Home Covid-19 The MHRA Is Taking The FDA As Their Template

The MHRA Is Taking The FDA As Their Template



One of – one of you understand – the big mistakes made over the Pond recently has been that people have been listening to the Food and Drug Administration. That FDA is a large and unwieldy bureaucracy tha, like all such with any actual power, doesn’t see the need to loosen their grip on the power they have. They also fall prey to the failing of all bureaucracies everywhere, an insistence that actually the perfect is not the enemy of the good.

The MHRA over here is doing exactly the same thing:

Boris Johnson’s plans to test millions of schoolchildren for coronavirus every week appear to be in disarray after the UK regulator refused to formally approve the daily testing of pupils in England, the Guardian has learned.

The Medicines and Healthcare products Regulatory Agency (MHRA) told the government on Tuesday it had not authorised the daily use of 30-minute tests due to concerns that they give people false reassurance if they test negative.

This could lead to pupils staying in school and potentially spreading the virus when they should be self-isolating.

The regulator’s decision undermines a key element of the government’s strategy to bring the pandemic under control – and is bound to raise fresh questions about the tests, and the safety of the schools that have been asked to use them.

It is entirely correct that these cheap and speedy tests are not perfect. And yet the need is for cheap and speedy tests that are not quite perfect.

The FDA, at one point, denied approval on a home test. Because such a home test would not be taking place in lab conditions. After that outcry they relented and said, well, OK. But only with a prescription. They required the signature of a doctor who wasn’t there and hadn’t seen the patient in order to do a test the point of which was that the doctor didn’t need to be there.

That was after their other interesting insistence. That the varied labs around the country – university, pharma company, research org – shouldn’t be allowed to do tests. You know, unlike that bloke in the Faroes who rerouted one for testing salmon for virii. All tests must be done by CDC. And in the CDC lab, on the CDC test. The CDC lab didn’t have the throughput to do this of course. And there was also that pesky little problem of the fact that CDC has infected it’s own tests with coronavirus anyway, making them entirely useless.

But the FDA had done something and that’s the point. As the FDA had dome something in a pandemic then the FDA remained the Big I Am during a pandemic.

Which is what the MHRA is doing here. If the government had said not to use the tests then the MHRA would be saying to use them. For the point and purpose here isn’t to do testing or not do testing. It’s to prove that the Cabinet must make obeisance to the MHRA at this time of national peril. For they, the bureaucracy, are and should be the Big I Am. They are the technocrats and we are all following the science, aren’t we denier!

It’ll be such an important meeting when the Cabinet turns up to ask permission that chocolate biscuits might be served and there’s no more telling sign of importance than that, is there?



  1. I do agree with you, and the government, here.

    The fact is that perpetual lockdown, and even worse, perpetual renewals of the lockdowns each time people think they can relax and get back to normal, are disastrous.

    A test system that scoops up most of the infectious and allows society to function with minimal fuss is clearly the way to go. I hope Parliament passes a law making this mandatory. Bills of Attainder (I’m old fashioned) to deal with any obstructionists would be the solution to any dissent.

  2. So MHRA has reservations about a diagnostic test that is applied to far too broad a population, far too frequently, for which the patient (or another untrained person, a teacher presumably) takes the sample, processes the sample, interprets the result, and then provides the ostensibly private health data of minors to several people who have no business knowing it with potentially far-reaching consequences (quarantine) for third parties?

    How refreshing to see some scientific and ethical thinking out there in the wild!

    • BinG – you’re hypothetical of horribles seems less bad than not testing, quite a bit, actually. No idea what “far too broad a population” means, or “far too frequently” for that matter. There a quite a few home test kits for pregnancy, drug use, etc. out in the world, seems to work pretty well.

      • You only take a pregnancy test when you have a pretty good idea that you are (or are at least making the effort to be) pregnant. The handful of million of such tests performed every year, on a sample far easier to collect than a nasal swab, will therefore not deliver a high absolute number of incorrect results either way.

        Because no test is perfectly accurate, population screening is very controversial, even for relatively common and high-consequence diseases (breast cancer, for example). Covid is a low consequence disease in most people, and while (pace vaccine roll out) the majority of the population is going to have had it eventually, you only have it for a couple of weeks of your life. Test everyone every week for months or years, and the overwhelming majority of those test results should be negative. The high frequency of testing means that most of your positives will be false positives (falsely reassuring people who aren’t actually infected that they won’t get it “again”), and enough true positive cases will be missed to make the exercise worthless.

        You test for transmissible covid by asking : “Do you have covid symptoms?” It requires only educating people to look out for such (anyone who has not cottoned on by now is likely unreachable), and then have a PCR or LFT upon presentation to confirm. A result, any individual result, backed up by clinical suspicion is far more reliable than any individual result from widespread and repeated broad population testing. That is just how medical tests work. All of them. Testing without indication can tell you something about population trends – it’s a useful research tool, but it throws up too many wrong and weird results to reliably inform the individual patient about anything.

  3. Bogan,

    It’s very difficult to work out what lockdowns actually achieve. My tendency is to think something between very little and the square root of fuck all, but it’s hard to be sure as it is the ultimate uncontrolled experiment. Even comparing different places with different lockdown strategies (Sweden always comes up) is complicated by the fact that epidemics naturally do different things in different places at any one time (see the UK which had its first wave in April, versus Germany, with similar lockdown strategy, which is only really having a first wave now). So you need to wait quite a long time to be sure what happened. Still, governments who want to do that to entire societies ought to be able to present a far better evidence base that there is (a) any effect at all, (b) that the benefits of lockdown outweigh harms. If lockdown were a drug it would get laughed out of the FDA.

    You don’t need a test to discover infectious people, because symptomatic covid correlates pretty much perfectly with infectiousness. The lockdown, masks, and so on, are entirely predicated on asymptomatic transmission being important, but we already have quite good evidence that asymptomatic transmission is close to zero. The most effective NPI to prevent community spread would be to constantly remind people to stay at home if they are sick (and seek medical treatment if it becomes serious). The only group you really need to prevent from getting infected are the elderly, particularly in care homes. Again, we have known this at least since the middle of last year. Younger people will die of it, and some healthy people will die of it, but not in greater numbers than is demonstrably acceptable from the respiratory viruses we are familiar with. There are many things that we just accept as a residual risk of life (including premature death from influenza) because the cost of preventing it, if it is at all preventable, is far too high.

    A society that had reacted sanely would have been able to support both of those activities easily and cheaply. Instead we are punishing everyone, indefinitely, in a futile attempt to prevent the inevitable.

    • Your approach certainly seems simpler, easier, quicker and cheaper than that supported by me or the UK government.

      Your argument about the elderly seems sensible – you’ve guessed about all the white hair I can see when I look in the mirror, haven’t you.

      Here in Oz, the general approach seems to be to lockdown until we get our artificial covid dose. We can do this since Oz is an island.

      I just hope the lockdownists don’t get the bit between their teeth and say, ‘Just a little bit longer, just a little bit more.’ But it seems to be trending that way.

      • We’re an island too (OK – one big island, one moderate and a few dozen small-tiny ones) but we import food so we can’t do total lockdown like Oz or NZ. HMG is, in Covid terms, between a wet place and a quicksand.

      • The longer this goes on the more people there will be who know someone that has lost their job, business, has had treatment delayed, education curtailed; that is probably already greater than the number of grannies ‘saved’. A reckoning will come…


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