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At least 1,099 records · Page 61Linked to original sources
PubMed2002

Mapping public policy on genetics.

The mapping of the human genome and related advances in genetics are stimulating the development of public policies on genetics. Certain notions that currently prevail in public policy development overall--including the importance of protecting privacy of information, an interest in cost-effectiveness, and the power of the anecdote--will help determine the future of public policy on genetics. Information areas affected include discrimination by insurers and employers, confidentiality, genetic databanks, genetic testing in law enforcement, and court-ordered genetic testing in civil cases. Service issues address clinical standards, insurance benefits, allocation of resources, and screening of populations at risk. Supply issues encompass funding of research and clinical positions. Likely government actions include, among others: (1) Requiring individual consent for the disclosure of personal information, except when such consent would impose inordinate costs; (2) licensing genetic databases; (3) allowing courts to use personal information in cases where a refusal to use such information would offend the public; (4) mandating health insurers to pay for cost-effective genetic services; (5) funding pharmaceutical research to develop tailored products to prevent or treat diseases; and (6) funding training programs.

Attitude↗
PubMed2006

Cosmetic psychopharmacology and the President's Council on Bioethics.

Advances in neuroscience and biotechnology have heightened the urgency of the debate over "cosmetic psychopharmacology," the use of drugs to enhance mood and temperament in the absence of illness. Beyond Therapy: Biotechnology and the Pursuit of Happiness (2003), the report of the President's Council on Bioethics, has criticized the use of cosmetic psychopharmacology. The Council claimed that cosmetic psychopharmacology will necessarily lead to "severing the link between feelings of happiness and our actions and experiences in the world," but it provided no satisfactory arguments to support this claim and ignored the possibility that cosmetic psychopharmacology might actually enhance the link between happiness and experience. The Council's arguments against cosmetic psychopharmacology depend heavily on the mistaken belief that Prozac and similar antidepressants are mood brighteners in healthy subjects. The empirical evidence, however, clearly indicates that these drugs are not forms of cosmetic psychopharmacology, thus negating much of the Council's arguments. The use of pharmaceutical agents to enhance mood or personality in normal individuals should not be rejected a priori. Instead, the effects of each agent on the individual and on society must be weighed using sound ethical reasoning and the best evidence available.

Advisory Committees↗
PubMed2001

Prescriber profiles.

Within a two-week period, two sales representatives from competing pharmaceutical companies visited the office of an orthopaedic group practice. One representative was elated that the group had been steadily prescribing his company's new arthritis medication. The physicians assumed that the representative was speaking about the number of sample packs used by their office. Several days later, a competing drug representative visited the office and complained that several physicians in the group were "not thinking of my company's medication first." The physicians were perplexed and asked him how he had come by that information. After multiple attempts at evading the question, the representative explained that pharmaceutical companies pay the drugstores for such data. Although unwilling to disclose the details of the arrangement, he did inform the physicians that the pharmaceutical companies know exactly which physicians are writing which prescriptions. He assured the physicians that patients' names are not disclosed. The physicians spoke to several pharmacists and other pharmaceutical representatives, who confirmed the practice.

Commerce↗
PubMed1997

[Our policy and future tasks related to ICH in anti-cancer drug development--a discussion from the viewpoint of an enterprise].

International harmonization of data to be submitted in order to receive governmental authorization for the release of new medicines (ICH) has been promoted by Japan, the USA and European countries. Because of this trend, the Japanese drug authority, the medical institutions which perform clinical trials of not yet authorized new drugs and the pharmaceutical companies which contract these trials to medical institutions, are now required to change greatly their conventional views concerning drug development. The trend towards ICH has also been having a great impact on the development of anti-cancer agents in Japan. The greatest impact of ICH is that it requires pharmaceutical companies to take responsibility for the planning, pursuit and management of clinical trials of new drugs. To meet this requirement, it is urgent that pharmaceutical companies educate and train staff members involved in drug development, so that they attain high levels of medical proficiency in the field concerned. It is also necessary for these companies to organize in house groups of specialists in making clinical trials, who can evaluate clinical data and make decisions about outcomes by themselves. At the same time, medical institutions are required to establish a system which supports the clinical trials carried out within the hospital, while meeting the appropriate guidelines. Thus, medical institutions are required to make greater efforts to ensure adequate disclosure of diagnosis of cancer to a patient, obtain informed consent from patients and develop a hospital system capable of conducting excellent clinical trials. The governmental authority related to drugs is required to improve drug administration, including streamlining regulations and providing consultation services concerning the appropriate strategy for particular clinical trials. If the relevant governmental authority, medical institutions, pharmaceutical companies and mass media cooperate with the goal of improving the environment and systems related to clinical trials, the current system of clinical trials will be improved significantly, allowing more scientific and ethical clinical trials. This, in turn, will promote the smoother development of anti cancer agents in this country. At present, both the views on and the manner of conducting clinical trials (especially phase I clinical trials) differ in Japan and Western countries. These differences cause differences in the scheduling of preclinical studies, possibly leading to delayed commencement of phase I clinical trials in Japan. Among these issues, the procedures for preclinical studies of safety and pharmacokinetics studies (absorption, distribution, metabolism and elimination of drugs) need to be internationally standardized as soon as possible.

Animals↗
PubMed2005

Ethical issues in the relationships with industry: an ongoing challenge. New Guidelines open for public comment.

Interactions between medical practitioners and industry have a profound impact on medical decision-making. It is important to establish clear guidelines to ensure that the values of clinical care, the welfare of society and science prevail over commercial imperatives and monetary values, The Royal Australasian Collage of Physicians has revised its Guidelines for the relationships involving medical practitioners and industry to provide practical assistance to health care professionals in the understanding and management of their interactions with industry. The Guidelines are advisory but provide argument and references to support their conclusions. They outline a practical approach to the management of dualities and conflicts of interests. Among other things, they recommend that gifts should be rejected, including those of small value and entertainment expenses. They argue that industry sponsorship to attend meetings should be restricted to cases where formal contributions are being made, that drug samples should not be accepted from pharmaceutical representatives and that endorsements of specific products and "advertorials" should be avoided. They propose that clinicians should not actively recruit their own patients into studies in which they are investigators and that it should be a condition of agreement to participate by researchers and approval by ethics committees that there is a commitment to make publicly available all results potentially relevant to clinical practice. The Guidelines are intended to reflect changing community attitudes and will continue to be revised from time to time.

Australia↗
PubMed1995

Bioequivalence. An updated reappraisal addressed to applications of interchangeable multi-source pharmaceutical products.

This paper reviews study procedures for bioequivalence trials, mainly addressed to the New Drug Application (NDA) of generic drugs, strictly referring to EU and USA guidelines on this matter. Specific attention is devoted to the most appropriate experimental designs, the size of the volunteer sample, the ethical issues involved, statistics to assess bioequivalence and the accepted standard format for final research reports. Some aspects which create serious problems in bioequivalence trials, most of which not fully covered by the EU and USA specific guidelines, are comprehensively discussed. These include a) drugs with elevated variability; b) endogeneous substances and the management of baseline value; c) modified release formulations; d) prodrugs; e) restrictions to be contained in forthcoming guidelines on chiral medicinal products; f) superbioavailability; g) drugs with elevated half-life and h) cases in which bioequivalence trials should not be needed. As generic drugs cost less than the innovator product, agencies have facilitated their NDA procedures by requiring a dossier on chemistry and pharmacy and a pivotal bioequivalence study to demonstrate that the generic formulation is fully interchangeable with the innovator product. Bioequivalence is thus the key requirement for an NDA of a generic drug, and trials should be planned, conducted and reported in the most appropriate way. With this in mind, this review is an up-to-date reappraisal that should stimulate the attention of scientists and regulatory authorities on some open questions on bioequivalence.

Dosage Forms↗
PubMed1995

Relationships between in vitro and in vivo biotransformation of drugs in humans and animals: pharmaco-toxicological consequences.

Given the crucial role played by hepatocytes in the detoxification/toxification processes of drugs, these cells have been increasingly used during the last decade in various pharmaco-toxicological areas. The majority of these studies have, however, dealt with animal cells, although examples of failures in the extrapolation of the data to man are frequent. This drawback, together with the ethical considerations in performing in vivo experiments, makes the application of the human hepatocyte model critical in the preclinical evaluation of new compounds. However, before making extensive use of these promising tools for prospective pharmaceutical research, one must ensure that they can generate data that correlate well with those obtained in vivo. This is only possible through extensive studies on drugs showing a variety of phase I and phase II metabolic pathways in hepatocytes from different species, including man, and comparison with in vivo data. Providing this validation step is undertaken, the use of such systems in drug research and development may greatly enhance the rational design of safe and effective drugs, allowing savings in time, cost and test materials as well as minimizing the use of animals.

Animals↗
PubMed2006

Paediatricians and the pharmaceutical industry: an industry perspective of the challenges ahead.

The relationship between healthcare professionals and the pharmaceutical industry is under intense scrutiny. Accusations of corrupt practices have been levelled at the industry by both the professional and the lay press. The environment is changing, with rising expectations of transparency and ethical standards. In addition, society is becoming increasingly risk averse. There have been examples of poor practice by industry in the past, and industry is learning from these. Equally, there are many examples of excellent practice where industry has worked effectively and ethically with clinicians. The goal of industry is to bring new medicines to benefit patients and shareholders. Commercial success is dependent upon putting the patient at the centre of activity. It also allows re-investment into research and development. This allies industry and healthcare professionals with a common and key ethical arbitrator--the patient. Industry is changing as an acknowledgement of the need to adapt to the culture change demanded by society. Self regulation is increasingly active and transparent; guidelines, laws and internal/external regulators exist to examine industry. However, for the changes in regulations, behaviour and practices to be fully effective, there is a need for dialogue between industry and healthcare professionals. Commitment is needed from both sides to work together to manage the relationship.

Drug Industry↗
PubMed1998

A duty to publish.

Explore the source record for details and available documents.

Biomedical Research↗
PubMed1996

Experiences and attitudes towards end-of-life decisions amongst Danish physicians.

In this survey we have investigated the experiences and attitudes of Danish physicians regarding end-of-life decisions. Most respondents have made decisions that involve hastening the death of a patient, and almost all find it acceptable to do so. Such decisions are made more often, and considered ethically more acceptable, with the informed consent of the patient than without. But both non-resuscitation decisions, and decisions to provide pain relief in doses that will shorten the patient's life, have been made and found acceptable by at least 50% of the respondents, even when there is no informed consent. Furthermore, 12% have doubled morphine dosages with fixed intervals, thus providing doses substantially higher than that necessary to control pain, without the informed consent of the patient. Two percent have helped in assisted suicide, and 5% have administered a lethal injection at the patient's request. Respectively 37% and 34% find these last two practices ethically acceptable. Amongst those that do not find them acceptable, the most important reasons to be opposed are, the doctrine of double effect, the doctrine of doing and allowing, and the view that human life is sacred. Amongst supporters, the most important reasons mentioned are, that the patient's right to self-determination should be respected, the view that a patient should not be forced to suffer, and the view that the patient has a right to be helped to a dignified death.

Analgesics, Opioid↗
PubMed1990

Unfinished feticide: the ethical problems.

Dr. Jansen's paper raises three main issues. The one with which he himself is most concerned is the question of which methods of abortion are ethically right, and whether methods which risk the birth of a damaged baby are wrong. But there are two others: first, how the (originally unintended) birth of a live but damaged child alters the moral situation, and secondly, whether the overcoming of sterility by inducing a multiple pregnancy in which some of the fetuses have to be killed in order for any of them to survive is at all morally acceptable.

Abortion, Eugenic↗