The newsletters promised “Life without pain!” through stem cell injections or intravenous administration to the patient at home. The appeal was obvious: More than 20% of adults in the United States suffer from chronic pain.
The flyers invited Iowans to free meals throughout the state. Prosecutors said salespeople would then go to potential clients’ homes for intense presentations disguised as previews. 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 and administered injections and IVs filled with stem cells obtained from the umbilical cord.
However, experts and regulators alternately call such methods scams, scams or simply unproven. In some cases, studies have documented real harm.
Last fall, Iowa Attorney General sued two owners responsible for mailings in her state, naming a Minnesota man who hosts a podcast about Christian entrepreneurship and his Florida business partner as accused of allegedly defrauding consumers, many of them elderly.
In filing the lawsuit, Iowa joined the New York attorneys general. North DakotaGeorgia, Nebraska, Arkansas and Washington state, which sued the businesses alleging they deceptively promoted unproven stem cell treatments.
Stem cells have long fascinated researchers for their ability to reproduce and, in some cases, transform into other types of cells. Because of this, they are believed to have the potential to treat many diseases and injuries.
But the FDA has approved only a few of these treatments, and only for certain forms of blood cancer and immune system disorders. Stem cells are considered experimental in most cases, even though they are marketed as treatments for conditions ranging from autism and emphysema to sports injuries.
FDA repeatedly warned Americans should be wary of companies selling unapproved, unproven and expensive stem cell treatments that sometimes lead to blindness, bacterial infections and tumors.
In a 2020 notice, the agency expressed concern that patients are being misled about products that are “sold illegally, have not been shown to be safe and effective, and in some cases may have serious safety concerns.”
Dr. Jeffrey Goldberg, Chairman of the Department of Ophthalmology at the Byers Eye Institute at Stanford University, whose work documented Loss of vision in some patients treated with cells taken from the patients’ own bodies, processed and reintroduced, lamented that people are “desperately willing to shell out large sums of money for unproven, and in some cases clearly bogus, so-called treatments.” »
From August 2017The FDA has issued nearly 30 warning letters regarding unproven treatments.
Experts including Dr. Paul Knopfler, a stem cell researcher at the University of California, Davis, and Lee Turner, a bioethicist at the University of California, Irvine, are among those who have raised the alarm that such federal actions are too insignificant enough to be adjusted. A US industry which, according to Turner’s estimates, in 2021 exceeded 2700 clinics.
Because states can seek significant fines from wayward operators, Turner said their lawsuits show promise.
“If you look at them collectively, over time they can start to have an impact,” he said.
The FDA offers training to attorneys general handling such cases. Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said federal regulators are collaborating with state law enforcement on a “shared mission.”
That puts people like Iowa Attorney General Brenna Byrd on the front lines.
Last year, Bird filed a case over mailers offering pain-free living to Iowans, naming as defendants the now-dissolved Biologics Health and Summit Partners Group, which operated under the name Summit Health Centers. The state also sued the owners of the companies: Riley Meek of Prior Lake, Minnesota, and Scott Thomas of Thonotosassa, Florida.
Neither man claims to have any medical training. However, during a series of free lunches throughout Iowa, participants listened to their presentations on how stem cells could supposedly repair damage associated with back or joint pain. The claims were received despite FDA Warning that no such product has been approved for the treatment of any orthopedic conditions.
One review featured a woman who said she had multiple sclerosis, fibromyalgia, degenerative joint problems and scoliosis. This meant that the treatment worked so well that she was able to stop using a walker and taking opioids. Prosecutors say leftists believe stem cells are effective in treating all of these diseases.
The company offered packages ranging from 5 million cells to 60 million to address customer ailments. The Iowa lawsuit describes the practice as “discrete commercial experiments.”
Research has shown that dead cells are often injected, Knopfler said.
The Iowa case is still in the discovery phase, with a trial scheduled for March 2025.
Meek and Thomas did not respond to several text messages and emails from The Associated Press. Neither did their lawyer, Nathan Russell, although he denied many of the allegations in court papers, including that the advertising information was “deceptive or misleading.” The case file emphasized that Mick and Thomas always emphasized that they were not doctors.
Instead, Mick promoted himself as a “$100 million dollar 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 even realizing it.”
Meek previously reached a settlement with the North Dakota Attorney General to resolve allegations that his business sold insulation and energy-saving products without proper licensing.
In the stem cell business, Bird argued in the Iowa lawsuit that the companies downplayed safety issues.
Promotional materials described the most concerning side effects as “flu-like symptoms” in “a very small percentage of patients.” This statement, according to Meek and Thomas’ lawyer, lacks context.
The complaints, which businessmen described as “rare”, included a man whose hip pain did not improve after $5,845 worth of treatment. His wife paid $2,650 for hers. Another person said she had “no improvement” after spending $16,580 on treatment for sciatic nerve pain and arthritis.
The nurse practitioner responded by saying that such patients might take longer to recover and should drink more water, the lawsuit says.
“The problem,” Knopfler said, “is that people are actually suffering and getting ripped off.”