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Throughout the 1980s, Cuban researchers at the country’s biotech campus known as the Scientific Pole were making innovative discoveries and began developing unique therapies and vaccines unavailable elsewhere in the world. The pace and level of innovation meant prioritizing the establishment of a dedicated, internationally‐certified institute for clinical trials. These and other accomplishments in science and related sectors, coupled with statistics revealing that 53% of all scientists in Cuba are women, prompted MEDICC Review to publish a series of interviews with outstanding Cuban women in science, technology and medicine. In this, the second installment in the series, we spoke with Dr María Amparo Pascual, a biostatistician, researcher and professor, and the driving force behind the design and establishment of Cuba’s Clinical Trials Coordinating Center (CENCEC). From 1991 to 2014, Dr Pascual served as founding director of CENCEC. During that time the center implemented internationally-recognized good clinical practices (GCP), launched the National Clinical Trials Coordinating Network to support trials overseen by CENCEC, began conferring master’s and doctoral degrees in clinical trials; initiated a quality management system for all trials (receiving ISO 9001 certification in 2008) and created the Cuban Public Registry of Clinical Trials—a bilingual, WHO–accredited Primary Registry, the first in the Americas. In 2013, the BBC recognized Dr Pascual as one of the most infl uential female scientists in Latin America for her achievements, including becoming Cuba’s first biostatistician and her work at CENCEC. In 2014, Dr Pascual stepped down as director of CENCEC but didn’t slow down or leave the center she helped build, literally from the ground up: she currently serves as management consultant and researcher at CENCEC, as well as director of the Research Ethics Evaluation System Project there. She is also a professor in the Center’s clinical trials graduate degree program and of bioethics at the Medical University of Havana. She is finishing her doctoral dissertation on clinical trials in Cuba and the founding and evolution of CENCEC.

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Cristian Morales, an economist by training, has dedicated his career to improving health and health equity in the Americas through his work with PAHO/WHO. This has taken him from floods and earthquakes in Haiti to PAHO’s Washington DC offices, where he was instrumental in achieving consensus on a resolution aiming for universal health—coverage plus access—approved by all governments in the Americas. Since 2015, he has served as PAHO/WHO Permanent Representative in Cuba and has recently been appointed to the analogous post in Mexico. At the end of his three years in Havana, MEDICC Review talked with Dr Morales about his experience, the Cuban health system, and the values it shares with the organization he represents. This is part one of the interview, the second part to be published in our January 2019 issue, in which we’ll talk more about the health system in Cuba itself, its achievements and also its challenges.

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He was born in Chicago, Illinois, USA, but his family is Cuban. After 1959, they returned to the island, where Dr Mitchell Valdés received his medical degree at the University of Havana in 1972. He went on to study clinical neurophysiology, earning his PhD with a dissertation on the auditory system’s sensory physiology. When the Neuroscience Center opened (as part of western Havana’s Scientific Pole). he became its director, a post he holds today. Dr Valdés, a Distinguished Member of the Cuban Academy of Sciences, is widely published and has collaborated with colleagues in dozens of countries, including the USA, UK, Italy and Holland. He is a full professor of clinical neurophysiology, sits on Cuba’s National Coordinating Group for Persons with Disabilities, and serves as an honorary professor at the University of Illinois at Chicago. What brought me to his office is the set of symptoms reported by some two dozen US diplomats in Cuba and more recently in China as well. And the controversy surrounding what might be the root cause—a topic that has crossed the line from medicine into politics. MEDICC Review’s intent was to hear from Dr Valdés on the science pertinent to the controversy.

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ABSTRACT INTRODUCTION Flow cytometry allows immunophenotypic characterization of important lymphocyte subpopulations for diagnosis of diseases such as cancer, autoimmune diseases, immunodeficiencies and some infections. Normal values of rare lymphoid cells in blood, quantified by cytometry, vary among different populations; so it is indispensable to obtain normal national values that can be used in clinical practice. OBJECTIVE Characterize distribution of rare T-lymphocyte populations in peripheral blood, specifically double-positive T, natural killer T and activated T lymphocytes, as well as their relationship to sex and age. METHODS A cross-sectional study was carried out in 129 adults (68 women, 61 men) aged >18 years, without chronic diseases or unhealthy habits, who signed informed consent. Peripheral blood was collected for immunophenotyping of lymphocyte subpopulations with monoclonal antibodies specific for CD4+CD8+ double-positive T cells, CD3+CD56+ natural killer T cells, and CD3+CD25+HLA-DR+ activated T cells. An eight-color flow cytometer (Beckman Coulter Gallios) was used. The analytic strategy was modified, associating variables of interest in a single graphic, using conventional monoclonal labeling antibodies. Medians and minimum and maximum percentiles (2.5 and 97.5, respectively) were used as descriptive statistics, stratified by sex, for cell counts and percentages. A linear regression model was applied to assess age effects and a two-tailed Mann-Whitney U test for independent samples was used to assess sex differences. The significance threshold was set as p ≤0.05. RESULTS Median percentages of total lymphocytes: natural killer T cells 6.3% (1.4%–23%) in men and 4.7% (0.8%–11.3%) in women (p = 0.003); activated T cells 1.0% (0.2%–2.2%) in men and 1.2% (0.4%–3.1%) in women, without statistical significance; and double positives 0.8% (0.1%–4.2%) in men and 0.9% (0.3–5.1) in women, also without statistical significance. Median cell counts (cells/μL) were: natural killer T cells, 126 (27–580) in men and 105 (20–279) in women (p = 0.023); activated T cells: 20 (4–46) in men and 25 (7–75) in women, (p = 0.013) and double-positive T cells: 17 (2–85) in men and 21 (7–154) in women, without statistical significance. Sex influenced natural killer T cells, but age did not. CONCLUSIONS Age does not affect counts and percentages of rare T lymphocyte subpopulations in the blood of healthy Cuban adults. Sex differences found for some phenotypes suggest the need for different reference values for women and men.

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ABSTRACT INTRODUCTION The consequences of de novo balanced structural chromosome aberrations diagnosed antenatally are unpredictable, and, as a result, they introduce uncertainty into genetic counseling decisions. OBJECTIVE Describe de novo balanced structural aberrations present at antenatal diagnosis in samples from pregnant women in five Latin American countries and determine their effect on carrier individuals. METHODS This was a retrospective observational study based on analysis of 109,011 antenatal tests conducted from January 1981 to December 2016 in Cuba, Uruguay, Costa Rica, Mexico, and Colombia. Thirteen cytogenetic laboratories provided information that included the cases analyzed during the study period; number of de novo balanced structural aberrations diagnosed antenatally; number of diagnoses with de novo balanced structural aberrations that resulted in termination of pregnancy; detailed descriptions of the karyotypes of de novo balanced structural aberration carriers, and descriptions of the form of diagnosis, including types of samples used (amniotic fluid, chorionic villus or fetal blood). Each laboratory also provided pathology reports and genetic counseling at time of diagnosis. Postnatal followup for pregnancies carried to term continued for at least two years. RESULTS Of the 109,011 antenatal tests studied, 72 (0.07%) showed de novo balanced structural aberrations. These events primarily involved chromosomes 1, 2, 7, 14, 18, and 20. Of the 79 breakpoints identified, the most common were 5p15.3, 7q11.2, 7q22, and 14q24. We identified three breakpoints corresponding to 3.8% (3q13.1, 3q13.2, and 9p12) that were not reported in other studies of de novo balanced structural aberrations diagnosed antenatally in patients from other geographic regions or in studies of chromosomal fragile sites. Two of these breakpoints (3q13.1 and 3q13.2) were associated with high risk of phenotypic abnormalities. Information on antenatal or postnatal followup was available for 62 (86%) of de novo balanced structural aberration carriers; of the 44 carriers with postnatal followup, 10 had phenotypic abnormalities. CONCLUSIONS Three new de novo breakpoints were identified, presumably related to genetic admixture characteristics in Latin America. Since some diseases associated with de novo balanced structural aberrations detected antenatally have a late onset, followup for at least two years is recommended for carriers of these aberrations. The information in this study is useful in genetic counseling for pregnant women in Latin America.

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ABSTRACT Public health systems face the contradiction of skyrocketing cancer incidence and cancer drug prices, thus limiting patient access to more effective treatments. The situation is particularly dire in low- and middle-income countries. We urgently need consensus on the main determinants of this problem, as well as specific, effective and feasible solutions. Analysis of available data reveals that the problem has reached its current magnitude only recently and is not related to the growing complexity of drug production technology, but rather to corporate profits and the failure of market mechanisms to allocate resources based on health needs. Despite the obstacles, there is ample room for effective intervention: joint price negotiations, cost transparency, greater support for creation of manufacturing capacity, and regulatory measures that facilitate introduction of generic and biosimilar drugs and reduce intellectual property barriers to better use of flexibilities in the Agreement on Trade-Related Aspects of Intellectual Property Rights. Such actions will not be effective if there is no consensus around them, or if low- and middle-income countries act in isolation. This is precisely where international organizations must intervene.

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A major challenge to achieve health coverage in Nigeria is expansion of health access to the poor, vulnerable and informal sectors, which constitute over 70% of the population of more than 186 million. Evidence from other countries suggests that it is difficult for contributory insurance schemes to achieve universal health coverage in such conditions, especially with such a large informal sector. In fact, Nigeria’s national social health insurance program has provided coverage to less than 5% of the population since its implementation in 2005, private voluntary health insurance has shown poor potential to extend coverage, and community-based health insurance has failed to expand access to poor, vulnerable and informal sector populations as well. Decentralization of health insurance to the states has limited potential to expand health insurance coverage for the poor, vulnerable and those in the informal sector. Furthermore, social health insurance in many developed countries has taken many years to achieve universal health coverage. This paper suggests that policy makers should consider adopting a tax-based, noncontributory, universal health-financing system as the primary funding mechanism to accelerate progress toward universal health coverage. Social health insurance and its decentralization to states for formal sector workers should serve as a supplement, while private voluntary health insurance should cover better-off groups. Simultaneously, it is critical to tackle issues of poor governance structures, mismanagement of funds, corruption, and lack of transparency and accountability within regulatory and implementing agencies, to ensure that monies allocated for expanded health insurance coverage are well managed. Although the proposed universal health coverage reform may take some years to achieve, it is more feasible to collect taxes, improve tax administration and expand the tax base than to enforce payment of contributions from non-salaried workers and those who cannot afford to pay for health insurance or for services out of pocket.