Bay Area Patients Stung By Unapproved Stem Cell Treatments As FDA Looks To Clamp Down
SAN JOSE (CBS SF) -- Hundreds of clinics are popping up all over the country offering unapproved and potentially dangerous stem cell treatments.
Earlier this year, we reported on a chiropractic clinic in Walnut Creek recruiting patients for these treatments through free lunch seminars. Now it appears another chiropractic clinic in San Jose is doing the same thing.
When Debra Hernandez she attended a free lunch seminar about a stem cell treatment earlier this year, she became filled with hope that it might be the long sought cure for her back pain.
"I was excited," Hernandez said.
It was held at the Advanced Health Center in San Jose, run by two chiropractor brothers – Drs. Brian and Jeff Coyle.
She signed up on the spot and said Jeff Coyle recommended she start her treatment by taking some take tests. "He estimated it would be about $2,500," said Hernandez.
All she had was a pet insurance card for her cat, with a $500 dollar limit. "So he says, 'Well, let me see if I can get it increased for you.' So he did, he says, 'Yeah we got you up to a $2,500 limit,'" said Hernandez.
Soon the tab started adding up. $649 for blood analysis, $649 for hormone testing and another $649 for a hair specimen. "It was a big chunk of hair that he removed from the back of my head, with a pair of office scissors!" said Hernandez.
When the results came back they showed many health issues. "If I didn't get help right now I was one foot in the grave," said Hernandez.
She says Coyle pushed her to continue, with a nutrition program that was going to be another $3,000 dollars. At that point, with no money left to spend, Hernandez stopped going to the Advanced Health Center, never receiving the stem cell treatment for which she had originally enrolled.
But others have, like Marilyn Kirchoff, who also attended a free lunch seminar. "These guys are really slick," said Kirchoff. "You know I am not a stupid person but that seminar, oh my God, they put all these things up there, you believe it."
She spent $13,000 dollars on stem cell injections, obtained - according to the company's website - from amniotic fluid and touted as able to "actually restore degenerated tissue while providing pain relief."
"They tell you you wouldn't be expected to see anything for about six weeks," said Kirchoff. "And it may take a lot longer. And I got nothing, I got nothing out of it."
Kirchoff said she was also talked into another $15,000 for a back therapy called Vax-D that she said made her back worse instead of better. Her total bill: $28,000.
"It's not five-hundred, it's thousands and thousands of dollars," said Kirchoff. "That is very debilitating. So that is just not right!"
Surgenex, the lab that manufactured the stem cell injections that Kirchoff received, is based in Scottsdale Arizona. It boasts that it's "pioneering the next generation of medicine," leveraging "unprecedented quality, safety and value."
Surgenex is registered with the U.S. Food and Drug Administration. But we found it has never been inspected by the FDA, and as it discloses on its website: "none of the currently marketed birth tissue derived therapies are approved by the Food and Drug Administration."
The FDA recently put out a video warning consumers about unapproved stem cell therapies that are illegal and potentially harmful. One woman became blind and 12 other patients developed life-threatening blood infections.
The FDA is stepping up enforcement but so far has cited only a handful of manufacturers.
It's something that frustrates Arnold Kriegstein, director of the Eli and Edythe Broad Center of Regeneration Medicine and Stem Cell Research at UCSF, one of the premier stem cell research labs in the country.
"The legitimate excitement about treating diseases with stem cells has led to some rather nefarious activities," said Kriegstein.
Research at UCSF covers many diseases that currently have no cure. "We are talking about major sources of disability for millions of people," said Kriegstein.
UCSF has already spun four startups that have applied for or are currently beginning FDA-approved clinical trials. "They range from liver regeneration to treating diabetes, heart disease, nervous system disorders," said Kriegstein.
But getting to an approved clinical trial is a slow process, 15 years in the making at UCSF, that clinics like Advanced Health Center have not gone through.
Neither company responded to our calls for comment. But we were able to catch up with Jeff Coyle as he was headed in to work. He refused to talk to us, told us to go away and closed the door on us.
"People like me need to know about this. Wait. Don't do it!" said Kirchoff.
"These are not good people, they are out for your money and that is all that they are interested in," said Hernandez.
The FDA is giving manufacturers of unapproved stem cell products another year to come into compliance by applying for what's known as an Investigational New Drug Approval. But enforcement is already underway. Just this month, the agency sent a warning letter to Yorba Linda-based Liveyon, warning that its stem cell products "lack FDA approval and represent a potential risk to the public health."
The agency also sent preliminary notices to Woodland Hills-based Chara Biologics and Florida-based RichSource Stem Cells for offering unapproved stem cells to patients, as well as letters to 20 manufacturers and health care providers that they may be offering unapproved products.