In terms of the ethicality of placebos, I believe they are very ethical because you aren't actually doing anything to the patient. In terms of necessity, I believe they are very necessary. I'm a firm believer in medicine when treating someone you always want to avoid what you don't need, or if there is a natural way to go about then that's the route you should take. With placebo's the power is in the anticipation. Essentially the person is no longer feeling as much pain because they think they took something to relieve the pain. As Dr. Simon mentioned the majority of feeling pain is mental, depending on the condition of course. So I personally believe placebo trials should be conducted before more experimental trials to see if they're even necessary.
Placebo trials are essential because they provide a data point that may be compared to the findings of other experiments. A placebo study can be likened to a control experiment in terms of setup. This guarantees that there is a trial that is not anticipated to change and that the different factors that are being altered can be monitored and quantified using a reference.
To be ethical, I believe that integrating a placebo-controlled trial in testing is not unethical. I feel that because participants are just required to report the impacts they are having, the experiment will have no negative consequences.
Placebo-controlled trials are an important part of clinical studies because they provide a comparison to new therapies. Placebo-controlled trials also help investigators determine the percent effective their drug or new therapy is, as well as help determine whether or not a therapy is truly safe and effective (and not just working by chance). However despite these benefits, placebo-controlled trials are highly debated and some argue that is actually unethical for a patient to receive a placebo if a proven therapy is available during the investigation. Additionally, it is argued that such placebo treatments actually hinder results and lack scientific research/merit. In addition to the ethical concern, some say that the placebo effect can actually cause unwarranted side effects such as drowsiness and rashes. I am wondering, would you feel comfortable participating in a clinical study if you knew there was a chance you could receive a placebo therapy? Are there some trials where a placebo study might be acceptable but not in others depending on the severity of the condition being investigated? Where is the line drawn and who should be the primary party responsible for making that decision?
Yes, I believe that placebo controlled trials are ethical and are very necessary to ensure that drugs and treatments are both effective and not creating fake results. This may seem like it is cruel, because some people are signing up for these trials hoping for one last miracle cure, but may receive a sugar pill that does not do anything. Especially if the drug ends up working and helping those who are taking, it may be too late for some individuals who were not given the actual treatment. While these may seem like problems, this process allows for the drugs to be tested properly and helps get the drug passed for release. Also, this is not unethical because patients are informed when they enter the study that they may be given the actual drug or a water/sugar pill that does not affect them. It is not like the group running the trial is trying to sneak this past the patients so they aren't aware of the situation at all. Unfortunately, this is a necessary test for most trials and can help hundreds of thousands of people by hurting a small few.
I believe the use of PCTs are ethical as well as necessary. Placebos allow studies to have a control they can test against the baseline of a patient/participant. Thanks to placebos we can see if a change in participant or patients behavior is due to the medicine or in their heads. There are also cases to where people who do not have illness and believe they do being prescribed a placebo and they claim they are healed. I believe it is necessary to help establish a balance and find out if a drug really works and if it really affects the patient as well as in what ways.
The use of placebo controls in clinical trials remains controversial. Ethical analysis and international ethical guidance permit the use of placebo controls in randomized trials when scientifically indicated in four cases: (1) when there is no proven effective treatment for the condition under study; (2) when withholding treatment poses negligible risks to participants; (3) when there are compelling methodological reasons for using placebo, and withholding treatment does not pose a risk of serious harm to participants; and, more controversially, (4) when there are compelling methodological reasons for using placebo, and the research is intended to develop interventions that can be implemented in the population from which trial participants are drawn, and the trial does not require participants to forgo treatment they would otherwise receive. The concept of methodological reasons is essential to assessing the ethics of placebo controls in these controversial cases. To be ethical, clinical research requires balancing rigorous science with the protection of human subjects. Most people accept the use of placebo controls in trials for conditions with no effective treatment. However, PCTs raise ethical concerns when a proven effective treatment exists, since randomizing subjects to a placebo exposes them to the potential harms of non-treatment. First, PCTs are acceptable when there is no proven effective intervention for the condition under study, or when placebo is compared against an investigational treatment added on to established treatment. This includes trials of treatments shown to be efficacious in some populations but where the data cannot be extrapolated to the population of interest. Use of placebo in this case is typically not ethically controversial. A second justification is sometimes invoked to justify placebo controls in trials of new treatments for conditions whose response to both established treatments and placebo is highly variable. For example, depression has fluctuating symptoms and a high placebo response rate. It is not uncommon to have inconsistent evidence of the efficacy of approved anti-depressants, showing superiority to placebo on some endpoints in some trials but not others. Demonstrating equivalence or non-inferiority of an investigational compared to an approved anti-depressant treatment may mean that the new drug is as efficacious as the established anti-depressant or that neither the established nor the investigational drug performed better than placebo in this trial. Similar phenomena can arise with anti-psychotics, treatments for mania, and analgesics. In such cases a placebo control may be necessary in order to establish the efficacy of a new treatment.
I believe placebo-controlled trials are very important and necessary in the clinical trial process. By using a placebo, researchers are able to ensure that none of the changes that occurred to the subjects happened by chance, through the placebo effect, and actually resulted from the treatment. This is extremely important to know in order to determine whether the treatment is actually effective. The use of placebo-controlled trials has garnered much controversy. I do understand how it can be seen as unethical that a placebo is being used when there is an effective treatment available. It is also seen as unethical in terms of clinical professionals, such as physicians, who have the obligation to offer optimal medical health. In the case of a clinical trial where there is no current effective treatment for the condition being studied, I think it is ethical to use a placebo. This means that giving the participants the placebo does not deter them from being any more healthy. I do not see any disadvantages to using placebos and think they are very beneficial to a study.
I think it's absolutely ethical because this procedure is preventing data error. I do understand the reason why you would think this practice is unethical due to the fact that you're tricking the patient, however using the placebo control trial is important to prevent patient from having euphoric hope mentality due to the doctor giving them the real medicine that might not be effective enough to heal them.
A placebo-controlled trial is a trial in which there are two (or more) groups. One group gets the active treatment, the other gets the placebo. Everything else is held the same between the two groups, so that any difference in their outcome can be attributed to the active treatment. Placebo-controlled trials are considered the "gold standard" for clinical trials because it has the best chance of determining whether an active treatment is effective. While some believe it to be unethical to use placebos in clinical trials, I feel that using placebos can prevent the widespread use of ineffective medical treatments to the population.
I struggle with the idea that placebo control trials are ethical. In cases where people are suffering from progressive and terminal illnesses, giving a portion of them a placebo instead of a drug that could potentially save their life feels mean. Also, I understand that this also gives the researchers a chance to study disease progression, but whether or not its moral is another question entirely. I guess in terminal cases, it may not matter much to the patients, but I still think it is in everyone's best interest to consider the ethics of it.
Placebo-controlled trials are necessary to rule out bias and adding a double-blind experimental design ensures that everyone is kept from knowing who receives what treatment. It keeps all variables the same and allows the science to be front and center. If researchers were aware of who received what treatment, it would instantly change the course of the study and create an unfair advantage for participants in the study. It would also lead to possible lawsuits because if participants knew they were not part of the experimental group and started declining in health -- that brings up the 'do no harm' clause. Have a placebo helps eliminate bias and keeps the focus on the treatment variables and how patients response to treatment.
I would have to disagree with many of my colleagues on this one. I actually believe it to be far more ethical and informational to compare new pharmaceuticals with the current standard of care vs the new drug. By doing this, all participants are being treated and the comparative analyses will show whether it is a superior treatment to the current standard of care, which should be the goal of all new drugs. I do believe that placebo trials were once all that we had to use in the past prior to the discovery of so many drugs, but now we have something to at least treat these patients with who have agreed to enter the studies. I just think it's better ethically and educationally.
I do think placebo trials are necessary as they provide a control as many responders stated above. There needs to be a space where no other factor except the drug is changed and to test this there must be a "sugar pill." I think @rachelpatel1796 made a note that is equally important, when researchers are conducting these studies many times there are therapies to assist with the recovery for the subjects experiencing symptoms post-trial that the placebo may have caused. In some instances, placebos may be harmful to the subjects but unfortunately to fully study the effects I think placebos are currently the only option to get the results needed for the safety and effect of the drugs.
@srg36 I think that placebos are absolutely necessary for clinical trials to study human research and development in gaining greater advancement in drug trials and to see if a drug is actually as effective as produced by the FDA approval. I think placebos in general are a way of showing the methodology of ensuring that there is a clear-cut pathway for a patient to gain confidence and believe that a drug has the ability to work and be an effective tool for future treatments of patients in clinical trials.
Placebos are a way to introduce a control into a study. Much like conducting a blind study, a placebo eliminates bias. More specifically bias that comes from the mind of a patient. We often underestimate the power of the brain. Without a placebo, just the idea of possible treatment could alter the perceived reality of some patients. The only downside I could see to studies with placebo is keeping patients from having possible treatment. However, I believe there are some rules regarding this as to when a study needs to end so that all affected patients can get the proper treatment.
