Clinical research is not clinical treatment – COVID-19 Vaccines

The primary goal of clinical research is not skewed in the best medical interest of the patient-subject. Instead, it is biased towards the development and discovery of an ethically generalizable method or knowledge.
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For the past 5 months and counting, we are audience to a midnight show of incompetence, with each performance lacking substance. This is despite readily available data that can be used to come up with sound and responsive strategies to end the public health crisis.

We have been conditioned to accept that the only answer to our predicament is blind obedience to iron-fisted authority figures – a type of obedience expected from ordinary citizens but never from immuned public officials.

As we count more days for the longest lockdown in the world, the Philippines’ crisis is bursting at the seams. Despite the clear demand for a strategic public health response, the President’s confidence in a miracle vaccine subjects Filipinos to participate in clinical trials for its completion.

Clinical research is not clinical treatment

To understand the definition of a vaccine trial, we must realize that even if research and therapy or treatment might coexist, these are not the main objectives of a clinical trial in clinical research.

The primary goal of clinical research is not skewed in the best medical interest of the patient-subject. Instead, it is biased towards the development and discovery of an ethically generalizable method or knowledge (Litton & Miller, 2005). The benefits we get from medical treatment depend on the discoveries made from clinical research (from Phase I through IV of a clinical trial). As we expect a very high ethical standard for various medical treatments, it is essential that the same ethical standard, if not higher, be the minimum requirement before proceeding with clinical research.

In fulfilling the minimum standard prerequisites of a genuine informed consent process, can we expect our law enforcers to fulfill the ethical standards given that we are subject to heavy-handed implementation and human rights violations? Can we expect them to have the ability to differentiate between administrative tickboxes and the minimum ethical standards in the conduct of a clinical research? How about our particularities as a country?

Close up on vaccine and medical syringe

Downplaying the risk for unknown benefits

There is a current narrative coming from those in power that the Philippines is a good site for conducting a vaccine clinical trial due to the presence of an active community transmission. We have to pull this narrative over its head and expose it for what it really represents for us Filipinos – we have become a captive population for vaccine clinical research due to state abandonment and neglect. Our vulnerabilities resulting from a non-existent national health strategy have been exposed and magnified by the current crisis. This has forced us to become subjects to an exploratory vaccine trial. We are now a vulnerable captive population, a currency to a medico-political trade among competing economic powers in the race to produce the first working COVID-19 vaccine.

A captive population in clinical research loses some if not all of their autonomy or freedom that informs their decision-making due to different forms of coercion. Given these particularities of a captive population, our ethical calculation of the possible vaccine clinical trial moves from issues involving informed consent to issues that involve autonomy or freedom of possible research subjects. Are we really free to become subjects to these vaccine clinical trials if the regime has touted the vaccine as our only hope in exiting this crisis? Are we really free to become subjects to these vaccine trials if we are not given a choice for a better course of action, as non-participation might not be more beneficial due to the extent of community virus transmission? An informed consent process is not the only minimum ethical standard requirement for a captive population that clings on to an unknown vaccine trial; their ability to exercise their freedom to participate through coercive forces is paramount.    

One thing that we need to be clear about is that by raising the banner of alarm and caution to call for the ethical conduct of a vaccine clinical trial is not an anti-science sentiment. The race against time for a cure or in this case for a working, effective, and safe vaccine should not compel us to become lax or devoid of the minimum ethical standards in achieving it. We do not want to further complicate a complex problem by introducing a possible harm not only to human subjects but to science as a whole. We have to be more cognizant of this reality, as we do not want to move out of this crisis with a population not just carrying the full brunt of the possible harms of a vaccine under clinical trial but also a population that distrusts science as an institution.

Solidarity trial or exploitation?

As we respond to the global call for a solidarity trial for COVID-19 treatments, we should protect our people against possible exploitation. Countries like the Philippines are more viable clinical trial settings as we are deemed to have more lax ethical research standards, lower minimum standard of health for clinical trials, and many more particularities that can be exploited. 

As clinical trial subjects, do we benefit economically from the success of a working, safe, and effective vaccine? The past months have shown the surge in the stock value of companies at the forefront of the race for the completion of a COVID-19 vaccine. We have to take stock of this reality that if we become subjects to the vaccine clinical trials, then our population is exposed to its harms and benefits without any economic benefits to gain. Altruism pushes us to participate in vaccine solidarity trials, but at the other end of the pole, it is the same companies and countries who will gain economically and politically from a working, safe, and effective vaccine, without a promise of affordability and accessibility. How will we be able to reconcile these realities, our bodies becoming data sets and currencies in exchange for the development of a vaccine, while another entity reaps the full economic and political benefits from it? Does solidarity call for the exploitation of the bodies of the people from the Global South for the material benefit of those from the Global North?

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