Effective regulatory approval process for food ingredient technologies

Most sciences and technologies related to food safety have advanced exponentially over the 40 years since passage in the U.S. of the Food Additive Amendment of 1958 to the Federal Food, Drug and Cosmetic (FD&C) Act. Effective regulatory decision making places a high premium on competent professional and administrative judgement applied to sound scientific data. This review discusses changes and lessons learned in the food safety sciences over the last 4 decades. Other segments of the safety and compliance infrastructure necessary to assure that the public receives safe and wholesome foods have not kept pace with the new scientific knowledge. The quality of foods in our marketplace can be improved only after the regulatory and legislative segments of the infrastructure, discussed in a companion symposium paper, are brought into better synchrony with the sciences.     

Receptor regulatory mechanisms of antimutagenic action

Based on the data available in the literature and his own findings, the author suggests that there is a receptor regulatory mechanism of action in some antimutagens. The primary signal can be induced by an antimutagen at different stages of a regulatory cascade: a membrane, cell effectors, and cell ensembles. At the terminal stage, there is an activation of the natural system of antimutagenesis activates and an enhanced cell resistance to a mutagen.     

Counterfactual thinking and regulatory focus: Implications for action versus inaction and sufficiency versus necessity.

Counterfactual thinking is associated with regulatory focus in a way that explains previous empirical incongruities, such as whether additive counterfactuals (mutations of inactions) occur more or less frequently than subtractive counterfactuals (mutations of actions). In Experiment 1, regulatory focus moderated this pattern, in that additive counterfactuals were activated by promotion failure, whereas subtractive counterfactuals were activated by prevention failure. In Experiment 2, additive counterfactuals evoked a prevention focus and expressed causal necessity. In Experiment 3, dejection activated additive counterfactuals, whereas agitation activated subtractive counterfactuals. These findings illuminate the interconnections among counterfactual thinking, motivation, and goals. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Setting priorities for science support

Computed posturography (stabilography) was used to examine the locomotor function of 165 children from 1-11 forms under the influence of different real and model loads. Analysis of age-specific changes in their upright stability (by the data on the lateral velocity of the body's oscillations) yielded allowable load weights of a daily complete set for schoolchildren.     

Major trends in psychotherapy: Implication for priorities for Psychotherapy.

Identifies and describes 7 major trends in psychotherapy of particular interest to the readership of Psychotherapy: psychoeconomics, the new client, gender and psychotherapy, psychotherapy and the elderly, drug therapy and psychotherapy, professional training at the doctoral level and beyond, and pragmatism. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Overview: Forging research priorities for women's mental health.

After a decade of reports underscoring the inadequacy of existing scientific knowledge for understanding gender differences in mental disorder and its treatment, the National Institute of Mental Health has developed a women's mental health research agenda with five priority areas for research: diagnosis and treatment of mental disorder, mental health issues for older women, violence against women, multiple roles, and poverty. This overview highlights some of the major findings in each of these five areas and introduces the more in-depth treatment given in this Psychology in the Public Forum section to the areas of violence, poverty, and multiple roles. It also underscores the importance of identifying sources of gender bias in all mental health research. Women's mental health issues have become officially recognized as part of the NIMH research agenda. Only time and continued monitoring will determine how these official policy priorities will become translated into actual funding and research initiatives. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Cryopreservation of non-human primate sperm: priorities for future research

Wild populations of many non-human primate species have declined alarmingly due to habitat destruction, hunting and genetic isolation. Captive breeding programmes to aid species survival could be enhanced by the use of assisted reproductive techniques, such as artificial insemination (AI), if a source of viable sperm was readily accessible. Cryobanks of primate sperm could provide such a supply if techniques for freezing sperm could be developed. Although sporadic attempts to cryopreserve primate sperm have been reported for some of the more frequently encountered zoo-maintained species, there is limited information available on techniques for sperm collection and storage. It is vital that adequate reporting of all cryopreservation attempts be made to avoid repetition of inappropriate methodologies and wastage of valuable genetic material from rare or endangered animals. An integrated approach to the cryobanking of non-human primate sperm is considered to be essential for species conservation. In this review, the factors affecting the success of sperm cryopreservation are outlined, existing information is compiled from previous reported attempts at cryopreservation, and suggestions are made for cryopreserving sperm in further non-human primate species. Moreover, recommendations are given for additional studies to augment existing data. It is intended that this information should serve as a guide for developing cryopreservation protocols in the future, particularly for endangered species.     

Health sector reform: priorities and packages

Using time-resolved fluorometry, a simple one-step dual-label immunometric assay has been developed, which allows simultaneous determination of pregnancy-associated plasma protein A (PAPP-A) and free beta-subunit of human chorionic gonadotrophin (beta-hCG) in first-trimester maternal serum samples. Two monoclonal antibodies were biotinylated and immobilized onto the surface of streptavidin-coated microtitration plates, and used to capture PAPP-A and beta-hCG. respectively. Europium (Eu) and Samarium (Sm) chelates were conjugated to two additional monoclonal antibodies acting as detection antibodies for PAPP-A and beta-hCG. The assay was performed using a 4-h one-step format. The within-run precision with buffer-based calibrators was below 8% over the working range of PAPP-A (40-10000 mIU/l) and beta-hCG (7.3-525 micrograms/l) and no hook effect was observed. The intra- and inter-assay coefficients of variation were below 7.1% for serum samples. PAPP-A and beta-hCG concentrations measured by the dual assay in 39 first-trimester serum samples correlated excellently with those obtained by DELFIA single-label PAPP-A (r = 0.997) and the beta-hCG part (r = 0.993) of the DELFIA AFP/beta hCG dual-label assay.     

Research priorities in hereditary hemochromatosis

The Working Group on Research Priorities used a formal nominal group technique to identify and prioritize the specific aims of applied research needed to provide the scientific basis for population screening for iron overload disorders. The most important applied research goal was characterization of the natural history of the relation between genotype and phenotype in hereditary hemochromatosis and other iron overload disorders. Three other important research objectives were development of an optimal approach to screening for iron overload; analyses of the cost-effectiveness of screening; and assessment of the ethical, legal, and social implications of screening. To achieve these specific aims, two research studies were recommended as being of the highest priority: a multicenter, cross-sectional, population-based study of the natural history of iron overload and a multicenter, case-control study of patients with disease manifestations potentially attributable to hereditary hemochromatosis in primary care and subspecialty clinics.     

Tensions in setting health care priorities for South Africa''s children

Intractable detrusor overactivity can result in considerable morbidity and, in the case of neurogenic bladder dysfunction, can put the upper tracts at risk. Once conservative treatments have been exhausted the aim of surgery is to increase functional bladder capacity and decrease the maximal detrusor pressure at this capacity. The mainstay of contemporary therapy has been augmentation cystoplasty; the different techniques and recent literature are reviewed herein. Bladder autoaugmentation is compared and contrasted with augmentation cystoplasty and its role is discussed, as is the less invasive technique of sacral neuromodulation with reference to their role within the range of surgical treatments for detrusor activity.     

Cancer in developing countries: Part II--Cancer control: strategies and priorities

In 1992 the first Hereditary Cancer Center in Poland has been organized in Szczecin. DESIGN: One of its goals is application of appropriate management in families with hereditary ovarian cancer. The aims of our program include studies of: incidence, clinical characterization, DNA diagnostic tests and efficiency of screening for early detection of hereditary ovarian tumors in North-West Poland. MATERIAL: Our program includes 234 families with 258 cases of ovarian cancers. RESULTS: Site-specific familial aggregation of ovarian cancer was diagnosed in 16 (6.84%) families, breast-ovarian cancer syndrome in 27 (11.54%), Lynch II syndrome in 5 (2.14%) families, undefined cancer family aggregation in 12 (5.13%) families, sporadic ovarian cancers diagnosed age of 44 in 56 (23.93%) families and other sporadic ovarian cancers in 118 (50.4%). In 17 patients with ovarian cancer from families with breast-ovarian cancer syndrome constitutional BRCA-1 gene mutations were studied by sequencing DNA on automated sequencer of PCR products for all 24 exons. In 1 patient constitutional mutation in exone 11 was detected. We found also multiply polymorphic changes. 124 women-members of 116 families with diagnosed hereditary predisposition for ovarian cancer have been studied for asymptomatic tumors by intravaginal USG and evaluation of CA 125 marker every 6 month beginning from 20-25 years of age. Up to now we found 5 cases of benign serous cystadenomas, 3 cases of cystadenomas of borderline malignancy and 1 cases of serous cystadenocarcinoma. CONCLUSIONS: It seems, that particular surveillance program in women from families with hereditary cancers can be the effective way of detection of early ovarian tumors. Clinical characterization of hereditary ovarian cancers in North-West Poland and other countries is similar.     

Management of myocardial infarction: the proper priorities

We calculated the rates for perioperative mortality and fatal pulmonary embolism (PE) after primary total hip replacement in a single UK health region, using a regional arthroplasty register and the tracing service of the Office of National Statistics. During 1990, there were 2111 consecutive primary replacements in 2090 separate procedures. Within 42 days of operation a total of 19 patients had died (0.91%, 95% CI 0.55 to 1.42). Postmortem examination showed that four deaths (0.19%, 95% CI 0.05 to 0.49) were definitely due to PE. The overall perioperative mortality and fatal PE rates are low and in our study did not appear to be altered by the use of chemical thromboprophylaxis (perioperative mortality rate: one-tailed Fisher's exact test, p = 0.39; fatal PE rate: one-tailed Fisher's exact test, p = 0.56). The routine use of chemical thromboprophylaxis for primary THR is still controversial. The issue should be addressed by an appropriate randomised, prospective study using overall mortality and fatal PE rate as the main outcome measures, but the feasibility of such a study is questioned.     

Management priorities in patients with polytrauma

BACKGROUND: The basic principles for the treatment of the polytraumatized patient is early resuscitation, followed by a physical examination and diagnostic studies. These are performed to establish the priorities for life-saving management and further treatment. DISCUSSION: Trauma management regarding musculoskeletal injuries is discussed in four different distinguished periods: (1) acute or resuscitation period (0-3 h); (2) primary or stabilization period (3-72 h); (3) secondary or regeneration period (days 3-8); and (4) tertiary or rehabilitation period (beyond day 8). For management during the acute period, a trauma algorithm is described, which consists of four different steps: (1) first look; (2) shock treatment; (3) check up; and (4) control and diagnosis. During the acute period, decompression of organ cavities (tension pneumothorax, cardiac tamponade) is performed along with life-saving operations for hemorrhage control of thoracic, abdominal, pelvic or external bleeding. The primary period (3-72 h) of treatment starts when the vital functions have been stabilized. During this period, so-called 'day-one' surgery is performed. During the secondary period (days 3-8), a phase of regeneration, a secondary deterioration of organ function must be prevented. During the tertiary phase (beyond day 8), in most cases, recovery usually continues and final reconstructive operations can be performed.     

Prevention services in primary care: taking time, setting priorities

Standard family history and family study methods were used with 650 first- and 1174 second-degree biological relatives of 133 adolescents who were studied initially 6 to 8 years ago. They included 69 prepubertal children considered at risk for suicidal behavior and 64 prepubertal children selected from the community. This study aimed to identify relationships between family psychopathology and adolescents' lifetime history of suicidal states. Family discord, suicide attempts of mother, and substance abuse of mothers and fathers were significantly more prevalent among adolescents with lifetime history of a suicide attempt. Mothers' and fathers' substance abuse was associated with adolescents' lifetime history of suicidal ideation. Results highlight importance of evaluating and treating family psychopathology to reduce risk for youth suicidal states.     

Sex differences in value priorities: Cross-cultural and multimethod studies.

The authors assess sex differences in the importance of 10 basic values as guiding principles. Findings from 127 samples in 70 countries (N = 77,528) reveal that men attribute consistently more importance than women do to power, stimulation, hedonism, achievement, and self-direction values; the reverse is true for benevolence and universalism values and less consistently for security values. The sexes do not differ on tradition and conformity values. Sex differences are small (median d = .15; maximum d = .32 [power]) and typically explain less variance than age and much less than culture. Culture moderates all sex differences and sample type and measurement instrument have minor influences. The authors discuss compatibility of findings with evolutionary psychology and sex role theory and propose an agenda for future research. (PsycINFO Database Record (c) 2010 APA, all rights reserved)