Quis custodiet COVID?

National Institute for Health Protection to replace Public Health England

Following the Health Secretary's decision to axe Public Health England (PHE) we are starting to see some of the extent of the fallout from the disproportionate response and mismanagement of the pandemic. As Total Health have repeatedly reported, the whole handling of the data and models underpinning political policy has been highly questionable, and even the accuracy of the death count has been shown to be incorrect with the number of reported deaths caused by COVID-19 now reduced by 12%. Someone has to take the blame. However, it is easy to point fingers and the bigger picture should be taken into consideration.

Competent and experienced diagnostic platform

Prior to the consolidation of pathology testing laboratories into a few commercial providers, the NHS and Public Health Laboratories used to have an excellent, well-informed and professional medical and laboratory testing base. Each hospital-based pathology laboratory had an independent responsibility to check both external peer-reviewed studies as well as conduct their own in-house assessment of all new testing kits (to measure their performance, accuracy and precision), prior to acceptance for routine clinical use. Furthermore, each laboratory took pride in the quality of the results and they competed with each other - setting new benchmarks to attain ever greater levels of diagnostic power (and associated) meaning. This meant that if you asked a pathologist or microbiologist for comparative information on what a test result actually indicated that they would provide a well considered reply based on a lot of input and experience. However, over the past thirty years, the testing laboratories have been amalgamated into a few mega labs. Worse still, following a market feeding frenzy the choice of testing kit they can use is now dominated by a couple of pharma's.

Diagnostic dumbing down

Furthermore, the full automation of diagnostic testing has reduced most clinical lab staff to machine operatives. The complex analytical techniques involving sophisticated testing reagents that once required highly skilled scientific staff has been replaced by the use of 'black box technology' remotely controlled by the pharmaceutical company supplier. This means that lab staff have lost their status, lost valuable skills, no-longer have the experience or insight into diagnostic methodologies and all this inevitably impacts on levels of motivation. The war for diagnostic dominance of the market has had an inevitably detrimental impact, especially on the medical laboratory staff at PHE. The government should not really be too surprised. However, the role of PHE goes far further than just testing for pandemic, and we have not yet heard what (if anything) the full proposals are likely to be other than that the new body could be called the National Institute for Health Protection (NIHP) and is planned to be effective in September.

Politicians need to be acutely aware of the fact that diagnostics (and diagnostic testing) underpins all of medicine, and there are huge dangers associated with being reliant on commercial organisations with their own agendas. Misunderstanding or misdiagnosing the situation can have dire consequences at medical, economic and political levels. There is clearly a need to understand the diagnostics first. The alternative is a bunch of knee-jerking and inappropriate reactions, which will lead us in only one direction.

Understanding COVID-19 diagnostics

The NIHP will then also be merged with NHS Track and Trace, but this raises even more questions. Until we know a) the accuracy of a test result, and b) what the result means - how can we know what the point of the new strategy is?

Any pathologist will stress that a test result is just a part of the overall diagnostic evidence. More information raises more questions than answers. For example, you might be told that you have a positive result for COVID-19, but what are you actually positive for? 

As Total Health highlighted back in March in Who tests the COVID-19 tests:

• Are you positive for the virus itself, or for some form of antibody to the virus? 
• How do you know that this result is accurate?
• How do you know that the test used has been properly evaluated?
• Has the result been confirmed by another or second (confirmatory) method?
• Do you just accept the result as a 100% fact?
• What does 'being positive' for COVID-19 actually mean?
• Does it mean you have active virus?
• Does it mean you are a carrier /infectious?
• Does it mean you are about to get sick?
• Should you be in quarantine? Or,
• does it mean that you are now immune?

To muddy the picture further, it is one thing being tested by an accredited clinical laboratory who can prove the accuracy of the result and provide an expert to explain the implications of the result, but self-testing using a DIY kit may raise more questions and cause more anxiety than it is perhaps meant to prevent.

Royal College of Pathologists (RCP) respond (20th Aug 2020) - these tests can mislead

Prof Jo Martin of the RCP says, "As an organisation committed to excellence in diagnosis, and high standards in patient care, we are concerned about Covid-19 antibody testing. We are aware that Covid-19 antibody testing devices, intended for professional use only, have been offered for direct sale to consumers without the required reassurance of appropriate laboratory or professional back up. The use of these for unsupervised self use test falls outside current regulations, and can mislead the public and put individuals at risk".

We want everyone to be assured about the tests they receive in healthcare, or that they purchase. We want to make sure that not only are they are of good quality, but that they give the right result and that the result is properly readable - that they are appropriately ‘useable’. The MHRA have done good work in this area, and we are asking that where devices are unregulated for use, urgent steps are taken to support enforcement and public safety.'

Tests will not clarify the picture

In an article published in The Lancet Respiratory Medicine the author says; The [laboratory] tests are undoubtedly useful epidemiological tools, particularly for estimating the prevalence of asymptomatic cases of COVID-19. Although, if it is indeed the case that only 5% or so of the population have been infected with SARS-CoV-2, then administering millions of antibody tests might not do much to clarify the picture in terms of overall prevalence. “It is looking as if we have flattened the curve [of new infections]”, explains Phil Beales (University College London, London, UK). “So unless there is a second wave of infections, we are not likely to see much of a change.”

At present any antibody test result will not tell you whether you are currently infected or whether you can infect others. If tested too soon there might be insufficient antibody. Furthermore, we do not know whether the presence of antibodies implies immunity. However, microbiologists suspect that infection will probably confer a degree of immunity.

So the fear is that kicking PHE while it is down is just a convenient political knee jerk. What is needed is a strategy informed by the (peer reviewed) diagnostic evidence, and associated models underpinned by that evidence.

In answer to the question; quiz custodiet COVID? The answer should be 'democracy', and perhaps this is the correct answer with the Health Secretary simply being the tool of that process. However, ill-informed decision making is the polar opposite of what a health system should be all about and does not engender trust. In Terry Pratchett's Discworld series, when Sir Sam Vimes is asked "Quis custodiet custard", he replies "I do". When he is then asked who watches Sam Vimes, he says "I do too". The not-so subtle difference is that Discworld is meant to be a parallel universe, and of course Sam Vimes has a good handle on the realities of his universe.

See also - Perkin Elmer take over COVID-19 testing in Wales