THE COVID-19 pandemic continues to take its toll on the world, with global infections having surpassed the 7.5 million mark, and almost half a million lives have been lost globally.
Dr Grant Murewanhema
The virus has spread to over 200 countries, and some continue to experience exponential increases in infections. This is probably the most rapidly spreading pathogen encountered in modern times, and increased globalization and mobility has not made the situation any better.
Governments have imposed lockdowns on citizens to curb transmission and flatten their curves. Global trade has tremendously declined and air travel is very scarce..
Economies are suffering as only essential services and industries are allowed to operate in most countries, and governments have to come up with bail-out plans for their suffering citizens. Healthcare resources are severely constrained even in the most sophisticated countries, and the workforce is exhausted and anxious.
Understandably the world is desperate for solutions; scientists and clinicians are desperate for solutions; politicians are desperate now more than ever; the general population is desperate; the pharmaceutical industry is also quite desperate because this could be an opportunity for them to post billions if not trillions in profits out of sales of effective therapeutics.
It is clear that the best intervention to deal with this pandemic would be a safe and effective vaccine, but vaccine development is a process that takes months to years. Whilst an effective vaccine is being sought this virus could be undergoing frequent mutations. Like most viruses of its nature, the SARS-CoV-2 is most likely to undergo periodic antigenic shifts and drifts, some of which could render discovered vaccines useless.
It is important to note that hundreds of vaccines are undergoing development, but the majority are still either in pre-clinical phases or early phases of clinical trials, and so far none are undergoing large scale clinical trials.
Whilst the search for an effective vaccine is going on, several other searches for effective medicines are underway. These include hydroxychloroquine, chloroquine and combinations with azithromycin. Several antivirals are also being tested, including the protease inhibitors (lopinavir/ritonavir), and remdesivir. Immune modulators, including the interferons are also being trialled; and others are testing convalescent sera, several anti-oxidants and vitamins.
The limited time frame and the virulence of the coronavirus means that the medicines have by and large undergone open-label trials, observational studies and poorly-controlled trials without comparator groups, and patient selections have not been optimal in most cases.
As we speak, the world is full of hope after receiving results suggesting that dexamethasone, a commonly prescribed and relatively cheap steroid, may improve outcomes in patients requiring ventilation. The ethics of trying medicines on people sick from a potentially lethal virus are becoming more and more controversial, and human right activists are raising their voices against scientists now more than ever. Vaccine trials have sparked controversies even before maturing into reality.
Traditionally, evidence of effectiveness and safety of medicines and investigational devices has been obtained from systematic reviews and meta-analyses of randomised controlled trials and also from well-conducted randomised controlled trials, which include an active and a control group. These randomised-controlled trials tend to be double-blind, placebo-controlled trials, where the researcher and patient are unaware of the product they are receiving, and the study product and placebo look similar.
Designs such as superiority and non-inferiority are also appropriate for comparing new drugs with existing drugs. Unfortunately, these appropriate study designs have not been conducted in the COVID-19 trials, and therefore most of them dont qualify to be called clinical trials. The quality of evidence coming from such studies should generally be considered very poor, or hypothesis-generating for appropriately designed studies. Unfortunately, due to the desperation highlighted above, results from some of these studies have been announced to politicians and the general public, in my own opinion, too prematurely, sometimes raising misplaced hope.
A scientific article is exactly what it is; a scientific article; and should be interpreted with scientific eyes. Unfortunately, in this infodemic and easy accessibility of information, some articles have landed in the hands of politicians and the general public in raw form.
One has to understand study designs, methodology, statistical concepts, the ideas of confidence intervals and p-values, statistical modeling, confounding and interactions (effect modification) among other concepts,before they can effectively and critically appraise a scientific paper. In the wrong hands, inappropriate and sometimes dangerous conclusions can be drawn.
In my opinion, access of scientific articles to politicians and to the general population must be limited, and they must be provided with appropriately interpreted versions. Non-medical journalists can spread incorrect/non-factual information based on non-scientific interpretation of scientific data, which can lead to dangerous medicine and consuming behaviours.
Yes, we are in desperate times, but we must continue to practice scientific medicine, and the principles underlying medicine and vaccine trials must never be overlooked. We must remain hopeful that we can defeat this virus together, the search for a safe and effective vaccine must continue, and so must the search for efficacious medicines. The general public must continue to be provided with factual information. Most importantly, the pharmaceutical industries must continue to exercise restraint and avoid profiteering out of humanitarian situations.
