The mailings promised "Life Without Pain!" via stem cell injections or IVs administered in a patient's own home. The allure was obvious: more than 20% of U.S. adults endure chronic pain.
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, Iowa's attorney general 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, , 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 , bacterial infections, and tumors.
In a , 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."
Jeffrey Goldberg, MD, PhD, chair of ophthalmology at the Byers Eye Institute at Stanford University, whose work has vision loss in some patients treated with cells removed from patients' own bodies, processed, and re-injected, 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 , the FDA has issued about 30 warning letters regarding the unproven treatments.
Experts, including Paul Knoepfler, PhD, a stem cell researcher at the University of California Davis, and Leigh Turner, PhD, a bioethicist at the University of California Irvine, are among those who have raised alarm that such federal action is too little to that Turner estimated in 2021 topped .
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. Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research, said federal regulators partner with state law enforcers in a "shared mission."
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 the 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. Iowa's 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 "King's Council Podcast." His and Thomas's 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."
Meek previously reached a settlement with the North Dakota attorney general to resolve allegations that a business he ran sold insulation and energy conservation products without a proper license.
As for the stem cell business, Bird argued in the Iowa lawsuit that the companies downplayed safety concerns.
Sales material described the most worrisome side effects as "flulike symptoms" in a "very small percentage of patients." It's an assertion that Meek's and Thomas's attorney argued lacked context.
Complaints, which the businessmen described as "rare," trickled in, including from a man whose hip pain hadn't improved after undergoing a $5,845 treatment. His wife paid $2,650 for hers. Another person said she had "no improvement whatsoever" after spending $16,580 to help her sciatic nerve pain and arthritis.
A nurse practitioner responded by telling such patients that healing could take longer and they should drink more water, the lawsuit said.
"The problem," Knoepfler said, "is that people actually get hurt and they get ripped off."