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PubMed1992

American College of Physicians Ethics Manual. Third edition.

Medicine, law, and social values are not static and must be re-examined periodically. This edition of the ACP Ethics Manual covers emerging issues in medical ethics and revisits some old issues. The overview of the evolution of medical ethics, which appeared in previous editions of the Manual, has been eliminated to allow more space for the consideration of today's ethical dilemmas. Other changes include a revised chapter on end-of-life care, discussion of physician-assisted suicide, revised sections on conflicts of interest and on medical risk to the physician and patient, given developments in human immunodeficiency virus (HIV) infection and the acquired immunodeficiency syndrome (AIDS), and discussion of sexual contact between physician and patient. A statement on disclosure of errors and a section on care of the physician's family have also been added. The sections on confidential information told by a patient's family or friend to the physician; on physician-pharmaceutical industry relations; on physicians in training; and on the impaired physician have been expanded. Sections on advertising, peer review, and resource allocation have been revised. The literature of biomedical ethics expands at a rate that does not allow a bibliography to remain current, so an exhaustive list of references or suggested readings is not included in this manual. Instead, only cited references are listed.

Codes of Ethics↗
PubMed1998

Treating gastro-oesophageal reflux disease during pregnancy and lactation: what are the safest therapy options?

Gastro-oesophageal reflux and heartburn are reported by 45 to 85% of women during pregnancy. Typically, the heartburn of pregnancy is new onset and is precipitated by the hormonal effects of estrogen and progesterone on lower oesophageal sphincter function. In mild cases, the patient should be reassured that reflux is commonly encountered during a normal pregnancy: lifestyle and dietary modifications may be all that are required. In a pregnant woman with moderate to severe reflux symptoms, the physician must discuss with the patient the benefits versus the risks of using drug therapy. Medications used for treating gastro-oesophageal reflux are not routinely or vigorously tested in randomised, controlled trials in women who are pregnant because of ethical and medico-legal concerns. Safety data are based on animal studies, human case reports and cohort studies as offered by physicians, pharmaceutical companies and regulatory authorities. If drug therapy is required, first-line therapy should consist of nonsystemically absorbed medications, including antacids or sucralfate, which offer little, if any, risk to the fetus. Systemic therapy with histamine H2 receptor antagonists (avoiding nizatidine) or prokinetic drugs (metoclopramide, cisapride) should be reserved for patients with more severe symptoms. Proton pump inhibitors are not recommended during pregnancy except for severe intractable cases of gastrooesophageal reflux or possibly prior to anaesthesia during labour and delivery. In these rare situations, animal teratogenicity studies suggests that lansoprazole may be the best choice. Use of the least possible amount of systemic drug needed to ameliorate the patient's symptoms is clearly the best for therapy. If reflux symptoms are intractable or atypical, endoscopy can safely be performed with conscious sedation and careful monitoring the mother and fetus.

Female↗
PubMed1989

Placebos in clinical trials of peptic ulcer. ACG Committee on FDA-Related Matters.

Placebo use in controlled clinical trials is often challenged as being unethical, as though the investigator in a clinical trial and the clinician are in conflict, one interested primarily in scientific validity, the other in patient care. This paper will review the specific issues in trials for short term (4-8 wk) peptic ulcer disease, demonstrating that controlled trials utilizing placebo are worthwhile, are safe, offer distinct advantages over alternative trials, and impose no real ethical conflict. The ethics regarding the use of a placebo for a controlled trial have been reviewed previously in this column (1). Placebo controls are appropriate in therapeutic trials when 1) standard therapy is either unavailable, of unproven efficacy, or possesses unacceptable side effects, 2) placebo itself is an effective therapy, or 3) the ongoing disease has little adverse effect on the patient. Furthermore, the use of placebo is considered advisable (2), "when the disease process is characterized by frequent spontaneous exacerbations and remissions." Certainly, peptic ulcer is such a disease. It has been argued that the decision to utilize placebo might be between only two individuals, the physician and his patient (3), but realistically, many more must approve the trial, through multi-center participation, involvement by the pharmaceutical industry, and peer review (including human research committee approvals).

Clinical Trials as Topic↗
PubMed1988

Drug evaluation and registration in Hungary.

In Hungary, the actual drug evaluation and registration system reflects international standards and national traditions. The compulsory drug registration system that was established in 1933 was among the first in Europe. Laboratory control (since 1927), clinical trials (since 1951) and human clinical pharmaceutical experiments (since 1967) are prerequisites for new-drug approval. Applications should be sent to the National Institute of Pharmacy, which has the overall responsibility for the registration of pharmaceutical products. Applications are assessed on the basis of the drug's quality, safety, and efficacy. The procedure follows several steps: evaluation of chemical and pharmaceutical data by the staff of the National Institute of Pharmacy; evaluation of toxicologic and pharmacologic documentation with the help of the Committee on Drug Administration; after consultation with the Committee on Medical Research Ethics (mandatory in cases of original new drugs), authorized clinical pharmacologic investigations are conducted in the units of the Clinical Pharmacological Network, which are supervised by the National Center for Clinical Pharmacology; clinical trials; application for registration (scientific evaluation); and finally, application to the Ministry of Health for a marketing authorization. The process may be facilitated appreciably for preparations already registered in another country. Moreover, Hungary is an active member in the World Health Organization (WHO), Pharmaceutical Inspection Convention of the European Free Trade Association (EFTA PIC), the Council of Mutual Economic Assistance (COMECON), and other international pharmaceutical and clinical pharmaceutical collaborations.

Drug Evaluation↗
PubMed1997

Interfacing managed care and long-term care: understanding the issues.

Both marketplace forces and legislative initiatives are forcing the traditional fee-for-service long-term health care sector into the managed care arena. To identify and address the issues surrounding quality and cost-effective pharmaceutical use at the interface between managed care and long-term care, the Philadelphia College of Pharmacy and Science convened a day-long conference between managed care and long-term care medical and pharmacy directors. This paper outlines the discussion and recommendations in respect to these issues.

Continuity of Patient Care↗
PubMed1995

Cultural studies of biomedicine: an agenda for research.

This paper outlines a 'cultural studies' approach to investigations of the transnational world of contemporary biomedicine. Although biomedicine is fostered by an international political economy and global community of medical educators and bioscientists, it is taught, practiced, organized and consumed in local contexts. This essay argues that cultural studies of contemporary biomedicine should focus on the dynamic relationship between local and international worlds of knowledge, technology and practice. Three issues illustrate this approach: (1) an exploration of the tensions inherent in the local and cosmopolitan shaping of 'clinical narratives', with examples drawn from comparative studies of oncology; (2) an exploration of the influence of biomedical research findings and international clinical trials on the production of clinical narratives, with examples drawn from current research on breast cancer; and (3) an exploration of the local or national and 'international' or 'transnational' dimensions of the production of biotechnologies and pharmaceutical therapeutics. The essay concludes with a discussion of the limits that privilege either universal or local perspectives and claims to knowledge and the ethical challenges that become apparent from this perspective.

Clinical Trials as Topic↗
PubMed2003

Health care policy: qualitative evidence and health technology assessment.

Since the late 1990s health technology assessment (HTA) has gained influence as a research and evaluation approach supporting health care policy. The focus on this methodology is congruent with the growing importance of evidence-based health care. Although HTA is a multidisciplinary discipline from a theoretical point of view, practice shows that social, ethical and psychological aspects are seldom truly integrated into the assessment of health technology. HTA is still very much biased by the medical and pharmaceutical research traditions. This contribution focuses on the question of how qualitative research findings could be useful as an additional source of information or as 'evidence' in HTA. Medical and health care scientists are seldom acquainted with qualitative research or judge it as a less (or un-)reliable form of research. 'Qualitative dimensions' of health care are not considered 'real' evidence. This contribution argues that qualitative findings could be put higher in the hierarchy of evidence generating research in health care. First it can be realized by improving the knowledge of the nature of qualitative research. Second qualitative findings can become more trustworthy information, if researchers themselves respect methodological prerequisites and clarify their theoretical perspective, research aims and use of research methods. Some methodological characteristics of qualitative research and 'evidence' are discussed for their contribution to HTA and evidence-based health care.

Evidence-Based Medicine↗