Flat White

The importance of informed consent in the Covid era

11 January 2022

9:00 AM

11 January 2022

9:00 AM

It used to go without saying that the morality of medical practice rested on informed consent. It is enshrined in the Australian Charter of Healthcare Rights and in international human rights law – at the core of this principle is the knowledge that ultimately, as medical professionals, we might be wrong. However, it seems the erosion of this principle is a consequence of pandemic policy-making

Being informed is a complex matter and relies on good faith of a number of parties. The doctor being motivated by the benefit to the patient. The patient being open to asking questions if they have concern. The government advocating for policy that is in the best interest of a patient. Pharmaceutical companies being transparent with efficacy and safety data surrounding drugs. It doesn’t just rely on the medical practitioner being contemporary with treatment guidelines, but it also relies on a complex understanding of the risks involved in treatment, such as side effects or adverse reactions.

The second part of the principle is consent.

Key to this is the voluntary aspect of agreement, the above conditions being met. Without this, we medical practitioners become avatars – part of a large healthcare industrial complex involving government, big pharma, and our own personal gain. If we remove consent, we are essentially removing the large asterisk next to each recommendation which says ‘we might be wrong’.

We don’t have to trawl too far back in time to find examples of where these principles have failed us. The list of drug withdrawals is long and constantly being updated. Just last year, Ranitidine, a drug most of us have prescribed for reflux, was withdrawn due to its carcinogenic effects. Other examples include Thalidomide, an antiemetic withdrawn in the sixties due to it causing foetal malformations and – more recently – Vioxx, withdrawn for cardiac complications. These are examples where informed consent acted well and in good faith.

When we look at the healthcare scandals involving deliberate wrongdoing, and thus the patient and/or doctors being deliberately misinformed, the examples are manifold. The most obvious to pinpoint are those of pharmaceutical companies. To list just the top examples: GSK settled for $3 Billion in 2012 and Pfizer for $2.3 billion in 2009 under the false claims act. These are companies who – in the case of Pfizer – have a revenue of around $40 billion, an unthinkably large sum that can be used to lobby governments for its own interest.

The most apposite example is that of Purdue Pharma (now bankrupt) and their part in the opioid epidemic. It is alleged that, having developed Oxycodone (an excellent drug), pharmaceutical giants employed specialist doctors to convince others about the benefits of their opiates. They did this on the basis of highly selective scientific studies – and here we see how financial pressure influences clinicians not to challenge assumptions that benefit them. These same companies influenced government organisations for favourable regulation. They then crossed the line between advocacy and advertising by funding organisations involved in pain advocacy. In this example, treating clinicians were duped, other clinicians were taking payment from pharmaceutical companies, and government agencies were passing legislation to favour those companies. Over half a million Americans have died from opioid usage in the last 20 years as a consequence.

The examples of where consent was removed from medical practice are more chilling and range from the Stanford Prison Experiment and Tuskegee, to war crimes – exemplified in the second world war.

As clinicians, when we discover we have been wrong, as long as we have acted in good faith, our defense rests purely on consent: we did not coerce patients to have an intervention. We offer a treatment for a medical problem with the attendant asterisk that they all have side effects, and our recommendation might be wrong.

There is a final element of informed consent often overlooked, and that is the specific relationship between a treating clinician and a patient. It is a personal relationship based on mutual respect where the deference to the clinician’s knowledge is tempered with respect for the patient’s preference, understanding and priorities.

A reasonable risk for a doctor may be unacceptable for a patient. With diseases such as Covid, where risk profiles differ enormously between population demographics the decision to take any treatment must be made on an individual basis. By removing an individual’s ability to make healthcare decisions for themselves, we are removing that fundamental element of healthcare practice. Sadly, this seems reflective of our society’s present lack of belief in the value of the individual.

So how will future generations look back on this? Perhaps it will be normal henceforth. However, perhaps it will be a moment of shame, when we let our profession and the moral basis for it, be overtaken by political and moral expedient. We should not forget the principles upon which we practice, and the right of patients to disagree with us. As medical practitioners, we are wrong more often than we like to admit.

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