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    Claims Substantiation

    To Tell the Truth? Or Just Tell a Lie?

    ...

    To Tell the Truth? Or Just Tell a Lie?
    People cheat—if they think they'll get away with it.
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    Nava Dayan, Dr. Nava Dayan LLC03.01.17
    Telling the truth is telling the facts with no judgment, from an objective point of view, with a degree of humility. It means revealing all the facts, not only the ones that may be beneficial or dovetail with one’s goals. It means highlighting limitations and revealing that we can only hypothesize, not conclude.


    Telling the truth is being moral, open, secure and, most of all, brave with no fear of loss or judgment from others. But human nature is selfish, self-preserving and egotistic; as a result, we often lie. Thankfully, many of us live in an environment that teaches moral values; the result is that most of us lie just a little. In this way, we think that we still gain from the lie but don’t feel too badly about ourselves. When it comes to business, creating false impressions for the consumer is so common it is the norm. We play the game of lying and being lied to—no wonder we live in mistrust and fear!


    Dan Ariely is the James B. Duke Professor of Psychology and Behavioral Economics at Duke University. A behavioral economist, he studies irrational behavior in business and explores the hidden reasons behind cheating.


    Ariely maintains that people ask themselves, “how much will I gain from my lie and how much do I lose if I am caught?” But in considering this equation, we tend to significantly minimize or even ignore the outcome of lying. If we lie we will be lied to.


    Kabbalists, who study the structure of the human soul, explain that because humans are created with a bad nature, we are constantly challenged to turn to good. Being bad and egotistical comes naturally. Being good and considerate requires constant work and spiritual fine-tuning.


    According to Ariely, we lie as long as it does not change our impression about ourselves. This sense of self-impression seems to be not only individual and flexible but mostly dependent on the environment we are in and on our emotional identity. According to Kabbalah, the only self-choice we have is selecting our environment—the people we are with, the books we read, the programs we watch, and places we go.


    In one experiment, Ariely discovered that those who swore by the Bible (even if they define themselves as atheists) or were asked to repeat the 10 Commandments before acting upon a task in which they could cheat, did not cheat at all. On the other hand, those who were exposed to a member of their team who cheated publically cheated much more and to a higher degree. Moral ethical behavior is, therefore, teachable; it is a behavior that if supported by the community, is exercised commonly. In our industry, we often hear: “everyone in the industry is cutting or rounding corners” therefore we are more likely to behave in a similar fashion.


    Does it mean that we all need to read and sign an ethical code manifest before and perhaps even during a project? Or perhaps we should constantly tune to our core ethics and make sure we surround ourselves with others who have high moral and ethical values?


    A concept that has been developed in modern life is adding another layer to this challenge.


    We all have multiple roles that we try to balance in day-to-day activity. We have roles within our core and expanded family, the workplace and social circles. Since each is a different environment, some of us lose unity of behavior. There is no logical reason why a mother should behave in a different manner to her children and to her employees as a manager if she is tapping into her inner core. Retaining such wholeness is a skill that can assist in day-to-day activities. A mother is not likely to mislead her children. Why would the same woman deceive her clients?


    What Would Mama Do?

    When leading a project that is associated with generating claims, our industry would probably look very different if we all treat our clients as if they were our children; if we tune our intention to such path of thinking and behavior, if we engage our hearts to our work and be one. Such practice is not only ethical, it creates focus of thoughts and most important, makes it easier to detect inaccuracies and dishonesties. A person who is truly honest has better clarity in understanding when others try to be deceptive.


    Being in the scientific and technological era of humanity, we learned, not rightfully, that scientific findings are held in high regard. If science reveals findings we tend to adopt them as if they are the ultimate truth. We forget that science is research; meaning re-searching. It is never the truth—it is what we believe to be the answer. It is a tool of exploration and re-exploring using our very own limited senses: sight, sound, smell, taste, and touch is the toolbox born to most of us.


    We must go further. In skin care product development, there are several common practices used to generate unreliable claims, which are detailed here.


    Presenting data that are not statistically significant. Such practice can be linked to a variety of aspects in study design such as the number of samples or panelists is too small to generate statistics or the generated statistics point toward non-significance but are omitted from data presentation and interpretation.


    Statistical significance is a key element in testing a scientific hypothesis. It helps determine whether the hypothesis should be precluded or adopted. If study results are not statistically significant, the phenomenon presented, for example improvement in the appearance of wrinkles, may be accidental and such claim should not be made. It means that the product may not work in the manner presented in the majority of the population.


    Conclusions based on anecdotes. Often a product idea materializes from personal experience of use or from family or friends sharing their experience. Basically, anecdotal evidence is a story told by individuals. As such, it cannot and should not be trusted and should not be used as a claim or in an advertisement. Even if several individuals tell similar stories, this is still not evidence. To substantiate anecdotal evidence an organized research should be conducted on a sufficiently large panel, in a scientifically savvy manner such that it allows researchers to draw statistical significance.


    Using non-relevant, more responsive population. The study tools should, as much as possible, reflect the population for which the product is intended. For example, in many in vitro models, skin cells are derived from foreskin. This is primarily for two reasons; one, it’s an easily accessible skin and two, since it is obtained from a newborn, these cells are very responsive and quickly divide, making the experiment faster, easier and cheaper. However, if the population of interest is elderly, cells derived from an elderly individual will reflect a better baseline to substantiate the claim. When considering a clinical study, if the product for example is aimed at elderly post-menopausal population but the study is conducted on young women population, the results may not reflect the true in-use goal. Young skin may be faster and more significant to respond when compared to elderly. In this case, results that are significant in young panel may not at all preform at the more senior population of interest. Such practice should be employed not only for age but also for other key factors such as lifestyle, ethnicity, season and environmental exposure. It requires the study and definition of the population of interest not only from a marketing perspective but more importantly, scientific perspective.


    Placebo-less studies. Many studies are conducted where the treatment formulation is compared to baseline before treatment begins and not to the base formulation without the actives claimed for activity. This may be very misleading. For example, a new moisturizing agent can be incorporated into a base formulation that contains glycerin. Since glycerin is a humectant and a moisturizing agent, it may exhibit a moisturizing effect. If the base alone is not being tested, one will not know the attributed effect of the glycerin and if the test article of interest is superior to it.


    Not revealing formulation content. The formula content is critical. Many compounds that are considered as non-actives may exhibit a biological, physical activity as well as cause adverse reactions. For example, high levels of surfactants can enhance skin permeation of actives, an occlusive formulation that is anhydrous or w/o emulsion may reduce transepidermal water loss and affect both skin hydration and permeation. If the composition and properties of the formulation are not revealed, one is limited in analyzing the potential reasons for the claimed effect on the skin.


    Not revealing method limitations. As noted, research, even if planned carefully, cannot fully predict real life exposure. Even a well-designed clinical study exhibits limitations. Revealing and explaining the study limitations alongside its benefits may assist in considering the results. For example, in recent years is has become popular to use gene expression to generate claims. But if gene expression has been upregulated or down regulated as a result of product treatment, even if significant, it cannot be correlated to activity—it merely presents an opportunity for correlation. After a gene is expressed, it must undergo an intense long cascade of biological events to be clinically relevant. Generally, in vitro studies, if not further correlated to clinical attributes, should not be used for claims. For example, if a compound is affecting levels of collagen in cell culture this is all it means under the set conditions of the limitations of the study. Claiming that it exhibits an anti-aging effect based on this fact alone is fabrication.


    Not revealing adverse reactions. A well planned clinical study for efficacy should include safety endpoints of observation, assessment, documentation and reporting. This is true even if the product was previously tested for some skin adverse reactions; i.e., primary irritation, sensitization or any other experience, measurable or not that is noticed and reported by panelist and study director. Such data should be collected, analyzed and considered in the product development path if assessed as important. Depending on the magnitude of reporting and its severity, professionals should be reviewing it and determine if such reports require a shift from original path. For example, if an individual reports severe systemic allergy to a product, even if the product is not affecting a large population of the study, the fact that it triggered potential anaphylaxis is alarming.


    No comparison to known benchmarks. If a study is conducted with the objective of presenting benefit but the consumer cannot relate to it or understand it, it may be of no value. Including in the study a known product or ingredient assists in relating the value to a known benchmark.


    In summary, when conducting an efficacy claims study, the question is not, “What should be selected from the results and presented to consumer to persuade purchase?” but rather, ”What does the consumer need to know about the product so that a decision to purchase can be made based on shared information?”



    Nava Dayan
    Owner
    Dr. Nava Dayan LLC

    Nava Dayan Ph.D. is the owner of Dr. Nava Dayan L.L.C, a skin science and research consultancy and serving the pharmaceutical, cosmetic, and personal care industries. She has 25 years of experience in the skin care segment, and more than 150 publication credits.
    Tel: 201-206-7341; E-mail: nava.dayan@verizon.net
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