Thursday, 26 January 2017

Betsy DeVos and 'Neurocore.'

DeVos-Backed Company Makes Questionable Claims on Autism, ADHD

Betsty-Devos-Confirmation-Hearing-Blog.jpgPresident Donald Trump's nominee to head the federal Education Department is a major backer of a company claiming its neurofeedback technology can "fix" problems such as attention-deficit hyperactivity disorder and has "proven and long-lasting" positive effects on children with autism.
Current scientific evidence does not support such claims, according to the clinical guidelines of the American Academy of Pediatrics and three leading researchers consulted by Education Week.
"It's misleading the public to say neurofeedback is effective in treating kids with ADHD and autism," said Nadine Gaab, an associate professor of pediatrics at the Boston Children's Hospital and a faculty member at the Harvard Graduate School of Education. 
"It's still an experimental treatment that needs more rigorous research," she said.
Launched in 2006, Neurocore is based in Grand Rapids, Mich. That's also the hometown of billionaire school-choice advocate Betsy DeVos, Trump's pick to become U.S. Secretary of Education.
DeVos sat on Neurocore's board from 2009 until November, when she resigned the position to avoid potential conflicts of interest should she be confirmed. As part of her divestiture plan, which has been approved by the federal Office of Government Ethics, DeVos and her husband will maintain an indirect financial interest in the company. On her disclosure forms, DeVos valued that stake at between $5 million and $25 million.
The Senate Health, Education, Labor and Pensions committee is scheduled to vote on DeVos' nomination on Jan. 31. Democrats have unsuccessfully pushed for a second chance to publicly question DeVos, whose plan to shed potential conflicts of interest had not been approved and made public at the time of her Jan. 17 hearing before the committee. Critics have also questioned DeVos' grasp of federal special education law and commitment to evidence-based science, among other complaints.
A spokesman for the DeVos family declined to respond to Education Week's inquiries about their investment in Neurocore.
"Currently, questions such as this and others submitted by senators are being answered and will be provided to the committee," John Truscott, the president and principal of Michigan public-relations firm Truscott Russman, wrote in an email.
The Trump administration did not respond to Education Week's request for comment.
Neurocore CEO Mark Murrison defended his company's work and marketing. He pointed to an emerging body of research in which neurofeedback in general has shown promise, as well as information Neurocore collects from its clients.
"What we provide to our clients truly makes a difference, and our internal outcomes data and testimonials bear that out," Murrison said in an interview.

An area of interest for the FTC

Over the past two years, the Federal Trade Commission has cracked down on a number of other companies for making unsubstantiated and misleading claims about "brain training" products and services, such as digital learning games.
That work is ongoing, said Michelle Rusk, a lawyer in the FTC's division of advertising practices. In an interview, Rusk declined to comment on whether the commission is looking at companies promoting neurofeedback treatments as part of that effort. In general, she said, investigating companies claiming to help children with neurological disorders and elderly consumers worried about memory loss remain a priority.
"Autism and ADHD are serious, and we would expect there to be high-quality scientific support for any claim of cognitive benefits in treating those conditions," Rusk said.
Neurocore's service is based in part on analyzing clients' brainwaves and other biological signs, then providing "neurofeedback sessions" through which users can ostensibly train their brains to function better.
A complete 30-session cycle costs $2,200. Neurocore partners with a health-care-lending firm to help clients finance those charges.
The company says it has worked with more than 10,000 children and adults at eight centers in Michigan and Florida. Another site is scheduled to open in Florida next month, and Murrison said he hopes to expand by as many as seven additional centers in the coming year.
Neurocore has "no plans to work with K-12 schools," he said.
The company does work extensively with children and families.

Questionable claims of effectiveness

On its website, Neurocore makes a number of claims about how its technology can help individuals, including children, with conditions such as attention-deficit hyperactivity disorder, autism, anxiety, depression, memory loss, migraines, and sleeplessness.
With regard to ADHD, for example, the company repeatedly describes its treatment as "proven and approved," saying that 76 percent of users "achieve nonclinical status" and 90 percent "report improvement."
"Overcome ADHD—without drugs," Neurocore's website says. "As you or your child progress through our natural treatment for ADHD using biofeedback and neurofeedback, you may find it possible to reduce or even eliminate medication."
The company makes similar claims with regard to autism, presenting itself as a "drug-free solution to curb the negative behaviors" associated with the condition.
"There is currently no cure for autism, but the symptoms can greatly improve through Neurocore's proven, natural autism treatment program," the website says. "Research shows that biofeedback can be an effective treatment."
Neurocore also claims that users of its neurofeedback training improve their IQ by an average of 12 points.
A "Why It Works" page purports to help potential customers "explore the science and research behind our brain-based program and life-changing results."
But many of the links direct readers to preliminary studies or popular news articles. The rigorous, independent, peer-reviewed studies referenced are about neurofeedback and biofeedback more generally, not Neurocore specifically.
Murrison, Neurocore's CEO, said his company "employ[s] protocols demonstrated to be effective in research such as this."
He acknowledged that there have to date not been any such high-quality studies conducted about Neurocore specifically. The first peer-reviewed study of the company's outcomes, for clients with anxiety and depression, "should be going to press in the next few months," he said. Another peer-reviewed study of Neurocore's impact on clients with ADHD is in the works.
When asked why his company would make direct claims of effectiveness prior to such research being completed and published, Murrison cited internal company data. Neurocore administers surveys to clients in which they self-report on their conditions before and after treatment.
"We've been in business for 10 years," Murrison said. "If we weren't able to make a difference in people's lives, we wouldn't be able to keep serving communities and expanding."
Neurocore also points to a document from a third-party company called PracticeWise, which indicates that biofeedback has been rated by the American Academy of Pediatrics as a high-quality support for treatment of ADHD.
But that document is not accurate, according to a letter sent by the academy to other companies making similar claims. 
The letter, which had not previously been sent to Neurocore, states that the academy's official position is that "more research is needed" on neurofeedback as a treatment for ADHD. It asks companies using the document referenced by Murrison to support claims of approval from the American Academy of Pediatrics to correct their websites and promotional materials.

A step back for science?

Scientific research frequently lags behind the private sector when it comes to evaluating new commercial applications for new technologies, said Michael Dougherty, a professor of psychology and the director of the Decision, Attention, and Memory Lab at the University of Maryland, College Park.
And innovation isn't a bad thing, Dougherty said.
The problem, he maintained, is when companies go too far in their marketing.
In 2015, for example, the Federal Trade Commission agreed to a $2 million settlement with Lumos Labs Inc., the creators of Lumosity, a hugely popular suite of computer- and app-based brain-training programs and games. The company had claimed its technology had "the potential to change lives" and was effective at improving children's working memory and protecting against cognitive impairments associated with attention-deficit disorders and other conditions. 
The commission also reached smaller settlements with a number of other brain-training companies. Among them: LearningRx, which the FTC cited for making "false and deceptive claims about improved cognition" for a wide variety of populations, including children with autism and attention-deficit disorders.
As states, districts, and schools across the country seek to implement and adjust to the new Every Student Succeeds Act, the question of what kind of evidence companies can use to justify claims of effectiveness will continue to grow in importance.
Given that, it's worrisome that the country's new education secretary nominee would remain closely tied to a company that has apparently made exaggerated and misleading claims about its service, said Ken Koedinger, a professor of psychology and human-computer interaction at Carnegie Mellon University in Pittsburgh.
"The department of education has made a lot of progress in the last 10 years or so in trying to help people in the field distinguish snake oil from the real thing," Koedinger said.
"I'd hate to see a step backwards with respect to the importance of scientific evidence in improving education."

Education Week (copyright 2017)


Betsy DeVos Won’t Shed Stake in Biofeedback Company, Filings Show

Betsy DeVos, the education secretary nominee, and her husband own part of a company that operates nine “brain performance centers.” CreditAl Drago/The New York Times
Betsy DeVos, the billionaire school choice advocate selected by President Donald J. Trump to serve as education secretary, is a strong supporter of using biofeedback technology to help children and teenagers enhance their performance in school.
Ms. DeVos and her husband, Richard DeVos Jr., are major financial backers of Neurocore, a Michigan company that operates drug-free “brain performance centers” that claim to have worked with 10,000 children and adults to overcome problems with attention deficit disorder, autism, sleeplessness and stress.
In an agreement with the Office of Government Ethics made public Friday, Ms. DeVos said that she had stepped down from the Neurocore board but that she would retain her financial interest in the company. She valued that stake at $5 million to $25 million in her financial disclosure statement.
On Friday evening, Senator Lamar Alexander of Tennessee, the Republican chairman of the Health, Education, Labor and Pensions Committee, said he would delay the initial vote on Ms. DeVos’s nomination by a week, until Jan. 31, as Democrats argued that the process had been rushed through, without enough time to answer remaining questions about her financial disclosures.
Continue reading the main story
Ms. DeVos and her husband promote Neurocore heavily on the website for Windquest Group, a family office the couple use to manage some of their many investments. The website, for instance, includes a link to a Washington Post article about Kirk Cousins, a Washington Redskins quarterback who describes how he “retrained” his brain to better perform on the field by going to a Neurocore center.
But the claims that Neurocore’s methods can help children improve their performance in school could present a conflict for Ms. DeVos if she is confirmed as education secretary — especially given that the company is moving to expand its national reach.
Neurocore, founded about a decade ago, operates seven of the brain performance centers in Michigan and recently opened two in Florida. It has said it has plans to open as many as seven other centers across the country this year. Ms. DeVos’s financial disclosure shows that she and her husband have an indirect interest in the company through a family partnership.
Richard W. Painter, a White House ethics adviser under President George W. Bush, said he was familiar with Neurocore and applauded the business and education concepts behind it — but he said the DeVoses would be better off selling their interests in the company.
“This is not an appropriate investment for the secretary of education,” Mr. Painter said in an email. “How schools respond to attention issues is a vitally important policy question and ties right into achievement. In my view, there should be support, including financial support, for alternatives to A.D.H.D. drug treatments that are covered by health insurance whereas alternatives often are not covered.”
He added, “The secretary would be barred from participating in that important policy decision if she or her husband owned an interest in this company.”
Ms. DeVos has drawn criticism from some Democrats and public education supporters because she has been an outspoken critic of public schools and supports charter schools as an alternative. In Michigan, she and her husband have been active in promoting charter schools.
She caused a stir this week at her confirmation hearing, which took place before the Office of Government Ethics had released her financial disclosure form, when she said that some schools might want to keep guns on hand to deal with possible grizzly bear attacks. She also did not seem to be familiar with a federal law that requires equal treatment for children with disabilities.
In her agreement with the ethics office, Ms. DeVos said she would “not participate personally and substantially in any particular matter” that could benefit Neurocore and seven family businesses in which she would continue to have a financial interest.
Ms. DeVos’s financial holdings may be the most complex by any of Mr. Trump’s cabinet nominees. At 108 pages, her financial disclosure form is longer than the one Mr. Trump himself filed last year.
She and her husband, according to the disclosure filing, have $583 million to $1.5 billion in assets.
The size of the family’s wealth is no surprise. Mr. DeVos’s father founded Amway, a multilevel marketing firm that specializes in selling health and beauty aids and had over $9 billion in sales in 2015. Richard DeVos Sr. is the 88th-richest person in the world, according to Forbes magazine.
The DeVoses’ financial holdings include a minority stake in Major League Baseball’s Chicago Cubs and an interest in the N.B.A.’s Orlando Magic, as well as an array of private equity firms and real estate entities.
In her filing, Ms. DeVos said she also had a financial interest in Theranos, the embattled blood-testing firm that was once a darling of Silicon Valley but was forced to close its laboratories and lay off 40 percent of its workers after a series of articles in The Wall Street Journal raised questions about its technology.
Ms. DeVos, in her filing, said that within 90 days of being confirmed, she would divest herself of her financial interest in 102 companies and investment funds.
Neurocore, however, appears to be an investment that Ms. DeVos and her husband have a particular interest in.
The company’s website claims impressive outcomes: for example, that 90 percent of people with attention deficit hyperactivity disorder report improvement and 76 percent “achieve a nonclinical status.” But Neurocore has not published results in the peer-reviewed literature.
A year ago, the company hired Dr. Majid Fotuhi, a physician and neuroscientist trained at Harvard and Johns Hopkins University, as its chief medical officer. He said Neurocore had recently begun analyzing its data and results would be published soon in a scientific journal.
Dr. Fotuhi said that Neurocore had no immediate plans to team up with schools but that he could envision that happening.
“Betsy DeVos really believes in improving brain performance and helping children who have syndromes such as attention deficit disorder,” he said.
An article in September in MiBiz in Michigan about Neurocore’s expansion plans said the DeVoses’ family office, Windquest Group, was the company’s main financial backer. In the article, Mark Murrison, Neurocore’s chief executive, said, “We’re a local company with sights on national expansion.”
On its website, Neurocore claims to use “data-driven, brain-based diagnostics and treatments” to help children and adults. The company says it uses “data from quantitative electroencephalography” to help diagnose problems and then treats them with “proven neurofeedback therapy.”
Neurocore, which charges about $2,000 for a recommended treatment of 30 sessions, has a deal with Prosper Funding, an online lending platform, to provide financing to clients. Neurocore also says that some insurance plans may cover treatments.
But in 2015, the Michigan State Department of Insurance and Financial Services upheld a denial of coverage determination by Blue Cross Blue Shield of Michigan for a person who had sought treatment from Neurocore for migraine headaches. The insurer had denied coverage, saying the “treatment was investigational.”
In its marketing materials, Neurocore makes a direct pitch to parents, featuring the personal stories of numerous children in YouTube videos and offering tips on Twitter about helping students focus at school.
On Friday, Neurocore posted a typical tweet — “Do you suspect your child may have teen ADHD? Check out these common signs” — with a link to its website and a photo of a student at his desk.
Not all experts are convinced of the effectiveness of Neurocore’s methods. A 2013 article in The Detroit News questioned the efficacy of diagnostic testing for A.D.H.D. through electroencephalography, citing an article in the American Academy of Pediatrics News that suggested more research was needed.
Still, Dr. Fotuhi expressed confidence in the field. “It’s in its infancy,” he said, “but I can envision in the coming years, we’ll have objective data.”

New York Times (copyright 2017)

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