Stem cell injections cause negative side effects and debt for patients

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.

That hasn’t slowed the growth of the business, nor has it softened the hard sell. An Arizona Republic analysis of 238 stem cell clinics across the state showed that many clinics advertised free informational sessions or educational sessions.

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.

Casa Grande resident Joyce Roberts displays the advertisement for the stem cell treatments she received.

Casa Grande resident Joyce Roberts displays the advertisement for the stem cell treatments she received.
Amanda Morris/The Republic

“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, 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.

Casa Grande resident Joyce Roberts is still paying off medical bills from her failed stem cell treatments.

Casa Grande resident Joyce Roberts is still paying off medical bills from her failed stem cell treatments.
Amanda Morris/The Republic

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.

Elevate Health Clinics disappeared the day after The Republic first made contact with Autor.

Autor spoke with The Republic in early February 2021 and stated that Elevate Health Clinics went out of business in December 2020.

Changing the name of a business or listing multiple businesses at a single location is not an uncommon practice for stem cell businesses, according to ASU professor and researcher Emma Frow. This makes it harder to keep track of businesses or doctors, she said. 

Autor himself used to be named Travis Broughton. 

In 2009, Autor agreed to a 10-year suspension of his license to be a chiropractor in response to allegations of double billing, having a sexual relationship with a patient and smoking marijuana during workplace lunch breaks.

Afterward, he remarried and wrote in an online post that he took his wife’s last name “to try and escape this nightmare I created.”

Now Autor is grappling with new legal issues.

In July 2020, state attorneys general in Iowa and Nebraska filed lawsuits against Travis Autor and against Stem Cell Centers accusing them of making “deceptive and misleading” claims about their stem cell therapy.

The Iowa lawsuit claims that hundreds of Iowans paid thousands of dollars for stem cell therapy at Autor’s businesses, with prices ranging from $1,400 to over $27,000.

The Nebraska lawsuit alleges that Autor and his businesses made at least $2.2 million in sales for stem cell therapy treatments sold in Nebraska alone.

Autor declined to comment on these lawsuits because they are ongoing.

“Mr. Autor denies any wrongdoing and he looks forward to defending the benefits of stem cell therapies in court,” his lawyer David Fautsch said.

In a 2017 YouTube video, Autor claimed that business profits were used to support stem cell research.

The company never published results from any formal studies, and Autor claims the company did not have the time or money to conduct a formal research study, called an investigational new drug study, according to FDA standards. Such a study is needed for FDA approval.

“Do you think a clinic … could afford to spend millions and millions and millions of dollars, on top of the man hours it takes, to do an IND study?” he asked. “IND studies are done by pharmaceutical companies.”

listed as a practicing naturopathic medicine doctor at the newly formed Wellspring Clinic in Scottsdale, which also offers stem cell treatments.

Just and Wellspring Clinic did not return multiple requests for comment.

The dangers of unapproved stem cell treatments can be even more serious, and can go well beyond a financial risk.

2017 FDA report documents cases of serious side effects from stem cell treatments, including blindness, and there are numerous news reports about stem cell treatments with serious complications or even death.

There are a growing number of lawsuits against stem cell clinics or stem cell companies, according to Andrew Yaffa, a Florida-based personal injury lawyer who started getting calls complaining about stem cell treatments in early 2015.

Since then, he said he’s received “dozens and dozens” of calls, and has represented patients who he alleges have gone blind and suffered brain damage and damaged joints from stem cell treatments.

“This is real snake oil,” he said.

Among those calls, he said he’s been contacted by several people in Arizona, which both Turner and Frow said seems to be one of the hot spots for the stem cell industry.

Cells seen through a microscope.

Cells seen through a microscope.
Tim Boyle / Getty Images

Some of the more prominent lawsuits nationwide have been against California-based stem cell manufacturer Liveyon, which victims allege sold and distributed stem cell products contaminated with E. coli. 

Liveyon issued a voluntary recall of some of its products in October 2018 “due to reported possible adverse reactions.”

In 2018 the CDC linked 12 cases of bacterial infection, including E. coli, in patients who had received Liveyon’s products. The CDC also tested six unopened vials of Liveyon’s products and found harmful bacteria in all vials.

In December 2019, the FDA sent a letter to Liveyon warning that they had inadequate manufacturing practices to prevent contamination of their products.

“I believe there were somewhere between a hundred and thirty and maybe two hundred people that received these contaminated … stem cell injections in various parts of their body,” said Arizona attorney Patrick McGroder.

McGroder said he represented two clients who allegedly received contaminated stem cell injections in connection with Liveyon and claimed that they had subsequent injuries that were “catastrophic.”

“It is a very destructive variable, a bacteria, especially when it gets in the blood,” he said.

One of his clients is Arizona resident Charlie Lotz. 

Lotz was a general contractor who did everything himself, according to McGroder. He is now over 80 and has suffered from osteoarthritis in his neck, shoulders and lower back. He attended a free stem cell dinner seminar hosted by the Compass Medical Center in July 2018, according to a lawsuit filed in March 2019. 

“That’s how they sell you. … They’ll invite you in for a free dinner, they’ll make a presentation about their product or their service and they’ll try and sign you up or sell you at the dinner,” McGroder said.

At the dinner, one of the chiropractors working with the center “emphasized the cutting-edge, low-risk, and healing nature of injections for individuals suffering from osteoarthritic pain,” according to the lawsuit.

Later, in a consultation, another chiropractor told Lotz he was the perfect candidate for the treatment and allegedly convinced him that stem cell injection therapy was safe, according to the lawsuit.

After being offered about 13% off an initial quoted price of $16,000, Lotz decided to go ahead with stem cell treatments.

He received stem cell injections in both his shoulders mid-afternoon on Aug. 14, 2018. A few hours later, the lawsuit says, Lotz felt severe pain in both shoulders and couldn’t move his arms.

His wife, Barbara Lotz, tried to call Compass Medical Center, but it was closed. The next morning, the couple went to the center, and, according to the lawsuit, a chiropractor and a physician’s assistant working at the center treated Lotz’s shoulder pain with laser light therapy and prescribed narcotic medication to Lotz.

In response to the lawsuit, the Compass Medical Center admitted to giving Lotz the light therapy and prescribing Lotz a painkiller called Percocet, but denied allegations of wrongdoing.

reported in December 2019 that Liveyon announced it would stop distributing its stem cell products in an effort to focus on clinical trials and getting FDA approval.

In filed responses to the lawsuit, Liveyon, the Compass Medical Center and doctors working with the Compass Medical Center at the time denied most of the allegations in Lotz’s suit and denied any wrongdoing.

Liveyon settled the case with Lotz in September 2019 and the medical director of the Compass Medical Center, James Sielski, settled the case with Lotz in December 2019, according to case filings. 

Other doctors working with the Compass Medical Center were also eventually dismissed from the lawsuit, according to the case filings, though it’s unclear why.

McGroder said the Liveyon settlement didn’t result in much compensation for Lotz.

“Unfortunately, they had very minimal insurance that had to be divided among a lot of people,” he said.

He declined to comment further on any settlements.

Genetech has since closed and its former president, Edward Pinos, could not be reached for comment.

Genetech and Pinos never made appearances in court for the lawsuit and it appears  they could not be reached by process servers. Though Pinos was initially served the lawsuit in March 2019, an attempt to serve an amended lawsuit to Pinos in May 2019 failed, according to case filings.

In filed responses to the lawsuit, both the Compass Medical Center and Liveyon claimed they believed Genetech’s stem cell products were pre-screened by the FDA.

“They sold a product they didn’t know anything about … it turned out not to be safe,” McGroder said. “Where was all the due diligence? Where was all the research?”

Though there are numerous examples of ongoing cutting-edge stem cell research to find new therapies stem cell scientists and experts say the techniques employed at stem cell clinics are drastically different and less controlled than treatments in research or clinical settings.

Without regulation and approval, there’s no way of knowing what customers are getting, and whether an injection or unapproved treatment actually contains stem cells, or whether it contains anything harmful.

“These companies are engaging in nothing short of human experimentation,” Yaffa said. “Each and every one of these patients are guinea pigs.”

Independent coverage of bioscience in Arizona is supported by a grant from the Flinn Foundation.



Source link