Conflictos de intereses en medicina. Recomendaciones del CETREMI.

Conflicts of interest are situations in which judgment and integrity of medical decisions or actions are influenced by a secondary interest, often of an economic nature. The Committee of Ethics and Transparency in the Physician-Industry Relationship of the National Academy of Medicine of Mexico recognizes that these conflicts occur in health professionals' daily life, but also in public and private institutions that provide health services, as well as in the academy and in research activities. Therefore, it is necessary to identify conflicting situations and always act in accordance with the patient's interest.

Los conflictos de interés son situaciones en las que el juicio y la integridad de las decisiones o acciones médicas son influidas por un interés secundario, frecuentemente de tipo económico. El Comité de Ética y Transparencia en la Relación Médico-­Industria de la Academia Nacional de Medicina de México reconoce que estos conflictos ocurren en la vida diaria de los profesionales de la salud, pero también en las instituciones de servicios de salud públicas y privadas, así como en la academia y en la investigación. Por ello, es necesario identificar situaciones de conflicto y actuar siempre de acuerdo con el interés del paciente.

Libertad de prescripción médica.

Doctors require flexibility for prescription. However, some limits are laid down both by current knowledge and by restrictions imposed by access and rules and regulations. The Committee for Ethics and Transparency in the Physician-Industry Relationship (CETREMI) of the National Academy of Medicine proposes several suggestions to help patients, which include the selection of the best alternatives for each case, formalization of prescription standards variations (doses, drug indications, etc.) written down in the medical records, and avoidance of fashions, untested novelties, argumentations solely based on advertising or commercial promotion and conflicts of interest.

Los médicos requieren flexibilidad para sus prescripciones. Sin embargo, algunos límites están marcados tanto por el conocimiento vigente como por las restricciones de acceso, normas y reglamentos. El Comité de Ética y Transparencia en la Relación Médico-Industria (CETREMI) propone varias sugerencias para ayudar a los pacientes, que incluyen la selección de las mejores alternativas para cada caso, la protocolización de variaciones a los estándares de prescripción (dosis, indicaciones, etcétera) por escrito en el expediente y eludir modas, novedades no probadas, argumentos simplemente publicitarios o promocionales y conflictos de interés.

Conflicts of interest in medicine. CETREMI recommendations.

Conflicts of interest are situations in which judgment and integrity of medical decisions or actions are influenced by a secondary interest, often of an economic nature. The Committee of Ethics and Transparency in the Physician-Industry Relationship of the National Academy of Medicine of Mexico recognizes that these conflicts occur in health professionals' daily life, but also in public and private institutions that provide health services, as well as in the academy and in research activities. Therefore, it is necessary to identify conflicting situations and always act in accordance with the patient's interest.

Importancia de la investigación clínica independiente en la medicina: dificultades y recomendaciones.

Clinical research is the most important tool for the identification of diagnostic and therapeutic strategies that derive in higher efficacy and safety. Despite its significance, successful implementation of clinical research faces numerous difficulties, with one the most relevant being limited availability of resources for the performance of independent clinical trials. Generally, the pharmaceutical industry absorbs the costs associated with most clinical trials; however, this can generate dissociation between subjects of interest and health priorities when economic interest is the main driver of these protocols. In addition to the relevant role played by the pharmaceutical industry, it is important that government agencies favor adequate conditions, both in economic and regulatory aspects, for the implementation of independent clinical research that addresses subjects of medical and therapeutic interest, even if it does not generate corporate economic benefits.

La investigación clínica es la herramienta de mayor importancia para la identificación de estrategias diagnósticas y terapéuticas que deriven en mayor eficacia y seguridad. A pesar de su trascendencia, la implementación exitosa de la investigación clínica presenta numerosas dificultades; entre las más relevantes se encuentra la poca disponibilidad de recursos para realizar ensayos clínicos independientes. Por lo general, la industria farmacéutica absorbe los costos asociados con la mayoría de los ensayos clínicos, sin embargo, esto puede generar una disociación entre los temas de interés y las prioridades en salud, al existir interés económico como principal motivación de estos protocolos. Además del papel relevante de la industria farmacéutica, es importante que las instancias gubernamentales favorezcan las condiciones, tanto económicas como regulatorias, para la implementación de investigación clínica independiente, que aborde temas de interés médico y terapéutico, aunque no genere beneficios económicos empresariales.

Sugerencias en torno a medicamentos de efectividad demostrada sin interés comercial para la industria farmacéutica.

Varios medicamentos de adecuada eficacia han sido retirados del mercado por razones financieras, ya sea por su reducido precio (la patente ha expirado) o porque han sido sustituidos por nuevos fármacos (con patentes vigentes); otros tantos no han sido desarrollados porque las enfermedades contra las que van dirigidos no son económicamente promisorias debido al tipo de población que las padece (estratos económicamente marginados o sin significación numérica). Deberán establecerse lineamientos e incentivos para la industria farmacéutica y de biotecnología.Several drugs with adequate efficacy have been withdrawn from the market for financial reasons, either due to their reduced price (the patent has expired) or because they have been substituted with new drugs (with patents in force); many others have not been developed because the diseases they are directed against are not economically promising owing to the type of population that suffers from them (economically marginalized or numerically non-significant strata). Guidelines and incentives for the pharmaceutical and biotechnological industry should be established.

Recomendaciones para la prescripción segura de opioides en el manejo del dolor crónico no oncológico.

El tratamiento del dolor crónico severo es una meta histórica de la medicina. Los opioides naturales (como la morfina) se han usado por muchos años y la aparición reciente de opioides sintéticos se ha sumado a esta opción terapéutica, sin embargo, el potencial adictivo de estas sustancias obliga a la reglamentación de su uso. Las agencias médicas internacionales recomiendan prudencia en el uso terapéutico de opioides.The treatment of chronic and severe pain is a principal goal of medicine. Natural opioids have been used for several years, and the recent development of synthetic opioids has increased therapeutic options; however, the addictive potential of these substances obliges the regulation of their use. International agencies recommend prudent rules in the therapeutic use of opioids.

[Recomendaciones a los cuerpos directivos de las agrupaciones médicas en su relación con la industria].

Continuing medical education activities are often financially supported by pharmaceutical and device companies. With the purpose to ensure ethics and accountability in the management of this assistance, the Committee of Ethics and Transparency in the Physician-Industry Relationship of the National Academy of Medicine of Mexico formulates recommendations to medical associations' leaders in this text.

Las actividades de educación médica continua con frecuencia son apoyadas financieramente por la industria farmacéutica y de implementos médicos. Con el propósito de velar por la ética y rendición de cuentas en el manejo de estos apoyos, en el presente texto el Comité de Ética y Transparencia en la Relación Médico-Industria (Cetremi) de la Academia Nacional de Medicina de México formula recomendaciones a los directivos de agrupaciones médicas.

[El consentimiento informado: recomendaciones para su documentación].

Informed consent is an indispensable element to obtain adequate patient participation either in research protocols or in therapeutic design. The Committee of Ethics and Transparency in the Physician-Industry Relationship (CETREMI) of the National Academy of Medicine developed several recommendations for informed consent to be documented.

El consentimiento informado es un elemento indispensable para obtener la adecuada participación del paciente, ya sea en protocolos de investigación o en diseños terapéuticos. El Comité de Ética y Transparencia en la Relación Médico-Industria (CETREMI) de la Academia Nacional de Medicina elaboró varias recomendaciones para documentar el consentimiento informado.

[What can doctors do to moderate healthcare costs?] / ¿Qué podemos hacer los médicos para moderar los costos de la atención médica?

Los costos de la atención médica pueden alcanzar niveles tales que marginen a algunos pacientes de los beneficios del avance científico y tecnológico. Las razones de estos elevados costos son diversas y en la mayoría de los casos no está en manos de los médicos moderarlos. En este escrito se proponen algunas acciones que los médicos podemos realizar para disminuir los costos de la atención médica. La magnitud del ahorro que se puede alcanzar con estas medidas es modesta, puesto que la mayor parte de los costos no dependen de los médicos, pero se trata de ofrecer nuestra contribución. Evitar todo lo superfluo: no más medicamentos ni estudios que los estrictamente necesarios, sin medicina defensiva; y no ceder ante la presión de pacientes y familiares para que se prescriban pruebas o medicamentos inútiles.

[Concept of "opinion leader": Recommendations of the Committee on Ethics and Transparency in the Medical-Industry Relationship (CETREMI) of the National Academy of Medicine (ANM)]. / Concepto de «líder de opinión¼: recomendaciones del Comité de Ética y Transparencia en la Relación Médico-Industria (CETREMI) de la Academia Nacional de Medicina (ANM).

La relación que involucra al médico y la industria abarca un espectro amplio de formas, para lo cual se requiere una exposición clara y transparente de términos y principios. Uno de los objetivos primordiales de la industria es contar con un respaldo académico que le permita dar a conocer las características y las propiedades de sus productos -eficacia, eficiencia y seguridad- con el propósito de ser prescritos y usados. Los fines de la industria son la venta de sus productos, el reconocimiento como empresas de prestigio y la ganancia económica. Implícitamente, para CETREMI el principio de mayor importancia en esta relación es indudablemente el beneficio del enfermo.

[Ethics and transparency committee of physicians in their relationship with the pharmaceutics: Industry recommendations for physician support]. / Comité de Ética y Transparencia en la Relación Médico-Industria (CETREMI); recomendaciones a la industria para el apoyo de los médicos.

Las siguientes recomendaciones a la industria farmacéutica se fundamentan en los principios éticos del CETREMI: - El paciente es lo primero: • Que la atención sea óptima para todos los pacientes. Que las compañías farmacéuticas apoyen las decisiones del médico que garanticen el tratamiento más eficaz, seguro, accesible y adecuado. • Que las compañías farmacéuticas colaboren para que los pacientes tengan acceso fácil y oportuno a los medicamentos. • Que las compañías farmacéuticas colaboren para que la información sobre los tratamientos beneficie a los pacientes en todos los rubros, incluyendo el económico.

[First Mexican consensus on recommendations of the multidisciplinary care of patients with glioblastoma multiforme (GBM): Mexican Interdisciplinary Group on Neuro-Oncology Research (GIMINO)]. / Primer consenso mexicano sobre recomendaciones de la atención multidisciplinaria del paciente con glioblastoma multiforme (GBM). Grupo Interdisciplinar Mexicano de Investigación en Neurooncología (GIMINO).

Glioblastoma multiforme is one of the most aggressive central nervous system tumors and with worse prognosis. Until now,treatments have managed to significantly increase the survival of these patients, depending on age, cognitive status, and autonomy of the individuals themselves. Based on these parameters, both initial or recurrence treatments are performed, as well as monitoring of disease by imaging studies. When the patient enters the terminal phase and curative treatments are suspended, respect for the previous wishes of the patient and development and implementation of palliative therapies must be guaranteed.

A novel stereotactic device for spinal irradiation in rats designed for a linear accelerator.

OBJECTIVE: Our purpose was to report the design and positioning accuracy testing of a stereotactic device designed for a linear accelerator to perform spinal radiosurgery in rats. METHODS: To define the spatial and repositioning accuracy of the device, we measured the 3-dimensional (3D) translation of a paraspinal fiducial mark implanted by microsurgery in 5 Wistar rats during a sequence of setups and treatment simulations, thus obtaining final 3D translation vectors and maximum displacements. RESULTS: For spatial accuracy, the differential coordinate translations were 0.8 +/- 0.3, 0.6 +/- 0.2 and 0.5 +/- 0.1 mm in the x-, y- and z-directions, respectively. The median magnitude of the 3D vector was 1.3 mm (sigma = 0.2 mm), with a maximum error of 2.2 mm. The differential coordinate translation for the repositioning accuracy showed values of 1.4 +/- 0.3, 1.3 +/- 0.3 and 0.8 +/- 0.1 mm for the x-, y- and z-coordinates, resulting in a 3D displacement vector of 2.2 mm (sigma = 0.2 mm) and a maximum displacement error of 3.6 mm. CONCLUSIONS: Using a linear accelerator, our novel stereotactic device provides accurate immobilization and repositioning of paraspinal structures under experimental conditions in rats.

Radiation transmission, leakage and beam penumbra measurements of a micro-multileaf collimator using GafChromic EBT film.

Micro-multileaf collimator systems coupled to linear accelerators for radioneurosurgery treatments require a rigorous dosimetric characterization in order to be used in 3D conformal and intensity modulated stereotactic radiosurgery and radiotherapy applications. This characterization involves high precision measurements of leaf transmission, leakage and beam penumbra through the collimation system and requires the use of detectors with high spatial resolution, high sensitivity and practically no energy dependence. In this work the use of GafChromic EBT radiochromic film to measure the basic dosimetric properties of the m3-mMLC (BrainLAB, Germany) micro-multileaf collimator system integrated to a 6 MV linear accelerator, is reported. Results show that average values of transmission and leakage radiation are 0.93 +/- 0.05% and 1.08 +/- 0.08%, respectively. The 80-20% beam penumbra were found to be 2.26 +/- 0.11 mm along the leaf side (perpendicular to leaf motion) and 2.31 +/- 0.11 mm along the leaf end (parallel to leaf motion) using square field sizes ranging from 9.1 to 1.8 cm. These measurements are in agreement with values reported in the literature for the same type of mMLC using different radiation detectors.

Intracranial arteriovenous malformations treated with LINAC-based conformal radiosurgery: validation of the radiosurgery-based arteriovenous malformation score as a predictor of outcome.

OBJECTIVE: To validate the radiosurgery-based arteriovenous malformation score (RBAS) as a predictor of outcome in patients with arteriovenous malformations (AVMs) treated with LINAC-based conformal radiosurgery. METHODS: We analysed 40 patients with a mean follow-up of 22 months. One patient (2.5%) pertained to Spetzler-Martin Grade I, 11 (27.5%) to Grade II, 19 (47.5%) to Grade III, eight (20%) to Grade IV and one (2.5%) to grade V. The mean RBAS was 2.0 (range: 0.76-5.56). The mean obliteration prediction index (OPI) and the Karlsson index (KI) were 0.74 (range: 0.2-2.86) and 109.48 (range: 3.0-350.7) respectively. Outcomes were analysed according to the OPI, KI and RBAS. RESULTS: We analysed different cutoff points in the RBAS and found a significant difference to predict the outcome in four scores: 1.2, 1.6, 1.7 and 1.8. In the group with RBAS < or = 1.8, 13 (68%) had an excellent outcome and six (33%) did not, while with RBAS>1.8, seven (32%) had an excellent outcome and 14 (67%) did not (p = 0.02). We did not find any correlation between Spetzler-Martin grading scale or OPI and outcome (p = 0.7 and p = 0.3 respectively). The KI predicted the excellent outcome in 8/9 patients (89%) with KI < or = 27 and in 12/31 patients (39%) with KI>27 (p = 0.08). CONCLUSION: The RBAS seems to be a good predictor of outcome in patients with AVMs treated with LINAC-based conformal radiosurgery as in patients treated with Gamma Knife. It remains only to find the best cutoff point based on a larger series and longer follow-up.

Intracranial arteriovenous malformations treated with linear accelerator-based conformal radiosurgery: clinical outcome and prediction of obliteration.

BACKGROUND: Little is written about the clinical outcome and predictor factors of obliteration and treatment success in patients with intracranial AVMs treated with LINAC-based conformal radiosurgery in Mexican institutions. METHODS: We analyzed 40 patients with intracranial AVMs with a mean follow-up of 29 (range, 23-34) months. Seven AVMs (17.5%) had a volume <1 cm(3); 10 (25%), 1 to 4 cm(3); 13 (32.5%), 4.1 to 10 cm(3); and 10 (25%), >10 cm(3). The mean prescription dose was 15.4 Gy. Twenty-six patients (68%) presented hemorrhage before treatment; 4 (10%), chronic headache; 14 (35%), seizures; and 3(8%), neurologic deficit. RESULTS: Seven patients (17.5%) underwent objective clinical improvement. Thirty patients (75%) remained without clinical changes. Three patients (7.5%) developed edema and 1 (2.5%) had a rebleeding after treatment. Twenty-five patients (63%) presented complete obliteration of the AVM. A successful treatment (obliteration without a new deficit) was obtained in 23 (58%) of the cases. The percentage of obliteration was in <1 cm(3) (86%), 1 to 4 cm(3) (80%), 4.1 to 10 cm(3) (54%), and >10 cm(3) (40%), without a significant difference between groups (P = .1). Patients with RBAS of 1.9, 48%; the successful treatment in the former resulted in 79% and, in the latter, 38% (P = .08 and P = .02, respectively). CONCLUSIONS: The clinical outcome was similar to other series. The RBAS seems to be a good predictor of obliteration and successful treatment in patients with AVMs treated with LINAC-based conformal radiosurgery.

Osteoplastic maxillotomy for treatment of neoplasms of the nasopharynx and infratemporal fossa.

Approaches to the infratemporal fossa and nasopharynx are difficult because of the anatomic complexity of these regions. We describe our experience with osteoplastic maxillotomy, with our own modifications, and evaluate oncological outcomes and postoperative quality of life. Ten patients underwent osteoplastic maxillotomy, 3 of whom had a diagnosis of malignancy, and 7 of whom had nasopharyngeal angiofibromas (NPAs). A Weber-Fergusson incision was made to develop facial flaps and preserve the vascularity of the maxilla. Osteotomies were performed through the facial aspects of the maxilla, on the orbital rims, and on the malar eminence for the medial variant of the procedure. The anterolateral variant involved descent of the temporalis muscle with preservation of the facial nerve, and a zygomatic osteotomy. Four craniotomies were done. Two patients had the medial variant of the procedure, and 8 had the anterolateral variant. The complications were transient and mild. The patients who had malignancies are alive with no disease, and there was 1 recurrence among the 7 patients with NPAs. We found excellent aesthetic results in 8 of the 10 patients, and no change in basic functions in 8 patients. Osteoplastic maxillotomy allows resection of massive NPAs with no significant bleeding. Resection of malignant lesions with good results is feasible.

Libertad de prescripción médica / Freedom of medical prescription

Resumen Los médicos requieren flexibilidad para sus prescripciones. Sin embargo, algunos límites están marcados tanto por el conocimiento vigente como por las restricciones de acceso, normas y reglamentos. El Comité de Ética y Transparencia en la Relación Médico-Industria (CETREMI) propone varias sugerencias para ayudar a los pacientes, que incluyen la selección de las mejores alternativas para cada caso, la protocolización de variaciones a los estándares de prescripción (dosis, indicaciones, etcétera) por escrito en el expediente y eludir modas, novedades no probadas, argumentos simplemente publicitarios o promocionales y conflictos de interés.

Abstract Doctors require flexibility for prescription. However, some limits are laid down both by current knowledge and by restrictions imposed by access and rules and regulations. The Committee for Ethics and Transparency in the Physician-Industry Relationship (CETREMI) of the National Academy of Medicine proposes several suggestions to help patients, which include the selection of the best alternatives for each case, formalization of prescription standards variations (doses, drug indications, etc.) written down in the medical records, and avoidance of fashions, untested novelties, argumentations solely based on advertising or commercial promotion and conflicts of interest.