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From a scientific viewpoint, the Human Genome Project is actually not in the dock, nor even under reasonable suspicion of wrongdoing. Overwhelmingly, it will prove of benefit to humanity. However, from legal, ethical and other societal points of view, there are many problems already being considered by bioethicists, philosophers, religious experts, lawyers and others in dialogue with scientists.
Large clinical trials are expensive to mount. Funding comes mainly from pharmaceutical companies seeking information on drug efficacy and adverse events. Patients should be informed of the financial and publication agreements reached between those conducting the trials. This is unlikely to have a significant effect on trial participation and will provide patients with information relevant to informed consent. A small proportion of monies raised from drug trials could be set aside to fund both a trial register site and further studies on adverse drug reactions.
The clinical approach to the patient with a suspected disorder of memory and intellect is to establish whether it is dementia, which parts of the brain are affected, what is the cause, what is the prognosis, and what can be done about it. The diagnosis of dementia usually requires the involvement of memory and at least one other cognitive system. Delirium and depression are important differential diagnoses. Patients with dementia should usually have some simple investigations after a careful history-taking and examination to identify "reversible" causes. The commonest cause of dementia is Alzheimer's disease, in which short-term memory disturbance is usually prominent. Other causes of dementia include cerebrovascular disease, Lewy-body disease and Pick's disease. There is now hope for patients with Alzheimer's disease (which can be treated with some success with cholinesterase inhibitors) and patients with vascular dementia, in whom aggressive control of causal risk factors may retard progression.
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The development of computerized decision support technologies is having a profound impact on the management of patient care. This article describes different types of clinical decision support software, examines appropriate usage and current examples of implementation, and reviews a range of ethical considerations. The authors are in the midst of implementing a computerized decision support system for care management in their managed care organization.
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The Internet provides new opportunities to information-based industries such as universities. If a vast majority of potential customers of our programs have access to the Internet, then it is conceivable that many universities will begin teaching Internet courses and that such courses could, in many cases, replace or at least augment existing face-to-face classroom activities. This paper is an account of one such course at Cleveland State University and the type of policy issues raised by the course at this institution.
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The relation between a pharmaceutical company and a clinical investigator combines a certain form of entrepreneurship with scientific endeavour. Both parties are concerned with the content of the clinical study as well as with its business aspects. A good contract is essential for the project to succeed. In three cases based on actual experience the contract failed. In the first case, dosage miscalculation in the hospital pharmacy led to side effects in patients as a consequence of which the study was stopped. The pharmaceutical company sued the investigator. In the second case the investigator published data in a congress abstract, which prevented a patent by the company. In the third case scientific information was published by the company with the principal investigator featuring in the acknowledgement section of the article only. Investigators should have their own standard contract ready, and they should invest time and energy in understanding the contracts of the research they are carrying out.
The diminished financial support by the government of clinical investigation has led to clinical units that depend for their infrastructure largely on contract research for the pharmaceutical industry. This poses a threat to the independence of scientific research, to the freedom to publish scientific results and to the continuity of the research. Moreover, it is not easy for a researcher to retain a position of integrity and independence in the face of a jungle of conflicting interests and not to let personal interests prevail. The difficult relation between the physician and the pharmaceutical industry is the subject of a forthcoming short series of articles.
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The invention listed below is owned by an agency of the U.S. Government and is available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally funded research and development.
The invention listed below is owned by an agency of the U.S. Government and is available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally funded research and development.