Texas Medical Board Clarifies Access To Ozone Therapy for the Treatment of COVID-19

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Jun 23, 2020, 09:00 ET

BRADY, Texas, June 23, 2020 /PRNewswire/ --

In response to the COVID-19 pandemic, Sheila Hemphill, CEO of Texas Right To Know submitted a request to the Texas Medical Board (TMB) to amend the "Violation Guidelines" for physicians. Board rule 190.8 (1) (A) which reads "failure to treat a patient according to the generally accepted standard of care" is a violation. Hemphill's request was to amend the rule by adding, "without patient informed consent." Currently the Center for Disease Control states there is no treatment for COVID-19; and, the only standard of care is infection control, supportive oxygen and ventilation. Therefore, any other treatment of COVID-19 by physicians would be a violation of this rule.

This rule change is supported by the World Medical Association's Declaration of Helsinki - Ethics Principals Regarding Unproven Interventions in Clinical Practice. Principal #37 states, "In the treatment of an individual patient, where proven interventions do not exist or other known interventions have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorized representative, may use an unproven intervention if in the physician's judgement it offers hope of saving life, re-establishing health or alleviating suffering..." Hemphill stated, "This rule change would enable patients to seek treatment based upon their own healthcare decisions after consultation with their physician and enable physicians to provide treatment for COVID-19 without fear of Federal Trade Commission, State or Federal Attorneys General, or TMB reprimand or reprisal."

At the recent TMB June 12 on-line meeting, TMB General Counsel, Scott Freshour, gave extensive explanation as to why the staff's recommendation was to refuse Hemphill's rule amendment. He states, "We did look very, very extensively at this, because it is an unproven therapy. I did paraphrase a little bit - Mrs. Hemphill just referenced item #37 from the World Medical Association Helsinki Ethical Responsibilities, talking about this otherwise unproven or unique therapy, which to us as board staff in reading that clearly, put it in under our CAM [Complementary and Alternative Medicine] rule – under the CAM rule as long as the physician documents that he or she has tried other conventional methods, if any exist, they can certainly move on to an alternative therapy and that is exactly where we felt this ozone therapy was and that rule 200 created the ability for physicians to use that as long as they documented it. So that is why we felt that the generally accepted standard of care rule that exists under board rule 190.8 did not need to be amended to say "without informed patient consent," because the focus of Mrs. Hemphill's request was on what was otherwise a CAM therapy… it is unnecessary and the rule as written now under 190.8 does not prohibit the use of ozone as long as they comply with board rule 200."

No public comments were permitted prior to the board vote and the board followed staff recommendation.

"I will be submitting this rule amendment again for the August 21^st meeting. This rule change request was perceived as being only for the use of ozone for the treatment of COVID-19. This rule change is intended to uphold patients' rights. Patients should not be required to fail conventional therapy prior to their physician being able to offer other non-standard of care treatment options. That is a decision that should be between the patient and their physician," said Hemphill. She continues, "For now, I am very grateful for Mr. Freshour's comments that brought clarity for the permissible use of ozone for treatment of COVID-19 under Chapter 200 board rules. Since there is no treatment for COVID-19, there are no conventional therapies that a patient has to fail prior to a physician offering ozone adjuvant therapy or other treatments. Patients should never be forced to receive conventional, much less experimental, medications or vaccines as a prerequisite to access other therapies of their choice for treatment for any illness or disease."

Ozone has been utilized medically for over 100 years with over 2,000 publications citing its efficacy and safety. Medical ozone Major Autohemotherapy (MAH) as an adjuvant treatment for COVID-19 is showing great success as reported by physicians in Italy, Spain, China, and other European and South American countries. The MAH treatment is similar to a common patient blood donation except the patient's IV bag is infused with ozone and then re-transfused back to the patient.

Regarding the use of ozone therapy in 17 hospitals in Italy, the Scientific Society of Oxygen Ozone Therapy reports 14% of infected patients receive negative test swabs in as little as 5 days of treatments. In hospitalized patients, 94% of non-intubated and 73% of intubated patients experience "rapid recovery" compared to the 80% fatality rate for intubated patients in New York (Businessinsider.com). The average number of days for patients to be extubated in New York is 11 to 21 days while patients who have received ozone is 5 days. There are currently single and multicenter, randomized, controlled clinical trials involving 800 patients and 26 hospitals underway studying ozone therapy for COVID-19 in multiple countries including Italy [1,2], Spain, [3,4], and China [5,6,7].