SALEM, Ore. -- A Salem doctor is under investigation by the Oregon Medical Board for allegedly performing medical procedures that were not clinically supported, placing her patients at risk.
Meanwhile, Dr. Elizebeth Rose Harmon contends her use of hormone therapy for men and women is in accordance with recent medical studies and her research into the subject.
"Dr. Harmon is trying to cooperate and move forward and wants to be a practicing doctor in this state," her attorney Sue-Del McCulloch said. "Her goal is to practice good medicine."
The board's concerns with Harmon include: treating pre- and post-menopausal women with testosterone for non-specific symptoms; treating men with testosterone whose testosterone levels were within the normal range; not confirming diagnoses before treatment; not informing patients their treatment wasn't approved by the FDA; and claiming benefits of a hormone treatment not supported by medical consensus.
"By extolling the benefits of and proceeding with testosterone, estradiol and thyroid treatment without clinical justification, (Harmon) exposed her patients to the risk of harm without clinical justification, and failed to conform her practice to the fundamental medical principle 'to first, do no harm,'" the Oregon Medical Board wrote in a June emergency suspension order.
The board suspended Harmon's license in June after she refused to stop performing these treatments during the course of the investigation. She has since signed that agreement, so the suspension was lifted in mid-July.
Agreeing to this kind of order is not an admission of wrongdoing.
"In Dr. Harmon’s case, she had not had any complications or complaint to her and she had hundreds of patients who opted for this treatment," McCulloch said Wednesday.
Bella Rose Medispa on Liberty St. SE in Salem on Wednesday, Aug. 1, 2018. (Photo: ANNA REED / Statesman Journal)
Harmon separately agreed in January to not perform lipoplasty after the medical board identified at least five patients who underwent the procedure at a level that Harmon's office — Bella Rose Medispa — is not accredited for.
The board said this "displayed a disregard for board rules that are designed to protect patient safety."
McCulloch said Harmon did not do many of these procedures and was already in the process of removing that operation from her office.
Harmon's license was suspended on June 13 after she refused to sign the original order barring her from performing certain procedures.
"As the (order) stands, I can’t sign it because I don’t think I would be able to provide what I believe is to be the most efficacious and current care," McCulloch said of her client's mindset.
McCulloch filled a restraining order in Marion County Circuit Court on June 26, putting that suspension on hold until after a court hearing.
The suspension went back into effect July 3, lasting until July 12 when Harmon agreed to the temporary ordered barring her from performing certain procedures.
"The course that this case has taken is quite unusual," said Nicole Krishnaswami, interim executive director of the Oregon Medical Board. "It’s an outlier for us."
McCulloch said Harmon doesn't believe she has done anything wrong. These are relatively new treatments, she said, and emerging research supports hormone treatment for these uses.
A call to Bella Rose Medispa requesting comment from Harmon was not returned Wednesday afternoon.
According to the Oregon Medical Board, they became concerned after a site visit in December when Harmon told investigators that she often treats patients with the insertion of BioTE testosterone pellets.
Some of the potential benefits of this treatment Harmon outlines to patients include: decreased risk of diabetes, heart disease, Alzheimer's and dementia; decreased frequency of migraine headaches, mood swings and anxiety, and increased energy and libido.
Testosterone pellets are not FDA approved. In 2017, the FDA issued a warning to the chairman of BioTE for making misleading claims about his product.
Patients who received pellets presented with symptoms from "mental fog" and fatigue to weight gain and low libido. The Oregon Medical Board listed in its suspension order six cases and specific concerns with the treatment of each patient.
"There is a pattern of the care falling below the standard we expect for licensees," Krishnaswami said.
