Abstract
OBJECTIVE: To identify and characterize the major symptoms, the clinical presentation and radiological abnormalities in patients with malignant mesothelioma (MM), admitted in a government institution specializing in diseases of the chest. MATERIAL AND METHODS: We performed a retrospective study which reviewed the medical records and radiological data of patients diagnosed with MM, admitted to the National Institute of Respiratory Diseases (INER) in Mexico City from 1991 to 1998. We included the following data: age, occupation, exposure to asbestos, onset, family history relative to other malignancies, clinical symptoms and radiological alterations. Percentages were calculated by sex and age group. RESULTS: There were 45 cases with MM and 80% were unable to document a history exposicional asbestos. The age group most often found among 51-60 years. Dyspnea and chest pain were the main symptoms. Radiological abnormalities constituted thickening and pleural effusion in 75% of patients. CONCLUSIONS: The clinical and radiological abnormalities in patients with MM without a history of exposure to asbestos were similar to those of patients with a history of exposure to asbestos.
Keywords: mesothelioma / clinical symptoms, mesothelioma / radiography; asbestos, genetic predisposition, Mexico
Abstract
OBJECTIVE: Our aim was to identify and describe the main symptoms, clinical presentation, and radiographic changes in malignant mesothelioma (MM) patients. MATERIAL AND METHODS: We reviewed the medical records and X-ray of all patients diagnosed with MM, admitted between 1991 and 1998 to the National Institute of Respiratory Diseases (INER), which is a governmental institution specialized in chest disease in Mexico City. The following data were collected: Age, occupation, asbestos exposure, latency, family history of cancer, clinical symptoms, and X-ray changes. Data are presented as percentages by sex and age group. RESULTS: We found 45 cases of MM, in 80% of them a history of asbestos exposure could not be documented. The 51-60 years age group had the highest frequency of MM. Dyspnea and chest pain were the presenting symptoms in most patients. Pleural thickening and pleural effusion were the X-ray abnormalities observed in 75% of the patients. CONCLUSIONS: The clinical and radiographic findings among patients with MM without asbestos exposure were similar to those with a history of asbestos exposure.
Key words: mesothelioma / diagnosis, clinical, mesothelioma / Radiography; asbestos, genetic predisposition, Mexico
Malignant mesothelioma (MM) is the most common malignant tumor in pleura.1, 2 The first histological description of this was made by E. Wagner in 1870, and it was not until 1960 when JC Wagner and colleagues have established a link between malignant mesothelioma and exposure to asbestos, thus described a disease with a long latency period, which affected mainly miners and mill workers exposed to 5-crocidolita.3
The incidence of MM in the global variable. In the United States of America (USA) 2 have been reported 200 new cases per year, an increase of approximately 50% in the last década.6, 7 In the UK, this neoplasm is responsible for 2 700 to 3 000 deaths year, and it is estimated that these figures continue to rise until the year 2020.8 after which predicts a decrease in incidence due to the implementation of regulatory measures on exposure and use of asbestos. In Mexico it is difficult to know the real impact of GM, since there is no recognized as an occupational disease case, and only 66 have been reported cases of asbestosis between 1995 and 1998 .* Gavira and collaborators in their work and health Asbestos in Mexico City, identified 52 cases of MM in the archives of the Pathology Department of the various national institutes of health, as well as the Instituto Mexicano del Seguro Social (IMSS) and the Institute of Security and Social Services of State Workers (ISSSTE) in the period 1980-1985.9
In the etiology of MM, 70% of cases can be established with a history or a history of direct or indirect exposure to asbestos, 10-12 however, could not be directly correlated to the intensity and duration of exposure to appearance of pleural disease. Exposure to asbestos is associated with the occurrence of chronic bronchitis, pulmonary fibrosis, and bronchogenic cancer. It is estimated that the risk of developing pleural disease secondary to such exposure is 8% -13% .1,3,4 radiation also appears to play an important role in the development of MM.13 Thus, in patients with seminoma, cervical cancer and Hodgkin's lymphoma treated with radiotherapy, there has been an increased incidence of MM.
From a genetic point of view, much remains unknown about this neoplasia. Analysis of histocompatibility antigens has not shown a correlation directa.14 Moreover, some reports mentioned that the lack of expression of GST-M1 gene (whose product acts on the detoxification of carcinogenic compounds), is associated with the appearance of neoplasia. Other players considered as probable inducers of GM are zeolita.15 and beryllium-17
Histologically, the MM is divided into three groups: epithelial, sarcomatoid and mixto.1 3.4 The sarcomatoid type is associated with large tumor masses, absence or minimal pleural effusion and increased frequency of blood-borne metastasis. The epithelial type is approximately 60% of the total and is divided into tubulopapilar, glandular and sólido.1, 2 mixed features common to the two.
The most frequent clinical manifestations in patients with MM are: characteristics without pleuritic chest pain (70%), dyspnea (25%), cough (20%), but some cases may be completely asintomáticos.1 radiological abnormalities are: pleural effusion (usually unilateral), thickening and mass pleural.2, 3 may be associated with mediastinal widening, for lymph node lymphatic, or invasion by tumor directa.1 3.4
The prognosis is bleak for the GM, the survival time is between 6 and 18 meses.2, 3 factors that are associated with a better prognosis are: age less than 55 years, absence of chest pain at presentation clinical presence of symptoms for more than six months at diagnosis, histologic type and high Karnowfsky epithelial. The presence of thrombocytosis, fever of unknown origin, or mixed sarcomatous histologic type and age over 65 years leads to a worse pronóstico.2 3.4
Because in recent years have seen at the National Institute of Respiratory Diseases (INER) a steady increase in the occurrence of this neoplasm, since in many cases the clinical behavior seems to be different than described in the literature, is decided to undertake this work in order to define the clinical and radiological features of MM patients who presented to the Institute.
Materials and methods
We reviewed medical records of all cases diagnosed with MM, and admitted to the INER within the period from January 1 1991 to December 31, 1998. In the data collection sheet included the following variables: age, occupation, time of evolution of symptoms (months), exposure to asbestos, smoke and other toxic.
Clinical data were: chest pain, cough, hemoptysis, weight loss and dyspnea. The radiological changes were grouped into: pleural thickening, pleural effusion, mediastinal shift and shrink. Were analyzed further diagnostic tests required in each case, taking the information recorded in the pleural fluid cytology and closed pleural biopsy or obtained by thoracoscopy. In the review of chest computed tomography, were assessed alterations in the lungs, as well as the presence of mediastinal lymph node masses and pleural thickening. As a method of extension study were included reports of liver and bone scan.
To determine the tumor stage was used the classification of the International Mesothelioma Interest Group (IMIG) 18 was also included in the data sheet information on the treatment and monitoring of the disease. Percentages were calculated by sex and age group.
Results
We studied 45 cases with a diagnosis of pleural mesothelioma, of whom 33 (73.3%) were males and 12 (26.7%) women. The age group with the highest frequency of MM in men was the 51-60 years, with a percentage of 42.4%, and the second group of higher frequency, ranged between 41 and 50 years (21.2%) and also in women the frequency was similar in the age groups 51-60 and 61-70 years, with a percentage of 33.3% in both groups (Figure 1). In males of 61-70 years, the observed frequency was 12.1%. In the age group 31-40 years were six cases in males and females only one in the group of 41-50 years, there were two cases of MM in women and seven men, while of the 18 cases MM in the age group 51-60 years, 14 were males and four females. For the remaining groups, the distribution of cases for each sex was similar.
These results differ somewhat from those reported by Yates and colleagues, 8 who reviewed 272 cases with MM and found that the average age of onset of this malignancy is 65.9 years, with no identified differences in the incidence of MM among both sexes . It is worth noting that in the present study the average age was 52.5 in men and women of 55 years.
Of the 45 patients, only 20% had a history of exposure to asbestos (eight men and one woman). This was primarily an industrial workforce. 80% of the cases studied did not have even indirect exposure to asbestos. Most cases without antecedent exposicional to asbestos occurred among males (69.4%), with an average age of 49 years, while 30.5% of cases with no history of asbestos exposicional were women, aged 59 and 75 years. Only 15 patients were history of smoking (eight males and seven females). It is worth mentioning that all data from the clinical file limitations inherent in any retrospective study, the absence of an association between exposure to asbestos and mesothelioma to be taken into account with some reservations.
With the aim of analyzing whether the GM without antecedent exposicional to asbestos showed the same clinical and radiological features in cases with history exposicional, patients were divided into two groups (Table I). In the first group, consisting of patients with evidence in the clinical history of exposure to asbestos, the most frequent symptoms were: chest pain, dyspnea, weight loss and cough. The incidence of these symptoms was similar in both sexes, with only the highest weight loss in women, but with no statistically significant difference. The most frequently observed radiological abnormalities were pleural effusion and thickening, as both disorders was higher than 75% of the mediastinal shift was observed in 37.5% of patients, while the retraction hemithorax was observed in only 25% of men .
In those patients in whom there was no antecedent exposicional to asbestos, the symptoms most frequently found at diagnosis were chest pain and dyspnea, which were found in more than 80% of cases in both men and women. Weight loss was present in more than 75% of patients. The most frequent radiological deterioration in this patient group was represented by the pleural effusion was found in more than 88% of cases. Occurrence of mediastinal displacement and retraction hemithorax was different in both sexes. Thus, 8% and 20% of men had decreased hemithorax and mediastinal shift, respectively, while in women the frequency of these alterations was 27.2% and 36.3% in the same order. Pleural thickening was different for each sex, as males were found in only 4% and women 72.7% (Table I).
From the detailed analysis of the family background of individual patients, they identified a group of patients referred at least one close relative with cancer. Due to the limited information on cases of familial predisposition to MM since it is not known the existence of a genetic component that may be important in the pathogenesis of neoplasia, it was decided to examine separately the group of patients.
Genetic load was defined as the group of patients with more than one close relative with any type of tumor. 80% of patients had no genetic load for malignancy, while 20% (nine cases) showed the antecedent itself. Thus, an analysis was, again, the presentation of clinical and radiological manifestations MM dividing the group between those patients who presented for genetic cancer and those who did not (Table II). Chest pain, breathlessness and weight loss were the most frequent clinical presentation in patients of both sexes and in both groups, with an incidence greater than 80%. The hemoptysis was present at diagnosis only in patients without genetic load, and its incidence was 12.5% in women and 3.5% in males. None of the patients with familial predisposition to malignancy was observed fever at diagnosis, but was present in more than 25% of patients without genetic load for neoplasia. Among the radiological abnormalities, over 75% of patients in both groups had pleural effusion, the pleural thickening was observed at a rate above 80% in cases with genetic loading for neoplasia. The frequency with which it was observed thickening and pleural effusion in patients without genetic load was above 42% and 85% respectively. Within the group of patients without a genetic load for malignancy was found hemithorax decreased to 14.2% in men and 37.5% of women, while in the group with this genetic alteration was detected in only 25% of women ( There were no cases in men).
Analyzing both the history of exposure to asbestos and the genetic load for malignancy (Table III), genetic males with and without exposure to asbestos had a mean age of 45.6 years, evolution time of symptoms of 1.4 months and a Symptoms at diagnosis similar to that described in the literature for the Anglo MM associated with asbestos. In this group the average age at diagnosis among women was 59.4 years. In the second group, comprising patients in whom no antecedent exposicional to asbestos showed no genetic load for neoplasia, the average age of presentation of MM was 48.6 years in men and women in 57 years, while the time elapsed between the onset of symptoms and diagnosis in both sexes was three months. The clinical and radiological had the same characteristics as the other groups. The third group of patients, consisting of cases in which there was precedent exposicional to asbestos but who had no genetic load for neoplasia, the mean age at diagnosis was 56.5 years in men and women in 35 years. Unfortunately, only one case could have female, who presented a very long time of evolution. Clinical symptoms observed in this patient at diagnosis were chest pain, breathlessness and weight loss. Thickening and pleural effusion were the most frequent radiological findings in this third group, but none has been observed retraction hemithorax or mediastinal shift. The fourth group, which includes cases where there was exposure to asbestos and presented for genetic cancer included only two men with a mean age of 52.2 years at diagnosis and with an interval of evolution, since the appearance of symptoms to diagnosis of 2.4 months, the clinical manifestation most frequently observed in this group was chest pain. Thickening and pleural effusion were present in both cases.
We also analyzed the interval between the onset of symptoms and the time of diagnosis (Table IV). In female patients without genetic load (66.6%), the range was 0.7-48 months, with an average of 4.1 months, whereas patients of the same sex with genetic load, the interval was 3-24 months with an average of 9.6 months. Of the 33 cases found in men, five (15.5%) had genetic load for neoplasia, and in them the interval between symptom onset and diagnosis ranged between 1 and 6 months, with an average of two months. In the remaining 28 cases (84.8%), duration between onset of symptoms and diagnosis was 0.5-18 months, with an average of 2.8 months. Therefore, the development of mesothelioma appears to be more aggressive in men, and among these, in which there is familial predisposition to cancer.
Finally, we separately analyzed the following variables: gender, genetic load and the latency period between the onset of symptoms and the time of diagnosis in different age groups. This period was lower in women with ages ranging from 43-46 years and 58-59 years, without genetic load (range three months), while in women of 56-57 years, with genetic load for malignancy, the interval was 18 months. In male patients, this difference was not marked. In men with the greatest genetic load latency period occurred in patients 77 years (eight months), and the interval was reduced to one month in patients from 42 to 69 years. Moreover, men without genetic load, the group of 32-39 years had the shortest latency period (1.9 months), and 63-68 years of which was the largest interval (9.5 months).
Regarding the clinical stage, the majority of patients had an IV IMIG, and several of them were metastases, primarily in the liver and spleen. The advanced clinical stage of the tumor is probably due to the patients when entering the INER pulmonary symptoms. Notably, the index Karnowfsky showed that the majority of patients was higher than 70%, and only one case was identified with a value of 40%.
Discussion
The results of this analysis correspond to a retrospective study of 45 cases admitted to the INER GM, the only tertiary center specializing in respiratory diseases in Mexico City.
Since 1960 was established as the main factor involved in the genesis of MM exposure to both direct and indirect asbestos.10, 17 In this review, cases in which there was documented exposure to asbestos were scarce. In the overall distribution by sex, the MM primarily affects males (83.3%), with a peak incidence in those who were between 51 and 60 years of age. The incidence of MM in women was not different in groups of 51 to 70 years. Yates and colleagues, in a review of 272 cases with MM, had a higher incidence in patients 65 years of both sexos.8
In our series, dyspnea, chest pain and cough were the most common clinical presentation of patients in both groups (with and without exposure to asbestos), and these results are similar to those reported in most series with a history of MM Exposure to asbestos.7, 17 In the series published by Yates and colleagues also found significant differences between the clinical presentation of MM associated with exposure to asbestos and those who had no history exposicional.8
Among the most common radiographic abnormalities associated with MM (x-ray postero-anterior chest) include pleural effusion, retraction hemithorax, mediastinal shift and thickening pleural.1, 2 In this paper, the pleural effusion was the most common radiological abnormality, together with pleural thickening. Although there are no pathognomonic nor tomographic findings of MM, Yilmaz and colaboradores19 studied retrospectively tomographic features of 46 cases of MM associated with exposure to asbestos, hence pleural thickening was the most common finding (99%), while the spill pleural involvement of the mediastinal pleura and the interlobar fissure, were presented in 91%, 57% and 54% of cases, respectively. Pleural calcifications and retraction of the hemithorax was affected in 26% and 30% of cases in the same order. In our series, only 25 of the 45 patients had CT scan done as part of the study protocol, the most common finding was pleural thickening, present in 44% of cases, followed by pleural effusion (36%).
Among the diagnostic procedures used in most patients the initial approach included thoracocentesis with pleural fluid cytology and closed pleural biopsy. Several authors have recognized the limited value of cytologic examination of pleural fluid for establishing the diagnosis of MM, as calculated 3,18,20,21 a diagnostic sensitivity of approximately 26%.
Boutin and colleagues reviewed 137 patients diagnosed with MM and compared the diagnostic efficacy of thoracoscopy in relation to closed pleural biopsy and cytologic analysis of pleural fluid. This study reported a sensitivity of 26% for cytologic examination of pleural fluid and 21% for closed pleural biopsy, with a cumulative sensitivity between the two procedures only 38.7%, and it was attributed to a material obtained by thoracoscopy diagnostic sensitivity of 80% .20 Our findings are consistent with those reported in series.
In this study, the diagnosis of MM could only be established definitively in the analysis of pleural fluid in one case, and the diagnosis was the most common inflammatory disorders. Of the 45 patients diagnosed with MM in the series presented here only 17 (37.5%) patients underwent thoracoscopy for diagnostic and staging. The most frequent histological type was epithelial Sarcomatoid followed.
At present, guidelines have been established in the field of management internacional18, 21 for the study, diagnosis and treatment of patients with suspicion of MM, which, in addition to an emphasis on detailed questioning and to identify exposure asbestos, highlighting the importance of completing the clinical diagnosis and supported in obtaining multiple biopsies through thoracoscopy. Although the diagnostic efficiency is increased by this method, you must not forget that this is an invasive procedure, not without complications, and that in most cases treatment is only palliative and MM with a poor prognosis in the short term; For this reason, the decision to perform thoracoscopy should be taken before evaluating the characteristics and circumstances of each patient.
Currently there is a tendency to classify exposure to asbestos: a) occupational (work) b) indirect or family, and c) environment, the latter is that which occurs in the vicinity of mines, factories or sites of natural asbestos, 22 and is more difficult to obtain, and therefore excluded. It is also known that the incidence of asbestos related not only to the duration of exposure, but also with its intensity. For some authors, short periods of exposure may be able to determine the onset of MM, as seems the case for the niños.22 The latency period between exposure to asbestos fibers and the appearance of the pleural neoplasia ranges from 5 and 70 years, so it is often difficult to establish in retrospect that exposición.10, 12.22
Unfortunately, in Mexico there are few studies focused on analyzing the incidence, characteristics and survival of patients with MM, so that despite the data obtained in our series, it is difficult to say that the old axiom, "Exposure to incidence of mesothelioma-asbestos "is not applicable. Thus, it is necessary to perform clinical and epidemiological studies on the possible contact of patients and their families, to provide an enhanced and comprehensive access to information for patients with MM.
The results obtained in this series show that 80% of cases had no exposure to asbestos, and that the clinical symptoms and radiographic abnormalities present at diagnosis are similar to those described in the Anglo-American literature for MM associated with exposure to asbestos. It is worth noting that because this study is retrospective, it was not possible to obtain a complete record of environmental and occupational exposure to asbestos of patients, so the data presented here should be considered with reservation.
Most series indicate that the antecedent to exposicional asbestos is present in 60% -80% of cases of MM, and given the high rate of exposure to asbestos (eg in the USA is estimated at 21 million Persons exposed only in the construction area) and the low incidence "relative" for this neoplasm, it is necessary to search for other etiologies that can influence the occurrence of this malignancy.
In this series, we found that only 20% of patients had family history of cancer. Huncharek and colaboradores23 studied 39 cases of MM, of whom 71% had family history of cancer. Although in this series did not find such a high percentage, this seems to be the only parameter to consider, as the number of patients with exposure to snuff, wood smoke or other inhalants was very low.
Comparison of clinical and radiographic findings between cases with and without antecedent exposicional to asbestos and between those with and without genetic load, showed no significant differences. However, it was a partnership with the time between the onset of symptoms and diagnosis.
Other factors have been implicated in the genesis of mesothelioma. Thus, for some authors the chronic inflammation in the pleural cavity could be one of them, 11 cases have been reported for recurrent pleural effusion and subsequently developed MM.22 Another officer involved in the pathogenesis of MM is radiation. Moreover, the latter's association with exposure to asbestos presents a synergistic effect for the development of mesotelioma.11 It is important to note that none of the patients in this series showed some of this background.
Several authors mention the existence of a familial predisposition or increased susceptibility gene in patients with MM. However, this work has not yet been carefully analyzed the role of familial or genetic predisposition in the genesis of MM. In the series presented here, clinical symptoms and radiologic abnormalities showed that both patients with positive genetic load as those in which there was no family history of malignancy, were common to those described for MM associated with asbestos. Thus, only differences in the time between the onset of symptoms and diagnosis, as well as the age at presentation of disease.
There are several works that mention a higher incidence of cancer in parents and relatives of patients with MM, but its meaning is still desconocido.23-26 Studies in Turkey found a higher frequency of histocompatibility antigens of B-41, HLA B-58 and DR-16 in patients with MM, in relation to population control groups and normal donor renales.14 were also described various chromosomal abnormalities in patients with mesothelioma. Especially frequent is a deletion of the long arm of chromosome 6.26 Other abnormalities described include monosomy on chromosomes 13 and 17 and, less frequently, on chromosomes 14 and 22. However, at present still unknown the implication of these findings in the development of GM and the predictive value of this still needs to be evaluated.
Tuesday, February 17, 2009
Sunday, February 15, 2009
FAGOR improving life for people with reduced mobility.
FAGOR improving life for people with reduced mobility.
• Fagor Day and participated in the Space Test 'technology in daily life. Access and use for disabled people 'who organized last Friday in Madrid the Association of Paraplegics and Physically Handicapped of the Great Community of Madrid, ASPAYM.
• Maior Vocce requires no learning period and thanks to him people with motor disabilities can enjoy greater autonomy, improving their quality of life.
• daily activities such as controlling lighting and blinds control, air conditioning, appliances, etc.. will be managed without leaving the site with a simple voice command.
Fagor Electrodomésticos last part came from, October 3, the Test Match and Space 'technology in daily life. Access and use for disabled people ', organized by the Association of Paraplegics and Physically Handicapped of the Great Community of Madrid, ASPAYM within the set of actions of its project' Inform @ tion: e-inclusion of disabled persons' and co-financed by the Ministry of Industry, Tourism and Trade under the Plan Avanza.
The aim of this conference was to raise awareness of existing technology, offering the opportunity to test their devices before purchase and create a space for exchange of views and future collaboration between professionals and users.
In this context, this group Fagor presented its new Vocce Maior, thanks to which, those with motor disabilities can enjoy greater autonomy, thereby improving their quality of life, as a home automation can control by voice. The company also conducted onsite demonstrations for attendees.
Everyday activities such as on / off the light, go up / down blinds, turn the air conditioning and appliances, etc.. may be managed by the user without scrolling and without recourse to others, from anywhere in the house and with full autonomy, with its radio communications technology, and with a simple voice command. Thanks to its ease of use and transportation, you may take for example on the wrist like a watch or hung from the neck.
Maior Vocce is unique in the current market for home automation, both in technology as a benefit. Allows control by voice, without any learning process, and can be used by several people at once and allows the control of elements from any place, without direct vision between the device and the control element.
• Fagor Day and participated in the Space Test 'technology in daily life. Access and use for disabled people 'who organized last Friday in Madrid the Association of Paraplegics and Physically Handicapped of the Great Community of Madrid, ASPAYM.
• Maior Vocce requires no learning period and thanks to him people with motor disabilities can enjoy greater autonomy, improving their quality of life.
• daily activities such as controlling lighting and blinds control, air conditioning, appliances, etc.. will be managed without leaving the site with a simple voice command.
Fagor Electrodomésticos last part came from, October 3, the Test Match and Space 'technology in daily life. Access and use for disabled people ', organized by the Association of Paraplegics and Physically Handicapped of the Great Community of Madrid, ASPAYM within the set of actions of its project' Inform @ tion: e-inclusion of disabled persons' and co-financed by the Ministry of Industry, Tourism and Trade under the Plan Avanza.
The aim of this conference was to raise awareness of existing technology, offering the opportunity to test their devices before purchase and create a space for exchange of views and future collaboration between professionals and users.
In this context, this group Fagor presented its new Vocce Maior, thanks to which, those with motor disabilities can enjoy greater autonomy, thereby improving their quality of life, as a home automation can control by voice. The company also conducted onsite demonstrations for attendees.
Everyday activities such as on / off the light, go up / down blinds, turn the air conditioning and appliances, etc.. may be managed by the user without scrolling and without recourse to others, from anywhere in the house and with full autonomy, with its radio communications technology, and with a simple voice command. Thanks to its ease of use and transportation, you may take for example on the wrist like a watch or hung from the neck.
Maior Vocce is unique in the current market for home automation, both in technology as a benefit. Allows control by voice, without any learning process, and can be used by several people at once and allows the control of elements from any place, without direct vision between the device and the control element.
Saturday, February 14, 2009
The use of psychotropic drugs to treat mental health problems do not always respond to rational criteria.
Section of Psychiatry of the Academy of Medical Sciences is organizing the conference in Bilbao, on the rational use of medicines in mental health services.
• A simplistic concept of mental illness and human behavior has contributed to extending treatment with psychotropic drugs for conditions that can hardly be regarded as psychiatric disorders, and should be approached differently.
• The popularization and trivialization of some use of some psychiatric medications have helped to extend the use of poorly justified. "Drugs like Prozac are already part of the culture of the XX and XXI century," says Dr. Uriarte Uriarte.
• In recent years it has been called into question the efficacy and safety of many of these drugs, especially when used indiscriminately, with little control, and without regard to other therapeutic alternatives.
Reflect on the different aspects that affect the assistance to mental health problems at present and, more specifically, those that affect the use of psychotropic drugs. This will be the main goal of Dr. Juan José Uriarte Uriarte, department head of the Psychiatric Rehabilitation Unit of Hospital de Zamudio. The lecture, organized by the Academy of Medical Sciences of Bilbao, to be entitled "The Use and Abuse of the prescription of psychoactive drugs. Towards a rational use ", will take place today Wednesday 28 January at 19.00 in the hall of the Medical Association of Bizkaia (Lersundi, 9-5 th).
The rapporteur will deepen the idea that the current use of medications in mental health does not always have a rational basis, as well as the different aspects that influence the use of psychoactive drugs. To do this start by reviewing the various interpretations of the concept of rationality applied to health and social changes that influence the practice of medicine today, with special reference to the extension of the concept of health. Then, before you jump right into the factors influencing the current distribution of psychotropic drugs, the expert will analyze the impact of poor knowledge of the causes and pathogenesis of mental diseases.
Causes of the spread of psychoactive drugs
The enormous success and spread of psychoactive drugs in the last decade has "various causes including: technical advances and the excessive reliance on technology, the relative effectiveness of alternative methods of intervention (such as psychotherapy), dissemination of models for evaluating interventions (clinical trials), social changes, changes in psychiatric nosology and the influence of the pharmaceutical industry, "says Dr. Uriarte. To all this must be added that the extension of the idea that the symptoms of mental illness depend on functions regulated by brain chemicals, and can be modified in a controlled and socially acceptable manner has contributed to "the incredible diffusion of drugs Prozac, as part of the culture of the XX and XXI century. "
"A simplistic notion of mental illness and human behavior has contributed to reducing the stigma associated with treatment with psychotropic drugs, especially antidepressants, which have been in a few years of being rejected or consumed in secret, to be sued in a direct by patients, "explains the expert psychiatrist. The extension of the mental health field has undoubtedly been exploited by the pharmaceutical industry, which has "stretched to the unspeakable traditional diseases like depression," and has contributed to an "explosion and expansion of mental health problems likely treatment, including situations bordering on normalcy, "such as shyness or hyperactive behavior in children," he adds.
Treatments questioned
However in recent years has been put into question the efficacy and safety of many drugs. Moreover the "lack of progress in the knowledge of the causes of mental illness eventually temper enthusiasm and unrealistic claims," says JJ Uriarte. It is noteworthy that the psychotropic drugs have traditionally had a competitor in the market for human diseases and psychiatric illness. These are the psychological and psychotherapeutic treatments, which "have even greater sympathy initial suffer from them, and even larger gaps that the psychotropic drugs," says the lecturer. It is necessary to move towards a greater understanding of the factors associated with greater efficacy and safety of our interventions, efficacy and safety, which often is achieved with an approach that cleverly combines the best of every type of collision, psychotherapeutic and psychopharmacological .
Furthermore it should be noted that the marketing of new drugs based on controlled clinical trials. But the information they provide "is often difficult to extrapolate to the clinical routine," so there is a need for research to reflect a more accurate what happens in real life and help us making decisions. Recent studies such as CATIE, have had a major impact on the psychiatric community and have led to deep-rooted beliefs are shaken.
• A simplistic concept of mental illness and human behavior has contributed to extending treatment with psychotropic drugs for conditions that can hardly be regarded as psychiatric disorders, and should be approached differently.
• The popularization and trivialization of some use of some psychiatric medications have helped to extend the use of poorly justified. "Drugs like Prozac are already part of the culture of the XX and XXI century," says Dr. Uriarte Uriarte.
• In recent years it has been called into question the efficacy and safety of many of these drugs, especially when used indiscriminately, with little control, and without regard to other therapeutic alternatives.
Reflect on the different aspects that affect the assistance to mental health problems at present and, more specifically, those that affect the use of psychotropic drugs. This will be the main goal of Dr. Juan José Uriarte Uriarte, department head of the Psychiatric Rehabilitation Unit of Hospital de Zamudio. The lecture, organized by the Academy of Medical Sciences of Bilbao, to be entitled "The Use and Abuse of the prescription of psychoactive drugs. Towards a rational use ", will take place today Wednesday 28 January at 19.00 in the hall of the Medical Association of Bizkaia (Lersundi, 9-5 th).
The rapporteur will deepen the idea that the current use of medications in mental health does not always have a rational basis, as well as the different aspects that influence the use of psychoactive drugs. To do this start by reviewing the various interpretations of the concept of rationality applied to health and social changes that influence the practice of medicine today, with special reference to the extension of the concept of health. Then, before you jump right into the factors influencing the current distribution of psychotropic drugs, the expert will analyze the impact of poor knowledge of the causes and pathogenesis of mental diseases.
Causes of the spread of psychoactive drugs
The enormous success and spread of psychoactive drugs in the last decade has "various causes including: technical advances and the excessive reliance on technology, the relative effectiveness of alternative methods of intervention (such as psychotherapy), dissemination of models for evaluating interventions (clinical trials), social changes, changes in psychiatric nosology and the influence of the pharmaceutical industry, "says Dr. Uriarte. To all this must be added that the extension of the idea that the symptoms of mental illness depend on functions regulated by brain chemicals, and can be modified in a controlled and socially acceptable manner has contributed to "the incredible diffusion of drugs Prozac, as part of the culture of the XX and XXI century. "
"A simplistic notion of mental illness and human behavior has contributed to reducing the stigma associated with treatment with psychotropic drugs, especially antidepressants, which have been in a few years of being rejected or consumed in secret, to be sued in a direct by patients, "explains the expert psychiatrist. The extension of the mental health field has undoubtedly been exploited by the pharmaceutical industry, which has "stretched to the unspeakable traditional diseases like depression," and has contributed to an "explosion and expansion of mental health problems likely treatment, including situations bordering on normalcy, "such as shyness or hyperactive behavior in children," he adds.
Treatments questioned
However in recent years has been put into question the efficacy and safety of many drugs. Moreover the "lack of progress in the knowledge of the causes of mental illness eventually temper enthusiasm and unrealistic claims," says JJ Uriarte. It is noteworthy that the psychotropic drugs have traditionally had a competitor in the market for human diseases and psychiatric illness. These are the psychological and psychotherapeutic treatments, which "have even greater sympathy initial suffer from them, and even larger gaps that the psychotropic drugs," says the lecturer. It is necessary to move towards a greater understanding of the factors associated with greater efficacy and safety of our interventions, efficacy and safety, which often is achieved with an approach that cleverly combines the best of every type of collision, psychotherapeutic and psychopharmacological .
Furthermore it should be noted that the marketing of new drugs based on controlled clinical trials. But the information they provide "is often difficult to extrapolate to the clinical routine," so there is a need for research to reflect a more accurate what happens in real life and help us making decisions. Recent studies such as CATIE, have had a major impact on the psychiatric community and have led to deep-rooted beliefs are shaken.
The Foundation Doctor Balmis rewarding career the prestigious vacunólogo José Antonio Navarro.
First Awards engaged in Vaccinology, Epidemiology and Preventive Medicine
Doctor Balmis Foundation, created under the auspices of the Rotary Club, Alicante, sponsored by Esteve, created the awards that bear his name to distinguish the most important personalities in the field of Vaccinology, Epidemiology and Preventive Medicine in Spain. In this first edition, which has an annual continuity, it has been recognized professional work of Dr. José Antonio Navarro Alonso, currently Chief of Vaccinology, Prevention and Protection of Health of the Regional Government of Murcia.
Member of the Spanish Association of Vaccinology, Navarro Alonso is also part of the Vaccine Safety Project of the World Health Organization and the European Advisory Group on Vaccines and Immunizations, among many other agencies. Collected the award yesterday, Friday January 23 in Alicante, in the hands of Health Minister, Bernat Soria, and the presence of leading authorities from the health and social, that they support the philosophy of dedication and service to the community promotes Prize.
It should be stressed that the Foundation Doctor Balmis aims to disseminate the values they embody the character of this great figure of the eighteenth century, well recognized in the Latin American countries and the Philippines, but it is a great unknown in Spain and his homeland, Alicante.
Francisco Javier Balmis devoted his life to medicine and pioneered the study of applications of the vaccine, especially smallpox, considered one of the pests that have caused more death to the human species. Played one of the most striking gestures of Medicine, to disseminate the vaccine in an expedition philanthropic giving around the world. Precisely the Rotary International was inspired by the feat of Dr. Balmis for the Polio Plus campaign, through which virtually eradicated polio in the world, through the vaccination of hundreds of thousands of children.
The Award ceremony was held yesterday, January 23 at 21:30 am in the Hotel Sidi San Juan (Alicante), hosts of the Rotary Club of Alicante, currently chaired by Dr. Jorge Alió, who also chairs the Foundation Doctor Balmis.
Bet Esteve Vaccine
Esteve, sponsor of the Doctor Balmis Prize Foundation, is a chemical-pharmaceutical group leader in Spain and with a strong international presence. Today the group offers a comprehensive solution within the health sector with a variety of segments in which it is active. The presence in the field of vaccines Esteve was achieved on the one hand, through the market (since 2000) of a broad portfolio of vaccines in the fields of influenza and meningitis, and more recently through its incorporation into a project with the Catalan Center for Research and Development of AIDS Vaccine (HIVACAT), a public-private initiative focused on developing a vaccine for HIV.
Esteve has expanded its scope of action towards preventive medicine, in particular vaccines. Every day there are more diseases could be prevented by vaccines, and the initiative responds to the Awards Balmis Esteve social commitment.
Doctor Balmis Foundation, created under the auspices of the Rotary Club, Alicante, sponsored by Esteve, created the awards that bear his name to distinguish the most important personalities in the field of Vaccinology, Epidemiology and Preventive Medicine in Spain. In this first edition, which has an annual continuity, it has been recognized professional work of Dr. José Antonio Navarro Alonso, currently Chief of Vaccinology, Prevention and Protection of Health of the Regional Government of Murcia.
Member of the Spanish Association of Vaccinology, Navarro Alonso is also part of the Vaccine Safety Project of the World Health Organization and the European Advisory Group on Vaccines and Immunizations, among many other agencies. Collected the award yesterday, Friday January 23 in Alicante, in the hands of Health Minister, Bernat Soria, and the presence of leading authorities from the health and social, that they support the philosophy of dedication and service to the community promotes Prize.
It should be stressed that the Foundation Doctor Balmis aims to disseminate the values they embody the character of this great figure of the eighteenth century, well recognized in the Latin American countries and the Philippines, but it is a great unknown in Spain and his homeland, Alicante.
Francisco Javier Balmis devoted his life to medicine and pioneered the study of applications of the vaccine, especially smallpox, considered one of the pests that have caused more death to the human species. Played one of the most striking gestures of Medicine, to disseminate the vaccine in an expedition philanthropic giving around the world. Precisely the Rotary International was inspired by the feat of Dr. Balmis for the Polio Plus campaign, through which virtually eradicated polio in the world, through the vaccination of hundreds of thousands of children.
The Award ceremony was held yesterday, January 23 at 21:30 am in the Hotel Sidi San Juan (Alicante), hosts of the Rotary Club of Alicante, currently chaired by Dr. Jorge Alió, who also chairs the Foundation Doctor Balmis.
Bet Esteve Vaccine
Esteve, sponsor of the Doctor Balmis Prize Foundation, is a chemical-pharmaceutical group leader in Spain and with a strong international presence. Today the group offers a comprehensive solution within the health sector with a variety of segments in which it is active. The presence in the field of vaccines Esteve was achieved on the one hand, through the market (since 2000) of a broad portfolio of vaccines in the fields of influenza and meningitis, and more recently through its incorporation into a project with the Catalan Center for Research and Development of AIDS Vaccine (HIVACAT), a public-private initiative focused on developing a vaccine for HIV.
Esteve has expanded its scope of action towards preventive medicine, in particular vaccines. Every day there are more diseases could be prevented by vaccines, and the initiative responds to the Awards Balmis Esteve social commitment.
Summary of presentations of the Fourth Course of Continuing Medical Education on Viral Hepatitis.
Between 26 and January 30 was held in the Medical Association of Madrid IV CONTINUING MEDICAL TRAINING COURSE ON VIRAL HEPATITIS. The course, as in other occasions, was led by Professor Juan González-Lahoz and Vincent Soriano, Hospital Carlos III of Madrid. Of note is the extensive participation (more than 200 physicians enrolled) and the quality of the speakers came from pointers hepatology services and / or infectious diseases in Spain.
There are at least 5 hepatotropic virus can infect and inflame the liver tissue: the hepatitis A virus (HAV), B (HBV), C (HCV), D (VHD) and E (HEV). Other viruses such as VHG, viruses and TTS SEN virus can infect the liver, although its pathogenic role is controversial.
HAV and HEV have preferred a fecal-oral transmission and a generally benign course. Today, its incidence in Spain is low due to good hygienic conditions and the existence of a vaccine against HAV andalusia. However, there have been small outbreaks of acute hepatitis A in patients promiscuous homosexual. Furthermore, acute hepatitis E should be considered in travelers and immigrants coming mainly from Southeast Asia.
Viral hepatitis produce greater public health problem in our country are caused by HBV and HCV.
Hepatitis B
Infection occurs through sexual contact, blood or by passage from mother to child. In adults almost always heal themselves, but between 3-5% of cases evolve into chronicity. When infection is acquired in childhood is the rule chronification. Between 15 and 40% of patients with chronic hepatitis B will develop cirrhosis.
It is essential to identify which patients will develop worse and therefore require treatment. The goal of treatment is to prevent viral replication and ideally eradicate the virus. The latter is complex, since the HBV integrates its genetic material into the nucleus of host cells. On the other hand it is known that the viral suppression prevents the progression to cirrhosis and its complications. There is "consensus" that should be addressed to patients with viral loads above 20,000 IU / ml and elevated transaminases, because they have a higher risk of progression.
The drugs currently approved for HBV are:
• Interferons. Achieve higher levels of healing in HBeAg + patients. But they have more side effects and are contraindicated in cirrhotic patients.
• Lamivudine. It was the first approved inhibitor of polymerase. Tolerated very well, but over time it always fails for the emergence of resistance.
• Telvivudina. Share some with lamivudine resistance and also its easy to generate resistance.
• entecavir. More powerful than the previous ones but if there is resistance to lamivudine is necessary to double the dose.
• Adefovir. It is useful for patients who failed previous drug.
• Tenofovir. The last drug approved against HBV and one of the most powerful.
Hepatitis Delta
The HDV is an RNA virus, capable of producing hepatotropic hepatitis, chronic hepatitis and fulminant hepatitis in some cases. It is the least frequent cause of chronic viral hepatitis but produces a severe liver disease. HDV infection occurs only in the context of an HBV infection, either infection or simultaneous coinfection of B and D or D-shaped overinfection affected previous HBsAg carriers. Clinically it is presented in a similar way but evolution and the prognosis is very different. Most of the B and D co-evolve to cure while the delta superinfections progress to chronicity.
Hepatitis C
HCV is characterized by its ability to chronic. About 2% of the Spanish population is infected by this virus and is the leading cause of liver transplantation. The evolution of HCV is usually asymptomatic, but about 20% of patients will develop liver cirrhosis in 20 years.
The treatment of choice is the combination of pegylated interferon (PEG-IFN) and ribavirin (RBV). Genotypes 2 and 3 were treated 6 months get a 80% cure. Genotypes 1 and 4 should be treated 1 years, achieving cure in half the patients. There are currently testing new drugs that inhibit viral enzymes, such as telaprevir, which acts on the protease of HCV and in combination with PEG-IFN and RBV may achieve higher cure rates in patients difficult to treat.
Vaccines against hepatotropic virus
There is now a vaccine against HAV andalusia consisting of inactivated virus. 2 doses are administered intramuscularly at an interval of 6 months and produces a nearly universal immunization.
Against HBV is a vaccine that is produced by genetic recombination. 3 doses are administered and is already included in the pediatric immunization schedule in Spain. This makes for a higher vaccination rates in children, 95% and 80% in adults.
Unfortunately, HCV is not successful to grow in the laboratory. This makes it difficult to investigate, among other things has not yet been able to develop a vaccine.
Vaccination against andalusia andalusia HAV and HBV should always indicated in patients with liver-based, as an acute hepatitis from any of these viruses on a sick liver can be fatal.
Hepatotropic virus coinfection with HIV
Shares with HIV, HBV and HCV transmission routes (especially parenterally) this makes coinfection is relatively frequent. This is an issue of this edge by having a series of special features:
• Since the introduction of highly active against HIV liver disease has become a major cause of morbidity and mortality in these patients.
• The evolution to cirrhosis is accelerated for both HBV and for HCV in HIV + patients.
• The treatment of viral hepatitis is more complex in these patients for drug interactions and hepatotoxicity phenomena.
• Response rates especially HCV with PEG-IFN and RBV are decreased in HIV + patients.
There are at least 5 hepatotropic virus can infect and inflame the liver tissue: the hepatitis A virus (HAV), B (HBV), C (HCV), D (VHD) and E (HEV). Other viruses such as VHG, viruses and TTS SEN virus can infect the liver, although its pathogenic role is controversial.
HAV and HEV have preferred a fecal-oral transmission and a generally benign course. Today, its incidence in Spain is low due to good hygienic conditions and the existence of a vaccine against HAV andalusia. However, there have been small outbreaks of acute hepatitis A in patients promiscuous homosexual. Furthermore, acute hepatitis E should be considered in travelers and immigrants coming mainly from Southeast Asia.
Viral hepatitis produce greater public health problem in our country are caused by HBV and HCV.
Hepatitis B
Infection occurs through sexual contact, blood or by passage from mother to child. In adults almost always heal themselves, but between 3-5% of cases evolve into chronicity. When infection is acquired in childhood is the rule chronification. Between 15 and 40% of patients with chronic hepatitis B will develop cirrhosis.
It is essential to identify which patients will develop worse and therefore require treatment. The goal of treatment is to prevent viral replication and ideally eradicate the virus. The latter is complex, since the HBV integrates its genetic material into the nucleus of host cells. On the other hand it is known that the viral suppression prevents the progression to cirrhosis and its complications. There is "consensus" that should be addressed to patients with viral loads above 20,000 IU / ml and elevated transaminases, because they have a higher risk of progression.
The drugs currently approved for HBV are:
• Interferons. Achieve higher levels of healing in HBeAg + patients. But they have more side effects and are contraindicated in cirrhotic patients.
• Lamivudine. It was the first approved inhibitor of polymerase. Tolerated very well, but over time it always fails for the emergence of resistance.
• Telvivudina. Share some with lamivudine resistance and also its easy to generate resistance.
• entecavir. More powerful than the previous ones but if there is resistance to lamivudine is necessary to double the dose.
• Adefovir. It is useful for patients who failed previous drug.
• Tenofovir. The last drug approved against HBV and one of the most powerful.
Hepatitis Delta
The HDV is an RNA virus, capable of producing hepatotropic hepatitis, chronic hepatitis and fulminant hepatitis in some cases. It is the least frequent cause of chronic viral hepatitis but produces a severe liver disease. HDV infection occurs only in the context of an HBV infection, either infection or simultaneous coinfection of B and D or D-shaped overinfection affected previous HBsAg carriers. Clinically it is presented in a similar way but evolution and the prognosis is very different. Most of the B and D co-evolve to cure while the delta superinfections progress to chronicity.
Hepatitis C
HCV is characterized by its ability to chronic. About 2% of the Spanish population is infected by this virus and is the leading cause of liver transplantation. The evolution of HCV is usually asymptomatic, but about 20% of patients will develop liver cirrhosis in 20 years.
The treatment of choice is the combination of pegylated interferon (PEG-IFN) and ribavirin (RBV). Genotypes 2 and 3 were treated 6 months get a 80% cure. Genotypes 1 and 4 should be treated 1 years, achieving cure in half the patients. There are currently testing new drugs that inhibit viral enzymes, such as telaprevir, which acts on the protease of HCV and in combination with PEG-IFN and RBV may achieve higher cure rates in patients difficult to treat.
Vaccines against hepatotropic virus
There is now a vaccine against HAV andalusia consisting of inactivated virus. 2 doses are administered intramuscularly at an interval of 6 months and produces a nearly universal immunization.
Against HBV is a vaccine that is produced by genetic recombination. 3 doses are administered and is already included in the pediatric immunization schedule in Spain. This makes for a higher vaccination rates in children, 95% and 80% in adults.
Unfortunately, HCV is not successful to grow in the laboratory. This makes it difficult to investigate, among other things has not yet been able to develop a vaccine.
Vaccination against andalusia andalusia HAV and HBV should always indicated in patients with liver-based, as an acute hepatitis from any of these viruses on a sick liver can be fatal.
Hepatotropic virus coinfection with HIV
Shares with HIV, HBV and HCV transmission routes (especially parenterally) this makes coinfection is relatively frequent. This is an issue of this edge by having a series of special features:
• Since the introduction of highly active against HIV liver disease has become a major cause of morbidity and mortality in these patients.
• The evolution to cirrhosis is accelerated for both HBV and for HCV in HIV + patients.
• The treatment of viral hepatitis is more complex in these patients for drug interactions and hepatotoxicity phenomena.
• Response rates especially HCV with PEG-IFN and RBV are decreased in HIV + patients.
Presentation in Spain of a new antiretroviral therapy to treat HIV-1.
Intelence ® (Etravirina) is the first reverse transcriptase inhibitor non-nucleoside analogue introduced in Europe in nearly 10 years
• The profile of a patient who would benefit from this new therapy is one that does not respond to current treatments
• Nearly 80% of patients treated with etravirina, in joint administration with other active drugs achieved undetectable viral load
• In Spain more than 700 patients have received compassionate use etravirina by or through an Expanded Access Program
Last January 30 was made in Spain INTELENCE ® (etravirina), a new therapeutic alternative for adults infected with HIV type 1 (HIV-1) that have been previously treated with other antiretrovirals, which have generated resistance to treatment.
INTELENCE ® (etravirina) belongs to a new generation of antiretroviral drugs that, taken together with a boosted protease inhibitor and other antiretroviral drugs, reduces the amount of HIV in the blood and keeps it low. Its aim is to curb the deterioration of the immune system, the emergence of infections and diseases associated with AIDS in those who have shown resistance to other therapies.
For Enrique Ortega, head of the Infectious Disease Unit of the Hospital General Universitario de Valencia, this new drug has an advantage because capital "is able to deal with him to a high percentage of people infected with HIV that showed resistance and in which treatments were no longer effective. " According to Jose Maria Gatell, head of Service of Infectious Diseases and AIDS of Hospital Clinic of Barcelona, "etravirina be used as a component of the combinations of rescue in adults who have failed one or more previous treatments, and generally with multiple resistance mutations andalusia virus. But due to its good tolerance may, in some situations, replacing the current ITNN (nevirapine or efavirenz) in earlier stages of infection. "
The indication of INTELENCE ® (etravirina) is based on the analysis performed at week 24, two studies DUET 1 and DUET 2 in 1203 adults infected with HIV-1 pretreatment was no longer effective and that showed resistance to inhibitors of reverse transcriptase non-nucleoside analogues (ITINN). Both studies examined the efficacy and safety of etravirina treatment in combination with an optimized base (TBO), which included darunavir / ritonavir. The data showed that 58.9% of patients treated with etravirina got an undetectable viral load (<50 copies / ml), compared with 41.1% of patients treated with placebo [p <0.0001], and 50% higher than the control group. The recommended dose of INTELENCE ® is 200 mg (two 100 mg tablets) taken orally twice daily after a meal. It is possible to dissolve the tablets in water.
In the pooled analysis of studies DUET 1 and DUET 2 to 48 weeks of treatment showed that about 80% of patients who are treated etravirina with two or more active drugs achieved undetectable viral load.
The incidence of neurological and psychiatric adverse events at 48 weeks of treatment with etravirina was similar to those receiving placebo. Also in people coinfected with hepatitis C and / or B, the appearance of adverse effects in the liver etravirina-treated group was similar to placebo.
The Ministry of Health through the General Directorate of Pharmacy and Health Products has just approved funding this new therapeutic alternative for adult patients infected by HIV-1 that have been previously treated with other drugs and who have generated a resistant virus. . "We had to wait almost 10 years to introduce a new ITNN, well tolerated, with a better resistance profile and able to rescue patients who had developed a certain level of resistance to the above. Means a significant improvement in the arsenal of treatments and an alternative to rescue the current ITNN in selected situations, "says Dr. Gatell. Ortega to the doctor, "with this new therapy is called the therapeutic range and it is likely that we are entering a new era of change in therapy initiation.
To etravirina marketing in Spain, more than 700 patients have been treated for compassionate use or expanded access program.
New horizons in the fight against HIV
The presentation of this new drug that takes place during the symposium "Improving the Present: Renovation and Innovation in the non-nucleoside" to be held this weekend in Valencia, brings together over 150 specialists on the occasion of the official presentation to the community etravirina medical and to discuss the new horizons that exist in the fight against HIV / AIDS. Dr. Gatell to "provide new therapeutic options for antiretroviral treatment changes make it simpler and better tolerated by patients and allows the possibility of developing a rescue treatment whose effectiveness is close to 100%." In the same line expressed that Dr. Ortega said that "the horizons of therapy are changing with the emergence of new drugs more effective and less adverse family therapy known to improve the existing ones and also acting against other targets of the virus hitherto impregnable. "
Etravirina was developed by Tibotec Pharmaceuticals, a Johnson & Johnson's group dedicated to research and development of new drugs in the area of virology. Janssen-Cilag International NV is the holder of the marketing authorization in the European Union. Spain INTELENCE ® is marketed by Janssen-Cilag SA,
Janssen-Cilag pharmaceutical company based in the research group belonging to the Johnson & Johnson, the multinational health sector more diversified and employs 119,000 people worldwide. For 120 years, Johnson & Johnson develops health care products and services for markets pharmaceutical, consumer and professional.
• The profile of a patient who would benefit from this new therapy is one that does not respond to current treatments
• Nearly 80% of patients treated with etravirina, in joint administration with other active drugs achieved undetectable viral load
• In Spain more than 700 patients have received compassionate use etravirina by or through an Expanded Access Program
Last January 30 was made in Spain INTELENCE ® (etravirina), a new therapeutic alternative for adults infected with HIV type 1 (HIV-1) that have been previously treated with other antiretrovirals, which have generated resistance to treatment.
INTELENCE ® (etravirina) belongs to a new generation of antiretroviral drugs that, taken together with a boosted protease inhibitor and other antiretroviral drugs, reduces the amount of HIV in the blood and keeps it low. Its aim is to curb the deterioration of the immune system, the emergence of infections and diseases associated with AIDS in those who have shown resistance to other therapies.
For Enrique Ortega, head of the Infectious Disease Unit of the Hospital General Universitario de Valencia, this new drug has an advantage because capital "is able to deal with him to a high percentage of people infected with HIV that showed resistance and in which treatments were no longer effective. " According to Jose Maria Gatell, head of Service of Infectious Diseases and AIDS of Hospital Clinic of Barcelona, "etravirina be used as a component of the combinations of rescue in adults who have failed one or more previous treatments, and generally with multiple resistance mutations andalusia virus. But due to its good tolerance may, in some situations, replacing the current ITNN (nevirapine or efavirenz) in earlier stages of infection. "
The indication of INTELENCE ® (etravirina) is based on the analysis performed at week 24, two studies DUET 1 and DUET 2 in 1203 adults infected with HIV-1 pretreatment was no longer effective and that showed resistance to inhibitors of reverse transcriptase non-nucleoside analogues (ITINN). Both studies examined the efficacy and safety of etravirina treatment in combination with an optimized base (TBO), which included darunavir / ritonavir. The data showed that 58.9% of patients treated with etravirina got an undetectable viral load (<50 copies / ml), compared with 41.1% of patients treated with placebo [p <0.0001], and 50% higher than the control group. The recommended dose of INTELENCE ® is 200 mg (two 100 mg tablets) taken orally twice daily after a meal. It is possible to dissolve the tablets in water.
In the pooled analysis of studies DUET 1 and DUET 2 to 48 weeks of treatment showed that about 80% of patients who are treated etravirina with two or more active drugs achieved undetectable viral load.
The incidence of neurological and psychiatric adverse events at 48 weeks of treatment with etravirina was similar to those receiving placebo. Also in people coinfected with hepatitis C and / or B, the appearance of adverse effects in the liver etravirina-treated group was similar to placebo.
The Ministry of Health through the General Directorate of Pharmacy and Health Products has just approved funding this new therapeutic alternative for adult patients infected by HIV-1 that have been previously treated with other drugs and who have generated a resistant virus. . "We had to wait almost 10 years to introduce a new ITNN, well tolerated, with a better resistance profile and able to rescue patients who had developed a certain level of resistance to the above. Means a significant improvement in the arsenal of treatments and an alternative to rescue the current ITNN in selected situations, "says Dr. Gatell. Ortega to the doctor, "with this new therapy is called the therapeutic range and it is likely that we are entering a new era of change in therapy initiation.
To etravirina marketing in Spain, more than 700 patients have been treated for compassionate use or expanded access program.
New horizons in the fight against HIV
The presentation of this new drug that takes place during the symposium "Improving the Present: Renovation and Innovation in the non-nucleoside" to be held this weekend in Valencia, brings together over 150 specialists on the occasion of the official presentation to the community etravirina medical and to discuss the new horizons that exist in the fight against HIV / AIDS. Dr. Gatell to "provide new therapeutic options for antiretroviral treatment changes make it simpler and better tolerated by patients and allows the possibility of developing a rescue treatment whose effectiveness is close to 100%." In the same line expressed that Dr. Ortega said that "the horizons of therapy are changing with the emergence of new drugs more effective and less adverse family therapy known to improve the existing ones and also acting against other targets of the virus hitherto impregnable. "
Etravirina was developed by Tibotec Pharmaceuticals, a Johnson & Johnson's group dedicated to research and development of new drugs in the area of virology. Janssen-Cilag International NV is the holder of the marketing authorization in the European Union. Spain INTELENCE ® is marketed by Janssen-Cilag SA,
Janssen-Cilag pharmaceutical company based in the research group belonging to the Johnson & Johnson, the multinational health sector more diversified and employs 119,000 people worldwide. For 120 years, Johnson & Johnson develops health care products and services for markets pharmaceutical, consumer and professional.
Epidemic Bronchiolitis Respiratory Syncytial Virus (RSV) will last until April.
• Bronchiolitis is the leading cause of hospitalization worldwide in less than a year.
• Prevention with monoclonal treatments are key to preventing infection in infants more vulnerable.
RSV, the leading cause of bronchiolitis, this year will remain in the air until April. Says Dr. Octavio Ramilo, Medical Director and Clinical Research at Childrens Medical Center of Texas, Dallas, "the dispersal of Respiratory Syncytial Virus (RSV) causes bronchiolitis is associated with climatic variations. It has been found that the combination of low temperatures and humidity makes the virus becomes more resistant. " This is what is happening this year in Spain. The winter cold and rain we are experiencing is contributing to the spread of RSV is more aggressive.
Bronchiolitis is considered the leading cause of hospitalization in the world in less than a year and the leading cause of severe respiratory infections in early life. In Spain, recent research suggests that 89.3% of RSV hospitalizations occurred between October and April. According to these studies, 27% of revenues from bronchiolitis occur during the months of March and April, with the rate of revenue in the past month, nearly 10%.
This high rate of hospitalization creates a high-cost centers, is why we in the words of Dr. Octavio Ramilo, Medical Director and Clinical Research at Childrens Medical Center of Texas, Dallas, "prevention is essential. Has been demonstrated that treatment with prophylactic work well in children under two years and those who are born preterm. In recent years, thanks to preventive treatment have been greatly reduced hospitalizations. "
At the same time, Ramilo explained that due to the variability of the virus and its relationship to climate, "the VRS could be extended even in the months of May and June, so it is necessary to continue preventative treatment and not leave the March. Especially vulnerable are those children who receive early discharge in March or April and have not received preventive treatment with prophylaxis. "
The causes of these children, and more particularly preterm infants are more vulnerable to RSV bronchiolitis, according to Dr. Ramilo, are due to "have a much weakened autoimmune system and respiratory system is more sensitive to any type of respiratory infection. "
At the same time, Ramilo argues that education is a key factor: "we must raise awareness among parents of hygiene and prevention measures that have to be with these children. It is imperative to wash the hands, to prevent children or people with influenza cough or closer to the baby and especially extremely premature babies with protection. Avoid loaded and closed environments. These measures are necessary to prevent the babies were infected with RSV. "
Bronchiolitis
Bronchiolitis is a common cause of infant morbidity caused by high demand in primary care and emergency services, and a high number of hospital admissions in young children and nosocomial infections.
RSV is the causative agent of this disease, characterized by an acute obstruction of the small airways. Their spread is very common in homes, day care and in hospital wards. In the last decade, is describing an increased incidence of hospitalizations for bronchiolitis, which is a significant increase in costs.
In Spain, bronchiolitis is a problem of public health care and economic impact is both short and long term.
• Prevention with monoclonal treatments are key to preventing infection in infants more vulnerable.
RSV, the leading cause of bronchiolitis, this year will remain in the air until April. Says Dr. Octavio Ramilo, Medical Director and Clinical Research at Childrens Medical Center of Texas, Dallas, "the dispersal of Respiratory Syncytial Virus (RSV) causes bronchiolitis is associated with climatic variations. It has been found that the combination of low temperatures and humidity makes the virus becomes more resistant. " This is what is happening this year in Spain. The winter cold and rain we are experiencing is contributing to the spread of RSV is more aggressive.
Bronchiolitis is considered the leading cause of hospitalization in the world in less than a year and the leading cause of severe respiratory infections in early life. In Spain, recent research suggests that 89.3% of RSV hospitalizations occurred between October and April. According to these studies, 27% of revenues from bronchiolitis occur during the months of March and April, with the rate of revenue in the past month, nearly 10%.
This high rate of hospitalization creates a high-cost centers, is why we in the words of Dr. Octavio Ramilo, Medical Director and Clinical Research at Childrens Medical Center of Texas, Dallas, "prevention is essential. Has been demonstrated that treatment with prophylactic work well in children under two years and those who are born preterm. In recent years, thanks to preventive treatment have been greatly reduced hospitalizations. "
At the same time, Ramilo explained that due to the variability of the virus and its relationship to climate, "the VRS could be extended even in the months of May and June, so it is necessary to continue preventative treatment and not leave the March. Especially vulnerable are those children who receive early discharge in March or April and have not received preventive treatment with prophylaxis. "
The causes of these children, and more particularly preterm infants are more vulnerable to RSV bronchiolitis, according to Dr. Ramilo, are due to "have a much weakened autoimmune system and respiratory system is more sensitive to any type of respiratory infection. "
At the same time, Ramilo argues that education is a key factor: "we must raise awareness among parents of hygiene and prevention measures that have to be with these children. It is imperative to wash the hands, to prevent children or people with influenza cough or closer to the baby and especially extremely premature babies with protection. Avoid loaded and closed environments. These measures are necessary to prevent the babies were infected with RSV. "
Bronchiolitis
Bronchiolitis is a common cause of infant morbidity caused by high demand in primary care and emergency services, and a high number of hospital admissions in young children and nosocomial infections.
RSV is the causative agent of this disease, characterized by an acute obstruction of the small airways. Their spread is very common in homes, day care and in hospital wards. In the last decade, is describing an increased incidence of hospitalizations for bronchiolitis, which is a significant increase in costs.
In Spain, bronchiolitis is a problem of public health care and economic impact is both short and long term.
Four out of five people who suffer from chronic venous insufficiency resulting from their work, are women.
• 65% of people relate to endure discomfort for five hours over two hours standing or sitting in their jobs are housewives, hairdressers, receptionists and waiters. • Only 36% of those symptomatic with your doctor for this problem. • 93 percent of those involved in his job fighting these symptoms with postural measures. • Request a business administration major and the prevention measures in the workplace. • The impact of chronic venous insufficiency of the lower labor ranges between 6 and 17% according to the doctors and reaches 20% according to the patients. "Chronic venous insufficiency (CVI) is a condition often deteriorates significantly the quality of life of people who have a job that requires them to stand or sit too long." Covered in the book on white chronic venous insufficiency (CVI) and its impact on the Spanish health system, who was president of the Spanish Chapter of Phlebology, Alberto Masegosa, warns that "the consulting physician or the use of preventive measures are low." The experts emphasized that "prevention campaigns should include the various fields, from those taken by the individual through corporate or government, and with the advice and collaboration of scientific societies." Masegosa explains why this need. "The drainage of blood from the veins of the lower limbs occurs efficiently during exercise, the effect of the pump of the calf muscle, and the lie, because they equalize the pressure between the veins of the lower limbs and the right atrium. Daily activities makes it difficult for many people exercise the power or lifting the legs with the consequent difficulty of draining blood from them. This is especially marked in certain occupational activities, especially those requiring several hours of prolonged standing or a sedentary lifestyle. Exposure to heat or nearby activities in hot environments, increasing the symptoms. " Continued discussion of the vascular surgeon. "In people without venous disease of the lower extremities that results in pain and swelling with a consequent deterioration in their quality of life. However, in the case of people with alteration in the normal functioning of the valves of the veins of the lower extremities, in addition to the symptoms increases the progression of their disease until more severe stages. Fieldwork carried out by the Spanish Chapter of Phlebology affects the impact of IVC in the professional field. The findings are enlightening. 65% of people reporting discomfort at some point in their careers were housewives, hairdressers, receptionists and waiters. Four out of five women who had symptoms. Of those who responded affirmatively to the existence of symptoms of CVI, the majority spent more than five hours a day standing or sitting two. Of those with symptoms 42% had daily, 26.8% had symptoms that were frequent and 33.1% had that occasionally. Only 36% of symptomatic individuals consulted their doctor for this problem. Rioja battle Postural measures 93%, elastic stockings, and medication with 34.9%, only 31.8% with medication and only came to the vascular surgeon 15.5%. The white paper references on chronic venous insufficiency (CVI) and its impact on the Spanish health published by the Spanish Chapter of Phlebology (CEF) of the Spanish Society of Angiology and Vascular Surgery (SEACV), is based on information obtained from surveys managers and professionals in medicine and to patients. Among the most notable findings of this white paper highlights the fact that "the preventive measures against the IVC in the workplace have significant efficacy. Moreover, the fact of having IVC and have a profession of risk produces a clear decrease in the quality of life. " The impact of chronic venous insufficiency of the sick leave in people who have IVC ranges between 6 and 17 per cent, according to doctors and reaches 20% according to the patients. | ||
Wednesday, February 11, 2009
Some terms in the Pharmaceutical Sector-3
Parallel Trade - Parallel Trade
Parallel trade, lower prices of goods purchased in a country, and subsequently higher prices for the same goods in another country is sold.
Patents
Patent, the patent owner the right to intellectual property law, is a document open to the public. At the same time, information relating to inventions made by the public and to increase public interest and is under the protection of the rights of inventors. Mucide, for publication of the invention, the patent owner to grant a limited monopoly patented product is made by others, the possibility to prevent the use or sale is made. Monopoly rights for a period (now 20 years since the patent application) and at national borders (where the patent is granted) is limited. However, the three conditions are fulfilled in the case of patents: innovation, invention of practicality and innovation in the industry.
Pharmacogenomics - Farmakogenomik
Detect genetic differences between individuals and the appropriate shape series treatment development process.
Pharmacology - Pharmacology
Pharmacology, drug discovery, development and effects of drugs, including an extensive examination covering all aspects of the discipline is.
Farmakovijilans
Medical products on the market life of the license is for the close supervision over the reliability and continuous oversight.
Battery (Patient Information Leaflet - Patient Information Leaflet)
In a specific order, all of the information provided with medicines. Usually, the patient receives medication, the medication is safe and effective use single source of information is explaining.
Prevalence - Prevalence
Terms of population affected by disease rate is used for.
Primary Care - Basic Maintenance
Basic care, age, gender, disease or organ system and the population of individuals with regard to the contacts and provided the first permanent, comprehensive and coordinated care means.
Proteins - Proteins
Proteins, amino acids with a much smaller molecular chain consists of occurs. Some amino acids in proteins can be dozens of thousands of some of it can be. Of each protein, amino acid structure and chain on the space depending on how the curl is a structure peculiar. This structure, protein functions are determined: transport function (hemoglobin blood moves through okisjen), against microbial defense (antibodies), hormonal activity (insulin, adrenaline, etc..), Cells of the biochemical reactions of the act (enzymes) as well as other functions that are available.
Proteomics - Proteomics
Proteomics, the protein in the organism to be isolated, to parse, it is considered as a functional definition and includes, all protein sequences in the tissue and the analysis of protein expression patterns. Genes, cells encode proteins that perform the basic activities are. Protein transmits the message, removes damaged tissue and to provide yapıtaşları performs vital reaction. Proteins, the molecular machinery of genetic instructions are fulfilled. Protein production or function abnormalities are associated with many diseases and health conditions. In the treatment of a specific disease in question is in the best way to understand the disease and to identify proteins associated with it is necessary to understand the function.
Public Health - Public Health
Public Health, Maastricht Treaty, the EC Treaty in the life of the 152nd Article has been covered. According to this Article, the Community, including drug addiction, disease prevention and infection, to cause disease to investigate the origin of the public are obliged to inform and encourage training. Amsterdam Treaty, the Community policies and activities of human health to ensure a high level of observance in the definition and implementation of this goal requires the support. According to Article 152, the actions taken in line with this objective, Member States complete the actions taken by the Community measures may include. However, in line yerindenlik policy, the actual approach to encourage cooperation between Member States should be.
Rx
Prescription drugs (the term is used in the United States)
SITC
(Standard International Trade Classification). Standard International Trade Classification.
SMEs - SMEs
Small and medium-scale enterprises is the abbreviation used for.
SmPC (Summary of Product Characteristics - Short Product Information)
A medical product to the EU institutions or officials of Member States to be reviewed by EMEA companies are required to submit a file. In Europe in terms of content and presentation of existing guidelines (Directive 65/65/EEC URL amending the Directive 83/570/EEC) had to be prepared in accordance with this file consists of four parts. In the first section, where short product information in the administrative information and a summary of the file is located. However, in Europe, is known as SPC or SmPC essential and inseparable part of the license approval.
SPC (Supplementary Protection Certificate - Additional Protection Certificate)
SPC for pharmaceutical products will apply. The European Union on 2 January 1993, entered into force by regulation. Products in the EU countries since the first time the marketing license to provide a maximum of 15 years, the patent applies to the longest period of 5 years SPC'nin.
Stem cell - Stem Cells
Stem cells, divided into many different specific cells and tissues in the human body with the capacity to reproduce and different from other cells and non-exclusive "master" cells are. Stem cells, early embryo, fetal and adult human development to periods in each phase are available. There are three types of stem cells: embryonic, fetal and adult. The use of adult stem cells created and discussions are not generally accepted, embryonic and fetal stem cell research on ethical perspective is discussed in many ways.
Transparency Committee - Transparency Committee
Directive 89/105/EEC (commonly called "Transparency Directive" is referred to as) created pursuant to the European Union Transparency Committee consists of representatives of Member States. The Committee is responsible for drug pricing and reimbursement, and on topics relating to the Transparency Directive, the Commission will make recommendations to.
TRIPs (Trade-Related Aspects of Intellectual Property Rights - Trade Associated with Intellectual Property Rights)
World Trade Organization's TRIPs Agreement, GATT'ın "the Uruguay Round" of negotiations has emerged as the aforementioned. In this understanding, the World Trade Organization members of the national laws of all states must put in, including patents, intellectual property rights are related to minimum international standards.
Vaccine - Vaccine
To develop protective immunity against infectious diseases medicines are given to the body. (reduced or dead microorganisms - bacteria or viruses). The purpose of disease to people profilaktik conventional vaccine to prevent infection. Therapeutic vaccines, chronic infection with the virus of human body immune system to action for the disposal of the products. Vaccines are preparations of natural, synthetic and may have been derived rekombinan DNA technology.
Virus - Virus
Smaller than bacteria, and live outside of the cell growth of microorganisms and viruses is not possible çoğalaması is called. Virus to survive and reproduce itself for the live cells attacked their chemical properties and uses.
WHO (World Health Organization - World Health Organization)
Center in 1948, which was established in Geneva World Health Organization, United Nations, made up of 191 members is a sub-organization. Organizations, international technical cooperation in the field of health promotion is, to control disease and to eliminate support for various programs and projects shall be executed. The goal is to increase the quality of basic human life
Parallel trade, lower prices of goods purchased in a country, and subsequently higher prices for the same goods in another country is sold.
Patents
Patent, the patent owner the right to intellectual property law, is a document open to the public. At the same time, information relating to inventions made by the public and to increase public interest and is under the protection of the rights of inventors. Mucide, for publication of the invention, the patent owner to grant a limited monopoly patented product is made by others, the possibility to prevent the use or sale is made. Monopoly rights for a period (now 20 years since the patent application) and at national borders (where the patent is granted) is limited. However, the three conditions are fulfilled in the case of patents: innovation, invention of practicality and innovation in the industry.
Pharmacogenomics - Farmakogenomik
Detect genetic differences between individuals and the appropriate shape series treatment development process.
Pharmacology - Pharmacology
Pharmacology, drug discovery, development and effects of drugs, including an extensive examination covering all aspects of the discipline is.
Farmakovijilans
Medical products on the market life of the license is for the close supervision over the reliability and continuous oversight.
Battery (Patient Information Leaflet - Patient Information Leaflet)
In a specific order, all of the information provided with medicines. Usually, the patient receives medication, the medication is safe and effective use single source of information is explaining.
Prevalence - Prevalence
Terms of population affected by disease rate is used for.
Primary Care - Basic Maintenance
Basic care, age, gender, disease or organ system and the population of individuals with regard to the contacts and provided the first permanent, comprehensive and coordinated care means.
Proteins - Proteins
Proteins, amino acids with a much smaller molecular chain consists of occurs. Some amino acids in proteins can be dozens of thousands of some of it can be. Of each protein, amino acid structure and chain on the space depending on how the curl is a structure peculiar. This structure, protein functions are determined: transport function (hemoglobin blood moves through okisjen), against microbial defense (antibodies), hormonal activity (insulin, adrenaline, etc..), Cells of the biochemical reactions of the act (enzymes) as well as other functions that are available.
Proteomics - Proteomics
Proteomics, the protein in the organism to be isolated, to parse, it is considered as a functional definition and includes, all protein sequences in the tissue and the analysis of protein expression patterns. Genes, cells encode proteins that perform the basic activities are. Protein transmits the message, removes damaged tissue and to provide yapıtaşları performs vital reaction. Proteins, the molecular machinery of genetic instructions are fulfilled. Protein production or function abnormalities are associated with many diseases and health conditions. In the treatment of a specific disease in question is in the best way to understand the disease and to identify proteins associated with it is necessary to understand the function.
Public Health - Public Health
Public Health, Maastricht Treaty, the EC Treaty in the life of the 152nd Article has been covered. According to this Article, the Community, including drug addiction, disease prevention and infection, to cause disease to investigate the origin of the public are obliged to inform and encourage training. Amsterdam Treaty, the Community policies and activities of human health to ensure a high level of observance in the definition and implementation of this goal requires the support. According to Article 152, the actions taken in line with this objective, Member States complete the actions taken by the Community measures may include. However, in line yerindenlik policy, the actual approach to encourage cooperation between Member States should be.
Rx
Prescription drugs (the term is used in the United States)
SITC
(Standard International Trade Classification). Standard International Trade Classification.
SMEs - SMEs
Small and medium-scale enterprises is the abbreviation used for.
SmPC (Summary of Product Characteristics - Short Product Information)
A medical product to the EU institutions or officials of Member States to be reviewed by EMEA companies are required to submit a file. In Europe in terms of content and presentation of existing guidelines (Directive 65/65/EEC URL amending the Directive 83/570/EEC) had to be prepared in accordance with this file consists of four parts. In the first section, where short product information in the administrative information and a summary of the file is located. However, in Europe, is known as SPC or SmPC essential and inseparable part of the license approval.
SPC (Supplementary Protection Certificate - Additional Protection Certificate)
SPC for pharmaceutical products will apply. The European Union on 2 January 1993, entered into force by regulation. Products in the EU countries since the first time the marketing license to provide a maximum of 15 years, the patent applies to the longest period of 5 years SPC'nin.
Stem cell - Stem Cells
Stem cells, divided into many different specific cells and tissues in the human body with the capacity to reproduce and different from other cells and non-exclusive "master" cells are. Stem cells, early embryo, fetal and adult human development to periods in each phase are available. There are three types of stem cells: embryonic, fetal and adult. The use of adult stem cells created and discussions are not generally accepted, embryonic and fetal stem cell research on ethical perspective is discussed in many ways.
Transparency Committee - Transparency Committee
Directive 89/105/EEC (commonly called "Transparency Directive" is referred to as) created pursuant to the European Union Transparency Committee consists of representatives of Member States. The Committee is responsible for drug pricing and reimbursement, and on topics relating to the Transparency Directive, the Commission will make recommendations to.
TRIPs (Trade-Related Aspects of Intellectual Property Rights - Trade Associated with Intellectual Property Rights)
World Trade Organization's TRIPs Agreement, GATT'ın "the Uruguay Round" of negotiations has emerged as the aforementioned. In this understanding, the World Trade Organization members of the national laws of all states must put in, including patents, intellectual property rights are related to minimum international standards.
Vaccine - Vaccine
To develop protective immunity against infectious diseases medicines are given to the body. (reduced or dead microorganisms - bacteria or viruses). The purpose of disease to people profilaktik conventional vaccine to prevent infection. Therapeutic vaccines, chronic infection with the virus of human body immune system to action for the disposal of the products. Vaccines are preparations of natural, synthetic and may have been derived rekombinan DNA technology.
Virus - Virus
Smaller than bacteria, and live outside of the cell growth of microorganisms and viruses is not possible çoğalaması is called. Virus to survive and reproduce itself for the live cells attacked their chemical properties and uses.
WHO (World Health Organization - World Health Organization)
Center in 1948, which was established in Geneva World Health Organization, United Nations, made up of 191 members is a sub-organization. Organizations, international technical cooperation in the field of health promotion is, to control disease and to eliminate support for various programs and projects shall be executed. The goal is to increase the quality of basic human life
Some terms in the Pharmaceutical Sector-2
EDL (Essential Drugs List-Essential Drugs List)
Model List of Essential Drugs DSÖ'nün, in developing countries to ensure a reasonable amount of drugs available has been created in the 1970s. Essential Drugs, the majority of the population consists of drugs that meet medical needs. Adequate amounts and proper dosage should always be accessible. Model List of Essential Drugs DSÖ'nün developing countries identify their priorities and make choices to medication. Model in the list of drugs DSÖ'nün more than 90% of the non-patent drugs is, therefore, almost close to zero by the law firm at a cost generic copies should be considered.
EMEA (European Agency for the Evaluation of Medicinal Products - European Agency for Evaluation of Medical Products)
Evaluation of the European Medical Products Agency, the European Medicines Agency is now called, began operations in 1995. Agency based in central London, the European Union member states and to assess the human and veterinary medicinal products and to check the existing scientific resources of Member States to coordinate.
EPAR-(European Public Assessment Report). European Public Assessment Report
Center for Medical Products Committee for Proprietary end process (Committee for Proprietary Medicinal Products - CPMP) reached by the final decision includes scientific. At the same time, the report, be specific in the direction of a medical license to the product of reason to explain the CPMP decision.
GATT (General Agreement on Tariffs and Trade - General Agreement on Tariffs and Trade)
In 1947, signed by 117 states is a comprehensive free trade agreement. GATT'ın aim, to promote world trade and global economic growth to contribute to supervise. Many of the issues, as well as all other member countries, member countries of import and export tariffs to the same act, the member countries based on the editor to provide copyright protection, trade-related issues to consult with each other and differences in a peaceful way to resolve is encouraging. With GATT, the agreements to ensure compliance to the WTO (World Trade Organization - WTO) was created with the name recognition of the regulatory body.
Generic - Generic
Non-patent drugs. A drug, the patent only until the end of the drug, manufactured by the company can be discovered. After the patent ends, any company is entitled to the same generic compound is produced.
Genes - Genes
Genes, the DNA carried by chromosomes from each other than to create individual is responsible for separating hereditary characteristics. Every human being has an estimated 100,000 separate genes. More generally the 'genes' of the term person has certain features can be used in relation to the transfer and inheritance.
Gene Therapy - Gene Therapy
Organisms with a genetic disease of the damaged gene is replaced with another gene. To isolate the gene and the functioning of cells is used to place rekombinan DNA techniques. People with more than 300 single-gene genetic disorders have been identified. These are an important part of gene therapy may be appropriate for.
Genome - Genome
The total of the genes carried by individuals or cells.
Genomics - Genome science
Genes and functions viewing is the name given to the sciences. Recent progress in genome science, the complex interaction of genetic and environmental factors, including the molecular mechanisms of disease to create a revolution in the information. In addition, genome science, the development of drugs for the thousands of new biological targets revealed by scientists and new medicines, vaccines and DNA diagnosis of innovative ways to create a revolutionary health by providing products to the discovery motion was passed. Genome science-based treatment between the "traditional" small chemical drugs, protein drugs and, potentially, gene therapy is available.
GCP (Good Clinical Practice - Good Clinical Practice)
Human subjects participated in the research design, execution, recording and reporting related to international ethical and scientific quality standards are. These standards, work safety and health of the subjects were taken under guarantee, to comply with principles of the Helsinki Declaration and reliable data for clinical research is to reassure the public.
GMP (Good Manufacturing Practice - Good Manufacturing Practice)
In accordance with Good Manufacturing Practices regulations, all drug producing companies in Europe, is the control of production processes. Production facilities, are required to comply with the rules check.
In the U.S. Hatch-Waxman Act out of the Hatch-Waxman Act (1984) through the generic drugs more widely available with the leading companies continue to develop new drugs for a balance between the incentives provided were established. Generic companies, the approval process for the patent with fewer early start have the right to violate. Since the date of the adoption of the Law of the generic drug market has increased at a rate of almost 50%.
Health - WHO definition - Health - DSÖ'nün Definition
Health, not only has an illness or weakness, a complete physical, mental and social wellbeing is a state. 152nd of the Treaty on European Union According to Article: "Community policies and activities relating to definition and application of human health at high levels will be supervising."
Health Outcome - Health Results
Health (or other) as a result of the provision of services in health status (mortality and morbidity) changes occur.
Health Outcomes Research - Health Outcomes Research
A specific medication, direct, indirect and non-tangible benefits and value-added benefits, including the young discipline / methodology is. According to the pharmaceutical industry, only the quality, reliability and efficiency should concentrate on such issues in the license approval process ( "farmakoekonomi" or "cost-effectiveness studies" is also referred to as) is not appropriate view.
HMO (Health Maintenance Organization - Health maintenance organization)
What you have received health care in a health plan that is followed. Managed care, you and your health plan participating in the coordination of health professionals are governed by the health plan. Are the most common management HMO'lar care plan.
Hormone - Hormones
Hormones, are molecules produced by a gland or tissue. Usually the blood moving through the hormones, in a distant organ or tissue effects. For example, the pancreas produces insulin, insulin also regulates the level of sugar in the organism. Hormones, nervous system, including the human body that coordinates the activities of billions of cells.
ICH (International Conference on harmonization - International integration / harmonization Conference)
Human Medical Products Licenses Technical Terms Relating Harmonizasyonuna International Conference (ICH), product license for the scientific and technical matters to discuss Europe, Japan and the U.S. and by licensing authorities of the three regions in the pharmaceutical industry professionals together is an important project. The purpose of the conference, product licenses and conditions relating to the interpretation of technical manuals and more harmonization in the implementation of recommendations for ways to provide.
Incidence - incidence
Number of new patients each year are affected disease.
Informed consent - Informed Olur
Participate in clinical research required to be informed that the concept of patient participation in clinical research on a reasonable decision to provide doctors / physicians and patients about the information (for example, potential risks, benefits, and alternatives) on the task is based on the principle.
INN
Put in place a molecule of activity is useful, it is an INN name (international non-proprietary name - an international non-proprietary name is not on) is given. This name is given according to international rules as are adopted and the World Health Organization affiliated to the approval of a special committee will be.
Innovation - Innovation
New products (innovative product) formation, in production to reduce costs (process innovation), or presented to the patient that a product's therapeutic value, which led to increased technological süreçtir.Yenilikler, new active ingredients in existing products and new indications of the same products use different ways can reveal.
International exhaustion of International Property Rights - International Intellectual Property Rights to be consumable in the International
Bölgesellik of rights based on the principles of this theory under the protection of a product of any country, the first legal sales after the product-related intellectual property rights owner of this product to another country (again) to be issued the right to restrict the loss means.
In Europe, the international rights to the policy in force is not exhausted. Community in that the depletion regime of rights to trademarks registered in the EU according to the region from outside the EU is a registered trademark owners of the branded goods imported within the Community can deny. The same situation applies to patented goods.
However, EU officials, European Union, under the protection of goods between Member States can move freely in a region considered to be one and unified. Accordingly, parallel imports within the EU territory will be granted.
IPRs (Intellectual Property Rights - Intellectual Property Rights)
In Law, patent, copyright and trademark laws, including the ownership and use of creative work is the edited field. Intellectual property rights, have submitted works to the benefit of humanity and the creative person or companies, without the approval of work to copy or mimic has been developed to protect against.
LDC (Least Developed Countries). The less developed countries (currently 49 countries).
Developing countries are scattered according to income levels: high-income, middle income, low income (see UNCTAD)
Medicinal Product - Medical Products
EU law, medical products, people or animals to treat disease or to prevent any substance or combination of substances is expressed as. People or animals or people in the medical diagnostics to recover physiological functions, correction or replacement of any substance or substances used in combination is considered as medicinal products.
For further information: drug regulation in the framework of Directive 65/65/EEC specifies the URL 2001/83/EEC amending the Directive to see.
MedDRA
(Medical Dictionary for Regulatory Activities Terminology)
Licensing Activities Terminology attached to the Medical Dictionary.
This vital medical resources International Conference on harmonization (ICH) and has been developed by the International Federation of Pharmaceutical Manufacturers Association (International Federation of Pharmaceutical Manufacturers Association - IFPMA) aittir. By providing a single source of medical terminology MedDRA, the medical products worldwide licensing activities related to increasing the effectiveness and transparency.
MEP
(Member of the European Parliament). (Short) Member of the European Parliament.
Millennium Development Goals (MDGs) - the Millennium Development Goals
The United Nations Millennium Summit in September 2000 adopted the Millennium Development Goals to the serious level of poverty reduction and improving the health of low income were found in the call. Identified goals and objectives, "the elimination of poverty on development and the creation of an environment" that are committed represents a partnership between developed countries.
Morbidity - morbidity
A specific disease in a specific region of the relative frequency.
Mortality - mortality
The number of deaths that occur within a specific period of time.
Mutual Recognition - Mutual Recognition
According to this procedure, provided by Member States of the license applicants in line with the preferences in one or more other Member States to apply. This procedure applies to most conventional drugs.
NGO - NGOs
Non-Governmental Organization.
NME-new Mokeküler Article
(New molecular entities). New molecular materials: human disease to be eliminated, to be alleviated, treatment, prevention or in vivo diagnostic use for the people of earlier treatment is not available and only if the prescription is presented as the targeted products (new chemical substances (ncesi - new chemical entities) biological products , including vaccines and biotechnology products).
ROOMS
(Official Development Assistance). Official Development Assistance
[size = 14t] Orphan Drug - Orphan Drug [/ size]
With a limited target population or to treat a rare disease, so the drugs are limited commercial and financial potential. The first time in the USA (1983) Orphan Drug Act entered into force in helping these patients and the drugs trade in terms of development to make it possible to provide incentives (and the exclusive market research expenses for the tax credit) has been developed for. In Europe, the Regulation on Orphan Medical Products more then (December 1999), "rare" as classified in the European Union and more than 10,000 people from around 5 in 5000 affecting illness diagnosis, prevention and treatment in the EU for the development of drugs entered into force for the purpose of animation.
OTC (Over the counter - Tezgahüstü Drugs)
Available is used for prescription drugs.
Outpatient Care - Foot Treatment of
Outpatient treatment services provided in clinics or emergency and medical services do not need to spend the night in hospital.
Model List of Essential Drugs DSÖ'nün, in developing countries to ensure a reasonable amount of drugs available has been created in the 1970s. Essential Drugs, the majority of the population consists of drugs that meet medical needs. Adequate amounts and proper dosage should always be accessible. Model List of Essential Drugs DSÖ'nün developing countries identify their priorities and make choices to medication. Model in the list of drugs DSÖ'nün more than 90% of the non-patent drugs is, therefore, almost close to zero by the law firm at a cost generic copies should be considered.
EMEA (European Agency for the Evaluation of Medicinal Products - European Agency for Evaluation of Medical Products)
Evaluation of the European Medical Products Agency, the European Medicines Agency is now called, began operations in 1995. Agency based in central London, the European Union member states and to assess the human and veterinary medicinal products and to check the existing scientific resources of Member States to coordinate.
EPAR-(European Public Assessment Report). European Public Assessment Report
Center for Medical Products Committee for Proprietary end process (Committee for Proprietary Medicinal Products - CPMP) reached by the final decision includes scientific. At the same time, the report, be specific in the direction of a medical license to the product of reason to explain the CPMP decision.
GATT (General Agreement on Tariffs and Trade - General Agreement on Tariffs and Trade)
In 1947, signed by 117 states is a comprehensive free trade agreement. GATT'ın aim, to promote world trade and global economic growth to contribute to supervise. Many of the issues, as well as all other member countries, member countries of import and export tariffs to the same act, the member countries based on the editor to provide copyright protection, trade-related issues to consult with each other and differences in a peaceful way to resolve is encouraging. With GATT, the agreements to ensure compliance to the WTO (World Trade Organization - WTO) was created with the name recognition of the regulatory body.
Generic - Generic
Non-patent drugs. A drug, the patent only until the end of the drug, manufactured by the company can be discovered. After the patent ends, any company is entitled to the same generic compound is produced.
Genes - Genes
Genes, the DNA carried by chromosomes from each other than to create individual is responsible for separating hereditary characteristics. Every human being has an estimated 100,000 separate genes. More generally the 'genes' of the term person has certain features can be used in relation to the transfer and inheritance.
Gene Therapy - Gene Therapy
Organisms with a genetic disease of the damaged gene is replaced with another gene. To isolate the gene and the functioning of cells is used to place rekombinan DNA techniques. People with more than 300 single-gene genetic disorders have been identified. These are an important part of gene therapy may be appropriate for.
Genome - Genome
The total of the genes carried by individuals or cells.
Genomics - Genome science
Genes and functions viewing is the name given to the sciences. Recent progress in genome science, the complex interaction of genetic and environmental factors, including the molecular mechanisms of disease to create a revolution in the information. In addition, genome science, the development of drugs for the thousands of new biological targets revealed by scientists and new medicines, vaccines and DNA diagnosis of innovative ways to create a revolutionary health by providing products to the discovery motion was passed. Genome science-based treatment between the "traditional" small chemical drugs, protein drugs and, potentially, gene therapy is available.
GCP (Good Clinical Practice - Good Clinical Practice)
Human subjects participated in the research design, execution, recording and reporting related to international ethical and scientific quality standards are. These standards, work safety and health of the subjects were taken under guarantee, to comply with principles of the Helsinki Declaration and reliable data for clinical research is to reassure the public.
GMP (Good Manufacturing Practice - Good Manufacturing Practice)
In accordance with Good Manufacturing Practices regulations, all drug producing companies in Europe, is the control of production processes. Production facilities, are required to comply with the rules check.
In the U.S. Hatch-Waxman Act out of the Hatch-Waxman Act (1984) through the generic drugs more widely available with the leading companies continue to develop new drugs for a balance between the incentives provided were established. Generic companies, the approval process for the patent with fewer early start have the right to violate. Since the date of the adoption of the Law of the generic drug market has increased at a rate of almost 50%.
Health - WHO definition - Health - DSÖ'nün Definition
Health, not only has an illness or weakness, a complete physical, mental and social wellbeing is a state. 152nd of the Treaty on European Union According to Article: "Community policies and activities relating to definition and application of human health at high levels will be supervising."
Health Outcome - Health Results
Health (or other) as a result of the provision of services in health status (mortality and morbidity) changes occur.
Health Outcomes Research - Health Outcomes Research
A specific medication, direct, indirect and non-tangible benefits and value-added benefits, including the young discipline / methodology is. According to the pharmaceutical industry, only the quality, reliability and efficiency should concentrate on such issues in the license approval process ( "farmakoekonomi" or "cost-effectiveness studies" is also referred to as) is not appropriate view.
HMO (Health Maintenance Organization - Health maintenance organization)
What you have received health care in a health plan that is followed. Managed care, you and your health plan participating in the coordination of health professionals are governed by the health plan. Are the most common management HMO'lar care plan.
Hormone - Hormones
Hormones, are molecules produced by a gland or tissue. Usually the blood moving through the hormones, in a distant organ or tissue effects. For example, the pancreas produces insulin, insulin also regulates the level of sugar in the organism. Hormones, nervous system, including the human body that coordinates the activities of billions of cells.
ICH (International Conference on harmonization - International integration / harmonization Conference)
Human Medical Products Licenses Technical Terms Relating Harmonizasyonuna International Conference (ICH), product license for the scientific and technical matters to discuss Europe, Japan and the U.S. and by licensing authorities of the three regions in the pharmaceutical industry professionals together is an important project. The purpose of the conference, product licenses and conditions relating to the interpretation of technical manuals and more harmonization in the implementation of recommendations for ways to provide.
Incidence - incidence
Number of new patients each year are affected disease.
Informed consent - Informed Olur
Participate in clinical research required to be informed that the concept of patient participation in clinical research on a reasonable decision to provide doctors / physicians and patients about the information (for example, potential risks, benefits, and alternatives) on the task is based on the principle.
INN
Put in place a molecule of activity is useful, it is an INN name (international non-proprietary name - an international non-proprietary name is not on) is given. This name is given according to international rules as are adopted and the World Health Organization affiliated to the approval of a special committee will be.
Innovation - Innovation
New products (innovative product) formation, in production to reduce costs (process innovation), or presented to the patient that a product's therapeutic value, which led to increased technological süreçtir.Yenilikler, new active ingredients in existing products and new indications of the same products use different ways can reveal.
International exhaustion of International Property Rights - International Intellectual Property Rights to be consumable in the International
Bölgesellik of rights based on the principles of this theory under the protection of a product of any country, the first legal sales after the product-related intellectual property rights owner of this product to another country (again) to be issued the right to restrict the loss means.
In Europe, the international rights to the policy in force is not exhausted. Community in that the depletion regime of rights to trademarks registered in the EU according to the region from outside the EU is a registered trademark owners of the branded goods imported within the Community can deny. The same situation applies to patented goods.
However, EU officials, European Union, under the protection of goods between Member States can move freely in a region considered to be one and unified. Accordingly, parallel imports within the EU territory will be granted.
IPRs (Intellectual Property Rights - Intellectual Property Rights)
In Law, patent, copyright and trademark laws, including the ownership and use of creative work is the edited field. Intellectual property rights, have submitted works to the benefit of humanity and the creative person or companies, without the approval of work to copy or mimic has been developed to protect against.
LDC (Least Developed Countries). The less developed countries (currently 49 countries).
Developing countries are scattered according to income levels: high-income, middle income, low income (see UNCTAD)
Medicinal Product - Medical Products
EU law, medical products, people or animals to treat disease or to prevent any substance or combination of substances is expressed as. People or animals or people in the medical diagnostics to recover physiological functions, correction or replacement of any substance or substances used in combination is considered as medicinal products.
For further information: drug regulation in the framework of Directive 65/65/EEC specifies the URL 2001/83/EEC amending the Directive to see.
MedDRA
(Medical Dictionary for Regulatory Activities Terminology)
Licensing Activities Terminology attached to the Medical Dictionary.
This vital medical resources International Conference on harmonization (ICH) and has been developed by the International Federation of Pharmaceutical Manufacturers Association (International Federation of Pharmaceutical Manufacturers Association - IFPMA) aittir. By providing a single source of medical terminology MedDRA, the medical products worldwide licensing activities related to increasing the effectiveness and transparency.
MEP
(Member of the European Parliament). (Short) Member of the European Parliament.
Millennium Development Goals (MDGs) - the Millennium Development Goals
The United Nations Millennium Summit in September 2000 adopted the Millennium Development Goals to the serious level of poverty reduction and improving the health of low income were found in the call. Identified goals and objectives, "the elimination of poverty on development and the creation of an environment" that are committed represents a partnership between developed countries.
Morbidity - morbidity
A specific disease in a specific region of the relative frequency.
Mortality - mortality
The number of deaths that occur within a specific period of time.
Mutual Recognition - Mutual Recognition
According to this procedure, provided by Member States of the license applicants in line with the preferences in one or more other Member States to apply. This procedure applies to most conventional drugs.
NGO - NGOs
Non-Governmental Organization.
NME-new Mokeküler Article
(New molecular entities). New molecular materials: human disease to be eliminated, to be alleviated, treatment, prevention or in vivo diagnostic use for the people of earlier treatment is not available and only if the prescription is presented as the targeted products (new chemical substances (ncesi - new chemical entities) biological products , including vaccines and biotechnology products).
ROOMS
(Official Development Assistance). Official Development Assistance
[size = 14t] Orphan Drug - Orphan Drug [/ size]
With a limited target population or to treat a rare disease, so the drugs are limited commercial and financial potential. The first time in the USA (1983) Orphan Drug Act entered into force in helping these patients and the drugs trade in terms of development to make it possible to provide incentives (and the exclusive market research expenses for the tax credit) has been developed for. In Europe, the Regulation on Orphan Medical Products more then (December 1999), "rare" as classified in the European Union and more than 10,000 people from around 5 in 5000 affecting illness diagnosis, prevention and treatment in the EU for the development of drugs entered into force for the purpose of animation.
OTC (Over the counter - Tezgahüstü Drugs)
Available is used for prescription drugs.
Outpatient Care - Foot Treatment of
Outpatient treatment services provided in clinics or emergency and medical services do not need to spend the night in hospital.
Some terms in the Pharmaceutical Sector-1
Acquis Communautaire of the Community acquis
Since the founding of the European Union adopted the common law is called the Community acquis. This is the European Union's 15 members signed a contract Devlet'li and contains approximately 80,000-page legislation.
Adherence - Commitment
Patients, in line with the proposed treatment, to what extent compliance with medical instructions and prescription drug use to explain. Developed countries, the general public about the long-term adherence to treatment is around 50%. This rate is much lower than in developing countries.
ADR - Adverse Drug Reaction - Adverse Drug Reaction
Profilaksisi of diseases, diagnosis, or treatment or modification of physiological function of the normal dose used in human medicine against the harmful and desirable means of the reaction.
Antimicrobial resistance - Antimicrobial resistance
Antimicrobial drugs (antibiotics and other antibacterial, antiviral, antifungal and antiparazit substances, including microorganisms to kill or prevent growth to any substance) in the field of health development, the treatment of infectious diseases and prevent infection of the very large extent has contributed. However, excessive or improper use of antibiotics (especially in children with respiratory infections) has led to the development of resistant organisms. Emergence and spread of antimicrobial resistance, the EU and the world, an important public health problem has become.
ATC - ATK
Anatomical, therapeutic, chemical letters of the word starts and an international system used sınıflandırılmasında drugs.
(Benchmarking) - Benchmarking
Benchmarking, to provide superior performance to reach the quest to find best practices sanayiideki.
Biotechnology - Biotechnology
Biotechnology yararlanılabilinmektedir in two ways.
Biotechnology, chemical compounds of living organisms (eg, antibiotics and vitamins) to produce or to change them to open the traditional biological methods. Second, the isolated DNA, copy, cut and re-assembly and DNA from a cell's genes to another based on the technology transfer capabilities to the host. A non-natural ways to change the genetic material and genetically modified organisms have been suffered organisms (GMO) is called.
Blockbuster
Worldwide more than 1 billion dollars is the term used for selling drugs.
Bolar
America, Roche Bolar and between firms of the proceedings with a court order made in watchman-Hatch Act amendments (1984), generic drug manufacturers license preparation for making application for a patent has not yet ended, the use of patented products has made it possible. This amendment, effective patent protection in the United States to provide for measures to be taken there is a part of the political compromise. In Europe, this compromise, SPC (EKB) in the regulations, and restrictions in force to license no more than 15 years. Bolar provision ( "early working" is also referred to as) will become established in Europe means impairment of balance.
Cadreac (Collaboration Agreement between Drug Regulatory Authorities in European Union Associated Countries - European Union Countries Drug Licensing Authorities Joint Cooperation Agreement Between)
Countries to join the Union as drug licensing authorities informal cooperation between the volunteers. Institutions are represented by directors. Purpose of this cooperation, the participation of institutions in areas of medicine to be eligible for a license to make is to help
Cell - Cell
Cell, is the basic unit of all living organisms. Some organisms live in a state of only one cell. Bacteria and certain animal and plant species in question is of the single cell. The average size of 60-100 trillion cells is a human being. Cells nourish themselves, produce energy, is found in the exchange of information with neighbors and will die when the time comes.
Centralized Procedure - Center Procedures
Medical products, since 1995 can be assessed through Center procedures. This procedure has been approved through the medical products are given a license is valid throughout the EU. Licenses, are given by the European Commission. The medicinal products derived from biotechnological processes for the use of these procedures is mandatory. More innovative products (for example, contains a new active ingredient products) companies or mutual recognition procedure, this procedure may choose to use. Center procedure is used, in London in the European Medical Products Evaluation Agency (EMEA - European Agency for the Evaluation of Medicinal Products) file must be present.
Clinical Trials - Clinical Research
Clinical research, patient's health to improve the reliability and effectiveness of a drug to evaluate the research work carried out on humans. On new drugs and pharmaceutical companies sponsoring clinical research is performed in the compound, including laboratory tests on the (chemical / biological / pharmacological / toxicological), intensive pre-clinical development efforts in successfully pass can start. This test required and only the results reached in the case of promising, companies may try drugs on humans.
Committee for Medicinal Products for Human Use - CHMP - Committee for Human Medical Products
European Medical Products Evaluation Agency (EMEA) under the Registered Medical Products Committee for evaluation of medicinal products for human questions about the scientific committee is responsible for preparing the Agency's views. The Committee is appointed by the Member States consists of 30 members.
Compassionate Use - Early Access Program for Humanitarian Purposes to medication
Medicine without a license is given to patients before the humanitarian situation.
Compulsory Licensing - Compulsory Licensing
TRIPs agreement, without the consent of the patent owner (for example, in emergency cases), states, solid, depending on conditions, the production or sale of a product that allows you to include provisions.
Counterfeit pharmaceutical - Counterfeit medicines (DSÖ'nün definition)
Identity and / or in terms of resources and fraud in order to know the wrong labels are counterfeit drugs. Taklit expression, can be used for both branded and generic products. Counterfeit products:
1) contains the right materials;
2) contains the wrong materials;
3) do not contain active ingredients;
4) that contain active ingredients in the wrong amount, or
5) packaging the product may be counterfeit.
CRO (Clinical Research Organization) - Clinical Research Organization
And clinical research of the pharmaceutical industry providing services organization specialized in the execution.
Daly-(Disability-adjusted Life Year) - Disability and life last year
Potential life lost due to premature death and disability due to lost years of productive by combining the creation of a disease refers to the total load. That a healthy life in a Daly is lost.
Data Exclusivity-Data Protection (also referred to as Data Protection) - (is also referred to as the Data Protection)
Proprietary information belonging to drugs, new drugs for effectiveness and reliability of the scientific research to reveal, and a license obtained from the authorities to get the licensing proprietary (confidential) information. Data protection period, a company related to a specific clinical data on medicinal products can protect their rights while. At that time, another company for making this data can not use generic drug license application. Data exclusivity, the TRIPs Agreement, Article 39.3 in accordance with an independent intellectual property rights protection is acquired.
Data Privacy - Data Privacy
Medical history and personal health data without the explicit approval of the individual, such as unexplained or individual information that can not be used for transfer.
Differential Pricing - Different Pricing
Sometimes "progressive pricing," with equity pricing "or" preferential pricing "is also referred to as. All of these terms, the poorest countries of the world by purchasing power is used to describe the principle of price adjustment.
Disease - Disease
In the general situation of the body or certain organs and vital functions that occur in the performance of the divider or parasitic disease is to change.
Doha Declaration - Doha Declaration
World Trade Organization (WTO) at the Doha (Qatar) 14 November 2001 at the Ministerial Conference adopted the "Declaration on the TRIPs Agreement and Public Health" stop. Provided more flexibility in the existing TRIPs Agreement makes clear that the developing countries to address national issues in providing emergency healthcare to the TRIPs Agreement, the commitment of member states to the WTO.
DTCI (Direct-to-Consumer Information - Consumer Direct Information
Is prohibited in Europe, the Direct to Consumer Promotion (Direct-to-Consumer Advertising - DTCA) In contrast, the pharmaceutical industry, all patients consult with their doctor of the health issues in the knowledge-based decision-making as possible to provide true, accurate and easy to understand access to the information you have been accepted . Europeans, including pharmaceutical companies, all sources have access to quality medicines. (see "Information for Patients").
Since the founding of the European Union adopted the common law is called the Community acquis. This is the European Union's 15 members signed a contract Devlet'li and contains approximately 80,000-page legislation.
Adherence - Commitment
Patients, in line with the proposed treatment, to what extent compliance with medical instructions and prescription drug use to explain. Developed countries, the general public about the long-term adherence to treatment is around 50%. This rate is much lower than in developing countries.
ADR - Adverse Drug Reaction - Adverse Drug Reaction
Profilaksisi of diseases, diagnosis, or treatment or modification of physiological function of the normal dose used in human medicine against the harmful and desirable means of the reaction.
Antimicrobial resistance - Antimicrobial resistance
Antimicrobial drugs (antibiotics and other antibacterial, antiviral, antifungal and antiparazit substances, including microorganisms to kill or prevent growth to any substance) in the field of health development, the treatment of infectious diseases and prevent infection of the very large extent has contributed. However, excessive or improper use of antibiotics (especially in children with respiratory infections) has led to the development of resistant organisms. Emergence and spread of antimicrobial resistance, the EU and the world, an important public health problem has become.
ATC - ATK
Anatomical, therapeutic, chemical letters of the word starts and an international system used sınıflandırılmasında drugs.
(Benchmarking) - Benchmarking
Benchmarking, to provide superior performance to reach the quest to find best practices sanayiideki.
Biotechnology - Biotechnology
Biotechnology yararlanılabilinmektedir in two ways.
Biotechnology, chemical compounds of living organisms (eg, antibiotics and vitamins) to produce or to change them to open the traditional biological methods. Second, the isolated DNA, copy, cut and re-assembly and DNA from a cell's genes to another based on the technology transfer capabilities to the host. A non-natural ways to change the genetic material and genetically modified organisms have been suffered organisms (GMO) is called.
Blockbuster
Worldwide more than 1 billion dollars is the term used for selling drugs.
Bolar
America, Roche Bolar and between firms of the proceedings with a court order made in watchman-Hatch Act amendments (1984), generic drug manufacturers license preparation for making application for a patent has not yet ended, the use of patented products has made it possible. This amendment, effective patent protection in the United States to provide for measures to be taken there is a part of the political compromise. In Europe, this compromise, SPC (EKB) in the regulations, and restrictions in force to license no more than 15 years. Bolar provision ( "early working" is also referred to as) will become established in Europe means impairment of balance.
Cadreac (Collaboration Agreement between Drug Regulatory Authorities in European Union Associated Countries - European Union Countries Drug Licensing Authorities Joint Cooperation Agreement Between)
Countries to join the Union as drug licensing authorities informal cooperation between the volunteers. Institutions are represented by directors. Purpose of this cooperation, the participation of institutions in areas of medicine to be eligible for a license to make is to help
Cell - Cell
Cell, is the basic unit of all living organisms. Some organisms live in a state of only one cell. Bacteria and certain animal and plant species in question is of the single cell. The average size of 60-100 trillion cells is a human being. Cells nourish themselves, produce energy, is found in the exchange of information with neighbors and will die when the time comes.
Centralized Procedure - Center Procedures
Medical products, since 1995 can be assessed through Center procedures. This procedure has been approved through the medical products are given a license is valid throughout the EU. Licenses, are given by the European Commission. The medicinal products derived from biotechnological processes for the use of these procedures is mandatory. More innovative products (for example, contains a new active ingredient products) companies or mutual recognition procedure, this procedure may choose to use. Center procedure is used, in London in the European Medical Products Evaluation Agency (EMEA - European Agency for the Evaluation of Medicinal Products) file must be present.
Clinical Trials - Clinical Research
Clinical research, patient's health to improve the reliability and effectiveness of a drug to evaluate the research work carried out on humans. On new drugs and pharmaceutical companies sponsoring clinical research is performed in the compound, including laboratory tests on the (chemical / biological / pharmacological / toxicological), intensive pre-clinical development efforts in successfully pass can start. This test required and only the results reached in the case of promising, companies may try drugs on humans.
Committee for Medicinal Products for Human Use - CHMP - Committee for Human Medical Products
European Medical Products Evaluation Agency (EMEA) under the Registered Medical Products Committee for evaluation of medicinal products for human questions about the scientific committee is responsible for preparing the Agency's views. The Committee is appointed by the Member States consists of 30 members.
Compassionate Use - Early Access Program for Humanitarian Purposes to medication
Medicine without a license is given to patients before the humanitarian situation.
Compulsory Licensing - Compulsory Licensing
TRIPs agreement, without the consent of the patent owner (for example, in emergency cases), states, solid, depending on conditions, the production or sale of a product that allows you to include provisions.
Counterfeit pharmaceutical - Counterfeit medicines (DSÖ'nün definition)
Identity and / or in terms of resources and fraud in order to know the wrong labels are counterfeit drugs. Taklit expression, can be used for both branded and generic products. Counterfeit products:
1) contains the right materials;
2) contains the wrong materials;
3) do not contain active ingredients;
4) that contain active ingredients in the wrong amount, or
5) packaging the product may be counterfeit.
CRO (Clinical Research Organization) - Clinical Research Organization
And clinical research of the pharmaceutical industry providing services organization specialized in the execution.
Daly-(Disability-adjusted Life Year) - Disability and life last year
Potential life lost due to premature death and disability due to lost years of productive by combining the creation of a disease refers to the total load. That a healthy life in a Daly is lost.
Data Exclusivity-Data Protection (also referred to as Data Protection) - (is also referred to as the Data Protection)
Proprietary information belonging to drugs, new drugs for effectiveness and reliability of the scientific research to reveal, and a license obtained from the authorities to get the licensing proprietary (confidential) information. Data protection period, a company related to a specific clinical data on medicinal products can protect their rights while. At that time, another company for making this data can not use generic drug license application. Data exclusivity, the TRIPs Agreement, Article 39.3 in accordance with an independent intellectual property rights protection is acquired.
Data Privacy - Data Privacy
Medical history and personal health data without the explicit approval of the individual, such as unexplained or individual information that can not be used for transfer.
Differential Pricing - Different Pricing
Sometimes "progressive pricing," with equity pricing "or" preferential pricing "is also referred to as. All of these terms, the poorest countries of the world by purchasing power is used to describe the principle of price adjustment.
Disease - Disease
In the general situation of the body or certain organs and vital functions that occur in the performance of the divider or parasitic disease is to change.
Doha Declaration - Doha Declaration
World Trade Organization (WTO) at the Doha (Qatar) 14 November 2001 at the Ministerial Conference adopted the "Declaration on the TRIPs Agreement and Public Health" stop. Provided more flexibility in the existing TRIPs Agreement makes clear that the developing countries to address national issues in providing emergency healthcare to the TRIPs Agreement, the commitment of member states to the WTO.
DTCI (Direct-to-Consumer Information - Consumer Direct Information
Is prohibited in Europe, the Direct to Consumer Promotion (Direct-to-Consumer Advertising - DTCA) In contrast, the pharmaceutical industry, all patients consult with their doctor of the health issues in the knowledge-based decision-making as possible to provide true, accurate and easy to understand access to the information you have been accepted . Europeans, including pharmaceutical companies, all sources have access to quality medicines. (see "Information for Patients").
European Commission blame the drug companies
Commission to market the drug companies to prevent competitors in the legal initiatives that were added.
Pharmaceutical companies take measures in accordance with law, emphasized the development and research objectives is to protect the investment says.
After the patent expired drugs for pharmaceutical companies producing cheaper versions of products into the European market are having trouble for a long time was expressed.
European Commission, the pharmaceutical manufacturers to enter the European market sometimes drugs cheaper to prevent a lot of overlap, have made application.
Commission at a time for a single drug, a full application for a patent in 1300 was done to this example.
700 cases
The European Commission's report, indicated that similar problems are experienced at the national level.
Approximately 700 patents related to open cases in the report that more than 200 brand name pharmaceutical companies in the main drug producing company to reach agreement was announced between.
More than 10 per cent of this agreement, the drug blocked the entrance to the market.
Unfair practices of the European Commission found that large penalties if drug companies could not be saved.
The Commission's report, has increased the pressure on the global pharmaceutical industry.
January 20 in the U.S. is prepared to take over the tasks of the new president Barack Obama'nın, the country is expected to work to reduce drug costs.
Pharmaceutical companies take measures in accordance with law, emphasized the development and research objectives is to protect the investment says.
After the patent expired drugs for pharmaceutical companies producing cheaper versions of products into the European market are having trouble for a long time was expressed.
European Commission, the pharmaceutical manufacturers to enter the European market sometimes drugs cheaper to prevent a lot of overlap, have made application.
Commission at a time for a single drug, a full application for a patent in 1300 was done to this example.
700 cases
The European Commission's report, indicated that similar problems are experienced at the national level.
Approximately 700 patents related to open cases in the report that more than 200 brand name pharmaceutical companies in the main drug producing company to reach agreement was announced between.
More than 10 per cent of this agreement, the drug blocked the entrance to the market.
Unfair practices of the European Commission found that large penalties if drug companies could not be saved.
The Commission's report, has increased the pressure on the global pharmaceutical industry.
January 20 in the U.S. is prepared to take over the tasks of the new president Barack Obama'nın, the country is expected to work to reduce drug costs.
Entry into the Japanese pharmaceutical giant Daiichi Sankyo Turkey
More interested in innovative medicines Japanese Daiichi Sankyo, has opened offices in Turkey. Company as the first thing he wanted to take osteoporosis medication in the market unveiled
ISTANBUL - Japanese pharmaceutical company Daiichi Sankyo, which will open Turkey office. Daiichi Sankyo'dan in the written description, Daiichi Sankyo Pharmaceutical Trading Ltd. All rights reserved. activities under the name of the company will be the center of Istanbul and Turkey to market Evista (Raloxifen) will enter the osteoporosis drug, he said.
Noted that the new institutions in Turkey's strategic management of Japanese pharmaceutical companies in Europe will take place in central Germany, the Munich head office, Turkey as well as offices in Germany, France, Britain, Spain and Italy all major western European pharmaceutical market is also centrally recorded.
Cardiology is growing in
, Noted that companies in the field of cardiology in the medium term growth target phrase was significant. Chairman Reinhard Bauer de Daiichi Sankyo Europe, issues related to assessments, the global pharmaceutical market in Turkey to increase the prevalence of a very important step for them said. In this way, until the year 2015 in Europe, leading pharmaceutical companies take its place among the goals one step closer to that expressed the Bauer, a multinational pharmaceutical company located in Turkey's Daiichi Sankyo'yu important factor affecting one of the market, and Turkey in the necessity of representation have been made . According to the information, research and sales of innovative medicines, pharmaceutical companies are interested in a Daiichi Sankyo in 2005, and Daiichi Sankyo is to combine traditional Japanese companies.
Turnover of 5.5 billion dollars
The company achieved a turnover of 5.5 billion Euro in 2007 in Tokyo center, the European center in Munich. With offices in 11 European countries with Daiichi Sankyo, research activities heart / circulatory, hematology, diabetes, antibiotics and cancer areas is getting intense.
ISTANBUL - Japanese pharmaceutical company Daiichi Sankyo, which will open Turkey office. Daiichi Sankyo'dan in the written description, Daiichi Sankyo Pharmaceutical Trading Ltd. All rights reserved. activities under the name of the company will be the center of Istanbul and Turkey to market Evista (Raloxifen) will enter the osteoporosis drug, he said.
Noted that the new institutions in Turkey's strategic management of Japanese pharmaceutical companies in Europe will take place in central Germany, the Munich head office, Turkey as well as offices in Germany, France, Britain, Spain and Italy all major western European pharmaceutical market is also centrally recorded.
Cardiology is growing in
, Noted that companies in the field of cardiology in the medium term growth target phrase was significant. Chairman Reinhard Bauer de Daiichi Sankyo Europe, issues related to assessments, the global pharmaceutical market in Turkey to increase the prevalence of a very important step for them said. In this way, until the year 2015 in Europe, leading pharmaceutical companies take its place among the goals one step closer to that expressed the Bauer, a multinational pharmaceutical company located in Turkey's Daiichi Sankyo'yu important factor affecting one of the market, and Turkey in the necessity of representation have been made . According to the information, research and sales of innovative medicines, pharmaceutical companies are interested in a Daiichi Sankyo in 2005, and Daiichi Sankyo is to combine traditional Japanese companies.
Turnover of 5.5 billion dollars
The company achieved a turnover of 5.5 billion Euro in 2007 in Tokyo center, the European center in Munich. With offices in 11 European countries with Daiichi Sankyo, research activities heart / circulatory, hematology, diabetes, antibiotics and cancer areas is getting intense.
Pharmaceutical industry from unfair competition worried
Turkey's EU membership negotiations on the drop-down titles will create unfair competition with the pharmaceutical sector concerned, the implementation does not wish to become a member. Intellectual Property Law on Tuesday we drop the additional protection under the certificate and that the data in the negotiation process into the future münhasiriyetinin (data exclusivity) 8 +2 +1 years to be removed, the reaction of the pharmaceutical industry has taken.
Equivalent European Medicines Association (EGA) performed by 4'üncüsü this year, "South East Europe Pharmaceutical Symposium" was held yesterday in Istanbul. Equivalent to the European integration process of the pharmaceutical industry be addressed in the symposium, particularly intellectual property rights was emphasized.
Symposium talk at the General Secretary of Turkey, Turgut Tokgöz Pharmaceuticals Employers' Unions, the EU harmonization process, the Turkish pharmaceutical industry as well as positive in terms of equivalent pharmaceutical industry will adversely affect the development, he said. Tokgöz, competition and intellectual property rights in a rational balance between the provision of a vital issue for the pharmaceutical industry is equivalent said.
EGA Director Greg Perry, the main concern in the region of the additional protection certificates, data exclusivity and patents are the bond issues, he said.
Equivalent European Medicines Association (EGA) performed by 4'üncüsü this year, "South East Europe Pharmaceutical Symposium" was held yesterday in Istanbul. Equivalent to the European integration process of the pharmaceutical industry be addressed in the symposium, particularly intellectual property rights was emphasized.
Symposium talk at the General Secretary of Turkey, Turgut Tokgöz Pharmaceuticals Employers' Unions, the EU harmonization process, the Turkish pharmaceutical industry as well as positive in terms of equivalent pharmaceutical industry will adversely affect the development, he said. Tokgöz, competition and intellectual property rights in a rational balance between the provision of a vital issue for the pharmaceutical industry is equivalent said.
EGA Director Greg Perry, the main concern in the region of the additional protection certificates, data exclusivity and patents are the bond issues, he said.
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