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Iowa joins states claiming stem cell patients were misled

Iowa has joined attorneys general in New York, North Dakota, Georgia, Nebraska, Arkansas and Washington state who have sued companies for fraudulently promoting unproven stem cell treatments.

The companies’ mailings promised “Living without pain!” via injections or infusions administered at the patient’s home. The appeal was obvious: more than 20% of American adults suffer from chronic pain.

The flyers invited Iowans to free dinners across the state. Then salespeople traveled to potential clients’ homes for high-pressure pitches disguised as pre-screenings, prosecutors said. More than 250 people signed up and paid $3,200 to $20,000 each, for a total of $1.5 million. For this purpose, a nurse specialist came to their home to administer injections and infusions filled with stem cells from the umbilical cord.

Yet experts and regulators have variously labeled such treatments as scams, scams or simply unproven. In some cases, studies have documented real damage.

Last fall, Iowa’s attorney general sued two business owners responsible for the mailings in her state, naming a Minnesota man who hosts a podcast on Christian entrepreneurship and his Florida business partner, claiming they harassed consumers, including many elderly people, had been misled.

Stem cells have long fascinated researchers because of their ability to reproduce and, in some cases, transform into other cell types. Therefore, they are believed to have the potential to treat many diseases and injuries.

But the FDA has approved only a handful of such therapies, and only for certain types of blood cancers and immune system disorders. Stem cells are considered experimental for most applications, 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 companies offering unapproved, unproven and costly stem cell therapies, which have occasionally caused blindness, bacterial infections and tumors.

In a 2020 notice, the agency expressed concern that patients are being misled about products that are “illegally marketed, have not been shown to be safe or effective, and in some cases may pose significant safety concerns.” Since August 2017, the FDA has issued about 30 warning letters about the 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 raised the alarm that such federal action is too little to regulate. an American industry that had more than 2,700 clinics in 2021, according to Turner.

Because states can seek significant fines against wayward operators, Turner said their legal actions are promising.

The FDA provides training to attorneys general who investigate such cases. Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said federal regulators are working with state law enforcement 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 pain-free lives, naming the now-dissolved Biologics Health and Summit Partners Group, which operated as Summit Health Centers, as defendants. The state also sued the companies’ owners: Rylee Meek, of Prior Lake, Minnesota, and Scott Thomas, of Thonotosassa, Florida.

Neither man claims to have any medical training. But at a series of free dinners in Iowa, attendees listened to their presentations on how stem cells could apparently repair damage related to back or joint pain. The claims came despite a warning from the FDA that such a product is not approved for the treatment of orthopedic conditions.

One testimonial included a woman who said she had multiple sclerosis, fibromyalgia, degenerative joint problems and scoliosis. It implied that the treatment worked so well that she was able to stop using a walker and taking opioids. Prosecutors say people have continued to believe that stem cells are effective in treating all of the conditions listed.

The company offered packages ranging from 5 million to 60 million cells to address customers’ ailments. The Iowa lawsuit described the practices as “scattershot experiments for profit.”

Research has shown that dead cells are often injected, Knoepfler said.

The Iowa case is still in the discovery phase and the trial is scheduled for March 2025.

Meek and Thomas did not return multiple text and email messages. Neither does their attorney, Nathan Russell.

photo FILE – Iowa Attorney General Brenna Bird speaks during a town hall campaign event for Republican presidential candidate Nikki Haley, Wednesday, May 17, 2023, in Ankeny, Iowa. Last fall, Bird sued a Minnesota man who hosts a podcast on Christian entrepreneurship and his Florida business partner, alleging they deceived and defrauded consumers by selling stem cell treatments whose flyers advertised “Living Without Pain.” can bring. But experts call these treatments quackery. According to Bird’s lawsuit, many of the deceived consumers were elderly. (AP Photo/Charlie Neibergall, file)
photo FILE – Iowa Attorney General Brenna Bird speaks during a Republican Party of Iowa election rally, Tuesday, Nov. 8, 2022, in Des Moines, Iowa. Last fall, Bird sued a Minnesota man who hosts a podcast on Christian entrepreneurship and his Florida business partner, alleging they deceived and defrauded consumers by selling stem cell treatments whose flyers advertised “Living Without Pain.” can bring. But experts call these treatments quackery. According to Bird’s lawsuit, many of the deceived consumers were elderly. (AP Photo/Charlie Neibergall, file)