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PubMed1995

Fishing for drugs from the sea: status and strategies.

Marine organisms represent an enormous, essentially unexploited, resource of natural products. Globally, the race to develop marine-derived drugs is well under way with many pharmaceutical companies positioning themselves to reap large profits by the exploitation of the ocean's rich chemical diversity. Targeted strategies, often in combination with high-throughput screening, are being employed in this hunt for novel pharmacotherapeutic agents. David de Vries and Phil Beart examine the potential, problems and technologies of an international pharmaceutical search that has important ethical considerations.

Biological Products↗
PubMed2005

European Medical Writers Association (EMWA) guidelines on the role of medical writers in developing peer-reviewed publications.

BACKGROUND: Many papers in biomedical journals are drafted not by the named authors, but by professional medical writers working under the direction of those authors, usually funded by pharmaceutical companies. Although this practice can improve both the quality and speed of publications, it has attracted controversy as a result of concerns about the inappropriate influence of pharmaceutical companies. OBJECTIVES: To define ethical standards for professional medical writers who prepare papers for publication in medical journals. CONSENSUS METHODS: Guidelines were drafted after a 4-round Delphi consultation among a group of experienced medical writers. The guidelines were then further refined by seeking comments on the draft from a range of interested parties. FINDINGS AND CONCLUSIONS: The guidelines stress the importance of respecting widely recognised authorship criteria, and in particular of ensuring that those listed as named authors have full control of the content of papers. The role of medical writers must be transparent, which normally means a mention in the acknowledgements section, together with a statement about funding. Writers and authors must have access to relevant data while writing papers. Medical writers have professional responsibilities to ensure that the papers they write are scientifically valid and are written in accordance with generally accepted ethical standards.

Authorship↗
PubMed1982

Review of restrictive actions under the Australian drug regulatory system.

An analysis of restrictive measures taken by the Australian Drug Evaluation Committee (ADEC) over the period of 27 months (from March, 1976, to June, 1978) was made by two non-Australian observers. During this period, the ADEC took 32 useful restrictive measures (a little more than one a month). The analysis was limited only to cases in which ADEC took substantial action; if less comprehensive measures were included, the number of valid actions to counter the occurrence of iatrogenic complications would be much greater. It is concluded that, although it is an undisputed fact that many pharmaceutical companies maintain the highest ethical standards, there is a need for the type of objective and dispassionate control exercised by the Australian Drug Evaluation Committee.

Animals↗
PubMed2001

Pharmacogenetics research network and knowledge base: 1st annual scientific meeting.

The National Institute of General Medical Sciences of the National Institutes of Health recently established a collaborative group of scientists, called the Pharmacogenetics Research Network. Central to the network is a shared, state-of-the-art data repository, the Pharmacogenetics Knowledge Base (PharmGKB), which is housed at Stanford University. Network investigators deposit pharmacogenetic data into PharmGKB, after all individually identifying information has been removed. Contents of PharmGKB will be freely accessible to the scientific community, with the goal of forging new links between gene variation and drug response. An open scientific meeting was held recently to introduce the research community to the network and to invite academic and industry-based researchers to deposit data into PharmGKB. Featured at the meeting were summaries of research progress to date, as well as discussions of issues intimately related to pharmacogenetics research, namely ethics and relations with the biotechnology and pharmaceutical industries.

Animals↗
PubMed2004

Prevalence and outcomes of pharmaceutical industry-sponsored clinical trials involving clozapine, risperidone, or olanzapine.

OBJECTIVE: The literature continues to highlight the debate on the ethics and merits of trials sponsored by the pharmaceutical industry. This study attempts to determine the prevalence and outcomes of industry-sponsored trials involving clozapine, risperidone, or olanzapine. METHODS: We searched the literature from January 1, 1990, to December 31, 2001, to capture all eligible clinical trials involving clozapine, risperidone, or olanzapine. The primary outcome measured was the clinical outcome of industry-sponsored studies. Secondary outcome measures included the following parameters: disclosure of any sponsorship and financial support, author(s) employed by the industry, use of comparator drug(s) within the trial, sample size, blinding, and use of placebo. RESULTS: The database comprised 372 articles. Of these trials, 124 (33.3%) were sponsored by the pharmaceutical industry. In general, trials sponsored by Eli Lilly or Janssen had better research design than trials not funded by the pharmaceutical industry. With regard to authorship, more trials funded by Eli Lilly (74.6%) were coauthored by an employee of the company, compared with trials funded by either Janssen (23.3%) or Novartis/Sandoz (5.6%). Further, more trials sponsored by Eli Lilly reported positive outcomes (92.1%), compared with Janssen-sponsored trials (88.4%) and Sandoz/Novartis-sponsored trials (72.2%). No negative results were reported in any of the industry-funded trials. CONCLUSIONS: One-third of the published clinical trials involving clozapine, risperidone, or olanzapine were funded by their respective manufacturer. The reported outcomes of the sponsored trials highly favour the manufacturer's product.

Benzodiazepines↗
PubMed1999

Proposed model for interaction between residents and residency training programs, and pharmaceutical industry.

Medical residents in training are as much targets of pharmaceutical-industry marketing as are physicians in practice. This interaction is often subtle and takes the form of sponsorship of meals at academic events, support for conference travel, books, and items such as pens and notepads. Most residency programs direct little time towards training in ethics and the critical analysis of pharmaceutical-industry marketing. We propose a model for the relationship between residents and residency programs, and the pharmaceutical industry that addresses the need for such interaction to be viewed in light of the patient-centered ethic of professional conduct and the ideal of unbiased medical practice. A committee of residents at different levels of training and two staff physicians received the mandate to examine this issue. The committee developed a set of guidelines and a proposed schema for the handling of funds from pharmaceutical companies (still not implemented). Each residency program would develop a common fund for money donated by pharmaceutical companies. This fund would be administered by a committee with defined priorities. The presence of residents on this committee under staff preceptorship would serve as a springboard for education on the subject. Guidelines for acknowledgement of sponsorship, solicitation of funds, gifts for care of patients, ongoing education, and the wider applicability of these proposals were also developed. Residents' interaction with the pharmaceutical industry during training could have lifelong influence on medical practice. We hope that our model will promote critical appraisal of the potential risks and benefits of this interaction.

Advertising↗
PubMed1987

An ethical committee for general practice in the west for Scotland: proposals received in the first year.

The particular ethical problems of research in general practice and pressure from local general practitioners and hospital ethical committees led to the development of an ethical committee for general practice in the west of Scotland. The workload of this ethical committee in its first year of existence is described.Despite the fact that many of the studies considered by the committee were sponsored by pharmaceutical companies and were often sophisticated, the ethical issues of a general practice setting had not always been fully appreciated. Of the 21 study proposals submitted over the year 13 showed areas of ethical uncertainty. However, all the studies were eventually approved. Most of the problems encountered were easily overcome and might have been avoided if the general practitioners undertaking the research had been able to seek advice from those with experience of research in general practice and in particular of the ethical issues involved. Local ethical committees for general practice, made up largely of general practitioners but with at least one lay member, might provide one such source of advice.

Ethics Committees, Research↗
PubMed2004

[Misconduct in clinical scientific investigations].

The most important ways of misconduct in clinical scientific research are falsifying results, plagiarize and over-interpretation. Motives are prestige, money, pressure of time and conflict of interests. The "publish or perish" phenomenon and the sometimes difficult attainable deadline play an important role. Furthermore, there is a "gray-zone" in which clinical scientific researchers are influenced by the pharmaceutical industry, leading to the writing of tendentious publications. Few data are available concerning the frequency of misconduct. In general, one may say that the phenomenon is underestimated. The number of professional organizations for the detection of misconduct and to start a balanced investigation procedure of this phenomenon is limited. An exception is "Office of Research Integrity" in the US that does pioneering work in the field. Some of the better journals in the profession are making serious efforts to detect misconduct (e.g. New England Journal of Medicine, British Medical Journal). To prevent misconduct the following measures can be considered: education concerning the topic in the faculties of medicine, biomedical sciences and pharmaceutics sciences; extension of the competences of the ethical committees; realistic financing of research and the establishing of a "clinical scientific fund", without any relation with the pharmaceutical industry, for the support of self-generated clinical project after 'peer review'. Finally, the questions can be raised if the Royal Academy of Medicine (Belgium) could not play a role in this important matter.

Belgium↗
PubMed2000

The conflict between ethics and business in community pharmacy: what about patient counseling?

Patient counseling is a cornerstone of ethical pharmacy practice and high quality pharmaceutical care. Counseling promotes patient compliance with prescription regimens and prevents dangerous drug interactions and medication errors. Counseling also promotes informed consent and protects pharmacists against legal risks. However, economic, social, and technological changes in pharmacy practice often force community pharmacists to choose between their professional obligations to counsel patients and business objectives. State and federal legislatures have enacted laws that require pharmacists to counsel patients, but these laws have had mixed results. This essay argues that community pharmacy's patient counseling conundrum can be solved through additional moral education persuasion, not through additional legal mandates.

Community Pharmacy Services↗