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PubMed1989

Hospital pharmacy: what is ethical?

Characteristics of ethical evaluations as they apply to the dilemmas faced by the pharmacist in the workplace are described, and the general principles and theories of Western normative ethics are discussed. Because ethical dilemmas are commonplace in pharmacy practice, pharmacists must develop a working knowledge of formal and systematic ethical analysis, as well as learn to distinguish ethical issues from social, psychological, political, and legal issues. Ethical evaluations are distinguished by three characteristics: They are ultimate, they possess universality, and they treat the good of everyone alike. Ethical analyses can be thought of as having four different and successive stages. The first stage is ensuring that all parties understand the facts of the specific case. If controversy remains after the facts are clear, parties to the dispute can proceed through three successive stages of general moral reflection: (1) the level of moral rules, (2) the level of ethical principles, and (3) the level of ethical theories. Specific moral rules cover groups of cases, and they generally are regarded as being derived from a shorter list of abstract moral principles. An ethical theory is a systematic position about which principles are morally significant, how the principles relate to each other, and how they should be tested. Pursuit of ethical dilemmas through the full hierarchy of levels of analysis exposes simplistic or irrational moral decisions and clarifies the nature of disputes.

Codes of Ethics↗
PubMed2006

Prevalence and factors associated with use of placebo control groups in randomized controlled trials in psoriasis: a cross-sectional study.

BACKGROUND: The ethics and science of using placebo control groups in clinical trials have been widely debated. Few studies, however, have examined factors associated with choice of control group. OBJECTIVE: Our aim was to assess the prevalence of use of placebo controls in randomized controlled trials in psoriasis and to identify factors associated with use of placebo controls in these trials. METHODS: This is a cross-sectional study of randomized controlled trials in psoriasis published from January 1, 2001 to December 20, 2005 and indexed in the Cochrane Central Register of Controlled Trials. We extracted data on types of control groups used, design issues (number of patients enrolled, primary end point), disease characteristics (psoriasis type and severity), and extrascientific issues (trial location, funding source, and year of publication). We used bivariable and multivariable logistic regression to determine factors associated with use of a placebo control group. RESULTS: Of 194 citations, 187 were available for review. One hundred thirty-five trials from 134 articles in 38 journals met inclusion criteria. Eighty-three trials (61.5%) enrolling 8171 subjects (41.7%) used active controls only, and 52 trials (38.5%) enrolling 11,406 subjects (58.3%) used placebo controls. Adjusted for trial location and funding source, trials significantly more likely to have used placebo controls included those conducted in the United States (odds ratio [OR], 5.79; 95% confidence interval [CI], 2.45-13.68; P < .001) and those funded by pharmaceutical companies (OR, 2.61; 95% CI, 1.19-5.73; P = .02). Predicted frequencies of placebo use ranged from 77.6% (industry-funded, conducted trials in the United States) to 18.6% (non-industry-funded trials not conducted in the United States). LIMITATIONS: Our searches may not have identified all published trials, and we did not have access to data from unpublished trials. CONCLUSIONS: Use of placebo controls has been more common in psoriasis trials conducted in the United States and funded by pharmaceutical companies. The findings suggest that ethical and scientific issues related to choice of control group in psoriasis trials are interpreted markedly differently depending on trial location and funding source.

Cross-Sectional Studies↗
PubMed1968

Setting new goals.

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Ethics, Pharmacy↗
PubMedDate not supplied

Prison for fraud.

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Animals↗
PubMed2005

Ototoxic eardrops and tympanic membrane perforations: time for a change?

Until recently the only available antibiotic eardrops for treatment of the discharging middle ear and mastoid cavity have been potentially ototoxic. With the advent of non-ototoxic fluoroquinolone eardrops, consensus panels in the USA, Canada and the UK have advocated the preferential use of these agents in the open middle ear. However, in Australia, no fluoroquinolone topical agent is approved for use with tympanic membrane perforations, and when used as an 'off label' eardrop, none is on the Pharmaceutical Benefits Scheme. This creates an ethical dilemma, particularly with best practice management of chronic suppurative otitis media in indigenous children. Despite concerns regarding resistance issues with ototopical use of systemic antibiotics, bacterial resistance has not been documented in major studies. For equity and ethical reasons, Australian regulatory authorities should consider approving a sterile non-ototoxic eardrop for use in the open middle ear.

Aminoglycosides↗
PubMed1992

The view and responsibility of the advertising agency toward advertising claims.

Health care advertising agencies must create communication that is simultaneously creative, scientifically accurate, relevant, within fair balance, simple, motivating, within approved labeling, and approvable by the client, the dental profession, and regulatory bodies. The advertising must also stimulate sales of the product being advertised. Subjective decisions concerning these requirements place the agency and its client at risk for financial losses and embarrassment.

Advertising↗
PubMed2003

Clinical research and industrial sponsoring: avenues towards transparency and credibility.

Clinical research is intended to serve the patient, in the pursuit of a deepened understanding of physiological interactions and their changes in disease, and of potentially beneficial implications for the patient. The impetus to perform clinical research is shaped by various intentions, such as the desire to provide cure or relief, striving for personal and professional success, public attention, financial considerations, or simply scientific curiosity. A similarly wide range of diverging interests must be assumed to impinge on diagnostic and therapeutic decisions in clinical work. How are we to perform clinical research and therapy with the patients' benefit in mind, in view of such a complex motivational status, and how are we to perceive the peculiar interests of those influencing clinical work, including ourselves? In this review, we attempt to elucidate the complex pathways of interaction between physicians and industrial sponsors. Special attention will be paid to the following topics: the pharmaceutical market, public interests, legal and ethical issues, conflicts of interest, and the potential impact of industry-sponsored drug trials on medical information and subsequent therapeutic decisions. We will conclude with recommendations for an acceptable position in the tension between cooperation and corruptibility, a position that grants priority to the patient's needs rather than third party interests.

Biomedical Research↗