BY Dr. Dharshana Kasthurirathna
Recently, the Government issued a gazette notification that indicated those who have not received the Covid-19 vaccines, including the booster shot, will not be permitted to enter public spaces from 30 April. This gazette has already been challenged in the Supreme Court (SC), on the basis that it violates the fundamental rights of citizens. The SC will eventually decide on the legality and the constitutionality of this gazette notification.
It is clear that the gazette directly violates the notion of “informed consent”, which is one of the fundamental principles of modern medical ethics. Even in traditional medical systems, this principle may have been practised, although not explicitly mentioned. Even prior to this gazette being issued, many Government and private organisations engaged in the practice of coercing and sometimes even forcing their employees to get vaccinated, with the threat of terminating their employment. There were many who were forced to get vaccinated primarily to save their livelihood and to support their families, even though in their minds, they did not want to get vaccinated. Some had to get vaccinated as they were not allowed to go overseas for higher studies or employment unless they were “fully vaccinated”. All these can be regarded as exceptions to the principle of informed consent where an individual is coerced or forced to receive a certain treatment, medication, or vaccine against their will, under the threat that they may have to incur some loss if they fail to comply.
This apparent violation of informed consent is nothing new. For instance, the vaccination status of children is often checked when they get enrolled to a school, which is another form of coercion to vaccinate children. However, that practice has gained more social acceptance, compared to the coercion concerning Covid-19 vaccines. With respect to the coercion concerning Covid-19 vaccines, there has been some visible resistance to this kind of coercive practice, perhaps due to the scale at which it has taken place.
Interestingly, those who are getting vaccinated to save their jobs or as a prerequisite for international travel too have to sign a “consent form” indicating that they are fully aware of the “rare adverse effects” of the Covid-19 vaccines. It is questionable as to whether such “consent” can be regarded as informed consent at all, as they are coerced to get vaccinated as a precondition to secure their livelihood or seek better educational and employment opportunities, or even travel freely in their own country. It is analogous to the Police threatening or torturing a suspect to seek a contrived confession, and thereby may be considered as consent given under duress. Consent under duress is no consent at all.
The concept of informed consent gained traction particularly after the Second World War, as a result of the Nuremberg trials where Nazi physicians were tried against the forced medical experimentation they performed against Jewish prisoners. Those physicians may indeed have believed that they were doing a “greater good” by pushing the boundaries of scientific endeavours. However, the horrors of forced medical experimentation on Jewish prisoners compelled the nations of the world to agree upon the Nuremberg Code (of which Sri Lanka too is a signatory), which stressed the importance of informed consent in medical experimentation and clinical trials.
Aside from the human rights argument, there are two pragmatic reasons as to why informed consent should be a principle that should not be violated under any circumstances.
The first reason is that, unsurprisingly, experts have been and can be wrong.
The grave mistakes of the medical establishment in declaring the “scientific truth” of the moment may have misled populations and led to the death and debilitation of millions of people over many decades.
For instance, the medical establishment claimed that smoking is not bad for health until the 1960s. Models dressed as doctors appeared in cigarette advertisements in prominent news magazines. It was the accepted “scientific truth” at the time and many would have acted upon it to take up smoking only to suffer the grave consequences later on.
If we go back further in history, it was in mid-19th Century that German-Hungarian physician Ignaz Philipp Semmelweis claimed that when doctors washed their hands prior to delivering babies, the mortality of mothers reduced drastically. His observation was ridiculed and he was considered a pariah by the medical establishment at the time. The relentless torment endured by him eventually led him to be admitted to a mental asylum and his tragic and untimely death.
At one point, dichlorodiphenyltrichloroethane (DDT) was indiscriminately being used as a means of combating mosquito-borne diseases. A few researchers and activists raised concerns over the potential health effects of DDT such as birth defects, fertility issues, and the increased risk of type two diabetes, in addition to its significant environmental impact. One of the most outspoken critics of the indiscriminate usage of DDT was Rachel Carson, who published the book The Silent Spring on the topic. She was vehemently attacked for her claims and even the mainstream news magazines and journals called her a “hysterical woman”. Almost a decade later, after the book was published, the Environmental Protection Agency of the US issued a cancellation order against the use of DDT. By then, it had been in use for decades, and one can only guess the harm it had had on the general population.
Dr. Alice Stewart was the first to discover that exposing pregnant females to x-ray imaging increased the risk of cancer among babies in the mid 1950s, based on her research. Her findings were initially disregarded and her career was severely hampered due to her “controversial” claims. It was almost two decades later that the medical establishment accepted the risk, and by that time many unsuspecting pregnant females and helpless unborns may have been subjected to radiation damage due to x-ray imaging.
There are similar historical examples in the world of vaccination as well. The oral polio vaccine (OPV), was discontinued in the UK in 2004 and the US in 2000 after it was discovered that it could lead to new vaccine-derived polio cases. However, many years after the OPV was discontinued in the West, it was being administered in numerous African nations, which led to new vaccine-derived polio outbreaks in countries such as Chad and Cameroon.
In the 1970s, a swine flu scare took over the US, which led to a mass vaccination campaign. However, it was soon discovered that the scare was overhyped and that the vaccines led to the deaths and neurological damage of certain individuals that received it, and the vaccination programme was eventually scrapped as a result.
In 2016, the World Health Organisation (WHO) recommended the first-ever dengue vaccine to be administered in high risk nations. The Philippines was the first country to try it out. It was soon discovered that the vaccine caused antibody-dependent enhancement which led to more severe disease among children that contracted dengue. This phenomenon led to the deaths of numerous children, and the officials in charge of the authorisation and regulation process were criminally charged and prosecuted.
What these painful historical examples demonstrate is that even under the best of intentions, the experts who represent the establishment view, could be wrong. Often the scientists and researchers who question the establishment view are ridiculed, marginalised, fired, have their research funding cut, their careers destroyed, and – in some extreme cases – jailed. The talking heads in the mainstream media often take the side of the medical establishment and the pharmaceutical industry in ridiculing and crushing any isolated opposing voices as “conspiracy theories”. This mass condemnation of critical views to the established narrative greatly discourages any meaningful scientific debate on important health-related topics, such as the effectiveness and safety of Covid-19 vaccines.
If there is informed consent, the individuals who may question the establishment view and listen to the experts who may oppose the establishment view may have a chance to act upon their conscience. It may even promote more rigourous scientific debate and eventually lead the scientific community to more sound and accurate conclusions. However, if consent is replaced by coercion or force, that dialogue may never take place and erroneous and harmful health-related opinions and policies may prevail without being challenged.
The other main reason as to why consent should never be violated is “regulatory capture”. It is a term used to describe the taking over of the regulatory bodies by the industry that they originally set out to regulate. For instance, in a study published in the British Medical Journal in 2016, it was shown that the majority of the Food and Drug Administration (FDA) staffers who were part of successful drug reviews of the haematology-oncology (refers to the combined medical practice of haematology, which is the study of the blood’s physiology, and oncology, which is the study of cancer) field over a period of nine years, eventually received job contracts in the pharmaceutical industry after they left the agency. The vast majority of FDA commissioners have joined the pharmaceutical industry after retirement, raising allegations of a “revolving door” between the regulatory bodies and the pharmaceutical companies that they claim to regulate.
In a country like Sri Lanka, where the politicisation of State organisations and corruption are rampant, one can only assume that the regulatory capture may be even more prevalent. It was not so long ago that the State Minister overseeing the National Medicines Regulatory Authority (NMRA) claimed that there is a “(pharmaceutical) drug mafia” behind the apparent deletion of a critical database at the NMRA. Nobody from the pharmaceutical industry has been charged over the incident yet, and it is safe to assume that the so called drug mafia is very much alive and active. What would prevent the enormously powerful and influential big pharma from influencing the regulatory bodies of a country like Sri Lanka with a weak economy and a highly politicised State sector?
Consent may be the last bastion of hope of the citizens against regulatory capture, and without that, the entire population may be at the mercy of the global pharmaceutical industry, as the regulatory bodies that are supposed to protect them may very well be compromised.
Thus, in addition to the very sound, legal, and constitutional argument, the possibility and the history of blunders by the medical establishment in its recommendations and the threat of regulatory capture alone should justify why informed consent should never be overridden or compromised under any circumstances.
(The writer is a senior lecturer in computer science and software engineering) ………………………………………………
The views and opinions expressed in this article are those of the writer, and do not necessarily reflect those of this publication.