November 07, 2016 10:44 PM
"The results were amazing."
"Almost immediately, I had less pain."
"It sounded like a miracle cure, and they sell it like a miracle cure."
Those are the words of patients who have undergone treatment involving two of the biggest buzzwords in medicine today: Stem cells.
As more and more for-profit clinics sell pricey, unproven and unapproved stem cell treatments, 5 EYEWITNESS NEWS wanted to find out whether such treatments offer patients hope - or just hype. Critics say they fear desperately ill patients are being exploited, while federal regulators fail to protect them.
The concept is cutting edge: Stem cells are removed from one part of a person's body, and then re-injected somewhere else, allowing the body to regenerate itself.
There is legitimate stem cell research taking place at institutions like the Mayo Clinic in Minnesota, and some of the results are promising. But the number of for-profit clinics selling stem cell treatments is skyrocketing nationwide. They've even popped up in Minnesota, offering to treat knee and shoulder pain.
That means Minnesotans are increasingly seeking them out.
A Pittance, For Hope
Many people take for granted the ability to make themselves a sandwich. Not Andrea Pendar.
"My children had to help me pour a glass of milk, and to lose that sense of independence is a really hard reality to deal with," Pendar said.
Pendar lives in Cottage Grove, and was diagnosed with multiple sclerosis five years ago. What began with tingling progressed into tremors and trouble getting around.
"If I had ended up in a wheelchair, I may never be able to get out of it," Pendar said.
When asked what she thinks would have happened to her if stem cell treatment had not been available, Pendar replied, "I would have applied for Social Security Disability Insurance."
She added that as a result, she would have never worked again.
That's when Pendar discovered a form of stem cell therapy, which also includes chemotherapy. She spent $49,000 to receive it last year at a clinic in Mexico.
For her, it was a pittance to spend on hope.
"My oldest daughter just said to me - she started crying. She just said, 'Mom, you're going to get better!'" Pendar said. "You tell people you're going to Mexico for a medical procedure, and people kind of look at you like, 'Are you nuts?' They think of the Tijuana back-alley clinic, and that's not at all what it was."
Pendar said she never thought she was taking a risk.
"I had complete confidence that I was making the right decision for me," Pendar said.
Pendar said that, following her treatment, her speech improved and her tremors eased almost immediately.
"I can almost sign my name again, which is huge progress," Pendar said.
Troubling Cases Emerge
As part of its investigation, 5 EYEWITNESS NEWS spoke with about a dozen Minnesota stem cell patients and their families. Most said they believed that stem cells helped improve their conditions.
However, one Minnesota man, who declined to be interviewed, said he paid more than $10,000 for stem cells to treat his MS. Nearly one year later, he said nothing had changed.
5 EYEWITNESS NEWS also uncovered several, far more troubling cases across the country.
Medical board documents detail the death of a stem cell patient in Florida. Recent research describes a woman who received stem cell treatment, and subsequently developed tumors in her kidney. One lawsuit claims stem cells caused "permanent blindness" in a Florida patient. Another lawsuit, filed by a patient from North Carolina, states a $7,500 treatment simply didn't work.
"We ought to be having a conversation of: Are people being defrauded?" said Leigh Turner, an associate professor at the University of Minnesota's Center for Bioethics, and an outspoken critic of stem cell clinics. "You're charging an awful lot of money, and maybe all you're providing is the placebo effect."
Treating the Untreatable
Turner points to claims proliferating on the internet, marketing stem cells to treat the untreatable. Myriad clinics and online businesses claim to treat Parkinson's, MS, ALS, and a wide variety of other diseases - and their websites often include a barrage of patient testimonials to back up the claims.
Yet none of those treatments have gone through the Food and Drug Administration's approval process, which ensures that many products are safe and effective before they can be sold to patients.
"We need to move beyond these dramatic marketing claims and ask, 'Where's the science behind it?'" Turner said. "They're charging people money, but they've done nothing to actually demonstrate that they're offering something that helps people in a meaningful kind of way."
Turner co-authored a report, released in June, which found that the number of stem cell clinics is exploding. His research found that 570 individual clinics now operate nationally - up from virtually zero a decade ago. The paper also stated that the exponential growth of such clinics presents "serious ethical, scientific, legal, regulatory, and policy concerns."
In Minnesota, 5 EYEWITNESS NEWS found only three businesses current operating, solely treating lesser ailments like joint pain and sports injuries.
"We're not seeing the full spectrum in terms of the number of businesses, and in terms of making marketing claims about 20, 30, 40 diseases and injuries," Turner said. "If you think about where things are likely to go, we're probably likely to see more of these businesses, (and Minnesota) looking more like other states."
And Turner placed the blame squarely on the FDA, which he called "a federal regulatory body that, for the most part, is sitting on its hands, doing very little."
"And that's how people get hurt," Turner said. "You could open up a stem cell clinic in southern California, or in Texas, or in Arizona, or Florida, and nobody was going to come knocking on your door saying say they were going to do an inspection."
"In most cases, these businesses operate as black boxes," Turner said.
"I Believe In Stem Cells All the Way"
"Sometimes it does feel like the Wild West out there," said Dr. Michael Badowski, a researcher at the University of Arizona and laboratory director at Celebration Stem Cell Centre in Gilbert, Ariz.
5 EYEWITNESS NEWS spoke with Badowski at a high-stakes FDA hearing held at the National Institutes of Health just outside Washington, D.C. in September. The FDA was soliciting feedback on its proposed draft guidances regarding stem cell treatment regulations - part of an effort to clarify its rules, which have been criticized as too open to interpretation.
The hearing drew hundreds of interested parties, including patients clamoring for cures, and skeptics demanding stricter regulations
"Without stem cell therapy, my life would literally be a different story," said Georgianna Crocker, a patient who testified during the hearing.
"I believe in stem cells all the way," said Carl Nicastro, a stem cell patient with MS who also testified at the hearing. "Before the stem cells, I couldn't brush my teeth. I couldn't take a shower. I couldn't feed myself."
At the hearing, patients from across the country begged top FDA officials to let them access their own stem cells without requiring costly and lengthy clinical trials, which typically precede FDA approval. Clinics argued that the treatments they administer to patients are medical procedures - not drugs - and therefore don't require FDA approval in the first place.
"The FDA will be complicit in criminalizing certain practices of medicine," warned Elliot Lander, co-founder and co-medical director of California-based Cell Surgical Network, during his testimony, urging the FDA to avoid tighter regulation of the industry.
The company is one of the most prominent stem cell clinics in the U.S., and offers treatments for a variety of serious diseases.
"The government should not regulate our bodies. I'm Kristin Comella, and I will always stand up for patient rights," said Kristin Comella, chief science officer for Florida-based U.S. Stem Cell, another prominent stem cell treatment provider.
On its website, U.S. Stem Cell touts stem cells to treat Parkinson's, ALS, and spinal cord injury, among other serious ailments.
"Patients have a right to use their own body to heal themselves," Comella told 5 EYEWITNESS NEWS after her testimony.
When asked whether the treatments her company provides have been proven to be safe and effective, Comella replied, "No. There's no double-blind studies at this point. But that shouldn't stop us from providing these treatments to patients."
5 EYEWITNESS NEWS asked Comella whether more evidence from the scientific community should emerge before such treatments are used on patients.
"Patients don't have the luxury of time, especially patients who are ill. They cannot wait 20-plus years for double-blind, placebo-controlled trials," Comella replied.
When asked about claims that stem cell clinics are exploiting vulnerable patients, Comella said, "We don't promise any cures to our patients, and we've been successful in helping a lot of patients. And the majority of patients do not feel like they've been taken advantage of in any way."
"We would never promise something to our patients, and we make sure that they fully understand the protocols and the procedures," Comella said.
"What Could Go Wrong?"
One stem cell patient from Pennsylvania, who was treated at a different clinic, attended the FDA hearing with his experience draped around his neck - a sign warning that he had suffered damage as a result of his treatment.
"The guy told me it was a 0.0001 percent risk. What could go wrong?" George Gibson said.
Gibson said he paid $20,000 at a clinic in Florida, hoping to improve his eyesight.
"This eye now has 10 percent of what I had before the operation," Gibson said. "Somebody has to be investigating these things."
More than two years before Gibson received his treatment, Turner sent a letter to the FDA, urging it to investigate the clinic Gibson was treated at to determine whether it was in compliance with federal regulations.
It's unclear if the FDA took any action as a result.
"Why did they do nothing? This was a business where there were a lot of red flags," Turner said.
Turner took his concerns to the FDA hearing, pressing federal officials to crack down.
"The out-of-control marketplace for stem cell interventions needs effective regulatory oversight," Turner told the panel of FDA officials.
While outnumbered by those opposed to increase regulation, Turner was joined by a handful of other voices calling for change.
During her testimony, Jeanne Loring, director of the Center for Regenerative Medicine, a research institute, said she feared "an increasing exploitation of desperate patients by incompetent clinics."
And Heather Rooks, scientific director for the International Society for Cellular Therapy, testified, "We do have concerns that stem cell treatments are being marketed directly to consumers without the safeguards in place to ensure likely safety and efficacy of experimental treatments."
FDA Warns, Allure Grows
FDA officials listened intently to two days of testimony, but they took no questions. The agency also declined repeated 5 EYEWITNESS NEWS requests for an interview.
Instead, the FDA cited a five-year-old "Consumer Health Information" bulletin, which stated, "The hope patients have for treatments not yet proven to be safe and effective may leave them vulnerable to unscrupulous providers of stem cell treatments that are illegal and potentially harmful."
That bulletin also warns patients, "Even if the cells are yours, there are safety risks."
"The value of stem cells as a treatment for most conditions is largely unproven and more information is needed about their potential benefits," the agency added, in an email. "This is an important topic and the FDA will evaluate the feedback we received as we work to finalize our guidance, which is intended to provide clarity around the FDA's established regulatory framework for these products."
The FDA has sent warning letters to a handful of stem cell clinics in recent years. But there is no telling when - or if - it will take additional, broader action.
The agency also says potential patients need to do their homework. Anyone considering a stem cell treatment should inquire as to whether the treatment is FDA-approved, or whether it will be part of an FDA-regulated clinical study.
Meanwhile, the allure of stem cell treatments continues to grow.
"Everybody can benefit from this procedure. There's no doubt about it," Pendar said.
A bill introduced in the U.S. Senate would fast-track approval for stem cell treatments. But many experts are firmly opposed.
Updated: November 07, 2016 10:44 PM
Created: November 03, 2016 09:01 AM
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