Through expanded access protocols, the Food and Drug Administration (FDA) allows patients with serious or immediately life-threatening diseases access to experimental drugs outside the clinical trial setting when no satisfactory alternative treatment is available. While the FDA has established a mechanism for providing patients with unapproved drug access, the regulations do not require the pharmaceutical company to provide the drug. The drug company’s permission to use its experimental drug is a necessary prerequisite to using the FDA’s expanded access mechanism. Increasingly, (...) drug companies are coming under scrutiny regarding the programs governing that decision-making power. Historically, disclosing whether a company has an expanded access program, and whether or how it would respond to an expanded access request, has been left to discretion of the drug companies themselves. Few manufacturers publish adequate expanded access protocols. As a result, patients were provided with little insight into how companies evaluate expanded access requests and are naturally skeptical as to the ethical integrity of the process. The recently passed 21st Century Cures Act changes that practice by requiring drug companies to have, and make publically available, their expanded access procedures including criteria for evaluating and responding to patient requests. In this article, we contend that complying with the new transparency provisions will require drug companies to respond to several unresolved expanded access issues. Namely, how to reconcile a patient’s desire to access lifesaving experimental therapies alongside the company and society’s interest in the efficient development of new drugs. Even more challenging, how can companies devise practices for evaluating and processing expanded access requests that also fairly and equitably acknowledge those concerns? In addressing these questions, this article explores the legal, regulatory, business, and societal influences that have shaped expanded access policies and practices. From there, we provide companies a framework that balances appropriately the desires of individuals and gaining the requisite approvals ensure access not just for one person but for society. (shrink)

The Pharmaceutical Benefits Scheme, operating in Australia under the National Health Act 1953, provides citizens equal access to subsidised pharmaceuticals. With ever-increasing costs of medicines and global financial pressure on all commodities, the sustainability of the PBS is of crucial importance on many social and political fronts. Direct-to-consumer advertising (DTCA) of prescription medicines is fast expanding, as pharmaceutical companies recognise and reinforce marketing potentials not only in healthcare professionals but also in consumers. DTCA is currently prohibited in Australia, but pharmaceutical (...) companies continuously lobby for the ban to be lifted. There is evidence that such marketing strategies influence consumer behaviour and concerns have been raised about whether DTCA could affect government expenditure on the PBS in Australia. This pharmacy-based study explored Australian consumer attitudes towards DTCA and whether consumer attitudes regarding DTCA differ based on socioeconomic status, measured in terms of income and education. Consumers from different socioeconomic areas in Sydney were asked to respond to a survey about an advertisement created specifically for the promotion of a mock prescription medicine. Their views about the intent, value and reliability of the advertisement were explored. The study found that consumers of lower socioeconomic status were more likely to perceive DTCA as a source of valuable and reliable medical information, and that they were more likely to request an advertised medication from their physician. If DTCA of prescription medicines was to be introduced in Australia, an increase in government expenditure on the PBS would be anticipated. Findings of this study also expose a deficit in respect for patients’ right to autonomy and informed consent which should be based on evidence-based, unbiased, information rather than advertisements. (shrink)

The earlier volume in this series dealt with two religions of Indian origin, namely, Buddhism and Jainism. The Indian religious scene, however, is characterized by not only religions which originated in India but also by religions which entered India from outside India and made their home here. Thus religious life in India has been enlivened throughout its history by the presence of religions of foreign origin on its soil almost from the very time they came into existence. This volume covers (...) three such religions—Zoraoastrianism, Judaism, and Islam. In the case of Zoraostianism, even its very beginnings are intertwined with India, as Zoroastrianism reformed a preexisting religion which had strong links to the Vedic heritage of India. This relationship took on a new dimension when a Zoroastrian community, fearing persecution in Persia after its Arab conquest, sought shelter in western India and ultimately went on to produce India’s pioneering nationalist in the figure of Dadabhai Naoroji ( 1825-1917), also known as the Grand Old Man of India. Jews found refuge in south India after the destruction of the Temple by the Romans in 70 C.E. and have remained a part of the Indian religious scene since then, some even returning to Israel after it was founded in 1948. Islam arrived in Kerala as soon as it was founded and one of the earliest mosques in the history of Islam is found in India. Islam differs from the previously mentioned religions inasmuch as it went on to gain political hegemony over parts of the country for considerable periods of time, which meant that its impact on the religious life of the subcontinent has been greater compared to the other religions. It has also meant that Islam has existed in a religiously plural environment in India for a longer period than elsewhere in the world so that not only has Islam left a mark on India, India has also left its mark on it. Indeed all the three religions covered in this volume share this dual feature, that they have profoundly influenced Indian religious life and have also in turn been profoundly influenced by their presence in India. (shrink)

The earlier volume in this series dealt with two religions of Indian origin, namely, Buddhism and Jainism. The Indian religious scene, however, is characterized by not only religions which originated in India but also by religions which entered India from outside India and made their home here. Thus religious life in India has been enlivened throughout its history by the presence of religions of foreign origin on its soil almost from the very time they came into existence. This volume covers (...) three such religions—Zoraoastrianism, Judaism, and Islam. In the case of Zoraostianism, even its very beginnings are intertwined with India, as Zoroastrianism reformed a preexisting religion which had strong links to the Vedic heritage of India. This relationship took on a new dimension when a Zoroastrian community, fearing persecution in Persia after its Arab conquest, sought shelter in western India and ultimately went on to produce India’s pioneering nationalist in the figure of Dadabhai Naoroji ( 1825-1917), also known as the Grand Old Man of India. Jews found refuge in south India after the destruction of the Temple by the Romans in 70 C.E. and have remained a part of the Indian religious scene since then, some even returning to Israel after it was founded in 1948. Islam arrived in Kerala as soon as it was founded and one of the earliest mosques in the history of Islam is found in India. Islam differs from the previously mentioned religions inasmuch as it went on to gain political hegemony over parts of the country for considerable periods of time, which meant that its impact on the religious life of the subcontinent has been greater compared to the other religions. It has also meant that Islam has existed in a religiously plural environment in India for a longer period than elsewhere in the world so that not only has Islam left a mark on India, India has also left its mark on it. Indeed all the three religions covered in this volume share this dual feature, that they have profoundly influenced Indian religious life and have also in turn been profoundly influenced by their presence in India. (shrink)

The Doris Duke Charitable Foundation's competitive career development award selects awardees annually. This paper describes changes DDCF made to its grants making process to improve gender representation in its applicant and awardee pools.

Does the level of marketing activity in a country contribute to societal well-being or quality of life? Does economic efficiency also play a positive role in societal well-being? Does economic efficiency also moderate or mediate the marketing activity effect on societal well-being? Marketing activity refers to the pervasiveness of promotion expenditures and number of retail outlets per capita in a country. Economic efficiency refers to the extent to which the economy is unhampered by corruption, burdensome government regulation, and a large (...) informal economy. We used secondary data from the World Bank and other statistical sources to answer these questions. Our study findings suggest that both marketing activity and economic efficiency contribute positively to societal well-being, and that economic efficiency plays more of a mediator than moderator role between marketing activity and societal well-being. The public policy implication of this study is that increases in marketing activity and economic efficiency in countries characterized as low on both dimensions should significantly increase the quality of life in those countries. (shrink)

In this paper we use the contemporary example of trans youth panics to introduce the notion of hermeneutical backlash, in which defenders of an established, unjust hermeneutical regime actively work to undermine and discredit hermeneutical liberation. We argue that the strategies and tropes of the trans youth panic illustrate a general propaganda vulnerability of epistemic liberation movements, and so are troubling for reasons that go beyond their application to trans youth. This exploration of a few specific cases of hermeneutical liberation (...) and hermeneutical backlash calls attention to the need for further theoretical work on the dynamics of struggles for hermeneutical justice. (shrink)

Recent studies show that racism still exists in the American medical profession, the fact of which legitimizes the historically long-legacy of mistrust towards medical profession and health authorities among African Americans. Thus, it was suspected that the participation of black patients in end-of-life care has always been significantly low stemmed primarily from their mistrust of the medical profession. On the other hand, much research finds that there are other reasons than the mistrust which makes African Americans feel reluctant to the (...) end-of-life care, such as cultural-religious difference and genuine misunderstanding of the services. If so, two crucial questions are raised. One is how pervasive or significant the mistrust is, compared to the other factors, when they opt out of the end-of-life care. The other is if there is a remedy or solution to the seemingly broken relationship. While no studies available answer these questions, we have conducted an experiment to explore them. The research was performed at two Philadelphia hospitals of Mercy Health System, and the result shows that Black patients’ mistrust is not too great to overcome and that education can remove the epistemic obstacles as well as overcome the mistrust. (shrink)

This article presents Minobe Tatsukichi’s emperor organ theory as a novel understanding of the temporality of founding. In contrast to a conventional framework of founding which legitimizes the constitution by postulating the pre-constitutional power of “the people,” emperor organ theory invents “the people” out of the Meiji Constitution as a democratically empowered subject to-come. In so doing, emperor organ theory calls upon the transformation of shin-min (臣民), the presumed subject of the emperor, into koku-min (国民), the people of this constitutional (...) state. However, emperor organ theory also highlights the contingency of founding moments: though koku-min emerged through the Diet as a conceptually new political actor in Japan’s nascent constitutional state, it never solidified its sovereign status as “the people.”. (shrink)

Brock Macdonald1, Evi Vakiani2, Rhonda K Yantiss3, Jun Lee4, Robert S Brown Jr5, Samuel H Sigal61Division of Gastroenterology, Department of Medicine, University of California-San Francisco, San Francisco, CA, 2Department of Pathology, Memorial Sloan–Kettering Cancer Center, New York, NY, 3Department of Pathology and Laboratory Medicine, New York Weill Cornell Medical College, New York, NY, 4Division of Nephrology, Department of Medicine, Weill Cornell Medical College, New York, NY, 5Division of Gastroenterology, Department of Medicine, Columbia University College of Physicians and Surgeons, New York, (...) NY, 6Division of Gastroenterology and Hepatology, Department of Medicine, New York University, New York, NY, USA: The use of sirolimus as an alternative to calcineurin inhibitors for posttransplant immunosuppression is associated with a variety of inflammatory conditions. In this report, we describe the case of a 34-year-old man who developed abnormal liver tests 6 years after live-donor kidney transplantation and 5 years after initiation of sirolimus-based immunosuppression. Elevated aminotransferase levels persisted after withdrawal of potentially hepatotoxic medications, and serologic evaluation for viral hepatitis, autoimmune disease, and genetic disorders was unrevealing. Liver biopsy revealed prominent hepatocellular injury associated with a mixed inflammatory infiltrate and liver tests normalized within 2 weeks of discontinuation of sirolimus. In this report, we review previous reports of sirolimus hepatotoxicity and propose a unifying hypothesis for the various inflammatory conditions that have been attributed to sirolimus.Keywords: sirolimus, immunosuppression, transplant, inflammatory conditions, hepatotoxicity. (shrink)

Co-authored by three prominent philosophers of art, Jazz and the Philosophy of Art is the first book in English to be exclusively devoted to philosophical issues in jazz. It covers such diverse topics as minstrelsy, bebop, Voodoo, social and tap dancing, parades, phonography, musical forgeries, and jazz singing, as well as Goodman's allographic/autographic distinction, Adorno's critique of popular music, and what improvisation is and is not. The book is organized into three parts. Drawing on innovative strategies adopted to address challenges (...) that arise for the project of defining art, Part I shows how historical definitions of art provide a blueprint for a historical definition of jazz. Part II extends the book's commitment to social-historical contextualism by exploring distinctive ways that jazz has shaped, and been shaped by, American culture. Chapters 4 and 5 use the lens of jazz vocals to provide perspective on racial issues previously unaddressed in the work, after which chapter 6 examines the broader premise that jazz was a socially progressive force in American popular culture. Part III concentrates on a topic that has entered into the arguments of each of the previous chapters: what is jazz improvisation? It outlines a pluralistic framework in which distinctive performance intentions distinguish distinctive kinds of jazz improvisation. This book is a comprehensive and valuable resource for any reader interested in the intersections between jazz and philosophy. (shrink)

In most general terms, my paper is about the mixture of agendas in the recording industry, where documentation, with its apparently educational implications, becomes difficult to distinguish from a range of distinct, even opposed, goals—which I group under the heading "fabrication." After a few historical remarks, I develop the concept of what I call works of phonography —that is, sound-constructs created by the use of recording machinery. I detail their ontological characteristics, as contrasted the features of ordinary musical works. WPs (...) are—I claim—replete. They are autographic. And they are phono-accessible—that is, accessible only through playbacks of authentic instances of their record artifacts, e.g., cassette tapes, CDs, etc. I then turn to Theodore Gracyk's recent study of rock music, arguing that his account is formally similar to my account of WPs. This raises the question of whether there be counter-examples to Gracyk's account—particularly of the sort that show his view to be too broad. I bring this to a focus finally by a comparison of rock recordings with jazz recordings—two classes that Gracyk tries to keep ontologically distinct. I argue that many classic jazz recordings are artifacts of the recording studio, no less than those Gracyk identifies as pure cases of rock music. In the same vein, I argue that, once recorded, the improvisational music of jazz is deformed—indeed, that it acquires features of WPs. This has the further implication that Gracyk cannot preserve his sharp distinction between rock and jazz records that he want's to maintain. (shrink)

What aspects of philosophical style really count? What aspects of philosophical writing count only as matters of style? Some features of philosophical writing and talking do seem to be of merely ornamental significance, worthy subjects only of gossip or banter. We are familiar with the academic sneer with which poor Professor Kluck is charged with having “somehow managed to confuse” one thing with another. A more serious stylistic matter, of course, would be Professor Kluck’s own willingness to use the apparatus (...) of modal logic in his pathetic endeavors. Or is that a matter of style? If so, does the same concept apply to such amusing and affective phenomena as accent and cadence? We have heard Professor Chisholm’s rising terminal voice inflection, if only because it is so widely imitated. One thinks of Professor Earle’s favorite condemnation “boring” pronounced with an “o” which seems to touch base on every vowel sound known to man. We are impressed by Goodman’s pithiness, and we register his penchant for alliterative triples. We compare Bergmann’s Laocöonian baroque prose with Quine’s soothing urbanity. It is an interesting fact that these are the features which come to mind when we begin to consider the whole question of philosophical style. Have we so internalized the parts that really count that they seem “white,” neutral, style-free? There might well be historical factors which encourage such blindness. Varying degrees of lingering transcendentalism about philosophical method would not be easily reconciled with the awful idea that one is merely speaking a local dialect. Of course the transcendentalism itself is rarely owned up to as such, as if it is assumed that it is Reason which speaks but that it is in poor taste to say so. Alternative methods, when confronted, generate distaste, horror, or the head-shaking sort of wonderment of the Eighteenth Century Parisian who wondered how on earth anyone could be a Persian. (shrink)

Collapse is a term that has attracted much attention in social science literature in recent years, but there remain substantial areas of disagreement about how it should be understood in historical contexts. More specifically, the use of the term collapse often merely serves to dramatize long-past events, to push human actors into the background, and to mystify the past intellectually. At the same time, since human societies are complex systems, the alternative involves grasping the challenges that a holistic analysis presents, (...) taking account of the many different levels and paces at which societies function, and developing appropriate methods that help to integrate science and history. Often neglected elements in considerations of collapse are the perceptions and beliefs of a historical society and how a given society deals with change; an important facet of this, almost entirely ignored in the discussion, is the understanding of time held by the individuals and social groups affected by change; and from this perspective ‘collapse’ depends very much on perception, including the perceptions of the modern commentator. With this in mind, this article challenges simplistic notions of ‘collapse’ in an effort to encourage a more nuanced understanding of the impact and process of both social and environmental change on past human societies. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Philosophy and Literature 26.1 (2002) 157-172 [Access article in PDF] Symposium: On Ken Burns's "Jazz" Jazz: America's Classical Music? 1 Lee B. Brown I VIEWERS OF KEN BURNS'S third cultural epic "Jazz" probably fell into one of three categories. 2 Some found it gripping. Some found it grating. Some found it both at once.The series has unforgettable moments: spectacular jitterbug sequences; Jimmy Lunceford's horn men fanning their trumpet bells (...) with hat mutes in sync; the close-up of the whirring cross-hand drumming of Art Blakey; the bitter-sweet glance Billie Holiday and Lester Young exchange in their last filmed appearance together; the occasional marriage of visuals to music. One riveting three minutes comes when the talking heads tune out, a 78-rpm disk of Louis Armstrong's "West End Blues" is set spinning, and the thrilling notes pour out on a carousel of visual imagery—finally freeze-framing on the face of the young genius himself.On the downside, the series is massively repetitious. As a result of Burns's decision to track two major figures—Louis Armstrong and Duke Ellington—from cradle to grave, the same cuts of Armstrong appear again and again, no matter what the time frame. Some of the series' commentators are particularly annoying—the fiddler of Burns's Civil War series, Matt Glaser, for instance, with his fatuous theories [End Page 157] about Louis Armstrong and Albert Einstein. And the documentary's heavy load of social freight—by Wynton Marsalis, and his mentors Albert Murray and Stanley Crouch 3 —threatens to flatten the music.The series is designed as informative entertainment, not Jazz 101. But Burns pays a price here, as he did in his documentary about baseball, in which not even the basics of the game, let alone any of the subtleties, were explained. In "Jazz" we get no explanation of what Jelly Roll Morton did to transform ragtime into jazz. (The series could easily have pressed Morton himself into service. With no sacrifice of his considerable charm, Morton did explain it, beautifully, in his recorded Library of Congress interviews. 4) Although the swing era gets big billing, no attempt is made to explain how swing rhythm actually works, as contrasted with earlier practices. (I have watched swing drummer Panama Francis entertain a packed hall with a brief but riveting illustration of how it works.)As jazz history, the film also has problems. Some legendary figures are resurrected unconvincingly. When Marsalis tells us what the legendary trumpet player Buddy Bolden sounded like, the illustrative off-camera trumpet is Marsalis's, not Bolden's, who embedded not one note in a record groove. Further, we face the tiresomely obvious problem of omissions. We hear nothing of Albert Ayler, Keith Jarrett, Sun Ra, Mildred Bailey, Benny Carter, Lennie Tristano, Erroll Garner, Eric Dolphy, Art Pepper, or Woody Herman. All we learn about Bill Evans—whose influence on jazz piano was huge—is that Miles Davis hired him even though he was white. Omissions are inevitable, of course. But there is a muted pattern to the exclusions. It was impossible for the series to avoid Benny Goodman, given his central role in the swing era. But white figures are too often either ignored or treated as alienated outsiders. We hear New York Times columnist Margo Jefferson opine that Bix Beiderbecke drank himself to death because he wasn't allowed to play with black musicians. In fact, many of the greatest players—white and black—never played with musicians of their own caliber.Most figures covered in the film are treated either with respect or with reverence. But things get nasty when matters turn to avant-gardists. Thus, Branford Marsalis—Wynton's talented brother—singles out the volcanic pianist Cecil Taylor for a particularly hostile attack. 5 Instead of explaining what Ornette Coleman meant by "free jazz," Albert Murray tells us that jazz is, by definition, free music—and by implication, that Coleman's concept must be fatuous. And Wynton has complained [End Page 158] elsewhere about a jazz avant-garde retreat into what he calls "a... (shrink)