The journal of biolaw & business最新文献

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An analysis of the proposal for population based screening for hereditary hemochromatosis in Massachusetts. 马萨诸塞州遗传性血色素沉着症人群筛查建议分析。
The journal of biolaw & business Pub Date : 2001-01-01
J M LeGraw
{"title":"An analysis of the proposal for population based screening for hereditary hemochromatosis in Massachusetts.","authors":"J M LeGraw","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The Massachusetts Senate is considering a bill which would require a screening test for iron overload diseases when such a test is medically necessary. The legislation is also authorized to establish, promote, and administer a statewide early detection program for the detection of hereditary hemochromatosis. Despite the challenges to a successful screening program which have been documented in the medical literature and the potential for genetic discrimination, the public health benefits justify this legislation as long as the necessary modifications and precautions are established.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"4 4","pages":"51-8"},"PeriodicalIF":0.0,"publicationDate":"2001-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"22389417","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Pharmaceutical advertising as a consumer empowerment device. 医药广告作为消费者赋权的一种手段。
The journal of biolaw & business Pub Date : 2001-01-01
P H Rubin
{"title":"Pharmaceutical advertising as a consumer empowerment device.","authors":"P H Rubin","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Pharmaceutical companies have greatly increased their level of \"direct-to-consumer\" (DTC) advertising in recent years. For 1998, estimates are that over $1.1 billion was spent on this form of advertising, increased from $850 million in 1997 and $600 million in 1996. In 1998, 84 separate drugs were advertised to consumers. The impetus was a decision in August of 1997 by the Food and Drug Administration to reduce the restrictions on DTC advertising on television. As a result, such ads have become very common on TV, and 32 products were advertised on TV in 1998. Pharmaceutical companies advertise because they think that advertising will make money for them. But how will this make money? It will make money by providing consumers with the information they need to make proper decisions about medication. That is, DTC advertising is profitable exactly because it empowers consumers and enables them to purchase useful drugs. The goals of advertising companies and consumers are both for consumers to have information about the most beneficial drug for particular conditions, and so advertising is beneficial both to manufacturers and to consumers. This article describes emerging trends in DTC within the context of the life sciences sector.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"4 4","pages":"59-65"},"PeriodicalIF":0.0,"publicationDate":"2001-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"22389419","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Genetic testing policy issues for the next millennium: abstract of remarks. 下一个千年的基因检测政策问题:评论摘要。
The journal of biolaw & business Pub Date : 2001-01-01
{"title":"Genetic testing policy issues for the next millennium: abstract of remarks.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"4 3","pages":"37-50"},"PeriodicalIF":0.0,"publicationDate":"2001-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"22565839","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Mapping of human genome raises serious issues for individual vs. corporate rights. 人类基因组图谱引发了个人与公司权利的严重问题。
The journal of biolaw & business Pub Date : 2001-01-01
J Court
{"title":"Mapping of human genome raises serious issues for individual vs. corporate rights.","authors":"J Court","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Unrestricted corporate control of genetic technologies opens a pandora's box for the balance of power between individuals and corporations. This column provides an overview of the issues raised by commercialization of the human genome from a citizen advocate's perspective.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"4 4","pages":"45-7"},"PeriodicalIF":0.0,"publicationDate":"2001-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"22389416","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Protecting human research subjects. 保护人类研究对象。
The journal of biolaw & business Pub Date : 2001-01-01
P W Fiscus
{"title":"Protecting human research subjects.","authors":"P W Fiscus","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>In early November, little more than a year after 18-year-old Jesse Gelsinger died in a gene-transfer trial at the University of Pennsylvania, his family reached an unspecified settlement with the research team and institutions involved in the experiment. Although the settlement with the university brought closure to the lawsuit, Gelsinger's death raised lingering concerns about the risks of clinical trials involving human subjects. Government investigations and hearings in the wake of the tragedy have led to greater scrutiny of how organizations conduct clinical trials and efforts to strengthen protections of human subjects. This well-intended scrutiny comes at a time when clinical trials are growing dramatically in number and complexity. This article outlines some of the emerging issues concerning human subject research as well as possible procedures for handling the associated risks.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"4 4","pages":"18-22"},"PeriodicalIF":0.0,"publicationDate":"2001-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"22390130","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Genetic testing: policy issues for the new millennium. 基因检测:新千年的政策问题。
The journal of biolaw & business Pub Date : 2001-01-01
E Ronchi
{"title":"Genetic testing: policy issues for the new millennium.","authors":"E Ronchi","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The purpose of this article is to provide a brief overview of the policy considerations underlying the Organization for Economic Cooperation and Development (OECD) workshop, \"Genetic Testing: Policy Issues for the New Millennium,\" which was organised and hosted by the governments of the United Kingdom (UK) and Austria in Vienna, 23-25 February 2000, with the support of the European Commission (EC). It reviews the various topics presented at the meeting and offers a brief summary of its main conclusions.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"4 3","pages":"34-6"},"PeriodicalIF":0.0,"publicationDate":"2001-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"22403166","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Biosamples, genomics, and human rights: context and content of Iceland's Biobanks Act. 生物样本、基因组学和人权:冰岛生物银行法案的背景和内容。
The journal of biolaw & business Pub Date : 2001-01-01
D E Winickoff
{"title":"Biosamples, genomics, and human rights: context and content of Iceland's Biobanks Act.","authors":"D E Winickoff","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>In recent years, human DNA sampling and collection has accelerated without the development of enforceable rules protecting the human rights of donors. The need for regulation of biobanking is especially acute in Iceland, whose parliament has granted a for-profit corporation, deCODE Genetics, an exclusive license to create a centralized database of health records for studies on human genetic variation. Until recently, how deCODE Genetics would get genetic material for its genotypic-phenotypic database remained unclear. However, in May 2000, the Icelandic Parliament passed the Icelandic Biobanks Act, the world's earliest attempt to construct binding rules for the use of biobanks in scientific research. Unfortunately, Iceland has lost an opportunity for bringing clear and ethically sound standards to the use of human biological samples in deCODE's database and in other projects: the Biobanks Act has extended a notion of \"presumed consent\" from the use of medical records to the use of patients' biological samples; worse, the act has made it possible--perhaps likely--that a donor's wish to withdraw his/her sample will be ignored. Inadequacies in the Act's legislative process help account for these deficiencies in the protection of donor autonomy.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"4 2","pages":"11-7"},"PeriodicalIF":0.0,"publicationDate":"2001-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"22197860","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Restoring public trust in gene therapy. 恢复公众对基因治疗的信任。
The journal of biolaw & business Pub Date : 2001-01-01
E M Kennedy
{"title":"Restoring public trust in gene therapy.","authors":"E M Kennedy","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"4 3","pages":"3-4"},"PeriodicalIF":0.0,"publicationDate":"2001-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"22565838","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Special challenges in applying genomics to population health. 将基因组学应用于人口健康方面的特殊挑战。
The journal of biolaw & business Pub Date : 2001-01-01
G S Omenn
{"title":"Special challenges in applying genomics to population health.","authors":"G S Omenn","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"4 4","pages":"3-6"},"PeriodicalIF":0.0,"publicationDate":"2001-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"22390129","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Clinical trials face heightened scrutiny as science and commerce appear to merge. 随着科学和商业的合并,临床试验面临着更严格的审查。
The journal of biolaw & business Pub Date : 2001-01-01
Alvin J Lorman
{"title":"Clinical trials face heightened scrutiny as science and commerce appear to merge.","authors":"Alvin J Lorman","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Clinical trials involving human subjects face increased scrutiny and regulation by the federal government that may lead to costly changes to the process. Prompted by a highly publicized death in a gene therapy trial, federal regulators are examining almost all aspects of clinical trial conduct, from how patients are recruited and how they give informed consent, to the relationship between the researchers and the company sponsoring the research. In addition to the heightened regulation, the government has announced that it will seek the power to impose civil money penalties on researchers who do not observe applicable patient protection regulations. In an effort to include more senior citizens in clinical trials, the government for the first time will cover certain costs of Medicare beneficiaries who participate in clinical trials. The risk of increased government involvement includes criminal prosecution of physicians for failing to follow the rules, as an innovative case in California demonstrates.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"4 4","pages":"23-32"},"PeriodicalIF":0.0,"publicationDate":"2001-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"22390131","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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