scholarly journals Islets Transplantation at a Crossroads - Need for Urgent Regulatory Update in the United States: Perspective Presented During the Scientific Sessions 2021 at the American Diabetes Association Congress

2022 ◽  
Vol 12 ◽  
Author(s):  
Piotr Witkowski ◽  
Louis H. Philipson ◽  
John B. Buse ◽  
R. Paul Robertson ◽  
Rodolfo Alejandro ◽  
...  

Clinical islet allotransplantation has been successfully regulated as tissue/organ for transplantation in number of countries and is recognized as a safe and efficacious therapy for selected patients with type 1 diabetes mellitus. However, in the United States, the FDA considers pancreatic islets as a biologic drug, and islet transplantation has not yet shifted from the experimental to the clinical arena for last 20 years. In order to transplant islets, the FDA requires a valid Biological License Application (BLA) in place. The BLA process is costly and lengthy. However, despite the application of drug manufacturing technology and regulations, the final islet product sterility and potency cannot be confirmed, even when islets meet all the predetermined release criteria. Therefore, further regulation of islets as drugs is obsolete and will continue to hinder clinical application of islet transplantation in the US. The Organ Procurement and Transplantation Network together with the United Network for Organ Sharing have developed separately from the FDA and BLA regulatory framework for human organs under the Human Resources & Services Administration to assure safety and efficacy of transplantation. Based on similar biologic characteristics of islets and human organs, we propose inclusion of islets into the existing regulatory framework for organs for transplantation, along with continued FDA oversight for islet processing, as it is for other cell/tissue products exempt from BLA. This approach would reassure islet quality, efficacy and access for Americans with diabetes to this effective procedure.

2020 ◽  
Vol 174 ◽  
pp. 02012
Author(s):  
Irina Verchagina ◽  
Irina Kolechkina ◽  
Elena Shustova

The article presents the results of a study of the regulatory framework and the experience of regulating the issues of reclamation of the developed space of the leading coal mining countries - the United States and China. The laws of China on mineral resources and environmental protection, the US practice of creating a system for restoring disturbed space as a result of mining, are examined


2018 ◽  
Vol 28 (1) ◽  
pp. 12-18 ◽  
Author(s):  
Laura A. Siminoff ◽  
Heather M. Gardiner ◽  
Maureen Wilson-Genderson ◽  
Teresa J. Shafer

Background: There is a discrepancy between the reported increase in donor conversion rates and the number of organs available for transplant. Methods: Secondary analysis of data obtained from the Scientific Registry of Transplant Recipients from January 2003 through December 2015 was performed. The primary outcomes were the (1) number of brain-dead donors from whom solid organs were recovered and (2) number of the organs transplanted. Descriptive statistics and growth plots were used to examine the trajectory of organ donation, recovery, and transplantation outcomes over the 11-year period. Results: From 2003 to 2006, the number of brain-dead donors increased from 6187 to 7375, remaining relatively stable at approximately 7200 thereafter. The average eligible deaths per organ procurement organization dropped from 182.7 (standard deviation [SD]: 131.3) in 2003 to 149.3 (SD: 111.4) in 2015. This suggests a total of 12 493 unrealized potential donors (2006-2015). Conclusions: Since 2006, a steady decline in the number of donor-eligible deaths was reported. In 2003, the reported eligible deaths was 11 326. This number peaked in 2004 at 11 346, tumbling to 9781 eligible donors in 2015, despite a 9% increase in the US population. From 2006 to 2015, the data indicate an artificial depression and underestimation of the true potential of brain-dead donors in the United States of conservatively 12 493 donors or 39 728 missing organs. New metrics providing objective but verifiable counts of the donor pool are needed.


Author(s):  
Steven Hurst

The United States, Iran and the Bomb provides the first comprehensive analysis of the US-Iranian nuclear relationship from its origins through to the signing of the Joint Comprehensive Plan of Action (JCPOA) in 2015. Starting with the Nixon administration in the 1970s, it analyses the policies of successive US administrations toward the Iranian nuclear programme. Emphasizing the centrality of domestic politics to decision-making on both sides, it offers both an explanation of the evolution of the relationship and a critique of successive US administrations' efforts to halt the Iranian nuclear programme, with neither coercive measures nor inducements effectively applied. The book further argues that factional politics inside Iran played a crucial role in Iranian nuclear decision-making and that American policy tended to reinforce the position of Iranian hardliners and undermine that of those who were prepared to compromise on the nuclear issue. In the final chapter it demonstrates how President Obama's alterations to American strategy, accompanied by shifts in Iranian domestic politics, finally brought about the signing of the JCPOA in 2015.


2014 ◽  
Vol 23 (3) ◽  
pp. 381-388 ◽  
Author(s):  
Euan Hague ◽  
Alan Mackie

The United States media have given rather little attention to the question of the Scottish referendum despite important economic, political and military links between the US and the UK/Scotland. For some in the US a ‘no’ vote would be greeted with relief given these ties: for others, a ‘yes’ vote would be acclaimed as an underdog escaping England's imperium, a narrative clearly echoing America's own founding story. This article explores commentary in the US press and media as well as reporting evidence from on-going interviews with the Scottish diaspora in the US. It concludes that there is as complex a picture of the 2014 referendum in the United States as there is in Scotland.


2018 ◽  
Vol 47 (3) ◽  
pp. 130-134

This section, updated regularly on the blog Palestine Square, covers popular conversations related to the Palestinians and the Arab-Israeli conflict during the quarter 16 November 2017 to 15 February 2018: #JerusalemIstheCapitalofPalestine went viral after U.S. president Donald Trump recognized Jerusalem as the capital of Israel and announced his intention to move the U.S. embassy there from Tel Aviv. The arrest of Palestinian teenager Ahed Tamimi for slapping an Israeli soldier also prompted a viral campaign under the hashtag #FreeAhed. A smaller campaign protested the exclusion of Palestinian human rights from the agenda of the annual Creating Change conference organized by the US-based National LGBTQ Task Force in Washington. And, UNRWA publicized its emergency funding appeal, following the decision of the United States to slash funding to the organization, with the hashtag #DignityIsPriceless.


2019 ◽  
Vol 35 (2) ◽  
pp. 143-170
Author(s):  
Gerardo Gurza-Lavalle

This work analyses the diplomatic conflicts that slavery and the problem of runaway slaves provoked in relations between Mexico and the United States from 1821 to 1857. Slavery became a source of conflict after the colonization of Texas. Later, after the US-Mexico War, slaves ran away into Mexican territory, and therefore slaveholders and politicians in Texas wanted a treaty of extradition that included a stipulation for the return of fugitives. This article contests recent historiography that considers the South (as a region) and southern politicians as strongly influential in the design of foreign policy, putting into question the actual power not only of the South but also of the United States as a whole. The problem of slavery divided the United States and rendered the pursuit of a proslavery foreign policy increasingly difficult. In addition, the South never acted as a unified bloc; there were considerable differences between the upper South and the lower South. These differences are noticeable in the fact that southerners in Congress never sought with enough energy a treaty of extradition with Mexico. The article also argues that Mexico found the necessary leeway to defend its own interests, even with the stark differential of wealth and resources existing between the two countries. El presente trabajo analiza los conflictos diplomáticos entre México y Estados Unidos que fueron provocados por la esclavitud y el problema de los esclavos fugitivos entre 1821 y 1857. La esclavitud se convirtió en fuente de conflicto tras la colonización de Texas. Más tarde, después de la guerra Mexico-Estados Unidos, algunos esclavos se fugaron al territorio mexicano y por lo tanto dueños y políticos solicitaron un tratado de extradición que incluyera una estipulación para el retorno de los fugitivos. Este artículo disputa la idea de la historiografía reciente que considera al Sur (en cuanto región), así como a los políticos sureños, como grandes influencias en el diseño de la política exterior, y pone en tela de juicio el verdadero poder no sólo del Sur sino de Estados Unidos en su conjunto. El problema de la esclavitud dividió a Estados Unidos y dificultó cada vez más el impulso de una política exterior que favoreciera la esclavitud. Además, el Sur jamás operó como unidad: había diferencias marcadas entre el Alto Sur y el Bajo Sur. Estas diferencias se observan en el hecho de que los sureños en el Congreso jamás se esforzaron en buscar con suficiente energía un tratado de extradición con México. El artículo también sostiene que México halló el margen de maniobra necesario para defender sus propios intereses, pese a los fuertes contrastes de riqueza y recursos entre los dos países.


Author(s):  
Ana Elizabeth Rosas

In the 1940s, curbing undocumented Mexican immigrant entry into the United States became a US government priority because of an alleged immigration surge, which was blamed for the unemployment of an estimated 252,000 US domestic agricultural laborers. Publicly committed to asserting its control of undocumented Mexican immigrant entry, the US government used Operation Wetback, a binational INS border-enforcement operation, to strike a delicate balance between satisfying US growers’ unending demands for surplus Mexican immigrant labor and responding to the jobs lost by US domestic agricultural laborers. Yet Operation Wetback would also unintentionally and unexpectedly fuel a distinctly transnational pathway to legalization, marriage, and extended family formation for some Mexican immigrants.On July 12, 1951, US president Harry S. Truman’s signing of Public Law 78 initiated such a pathway for an estimated 125,000 undocumented Mexican immigrant laborers throughout the United States. This law was an extension the Bracero Program, a labor agreement between the Mexican and US governments that authorized the temporary contracting of braceros (male Mexican contract laborers) for labor in agricultural production and railroad maintenance. It was formative to undocumented Mexican immigrant laborers’ transnational pursuit of decisively personal goals in both Mexico and the United States.Section 501 of this law, which allowed employers to sponsor certain undocumented laborers, became a transnational pathway toward formalizing extended family relationships between braceros and Mexican American women. This article seeks to begin a discussion on how Operation Wetback unwittingly inspired a distinctly transnational approach to personal extended family relationships in Mexico and the United States among individuals of Mexican descent and varying legal statuses, a social matrix that remains relatively unexplored.


2019 ◽  
Author(s):  
Gremil Alessandro Naz

<p>This paper examines the changes in Filipino immigrants’ perceptions about themselves and of Americans before and after coming to the United States. Filipinos have a general perception of themselves as an ethnic group. They also have perceptions about Americans whose media products regularly reach the Philippines. Eleven Filipinos who have permanently migrated to the US were interviewed about their perceptions of Filipinos and Americans. Before coming to the US, they saw themselves as hardworking, family-oriented, poor, shy, corrupt, proud, adaptable, fatalistic, humble, adventurous, persevering, gossipmonger, and happy. They described Americans as rich, arrogant, educated, workaholic, proud, powerful, spoiled, helpful, boastful, materialistic, individualistic, talented, domineering, friendly, accommodating, helpful, clean, and kind. Most of the respondents changed their perceptions of Filipinos and of Americans after coming to the US. They now view Filipinos as having acquired American values or “Americanized.” On the other hand, they stopped perceiving Americans as a homogenous group possessing the same values after they got into direct contact with them. The findings validate social perception and appraisal theory, and symbolic interaction theory.</p>


2009 ◽  
Vol 1 (1) ◽  
pp. 93-116 ◽  
Author(s):  
Mauricio Tenorio-Trillo

By identifying two general issues in recent history textbook controversies worldwide (oblivion and inclusion), this article examines understandings of the United States in Mexico's history textbooks (especially those of 1992) as a means to test the limits of historical imagining between U. S. and Mexican historiographies. Drawing lessons from recent European and Indian historiographical debates, the article argues that many of the historical clashes between the nationalist historiographies of Mexico and the United States could be taught as series of unsolved enigmas, ironies, and contradictions in the midst of a central enigma: the persistence of two nationalist historiographies incapable of contemplating their common ground. The article maintains that lo mexicano has been a constant part of the past and present of the US, and lo gringo an intrinsic component of Mexico's history. The di erences in their historical tracks have been made into monumental ontological oppositions, which are in fact two tracks—often overlapping—of the same and shared con ictual and complex experience.


Author(s):  
Halyna Shchyhelska

2018 marks the 100th anniversary of the proclamation of Ukrainian independence. OnJanuary 22, 1918, the Ukrainian People’s Republic proclaimed its independence by adopting the IV Universal of the Ukrainian Central Rada, although this significant event was «wiped out» from the public consciousness on the territory of Ukraine during the years of the Soviet totalitarian regime. At the same time, January 22 was a crucial event for the Ukrainian diaspora in the USA. This article examines how American Ukrainians interacted with the USA Government institutions regarding the celebration and recognition of the Ukrainian Independence day on January 22. The attention is focused on the activities of ethnic Ukrainians in the United States, directed at the organization of the special celebration of the Ukrainian Independence anniversaries in the US Congress and cities. Drawing from the diaspora press and Congressional Records, this article argues that many members of Congress participated in the observed celebration and expressed kind feelings to the Ukrainian people, recognised their fight for freedom, during the House of Representatives and Senate sessions. Several Congressmen submitted the resolutions in the US Congress urging the President of United States to designate January 22 as «Ukrainian lndependence Day». January 22 was proclaimed Ukrainian Day by the governors of fifteen States and mayors of many cities. Keywords: January 22, Ukrainian independence day, Ukrainian diaspora, USA, interaction, Congress


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