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Complimentary journeys to the World Congress of Gastroenterology--an inquiry of potential sponsors and beneficiaries.

UNLABELLED: One of the most effective tools of pharmaceutical marketing is the distribution of gifts to physicians whose magnitude remains ill defined. This anonymous survey determines the frequency with which physicians receive travel awards from drug companies to attend International Medical Conventions and attempts to obtain the recipients' opinion on ethical and legal issues related to such sponsorships. METHODS: A questionnaire was mailed to all members of the German Gastroenterological Association who had attended the most recent World Congress of Gastroenterology and to 30 pharmaceutical companies. Questions concerned the physician's role at the congress, the mode of payment for travel, lodging and convention fees as well as the attendees' opinion on ethical and legal issues related to sponsoring by pharmaceutical companies. RESULTS: 78% of the contacted physicians returned the questionnaire. 67% (95% CI [55, 80]) of them received compensation for their travel expenses by industry, and the majority of them stated that they would not have attended the congress if such sponsoring had not occurred. More than two thirds believed that sponsoring by drug companies neither interferes with ethical and legal issues nor affects prescribing behavior. Such opinions were more frequently expressed by sponsored than nonsponsored attendees (p = 0.003). 20% of the contacted drug companies returned the questionnaire, one of whom expressed concerns regarding the ethics of sponsorships. CONCLUSIONS: International conventions would suffer from a significant deprivation of attendance if the attendees' expenses were not subsidized by industry. Recognition of ethical and legal issues related to such sponsoring appears to be limited and requires further discussion within the medical community.

Attitude of Health Personnel↗

Drugs and medical ethics.

Naturopathy has received considerable interest all over the world recently. The use of its methods and its consequences have raised legal and ethical problems. This article reports on the use of two 'oncolytic' drugs. Neither of them was produced by cancer researchers and neither passed the analytic examination required in pharmaceutical research. During their use--they were prescribed and applied by physicians--conventional treatment was withdrawn. The ethical responsibility of doctors using fringe medicine drugs is dealt with. Naturopathy may, however, have a role in official medicine in certain cases.

Antineoplastic Agents↗

Ethical dilemmas encountered during clinical drug trials.

We are fortunate to live in an era when medicine is making important progress in the diagnosis of many diseases, which have plagued mankind for centuries. The pace of progress is really staggering. New potent drugs are introduced continuously. The evaluation of their efficacy and safety is an arduous and costly process that involves laboratory work, animal studies and human trials. Someone must take a new drug first hence, human experimentation is unavoidable. Over the years, principles and rules have been introduced to guarantee respect for the individual. In our present state of knowledge, randomised clinical trials are necessary. They aim not only at the actual patient's treatment, but also to serve future patients who will need the drug. We should appreciate that conscientious people have established an ethical basis for the proper conduct of RCTs. Individual investigators in basic sciences, in institutions, and the pharmaceutical companies, all contribute to a common end--the production of useful drugs. Most of us are involved in clinical trials. The present review has discussed briefly some of the ethical dilemmas encountered during the clinical trial process in order to encourage the exercise of more humane medicine.

Authorship↗

Global gene mining and the pharmaceutical industry.

Worldwide efforts are ongoing in optimizing medical treatment by searching for the right medicine at the right dose for the individual. Metabolism is regulated by polymorphisms, which may be tested by relatively simple SNP analysis, however requiring DNA from the test individuals. Target genes for the efficiency of a given medicine or predisposition of a given disease are also subject to population studies, e.g., in Iceland, Estonia, Sweden, etc. For hypothesis testing and generation, several bio-banks with samples from patients and healthy persons within the pharmaceutical industry have been established during the past 10 years. Thus, more than 100,000 samples are stored in the freezers of either the pharmaceutical companies or their contractual partners at universities and test institutions. Ethical issues related to data protection of the individuals providing samples to bio-banks are several: nature and extent of information prior to consent, coverage of the consent given by the study person, labeling and storage of the sample and data (coded or anonymized). In general, genetic test data, once obtained, are permanent and cannot be changed. The test data may imply information that is not beneficial to the patient and his/her family (e.g., employment opportunities, insurance, etc.). Furthermore, there may be a long latency between the analysis of the genetic test and the clinical expression of the disease and wide differences in the disease patterns. Consequently, information about some genetic test data may stigmatize patients leading to poor quality of life. This has raised the issue of 'genetic exceptionalism' justifying specific regulation of use of genetic information. Discussions on how to handle sampling and data are ongoing within the industry and the regulatory sphere, the European Agency for the Evaluation of Medicinal Products (EMEA) having issued a position paper, the Council for International Organizations of Medical Sciences (CIOMS) having a working group on this issue, and the European Society of Human Genetics preparing background paper on 'Polymorphic sequence variants in medicine: Technical, social, legal and ethical issues. Pharmacogenetics as an example'. Within the European project Privacy in Research Ethics and Law (PRIVIREAL), recommendations for common European guidelines for membership in research ethical committees have been discussed, balancing the interests and assuring independence and legal competence. Good decision making, assuring legality of protocols and assessment of data protection is suggested to be part of any evaluation of protocols.

Drug Industry↗