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Results for “ETHICS, PHARMACEUTICAL”

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PubMed1981

[Treatment of drug addicts under the aspect of medicoprofessional ethics (author's transl)].

The problem of an effective treatment of drug addicts is getting more and more important. This applies in particular to youngsters who have become addicted to opiate drugs. The medical profession is confronted by the question to what extent they can contribute towards tackling this task. It is becoming evident that success can be achieved if physicians join hands with skilled social workers. Insofar as drug-free methods are applied, the realization of such co-operation does not involve any obvious legal or ethical difficulties linked to a professional code. However, there is an obstacle to the development and critical testing of new methods in the field of addiction, namely, the scholastic tendency to recognize definite therapeutic methods only as being in line with professional ethics, whereas other methods, especially those supported by the use of pharmaceuticals, are rejected or discriminated right away as erroneous or illegal. It is suggested to gradually come away from this scholastic position and to utilize the criteria normally applicable and well-tried in the medico-scientific field. Differentiation between methods in line with professional ethics and questionable methods can be effected only against the background of empirical results.

Ambulatory Care↗
PubMed1993

Drug marketing in French-speaking African countries.

Pharmaceutical companies are often criticized for the quality of their drug advertisements in developing countries. The quantitative data we have collected on advertisements in Francophone African countries confirm these criticisms. In 1990, only 41 out of 141 advertisements published in 6 medical and paramedical journals aimed at Francophone health personnel in Africa conformed to French standards for accuracy and objectivity. Indications were absent from 5 (3.5%) advertisements and exaggerated in 42 (29.8%); side-effects were not mentioned at all in 37 (26.2%) advertisements and were incomplete in a further 20 (14.2%). Similarly, contraindications were absent from 30 (21.3%) advertisements and incomplete in 19 (13.5%). It is clear that pharmaceutical companies do not always follow a code of ethical conduct and that they frequently exploit the lack of effective controls in developing countries. This attitude creates a hazard to public health and tarnishes the image of the companies concerned.

Advertising↗
PubMed2004

Trends in accessibility to medicines for children in New Zealand: 1998-2002.

BACKGROUND: Reported rates of unlicensed and off-label use of medicines in children raise concerns regarding overall access of children to medicines OBJECTIVE: To assess changes in availability of proprietary formulations suitable for infants and young children; licensing of medicines; and subsidization of medicines for children in New Zealand. METHODS: Review of the New Ethicals Catalogue, New Ethicals Compendium, product data sheets and the New Zealand Pharmaceutical Schedule covering the years 1998-2002 inclusive. RESULTS: There was a decrease in the total number of medicines licensed in New Zealand from 2014 to 1840; but there was an increase in the number and percentage of suitable formulations that were licensed for paediatric use from 616[31%] to 642[35%]. The number of suitable paediatric formulations that were subsidized decreased from 281[13.9%] to 260[14.1%]. The number of orally available chemical entities with suitable formulations, licensed and subsidized for paediatric use declined from 101[5.0%] to 94[5.1%], but all of these chemical entities that were withdrawn had therapeutic alternatives that were licensed and subsidized. Only 36% of new medicines that had licensing for children were licensed for the 0-23 month age group. CONCLUSION: There have been modest improvements in licensing of medicines for children in New Zealand from 1998 to 2002.

Adolescent↗
PubMedDate not supplied

More the same than different: worldwide drug policy issues.

Pharmaceutical policies in Europe were described in the previous issue of the journal. These policies were described in 5 areas: regulation and access; pricing, price control, and cost; publicly administered drug insurance; patient advocacy; and research ethics. While the underlying policy issues are strikingly similar, each country has developed its own set of solutions to address them. This article provides insight into the Canadian drug policy environment by comparing and contrasting it with the European experience.

Ethics, Research↗
PubMed2001

Routine experimental system for defining conditions used in photodynamic therapy and fluorescence photodetection of (non-) neoplastic epithelia.

A common method to induce enhanced short-term endogenous porphyrin synthesis and accumulation in cell is the topical, systemic application of 5-aminolevulinic acid or one of its derivatives. This circumvents the intravenous administration of photosensitizers normally used for photodynamic therapy (PDT) of fluorescence photodetection. However, in the majority of potential medical indications, optimal conditions with respect to the porphyrin precursor or its pharmaceutical formulation have not yet been found. Due to ethical restrictions and animal right directives, the number of available test objects is limited. Hence, definition and use of nonanimal test methods are needed. Tissue and organ cultures are a promising approach in replacing cost intensive animal models in early stages of drug development. In this paper, we present a tissue culture, which can among others be used routinely to answer specific questions emerging in the field of photodynamic therapy and fluorescence photodetection. This technique uses mucosae excised from sheep paranasal sinuses or pig bladder, which is cultured under controlled conditions. It allows quasiquantitative testing of different protoporphyrin IX precursors with respect to dose-response curves and pharmacokinetics, as well as the evaluation of different incubation conditions and/or different drug formulations. Furthermore, this approach, when combined with the use of electron microscopy and fluorescence-based methods, can be used to quantitatively determine the therapeutic outcome following protoporphyrin IX-mediated PDT.

Aminolevulinic Acid↗
PubMed2000

Genomics. University company to exploit heart data.

This month, Boston University, which directs the Framingham Heart Study, a massive government effort begun in 1948 to monitor the cardiovascular health of more than 10,000 residents of this suburb of Boston, announced plans to form a bioinformatics company that will mine the data. The university will own 20% of Framingham Genomic Medicine Inc., which hopes to raise $21 million to begin modernizing the immense database and packaging it in a format that will be valuable to the pharmaceutical industry. The plan raises a host of difficult ethical issues, including patient privacy, academic conflicts of interest, and reciprocal value to the Framingham residents whose medical data will form the basis for the new enterprise.

Bioethics↗
PubMedDate not supplied

Under the shelter of ethics.

Problems of ethics committees in post-communist Russia are briefly discussed. The first ethics committees were established in 1980s upon the initiative of international pharmaceutical companies involved in clinical trials. Generally, such committees exist at hospitals conducting these trials and at research institutions dealing with human experimentation. They are bureaucratic structures heavily dependent on hospital or institution administration. Publication of research results in international periodicals is the main reason for their existence. An officially recognized National Ethics Committee is non-existent although there are several competing ethics committees at a national level (at the Ministry of Health, Academy of Sciences, Academy of Medical Sciences, Russian Medical association etc.). There is no federal legislation on the structure and status of ethics committees.

Advisory Committees↗
PubMed1998

Freebies for subject 641: a discussion of the ethical prospect of providing drug trial subjects with post-trial access to the drug tested--a Canadian perspective.

"Pharmaceutical Company Incorporated" is developing a new drugs to treat AIDS. The Company is hoping to begin clinical trials soon and has submitted its tiral proposal for consideration by the Research Ethics Board (REB). The proposal includes provision to supply the drug free of charge to trial subjects if the drug is shown to be effective and safe. The members of the REB are split as to whether such an offer is acceptable. Some members of the REB are concerned that the offer is an undue inducement for prospective subjects to participate in the clinical trial.

Canada↗
PubMed2001

Drug use investigation (DUI) and prescription-event monitoring in Japan (J-PEM).

OBJECTIVE: To present ethical issues and relevant problems in observational studies of drug safety in Japan. METHODS: The Pharmaceutical Affairs Law, associated ordinances, and notifications relevant to Drug Use Investigations (DUIs), and published documents for two pilot studies of prescription-event monitoring in Japan (J-PEM) were examined, particularly with regard to the protection of privacy. Information relevant to the proposed legislation intended to protect personal information and proposed guidelines on ethical issues in epidemiological studies were also collected. RESULTS AND CONCLUSION: The formal studies inaugurated as the 'side-effect investigations' in the late 1960s and replaced by those of the DUI in 1980 have been conducted by drug manufacturers, in accordance with the Pharmaceutical Affairs Law. The first pilot study of J-PEM was started in 1997 and the second one is currently operated under a Health Sciences Research grant, supported by the Ministry of Health and Welfare. Those observational studies have been conducted while maintaining the confidentiality of personal data, but without requiring either approval by institutional ethics boards or informed consent from patients. However, according to the Pharmaceutical Affairs Law, those involved in postmarketing surveillance studies must protect the privacy of study subjects and those who break this rule may be subject to penalties. Ethical issues associated with pharmacoepidemiological studies will be clearly determined in Japan before the end of 2001 when the law designed to protect personal information will be introduced and official guidelines on ethical issues in epidemiological studies will have come into effect.

Bioethics↗
PubMed2004

The medical profession and the pharmaceutical industry: when will we open our eyes?

There is evidence that drug-marketing techniques affect doctors' prescribing practices. This has ethical implications for doctors, as it affects the trust required in the doctor-patient relationship. Doctors need to recognise they are affected by drug marketing, and take steps to maintain their independence from the pharmaceutical industry.

Attitude of Health Personnel↗
PubMed2004

Beyond a western bioethics?

Like theology and ethics generally, bioethics has increasingly developed a global consciousness. Controversies over AIDS research and access to affordable AIDS treatment have generated new awareness about the importance of international collaboration as well as the difficulty of achieving moral consensus across economic, political, and cultural divides. Advances in scientific and medical knowledge through initiatives such as the Human Genome Project invite new questions about the nature of health care as a common good. This budding global consciousness serves as a starting point for examining contemporary challenges to the secular, principle-based Western bioethics that has dominated national and international debate for three decades.

Acquired Immunodeficiency Syndrome↗
PubMed2003

Ethical issues in the management of Helicobacter pylori infection.

Medical ethics are not absolute; they change according to social attitudes, technological advances and alterations in the doctor/patient relationship. The discovery of Helicobacter pylori highlighted entrenched attitudes in academia and the pharmaceutical industry that were not always appropriate. The explosion of research that followed was ethically controlled by local research ethics committees and the system of peer review and editorial responsibility. Now that effective treatments are available, the control arm in trials of new therapy should be either placebo (giving the option of effective treatment later) or a first-line treatment; mono and dual therapy should not be employed because of the risk of inducing bacterial resistance. Ethical issues that still remain include whether always to test patients for H pylori at endoscopy and what information should be given when they test positive. The most important issue is the approach of the medical profession to the high death rate carried by H pylori infection. Peptic ulcer and gastric cancer together account for a large number of deaths worldwide, and the medical profession and public health services have not yet grappled with this problem, neither advocating universal testing and treatment nor funding or research to determine whether this approach would be effective.

Ethics, Medical↗