This is the first installment in a two-part investigation of Trina Health, a national clinic chain offering a unique and some say unproven treatment for patients with diabetes, whose founder and chief executive is now caught up in a federal prosecution.
Lawyer G. Ford Gilbert and his network of Trina Health clinics promise a nonsurgical treatment that restores vision, repairs damaged kidneys, and reverses heart disease and cognitive decline related to diabetes.
They claim the treatment heals wounds in the legs and feet, repairs damage from stroke, and eliminates neuropathy, through a proprietary protocol of "microburst" insulin infusions, licensed by Gilbert's Sacramento, Calif.-based company and delivered through investor-owned and operated outpatient clinics.
The Trina CEO calls the procedure "miraculous," and the first "real change" in treatment for people with type 1 or type 2 diabetes since the 1921 discovery of insulin.
But the American Diabetes Association dissuades patients from seeking Gilbert's branded "Artificial Pancreas Treatment," saying people with diabetes are a particularly vulnerable population. Top diabetes specialists have called it outright fraud and a scam. Nor has he seemed daunted by difficulties in winning reimbursement from third-party payers including Medicare and some private insurers, which say the expensive procedure lacks evidence of medical benefit.
Despite these obstacles, despite investigations, audits and payment denials that have shut down many of his clinics, Gilbert has openly marketed his infusion protocols for years, expanding across 17 states.
Now his Trina Health operation faces a new threat. A federal grand jury in Alabama indicted Gilbert on charges of fraud and bribery in a failed scheme that prosecutors said was intended to get a state law passed to force coverage of Trina infusions. Since the indictment was unsealed on April 2, a New York clinic has taken the Trina logo off its website; the Las Vegas clinic stopped offering the treatments.
Over the years, Gilbert and his clinics have billed Medicare and private insurers untold millions of dollars through stratagems to disguise the treatment's nature, and which were cited in the Alabama charges.
Battles over coverage of new treatments and drugs are not uncommon. But Trina Health thrived despite disagreements over their worth.
Gilbert has used his evangelical zeal to persuade investor and clinician groups to buy his protocols and open more than two dozen clinics, from Miami to the Bronx and from Las Vegas to San Diego. Each clinic pays Gilbert about $300,000 or more in start-up costs, depending on the size of the operation.
Trina Health also has looked to expand beyond the United States. The company website says there is a clinic in India, and Gilbert said he is in talks to launch others in Indonesia and Thailand. He said four clinics would soon open in the U.S. territory of Puerto Rico, with coverage from Medicaid.
"It's basically a land rush to open clinics, because people see that we help their very ill diabetic patients," Gilbert said before the indictment. (Neither Gilbert nor his attorney have responded to inewsource/MedPage Today inquiries since the indictment in Alabama was unsealed.) He insisted that virtually every patient who has undergone the infusions has seen a dramatic reversal of diabetes complications.
Gilbert said the reason doctors who treat people with diabetes don't recognize the benefits of the Trina procedure is because "there's a lot of inertia involved in medicine."
Trina's insulin infusion protocol
The roots of Trina's procedure go back more than 30 years to the lab of Thomas Aoki, MD, then at the University of California Davis. Working from observations that the human pancreas does not release insulin steadily through the day, but in bursts as stimulated by changes in blood glucose and other signals, he developed a treatment protocol in which insulin is infused in small, frequent doses over several hours. He branded (and patented) it as Metabolic Activation Therapy.
Initially, Ford Gilbert worked with Aoki as his business partner, but the two had a falling-out some 15 years ago leading to litigation that continues to this day. Aoki accuses Gilbert of illegally copying his methods; Gilbert says he has made important modifications.
Trina's website describes the "Artificial Pancreas Treatment" procedure as follows:
Patients report to the clinic between 7:00 am and 8:30 am for the initial clinical assessment to perform the following:
Capture vital signs.
Determine initial glucose level.
Review medications.
Assess patient's overall condition.
Establish an intravenous (IV) line.
MII Treatment Session
mU/kg [sic; no number is given on the Trina site] of insulin, pulsed at 10 pulses/hour over 1 hour is administered by the Bionica Microdose Infusion Device programmed for the concentration, frequency and duration of pulses, and rest intervals.
Glucose levels are taken every 30 minutes or more frequently as medically indicated in patients with a tendency for hypoglycemia.
Oral carbohydrates are given to keep blood glucose in a specific range based on patients weight.
There is a rest period of 30 minutes between treatments in order to stabilize blood glucose levels.
This cycle is repeated twice more in a single treatment day.
Patient is evaluated after the session and discharged when stable.
Though branded as an Artificial Pancreas Treatment, a Trina infusion does not replace the pancreas, an aspect of Gilbert's marketing campaign that he acknowledges is confusing.
Each infusion session lasts about four hours. Patients sit in recliners, where they can watch a movie on their electronic tablet or chat with fellow patients. Some take a nap. Typically, the sessions are weekly for the first 12 weeks to 6 months, and less frequently afterward.
During the sessions, patients intermittently drink two glucose mixtures resembling two typical meals and undergo breathing tests to measure metabolism.
"We restore health to the worst of the worst of the worst -- to the people who are literally train wrecks," Gilbert told inewsource/MedPage Today, including patients with dementia, retinopathy, nonhealing wounds, and painful neuropathy.
John McCreary, 69, of Poway, Calif., said he has been getting weekly infusions since last summer, and has seen benefits. "I would say 80 percent of the neuropathy in my hands has disappeared at this point. Before (Trina) it literally felt like I was constantly grabbing on to a barrel cactus."
The 70-year-old Gilbert said he undergoes infusions, too, and has for years "because I get an energy ability that I do not otherwise have."
"Wouldn't we all be doing this?"
One of Trina Health's outspoken critics is a nationally known diabetologist who extensively reviewed the Trina procedure with Gilbert.
John Buse, MD, of the University of North Carolina and past president of the board of medicine and science for the American Diabetes Association, looked into the evidence behind the infusions in mid-2016 at the request of a North Carolina businessman who was considering opening a Trina clinic.
After spending 10 to 15 hours analyzing about 50 articles Gilbert had sent him, and after an hour-long conference call with Gilbert and his team, Buse said he was unpersuaded.
"The advice that I gave the businessman from North Carolina ... is that he probably could make money on it, but to me it's sort of -- it was a scam. It's just not backed up by medical evidence that he would meet his objective of helping people with diabetes in North Carolina."
In a lengthy email exchange with Gilbert after his analysis, Buse wrote to him: "I tell you what has me hung up. Your uncontrolled studies and slides suggest that everyone gets better and no adverse events occur. I have treated several thousand patients with diabetes and participated or run several hundred trials and that never happens."
Buse added, "if there is any controlled data of (clinical) trials of more than 30 people for more than a year that I missed, please point it out to me."
Gilbert initially denied ever having spoken with Buse, then later challenged the doctor's credibility, saying Buse had not used the Trina protocol on any patients so he wasn't qualified to give an opinion.
The science behind pulsed insulin infusions "is not preposterous," Buse said. But a patient would have to endure much longer infusions every day, or every other day, to get an effect, Buse said. Plus, he said, the claims Trina Health makes about its procedure involve "improving complications, and there's just no evidence that that happens."
Gilbert cites a study by George Dailey III, MD, of the Scripps Clinic in San Diego, as showing that microburst infusions work. Dailey said it does no such thing.
Every so often, Dailey said, he gets calls from a health plan or an insurance company "asking me if this is something legitimate that they should consider," and if they should include it in their coverage. His answer is no.
"Trina is banking on the impracticality of proving that their therapy doesn't work (that would take a very long study to prove) and the availability of a 'sucker born every minute,' as P.T. Barnum is famously supposed to have said," Steven Russell, MD, a diabetologist at Massachusetts General Hospital who is part of a "bionic pancreas" research collaboration, wrote in an email.
And if the Trina treatment really delivered such stunning results, said Daniel Einhorn, MD, a La Jolla, Calif., endocrinologist who is medical director of the Scripps Whittier Diabetes Institute and past president of the American Association of Clinical Endocrinologists, "wouldn't we all be doing this?"
Tomorrow: The walls close in on Trina.
This investigation was conducted by San Diego-based inewsource in partnership with MedPage Today.