The California Medical Board has begun possible license revocation proceedings against a doctor who was the subject of a Milwaukee Journal Sentinel/鶹ý investigation.
Michael Arata, MD, of Newport Beach, is one of a small group of doctors who performed a risky, unproven vein-opening procedure on desperate patients with chronic cerebrospinal venous insufficiency (CCSVI), a condition purportedly linked to multiple sclerosis (MS); the doctors often charged thousands of dollars up front.
The March investigative story noted that between 2012 and 2017, Arata got three letters from the FDA warning of objectionable conditions and suggesting that he "repeatedly and/or deliberately" violated federal laws governing clinical research.
One woman died after Arata performed the procedure on her, according to her husband, who said she had bought into the procedure's promise after seeing posters advertising a presentation by Arata at a hotel convention hall in Canada. However, the Journal Sentinel/鶹ý investigation revealed that the California Medical Board had taken no action against him.
The story highlighted the lack of communication between the FDA, in its role overseeing the conduct of medical research, and state medical boards that take disciplinary action. It is part of an ongoing series showing that hundreds of physicians who have been publicly disciplined, chastised, or barred from practicing by one state medical board have been allowed to practice elsewhere with a clean license.
On June 28th, 3 months after the Journal Sentinel/鶹ý report, Kimberly Kirchmeyer, executive director of the Medical Board of California, began proceedings that could result in the revocation of Arata's license or a suspension of up to 1 year.
The action also seeks to revoke or suspend Arata's authority to supervise advanced practice nurses and physician assistants.
In a , Arata is accused of gross negligence, repeated negligent acts, dishonesty or corruption, failure to maintain adequate records, and unprofessional conduct.
The allegations cited his use of a balloon angioplasty, a vein-opening procedure to treat what he called "autonomic dysfunction" in disorders such as MS, Parkinson's, traumatic brain injury, and chronic Lyme disease. The board action called it "a risky and disproven invasive procedure."
It also said that Arata used another angioplasty procedure (sometimes called libation therapy) to open narrowed veins in the neck and chest of people with CCSVI, a condition supposedly linked to MS, though there is no clear evidence of such a connection.
Carlos Villatoro, a spokesman for the Medical Board of California, said he could not comment on whether the board's action was prompted by the Journal Sentinel/鶹ý investigation. "I can tell you this: we get complaints from all ways, including the media," he said.
Arata did not respond to phone calls to his office.
The board action, known as an accusation, highlighted the case of a 71-year-old woman with MS who went to Arata in late 2014. It said the woman was told she could be treated at a cost of $13,000, which would be covered by Medicare and her secondary insurance. She was asked for a $1,000 deposit.
The board document also said that in January 2015, the woman was asked for another $2,000, which she refused to pay. The procedure was done that month and she was told that, eventually, all patients see improvement of their MS symptoms.
Arata also performed excessive and unnecessary lab tests, according to the filing. The day after the procedure, she returned to Arata's office and he told her it was a "success."
However, Arata then told her that many of his patients also opt for a stem cell treatment and those who did had better outcomes. She was told that could be done the next day for another $10,000.
Many stem cell therapies are largely unproven. Last year, and have been linked to "unscrupulous actors." The agency also cracked down on a pair of clinics selling the unapproved treatments.
After Arata's patient turned down the stem cell treatment, she was told the price could be cut to $6,000; again she declined.
In June 2015, 6 months after the vein procedure, she got a bill for $16,000 from Arata. Checking further, she learned that Arata had billed Medicare for $113,000 and billed $47,000 to her private insurance. When she complained to Arata's office, she was told there had been a billing error and the matter was being addressed.
Since the procedure was performed, she said, she has received no relief from her symptoms.
No date has been set for the disciplinary hearing against Arata.