Sharon Hodgson, Member of Parliament for Washington and Sunderland West, has today called on the Government to accept all nine of the recommendations of the Independent Medicines and Medical Devices Safety Review.
The Review, chaired by Baroness Cumberlege, which examined how the healthcare system in England responds to reports about harmful side effects from medicines and medical devices, in particular: hormone pregnancy tests, such as Primodos; sodium valproate and pelvic mesh implants, published its recommendations today.
The Review recommends that the Government immediately apologise on behalf of the healthcare system to the families affected by Primodos, sodium valproate and pelvic mesh; the appointment of a Patient Safety Commissioner and a central patient-identifiable database to collect key details of the implantation of all devices at the time of operation.
Sharon, who was formerly the Shadow Minister for Public Health, has been working with and supporting patients and campaign groups on these issues for many years.
“I have heard of the devastating and heart-breaking affects mesh, Primodos and sodium valproate have had on patients and their families, and I know first-hand the impact mesh has had on patients as my own Mam has been badly affected.
“Patients and their families have fought tirelessly for years to get the recognition and acknowledgement that they have today, thanks to the publication of the Independent Medicines and Medical Devices Safety Review.
“I now call on the Government to accept and implement all of these recommendations as a matter of urgency. Patient safety must never be swept under the carpet ever again.”
Updated 16/05/2018 - Sharon writes to Baroness Cumberlege regarding the Medicines and Medical Devices Safety Review
Click on the image above to download the letter.
Previous post of 13/04/2018 below
Medicines and Medical Devices Safety Review
Over many years, Sharon has met with victims, campaigners and charities who support and campaign for justice for victims of Primodos, Valproate and Vaginal Mesh.
Sharon spoke in a Backbench Business Debate secured by Yasmin Qureshi MP on Hormone Pregnancy Tests, or also known as Primodos, which was used in the 1950s, 1960s and 1970s and the adverse affects it had on women and their babies. In her speech, Sharon joined cross-party calls for a judge-led public inquiry into this scandal.
You can read the full debate here: Primodos Backbench Business Debate 14.11.17
Read Sharon's contribution to the debate pasted below:
I congratulate the right hon. Member for Hemel Hempstead (Sir Mike Penning), who opened the debate so powerfully, and my hon. Friend the Member for Bolton South East (Yasmin Qureshi), who has been a strident campaigner on this issue for more than six years and knew all about it before it had even reached my consciousness. She gave an excellent, if rather too short, speech. I thank all other Members for their passionate and thoughtful contributions; because of the time constraints, I hope they will please forgive me for not naming them all. Ultimately, thanks must go, as others have said, to Marie Lyon, the chair of the Association for Children Damaged by Hormone Pregnancy Tests. I am sure that I speak for all of us in the House today when I say that she has the utmost respect and admiration of Members from across the House.
I want to touch on not only the science that was used to come to the conclusions in the review, but what is missing and what should have been considered before any conclusions were drawn. I will then highlight why this is a matter of injustice and why it is important that answers are found so that we can finally conclude this sad chapter.
The main sticking point of the review’s conclusions is that the expert working group found that the science did not support a causal association between HPTs during pregnancy and adverse outcomes. My focus will be on the science used and the historical documentation that we are aware of, but which seems not to have been considered—we heard about some of it in the excellent speech by the right hon. Member for Kingston and Surbiton (Sir Edward Davey). I will not deviate into the important argument about “possible” and “causal”, as that was covered comprehensively by other Members, including the right hon. Member for Hemel Hempstead.
I must make it clear from the outset that I am no scientist—I am sure that Members are aware of that—and my speech is not a critique of the integrity and expertise of the specialists involved. However, the conclusions arrived at in the report and the conversations I have had with many of those who have been involved in the campaign show a need for us to be critical of what was concluded by the expert working group. That is our duty as Members of Parliament, especially when it comes to what is such an important matter for so many women and their families, and also because a great deal of public funds were invested in the review over the past few years.
In the report’s consideration of the scientific detail regarding HPTs, it is argued that there are inconsistencies in the conclusions drawn from the evidence used. Take, for example, the fact that of the 15 studies that looked at heart defects, 11 favoured a link, and of five studies into limb reduction, all found a link, yet those studies were deemed to show “insufficient evidence” of the drug’s harm. Even information I requested recently and got just this week from the Medicines and Healthcare Products Regulatory Agency in the lead up to this debate is at odds with the conclusions of the review, including graphs that plot birth defects against the availability of HPTs. Even to my untrained eye, they show a possible link. In one graph on all malformations, it is clear that birth defects increased during the period in which HPTs were on the market, and shortly afterwards. They began to decrease soon after HPTs were taken off the market.
Further, in the briefing I received, the MHRA said that for every 100 babies born in the general population, around two to four are expected to have a birth defect, which means that 14,000 babies a year would be expected to be born with a birth defect. That is just generally. Using those figures, the MHRA concluded that for the more than 1 million women who took HPTs, as many as 19,000 babies would be born with a birth defect, irrespective of any additional risk from HPTs. Yet let us compare Primodos to thalidomide, for instance. More than 30 million thalidomide prescriptions saw 600 children affected in the UK, which is a rate—I have had help with these numbers —of 0.002%. Some 1.2 million Primodos prescriptions were sold and 800 children were affected, which is a rate of 0.06%. That shows a much higher prevalence caused by Primodos compared with thalidomide. It also shows how little meaning a comparison of HPT adverse reactions has against today’s prevalence of birth defects in the general population, and it is hardly a defence of disproving a link.
As I have said, I am no scientific professional, but I believe that the red flags that arise when reading what the evidence says and what conclusions were drawn from it are not ones that only an expert in this field would see. This reflects the arguments that were raised last week by Dr Neil Vargesson—that the report does not provide definitive evidence that the drug was safe. As others have said, the only conclusion that can be drawn is that a link cannot be ruled out.
That leads me on to my next point, which is to touch briefly on the historical perspective and cover-up of the evidence. We have got to use that word—it is the only word we can use—as this is something that should have been considered by the expert working group.
One such example was in 1975, when the UK regulator knew of a potential five-to-one risk that the drug could cause deformities, but that evidence was apparently later destroyed. This is a running theme—I do not have time to go into it all—through the chronology of this scandal. We see multiple examples of suppressed information regarding the adverse effects and delayed notification of those effects to medical professionals who administered the drugs.
It is also deeply concerning that this drug came into the market in 1958, with no studies on its effects at all until 1963. Five years passed before it even underwent teratogenic testing. It was still officially in circulation until 1975, but we are aware of cases of its use up until 1978. All the evidence uncovered should have been considered as part of the review. The question is: why was it not?
With any scandal such as this, it is important that those affected have the trust and confidence of any review or inquiry undertaken. In this instance, that has not been the case. The victims feel that the review has muddied the waters even more and that their views have been ignored. I have been told many harrowing stories, many of which we have heard today, and how, time and again, they have been ignored. These women did not ask to be given HPTs. Nor were they ever made aware of the effects that they could have on them or their unborn baby. They were just given them—sometimes out of a supply in a drawer on the doctor’s desk. There were no warnings, no explanations, no discussions.
A great injustice has been inflicted on these women. It is up to this House to put pressure on the Government of the day, here and now, in a fully cross-party, non-partisan way, to make things right. It is paramount that a judge-led public inquiry be conducted—one that is independent and can fully examine all the materials and documentation available and insist that all information be made public, including that which has been withheld so far. I hope that this debate helps us to take that one step further to achieving that.
In closing, may I quote the hon. Member for Mid Norfolk (George Freeman), the then Minister for Life Sciences? In October 2014, when he instigated this review, he said that the review would
“shed light on the issue and bring the all-important closure in an era of transparency”.—[Official Report, 23 October 2014; Vol. 586, c. 1143.]
Let this debate and the following actions by the Minister ensure that what was promised in 2014 is actually achieved.