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How a doctor’s tip and a Facebook algorithm led to an award-winning series Date: 07/24/19

By Cheryl Clark

This is the story of how a doctor’s tip, with help from a Facebook algorithm, led to an award-winning series about a nationwide network of diabetes clinics that some experts called a scam. The story does not end well for the network’s founder, G. Ford Gilbert, who goes to federal prison in August.

Recently, two young journalists asked how one becomes an investigative journalist. Their question took me aback, because I couldn’t think of an answer that would be at once pithy and wise. There’s the adage that all journalists should be “investigative,” but that would sidestep their question.

So my advice to them was this: just do one story, and follow it wherever your curiosity takes you. Keep asking questions, even after it runs, and that story will usually lead to another, and another, and another.

That’s pretty much happened with "Hustling Hope," a 2018/2019 MedPage Today and inewsource.org series about a national network of infusion clinics called Trina Health that promised to relieve just about any complication from diabetes: neuropathy, nephropathy, cardiovascular problems and even erectile dysfunction. The treatment? You sit for four hours every week as a special pump pulses insulin to your bloodstream, a procedure whose effect was said to mimic that of the pancreas.

If it would do all of that, why weren’t pulsed-insulin infusions available everywhere? It sounded too good to be true.

How I learned about Trina is probably what happens to a lot of journalists who stumble onto a great story. The path might be circuitous and require a lot of patience and curiosity.

In May of 2017, I was preparing to cover the American Diabetes Association’s annual conference in San Diego for MedPage Today and inewsource.org, and needed some experts to help me learn the hot topics. As my interview with one San Diego endocrinologist was winding down, the doctor said there was “one more thing,” just like Columbo, the TV detective who almost always had one more question. Did I know anything about “Trina,” a “miraculous” diabetes treatment that some patients were inquiring about? The doctor’s voice went low: I should check it out. It’s “very strange.”

I made a note, then forgot all about it. A few months later, after one ADA meeting story led to another, the “Trina” story would be staring me in the face. Back to Trina in a minute, because I should explain the path of stories that led me there.

They included one about Medicare’s new diabetes prevention program for overweight seniors with “pre-diabetes,” then one on the increase in the cost of diabetes drugs, which were on display in huge kiosks at the convention and a third on a local hospital system’s decision to remove from its pharmacy shelves all supplies of the popular drug Invokana after a U.S. Food and Drug Administration warning appeared to link it to a doubled risk of amputations.

I wondered whether California’s hospital discharge data — the largest such dataset in the country — would show a spike in amputations among patients with diabetes after 2013, when Invokana received FDA approval. After loading up spreadsheets from the state agency, I sorted the data by county, hospital, payer, whether scheduled or emergency, and by body part.

Sure enough, the data showed a skyrocketing rate of diabetes-related amputations for all body parts, confirmed on a national level by the Centers for Disease Control and Prevention, disproportionate to the number of new diabetes diagnoses. My premise was disproved, because the surgeries appeared to have no link to the drug since the increase in amputations began long before Invokana was licensed and was more likely tied to states cancelling Medicaid reimbursement for wound care during the 2008-09 recession.

I posted the amputation story on Facebook, and in a matter of hours, Facebook’s algorithm loaded an ad for a Trina clinic — one near my home in San Diego — right into my news feed. The ad said that Trina prevented amputations. It also said that Trina was covered by insurance and Medicare.

I remembered the endocrinologist’s tip about the “very strange” procedure.

Below the ad were comments from many people who claimed to have had their diabetes symptoms improved through the infusions. But one post, from Patricia Wu, M.D., who I later confirmed was a Kaiser Permanente endocrinologist, called it “a scam.” I took screen shots of everything.

I contacted some of the patients who had posted praise for Trina. A few agreed to share their stories and show me their explanation of benefit statements verifying that indeed Medicare or private insurance covered these treatments. That seemed odd, because I also found a 2009 decision memo from the Centers for Medicare and Medicaid Services, whose extensive review of all the data found insufficient evidence that outpatient-pulsed insulin infusions had any benefit.

CMS instructed any provider performing these procedures to code them as “G9147,” which meant that it would not be covered.

Private insurance companies generally follow Medicare’s rules. So I knew I had a good story, and so did my editors at MedPage Today. At inewsource, my editor wanted fewer policy wonk pieces and more hard-hitting investigative exposés from me, so she was happy as well.

Either this was a miracle cure for diabetes symptoms that drug companies and endocrinologists were covering up (unlikely) or, perhaps, an organized system for massive fraud that used the placebo effect and newer medications to take credit for results. My task wasn’t to determine whether this treatment worked, but whether experts thought it was fraud.

Digging into the patients’ benefit statements, I discovered that claims for the infusion sessions were being submitted not as G9147, but as separate office services, such as CPT 99214, the second highest level of physician’s office service, or “pump maintenance” for an infusion pump. Some might say the infusions were being disguised.

I should say here that many patients swore that they felt better with Trina. But when I asked them if they were doing anything different to control their diabetes, most had recently started one of the many new diabetes drugs or were using continuous glucose monitors. Other diabetes experts familiar with Trina said those treatment changes were probably responsible, or the placebo effect was hard at work.

I also found several patients who said they had suffered harm from Trina infusions.

There were a dizzying and tangled array of threads to pursue. The clinic network’s founder was a Sacramento lawyer, G. Ford Gilbert, who was being sued in a number of courts. Gilbert had sold franchises for Trina to dozens of investors — ordinary citizens, physicians and even a hospital — for between $300,000 and $450,000 each on a promise that claims would generate seamless federal and commercial reimbursement.

Some of those buyers weren’t happy when their claims were denied and now, instead of getting reimbursed, they were getting clawback demands. A clawback is a demand for repayment from Medicare or other payers.

There was more. The former head of the University of California at Davis department of endocrinology had filed a patent infringement lawsuit against the lawyer saying the whole idea was his from years ago.

A respected couple in the rural Montana town of Dillon — they also happened to be the coroner and deputy coroner and the owners of the town’s only funeral home — had purchased Gilbert’s franchise only to suddenly receive cease and desist notices from BlueCross BlueShield of Montana, which determined the “treatments” were the same as what Medicare in 2009 had reviewed. The coroner, Ron Briggs who had diabetes, had been receiving Trina treatments himself. He and his wife sued BCBS. They were angry and tearful. And now broke.

The plot was getting thicker. We decided to go to Montana.

Half of the inewsource team — two videographer/photographers, editor Lorie Hearn and I — flew and drove to Dillon over three days in late November/early December 2017 to interview the couple and the clinic’s former patients. We also interviewed the town’s doctors to see how Trina had affected the town with a population of 4,000. We learned that doctors had refused to validate Trina as an effective therapy and did not support the couple’s efforts, so the couple badmouthed the hospital and its clinicians, a dangerous thing in a town where the next nearest medical facility is over an hour’s drive. We interviewed the doctors, who said on camera they couldn’t support a treatment that had no scientific merit.

We learned that some diabetes patients did not follow their physicians’ care recommendations for serious conditions such as heart failure, and instead spent time getting Trina infusions. Trina, we realized, could be indirectly causing more than just financial harm.

One of the saddest parts of the series was the impact on a critical access hospital in a Mississippi county that ranks among counties with the 40 highest rates of poverty in the country. North Sunflower Medical Center in Ruleville, Miss., had bought Gilbert’s franchise and was treating dozens of patients every day, but was losing tens of thousands of dollars each month after payers stopped reimbursing. Somehow, they kept providing the treatment on Gilbert’s reassurance that insurers would see the light, and reverse their decision.

Other clinics, in Kansas, Louisiana, Texas and Utah had gone out of business, even as new clinics were opening up in Nevada, New Jersey, Virginia and New York. Clinics in Texas, Florida, Arizona and California had managed to stay afloat, but in time some of the California clinics would close.

The Trina empire eventually came tumbling down because of what Gilbert did in Alabama. He tried to bribe a state lawmaker to force the state’s major commercial insurer, BlueCross BlueShield of Alabama, to resume reimbursement and make several clinics, whose owners had paid hundreds of thousands of dollars, whole again. He got caught. Instead, Gilbert was indicted by a federal grand jury on seven counts of public corruption, including health care fraud, bribery and racketeering. In January 2019, Gilbert pleaded guilty to one count of bribery in a deal that puts him in federal prison for six months and home confinement for another six.

A U.S. Attorney’s office filing would later call Gilbert’s Trina enterprise a “pyramid scheme” in that money was made in the selling of franchises to open clinics. “Gilbert sold people on a promise that was not likely to ever be fulfilled,” the assistant U.S. Attorney said.

One interesting aspect of the story was Gilbert’s boast that a big star in medicine was helping him get the word out about Trina’s benefits. This boast contradicted what many nationally prominent endocrinologists and diabetes researchers had said about Trina. Some used terms such as “snake oil” to describe it. But there was a big star: Jack Lewin, M.D., the former CEO of the California Medical Association and of the American College of Cardiology, the former president and CEO of the Cardiovascular Research Foundation, and a longtime source for many journalists.

With Gilbert’s urging and arrangement, I contacted Lewin, who told me he was working with a group of New York investors to organize a clinical trial to test many of the claims Gilbert and some patients had made about the infusions’ ability to resolve complications of diabetes. The investors wanted to start a Trina clinic in the South Bronx and apparently had purchased Gilbert’s protocol.

Lewin insisted he was strictly and scientifically objective about Trina. “I have no monetary investments or financial conflict about it,” Lewin said. “However, the research comes out, that's how I will feel.”

While he found the concept interesting and was impressed after talking with 60 or 70 patients about their experiences during two days at two California clinics, his opinion would be formed only from clinical trial results. As days went by, it became clear the clinic had opened without clinical trial validation Lewin said the treatments needed. Gilbert was featured at opening ceremonies. Lewin was functioning as a hired clinic consultant for the South Bronx clinic’s investors. And Lewin was all over TV saying that Trina worked!

He appeared on at least three New York talk shows touting Trina as if he were selling patients on a treatment that he knew worked wonders. In one, he said, “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.”

During another talk show, Lewin called Trina “exciting.” He said, “In 90 percent of the patients in the research we’ve done so far, the neuropathy is gone, or 90 percent gone.”

There were other inconsistencies. A promised trial at the University of California at Irvine, for which Lewin at one point said he would serve as principal investigator, and which Gilbert and Lewin said or implied was about to start, had not passed the required scientific review committee. Nor did it have Institutional Review Board approval. UCI later rejected the application.

One of the more exciting events to come out of this series was the airing a year ago by PBS NewsHour of the Montana part of the story. That gave this story unique exposure and enabled a wider audience for the great videos and photography taken by inewsource’s Megan Wood and Brandon Quester. I am most appreciative for my editor, Lorie Hearn, who saw the potential for this story all along, and to MedPage Today, which subsidized my inewsource salary for the project, and Peggy Peck for her encouragement.

Many of the threads from the Trina story are still hanging. So the story may not be over just yet.

There is another story, and another.

Cheryl Clark is a senior investigations reporter for MedPage Today, in New York, and for inewsource/KPBS in San Diego. She lives in San Diego. The Hustling Hope series has won several awards, including first place in the small market investigative category in AHCJ's 2018 Awards for Excellence in Health Care Journalism.