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Results for “ETHICS, PHARMACEUTICAL”

Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

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At least 1,063 records · Page 59Linked to original sources
PubMed1995

[Legal liability in clinical trials from the viewpoint of the clinician].

After a long-term work in the U.S., the liability for clinical trials is explained. The researching physician carries the responsibility for new drugs. He has to apply for the license for the study by the appropriate authority and he carries the responsibility for the consent of the volunteers which have to be informed before the trial. The studies initiated by the pharmaceutical companies relieve the researching physician from some of the responsibilities. They exert a strong control during the drug tests. The researching physician has the responsibility as a "scholarly mediator". The ethic commission inspects all stages of the study.

Attitude of Health Personnel↗
PubMed1997

Financial equivalent, industry sponsored research and conflict of interest.

Conflicts of interest for the clinician(physician)-researcher are not limited only to direct and clear financial support by manufacturers of the pharmaceutical and medical device industry, but rather include delicate indirect monetary and research support. Today professionals face an inevitable choice between two opposing moral orders, one based in the primacy of ethical obligations to the sick, the other in the primacy of self-interest and the marketplace. Some medical ethicists urge, reshape ethical codes to conform to the ethos of the marketplace, which legitimates self-interest over beneficence and makes vices out of most of traditional virtues. Second opinion represents the ethicists who recommend a firm stand in belief that being a physician imposes certain specific obligations. Medicine is at heart a moral enterprise and those who practice it are de facto members of a moral community. The market introduces an alien-till this time unknown-set of economic values into an institution (medicine) whose inherent ends are altruistic, but in countries under health care reform it brings a complex of special ethical issues in connection with deficient legislation and not firm ethical rules adopted. (Ref. 17.)

Biomedical Research↗
PubMed1998

Quality of life through therapeutic advances. Pharmaceutical company news: Ipsen N.V.

IPSEN is the Belgian subsidiary of the independent European pharmaceutical company Beaufour Ipsen, founded in 1929 by Dr. Henri Beaufour. With an expanding international presence, the group invests almost 20% of group turnover in research and development of high technology ethical products. Beaufour Ipsen R & D's fundamental goal is quality of life for patients with a special emphasis on homeostatic regulation, achieving the optimal efficacy versus tolerance ratio.

Antineoplastic Agents, Hormonal↗
PubMed1993

The effect on resident attitudes of regulatory policies regarding pharmaceutical representative activities.

OBJECTIVE: To determine the effect on resident attitudes of policies regarding pharmaceutical representative interactions with residents. DESIGN: Cross-sectional survey. SETTING: National sample of U.S. family medicine residencies. PARTICIPANTS: Three hundred seventy-eight residents from 14 randomly selected programs. Seven programs had written policies and restrictions (restricted programs), and seven had no such restriction or guideline (free programs). MEASUREMENTS AND MAIN RESULTS: The authors assessed resident attitudes regarding the perception of benefit from pharmaceutical representative activities, the usefulness of various sources of drug information, and the appropriateness of accepting gifts from a pharmaceutical representative. There were 265/378 respondents (70% response rate). Residents from restricted programs reported fewer benefits from pharmaceutical representative interactions and were less likely to feel that acceptance of gifts was appropriate. The amount of exposure to pharmaceutical representatives was positively correlated with perceived benefit and negatively correlated with ratings of appropriateness of gift acceptance. CONCLUSION: Regulatory policies can influence resident attitudes and perceptions. Training programs should develop written policies to help guide resident-pharmaceutical representative interactions.

Attitude of Health Personnel↗
PubMed2005

Tumour invasion and metastasis: challenges facing drug discovery.

Initial attempts at directly targeting metastatic spread using inhibitors of matrix metalloproteases failed to deliver the promise of anti-invasive therapy. A new generation of targeted agents with the potential to act as anti-invasives has recently entered the clinic but there is, as yet, no clear route to demonstrate an effect upon tumour metastasis. Because advances with monoclonal antibodies are likely to increase the number of potential anti-invasive agents, more clinically predictive drug discovery cascades are required to reduce the perceived risks associated with their generation. Once they reach the clinic, new approaches will be essential to help early indicators of clinical response meet ethical standards and avoid unnecessary clinical failures.

Drug Design↗
PubMed2001

[Orphan drugs: some legal, ethical and economics aspects].

Besides well-known diseases, about 5,000 identified are classed as "orphan" because of the lack of any response in terms of diagnosis, prevention and treatment. The development of drugs for these diseases, intended for a limited number of patients, often requires considerable research, and subsequently, cost. The aim of the present article is to discuss the ethical, political and economic problems relevant to the development and disposal of drugs specifically designed for these diseases, now commonly called "orphan" drugs. These questions have been raised at discussions and dialogues at the European Parliament where European regulations on orphan drugs were adopted on December 15, 1999. These regulations (141/2000/EEC) came into effect in the European Union on January 22, 2000, and are widely inspired from the American model. The regulations stipulate that the criterion for designation of the drug is based on a disease prevalence of 5/10000). Advantages commonly recognized for the orphan drug status concern: community registration (centralized marketing approval), eligibility for grants and national or community fiscal support, lower or canceled registration fees, technical contribution via the European drug agency (EMEA), and exclusive rights for a 10-year period. On May 12, 2000, the European Commission completed the status by adopting rules establishing the criteria used for designating a drug as an orphan drug. This document implements the dispositions available to pharmaceutical firms inciting them to invest in the development of orphan drugs.

Drug Costs↗
PubMedDate not supplied

Development of pharmaceutical care in The Netherlands: pharmacy's contemporary focus on the patient.

OBJECTIVE: To describe how developments in the pharmacy profession in The Netherlands converged into the current movement toward pharmaceutical care. SETTING: Dutch community pharmacy. DESCRIPTION: Literature was reviewed for key elements of pharmacists' professional development over the last 40 years--the pharmacist-physician relationship, the pharmacist-patient relationship, the education of the pharmacist, provision of information to patients, medication surveillance, clinical pharmacy, and social pharmacy. Consideration was given to how, when and if these elements interacted and contributed to the movement toward pharmaceutical care. RESULTS: During the early years of the 20th century the professional role of the pharmacist, based on preparing medications, declined because of the increased industrial production of drugs. In The Netherlands, a number of developments, starting around 1995, led to a "reprofessionalization" movement in pharmacy, characterized by pharmacists' increased awareness of social and ethical responsibilities with respect to drugs and patients. These developments included an improved relationship between pharmacists and physicians, the implementation of clinical pharmacy and medical surveillance in daily community pharmacy practice in the 1970s and 1980s, and the increased awareness of the rights of patients to quality drug information and counseling in the 1980s and 1990s. By the end of 1980 these trends had coalesced into a professional movement supporting the need for a pharmaceutical care model of practice. CONCLUSION: Dutch pharmacy is gradually implementing pharmaceutical care in daily community practice. However, a proactive attitude, not only from the "front runners," but from all pharmacists, is desirable if pharmaceutical care is to be incorporated into routine community practice.

History, 20th Century↗
PubMed2000

[What's new in pediatric pharmacology?].

Only a minority of the drugs administered to children and infants have a pediatric labeling and have been sufficiently tested for efficacy, safety and correct pediatric dosing, which cannot necessarily be extrapolated from adult data. This situation is scientifically and ethically unacceptable. To address this problem, the suggestion is being made in several countries that more formal legal requirements should be introduced. In the United States, in 1997, a new legislation encouraged pharmaceutical companies to study medicines in children (for example, by offering the financial incentive of a six-month extension to patent exclusivity). However, there are undeniable difficulties in pediatric and neonatal studies. To minimize the risks of clinical investigation in children, appropriate methodologies should be used. New in vitro and in vivo methods are now available, taking into account pediatric characteristics.

Child↗
PubMed2003

Developing a human immunodeficiency virus/acquired immunodeficiency syndrome therapeutic research agenda for resource-limited countries: a consensus statement.

To develop a research agenda for use of antiretroviral therapy (ART) in countries with highly limited resources for health, research questions focused on 3 areas: when therapy should be initiated, what therapies should be used, and the most appropriate methods for patient monitoring. Participants from 23 countries and 6 continents were clinical and academic researchers, health care practitioners, policy authorities, pharmaceutical experts, and health care advocates. The conference attendees reviewed background materials and participated in 13 state-of-the-art presentations on ART provision in resource-limited countries, treatment access, ethics, community issues, and sustainability. Conferees separated into smaller groups to identify priorities for specific research agendas. Existing multinational human immunodeficiency virus (HIV) clinical trials networks, such as the HIVNAT (The Netherlands, Australia, and Thailand) Network, were studied as infrastructure models for research into affordable, sustainable treatment and monitoring strategies suitable for resource-limited settings. The delivery of ART in resource-limited countries is a vital priority for health care providers and the millions of people living with HIV disease. To achieve sustainable approaches to HIV/acquired immunodeficiency syndrome care, research relevant to resource-limited settings must involve local researchers and community representatives to promote development of local capacity.

Clinical Trials as Topic↗
PubMed2001

Paid celebrity endorsement in health promotion: a case study from Australia.

In late 1998, Australian cricketer Shane Warne was allegedly paid A$200 000 ( pound78 060, US$123 000) by a pharmaceutical company to publicize his attempt to stop smoking. Warne failed to stop, and his continuing smoking remained newsworthy more than a year later. The arrangement caused considerable media controversy about the ethics of payment for charitable or socially worthy actions. This paper explores the community's reaction to payment for modelling a healthy behaviour, discussing the values that Warne transgressed and whether these mattered, given that the campaign caused an unprecedented rise in the use of nicotine replacement therapy.

Advertising↗