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krp76 replied to the topic Placebo-controlled trials: Are they ethical? Are they necessary ? in the forum Clinical Research Basics 7 years, 5 months ago
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