We have seen that all acute viral respiratory episodes have similar features, and it is impossible to identify the agent(s) accurately unless a laboratory test is run, as in our cases B and C.

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We have described the fault lines as poor decision-making, poor science, political politicking, and commercial interest, which favour the confusion of causes. The use of the F word “Flu” is the marker of the three shells game.

Let’s go further and consider all RNA respiratory viruses like an ever-changing galaxy, a cloud that continually morphs into different forms randomly. It is random as viruses are not living beings, do not behave or think and need to enter our body's cells to reproduce. This cloud is both a metaphorical term and a biological reality. Let’s see why.

During the height of the Covid pandemic, politicians and their clones wrung their hands because of the presence or sudden appearance of “variants”, which is another term for mutations. 

This flabbergasted us, as all viruses mutate, some quicker than others (it is in their job description), but it is not at all clear what this means in practical terms. 

Just because there has been a mutation does not necessarily mean that the agent is more or less virulent, transmissible and so on. However, we were not sure why this oh-so-amazing discovery should have surprised (for example) Prime Minister Boris Johnson’s briefers. 

They must have been deeply ignorant of the history of coronaviridae, as clear evidence of mutation has been available since 1984 from the very unit which isolated the first coronavirus.

The MRC Common Cold Unit scientist Sylvia Reed wrote in 1984 that:

“Although the strains of HCV that were grown in tissue culture were all related to the prototype 229E, they appeared not to be identical with it, and this heterogeneity is probably a significant factor in the epidemiology of HCV infections.”

By HCV, Dr Reed meant Human Coronavirus and Reed was writing about experiments carried out in the 70s, so 50 years ago. 229E is another of the many incarnations of these mutable organisms, usually associated with colds but sometimes with severe bouts of influenza-like illness (ILI). We like the term “prototype” as it describes the reality that the viral antigenic configuration you got infected with may have changed by the time you shed it in your body fluids. Wow!

The crass ignorance of some decision-makers and the catastrophic consequences of their decisions, which are becoming clearer as each day passes, make us wonder whether we are on the threshold of the opening of a sort of respiratory virus mart. 

A supermarket of opportunities centred around each of the galaxy of agents. This is the metaphorical cloud. Some agents may be easier to commercialise than others, but as long as certain conditions are met, the scope for exploitation, or if you are an optimist for benefiting society, is vast.

For example, we have known for a long time that RSV is a potentially dangerous microorganism, and in theory, we could repeat the commercialisation of any of these agents by marking them as threats and producing biologics and pharmaceuticals to combat them. Testing for them is no longer a problem thanks to the flexibility and availability of PCR.

There are a series of caveats to this vision, though.

First and foremost, the buildup to commercialise the threat has to be credible. RSV certainly ticked that box for premature or very small babies. In the elderly and frail, any bug is a threat, so that box is ticked, too.

Second, you need to pick a target that mutates relatively frequently. This is likely for all RNA viruses and helps to convince public health authorities to follow the influenza and now Covid model of yearly or periodic re-vaccination.

Then, you need a very strong public health-government link. This is key if your product is experimental or predicated on sparse data. Public health must convince the government that it needs that product, regardless of the cost, logistics and potential harms. That way, as with influenza pandemic vaccines, you get the government to underwrite most of the risks.

What would be a safety net for the public to minimise the risk of the Cloud Mart actually taking off at good speed?

Here are a few ideas.

Large, well-designed, randomised controlled trials carried out in different populations and across a swathe of different countries.

Large prospective protocol-driven comparative cohorts assessing aspects not easily tested in trials, such as long-term toxicity and compliance.

A regulatory bar set not on surrogate outcomes (such as antibody response to a vaccine or manufacturer-run trials for drugs with inscrutable proprietary data) but on clinical outcomes that matter. The most important outcome is death, specific to the agent or with protocol-driven attribution rules narrowing the chance of alternative interpretations.

The de-coupling of regulatory and pharmacoepidemiology functions from political or industry influence with a 5-year revolving door time bar. With a rigid separation in fact and media profile between licensing and public funding, you can license the interventions, but this should be no guarantee of reimbursement.  

What is required to ensure equitable reimbursement is the equally rigid separation of bodies that recommend the intervention and then assess its effects. US CDC has shown how far it is willing to manipulate studies, data and people to pretend it is impartial. 

We have set out the opposite of the commercial playbook that underpins the exploitation of the F-word universe. It's only when the false dawns and the money has run out that it might come to fruition. Until then, it’ll be more of the same. 

Readings

Reed, S.E., The behaviour of recent isolates of human respiratory coronavirus in vitro and in volunteers: evidence of heterogeneity among 229E-related strains. J Med Virol, 1984. 13(2): p. 179-92. 10.1002/jmv.1890130208.

Call SA, Vollenweider MA, Hornung CA, Simel DL, McKinney WP. Does This Patient Have Influenza? JAMA.2005;293(8):987–997. doi:10.1001/jama.293.8.987