Right of Reply of Aepromo to the story “Ozone Therapy is a Major Hoax that we Must Denounce”
August 18, 2018
Right of Reply translated from Spanish into English by Roberto Quintero.
Story run by the Spanish newspaper El Mundo on August 14, 2018.
Second printing newspaper in Spain.
Second most consulted digital newspaper in Spanish in the world.
Right of reply of Aepromo to the story “Ozone therapy is a major hoax that we must denounce” run by the Spanish newspaper El Mundo on August 14, 2018. http://www.elmundo.es/ciencia-y- salud/salud/2018/08/14/5b705e85ca474155498b4651.html Page consulted August 18, 2018. Malicious story, with basic deliberate errors and written from the most absolute ignorance of ozone therapy.
Story written by Laura Tardón “journalist of the EL MUNDO Health Section” and curiously “awarded at the II edition of the Journalism Prize of the Roche Institute” [Foundation created by Roche Farma Spain manufacturer of medicines against cancer], according to information from the same newspaper (January 29, 2016). So the journalist writes from a clear conflict of interests.
The signatories of this right of reply are registered physicians and members of the Management Board of AEPROMO (Spanish Association of Medical Professionals in Ozone Therapy), which is a non-profit scientific entity registered before the Ministry of Interior and with FIN (Fiscal Identification Number) B54213025R. The members of AEPROMO are registered professionals.
The story is full of unfounded errors, contains biased information without checking, is made from half-truths and unfounded accusations. Borrowing the phrase from one of her interviewees, Laura Tardón qualifies the ozone therapy as “major hoax “. With this she is saying that we are deliberately cheating our patients. Serious accusation that by not having been contrasted puts us in a situation of defenselessness.
We are neither journalists nor we try to be, but in a story supposedly informative and objective, the author should have contrasted the information collected with scientific and associative bodies such as AEPROMO, an association that represents most of the Spanish ozone therapists physicians. Since ozone therapy is an “exclusively medical act”, in Spain it is practiced by physicians duly trained in it. An important number are specialists in different branches of medicine, and even department heads in public hospitals.
The story falsely points out that “ozone therapy does not seem to have limits on its healing power”. AEPROMO and the scientific documentation available to the therapy, categorically states that it does have limits and the list of treatable diseases are listed in the Madrid Declaration on Ozone Therapy (Isco3, 2nd ed., 2015), https://isco3.org/madrid-declaration-on-ozone-therapy-2nd-edition-2/ which is the world reference document for its practice and which it has been translated into twelve languages. The two editions of this document (2010 and 2015) that puts together the criteria of its practice, were officially presented at congresses organized at the Royal National Academy of Medicine (Madrid, Spain).
Ms. Begoña Barragán, president of the Spanish Group of Patients with Cancer (GEPAC for its acronym in Spanish), an organization sponsored by the pharmaceutical companies Astellas Pharma, Ferrer and Roche, and Dr. Jerónimo Fernández Torrente of the Medical College Organization (OMC for its acronym in Spanish) point out in the story that there are no scientific researches that support the use of ozone therapy for cancer. In the first place, GEPAC, being sponsored by three pharmaceutical companies that manufacture cancer drugs, is completely disqualified due to a clear conflict of interest. Secondly, AEPROMO has never trumpeted that ozone can cure cancer. We do say that it serves as “complementary treatment, adjuvant or palliative in the treatment of cancer.” Nor have we indicated that it serves to cure AIDS. Medical ozone does not have those indications or connotations.
Ozone (breathed) is a toxic gas. This is stated in the Madrid Declaration on Ozone Therapy. The ozone- oxygen medical mixture, like any medication, is used in therapeutic concentrations, if the physician leave these margins he will find ineffective or toxic concentrations. The Madrid Declaration on Ozone Therapy (Isco3, 2nd ed., 2015) precisely determines the doses to be delivered to the patient. Therefore, medical ozone should only be used by health professionals properly trained in its management, and must be administered exclusively by equipment that has the CE Marking [CE Marking on a product is a manufacturer’s declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation. http://www.ce-marking.org/what-is-ce-marking.html, translator’s note] with classification IIb, that is, the same classification that has a defibrillator or electric scalpel.
The story states that the therapy does not have a scientific basis or publications that support it. False statement. Either the ignorance is supine or there is bad intention. A simple online search will find in MedLine 3,153 records referring to ozone therapy, of which 235 are clinical studies published in PubMed. In addition, AEPROMO has the Spanish Journal of Ozone Therapy, indexed in Dialnet and Latindex. It is an online scientific and bilingual (English and Spanish) journal, with peer review, of free access and annual publication that has been published uninterrupted since 2011.
Fernández Torrente of the Medical College Organization (OMC) emphasizes in the story that “ozone therapy is neither approved by the European Medicines Agency (EMA) or by the American (FDA).” False statement. When looking among active substances in research it will be found that ozone does appear as an authorized substance; is found during the registration process of a clinical trial on the web site of the European Medicines Agency (EMA), on the EudraCT website. https://eudract.ema.europa.eu/results-web/. On the other hand, the Spanish Agency of Medicines and Medical Devices (AEMPS for its Spanish acronym) has authorized the realization in Spain with ozone, at least, of a couple of clinical trials, a post- authorization prospective follow-up study (EPA-SP) and other types of post- authorization studies.
Fernández Torrente deliberately forgets or perhaps ignores that ozone therapy is practiced efficiently in 23 public hospitals Pain Units of our country. He forgets, or omits or ignores that ozone therapy is legally authorized in the public and private health sectors of our neighbor Portugal, as it is in Greece, Turkey, Russia (where it is located the only research center of ozone therapy in the world) and Ukraine. In more distant horizons it is in Cuba, Dubai in the United Arab Emirates, China, and Oman. Brazil has regulated the use of ozone therapy in dentistry. In Spain in response to express requests from AEPROMO, 15 out of its 17 autonomous communities, have listed in writing the requirements for their practice. The therapy, widely used in Germany, is fully tolerated by its health authorities as in the rest of the European Union. Although in the United States the FDA says that “ozone is a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy” ozone therapy may be practiced legally in 15 of its states under the umbrella of the unconventional therapies. And finally, Spain and Europe have their own institutions of great competence and respect (the AEMPS and the EMA) as to base ourselves on what the FDA says. Proudly, Spain is light years away in the development, implementation and research of this therapeutic form in a successful, safe and effective way.
Demonstrating an absolute lack of awareness about this therapy, Fernández Torrente affirms that this therapy has caused “deaths” and does so without citing any source. That is absolutely false. This has never happened, much less in Spanish territory. On the contrary, allopathic medication has killed people. By analogy, if chemotherapy is poorly administered it can also produce lethal effects. The WHO cites the case – as an example- of a 39-year-old patient with cancer. He died because he had been given four times more the dose of chemotherapy required. (http://www.who.int/patientsafety/information_centre/reports/Alliance_Forward_Progra mme_2008.pdf. Page consulted Sept 4, 2008).
In Spain out of the 5,624 hospitalized patients analyzed in the National Study of Adverse Effects, 1,063 (18.9%) were detected with adverse effects. Healthcare was responsible in 9.3% of the cases, while hospital care was of 8.4%. The medication was responsible for the adverse effects in 37.4% of the cases, nosocomial infections of any type in 25.3% and 25.0% were related to technical problems during a procedure. (http://www.msc.es/organizacion/sns/planCalidadSNS/pdf/excelencia/opsc_sp2.pdf
Page consulted Sept 6, 2009)
In June 2017, the World Health Organization (WHO) decided to withdraw Oseltamivir (Tamiflu or Zanamivir) from its list of essential medicines. It was the result of a long struggle of scientists, which began in 2009 as a result of the influenza A / H1N1 pandemic. The scientists had to face the pharmaceutical Roche, the same that sponsors the Association of Patients against Cancer (GEPAC) and awards the author of the article, Laura Tardón.
The shameful story begins with the publication of the first plan for pandemic influenza of WHO in 1999 following the first human cases of avian influenza, developed together with a group (ESWI- European Scientific Working group on Influenza) funded by Roche and other producers of influenza drugs. In 2002, WHO recommended that countries maintain large reserves of this drug, including Spain.
Following the “supposed” influenza A / H1N1 pandemic in 2009, Cochrane (an international body dedicated to evidence-based assessments) reviewed the Oseltamivir articles and found that Roche had more unpublished results. It asked Roche for the complete databases, but upon receiving them it found that they were all incomplete.
Finally, Cochrane obtained the complete research reports of Roche (25,453 pages) through a new transparency mechanism of the European Union in 2011. The final findings of the study made with these data (Ebell, 2017 10.1136 / bmj.j3266) were a small reduction in the duration time of symptoms, no evidence that the probability of pneumonia, hospitalization or complications required treatment with antibiotics.
These results led WHO to withdraw Oseltamivir from its list of essential drugs, where it had been since 2010. The business for Roche was 18 billion dollars between 1999 and 2014 (BMJ 2014; 348: g2695).
But the story unfortunately does not stay there. As there are controls in Europe and Roche cannot ignore them, it is selling them in third world countries to deal with the Chikungunya virus and the Zyka virus.
On the other hand, hospital errors – says WHO – have cost some countries between US $ 6 billion and US $ 29 billion for additional hospital expenses, infections acquired in hospitals, economic loss to patients, and judicial processes. (http://www.who.int/patientsafety/information_centre/reports/Alliance_Forward_Progra mme_2008.pdf page consulted Sept 4, 2008)
Faced with the panorama of the safety of the medical treatments that we have reviewed, AEPROMO asks: Why is it requested to ozone therapy results well above those reported by allopathic treatments? The use of ozone would greatly reduce everything described. For example, nosocomial infections would be drastically reduced thanks to the bactericidal properties of ozone, it would reduce the high costs to social security in drugs that are often administered indiscriminately and unnecessarily creating drug resistance. It would reduce the administration of corticosteroids and NSAIDs. But since that does come into direct and frontal conflict with the interests of pharmaceutical companies, which are very interested in keeping chronically ill, from that they live and earn millions, then ozone does not matter so they have to attack it. We are sure that if ozone could be packaged and sold in pharmacies, the pharma industry would have appropriated it. That is the cruel and real truth that lies behind the war against ozone therapy.
It is necessary to emphasize that the Madrid Official College of Physicians (ICOMEM for its acronym in Spanish) which through its president Dr. Miguel Ángel Sánchez Chillón, who in the same story expresses himself against ozone therapy, never gave an answer to our written request sent on 7 September 2017 to have a “work meeting”. In the different relationships we have had with the ICOMEM, since 2010, none of its representatives had spoken against ozone therapy. It is the first time, through a newspaper, that it does so, but having previously rejected any scientific discussion on the subject in its own headquarters. Curious too.
AEPROMO, like 15 Spanish autonomous communities, qualifies ozone therapy as a “medical act” that must be performed by properly trained physicians with professional experience and in the areas of their competencies. The members of AEPROMO are called to apply ozone therapy in accordance with the protocols of action approved by its scientific committee and Management Board, to exclusively use the routes of application stipulated in the Madrid Declaration of Ozone Therapy (Isco3, 2nd ed., 2015), and to apply ozone therapy only in the diseases listed in the same declaration.
All the congresses held by AEPROMO, without exception, have received the title of “Health Interest” and have been held in Spanish public universities medical schools such as the Madrid Complutense, King Juan Carlos and the Royal National Academy of Medicine. Some of these scientific activities have been inaugurated by representatives of the Madrid Regional Ministry of Health and the universities. The training courses organized by AEPROMO are carried out in health environments with authorization of operation granted by the Regional Ministry of Health. AEPROMO does not organized them in hotels.
We are aware that a very small number of health professionals do advocate ozone therapy as the “cure all”, including cancer and AIDS. But it is something to regulate and control through the competent bodies with which we have always been open to collaborate. Our directives are clear, every member of AEPROMO that gets out of those frames, will have to accept and face the consequences of their actions. This principle applies to every medical act. The bulk of the ozone therapy physicians use the therapy correctly and under the scientific precepts of it.
Let’s be clear: AEPROMO is not saying neither directly nor indirectly that we are against conventional allopathic medicine. By no means! We are physicians and we practice daily conventional allopathic medicine. We must know the medications, the side effects they produce and take them into account at the time of prescribing them to patients. Ozone therapy is part of the techniques of new technologies that complement and facilitate conventional treatments. It is one more tool of the medical arsenal of the doctor.
Very truly yours,
(Signed) AEPROMO Management Board Dr. Adriana Schwartz, President
Dr. Enrique Riverola Gurruchaga, Vice President Dr. Agustí Molíns Olmos, Secretary
Dr. Alejandro González, Treasurer Dr. Esteban González, Member
Dr. Antonio Escamilla Garrido, Member
Dr. Humberto Loscertales Guardiola, Member Dr. Antonio Corralero Romaguera, Member Dr. Marcelo Migliora, Member
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