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What Does ‘Clinically Proven’ Actually Mean?

Doug Richie Jr. DPM FACFAS FAAPSM

12/17/2015

Why are vendors claiming their products are “clinically proven”?

I have always marveled at the bold statements made in advertisements for weight loss products, wrinkle creams and dietary supplements, which use phrases such as “doctor recommended” and “clinically proven” to assure the consumer that the product actually works. Traditionally, pharmaceutical companies and medical device companies have avoided using these misleading phrases when marketing their products to medical professionals. At least until now.

Unfortunately, the phrase “clinically proven” is now in use in advertising to the podiatric profession.^1,2 This raises the question: What does “clinically proven” actually mean?

A simple Internet search, asking the question “What does ‘clinically proven’ mean?” reveals a number of websites that poke fun at this phrase. On a Yahoo website, the question posted is: “You hear the term ‘clinically proven’ in advertising so often that it seems meaningless. What criteria does the product have to meet to be able to use this term?”³

As the website answers, “It means (usually) that there was more than one controlled study. ‘Clinically shown’ means there was only one study.”³

According to Urban Dictionary, “‘Clinically proven’ may mean virtually anything ... including nothing. A ‘clinically proven’ statement in advertising is an effective sales pitch, usually a vague claim that requires no hard evidence and is not easy to disprove. As long as the mandatory ‘These statements have not been evaluated by the FDA ...’ disclaimer is on the label, it is not necessary to have competent and reliable scientific evidence to back it up.”⁴

If this disclaimer statement is not on the product label or advertisement, the Food and Drug Administration (FDA) will take action against companies that make false promises in advertising regarding medical benefits. When visiting the FDA website, there are numerous documents relevant to regulations for making medical claims, regulated by the Federal Food, Drug and Cosmetic Act.⁵ There are documents showing action taken by the FDA when companies use “clinically proven” but do not have adequate data to make such a claim. Specifically, two documents are available regarding “clinically proven” claims made by General Mills (promising Cheerios would lower cholesterol) and Novartis’ claims of efficacy of its motion sickness patch.^6,7

For the general public, seeing the phrase “clinically proven” is commonplace, particularly in advertisements and on product labels for anti-aging creams and weight loss products. It is clear that companies use this phrase rampantly without any regard for real meaning in the direct-to-consumer marketplace. You can see several hundred labels for these products using “clinically proven” on this Google page (https://tinyurl.com/jj72yf6 ).⁸

Companies that market products to educated medical practitioners have been cautious about using misleading phrases commonly used in the consumer marketplace. Healthcare professionals scrutinize advertising claims for good reason. To these professionals, the term “clinical” suggests “clinical trials,” which are the foundation of testing regulated by the FDA in order for a product to make claims of efficacy and safety. Medical professionals would generally assume that, when a pharmaceutical company or medical device company uses the phrase “clinically proven,” the product had been tested in clinical trials.

In clinical trials, the larger scale comparative studies occur in four phases.

Phase 1: Screening for safety

Phase 2: Establishing the efficacy of the drug, usually against a placebo

Phase 3: Final confirmation of safety and efficacy

Phase 4: Sentry studies during sales

Therefore, medical professionals would expect that if a product were truly “clinically proven” it would have had testing in numerous trials that validate the claims beyond any reasonable doubt. Even then, the question arises whether any product can make such a claim.

Let’s take the example of a company that intends to test its ankle brace to determine if it can improve balance in older adults. The company sponsors a single study. In this study, researchers measure three different balance performance tasks in a laboratory setting with the study participants wearing the test brace and compare them to a barefoot group and a group only using shoes without the ankle brace.

The first question: Is this a clinical trial? The results of the study show that the test brace only improved balance in one out of the three tests and failed to show any significant improvement in the other two tests. The second question: Should this company advertise that the product has “proven” benefit?

A blog posted by Dr. Lucy Hornstein provides interesting insight on both of these questions.⁹ She states: “‘Clinical’ is an adjective referring to that which can be observed in or involves patients. It’s the hands-on part of medicine that can’t be replicated in a lab, not taught from a book. There is virtually no such thing as ‘proof’ in the scientific sense. Laboratory and patient-based medical research can strongly suggest things. Scientific evidence can accumulate supporting things; the more the better, of course.”

Dr. Hornstein makes an important point about using the word “proven” when summarizing the results of scientific research. The fact is that it is impossible to “prove” anything in a clinical trial. The best studies can only provide a probability of outcome based upon statistical analysis. No study can “prove” that any therapeutic intervention works. Therefore, the use of the term “proven” is inappropriate for use in scientific reporting and medical advertising.

Companies that advertise to well-educated medical professionals should raise the bar and maintain honesty and credibility when making statements regarding scientific studies of their products. I would suggest that companies use the term “clinically tested” when they have actually performed multiple clinical studies that have produced statistically valid conclusions. If a single laboratory study has occurred, the company should not use the word “clinical.” In all cases, companies should never use the word “proven” in advertising of medical products and this word’s use should be a red flag for misrepresentation of claims.

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