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PubMed2000

Impacts of international trade, services and investment treaties on alcohol regulation.

There is an underlying incompatibility between government efforts to minimize the harm associated with alcohol, particularly by regulating its supply, and international commercial treaties that promote the freer flow of goods, services and investment. These treaties have already forced changes to many government measures affecting alcohol availability and control, primarily by constraining the activities of government alcohol monopolies and by altering taxation regimes. The North American Free Trade Agreement and the World Trade Organization agreements open new avenues for challenges against alcohol control measures. Some of these agreements extend beyond trade, border measures and differential taxation and allow challenges that intrude into areas of non-discriminatory domestic regulation affecting market access, intellectual property, investment and services. Effective protection from these agreements for vital public health measures has rarely been obtained, although it is increasingly essential. The WTO "services" agreement, basically unknown to the public, is currently being re-negotiated and poses the gravest new challenge to policies designed to influence patterns of alcohol use and minimize alcohol-related harm. In future, these international agreements will probably affect adversely those alcohol approaches considered to be the most effective or promising. These include: maintaining effective state monopolies, restricting the number and locations of retail outlets, taxing and regulating beverages according to alcohol strength, restricting commercial advertising, and maintaining and enhancing public alcohol education and treatment programs. These effects can, in turn, be expected to increase the availability and access to alcohol, to lower alcohol taxes, and to increase advertising and promotion, resulting in increased alcohol consumption and associated health problems. Until more balanced international rules are developed, the challenge facing alcohol policy researchers is to defend national and local alcohol measures from further erosion. This will require greater coordination with researchers in other affected sectors, intervention with government representatives in health and related areas and the promotion of alternative approaches to current international commercial agreements.

Alcohol Drinking↗
PubMedDate not supplied

The end of print: digitization and its consequence--revolutionary changes in scholarly and social communication and in scientific research.

The transformation from print to digital media for scientific communication, driven in part by the growth of the Internet and the tremendous explosion in the amount of information now available to everybody, is creating fundamental changes in institutions such as publishers, libraries, and universities that primarily exist for the creation, management, and distribution of information and knowledge. Scientific, technological, and medical journals are the first publications to be completely transformed from print to digital format but monographs are beginning to appear in digital format as well and soon all communication and publishing of scientific information will be entirely electronic. In fact, this change is affecting all components of the scientific enterprise, from personal correspondence and laboratory methods to peer reviewing and the quality assessment of scientific research. Along with these radical and rapid changes in information presentation and distribution are coincident changes in the expectations of both the public and other scientists, with both groups demanding ever more rapid, open, and global access to scientific information than has been available in the past. The consequence of this revolution in the mechanics of communications technology is threatening the very existence of a number of highly regarded institutions such as intellectual property, commercial publishers, scientific societies, and academic libraries and might soon begin to threaten even the traditional university.

Communication↗
PubMedDate not supplied

The World Trade Organization: implications for health policy.

Agreements negotiated at the World Trade Organization already have important implications for health and health policy. They impact on the ability of governments to regulate trade in the interests of health; on national and international governance and public health standards; and on the future of the precautionary principle. Agreements on trade-related aspects of intellectual property rights and trade in health services could benefit the multi-national health care and pharmaceutical industries, and impact negatively on cost and equity.

Developing Countries↗
PubMed1998

A model agreement for genetic research in socially identifiable populations.

Genetic research increasingly focuses on population-specific human genetic diversity. However, the naming of a human population in public databases and scientific publications entails collective risks for its members. Those collective risks can be evaluated and protections can be put in place by the establishment of a dialogue with the subject population, before a research study is initiated. Here we describe an agreement to undertake genetic research with a Native American tribe. We identified the culturally appropriate public and private social units within which community members are accustomed to make decisions about health. We then engaged those units in a process of communal discourse. In their discourses about our proposed study, community members expressed most concern about culturally specific implications. We also found that, in this population, private social units were more influential in communal decision making than were public authorities. An agreement was reached that defined the scope of research, provided options for naming the population in publications (including anonymity), and addressed the distribution of royalties from intellectual property, the future use of archival samples, and specific cultural concerns. We found that informed consent by individuals could not fully address these collective issues. This approach may serve as a general model for the undertaking of population-specific genetic studies.

Confidentiality↗
PubMed2002

Maya medicine in the biological gaze: bioprospecting research as herbal fetishism.

The relationship of human societies to territory and natural resources is being drastically altered by a series of global agreements concerning trade, intellectual property, and the conservation and use of genetic resources. Through a characteristic style of collective appropriation of their tropical ecosystems, Maya societies have created local institutions for governing access to their common resources. However, new mechanisms of global governance require access to Maya biodiversity for world commercial interests. The Chiapas Highland Maya already face this prospect in the International Cooperative Biodiversity Group drug discovery project, which proposes to use Maya medical knowledge to screen plants for potential pharmaceuticals. The ethnobiological focus of the project emphasizes the naturalistic aspects of Maya medicine, primarily the use of herbal remedies. This biological gaze decontextualizes the situated knowledge of Maya healers, ignoring the cultural context in which they create and apply that knowledge. The search for raw materials for the production of universal medical technology results in symbolic violence to the cultural logic of Maya peoples. Only the full recognition of Maya peoples' collective rights to territory and respect for their local common-resource institutions will provide ultimate protection for their cultural and natural patrimony.

Anthropology, Cultural↗
PubMed2003

Global herbal medicine: a critique.

Herbal medicine finds itself at a crossroads. If it continues to become mainstreamed in a commodity-driven health industry, its focus will change from craft-based tradition to globalized industry. On the other hand, if the fundamental importance of tradition to indigenous and nonindigenous medicine is respected, ecologic and cultural issues arise. Central here are the issues associated with control of both land and culture. Many indigenous cultures and their local ecologies are currently threatened by globalization. Historically, successful large corporations have neither respected the environment nor easily acknowledged indigenous claims to land and intellectual property, so no easy resolution of these conflicts seems likely. Our case study of Mapuche medicine allows us to explore the social and cultural conflicts that many practising herbalists experience. We argue that because of the basic contradictions involved, the protection of cultures and ecologies that underpin the discipline must be made a clear priority. We argue that local cultural traditions are clearly at odds with a globalizing herbal industry.

Biotechnology↗
PubMed2004

Defining minimum standards of practice for incorporating African traditional medicine into HIV/AIDS prevention, care, and support: a regional initiative in eastern and southern Africa.

In many resource-poor settings of Africa, a majority of people living with HIV/AIDS depend on and choose traditional healers for psychosocial counseling and health care. If the current pan-African prevention and care efforts spurred by the HIV pandemic do not actively engage African Traditional Medicine, they will effectively miss 80%, the vast majority of the African people who, according to the World Health Organization, rely on traditional medicine for their primary health care needs. In 2001, the Ugandan nongovernmental organization, Traditional and Modern Health Practitioners Together Against AIDS and Other Diseases, in Kampala, identified the need for a concerted, systematic, and sustained effort at both local and regional levels to support and validate African Traditional Medicine on several fronts. The Eastern & Southern Africa Regional Initiative on Traditional Medicine and AIDS was borne out of this assessment. It convened a regional consultation in May 2003, which produced a series of proposed standards around six main themes related to traditional medicine and HIV/AIDS: the systematic evaluation of traditional remedies; spiritual aspects of healing; HIV prevention and care; processing and packaging of traditional remedies; protection of indigenous knowledge; and intellectual property rights related to traditional health systems. These standards, summarized in this paper, will be incorporated into programs on traditional medicine and HIV/AIDS by various implementers in the region. A number of strategies to test and implement these recommendations are also defined.

Acquired Immunodeficiency Syndrome↗
PubMed2005

Generation of cell lines for drug discovery through random activation of gene expression: application to the human histamine H3 receptor.

Target-based high-throughput screening (HTS) plays an integral role in drug discovery. The implementation of HTS assays generally requires high expression levels of the target protein, and this is typically accomplished using recombinant cDNA methodologies. However, the isolated gene sequences to many drug targets have intellectual property claims that restrict the ability to implement drug discovery programs. The present study describes the pharmacological characterization of the human histamine H3 receptor that was expressed using random activation of gene expression (RAGE), a technology that over-expresses proteins by up-regulating endogenous genes rather than introducing cDNA expression vectors into the cell. Saturation binding analysis using [125I]iodoproxyfan and RAGE-H3 membranes revealed a single class of binding sites with a K(D) value of 0.77 nM and a B(max) equal to 756 fmol/mg of protein. Competition binding studies showed that the rank order of potency for H3 agonists was N(alpha)-methylhistamine approximately (R)-alpha- methylhistamine > histamine and that the rank order of potency for H3 antagonists was clobenpropit > iodophenpropit > thioperamide. The same rank order of potency for H3 agonists and antagonists was observed in the functional assays as in the binding assays. The Fluorometic Imaging Plate Reader assays in RAGE-H3 cells gave high Z' values for agonist and antagonist screening, respectively. These results reveal that the human H3 receptor expressed with the RAGE technology is pharmacologically comparable to that expressed through recombinant methods. Moreover, the level of expression of the H3 receptor in the RAGE-H3 cells is suitable for HTS and secondary assays.

Binding, Competitive↗
PubMed2005

Emergence of a scientific and commercial research and development infrastructure for human gene therapy.

A research and clinical subfield known as "human gene therapy" has grown rapidly since 1990, when the first human trials were approved in the United States. Using quantitative data, this paper describes and analyzes the research and commercial infrastructure, including academic centers, publications, intellectual property, and biotechnology firms, that has developed around the goal of discovering clinical applications for the modification and transport of DNA to somatic cells. Despite setbacks and few documented successes, the subfield of human gene therapy continues to serve as an influential clinical paradigm for the treatment of inherited and noninherited diseases.

Biomedical Research↗
PubMed2002

The Victorian emergency department collaboration.

OBJECTIVES: The aim of the project was to bring together 17 major emergency departments across Victoria, Australia, and the Australian Capital Territory to work together over an 8-month period to reduce both clinical and operational waits and delays, and to improve patient satisfaction. DESIGN: The collaborative was based on the Institute for Healthcare Improvement's Breakthrough Series, and utlilized their intellectual property and methodology adapted for the Australian setting. SETTING: The largest (by annual attendances) 17 emergency departments in the State of Victoria and one hospital in the Australian Capital Territory participated. STUDY PARTICIPANTS: Each hospital sent a team of three to five persons, which included the Emergency Department Medical Director and Nurse in Charge, and an Executive Sponsor to each learning session. INTERVENTIONS: The teams were required to attend four learning sessions, to participate during the action period in both clinical and operational improvement activities, and to report regularly in the form of data reports and conference calls. MAIN OUTCOME MEASURES: Each team selected at least one or two clinical topics for improvement and at least one operational project to undertake during the life of the collaborative. A patient satisfaction survey was commenced towards the end of the project. RESULTS: Forty-seven clinical projects were nominated during the life of the collaborative and 32 of these were completed, with 31 resulting in significant improvement or achieving target. Thirty-nine operational projects were nominated, 30 of which were completed, with 24 of these achieving improvement or target. Numerous additional achievements occurred, which evolved from the framework of supported collaboration. CONCLUSION: The spread of knowledge and innovation can be best facilitated rapidly by teams working together using a structured program in a supported environment.

Australian Capital Territory↗
PubMed1992

Beyond the college walls.

The author outlines historical and current reasons that the National Institutes of Health (NIH) and academic medicine are inherently political and are now facing expanding political exposure. She emphasizes especially the power of modern discoveries in biology; this power stems from the many practical benefits that these discoveries can bring and their economic implications, and the growing public awareness of these benefits and implications. She then discusses the political realities of the biomedical enterprise, illustrating them by describing the nature of issues surrounding (1) the NIH budget and (2) technology transfer. Discussion of the latter topic includes a detailed description of controversies about patents (which revolve around the issue of who owns and controls the distribution and use of scientific information) and several important policy issues that are raised by these controversies (e.g., should there be uniform international policies regarding intellectual property rights associated with discoveries of novel biologically expressed genes of uncertain in-vivo function, and if so, how is that achieved?). The author concludes by stating that these examples of the politics of knowledge and of the NIH are among many vital biomedical issues of American life (which she lists) that require the academic medicine community to look beyond its own walls and participate in the complex world of politics and public policy.

Economics, Medical↗
PubMed1993

Integrity in the education of researchers.

Great efforts are being made to provide training in appropriate research practices, but less is said about how trainees should be treated and how this treatment will affect the ethics they will absorb from the research environment rather than from the ethics training. Research laboratories by definition create tension between the productivity needed on a project that is essentially the intellectual property of the faculty investigator and the goals and needs of the trainee for education. After examining issues involved in how trainees are recruited to laboratories, the authors discuss some of the ethical problems that routinely arise in the laboratory setting. The faculty preceptor has clear obligations to trainees, such as assistance in the development of the trainee's research work, ongoing supervision, feedback, and interaction, training in oral and written presentations, and mentoring in complex issues of contemporary science. Increasing commercialization of research presents additional difficulties for both preceptor and trainee. Finally, both are concerned with issues of completion and separation, about the end of the training relationship and the beginning of the trainee's professional career. The authors conclude that it is not enough to rely on the traditional approach of transmitting ethical and technically valid research practices "by example"--being a preceptor now carries with it an obligation to inculcate these standards consciously and systematically.

Academic Medical Centers↗
PubMed1993

Problems in research integrity arising from misconceptions about the ownership of research.

Many allegations of scientific misconduct result from activities that are perceived by the complainants as the "theft" of ideas, experimental results, or other intellectual property. The authors' thesis is that many of these allegations originate in misconceptions about the ownership of publicly supported scientific research. Some universities and medical schools may have their own codes for authorship, and journals and professional societies have codes or guidelines. In the NIH intramural programs, research data are considered to be the property of the institutes, not the individual researchers. In contrast, the training and experience of most scientists lead them to consider research data as being theirs. The paper discusses the origins of this attitude toward data and the ways that the structures of university laboratories and training programs lead to confusion and misunderstandings of researchers' "rights" to data. Also, emotional and personality factors often complicate these issues and lead to confrontations. Other misconceptions widely held among researchers: the false concepts of "my grant" and the "co-principal" investigator, ideas about who is and is not qualified to be an author, and ideas about sharing data. The authors emphasize the importance of scientifically literate legal advisers and the necessity for graduate students, postdoctoral fellows, and professors to understand their institutions' and grantors' guidelines and their obligations as scientists. At the heart of these obligations at all levels of research is honesty.

Academic Medical Centers↗
PubMed2001

Conflict resolution at the University of Ottawa Faculty of Medicine: The Pelican and the sign of the triangle.

In 1997 the University of Ottawa Medical School adopted a conflict-resolution policy for informally dealing with complaints of abuse, harassment and intimidation, sexual harassment, and scientific misconduct or misappropriation of intellectual property. In collaboration with the university's Faculty of Law, general conflict-resolution workshops were given for faculty and administration and mediation training was provided to medical faculty designated "complaint officers" under the policy. In this article, the authors describe the policy and training and then analyze the first major incident arising after the policy's implementation: the publication of disrespectful misogynist material in The Pelican, a medical student society newsletter. The Pelican incident is used as a "lessons learned" case study both in terms of its multiple outcomes and as an opportunity to pinpoint some important policy and practical considerations that emerged in implementing a conflict-resolution policy. The article also describes the results of a learning environment survey conducted after the Pelican incident.

Conflict, Psychological↗
PubMed2003

Tufts Health Sciences Database: lessons, issues, and opportunities.

The authors present their seven-year experience with developing the Tufts Health Sciences Database (Tufts HSDB), a database-driven information management system that combines the strengths of a digital library, content delivery tools, and curriculum management. They describe a future where online tools will provide a health sciences learning infrastructure that fosters the work of an increasingly interdisciplinary community of learners and allows content to be shared across institutions as well as with academic and commercial information repositories. The authors note the key partners in Tufts HSDB's success--the close collaboration of the health sciences library, educational affairs, and information technology staff. Tufts HSDB moved quickly from serving the medical curriculum to supporting Tufts' veterinary, dental, biomedical sciences, and nutrition schools, thus leveraging Tufts HSDB research and development with university-wide efforts including Internet2 middleware, wireless access, information security, and digital libraries. The authors identify major effects on teaching and learning, e.g., what is better taught with multimedia, how faculty preparation and student learning time can be more efficient and effective, how content integration for interdisciplinary teaching and learning is promoted, and how continuous improvement methods can be integrated. Also addressed are issues of faculty development, copyright and intellectual property, budgetary concerns, and coordinating IT across schools and hospitals. The authors describe Tufts' recent experience with sharing its infrastructure with other schools, and welcome inquiries from those wishing to explore national and international partnerships to create a truly open and integrated infrastructure for education across the health sciences.

Academic Medical Centers↗
PubMed2003

Sharing digital teaching resources: breaking down barriers by addressing the concerns of faculty members.

PURPOSE: Regional and institutional databases have been created to improve access to educational resources and to avert unnecessary duplication. The growth and success of these databases depend upon the willingness of faculty members to contribute their materials. This qualitative study seeks to identify the barriers that block the free exchange of educational multimedia and the incentives that could be created to overcome educators' concerns. METHOD: In 2001, 34 faculty members from 13 U.S. medical schools each participated in one of five focus groups. They responded to three hypothetical scenarios depicting opportunities for sharing educational resources. Participants' responses were categorized hierarchically and sent back to them for feedback. RESULTS: Participants strongly supported multimedia databases, particularly those that serve a national audience. Obstacles for contributing materials included the lack of institutional recognition for educational innovation, confusing intellectual property policies, the hassle involved in sharing materials, and the perceived commercial potential of the materials. Peer review of educational materials was seen as an important incentive. CONCLUSIONS: Medical schools could benefit from the free exchange of high-quality educational multimedia but need to address the concerns of faculty by clarifying institutional copyright rules, streamlining the donation process, and providing assistance with cataloging assets. Removing departmental pressures to commercialize materials and recognizing peer-reviewed donations as academic achievement could foster a culture of sharing.

Attitude of Health Personnel↗
PubMed1999

Application of legal and regulatory rules and policies to benchmarking systems.

Although there are few federal or state laws that address benchmarking systems, there are legal issues of which those who develop or use benchmarking system should be aware. Benchmarks may be used as standards of care in tort or professional discipline actions. Use of benchmark data to set fees or exclude providers may raise antitrust concerns. Payers may use benchmark data to set coverage policies or payment rates. Which data are included in benchmarking systems and who has access to those data raise issues of confidentiality. Lastly, benchmarking system developers may want to protect their intellectual property rights and may need to consider medical device laws if they claim that the systems may be used in patient management.

Antitrust Laws↗
PubMed1998

Measurement of intraoperative brain surface deformation under a craniotomy.

OBJECTIVE: Several causes of spatial inaccuracies in image-guided surgery have been carefully studied and documented for several systems. These include error in identifying the external features used for registration, geometrical distortion in the preoperative images, and error in tracking the surgical instruments. Another potentially important source of error is brain deformation between the time of imaging and the time of surgery or during surgery. In this study, we measured the deformation of the dura and brain surfaces between the time of imaging and the start of surgical resection for 21 patients. METHODS: All patients underwent intraoperative functional mapping, allowing us to measure brain surface motion at two times that were separated by nearly an hour after opening the dura but before performing resection. The positions of the dura and brain surfaces were recorded and transformed to the coordinate space of a preoperative magnetic resonance image, using the Acustar surgical navigation system (manufactured by Johnson & Johnson Professional, Inc., Randolph, MA) (the Acustar trademark and associated intellectual property rights are now owned by Picker International, Highland Heights, OH). This system performs image registration with bone-implanted markers and tracks a surgical probe by optical triangulation. RESULTS: The mean displacements of the dura and the first and second brain surfaces were 1.2, 4.4, and 5.6 mm, respectively, with corresponding mean volume reductions under the craniotomy of 6, 22, and 29 cc. The maximum displacement was greater than 10 mm in approximately one-third of the patients for the first brain surface measurement and one-half of the patients for the second. In all cases, the direction of brain shift corresponded to a "sinking" of the brain intraoperatively, compared with its preoperative position. Analysis of the measurement error revealed that its magnitude was approximately 1 to 2 mm. We observed two different patterns of the brain surface deformation field, depending on the inclination of the craniotomy with respect to gravity. Separate measurements of brain deformation within the closed cranium caused by changes in patient head orientation with respect to gravity suggested that less than 1 mm of the brain shift recorded intraoperatively could have resulted from the change in patient orientation between the time of imaging and the time of surgery. CONCLUSION: These results suggest that intraoperative brain deformation is an important source of error that needs to be considered when using surgical navigation systems.

Adult↗