• The Korean Society of Law and Medicine
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• v.21 no.1
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• pp.223-259
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• 2020

With COVID-19 spreading rapidly around the world, research and development issues on treatments and vaccines for the virus are of high interest. Among them, Remdesivir was the first to show noticeable therapeutic effects and began clinical trials, with each country authorizing the use of the drug through emergency approval. However, Gilead Co., Ltd., the developer of Remdesivir, received a lot of criticism from civic groups for submitting the application for the marketing authorization as an orphan drug. This is because when a new drug got a marketing authorization as an orphan drug could be granted an exclusive status for seven year. The long-term exclusive status of an orphan drug comes from the policy purpose of motivating pharmaceutical companies to develop treatment opportunities for patients suffering from rare diseases, which was not appropriate to apply to infectious disease treatments. This paper provides a review of the problems and improvement directions of the domestic system through comparative legal consideration against the United States, Europe and Japan for the statutes which give exclusive status to medicines. The domestic system has a fundamental problem that it does not have explicit provisions in the statute in the manner of granting exclusive status, and that it uses the review system to give it exclusive status indirectly. In addition, in the case of orphan drugs, the "Rare Diseases Management Act" and the "Regulations on Examination of Items Permission and Reporting of Drugs" provide overlapping review periods, and despite the relatively long monopoly period, there seems to be no check clause to recover exclusive status in the event of a change in circumstances. Given that biopharmaceuticals are difficult to obtain patents, the lack of such provisions is a pity of domestic legislation, although granting exclusive rights may be a great motivation to induce drug development. In the United States, given that the first biosimilar also has a one-year monopoly period, it can be interpreted that domestic legislation is quite strictly limited to granting exclusive status to biopharmaceuticals. The need for improvement of the domestic system will be recognized in that it could undermine local pharmaceutical companies' willingness to develop biopharmaceuticals in the future, and in that it is also necessary to harmonize international regulations. Taking advantage of the emergence of COVID-19 as an opportunity, we look again at the problems of the domestic system that grants exclusive rights to medicines and hope that an overall revision of the relevant legislation will be made to establish a unified legal basis.

• The Korean Society of Law and Medicine
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• v.21 no.1
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• pp.107-152
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• 2020

During the main ruling in 2019, a number of rulings that were of interest or meaningful were handed down, such as just because the complication of medical practice has occurred, there is no presumption of negligence, a case involving a fall accident in which a lot of culpability has recently been made. the death of a well-known singer that caused a sensation, a case about damages caused by MERS in 2015, which is more meaningful in connection with damages caused by COVID-19, an infectious disease that has recently hit the world, including Korea. In preaching the principles of the law, just because there has been a complication caused by medical practice, there is no presumption of negligence, 'The scope of the complication without presumption of negligence' was determined differently by the court, the court was not able to specify the criteria. Specific circumstances were presented to limit the responsibility of the medical institution while acknowledging the malpractice of the medical institution in relation to the fall accident. In relation to the scope of damages, judgment was made on issues related to the calculation of lost profits of medical malpractice; criteria for determining celebrities' daily income, criteria for determining daily income in case of receiving survivor's pension due to medical accident, an incident in which the daily income is denied if the labor capacity is already lost at the time of a medical accident. But, it seems that judgments should be made based on clearer and more reasonable standards. Related to Medical Advertise, specific logic of judgment was presented as to whether it was interpreted as being in accordance with the specific prohibition listed in Article 27 paragraph 3 of the Medical Law, which is the criterion for violation of the Medical Law, or if it constitutes a significant harm to the order of the medical market. In response to the prohibition of operating the multiple medical institutions, the Constitutional Court decided that it was constitutional because it did not violate the regulations on excessive funding, and rationally limited the scope of the prohibited 'redundant operation'. The Supreme Court ruled for the first time that even a medical institution established and operated in violation of the Medical Service Act did not make it impossible to receive all medical care benefits implemented by a medical institution under the National Health Insurance Act. Significant rulings were finalized that recognized the existence of specific protection obligations for the people of the country in the management of infectious diseases.

• Journal of Society of Preventive Korean Medicine
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• v.9 no.2
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• pp.1-16
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• 2005

The present study is designed to provide basic data for the future health promotion projects to be aimed at improving quality of life for the elderly people in the increasingly aging society of Korea by investigating factors related to the yangseng of old people in rural areas. The results of this study are intended to serve as fundamental for efficient approach toward health promotion projects for the elderly in rural communities. For this purpose, a survey by questionnaires was conducted to rural inhabitants from May to June 2004. The replies were analyzed from the perspective of Oriental medicine for yangseng. 1. The average points of health care appeared to be 3.24. In details by sub-areas, morality was 3.79, followed by 3.74 for activities and rest, 3.73 for sleeping, 3.29 for diet, 3.25 for mind, 2.88 for season, 2.12 for exercise and 1.95 for sexual life in sequence, showing that the yangseng of morality was scored highest while the area of sexual life were rated lowest. 2. As for the extent of health care depending on the characters of the subjects, spoused ones, married couples living alone, while the higher educated and the more leisure is utilized, the more the care is paid for yangseng. 3. Concerning the extent of yangseng depending on the general characters of the subjects, men showed more yangseng in activities and rest. The group aged 70 to 74 acquired the highest points in mind yangseng. The group with spouse featured higher concern for yangseng in the categories of morality, diet, activities and rest, sleeping and sexual life. Married couples who are living with no other family members recorded the highest points in the areas of morality, diet, sleeping and sexual life(P<0.05). 4. In terms of socioeconomic characters, the more one is educated, the more he/she is tended to take yangseng in the exercise, sleeping and sexual life. The group with occupation is inclined to take more yangseng in the activities and rest and sleeping. When people have to work for their keep, they usually showed to have highest yangseng for sleeping. People who enjoy leisure showed higher yangseng in all areas except for morality. In case man has religion, he showed more yangseng in the activities and rest, exercise and sleeping(P<0.05). 5. Those who reply they are confident with health showed higher yangseng. No significant difference was found in all areas except for sexual life in which high care is taken for yangseng, as far as one has no disease. Those who are confident with health had highest yangseng in all areas except for season yangseng(P<0.05). As seen above, extents of yangseng by the old people in the rural area are found to have difference depending on the individual and socioeconomic characters, factors which should be seriously considered in the local health promotion projects and projects for the health of the elderly. Particularly important is to launch health promotion programs and to analyze their effects to promote health care particularly in the areas of sexual life, exercise and season yangseng that turned out to be lowest by taking into account of yangseng in each sub-area.

• Journal of the Korean Society of Radiology
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• v.14 no.2
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• pp.157-168
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• 2020

Advancements in segmentation methodology has made automatic segmentation of brain structures using structural images accurate and consistent. One method of automatic segmentation, which involves registering atlas information from template space to subject space, requires a high quality atlas with accurate boundaries for consistent segmentation. The Allen Mouse Brain Atlas, which has been widely accepted as a high quality reference of the mouse brain, has been used in various segmentations and can provide accurate coordinates and boundaries of mouse brain structures for tractography. Through probabilistic tractography, diffusion tensor images can be used to map comprehensive neuronal network of white matter pathways of the brain. Comparisons between neural networks of mouse and human brains showed that various clinical tests on mouse models were able to simulate disease pathology of human brains, increasing the importance of clinical mouse brain studies. However, differences between brain size of human and mouse brain has made it difficult to achieve the necessary image quality for analysis and the conditions for sufficient image quality such as a long scan time makes using live samples unrealistic. In order to secure a mouse brain image with a sufficient scan time, an Ex-vivo experiment of a mouse brain was conducted for this study. Using FSL, a tool for analyzing tensor images, we proposed a semi-automated segmentation and tractography analysis pipeline of the mouse brain and applied it to various mouse models. Also, in order to determine the useful signal-to-noise ratio of the diffusion tensor image acquired for the tractography analysis, images with various excitation numbers were compared.

• Parasites, Hosts and Diseases
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• v.31 no.1
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• pp.57-66
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• 1993

The potential of fumagillin dicyclohexylamine salt to treat and prevent intestinal giant-cystic disease in Israel carp, Cyprinus carpio nudus, was monitored in field experimental studies. In experiment 1 (therapeutic), most fish were already naturally infected with more advanced stage of Relohqnellu: kitnuet. Fumagillin was administered to ash (mean body weiht of 830 g for a Penod of one month at a dose of 10.62 mg in the first group and 5.3 mg in the second group per fi sh per day. In experiment 2 (fprophylactlcl), most flesh also were already naturally infected with an early developmental stage of the protozoa and fish (average body weight of 484 g) were administered fumagillln for 45 days at a dose of 3.95 mg per fish per day. In both experiments, the cumulative mortalities of fish and the extrusion rates of the polar filaments of the spores were significantly decreased in a dose-independent fashion. In experiment 2 no dead fish were observed. No adverse side effects of the drug were observed among fish from any dosage group. In experiment 2, an oval or dot-like concave lesion of most cysts developed at the 7th day and the vegetative form was never observed at the 17th day postmedication and the cysts were grossly reduced in size as compared with the control group, beginning at the 24th day until the end of the study. In contrast, it was scarcely effective to the cysts in experiment 1. Taking the seasonal development of the protozoa into consideration, the above results revealed that oral administration of fumagillin at 3.95 mg/500 g body weight/day for a month Is the optimal dose for the treatment and prevention of thelohanellosls caused by T kitnuei among C. carpio nudus.

• Journal of Plant Biotechnology
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• v.33 no.4
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• pp.309-313
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• 2006

Discovery of single nucleotide polymorphisms (SNPs), including small insertions and deletions, is one of the hot topics in genetic research. The most common type of sequence variant consists of single base differences or small insertions and deletions at specific nucleotide positions. Significance of SNPs in rice is increasing for genetic research, positional cloning and molecular breeding. $F_2$ 170 lines and $F_3$ 194 lines derived from Sangjuchalbyeo/HR13721-53-3-1-3-3-2-2 Were used for Searching SNP markers related to bacterial blight resistance. Sangjuchalbyeo is susceptible to bacterial blight, but HR13721-53-3-1-3-3-2-2 has Xa1 gene resistant to bacterial blight. Individual lines were inoculated with $K_1$ race of bacterial blight and resistant or susceptible was evaluated after 3 weeks from inoculation. The genotypes of population were analysed by PCR-RFLP for SNP marker developing. The segregation of $F_2\;and\;F_3$ population showed almost 3:1, 1:1 ratio, respectively. Analysis of genotype using SNP marker is capable of confirming resistance for $K_1$ race and genotype through amplifying the gene using 16PFXal primer and digested the PCR product with Eco RV. There were close relation between resistance test for $K_1$ race and SNP marker genotype. Especially, DNA analysis using SNP marker is capable of judging homozygote/heterozygote in $F_2$ population compared with resistant test for Kl race. So, it seems to improve the selection efficiency in disease resistant breeding.

• Pediatric Gastroenterology, Hepatology & Nutrition
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• v.12 no.2
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• pp.207-214
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• 2009

Purpose: Childhood obesity can be complicated by hypertension, hyperlipidemia, non-alcoholic fatty liver disease, and diabetes mellitus. The aim of this study was to evaluate the prevalence of obesity and metabolic complications of children and adolescents based on the degree of obesity. Methods: We analyzed the records of 8,880 students who received student health examinations between May 2006 and October 2008 at the Eulji General Hospital. The prevalence of obesity was evaluated by the body mass index and obesity index. A total of 1,076 obese students had blood tests. We analyzed aspartate aminotransferase (AST), alanine aminotransferase (ALT), fasting glucose, total cholesterol, and blood pressure according to the degree of obesity. Results: According to the body mass index, the overall prevalence of obesity was 7.2% (7.8% of male and 6.5% of female students). Based on the obesity index, 12.3% of students (mild: 6.3%, moderate: 5.0%, and severe: 1.0%) were obese. The prevalence of hypercholesterolemia, ALT elevation, and hypertension were increased as a function of the degree of obesity (p<0.05), but hyperglycemia showed no significant differences (p=0.298). The overall prevalence of ALT elevation was 17.7% (mild obese group, 10.4%; moderate obese group, 20.5%; and severe obese group, 46.8%). The prevalence of hypercholesterolemia, hypertension, and hyperglycemia were significantly higher in the elevated ALT group (24.7%, 42.6%, and 5.2%, respectively) compared to the normal ALT group (11.1%, 29.8%, and 2.0%, respectively; p<0.05). Conclusion: Hypercholesterolemia, liver function test abnormalities, and hypertension were associated with the degree of obesity. We should focus our attention on managing obese children and adolescents to prevent metabolic complications.

• Pediatric Gastroenterology, Hepatology & Nutrition
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• v.13 no.1
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• pp.30-35
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• 2010

Purpose: Infectious ileocecitis is an infection confined to the ileocecal area and one of the most common causes of pediatric abdominal pain. This study was performed to demonstrate the clinical features of infectious ileocecitis in children. Methods: The medical records and radiologic findings of 37 patients with ileocecitis diagnosed by ultrasonography and/or computed tomography, who were admitted to Pusan National University Hospital from January 2004 and July 2008, were reviewed retrospectively. Viral gastroenteritis and secondary ileocecitis were excluded. Results: The mean age of the patients was 4.8${\pm}$3.4 years. One-half of the patients were preschool children. The chief complaint was abdominal pain (75.7%), diarrhea (10.8%), and vomiting (8.1%). Accompanying symptoms were fever (56.8%), vomiting (21.6%), and diarrhea (16.2%). The mean duration of abdominal pain, fever, diarrhea, and vomiting was 3.8${\pm}$2.1, 3.0${\pm}$1.9, 3.4${\pm}$1.9, and 2.4${\pm}$2.3 days, respectively. The frequency of diarrhea and vomiting was 5.8${\pm}$2.2 and 4.0${\pm}$2.8 per day, respectively. Diagnosis was made by abdominal ultrasonography in 22 patients (59.5%), abdominal CT in 2 patients (5.4%), and both modalities in 13 patients (35.1%). Besides the radiologic finding of thickening of the bowel wall, mesenteric lymphadenitis (59.5%), ascites (5.4%), and both mesenteric lymphadenitis and ascites (16.2%) were revealed. The mean duration of illness was 7.5${\pm}$5.0 days. There were no specific laboratory findings, and culture studies with stool or blood were negative. All of the patients recovered completely without specific treatment. Conclusion: Infectious ileocecitis has acute appendicitis-mimicking symptoms, but is self-limited within a few days, thus unnecessary treatment and work-up is avoided. However, distinguishing infectious ileocecitis from appendicitis, inflammatory bowel disease, and mesenteric lymphadenitis is important.

• Pediatric Gastroenterology, Hepatology & Nutrition
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• v.13 no.1
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• pp.58-65
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• 2010

Purpose: Since there are few studies involving acute pancreatitis in children, we reviewed our experience with this medical condition to describe the clinical features. Methods: A retrospective analysis was conducted by reviewing the medical records of 41 patients with AP who were admitted to the Department of Pediatrics of Pusan National University Hospital between January 1996 and June 2007. Results: Twenty males and 21 females (mean age, 8.7${\pm}$4.5 years) were included. In 22 patients (53.7%), no definitive causes were found. The most common etiologies were choledochal cysts (22.0%). Necrotizing pancreatitis was diagnosed in 5 patients (12.2%), and recurrent acute pancreatitis in 4 patients (9.8%). CT findings included pancreatic swelling (43.9%), peripancreatic fluid collection (29.3%), ascites (24.4%), and peripancreatic fat necrosis (12.2%). Serum amylase and lipase levels at diagnosis were 535.3${\pm}$553.2 and 766.2${\pm}$723.6 U/L, respectively, and were normalized within 1 week in 22 and 14 patients, respectively. On the basis of the Balthazar scale, 2 patients were diagnosed with severe AP. In 4 patients (9.8%), a surgical procedure was indicated. Major complications included ascites (32.3%), sepsis (16.1%), and pseudocyst and renal impairments (12.9%). Two patients died from multi-organ failure. Conclusion: The etiologies of AP in children are varied. Most children have a single episode and a self-limited course. However, AP of childhood still carries significant morbidity and mortality. Early diagnosis, appropriate treatment according to disease severity, and management of complications are important.

• Pediatric Infection and Vaccine
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• v.8 no.1
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• pp.94-100
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• 2001

Purpose : Enterovirus is a common cause of aseptic meningitis and nonspecific febrile illness in young children. During the summer and fall months, enterovirus-infected young children are frequently admitted and evaluated to rule out bacterial sepsis and/or meningitis. The purpose of this study was to evaluate the relationship between nonpolio enterovirus infection and febrile illness in infants under 3 months of age during the summer, fall months by using a stool culture to identify the presence of enterovirus. Methods : Patients included febrile infants under 3 months of age admitted to Masan Fatima Hospital for sepsis evaluation from May 1999 to September 1999. Cultures were performed from stool and Cerebrospinal fluid samples and then were tested for enterovirus infection. Viral isolation and serotype identification were performed by cell culture and immunofluorescent testing. Enteroviruses not typed by immunofluorescent testing were confirmed by reverse transcription-polymerase chain reaction. Results : A total of 44 febrile infants were enrolled; of those, 20(45%) were positive for enterovirus. Two enterovirus culture-positive infants had concomitant urinary tract infection and one had Kawasaki disease. All infants infected with an enterovirus recovered without complications. Serotype of 20 enteroviruses were isolated from stool, 3 of echovirus type 9, 1 of echovirus type 11, 1 Coxsachievirus type B4, 15 of untyped enteroviruses. One untyped enterovirus was isolated in the CSF. Conclusion : Nonpolio enterovirus infections are associated with nonspecific febrile illnesses in infants under 3 months of age.