Science Policy

Pandemonium

“Diverse fears and imaginings were born in those left alive, and all of them took recourse to the most cruel precaution: to avoid and run away from the sick and their things; by doing this, each person believed they could preserve their health.”

Boccaccio, The Decameron

The Black Death was one of the greatest epidemiological disasters of human history. The first wave of this new disease is thought to have wiped out a third of the population of 13th century Europe—a social and psychological catastrophe. Whole genetic sub-populations were obliterated. Centuries later, the Spanish flu of 1918 killed more than died in WWI.

Today, we understand that these disasters were the result of the evolution of new diseases, which, with little natural resistance and no treatment, were able to spread and kill undetected. Given that the term ‘pandemic’ is never out of the media for long, it is clearly something that we remain afraid of.

And with good reason. As we come into closer contact with wildlife through intensive farming, or by encroaching on wild areas, there is a greater risk that new pathogens will make the species jump, AIDS being one example. Then there is always the risk that an influenza strain will mutate into a more deadly form. What’s more, transcontinental flights provide a vehicle for spreading disease beyond the wildest dreams of Yersinia pestis, the culprit behind the Black Death.

So what if a disease does escalate from epidemic to pandemic? Modern medicine has come a long way—surely scientists should be able to find a cure soon?

Actually, most drugs take 10–15 years to make it to market, following rigorous clinical trials to check safety and efficacy. But in a pandemic we don’t have the luxury of time–clearly it is absurd to take this approach if millions are dying. So what do we do instead?

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I am sat in a small, tucked-away lecture room, at a STS seminar listening to ethicists from UCL and elsewhere debate this very question. Clearly the regulations should be relaxed, but to what extent? Finding a strategy with the right ethical balance between the welfare of those taking part in the trial and other sufferers is a difficult task. And even more so when the parameters involved are uncertain. For a novel pathogen with no drug, research participants may be lucky to receive the new treatment first, despite potential side-effects. So how to we decide who gets it first?

The restrictive nature of our current regulations is underpinned by the precautionary principle, which privileges future risks ahead of current potential benefits.

There are a couple of exceptions. Doctors can sometimes try off-label use of established drugs. A critically ill baby was saved through the administration of Viagra—the doctors theorised that the drug would dilate blood vessels around the lungs, helping the baby to obtain oxygen. An experimental treatment can also be used in individual cases where no other treatment has worked and the patient is likely to die.

Even with such exceptions, current regulations will be of limited use in a pandemic. But we can’t abandon it altogether. Some regulation is needed because of the asymmetry of risk in the researcher-patient relationship—far more is at stake for the patient than the doctor, so patients need some protection. And without some way of coordinating activity it is difficult to make progress with developing a drug.

The discussion is lead by Dr Sarah Edwards of UCL, who has just published a paper arguing that current regulation should be relaxed somewhat to allow wider access to treatment. She suggests that we should be moving towards natural experiments, piggy-backing scientific evaluation on naturally occurring circumstances.

A randomised control trial is normally the gold standard in drug development, but in a pandemic it is unwise to bring people in close proximity to each other, and the horrible dilemma of giving half the patients a placebo is akin to giving half the patients a death sentence. Rolling out new treatments incrementally to naturally quarantined groups, using the next-in-line group as a control, goes some way towards dealing with these issues.

In the case of a pandemic, the world is meant to be lead by the advice of WHO. Although it has a number of strategic plans, nobody has really thought about the ethics until now. But in a chaotic situation where time is of the essence, having thought through the ethical arguments beforehand could save lives. This issue is being addressed at a conference in June, where Dr Edwards hopes to persuade WHO to take on her advice.

Rosamund Pearce is currently studying for an MSc in Science Communication at Imperial College London.

Image: Lead mortuary cross. Image credit: Science Museum, London. Wellcome Images 

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