Proposed Settlement Allows for Continued Deceptive Marketing of Neuriva
TINA.org files brief urging court to deny final approval of settlement that is unfair to consumers.
Unsubstantiated claims to treat ADHD, autism and depression are rampant in company's marketing.
Neurocore, a “brain training” company backed by Education Secretary Betsy DeVos with centers in Michigan and Florida, claims on its website to offer “[s]cience-based, drug-free programs to strengthen your brain.” The medical conditions the company asserts its programs treat — in a drop-down list on its website under “Who We Help,” among other places — are impressive, and include ADHD, anxiety, autism spectrum disorder, depression and migraines. Clicking on the majority of these maladies leads visitors to a page with testimonials from patients or the family members of patients who have completed Neurocore’s 30-session program. One ADHD testimonial states, in part:
My 7-year-old son struggled with two main issues, ADHD and sleep interruption. In an effort to avoid medication, we decided to try Neurocore. His sleep improved almost immediately. He is more focused now and his teacher reported a significant improvement in behavior and his ability to focus and complete assignments after about the halfway mark [of treatment].
An excerpt from another testimonial from a parent of a child with depression says:
My daughter was struggling with severe depression. She had days when she couldn’t get off the couch. Her personality changed — my sweet, kind child became angry, self-loathing, and withdrawn. My husband and I didn’t know what to do… My daughter no longer suffers from depression. She has literally transformed.
These are just two of the many problematic disease-treatment claims present in Neurocore’s marketing — problematic because Neurocore does not posses the competent and reliable scientific evidence that is required by law to make such claims. (Hence the disclaimer that states, in part, “Results will vary. Consumers should not expect to experience the same results,” though such a disclaimer does not get Neurocore off the hook, legally speaking.)
In fact, TINA.org has compiled more than 150 examples in publication today in which Neurocore claims, directly and through the use of testimonials, that its brain training programs can treat or alleviate the symptoms of medical disorders including ADHD, anxiety, autism, depression, migraines, memory loss and insomnia, without sufficient scientific evidence to support the claims.
Unsubstantiated health claims are not limited to the company’s website. They can also be found on Neurocore’s various social media pages:
As a result of these findings, TINA.org on Tuesday filed complaints with the FTC and FDA urging the agencies to take appropriate enforcement action.
“For several years now, Neurocore has brazenly marketed its services to susceptible populations with inappropriate disease-treatment claims,” said TINA.org Executive Director Bonnie Patten. “Taking advantage of those with mental health issues and psychiatric disorders to turn a profit is simply not acceptable.”
How it works (or doesn’t)
Neurocore’s brain training programs, which include an at-home regimen called Neurocore Thrive, use a technique called neurofeedback. Advocates of neurofeedback like Neurocore believe it’s possible to regulate the brain — and in Neurocore’s case, form and strengthen new connections and pathways, resulting in the “non-invasive treatment” of a number of medical conditions — by monitoring the organ in real time. A session at one of Neurocore’s “brain performance” centers consists of watching a 45-minute movie on a computer screen that pauses or shrinks depending on the client’s brainwave activity and breathing patterns, while neurofeedback sensors connected to the client’s ears and head measure the electrical activity of the brain. Neurocore charges around $2,000 for 30 of these sessions.
But neurofeedback has its critics. As the National Advertising Review Board (NARB), the appellate unit in the advertising industry’s system of self-regulation, noted in a decision that affirmed a previous ruling involving Neurocore’s unsubstantiated health claims:
…the results [of studies that have investigated neurofeedback’s ability to treat serious medical conditions] are not consistent and questions have been raised as to the sufficiency of studies that have been conducted.
Robert Thibault, a neuroscientist and postdoctoral researcher at the University of Bristol, is among those raising questions. In a 2018 guest blog on TINA.org, Thibault had this to say on the perceived benefits of neurofeedback after reviewing “thousands of academic papers” on the topic:
Changes in behavior relied purely on placebo effects. … false feedback worked just as well as real feedback. In other words, it doesn’t matter if you watch your own brain, or if you watch a recording of Jim’s brain from last week, you’ll improve all the same.
The benefits seem to stem from being highly motivated and exerting effort, rather than from altering brainwaves.
In other words, neurofeedback patients trick themselves into believing the therapy works.
Other experts, commenting specifically on Neurocore, warn that the company’s business and marketing practices can lead consumers to ignore proven treatments.
“This causes real harm to children because it diverts attention, hope and resources,” Dr. Matthew Siegel, a child psychiatrist who co-wrote autism practice standards for the American Academy of Child and Adolescent Psychiatry, told The New York Times in 2017. “If there were something out there that was uniquely powerful and wonderful, we’d all be using it.”
Russell Barkley, a psychiatry professor at Virginia Commonwealth University and ADHD specialist, said in an interview with the Washington Post in 2017 that attempting to regulate the brain with neurofeedback could actually make brain function worse. (Unlike these experts, the assessments used by Neurocore staff to diagnose individuals with conditions such as ADHD and depression are conducted by social workers.)
Neurofeedback is not an FDA-approved therapy — for any medical condition. Meanwhile, in the case of ADHD, the FDA has approved several medications to help reduce symptoms and improve functioning in children as young as six.
Increased scrutiny of brain training programs
TINA.org is not the first to challenge Neurocore’s unsubstantiated health claims. In 2017, the National Advertising Division recommended that Neurocore discontinue several disease-treatment claims after it found evidence offered by the company in support of the claims “insufficiently reliable” to substantiate them. When Neurocore appealed the decision to NARB, which would eventually affirm the ruling, the company said in a statement that it “stands firmly behind the accuracy and integrity of the results reported by the clients who complete its program.” But, according to the NAD press release in which this statement appears, Neurocore’s own statistician understood that internal client data weren’t a good fit for the types of treatment claims the company was making:
NAD noted that, as Neurocore’s own statistical expert report explained, there is a difference between clinical studies and observational studies. Observational studies, like Neurocore’s review of internal data, provide information on the treatment of a particular group of people but they do not provide a basis for inferring or projecting how another population will respond to the same treatment. As Neurocore’s statistician explained, “descriptive statistics do not, however, allow us to make conclusions beyond the data analyzed.”
To put it a different way, internal client data do not meet the definition of competent and reliable scientific evidence, which is what is required to substantiate these types of disease-treatment claims. (For such advertising claims, marketers need at least one randomized, controlled human clinical trial.)
This is a lesson that the marketers of Lumosity learned the hard way. After the FTC alleged in a 2016 complaint that the company exaggerated the cognitive benefits of playing its “brain training” games, Lumosity agreed to pay $2 million to settle the deceptive advertising charges. Said FTC Commissioner Julie Brill at the time:
I write … to express my concerns regarding the marketing of brain training programs going forward. In particular, I caution Lumosity and other companies about making representations that overstate the benefits of these products or misleadingly imply that improvements in the game transfer to real-world benefits … Because claims that indicate scientific support can easily imply to consumers greater health benefits than are actually the case, companies marketing brain training products should carefully evaluate their advertising to make sure consumers do not take away a stronger efficacy message than scientific evidence supports.
The settlement also prohibits Lumosity from making certain representations about its product unless it has the proper science to back up its claims. The FTC is seeking a similar outcome to its lawsuit against the makers of Prevagen, a supplement marketed to improve memory that makes some of the same claims targeting seniors as Neurocore’s Memory Boot Camp.
Read more about TINA.org’s complaint against Neurocore here.
UPDATE 9/25/20: In January 2020, NARB referred advertising claims by Neurocore to the FTC after determining that Neurocore was not complying with the panel’s recommendations despite saying it would. In April 2020, the FTC informed NARB that it was closing out its investigation after discussions with Neurocore that resulted in the company clarifying efficacy claims based on client outcome data and adding clear and conspicuous disclosures. “Accordingly, we have determined not to take additional action at this time,” the FTC said.
TINA.org files brief urging court to deny final approval of settlement that is unfair to consumers.
TINA.org complaint comes four years after MLM paid $200 million to settle FTC deceptive advertising charges.
We have to make sure we’re not seen as “taking advantage of a crisis situation,” said DSA President Joe Mariano.