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Crowdfunding campaigns for unproven stem cell treatments are often misleading, U of M researcher finds

The misinformation presented by the crowdfunding campaigns echoes the misleading messages about treatments that the clinics peddle directly to consumers, the U study also found.

A researcher controlling stem cell culture media at an aseptic room in a laboratory in Seongnam, South Korea.

On Wednesday, government officials from the Department of Justice (DOJ) and the Food and Drug Administration (FDA) went to court to stop two of the largest stem cell clinic companies in the United States from marketing scientifically unproven — and unregulated — stem cell therapies to patients.

The agencies said they were seeking permanent injunctions against the companies — US Stem Cell, based in Florida, and the California Stem Cell Treatment Center — to keep them “from marketing stem cell products without FDA approval and for significant deviations from current good manufacturing practice requirements.”

“We cannot allow unproven products that exploit the hope of patients and their loved ones,” FDA Commissioner Scott Gottlieb said in a released statement.

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So far, stem cell therapies have been found to be effective for only a few medical conditions — mostly certain cancers and blood and immune disorders. Yet that hasn’t stopped hundreds of for-profit clinics across the country from selling unproven, expensive and potentially harmful stem cell procedures to people with a wide variety of other chronic or serious illnesses, including age-related macular degeneration (AMD), Parkinson’s disease, amyotrophic lateral sclerosis (ALS) and chronic obstructive pulmonary disease (COPD).

Misleading statements

Yesterday’s FDA action is welcomed by Leigh Turner, a University of Minnesota bioethicist who is one of the country’s leading critics of clinics marketing unproven stem cell treatments to patients.

“Given that patients have suffered serious injuries at the clinics named in these complaints, I welcome yesterday’s announcement,” Leigh told MinnPost in an email. “I hope the FDA and DOJ initiate legal proceedings against additional companies that use manipulative marketing techniques to prey upon vulnerable and often seriously ill individuals.”

In a research letter published Tuesday in the Journal of the American Medical Association (JAMA), Turner reported on his latest findings regarding the marketing of unproven stem cell interventions. For this new study, he looked at the online crowdfunding campaigns that patients across the country are increasingly using to raise money to cover the cost of such therapies.

The treatments can run into the tens of thousands of dollars, and are generally not covered by health insurance.

Turner’s study found that, like the clinics’ own direct-to-consumer marketing, many crowdfunding campaigns for unproven stem cell therapies describe the treatments inaccurately: They underestimate the risks and exaggerate their effectiveness.

“These findings suggest that medical crowdfunding campaigns convey potential misleading messages about stem cell-based interventions,” Turner and his co-authors write in their paper. “These claims may be especially powerful when embedded within compelling personal narratives.”

The study also found that the misinformation presented by the crowdfunding campaigns echoes the misleading messages about the treatments that the clinics peddle directly to consumers on their websites.

The messaging similarities are not surprising, though. Many of the clinics “basically tell their patients how to go and do the crowdfunding,” said Turner in an interview with MinnPost.

“The businesses are pretty strategic,” he explained. “They’re looking for patients who can pay cash, and they know a lot of individuals don’t have that money, so they kind of tell them about different ways that they can go out and try to get people to donate so they can come back and have the procedure.”

Study specifics

For the JAMA study, Turner and his co-authors ran the names of 351 U.S. businesses that market unproven stem cell treatments through two popular crowdfunding websites, GoFundMe and YouCaring, during a four-month period late last year. The researchers identified 408 campaigns seeking donations for stem cell interventions advertised by 50 individual businesses. These campaigns were requesting $7.4 million, and, by the end of the four-month study period, had raised $1.4 million from more than 13,000 donors.

When the researchers analyzed each campaign’s statements about the unproven stem cell intervention for which it was raising money, they found that 178 of the campaigns (43.6 percent) claimed that the treatment was definitely or certainly going to be effective, and another 124 (30 percent) expressed optimism or hope that it would be so.

Only 36 of the campaigns raised the issue of risk, and in each of those cases the risk was described as low or nonexistent compared with the approved medical treatment for the patient’s condition.

What family and friends can do

Turner has a great deal of empathy for patients who turn to crowdfunding when they are seriously ill. “These platforms are filled with sad, upsetting, powerful stories about people who have serious illnesses,” he said.

Leigh Turner

Leigh Turner

But he’s also deeply troubled by the misinformation that patients and their families are receiving from clinics marketing dubious stem cell treatments to vulnerable patients — misinformation that is being repeated and spread by the crowdfunding campaigns.

People who go to clinics that perform unproven stem cell procedures “may end up coming out in much worse health than they were when they arrived,” he pointed out. They may also spend thousands of dollars — indeed tens of thousands of dollars — without getting anything in return.

“These are basically interventions that don’t have substantial evidence of safety or efficacy behind them — that’s why mainstream medical sectors don’t perform them,” said Turner. “It’s also why insurers don’t provide coverage for them. And so that means that people either have to pay out of pocket and dip into their savings accounts, or take out a mortgage on their home — or turn to other people for help.”

So what should people do when a friend or family member requests money for an unproven stem cell treatment for a serious illness?

“When someone creates a crowdfunding page, it’s understandable that people want to react in a compassionate way and make donations,” said Turner. “The problem is that those acts, while meant to be thoughtful and considerate, may be providing the financial resources that end up giving someone what they need to go to a clinic that could put them at risk of harm.”

A better approach is to have a conversation with the person about how these procedures are being overhyped and oversold.

“Family members and friends who have an understanding of evidence-based medicine, who are aware that these procedures don’t have a meaningful evidence base behind them — they can try and help patients who are thinking of having these procedures understand that the evidence base isn’t compelling, that businesses make all kinds of bold advertising claims without a shred of data behind them,” said Turner.

“But they’re not easy conversations to have,” he added.

FMI:  You’ll find Turner’s study on JAMA’s website.