The Medical Board of California has one accusation James Novak, MD, a San Diego family doctor whose office on the beach was part of the national network of Trina Health clinics that gave questionable insulin infusions to people with diabetes.
A series of stories published by MedPage today 2018-2020 studied the Trina treatment developed by G. Ford Gilbert, a now-banned Sacramento attorney. Gilbert sold specialized infusion pumps and guidelines to dozens of investors like Novak, who opened clinics that hosted the weekly 4-hour sessions.
Gilbert told his buyers that insurance companies and Medicare paid for the IVs, but they didn’t – or if they did initially, the investigators soon found the treatments had no evidence of effectiveness and stopped.
Gilbert finally went to jail for bribing an Alabama legislature to direct insurance carriers to reimburse claims if they previously refused to pay for the trial.
Nationally known endocrinology experts said the treatment appeared to be more of a business fraud than medical therapy, and many clinic vendors who bought the IV rights for hundreds of thousands of dollars with promises of $ 400 to $ 700 per session reimbursement eventually the business gave up.
In at least one case, an endocrinologist who later treated a Trina patient who was in Novak’s care said that the infusions not only did not help the patient, they made her health problems worse. Several San Diego patients interviewed said Novak advised them not to tell their other providers that they are undergoing treatment with Trina.
In their indictment, the California licensing authority said they could revoke or suspend Novak’s license.
The board’s complaint cited three reasons for Novak’s discipline: he was repeatedly negligent in administering the Trina treatments to two patients in 2017; he failed to keep adequate and accurate medical records; and he has committed unprofessional behavior.
Novak “documented a limited history of Patient A and diabetes complications” for a 34-year-old woman who was diagnosed with insulin-dependent diabetes at age 12 and who is using an insulin pump, the state agency said.
“The note did not document whether the respondent did a physical exam, whether the respondent checked the blood glucose test data at home, or whether the respondent checked the specific amounts of insulin that Patient A is currently taking,” they continued.
In addition, Novak’s documentation did not include whether the patient should see a family doctor or an endocrinologist to manage her insulin pump and monitor for diabetic complications once Trina was started.
He also planned for the patient to receive Trina “without first attempting to review medical records of other medical providers documenting information and / or data about her diabetes complications,” nor did he or his home nurse check during her Trina. medical records of other therapy providers.
There were no referrals for eye exams, no laboratory prescriptions for microalbuminuria or dyslipidemia, and no foot exams to check for neuropathy, the committee’s indictment said.
Novak could not be reached for comment prior to publication.
Last updated on June 3, 2021