The Placebo Effect: Changing the Way We Think About Placebo-Controlled Trials

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I was hoping that there would have been a more in-depth discussion about the effects of placebos in our Psych 1001 course. While seemingly everyone knows about a "placebo" effect, a perceived benefit when in fact no test article was given, the use of placebo-controlled trials is looked upon as being much more important in the United States than it is in the European Union and in other countries throughout the world; at least when it applies to medical research, including research on psychological conditions such as depression.

Studies recently have reported that there is staggering little control over what is often described as a sugar pill, an inert pill or a pill with no medicine in it. It is suspected that, at times, the inert ingredients in a placebo may in fact sway the results of a study. In psychological research, and in other important medical research, such as a clinical trial with cancer patients, is it really ever ethical to give a placebo? Most individuals argue that as long as the use of a placebo is being disclosed to research participants and that a physician makes certain that s/he always acts in the best interest of the research subject that the use of a placebo is acceptable. Other individuals argue that placebo-controlled trials are unnecessary as they only test significant differences from the placebo not an improvement over the baseline medical symptomatology.

My office recently was asked to work on a clinical trial where subjects with advanced cancer who have expended conventional treatments would be randomized to a treatment with a new drug or to a placebo. The argument was that this was ethical simply because the cancer was slow to advance and that the subject could be offered treatment with the study drug once disease progression was formally documented by scans. I would argue that this goes against the Hippocratic Oath to "first, do no harm" and that withholding a potential treatment until further disease progression is noted goes against the Declaration of Helsinki, which states "In any medical study, every patient--including those of a control group, if any- should be assured of the best proven diagnostic and therapeutic method."

It appears to me that perhaps there should be some additional guidelines put in place by the U.S. Food and Drug Administration about the use of placebos. Perhaps a simple disclosure of what the placebo is composed of should be taken into consideration when determining if the drug data shows efficacy and a more rigorous definition on when placebos should not be used should be put into place. We live in a time where new findings in research move so fast that government regulation simply cannot keep up; but the United States should really reconsider the conditions of when the use of a placebo is acceptable.

Lisa Hostetler

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This page contains a single entry by hoste005 published on September 30, 2011 10:54 AM.

Placebo Effect was the previous entry in this blog.

Human Obedience: Crossing the line is the next entry in this blog.

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