The use of genetic information in the insurance sector - a German perspective

El presente trabajo ofrece una introducción al marco normativo alemán relativo a la utilización de la información genética en el sector de los seguros. Se examinan los principales contenidos y los temas más controvertidos de la normativa en cuestión. El objetivo de esta norma es garantizar de dignidad humana, respetando el derecho a la autodeterminación informativa en relación con los datos genéticos, incluyendo el derecho del individuo a no saber acerca de sus características genéticas, habiendo una serie de cuestiones abiertas que han de ser abordadas. En este sentido, se examina la influencia de la prohibición de solicitar pruebas genéticas y de utilizar los resultados de dichas pruebas por la aseguradora. En examen lleva a algunos resultados explícitos, como la suposición de que, además de la prohibición del uso de las pruebas genéticas, el hecho de que las preguntas sobre el historial médico de la familia sean inadmisibles. Los autores abordan la definición de las pruebas genéticas y la cuestión de en qué medida los resultados de las pruebas genéticas de diagnóstico todavía puede hacerse uso de en el contexto de la obligación de la persona asegurada para mostrar condiciones y enfermedades preexistentes, en el momento de la celebración del contrato (...) (AU)

The following paper offers an introduction to the legal framework concerning the use of genetic information in the insurance sector in Germany. The main contents and the controversial issues of the key regulation are examined. The aim of this rule being to secure human dignity by respecting the rights to informational self-determination regarding genetic data, including the individual’s right not to know about their genetic characteristics, there are a number of open issues which are being addressed. For instance, the influence of the prohibition to ask for genetic testing and to use the results of any such testing by the insurer is examined. This examination leads to some explicit results, such as the assumption that in addition to the ban on the use of genetic testing no questions about family medical history are admissible. The authors embark on the definition of genetic testing and the question to what extent the results of diagnostic genetic testing may still be made use of in the context of the insured person´s obligation to display preexisting conditions and diseases when the contract is concluded (...) (AU)

The use of genetic information in the insurance sector--a German perspective.

The following paper offers an introduction to the legal framework concerning the use of genetic information in the insurance sector in Germany. The main contents and the controversial issues of the key regulation are examined. The aim of this rule being to secure human dignity by respecting the right to informational self-determination regarding genetic data, including the individual's right not to know about their genetic characteristics, there are a number of open issues which are being addressed. For instance, the influence of the prohibition to ask for genetic testing and to use the results of any such testing by the insurer is examined. This examination leads to some explicit results, such as the assumption that in addition to the ban on the use of genetic testing no questions about family medical history are admissible. The authors embark on the definition of genetic testing and the question to what extent the results of diagnostic genetic testing may still be made use of in the context of the insured person's obligation to display pre-existing conditions and diseases when the contract is concluded. In this respect distinctions between diagnostic and predictive genetic testing as well as between disease and disposition are drawn. Furthermore, the exceptions from the prohibition to use results of genetic testing are examined, and the scope of the prohibition of acceptance of results of genetic testing even if performed at the instigation of the insured is explored. Finally the consequences, encompassing criminal liability and private law ramifications, of the violation of the prohibition are presented. In this context, a narrow understanding of the aggravated criminal offence of using results of genetic testing with the intent to personal enrichment or in return for payments is developed. Finally the effects on the validity of the insurance contract and the question whether the insurer may be forced to conclude a contract are examined.

Differential diagnosis of benign and malign pancreatic masses with 18F-fluordeoxyglucose-positron emission tomography recorded with a dual-head coincidence gamma camera.

INTRODUCTION: Metabolic imaging using 18F-fluordeoxyglucose and a ring-positron emission tomography camera is an established method in the differential diagnosis of pancreatic masses. Ring-positron emission tomography cameras, however, are expensive and available in only few specialized centres. The aim of this study was to investigate how far 18F-fluordeoxyglucose scan with a conventional dual-head gamma-camera could differentiate between benign and malign pancreatic masses. MATERIAL AND METHODS: Forty-one patients (male/female: 25/16; mean age: 64.0 years; range: 41-86 years) with a pancreatic mass detected by ultrasound, computed tomography or MRI were included. In all patients 18F-fluordeoxyglucose scan was performed after overnight fasting and injection of 4 mCi 18F-fluordeoxyglucose using an ADAC Vertex MCD dual head gamma-camera (ADAC; Milpitas, California, USA), equipped with a 5/8-inch NaI-crystal. Images were acquired through a 180 degrees grade rotation in the three dimensional mode. The chosen matrix was 128 x 128 x 16, a Butterworthfilter (ADAC) was used and data were transferred into visible sinograms via Fourier-Rebinning. Coronar, sagittal and transversal slices of 3.9 mm thickness each were acquired. Focal tracer enhancement was suspicious for a malignoma and therefore regarded as positive, diffuse or no tracer uptake was suspicious for a benign process and was regarded as negative for cancer. DEFINITION OF GOLD STANDARDS: A diagnosis of cancer had to be confirmed histologically by specimens obtained by 18G-needle biopsy, surgical resection or at autopsy. A diagnosis of an inflammatory mass was considered proven, if no carcinoma could be found histologically in the surgically resected mass or at autopsy, or if there was no progression of the disease during a follow-up of at least 12 months. RESULTS: In 22 patients carcinoma was diagnosed (pancreatic cancer: n=17; endocrine tumour: n=3; carcinoma of the common bile duct: n=2). 18F-fluordeoxyglucose scan showed a focal tracer enhancement in 19 of these 22 patients (sensitivity: 86.4%). False negative results were acquired in two patients with cancer of the common bile duct and in one patient with poorly controlled insulin-dependent diabetes mellitus. In 19 patients the final diagnosis was an inflammatory pancreatic mass. 18F-fluordeoxyglucose scan showed a diffuse tracer enhancement in 15 of these 19 patients (specificity: 78.9%). False positive results were acquired in three patients whose blood tests showed signs of an acute episode of chronic pancreatitis. Positive and negative predictive values of 18F-fluordeoxyglucose scan were 82.6% and 83.3%, respectively. CONCLUSION: 18F-fluordeoxyglucose scan with a conventional dual-head gamma-camera is a highly sensitive and specific method in the differential diagnosis of benign and malign pancreatic masses.

Neurosarcoidosis--a diagnostic pitfall with consequences.

Neurosarcoidosis is often a diagnostic dilemma, especially in the absence of other organ involvement. We report a 64-year-old patient who had suffered from paraplegia due to an intramedullar process since 1995. The presumptive diagnosis based on computed tomography was spinal cord infarction. Six years later, he complained about increasing paresthesia. Magnetic resonance imaging of the spinal cord showed nodular meningeal enhancement. Computed tomography of the thorax revealed mediastinal and hilar lymphadenopathy. Bronchoscopy under generalized anesthesia was performed. The differential cell count in bronchoalveolar lavage fluid showed 39% lymphocytes and a CD4(+)/CD8(+) ratio of 17.7. Histological examination of biopsy specimens from the hilar lymph nodes revealed non-necrotizing granulomas with epitheloid cells and Langerhans-type giant cells, consistent with the diagnosis of sarcoidosis. As a result of these findings, lumbar puncture was undertaken and a raised protein concentration and pleocytosis were found in the cerebrospinal fluid. The number of lymphocytes (9,250 lymphocytes/l) and a CD4(+)/CD8(+) ratio of 10.78 led to the diagnosis of neurosarcoidosis. Paralysis might have been prevented if the correct diagnosis of neurosarcoidosis had been established earlier in this patient.

Surgical treatment for severe acute pancreatitis: extent and surgical control of necrosis determine outcome.

In patients operated on for severe acute pancreatitis (SAP), the factors determining outcome remain unclear. From 1986 to 1998 a total of 340 patients with a diagnosis of SAP and in need of operative treatment were admitted to the intensive care unit (ICU) of a university hospital and a secondary care hospital. The mean APACHE II score on the day of admission was 16.1 (range 8-35). All patients required operative therapy. Among the 340 patients, 270 (79.4%) had to be reoperated: 196 patients (72.6%) underwent operative revisions on demand, and 74 (27.4%) patients had preplanned reoperation. The overall mortality was 39.1% (133 patients). Septic organ failure in 126 patients (37.1%) and myocardial infarction or pulmonary embolism in 7 patients (2%) were the causes of death. The patient's age (p < 0.0002), APACHE II scores at admission (p < 0.0001), presence or development of (single or multiple) organ failure (p < 0.002), infection (p < 0.02) and extent (p < 0.04) of pancreatic necrosis, and surgical control of local necrosis (p < 0.0001) significantly determined survival. SAP that requires surgical treatment is associated with high in-hospital mortality. Surgical control of local necrosis is the precondition for survival. Advanced age of the patient, high APACHE II score at admission, development of organ failure, and the extent and infection of pancreatic necrosis influence the outcome.