Company Selling Unproven Insulin Infusions in Legal Battle Over Money, Control

— Court docs show firm evolved from Trina, a diabetes scheme that fell apart

 A photo of patients, nurses, and a doctor in a sunny infusion clinic.

Behind the scenes of an outpatient insulin infusion procedure that medical experts say advertises unproven claims sits a nasty legal drama involving feuding leaders of Well Cell Global of Houston, also known as Diabetes Relief.

The company has been selling pumps, protocols, and licenses for the infusions, marketed as Physiologic Insulin Resensitization, or PIR, to clinics or physician practices around the nation. Its co-founder and CEO, Scott Hepford, maintains the treatments can improve health outcomes for people with a variety of medical conditions, from diabetes to psoriasis to Parkinson's.

Perhaps unbeknownst to investors, licensees, or patients, however, is the turmoil that has plagued the company.

Three years ago, Hepford's original partner, Hunter Carr, filed a lawsuit against him and a newer partner, internist Stanley T. Lewis, MD, as well as several other newer company officials. Carr claimed he was a victim of a July 24, 2020 scheme to push him out without paying him his share of the company's worth. He said the assets of Diabetes Relief were moved into Well Cell Global, a new company, and out of his control, and he was removed from Diabetes Relief that month.

What Hepford and Lewis did was "a classic ambush," Carr's attorney Christopher Stevenson said in an interview with MedPage Today. According to Carr's attorney, "[t]hey lied to him ... and negotiated these deals in secret behind his back. But the worst thing they did was they sold the assets of the company to a company they owned for well below the value of these assets."

Stevenson said Carr now wants 40.9% -- his share of the company when he was forced out -- of the value an analyst said the company had at the time, between $16.5 million and $27 million. Carr's share, Stevenson said, is in the ballpark of $6.91 million.

Some of Carr's court filings also name three other defendants: Roy Hinman, MD, of St. Augustine, Florida, a company investor who runs several PIR clinics; Brian Loveridge, MD, who began Diabetes Relief clinics in Utah; and the company's marketing head, Glenn Massey.

The reason Carr had to be removed, Hepford said in his August 21, 2021 deposition, was allegedly because Carr had blocked many of the license deals that the company was trying to sign with various clinics. Carr was frequently argumentative, with "screaming, yelling," Hepford said. Other testimony from a Diabetes Relief nurse practitioner alleged Carr demonstrated "belligerent" and "aggressive" behavior toward staff.

As clinic owners and potential customers were recruited with promises of remarkable patient benefits as well as profits, Hepford said in his deposition that Diabetes Relief was "hemorrhaging money, that we were completely incapable internally of having a functional operation, that we were being held hostage in a corporate lockup scenario. And every time we tried to put something in place, the negative control that your client [Carr] exerted would not allow that to happen."

"Go look up textbook personality narcissist, right – narcissistic personality disorder, and he checks every box," Hepford said in the deposition. "It was like walking in a minefield and threading needles for a living working with him."

Documents filed in Harris County District Court reveal a number of inconsistencies in claims Hepford and some PIR licensees have made about PIR and its origins, specifically with respect to Trina, a network of insulin clinics marketed as "artificial pancreas," which leading endocrinology experts labeled a scam. Trina, the subject of a series of stories published by MedPage Today and inewsource in 2018, flourished briefly between five and 10 years ago.

That PIR clinics are now flourishing, with Medicare and insurance companies reportedly reimbursing for the insulin infusions, is a concern. In 2009, the Centers for Medicare & Medicaid Services reviewed data submitted to it and determined that outpatient IV insulin therapy, or OIVIT, administered in pulses and balanced with intermittent glucose, did not benefit patients and refused to pay for it.

Hepford and his representatives insisted in several recent emails to MedPage Today that Well Cell is nothing like Trina, whose clinics folded after Medicare and insurance companies -- which initially paid between $450 and $700 per infusion -- realized the treatments were the same as OIVIT and stopped paying.

Hepford declined several requests to explain how PIR as a treatment differs from OIVIT, although sources told MedPage Today the infusions -- pulsed IV insulin balanced with glucose -- appear to be essentially the same.

The now-disbarred attorney behind Trina, G. Ford Gilbert, went to prison on a federal bribery charge, convicted of trying to persuade an Alabama lawmaker to order insurance companies to pay for it after they had refused. Additionally, a California court found that Gilbert's infusions were copied from a California endocrinologist's experimental therapy and ordered him to pay him back $8 million.

Hepford told MedPage Today that he and Carr had considered making a deal for the West Houston Trina Clinic in 2014 but that the deal didn't go through.

But court documents in this case suggest Well Cell and Diabetes Relief indeed are rooted in the Trina Clinic in West Houston, which ran under the name Health Restoration Partners. In a sworn statement, Carr stated that he and Hepford acquired it in 2014 and rebranded it as Diabetes Relief the following January, with a new website. In his deposition, Hepford acknowledged that he and Carr took over the business and carried it forward under a new name, Diabetes Relief.

According to business data and analytics company Dun & Bradstreet's filing online, Health Restoration Partners was listed under the name "Trina Health West Houston."

Hepford said in his deposition that "over the course of many months we were able to uncover that they had probably been taken advantage of by a bad actor based out of California that, I guess, got them into the space. The medical records were terrible, based on the consultants we brought in to look. The billing practices were a debacle. Their operational systems and processes were just very – beyond distressed asset is probably a good way to describe what it – what it was."

After paying numerous experts to advise them, Hepford continued, "we had identified and/or discovered and/or created enough that it deemed us going and protecting it and getting our own patents."

"We were trying to figure out how to take a medical technology to the market," he said in his deposition. Hepford said he and Carr agreed, "We need to put this – all of – all of our efforts into a new, different company."

It remains unclear what, if anything, Diabetes Relief or Well Cell changed about the infusions from when they were administered under the Trina "artificial pancreas" brand.

Hepford also insisted that his company doesn't administer infusions itself but merely sells the tools to clinics. But Hepford said in his deposition that Diabetes Relief received an NPI number to run clinics in several locations, and hired a medical assistant and a registered nurse, a billing collector and a physician, Dr. Dunn, who left the company.

A Google search shows Kimberly Dunn, MD, is listed as having worked at the Diabetes Relief clinic at the same Houston address as Carr and Hepford's Trina Health West Houston clinic, at the same address advertised on the Trina Health website in 2014, and in the same building as Well Cell Global's current offices.

Dunn did not return requests for comment about her involvement or the reasons for her departure.

Hepford and Lewis declined comment citing pending litigation. Carr did not return calls and emails requesting his response. And Kevin Leyendecker, Hepford's attorney, did not consent to be interviewed.

Stevenson was asked whether what Carr is asking for in his lawsuit might be unrealistic if Medicare and private insurance companies determine that PIR is basically OIVIT and stop paying, claw back money already reimbursed, and bankrupt clinic investors file lawsuits.

"Even if it was determined that there was rampant fraud in Diabetes Relief, and (investors) were bankrupted because they were miscoding the treatments, and that spilled over into Well Cell Global and their other business partners and killed this business ... if that happened, what would be the impact on Mr. Carr?" Stevenson asked rhetorically.

"The answer to that is nothing. Because again, the measure of damages is based on the value of the company as of July 24, 2020. Not on anything that happened subsequently."

Stevenson acknowledged the issue with reimbursement and that PIR is unproven.

Some clinic websites boast the infusions can restore erectile function, control weight, help with dementia symptoms, and improve sleep and mood.

And during a May town hall at a rural Texas hospital that is administering PIR to some 215 patients, Hepford called the infusions "cutting edge," and said they are "literally creating energy in every single cell in the entire human body."

There is, he said, "a lot of anecdotal evidence that these treatments do work," Stevenson told MedPage Today. "But the problem is that it has not been adequately researched by whatever qualifications, whatever medical schools, whatever trials ... have to get subjected to in order to gain the acceptance of the medical community and to be approved treatments and be paid for by Medicare and insurance companies. That simply has not been done yet. And so, you know, no one can say today, yes they work or no, they don't because the studies haven't been completed."

Carr's lawsuit was scheduled for a 2-week jury trial this month with nearly 400 filings in the docket. But Stevenson said the case is now being rescheduled, and the parties may soon begin mediation.

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    Cheryl Clark has been a medical & science journalist for more than three decades.