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Placebo-controlled trials: Are they ethical? Are they necessary ?

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(@knd26)
Posts: 78
Estimable Member
 

I agree with many of the above posts, that placebo clinical trials are both ethical and necessary. The placebo effect as said in the lecture this week can reduce pain by at up to 20% because of how much of this is controlled by your mind. As stated in my biology of addiction class, even when people know the drug is a placebo, they still feel the beneficial effects. This phenomenon is extremely important to measure when looking at the efficacy of the drug to determine how much is due to the expectation as opposed to the drug itself. One ethical dilemma that could be argued is people thinking they are receiving a drug to save them when they are not; in the same token it could also give them a placebo effect where they phycological feel more hopeful and see those effects physically. Overall, I think these studies are necessary and should be double blinded to make sure the investigator or person delivering the drug does not give away the placebo effect.

 

 
Posted : 28/10/2022 1:38 pm
(@veron_perez)
Posts: 78
Trusted Member
 

Placebos are generally agreed to be unethical when it can cause harm or irreversible damage to the patient. But one advantage to placebos is that they can be helpful in determining the actual strength of the device or drug being tested. Researchers would have certain expectations for their results so there could be an air of bias on what they convey to the patients. Placebos eliminate this effect to allow for a better understanding on how well the device/drug actually works.  Placebo controls are ethically justifiable when there are appropriate considerations taken and their use in the research does not cause or expose the subjects to excessive risks of harm.

 
Posted : 30/10/2022 7:41 pm
(@sandra-raju)
Posts: 38
Eminent Member
 

In the past there were major ethical concerns with placebo studies. A infamous example of a placebo study that comes to mind is the Tuskegee Syphilis Study. This was a study conducted between 1932 and 1972 by the United States Public Health Service and the Centers for Disease Control and Prevention on a group of 400 African American men with syphilis. The goal of the study was to “observe the natural history of untreated syphilis” in black populations, [1] but participants in the study weren't informed of this and instead told they were receiving treatment (essentially nonconsensually being placed as a placebo). There were many ethical issues with the study such as racism, paternalism, and unfair subject selection in research, but the one that I feel relates to this discussion is the blatant lack of informed consent. Many African American individuals who participated in the study died because they were not receiving treatment despite thinking that they were and in turn also infecting their wives and subsequently their later born children with the disease. Even when penicillin was deemed a safe and reliable cure for the disease, the scientist conducting the study did not provide it to the participants in the study. 

I do think placebo studies are necessary in experiments as they can be an effective control in drug testing. However, it is important that during these studies the participants are protected and are not at risk, especially if they have a life-threatening disease. From this study and many more, much more stricter rules and regulations are in place to ensure that placebo studies are monitored and safe for the participants.

 

1 - https://www.mcgill.ca/oss/article/history/40-years-human-experimentation-america-tuskegee-study

 

 

 
Posted : 30/10/2022 8:34 pm
(@mj386)
Posts: 78
Trusted Member
 

I believe that placebo-controlled trials are ethical and necessary. As was mentioned in our lecture, around 20% of pain experienced is experienced in the mind. While pain can be a powerful feeling to experience and go through, it depends on the person's mindset. With placebos, the one intaking and observing the effects of the product could understand if it's all in the head or if their pain requires immediate attention and care.

 
Posted : 30/10/2022 8:50 pm
(@jbarbee)
Posts: 78
Trusted Member
 

Placebo-controlled trials allow the unbiased effects of the known device or drug versus the placebo. Certain aspects of placebo-controlled trials may be deemed as unethical depending on the scope of the study. For example, if a placebo-controlled trial is studying the effects of a drug on a population with a given disease known to have an effective treatment, it is unethical as the controlled population will only be receiving the placebo. Although it may be unethical, I do believe that these placebo trials are necessary to obtain unbiased results by "minimizing the influence of patient expectations on the outcomes". While placebo groups may only be used as a "negative" control, there are chances that the placebo effect may make subjects in the group feel treated after only receiving the placebo. Placebo-controlled trials are certainly effective and provide clinical significance.

https://www.ncbi.nlm.nih.gov/books/NBK513296/

 
Posted : 30/10/2022 9:14 pm
(@sm2744)
Posts: 78
Trusted Member
 

I think that placebo controlled studies are ethical and necessary for clinical trials. Conducting a PCT provides the researcher with data that can show if the treatment that the patient receiving is has a statistically significant impact on the ailment they are experiencing. It allows for a baseline comparison. Our brains are very good at tricking us so it is important to rule out that this is what is happening during treatment.

For the most part, I believe that they are ethical. The reason that trials need to be conducted is because there isn't a treatment for the disease/sickness they are trying to treat. Patients who enroll in these studies know that there could be a positive/negative or no impact on their condition. While it would be very unfortunate to see progression of their disease due to being in the placebo group of the trial, the patient understood prior to the start that there was no guarantee of a positive impact. They were enrolled because there was no other treatment option. I think that if the trials conclude with a positive result, the placebo group should be offered the treatment as a "thank you." Without them, other patients may have continued being treated with drugs whose cons (with the comparison to the placebo) now outweighed the pros. 

 
Posted : 30/10/2022 9:33 pm
 jt63
(@jt63njit-edu)
Posts: 39
Eminent Member
 

I think, placebo is ethical if patient is informed and agrees to its use. It is necessary because comparing results from the placebo with the real drug group suggests whether changes in the test group result from the treatment or occur by chance.

 
Posted : 30/10/2022 10:40 pm
(@sumayia-chowdhury)
Posts: 36
Eminent Member
 

I believe a placebo is ethical due to the benefit of science and medicine it provides. I agree the patient might got deceived by the caregiver. However, it is better than prescribing hundreds of patients unnecessary drugs. Of course, placebo shouldn’t be given in place of another medication that the physician expects to be more effective. The ethical argument in favor of using placebos in medical practice is strengthened by studies that show the beneficial effects of placebos. And there is no simple answer, and the debate continues. Some of the strongest evidence that placebo use is ethically acceptable and justified in medical practice is the possibility of reducing the intake of potentially toxic, dangerous drugs. The open-label paradigm, for the study of placebos, provides evidence that placebos may be beneficial. Therefore, I believe placebo is essential and ethical.

 
Posted : 13/12/2022 1:35 am
(@ac685)
Posts: 24
Eminent Member
 

I believe placebo trials are extremely beneficial when determining the effectiveness of a device or product. By comparing trials using a placebo vs. without one, clear results can be found regarding the efficacy of the device. Although effective, I just think they are somewhat unethical, especially when patients' lives are at stake. It's unfortunate that people receive placebos, especially in instances where their disease might be life-threatening. 

 
Posted : 14/12/2022 11:35 pm
(@akilia23)
Posts: 22
Eminent Member
 

Placebo-controlled trials are ethical and they are in place in many drug clinical trials. I don't however, believe them to be necessary. A placebo is a fake, and is used in most cases as a control, but I feel as though it is an unnecessary inclusion and very unfair. The reason a clinical trial is even in place is because they are trying to solve a problem, so a placebo (ie a fake drug) is doing nothing for the patient, so I don't see why bother. The results of a placebo will be no improvement. Of course, there're a few circumstances where placebos work because the Mind is a powerful thing, but that is so rear that I believe the time wasted isn't worth it

 
Posted : 30/03/2023 10:03 pm
(@danieshat1)
Posts: 22
Eminent Member
 

I find placebo-controlled trials interesting as a person that wants to assess the impact of a drug.  I feel like from a patient's perspective may or may not be harsh depending on the severity of reason why they may need the drug. If the reason for the drug is for something serious, the patient will understand that it is a study, but are still hoping for a positive outcome for their condition. I feel like the anticipation of if they are going to receive the drug or not can weigh on the patient. Also, the thought of if the actual drug will have a good outcome or bad outcome can impact the patient's mindset as well.

 
Posted : 01/04/2023 2:25 pm
(@gsanniezmsm-edu)
Posts: 21
Eminent Member
 

The use of placebo-controlled trials, provides researches with a baseline group to compare the effectiveness of the drug being tested within the treatment group. Allowing researchers to follow at least two different group of individuals with the same prognosis. Researchers are able to calculate the difference in disease states and progress or regression of health between a group of individuals that given a experimental drug, to a group that is living their life’s as they normally would with no intervention. I can understand were the notion of PCT not being ethical. Due to the fact that one group is being told that they are getting an intervention to improve their health when in actuality they aren’t. However, before the study occurs if participants are made aware that this is a PCT. If the participant still consents after knowing their is a possibility they will receive the placebo. Then the ethical threat is eliminated. 

 
Posted : 01/04/2023 4:55 pm
(@astone46)
Posts: 18
Active Member
 

The use of placebo-controlled studies in medical research is a topic of ongoing ethical debate. On one hand, placebo controls are often seen as the gold standard in clinical trials because they allow researchers to evaluate the efficacy of a treatment while controlling for the placebo effect. However, some argue that placebo controls are unethical because they expose participants to a risk of harm without the potential for benefit. To address these concerns, some researchers advocate for the use of active controls or alternative study designs that minimize the need for placebos. Ultimately, the ethical use of placebo controls depends on the specific context of the study and the risks and benefits to participants. Ethical considerations should be carefully weighed and openly discussed to ensure that research is conducted in a responsible and respectful manner.

 

 

 
Posted : 01/04/2023 9:40 pm
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