Friday, September 17

The dangerous wild card of “compassionate use”: an open door to pseudo-therapies

On August 11, the media leaked that the Contentious-Administrative Court No. 1 of Castellón allowed, against the will of the health personnel of the Hospital de la Plana, apply ozone therapy to a patient with severe pneumonia due to COVID-19. The family had requested days before the administration of this gas due to the lack of response of the affected person to conventional treatment, admitted since mid-July. A request that was denied at the time by the doctors of that center. However, the court established, as a precautionary measure, the urgent authorization of ozone therapy as a compassionate treatment. Finally, this treatment without scientific support was applied at the Hospital de la Plana by an external doctor specialized in this therapy without scientific evidence.

The court decision has met with strong opposition from multiple health professionals and medical societies. Among them, the Valencian Society of Intensive, Critical Medicine and Coronary Units has published a statement in which they state: “The use of ozone at this time is not considered as a safe and effective alternative in critical patients affected by COVID 19. The studies published with the use of this” biocide “are studies of low scientific impact and in no case with critically ill patients “.

In turn, the board of the Hospital Universitario de la Plana expresses its “rejection of the authorization of personnel outside the National Health System to act in public hospitals, administering therapies not authorized by the Spanish Agency for Medicines and against the clinical criteria of the personnel of the service responsible for patient care. We consider that the admission of external persons in public centers acting against the clinical criteria of the center’s staff constitutes a serious interference in the normal functioning of the health system and a serious impact on the general interest to have available safe and effective public health “.

The General Council of Official Medical Associations (CGCOM) also has pronounced recently on the judicial measure and considers “that the interference of the judicial authority in the practice of Medicine alters the evaluation processes and clinical practice guidelines of a health system with a defined portfolio of services.”

The controversial order of the judge: without considering the scientific evidence

In the court order published on August 13 on this issue, it can be read: “It is not the responsibility of the undersigned to pronounce on the efficacy or ineffectiveness of the treatment requested by the appellant, being also aware of the existence of dissenting positions in this regard, To which contributes the lack of total knowledge about the Covid-19 disease, its behavior, eventual mutations, as well as the lack of a curative treatment for it, all of which generates a certain degree of uncertainty, which tries to be replaced rationally through the establishment of guidelines or uniform protocols in their treatment. concurrence of the necessary requirements for the adoption of the precautionary measure […]”.

Among the positions that the judge considers “disagreeing” is the position of the family that defends that “ozone therapy is currently a viable alternative to save Mr. [nombre omitido para proteger el anonimato del paciente], because as stated, ozone therapy is being used in other hospitals in Spain, as well as in other countries, and is giving very good results in serious patients, since we are in the presence of a disease for which it is not curative treatment is still available. ”

The above statement contains data that is false and should no longer be taken into account. In particular, it is not true that ozone therapy is working “very well.” There is, for now, no scientific evidence that ozone therapy provides any benefit for those affected by COVID-19, nor are its potential risks known, especially among the most critical patients. The studies carried out at the moment have important methodological limitations that prevent us from knowing their potential usefulness or danger.

The wild card of “compassionate use”

Spanish legislation contemplates, in the Royal Decree 1015 / 2oo9, of June 19, the use of investigational drugs under special circumstances, a concept called “compassionate use.” However, approval of this compassionate use in the hospital setting occurs under very defined circumstances. Among the requirements, patients must have a chronic, seriously debilitating or life-threatening illness and that the conventional treatment received was not effective.

However, there is no indication for ozone therapy approved by the Spanish Medicines Agency or by any other agency in Europe or the United States, nor is it considered a “medicine” as such. Although there are some clinical trials with ozone, these have a very small number of patients that makes it impossible to know its efficacy for the treatment of various diseases, even less for the disease caused by SARS-CoV-2. In other words, there is no scientific evidence (we are not even talking about scientific evidence anymore) that justifies the compassionate use of this gas for a severe COVID-19 patient, even less in a public hospital where the treatments being administered must have been proven. its safety and efficacy.

Judicially justifying the compassionate use of ozone in the public health system is really dangerous, because it opens the door to authorize, through this same route, many other therapies without any demonstrated efficacy, but which have some worthless clinical trial behind to know their usefulness real. In this set we could find various pseudotherapies such as reiki, homeopathy, acupuncture or chiropractic. The national health system should not waste its already limited budget on therapies without any guarantee of efficacy, because it would be detrimental to the group of patients who use it.

Although medicine respects the principle of autonomy of the patient, by which he is given the freedom to decide on his own health, this does not imply at all a license to choose à la carte treatments. Our public health is designed to improve the health of the largest possible number of people and this could not be achieved if patients chose to receive their treatments based on their personal tastes or preferences, with their backs to medical science.

Lowering the bar as has occurred in this particular case, allowing any therapy to be applied in the public health system, sets a dangerous precedent and can encourage, as expressed in the Association to Protect the Sick from Pseudoscientific Therapies (APETP) “For more families to go to court to try to force healthcare professionals to practice or allow treatments that they disapprove of on medical, scientific and ethical grounds.” From said Association they add a reflection that I fully share: “We understand that, in situations of special gravity and despair, the sick and their families try to go to all means, no matter how crazy, but false therapies will not alleviate their suffering, and in many cases they can even increase it. In this sense, we make a call for reflection by those involved: not everything goes, and much less in terms of health “.