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At least 217 records · Page 12Linked to original sources
PubMed2002

Consent to open label extension studies: some ethical issues.

A frequent feature of pharmaceutical research is the open label extension study, in which patients participating in double blind placebo controlled trials of new medications are invited, on completion of the initial trial, to take the study drug for some further period. Patients are openly given the active substance at this stage, regardless of their assignment in the initial trial. Investigators are typically reluctant to unblind the patients' assignment at the point of entry into the open label phase, on the grounds that this may introduce ascertainment bias in the main study. It is argued that patients invited to participate in open label extension studies cannot give a proper consent to such research unless they know to which arm of the main trial they were recruited. It is further argued that to recruit certain groups of patients from placebo controlled trials into open label extension studies may also be unethical for clinical reasons.

Biomedical Research↗
PubMed2001

Family consent and the pursuit of better medicines through genetic research.

Rapid changes in the science and technology related to genetic research are challenging scientists, health care providers, ethicists, regulators, patient groups, and the pharmaceutical industry to keep pace with ethically grounded, workable guidelines for both the research and clinical applications of human genetics. We describe the genetic research being conducted by one pharmaceutical company (GlaxoSmithKline) and how the company is addressing the ethical, legal, and social issues surrounding this research; discuss an industry working group's attempt to advance pharmacogenetic research by openly addressing and disseminating information on related ethical, legal, and regulatory issues; identify scientific and ethical differences among various types of genetic research; discuss potential implications of family consent on subject privacy and autonomy, data collection, and study conduct; and suggest points to consider when study sponsors, investigators, and ethics committees evaluate research proposals. Public and expert opinion regarding informed consent in genetic research is evolving as a result of increased education, discussion, and understanding of the relevant issues. Five years ago, there was strong support for anonymity in genetic research as a privacy safeguard. Now, an increasingly popular school of thought advocates against anonymity to preserve an individual's ability to withdraw and, if desired, access research results. It is important to recognize this evolution and address consent issues in a reasoned, practical, and consistent way, including input from patients and their families, health care providers, ethicists, scientists, regulatory bodies, research sponsors, and the lay community. Responsibility for assessing issues related to family consent for research should remain with local investigators, ethics boards, and study sponsors. A "one-size-fits-all" perspective in the form of new regulations, for example, would likely be a disservice to all.

Access to Information↗
PubMed1993

[Current challenges for the pharmaceutical research industry].

The Research Pharmaceutical Industry is currently facing a number of increasingly complex challenges. Today indeed, the discovery and marketing of innovative medicines is linked: not only to Compagnies' abilities to solve relatively basic and traditional difficulties which have deeply changed over the past few years, for instance: the regulatory constraints, the dramatic increase in development costs, the critical mass required for investments, the development time periods and the protection of innovation, human resources and organization; but also to the acceptance of recent factors which the Research Pharmaceutical Industry must imperatively overcome, such as: the new Research channels and namely biotechnologies, the building of a pharmaceutical Europe and the internationalization of molecules, the needs of the third world, the innovation financing and the control of Health expenditures, the public opinion's shift in expectations regarding ethical and environmental issues. The Pharmaceutical Industry is currently in a shake-up phase during which it will undergo deep changes, with regard both to its activities and in relations with its environment.

Drug Costs↗
PubMedDate not supplied

Consistent standards in medication use: the need to care for patients from research to practice.

OBJECTIVE: To propose adoption of practice standards for pharmacists based on the principles of pharmaceutical care that are parallel to internationally accepted ethical precepts governing clinical research. DATA SOURCES: Relevant literature selected by the authors. SUMMARY: Pharmaceutical care practice standards can create a continuum of high quality care for patients from research through practice and are presented as a rational solution to managing the benefits and risks of medication use. By implementing these practice standards, patients are empowered to become active participants in the treatment process, knowledge of drug effectiveness and safety is increased, and the pharmaceutical care practitioner's responsibilities are delineated. More than a quarter century ago, the research community adopted the ethical principles of respect for persons, beneficence, and justice, as outlined in the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Under these guidelines, research subjects are considered participants, knowledge of medication efficacy and safety has increased, and investigator responsibilities have been defined. However, these guidelines only apply to the life cycle of a drug before approval by the Food and Drug Administration. Once the product is released for general use, fewer standards are applied. Pharmacy has the opportunity to establish parallel standards for the clinical use of medications in patients by establishing patient care practices in consonance with pharmaceutical care practice. CONCLUSION: Pharmaceutical care practitioners need to apply new practice standards that allow them to contribute meaningfully to appropriate, effective, safe, and convenient drug therapy for all patients. Such pharmaceutical care practice standards could ensure consistent vigilance throughout the life cycle of the drug product and result in rational, appropriate, effective, safe, and convenient drug therapy for all patients.

Drug Therapy↗
PubMedDate not supplied

[The physician and the pharmaceutical industry].

In recent times, a new relationship has been developed between the medical community and the pharmaceutical industry. Owing to the large economical potential of the latter, a growing pressure has been felt on the medical group, in order to follow the interest of the industrial complex. This pressure is not always located within a ethical niche. Actions of the pharmaceutical companies in this respect are described, and a claim is made to establish regulations for a better relationship between the two entities.

Drug Industry↗
PubMed2006

Human tissue for in vitro research as an alternative to animal experiments: a charitable "honest broker" model to fulfil ethical and legal regulations and to protect research participants.

Research with human tissue offers the possibility not only of improving preclinical pharmaceutical research and safety assessment, but also of the substitution of some animal experiments. Surgically removed human tissue is discarded after pathological evaluation. This tissue would be of enormous value for research, especially in the pharmaceutical branch, if it were readily available in an ethically and legally approved manner. But there are public concerns about the use of human tissue, especially for "commercial" purposes, such as in the pharmaceutical industry. The question is whether the ethical boundaries are sufficiently respected in the course of striving for industrial profit. To overcome this problem, a clear procedure for tissue donation, collection, supply and allocation must be established, which is guaranteed to be independent of special interests. The persisting problem seems to be the lack of an authority which asks for informed consent, coordinates tissue as well as blinded data collection, and supplies research facilities with tissue samples in a transparent manner. Therefore, a charitable, state-controlled foundation acting as an "honest broker" was initiated, to cover the ethical and legal aspects, as well as to protect the research participants in their use of human tissue as an alternative to animal experiments.

Animal Testing Alternatives↗
PubMed1990

Attitudes of internal medicine faculty and residents toward professional interaction with pharmaceutical sales representatives.

We surveyed faculty and residents from seven hospitals affiliated with three academic internal medicine training programs about their perceptions of the informational and service benefits vs the risks of ethical compromise involved in interactions with pharmaceutical sales representatives. Questionnaires were returned by 467 (81%) of 575 physicians surveyed. Residents and faculty generally had somewhat negative attitudes toward the educational and informational value of detailing activities at their institutions but indicated that representatives supported important conferences and speakers. Residents were more likely than faculty to perceive contacts with sales representatives as potentially influencing physician decision making. Sixty-seven percent of faculty and 77% of residents indicated that physicians could be compromised by accepting gifts. More than half of the physicians who suggested that such compromise was possible indicated that acceptance of gifts worth more than +100 from drug companies would be likely to compromise a physician's independence and objectivity. A majority of both faculty and house staff favored eliminating presentations by pharmaceutical representatives at their hospitals. Only 10% thought they had had sufficient training during medical school and residency regarding professional interaction with sales representatives.

Adult↗
PubMedDate not supplied

The hidden costs of free lunches: fraud and abuse in physician-pharmaceutical arrangements.

When it comes to physician-pharmaceutical manufacturer relationships, the old adage "there's no such thing as a free lunch" has been given much support lately by federal fraud and abuse enforcement authorities. In light of recent enforcement developments and initiatives, physicians must now, more than ever, develop an understanding of the legal boundaries of regulatory and ethical guidelines and carefully evaluate their relationships with pharmaceutical manufacturers for compliance. This article reviews existing regulatory and ethical guidance applicable to physician-pharmaceutical industry relationships, applies that guidance to common interactions between physicians and the industry, and offers tips for maintaining compliance.

American Medical Association↗
PubMed2001

[Safety assessment of new products developed by the pharmaceutical industry].

Safety assessment of new products developed by the pharmaceutical industry is a scientific, ethical and economic requirement. The finality is an assessment of the benefit/risk ratio of these products, a fundamental issue for their registration. Conventional studies, such as defined by ICH guidelines, and their timing versus clinical trials are reported here. General conditions for management and cost are discussed. Nevertheless, these conventional studies are poorly adapted to current requirements due to insufficient throughput and lack of discriminating potential. Consequently, new tools are being proposed (genomics, proteomics, metabonomics, etc.), allowing, for example, a faster and more relevant screening of leading compounds designed to be administered in humans in clinical trials. Nevertheless, these tools are complex, expensive and probably reserved for the largest companies. A well-balanced approach, including the choice of reasonable objectives, should enable rapid enrichment of our assessment potential, excluding abrupt, unproductive and premature changes.

Animals↗
PubMed1995

Symposium on health economics in oncology. Freiburg, Germany, June 1995.

Dr. E. Enghofer (Wien, Austria) summarized the content of the presentations and discussions of the symposium in his concluding remarks. 1. The organizers should be congradulated on their initiative in bringing together at the symposium experts from different disciplines, i.e., medicine, ethics, health economics, jurisprudence, the pharmaceutical industry and, last but not least, cost providers. 2. Health economics as an issue in health care has been around for quite some while. One example can be found in the German Drug Guidelines dating back to 1990, where the following terms have already been defined: therapeutic benefit, medical needs, and achieving therapeutic goals. 3. Health economics serves as a "support function" in the medical decision-making process. It has as yet no decisive role in the application to license a drug nor in questions concerning a physician's liability. Health economics as a discipline, however, was a reminder of, and served as a catalytic function for: a) The differentiation between the benefit of a medical intervention and its pure effectiveness. b) The definition of medical standards as a means to compare the quality of health care between different institutions, to uncover quality deficits and to develop strategies for the optimization of medical quality (quality management). Routine deviation from these standards is unethical. The German Cancer Society has taken on the task of defining such standards in cancer care. c) The difference between rationalising and rationing health care. The spending of the current health-care budget needs to be screened for unnecessary and/or inappropriate diagnostic procedures and treatment modalities as well as for "below-standard" care. The money that can be saved here can then be shifted towards financing "state of the art" medicine or can be used in the decision to substitute certain procedures. 4. The a priori definition of the desired outcome of a medical intervention is of paramount importance for the evaluation of the actual treatment result. Economical evaluations are easier when cure rather than palliation is the aim of a particular treatment and when alternative therapies do exist such that cost comparisons are possible. In any case, therapeutic interventions need to be adapted to the desired treatment goal; only then can the question be answered whether or not the means (cost) are (is) justified. 5. Outcome studies need to take into account every relevant medical aspect (i.e. disease management studies), and they should be accompanied by evaluation studies. The latter must also include unselected patients in daily practice.(ABSTRACT TRUNCATED AT 400 WORDS)

Antineoplastic Agents↗