Search PubMed⌕ Search

SEARCH · Search PubMed

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.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 1,171 records · Page 65Linked to original sources
PubMed2002

[Therapy optimization studies torn between science and funding].

There is no doubt that clinical studies are valuable cornerstones in the development of rational diagnostics and therapy, for the patients' safety, for quality assurance as well as for the development of a body of evidence in medicine. Well recognized multicentric study groups are active in several medical disciplines in Germany. Public funding resources however are miserable as compared to other countries. For example in hematology and oncology funds are almost exclusively available by private foundations as the Deutsche Krebshilfe only. Additionally physicians and institutions who are actively promoting clinical studies have to pay charges for patients' insurance and for registration of studies by the authorities. Furthermore there are increasing difficulties obtaining reimbursement for patients' care in clinical studies. In this context outdated regulations of the German Sozialgesetzbuch V lawbook play an important role. In summary a pronounced reform deficit paired with bureocratic tendencies has become manifested. The most important demands are in this situation: a reliable and realistic regulatory basis for treatment-related clinical studies has to be created. Studies on treatment strategies with registered drugs have to be free from the obligatory patients' insurance which is required for study with non-registered drugs. It has to be clarified that in these studies some regulations of good clinical practice as obligatory external monitoring and source data verification are not feasible and will not be required. The Sozialgesetzbuch V has to be adapted and the actual ban of clinical studies in private practice has to be ended. Treatment related clinical studies have to be free from charges of ethical committees and regulatory authorities. Thereby the financial overload of clinical studies could be reduced and some motivation for further bureocratic proliferation is removed. Finally a longterm, reliable funding resource has to be created independently from the pharmaceutical industry. A possible model could be a foundation for treatment-related studies which is financed by public funds and by funds from the reimbursement companies.

Arthritis, Rheumatoid↗
PubMedDate not supplied

Pharmaceutical marketing: implications for medical residency training.

An educational intervention was developed to improve family practice residents' ability to obtain useful information from pharmaceutical representatives. The curriculum is based on the traditional one-on-one drug detail. The objectives are to develop residents' skills in controlling the interview, promote skills for critically analyzing drug-promotional material, and discuss ethical issues. The contents include an assessment tool, suggested readings, and interview questions with rationale. After 5 years, residents' confidence in all areas of the curriculum improved significantly.

Drug Industry↗
PubMed1996

[The controversy about so-called "active euthanasia"].

In the past few years, the discussion about the right to kill severely ill patients for humanitarian reasons--once called euthanasia and after World War II in the German speaking countries as euphemism called 'aktive Sterbehilfe' (active help to die)--has become more intensive. Actually, only the Netherlands do officially practice euthanasia. But the variant that consists in putting a pharmaceutical at the patient's disposal in order to kill himself is very well known in other countries, e.g. in Switzerland, where the pressure on the legislator to also legalize euthanasia grows. Taking into account medico-ethical reasons, historical experiences, alarming euthanasia ideas in bioethics and social philosophy, the danger due to the impossibility to control the development in this field, and the insidious extension of euthanasia indications, the author rejects firmly the idea of legalized euthanasia. These problems are related to those that occur in fixing the moment of death of potential organ donors. A lack of organs in transplantation medicine should not lead physicians to explant organs from donors in a dying condition. For physicians who take care of potential organ donors and who have to look after their interests towards transplantation teams, it is often too difficult to cope with this task. Local ethical commissions should support them.

Brain Death↗
PubMed1998

[Drug research in Germany--problems and chances--from the viewpoint of the drug industry].

A trend can be observed for multinational research-based drug companies shifting their resources away from Germany (and partly also from Europe) and expanding their preclinical and clinical drug research and development programmes and organizations in the USA. The main reasons, which are presently under discussion in Germany, are the image and public acceptance of clinical drug research, professionalism of clinical studies (i.e. availability of an adequate infrastructure), the process of ethics committees votes, the citation impact of publications, the legal obstacles, the implementation of Good Clinical Practice (GCP), the regulatory and institutional situation and the political environment. These problems have been recognised and appraised recently by the pharmaceutical industry, universities, scientific associations, and governmental institutions. Prerequisites to improve the basic conditions of clinical research in Germany to make it internationally competitive are proposed in this paper.

Clinical Trials as Topic↗
PubMed2003

Clinical trials in jeopardy.

BACKGROUND: The controlled clinical trial, the gold standard for clinical research, is in jeopardy. The pharmaceutical industry is rapidly expanding its command over clinical trials but scientific rigor requires independence and objectivity. Safeguarding such criteria is hard because industrial sponsors, benefit directly from favorable results and are virtually in complete control. OBJECTIVE: To review flawed procedures jeopardizing the credibility of trials and to look for possible solutions to the conflict between sponsored industry and scientific independence. RESULTS: Flawed procedures jeopardizing current clinical trials can be listed as follows. Industries, at least in Europe, are allowed to choose their own independent protocol review board prior for approval. The independent protocol review board approves protocols even when the research is beyond the scope of its expertise. Health institutions hosting multicenter trials are requested to refrain from scientific or ethic assessment of the trial. Trial monitors are often employees of industry. Data control is predominantly in the hands of the sponsor. Interim analyses are rarely performed by independent groups. The scientific committee of the trial consists largely of prominent but otherwise uninvolved physicians attached to the study. The analysis and report of the trial is generally provided by clinical associates of the pharmaceutical companies and, after a brief review, co-signed by prominent physicians attached to the study. POSSIBLE SOLUTIONS: Possible solutions to the conflict between sponsored industry and scientific independence could include the following. Surveillance by independent observers during each stage of the trial is desirable. In contrast, tight control of study data, analysis, and interpretation by the commercial sponsor is undesirable. If, instead, the pharmaceutical industry allows the profession to more actively participate in different stages of the trial, scientific research will be better served, reasonable biological questions will be better answered, and, because the profession will be more convinced of the objective character of the research, it will not be counterproductive to the sales.

Conflict of Interest↗
PubMed1993

Some ways that technology and terminology distort the euthanasia issue.

Technology and terminology often detract from a reasoned appraisal of the euthanasia option, especially in those discussions that argue for euthanasia's incorporation into a beneficence-based medical model. "Beneficent euthanasia," assuming there is such a thing, poses special challenges to the traditional provider-patient relationship. These challenges argue for well-defined limits of beneficence and a more equitable distribution of responsiblity between participants. We should not allow technology and terminology to generate an unrealistic portrayal of patient death and its ramifications. Participants need to acknowledge their roles in the decision to kill and the obligations that those roles entail. Perhaps we can reach ethical consensus concerning euthanasia by first reasserting our span of control over the technology that can extend the near-death period and by openly discusssing euthanasia's implications.

Altruism↗
PubMed1998

The ethics of HIV research in developing nations.

This paper discusses a dispute concerning the ethics of research on preventing the perinatal transmission of HIV in developing nations. Critics of this research argue that it is unethical because it denies a proven treatment to placebo-control groups. Since studies conducted in developed nations would not deny this treatment to subjects, the critics maintain that these experiments manifest a double standard for ethical research and that a single standard of ethics should apply to all research on human subjects. Proponents of the research, however, argue that these charges fail to understand the ethical complexities of research in developing nations, and that study designs can vary according to the social, economic, and scientific conditions of research. This essay explores some of the ethical issues raised by this controversial case in order to shed some light on the deeper, meta-ethical questions. The paper argues that standards of ethical research on human subjects are universal but not absolute: there are some general ethical principles that apply to all cases of human subjects research but the application of these principles must take into account factors inherent in particular situations.

Acquired Immunodeficiency Syndrome↗
PubMed1996

Trial-and-error ethics: experimenting with non-heartbeating cadaver organ donation.

It seems commendable that Michael A. DeVita and James V. Snyder, and the physicians, nurses, and Ethics Committee of the University of Pittsburgh Medical Center (UPMC) on whose behalf they write, continually and publicly reflect on the policy they have enacted to obtain organs from non-heartbeating cadaver donors, and that they are willing to change their procedures in the light of their experiences with their protocol for this type of transplant, and the criticisms of it they have invited. It is also disquieting because, in effect, the Medical Center is engaged in trial-and-error experimentation with some features of the protocol that, from the outset, should not have been a part of it, and with certain revisions of the protocol that are as questionable as what has been modified. Is it really as virtuous as it appears, then, for UPMC health professionals and Ethics Committee members to constantly reevaluate and alter their policy for non-heartbeating organ donation, and for their spokespersons to issue one report after another containing their latest thoughts and actions in this regard?

Attitude↗