Moisés Russo

Transparencia en la investigación biomédica: A propósito de los riesgos asociados al uso de Avandia

The question of how and when to communicate potential risks associated with new drugs has remained an important focus of tension between the pharmaceutical industry and regulatory entities, such as the American Food and Drug Administration. Recently there has been widespread concern related to the cardiovascular risks associated with the use of Avandia, a rosiglitazone produced by Glaxo Smith Kline. In fact, several metaanalyses involving rosiglitazone provided a relatively consistent message that rosiglitazone increases the risk of myocardial ischemic events. In the present article, we review the controversy regarding the way the pharmaceutical company handled this issue, and we describe examples of inappropriate conduct regarding an industry-sponsored clinical trial with this drug. We raise several important ethical questions related to the way researchers handle conflicts of interest when they are employees of the pharmaceutical industry. Finally, we discuss the requirements to conduct biomedical research funded by the pharmaceutical industry in Chile.

Encuesta de opinión pública sobre reproducción humana y usos de tecnología de reproducción asistida en habitantes de Santiago, Chile

BACKGROUND Advances in reproductive medicine and the use of assisted reproductive technologies (ART) have a great impact in the lives of people and the conformation of their families. AIM To report the results of an opinion survey applied to inhabitants of Santiago, Chile about the use of ART to conceive. MATERIAL AND METHODS A survey was designed and applied to a random representative sample of 1.500 people between the ages of 18 and 65 in the 34 municipalities of Santiago. RESULTS Eighty eight percent of respondents support the use of medical assistance to conceive children. Wide approval exists for the use of in vitro fertilization (IVF) by heterosexual couples, even when not married (85.9%) and by single women (70.4%), by both mole and female participants of every socioeconomic level, age group and religious affiliation. Support decreases significantly when the use of IVF is considered for post-menopausal women (35.1 %) and by same-sex couples (26.6%). CONCLUSIONS Results of this survey indicate that the majority of inhabitants in Santiago favor the use of ART, including IVF. This support decreases significantly for elderly women and homosexual couples.

Mieloma múltiple en Chile: pasado, presente y futuro del programa nacional de drogas antineoplásicas (PANDA). Revisión de 1.103 pacientes

BACKGROUND Multiple myeloma (MM) is one of the most common malignancies found in hematology. AIM To describe the features of patients with MM and perform a survival analysis according to the different treatment protocols used between 2000 and 2016. MATERIAL AND METHODS Analysis of the database of the Chilean national anti-neoplastic drug program. Information was obtained from 1,103 patients, with a median age of 64.5 years (range 27-95) and a male to female ratio of 1:1.2. RESULTS The mean overall survival (OS) of patients receiving or not receiving Thalidomide was 46 and 30 months, respectively (p < 0.01). The mean OS of patients treated before 2007 (treated with melphalan and prednisone) and between 2007 and 2012 (treated with thalidomide and dexamethasone) was 36 and 48 months respectively. In the group starting in 2013 (treated with cyclophosphamide, thalidomide and dexamethasone) the median survival had not been reached at 20 months of follow up (p = 0.01 for all comparisons). Autologous transplantation (AT) was carried out in only 18% of the eligible patients. The median OS of the patients who receive an AT had not been reached at 48 month compared with 36 month among those who did not received the procedure (p < 0.01). CONCLUSIONS Even though overall survival has improved with time, new drugs must be introduced in our protocols to obtain similar results to those obtained worldwide.

Extranodal lymphomas in the public health system in Chile: Analysis of 1251 patients from the National Adult Cancer Program

The aim of the study was to describe the clinical and epidemiological characteristics, anatomic and histologic distribution, and treatment results of extranodal lymphomas (ENLs), diagnosed and treated in the public health system in Chile. We included patients with ENL diagnosed from 1998 to 2014, in 17 cancer centers, registered prospectively in the database of the National Adult Cancer Program (PANDA) of the Ministry of Health. Treatment was based on the local protocols for each lymphoma subtype. Extranodal lymphoma was documented in 1215 of 4907 non‐Hodgkin lymphomas diagnosed in that period (25%). Median age was 59 years (range, 16‐95), and 55% were female. The gastrointestinal (GI) tract was the most common location (38%), followed by the head and neck (24%) and the skin (15%). B‐cell lymphomas accounted for 78% of cases, diffuse large B‐cell lymphoma being the most common histologic subtype (68%). Mycosis fungoides/Sezary syndrome was the most frequent T‐cell subtype (36%), followed by NK/T‐cell lymphomanasal type (24%). In comparison with western countries, Chile showed a significantly high prevalence of NK/T‐cell lymphoma nasal type, while the frequency of B‐cell ENL and the anatomic distribution appeared similar, being GI the most commonly involved site.

Caracterización del metabolismo óseo mineral en pacientes con enfermedad renal crónica en hemodiálisis en el Servicio de Salud Metropolitano Sur, Santiago de Chile

Background: Chronic Kidney Disease - Mineral and Bone Disorder (CKD-MBD) is a condition of dialysis patients associated with both morbidity and mortality. Management is based on clinical guidelines with goals that are hard to comply with. Aim: To describe and compare biochemical variables associated with this disorder in two different time periods. Material and methods: Revision of medical records of 814 patients (49% females) dialyzed during 2009 and 1018 patients (48% females), dialyzed during 2012 in Southern Metropolitan Santiago. Information about serum calcium, phosphorus, parathyroid hormone (PTH) and albumin was retrieved. Results: Median PTH values in 2009 and 2012 were 222.5 and 353.5 pg/ml respectively (p<0.05). The figures for serum calcium corrected by albumin were 9.0 and 8.5 mg/dl respectively (p<0.05). The figures for phosphorus were 4.7 and 5.0 mg/dl respectively (p<0.05). The Calcium x Phosphorus product was 41.4 and 42.5 mg2/dl2 (p<0.05). Of note, the proportion patients with serum calcium below recommended levels (<8.4 mg/dl) increased from 16% to 40% from 2009 to 2012. The proportion of patients with biochemical variables within recommended ranges was lower in 2012 than in 2009. Conclusions: There was a low proportion of patients with bone metabolism parameters within ranges recommended by clinical guidelines. These parameters were worst in 2012.BACKGROUND Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD) is a condition of dialysis patients associated with both morbidity and mortality. Management is based on clinical guidelines with goals that are hard to comply with. AIM To describe and compare biochemical variables associated with this disorder in two different time periods. MATERIAL AND METHODS Revision of medical records of 814 patients (49% females) dialyzed during 2009 and 1018 patients (48% females), dialyzed during 2012 in Southern Metropolitan Santiago. Information about serum calcium, phosphorus, parathyroid hormone (PTH) and albumin was retrieved. RESULTS Median PTH values in 2009 and 2012 were 222.5 and 353.5 pg/ml respectively (p < 0.05). The figures for serum calcium corrected by albumin were 9.0 and 8.5 mg/dl respectively (p < 0.05). The figures for phosphorus were 4.7 and 5.0 mg/dl respectively (p < 0.05). The Calcium x Phosphorus product was 41.4 and 42.5 mg²/dl² (p < 0.05). Of note, the proportion patients with serum calcium below recommended levels (< 8.4 mg/dl) increased from 16% to 40% from 2009 to 2012. The proportion of patients with biochemical variables within recommended ranges was lower in 2012 than in 2009. CONCLUSIONS There was a low proportion of patients with bone metabolism parameters within ranges recommended by clinical guidelines. These parameters were worst in 2012.

Estudio exploratorio del impacto del alfabetismo funcional sobre conductas sanitarias deficientes a nivel poblacional

BACKGROUND Health Literacy is the set of skills that constitute the ability to perform reading and numerical tasks to function in the health care environment. People with functional illiteracy are unable to understand written documents and therefore sanitary information. AIM To explore the effects of functional illiteracy on personal health care behaviors in Chile. MATERIAL AND METHODS Using the Chilean Social Characterization Survey of 2006, respondents were separated into those that had read a book in the last year and those that had not as a proxy variable for functional literacy. Using econometric models, the impact of this variable on having a Papanicolaou (PAP) smear done and consulting in primary health clinics rather than in emergency services, was explored. RESULTS The survey is nationally representative, and 76% interviewees declared not having read a book in the last year. Probability of having a PAP smear done during the last three years was higher among women who had read a book with an OR of 1.19 (1.15-1.25). Likewise, the probability of consulting in emergency services rather than in primary health clinics was lower among those who had read a book with an OR of 0.85 (0.80-0.91). CONCLUSIONS This study provides evidence of possible impacts of low functional literacy in health care behaviors in the Chilean population.Background: Health Literacy is the set of skills that constitute the ability to perform reading and numerical tasks to function in the health care environment. People with functional illiteracy are unable to understand written documents and therefore sanitary information. Aim: To explore the effects of functional illiteracy on personal health care behaviors in Chile. Material and methods: Using the Chilean Social Characterization Survey of 2006, respondents were separated into those that had read a book in the last year and those that had not as a proxy variable for functional literacy. Using econometric models, the impact of this variable on having a Papanicolaou (PAP) smear done and consulting in primary health clinics rather than in emergency services, was explored. Results: The survey is nationally representative, and 76% interviewees declared not having read a book in the last year. Probability of having a PAP smear done during the last three years was higher among women who had read a book with an OR of 1.19 (1.15 – 1.25) . Likewise, the probability of consulting in emergency services rather than in primary health clinics was lower among those who had read a book with an OR of 0.85 (0.80-0.91). Conclusions: This study provides evidence of possible impacts of low functional literacy in health care behaviors in the Chilean population.