Science and Law
30th May 2013

The Placebo Effect: From Clinical Trials to Courtroom Trials

The placebo effect refers to a positive health outcome that results from a patient’s belief that a treatment will be effective. The placebo effect is a real, physiological phenomenon that can be measured using standard scientific techniques.

The Placebo Effect: From Clinical Trials to Courtroom Trials

The mysterious and powerful placebo effect is at the center of an emerging trend in consumer fraud litigation. We’re all familiar with the role the placebo effect plays in personal injury lawsuits against drug companies. But we’ve recently been involved in consumer fraud cases that employ a divergent approach to addressing the placebo effect.

The placebo effect refers to a positive health outcome that results from a patient’s belief that a treatment will be effective. The placebo effect is a real, physiological phenomenon that can be measured using standard scientific techniques. You may be familiar with the 1955 landmark paper The Powerful Placebo, in which Henry K. Beecher, M.D., quantified the placebo effect across 15 studies, although the findings have been disputed.

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A more recent comprehensive review of the placebo effect reported on the following intriguing results: administering two placebos is more effective than administering one, placebo injections are more effective than oral placebos, bright-colored placebos are more effective than light-colored ones, and larger placebos are more effective than smaller ones. The placebo effect is not limited to medication. Sham arthroscopic surgery of the knee and sham brain surgery (both placebo treatments) have produced the same outcomes as the actual surgical procedures.

Harvard Medical School recently created the Program in Placebo Studies (PiPS), headed up by Ted Kaptchuk, to study the benefits of the placebo effect.

As noted earlier, the placebo effect plays a significant role in lawsuits against drug companies. Clinical drug trials typically include a placebo control group, allowing researchers and the Food and Drug Administration to effectively evaluate the efficacy of any new medication. In personal injury lawsuits against drug companies, plaintiffs are inclined to ignore the relevance of the placebo effect. They claim a particular drug caused a negative health outcome, but fail to produce comparative evidence demonstrating that a placebo control group did not have the same outcome.

In recent years, we’ve seen something of a reversal. In consumer fraud cases, instead of circumventing the placebo issue, plaintiffs focus on the performance of a particular medication compared to a placebo.

For example, a lawsuit filed against Pfizer earlier this year claims the majority of clinical trials designed to test the antidepressant Zoloft showed the drug was no more effective than a sugar pill, and seeks a refund for consumers who purchased the medication. Pfizer says the lawsuit is groundless, citing extensive scientific research and insight from experts.

The lawsuit is reminiscent of claims against other a host of other health-related consumer products including energy drinks, wrinkle-reducing creams, and weight loss products. Undoubtedly, the merits of the lawsuits will be driven by placebo controlled data. For example, if the products can be shown to be statistically significantly superior to placebo, the defendant could have a good shot at winning the case.

Back in 2008, the herbal cold remedy Airborne faced a false advertising claim. Airborne denied any wrongdoing but agreed to settle the case and issue refunds to consumers who purchased the product. The lawsuit was filed after an ABC News report revealed that the company’s clinical trials were not conducted by scientists.

While Pfizer’s research undoubtedly exceeded the scope and quality of Airborne’s, the lawsuit still questions the validity of the efficacy data presented to the FDA and, implicitly, the validity of the placebo control groups. In this research program, because we are dealing with softer, more subjective endpoints, some might argue that it is even more important to control for the placebo effect. Nevertheless, research over the decades has demonstrated the importance of the placebo effect in studies involving subjective psychological components as well as studies involving clear and measurable physiological components.

From our perspective, the Zoloft case is part of a trend in consumer fraud litigation. Pharmaceutical companies have often confronted personal injury lawsuits from patients who claim a drug harmed them. But in cases like the Zoloft claim, patients are alleging that a drug simply didn’t work. We expect to see more cases challenging a particular drug’s efficacy compared to a placebo. As in the Zoloft case, insight from mental health experts and their interpretation of the scientific data will play a pivotal role.

About Innovative Science Solutions

Innovative Science Solutions (ISS) is a leading scientific consulting firm for the worldwide pharmaceutical, biotechnology, and medical device industries. We are an expert team of scientists, regulatory strategists, and consultants providing a wide range of fully-integrated services to industry and counsel including:

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For complex litigation support, ISS delivers specialized solutions for your science hurdles. With over 13 years of experience, let our proven blend of success and innovation work for you.

 

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