An email sent to Dr June Raine, chief executive of the Medicines & Healthcare products Regulatory Agency
23 May 2021
Dear Dr June Raine,
I am writing to draw your attention to the ways in which the government is expanding the use of lateral flow tests in community settings and, in so doing, is creating potential direct health harms at huge cost, in addition to undermining our civil liberties and participation in public life.
I have recently been informed that I am expected to have a negative LFT test in order to participate in a public hearing of the Infected Blood Enquiry (see email below). My daughter-in-law, who is pregnant, has been informed by the midwives that national guidance is being drawn up which will require her to have an LFT while attending maternity OPs at UCLH (see emails attached). UCLH and NICE guidance do not require LFTs for OP clinics. The school my niece attends is handing out lateral flow tests every Monday to do testing twice a week. She tells me none of the students have been shown how to do the tests, nor have they been told what the tests mean, and none of them actually do the tests. Most recently on Saturday 15 May those 21,000 people attending the Cup Final between Chelsea and Leicester were told that admission to the ground required proof of a negative lateral flow test up to two days prior to attending. A number of other sporting and music events have also imposed similar conditions on participants. All these tests were/are provided free and at great cost to the taxpayer.
As these examples show, the LFT is now being used widely as a test to enable ie a green light test.
- The LFT is being used as a test to enable. LFTs are tests for infection of limited sensitivity. They are not tests for infectiousness, despite claims to the contrary. They have not been evaluated as a screening test.
- Even if the test were a useful case-finding test, the approach to its use is disproportionate: currently infection rates in most parts of the country are extremely low, so not only will the yield be low but as prevalence falls false positives will outnumber true positives
- The effectiveness of this test as a screening tool, identifying the need for the intervention of isolation, is unknown and un-evidenced despite the billions of pounds spent to date. Recent data on their use in schools and care homes is not encouraging.
In summary, there is accumulating evidence that widespread use of these tests represents potential or actual harm to health.
The MHRA gave authorisation for exceptional use of lateral flow tests in December 2020, which expires on 22 June 2021. I have been unable to find the documents setting out the basis of the authorisation on the government website and neither have my colleagues.
I have a number of requests.
First, I am asking the MHRA to publish its exceptional use authorisation documentation in full.
Second, I am asking that the MHRA qualify its advice to emphasise that these tests are not fit for ‘green light’ use, based on the accumulating evidence, to much of which the public has limited or no access: none of the results of the so-called ‘pilots’ in schools has been released, despite FOI requests.
Third, I would be grateful if you would provide me with
- a summary of the activities that MHRA is carrying out in relation to the performance of the tests, and the safety of people using them
- a description of, and the details of the operation of, the information system MHRA is using for the purpose of those activities
- a description of the cost effectiveness and value for money analyses that MHRA and or DHSC has carried out
Allyson M Pollock
Email 1. Infected Blood Enquiry email sent 14 May 2021 from the Engagement Team of the Infected Blood Enquiry
Thank you for registering your interest in attending the upcoming public hearings at London, Fleetbank House. We have registered you to attend on the following dates:
You have been allocated a seat in the main hearing room for both of your chosen dates. If these dates are incorrect in any way, or you are no longer able to attend, please contact us urgently so we can update our attendance register.
Lateral Flow Testing: You must test negative for coronavirus to attend the Inquiry hearings. Everyone attending is expected to take a COVID-19 lateral flow test before travelling to Fleetbank House. You can order tests here. Further information on COVID-19 lateral flow testing is available here. ….
The Engagement Team
2. Email sent to expectant mothers from UCLH on 07 May 2021
Lateral Flow Tests: Maternity patient and partner update
Please be aware that there is soon going to be a new requirement for a COVID-19 Lateral Flow Tests to be completed for all maternity patients and their named support partner before every outpatient appointment, as per National guidance.
These Rapid tests can be ordered through:
Or from your local pharmacy or testing site.
This new requirement will come into effect in the next 2 weeks and therefore we urge you to order enough stock from the above methods, for your upcoming outpatient appointments for yourself and your support partner.
Further guidance will be released soon.
UCLH Maternity Department
Reply from a midwife
3. Email sent on 15 May 2021 from community midwife
This is not a UCLH decision it’s is an NHS England directive and proving a nightmare to implement.
NB This email does not accord with UCLH policy – or with NICE guidance