FTC Cracks Down on Quack Stem Cell Treatment

In The Politics of Autism, I write:

The conventional wisdom is that any kind of treatment is likely to be less effective as the child gets older, so parents of autistic children usually believe that they are working against the clock. They will not be satisfied with the ambiguities surrounding ABA, nor will they want to wait for some future research finding that might slightly increase its effectiveness. They want results now. Because there are no scientifically-validated drugs for the core symptoms of autism, they look outside the boundaries of mainstream medicine and FDA approval. Studies have found that anywhere from 28 to 54 percent of autistic children receive “complementary and alternative medicine” (CAM), and these numbers probably understate CAM usage.

A release from FTC:

A California-based physician and the two companies he controls have settled charges of deceptively advertising that “amniotic stem cell therapy” can treat serious diseases, including Parkinson’s disease, autism, macular degeneration, cerebral palsy, multiple sclerosis, and heart attacks.

The settlement prohibits the defendants from making these and other health claims in the future unless the claims are true and supported by competent and reliable scientific evidence. The settlement also imposes a partially suspended $3.31 million judgment and requires the defendants to notify current and former patients about the order within 30 days.

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According to the Commission’s complaint, Dr. Bryn Jarald Henderson, D.O. and the two companies he owns and operates, Regenerative Medical Group and Telehealth Medical Group, earned at least $3.31 million offering stem cell therapy between 2014 and 2017. Initial stem cell therapy injections ranged from $9,500 to $15,000, with patients encouraged to undergo multiple treatments. Follow-up “booster” treatments cost between $5,000 and $8,000 each.

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Advertising on the website stemcell.life, the defendants even claimed that the therapy could restore the vision of blind patients, citing the case of a “101 year old Lady once blind for 7 years” who, thanks to stem cell therapy, could see again. The website’s homepage boasted that the therapy could “reverse autism symptoms.”

The proposed order settling the FTC’s charges prohibits the defendants from misrepresenting that any product or service: 1) cures, mitigates, or treats any disease or health condition, including Parkinson’s disease, autism, multiple sclerosis, cerebral palsy, traumatic brain injury, heart disease, macular degeneration, chronic kidney disease, osteoarthritis, and stroke; or 2) is comparable, or better than, conventional medical treatments in treating any health condition, unless such claims are true and can be supported by competent and reliable scientific evidence.

DeVos Autism "Treatment"

In The Politics of Autism, I write:

The conventional wisdom is that any kind of treatment is likely to be less effective as the child gets older, so parents of autistic children usually believe that they are working against the clock. They will not be satisfied with the ambiguities surrounding ABA, nor will they want to wait for some future research finding that might slightly increase its effectiveness. They want results now. Because there are no scientifically-validated drugs for the core symptoms of autism, they look outside the boundaries of mainstream medicine and FDA approval. Studies have found that anywhere from 28 to 54 percent of autistic children receive “complementary and alternative medicine” (CAM), and these numbers probably understate CAM usage.

Sheri Fink, Steve Eder, and Matthew Goldstein report at The New York Times about Betsy DeVos's stake in a controversial company that claims to help with autism.

Neurocore has not published its results in peer-reviewed medical literature. Its techniques — including mapping brain waves to diagnose problems and using neurofeedback, a form of biofeedback, to treat them — are not considered standards of care for the majority of the disorders it treats, including autism. Social workers, not doctors, perform assessments, and low-paid technicians with little training apply the methods to patients, including children with complex problems.

In interviews, nearly a dozen child psychiatrists and psychologists with expertise in autism and attention deficit hyperactivity disorder, or A.D.H.D., expressed caution regarding some of Neurocore’s assertions, advertising and methods.

“This causes real harm to children because it diverts attention, hope and resources,” said Dr. Matthew Siegel, a child psychiatrist at Maine Behavioral Healthcare and associate professor at Tufts School of Medicine, who co-wrote autism practice standards for the American Academy of Child and Adolescent Psychiatry. “If there were something out there that was uniquely powerful and wonderful, we’d all be using it.”

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Over the past year, the Federal Trade Commission has begun to crack down on some companies promoting the successes of brain training programs for treating a variety of problems.

Last January, Lumos Labs, the creator of Lumosity games, agreed to pay a $2 million fine over advertising claims that said its educational-oriented games could help children perform better in school by targeting specific areas of the brain. A few months later, the F.T.C. imposed sanctions on the developers of the LearningRx “brain training” programs for advertisements that claimed its product could “permanently improve serious health conditions” like A.D.H.D., autism and dementia.

FTC Cracks Down on "Brain Training"

In The Politics of Autism, I write:

The conventional wisdom is that any kind of treatment is likely to be less effective as the child gets older, so parents of autistic children usually believe that they are working against the clock. They will not be satisfied with the ambiguities surrounding ABA, nor will they want to wait for some future research finding that might slightly increase its effectiveness. They want results now. Because there are no scientifically-validated drugs for the core symptoms of autism, they look outside the boundaries of mainstream medicine and FDA approval.

A May 18 release from the Federal Trade Commission: (h/t Disability Scoop)

The developers and marketers of the LearningRx “brain training” programs have agreed to stop making a range of false and unsubstantiated claims and pay $200,000 under a settlement with the Federal Trade Commission.

According to the FTC’s complaint, LearningRx Franchise Corp. and its CEO, Dr. Ken Gibson, deceptively claimed that their programs were clinically proven to permanently improve serious health conditions like ADHD, autism, dementia, Alzheimer’s disease, strokes, and concussions and that the training substantially improved school grades and college admission test scores, career earnings, and job and athletic performance. They also allegedly claimed that LearningRx brain training is 10 times more cost-effective than tutoring.

“Companies that say they can significantly improve serious health conditions or how your brain functions in everyday situations need to back up those claims with sound science,” said Jessica Rich, Director of the FTC’s Bureau of Consumer Protection. “In this case, the defendants couldn’t show their training provides the health or other real-world benefits they claimed.”

According to the FTC, the defendants promoted LearningRx through LearningRx.com and affiliated websites, as well as through a blog, Facebook and Twitter posts, print and radio ads, and direct mail pieces. They also allegedly used Google search ads to target consumers searching for terms such as “cure for ADD,” “autism cure,” “Asperger cure,” and “severe traumatic brain injury cure.” The defendants, based in Colorado Springs, Colorado, offered LearningRx training through more than 80 LearningRx centers that it franchised in 25 states.

The proposed order settling the FTC’s charges prohibits the defendants from claiming that their programs improve performance at work or in athletics, or improve the cognitive function of individuals with age-related or other health conditions, unless the claims are not misleading and substantiated by human clinical testing.

The order further prohibits the defendants from making unsubstantiated claims about the performance, benefits, or efficacy of their programs, including claims about improvement in school grades or scores on standardized academic tests, performance on everyday tasks, increased income, or superiority to academic tutoring. Finally, the order prohibits the defendants from misrepresenting the existence or results of any tests or studies, and from providing others with the means to make the prohibited claims. The order imposes a $4,000,000 judgment against the company, which will be suspended upon the payment of $200,000 as disgorgement of ill-gotten gains.

The Commission vote authorizing the staff to file the complaint and proposed stipulated final judgment and order was 3-0. The complaint and order were filed in the U.S. District Court for the District of Colorado.

NOTE: The Commission files a complaint when it has “reason to believe” that the law has been or is being violated and it appears to the Commission that a proceeding is in the public interest. Stipulated final orders have the force of law when approved and signed by the District Court judge.

The FTC is a member of the National Prevention Council, which provides coordination and leadership at the federal level regarding prevention, wellness, and health promotion practices. This case advances the National Prevention Council’s goal of increasing the number of Americans who are healthy at every stage of life. These cases are part of the FTC’s ongoing effects to protect consumers from misleading health advertising.

The Federal Trade Commission works to promote competition, and protect and educate consumers. You can learn more about consumer topics and file a consumer complaint online or by calling 1-877-FTC-HELP (382-4357). Like the FTC on Facebook(link is external), follow us on Twitter(link is external), read our blogs and subscribe to press releases for the latest FTC news and resources.

FTC Nails Company That Complained About Another Company's Autism Claims

Last year, the Advertising Self-Regulatory Council reported:

The National Advertising Division has recommended that Pursuit of Research, LLC, discontinue all challenged claims for the company’s Nutriiveda dietary supplements, which are marketed as “cures” for conditions that include attention deficit disorder, apraxia, autism, diabetes, dyspraxia, seizures, traumatic brain injury and stroke. The advertiser said it will appeal NAD’s decision to the National Advertising Review Board (NARB.)\

The claims at issue were challenged by Nourishlife, LLC, manufacturer of a competing product, Speech Nutrients.

A release from the Federal Trade Commission:

An Illinois company and its owner will stop making allegedly deceptive claims that their dietary supplements are proven effective at treating childhood speech disorders, including those associated with autism, in order to settle Federal Trade Commission charges. Under the FTC settlement, the defendants also will pay $200,000 and are required to disclose any material connections with their endorsers.

“Parents of children with speech disorders need accurate information about products that may be able to help,” said Jessica Rich, Director of the Bureau of Consumer Protection. “This company took advantage of parents’ trust.”

Since at least 2008, NourishLife, LLC and its owner, Mark Nottoli, have sold Speak softgels and capsules and Speak Smooth liquid children’s supplements online and through a network of distributors for more than $70 per bottle. The supplements -- which contain Omega-3 and Omega-6 fatty acids and Vitamins E and K -- were advertised via the Internet, including search engine ads such as Google sponsored links and on websites, and at conferences on autism spectrum disorders.

For example, a Google sponsored link for Speak products, which could display if consumers searched on the term “toddler speech problems,” contained the statement, “Healthy Speech for Child – SpeechNutrients speak Supplement” and linked to a web page claiming the supplements were developed by a pediatrician to support “normal and healthy speech development and maintenance.” That web page also included a statement from a parent endorsing the product, who said “[my daughter] is speaking in more complex sentences and she is less gittery [sic], more focused.” Other statements from parent endorsers appeared in product brochures and on speechnutrients.com, such as:

“Speak vitamins have made my little boy talk. He is five years old and has not spoken until I began giving him the vitamins.”

“We were really amazed when Ben started singing along with a song on the radio . . . . and he was singing 3+ word phrases, not just one word here & there.”

According to the FTC’s complaint, between 2008 and late 2013, ads for Speak products made unsupported claimsthat the supplements develop and maintain normal, healthy speech and language capabilities in children, including those with verbal apraxia -- a motor speech disorder affecting the ability to utter sounds, syllables, and words.
These ads, the complaint asserts, also falsely claimed that Speak products are scientifically proven to improve children’s speech. In addition, the complaint charges that ads for Speak products deceptively claimed that the supplements are effective in treating or mitigating verbal apraxia and communication and behavioral difficulties in children with an autism spectrum disorder.