Randomized, placebo controlled trials (PCTs) are widely considered to be the most rigorous method of evaluating the efficacy of treatment or prevention interventions. To be ethical, clinical research requires balancing rigorous science with the protection of human subjects.
When is it ethical to use placebo in clinical trial?
The World Medical Association has reaffirmed its view that in general it is ethically unacceptable to conduct placebo controlled trials if a proven therapy is available for the condition under investigation.
Is using placebo for patient treatment ethical Why or why not?
Placebo use, however, is criticized as being unethical for two reasons. First, placebos are supposedly ineffective (or less effective than “real” treatments), so the ethical requirement of beneficence (and “relative” nonmaleficence) renders their use unethical.
Is it ethical to give a placebo to clinical trial participants?
The leading ethical position on placebo-controlled clinical trials is that whenever proven effective treatment exists for a given condition, it is unethical to test a new treatment for that condition against placebo.
What are the ethical issues in placebo use?
The ethical problem with placebo treatment is not that the patient is receiving an ineffective medicine—the placebo, as we have claimed, may be quite effective, just as the standard medication may prove, in any particular case, to be useless or even harmful; furthermore, the placebo will usually have the advantage of ...
What is the ethical problem with giving a patient a placebo and saying it is an antidepressant?
While some placebo use is patently unethical – providing a treatment that "has no scientific basis and is dangerous, is calculated to deceive the patient by giving false hope, or which may cause the patient to delay in seeking proper care" – other uses of placebos are widely seen as ethical, writes Barnhill.
Is it justifiable to deceive a patient with a placebo?
Using deception for the placebo effect violates the ethical principles of respect for patient autonomy and informed consent. It can also undermine trust and damage the patient-physician relationship.
Can the use of placebos be ethically justified in research involving children?
Placebo use can be considered ethical if the following conditions are met: The potential subjects have asymptomatic, mild-to-moderate primary hypertension; The potential subjects do not have hypertension-related target organ damage; Placebo treatment will be of short duration (generally <4–8 weeks);
When is a placebo used in a clinical trial?
Placebos have been used in clinical trials for nearly as long as there have been clinical trials. The introduction of a placebo, or sugar pill, as they’re colloquially known, is used to measure any placebo effect variable within the results of the trial. The placebo effect is observed when a patient has a positive result from taking a placebo.
Why is placebo used in research?
As a side result, the use of a placebo can also be used to eliminate or reduce research bias.
Why was rofecoxib pulled from the market?
As a result, the drug was eventually pulled from the market because of a high risk of sudden cardiac death after another 3-year study was conducted.
Why is it hard to compromise the use of placebos?
It’s hard to say whether we should compromise the use of placebos because of these ethical considerations when the same placebos may end up providing information that could protect or save lives once the drug completes its clinical trials.
What is double blind clinical trial?
One common type of trial is known as a “double-blind” clinical trial. During this type of trial, half of the participants receive a placebo instead of the medication being tested. No one, even the doctors administering the drug, knows who is receiving the placebo and who is receiving the actual medication. While it can be an effective method ...
Is it unethical to use placebos?
There are a growing number of medical professionals who consider the use of placebos unethical, especially when the efficacy of the treatment has already been proven. But those same placebos may end up providing information that could protect or save lives once the drug completes its clinical trials. Clinical trials are a big part of medical ...
Is it unethical to conduct a double blind trial?
Some professionals feel it is unethical to conduct trials without the use of placebos, arguing drug trials are not a black-and-white industry. There are many shades of gray that have to be considered—up to and including the fact that a double-blind trial isn’t always able to establish drug efficacy.
What is a placebo controlled trial?
A placebo-controlled, double-blind, randomized clinical trial is the historical gold standard for clinical research, and is fundamental to the development of evidence-based medicine. Apcalisz.com research has shown that placebos produce strong, genuine psychobiological effects in both laboratory and clinical settings.
Why are placebo controls warranted?
The use of placebo controls is warranted in trials of new treatments for medical conditions when responses to both established treatments and placebo treatments are erratic. For example, depression trials have fluctuating and high placebo response rates.
Why are PCTs dangerous?
To summarize, PCTs may be dangerous if used in trials involving serious medical conditions, as they could deprive patients of available, effective therapy due to the principle of beneficence not being followed. Investigators need to be careful on a case-by-case basis, otherwise they could expose patients to unacceptable risks.
Why are PCTs important?
PCTs are still important due to the psychological nature of many diseases (psychiatric conditions, peptic ulcers, etc.), and are required in situations when it is difficult to read the results of different equivalency trials due to extensive variations in the responses of study subjects to the active drug.
What happens in the absence of PCTs?
In the absence of PCTs, every adverse event (AE) will be causally linked to the study drug; meanwhile, PCTs are expected to provide a clearer picture of the safety, efficacy, and AEs associated with the investigational drug. In the absence of such trials, ineffective drugs may come in the market, while effective drugs are kept out.
Why did the FDA insist on placebo controls for antidepressants?
As an example, FDA insisted on placebo controls for antidepressants and proton-pump inhibitors, because it is difficult to read the results of different equivalency trials for such products due to extensive variations in the responses of study subjects to the active drugs or to placebos. {12}.
What is randomized double blind study?
The randomized, placebo-controlled, double-blind study is widely considered to be the foremost operational revolution in clinical research which produces the best evidence for the new treatment. {2} However, situations may arise in which PCTs lack both scientific and clinical merit, and violate the principle of “clinical equipoise.” Their use may be viewed as not only against the principles of beneficence and human autonomy in general, but also as questionable in vulnerable groups such as children, psychiatric patients, and patients suffering from serious conditions. {32–34}
What ethical problem is most frequently mentioned regarding the administration of the placebo?
The ethical problem most frequently mentioned regarding the administration of the placebo is that the physician is deceiving the patient. The patient wants an effective treatment—not a placebo.
What is a placebo in medicine?
In the past, placebos were mentioned mostly in the context of medicine or described as sugar pills or substances used in clinical research. Modern definitions of placebos are much wider. With expanding research involving placebo and placebo-related effects comes new scientific concepts.
What are the effects of placebos?
Placebos are present in our everyday lives and sometimes they have a big influence on behaviors and experiences. Placebo effects (or placebo responses) are positive effects induced by placebos. These effects are biopsychological and have been shown in a wide range of research areas, including pain, motor skills, hormone systems, immunology, ...
What percentage of physicians believe placebos are positive?
Fifty-six percent of the physicians said they had used a placebo in clinical practice. Eighty-five percent of the physicians said they believe placebos can have positive effects, while 8 percent said clinical placebo use should be prohibited. In addition, the physicians indicated that they believed various routine clinical practices produce placebo ...
What is the rationality of placebos?
The Rationality of Science. Placebos are often used in research and administered in clinical practice. Placebo-related effects occur in everyday interactions, even when we are not aware they are at work. In the past, placebos were mentioned mostly in the context of medicine or described as sugar pills or substances used in clinical research.
Do patients get placebos?
In a classical clinical trial, participants are told they may receive a placebo or an active treatment. In clinical practice, physicians often give patients placebos but inform them they are receiving the real drug treatment. As an example, patients are often administered an inert pill or saline shot to treat pain, being told they are receiving a powerful painkiller. This placebo deception works in many cases. The patient gets better, even without use of the powerful painkiller. Medical personnel might be reluctant about admitting they use placebos, as their use in clinical practice is often questioned from an ethical perspective (Benedetti 2009).
Is placebo use ethically acceptable?
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.
Why Use Placebos in Clinical Trials?
Ethical Concerns For Placebo Use
- There are multiple schools of thought when it comes to the ethics of placebo use in clinical trials. Placebos make sense for drugs and treatments in their first clinical phase. During Phase I, the optimum dosage is determined and any major side effects present themselves. This stage of the trial is almost always conducted with healthy adult volunte...
Greater Risks Than Ethics
- Additionally, though this has little impact on ethics, studies completed without a placebo group might not have all the information they need to safely prescribe and market a drug. A trial conducted to study the risk of myocardial infarction associated with the use of a drug known as rofecoxib utilized two groups: 1. One group taking just the drug 2. One taking the drug along wit…
What About ‘Right to Try’ Laws?
- Right to Try laws have been passed in 33 states, as of the time of this writing. These laws allow terminally ill patients to bypass the FDA’s “Compassionate Use” applicationprocess and receive treatment utilizing experimental drugs that have passed Phase I of their clinical trials. Compassionate use applications can take months or years to be approved, and many terminally …
Finding The Balance Between Ethics and Science
- There are a growing number of medical professionals who consider the use of placebos unethical, especially when the efficacy of the treatment has already been proven. The most likely course of action will be to find a balance between the ethics and the science of the situation, and anyone who’s ever worked on an ethically gray topic knows how difficult that can be. It’s hard to say whe…