The ethics of placebo in clinical trials

Introduction

Many experiments have been conducted regarding placebo. One of the more popular ones is the rubber hand experiment. In this experiment a number of random participants were brought into a room where they were sat by a table with an instructor in front of them. They were then instructed to put both their hands down on the table, a divider is then put between their two hands and a rubber hand is placed in front of the participant where their left hand would’ve been if not for the divider. The participants can only see their right hand and the rubber hand so the experiment can now begin.

The instructor takes a thermal pain stimulus and places it on the rubber hand and the left hand of the participants at the same time. This is done so that their brain will adopt the rubber hand as its own. This works because they can see the thermal stimulant being placed on the rubber hand and yet they feel the pain. So then the brain will think this rubber hand is now my left hand since I see the stimulant on it and feel the pain. It is believed that the brain at this stage starts believing this rubber hand as its own.

The instructor then brought out a couple different materials to experiment with. The rubber hand was then touched with all these random objects and the participants said they felt as if their own hand was the one being touched. There was even an instance where the rubber hand was hit with a hammer and the participants reported feeling for a while as if their own hand was the one hit. On the other hand when their real left hand was touched with a multitude of different objects it felt to the participants as if nothing were touched. Others reported feeling their hand being touched but very lightly as if their hands were barely grazed. (Coleshill, M. J., George, D. N., Mazzoni, G.)

Placebo is described in the dictionary as an inert medicine administered in clinical settings for its use in mentally relieving the patients of distress rather than its actual effect on an illness. This simply means giving patients medicine that doesn’t actually do anything to improve the patients illness, but it is still given to give the patients some peace of mind so that when they are administered the actual medicine or treatment their mind is at ease since the previous treatment, with the inert medicine, went so smoothly. In this article I will be discussing how placebo can be used, its effects and the ethics concerning its use in the medical field.

How placebo works

Oftentimes placebo is used to test out the effectiveness of new treatments and medicine. It is done so by having two different trials, the placebo one being the control. The results of the experiment will then show us just how effective the treatment actually is, not just because of our bias in believing drugs administered by doctors will cure our illnesses.

Places where it can be used ethically

Though the use of placebo is controversial in many areas of medicine, there are four places namely that it is ethically acceptable to use it.

The first instance is when there aren’t any proven effective interventions for the condition, or when it is compared against an investigational treatment added to an established treatment. This simply means that any particular condition that doesn’t have any effective treatments in place, or one that does have an effective treatment is added with an experimental one. In these cases placebo is allowed and totally alright to use.
The second instance is when withholding an established, effective intervention would expose subjects to, at most, temporary discomfort or delay in relief of symptoms. This is telling us that placebo is acceptable if when we purposely delay giving a patient an effective treatment to their condition, it will cause little to no harm. The fact is giving them the treatment or not giving them the treatment poses almost the exact same results.
The third case in which placebo is acceptable is regarding a newer treatment for a condition whose response to established treatments and placebo is highly variable. This is just stating that when there is a condition in place that has multiple different treatments and given to multiple different patients it presents us with a variety of different reactions to them from each individual. Additionally, the reactions to the placebo treatment also varies from patient to patient.
The fourth is that the placebo is allowed in certain unusual conditions in developing countries. This is referring to cases where certain treatments may not be available in developing countries for a variety of reasons. The treatments are then switched with placebo to see their effectiveness on the population before administering the actual treatment to them.

Issues to be addressed with placebo

Social value is something that needs to be considered when dealing with clinical trials and the use of placebo. Social value in this case is regarding the value that the information produced from the study provides. We need to identify whether the data that this study will provide is important to progressing and furthering the studies in place for the particular condition.

Whether there is need for a randomized controlled trial is also a question raised when dealing with placebo in medicine. Is it even possible to determine, in certain cases, whether the treatment is effective without the use of a randomized controlled trial using placebo? Sometimes without the use of a controlled placebo group in a clinical trial, it is virtually impossible to be able to tell just how effective a treatment is, or if a certain element of a treatment even works or not. Additionally, if a certain factor or condition changes the degree of effectiveness of a particular treatment.

Uncertainty of the risks and benefits between different control groups could pose a problem to placebo guided trials. It could be a violation of patient rights if clinicians are not even certain about the effectiveness of the medicine they are giving to their patients. In the cases where there are proven treatments that work well, it doesn’t make sense to make patients undergo something that researchers aren’t even sure of themselves. When instead the patients can get the best treatment for their condition. (Gupta, U., Verma, M.)

There’s also the potential for harm in using placebo. Are there more chances of being harmed or benefited because of placebo trials?The chances of harm changes with location and the type of condition being treated. There are also chances that a patient’s condition may relapse after the placebo trial. When conducting clinical trials it is very important to minimize the likelihood of harm, and to closely monitor the patients for a period of time to insure that the treatment is going smoothly.

Some concerns are raised as to the possibility of there being double standards in the care of different patients. In developing countries placebo is often given when the treatment for a condition is already known and widely used in more developed countries. The treatments are affordable in developed countries and expensive in developing countries. This makes it quite hard for the majority of the public in the developing countries to have access to treatment for such conditions. As discussed above though this could be due to the cost of transporting it from developed to developing countries. It is easier and safer to first assess how the treatment works in different environments before transporting it, so placebo is used in its place. Once the results have been concluded the treatments are then given to the developing countries for use.

Conclusion

It is understandable for many to question the effectiveness and ethics of using placebo in clinical trials and for collecting important medical data. Which will then affect the way in which treatment is being administered to patients around the world. But we also need to understand that sometimes placebo is an even safer option than administering the actual treatment. It helps to show us the way the patients will react, if the reaction varies from patient to patient, etc all without having to actually take the risk of giving them treatment that may be harmful or not work for them. It helps us conduct research on a wide range of individuals and collect an ample amount of data which makes it easier and more cost effective to produce.

The use of placebo even aids with treatment for children. It is more reasonable to test on children the effects a treatment might have on them without actually administering the medicine. In order that if there are any side effects or negative outcomes we will know and it won’t affect the children in the long run.

Though there are still many inconclusive aspects of using placebo in clinical trials, it has proven to be very effective and helpful in many other aspects, so it is definitely something worth spending our effort and time into. It is sometimes necessary to take a scientific risk for a greater reward. In this case the risk isn’t even that enormous or life threatening, and the reward would mean a faster and more efficient advancement in our treatment plans for patients with all sorts of conditions anywhere in the world.