Shabby sales tactics or shameful acceptance of the goods?
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Drug Industry↗
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Results for “ETHICS, PHARMACEUTICAL”
Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.
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Ethical conflicts in public health research and practice: antimicrobial resistance and the ethics of drug development.
Since the 1960s, scientists and pharmaceutical representatives have called for the advancement and development of new antimicrobial drugs to combat infectious diseases. In January 2005, Senate Majority Leader Bill Frist (R-TN), MD, introduced a biopreparedness bill that included provisions for patent extensions and tax incentives to stimulate industry research on new antimicrobials. Although government stimulus for private development of new antimicrobials is important, it does not resolve long-standing conflicts of interest between private entities and society. Rising rates of antimicrobial resistance have only exacerbated these conflicts. We used methicillin-resistant Staphylococcus aureus as a case study for reviewing these problems, and we have suggested alternative approaches that may halt the vicious cycle of resistance and obsolescence generated by the current model of antimicrobial production.
Anti-Bacterial Agents↗
Attitudes of general practitioners in New Zealand to pharmaceutical representatives.
BACKGROUND: Pharmaceutical representatives are a vital component of the marketing of pharmaceutical products and an important source of prescribing information for general practitioners. AIM: A study was undertaken to explore the attitudes of New Zealand general practitioners to pharmaceutical representatives. METHOD: A questionnaire survey of 100 general practitioners was undertaken to which 67 general practitioners responded. RESULTS: The provision of practical prescribing advice by representatives and gifts relevant to medicine were seen as desirable activities by many respondents. However, gifts of value considerably greater than suggested acceptable in recent guidelines for general practitioners were also highly favoured by some practitioners. CONCLUSION: Current ethical guidelines setting out the relationship between pharmaceutical representatives and medical practitioners are inadequate and should be based on the need for the general practitioner to become an unbiased promoter of patient health.
Adult↗
Relations between academic departments of psychiatry and pharmaceutical companies.
The financial pressures placed on academic departments of psychiatry make the offers of assistance from pharmaceutical companies very attractive. The authors provide a sequential three-step decision-making approach to help the academic physician and the psychiatry department address the ethical issues involved in any given interaction with a pharmaceutical company. They also provide examples of the application of these guidelines.
Drug Industry↗
[Determination of drug posology in pediatrics].
The dosage of drugs which might be used in children must be determined to avoid empirical use, even when no application has been submitted for a paediatric licence. Toxicological evaluation and assessment of the effects on growth, an adapted pharmaceutical form and paediatric pharmacokinetic and adult clinical data are essential before conducting trials designed to determine the paediatric dosage. The dose used during preliminary studies is extrapolated from the adult dose expressed in relation to weight, tested in a dose-effect study, and then more accurately defined on the basis of pharmacokinetic data in different age groups. Obtaining consent from both parents for studies whose direct benefit is not always obvious, as well as the global cost of these studies, constitute drawbacks to paediatric drug development. Incentives to determine a paediatric dosage could consist of public participation in funding, prolongation of the patent, and granting an advantageous price for a specifically paediatric pharmaceutical form or indication.
Age Factors↗
Why APhA should reject its code of ethics.
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Codes of Ethics↗
Legal and ethical obligations to conduct a clinical drug trial in Australia as an investigator initiated and sponsored study for an overseas pharmaceutical company.
Most multi-centre trials are both financed and sponsored by the pharmaceutical company involved. What follows will map the path adopted for an investigator initiated and sponsored study for a new indication of an established medication. The chief investigators of a company-sponsored, investigator-initiated, multi-centre, placebo-controlled study of an established medication, Pharmaceutical Benefit Scheme (PBS) listed for treatment of one condition but trialled in the management of another condition (trial of off-label use), were approached to submit a protocol to repeat the type of study with a different compound. The new study would test a different agent, also PBS listed, for the same condition as in the initial study and with the same off-licence application. The company would finance the study, provide the medication and matched placebo but only review the investigator-initiated protocol which would be sponsored by the principal investigator. This required the investigator to implement the trial, as would normally be done by the pharmaceutical company, yet also act as its principal investigator. The principal investigator, with colleagues and a Clinical Research Organisation (CRO), developed a protocol, adapted for the new agent, and submitted it for approval. Upon acceptance a contract was negotiated with the pharmaceutical company which had to overcome jurisdictional conflicts between common law and civil law legal systems. A CRO was contracted to undertake administrative functions which dictated special contractual agreements to overcome possible conflicts of interest for a sponsor/investigator to protect patient interests. There was need to find indemnification insurance with jurisdictional problems, co-investigators, ethics committee approvals and finance management as just some of the difficulties encountered. The paper will outline how these obstacles were overcome and how ethical and legal issues were respected through compromise. The ethical and legal obligations were addressed in a fashion which allowed the conduct of a trial adopting a proven methodology but novel infrastructure such that it was a totally independent study with regards conduct and reporting of final data, irrespective of the results being either positive or negative. This may represent a more acceptable way to ensure that future clinical trials are devoid of undue influence from the pharmaceutical industry which may still fund the study.
Australia↗
Prescribing viagra in an ethically responsible fashion.
Sildenafil citrate (Viagra) and other newly released pharmaceuticals that assist erectile dysfunction may be one of the most important categories of drugs released in the past decade. Sildenafil is distinctive because it creates a new therapeutic relationship not only between patient and physician, but also with sexual partner(s). Physicians must first evaluate the patient comprehensively, addressing not only erectile function and sexual performance, but overall physical and mental health. Since the drug does impact others, an expanded model for informed consent needs to be considered. Three models to consider include the public health one, ethically justified limits on confidentiality, and a biopsychosocial one. The biopsychosocial model may be preferred because it expands the patient-physician dyad to directly include others. Physicians also need to distinguish between professional, role-related obligations and personal conscience when treating patients whose sexual beliefs and practices differ from their own. Other ethical issues include inappropriate prescribing over the Internet, dealing with unrealistic patient expectations, and fairness in paying for treatment for sexual conditions in both men and women. With these proposed guidelines, physicians can continue to provide steady, reliable guidance for patients while working with yet another scientific advance in medicine.
Counseling↗
The role of bioethics in the international prescription drug market: economics and global justice.
In terms of health care access, bioethics has an important role to inform and shape policy issues and develop interdisciplinary ideas and interventions. The rising price of prescription drugs presents one of the most looming barriers to health care access in the world today. Including both theoretical and practical features of the pharmaceutical industry's behavior is necessary to find ethical solutions towards increasing access. Bioethics can evaluate global justice by weighing human rights theory and future innovation at the macro level, and by addressing market forces and responsibilities at the micro level. Inherent structural features of pharmaceuticals, such as its reliance on research and development, cause the industry to employ pricing strategies that seem counter-intuitive to conventional wisdom, but that result in producing a just allocation as defined by market forces. Parallel trade and drug exportation/reimportation threaten the saliency of the industry's differential pricing scheme; a case-study of a single "Euro-price" within the European Union illustrates how this will actually create harm to the most needy member states. This complex situation requires solutions weighing arguments from human rights theory with those from economic theory to arrive at the most globally just allocation of prescription drugs in the global marketplace, as well as to ensure future innovation and scientific progress. Bioethicists as well as economists need to partake urgently in this discourse for the betterment of the global injustices in the international prescription drug market.
Bioethics↗
Polio, politics, publicity, and duplicity: ethical aspects in the development of the Salk vaccine.
This paper is an historical account of the discovery, testing, and early distribution of the Salk polio vaccine. The discovery posed fundamental dilemmas of medical research, pharmaceutical production, and public health. This paper assesses the ethical problems which arose, and examines critically their resolution. The National Foundation for Infantile Paralysis (March of Dimes) financed and directed the discovery of the vaccine, subsequent field trials, and early distribution. The Foundation's role is analyzed with special attention to the conflicts between its philanthropic and scientific functions. The reat public demand which the discovery of the vaccine generated created a need for federal control which was only partly met. The federal government did not have sufficient institutional and legal mechanisms to assure the safety of the vaccine and protect the public. This discussion illustrates the failure of the government to keep pace with medical technology.
Child↗
The company we keep: why physicians should refuse to see pharmaceutical representatives.
Whether physicians ought to interact with pharmaceutical sales representatives (reps) is a question worthy of careful ethical analysis. The issue presents a challenge to both professional integrity and time management. Empirical data suggest that interactions with pharmaceutical reps increase the chances that the physician will act contrary to duties owed to the patient. Ideally, a physician might both interact with reps and also do the research necessary to counteract the commercial bias in their messages. But a physician who actually did that research would, in turn, be devoting a good deal of time that might better be spent in other activities. The counterargument, that one is obligated to see representatives to obtain free samples to best serve one's patients, can be shown in most practice settings not to be compelling. Physicians ought to refuse to visit with representatives as a matter of both professional integrity and sensible time management.
Commerce↗
Thick prescriptions: toward an interpretation of pharmaceutical sales practices.
Anthropologists of medicine and science are increasingly studying all aspects of pharmaceutical industry practices--from research and development to the marketing of prescription drugs. This article ethnographically explores one particular stage in the life cycle of pharmaceuticals: sales and marketing. Drawing on a range of sources-investigative journalism, medical ethics, and autoethnography--the author examines the day-to-day activities of pharmaceutical salespersons, or drug reps, during the 1990s. He describes in detail the pharmaceutical gift cycle, a three-way exchange network between doctors, salespersons, and patients and how this process of exchange is currently in a state of involution. This gift economy exists to generate prescriptions (scripts) and can mask and/or perpetuate risks and side effects for patients. With implications of pharmaceutical industry practices impacting everything from the personal-psychological to the global political economy, medical anthropologists can play a lead role in the emerging scholarly discourse concerned with critical pharmaceutical studies.
Drug Industry↗
Policies regulating the activities of pharmaceutical representatives in residency programs.
BACKGROUND: Residents frequently interact with pharmaceutical representatives during their training. The purpose of this study was to determine the prevalence of policies restricting or regulating the interactions of pharmaceutical representatives with family medicine residents. METHODS: A descriptive, cross-sectional survey was sent to all 386 accredited family practice residency programs. Programs were surveyed for the presence of restrictions or policies regarding the following circumstances and activities through which pharmaceutical representative-resident interactions could occur: (1) contact during working hours, (2) clinic drug samples, (3) personal samples for residents, (4) displays, (5) distribution of literature, (6) gifts and outings, and (7) group presentations. RESULTS: Overall, residency programs tended to allow most of these activities and had only informal guidelines regarding pharmaceutical representative interaction. Written policies were present in 58% of the programs. Prohibitions of some type were present in 41% of the programs. A higher prevalence of written policies was noted in military programs, larger programs, and programs located in hospitals with only family practice residents. CONCLUSIONS: There are wide variations among family practice residency programs regarding the regulation of pharmaceutical representative-resident interactions. In view of the educational mission of residency training programs and the recent concern over the ethics of the relationship between the medical profession and the pharmaceutical industry, it would be prudent for all residencies to develop written policies addressing the activities of pharmaceutical representatives in training sites.
Drug Industry↗
Ethics and drug company gifts to physicians.
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Advertising↗
[A structure based pharmaceutical database for drug interactions].
A structure-based pharmaceutical database for drug interactions has been developed. This database is based on the ISIS/Desktop and the Microsoft Access relational database system for Windows. Data of Japanese accepted name, molecular formula, molecular weight, CAS registry number, therapeutic category index code, structural formula, Japan ethical drugs code, side effects information, drug interactions information were taken from "Japanese Accepted Names for Pharmaceuticals 1992", "Drugs in Japan Ethical Drugs 1993" and "Drug Intelligence Reinforce".
Chemistry, Pharmaceutical↗
[Historical sketch of modern pharmaceutical science and technology (Part 4). Post World War II 50 years].
A short history of the pharmaceutical science and technology, postwar 50 years is divided into nine sections for the purpose of discussion. 1. Japan's postwar rehabilitation, Japanese pharmaceutical industries and newly developed pharmaceutical sciences and technologies. In 1945, the Japanese pharmaceutical industry was reconstructed. Production of penicillin was carried out with the strong support of the U.S. Occupation Forces. New sciences in pharmacy (biochemistry, biopharmacy, pharmacology, microbiology, physical chemistry, etc.) were introduced in this period. 2. Introduction age of foreign new drugs and technology (1951 to 1960s). Japan gained independence in 1951. Japanese pharmaceutical companies imported many new drugs and new pharmaceutical technologies from the U.S.A. and European countries in this period. Then, these companies were reconstruction rapidly. However, consequently Japanese pharmaceutical companies were formed as an imitation industry. 3. Rapid economic growth period for pharmaceutical companies (1956 to 1970s). In this period, many Japanese pharmaceutical companies grew rapidly at an annual rate of 15-20% over a period of 15 years, especially with regard to the production of active vitamin B1 analog drugs and some OTC (public health drugs). Some major companies made large profits, which were used to construct research facilities. 4. Problems for the harmful effects of medicines and its ethical responsibility. In the 1970s, many public toxic and harmful effects of medicines were caused, especially SMON's disease. In this time, many pharmaceutical companies changed to its security got development of ethical drugs. 5. Self development of new drugs and administration of pharmaceutical rules (1970s). During the 1970s, many pharmaceutical laws (GLP, GCP, GMP, GPMSP etc.) were enacted by the Ministry of Health and Welfare. In 1976, the Japanese Pharmaceutical Affairs Law was revised, which set forth standards regarding the efficacy and safety of ethical drugs and re-evaluation of drugs. Many facilities were built for the purpose of ensuring efficacy and safety, as shwon in Table 1. 6. Problems of Intellectual Property and followed the revisionist line of research and development for new ethical drugs. In 1976, Japanese pharmaceutical companies ceased to be an imitation industry, and increased research for the development of new drugs. 7. Pharmaceutical science and technology innovation (After 1985). Many of the pharmaceutical innovations during this period were as follows: 7.1) Technology innovation for evaluation of drug efficacy; 7.2) 1st to 3rd medical diagnostic technology innovations; 7.3) medical analytical methods and spectrometry technologies; 7.4) Computer-aided drug-design technology and drug information technology innovation; and 7.5) Drug delivery system and treatment drugs. 8. Recent research and development of new ethical drugs in Japan (1970 to 1995). Cephalosporine type beta-lactams (cefazolin, cefametazole, furomoxef, cefdinir), new quinolones (norfloxcin, ofloxacin, tosfloxcin), H1-Blockers (famotidine), Ca-antagonists (diltiazem, nicardipine), and other new drugs (pravastatine, taclolimus, leuprine) etc. came onto the market. 9. International Harmonization Age and Review toward 21 century. The rapid development and globalization of the pharmaceutical market has promoted international harmonization and rationalization of pharmaceutical regulatory affairs. In 1990, the Japan Pharmaceutical Manufacturers Association published a report toward 21 century, which described practical plans.
Biotechnology↗
Identification of a 49-bp fragment of the HvLTP2 promoter directing aleurone cell specific expression.
Identification of regulatory elements directing definite and specific spatiotemporal expression patterns is a prerequisite to the next generation of transgenic plants with commercial and ethical feasibility for producing plantibodies or other pharmaceutically important compounds. Here we describe the functional dissection of the barley nonspecific lipid transfer protein gene promoter, HvLTP2. The gene is specifically expressed in aleurone cells of cereals and used as an aleurone marker in maize and rice. The transcript is uniformly localised in the barley aleurone cells from around 10 DAP. Patchy expression in aleurone cells of transgenic rice has been reported and explained by silencing of transgenes. We have performed deletion analyses of the 801-bp HvLTP2 promoter to gain insight into the molecular basis of its regulation and the presence of putative regulatory elements. From the deletion studies, a 49-bp promoter region directing aleurone-specific expression was identified. Simultaneously, in vivo footprinting was carried out to identify promoter elements bound by putative regulatory proteins. Within the 49-bp fragment, the most promising candidate for a minimal cis-acting regulatory region directing aleurone specificity is the ds-sequence. Based on our results, we hypothesise that the ds-sequence directs aleurone specificity, possibly through a concerted action with elements directing general expression in the seed. Moreover, we present an overview of LTP2 elements putatively involved in directing seed, endosperm, and aleurone expression. Additionally, we report HvLTP2 expression in the embryo, not previously detected. The regulatory element(s) directing expression in embryo is located downstream of the 49-bp fragment directing aleurone specificity, thus demonstrating independent control of aleurone and embryo-localised expression. Finally, we discuss the existence of several endosperm-specific boxes and whether alternative promoter elements and combinations of them may direct aleurone expression, explaining why comparing different genes expressed in aleurone fail to identify only one required, common promoter element.
Base Sequence↗
Drug distribution in the training room.
Individuals providing medications for athletes have a responsibility to provide high-quality pharmaceutical care while meeting both legal and ethical requirements. Pharmacotherapy monitoring and patient counseling about prescription drugs are recent additions to legal requirements in most states. Quality control of drug selection, labeling, and packaging as well as optimum storage, security, and accountability are essential in promoting positive patient outcomes.
Athletic Injuries↗