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The release in 1993 of a new reference material for serum proteins, CRM 470/RPPHS 5 has given rise to a great improvement in the between-laboratory variability of serum protein measurements worldwide. Conversion to the new reference material results in significant changes in reference values for some proteins. The establishment of new reference ranges will take a considerable time, and in the interim several professional societies and diagnostic companies have agreed to use consensus reference ranges based on studies already undertaken.
The Food and Drug Administration (FDA) is proposing to amend its regulations pursuant to an international agreement that is expected to be concluded between the United States and the European Community (EC) (Ref. 1). Under the terms of that agreement, FDA may normally endorse good manufacturing practice (GMP) inspection reports for pharmaceuticals provided by equivalent EC Member State regulatory authorities and medical device quality system evaluation reports and certain medical device premarket evaluation reports provided by equivalent conformity assessment bodies. FDA is taking this action to enhance its ability to ensure the safety and efficacy of pharmaceuticals and medical devices through more efficient and effective utilization of its regulatory resources. The agency is requesting comments on the proposed rule.
BACKGROUND: Smoking is a risk factor for sensitization to some occupational allergens, but its association with sensitization to common environmental allergens remains unclear. OBJECTIVE: We sought to determine the association of smoking with total IgE levels and with sensitization to 3 common environmental allergens in data from the European Community Respiratory Health Survey. METHODS: A detailed smoking history and blood sample for determination of serum total IgE and specific IgE levels to house dust mite, grass, and cat allergens was obtained from 13,002 randomly selected young adults living in the areas served by 34 centers in 14 countries. Associations with smoking status and amount smoked were determined. Because there was evidence of heterogeneity between centers in the association of age, sex, and smoking with sensitization, odds ratios (ORs) were determined for each center and combined by using random-effects meta-analysis. RESULTS: Compared with lifetime nonsmokers, current smokers were at an increased risk of sensitization to house dust mite allergen (OR, 1.13; 95% confidence interval [CI], 1.02-1.26) but a decreased risk of sensitization to grass (OR, 0.76; 95% CI, 0.67-0.88) and cat allergens (OR, 0.69; 95% CI, 0.59-0.80). Exclusion of those with symptoms suggestive of current asthma strengthened the association of smoking with sensitization to house dust mite allergen (OR, 1.29; 95% CI, 1.11-1. 50). The geometric mean total IgE level was higher in smokers and was higher among those who currently smoked the most compared with those who smoked less than 5 cigarettes per day. CONCLUSION: The association between smoking and sensitization to common environmental allergens is different for different allergens.
This paper summarizes the Community directives on water quality. In particular the directive on water for human consumption is discussed in relation to its philosophy, the procedure that was adopted for its preparation and the position of the Commission in respect to the more observations derived from the difficulties encountered by member states in its application. The role and the activity of the Institutions of the European Community as well as their relationships with member states are also discussed.
BACKGROUND: Atopy may impair ventilatory function, but results are controversial. We assess the association between individual reactivity to allergens and the level of baseline maximal one-second forced expiratory volume (FEV1), by smoking and respiratory symptoms. METHODS: The 1472 participants (response 44.5%) of the five Spanish areas of the European Community Respiratory Health Survey (ECRHS) who performed respiratory function tests, skin prick tests and/or specific IgE against common aeroallergens (e.g. mites, pets, mould, pollens) are included. Bronchial hyperreactivity (BHR) was measured with a methacholine challenge. RESULTS: After adjusting for BHR and smoking, in addition to the other allergens, skin reactivity to Alternaria (-208 ml; 95% CI :-451, 35) and IgE antibodies against cat (-124 ml; 95% CI:-269, 21) and Timothy grass (-115 ml, 95% CI:-190, -40) were associated with a decrease in FEV1 in females. Among males, skin reactivity to olive showed the strongest association (-111 ml; 95% CI: -261, 38). The associations were stronger in females. Smoking modifies the association for Alternaria and cat (P for interaction < 0.05). While cat is associated with a decrease in FEV1 in current smokers (-190 ml), Alternaria (-336 ml) was associated among never smokers. The exclusion of subjects with asthma symptoms, or adjustment for respiratory symptoms, led to similar results. CONCLUSIONS: We conclude that immunoresponse to individual allergens (particularly outdoor) is associated with the level of FEV1, and this association occurred independently of asthma, and in smokers and non-smokers, which may be of interest in natural history of chronic obstructive pulmonary disease (COPD).
In 3 prior meta-analyses, the relationship between the Big Five factors of personality and job criteria was investigated. However, these meta-analyses showed different findings. Furthermore, these reviews included studies carried out only in the United States and Canada. This study reports meta-analytic research on the same topic but with studies conducted in the European Community, which were not included in the prior reviews. The results indicate that Conscientiousness and Emotional Stability are valid predictors across job criteria and occupational groups. The remaining factors are valid only for some criteria and for some occupational groups. Extraversion was a predictor for 2 occupations, and Openness and Agreeableness were valid predictors of training proficiency. These findings are consistent with M.R. Barrick and M.K. Mount (1991) and L.M. Hough, N.K. Eaton, M.D. Dunnette, J.D. Kamp, and R.A. McCloy (1990). Implications of the results for future research and the practice of personnel selection are suggested.
Alport syndrome (AS) is a type IV collagen hereditary disease characterized by progressive hematuric nephritis, hearing loss, and ocular changes. Mutations in the COL4A5 collagen gene are responsible for the more common X-linked dominant form of the disease characterized by much less severe disease in girls and women. A "European Community Alport Syndrome Concerted Action" (ECASCA) group was established to delineate the Alport syndrome phenotype in each gender and to determine genotype-phenotype correlations in a large number of families. Data concerning 329 families, 250 of them with an X-linked transmission, were collected. Characteristics of heterozygous girls and women belonging to the 195 families with proven COL4A5 mutation are compared with those of hemizygous boys and men. Hematuria was observed in 95% of carriers and consistently absent in the others. Proteinuria, hearing loss, and ocular defects developed in 75%, 28%, and 15%, respectively. The probability of developing end-stage renal disease or deafness before the age of 40 yr was 12% and 10%, respectively, in girls and women versus 90 and 80%, respectively, in boys and men. The risk of progression to end-stage renal disease appears to increase after the age of 60 yr in women. Because of the absence of genotype-phenotype correlation and the large intrafamilial phenotypic heterogeneity, early prognosis of the disease in X-linked Alport syndrome carriers remains moot. Risk factors for developing renal failure have been identified: the occurrence and progressive increase in proteinuria, and the development of a hearing defect.
We assessed the association of asthma prevalence in young adults with susceptibility factors and environmental exposures, taking into account the age at asthma onset. A random sample of the general population, aged 20-44 yrs, in five areas of Spain (Albacete, Barcelona, Galdakao, Huelva, and Oviedo) was selected in the frame of the European Community Respiratory Health Survey (ECRHS). Overall, 2,646 subjects (response rate = 60.9%) responded to a respiratory questionnaire and 1,797 (41.4%) finalized a bronchial challenge. Atopy to perennial (odds ratio (OR) = 10.2, 95% confidence interval 4.2-25) and seasonal allergens (11.5, 4.6-28), parental asthma (4.5, 2.5-8.4), and birth order (OR for no older siblings in comparison to having more than two = 3.2, 1.2-9.1) were associated with current asthma whatever the age of asthma onset. Past asthma was associated to a lesser extent with atopy (OR around 3.5 to both perennial and seasonal allergens). Lower respiratory tract infections before the age of 5 yrs (LRTI), having had a pet in childhood, and being born in a younger cohort were associated with asthma starting before the age of 15 yrs, but not after. Male gender was more frequent in childhood asthma and female gender in adulthood. In addition to the known risk factors of asthma (atopy to perennial allergens, parental asthma) we provide evidence for an association of asthma (whatever the age of onset) with sensitization to seasonal allergens, and having less than three older siblings; and for an association of childhood asthma with lower respiratory tract infections.
The Food and Drug Administration (FDA) is announcing the establishment of a public docket for the submission and public availability of information concerning the implementation of the Mutual Recognition Agreement (MRA) between the United States and the European Community (EC) in the areas of pharmaceutical good manufacturing practices (GMP's) and medical devices. FDA is also establishing contact points for information covering particular subjects under the MRA implementation, and the agency is making appropriate information available on the FDA web site.
BACKGROUND: In studies from Italy and Greece a Mediterranean dietary pattern predicts overall survival. Despite an increase in the movement of food around the world, there is still a wide spectrum of dietary patterns and the aim of the present study was to examine the association between a Mediterranean dietary pattern and mortality in a cohort of elderly people living in a North European Community. METHODS: Diet and nutritional status was studied among 202 men and women born 1914-1918 and living in a Danish Municipality (Roskilde) in 1988. They were followed for 6 years. RESULTS: A diet score, with seven dietary characteristics of the Mediterranean diet, was associated with a significant reduction in overall mortality. A one unit increase in the diet score predicted a 21% (95% confidence interval 2-36%) reduction in mortality. Subjects with high diet scores (> or = 4) had significantly higher plasma carotene levels than those with a low score and plasma carotene was negatively associated with mortality. CONCLUSION: A Mediterranean diet score predicts survival in a North European population. Plasma carotene may serve as an intermediate factor in this association.
Biotechnology represents an opportunity for innovative products, new markets, or capital investments, depending on one's perspective. A primary consideration in regulating this industry is to ensure that innovation is not stifled yet the public is protected from potentially unsafe or ineffective products. We compared the regulatory requirements and procedures for obtaining marketing approval for biotechnology products in the European Community (EC) and the United States and identified key concerns of the biotechnology industry regarding the regulatory aspects of these products. The methodology consisted of a secondary literature review and mail survey. Biotechnology products are approved faster in the EC than the US. Both the EC and the US use advisory or expert committees in their respective approval procedures, although the EC does so more regularly. Market exclusivity provisions for biotechnology products range from 6 to 10 years in the EC compared with 7 years for "orphan" biotechnology products in the US. Regulatory affairs managers of the biotechnology industry were most concerned about application review time periods, communication with regulatory agencies, consistency in implementing regulations, and public policy changes. These concerns provide insight into the deficiencies that exist in regulatory processes and are valuable in identifying problems and implementing improvements.
We aim to assess whether respiratory symptoms are associated with lung function in young adults, and whether any such relation is similar in those with asthma, in men and women, and in different countries. Study participants (aged 20-44 years) were randomly selected from the general population in 35 centres in 15 countries as part of the European Community Respiratory Health Study. In all, 12,541 subjects (47%) completed a respiratory symptoms questionnaire and spirometry, metacholine challenge and immunoglobulin E tests. Indicators of diagnosed asthma showed the largest association with airways obstruction (FEV1--maximal 1-s forced expiratory volume/forced vital capacity--FVC < 70%), followed by symptoms of wheezing or shortness of breath, in both genders. Among the 96% of subjects whose FEV1/FVC ratios were greater or equal to 70%, wheezing or shortness of breath was associated with lower FEV1 levels (-211 ml in men and -169 ml in women (P < 0.01)), independent of diagnosed asthma, smoking, atopy or bronchial responsiveness. This association was not explained by a lower FVC. Symptoms of chronic bronchial mucus hypersecretion (chronic phlegm) were unrelated to both airways obstruction and FEV1 levels. Findings were homogeneous across all centres. These results suggest that lung diseases that cause wheezing are generally associated with impaired lung function.
BACKGROUND: Previous literature has indicated that environmental exposures in childhood influence development of atopic sensitization. OBJECTIVE: We sought to study the association between childhood environment and adult atopy. METHODS: Thirteen thousand nine hundred thirty-two subjects aged 20 to 44 years from 36 areas in Europe, New Zealand, the United States, and Australia took part in the European Community Respiratory Health Survey, answering interviewer-led questionnaires and providing blood tests for measurement of specific IgE to grass, house dust mite, cat, and Cladosporium allergens. RESULTS: Atopy was negatively associated with family size (OR = 0. 93; 95% CI = 0.90-0.96 per 1 sib), partly attributable to an independent protective effect of a greater number of brothers (OR = 0.92; 95% CI = 0.89-0.95 per 1 brother). Accounting for total number of siblings, no further influence was detected for number of older or younger siblings. Bedroom sharing was associated with a lower prevalence of atopy, particularly to cat allergen. A protective effect of family size and bedroom sharing could only be detected in subjects reporting no parental allergy (family size, test for interaction P =.012). The presence of a dog in the home in childhood was negatively associated with adult atopy (OR = 0.85, 95% CI = 0. 78-0.92), an effect that remained after adjustment for parental allergy, sibling allergy, and adult pet ownership. CONCLUSION: Subjects from large families with brothers, shared bedrooms, and dogs in childhood were less often atopic as adults. Our findings are consistent with the hypothesis that infectious agents could inhibit development of atopy during childhood. However, in subjects with a strong genetic predisposition, environmental factors in childhood are possibly of less importance.
Discussing cost-sharing in health care as a means to arrive at certain cost retrenchments is nowadays a popular topic in Switzerland. This also holds true for patient part-payment of medicines, through which the level of reimbursement of prescription medicines by sick-funds may be decreased. This paper reviews recent changes in the patient part-payment system for drugs in 6 countries of the European Community. It is investigated whether the rate of self-medication increases, when patient part-payment systems for drugs are intensified. Especially the English situation seems to prove the validity of this correlation. However, one should be cautious, because many other factors--such as whether a medicine has a prescription-only status or not--may also play a prominent role.