The mailings promised Life Without Pain! via stem cell injections or IVs administered in a patients own home. The allure was obvious: more than 20% of U.S. adults suffer from chronic pain.
A court exhibit from a lawsuit filed by Iowa Attorney General Brenna Bird is seen on a laptop computer May 8 in Urbandale, Iowa.
The flyers invited Iowans to free dinners across the state. Afterward, sales people traveled to potential customers homes for high-pressure pitches disguised as pre-screenings, according to prosecutors. More than 250 people signed up, paying $3,200 to $20,000 each for a total of $1.5 million. For this, a nurse practitioner came to their homes to administer injections and IVs filled with stem cells derived from umbilical cords.
Yet experts and regulators have alternately labeled such treatments as ripoffs, scams or simply unproven. In some cases, studies have documented real harm.
Last fall, Iowas attorney general sued two proprietors responsible for the mailings in her state, naming a Minnesota man who hosts a Christian entrepreneurship podcast and his Florida business partner for allegedly deceiving consumers, many of them elderly.
In bringing the lawsuit, Iowa joined attorneys general in New York, North Dakota, Georgia, Nebraska, Arkansas and Washington state who have sued businesses alleging they fraudulently promoted unproven stem cell treatments.
Stem cells have long fascinated researchers because of their ability to reproduce and, in some cases, transform into other cell types. Because of this, they are thought to hold the potential for treating many diseases and injuries.
But the FDA has approved only a handful of such therapies, and only for certain forms of blood cancer and immune system disorders. Stem cells are considered experimental for most uses, despite being marketed as a treatment for everything from autism and emphysema to sports injuries.
The FDA has repeatedly warned Americans to be wary of businesses hawking unapproved, unproven and costly stem cell therapies, which occasionally have caused blindness, bacterial infections and tumors.
In a 2020 notice, the agency expressed concern about patients being misled about products that are illegally marketed, have not been shown to be safe or effective, and, in some cases, may have significant safety issues.
Dr. Jeffrey Goldberg, chair of ophthalmology at the Byers Eye Institute at Stanford University, whose work has documented vision loss in some patients treated with cells removed from patients' own bodies, processed and reinjected, lamented that people are "desperately willing to shell out large sums of money for unproven and in some cases, explicitly sort of sham, so-called therapeutics.
Since August 2017, the FDA has issued about 30 warning letters regarding the unproven treatments.
Experts, including Dr. Paul Knoepfler, a stem cell researcher at the University of California at Davis, and Leigh Turner, a bioethicist at the University of California, Irvine, are among those who have raised alarm that such federal action is too little to regulate a U.S. industry which Turner estimated in 2021 topped 2,700 clinics.
Because states can seek substantial fines against wayward operators, Turner said their legal actions offer promise.
"If you look at them collectively, they might over time start to have an impact, he said.
The FDA offers training to attorneys general pursuing such cases. Dr. Peter Marks, director of the FDAs Center for Biologics Evaluation and Research, said federal regulators partner with state law enforcers in a shared mission.
Iowa Attorney General Brenna Bird speaks during a town hall campaign event for Republican presidential candidate Nikki Haley on May 17, 2023, in Ankeny, Iowa.
That puts people like Iowa Attorney General Brenna Bird on the front lines.
Last year, Bird brought the case over mailers offering Iowans a pain-free life, naming the now dissolved Biologics Health and Summit Partners Group, which operated under the name Summit Health Centers, as defendants. The state also sued the companies' proprietors: Rylee Meek, of Prior Lake, Minnesota, and Scott Thomas, of Thonotosassa, Florida.
Neither man claims to have any medical training. Yet over a series of free dinners across Iowa, attendees listened to their presentations about how stem cells could ostensibly repair damage linked to back or joint pain. The claims came despite an FDA warning that no such product has been approved to treat any orthopedic condition.
One testimonial featured a woman quoted as saying she had multiple sclerosis, fibromyalgia, degenerative joint problems and scoliosis. It implied the treatment worked so well she was able to stop using a walker and taking opioids. Prosecutors say that left people believing stem cells are effective at treating all the conditions listed.
The company offered packages ranging from 5 million cells to up to 60 million to fix customers' ailments. Iowas lawsuit described the practices as scattershot, for-profit experimentations.
Research has shown dead cells are often injected, Knoepfler said.
The Iowa case is still in the discovery stage, with the trial set for March 2025.
Meek and Thomas did not return multiple text and email messages from The Associated Press. Nor did their attorney, Nathan Russell, though he did rebut many of the allegations in court filings, including that the promotional information was deceptive or misleading. The filing stressed that Meek and Thomas always emphasized they were not doctors.
Instead, Meek promoted himself as the $100 million man and touted his business prowess on his Kings Council podcast. His and Thomas book, Intentional Influence in Sales: The Power of Persuasion with Neuro-linguistic Programming, is described as a way to get people to think the way you want them to think, without them even realizing it.
Nearly a quarter of Americans struggle with symptoms of depression, according to the latest Centers for Disease Control and Prevention data from an October 2023 survey. That number is down from 2020 to 2021, when the COVID-19 pandemic exacerbated mental health conditions for millions of Americans.
Like other forms of mental illness, depression impacts groups of people differently depending on their unique backgrounds and experiences. While depression is among the most common forms of mental illness, some portions of the U.S. are seeing rates of depression fall faster than others.
Northwell Health partnered with Stacker to look at which groups of people are the most likely to feel depressed, using data from the CDC.
Signs someone may have depression include an inability to focus, thoughts of death or suicide, hopelessness, and low self-worth, as well as changes in appetite and sleep patterns, according to the World Health Organization.
Depression can be transitorybrought on by the loss of a loved one or other difficult life eventsor chronic, such as for those who live with bipolar disorder. The latest data on depression rates suggest some of the uptick in depression during COVID-19 may have been more of the former.
Depression has lingered at elevated levels for some communities, including young people and those who identify as part of the LGBTQ+ community.
Americans ages 18 to 29 years old report the highest levels of depression, with those 30 to 49 years old showing the next highest levels, according to the CDC. Rates of depression taper off even more as Americans clear the age of 60.
Higher reported rates of depression in young people could partially be attributed to the way each generation views mental illness. Members of Gen Z, those born between 1997 and 2012, have been more open to talking about mental illness and seeking therapy, for example, than older generations who came of age at a time when mental health disorders were heavily stigmatized in media and popular culture.
Surveys have found that discrimination is often cited as a significant source of stress; Black and Hispanic adults, specifically, report higher levels of stress from discrimination compared to their white peers.
When it comes to depression rates, a similar trend appears. Hispanic, multiracial, and Black Americans report elevated rates of depression compared to white Americans, according to the latest survey data the CDC collected in late 2023.
Furthermore, LGBTQ+ Americans have reported higher levels of stress and mental illness compared to straight, cisgender people. Transgender individuals are also more than six times as likely to attempt suicide, according to a Swedish study published in The American Journal of Psychiatryone of the only studies to compile such data for an entire country over a 10-year period.
The current rates of depression among more vulnerable groups are particularly concerning at a time when mental health professionals are struggling to meet a higher demand for mental health care services.
Story editing byShannon Luders-Manuel. Copy editing by Tim Bruns.
This story originally appeared on Northwell Health and was produced and distributed in partnership with Stacker Studio.
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