ľֱ and San Diego-based inewsource have been taking a close look at offering a proprietary and controversial regimen of insulin infusions, touted as halting or even reversing diabetic complications. Some clinics have now closed and the company's founder was recently indicted on federal charges. Here, we detail questionable practices at one Trina clinic.
SAN DIEGO -- A type 1 diabetes patient, backed by her endocrinologist, said that treatments she received at a Trina Health clinic here run by James Novak, MD, not only didn't relieve her health problems but actively worsened them.
Meghan Lynch, 35, said she would come home from the treatments and collapse, falling so soundly asleep that neither her two barking dogs nor her roommate could wake her. The issue, she said, was hyperglycemia, and if it got any worse, "I would have been hospitalized, definitely," she said.
Lynch decided to tell her story after reading about Trina founder G. Ford Gilbert, JD, and his infusion procedure in a ľֱ/inewsource report.
Novak told her not to tell any endocrinologist she was getting Trina treatments, Lynch said.
San Diego physicians who know their patients have undergone the Trina procedure at Novak's clinic told ľֱ/inewsource they could not recall Novak ever asking for medical records or sending them from Trina sessions.
One, , MD, said he and his physician assistants have seen at least one patient who underwent Trina treatments at Novak's clinic. Neither he nor his staff could recall ever receiving a request for a medical record from Novak or his clinic.
Some patients interviewed about the Trina infusions said they were reluctant to tell their doctors about them. One, John McCreary of Poway, a patient with type 2 diabetes, said he did not tell his endocrinologist that he was undergoing Trina treatments.
At least two patients interviewed also said Novak did not get medical records from their other physicians to document the history of their diabetes or any diabetes-related conditions before starting the infusions. They said Novak would listen to the patients describe their health status, check their blood sugar, and proceed from there.
Novak did not respond to numerous phone and email requests to discuss Lynch's complaints. When a reporter visited his practice , she was told that Novak declined to comment. Because no one at the clinic would answer questions in recent weeks from ľֱ/inewsource, it is unclear whether Novak still offers the diabetes infusions.
In a phone interview with Novak last November that included Gilbert, the doctor said his clinic was administering Trina insulin infusions to about 25 patients a week.
Novak said he was "interested in holistic treatments, and whatever we can do to return the body to a more natural balance." He said he had been offering the Trina infusions since August 2016.
Looking for help
Lynch, who works in public relations for a New York-based company, saw a Facebook ad last summer for Novak's Trina clinic and its "Artificial Pancreas Treatment." She thought it might be the answer to lowering her blood sugar, which she hadn't been able to keep under control since she moved to San Diego from New Jersey a year earlier.
She had doubts, she said, but the fact that Novak was in the Scripps Health network and was covered by her Blue Cross Blue Shield of Michigan health plan gave Novak and his clinic some credibility.
When she met with Novak the first time, Lynch recalled, "right away" he advised her not to consult with any endocrinologists or other diabetes experts, because they "wouldn't understand the benefit of this type of treatment."
After getting information from Novak, his clinic staff, and the Trina Health website, Lynch came away convinced that the infusions would work so well, "I wouldn't need to worry about seeing an endocrinologist."
Novak and his staff never used the word "cure," but she said that's what she believed would happen with her diabetes.
Lynch said she underwent eight Trina sessions over two months. After each one she became increasingly frightened. The sugary beverages she had to drink during the four-hour procedure spiked her blood sugar levels to 400 mg/dL and higher, and she was sent home with blood sugar levels that high.
After many of the treatments, she was in "a complete zombie-like state," Lynch said.
"The next day I would have trouble waking up and I felt like my energy levels were zapping more going through that treatment," she said.
Concerned, she made an appointment last fall with , an endocrinologist at the Scripps Clinic, and told her about Novak's insulin infusions. She assumed Chang would know about the Trina procedure since Chang and Novak were both in the Scripps Health network.
But Chang had never heard of Trina -- or Novak -- and was alarmed by what Lynch described.
In diabetes, "treatments are always aimed at achieving normal blood sugars within a reasonable range," Chang said. "Above 400 is completely unreasonable and puts that patient at risk for diabetic ketoacidosis, which would require hospitalization."
Chang said no doctor should ever tell a patient not to seek an opinion from another doctor and that it would have been "highly unethical" for Novak to have said that to Lynch.
The danger for Lynch was compounded, Chang said, because Lynch has battled thyroid cancer, a condition that requires medications usually prescribed and managed by clinicians -- generally endocrinologists with special training in thyroid disease.
Under investigation
Chang said she reported Lynch's story to physician leadership at Scripps Health, which Chang said launched an investigation. She said a quality oversight committee at Scripps Mercy Hospital also was looking into Novak's clinic. Novak is listed as part of the medical staff at Scripps Mercy Hospital.
Asked about the status of that investigation, James LaBelle, MD, chief medical officer and senior vice president for Scripps Health, wrote in an email that "any investigation of Dr. Novak or any other member of Scripps medical staff" would be kept confidential and would take place under rules of peer review by the hospital medical staff.
He emphasized that in California, a hospital's medical staff "does not have purview over a physician's private practice, only their practice of medicine within the hospital."
He said if Novak "has engaged in any unethical behaviors in his outpatient practice, Scripps Health and the San Diego community should be able to trust that the Medical Board of California would take appropriate action."
The board would investigate if a complaint is filed, but none had been as of last week.
Now that she is seeing Chang, Lynch said, she is getting prescription medications that keep her blood sugar levels under much better control.
In retrospect, Lynch said, "I was naive to keep going [to Novak's clinic] without going to see an actual endocrinologist." When she remembers the conversations she had with Novak and his team, everything seemed to her like a "sales recruiting" pitch.
"And being in sales, I feel very dumb about the situation, because I should have seen the pitch," Lynch said.