Placebo Effect in Clinical Trials
Anyone involved in the healthcare industry has undoubtedly heard of the placebo effect. In everyday life, the placebo effect is everywhere. For example, think about your friend who says that simply working out when they have a cold makes them feel better. Exercising didn’t really defeat their cold, but they were able to convince themselves they felt better afterward. What is the placebo effect in medicine, and what is its effect on clinical trials?
The Placebo Effect Explained
According to WebMD, the placebo effect is simply defined as “anything that seems to be a
‘real’ medical treatment, but isn’t.” This ranges from treatments such as shots or pills to any other type of physical treatment that doesn’t contain any sort of active substance that alters human health. Placebos are often used in clinical trials to determine the effects of a new drug or treatment on particular conditions.
For example, participants would be given a white pill to take as a potential treatment for severe, recurring headaches. However, individuals in the test group are not told whether they’ve received the actual treatment or a placebo (fake) pill. The placebo effect comes into play when people report positive or negative reactions to the drug, even though they received the fake treatment.
The placebo effect boils down to the connection between mind and body. In some cases, when a person expects a pill or treatment to improve their physical condition, it’s entirely possible their body chemistry can actually cause effects similar to those of an actual medication.
Placebo Effect in Clinical Trials
The placebo effect can strike fear in the hearts of pharmaceutical companies everywhere. It costs millions of dollars to bring a new drug to market, but what happens in the placebo effect derails all of your progress? Detailed on Wired.com, there was a famous case of this effect from 2002 involving pharmaceutical giant Merck.
In short, in 2002 Merck found itself languishing in the marketplace against its competitors. The company not brought new drugs to market recently, and existing patents on key drugs were about to expire. The company was relying on a new drug to treat depression, which was in the clinical trial phase and experiencing great success. There was just one problem: the placebo effect.
Participants in the trial were responding to Merck’s MK-869 drug, reporting less hopelessness in their lives and a lifting of their anxiety, and with minimal side effects. Unfortunately, an equal number of participants receiving a placebo in the clinical trials reported the exact same benefits from a pill containing only milk sugar.
Placebos are meant to help researchers determine the effectiveness of the actual drug in one group of participants by comparing their results to those of a second group of participants receiving a fake treatment. The problem arises when individuals self-report their symptoms, and show outward signs of improvement. This calls into question the effectiveness of the actual drug in treating a given condition.
The placebo effect isn’t limited to disorders of the mind such as depression either. The American Parkinson’s Disease Association reported a 20-30% increase in motor skills among patients on a placebo in one study, and another study found asthma patients taking a placebo inhaler feeling as good as those taking a prescription inhaler.
Researchers need to closely track the placebo effect in any clinical trial because it poses the threat of derailing a potentially life-saving drug on its route to market if no cause for improvements in the group on the placebo can be found.