Adult stem cells may skirt the pesky theological issues raised by embryonic stem cell research, but their unregulated marketplace is raising ethical issues of its own.
A study released at the end of last month found hundreds of clinics across the country that are marketing “unapproved” stem-cell therapies directly to patients.
An online search for “Texas stem cell treatment,” brings up a website for the Innovations Stem Cell Center, a clinic out of Dallas. Its home page for their site features a video clip of a grey-haired doctor, decked in scrubs, explaining the science of stem cells to an attentive show host of WFAA-TV's "Good Morning Texas."
The website also cautions that the FDA “has NOT approved the use of adult stem cells," but still offers treatments for pulmonary disorders, Parkinson’s disease, multiple sclerosis and even erectile dysfunction; and suggests that, if a condition is not listed, would-be clients should "contact us for availability.”
“It’s really interesting to go to these sites and go to the pull-down menus,” said Christopher Scott, a bio-ethicist with the Baylor College of Medicine.“All you have to do is click on whatever it is you think you have and they will give you some sort of quote, unquote, treatment.”
This, he said, is flagrantly unethical. While adult and embryotic stem cells offer a lot of promise, they have been approved by the FDA only to treat a limited number of ailments – mostly cancers.
There is nowhere near enough evidence for these clinics to justify doling out the treatments that they do, Scott said. He even objects to using the word “treatment” in conjunction with these potentially dangerous procedures.
The study cataloged 571 clinics nationwide that are directly marketing unapproved stem cell treatments to consumers. Seventy-two of those clinics are in Texas.
“Some of those clinics are definitely on the edge,” said Dr. David Harris, with the Center for Healing and Regenerative Medicine in Austin.
He’s been treating patients for musculoskeletal injuries with adult stem cells for a few years now.
“I actually agree with the bio-ethicists’ to a certain point,” he said.
He sees the evidence for what he does as robust, and is wary of being lumped in with clinics that treat neurological conditions, for which he agrees that there is little evidence at this point.
But his clinic is on that same list.
Dr. Leigh Turner, one of the authors of the study, said that you can find debate among respectable orthopedic surgeons, and that some agree with Dr. Harris – that stem cells are a legitimate therapy for musculoskeletal conditions.
But neither Dr. Scott nor he believe the evidence is there yet. They look to the insurance companies, who won’t cover the costs of what they consider unproven treatment.
There are definitely good researchers out there, and some of these clinics could be doing cutting edge work, Scott said. But, for him, the lack of regulation really muddies the water.
He advises that people watch out for clinics who offer too many, often glowing, patient testimonials.
“Anecdotes are not science,” he said. “The ones who are doing it the right way often say nothing about the therapeutic claims of their products. That’s in stark contrast to claims that this is going to get you up out of your wheelchair.”