By John Voudouris
When looking at the ethics behind scientific testing on living humans, one is
faced with a dilemma. To risk the wellbeing of another human in hopes of finding a
potentially life-saving cure, or to refrain from taking any risk and have little chance of
finding an effective cure. As Machiavelli declared: do the ends justify the means?
Unfortunately, life is not this simple. There are cases in which human testing may be
acceptable, and other scenarios where the risk is too large.
To make this evaluation, some precedents must be set. In the United States (and
most other developed countries), the process for human testing approval requires
significant evidence from animal tests (generally primates or other similar organisms to
humans). However, around 70-75% of drugs approved by the FDA for human trials
based on animal tests are later found to be unsafe or ineffective (PCRM, 2021). Hence,
this process in the US could be considered unsafe. An example of such an incident
would be in 2016 when 1 person died and 5 were hospitalized because of an adverse
reaction to a mood disorder drug, BIA 10-2474. An expert commented that “BIA 10-
2474 was administered to the volunteers at a dose 10 times greater than that needed to
completely inhibit the FAAH enzyme (The Guardian, 2016).” Even with a pre-clinically
tested drug in an approved trial, fatal mistakes can happen.
Going back to the Machiavellian ideology, one must consider if the ends, which in
this case would be potentially saving lives, justify the means – in this case testing drugs
with some risk. As also mentioned earlier, the justification of human testing must be
taken on a case by case basis and a thorough risk assessment must be completed for
the patients. If someone has terminal cancer, has been resisting all therapies and has a
limited amount of time to live, it would be worth the risk to try a new drug that has
responded well to in vivo testing (assuming that the patient consents). If the experiment
fails, which is highly unlikely after in vivo testing, the individual will not experience much
difference, as they would die relatively soon anyway. However, if the experiment works,
then the individual would live a longer life, benefiting them overall and paving the way
for improvement in the lives of many other cancer patients. In my eyes, this is perfectly
justified.
Although it was mentioned that around 75% of drugs approved by the FDA based
on animal tests are ultimately unsafe or ineffective against humans, the 25% that is
effective could have a profound effect on the lives of many people. There is always a
chance that a drug could be very effective in human trials, but the only real way to find
out is by actually conducting tests. It is my belief that testing on children should be
avoided unless it is specifically targeting life-threatening diseases only in children.
An example of this would be how Sidney Farber found the cure to acute lymphoid leukemia
in children, by testing antifolates, a relatively low-risk procedure. The reward was
thousands of young lives throughout several decades. Under the theory of Utilitarianism
(the greatest good for the greatest number of people), testing on children would be
unethical because they have a much longer life to live compared to an adult or senior. If
you are sparing the life of a child – assuming that the drug would have an adverse
reaction – you are doing greater good than by sparing the life of an older individual.
While this sounds dark, it justifies the opinion that testing on children must generally be
avoided.
In summary, there is no clear, simple answer to the ethics of human testing. I
believe that most individuals agree that there must be regulation to a certain extent, but
to put a complete ban on human testing would limit the potential of science. Scientists
must follow the Hippocratic oath and “first, do no harm.” Then, a comprehensive risk
analysis must be conducted for each test based on in vivo testing followed by a
consideration of the pros and cons with patients that (ideally) have no other alternative
to death. This would minimize any heartbreak or ethical concerns. Finally, scientists
must consider the utilitarian point of view by trying to do “the greatest good for the
greatest number of people,” which would be the patients whose lives would be saved by
the therapy.
SOURCES
Physicians Committee for Responsible Medicine (PCRM). (2021). Human
Experimentation: An Introduction to the Ethical Issues.
Retrieved 28 July 2021, from https://www.pcrm.org/ethical-science/human-experimentation-an-introduction-to-the-ethical-issues
The Guardian. (2016). Man who died in French drug trial had ‘unprecedented’ reaction,
say experts. Retrieved 28 July 2021, from
https://www.theguardian.com/science/2016/mar/07/french-drug-trial-man-dead-expert-report-unprecidented-reaction
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