatment works. The National Institute for Health and Care Excellence uses meta-analysis, and it is the cornerstone of Cochrane—previously known as the Cochrane Collaboration. The only group that discounts meta-analysis is the MHRA. Why? To say that meta-analysis was not the appropriate method is completely incompatible with an evidence-based approach.

Let me take up the matter of the independence of the expert working group. We have been told several times, by a number of Ministers, that the entire process was completely independent. It is my view that the Government are not well served by their current processes, the lack of independence and the lack of impartiality. What is in doubt is the question of whether the Government have the independent expertise required to hold Government bodies such as the MHRA to account and provide us with independent evidence with which to make informed decisions.

As the Minister is aware, in February 2018, Baroness Cumberlege began a joint non-scientific review into Primodos, sodium valproate and mesh implants, and we expect it to conclude in the next few months. Baroness Cumberlege invited the expert working group to give oral evidence to the review team, and this is how Ailsa Gebbie, the group’s chair, described herself at the beginning of an evidence session:

“I’m also the chair of the MHRA and the expert working group on hormones and women’s health that reviews all products and medicines and drugs related to women”.

What does independent mean if the chair describes herself in that way?

In 2015, the Commission on Human Medicines agreed to establish an expert working group to review the available data on a possible association between the hormone pregnancy test, Primodos, and adverse outcomes in pregnancy, and to make a recommendation. The commission appears to have commissioned the MHRA to do an independent review. Perhaps the independence of the MHRA can be summed up in its response to Marie Lyon, who in conversation with the agency had reminded it of its responsibility to the public interest. She was immediately corrected:

“No, the job of the MHRA is to represent Pharma”.

Of course, the agency is correct—it is substantially funded by the pharmaceutical industry and cannot be considered independent by any stretch of the imagination. Can the Minister explain why we are expected to have confidence in the independence of a review that was run by an organisation part-funded by pharma? How can we be expected to trust claims that Bayer, the manufacturer of Primodos, has no links to the MHRA? Yes, we had a review, but I am not sure we can call it independent. Will the Minister do the right thing and withdraw the expert working group report?

If the Minister needs any further evidence, perhaps I can point her to the testimony of Sandra Malcolm, a recent whistleblower. Mrs Malcolm worked for the manufacturer of Primodos, which is now owned by Bayer. While at the company in 1971, she discovered she was pregnant and spoke to colleagues:

“I was in reception one day and there were two guys there. One may have been a medical rep and he said to me ‘you want a dose of Primodos’ and the other said ‘I think it’s been taken off the market’, and the other one said ‘no, you can get it’. So with that information I went upstairs to see one of the doctors. I said ‘I’m a week overdue and can I have some Primodos?’ And he said ‘I can’t give it to you because it may not work and it may cause deformities’, so I thought that was a definite no.”

Mrs Malcolm said that after the conversation she decided not to take the drug “for obvious reasons” and that she assumed it was no longer on the market. However, many years later, when she saw a report about Primodos causing deformities, she was shocked to discover it had remained on the market for many years after problems had been listed.

Vast swathes of evidence clearly point to a cover-up by the drug company and the Government regulators at the time. It is utterly disgraceful that until this day the evidence has been ignored, as it was by the expert working group review.