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BIO Comments On White House Letter On Biosimilars
Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood issued the following statement regarding the letter sent yesterday from the Obama Administration to House Energy and Commerce Committee Chairman Henry Waxman regarding biosimilars:

Senate GOP Escalates Criticism Of Supreme Court Nominee Sotomayor In Speeches
Senate Republicans on Tuesday in the first in a series of floor addresses launched more strongly worded criticism of Supreme Court nominee Judge Sonia Sotomayor"s judicial record and previous speeches, Politico reports. Although the floor speeches are not likely to undermine the Democratic majority"s support for Sotomayor or block her confirmation, they indicate a shift in strategy for the GOP as it tries to generate more opposition to the nomination, according to Politico. As senators approach the weeklong July 4 recess, Republicans are attempting to show that they have "no intention of lying down in the face of what appears to be an increasingly inevitable confirmation," Politico reports. Senate Minority Leader Mitch McConnell (R-Ky.), Senate Judiciary Committee ranking Republican Jeff Sessions (Ala.) and Sen. John Cornyn (R-Texas) used their time on the Senate floor to attempt to portray Sotomayor as a "judicial activist" and to attack President Obama"s previous statements that he would like to appoint a judge who displays "empathy" (Isenstadt, Politico, 6/24). Republicans also reiterated they will attempt to delay Sotomayor"s confirmation hearing, scheduled to begin July 13, if they do not feel they have enough time to review her judicial record, Roll Call reports. They also questioned Sotomayor"s involvement with the civil rights group LatinoJustice PRLDEF, which they labeled "far left," taking up a line of criticism that other conservatives have pushed. Sotomayor served as a board member for the group from 1980 to 1992. Democrats and White House officials are aggressively defending Sotomayor"s record, arguing that her lengthy judicial career supersedes any public statements or speeches she made in the past, according to Roll Call. Both said that their strategy is to avoid a point-counterpoint argument with Republicans. A White House official said there is "no reason to speculate on her record," which includes more than 3,000 panel decisions. Senate Judiciary Committee Chair Patrick Leahy (D-Vt.) said that he has been "struck by her extraordinary career and how she"s excelled at everything she"s done." Leahy said that he is not convinced that Republicans need more time, noting that the Senate is using the same confirmation timetable as it used for Chief Justice John Roberts. Although Leahy said that he might be willing to discuss a schedule change if Republicans agreed not to filibuster or delay the nomination, he added that Republicans have not suggested such a deal at this point (Stanton, Roll Call, 6/24).
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Diagnostics

When Children Have Breathing Problems

Increasing numbers of children around the world are suffering from respiratory problems - coughing, wheezing and asthma attacks. Although the key external causes of these diseases were identified a long time ago (traffic and industrial air pollution), it had not previously been possible to distinguish clearly between these two factors so as to have a targeted impact on them. Researchers at the Helmholtz Centre for Environmental Research (UFZ) and the University of Leipzig carried out research in this area together with colleagues from the University of La Plata and can now confirm that air pollution caused by industry has even more grave effects than vehicle exhaust fumes. The recently completed study on "Combined effects of airborne pollutants as risk factors for environmental diseases" was conducted as part of a long-standing collaborative venture, supported by the international office of the German Federal Ministry of Education and Research, between the Helmholtz Centre for Environmental Research (UFZ), the University of Leipzig and the University of La Plata in Argentina. The results have been published in several internationally-respected journals, including the Journal of Allergy and Clinical Immunology and Toxicology. The UFZ researchers, who work in the Division of Health Research in Leipzig, concentrated on three courses of analysis: "Firstly," says Leipzig-based biologist Andrea MÃøller, "we used measurement techniques to draw accurate conclusions about the actual pollution of breathing air. We filtered out particulate matter of different grain sizes, polycyclic aromatic compounds, such as benzo(a)pyrene, that adhere to these particles, and volatile organic compounds, such as benzene and hexane. Secondly, we tested their toxic and mutagenic properties. We selected four comparative regions: a residential area in the immediate vicinity of Argentina"s largest oil refinery, an area with heavy traffic in the centre of La Plata, a suburban area and a rural area." The children whose health formed the basis of the third course of analysis were selected from the same four areas. Around 1200 girls and boys aged between six and twelve were involved in the research that lasted about two years. With a parent-completed questionnaire data about the children"s health symptoms were asked, such as coughs, wheezing, pneumonia and asthma attacks. Some of the children from each of the four regions were also invited to take a lung function test by the local paediatricians involved in the project. During the test the children were asked to blow into measuring devices - first hard and then slowly. This provided a measurement of the extent to which their bronchial tubes were constricted and therefore limited in function. When all these measurements were concluded in La Plata at the end of 2006, thousands of pieces of data had to be compiled and correlated. It is possible to draw some notable conclusions from the columns of numbers and tables. They show, for instance, that the different respiratory disease symptoms in the industrial areas included in the study affect between a quarter and a third of all children. In the suburbs and in the countryside only half as many children tend to be affected and even in the city centre only around one or two per cent more children are affected than in the relatively unpolluted areas. The lung function of children from the industrial area was also significantly impaired. The researchers had not been expecting to find such a marked contrast. Key culprits also appear to have been filtered out of the mass of pollutants. "Using novel statistical techniques, we identified the fingerprint of the industrial pollution in all sampled areas," says Leipzig-based meteorologist Dr. Uwe Schlink, explaining the analysis. "The level of the pollution, however, depends on the distance, season and weather situation. With an annual average of 20 micrograms of benzene per cubic metre air measured in the industrial areas of La Plata, but only 2.9 at traffic junctions in the city and 1.9 in rural areas, the health risk of industrial emissions is clear." However, the research was about more than drawing scientific conclusions about which pollutants are the main cause of health problems. The researchers in Leipzig and their Argentinean colleagues in particular, were and still are working to raise public awareness of their research findings. They do this through parents" meetings at schools associated with the project and through lectures at the University of La Plata, through international publications and by lobbying government authorities and businesses. "At least we have helped change things for children in La Plata already," Andrea MÃøller is pleased to report: Because the chemical companies felt under pressure, they are now modernising their plants. "What would be interesting now would be to see how quickly the air pollution diminishes and to what extent children"s health improves as a result. Whether the total mass of particulates or the number of particles per cubic centimetre is more important in terms of health problems and how we can influence climate impacts are also very topical questions," says physicist Dr Ulrich Franck. "In any case, we will continue to research these topics also in other cities around the world." Publications: Fernando A. Wichmann, Andrea MÃøller, Luciano E. Busi, Natalia Cianni, Laura Massolo, Uwe Schlink, Andres Porta, Peter David Sly (2009): Increased asthma and respiratory symptoms in children exposed to petrochemical pollution. J ALLERGY CLIN IMMUNOL, Vol. 123, Number 3 doi:10.1016/j.jaci.2008.09.052 http://www.jacionline.org/article/S0091-6749(08)01879-4/abstract Wichmann G, Franck U, Herbarth O, Rehwagen M, Dietz A, Massolo L, Ronco A, MÃøller A. (2009): Different immunomodulatory effects associated with sub-micrometer particles in ambient air from rural, urban and industrial areas. Toxicology.257(3):127-36. http://dx.doi.org/10.1016/j.tox.2008.12.024 Massolo L; Rehwagen M, Porta A, Ronco A, Herbarth O, Mueller A. Indoor-outdoor distribution and risk assessment of volatile organic compounds in the atmosphere of industrial and urban areas. Environmental Toxicology 2009 http://dx.doi.org/10.1002/tox.20504 Cianni, N., MÃøller, A., Lespadel, P., Aguilar, M., Martin, M., Chiapperini, V., Bussi, L., Massolo, L., Wichmann, F., Porta, A. (2009): Calidad del Aire y Salud infatil en areas urbanas e industriales. ContaminaciÃön atmosférica en Argentina. Buenos Aires (in press) Massolo, L., MÃøller, A., Herbarth, O., Ronco, A. E., Porta, A. (2009): ContaminaciÃön atmosférica y salud infantil en áreas urbanas e industriales de La Plata, Argentina. Acta Bioquímica Clínica Latinoamericana (in press) MÃøller, A., Wichmann, G., Massolo, L., Porta, A., Schlink, U., Ronco, A., Herbarth, O. (2009): Risk assessment of airborne particles and volatile organic compounds from industrial areas. Industrial pollution including oil spills (in press) Schlink, U., Rehwagen, M., Massolo, L., Herbarth, O., MÃøller, A., Ronco, A. (2005): Apportionment and Identification of VOC Fingerprints in the Region of La Plata, Argentina. In: Urban Air Quality, RJ Sokhi, MM Millan, N Moussiopoulos (eds.), Publisher: University of Hertfordshire, ISBN I-898543-92-5 (CD). Tilo Arnhold Helmholtz Association of German Research Centres


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