As Dr.Simon mentioned about placebo-controlled trials, which is A “dummy” device or drug is used on one group of patients and compared to patients with the real one, or sometimes called a ‘sugar pill. Or a fake ultrasound device in a bone healing study.
So, Do you think Placebo-controlled trials: Are they ethical? Are they necessary ? Also, what are the advantages and disadvantages of using PCTs ?
I think PCTs is rarely used in some circumstances like asthma patients for example. The advantage of using PCTs is Zero risk of overdose.Also, Placebos are always better than no treatment.
So, What are your thoughts about placebo controlled trials ?
I think the use of placebos are important. As Dr. Simon also mentioned in his lecture, the placebo effect is a very real thing, and in order to know how effective the drug or device is, the investigator must also have a good understanding of how big of an impact the placebo effect is having on the treatment. If they don't use a placebo, the results that they get may be highly inflated. I guess one of the downsides is that if the placebo effect is negligible, the patient wouldn't reap the potential benefits of the new drug. However, all participants are informed of the possibility of receiving a placebo, so I do think that it is ethical to use placebos. It is a personal decision that each participant must make.
It is my belief that placebo controlled studies are necessary and ethical, yet should not be the “proof” that a drug/ medical-device combination is effective. This is due to the many curiosities that still surround the idea of a placebo and its potential to alter both the subject’s perception and physical wellbeing. Many underestimate the power of the mind and its ability to heal through sheer belief that and the many beneficial outcomes that come from simply being in a positive mindset. It is interesting to note in an experiment where patients are given a placebo, whether they are told it is fake or not, a given percentage will still have positive physiological responses. This phenome must be accounted for when analyzing the final data. An addition, contrary to what merzkrashed mentioned above, placebos can cause negative responses. There have been studies where patients thought they were being exposed to an (false) irritant and have broken out in the expected reaction. Read more in below reference.
I agree with @srg36 that placebos are very important. The expectation is a very powerful thing. Similar to the example Dr. Simon mentioned in the lecture, sometimes, when people call to make an appointment with a doctor/therapist, they already feel better even before they see the doctor/therapist. Another point I want to point out is that in most cases, the studies also need to be double-blind so both researchers and subject do not know if the subject is taking study med/device or placebo. That way, the study is not bias and the "placebo" wouldn't create any effect on the result. It also makes the study "cleaner" and makes it easier on the examiner/doctor in case he/she has a connection with a patient (ect) and may unintentionally skew the results. For example: imagine if you are a doctor and your cousin is on a trial, if he or she is on placebo, it's better if you don't know because you may tempt to tell him/her, you also may lose your job if you do so. Therefore, in my opinion, placebos are necessary and ethical.
Placebo trials are important because they create a data point which can be used as a comparison point for the results of the other administered trials. A placebo trial can be compared to experimental set-ups as the control experiment. This ensures that there is a trial that is expected not to change and from there, the different factor that are being changed can be observed and has a reference to quantify the changes.
In terms of ethics, I think that there is nothing unethical with including a placebo-controlled trial in testing. I believe this since participants are only needed to report the effects that they are experiencing, there is nothing harmful coming out of the trial.
I agree with the posts above that placebo trials are needed. However, the experiment design must be controlled in a way such that ethical concerns are mitigated. Ethical concerns arise when a proven effective treatment exists for fear that the placebo exposes patients to the potential harms of non-treatment.
There are general guidelines for when it is ethical to use placebo controls.
1)When there is no proven effective intervention for condition under study or when placebo is compared against an investigational treatment added on to established treatment.
2)When withholding an established, effective intervention would expose subjects to, at most, temporary discomfort or delay in relief of symptoms. In this case, the placebo is ok if the patient goes untreated and there are relatively no negative consequences or no treatment is an acceptable alternative.
3)If trial outcomes show a high expected placebo response or mixed data on effectiveness of standard treatment. For example, depression has fluctuating symptoms and a high placebo response rate.
4) When participants are not deprived of interventions they would otherwise receive and when research intended to develop interventions that will benefit the host population.
Millum, Joseph, and Christine Grady. “The Ethics of Placebo-Controlled Trials: Methodological Justifications.” Contemporary clinical trials 36.2 (2013): 10.1016/j.cct.2013.09.003. PMC. Web. 27 Oct. 2017.
The Placebo-controlled trials are very beneficial in determining the efficiency of a product. With the Placebo trials, one group of subjects receives the real product, while the other group receives the imitation one. As a result neither group knowing which form they have, there is a less chance of a Placebo effect being present. The main issue that arises with this type of trial is giving patients with an advanced disease, the Placebo. As a result, they are given a treatment that will not benefit them at the end. On the other hand, because the subject does not know whether they are on the Placebo or not, they may feel that they are doing better mentally. With patients unaware of which type of product they received, the data collected can be analyzed to see how effective the product was.
I personally feel as though placebos are necessary for studies and clinical trials. When doing statistical analysis, you'll have a controlled-group that'll receive the drug or device in question for actual treatment and perhaps another group that'll receive a type of "sugar pill" or something else that won't treat the illness or condition, but the patient or subject is led to believe that it will do something. This may come off immediately as unethical; however, since these trials are conducted on humans, part of the informed consent form a subject is supposed to sign should clearly outline that they'll receive a placebo. Placebos have their appropriate times to be used while other times it should not be used at all. Placebos are only appropriate when the placebo itself won't negatively affect the patient and if it is scientifically necessary. Placebos, when used, should be used to prove the effectiveness of the trial with high placebo effect rates or in absence of an effective therapy or treatment.
Yes, I do think that Placebo-controlled trials are both ethical and necessary. When performing any scientific study, I think it is very important to have a control to be able to compare the effects of whatever it is you are studying (medication, treatments, etc.) to someone that has not received these medications or treatments. Having a control gives you the ability to see what would happen to your samples or patients if the medication or treatment was not administered. In my opinion having a control allows you have more accurate data instead of assuming what the results of a controlled sample or patient would have been. I do not see many disadvantages with having a control, besides the additional amount of money it cost to include the extra control patients in the clinical research study.
I think placebo controlled trial are very important because this would help subject have control Vs experimental subject which would help better understand the trials which would help develop the treatment in an effective way. Because one should always have something to compare the results. I also agree that in certain cases Placibo itself would cure the disease and than we would have two ways to cure to cure. In cases double blind might help but I think if only patients blind and Investigator knows what they administer would be really benificial for treatment like this.
Placebos have been viewed as a necessary process in bolstering scientific proof on the effectiveness of products and evidence that one product is superior to another, within many industries. Personally I believe that placebos are necessary in order to gain the most input on a product, however it is an ethical grey area in which many pros and cons are present. First off placebos within industries such as pharmaceuticals do not provide a negative effect necessarily as they are harmless to the patient, a counter argument is that they may skew results with the power of convincing patients that they are receiving an actual treatment also known as the placebo effect. This deviation is not necessarily bad for the patient if it results in a better clinical outcome, however it is bad for the study as the baseline and comparison is skewed. Now as we dive into medical devices it becomes more controversial as for medical devices many products are implant products and require surgery. Placebos within medical device result in the patient being prodded and cut open with no benefit in health. In fact placebo surgery can be viewed as being detrimental to the patient as they are actually being harmed and receiving no treatment in return. Although this is an ethical grey area the placebo surgeries do have the tremendous advantage of saving countless lives as the information received from them allow independent researchers to weed out scam medical devices that claim breakthrough innovation, and can clearly be seen as false once a placebo trial is placed alongside the actual product. These are both sides of the coin for placebo trials and I believe that in the end whether pharmaceuticals or medical devices they provide great benefit for the majority of patients, even with the setbacks that can arise they are necessary in the scientific field. Two interesting articles that I read through give great insight into both perspectives on the pros and cons of the trials, if you are going to read through them first take a look at the wsj article and then forbes, since forbes is a response to the wsj article.
Sources
https://www.wsj.com/articles/the-fda-wants-you-for-sham-surgery-1392769018
Placebo controlled trials are a staple of medical trials. Placebo trials allow for researchers to understand the efficacy of a novel drug or procedure. There is always concern for ethical issues when providing placebo therapy because certain patients will not be receiving potential treatment. However, these patients are told that there is a chance for them to receive placebo instead of the actual therapy. Thus, there should be no ethical concerns in that sense. Additionally, patients are given actual therapy after the trial if they would like. However, placebo therapy does play an interesting role in studies. At times, placebo therapy can provide interesting results and sometimes work as effectively as the actual therapy.
Placebo-controlled trials are necessary to the effectiveness of certain studies. In order to be sure that the drug or device is the factor that is in actuality changing the condition of the patient or just a change of mentality. There are cases where the placebo effect is so powerful that a patient will feel healed or treated, and the use of the drug would be unnecessary. Then in cases where the patients with the placebo do not feel any change but the ones with the real drug do, then researches could know with more confidence the results of their findings.
Placebo-controlled trials have been around in clinical testing for a long time. Placebos mainly act as a control procedure that needs to be done in order to keep all the variables the same, except for the actual drug. It can also shed light on the psychological effects that occur such as the placebo effect. It can show that just "thinking" that a drug is working, can help the treatment process. In some situations, many ethical issues can arise, but I believe that they are necessary to act as a control variable and compare the clinical study to something. Reading about many clinical trials, I have come to know that many people are actually told the guidelines of the study and as akashranpura mentioned above, they are sometimes told they may or may not receive a placebo instead of an actual treatment plan. Most patients are also given therapy for any issues that may arise or are compensated for being in the study. The main disadvantage of PCTs are that they could affect the patient or person receiving the placebo. In this case, there may be harm to the person and the experimenters are held reliable.
I do think that having placebo-controlled trials are ethically sound and necessary. There are guidelines place with a huge emphasize on when a person should be placed in a trial. The well-being of participants should be considered, and whether or not it is worth having the patient take part in this study when they are already receiving adequate treatment and whether or not being on the trail might make them worse. "Placebo controls are not to be used if there is evidence of the efficacy of another treatment or “good evidence” that the experimental therapy is effective. These guidelines call on institutional review boards to perform a careful risk-benefit analysis when considering whether to allow a placebo-controlled trial." There are also guidelines placed on when a PCT can take in a trial. "(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." In short, ethical issues arise when the participants are looked over. If their health and safety is placed in priority rather than the success of the trial and or other corrupt motives, then there would be no issue. The guidelines above facilitate in the prevention of unethical methods, and therefore having PCT is still a very efficient method of comparing data.
Chiodo, G. T., Tolle, S. W., & Bevan, L. (2000). Placebo-controlled trials: good science or medical neglect? Western Journal of Medicine, 172(4), 271–273.
Millum, J., & Grady, C. (2013). The Ethics of Placebo-controlled Trials: Methodological Justifications. Contemporary Clinical Trials, 36(2), 10.1016/j.cct.2013.09.003. http://doi.org/10.1016/j.cct.2013.09.003
