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The Medical Board of California has filed an against James Novak, MD, a San Diego family physician whose beach-area office practice was part of the national network of Trina Health clinics administering questionable insulin infusions to people with diabetes.

A series of stories published by MedPage Today from 2018 to 2020 examined the Trina treatment, which was developed by G. Ford Gilbert, a now-disbarred Sacramento lawyer. Gilbert sold specialized infusion pumps and guidelines to dozens of investors such as Novak, who launched clinics where the 4-hour weekly sessions took place.

Gilbert told his buyers that insurance companies and Medicare paid for the infusions, but they did not -- or if they did initially, auditors soon realized that the treatments lacked evidence of efficacy and stopped.

Gilbert eventually went to for bribing an Alabama lawmaker to order insurance carriers to reimburse claims when they had previously refused to pay for the procedure.

Nationally known endocrinology experts said the treatment seemed to be more of a business scam than a medical therapy, and many clinic providers who purchased the rights to administer the infusions for hundreds of thousands of dollars on the promise of a $400 to $700 reimbursement per session eventually went out of business.

In at least one case, an endocrinologist who later treated a Trina patient who had been under Novak's care said that the infusions not only didn't help the patient, but made her health issues worse. Several San Diego patients interviewed said that Novak advised them not to tell their other providers that they were undergoing treatment with Trina.

In its accusation, the California licensing agency said it may revoke or suspend Novak's license.

The board's complaint cited three causes for Novak's discipline: he was repeatedly negligent in the process of administering the Trina treatments to two patients in 2017; he failed to maintain adequate and accurate medical records; and he committed unprofessional conduct.

Novak "documented a limited medical history of Patient A and diabetes complications" for a 34-year-old woman diagnosed with insulin-dependent diabetes at age 12 who was using an insulin pump, the state agency said.

"The note did not document whether Respondent performed a physical examination, whether Respondent reviewed home blood glucose monitoring data, or whether Respondent reviewed the specific amounts of insulin then-currently being taken by Patient A," they continued.

Additionally, Novak's documentation did not include whether the patient should follow up with a primary care physician or an endocrinologist to manage her insulin pump and to monitor for diabetic complications once Trina was started.

He also scheduled the patient to receive Trina "without first attempting to review medical records from other medical providers documenting information and/or data about her diabetes complications," nor did he or his family nurse practitioner review any medical records from other providers during her Trina therapy.

There were no referrals for eye exams, no lab orders for microalbuminuria or dyslipidemia, and no foot examinations to check for neuropathy, the board accusation stated.

Novak could not be reached for comment before publication.

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