The controversial ozone therapy approved by Congress and which Lula is pressured to veto – 03/08/2023 – Equilíbrio

President Luiz Inácio Lula da Silva (PT) has until this Friday (4/8) to decide whether to sanction or veto a law that authorizes health professionals with higher education to apply ozone therapy as a complementary treatment (that is, in addition to other treatments).

Although the proposal was approved with little resistance in Congress, the president has been pressured to overturn the law by entities that claim that there is no scientific proof of the effectiveness of this technique, such as the National Academy of Medicine (ANM) and the Brazilian Medical Association ( AMB). The Ministry of Health itself recommended vetoing the law for the same reason.

The Federal Council of Pharmacy, in turn, sent a letter to the president supporting the sanction.

Ozone therapy consists of applying a mixture of oxygen and ozone gas to the human body. Defenders of the technique say that ozone has anti-inflammatory, antiseptic properties and improves body oxygenation.

Today, ozone therapy is only authorized in Brazil for some dental and aesthetic procedures. Despite this, dozens of clinics operate irregularly, as shown by BBC News Brasil in 2021.

Advertisements proliferate on the internet offering applications of ozone gas through the anus, vagina and intravenously, for example, which would help, according to the advertisements, in the cure of cancer, in the fight against viral infections, endometriosis, hernia, circulatory diseases and depression — benefits not scientifically proven, according to the Federal Council of Medicine (CFM), which in 2018 carried out a review of available studies.

Questioned by BBC News Brasil, the CFM did not answer whether it is in favor or against the sanction of the new law. At the request of the Brazilian Association of Ozone Therapy (Aboz), the council now has a new group studying whether there is a scientific basis for regulating the technique in Brazil, but declined to provide details for the report.

By means of a note, the CFM clarified that “ozone therapy has no scientific recognition for the treatment of diseases” and that “it is still an experimental procedure, whose clinical application is not released, and should only occur in the environment of scientific studies , according to criteria defined by the CEP/CONEP System”.

“Among the conditions foreseen for participation in these studies are: the agreement of the interested parties with the conditions under which the research will be carried out, the guarantee of secrecy and anonymity for those who undergo the practice, the offer of medical-hospital support in case of adverse effects and the non-payment of treatment in any of its stages”, the note also said.

Other health councils, in turn, authorize their professionals to apply the technique, such as the federal councils for Pharmacy (CFF), Dentistry (CFO), Physiotherapy (COFFITO) and Nursing (COFEN).

However, as the National Health Surveillance Agency (Anvisa) only approved the use of ozone therapy equipment for some dental and aesthetic treatments, today these professionals cannot apply the technique for other purposes, which would constitute a health infraction, punishable by fines and closure of the establishment.

“Ozone therapy is a complementary and multidisciplinary procedure, which does not replace the techniques and treatments already incorporated into the health system, but rather adds to established treatments, as a new therapeutic option, promoting a better quality of life for patients”, he defended. the Federal Council of Pharmacy (CFF) in a letter to Lula.

“The importance of ozone therapy for public health is widely evidenced, given the incorporation of this practice by the SUS to the list of Integrative and Complementary Health Practices (PICS),” the letter also says.

A 2018 ordinance by the Ministry of Health, during the administration of Minister Ricardo Barros, in fact included the technique in the list of these practices, alongside other treatments such as homeopathy and acupuncture. The PICS are described by the folder as “therapeutic resources that seek the prevention of diseases and the recovery of health, with emphasis on welcoming listening, the development of the therapeutic bond and the integration of the human being with the environment and society”.

However, the Ministry of Health told the report that ozone therapy is only offered in SUS for dental treatment, following Anvisa rules.

What could change with the new law?

The approved bill authorizes ozone therapy as a complementary procedure under certain conditions: the technique can only be applied by a higher-level health professional registered with its professional inspection council and by means of medical ozone production equipment authorized by the Anvisa. In addition, the patient should be informed of the complementary character of the technique.

BBC News Brasil consulted Anvisa on how the law would be applied, should it come into force. According to the answer, there would be no change in practice: in the body’s view, ozone therapy equipment authorized by Anvisa for dental and aesthetic use would continue to be allowed only for this purpose.

“It is important to clarify that companies that, perhaps, give rise to the submission of regularization of new ozone-emitting equipment with indications of use different from those mentioned in Technical Note No. 43/2022 must present clinical studies with effective and safe results in order to corroborate this them, as provided in RDC nº 546/2021 and, when applicable, in RDC nº 548/2021”, said Anvisa.

“Thus, only after approval by Anvisa can the equipment be used for other purposes”, reinforced the agency.

Lawyer and health worker Silvio Guidi told BBC News Brasil that he had a different reading. In his understanding, the law opens the way for health professionals to use equipment already approved by Anvisa in other types of complementary treatment.

Guidi’s expectation, however, is that the law will not be applied. In the event that Lula sanctions the new legislation or that Congress overturns its veto, the lawyer believes that the law tends to be considered unconstitutional by the Federal Supreme Court, in the same way that occurred in 2020 with the law that authorized the use of synthetic phosphoethanolamine, known as the “cancer pill” by patients diagnosed with malignant neoplasia.

For Guidi, only the Federal Council of Medicine and Anvisa could expand the use of ozone therapy in the country. “The feeling I have is that Congress (by approving this law) is turning around a regulatory technique established within our country for the approval of medical equipment and procedures”, he criticized.

The bill passed Congress without much controversy.

The matter was initially approved in 2017 by the Senate Social Affairs Committee on a terminative basis, that is, it was sent to the Chamber for analysis without going through the plenary.

Afterwards, it was approved in 2021 by deputies in two committees and returned to the Senate also without going through the plenary of the House.

And, in July of this year, the senators approved the project in a symbolic vote, sending the matter for presidential sanction.

BBC News Brasil tried to hear Senator Otto Alencar (PSD-BA), who is a doctor and reported on the project in the Senate, but he did not respond to requests for an interview.

Also a doctor, Senator Hiran Gonçalves (PP-RR) was the only one who spoke during the symbolic vote, and expressed concern with the approval of the law. In his view, Congress is not the appropriate institution to authorize medical treatments in the country.

He fears that the law, if it comes into force, will lead patients to neglect other treatments, because they believe in the benefits of ozone therapy.

“The problem (with the approval of this law) is that you end up encouraging people indirectly to use a technique that is not an effective treatment and leave your treatments more effective and with more scientific evidence aside”, he told the report.

For obstetrician César Fernandes, president of the Brazilian Medical Association (AMB), it is not correct to promote a treatment that, in addition to not being proven effective, poses risks to patients, depending on the doses applied.

“There are several routes of application. It can burn the mucous membranes of the rectum, bladder and mouth, for example. And, depending on the amounts in which it is inhaled or absorbed by the body, it can cause vascular, cardiological, brain damage. , is not totally innocuous. It will depend on the dose, on the route of administration”, he points out.

What does the Brazilian Association of Ozoniotherapy say?

The approval of the law relied heavily on the Brazilian Association of Ozone Therapy (Aboz), an entity that promotes the technique and sells courses for its application.

The president of the institution, Antônio Teixeira, maintains that there are scientific advances to prove the effectiveness of ozone therapy, especially in the complementary treatment of pain and inflammation, such as knee osteoarthritis and low back pain (low back pain) associated with herniated disc. It is in this field that Aboz is currently trying to expand regulations at Anvisa and CFM, he explained.

Teixeira, however, says that the technique brings broader benefits. The Aboz website lists pathologies that could be treated, such as cancer tumors, hepatitis, ulcers, herniated discs, intestinal inflammation, among others.

“The big question that needs to be clear is that ozone is not a medicine, it does not act in the same way as a medicine, acting on a specific disease”, Teixeira told the report.

“Medical ozone is a therapeutic resource that modulates the endogenous antioxidant system, improves tissue oxygenation, activates immunocompetent cells and has topical antimicrobial activity. Its applicability, therefore, is wide and its indications are based on these molecular mechanisms of action”, he defends .

In defense of the treatment, Aboz also highlights the use of ozone therapy in other countries, such as Cuba, China, Portugal and Spain. The entity’s portal highlights the information that, “in Germany, this medical procedure is part of the treatments paid for by government health insurance” and adds that, “yearly, millions of patients are treated with Ozone Therapy” in the country .

However, the body responsible for defining the treatments covered by health insurance in Germany (Gemeinsamer Bundesausschuss) told BBC News Brasil that ozone therapy was excluded from standard coverage in the year 2000.

“This means that ozone therapy cannot be claimed through the statutory health insurance scheme. It is offered as a private payment service in Germany, but we do not collect figures on the frequency of use,” it said.

The resolution on the decision informs that the review of the scientific literature existing at that time did not point to reliable evidence of benefit and medical necessity. The document also says that the body’s decision was unanimous and that there was no challenge from the German Ministry of Health.

The report also consulted the German body corresponding to Anvisa (Bundesinstitut für Arzneimittel und Medizinprodukte). The institution informed that “ozone is not an authorized medicine” in the country. On the other hand, he clarified that “there is the so-called freedom of therapy” in Germany.

“This means that a product does not necessarily need authorization as a medicine to be selected by a physician as a therapy for a patient,” it added.