A San Diego woman says she was put at risk of hospitalization last year after receiving a series of insulin infusions at Dr. James Novak’s Trina Health clinic in Pacific Beach. The woman and her endocrinologist said the infusions spiked her blood sugar to dangerously high levels.
Why this matters
The nation has a limited supply of healthcare dollars to spend on drugs and services, which is why the government and health plans require scientific evidence of patient benefit. This is especially important for the 30.3 million people in the U.S. with diabetes, whose medical costs in 2012 totaled $245 billion.
Leadership at Scripps Health started an investigation of Novak’s practice when they learned about the incident, the endocrinologist said. And the founder of the Trina infusion procedure, Sacramento lawyer G. Ford Gilbert, faces federal criminal charges related to his network of clinics.
Meghan Lynch, 35, who has Type 1 diabetes, 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. If her blood sugars had continued to increase, “I would have been hospitalized, definitely,” she said.
Lynch decided to tell her story after reading about Gilbert and his Trina infusion procedure in an inewsource investigation. Lynch said Novak told her not to tell any endocrinologist she was getting Trina treatments. Doctors around San Diego said Novak’s clinic has never asked for medical histories on their patients to make sure they have diabetes or that they suffer from complications that Trina advocates claim are improved or eliminated.
Novak, a family medicine doctor did not respond to numerous phone and email requests to discuss Lynch’s complaints. An inewsource reporter who visited his practice on Lamont Street was told by an office manager that Novak declined to comment.
A federal indictment unsealed last month in Alabama charged Trina founder Gilbert with healthcare fraud and public corruption for allegedly trying to bribe state legislators to pass a law requiring an insurance company to pay for Trina infusions.
Since the indictment, several clinics have stopped advertising the Trina treatments. And in the past couple of years, 13 clinics have closed down in eight states.
Meanwhile, dozens of diabetes experts and researchers have used terms such as “scam,” “fraud” and “snake oil” to describe the Trina procedure, saying there is insufficient scientific evidence it benefits patients.
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.
About this investigation
inewsource has spent months investigating a California lawyer and his practices in promoting what he calls a “miraculous” procedure for reversing the complications of diabetes, a condition that affects 30.3 million Americans.
Senior healthcare reporter Cheryl Clark began asking questions about the insulin infusion procedure advertised by Trina Health after learning it was being offered in San Diego. The inewsource mission is accountability journalism, and Clark focused her inquiries on the risk of harm to patients and the cost to the healthcare system.
She has interviewed more than 100 people for this investigation, including Trina founder and CEO G. Ford Gilbert at his Sacramento headquarters. Gilbert was charged with fraud and bribery in Alabama in a federal indictment unsealed April 2.
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 said she thought the infusions worked so well, “I wouldn’t need to worry about seeing an endocrinologist.” Although Novak and his staff never used the word “cure,” she said she thought that’s what would happen with her diabetes.
Lynch said she underwent eight Trina sessions over two months, and 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 and higher, and the Trina staff let her go home in that state, putting her at risk of a serious condition called ketoacidosis, which usually results in hospitalization, she said.
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.”
Lynch said she tried to inject herself with insulin to lower her blood sugar levels to counteract the sugar from the glucose drinks. But it was tough, given how she kept falling asleep.
Concerned, she made an appointment last fall with Dr. Amy Chang, 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.
“Patients have a right to know about the therapies they’re receiving. They have a right to know what the risks are to their health and potential benefits, if there are any,” she said.
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.
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, Dr. James LaBelle, 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 licenses doctors and investigates complaints. If warranted, the board files accusations, which could result in limitations or revocation of a license. In Novak’s case, no such accusation was filed as of Thursday.
Lynch said she spent a lot of time and money getting the infusions. She paid $100 out of pocket for each session, and her insurance company paid an additional $425. Though her bills showed Novak was charging for office visits, Lynch said Novak rarely spoke with her during her infusion sessions. “He barely even said hi,” she said.
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 get Trina infusions) 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.
In a phone interview with Novak in November that included Gilbert, the Trina Health CEO, 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.
Other San Diego doctors who know their patients have undergone the Trina procedure at Novak’s clinic, said they could not recall Novak ever asking them for medical records or sending them records from Trina sessions. It’s a common practice among doctors to share information about mutual patients.
One, Dr. Georges Argoud, an endocrinologist in Solana Beach and Chula Vista, 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, Dr. Christopher Marx, that he was undergoing Trina treatments.
At least two patients interviewed also said Novak did not get their 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.
Tracey Ott of Santee, a Type 1 diabetes patient, said the initial process for her last July was simple. “When you go for the (first) treatment, they check your sugar and all that, and they go from there with how they treat you,” she said.
Ott, 45, said she turned over all of her medical care to Novak. In an interview with inewsource in November, she said the infusions, plus a drug called gabapentin, were helping her neuropathy get better.
When she mentioned the Trina infusions to her former family medicine physician, Dr. Lee Remington-Boone, she “wanted to hear nothing about it. She pretty much thought I was a little crazy,” Ott said.
Because no one at the clinic would answer questions in recent weeks from inewsource, it is unclear whether Novak still offers the diabetes infusions.
UPDATE: June 3, 2019
An earlier version of this story included a link to the Trina Health website, which is no longer accessible. inewsource has replaced it with an archived version.
A California lawyer who promotes a “miraculous” treatment for diabetes has built a global network, despite doctors’ rebukes and reimbursement denials. This is the first story in an ongoing series.
The second in an investigative series about Trina Health, which advertises its treatment as “miraculous” in reversing the complications of diabetes.
Ron and Julie Briggs lost their life savings when they paid to bring a Trina Health clinic to their small town. This is the third story in an ongoing series.
Sacramento lawyer and Trina founder G. Ford Gilbert hitched his clinic’s expansion plans to a big national name in organized medicine and health policy: Dr. Jack Lewin.
We’ll let you know when big things happen.