The mailings promised “A life without pain!” » via stem cell injections or intravenous infusions administered at the patient’s home. The appeal was obvious: More than 20 percent of American adults suffer from chronic pain.
The flyers invited Iowans to free dinners across the state. Afterward, prosecutors say, the salespeople visited potential customers’ homes for high-pressure presentations disguised as prescreenings. More than 250 people signed up, paying between $3,200 and $20,000 each, for a total of $1.5 million. To do this, a nurse practitioner came to their home to administer injections and IVs filled with stem cells derived from the umbilical cord.
Yet experts and regulators have alternately called these treatments scams, scams or simply unproven. In some cases, studies have documented actual harm.
Last fall, Iowa Attorney General for follow-up two landlords responsible for mailings in his state, naming a Minnesota man who hosts a Christian entrepreneurship podcast and his Florida business partner for allegedly misleading consumers, many of whom are elderly.
In filing this lawsuit, Iowa joined the attorneys general of New York, North DakotaGeorgia, Nebraska, Arkansas and Washington state sued companies 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 types of cells. For this reason, it is believed that they could potentially treat many illnesses and injuries.
But the FDA has approved only a handful of these therapies, and only for certain forms of blood cancer and immune system disorders. Stem cells are considered experimental for most uses, although they are marketed as a treatment for everything from autism and emphysema to sports injuries.
The FDA has repeatedly said warned Americans should be wary of companies selling unapproved, unproven, and expensive stem cell therapies, which have sometimes caused harm. blindness, bacterial infections and tumors.
In a 2020 advisory, the agency expressed concern that patients were being misled about products that are “illegally marketed, have not been shown to be safe or effective and, in in some cases, may present significant security issues.”
Dr. Jeffrey Goldberg, chairman of ophthalmology at the Byers Eye Institute at Stanford University, whose work has documented vision loss in some patients treated with cells taken from their own bodies, processed and reinjected, lamented that people are “desperately willing to fork out large sums of money for so-called unproven therapeutics and, in some cases , explicitly misleading. »
Since August 2017the FDA has issued approximately 30 warning letters regarding unproven treatments.
Experts including Dr. Paul Knoepfler, a stem cell researcher at the University of California, Davis, and Leigh Turner, a bioethicist at the University of California, Irvine, are among those who have sounded the alarm over the fact that such federal action is too limited to regulate. A American industry that Turner estimated in 2021 exceeded 2,700 clinics.
Since states can seek substantial fines from wayward operators, Turner said their legal actions are promising.
“If you look at them collectively, they could, over time, start to have an impact,” he said.
The FDA provides training for attorneys general who pursue such cases. Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said federal regulators partner with state law enforcement in a “shared mission.”
That puts people like Iowa Attorney General Brenna Bird on the front lines.
Last year, Bird filed suit against mailers offering Iowans a pain-free life, naming as defendants the now-dissolved Biologics Health Group and Summit Partners, which operated as Summit Health Centers. The state also prosecuted the business owners: Rylee Meek, of Prior Lake, Minnesota, and Scott Thomas, of Thonotosassa, Florida.
Neither man claims to have any medical training. Yet at a series of free dinners in Iowa, attendees listened to their presentations on how stem cells could apparently repair damage from back or joint pain. The complaints came despite a FDA Warning that no such product has been approved to treat any orthopedic condition.
One testimony featured a woman saying she suffered from multiple sclerosis, fibromyalgia, degenerative joint problems and scoliosis. This implied that the treatment worked so well that she was able to stop using a walker and taking opioids. Prosecutors say this led people to believe that stem cells are effective in treating all of the conditions listed.
The company offered packages ranging from 5 million cells to 60 million to treat customer ailments. The Iowa lawsuit described the practices as “scattered, for-profit experiments.”
Research has shown that dead cells are often injected, Knoepfler said.
The Iowa case is still in the discovery stage, with trial scheduled for March 2025.
Meek and Thomas did not return multiple text messages and emails from The Associated Press. Neither did their lawyer, Nathan Russell, although he refuted numerous allegations filed in court, including that the promotional information was “misleading or misleading.” The filing points out that Meek and Thomas always emphasized that they were not doctors.
Instead, Meek introduced 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 realize it.”
Meek had already reached an agreement with the North Dakota attorney general to resolve allegations that a company he managed sold insulation and energy-saving products without proper licensing.
As for the stem cell industry, Bird argued in the Iowa lawsuit that the companies downplayed safety concerns.
The sales materials described the most concerning side effects as “flu-like symptoms” in a “very small percentage of patients.” It’s a claim that Meek and Thomas’ lawyers said lacked context.
Complaints, which businessmen describe as “rare,” poured in, including from a man whose hip pain did not improve after undergoing $5,845 in treatment. His wife paid $2,650 for hers. Another person said she had “no improvement” after spending $16,580 to relieve her sciatic nerve pain and arthritis.
A nurse practitioner responded by telling these patients that healing might take longer and that they should drink more water, according to the lawsuit.
“The problem,” Knoepfler said, “is that people get hurt and get ripped off.”