To the Secretary, Infected Blood Inquiry
Thank you for your letter of 26 May 2021.
I am disappointed by your position to deny access to the public hearings, and by your reasoning.
As you correctly state, the MHRA authorises (Innova) lateral flow tests solely – currently, until 22 June 2021 – for the use in the testing of large sections of the population to detect infection in asymptomatic individuals (paragraph 2 of the authorisation, first sentence). I note in passing though that the claim that you are using the test solely for use in large sections of the population is not correct. Large sections of the population are not attending the hearings, and there is no general legal requirement for large sections of the population to have the test.
More to the point, however, you do not correctly state the second sentence of paragraph 2. You assert that “the MHRA does not support the use of the test for a ‘test to enable’ function that would allow activities otherwise unsafe to occur”. The second sentence actually reads:
We [MHRA] do not currently support the use of the test for a ‘test to enable’ function until we are satisfied there is evidence to support this.
Your gloss on the second sentence equates function with ‘activities otherwise unsafe to occur’ but that those unsafe activities are mitigated by risk reduction measures, such as social distancing and masking. The MHRA in its authorisation makes no reference to otherwise unsafe activities or risk reduction measures. In making LFTs mandatory you are using the test to enable function as that is the only way in which participants can attend the public hearings in person.
I understand and share the important concern to protect those people who have already suffered greatly from illness and are at risk of disease. However, moving from concern to denial of entry must be based on scientific evidence. MHRA does not have that evidence. Indeed, it has imposed several stringent conditions on the Department of Health and Social Care, including the submission of information, evidence and monitoring reports (though not the risk reduction measures you describe).
Authorisation of the Innova LFT in December 2020 was limited to ‘a red light function’ because of the lack of evidence on performance and sensitivity in asymptomatic people. This was in line with the manufacturer’s Instructions for Use, which explicitly limited use to individuals suspected of COVID-19 by their healthcare providers within five days of onset:
The SARS-CoV-2 Antigen Rapid Qualitative Test is a colloidal gold immunochromatography intended for the qualitative detection of nucleocapsid antigens from SARS-CoV-2 in human nasal swabs or throat swabs from individuals who are suspected of COVID-19 by their healthcare provider. (sic) within the first five days of the onset of symptoms
Since December, a growing body of evidence has emerged that the Innova LFT tests have poor performance and low sensitivity in asymptomatic people (see list of references below).1 2 3 4 5 6 7 8 9
There is a deep irony in your position. In May 1983, Dr N. S. Galbraith, director of the Communicable Disease Surveillance Centre, wrote to Dr Ian Field at the Department of Health and Social Security. Drawing attention to the death from AIDS of a haemophiliac who had received Factor VIII concentrate imported from the US Galbraith stated: “I have reviewed the literature and come to the conclusion that all blood products made from blood donated in the USA after 1978 should be withdrawn from use until the risk of AIDS transmission by these products has been clarified … I am most surprised that the USA manufacturers of the implicated blood products have not informed their customers of this new hazard. I assume no critical warning has been received in the United Kingdom?” Despite Galbraith’s recommendation, the products were not withdrawn. If his expert view had been respected and heeded by those in authority, widespread suffering would have been avoided, and this inquiry would not have been necessary.
The issue of whose views are respected and heeded is now playing out again. My suggestion to you of a discussion with Professor Jon Deeks, the expert on LFTs, and Dr Angela Raffle, lead author of the definitive work on screening/mass testing, has not been taken up. This has led me to question whether my contribution as a public health physician of almost 40 years’ experience is valued. I also believe this would not have happened if I had been a senior male professor.
Finally, it is worth pointing out that while the victims of infected blood and their families have waited decades for this inquiry, and many have also suffered great financial hardship, the government awarded eight contracts (including two variations) for the Innova LFTs valued at over £2 billion between September 2020 and March 2021.
I will not therefore attend the public hearings in person in view of the pre-condition you are imposing on me. The easy course of action would be to take an LFT test, as no doubt many have felt coerced to do, but I do not wish to be complicit in the use of tests outside of their authorisation and Instructions for Use, and in the absence of a sound evidence base, all in the name of ‘health protection’. To my mind, that would not uphold human rights and freedoms and would be a travesty of public health principles.
I would, however, ask you again to meet with screening and test experts, with a view to reconsidering your policy.
Allyson M Pollock
Clinical Professor of Public Health
- Raffle A, Taylor-Phillips S, Sitch A. Mapping the outcomes of covid-19 testing reveals the best opportunities for system improvement. BMJ Opinion 09 Apr 2021. https://blogs.bmj.com/bmj/2021/04/09/mapping-the-outcomes-of-covid-19-testing-programmes-reveals-the-best-opportunities-for-improvement/
- Raffle A, Gill M. Mass screening for asymptomatic SARS-CoV-2 infection. BMJ 2021;373:n1058. https://doi.org/10.1136/bmj.n1058
- Science Media Centre. Expert reaction to new analysis on Lateral Flow Device specificity. 10 Mar 2021. https://www.sciencemediacentre.org/expert-reaction-to-new-analysis-on-lateral-flow-device-specificity/
- Pollock AM, Lancaster J. Asymptomatic transmission of covid-19. BMJ 2020;371:m4851. https://doi.org/10.1136/bmj.m4851
- Qiu X, Nergiz AI, Maraolo AE, Bogoch II, Low N Cevik M. The role of asymptomatic and pre-symptomatic infection in SARS-CoV-2 transmission-a living systematic review. Clin Microbiol Infect 2021 Apr;27(4):511-519. https://doi.org/10.1016/j.cmi.2021.01.011
- Kent C. UK’s mass Covid-19 testing policy unlikely to reduce transmission, say experts. Medical Device Network. 29 Apr 2021. https://www.medicaldevice-network.com/news/mass-testing-covid-19/
- Iacobucci G. Covid-19: MHRA is concerned over use of rapid lateral flow devices for mass testing. BMJ 2021;373:n1090. https://doi.org/10.1136/bmj.n1090
- Griffin S. Covid-19: Lateral flow tests are better at identifying people with symptoms, finds Cochrane review. BMJ 2021;372:n823. https://doi.org/10.1136/bmj.n823
- Dinnes J, Deeks JJ, Berhane S et al. Rapid, point-of-care antigen and molecular-based tests for diagnosis of SARS-CoV-2 infection. Cochrane Database Syst Rev. 24 Mar 2021;3(3):CD013705. https://doi.org/10.1002/14651858.CD013705.pub2