Complications following cell therapy

So far, the law in the Federal Republic of Germany still allows the injection of fresh-cell preparations from animals as a roborant to increase the vitality of the organism and to strengthen the body's immune defense system. The use of "sicca-cell" preparations was provisionally forbidden in 1987 by the Federal Health Organization (Bundesgesundheitsamt; BGA). Prohibition of fresh-cell injections would have exceeded the authority of this office, although the same serious reservations also applied in the case of this treatment method. Several publications that have appeared since 1955 have reported serious complications of this therapy, some life-threatening and some even lethal. Two further cases are now added: (1) A woman aged 69 had been receiving treatment with cell injections for 9 years. Immediately after an injection of sicca cells she collapsed and was hospitalized; 7 days thereafter she developed an ascending paralysis with increasing inability to swallow or breathe. She died 25 days after the injection as a consequence of central and peripheral respiratory failure. Autopsy revealed the alterations typical for acute Landry-Guillain-Barré-Strohl syndrome. (2) A 76-year-old healthy woman had been receiving treatment with fresh-cell preparations for several years. After an injection of cell suspensions a painful local swelling was observed. The symptoms were interpreted as the consequence of an iatrogenic local hematoma, and repeated punctures were performed to obtain blood. The patient was transferred to a surgical department for further therapy. Two days after the injection she suddenly died with signs of acute cardiovascular failure. Autopsy revealed the signs of a fulminating clostridial infection and also the characteristic signs of Landry-Guillain-Barré syndrome with involvement of the autonomic nervous system. In both cases the development of an inflammatory process in the peripheral nervous system could be interpreted as an immune-mediated allergic disease, related to the repeated injection of heterologous antigenic material containing nervous tissues. This hypothesis would also explain the two other cases already published and would be consistent with the observed perivenous leukoencephalopathy of the central nervous system. The human disease pictures correspond to the well-established animal models of EAEM (experimental allergic encephalomyelitis) and EAN (experimental allergic neuritis). The pathogenesis is discussed; the major role of the central and peripheral nervous system is stressed, with special reference to the risk of acute autonomic failure. The need for specific autopsy techniques for the investigation of the entire nervous system, including spinal cord, roots, spinal ganglia and peripheral nerves with sympathetic chains, is raised.     

Fatal decompression sickness following therapeutic hyperbaric environment (author's transl)

In Hannover/Germany in 1976 a so called "Society for Regenerative Hyperbaric Therapy" (Gesellschaft für Regenerative Uberdruck-Therapie) subjected 20 patients within two coupled multi-place chambers to a simulated hyperbaric environment, equivalent to a maximum of 4 ata, followed usually by gradual reductions of the pressure. The patients were of an average age of 67.2 years and were afflicted by various disorders. During one of the "dives" a patient developed air embolism of the central nervous system. During ensuing confusion of the chamber was opened suddenly, with resultant explosive reduction of the high pressure. This resulted in five letal accidents of decompression sickness. Post mortem examination revealed diffuse distribution of gas bubbles throughout the entire body. By elecronmicroscopy each bubble was covered by an osmiophilic coat. Post mortem findings are discussed and correlated with well-known and new clinical symptomes. These observations present for the first time fatal accidents of decompression sickness in humans, associated with hyperbaric air-therapy.     

Pitfalls in the diagnosis of drug smuggler's abdomen

Narcotics "body packing" can be detected in abdominal X-rays by the ring shadow caused by air trapped in the packs. In a series of 82 cases admitted for abdominal X-ray in Helsinki, Finland, in 1982 through 1988, we encountered 9 (11.0%) true positives, 3 (3.6%) false positives, and 1 (1.2%) false negative. The false positives were due to the constipation often associated with the narcotics abuse. The false negative X-ray diagnosis was attributable to an inexperienced radiologist. False negatives may also be associated with packets containing marijuana, packs with few wrappings, aluminum-foil coated packs, and machine-packed narcotics. Searching for trapped air in radiographs, repeated X-raying by an experienced radiologist, use of computed tomography, or combined urinary drug screening may be applied to diminish false findings and to avoid unnecessary arrest for the purpose of fecal screening over several days.     

经行政程序处理完的事情，当事人能否请求司法救济

请求司法救济是公民、法人运用法律武器保护自己合法权益的手段,但在司法实践中有些当事人不能正确运用法律武器保护自己的权利,且将行政程序处理完的事情请求司法救济。本文作者从几个方面分析了该案当事人的脱法行为,阐述了行政程序与法律程序在该案中适用范围及一事不再理原则在实践中的运用。     

Intellectual Property,Access to Medicines,and Health: New Research Horizons

In this introduction, we review the literature on intellectual property rights and access to medicines, identifying two distinct generations of research. The first generation analyzes the origins of new intellectual property rules, in particular the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), and the significance of TRIPS to developing countries. The second generation examines national-level experiences, as countries adjust their laws and practices to conform to TRIPS. Based on the insights provided by the articles in the special issue, we contribute to the second generation by considering a pair of overarching sets of issues. First, we highlight the domestic political challenges that affect how countries go about implementing their new obligations under TRIPS. We argue that alliances and coalitions are necessary to underpin the use of policy instruments designed to conform to TRIPS while taking into account local conditions and needs, and we present insights that allow us to understand why alliances and coalitions are difficult to construct and sustain in this area. Second, we explain why policies that many countries adopt in response to TRIPS often do not generate their desired or intended outcomes. In the last section of the introduction, we review the articles that appear in this special issue.     

Spotlight on research integrity: international insights on strengthening research culture in the forensic sciences and beyond

The Singapore Statement on Research Integrity, articulated during the 2nd World Conference on Research Integrity in 2010, encompasses principles that apply to all research endeavours, including the various disciplines that comprise the field of forensic science Singapore Statement on Research Integrity (2010) (https://wcrif.org/guidance/singapore-statement). Cases of research misconduct and breaches of research integrity in any field undermine the trustworthiness of research and make it difficult if not impossible for others to rely upon and replicate research results. Moreover, problems in the research environment, whether in the academic, public, or private sector, can include bullying and harassment, discrimination, abuse of power and corruption, as well as competitive pressures related to employment and status.