Newly emerging pandemics like Covid-19 raise many ethical issues for medical staff. Especially – If there are no available treatments, should you improvise based on anecdotal evidence? As with most ethical issues – the answers are not clear.
On the one hand we have US President Donald Trump – who applies the quick-fix logic of a businessman surrounded by staff to handle details. Sometimes suggesting weird, off the wall things can be just what’s needed to boost innovation. As long as people don’t then take matters into their own hands and try swallowing bleach because they think the President suggested it!
On the other hand, we have the tried and tested approach of Good Clinical Practice and rigorous double-blinded trials. These are the bedrock of medical research and represent the safest way forward. However, double blinds become problematic where there is no “standard” treatment to compare with a test drug.
Doctors at the sharp end of pandemics like Covid-19 are faced with a stark choice – try something they think might work or carry on trying to support the patient until the recover. Some of the earliest Covid-19 patients in China, were given the anti-retroviral drug, lopinavir–pitonavir, and the rheumatoid arthritis drug, Actemra (tocilizumab).
The important point here, is that the drugs were controlled and the patients observed. There are no placebos in the true sense – the control group were given ventilation and other support but not specific control drugs.
This approach has been followed in other pandemics, and The WHO’s Covid-19 trials are not double-blind because they argued that they needed to balance rigor with speed.
So where does this leave ethical review?
We all know the story of the tortoise and the hare. Rushing full tilt into drug testing can actually delay things according to Rebecca Li, executive director of the Multi-regional Clinical Trial Center at Harvard University.
She points out that the vast majority of experimental drugs do not succeed. Without properly reviewed and planned trials, researchers risk going down rabbit holes and wasting valuable research effort. It is hard not to get carried along by the overriding sense of urgency that is gripping the healthcare sector, but this does not mean ethics should go out of the window.
Sure, rely on the most efficient ethical review tools at your disposal to reduce wasted time but don’t throw the baby out with the bathwater. If you can find ways to speed up peer view processes for example – use them!
Follow Good Clinical Practice, rely on tools like Ethics Review Manager and be pragmatic.
Otherwise we might just end up swallowing bleach…
Ashley is Infonetica's Account Manager, who makes sure that all our clients continue to get the products and support they need - especially during the pandemic. As one of the longest standing members of the team he has worked in most parts of the business and so understands how all the products fit together into a coherent package. Ashley likes to listen to music, especially his favourite group: Orbital.