Time: The Most Overlooked Factor of Experimental Therapies
By: Justin Health
Tags: Virus, Medical, Coronavirus

Since the late 20th century, deadly viruses constantly emerged every couple of years starting with Acquired immunodeficiency syndrome (AIDS) in the 1980s, the SARS in 2002, to the COVID-19 today. These were all emergency crises, epidemics where an unexpected deadly virus infects citizens and our immediate response was to search for a cure. Prior to the cure’s release, experimental therapies occur to ensure its usefulness and safety. Experimental therapy by definition is a series of clinical trials in hopes to find a cure for a newly discovered disease. Experimental therapies during emergencies like the COVID-19 should be administered extensively because the newly invented vaccines are inevitable to potential unexpected side effects, shortened clinical trials will be of lesser value, and ethical issues will result from pointless and inaccurate testings.

Many drugs that are created come with their side effects, some of which can be deadly. After it is listed in the market, it is only a matter of time before they are discovered from the variety of scenarios the drug will go through. This is why it typically takes years for a drug to be released as more trials decrease the chance of unexpected side effects. Therefore, it is extremely dangerous to shorten the time of experimental therapies. Once a drug is put out into the market, everyone who uses the drug is susceptible to potential risks of side effects.

When clinical trials were being operated to cure Ebola in 2014, the disease died out on its own and the trials ended before a vaccine was made. Experts say this may be the case for the Coronavirus. Professor Matteo Bassetti, the head of infectious diseases clinic at Italy’s Policlinico San Martino Hospital, explained how the virus mutated making the disease less deadly. “Even elderly patients, aged 80 or 90, are now sitting up in bed, and they are breathing without help. The same patients would have died in two or three days before,”(1) Bassetti said.

Speaking of mutation, the Coronavirus constantly mutates, so the chance of making a successful vaccine within a short amount of time is far-fetched. According to the Washington Post, researcher Egon Ozer, an infectious-disease specialist at the Northwestern University Feinberg School of Medicine, found that 95% of all the genomes he sequenced were mutated (2). For our body to protect the virus, our immune system generates antibodies that target the spike protein, a part of the virus that invades the cells (3). However, the mutation causes the antibodies from vaccines unable to recognize the protein. Therefore, experimental therapy requires sufficient time and short clinical trials will be of little to no value.

COVID-19 Fatality Rate by AGE:

Furthermore, the chance of dying from COVID-19 is very low, especially for the younger generation. The current death rate of ages below 70 was less than 4%, although this may change (4). Although it would still be too quick to say that the Coronavirus should not be taken seriously as it still permanently damages lungs and the small chance of death always exists, both the fact that the death rate is already low and the chance of the Coronavirus dying out by itself like the Ebola proves how urgently developing a medicine and listing it on the market will be more risky than beneficial to society.

Experimental therapies begin by using animals that have the most similar characteristics to humans. However, results gained from these experiments only partially reflect whether the drug has a practical use. Testing on humans is the ultimate measure of confirming the use. This is where ethical issues come into play. Experimental therapies are easier to be said than done not only because scientists struggle to find out the science behind the cure, but also because of the ethical issues involved. Pacing the trials in hopes to create a cure in the shortest amount of time creates an abundance of ethical problems.

Due to the pressure of time, experiments are often conducted carelessly, which makes them ultimately pointless or inaccurate. If an experiment is designed in a way where the probability of a meaningful outcome is low, it is generally considered unethical (5). Several trials have been done using hydroxychloroquine or chloroquine, a cheap drug initially used to treat malaria, and chloroquine often compounded by a second generation macrolide regardless of the lack of scientific explanation on how they will help cure the Coronavirus. One of these trials increased the risk of in-hospital mortality and was associated with an increased risk of De-Novo Ventricular arrhythmia (6). Ventricular Arrhythmia is an abnormal heartbeat that occurs in the lower heart chambers. Such careless or inaccurate experiments are unethical because they only expose patients at a greater risk.

There is no doubt experimental therapies done in urgent manners are going to have negative consequences especially in the case of COVID-19. Not only will shortened, unethical trials put test subjects at risk, but the vaccines released into the market may also have unexpected, potentially lethal, side effects. Moreover, because the chance of dying from the virus is already low and studies show the disease may even die out on its own, speeding up trials to develop a cure in the shortest amount of time is ineffective.

Citations:

[1] COVID-19 is weakening, could die out without vaccine, specialist claims. The Jerusalem Post, (2020).

[2] S, Kaplan, et al., This coronavirus mutation has taken over the world. Scientists are trying to understand why. The Washington Post, (2020).

[3] C, Crossan. What coronavirus mutations mean for its vaccine, treatment and testing. Scroll.in, (2020).

[4] Age, Sex, Existing Conditions of COVID-19 Cases and Deaths. Worldometers, (2020).

[5] A. Klein. Ethics in Clinical Trials and Drug Development. Pharma Focus Asia, (2020).

[6] M. Mehra. RETRACTED: Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis. The Lancet, (2020).