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PubMed1992

[Effects of R80122. The influence of a new phosphodiesterase inhibitor on global and intestinal hemodynamics in coronary surgery patients].

Phosphodiesterase III inhibitors have been established in recent years in the therapy of congestive heart failure. Many disadvantages, such as extensive vasodilation and the lack of proven positive inotropic properties combined with thrombepenia and elevation of transaminases, have complicated the handling of the drug in clinical practice. Enoximone, an imidazole derivative, has been demonstrated to be more cardioselective and vasodilation has been found to be less pronounced than with amrinone. As a consequence, research was performed to enhance the cardioselectivity of phosphodiesterase III inhibitors by reduction of non-specific cross-reactivity with other phosphodiesterases, and R80122 (Janssen Pharmaceutics, Belgium) was introduced into clinical practice. R80122 ((E)-Ncyclohexal-N-methyl-2[[[phenyl (1,2,3,5-tetrahydro-2 oxoimidazo [2,1b]-quinazolin-7-yl)methylene] amino] oxy] acetamide) is a selective inhibitor of phosphodiesterase (PDE) IIIc, which is localized in the myocardium. Thus, its inhibition leads to a positive inotropic effect, whereas phosphodiesterase IIIRo is found in the vessel wall and causes vasodilation. This study was performed to investigate the hemodynamic profile of R80122 under clinical conditions. Additionally, the intestinal hemodynamics were recorded and changes in intestinal perfusion compared with changes in global hemodynamics. METHODS. The study was thoroughly discussed and approved by the local ethics committee; all patients gave written informed consent. The investigation was performed on ten male patients who were about to undergo elective coronary artery bypass surgery. History, physical examination and laboratory results were within the normal limits and revealed no evidence of liver disease. The usual medication was continued until the day before the operation. Premedication consisted of 2 mg flunitrazepam p.o. in the evening before the operation and 1.5 h before induction of anaesthesia. The determination of hepatic plasma flow was performed by the indocyanine green (ICG) infusion extraction technique using liver vein catheterization. After induction of anaesthesia (MP1), after application of a bolus dose of R80122 (0.3 mg/kg BW) (MP2) and at sternotomy (MP3), hemodynamic data (heart rate, arterial pressure, cardiac output) were recorded and blood samples for the determination of hepatic plasma flow by the concentration of ICG were collected. Anaesthesia was induced with a bolus dose of 0.2 mg/kg BW etomidate, 7 micrograms/kgBW fentanyl and 0.1 mg/kgBW pancuronium and maintained with a continuous infusion of 20 micrograms/min fentanyl, 300 micrograms/min midazolam and mechanical ventilation with O2/N2O at an FiO2 of 0.5. Statistical analysis was performed using the Wilcoxon-Mann-Whitney U test comparing the results after induction of anesthesia (MPI) with those after application of R80122 (MPII) and the results of MPII with those at sternotomy (MPIII). Statistical significance was assumed at P less than 0.05. RESULTS. After the induction of anaesthesia, the median heart rate (HR) was 56/min and did not change after administration of R80122. During sternotomy there was a significant increase in the HR from 64 to 78/min (P less than 0.05). Median arterial blood pressure (MAP) tended to decreased from 91 mm Hg after induction of 77 mm Hg after administration of R80122, although there was no statistical significance because of interindividual differences in the tendencies. At sternotomy, MAP remained unchanged. Cardiac output (CO) increased by 60% after administration of R80122 (P less than 0.01) and did not change during sternotomy. As a consequence of the changes in HR and CO, stroke volume (SV) increased by 22% after administration of R80122 (P less than 0.025) and decreased to control values during sternotomy.

Adult↗
PubMed1995

Cost-effectiveness: from whose perspective?

Evaluating the cost-effectiveness of medical interventions, particularly pharmaceuticals, has been the focus of much debate in this country over the past few years. Although the support for efficient utilization of monies is widespread, the delicate balance between optimizing patient outcome with the costs to do so in high-risk patients is especially difficult. Although research in the field of cost-effectiveness is widespread, at present there are few guidelines in this country. Furthermore, the introduction of bias is a serious concern in the interpretation and validation of studies, often limiting their utility. Guidelines that can be implemented to minimize bias in economic research have been identified to include administrative, methodology-based, and ethical parameters. The standardization and implementation of such guidelines can reduce bias in economic research and optimize study validity. This review focuses on these issues and suggests that initial steps to produce unbiased economic research include total disclosure, appropriate comparator selection, complete release of all relevant data, and the cooperation of all involved parties.

Acquired Immunodeficiency Syndrome↗
PubMed2004

The role of the unblinded sponsor statistician.

In clinical trials sponsored by Merck the unblinded statistician is typically an employee of the company. From a pharmaceutical industry perspective, advantages of this approach include ensuring that the unblinded statistician is knowledgeable regarding the experimental treatments, therapeutic area and study objectives; that the quality of the analysis conforms to rigorous standards; and that the allocation schedule, database and interim results are kept confidential. These advantages are felt to outweigh any potential disadvantages.

Clinical Trials Data Monitoring Committees↗
PubMed2002

Integration of safety pharmacology endpoints into toxicology studies.

In the ILSI Human Toxicity Program, human toxicity was identified with 94% in studies of 1 month or less duration. Safety pharmacology studies and 1 month toxicity studies are prerequisites of INDs. These studies contributed in 69% to the predictivity of human toxicity. Correlating data from pharmacology and toxicology data will therefore enhance the predictivity of human toxicity. The ILSI Human Toxicity Program also showed that non-rodent toxicology studies were more predictive of human toxicity than rodents. Consequently, the usage of non-rodents, especially dogs, produces data more relevant to the safety of humans. Integration of data from safety pharmacology and pharmacological endpoints from integrated toxicology studies, which cover a wide dose range, allow data interpretation also concerning chronic effects. Differences in relation to chronic exposure and species specific pharmacodynamic effects can be taken into consideration. In vivo data in pharmacology are taken from a larger number of species. Usually, pharmacokinetic data and histopathology are often lacking in pharmacology (e.g. guinea pig). Studies in a smaller number of species, which are incorporating pharmacology, pharmacodynamic and toxicology, allow also crossinterpretation with data from clinical chemistry, haematology and histopathology. Endpoints relating to behaviour (functional observation battery/FOB) and cardiovascular toxicity can be integrated into regulatory toxicology. Technical progress in non-invasive methodology and refined measurements for pharmacological parameters and standardization of study design allow the incorporation into regulatory toxicity studies today. The limitations of conducting pharmacological measurements in regulatory toxicology studies are acknowledged. Safety pharmacology studies should complement toxicity studies in terms of choice of species and dose regimen. Ethical usage of animals, especially dogs or monkeys, can only be justified in the future, when more clinically relevant data can be gained from fewer in vivo studies. Multidisciplinary co-operation between pharmacology, pharmacokinetics and toxicology will lead to refinements and reduction of in-vivo studies when functional parameters are integrated into regulatory studies.

Animals↗
PubMedDate not supplied

The pharmaceutical industry and mental health nursing.

Mental health nurses (MHNs) have a long and varied relationship with the pharmaceutical industry, including the attendance of educational seminars and the acceptance of promotional material. This article presents evidence that suggests MHNs may need to review this relationship regardless of their beliefs about the role of pharmacological interventions in the treatment of mental illness. It also explores the influence of advertising within professional journals and calls for greater debate on this issue.

Advertising↗
PubMed1995

Interactions with the pharmaceutical industry: experiences and attitudes of psychiatry residents, interns and clerks.

OBJECTIVE: To examine the type and number of interactions of psychiatry residents, interns and clerks with sales representatives of pharmaceutical companies and the attitudes of physicians-in-training toward these interactions. DESIGN: Survey conducted with the use of a self-report questionnaire. SETTING: Seven teaching hospitals affiliated with the Department of Psychiatry, University of Toronto. PARTICIPANTS: All 105 residents, interns and clerks training in psychiatry at the seven teaching hospitals between October 1993 and February 1994 were eligible; 74 completed questionnaires, for a response rate of 70%. One respondent was excluded from the analysis. OUTCOME MEASURES: Number of personal meetings and "drug lunches" attended, number of drug samples and promotional items received and estimated value of gifts received by each physician-in-training during a 1-year period as well as attitudes of residents, interns and clerks about interactions with pharmaceutical representatives. RESULTS: Median number of personal meetings reported was 1 (range 0 to 35), of drug lunches attended was 10 (range 0 to 70), of promotional items received was 2 (range 0 to 75) and of drug samples received was 1 (range 0 to 20). Trainees' median estimate of the value of gifts received was $20 (range $0 to $800 Fewer than one third felt that pharmaceutical representatives were a source of accurate information about drugs; however, 71% (52/73) disagreed with the statement that representatives should be banned from making presentations. Although only 15% (11/73) felt they had sufficient training about meeting with pharmaceutical representatives, 34% (25/73) felt that discussions with representatives would have no impact on their prescribing practices, and 56% (41/73) felt that receiving gifts would have no impact on prescribing. Fewer than half said they would maintain the same degree of contact with representatives if they did not receive promotional gifts. The more money and promotional items a physician-in-training had received, the more likely he or she was to believe that discussions with representatives did not affect prescribing (p < 0.05). Clerks, interns and junior (first-year and second-year) residents attended two to three times more drug lunches than senior (third-year and fourth-year) residents, and significantly more junior than senior residents felt that pharmaceutical representatives have a valuable teaching role. Junior residents were three times more likely than senior residents to have received drug samples. CONCLUSIONS: Interactions between pharmaceutical representatives and psychiatry residents, interns and clerks are common. The physicians-in-training perceive little educational value in these contacts and many, especially clerks, interns and junior residents, disavow the potential of these interactions to influence prescribing. Therefore, supervisors of postgraduate medical training programs may wish to provide instruction concerning potential conflicts of interest inherent in these types of interactions.

Advertising↗
PubMed2004

Depressing research.

Suppression of the publication of negative trials of serotonin-selective reuptake inhibitors (SSRI) in children (Apr 24, p 1335) is more than just a matter of "confusion, manipulation, and institutional failure". It is a crime. To blandly illustrate its severity, we can analogise the situation as follows: would you be concerned if a colleague prescribed penicillin to a child who had an uncomplicated upper respiratory tract infection of viral aetiology? Would you be more concerned if you heard that this child had a serious anaphylactic reaction to the penicillin at home? And how much more concerned would you be if you found out that the prescribing doctor was previously aware of the child's severe penicillin allergy? The latter scenario could be deemed malpractice. How, then, is it acceptable for pharmaceutical companies to suppress publication of SSRI studies that showed a lack of efficacy and an increased risk of serious adverse events in the children and adolescents in experimental trial groups (other than for fluoxetine)? Intentional concealment of these data, an accusation for which there is already public evidence, must be considered a form of corporate violence.

Adolescent↗
PubMed1998

HIV vaccine research and human rights: examples from three countries planning efficacy trials.

The protection of human rights will be critical to the success of HIV vaccine trials throughout the world. A vaccine for HIV remains our best hope to control the global epidemic. In order to launch and sustain useful and successful human trials of HIV vaccines, a partnership between scientists, governments, pharmaceutical companies, and affected communities is essential. This article provides a review of some of the key issues relevant to human rights in the design, testing, and dissemination of HIV vaccines. The article gives specific examples from three countries -- Brazil, Thailand, and the United States -- which may initiate large-scale trials in the near future.

Brazil↗
PubMed1996

Genes, disease and medicine.

1. Information and technologies derived from genomic research are beginning to revolutionize the study of disease. It is now being predicted that the human genome sequencing project will be more than 90% complete by the end of this decade and that most of the major genes involved in common diseases will have been identified by that time. Correlations between genetic mutations, disease susceptibility, and adverse reactions to drugs are already being established and it seems inevitable that this will lead to the development of novel therapies accurately targeted at subsets of patients most likely to show a favourable response. 2. Targeted therapies present a significant challenge to the pharmaceutical industry because the potential market for such drugs is likely to be smaller than for current 'phenotypic' treatments. However, application of molecular genetic technologies may allow parallel reductions in development costs since it should be more straightforward to demonstrate efficacy and safety in accurately selected patient groups, reducing the requirement for large clinical trials. 3. Gene-based diagnostics have the potential to radically improve medical practice, and progress in genetic testing technology has been impressive. Yet there is growing concern that commercial and other pressures may result in genetic testing being made widely available before the biological consequences of mutations in disease susceptibility genes are fully understood and before the legal, ethical and psychological consequences of testing have been fully debated.

Animals↗
PubMed2006

Mental health nursing students' relationships with the pharmaceutical industry.

INTRODUCTION: The medical profession's relationship with the pharmaceutical industry (PI) has come under increased scrutiny in recent years, however little is known on the subject in mental health nursing. AIMS: The study sought to investigate: (1) the frequency of contact between mental health nursing students and PI employees; (2) students' attitudes and beliefs about their relationship with the PI; (3) the range of 'gifts', promotional items and hospitality accepted or seen in clinical environments by students in a one year period; and (4) students' attitudes to 'gifts', promotional items and hospitality offered by the industry. METHOD: Employing a survey design, a 35-item questionnaire was distributed to 472 students at two universities in the UK. Data were analysed from 347 respondents by means of descriptive statistics and simple content analysis. RESULTS: The findings suggest that students have significant contact with the industry through one-to-one meetings with pharmaceutical representatives (PRs) and by attending events giving information on specific drugs or general mental health issues. Students also identified a number of benefits (e.g. receiving "up-to-date" information on new drugs) and problems (e.g. the potential influence exerted on practitioners to use their drugs) arising out of this contact. Most students (79.8%) had accepted some form of 'gift' from the industry but few (11.5%) believed it was unacceptable to do so. The presence of promotional items in the clinical environment was seen as advertising (84.4%) but few students (19.3%) believed clinical environment should be free of these items. Over half (57.1%) of the students believed that PRs did not always give unbiased information but thought that they and mental health nurses in general would be able to detect any bias. CONCLUSIONS: In parallel with medicine, the study has shown that the pharmaceutical industry has at least the potential to influence mental health nursing students. Within medicine this realisation has triggered a vigorous debate on how medical schools should respond to the promotional activities of the PI. We suggest this study goes some way to demonstrating there is a need for these issues to be debated in the education of mental health nurses.

Attitude of Health Personnel↗
PubMed1997

Ally, advocate, analyst, agenda-setter? Positions and perceptions of Swedish medical journalists.

Medical journalists in the mass media play a key role in health information dissemination and risk/benefit education. Public education on the rational use of various health technologies, e.g. pharmaceuticals, is increasingly important as part of ongoing global health sector reforms. In a survey of 110 Swedish medical journalists (55% response rate) about medicinal drugs, risk perceptions and professional concerns, fact-giving, stimulating, and critical functions were rated as the most important journalist role attributes, followed by advocacy of patient interests and of public health goals. Major perceived problems were self-imposed professional demands, job stress, knowledge and time constraints, and selection and contextualization of news material. In terms of medicinal drugs, attitudes were strongly in favor of a unique drug information role for the media and critical of physician prescribing and information-giving. Views on the appropriateness of specific ethical rules or guidelines for medical journalists were sharply divided. The results offer some promise for increased alliance-building between public health and the mass media.

Attitude to Health↗
PubMedDate not supplied

Generics: what's in a name?

Historically, the most common intervention performed by physicians has been the writing of a prescription. Often the prescription was a combination of active agents and an inactive base. This art is no longer practiced in the United States. Currently, most prescriptions are written for specific "drugs." As the prescription is being written, the physician must decide to administer a brand-name or a generic equivalent. Generics are a class of medications prescribed for reasons of economy, and the physician and the patient expect that the therapeutic effect will be exactly the same as for the brand-name. Bioequivalence of specific agents can be assessed using the FDA's Orange Book. In addition to bioequivalence, many other scientific, ethical, and economic issues should be considered before a decision is made. Prescribing vigilance is necessary, because in many instances available information is often controlling or insufficient to support rational decisions. Brand-names, rather than generics, should be selected when the therapeutic index is narrow or if the likelihood of generic switching is high. The paper will discuss all aspects of the subject.

Chemistry, Pharmaceutical↗
PubMedDate not supplied

Simultaneous determination of eleven dyes and their aluminum lakes in drugs.

A 3-step extraction method was developed for the simultaneous determination of 11 dyes and their aluminum lakes in drugs. The dyes were first extracted with warm water (approximately 60 degrees C) and were cleaned up by solid-phase extraction with a tC18 cartridge. Aluminum lake dyes that remained in the precipitate were extracted with 0.02M NaOH. Aluminum in the dye lakes was reextracted into the organic layer with acetylacetone-butyl acetate (1 + 9, v/v), as an acetylacetone chelate, and was quantified by atomic absorption spectrometry. The dye portions of the aluminum lakes remained in the aqueous layer and were cleaned up in the same way as the dyes. The dyes and the dye portions of the aluminum lakes were quantified by ion-pair liquid chromatography with a photodiode array detector within 20 min. The recoveries of dyes from drug fortified at 10 microg of each dye per pill were 87.0-102.2%, and the recoveries of dyes from drugs fortified at 50 microg of each dye lake per pill were 82.9-101.6%, except for recoveries of indigo carmine. In 40 ethical and over-the-counter drugs, dyes that were not indicated in the package insert information for drugs were detected in 5 samples. The highest amount of dye found in a drug was 1169.5 microg erythrosine, which was detected in a capsule of antibiotic. Aluminum lake dyes were detected in 8 samples of various dosage forms.

Aluminum↗
PubMed1997

An Engelhardtian analysis of interactions between pharmaceutical sales representatives and physicians.

Physician conflict of interest has been of concern since Hippocrates and rarely is this concern more evident than in the relationship between pharmaceutical sales representatives (PSR) and physicians. Given the acrimonious public debates concerning this issue a careful exploration of the concerns at sake and the conceptual arguments which support such concerns is called for. In this piece I will take as heuristic the conceptual philosophical framework argued for by H. Tristram Engelhardt. This framework would sanction interactions between PSRs and physicians given that such relationships are free and without coercion. Further, patients must be informed, uncoerced and free in choosing such relationships with physicians who engage in interactions with PSRs. I consider four major criticisms which claim that PSR-physician interactions are morally impermissible: 1) influence, 2) "patients do not choose, but they pay," 3) violation of ethical principles, and 4) erosion of the patient-physician relationship. Each is shown to be unpersuasive under Engelhardtian philosophy. As long as the principle of permission and informed consent obtain without coercion than the interaction between PSRs and physicians would be construed to be morally permissible.

Beneficence↗
PubMed2006

Refusals by pharmacists to dispense emergency contraception: a critique.

Over the past several months, numerous instances have been reported in the United States media of pharmacists refusing to fill prescriptions written for emergency postcoital contraceptives. These pharmacists have asserted a "professional right of conscience" not to participate in what they interpret as an immoral act. In this commentary, we examine this assertion and conclude that it is not justifiable, for the following reasons: 1) postcoital contraception does not interfere with an implanted pregnancy and, therefore, does not cause an abortion; 2) because pharmacists do not control the therapeutic decision to prescribe medication but only exercise supervisory control over its dispensation, they do not possess the "professional right" to refuse to fill a legitimate prescription; 3) even if one were to grant pharmacists the "professional right" not to dispense prescriptions based on their own personal values and opinions, pharmacists "at the counter" lack the fundamental prerequisites necessary for making clinically sound ethical decisions, that is, they do not have access to the patient's complete medical background or the patient's own ethical preferences, have not discussed relevant quality-of-life issues with the patient, and do not understand the context in which the patient's clinical problem is occurring. We conclude that a policy that allows pharmacists to dispense or not dispense medications to patients on the basis of their personal values and opinions is inimical to the public welfare and should not be permitted.

Adolescent↗
PubMed2005

Face transplantation: a medical perspective.

In May 2004, researchers at the University of Louisville Medical Center in Kentucky submitted a 30-page detailed document to the University's Institutional Review Board (IRB) that outlines their plan for the first face transplant. Despite the fact that both the Royal College of Surgeons in England in 2003 and France's Comite Consultatif National d'Ethique in 2004 issued reports saying that the risks of this surgery far outweigh the benefits to justify it at the present time, the IRB at the University of Louisville is presently studying the proposal. These medical professionals believe they have the microsurgical skills and the anatomical knowledge needed to perform this surgery as well as the pharmaceutical recipe needed to suppress the immune system while ensuring tolerable levels of toxicity in the patient. However, with the number of serious unknowns about this surgery, the risk of further injury and even death to the recipients, and the viable option of reconstructive surgery, face transplantation, a the present time, is not a just use of medical resources, in the best interest of the patient, or an effective way to accomplish the goals of medicine.

Ethics Committees, Research↗
PubMed2000

The first international meeting of the Research Initiative on Traditional Antimalarial Methods (RITAM).

The first international meeting of the Research Initiative on Traditional Antimalarial Methods (RITAM) was held at the Regional Dermatology Training Centre (RDTC) of the Tumaini University of Health Sciences, Moshi, Tanzania, on December 8-11, 1999. This Inaugural Meeting of RITAM, jointly hosted by the Global Initiative for Traditional Systems of Health (GIFTS) at Oxford University and the World Health Organization (WHO), was designed to develop a strategy for more effective, evidence-based use of traditional medicines that can also inform malaria-control policy decisions. RITAM was established during 1999 as a network of researchers and other people who are active or interested in the study and use of traditional, plant-based antimalarials. RITAM is a partnership between GIFTS of Health, University of Oxford and the Tropical Disease Research (TDR) Programme of WHO. Malaria is one of the key health issues affecting developing countries, particularly in sub-Saharan Africa and Asia. With increasing drug resistance and the high cost of pharmaceutical drugs, the use of herbal antimalarials is popular. The conference was attended by biologic and social scientists, clinicians, traditional healers, and policy makers from Africa, Asia, Europe, and the Americas. The meeting was funded by the Rockefeller Foundation, the Nuffield Foundation's Commonwealth Programme, WHO's TDR Programme, and direct support to delegates was provided by other funders. The meeting addressed the need for research and policy on the prophylactic and therapeutic effects of medicinal plants as well as on vector control and repellence. There were five main outputs from the meeting: (1) targets for making a significant contribution to the control of malaria through the use of traditional antimalarial methods; (2) methods for achieving these targets, including ethical guidelines; (3) an implementation strategy for moving this field ahead quickly and soundly and for putting research findings into practice; (4) linkages established between researchers working on traditional antimalarial methods, based on agreed research priorities and designed to avoid unnecessary replication; and (5) strengthening the RITAM database of current knowledge on traditional herbal antimalarial methods. Four specialist groups were established to develop the above: (1) policy, advocacy, and funding; (2) preclinical studies; (3) clinical development; and (4) repellance and vector control. These will be coordinated by an executive committee managed by GIFTS. Two meetings are planned in 2000: a natural-products chemistry meeting at WHO in Geneva, Switzerland, in June; and a symposium at the World Congress on Tropical Medicine in Cartagena, Colombia, in August.

Antimalarials↗