Restrictions impeding web-based courses: a survey of publishers' variation in authorising access to high quality on-line literature

BACKGROUND: Web-based delivery of educational programmes is becoming increasingly popular and is expected to expand, especially in medicine. The successful implementation of these programmes is reliant on their ability to provide access to web based materials, including high quality published work. Publishers' responses to requests to access health literature in the context of developing an electronic Master's degree course are described. METHODS: Two different permission requests were submitted to publishers. The first was to store an electronic version of a journal article, to which we subscribe, on a secure password protected server. The second was to reproduce extracts of published material on password protected web pages and CD Rom. RESULTS: Eight of 16 publishers were willing to grant permission to store electronic versions of articles without levying charges additional to the subscription. Twenty of 35 publishers gave permission to reproduce extracts of published work at no fee. Publishers' responses were highly variable to the requests for access to published material. This may be influenced by vague terminology within the 'fair dealing' provision in the copyright legislation, which seems to leave it open to individual interpretation. Considerable resource costs were incurred by the exercise. Time expended included those incurred by us: research to identify informed representatives within the publishing organisation, request 'chase-ups' and alternative examples being sought if publishers were uncooperative; and the publisher when dealing with numerous permission requests. Financial costs were also incurred by both parties through additional staffing and paperwork generated by the permission process, the latter including those purely borne by educators due to the necessary provision of photocopy 'course packs' when no suitably alternative material could be found if publishers were uncooperative. Finally we discuss the resultant bias in material towards readily available electronic resources as a result of publisher's uncooperative stance and encourage initiatives that aim to improve open electronic access. CONCLUSIONS: The permission request process has been expensive and has resulted in reduced access for students to the relevant literature. Variations in the responses from publishers suggest that for educational purposes common policies could be agreed and unnecessary restrictions removed in the future

Distilling the essence of general practice:a learning journey in progress.

Over the past 5 years, general practice in the UK has undergone major change. Starting with the introduction of the new GMS contract in 2004, it has continued apace with the establishment of Postgraduate Medical Education Training Board, a GP training curriculum, and nMRCGP. The NHS is developing very differently in the four countries of the UK. Regulation of the profession is under review, and a system of relicensing, recertification, and revalidation is being introduced. The Essence project, initiated by RCGP Scotland in conjunction with International Futures Forum 4 years ago is a constructive response to these changes. It has included learning journeys, a discussion day for GPs, and commissioned short pieces of 100 words from GPs and patients. From an analysis of these, some characteristics of the essence of general practice have been defined. These include key roles and core personal qualities for GPs. It is argued that general practice has important and unique advantages — trust, coordination, continuity, flexibility, universal coverage, and leadership — which mean that it should continue to be central to the development of primary care throughout the UK

Drug Evaluation and the Permissive Principle: Continuities and Contradictions between Standards and Practices in Antidepressant Regulation

Pharmaceuticals are not permitted on to the market unless they are granted regulatory approval. The regulatory process is, therefore, crucial in whether or not a drug is widely prescribed. Regulatory agencies have developed standards of performance that pharmaceuticals are supposed to meet before entering the market. Regulation of technologies is often discussed by reference to the precautionary principle. In contrast, this paper develops the concept of the `permissive principle' as a way of understanding the departure of regulators' practices from standards of drug efficacy to which regulatory agencies themselves subscribe. By taking a case study of antidepressant regulation in the UK and the USA, the mechanisms of permissive regulatory practices are examined. An STS methodology of both spatial (international) and temporal comparisons of regulatory practices with regulatory standards is employed to identify the nature and extent of the permissive regulation. It is found that the permissive principle was adopted by drug regulators in the UK and the USA, but more so by the former than the latter. Evidently, permissive regulation, which favours the commercial interests of the drug manufacturer, but is contrary to the interests of patients, may penetrate to the heart of regulatory science. On the other hand, permissive regulation of specific drugs should not be regarded as an inevitable result of marketing strategies and concomitant networks deployed by powerful pharmaceutical companies, because the extent of permissive regulation may vary according to the intra-institutional normative commitments of regulators to uphold their technical standards against the commercial interests of the manufacturer. Likely sociological factors that can account for such permissive regulatory practices are `corporate bias', secrecy and excessive regulatory trust in the pharmaceutical industry in the UK, political expediency and ideological capture in the USA, combined in both countries with some regulatory deference to the clinical autonomy of the psychiatry profession

Bias in science and medical knowledge: the Opren Controversy

Analysis of the scientific evaluation of medicine safety has been neglected in sociology. This article examines the influence of interests and values on scientists' safety evaluation of the medical drug Opren in industrial and government contexts. By systematically identifying inconsistencies in the technical justifications of industrial and government scientists it is argued that the concept of interest-based bias is crucial for explaining the development of medical knowledge. Specifically, evidence is adduced to suggest that industrial interests biased scientists' production and interpretation of medical knowledge about Opren with potentially adverse consequences for patients' interests in safe medication. The Mertonian `ethos' of science is seen to have very little application to the work of scientists in the context of drug regulation, giving way to institutional instrumentalism. The paper concludes by proposing an alternative system for the clinical testing and regulation of drugs which could discourage such industrial bias and provide greater patient protection

Deficits, expectations and paradigms in British and American drug safety assessment: prising open the black box of regulatory science

This article examines the regulation of nonsteroidal anti-inflammatory drugs (NSAIDs), with particular focus on products approved for marketing in the United Kingdom, while denied marketing approval in the United States on safety grounds, and then subsequently withdrawn from the UK market on those grounds. Using international comparison of regulatory data never before accessed outside government and companies, together with interviews with relevant industry scientists and regulators, the article demonstrates the importance of regulatory expectations, deficits and paradigms. It is argued both that these sociological concepts can be enriched by their application to detailed comparative case study of regulatory science, and that they provide an important policy-relevant framework with which to understand discrepant drug regulatory processes in a sociohistorical context. It is found that regulatory expectations and paradigms may be regarded as mediating factors between political culture and structural interests, on the one hand, and the outcomes of regulatory science (including deficits), on the other

Distributing the Benefit of the Doubt: Scientists, Regulators, and Drug Safety

This article examines how scientists and regulators distribute the benefit of the doubt about drug safety under conditions of scientific uncertainty. The focus of the empirical research is the regulatory controversy over the hepatorenal toxicity of benoxaprofen in the United Kingdom and the United States. By scrutinizing the technical coherence of the arguments put forward by industrial and government scientists, it is concluded that these scientists are willing to award the commercial interests of the pharmaceutical industry an enormous benefit of the sccentific doubt, which is not consistent with the best interests of patients. Interpretative flexibility, the burden of proof falling on regulators and their trust in, and dependence on, industrial scientists facilitates that distribution of the benefit of the scientific doubt. However, regulatory authorities' need for viability and the rationality common to opposing scientific views suggest that it is possible, in principle, to alter this dominant trend. To achieve adequate patient protection, drug regulation in the United Kingdom and the United States requires extensive reform. Some preliminary policy changes are sketched