Dr. James Novak’s Pacfic Beach medical office, where he has treated San Diego-area patients with an IV insulin infusion procedure marketed by Trina Health, is shown on April 9, 2018. (Megan Wood/inewsource)
Just about every Tuesday morning around 7:30, John McCreary of Poway can be found waiting for Dr. James Novak’s office to open. Almost always, McCreary said, he’s the first one there.
Novak’s practice is listed as the only one in the San Diego area offering Trina Health’s “Artificial Pancreas Treatment,” a four-hour IV insulin infusion procedure for people with diabetes. Some people like McCreary, 69, who has wrestled with diabetic nerve pain for years, said they think the procedure is working for them.
Poway resident John McCreary, at his home on Nov. 12, 2017, is a patient at Dr. James Novak’s Trina Health clinic in Pacific Beach. (Megan Wood/inewsource)
Why this matters
The nation has a limited supply of healthcare dollars to spend on drugs and services, which is why the government and health plans require scientific evidence of patient benefit. This is especially important for the 30.3 million people in the U.S. with diabetes, whose medical costs in 2012 totaled $245 billion.
Since he started going to Novak for the infusions last summer, he said the infusions have been effective. They have made the painful tingling in his hands — “like I was just constantly grabbing on to a barrel cactus” — almost disappear, McCreary said. He said his Medicare coverage and his supplemental plan from Colonial Penn Life Insurance Co. have paid for everything.
McCreary said he is supposed to go today for his infusion. He hasn’t heard that anything will change at the clinic since the news last week that Trina founder and CEO G. Ford Gilbert was indicted on fraud and bribery charges in Alabama.
“I guess it’s going to be a wait and see situation,” he said.
Gilbert is accused of bribery, health care fraud and wire fraud, among other charges, in what federal prosecutors call a “public corruption scheme.” He is accused of paying an Alabama politician to try to get legislation passed that would have required an insurance plan there to pay for his infusions. The plan and Medicare had previously denied coverage, based on the lack of scientific proof that IV insulin infusions actually benefit patients. The legislation never passed. Gilbert and two other defendants are due in court on April 18.
In a text message on Monday, Gilbert said he thinks news coverage has treated him unfairly, and that an inewsourcestory published Saturday has “hurt a lot of people.”
Over the past weeks, at least two clinics have stopped offering the infusions, and at least one, the Diabetes Relief Center in South Bronx, has removed the Trina logo and all references to Gilbert from its website. Several other clinics’ websites are said to be undergoing maintenance.
An issue mentioned in the indictment and in lawsuits is the way Trina Health and its clinics bill Medicare and private insurance plans. Medicare denied coverage of IV insulin infusions in a decision in 2009, saying there was not adequate scientific evidence it benefited patients. Health plans followed in denying coverage.
Gilbert found a way to submit claims for the procedure by dividing it into various component parts, such as “refilling and maintenance of portable pump,” “infusion into a vein for therapy,” and “established patient office or other outpatient visit, typically 25 minutes” in order to get paid. BlueCross Blue Shield in Alabama and Montana have stopped reimbursing for Trina treatments.
G. Ford Gilbert, founder and CEO of Trina Health, is shown in an office at the company’s Sacramento headquarters on Feb. 5, 2018. (Megan Wood/inewsource)
Even though some patients said the insulin infusion treatment benefited them, several San Diego endocrinologists who specialize in treating people with diabetes call the Trina Health procedure nothing more than a scam.
One is Dr. Georges Argoud, who has offices in Solana Beach and Chula Vista. He said he tries to talk patients out of the insulin infusions.
Argoud called it a “travesty” that Trina clinics are “misleading the public” and “victimizing those that are not able to detect a scam.” The treatment and the infusions, he said, are “a waste of Medicare resources.” Argoud, like other experts interviewed by inewsource, cited the lack of clinical evidence that Trina infusions have the positive benefits advertised.
About this investigation
inewsource has spent months investigating a California lawyer and his practices in promoting what he calls a “miraculous” procedure for reversing the complications of diabetes, a condition that affects 30.3 million Americans.
Senior healthcare reporter Cheryl Clark began asking questions about the insulin infusion procedure advertised by Trina Health after learning it was being offered in San Diego. The inewsource mission is accountability journalism, and Clark focused her inquiries on the risk of harm to patients and the cost to the healthcare system.
She has interviewed more than 100 people for this investigation, including Trina founder and CEO G. Ford Gilbert at his Sacramento headquarters. Gilbert was charged with fraud and bribery in Alabama in a federal indictment unsealed April 2.
Novak told inewsource he started San Diego’s Trina Health clinic in August 2016 as an addition to his family medicine practice on Lamont Street in Pacific Beach. His is one of about a dozen that have recently operated nationally from Las Vegas to Miami and from Sacramento to Scottsdale.
Novak told inewsource that as of late last year, his Trina clinic had about 25 patients a week.
“The majority of people who do this process get enough benefit out of it that they elect to keep coming,” Novak said. Many of his patients have “significant quality of life complications from the diabetes that they want to improve.”
Novak said most of his patients getting the Trina infusions are coping with neuropathy. Others have a type of eye disease called retinopathy, or they suffer from “erectile dysfunction, or gastroparesis, where their gut isn’t working, and they’re having digestive issues, and we have a number … with significant fatty liver disease,” he said. Some of his patients have prediabetes.
Facebook used to promote Trina infusions
Jeannette Testamark, one of Novak’s patients, said she learned about the Trina infusions when she saw a post last year on Facebook publicizing the Pacific Beach clinic. In comments on Facebook, the College Area resident said she was getting the infusions last July.
A screenshot of a Trina Health advertisement posted on Facebook on May 15, 2017.
Testamark told inewsource she doesn’t like that the infusion procedure requires her to be stuck nine times during the four-hour sessions. But, she said, her energy had increased “to the point that I just recently joined the Y, so I could get back into exercising again.” The pain in her legs? “It’s pretty much gone,” she said.
Testamark said Medicare covered her Trina sessions.
Novak, a member of the medical staff at Scripps Mercy Hospital, said he hasn’t “really seen anybody have a bad result” from the Trina procedure. He said he offers the infusions as part of his practice, because “I’m interested in holistic treatments and whatever we can do to return the body to a more natural balance.” The infusions, he said, improve blood flow to the limbs and that helps heal wounds that affect people with diabetes.
Novak declined to be interviewed in person but spoke briefly last fall with inewsource during a conference call with Trina CEO Gilbert. Attempts to reach Novak this week were unsuccessful.
Gilbert said clinicians providing the Trina infusions sign a confidentiality agreement, but he said he would allow Novak to discuss his Trina practice.
Several San Diego area Facebook users posted more than 100 comments beneath a link to an advertorial on Facebook about the San Diego clinic last year. Many said they first heard about the Trina infusions on Facebook. When asked about the advertorial last fall, Gilbert said it had been removed. He said it contained inaccurate claims.
San Diego doctors doubt Trina benefits patients
Retired nurse Arlene Way, 83, of Spring Valley said her podiatrist, Walter Jolley, referred her to Novak’s clinic so she could get the Trina insulin infusions for her neuropathy. Since she began receiving them, Way said, the sensations in her feet are returning.
“Now I feel all kinds of things,” she said. Medicare and her supplemental plan, United Healthcare, completely cover her sessions. Billing statements she shared showed the procedure was broken down into component parts.
But when Way told her endocrinologist, Dr. Jeffrey Sandler, about undergoing Trina infusions, she said he told her “he didn’t really expect much to happen, but he didn’t object to my participating in the program.”
Sandler, a Scripps Mercy physician, said in an interview that he has told patients who come to him with Trina Health brochures to throw them away.
Diabetes specialists from around the country, including 11 from San Diego County, criticized Trina Health’s claims, some saying the procedure is a waste of time and money. Others say the pitch for the procedure — which de-emphasizes the importance of blood sugar control — can interfere with proven diabetes care plans.
Dr. Patricia Shen-Chi Wu, an endocrinologist with Kaiser Permanente San Diego, commented on a Facebook post last July on the new San Diego Trina clinic. She said the artificial pancreas claims are “a scam.”
In an email to inewsource, she said, “If Kaiser Permanente has any patients undergoing Trina infusions, they’d be doing it against our advice.”
Dr. Jeremy Pettus of the La Jolla-based Center for Metabolic Research at the VA San Diego Medical Center, said the Trina website “is concerning.”
“Unfortunately, treatments like these … often cost thousands of dollars and prey on people’s vulnerability, which is horrible,” Pettus said. “Thankfully, I don’t know of patients that have gone through this particular treatment and would steer them away, for sure, if they asked me about it.”
Trina founder Gilbert references a study by Dr. George Dailey, a Scripps Clinic endocrinologist, that Gilbert said shows his pulsed insulin infusion works. But Dailey said it does no such thing.
Yet every so often, Dailey gets a call 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.
Besides, he said, the promises made on Trina Health’s website, that so many complications of diabetes can be reversed or prevented, are unrealistic.
“Obviously, I’m concerned that I’ve never seen a legitimate publication anywhere else regarding this, so a bunch of patient testimonials is kind of worrisome, if that’s the basis for the promotion here,” Dailey said.
Dr. Steven Edelman, an endocrinology researcher at the University of California San Diego and founder and director of Take Control of Your Diabetes forums, told inewsource in an email he knows about Trina Health and its founder.
“I do know it is unproven and a scam,” Edelman said. “They have been ripping people off for years.”
He declined to comment further.
Despite criticism from the San Diego diabetes doctors, Gilbert said he plans to open another Trina clinic this summer in La Jolla.
UPDATE: June 3, 2019
An earlier version of this story included a link to the Trina Health website, which is no longer accessible. inewsource has replaced it with an archived version.
Cheryl Clark is a contributing healthcare reporter at inewsource. To contact her with questions, tips or corrections, email clarkcheryl@inewsource.org.
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