Trends in antihypertensive drug advertising, 1985-1996.
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BACKGROUND: Over the past decade, calcium channel blockers (CCBs) and ACE inhibitors have been used increasingly in the treatment of hypertension. In contrast, beta-blocker and diuretic use has decreased. It has been suggested that pharmaceutical marketing has influenced these prescribing patterns. No objective analysis of advertising for antihypertensive therapies exists, however. METHODS AND RESULTS: We reviewed the January, April, July, and October issues of the New England Journal of Medicine from 1985 to 1996 (210 issues). The intensity of drug promotion was measured as the proportion of advertising pages used to promote a given medication. Statistical analyses used the chi2 test for trend. Advertising for CCBs increased from 4.6% of advertising pages in 1985 to 26.9% in 1996, while advertising for beta-blockers (12.4% in 1985 to 0% in 1996) and diuretics (4.2% to 0%) decreased (all P<0.0001). A nonsignificant increase was observed in advertising for ACE inhibitors (3.5% to 4.3%, P=0.17). Although the total number of drug advertising pages per issue decreased from 60 pages in 1985 to 42 pages in 1996 (P<0.001), the number of pages devoted to calcium channel blocker advertisements nearly quadrupled. CONCLUSIONS: Increasing promotion of CCBs has mirrored trends in physician prescribing. An association between advertising and prescribing patterns could explain why CCBs have supplanted better-substantiated therapies for hypertension. (+info)
An Advisory Committee Statement (ACS). National Advisory Committee on Immunization (NACI). Statement on influenza vaccination for the 1998-1999 season.
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The National Advisory Committee on Immunization (NACI) provides Health Canada with ongoing and timely medical, scientific, and public-health advice relating to immunization. Health Canada acknowledges that the advice and recommendations set out in this statement are based upon the best current available scientific knowledge, and is disseminating this document for information purposes. Persons administering or using the vaccine should also be aware of the contents of the relevant product monograph(s). Recommendations for use and other information set out herein may differ from that set out in the monograph(s) of the Canadian licensed manufacturer(s) of the vaccine(s). Manufacturer(s) have only sought approval of the vaccine(s) and provided evidence as to its safety and efficacy when used in accordance with the product monographs. (+info)
Utilization of genetically altered animals in the pharmaceutical industry.
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The study of transgenic and gene-deleted (knockout) mice provides important insights into the in vivo function and interaction of specific gene products. Within the pharmaceutical industry, genetically altered mice are used predominantly in discovery research to characterize the diverse functions of one or multiple gene products or to establish animal models of human disease for proof-of-concept studies. We recently used genetically altered animals in drug discovery to examine the NF-kappaB family of transcriptional regulatory genes and to elucidate their essential role in the early onset of immune and inflammatory responses. Transgenic and knockout mice are also useful in drug development, because questions regarding risk assessment and carcinogenesis, xenobiotic metabolism, receptor- and ligand-mediated toxicity, and immunotoxicity can be evaluated using these genetically altered mice. For example, the p53 knockout mouse is one of several genetically altered mice whose use may increase the sensitivity and decrease the time and cost of rodent carcinogenicity bioassays. As with any experimental model system, data obtained from genetically altered mice must be interpreted carefully. The complete inactivation of a gene may result in altered expression of related genes or physiologic compensation for the loss of the gene product. Consideration must also be given to the genetic background of the mouse strain and the impact of strain variability on disease or toxicity models. Despite these potential limitations, knockout mice provide a powerful tool for the advancement of drugs in the pharmaceutical industry. (+info)
Status of new medicines approved by the European Medicines Evaluation Agency regarding paediatric use.
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AIMS: To evaluate the activity of the European Medicines Evaluation Agency with regard to the registration for paediatric use of new medicines granted a marketing authorization. METHODS: European Public Assessment Reports published on the Internet from January 95 until April 98 have been analysed using the browser Microsoft Explorer and the software Adobe Acrobat Reader. RESULTS: Of the 45 new substances licensed since January 95, 29 (64%) were of possible use in children but only 10 were licensed for paediatric use. For the 19 drugs of possible use in children, but not approved for such a use, in nine instances (47%) their summary of product characteristics reported that their use in children has not been established. CONCLUSIONS: A change of practice by pharmaceutical companies and regulatory authorities is imperative so that children are not precluded from having the same rights to medicines as adults. (+info)
The prevalence and incidence of medical conditions in healthy pharmaceutical company employees who volunteer to participate in medical research.
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AIMS: Although clinical research in healthy volunteers is commonly performed there have been few studies of the value of the medical screening of subjects. The aim of this study was to investigate the prevalence and incidence of medical conditions found during the medical screening of 'healthy' subjects employed in a pharmaceutical company who volunteered to participate in medical research. METHODS: This was a retrospective study of the medical notes of all the subjects who volunteered for membership of the Zeneca Clinical Pharmacology Unit's healthy volunteer panel over a 4 year period from 1990 to 1994. The prevalence of medical conditions found at presentation was determined. The incidence of medical conditions during the 4 year observation period was also ascertained. Medical screening included a full medical history and examination, clinical chemistry, haematology and urinalysis screens, pulmonary function tests, ECGs, 24 h ambulatory cardiac monitoring and a request for information from the volunteer's General Practitioner. RESULTS: Prevalence-1293 subjects volunteered to join the panel of which 156 subjects (12%) were not accepted at presentation including 141 (10. 9%) for medical reasons. The most medical common reasons were; previously diagnosed medical conditions (3.3%), cardiovascular abnormalities (1.9%), abnormal liver function tests (1.9%), anaemia (1.2%), hyperlipidaemia (1.1%), excess alcohol intake (0.6%) and thyroid disease (0.5%). Incidence-36 of the 1137 volunteers (0.8% per year) accepted onto the panel subsequently developed medical conditions of which the most common were; anaemia (0.29% per year), cardiovascular abnormalities (0.13% per year) and vasovagal syncope (0.13% per year). CONCLUSIONS: This study demonstrates the importance of medical screening before healthy volunteers participate in clinical research. (+info)
Occupational asthma induced by cephalosporins.
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A 20-yr-old pharmaceutical worker who developed attacks of shortness of breath and wheezing 9 months after beginning work on a process in which cefadroxil powder was bottled or encapsulated will be described. Skin test with cefaxodril was negative. Baseline spirometry and methacholine inhalation test were normal. A controlled bronchial challenge test was carried out in a closed-circuit system with assessment of respirable dust concentration. Exposure to cefadroxil powder at a mean concentration of 10 mg x m(-3) for 10 min elicited an isolated immediate asthmatic response, but no response was observed to control challenge with lactose. Single-blind oral challenge test with amoxicillin up to 500 mg was well tolerated, whereas the oral challenge with cephalexin (25 mg) elicited an immediate asthmatic response. This patient had developed occupational asthma caused by inhalation of cefadroxil as confirmed by specific inhalation test. Since she tolerated oral amoxicillin, a synthetic penicillin with the side-chain identical to that of cefadroxil, it seems that she may be sensitized to the dihydrothiazine ring of cephalosporins. (+info)
Drug and Therapeutics (D & T) committees in Dutch hospitals: a nation-wide survey of structure, activities, and drug selection procedures.
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AIMS: To determine structure, activities and drug selection processes used by Dutch hospital drug and therapeutics (D & T) committees. METHODS: A pretested structured survey questionnaire based on the Australian process and impact indicators, previous research, and consultation of professionals was developed. Subsequently, D & T committees that met predefined selection criteria were asked to participate. RESULTS: The overall response rate was 70% (38/54). D & T committees varied considerably in size and representation of clinical expertise. Although responsibilities were theoretically alike, actual responsibilities were frequently passed on to other authorities, such as pharmacy staff. Few committees used detailed guidelines or decision supportive matrices to establish transparency in drug selection. With respect to drug selection, the value scores on the information resources used, the factors involved, and the selection criteria used varied. Hospital pharmacists were likely to be most involved and to have the greatest impact. A consensus was most difficult to achieve for drugs used in cardiology, oncology, and psychiatry. Interference of industrial marketing strategies on drug selection was recognized and identified. CONCLUSIONS: Our results indicate that Dutch hospital D & T committees differ with respect to their clinical expertise and their activities, a situation comparable with that observed in other countries. Furthermore, the lack of transparency in drug selection was considerable. These findings clarify the differences previously found between Dutch hospital drug formularies. (+info)
The impact of relational activities on HMO organizational outcomes.
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OBJECTIVE: To report the findings of an empirical study of health maintenance organization (HMO) organizational outcomes and relational activities in HMO-pharmaceutical manufacturer relations. STUDY DESIGN: A mailed survey of a national random sample of 273 HMOs. SUBJECTS AND METHODS: Data were obtained from 111 HMOs regarding their inter-organizational relations with a pharmaceutical manufacturer. Respondents reported on 3 relational activities (initiating behavior, flexibility, bidirectional communication) and 4 HMO organizational outcomes (long-term orientation, equity in sharing costs and benefits, commitment between partners, financial performance). Also, 3 control variables were assessed: number of enrolled beneficiaries, HMO type, and estimated annual acquisition costs of pharmaceuticals. Four multiple regression analyses were performed, each with one organizational outcome variable as the dependent variable. Measures of relational activities and the control variables were the independent variables in the regressions. RESULTS: The response rate was 40.7%. All 3 relational activities showed significant associations with HMO organizational outcomes. Two relational activities (bidirectional communication, initiating behavior) showed significant and positive associations with a long-term orientation. Independent practice association (IPA)-model HMOs were less likely to report a long-term orientation toward a pharmaceutical manufacturer than other types of HMOs (adjusted R2 = 0.40). Bidirectional communication and flexibility were significantly and positively associated with the equity of costs and benefits (adjusted R2 = 0.29). Commitment had significant positive associations with all 3 relational activities (adjusted R2 = 0.50). All 3 relational activities had significant positive associations with financial performance. HMOs with an annual acquisition cost > $2 million were less likely to report favorable financial performance associated with a pharmaceutical manufacturer than were HMOs with lower costs (adjusted R2 = 0.42). CONCLUSION: Relational activities, such as initiating behavior, flexibility, and bidirectional communication, can facilitate positive outcomes for HMOs. It is important for all parties interested in healthcare to recognize that managing care creates a tension between achieving patient outcomes and organizational outcomes. (+info)