The online seems to promise everything an arthritis patient could want.
The six-minute segment mimics a morning talk show, using a polished TV host to interview guests around a coffee table. Dr. Adam Pourcho extols the benefits of stem cells and 鈥渞egenerative medicine鈥� for healing joints without surgery. Pourcho, a sports medicine specialist, says he has used platelet injections to treat his own knee pain, as well as a tendon injury in his elbow. Extending his arm, he says, 鈥淚t鈥檚 completely healed.鈥�
Brendan Hyland, a gym teacher and track coach, describes withstanding intense heel pain for 18 months before seeing Pourcho. Four months after the injections, he says, he was pain-free and has since gone on a 40-mile hike.
鈥淚 don鈥檛 have any pain that stops me from doing anything I want,鈥� Hyland says.
The video鈥檚 cheerleading tone mimics the used to promote stem cell clinics, several of which have recently gotten into hot water with federal regulators, said , a professor of cell biology and human anatomy at the University of California-Davis School of Medicine. But the marketing video wasn鈥檛 filmed by a little-known operator.
It was sponsored by Medical Center, the largest nonprofit health provider in the Seattle area.
Swedish is one of a growing number of and 鈥� including the , the and the 鈥� that have entered the lucrative business of and , including platelet injections. Typical treatments involve or cells, or with extracts of , the cell fragments known for their role in clotting blood. Many patients seek out regenerative medicine to stave off surgery, even though the supporting these experimental therapies is , Knoepfler said.
Hospitals say they鈥檙e providing options to patients who have exhausted standard treatments. But critics suggest the hospitals are exploiting desperate patients and profiting from trendy treatments.
The is attempting to shut down clinics that hawk unapproved stem cell therapies, which have been linked to and at . Although doctors usually need preapproval to treat patients with human cells, the FDA has carved out a , as long as the cells meet certain criteria, said Barbara Binzak Blumenfeld, an attorney who specializes in food and drug law at Buchanan Ingersoll & Rooney in Washington.
Hospitals like Mayo are careful to follow these criteria, to avoid running afoul of the FDA, said Dr. Shane Shapiro, program director for the Regenerative Medicine Therapeutics Suites at Mayo Clinic鈥檚 campus in Florida.
鈥楨xpensive Placebos鈥�
While hospital-based stem cell treatments may be legal, there鈥檚 no they work, said Leigh Turner, an associate professor at the University of Minnesota鈥檚 Center for Bioethics who has published a series of articles describing the size and dynamics of the
鈥淔DA approval isn鈥檛 needed and physicians can claim they aren鈥檛 violating federal regulations,鈥� Turner said. 鈥淏ut just because something is legal doesn鈥檛 make it ethical.鈥�
For doctors and hospitals, stem cells are easy money, Turner said. Patients typically pay a treatment for platelets and up to for fat and bone marrow injections. As a bonus, doctors don鈥檛 have to wrangle with insurance companies, which view the procedures as and largely
鈥淚t鈥檚 an out-of-pocket, cash-on-the-barrel economy,鈥� Turner said. Across the country, 鈥渃linicians at elite medical facilities are lining their pockets by providing .鈥�
Some patient advocates worry that hospitals are more interested in capturing a slice of the stem-cell market than in proving their treatments actually work.
鈥淚t鈥檚 lucrative. It鈥檚 easy to do. All these reputable institutions, they don鈥檛 want to miss out on the business,鈥� said Dr. James Rickert, president of the Society for Patient Centered Orthopedics, which advocates for high-quality care. 鈥淚t preys on people鈥檚 desperation.鈥�
In a joint statement, Pourcho and Swedish defended the online video.
鈥淭he terminology was kept simple and with analogies that the lay person would understand,鈥� according to the statement. 鈥淎s with any treatment that we provide, we encourage patients to research and consider all potential treatment options before deciding on what is best for them.鈥�
But Knoepfler said the guests on the video make several 鈥渦nbelievable鈥� claims.
At one point, Dr. Pourcho says that that tell the brain which types of stem cells to send to the site of an injury. According to Pourcho, these instructions make sure that tissues are repaired with the appropriate type of cell, and 鈥渟o you don鈥檛 get, say, eyeball in your hand.鈥�
Knoepfler, who has studied stem cell biology for two decades, said he has never heard of 鈥渁ny possibility of growing eyeball or other random tissues in your hand.鈥� Knoepfler, who wrote about the video in February on his blog, , said, 鈥淭here鈥檚 no way that the adult brain could send that kind of stem cells anywhere in the body.鈥�
The marketing video debuted in July on KING-TV, a Seattle station, as part of a local lifestyles show called 鈥淣ew Day Northwest.鈥� Although much of the show is produced by the KING 5 news team, some segments 鈥� like Pourcho鈥檚 interview 鈥� are sponsored by local advertisers, said Jim Rose, president and general manager of KING 5 Media Group.
After being contacted by KHN, Rose asked Swedish to remove the video from YouTube because it wasn鈥檛 labeled as sponsored content. Omitting that label could allow the video to be confused with news programming. The video now appears only on the KING-TV website, where Swedish is labeled as the sponsor.
鈥淭he goal is to clearly inform viewers of paid content so they can distinguish editorial and news content from paid material,鈥� Rose said. 鈥淲e value the public鈥檚 trust.鈥�
Increasing Scrutiny
Federal authorities have recently begun cracking down on doctors who make unproven claims or sell unapproved stem cell products.
In October, the fined stem cell clinics millions of dollars for deceptive advertising, noting that the companies claimed to be able to treat or cure autism, Parkinson鈥檚 disease and other serious diseases.
In a recent interview Scott Gottlieb, the FDA commissioner, said the agency will continue to go after what he called 鈥渂ad actors.鈥�
With stem cell clinics in operation, the FDA is first targeting those posing the biggest threat, such as doctors who inject stem cells directly into the eye or brain.
鈥淭here are clearly bad actors who are well over the line and who are creating significant risks for patients,鈥� Gottlieb said.
Gottlieb, set to leave office April 5, said he鈥檚 also concerned about the financial exploitation of patients in pain.
鈥淭here鈥檚 economic harm here, where products are being promoted that aren鈥檛 providing any proven benefits and where patients are paying out-of-pocket,鈥� Gottlieb said.
Dr. Peter Marks, director of the FDA鈥檚 Center for Biologics Evaluation and Research, said there is a broad 鈥渟pectrum鈥� of stem cell providers, ranging from university scientists leading rigorous clinical trials to doctors who promise stem cells are 鈥渇or just about anything.鈥� Hospitals operate somewhere in the middle, Marks said.
鈥淭he good news is that they鈥檙e somewhat closer to the most rigorous academics,鈥� he said.
The Mayo Clinic鈥檚 regenerative medicine program, for example, focuses conditions such as , where injections pose few serious risks, even if that鈥檚 not yet the standard of care, Shapiro said.
Rickert said it鈥檚 easy to see why hospitals are eager to get in the game.
The market for arthritis treatment is huge and growing. At least have the most common form of arthritis, with diagnoses expected to soar as the population ages. Platelet injections for arthritis generated in revenue in 2015, according to an article last year in The Journal of Knee Surgery.
鈥淲e have patients in our offices demanding these treatments,鈥� Shapiro said. 鈥淚f they don鈥檛 get them from us, they will get them somewhere else.鈥�
Doctors at the Mayo Clinic try to provide stem cell treatments and similar therapies responsibly, Shapiro said. In Shapiro described the hospital鈥檚 consultation service, in which doctors explain patients鈥� options and clear up misconceptions about what stem cells and other injections can do. Doctors can refer patients to treatment or clinical trials.
鈥淢ost of the patients do not get a regenerative [stem cell] procedure,鈥� Shapiro said. 鈥淭hey don鈥檛 get it because after we have a frank conversation, they decide, 鈥楳aybe it鈥檚 not for me.鈥欌��
Lots Of Hype, Little Proof
Although some hospitals boast of high success rates for their stem cell procedures, often paints a different story.
The says that 40 to 70% of patients 鈥渇ind some level of pain relief.鈥� Atlanta-based claims that 75 to 80% of patients 鈥渉ave had significant pain relief and improved function.鈥� In the Swedish video, Pourcho claims 鈥渨e can treat really any tendon or any joint鈥� with PRP.
The strongest evidence for PRP is in pain relief for arthritic knees and tennis elbow, where it appears to be safe and perhaps helpful, said Dr. Nicolas Piuzzi, an orthopedic surgeon at the Cleveland Clinic.
But PRP hasn鈥檛 been proven to help every part of the body, he said.
PRP has been linked to serious complications when injected to treat an injury to the tendon connecting the kneecap to the shinbone. In a 2013 paper, researchers described the cases of three patients whose pain got dramatically worse after PRP injections. One patient lost bone and underwent surgery to repair the damage.
鈥淧eople will say, 鈥業f you inject PRP, you will return to sports faster,鈥欌�� said Dr. Freddie Fu, chairman of orthopedic surgery at the University of Pittsburgh Medical Center. 鈥淏ut that hasn鈥檛 been proven.鈥�
A of PRP found it relieved knee pain slightly better than injections of hyaluronic acid. But that鈥檚 nothing to brag about, Rickert said, given that . While some PRP studies have shown more , Rickert notes that most were so small or that their .
In its 2013 guidelines for knee arthritis, the said it is 鈥渦nable to recommend for or against鈥� PRP.
鈥淧RP is sort of a 鈥榖uyer beware鈥� situation,鈥� said Dr. William Li, president and CEO of the Angiogenesis Foundation, whose research focuses on blood vessel formation. 鈥淚t鈥檚 the poor man鈥檚 approach to biotechnology.鈥�
Tests of other stem cell injections also have failed to live up to expectations.
Shapiro published a rigorously designed study last year in , a medical journal, that found bone marrow injections were no better at relieving knee pain than saltwater injections. Rickert noted that patients who are in pain often get relief from placebos. The more invasive the procedure, the stronger the placebo effect, he said, perhaps because patients become invested in the idea that an intervention will really help. Even saltwater injections help 70% of patients, Fu said.
A 2016 review in the Surgery concluded that 鈥渢he value and effective use of cell therapy in orthopaedics remain unclear.鈥� The following year, a review in the concluded, 鈥淲e do not recommend stem cell therapy鈥� for knee arthritis.
Shapiro said hospitals and health plans are right to be cautious.
鈥淭he insurance companies don鈥檛 pay for fat grafting or bone-marrow aspiration, and rightly so,鈥� Shapiro said. 鈥淭hat鈥檚 because we don鈥檛 have enough evidence.鈥�
Rickert, an orthopedist in Bedford, Ind., said fat, bone marrow and platelet injections should be offered only through clinical trials, which carefully evaluate experimental treatments. Patients shouldn鈥檛 be charged for these services until they鈥檝e been tested and shown to work.
Orthopedists 鈥� surgeons who specialize in bones and muscles 鈥� have a history of performing unproven procedures, including , surgery for and for worn-out knees, Turner said. Recently, studies have shown them to be no more effective than placebos.
Misleading Marketing
Some argue that joint injections shouldn鈥檛 be marketed as stem cell treatments at all.
Piuzzi said he prefers to call the injections 鈥渙rthobiologics,鈥漬oting that platelets are not even cells, let alone stem cells. The number of stem cells in fat and bone marrow injections is extremely small, he said. In fat tissue, only about 1 in 2,000 cells is a stem cell, according to a March paper in . Stem cells are even rarer in bone marrow, where 1 in 10,000 to 20,000 cells is a stem cell.
Patients are attracted to regenerative medicine because they assume it will regrow their lost cartilage, Piuzzi said. There鈥檚 no solid evidence that the commercial injections used today spur tissue growth, Piuzzi said. Although doctors hope that platelets will release anti-inflammatory substances, which could theoretically help calm an inflamed joint, they don鈥檛 know why some patients who receive platelet injections feel better, but others don鈥檛.
So, it comes as no surprise that many patients have trouble sorting through the hype.
Florida resident Kathy Walsh, 61, said she wasted nearly $10,000 on stem cell and platelet injections at a Miami clinic, hoping to avoid knee replacement surgery.
When Walsh heard about a doctor in Miami claiming to regenerate knee cartilage with stem cells, 鈥渋t seemed like an answer to a prayer,鈥� said Walsh, of Stuart, Fla. 鈥淵ou鈥檙e so much in pain and so frustrated that you cling to every bit of hope you can get, even if it does cost you a lot of money.鈥�
The injections eased her pain for only a few months. Eventually, she had both knees replaced. She has been nearly pain-free ever since. 鈥淢y only regret,鈥� she said, 鈥渋s that I wasted so much time and money.鈥�
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