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Stem Cell Company Persuades Employers To Steer Workers Toward Controversial Therapy

A Midwestern grocery chain, Hy-Vee, is taking an uncommon — and extremely controversial — method to lowering well being care prices.

Before workers in sure cities can endure knee alternative, they first should go to a stem cell supplier. Hy-Vee has contracted with one of many United States’ main stem cell corporations — Regenexx, primarily based in Des Moines, Iowa — that claims injections of concentrated bone marrow or platelets might help sufferers keep away from costly joint surgery.

Regenexx has persuaded over 100 employers to incorporate its providers of their medical health insurance plans. In a marketing booklet, Regenexx, whose injections vary in value from $1,500 to $9,000, notes that its remedies price a fraction of main surgical procedure. A single knee alternative, for instance, ranges from $19,000 to $30,000 in the U.S.

The advantages of stem cells are hotly debated in the medical community, and federal regulators have warned the general public to watch out for clinics that peddle unapproved injections as a cure-all. Many medical doctors and ethicists say they concern the general public is being misled about how effectively stem cells work — and whether or not the procedures save their cash or waste it.

“This definitely is not a high-quality, proven treatment,” mentioned Dr. Freddie Fu, chairman of orthopedic surgical procedure on the University of Pittsburgh Medical Center.

Knee Pain and the Bottom Line

Health insurance coverage usually doesn’t cowl stem cell injections, with the exception of certain accepted treatments, equivalent to bone-marrow transplants for cancer and aplastic anemia. Aetna, the United States’ third-largest well being insurer, dismisses stem cells and platelet injections as experimental; Anthem, the nation’s second-biggest medical health insurance supplier, classifies the injections as “not medically necessary.” Without insurance coverage protection, sufferers are compelled to pay out-of-pocket or forgo therapy.

So as an alternative of coping with disapproving insurance coverage executives, Regenexx appeals on to employers giant sufficient to fund their very own well being plans. These companies have the liberty to customise their plans, masking providers that aren’t a part of a typical insurance coverage package deal. Over half of U.S. employees insured by means of their jobs belong to such plans, in line with the Employee Benefit Research Institute, a D.C.-based nonprofit.

Perhaps Regenexx’s best-known company shopper is Des Moines-based Meredith Corp., which owns multiple TV and radio stations, in addition to magazines equivalent to Better Homes & Gardens. (Meredith owned Time journal till September 2018.)

In a press release, Regenexx mentioned its objective is to “replace more invasive surgical orthopedics” with nonsurgical choices, noting that latest analysis has discovered many joint operations are ineffective. On its website, Regenexx claims its procedures “repair and regenerate damaged or degenerated bone, cartilage, muscle, tendons, and ligaments.” In a bone marrow stem cell procedure, for instance, a health care provider withdraws bone marrow cells from a affected person’s hip, concentrates them, then reinjects them into an issue space, equivalent to an arthritic knee. Doctors goal the precise location within the joint utilizing ultrasound. For a “platelet-rich plasma” therapy, medical doctors draw blood, focus the platelets, then inject them into the goal space.

Regenexx, beforehand referred to as Regenerative Sciences, is without doubt one of the oldest stem cell corporations within the U.S. When it opened its doorways in 2005, it had solely a handful of rivals. Today, there are greater than 1,000 stem clinics within the U.S., mentioned Leigh Turner, an affiliate professor on the University of Minnesota’s Center for Bioethics, who has printed a series of articles describing the stem cell market.

At instances, Regenexx has clashed with the Food and Drug Administration. In 2010, for instance, Regenexx sued the FDA, claiming the company lacked the authority to manage its procedures, which concerned culturing stem cells earlier than reinjecting them into sufferers. Regenexx misplaced its case and was countersued by the FDA, which charged that Regenexx was advertising and marketing an unapproved drug. In 2014, the U.S. Court of Appeals in Washington sided with the FDA, forcing Regenexx to cease performing the controversial procedures. Today, Regenexx performs this process solely within the Cayman Islands, the place the federal government permits it. The Cayman Islands, the place there may be much less authorities regulation of well being care, has turn into referred to as a medical tourism vacation spot, Turner mentioned.

Regenexx says that the remedies provided at its U.S. clinics adjust to FDA laws, which require that cells injected into sufferers endure not more than “minimal manipulation.”

On its web site, Regenexx lists more than two dozen studies led by its medical doctors. For instance, its chief medical officer, Dr. Chris Centeno, printed a small study final 12 months that discovered sufferers with knee arthritis who obtained bone marrow and platelets fared higher than these randomly assigned to train remedy. Regenexx says it tries to be clear about its outcomes, noting that it posts data on patient results. In a press release, the corporate mentioned most sufferers it treats for knee ache have good functioning 5 years later.

A Regenexx advertising and marketing booklet says 70% of orthopedic surgeries “can be completely avoided with a Regenexx procedure” — a declare Fu known as “silly.”

“There is zero evidence that you can replace 70% of surgeries with stem cells,” he mentioned.

Recent analysis suggests stem cells and platelets may match no higher than placebos, Fu added. In a recent analysis, over 80% of sufferers with knee arthritis skilled a noticeable enchancment in ache after receiving easy saltwater injections, writes Dr. Benjamin Rothrauff, a postdoctoral fellow who works with Fu on the University of Pittsburgh.

There’s additionally no definitive proof stem cells and platelets can regrow misplaced cartilage, Fu mentioned. A 2018 evaluate concluded platelets have “marginal effectiveness,” and consultants notice that the majority printed research are so small or poorly designed that their results aren’t reliable.

Is Regenexx Actually Saving Employers Money?

If Regenexx remedies labored in addition to the corporate claims, insurance coverage corporations would rush to cowl them, Turner mentioned. But the notion that Regenexx will save employers cash hasn’t been confirmed and is “a boastful claim with no clinical merit,” mentioned Henry Garlich, director of well being care worth options and enhanced scientific applications at Blue Shield of California, who has reviewed Regenexx’s publications.

“The problem is that we don’t have enough data. When a company does not have this type of evidence, then they will go direct to the consumer market,” Garlich mentioned. “Some vulnerable individuals, including companies that want to reduce their health care costs, may buy what they’re selling.” If Regenexx procedures don’t work, Garlich mentioned, an employer might find yourself paying twice — as soon as for stem cells and as soon as for knee alternative.

Some employers are, in actual fact, skeptical. The Des Moines Public Schools has opted to not add Regenexx to its worker well being plan, mentioned Catherine McKay, director of worker providers for the college system. She mentioned a salesman for an area stem cell clinic, which has since merged with Regenexx, instructed her the remedies might save the college system numerous cash. McKay wasn’t offered.

“My experience with them has not been great, in terms of marketing and sales. They’re very, very pushy,” McKay mentioned. “They claim they can get people back to work earlier” than surgical procedure. “But if I still need knee surgery a year down the road, that doesn’t cut my costs.”

The Des Moines faculty system has agreed to contemplate masking Regenexx procedures as a part of its employees’ compensation program on a case-by-case foundation, McKay mentioned. The faculty system has not signed a contract with Regenexx, nevertheless, and hasn’t included Regenexx in its well being plan.

McKay mentioned she is aware of of two faculty workers who’ve tried Regenexx. While one worker was glad with the outcomes, McKay mentioned, one other “went through a couple procedures and ended up needing surgery anyway.”

Corporate executives have turn into a few of Regenexx’s largest boosters. Hy-Vee’s former chairman and CEO, Ric Jurgens, seems in a Regenexx marketing brochure and says that he turned to Regenexx due to heel ache. The brochure, which was removed from a Regenexx web site after Kaiser Health News started reporting this story, quotes Jurgens as saying, “I knew that giving our employees the chance to explore options besides surgery was in their best interest.”

Hy-Vee didn’t make Jurgens or different workers out there to interview.

Steve Lacy, Meredith’s former CEO and present board chairman, mentioned he underwent a Regenexx process two years after his firm started masking stem cell remedies. He had been going through knee surgical procedure and thought stem cells had been price a attempt. The process obtained him again to doing every part he needs to do, Lacy mentioned, even working a number of days every week. He additionally has carried out every day bodily remedy for over two years. “The rehab and recovery is far less onerous” with the Regenexx process than with surgical procedure, Lacy mentioned. “If the procedure doesn’t work for an individual, there’s no harm.”

Meredith has spent about $400,000 in 4 years on 85 workers who’ve had Regenexx remedies, or about $four,700 a affected person, mentioned Meredith spokesman Art Slusark. That’s a small share of the roughly $75 million a 12 months that Meredith spends on its medical plan, he mentioned.

At its headquarters, Meredith has promoted Regenexx procedures by means of e-mail, posters and “lunch-and-learn” periods within the workplace, mentioned Jenny McCoy, Meredith’s company communications director.

McCoy herself has turn into a poster youngster for Regenexx’s advantages. She and two different Meredith workers seem with Lacy in a marketing video on the Regenexx website. Although McCoy had begun to expertise knee and hip ache throughout train, she mentioned in an interview that her ache was not extreme sufficient to wish surgical procedure. McCoy underwent platelet injections two years in the past and is pain-free immediately, she mentioned.

“I thought, ‘If Meredith is covering it, I might as well have it done early before [the pain] causes me too many problems,’” mentioned McCoy, 52. Given the worth tag, she mentioned, “I would not have done it otherwise. I wouldn’t have even known about it.” In the Regenexx advertising and marketing video, Lacy is proven saying stem cells saved Meredith roughly $700,000 in a single 12 months. Lacy mentioned he estimated that quantity by evaluating what Meredith spent on Regenexx with what it might have spent on hip and knee replacements.

But Slusark mentioned Meredith hasn’t examined worker medical data to find out what number of had been eligible for surgical procedure or what number of wanted joint surgical procedure after making an attempt Regenexx. “We don’t spend a lot of time calculating savings,” Slusark mentioned.

Without that medical data, Meredith can’t precisely estimate how a lot cash it saved, if any, Fu mentioned. He famous that comparatively few folks with joint ache endure surgical procedure, which medical doctors usually view as a final resort for sufferers who’ve exhausted all different therapy choices. Although 14 million Americans have knee arthritis, the Arthritis Foundation estimates that medical doctors carry out solely about 757,000 knee replacements every year.

Before recommending joint alternative, medical doctors usually inform sufferers to attempt train, bodily remedy, weight reduction, supportive shoe inserts or steroid injections, Garlich mentioned. Physical remedy, particularly, helps many sufferers, mentioned Fu; it’s potential that PT, and never the stem cell injections, ought to get the credit score for Lacy’s restoration.

How the Patients Feel

Regenexx has posted video interviews of dozens of glad clients on its web site, together with a refinery employee handled for a non-healing wrist fracture, a snowboarder who had stem cell remedy in his knees and an avid weightlifter with a number of shoulder issues. All say Regenexx helped them.

Other Regenexx sufferers say the remedies wasted their money and time. Several sufferers who posted on-line opinions of the corporate agreed to be interviewed for this text.

One is Amanda Lynch, a 42-year-old Australian trapeze artist who lives in Montreal. Lynch mentioned she spent $7,700 final 12 months to deal with an injured ligament at a Regenexx clinic in Colorado. Doctors administered a sequence of injections in her knee over a number of days, together with platelets and her bone marrow, Lynch mentioned. She shared copies of the emails she exchanged with the clinic, a invoice from Regenexx and a doc by which medical doctors evaluated her candidacy for therapy.

But inside just a few months, Lynch needed to endure surgical procedure in Montreal for each knees, she mentioned, paying a further $16,100, in line with her medical invoice. Because Lynch is Australian, she was not eligible without spending a dime care within the Canadian well being system and needed to pay out-of-pocket.

Roland Jersevic, a 67-year-old lawyer dwelling in Saginaw, Mich., mentioned he wanted knee alternative after his stem cell remedies failed to alleviate his arthritis. Jersevic mentioned he went to a Regenexx clinic in Toledo, Ohio, in 2015 to get assist with extreme arthritis in his knees, which had induced his legs to bow. “The pain was horrendous all the time,” he mentioned. Jersevic’s medical payments, obtained for this text, present that he paid the clinic $7,500 out-of-pocket as a result of his insurance coverage wouldn’t cowl stem cell remedy. “They told me they were going to regrow my cartilage,” he mentioned, referring to Regenexx. “I wanted it to work.”

Although the fats and bone marrow injections might have given Jersevic a “little bit” of momentary reduction, his ache quickly returned, he mentioned. Regenexx provided to manage extra injections, at a further price, Jersevic mentioned. “At that point, I had lost all faith in what they were doing. To spend more money on a booster — what for? It wasn’t working.”

Jersevic had each knees changed in summer time 2016, his medical data present, and his insurance coverage paid many of the invoice. His knee ache is gone, and Jersevic mentioned he felt effectively sufficient to return to track-and-field competitions — together with hurdles and pole vaulting — in 2017.

“When your knees are that bad, it’s not going to work for you,” Jersevic mentioned. “They should tell you it’s not going to work for you. But they want the cash.”

In response, Regenexx famous that many sufferers who endure knee surgical procedure are additionally unhappy with the results. Research means that as much as one-third of those that have knees changed proceed to expertise power ache, whereas one-fifth report that they’re dissatisfied with the outcomes of their surgical procedure.

“We are disappointed to learn of any patients who didn’t have a positive outcome,” Regenexx mentioned in a press release. “Our goal at Regenexx is to achieve the best possible clinical efficacy, and we are actively researching to find out why some patients respond better than others.”

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