Wednesday, March 19, 2014
John Catanzaro, a Bothell naturopathic physician whose license was recently suspended by the state, says he has helped — not hurt — many patients with the “cancer vaccine” he created from their tissues and has followed proper procedures, including obtaining informed consent.
In a reply submitted Friday to the Department of Health’s Board of Naturopathy, Catanzaro asked for a settlement opportunity and hearing to contest the board’s statement of charges against him, issued Jan. 24. The board suspended his license to practice four days later.
The charges allege that Catanzaro, who was medical director of the HWIFC Cancer Research Group, did not obtain proper permits for research on patients, had no independent oversight and did not keep adequate records to determine whether the cancer vaccine was working.
In addition, the state alleged his lab had no certification or quality-control data to show that the vaccines he created for injection into “vulnerable cancer patients” were safe.
In his response, Catanzaro said he was not guilty of any basis for sanction, including unprofessional conduct, dishonesty, misrepresentation or fraud.
“I have not been negligent, incompetent or committed malpractice in the use of the vaccine,” he wrote, and had not violated any federal statute or administrative rules regulating his profession or setting patient-care standards.
None of his patients experienced any injury, he said, or was placed at “unreasonable risk of harm,” as the state alleges, or even experienced unexpected or troubling adverse events because of the vaccine.
“To the contrary, most of my patients had received a bleak prognosis because of their cancer before they began treatment with me, but have experienced a prolonged life and improved quality of life through the use of the autologous vaccine.”
He said only one patient was actually a “research subject,” and he obtained the proper permit from the federal government. However, he said the research protocol he submitted to an independent research-review board was originally disapproved. Later, that board told him that using the vaccine on a patient “was not serious non-compliance,” he said.
No patient complaints were referenced in the state’s investigative file, which was obtained by The Seattle Times through a public-disclosure request.
Leanna Standish, medical director and founder of Bastyr University’s Integrated Oncology Research Center, reviewed the case for the state board.
“Dr. Catanzaro is to be commended for his passionate attempt to translate basic cancer immunology into an individualized cancer vaccine for patients with advanced disease,” she wrote, and may be viewed as an “advanced integrative oncology provider, even a pioneer.”
However, she said, evidence showed that Catanzaro’s “disregard for basic quality controls and research protocol creates substantial and imminent risk for patients.”
In documents, Standish wrote, “It does not appear that psychologically vulnerable cancer patients are fully informed about the ‘research’ in which they are asked to participate.” Without that, “presentation of the clinical care in the guise of a research study is a ruse.”
Use of the terms “study” and “research”, she added, “may encourage patients and their family and friends to initiate a time-consuming and expensive treatment that in the end does not extend the length or quality of their lives.”
In addition, she said it appeared Catanzaro “has attempted to mislead the Naturopathy Board with inaccurate representations” of his regulatory research approval and oversight.
The original complaint was filed in February 2012 by an oncologist at a large Seattle-based medical center, who said her center recently had seen two breast-cancer patients who were receiving care from Catanzaro.
Catanzaro wanted the medical center to provide patient tissues for the vaccines, she said, but when she asked him for references and data regarding his procedures and outcomes, “he was unable to provide any.”
She provided tissue from one patient at the patient’s request, said the oncologist, who was not identified because she is a whistle-blower. “Then I looked further into his practice and realized that he appears to be doing research.”
Medical-center research and legal personnel advised her against giving him tissue “unless this is sanctioned research,” she said, so she told Catanzaro he needed approval from the medical center’s research oversight board.
The oncologist said she found it disturbing that Catanzaro appears to be charging patients for an “unproven and unregulated treatment and leading them to believe that it will cure their cancers.”
Standish, in her review of evidence for the board, said Catanzaro’s administration of the vaccine, while novel and uncommon among naturopathic physicians, is within the scope of naturopathic medical practice. She also commended him for his “clear communication” with two patients’ medical oncology team at the medical center.
And although Catanzaro’s earlier characterizations that his research was funded by donations “seems disingenuous to me,” Standish wrote, the amount he billed patients for the vaccine appeared reasonable.
However, Catanzaro doesn’t have much training or experience in clinical trials “and appears naive” about research regulations as well as study design, she said.
“Ultimately, I believe he is well-meaning and has his patients’ interest at heart,” with treatment based in solid theory, she said, but if his group is serious about research, it should fund audits and patient follow-ups.
“It may actually be an effective and safe treatment but we will never know because of the lack of scientific rigor,” she concluded. “From a scientific point of view this is unethical.”