Last month, 番茄社区 and San Diego-based partner inewsource reported on Trina Health, a chain of diabetes care clinics providing a controversial regimen of insulin infusions. That investigation focused on Trina's origins and marketing claims and on founder G. Ford Gilbert's business and legal troubles. Here we report on a well-known figure in cardiovascular medicine who -- unlike nearly all of his physician colleagues -- found the claims credible and lent his name to the enterprise.
Lawyer G. Ford Gilbert, the recently indicted founder of the national diabetes network , hitched his clinic's expansion plans to a big name in organized medicine and health policy: , MD.
Lewin was CEO of the California Medical Association for more than 11 years, CEO of the American College of Cardiology for more than five and president and CEO of the Cardiovascular Research Foundation for four. He chairs the board of the National Coalition on Health Care in Washington, D.C.
In the spring of 2017, Lewin added another title to his resume. He took on a job as for a New York investor group that had contracted with Gilbert to open one of the largest Trina clinics in the country, the .
Gilbert says his "" protocols, which he has sold to numerous medical and investor groups for $300,000 or more since 2011, reverse complications of diabetes -- like nerve pain, heart disease and kidney damage -- through four-hour long weekly IV infusions of insulin.
But dozens of diabetes experts call Gilbert's treatment a "scam" or "a fraud," saying it lacks scientific evidence of benefit. They point out that appropriate clinical trials have not been done, and Medicare and insurance companies have refused to cover outpatient insulin infusions. As a result, many clinics shut down.
In Alabama, a federal indictment unsealed April 2 charged Gilbert with conspiracy and health care fraud. Prosecutors said Gilbert tried to bribe state lawmakers to pass legislation to force BlueCross BlueShield to cover Trina.
Before that indictment, Gilbert frequently dropped Lewin's name as a physician who believed in the Trina method for reversing complications of diabetes.
In an interview in November, Lewin expressed enthusiasm about the potential benefits of Trina, while insisting that clinical trials still needed to be conducted. He planned to get one off the ground.
Lewin told 番茄社区/inewsource that Gilbert "prevented his therapy from becoming scientifically respected by not funding legitimate research."
Gilbert had told 番茄社区/inewsource last fall that he had made a conscious decision not to fund or pursue clinical trials.
"If I did clinical trials then I would be admitting that it is experimental, and we were getting paid by Medicare and there was no reason to do them," he said. If he did fund them, Gilbert said, "Insurance companies and Medicare would ram that down my throat and stop paying."
In April, Lewin said he now has nothing to do with Trina Health as a company. "My only regret is how much time I've spent." He called Gilbert's arrest a "huge setback" for the study he wanted to do, saying it is "very, very sad.
Lewin has now distanced himself from Trina, and is advising other clinic owners to do the same.
He told 番茄社区/inewsource, "Ford never had any permission to put me anywhere," referring to the many times his name was included in Gilbert's communications, papers and slide presentation.
Nevertheless, for many months, Lewin frequently touted Gilbert and his Trina brand.
His association with Gilbert began, he said, when the leader of a New York investor group that planned to open a Trina clinic in the South Bronx asked him to "vet" Gilbert's treatment protocol. At first, he said, he was a "total skeptic." But Lewin said that over time, he got to know Gilbert, calling him "an evangelist."
In an email Nov. 8, Lewin wrote: "Ford Gilbert and others have convinced this respectable group [New Care Ventures] and others elsewhere in the country that there is something of great value to pursue. He's not in my opinion motivated by money but by a real passion that he has something to offer.... Ford is a good and well-intentioned man. Of that I have no doubt."
So, Lewin said, he flew to California and spent three days talking with "60 or 70" patients as they underwent infusions at Trina Health clinics in Newport Beach and Sacramento.
Lewin didn't look at their medical histories or consult with their physicians, he said. But he found their stories, especially those who said their nerve pain or neuropathy improved, to be "pretty astounding actually."
"I have never seen anybody with diabetic neuropathy where it got better," he said.
Lewin was surprised. "I was expecting to be amused, and to see this as some farcical thing," he said, "but then I realized it wasn't. There's something to it."
During those November interviews, Lewin repeatedly insisted that while he was enthusiastic about Trina's potential, he would reserve clinical judgment until a controlled trial produced conclusive results.
Lewin said New Care Ventures hired him "as a consultant" to help design the clinical trial protocol with , PhD, an islet researcher at the University of California Irvine where the trial would take place. A protocol was submitted to the university's institutional review board, where it still awaits review. Lewin said this week he is now "exploring other sites" for a clinical trial location.
He insisted he would be objective in running a trial. "I have no monetary investments or financial conflict about it," Lewin said. "However the research comes out, that's how I will feel."
Last year, though, he sounded a lot less circumspect.
He appeared in opening ceremonies and talk shows promoting both Gilbert and the South Bronx clinic. He proclaimed Trina Health's many health benefits as if the trial had concluded when the protocol had not yet been submitted to UCI.
For example, he told , host of the talk show "," in July, "If you take this treatment, it restores normal metabolism in your body. You can digest carbohydrates in the way that non-diabetics do, and the effect of that is that it reverses neuropathy, it gets rid of (what) causes amputations ultimately, it reverses the risk of kidney disease. It reverses the risk of heart disease. It's amazing."
In an October with Axelbank, Lewin called Trina "exciting." He said, "In 90% of the patients in the research we've done far, the neuropathy is gone, or 90% gone."
In a Nov. 15 interview, he television host Daren Jaime on the that there are "thousands of patients who attest to this having saved them, gotten rid of their neuropathy and gotten rid of all these other symptoms," crediting Gilbert.
Several clinical trial experts said Lewin's comments aren't the sort made by scientists awaiting a clinical trial's conclusions.
Medical ethicist Arthur Caplan, PhD, at New York University Langone Health, took issue with Lewin's broadcast comments. "He does need to be cautious in being overly enthusiastic and promoting a treatment until (a) trial is done," he told 番茄社区/inewsource. "His enthusiasm ... can't and shouldn't be spun to recruit subjects."
For much of the last year, until his arrest April 2, Gilbert continued to drop Lewin's name as he boasted plans for expansion in Puerto Rico, Virginia, New Jersey, Miami, La Jolla and Texas. Gilbert included Lewin's photo and titles in the fourth of his 173-slide pitch to potential investors.
Gilbert frequently copied Lewin on emails and arranged interviews with him and a 番茄社区/inewsource reporter. Last November, Gilbert said, Lewin was to be on Trina Health's scientific advisory board but he declined.
After Gilbert was indicted, Lewin said he advised the Trina clinics to "distance themselves" from the Trina brand and Ford Gilbert.
"They have to decide to go on their own. All of them had the same experience of beginning this process, having been told Medicare funding was available," Lewin said.
Lewin added that clinics still operating may be at risk of health plan and Medicare audits, denials and possibly demands for repayment, now that the addresses of the clinics may be on the Department of Justice's radar. And, he added, "I don't think any of these (clinics) can operate without Medicare [reimbursement]."
"Anywhere an organization is associated with the name [Trina]," he said, federal officials will be taking a close look. "They're all at risk of a clawback," he said.
Later, in a May 2 email, he said that some Trina clinics had "apparently negotiated directly" with Medicare officials and may retain reimbursement. He did not elaborate.
The South Bronx clinic's website removed the brand name "Trina," as well as all videos and mentions of Gilbert. Other clinics no longer answered the phone using the name "Trina."
During federal court arraignment April 18 in Alabama, Gilbert pleaded not guilty to all charges in the indictment.