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At least 667 records · Page 37Linked to original sources
PubMed1987

Drug promotion.

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PubMed1980

[The experiment of medicaments on a healthy man. Its situation compared to the French law and the medical ethics (author's transl)].

After having looked at which was the value and the scientific extent of experiments on a healthy man, the authors show in which conditions this type of experiment can be considered as ethical. Two points are important in order to admit this ethical character: the necessity of the experiment and the existence of a collective benefit. Then, the juridical outline of these experiments is debated and the authors remind: --that medicinal products are experimented on the healthy man, --that there are texts which make official the acts offering risk, with collective benefit exclusively, --that a law imposes experiments for non-medicinal products. Finally, the types of responsibilities which could be looked at in case of experiment on a healthy man, with collective benefit, are debated.

Clinical Trials as Topic↗
PubMed1993

Prospects for cervical cancer vaccines.

As we have seen, the technical problems of developing cheap, effective vaccines against HPV associated tumours are formidable, but they are by no means insuperable. Experiments in cows with BPV2 show that both therapeutic and prophylactic vaccines work to some extent and the immunogens used are by no means the best that could now be envisaged. The fact that human trials are now under consideration or in progress with both protein vaccines and recombinant vaccinia virus vectors is also very encouraging. There are still both practical and ethical problems, as with any sexually transmitted disease, but the main problem is one of support. Pharmaceutical companies see no immediate profit in vaccines of this type, preferring to invest in drugs for treatment or diagnostic kits for detection. Vaccines against HPV are unlikely to be forthcoming, and indeed, the people most in need of protection against cervical cancer are the least able to afford any sort of treatment, especially a preventive one. This leaves the cancer charities, and these in their present financial difficulties are understandably reluctant to commit substantial resources to the long term programmes that are needed to tackle the problems of developing and evaluating candidate vaccines. It seems certain that intervention against HPV and cervical cancer will come in time, but with the present level of commitment, progress is inevitably going to be less rapid than one would like.

Female↗
PubMed2005

[The Ethics Committee meeting in Belgium May 7, 2004, on human experimentation].

The European directive 2001/20/EC concerning the performance or clinical trials has been transposed in the Belgian law of May 7, 2004, entitled "Loi relative aux expérimentations sur la personne humaine" (Moniteur belge, May 18, 2004)". The range of the law is larger than those of the directive. Several new elements must be underlined: 1. Any experimentation on a human being may only begin if the promoter received a positive advice from an ethical committee according to the provision of the law. 2. For multicentric assays, a single opinion, identical for all the participating centres must be obtained. This implies a close dialogue between the ethical committees. A central committee is proposed by the industrial promoter. Each clinical trial of a drug must have a unique identification number obtained at the European agency for the evaluation of medicinal products (EMEA). 3. Taking into account the fear of the pharmaceutical industry that some clinical studies could be "delocalized", the authorities accepted to reduce to twenty- eight days (instead of 60) the delay granted to the ethical committee in order to produce their single opinion. 4. The law of May 7, 2004, clearly defines the dispositions related to the protection of the participants. Particular dispositions are foreseen for the protection of minors, incapable adults and patients in emergency. 5. The promoter endorses, even without fault, the responsibility of the damage caused to the participant or his descendants. An insurance covering this risk must be contracted.

Belgium↗
PubMed2004

The policy implications of gender mainstreaming for healthcare research in the EU.

Scientific and technological progress in the life sciences and modern biotechnology is continuing at a breathtaking pace. At the same time, the potential implications for individuals and society are giving rise to intense debate. This article gives a background to the European Institute of Women's Health (EIWH) and the work of the organisation in contributing to and developing policy at a European level. We will identify the policy issues related to gender-based healthcare research arising from the EU 6th Framework Programme for Research, which was introduced this year, and the implications for the EU Public Health Strategy. Additionally, the issues of personalized medicine and the promise of biotechnology for improved medicines and healthcare will be addressed from a gender perspective. What are the prospects in the medium and long term? How can we best address the ethical and socio-economic implications?

Economics, Pharmaceutical↗
PubMed1993

Building an effective therapeutic alliance: competence, trustworthiness, and caring.

Patient counseling and pharmaceutical care require much more than the provision of information. They require a commitment on the part of the pharmacist to the well-being of the patient. They also require the formation of a therapeutic alliance. Patients are not likely to tell pharmacists about problems they have in managing their drug therapy if they believe they will be judged or scolded for nonadherence. Patients must feel safe enough to present problems or ask questions. In responding to how patients manage their illnesses and interpret the pharmacists' instructions, pharmacists must treat each patient as unique. Pharmacists must develop a flexible system of response. What is comforting to one patient might be frightening to another. By developing a flexible system of response, pharmacists will be able to treat patients more effectively. There are no right or wrong answers, only those that work. A pharmacist's basic understanding and true desire to care for the patient will increase the number of successful responses.

Comprehension↗
PubMed2004

Ethics in the marketing of medical services.

This paper deals with the ethics of marketing medical services by physicians, medical groups, hospitals and other mainstream medical caregivers in the United States. It does not deal with pharmaceutical marketing, since that raises a number of special issues, some of them legal and some having to do with the unique culture of pharmaceutical marketing, which really ought to be dealt with separately. Nor does it touch on the little-explored field of marketing alternative and complementary medicine. It begins with a general description of what is included in "the marketing process." It then briefly tours some of the difficulties faced by those who would market medical services ethically, and ends with some comments on the relevance of professionalism to ethical marketing.

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PubMed2001

Clinical trials integrity: a CRO perspective.

When contract research organizations (CROs) were first formed, pharmaceutical companies outsourced to them only certain aspects of the conduct of their clinical trials. At first CROs were highly specialized entities, providing, for example, either biostatistical advice, clinical research associates who monitored investigational sites for regulatory compliance, or regulatory support. Gradually, full service CROs emerged, offering a full range of services for clinical trials, including the selection of investigators and investigational sites, assistance with patient recruitment, safety surveillance and reporting, site audits, and data management and biostatistics. This evolving relationship between CROs and the pharmaceutical and medical device industries has resulted in CROs assuming more and more of the regulatory and ethical risks and responsibilities inherent in the conduct of clinical trials. In this full service role, CROs, unlike sponsors, are not interested in the outcome of study, but like sponsors, are subject to heavy regulation by the federal government, must follow applicable state laws, must respect international guidelines, and are obliged to follow their own operating procedures. Moreover, they are judged by the industry on the basis of the scope and quality of services provided, including the degree of adherence to the research protocol, regulatory requirements, and timelines; the quality of the professional working relationships with investigators and institutions, both academic and community-based; and the validity of the data. Further, CROs are subject to comprehensive audits by sponsoring companies, FDA, and other regulatory authorities. For all these reasons, CROs are being tasked with strict vigilance of all stages of the clinical trial process to ensure that the laws, regulations, and industry standards designed for the protection of human subjects and data integrity are maintained.

Advisory Committees↗
PubMed1994

Public information and the ethical responsibility of the industry.

Biotechnology and gene technology are recognized by experts as invaluable and unique tools to find solutions to or improve many problems in health, agriculture and management of the environment, and are regarded as a driving economic force in the next century. They are, however, by large not accepted by the public and the discussion on gene technology is often emotional or even controversial. This situation is not favorable to a constructive and open debate. Science, economic forces and society coexist symbiotically and a broad debate on all aspects including the social and ethical issues of biotechnology is essential. A mutual understanding and acceptance are prerequisites to the democratic process of the elaboration of sound regulation and appropriate administration. To this aim, a task force was initiated in Switzerland by the pharmaceutical industry. Its goal is to provide information on relevant aspects of biotechnology and to participate in the dialogue with the Swiss public and politicians on critical issues like risk assessment, ethics, safety, novel food and legislation. A documentation service, teaching material, national poster campaign, exhibitions and debates on specific issues are the contributions of the industry to a fair information in favor of the improved background to an educated and open debate.

Biotechnology↗