Stem cell clinics attract patients, scrutiny
By TODD ACKERMAN
Sunday, December 3, 2017
HOUSTON — Martha Barden hobbled around in so much pain — barely able to navigate stairs, always calculating distances she could walk — that her husband told her she needed knee replacement.
The Houston Chronicle reports the Friendswood woman didn't disagree, but she wasn't keen on surgery, which hadn't done wonders for some of her friends and made her nervous at 65 years of age. She was more interested in the promise of stem cell therapy, touted for an ability to rejuvenate aging or injured joints.
"I noticed that lots of athletes had done stem cell treatment and figured if it's good enough for them, it's probably good enough for me," said Barden, who skied and played tennis in her younger years. "I could always have surgery later if it didn't work."
In April, Barden got an injection of stem cells at a Pearland clinic, one of more than 100 for-profit businesses in Texas providing the increasingly popular but unproven and expensive therapy. A recent report found the state is one of the nation's stem cell hotbeds, promoting the treatment as a possible cure for everything from multiple sclerosis and Alzheimer's to diabetes and hypertension.
The numbers only figure to increase as a result of a 2017 Texas law that facilitates clinics purporting to use such cells as treatment for people with chronic illness — without the regulatory testing and approval normally required under federal law. A companion piece to the 2015 right-to-try law that seeks to make pharmaceutical drugs still in clinical trials accessible to cancer patients, the new law would allow patients with chronic conditions to give stem cell therapy a shot.
The new law, which went into effect in September, makes Texas the first U.S. state to sanction experimental stem cell therapy and the latest to provoke scientists, some of whom express fear such backing will lend legitimacy to adventurous treatments, prey upon the desperation of patients and give rise to hucksters.
It certainly will impose demands on patients to choose wisely among the maze of clinics, given that some patients report dramatic improvement, some report no benefit and a few report disastrous results. The latter include cases of patients going blind after receiving injections in the eye.
The law could also put some Texas clinics on a collision course with the federal government, which in November announced plans to crack down on some stem cell practices. Food and Drug Administration Commissioner Scott Gottlieb acknowledged the field's promise but warned that the agency must "meet its obligation to ensure the safety and efficacy of medical products patients rely upon."
"Stem cells have been called everything from cure-alls to miracle treatments," the FDA said in a consumer health alert with the announcement. "Don't believe the hype."
No one doubts the potential of stem cells, long used to treat blood cancers and more recently found to possess even greater versatility. Their ability to grow into different kinds of tissue and the possibility they can repair organ function has excited researchers in the Texas Medical Center and around the nation for 20 years now. They envision it as the linchpin of a new field, regenerative medicine.
But progress harnessing stem cells' potential has been slow. Most scientists deploying the cells in clinical trials say they are not yet ready for mainstream use.
Such warnings didn't deter then-Gov. Rick Perry from getting the therapy for his ailing back in 2011. A Houston orthopedic surgeon took stem cells from Perry's fatty tissue, had them treated and expanded in a for-profit Sugar Land laboratory and then reinfused them in Perry during back surgery. Though Perry claimed that he got great relief from the procedure, he later blamed his continuing back pain for the "oops" moment and other gaffes that sunk his once-promising 2012 presidential campaign.
As governor, Perry was one of stem cell therapy's great boosters. At a 2012 Houston gathering of researchers, industry leaders and patients, he compared stem cell treatment to previous innovations in space and heart care and said the field "holds the promise of miracles" desperately needed by people across the world. Urging stem cell companies to locate or relocate in Texas, he said the state's "wildcat spirit" and "conducive climate" could make their businesses blossom here.
Five years later, despite an increase in stem cell clinics, Texas legislators decided that access for patients with chronic illness wasn't happening fast enough. They learned of Americans leaving the country for stem cell treatment and concluded there was no good reason patients shouldn't be able to get the therapy in Texas.
The resulting bill set up a process for patients whose chronic ailments haven't responded to conventional treatment to get stem cell therapy in Texas hospitals and clinics.
It requires an institutional review board to be in place to monitor the therapy, but those details have yet to be worked out by the Texas Medical Board.
"I would rather have the state helping out with these therapies than wait for the FDA to make up their mind in 20 years," said Sen. Paul Bettencourt, R-Houston, one of the bill's authors. "If stem cells can save lives or improve their quality, we need to get government out of the way so it can flourish."
Leigh Turner, a University of Minnesota bioethicist who testified against the Texas bill in the 2017 Legislature, argues that the notion Americans have to travel outside the country for the therapy is a fallacy. He co-authored a 2016 report that showed stem cell clinics are already sprouting up all over the United States.
In all, the report found 570 such clinics, a number that has continued to grow, said Turner. Only California and Florida are home to more than Texas, where Austin, San Antonio and Houston, in that order, boast the highest numbers.
Barden received her infusion of stem cells at Premier Medical Group, an upscale integrative clinic — it also incorporates acupuncture, chiropractic care, physical therapy and nutrition counseling — primarily for patients who want their muscle, nerve, joint or disc pain treated without drugs or surgery. The clinic was a focus of attention when Sean Salisbury, broadcaster and former NFL player, got stem cell therapy there.
For a single injection of stem cells taken from umbilical cord tissue and blood, Premier charges $5,000 for the knee, $8,500 for the neck or hip, and $10,000 for the lower back — no portion of which is reimbursed by any type of insurance. In most cases, just one injection is needed, but severe cases can require additional injections at the start or at a later time, according to Premier Medical Group.
Barden landed at Premier after attending an "educational seminar" she read about on Facebook.
The events, termed "infomercial seminars" by critics, have been promoted on network television station's local affiliates and in front-page wrap-around newspaper advertisements by a group called the Stem Cell Institute of America. The Houston Chronicle was among the papers to run the ad.
"We all want to be self-sufficient human beings, not reliant upon people pushing us around in a wheelchair," James Parsons, Premier's director, told a crowd of mostly senior citizens at one of the seminars advertised by the institute. "Stem cells can provide that sort of life-changing result - people who come in in wheelchairs and go to walkers to canes to nothing. It's phenomenal."
Parsons, a former college baseball player who's received stem cell treatment for a myriad of injuries, told the crowd that 75 percent to 90 percent of patients get complete pain relief and full function within six months of receiving an injection.
Seven months out, Barden's improvement hasn't been quite that impressive, but she said she's pleased with the results. She estimates she's probably 80 percent better, off painkillers and able to walk longer distances before feeling a twinge in her knee. She says it was money well spent.
Parsons downplays the relationship with Stem Cell Institute of America, controversial among some observers and bloggers because one of its leaders was convicted of health care billing fraud in 2007.
The 3-year-old organization provides business help to independent practitioners, mostly chiropractors, who have added stem cell therapy to their clinics, said owner Steve Peyroux. It provides no oversight or membership requirements.
"Stem cell therapy isn't an easy business for doctors," said Peyroux, whose company represents about 120 clinics around the country. "Stem cell vendors offer an array of products, most expensive. You have to train some people, hire others. It takes business acumen to pull off" opening a clinic.
Parsons says the relationship is "just marketing," which gets a rise out of Turner, the Minnesota bioethicist and report author. He notes the organization's ads and website makes it look like a national franchise of clinics when it's "nothing more than a bunch of unrelated chiropractic offices. It's just a marketing front?"
In a blog comment, stem cell researcher Henry Young expresses concern that many clinic personnel are trained in "everything you ever wanted to know about stem cells, including treatment paradigms" in three- or five-day courses. As someone still just beginning to "learn the do's and don'ts" of stem cell treatment after 40 years in the field, Young wrote that the hubris behind the idea expertise can be learned in such a short time "boggles my mind."
The FDA's crackdown won't target clinics that focus on joint and muscle pain like Premier Medical Group in Pearland because such procedures are considered relatively safe. FDA officials said they instead will focus their enforcement efforts on "bad actors" who inject stem cells into the bloodstream, nervous system or eyes. Those procedures pose the biggest risk to patients, they said.
Turner fears the strategy, probably logical prioritizing given the FDA's limited resources, will nonetheless send the message that most stem cell clinics are fine and do nothing to stop their continued proliferation. Similarly, he worries that no one in Texas will enforce regulatory standards set forth in the new right-to-try stem cell law.
Doris Taylor, the Texas Heart Institute's director of regenerative medicine research, says the increase in stem cell clinics speaks to patients' frustration with the lack of treatment options 20 years after the field first flashed promise. She says the failure reflects not just hurdles making the therapy work, but funding difficulties that have caused companies to shut down even as they got positive results. Regenerative medicine needs new strategies to get therapies to the marketplace, she said.
"I can tell you firsthand that people faced with a chronic or potentially terminal illness want a solution," said Taylor, a cancer survivor working to develop a natural heart made from stem cells. "But people have to remember that stem cells aren't like drugs — you can stop taking drugs if it has unintended consequences. You can't take back stem cells injected in the body."