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Annette Merholm

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Annette Merholm

Na 50 Nachlass Arthur Schopenhauer - 'Schopenhauer-Archiv', 800 - Ausführliche Schilderung von Kriegshandlungen französischer Soldaten in Danzig

abgedruckt in: Schopenhauer-Jahrbuch 61 (1980), S. 139

Na 50 Nachlass Arthur Schopenhauer - 'Schopenhauer-Archiv', 799 - Bitte um Nachricht aus Hamburg

abgedruckt in: Schopenhauer-Jahrbuch 61 (1980), S. 138-139

Ms.Ff.F.Stoltze 3. 413 - Brief von Friedrich Stoltze an Adolf Stoltze

Familienstreitigkeiten, Annette Stoltze, Ihr Sohn Fritz

Effects of congressional modernization laws on public access to innovative medical device technologies

The Federal Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid (CMS) play key roles in making Class III, medical devices available to the public, and they are required by law to meet statutory deadlines for applications under review. Historically, both agencies have failed to meet their respective statutory requirements. Since these failures affect patient access and may adversely impact public health, Congress has enacted several “modernization” laws. However, the effectiveness of these modernization laws has not been adequately studied or established for Class III medical devices. ^ The aim of this research study was, therefore, to analyze how these modernization laws may have affected public access to medical devices. Two questions were addressed: (1) How have the FDA modernization laws affected the time to approval for medical device premarket approval applications (PMAs)? (2) How has the CMS modernization law affected the time to approval for national coverage decisions (NCDs)? The data for this research study were collected from publicly available databases for the period January 1, 1995, through December 31, 2008. These dates were selected to ensure that a sufficient period of time was captured to measure pre- and post-modernization effects on time to approval. All records containing original PMAs were obtained from the FDA database, and all records containing NCDs were obtained from the CMS database. Source documents, including FDA premarket approval letters and CMS national coverage decision memoranda, were reviewed to obtain additional data not found in the search results. Analyses were conducted to determine the effects of the pre- and post-modernization laws on time to approval. Secondary analyses of FDA subcategories were conducted to uncover any causal factors that might explain differences in time to approval and to compare with the primary trends. The primary analysis showed that the FDA modernization laws of 1997 and 2002 initially reduced PMA time to approval; after the 2002 modernization law, the time to approval began increasing and continued to increase through December 2008. The non-combined, subcategory approval trends were similar to the primary analysis trends. The combined, subcategory analysis showed no clear trends with the exception of non-implantable devices, for which time to approval trended down after 1997. The CMS modernization law of 2003 reduced NCD time to approval, a trend that continued through December 2008. This study also showed that approximately 86% of PMA devices do not receive NCDs. ^ As a result of this research study, recommendations are offered to help resolve statutory non-compliance and access issues, as follows: (1) Authorities should examine underlying causal factors for the observed trends; (2) Process improvements should be made to better coordinate FDA and CMS activities to include sharing data, reducing duplication, and establishing clear criteria for “safe and effective” and “reasonable and necessary”; (3) A common identifier should be established to allow tracking and trending of applications between FDA and CMS databases; (4) Statutory requirements may need to be revised; and (5) An investigation should be undertaken to determine why NCDs are not issued for the majority of PMAs. Any process improvements should be made without creating additional safety risks and adversely impacting public health. Finally, additional studies are needed to fully characterize and better understand the trends identified in this research study.^

Information sources influencing urban Mexican-American women's cancer screening participation

Breast and cervical cancer, though less common in Mexican-American than in Anglo women, are more likely to go undetected in Mexican-American women, leaving them more vulnerable to advanced disease and death. Although highly effective screening tests--the Pap smear and the mammogram--can detect these cancers early, many Mexican-American women do not regularly undergo these preventive screening tests.^ To explore the differential influence of encouraging sources of health information, this investigation examined the relationship between encouragement from a "peer"--husband or partner, child or children, other family members, or close friends--and a "health professional"--a doctor, a nurse, or another health professional--on Mexican-American women's cancer screening intentions and behaviors. Furthermore, this research explored whether the sources' influence on cancer screening intentions and behaviors differed depending on level of acculturation.^ One thousand seven hundred eleven surveys of Mexican-American women were analyzed to identify the source that most effectively encourages these women to participate in cancer screening. The data provided evidence that health professionals strongly influenced this population's cancer screening intentions and behaviors. Evidence for peer influence was also found; however, it was usually weaker, and, in some cases, negligible. Peer encouragement was related to Pap test behaviors and mammogram intentions, but not to Pap test intentions or mammogram behaviors. Consistently, women reported greater intentions and screening behaviors when encouraged from a health professional than from a peer. Acculturation was not found to be a modifying variable related to the relationship between sources of information and Pap test or mammogram intentions and behaviors.^ Because health professionals were identified as strongly influencing both intentions and behaviors for Pap tests and mammograms, further efforts should be undertaken to urge them to encourage their clients to obtain cancer screening. Failure to provide this encouragement leads to missed opportunities. Enlisting support from peers also may help to increase cancer screening participation in urban Mexican-American women; however, the consistently greater intentions and behaviors related to a health professional's encouragement indicated the greater power of the latter. ^

Corg, CaCO3, bulk densities, accumulation rates and ages of ODP Leg 167 sites and three piston cores, California margin

Sediments from five Leg 167 drill sites and three piston cores were analyzed for Corg and CaCO3. Oxygen isotope stratigraphy on benthic foraminifers was used to assign age models to these sedimentary records. We find that the northern and central California margin is characterized by k.y.-scale events that can be found in both the CaCO3 and Corg time series. We show that the CaCO3 events are caused by changes in CaCO3 production by plankton, not by dissolution. We also show that these CaCO3 events occur in marine isotope Stages (MIS) 2, 3, and 4 during Dansgaard/Oeschger interstadials. They occur most strongly, however, on the MIS 5/4 glaciation and MIS 2/1 deglaciation. We believe that the link between the northeastern Pacific Ocean and North Atlantic is primarily transmitted by the atmosphere, not the ocean. Highest CaCO3 production and burial occurs when the surface ocean is somewhat cooler than the modern ocean, and the surface mixed layer is somewhat more stable.