NARB PANEL #225 Appeal of the NAD Final Decision Regarding Advertising Claims for Neurocore, LLC Neurocore Brain Performance Centers Panel Members Jef Richards (Chair) Chair and Professor, Advertising & Public Relations Michigan State University Michael Bollinger President Smith Brothers Agency, LP Tim Alessi Director of New Product Development LG Electronics Adam Benaroya Senior Manager, Global Performance Media & Media Analytics Hewlett Packard Enterprises Russ Findlay Head of Marketing - CMO HISCOX Representing the National Advertising Review Board Alan Cohen, Vice Chair Saveeta Dhanai, Coordinator Representing Neurocore, LLC Mark Murrison, CEO Dr. Elyse White, Chief Science Officer Jason Mahar, In-House Counsel, Windquest Group Anthony E. DiResta, Holland & Knight, LLP DaMorus Cohen, Holland & Knight, LLP Representing the National Advertising Division Laura Brett, Director Kathleen Dunnigan, Staff Attorney La Toya C. Sutton, Staff Attorney
REPORT OF NARB PANEL 225 Decision Issued: June 04, 2018 Appeal of NAD Final Decision Regarding Claims by Neurocore, LLC for Neurocore Brain Performance Centers BACKGROUND Claims made by Neurocore, LLC ( Neurocore ) for its Neurocore Brain Performance Centers were reviewed by the National Advertising Division ( NAD ) as part of its ongoing monitoring program. The NAD requested that Neurocore provide substantiation for the following express claims: Non-quantified claims Control your anxiety without medication. Strengthen your brain to fight depression without medication. You ll experience improved memory, as well as better sleep, focus, mood, mental clarity and overall cognitive performance. A natural remedy for migraines. Sleep soundly without medication. Quantified claims Our Anxiety Outcomes* 1 90% report fewer or less frequent Anxiety symptoms 2 *** 78% achieve non-clinical status 3 Our Depression Outcomes* 4 1 The asterisk refers to the following statement on the bottom of the page: Of those presenting with a Clinical status (T-score 70) on the Achenbach System of Empirically Based Assessment (ASEBA) DSM-Oriented Anxiety Problems Scale. 2 A footnote refers to the following statement on the bottom of the page: Reduction of T-score by at least 1 point on the ASEBA DSM-oriented Anxiety Problems Scale. 3 A footnote refers to the following on the bottom of the page: Non-clinical status includes Borderline status (Tscore between 65 and 69) and Normal status (T-score < 65) on the ASEBA DSM-Oriented Anxiety Problems Scale. 4 The asterisk refers to the following statement on the bottom of the page: Of those presenting with a Clinical status (T-score 70) on the Achenbach System of Empirically Based Assessment (ASEBA) DSM-Oriented Depressive Problems Scale. 2
91% report fewer or less frequent Depressive symptoms 5 *** 72% achieve non-clinical status 6 Our ADHD Outcomes 7 90% report fewer or less frequent ADHD symptoms *** 76% achieve non-clinical status 81% of children who come to us on ADHD meds and complete our program are able to reduce or eliminate their use of medications upon program completion*. *Results of one research study done in collaboration with a major Midwest insurance company. 25% reduction in reported symptoms on the autism evaluation checklists. The NAD also requested substantiation for consumer testimonials advertised by Neurocore. The NAD determined that Neurocore s evidence was insufficiently reliable to substantiate the challenged express claims and recommended that the claims be discontinued. The NAD also recommended that Neurocore discontinue advertised testimonials claiming that Neurocore clients have reduced or eliminated the need for medication for ADHD, anxiety, depression, memory problems, migraines or sleep disorders. The NAD further cautioned Neurocore to discontinue its use of testimonials which make claims that Neurocore could not support. Neurocore has appealed the NAD s recommendations. FINDINGS AND CONCLUSIONS Neurocore program Neurocore Brain Performance Centers offer neurofeedback, biofeedback, psychoeducation, and lifestyle modification designed to help clients with a variety of issues including ADHD (Attention Deficit Hyperactivity Disorder), anxiety, depression, memory and sleep problems. 5 A footnote refers to the following statement on the bottom of the page: Reduction of T-score by at least 1 point on the ASEBA DSM-Oriented Depressive Problems Scale. 6 A footnote refers to the following statement on the bottom of the page: Non-clinical status includes Borderline status (T-score between 65 and 69) and Normal status (T-score < 65) on the ASEBA DSM-Oriented Depressive Problems Scale. 7 While the record does not include the specific website page with these advertised outcomes, it is the panel s understanding that these claims were accompanied by disclaimers similar to the ones used as part of the anxiety and depression outcome claims. 3
Neurocore clients undergo an initial assessment that includes the Achenbach System of Empirically Based Assessment ( ASEBA ), a collection of behavioral questionnaires used to assess an individual s competencies, strengths, adaptive functioning, and behavioral, emotional and social problems. 8 The results of the ASEBA are expressed as a T Score for individual disorders (e.g., ADHD, anxiety or depression) that indicates whether the individual is normal, borderline, or clinical with respect to that disorder. 9 Neurocore s expert stated that the ASEBA has been validated and correlated with other self-report evaluations including the Diagnostic and Statistical Manual of Mental Disorders, 5 th Edition, one of the basic tools used in modern psychiatry for the assessment and diagnosis of behavioral and psychological problems. The initial assessment also includes a series of biofeedback tests (heart rate, blood pressure, and breathing pattern) as well as a nineteen-site quantitative electroencephalography ( QEEG ) reading that maps electrical functions of the brain, compares those readings to a normal range, and identifies specific brain wave functions to target using neurofeedback. A Neurocore employee provides each client with an overview of the initial assessment. For clients who choose to continue, the basic Neurocore program consists of thirty sessions of biofeedback and neurofeedback designed to optimize the client s breathing and brain activity to remain in the normal range. Psychoeducation and lifestyle modification counseling is also provided when appropriate. Client progress is reviewed during the course of the thirty sessions. After completing thirty sessions, the client undergoes a post-assessment that is identical to the initial assessment. Substantiation offered by Neurocore In support of the challenged advertising claims, Neurocore relied on: Scientific treatises discussing the effectiveness of biofeedback and neurofeedback in treating various disorders; Expert reports as to the efficacy of neurofeedback and the reliability of the ASEBA; Clinical studies evaluating the efficacy of neurofeedback and biofeedback; and Neurocore s 2012 and 2016 internal studies that evaluated progress of clients based on their pre-treatment and post-treatment ASEBA scores. The scientific treatises submitted by Neurocore include analysis of studies evaluating the effectiveness of biofeedback and neurofeedback in treating a variety of physical and psychological problems. These treatises present a mixed view as to the effectiveness of neurofeedback in treating disorders such as ADHD, anxiety, depression, and Autism Spectrum 8 The initial assessment also includes The Pittsburgh Sleep Quality Index and The Insomnia Severity Index. 9 A T score below 65 is considered normal; a T score of 65-69 is considered borderline; and a T score of 70 and above is considered clinical. According to the expert testimony presented by Neurocore, a change of 3 points in the ASEBA T score is considered to be the minimal clinically important difference ( MCID ) (i.e., a change with clinical significance). 4
Disorder. While some treatises conclude that neurofeedback is efficacious in treating certain disorders, others note inconsistent study findings and the need for better studies. Neurocore also provided expert opinions from Dr. Thatcher, a member of Neurocore s scientific advisory board, who reviewed the science of neurofeedback and identified specific clinical trials that found neurofeedback to be effective in treating individuals with a variety of disorders. Dr. Thatcher noted that several of these studies used protocols similar to protocols used in the Neurocore program. Dr. Thatcher acknowledged that some neurofeedback studies had failed to establish the efficacy of neurofeedback but opined that these studies were technically flawed. Neurocore also submitted numerous clinical studies that it maintained show neurofeedback and biofeedback are effective in treating individuals with a variety of disorders that include ADHD, anxiety, depression and memory loss. Finally, Neurocore offered two internal studies that assessed progress made by clients in its program. The 2012 study evaluated 127 children who completed the Neurocore program. This study found that 48 of the children began the program on ADHD medication; approximately 65% eliminated the use of ADHD medication and another approximately 17% reduced their dosage. Neurocore s second internal study was conducted in October 2016 and compared pre/post assessment ASEBA T scores for Neurocore clients who (a) started treatment after July 2014 when Neurocore first began using the ASEBA as an assessment tool, (b) completed 30 neurofeedback sessions and a post-assessment evaluation, and (c) had pre-assessment ASEBA T scores in the clinical range (i.e., 70) for ADHD, anxiety, or depression. Has Neurocore provided a reasonable basis in support of the challenged express claims? Neurocore has the burden of providing a reasonable basis, through competent and reliable scientific evidence, to support the challenged health-related claims. The panel notes that the Federal Trade Commission ( FTC ) has generally defined competent and reliable scientific evidence as: Tests, analyses, research, studies, or other evidence based upon the expertise of professionals in the relevant area, that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results. While there is evidence in the record that supports the potential efficacy of neurofeedback in treating ADHD, it has been frequently noted in both scientific literature and individual studies that studies have shown inconsistent results and there is a need for further studies that are larger, randomized and controlled. The record also provides a lesser body of scientific evidence that supports the potential efficacy of neurofeedback in treating other conditions referenced in Neurocore advertisements (anxiety, depression, sleep problems, memory problems, migraines and Autism Spectrum Disorder), 5
although the results are not consistent and questions have been raised as to the sufficiency of studies that have been conducted. The record also includes support for the potential efficacy of biofeedback, by itself or in conjunction with neurofeedback, in treating some of the conditions referenced in Neurocore s advertising. The panel notes, as did NAD, that test protocols in the submitted studies vary widely. While Neurocore pointed to several studies that used protocols similar to Neurocore program protocols, Neurocore has asserted that its interventions are customized for each client. At the very least, this makes it difficult to determine the degree of scientific support for efficacy of the specific interventions offered by the Neurocore program. While the panel recognizes that Neurocore s internal studies are relevant to the outcome claims discussed below, the panel does not believe that these studies constitute competent and reliable scientific evidence establishing the efficacy of neurofeedback in treating a wide variety of disorders. It is clear, and was acknowledged by Neurocore s expert statistician, that this type of internal study data is observational and not reliable for predicting results with respect to a different population. The panel also agrees with the NAD s concerns that the internal studies were not controlled and were potentially influenced by experimental bias. Non-quantified claims challenged by the NAD Two of the non-quantified claims challenged by the NAD ( Control your anxiety without medication and Strengthen your brain to fight depression without medication ) reasonably convey a strong message that the Neurocore program will effectively enable clients to control anxiety or depression without medication. The panel agrees with the NAD that the record in this case does not provide a reasonable basis in support of this message. The panel also agrees with the NAD that Neurocore s substantiation is insufficient to support claims that promise Neurocore clients will experience improved memory, as well as better sleep, focus, mood, mental clarity and overall cognitive performance and claims that the Neurocore program provides a natural remedy for migraines or enables clients to sleep soundly without medication. Neurocore represented to the panel that, in light of the [NAD Decision], it had already discontinued the above non-quantified claims. The panel acknowledges this is an appropriate step and thanks Neurocore for its respect shown for the role of the NAD in ensuring the integrity of advertising. Quantified claims challenged by the NAD The challenged quantified claims are primarily client outcome claims made with respect to Neurocore s effectiveness in treating ADHD, depression and anxiety. Similar claims are made with respect to each disorder under the heading Our [Disorder] Outcomes and claim that: 6
A specified percentage report fewer or less frequent symptoms of the referenced disorder; and A specified percentage achieve non-clinical status with respect to the referenced disorder. The following disclaimers accompany these claims: With respect to the Our [Disorder] Outcomes heading, an asterisk refers to language at the bottom of the page stating Of those presenting with a Clinical status (T-score 70) on the Achenbach System of Empirically Based Assessment (ASEBA) DSM-Oriented [Disorder] Problems Scale. With respect to the report fewer or less frequent symptoms claim, a footnote refers to language at the bottom of the page stating Reduction of T-score by at least 1 point on the ASEBA DSM-oriented [Disorder] Problems Scale. With respect to the achieve non-clinical status claim, a footnote refers to language at the bottom of the page stating Non-clinical status includes Borderline status (T-score between 65 and 69) and Normal status (T-score < 65) on the ASEBA DSM-Oriented [Disorder] Problems Scale. As a starting point, the panel believes that the general Our Outcomes heading in the main claim reasonably conveys a message that the statistics set out below the heading represent outcomes for all clients who sought treatment from Neurocore for the specified disorder. This would necessarily include clients who did not start out with a clinical score as well as clients who did not complete the program. The asterisked disclaimer, which limits the claim to clients presenting with a clinical status on the ASEBA, would thus not be acceptable because it contradicts the main claim. 10 The panel also finds that the disclaimer referring to clients presenting with a clinical status on the ASEBA is confusing and not likely to be understood by consumers who are not familiar with psychological testing and/or the ASEBA. The panel is also troubled by the fact that the report fewer or less frequent symptoms claims purport to state a percentage of clients who have directly reported fewer or less frequent symptoms of the referenced disorder after treatment. However, the claimed percentage does not reflect actual reports of fewer or less frequent symptoms, but rather reflects a decrease in ASEBA T scores that is based on the ASEBA s interpretation of client responses to a variety of behavioral questions. The footnote referenced in the report fewer or less frequent symptoms claim is also confusing and not likely to be understood by consumers who are not familiar with psychological testing 10 While the panel recognizes that Neurocore may make truthful and non-misleading outcome claims limited to a specified subset of its clients, any such limitation should be clearly and conspicuously stated as part of the main claim. 7
and/or the ASEBA. In addition, the panel notes that the claimed lessening of symptom reports is based on a T-score reduction of at least 1 point despite Neurocore s assertion that a reduction of 3 points is considered to be the minimal clinically important difference. The panel further finds that one of the messages reasonably conveyed by the claim that a specified percentage achieved non-clinical status is that the specified percentage were clinically determined to have been effectively cured of the disorder, a message that is not supported by the record. The referenced footnote, while somewhat confusing, does not prevent a cured message from being reasonably conveyed. Neurocore represented to the panel that is has discontinued the above challenged quantified claims, although the panel is troubled by Neurocore s representation that it will continue to advertise the percentage of Neurocore clients who experienced a clinically important reduction of symptoms as well as the percentage of clients who no longer met symptomatic thresholds for ADHD/anxiety/depression. 11 In the context in which Neurocore s outcome claims are made, a claim that clients experienced a clinically important reduction of symptoms reasonably conveys a message that a significant reduction of symptoms has been clinically determined. Similarly, a claim that clients no longer meets symptomatic thresholds for a disorder reasonably conveys a message that it has been clinically determined the clients have been cured of the disorder. While the record shows that the ASEBA is one of many tools used to assess psychological disorders, the record does not support a finding that ASEBA results by themselves are determinative of whether a person is suffering from a psychological disorder or has experienced a significant reduction in symptoms. 12 Overall, the panel does not believe that a change in ASEBA T scores reasonably supports, or is a good fit for, the quantified improvement claims as advertised by Neurocore. 13 The NAD also challenged Neurocore s claim that 81% of children who started the Neurocore program on ADHD medication and completed the program were able to reduce or eliminate their use of medications upon program completion. This claim was based on the 2012 Neurocore internal study, which included 48 children who began the program on ADHD medication. This claim reasonably conveys a message that the elimination/reduction of medication was solely 11 While these claims were referenced in the NAD decision, they were not included in the list of claims initially challenged by the NAD. 12 In addition, the panel believes that claims that a client has shown a clinically important reduction of symptoms or no longer meets a disorder s symptomatic thresholds reasonably conveys a message that the improvement is behaviorally noticeable. While the record shows that the ASEBA sets 3 points as the minimal clinically important difference, the record does not support a finding that a 3-point drop in ASEBA T Scores, or a lesser point drop that takes a client s score out of the clinical range, results in behaviorally noticeable improvement. 13 Neurocore s quantified outcome claims are advertised as prominent headline claims. While a discussion of ASEBA results may be appropriate in other contexts on the Neurocore website or in Neurocore materials, the panel does not believe that quantified claims of client improvement based on ASEBA T scores should be made in headline claims as done in Neurocore advertising. Any such discussion should be careful to avoid stating or implying that changes in ASEBA T scores demonstrate that clients experienced a significant reduction in symptoms and/or were cured. 8
based on interventions provided by the Neurocore program, which is not supported by the record. Neurocore represented to the panel that it has discontinued this claim. Finally, the NAD challenged Neurocore s 25% reduction in reported symptoms on the autism evaluation checklists claim. Neurocore represented to the panel that it has discontinued this claim, which it notes was a reference to a published article. The panel agrees that discontinuance of the claim is appropriate. Testimonials Neurocore s website features numerous testimonials from Neurocore clients in both written and video form. Many of the video testimonials are also featured on Neurocore s YouTube channel. The FTC Guides Concerning the Use of Endorsements and Testimonials in Advertising ( FTC Guides ) provide that advertised consumer testimonials about the performance of an advertised service will be interpreted as representing that the service is effective for the purpose depicted in the advertisement. The FTC Guides further provide that advertisers must thus have adequate substantiation, including competent and reliable scientific evidence when appropriate, to support such claims as would be required if the advertiser made the representation directly. The FTC Guides also provide that advertised consumer testimonials relating to consumer experience on a central or key attribute of a service will likely be interpreted as representing that the consumer s experience is representative of what consumers will generally achieve with the advertised service. If the advertiser does not have adequate substantiation for that representation, the FTC Guides state that the advertisement should clearly and conspicuously disclose the generally expected performance in the depicted circumstances. The panel agrees with the NAD that a number of the challenged testimonials reasonably convey messages that the Neurocore program reduced or eliminated the need for medication for challenging conditions such as ADHD, anxiety or depression. The panel also agrees with the NAD that Neurocore has not provided adequate substantiation to support these claims as required by the FTC Guides. Neurocore represented to the panel that it has removed all testimonials from its website that reference reduction or elimination of medication. 14 However, a question was raised at the hearing as to whether Neurocore has removed these testimonials from its YouTube channel. The NAD also cautioned Neurocore to discontinue its use of testimonials which make claims that the advertiser could not support. This appears to require only that Neurocore do what the FTC 14 Neurocore also represented to the panel that it has added a global disclaimer to its website that includes the following statement: If you take prescription medication for any of [the conditions referenced on Neurocore s website or print materials], you should consult with your doctor before discontinuing use of such medications. The panel believes this is important information that should be clearly and conspicuously disclosed in any advertising stating or implying that the Neurocore program is drug free. 9
Guides require have adequate substantiation to support claims made through testimonials. 15 The panel agrees with the NAD that this is an appropriate caution. DECISION The panel recommends that Neurocore discontinue the challenged express claims, including quantified outcome claims based on Neurocore s internal studies. The panel notes that its decision does not preclude Neurocore from discussing on its website and in promotional materials in a truthful and non-misleading manner pre/post assessment ASEBA results in a context that (a) does not make headline claims based on ASEBA T score changes and (b) does not state or imply that changes in ASEBA T scores demonstrate that clients experienced a significant reduction in symptoms and/or were cured. The panel also recommends that Neurocore discontinue advertising testimonials, including those on YouTube, that claim Neurocore clients have reduced or eliminated the need for medication for ADHD, anxiety, depression, memory problems, migraines or sleep disorders. Finally, the panel recommends that Neurocore clearly and conspicuously disclose, in any advertising stating or implying that the Neurocore program is drug free, that consumers who take prescription medication for any condition for which Neurocore offers treatment should consult with their doctor before discontinuing use of such medications. The panel thanks Neurocore for its commitment to and participation in the advertising industry s self-regulatory efforts to ensure the truthfulness and accuracy of advertising claims. ADVERTISER S STATEMENT Neurocore will comply with the NARB panel s recommendations. Neurocore respects and values the self-regulatory process and appreciates the NARB s evaluation of Neurocore s advertising. Neurocore takes pride in being able to offer a viable, non-chemical treatment program for mental and behavioral conditions that impact millions of consumers. But Neurocore also takes pride in disseminating truthful and accurate information to consumers. As such, Neurocore is always looking for opportunities to more clearly communicate the benefits of its program to consumers and welcomes the NARB panel s recommendations. 2018. Council of Better Business Bureaus, Inc. 15 Neurocore represented to the panel that its website outcome claims now include a disclaimer stating that (a) individual results may vary and (b) the cited percentages are not claimed to represent typical results and are not intended to represent or guarantee that anyone will achieve the same or similar results. While the panel notes that the FTC Guides provide specific guidance as to the sufficiency of disclaimers such as results not typical and you are not likely to have similar results, the question as to whether Neurocore s current advertising complies with the FTC Guides is not before the panel. 10