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 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 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 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. Iowa’s lawsuit described the practices as “scattershot, for-profit experimentations.”
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