Happy New Year to everyone! Over the last year we have all been busy looking after our families and dealing with the pandemic in our own ways and we needed to take a break from the Time for Action Campaign. However, we are back and thought we would provide an update.

CUMBERLEGE REPORT ON SIDE-EFFECTS TO MEDICINES/DEVICES

We have been watching the progress of the Independent Medicines and Medical Devices Safety Review led by Baroness Cumberlege. This review was commissioned by Theresa May and Jeremy Hunt to look at the way patients and patient groups were treated when they raised the issues of suspected side effects from the Primodos hormone pregnancy tests, the Sodium Valproate epilepsy drug and mesh products. The report can be read here and the Time For Action statement on the report can be read here. The review took evidence from more than 700 affected families from across the country and Baroness Cumberlege said:

I and members of the Review team have conducted many reviews and we all agree – we have never encountered anything like this, the intensity of suffering, the fact that it has lasted for decades. And the sheer scale. This is not a story of a few isolated incidents. No one knows the exact numbers affected by mesh, Primodos and sodium valproate but it is in the thousands. Tens of thousands.

Baroness Cumberlege, Press Conference Speech, 8 July 2020

Time for Action asked for the HPV vaccinations to be included in the Review and this request was rejected. However, comprehensive evidence was submitted and this is mentioned in the report:

Finally, as complex and wide-ranging as our Review proved to be, we know that there are many who contacted us during the course of our work and who were disappointed that we could not also consider their concerns about other medications and devices on the market. The list is long – Essure (a contraceptive device), Roaccutane (a treatment for severe acne that can cause birth defects if used in pregnancy), Poly Implant Prostheses (PIP) breast implants, cervical cancer vaccination, in utero exposure to hormones, valproate use in children…. We believe that what we have to say and recommend for the future will have an important read-across to these and other interventions and the manner in which they are approved, delivered, regulated and monitored.” (Emphasis our own)

First Do No Harm, IMMDS Review, 1.8, Pg 2

The full report was published in July and there were nine recommendations. The ones that are relevant to our campaign are:

  • That a Patient Safety Commissioner is appointed. This person would be the patients’ port of call, listener and advocate, who holds the system to account, monitors trends, and demands action.
  • A Redress Agency for those harmed by medicines and medical devices in future should be established.
  • The regulator of medicines and medical devices, the MHRA, needs to put patients at the heart of its activity, and to overhaul adverse event reporting and medical device regulation.
  • Finally, that the Government immediately sets up a task force to implement the Review’s recommendations.

On the MHRA, the IMMDS Review team says:

A regulator must work both for patients and with them. This hasn’t been the case in the past. We are recommending that the regulator of medicines and medical devices, the MHRA, is overhauled. It needs to change and radically improve the way that concerns about medicines and devices are detected and acted upon. The regulation of devices in particular needs urgent change. The MHRA needs to engage more with patients and track how medicines and devices improve – or fail to improve – patients’ health and quality of life. It needs to raise public awareness of its role and it needs to ensure that patients have a core role in its work.”

Baroness Cumberlege, Press Conference Speech, 8 July 2020

So in July we were optimistic that this excellent report would help the Time For Action campaign in our quest for side-effects to HPV vaccinations to be recognised and properly investigated.  Matt Hancock and Nadine Dorries both apologised to patients who had been affected by the three products investigated and said that would look more closely at the report before deciding what actions to take. Nadine Dorries declined to answer questions in the House of Commons citing ongoing legal action. Since then, nothing has happened.

ALL PARTY PARLIAMENTARY GROUP – FIRST DO NO HARM

An APPG (All Party Parliamentary Group) called ‘First Do No Harm’ was set up in November to raise awareness of and build support for the recommendations and to ensure they are implemented by the UK government and others. Jeremy Hunt and Baroness Cumberlege are co-Chairs and Lord O’Shaughnessy is Vice Chair. The Time For Action campaign group heard just before Christmas that it was reported at a meeting of the APPG that the Government have agreed to appoint a Patient Safety Commissioner. Scotland and Wales had already agreed to do this.

It is really important that the people appointed as Patient Safety Commissioners in England, Scotland, Wales & NI are completely independent of the Department of Health, the MHRA and the pharmaceutical industry – and there is an action we can all take to help achieve this:

CALL TO ACTION – Please support the Time For Action campaign group by writing to your MP and the APPG

Please write to your MP and copy to Chair of the APPG (huntj@parliament.uk) asking them to support the APPG in its aim to get the Cumberlege recommendations implemented and in particular that the Patient Safety Commissioner must be completely independent and acting on behalf of patients, with no conflicts of interest.

It is our view that the APPG and the MPs involved in the Primodos, Valproate and mesh campaigns are influential and using every avenue to get actions taken on behalf of affected patients. We are campaigning on a much more contentious issue, particularly at the moment with the introduction of the Covid-19 vaccinations. If the APPG is not successful, then we need to think about where to go with our campaign and if there really are any routes that will achieve success.

OTHER WORK IN PROGRESS

We have also been working on the following areas:

  • Following up on the Scottish study (2019) that showed a significant reduction of HPV16/18 in vaccinated girls and there was a big press campaign using this as evidence that the vaccination programme was working. We have been in correspondence with the authors to find out whether this has led to any decrease in the rates of invasive cervical cancer (since this is the basis of the marketing campaign pitched to our families). We have heard that few invasive cancers were found in vaccinated and unvaccinated groups, so they were waiting for more data before publishing on this. We will continue to follow this up.
  • We have been following the trends in invasive cervical cancer statistics from the Office for National Statistics and plotting these. There is more investigation to be done and we will report on the Facebook group.
  • There are four legal cases in progress in the USA based on lack of informed consent. We will be following these, as they might eventually have an impact in the UK.
  • We continue to communicate with the MHRA and receive quarterly data on reported suspected side-effects. We have also followed up on correspondence with June Raine, the Acting CEO. We will post an update on the Facebook Group shortly.
  • We continue to communicate with Public Health England on data for invasive cervical cancer. We will post an update on the Facebook Group shortly.
  • Caron, Carol and Emily took part in an MHRA working group on pandemic systems delivery and the new Covid-19 database for suspected side-effects. An update on this will be posted on the Facebook Group.

UPDATING YELLOW CARD REPORTS

In addition to the action point above, there is one other really important action that we need everyone to help with:

CALL TO ACTION – Please contact the MHRA to update your Yellow Card Report

If you haven’t submitted a Yellow Card report to the MHRA, please do so, as it’s important the adverse reaction figures held by the MHRA reflect the severity of the issue. Yellow Card reports can be submitted here.

If you have already submitted a Yellow Card report, please contact the MHRA to update your report – this can be done by emailing the MHRA at yellowcard@mhra.gov.uk and quoting your initial Yellow Card reference number.

Please be very specific about the following:

  • Length of time your daughter has been unwell
  • Severity of symptoms and effect on her daily life and education
  • Diagnosis or change to diagnosis. Please include consultant letters where possible, as these hold more weight with the MHRA/manufacturer than parent/patient reports.

We need to continue to put on record that there are girls/young women and boys who have not recovered from the reported suspected side-effects. Please ask the MHRA to confirm that the Yellow Card has been updated.

Finally, thank you to everyone for following our group and we will do our best to make updates and information more regular in 2021.

Kind regards and best wishes for the coming year

The Time For Action campaign committee