'Cutting Edge' Program For Children With Autism And ADHD Rests On Razor-Thin Evidence

Jun 18, 2018
Originally published on June 25, 2018 9:35 pm

Some parents see it coming. Natalie was not that kind of parent.

Even after the director and a teacher at her older son's day care sat her down one afternoon in 2011 to detail the 3-year-old's difficulty socializing and his tendency to chatter endlessly about topics his peers showed no interest in, she still didn't get the message.

Her son, the two educators eventually spelled out, might be on the autism spectrum.

"I was in tears at the end," she says. "When I got home, I was just devastated."

Natalie broke the news to her wife, Stephanie, whose mind fast-forwarded to a distressing future. Would her son — a squat, cheerful boy who, despite his affectionate nature, didn't have any playmates — ever be able to make friends?

When a doctor eventually confirmed he had an autism spectrum disorder, the diagnosis came with a suggestion: Perhaps the boy would benefit from Prozac when he turned 7.

"That was when both of us fell apart in that meeting," Natalie says. For both parents, medication wasn't an option.

"Prozac is a very powerful drug for adults. Why would you give it to a 7-year-old?" Stephanie wondered after the doctor's visit. "I welled up with all of this emotion. And I said I will not let that happen."

(To protect their privacy, we are only using Natalie's and Stephanie's first names. We are not naming their children.)

The fear of psychotropic drugs led the family to pursue alternative treatments for autism.

To start, they dropped gluten.

Then one day, as Natalie roamed the aisles of a gluten-free expo in a Chicago suburb not far from where the family lives, she came across a booth for a Brain Balance Achievement Center.

Natalie says the program claimed to help with disorders ranging from dyslexia to ADHD and autism. Best of all, it didn't involve prescription drugs.

"We were very excited," Stephanie says. "Maybe we found a solution that wasn't going to be about medicine. I was very, very hopeful."

"It will completely, absolutely, 100 percent change your life"

Natalie had stumbled upon one of 113 Brain Balance franchises across the country. Seventeen more are in the works. In the dozen years since its inception, Brain Balance says, it has helped roughly 25,000 children. The company says it is currently taking in over $50 million in annual revenue.

Although Brain Balance isn't the only purveyor of alternative approaches for developmental disorders in the U.S., the scale of the enterprise sets it apart. The company's approach is still relatively new and not widely known, meaning many experts in the field of childhood development have not vetted its effectiveness.

Brain Balance says its nonmedical and drug-free program helps children who struggle with ADHD, autism spectrum disorders and learning and processing disorders. The company says it addresses a child's challenges with a combination of physical exercises, nutritional guidance and academic training.

An NPR investigation of Brain Balance reveals a company whose promises have resonated with parents averse to medication. But Brain Balance also appears to have overstated the scientific evidence in its messaging to families, who can easily spend over $10,000 in six months, a common length of enrollment.

Brain Balance's metrics for consumer satisfaction are impressive. Customers rate the program, on average, an 8.5 on a 10-point scale in surveys, according to the company.

The ratings square with comments in online forums and in interviews NPR conducted with 18 parents who enrolled their children. Across the country, about three dozen centers are run by parents who began as happy customers.

Brain Balance's website is where caretakers encounter the company's strongest pitch: dozens upon dozens of parent testimonials.

One of the company's television commercials begins with a montage of formerly frustrated mothers. But, they all agree, Brain Balance put an end to their kids' challenges. One woman insists "it will completely, absolutely, 100 percent change your life."

Autism "can become a thing of the past"

The man who created Brain Balance, Robert Melillo, is often introduced as "Dr. Melillo" in media appearances. He has a doctorate and an active license in chiropractic. He is also acknowledged as an expert in the field of functional neurology, chiropractic's controversial alternative to mainstream neurology.

Melillo's biography states he has master's degrees in neuroscience and clinical rehabilitation neuropsychology, though it does not say from where. A curriculum vitae for Melillo that NPR found on a website for chiropractic licensing boards says the master's in neuroscience came from the Carrick Institute for Graduate Studies, a chiropractic academy in Florida that isn't accredited by any of the agencies recognized by the Department of Education. His second master's degree is from a now-defunct program at Touro College, a private educational organization based in New York.

Melillo says it was during an intense period of research in the 1990s, while his own son struggled with attention issues, that he conceived of a single disorder to explain everything from autism to ADHD to dyslexia. He called it functional disconnection syndrome.

As he writes in his book, Disconnected Kids, the syndrome occurs when "areas in the brain, especially the two hemispheres of the brain, are not electrically balanced, or synchronized." The particulars of this imbalance are not clearly defined in the book, but numerous metaphors — some involving concert orchestras with bad timing or tuning — paint a picture of a child's brain unable to communicate with itself.

According to Melillo, a weak right hemisphere (the emotional half) can lead to autism and ADHD; a weak left hemisphere (the logical half) often causes learning disorders like dyslexia.

And he argues in the book that for people who follow his program, "ADHD, dyslexia, and even autism, among others, can become a thing of the past."

He even appears to see his program as the answer to societal problems.

In February, one day after the mass shooting at Marjory Stoneman Douglas High School in Parkland, Fla., Melillo used his public Facebook page to envision a world where Brain Balance had reached the shooter.

"I can't help but wonder if Brain Balance and Brain Integration could have prevented this tragedy," Melillo wrote in the post alongside a news report in which the shooter's relatives said the teenager had been diagnosed with autism and took medication.

"We have to make the whole world more aware of Brain Imbalances and how they can be helped especially in kids," he added. "This is my mission now."

What happens at Brain Balance

Stephanie and Natalie say they watched their older son from the other side of a two-way mirror as a Brain Balance staff member ran him through a series of tests during his baseline assessment. Later, they received his results: eight pages of ratings in unfamiliar categories.

"I have two master's [degrees] and a Ph.D., and I needed them explained to me," Natalie says. Their son had a weak right hemisphere. Additionally, his "frontal lobe acquisition" was lacking. His primitive reflexes were also in bad shape, according to the assessment, portions of which were shared with NPR.

The center recommended six months of one-hour sessions three times a week, a common course of intervention.

Brain Balance's approach breaks down into three broad categories: academic, nutrition and sensory-motor.

The academic exercises focus on the same areas targeted by many after-school tutoring programs. The nutritional component recommends decreasing a child's intake of gluten, dairy and refined sugar.

The third, and most complex, prong of Brain Balance's intervention is its sensory-motor training, a diverse set of physical exercises. Parents and former employees describe activities like walking across balance beams, syncing actions with a computerized metronome and being spun in swivel chairs.

Consistent with Melillo's theory, Brain Balance focuses much of its sensory-motor training on one-half of the child's body to send strengthening signals up and across to the supposedly weak, opposite hemisphere of the brain. (Much of the human brain indeed maps to the opposite half of the human body.)

For instance, with a "right brain weak" child like Stephanie and Natalie's son, Brain Balance may have him wear a vibrating armband on his left biceps or eyeglasses that allow light only onto the left visual field. Or they may simply have him stand on his left leg.

It has not been uncommon for parents to enroll their children for at least six months, costing roughly $12,000. The company recently said its average enrollment is now about four months. Assessments and optional nutritional supplements and blood tests can add hundreds of dollars.

The program isn't covered by insurance. Brain Balance offers payment plans to parents who can't cover the cost immediately. As of publication, close to 200 families have solicited money from relatives and friends with GoFundMe.com campaigns.

Natalie and Stephanie were quoted $5,000 for their first three months, with the option to re-up for more after.

"When you're talking about your child's self-esteem and knowing it's the most important thing, what are you going to do?" Stephanie says. "Maybe work a few more years and take a little bit out of your retirement so that maybe — if you nip this thing in the bud — he's able to have a better life going forward?"

They dipped into their retirement savings and enrolled both their sons at a total cost of more than $15,000.

"Cutting edge" science

In numerous media appearances, Melillo hasn't been shy about publicizing the strength of his program's scientific evidence.

"This isn't smoke and mirrors. This is real stuff. ... [Parents] are going to get real answers," Melillo told a radio host in 2010. "We've shown in our centers that we can correct these problems completely. We've proved that in research," he said on TV in 2014. "We use really cutting-edge brain science to address the issue," he said in 2016.

Yet a dozen experts in autism spectrum disorder, ADHD, dyslexia and childhood psychiatry interviewed by NPR all identified flaws in Brain Balance's approach.

They said the company's idea of imbalanced hemispheres was too simplistic and built upon the popular, discredited myth of the logical left brain and the intuitive right brain.

"It doesn't make sense," says Mark Mahone, a pediatric neuropsychologist at the Kennedy Krieger Institute in Baltimore. "In virtually every activity that one does ... both hemispheres of the brain are very, very active. ... It's not as simple as just being a left- or a right-hemisphere problem. Nothing is that simple."

As for the three-pronged Brain Balance regimen, experts NPR spoke with said there is no solid evidence suggesting gluten, dairy or sugar consumption affects ADHD, autism or dyslexia. And although physical exercise may have modest impacts on inattention and tutoring can help in school, these interventions can be found elsewhere for much less money. No expert suggested either as a front-line remedy for ADHD or autism.

Doctors and researchers NPR interviewed also questioned the diagnostic metrics Brain Balance uses.

For example, the company tests children for the primitive reflexes that drive infants to instinctively suckle or grab a finger. Natalie and Stephanie were told their son's lingering primitive reflexes were connected to his behavioral issues.

But multiple pediatricians said it is exceptionally rare for children older than 4 to retain any primitive reflexes.

"Typically by 1 year of age these primitive reflexes have disappeared," says Dr. Andrew Adesman, a developmental pediatrician at Cohen Children's Medical Center of New York. "The major exception is children who have cerebral palsy."

Melillo disagreed with the experts' opinions. "I think they're completely wrong," he says.

"Pediatricians rarely look at primitive reflexes after infancy, but if they did, they will find that, in many cases, they are still there," he wrote in an email.

Melillo also pushed back against the medical consensus that autism, ADHD and dyslexia aren't caused by hemispheric differences and that gluten doesn't affect such disorders.

"I can show you a lot of papers that actually say that there is a relationship between food sensitivities, gluten sensitivity and different types of issues and conditions," he says. "So again, it depends on the expert."

"Evidence based"?

There are two published studies of Brain Balance, which the company has said show that 81 percent of children with ADHD no longer displayed symptoms after three months in the program.

"We have two studies now," Melillo said on local TV in 2013. "So that means that we qualify as what we call 'evidence based' at this point."

Brain Balance touted one of the studies on its blog with the headline, "Control Study Shows Brain Balance Eliminates ADHD Symptoms."

The studies, however, have serious scientific shortcomings.

Melillo, someone with a clear financial interest in the outcome, co-authored the first one.

He also had parents rate their own children's improvement in ADHD symptoms but didn't compare them with other kids who weren't in Brain Balance.

Without a control group, a study cannot definitively determine whether an intervention — a pill or procedure or program — is the reason for improvement or whether any change is simply the placebo effect.

The second study did feature a control group of children with ADHD who didn't do Brain Balance. But it compared them with the same children from the first study published years earlier instead of randomly assigning children into simultaneous treatment and control groups.

"My issue with these data is that there's no legitimate comparison for the treatment group, so we really don't know if [Brain Balance] helps," says Dr. Paul Wang, deputy director for clinical research at the Simons Foundation.

The experts NPR consulted took issue with other aspects of the studies as well.

The kids in the treatment and control groups differed in important ways, the experts said, rendering comparisons between them less meaningful. The two groups weren't drawn from the same centers; all of the treatment group was medicated while only 60 percent of the controls were; and at baseline the controls scored more severe on an ADHD rating scale.

Curiously, even though the second study reused the treatment group data from the first study published years earlier, it reported different improvements on those same kids' test scores. The lead author on both studies, Gerry Leisman, a professor of neuro and rehabilitation sciences at the University of Haifa in Israel, explained one of the test score differences as a "reviewer correction" but did not provide explanations for any of the six remaining discrepancies.

Dr. James McGough, a professor of clinical psychiatry at UCLA's David Geffen Medical School, wasn't convinced by Brain Balance's published research. "It means absolutely nothing. ... What we have here, in my view, is a marketing piece."

At least one state remains similarly unconvinced.

In 2015, Wisconsin's Department of Health Services determined Brain Balance had "insufficient evidence" to show it was a "proven and effective treatment for individuals with autism spectrum disorder and/or other developmental disabilities," as the Milwaukee Journal-Sentinel reported. The state assigned Brain Balance to the second-lowest ranking on its five-tier system. The only lower ranking is for "potentially harmful" treatments.

Brain Balance defends its approach

Asked by NPR why Brain Balance hadn't been tested more thoroughly before its nationwide expansion began a decade ago, Melillo says the company was "faced with a dilemma." While he did feel an obligation to validate his approach, he says he knew Brain Balance worked and didn't want to deprive his clients of its benefits while waiting for clinical trials. "All these 25,000 families that we've helped, are they left suffering for years on end?"

"What was done to date was commensurate to the resources that we had," says Aleem Choudhry, the chairman of Brain Balance and a managing member at Crane Street Capital, which invested in the franchise in 2013.

The company says ADHD was the only disorder to be studied thus far because — contrary to the opinion of all the experts contacted by NPR — it is neurologically equivalent to others like autism, dyslexia and OCD. If Brain Balance improves ADHD symptoms, Melillo says, "then we believe that we're going to get the same results in the other types of issues, because they're really the same problem."

Melillo also says the company's proprietary records from about 80,000 before-and-after client assessments qualify as corroboration. Melillo disputed the idea that his company's own data may require third-party review. "Data is data," he says. "There's no bias in the way we collect this."

A new study of a computerized version of Brain Balance is underway at a Harvard-affiliated hospital and features a concurrent control group of children.

But Melillo says that questions about the research behind Brain Balance ultimately miss a larger, more important point.

"Families are out there struggling and suffering, and they don't really give a crap about the data or the research, to be quite honest," he says. "When they go through it and they see the difference in their child ... that's what matters to them."

Choudhry, the company's chairman, later clarified that "we very much do care about the data."

No easy answer

With both their boys enrolled in Brain Balance, the routine for Stephanie and Natalie's family was frantic.

Three times a week, Stephanie would ferry their sons against traffic to and from their sessions. Family dinners became more rushed. Soccer and swimming were abandoned.

Lost time is often a hidden cost of any form of treatment.

The mothers began observing changes in their older son. They say his previously weak sense of smell suddenly blossomed, first for brownies and then other foods. And he became less obsessed with characters he had repetitively sketched in his notebooks and imbued with rich inner lives. (His parents are torn as to whether this was a positive development.) He also advanced in certain Brain Balance measures, including his primitive reflexes.

"It's not that the needle didn't move on some of those dimensions," says Natalie. "But if you step back at the 10,000- or 100,000-foot view and say, 'Is this kid different in a way that his life is going to be better or altered?' the answer is 'No.' OK, so now he can smell brownies that he couldn't smell before but is his life different?"

She says she and her wife began to feel discouraged, thinking about the "aura around this program that says your child's going to be different and better-adjusted."

Eric Rossen of the National Association of School Psychologists isn't surprised by Brain Balance's popularity as an option beyond what schools and insurance will cover.

He says many parents are frustrated by mainstream medicine's limits when it comes to complex disorders like autism. And schools are sometimes too strapped for resources to provide students with learning disorders all the help their parents may want.

"Most parents will say they would die for their children," Rossen says. "So to say, 'I want to provide some therapy and pay a few thousand dollars' is quite short of dying for them and it's totally reasonable."

But he says "the problem is they are easy prey for certain providers that can make promises that cannot necessarily be kept or are not necessarily backed by scientific data."

For parents looking to find evidence-based third-party interventions, experts suggest the What Works Clearinghouse, which is backed by the Department of Education, or the Substance Abuse and Mental Health Services Administration's own resource.

Brain Balance's protocol doesn't appear to pose any physical or developmental harms to children. Instead, the program's costs may come in other ways: siphoning away time and money, and prolonging the hope in some parents that their child may one day shed his or her disorder.

Dr. Susan Hyman, a professor of pediatrics at the University of Rochester who has studied autism treatments for decades, says many alternative providers do this by offering an unrealistically simple solution.

"If you were to come to a traditional provider who said, 'You know I'm going to have you work really, really, really hard. ... I might have some drugs. Drugs have side effects. And 90 percent of the time, as an adult, he is still going to have autism,' that's a far less attractive message than 'I can help you.' "

Beyond Brain Balance

By the end of their older son's second three-month session at Brain Balance, Stephanie and Natalie had completely soured on it. They stopped believing that vibrating armbands and spinning in swivel chairs would translate to social success.

They decided to not continue.

Later, in second grade, their older son began to work with a social worker at school who taught him how to have socially acceptable conversation with his peers.

And Stephanie and Natalie did something else — the unthinkable.

They put their son on a medication called Strattera. Calibrating the proper dosage with tolerable side effects was a drawn-out process, but eventually they reached an equilibrium. Their older son ended up with a new diagnosis that has some overlap with autism but is more consistent with ADHD, which the medication treats.

Today, he seems to be navigating the world more successfully than before.

On a Saturday last August, their older son — who once plaintively asked his parents, "Why aren't I invited to birthday parties?" — had just wrapped up a party to celebrate turning 10 years old.

Natalie and Stephanie had pizzas delivered and rented a truck lined with pleather sofas on one side and video game systems along the other. The children sat in pairs and used their greasy fingers to dispatch their avatars against each other in virtual battle.

"They were yelling my son's name and saying 'Come play with me! Come play with me!' " recalls Natalie.

The birthday boy says he invited almost all of his friends, from school and camp, and all but one showed up, which was more than he could have ever imagined before.

"Because," he says before pausing. "I haven't had friends for a bit. Until I got my medicine. I got some treatment. I got help. Now, I have tons of friends."

The reporter, Chris Benderev, can be contacted at cbenderev@npr.org.

Copyright 2018 NPR. To see more, visit http://www.npr.org/.

MARY LOUISE KELLY, HOST:

Millions of families are trying to help their kids who have been diagnosed with developmental disorders like autism and ADHD. In the search for help, many consider approaches that lie outside the medical mainstream. One of them comes from a national franchise called Brain Balance.

(SOUNDBITE OF ARCHIVED RECORDING)

UNIDENTIFIED PERSON #1: If one hemisphere of the brain dominates the other, learning and behavior are affected. Brain Balance fixes this connection, resulting in a life-changing improvement.

KELLY: Over the past year, NPR's Chris Benderev has been investigating Brain Balance. He found the company's claims rest on shaky science. His story starts with one family who's spent thousands of dollars on the program to try to help their son.

CHRIS BENDEREV, BYLINE: When I first to get to Stephanie and Natalie's house outside Chicago, they try to explain to their sons who I am and why I'm here.

NATALIE: Right, so he's a radio reporter.

BENDEREV: But here's his way more interesting to two rambunctious boys - a fuzzy microphone cover.

UNIDENTIFIED CHILD #1: Fuzzy.

BENDEREV: (Laughter).

(CROSSTALK)

STEPHANIE: Stop. Stop.

UNIDENTIFIED CHILD #2: Hi.

NATALIE: Do you know what a reporter is?

UNIDENTIFIED CHILD #2: Yeah, like, a...

BENDEREV: So then they send their boys to go play in the basement.

NATALIE: So no music, guys, during the recording, OK?

BENDEREV: And eventually Stephanie, Natalie and I sit down in their living room. To protect their children's privacy, by the way, we're not using their last names or their kids' names. Stephanie starts their story back in 2011. That's when a doctor diagnosed her older son with an autism spectrum disorder. They were terrified.

STEPHANIE: It's, like, what is he going to be capable of? Is he going to have a buddy, a friend? Is he going to have a best friend?

BENDEREV: But Natalie says that the possible treatment was just as scary.

NATALIE: That doctor at that time - one of the things he said is, at some point, you may want to medicate him.

BENDEREV: Specifically, medicate their son with Prozac when he turns 7.

STEPHANIE: I'm like, Prozac is a very powerful drug for adults. Why would you give it to a 7-year-old? And I welled up with all of this emotion, and I said, I will not let that happen.

BENDEREV: Stephanie and Natalie were determined to avoid any medication, so they tried other things, like giving up gluten. And then one day at a gluten-free conference, they heard about something new called Brain Balance. Here's one of their TV ads featuring parent testimonials.

(SOUNDBITE OF ARCHIVED RECORDING)

UNIDENTIFIED PERSON #2: It will completely, absolutely, 100 percent change your life.

UNIDENTIFIED PERSON #3: If your child is struggling, Brain Balance works. Call 800...

STEPHANIE: We were very excited. I was very excited that maybe we found a solution that wasn't going to be about medicine.

BENDEREV: So they signed up and got their son evaluated at a center. And then they got his scorecard back.

NATALIE: Like, they gave you this two-page sheet of bubble charts, and a lot of those things - even though I have two masters' and a Ph.D., I needed them explained to me.

BENDEREV: The scorecard had lots of terms that they hadn't heard before, terms that most people haven't heard. Apparently their son had poor frontal lobe acquisition and unsuppressed Galant and asymmetric tonic neck reflexes. It sounded alarming, but the staff was friendly. Her son liked it - and best of all, no meds. And they say they were told Brain Balance's training program would treat his autism which was causing problems socially.

STEPHANIE: He would say things about not being able to make friends. Why aren't I invited to birthday parties? Why don't I have playdates? So those...

NATALIE: He'd see his little brother having those experiences, and he wasn't having them. And he couldn't understand why.

BENDEREV: Brain Balance did cost a lot. But...

STEPHANIE: At that point when you're talking about your child's self-esteem and knowing it's the most important thing, what are you going to do? Maybe work a few more years. Take a little bit out of your retirement so that maybe if you nip this thing in the bud, he's able to have a better life going forward.

BENDEREV: Did you have to do things like that - take money out of retirement?

STEPHANIE: At that time, that's what we did.

BENDEREV: They were not alone in taking that plunge. Brain Balance has over 110 centers in the U.S. and more on the way. It's not uncommon for parents to enroll their kids for at least six months, which costs about $12,000. Insurance doesn't cover Brain Balance, so everything is out-of-pocket. But the company says that its new theory of the brain has helped 25,000 kids so far, which makes it a pretty big player in the world of alternative therapies. So what is Brain Balance's program, and who came up with it?

(SOUNDBITE OF ARCHIVED RECORDING)

UNIDENTIFIED PERSON #4: Dr. Robert Melillo is here this morning. Doctor, good to see you this morning.

UNIDENTIFIED PERSON #5: It's nice to meet you.

ROBERT MELILLO: It's great to be here. I'm very excited.

BENDEREV: Robert Melillo created Brain Balance. He's a licensed chiropractor. And in the 1990s, he formed this grand theory about ADHD, autism, dyslexia and other developmental and learning disorders. He says they are all really the same problem - an imbalance in the brain. Specifically, one half or hemisphere becomes weaker than the other half. Here he is on local TV.

(SOUNDBITE OF ARCHIVED RECORDING)

MELILLO: So for instance, dyslexia, language problems, academic problems are really more left-brain delays. And on the other hand, we get someone with, like, ADHD or OCD or autism. They have a right-brain delay.

BENDEREV: At Brain Balance, they say they do a few different things to rebalance the brain. They modify diet - no gluten or dairy, a lot less refined sugar. They do academic tutoring, and they do something called sensorimotor training. To explain one aspect of it, think back to high school biology.

Maybe you remember how each half of your body is controlled by the opposite half of your brain. So for a boy with autism, which Brain Balance claims is a weak right brain, they try to activate the left side of his body. They'll have the boy wear sunglasses that only let in light to his left visual field or wear an armband that vibrates on his left arm or just stand on his left leg for a while. These activations, they say, will travel up and across to strengthen the right brain.

So the big question, is does Brain Balance work? Well, whenever Robert Melillo goes on local TV or radio to promote a new center, he says it's scientifically proven to deliver big results.

(SOUNDBITE OF ARCHIVED RECORDING)

MELILLO: Yeah, I mean, there's a lot of science underneath this, and again...

We've shown in our centers that we can correct these problems completely. We've proved that in research.

You know, most of the kids come in. They're on medication. And by the time they leave, they've been taken off that medication by their doctor.

BENDEREV: But NPR spoke to over a dozen experts in ADHD, autism and child psychology, and they say Brain Balance's science doesn't hold water. For one thing, Robert Melillo's theory is based on the popular myth that the left brain does logic, and the right brain does emotion. But Mark Mahone, a pediatric neuropsychologist at the Kennedy Krieger Institute, says...

MARK MAHONE: In virtually every activity that one does, both hemispheres of the brain are very, very active. And it's not as simple as just being a left or right hemisphere problem. You know, nothing is that simple.

BENDEREV: When you ask Brain Balance about their evidence, they point you to two studies which report a big improvement in ADHD symptoms after three months in the program - nothing on any other disorders yet, by the way. But those two studies have serious flaws. For one thing, the first study had Melillo as one of its authors.

JAMES MCGOUGH: You can't research your own product and declare it a success. That's not considered legitimate.

BENDEREV: That's Dr. James McGough. He's a child and adolescent psychiatrist at UCLA who's been studying ADHD and autism for decades. He and several other experts we talked to say the biggest problem with the first study was this. There was no control group of kids who didn't do Brain Balance. If you can't compare to a control, you can never know if any improvement is just a placebo effect. Dr. Paul Wang of the Simons Foundation has run a lot of clinical research on autism in his career. And he says another problem with this first study - parents were the ones scoring their kids' ADHD symptoms.

PAUL WANG: The parents know what treatment the child is getting, and if they hope the child will get better with the treatment, then that might be reflected on their scores.

BENDEREV: In other words, the parents might be scoring their kids higher because they want them to get better. Now, Brain Balance's second study did have a control group - kids who didn't do the program. But that's all that it had. It simply compared new kids to the kids from the first study three years earlier. Here's James McGough of UCLA again.

MCGOUGH: They did their one study, then they just found a bunch of other kids and compared them to those. That's not scientifically sound.

BENDEREV: Now, there is a new third study underway, but the results aren't in yet.

MCGOUGH: So this claim that this is evidence-based is somewhere between a fantasy and just a lie.

BENDEREV: When we asked to talk to Brain Balance about their science, they arranged an interview with their creator.

MELILLO: I'm Dr. Robert Melillo. I'm the co-founder of Brain Balance Achievement Centers, and I'm also associate professor at Northwest University.

BENDEREV: At Northwestern University?

MELILLO: No, at - actually, I'm sorry - at...

BENDEREV: Sure.

MELILLO: ...National University for Life Sciences (ph) in Chicago.

BENDEREV: We looked it up. He's adjunct faculty at the National University of Health Sciences in Chicago, which offers degrees in chiropractic, acupuncture and similar fields. And as a reminder, he is not a medical doctor. Melillo says that the experts we spoke with are, quote, "completely wrong about his program." He says he wishes he had better studies, but he says the company hasn't had enough resources to pay for those, and he didn't want to wait and deprive kids of something that in his eyes works. And he reminded me that Brain Balance has its own internal data from all the assessments it's ever run on kids.

MELILLO: We have something like 80,000 before-and-after assessments that we've looked at. The data is there. We have it. We see it. The best way to get it out there is another thing. This isn't just anecdotal. This is real.

BENDEREV: The data have not been published in a peer-reviewed academic journal. But Melillo disputes the idea that he's overstated the company's scientific legitimacy. He says he doesn't feel that he's misled anyone, and he feels that arguments about the science miss a more important point.

MELILLO: You know, we can go and argue. Parents are out there, and families are out there struggling and suffering. And they don't really give a crap about the data or the research, to be quite honest. They care about, what are you going to do for my kid? And when they go through it and they see the difference in their child, that's what matters to them.

BENDEREV: And Brain Balance says it has a lot of happy customers. The company says their average satisfaction rating is an 8.5 on a 10-point scale. We talked with 18 parents who enrolled their kids, and the majority were very pleased. But not everyone is satisfied.

STEPHANIE: We were like, this is not what we thought it was going to be. This is not working. And then we just said, we're done with this.

BENDEREV: Stephanie and Natalie stopped Brain Balance after six months. They'd spent over $15,000 at that point. And for what it's worth, they say they did notice that their son's sense of smell had improved. But that's not why they signed up.

UNIDENTIFIED CHILD #2: Mommy, did...

BENDEREV: They say their son has gotten better at socializing. He started sessions with a social worker at school, and he takes medications...

NATALIE: Hey, buddy. Will you take that for me, please?

BENDEREV: ...Not Prozac, which they've been so scared of. Their son's diagnosis eventually morphed into something closer to ADHD, and that's what he takes his meds for. On the day I arrived, their older son had just had his 10th birthday party.

Tell me about your birthday party today.

UNIDENTIFIED CHILD #2: Can I get a drink first? I'm...

BENDEREV: Yes, you may - very polite.

He says it was amazing. A bunch of his friends showed up, and everybody was playing video games and having a great time.

UNIDENTIFIED CHILD #2: I haven't had friends for a bit, as my mom has already told you, until I got my medicine. I got some treatment. I got help. Now I have tons of friends.

BENDEREV: His parents, Stephanie and Natalie, found a system that works for them, and they're glad to have Brain Balance behind them. The people they met at Brain Balance were clearly trying to help their son, they say. But they feel misled by how it was marketed.

NATALIE: You're reading the parent testimonials. You're caught up in the emotion of having maybe found something.

STEPHANIE: You want help for your child, and this is a company that claims to help your children. So that's what you're expecting.

NATALIE: So it's really good marketing to a desperate market.

BENDEREV: They say they were part of that market, and now they want others in it to hear their story. Chris Benderev, NPR News. Transcript provided by NPR, Copyright NPR.

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