Stem cell injections cause negative side effects and debt for patients
The first time Joyce Roberts fell, she says, she tore cartilage in both her knees, broke her wrist and injured her shoulders.
She’s fallen many times since.
Roberts, who lives in Casa Grande, is in her 70s and doesn’t have much cartilage left in either of her knee joints, making it painful and unsteady for her to walk.
“I’m just walking on bone on bone,” Roberts said. “That’s probably part of the reason why I fall so often.”
Because she lives alone and is older, Roberts said she didn’t think knee surgery would be a good option, fearing she wouldn’t have anyone to take care of her while she recuperated.
Then one day, she saw a newspaper advertisement for stem cell treatments.
The stem cell treatment company in the ad was holding an event marketed as an educational stem cell seminar. Roberts attended and what she heard caught her attention: Stem cells, she was told, could regrow the cartilage in her knee.
“My understanding of how stem cells are supposed to work is that they attack your bad tissue and regenerate it so that it is healthy,” she said.
Someone attending a seminar like the one Roberts walked into could leave with that belief, even though at present, stem cells are only approved by the Food and Drug Administration as treatments for certain blood and immune disorders. There are no other approved uses outside of investigational clinical studies.
Such seminars appear to be an effective way for clinics to recruit new customers, according to an analysis by Paul Knoepfler, a biologist and professor at the UC Davis School of Medicine who studies stem cells.
He writes in his analysis that the experience of personally attending one seminar “felt more like attending a persuasive entertainment show or something on a television shopping network than an educational seminar.”
He describes the seminar as an opportunity to make a hard sell to attendees and characterized some of the medical claims made at the seminar as questionable, while also noting that no disclaimers were added.
David Harris, a stem cell researcher at the University of Arizona, said he has seen similar patterns at seminars he attended. He said he was given a free dinner in exchange for attending the seminars, which he described as a marketing spiel.
“While you’re having your meal, they give a little slide show, a little song and dance, talking about how great everything is,” he said.
The FDA has issued a warning about unapproved treatments, calling some of them illegal and potentially dangerous. In 2017 the FDA issued guidance clarifying that many stem cells products are drugs that must be proven to be safe and effective in formal clinical research studies to get approval. In these studies, stem cell companies would need to collect data and use necessary controls to measure the treatment’s effects.
The agency gave stem cell businesses until May 2021 to comply with FDA regulations, register with the FDA and obtain permission to start clinical trials. In the meantime, the FDA also announced in 2017 that it would pursue greater enforcement of the rules and crack down on what it called “bad actors” within the industry.
In the statement, then-FDA Commissioner Scott Gottlieb described bad actors as those who “make deceptive, and sometimes corrupt, assurances to patients based on unproven and, in some cases, dangerously dubious products,” and said the FDA would target those who were “clearly stepping over the line.”
Over three years later, with only a few months left to comply with FDA regulations, a Republic analysis of 152 stem cell businesses in Arizona found only three had listed studies on ClinicalTrials.gov, one way to indicate they were pursuing some form of compliance.
Instead of presenting data on the success rates of stem cell products, many stem cell businesses rely on patient testimonials to sell their product, said Zubin Master, a stem cell ethics and policy researcher at the Mayo Clinic in Minnesota.
But those narratives could be cherry-picked and not fully transparent about the risks of the procedure. In a 2019 study, Master analyzed 159 online patient testimonials of stem cell therapies and found that patients mentioned benefits in 95% of the videos but only mentioned risks in about 10%. In videos mentioning risk, Master wrote that in all but one, risks were underemphasized.
At one November 2019 seminar, eight or so prospective patients sat and listened, including one who used a wheelchair and hoped that stem cells would allow him to walk again.
Though the seminar was held at a chiropractor’s office called My Chiropractor Health & Wellness, the presentation was given by a representative of BioGenix, a Texas-based stem cell product distributor. In the presentation and on BioGenix’s website, the company cites the FDA to claim that its products are produced in a federally compliant laboratory.
BioGenix and My Chiropractor have not responded to requests for comment.
Mentioning the FDA in advertisements is a marketing tactic used to make prospective clients feel safer about getting an unregulated, unapproved treatment, according to University of Minnesota researcher Leigh Turner, who has studied the stem cell industry for nearly a decade.
In a 2018 study, Turner discussed numerous ways in which stem cell businesses use references to science, studies or regulatory bodies to “promote unproven stem cell products and make themselves appear credible.”
He called such references “tokens of legitimacy,” which can confuse clients about the FDA’s involvement with their treatments. While the lab itself may be inspected, clients may mistakenly believe that the treatments are also FDA approved or part of credible research when that’s not always the case.
“The stem cell facility that I went to assured me that their stem cells were inspected by the FDA, and I don’t understand how they can be inspected and then yet they don’t approve them,” Roberts said.
While she knew the treatment was not FDA-approved and was not guaranteed to work, Roberts said she became convinced that stem cells were her best treatment option.
Roberts had previously been diagnosed with fibromyalgia, which causes severe widespread muscle pain and fatigue.
By 2018, she said her fibromyalgia symptoms had been in remission for over a year, but she was still concerned about whether her condition would be affected by the stem cell treatment, or vice versa.
According to medical records, her first consultation and treatment for stem cells was on Oct. 15, 2018, at a clinic called the Stem Cell Centers of Tempe. When she brought up concerns about fibromyalgia to the doctor who administered her treatment, she said he brushed them off.
“He said, ‘I’ve been doing this a long time. I know what I’m doing.’ So I let him continue,” Roberts recalled.