Representative photo: Tamanna Rumee/Unsplash
A new clinical event underlines the need for robust national guidelines to treat COVID-19. Mucormycosis, colloquially called ‘black fungus’, is a severe fungal infection that has affected many COVID-19 patients in India. How should we view the origin of this problem?
Many experts and journalists have reported on the Indian government’s mismanagement of the country’s COVID-19 crisis. Indeed, should we investigate governments’ response to the COVID-19 pandemic worldwide, we will find evidence of negligence in many countries. Many of them, including our own, threw caution to the wind at different points of time.
This principle, of acting to prevent, first came about in relation to environmental waste. It can be interpreted in different ways but fundamentally the principle said organisations can’t advance lack of knowledge as a justification of environmental risk. The burden of proof is on the organisation seeking to perform the risky act.
The Wingspread statement of 1998 embedded it in public health: “When an activity raises threats of harm to human health or the environment, precautionary measures should be taken even if some cause and effect relationships are not fully established scientifically.”
Many, if not most, countries didn’t take adequate precautions at the pandemic’s onset and haven’t exercised sufficient caution to avoid ongoing harm. Even among offending countries, not practising caution due to a paucity of evidence was one thing – with Sweden and the US as examples; disregarding such evidence was another. It was, and is, criminally negligent. When every country was experiencing its second wave, the precautionary approach was to prepare for worse and strictly maintain distancing and hygiene protocols.
Of course, the precautionary principle is not without its critics, who believe it’s risk-averse and impedes progress, especially during emergencies. During India’s COVID-19 epidemic itself, we have been witness to the many tensions between imposing lockdowns and easing restrictions to the economy.
But at the same time the principal dictum for every individual physician is first do no harm. So on a day-to-day level, physicians dealing with COVID-19 have used both the precautionary principle and risk-benefit analyses to guide them, striving always to do no harm.
Consider the use of steroids.
Mucormycosis is the result of an opportunistic infection. Spores of the Mucor fungus are prevalent in the air we breathe and our immune systems are usually good at destroying any that we might inhale. But when the system is distracted or weakened by another infection – like COVID-19 – Mucor jumps at the opportunity and becomes deadly.
The problem is that doctors regularly use steroids to treat people with severe COVID-19. India also has the world’s largest burden of diabetes, and diabetes is a comorbidity for COVID-19. And the combination of steroids and poorly controlled diabetes is fertile ground for mucormycosis.
The question automatically arises: Is the treatment for COVID-19 harming patients?
There is a huge variation across India of how doctors treat COVID-19 patients. In many countries, data from clinical trials and case reports from the first waves went on to inform clinical guidelines – including the dose, duration and triggers necessitating the start of steroids.
The question in effect becomes “how can we understand, and justify, variations in the use of steroids during the second wave?”
For a start, let’s consider the role of guidelines.
Systematic guidelines and protocols shape contemporary medical practice. (In fact, we are in a ‘post-guideline era’ in which generic recommendations can be fine-tuned to a patient’s needs.) They didn’t exist in the 1980s, when doctors followed recipes that they deemed to be sensible and passed them on to others. However, the practice of modern medicine is based on evidence; evidence comes from clinical trials; and guidelines provide a framework for best practices using evidence of the highest quality obtained thus. In many situations, doctors treating patients ‘outside’ guidelines exposes them to accusations of negligence or malpractice.
COVID-19 is different, however. We didn’t know until late 2020 that some drugs are useless – indeed, harmful – and that some others are of great value. In the first half of 2020, uncertainty ruled the roost even as physicians drew on their experiences of different infections and accrued clinical experience. Protocols are designed to help in exactly such situations. Based on prior experience and expert opinion, they serve to harmonise and standardise practice even as researchers conduct clinical trials and collect evidence. Steroids themselves are a case in point: we know from trials during the first waves last year that they can be very useful if they’re used in a very specific way.
But in the current crisis in India, how should the medical fraternity deal with a crisis that has already run away, in which physicians are expected to do everything possible to avoid having to scrounge for oxygen cylinders? The irony is that protocols and guidelines will help us immensely now.
When our options are so limited, it’s tempting to extrapolate half-formed data and/or turn to debunked treatments. The overuse of steroids outside their specific remit is an example of the former and the use of plasma and drugs like ivermectin, of the latter. People who know better have unequivocally dismissed convalescent blood plasma transfusions to help treat COVID-19. In fact, it was Indian data that hammered the first evidence-based nail into plasma therapy’s coffin.
The indiscriminate use of plasma is not only useless but harmful. At least two studies have pointed to the possibility of the novel coronavirus mutating into ‘stronger’ forms to evade transfused antibodies. A strained healthcare system, leading to improper checks, and incentives to donate blood could also heighten the risk of infections spreading through the fluid.
Central guidelines have a crucial role in shaping practice and defining benchmarks for accountability. The ones that exist are misleading and obscure. COVID-19 has already exposed incredible degrees of political failure worldwide – but just one step down from that rung of the ladder, we face failures of public health governance and medical decision-making. Public health governance is in abeyance. Medical decision-making is currently limited to individuals or, at best, institutions.
This is unacceptable because we were supposed to be in a position of lower uncertainty, not higher. Every doctor and hospital had their recipes during the first wave; they shouldn’t be expected to do so during the second wave as well. Patients deserve to reap the rewards of clinical trials and other data that physicians have already collected. But for this to happen, we need a credible and authoritative central medical body that makes pragmatic decisions and issues sensible guidelines. These guidelines should be available to practicing doctors at the touch of a button.
Such a body will ensure two things: doctors won’t feel pressured to use medicines that have no rationale, and doctors will be enabled to not prescribe medicines outside their therapeutic windows. And perhaps most of all, it will ensure they do no harm.
Note: This article was first published on May 19 and was republished on May 24, 2021.
Mallika Sekhar is a consultant haematologist, Royal Free London NHS Trust, and honorary associate professor of haematology, University College London.