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PubMed2005

Penny and pound wise: pharmacoeconomics from a governmental perspective.

Because of growing pressure on the healthcare budget in The Netherlands, appropriate justification of current expenditures and future investments in public healthcare are becoming increasingly important. Therefore, the Dutch Ministry of Health, Welfare and Sport is expanding its use of pharmacoeconomic evaluation in informed reimbursement decision-making of new pharmaceuticals. Since June 2002, pharmaceutical companies have been invited to submit a pharmacoeconomic dossier with their reimbursement applications of innovative drugs. As of January 2005 submission of a pharmacoeconomic dossier is mandatory for all drugs claiming to have therapeutic value. Currently, several European governmental and non-governmental organisations are making efforts to harmonise pharmacoeconomic research guidelines at the EU level. Ultimately, this may facilitate a more efficient way of conducting pharmacoeconomic research and encourage the use of pharmacoeconomic data by national assessment agencies and governments. It is anticipated that international pharmaceutical companies will increasingly invest in pharmacoeconomics while government staff will become more experienced in appraising the dossiers, thus resulting in an upward momentum in the quality and usability of pharmacoeconomic data. From the Dutch government's perspective, the use of pharmacoeconomic evaluation in reimbursement decision-making should offer a true opportunity for pharmaceutical companies to present the added value for money of new drugs. Using pharmacoeconomic data, costs, benefits and effects of pharmaceuticals are increasingly being considered from a societal perspective, thus going beyond the sole consideration of the impact on the pharmaceutical budget.

Economics, Pharmaceutical↗
PubMedDate not supplied

Surveillance of pesticide-related illness in the developing world: putting the data to work.

With PLAGSALUD support, pesticide illness surveillance has extended to all seven Central American countries, producing 7,000 poisoning reports in 2000, but governments' use of the surveillance data has been limited by inadequacies of data management, interpretation, and reporting and an influential pesticide industry in weak economies. Overrepresented reports of suicides minimize occupational hazards. In six countries, 32,245 questionnaire responses indicated 98% underreporting of pesticide poisonings and a regional estimate of 400,000 poisonings per year (1.9% of the population), 76% work-related. A potentially far-reaching measure to come out of this surveillance is an agreement of the ministers of health of Central America and the Dominican Republic (RESSCAD 2000) for a harmonized list of banned and restricted pesticides, including the 12 most frequently reported. The RESSCAD agreement has met considerable resistance from industry. Its achievement versus failure will disclose the ability of Central American governments to prioritize protection of human health against commercial corporate interests. Surveillance data have potential for policy reform, but a more aggressive health sector is needed, linked with the environmental sector, grass-roots organizations, and universities.

Central America↗
PubMed2002

Length scales of acceleration for locally isotropic turbulence.

Length scales are determined that govern the behavior at small separations of the correlations of fluid-particle acceleration, viscous force, and pressure gradient. The length scales and an associated universal constant are quantified on the basis of published data. The length scale governing pressure spectra at high wave numbers is discussed. Fluid-particle acceleration correlation is governed by two length scales: one arises from the pressure gradient, the other from the viscous force.

Journal Article↗
PubMed2001

Pharmacokinetic-pharmacodynamic modelling of human insulin: validity of pharmacological availability as a substitute for extent of bioavailability.

A method for assessing the extent of bioavailability (EBA) of human insulin from pharmacological data was determined. The time course governing increases in the plasma concentration of immuno-reactive insulin (IRI), as well as its pharmacological effects (glucodynamics), was determined after the intravascular administration of varying doses of human insulin. Pharmacokinetic (PK), pharmacodynamic (PD), and link models were constructed to elucidate the quantitative relationship between plasma IRI levels and pharmacological effects. After extravascular administration of the test formulation, only the time course governing the observed pharmacological effects was determined. The pharmacological data was translated into theoretical plasma concentration data, using the PK-PD model. Following this, the area under the theoretical plasma concentration-time curve (AUC) of the test formulation was calculated. The EBA was then estimated against a reference (intravascular) formulation, using a conventional equation. Since the pharmacological effects of insulin were observed to be highly dosing-rate-dependent, the PD model used in this study was modified to apply over a wide range of infusion rates. The results of the PK-PD analysis indicate that the doses administered can be accurately predicted from pharmacological data. To validate this method, the EBAs of controlled release formulations (the Osmotic Mini Pumps) of insulin, subcutaneously administered to the rat, were estimated. The EBA values obtained (92-96%) fell within a reasonable range. The area under the effect-time curves (AUE) obtained following subcutaneous applications of the Osmotic Mini Pump were calculated in a model-independent manner, in addition to pharmacological availabilities (PA), which were estimated against the reference (intravascular) formulations. The estimated PA values varied from 312% to 78%, in accordance with the intravascular input rates of the reference formulations. This indicates that PA should not be used as a substitute for EBA, unless data involving similar intravascular dosing rates to that of the reference formulations is available.

Animals↗
PubMed1997

An ecological study of trends in cancer incidence and dietary changes in Hong Kong.

Cancer incidence rates from the Hong Kong Cancer Registry show significant increases in lung and colon cancers and decreases in nasopharyngeal cancer in both sexes from 1973 to 1992. Moreover, cervical cancer and male esophageal cancer have declined significantly, and changes in the trends of cancer of the following sites were of borderline significance: decreasing male laryngeal and female esophageal cancers and increasing prostate and female breast cancers. These changes have occurred along with dietary shifts in the population, from a diet predominantly of rice and small portions of meat, vegetables, and fish to one with larger portions of all foods but rice and eggs. The latter data were gathered from six government household surveys from 1963-64 to 1994-95. By combining the two data sets, correlation coefficients were calculated for per capita consumption patterns of eight foods (rice, pork, beef, poultry, saltwater fish, freshwater fish, fresh vegetables, and eggs) and cancer incidence data of the same year or 10 years later. Higher meat intakes were significantly and positively correlated with cancers of the colon, rectum, prostate, and female breast. The correlations also suggested that current diets were more influential than diets a decade before for cancers of the lung, esophagus, rectum, and prostate. Cancers of the nasopharynx and colon were significantly correlated with current and past diets. These results support the hypothesis that intakes of meat and its associated fat are risk factors for colon, rectal, prostate, and female breast cancers.

Animals↗
PubMed2005

African Americans' opinions about human-genetics research.

BACKGROUND: Research on attitudes toward genetics and medicine registers skepticism among minority communities, but the reasons for this skepticism are not well known. In the past, studies linked mistrust of the medical system to historical ethics violations involving minority groups and to suspicions about ideological premise and political intent. METHODS: To assess public knowledge, attitudes, and behavior regarding human-genetics research, we surveyed 858 Americans onsite in four community settings or online in a geographically nonspecific manner. RESULTS: Compared to participants as a whole, African Americans were significantly more likely to believe that clinical trials might be dangerous and that the federal government knowingly conducted unethical research, including studies in which risky vaccines were administered to prison populations. However, African Americans were also significantly more likely to believe that the federal government worked to prevent environmental exposure to toxicants harmful to people with genetic vulnerabilities. CONCLUSIONS: Our data suggest that most Americans trust government to act ethically in sponsoring and conducting research, including genetics research, but that African Americans are particularly likely to see government as powerfully protective in some settings yet selectively disingenuous in others.

Black or African American↗
PubMed2026

Chemogenomic maps reveal a PRDX1-dependent iron-damage axis in the DNA damage response.

The DNA damage response (DDR) is a sophisticated network of cellular pathways whose perturbation leads to genome instability and is a key hallmark of oncogenesis. Here, we present data from 32 genome-scale loss-of-function CRISPR interference chemical-genetic screens with inhibitors targeting core constituents of the DDR machinery (PARP, ATR, ATM, DNAPK and WEE1), as both single agents and in combination with poly(ADP-ribose) polymerase inhibitors. These experiments identify >1,000 genes whose perturbation modifies the DDR and provides a rich resource to the DDR community. In addition, this compendium of functional genomics data reveals key principles governing the DDR and highlights a strong chemical-genetic interaction between loss of activity of the peroxiredoxin PRDX1 and all tested DDR inhibitors through a mechanism involving iron availability mediated by an MRGBP-PAX7-IREB2 axis. Our data position PRDX1 as a key suppressor of DNA damage accumulation and potential druggable target in combination with DDR inhibitors.

Journal Article↗
PubMed2006

Retrospective analysis of utilization patterns and cost implications of coxibs among seniors in Quebec, Canada: what is the potential impact of the withdrawal of rofecoxib?

OBJECTIVE: In September 2004, the manufacturer of rofecoxib announced a voluntary worldwide withdrawal of the drug. The impact of this withdrawal on drug budgets is unclear. This study evaluated average daily doses and costs of rofecoxib and celecoxib and concomitant use of gastroprotective agents (GPAs) in elderly patients with osteoarthritis (OA) or rheumatoid arthritis (RA) in Quebec, prior to the rofecoxib withdrawal. METHODS: This retrospective cohort study used prescription drug and medical service data from the Quebec government health agency administrative database and included coxib users > or =66 years of age with OA or RA who filled > or =3 consecutive rofecoxib or celecoxib prescriptions in 2001-2002. Results were adjusted for gastrointestinal risk factors and other patient baseline characteristics. RESULTS: Data were analyzed for 11,975 rofecoxib and 12,480 celecoxib users. Mean daily dosages were 20.7 mg for rofecoxib and 231.3 mg for celecoxib. Rofecoxib users consumed a mean +/- SD of 0.95 +/- 0.43 pills per day, and celecoxib users took 1.34 +/- 0.65 pills per day. Mean +/- SD unadjusted daily acquisition costs were $1.18 +/- $0.53 (Canadian) for rofecoxib and $1.45 +/- $0.74 for celecoxib. After adjusting for patient baseline characteristics, the mean daily acquisition cost for rofecoxib was $0.25 lower than for celecoxib. Rofecoxib users were less likely than celecoxib users to fill a GPA coprescription (odds ratio 0.88; 95% confidence interval 0.81, 0.95). Subgroup analyses yielded comparable results. CONCLUSION: Celecoxib appears to be a more expensive therapeutic option than rofecoxib due to a relatively higher daily dose and tablet consumption.

Aged↗
PubMed1997

Practical application of non-whole animal alternatives: summary of IRAG workshop on eye irritation testing. Interagency Regulatory Alternatives Group.

In November 1993, the Interagency Regulatory Alternatives Group (IRAG) sponsored a workshop to examine the current scientific status of alternatives to the Draize eye irritation test by assessing the current practical application of methods used to predict in vivo eye irritation. Laboratories from around the world were invited to submit detailed in vitro and in vivo data in parallel according to a specific set of guidelines in a consistent format. In vitro scores were compared with individual tissue scores. Over 60 data sets from 41 laboratories were received for 29 different test methods. Methods were grouped into five categories: organotypic models, chorioallantoic membrane-based assays, cell function-based assays, cytotoxicity assays and other systems. Data submissions and correlation analyses have been used to demonstrate the application of guidelines in method evaluations. Findings are summarized and future directions are indicated. A significant outcome of the workshop was the co-operation demonstrated among representatives of industry, academia and government in sharing test data on more than 2000 chemicals, products and product formulations for evaluation by their peers. Information obtained from this workshop will add to the weight of scientific evidence and scientific consensus about in vitro test methods and will establish credibility for regulatory acceptance of non-whole animal alternatives for ocular irritation.

Animal Testing Alternatives↗
PubMedDate not supplied

[Traffic accidents: a qualitative approach from Campinas, São Paulo, Brazil].

This article takes an interdisciplinary qualitative approach to the problem of traffic accidents in Campinas, São Paulo, Brazil. The authors begin by analyzing the "municipalization" (i.e., decentralization to the municipal level) of transport and traffic management in Campinas based on social representations by members of the local government's technical staff. Data demonstrate a significant drop in traffic accident mortality in Campinas in the last ten years. The findings illustrate how new transport and traffic policies had several positive effects. Special attention is given to the objectives, strategies, and obstacles dealt with by local government in the "municipalization" of traffic. The paper concludes by emphasizing the need for specific public policies to revitalize urban mass transportation, including special traffic safety educational programs.

Accidents, Traffic↗
PubMed1993

Documenting temporal trends of polychlorinated biphenyls in the environment.

In the 15 years since the regulation of polychlorinated biphenyls (PCBs) in the United States, numerous studies have been undertaken to assess PCB levels in the environment. This report reviews the available data from published literature and government agency reports on temporal trends of PCB levels in various environmental compartments. Adequate data were identified to discuss PCB trends in foods for human consumption, human adipose tissue, human blood sera, various fish species, and shellfish. The review found that PCB levels in the human diet currently are less than 1% of the levels detected in the early 1970s as measured by the nationwide Total Diet Study of the FDA. Similarly, EPA data indicate a decrease in the percentage of persons with over 1 ppm of PCBs in adipose tissue from 62% in 1972 to 2% in 1984 when the study was terminated. Studies by the National Oceanic and Atmospheric Administration (NOAA) and other groups have shown a 2- to 10-fold decline in PCB contamination in fish and shellfish from the early 1970s to the late 1980s. The most dramatic declines across all environmental compartments appear in the late 1970s to the mid-1980s which corresponds to the time frame when regulatory controls were imposed by the Toxic Substances Control Act (TSCA). These declines are expected to continue but at slower rates.

Animals↗
PubMed2006

Individual factors affecting the risk of death for rear-seated passengers in road crashes.

We studied the effect of age, gender, use of restraint systems and seat position on the risk of death for rear-seated passengers of cars involved in road crashes. The data source was the Spanish register of traffic crashes with victims compiled by the Government's General Traffic Directorate. Data for crashes recorded from 1993 to 2002, inclusive, were studied. We used a matched cohort design to analyze all 5260 rear-seated passengers in vehicles occupied by two or three rear-seated passengers for accidents in which at least one of these passengers was killed. Conditional Poisson regression with death as the dependent variable was used. An increased risk of death was observed for females and children aged <3 years. For passengers aged 25 years and older, the risk increased with age. The use of restraint systems and central and right-side seats was associated with a lower risk. These results should be considered in research focused on passenger fragility and strategies to prevent injury and death.

Accidents, Traffic↗
PubMedDate not supplied

Object manifestations for medical imaging applications.

As healthcare providers become increasingly decentralized and distributed, information systems support must follow suit by providing healthcare professionals with flexible, adaptable and secure views of medical data in a timely fashion. To this end, this paper introduces the notion of manifestations of medical image objects in a heterogeneous client environment. We define the fundamental building blocks of manifestations using object-oriented concepts. Examples are given of how constraints and rules can be used to govern the presentation of data within objects and for the environmental (e.g. hardware and network) and user defined factors (e.g. preferences) that act as inputs to manifestations. Using these techniques, we give several examples of user interactions with a system based on manifestations. This paper demonstrates how objects can be efficiently and effectively presented to users with various information appliances using manifestation techniques.

Computer Security↗
PubMed1987

Hospital corporate restructuring gains widespread acceptance.

Corporate restructuring is becoming an increasingly popular strategy for hospitals faced with declining revenues, new regulatory incentives or expanded market objectives. This article, based on data from two American Hospital Association surveys of hospital governing boards, explores the corporate restructuring trend in hospitals and considers its impact upon hospital governance.

Data Collection↗