BackgroundThe U.S. Food and Drug Administration traditionally has kept confidential significant amounts of information relevant to the approval or non-approval of specific drugs, devices, and biologics and about the regulatory status of such medical products in FDA’s pipeline.ObjectiveTo develop practical recommendations for FDA to improve its transparency to the public that FDA could implement by rulemaking or other regulatory processes without further congressional authorization. These recommendations would build on the work of FDA’s Transparency Task Force in 2010.MethodsIn 2016-2017, we convened (...) a team of academic faculty from Harvard Medical School, Brigham and Women’s Hospital, Yale Medical School, Yale Law School, and Johns Hopkins Bloomberg School of Public Health to develop recommendations through an iterative process of reviewing FDA’s practices, considering the legal and policy constraints on FDA in expanding transparency, and obtaining insights from independent observers of FDA.ResultsThe team developed 18 specific recommendations for improving FDA’s transparency to the public. FDA could adopt all these recommendations without further congressional action.FundingThe development of the Blueprint for Transparency at the U.S. Food and Drug Administration was funded by the Laura and John Arnold Foundation. (shrink)

First Philosophy and the Kinds of Substance JOSEPH G. DEFILIPPO ON A CERTAIN INTERPRETATION Aristotle's Metaphysics contains two incompati- ble conceptions of metaphysics or, as he calls it, first philosophy. At two points in the treatise he identifies first philosophy with theology . Along with this identification comes a certain view about the nature and number of theoretical sciences. We are told in E. 1 that there are three: natural philosophy, mathematics, and theology. Natural philosophy deals with nonseparate,' mutable (...) substance, whereas the objects of mathematics are nonseparate but immutable. It is left to theology to study substance that is both separate and immutable . Hence it is prior to the other two theoretical sciences and more worthy of honor. But for Aristotle first philosophy is not merely a compartmentalized science concerned with a single genus or kind of substance; he means it to be a universal science of "being qua being." Indeed, it is the status of first philosophy as the primary theoretical science that is supposed to provide for its universal scope. As he says in E. 1, it is universal "in this way, because it is first" 0o26a3o-31). Large and well- known difficulties loom in the way of this tantalizing idea. First, it is not clear how theology's position of primacy is the cause of its universal scope; if anything, divine substance seems to be a special item within a more.. (shrink)

This study examined the effect of various antecedent variables on marketers’ perceptions of the role of ethics and socialresponsibility in the overall success of the firm. Variables examined included Hofstede’s cultural dimensions (i.e., power distance, uncertainty avoidance, individualism, masculinity, and Confucian dynamism), as well as corporate ethical values and enforcement ofan ethics code. Additionally, individual variables such as ethical idealism and relativism were included. Results indicated that most ofthese variables impacted marketers’ perceptions of the importance of ethics and social responsibility, (...) although to varying degrees. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:The "Thinking of Thinking" in MetaphysicsA.9 JOSEPH G. DE FILIPPO a+~6v &Qa voE[, e~eQ ~o~t ~6 XQ&~O~OV, xetl. I~o~tv ~1VdOloLgvo1]o~t0g v6"qotg. (A.9, 1o74b33-34) Therefore it thinks itself, if indeed it is most powerful, and its thinking is the thinking of thinking. Thus culminates Aristotle's treatment of God's activity in the twelfth book of the Metaphysics. The conclusion seems transparent. God is an intellect (vo~Sg); since he is also (...) the best thing, and it is absurd that he should think anything worse than himself, he therefore thinks himself. And since he is nothing other than a thinking (v6"qotg), what he thinks of is thinking (vo~loEe0g). "Thinking of thinking," however, is a notion that is as ambiguous in ancient Greek as it is in English. It is just not clear what sort of thing such a reflexively self-thinking mind would be, though it might seem natural to construe the activity of Aristotle's God as somehow an act of pure self-awareness, self-consciousness or self-knowledge. On such an understanding God would be a separately existing consciousness, with himself or his activity as the only object of that consciousness. In 196 9 R. Norman published a paper which disputed this sort of interpretation.' He argued that when one considers Aristotle's theory of, R. Norman, "Aristotle's Philosopher-God," Phronesis 14 (1969): 63-74 (reprinted in Articles on Aristotle, vol. 4, ed. J. Barnes, M. Schofield and R. Sorabji [London, 1979], 93-1o2). While I a-m indebted to Norman's basic approach, my treatment of God's self-thought differs substantially from his in two respects. First, although it isessential to recognize that in Aristotle human thought too thinks itself, this does not justify the conclusion that God's thinking is "of the same kind as our own normal abstract thought" (73). As 1shall argue below in section 4, the characterization of the Prime Mover as v6"qoLgvo~o~t0g is meant specifically to differentiate its activity from the selfthinking of human volSg;human thought could never be characterized as v6"qotgvofioEt0g.Secondly, Norman does not isolate the real source of A.9's argument, which, as l shall argue, is the potential conflict between Aristotle's own physical and psychological theories. M. Wedin, Mind and Imagination in Aristotle (New Haven, 1988), 229-45, also argues against Norman's thesis that human and divine thought are the same in kind. [543] 544 JOURNAL OF THE HISTORY OF PHILOSOPHY 33:4 OCTOBER 1995 volSg from De Anima III.4-8, it is clear that the conception of God as a selfthinking mind does not entail that he engages in self-contemplation in the normal sense of the term. On Norman's interpretation, God thinks himself because he thinks a definite content with which he is numerically identical, according to the well-known Aristotelian doctrine of the unity of vo~g with its object of thought (vo~lx6v). To describe this act simply as self-contemplation belies the fact that its object must have an intelligible content, which in the case of God is not adequately described as his "self," for this self would indeed be nothing more than an act of self-contemplation. While many commentators have followed Norman in recognizing that the description of God as "thinking himself" is drawn from the De Anima's characterization of self-thinking, there has persisted a tendency to interpret Aristotle 's God as engaged in an act of pure self-awareness or under some similar description.' The reason for this persistence is due, I believe, to a crucial difference between chapters 7 and 9 of book A. Whereas both chapters characterize the Prime Mover (PM) as a self-thinker, in chapter 9 he is also said to be ~1 v61]otg vo~loec0g V6tlOtg (the thinking of thinking), which understandably appears to be a much more specific delineation of his thought content. A. 7 tells us that the PM is a vofJg that thinks itself (to72b18-3o); according to De Anima III. 4 that simply is what voa)g does at the highest level of actuality, since it... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:The "Thinking of Thinking" in MetaphysicsA.9 JOSEPH G. DE FILIPPO a+~6v &Qa voE[, e~eQ ~o~t ~6 XQ&~O~OV, xetl. I~o~tv ~1VdOloLgvo1]o~t0g v6"qotg. (A.9, 1o74b33-34) Therefore it thinks itself, if indeed it is most powerful, and its thinking is the thinking of thinking. Thus culminates Aristotle's treatment of God's activity in the twelfth book of the Metaphysics. The conclusion seems transparent. God is an intellect (vo~Sg); since he is also (...) the best thing, and it is absurd that he should think anything worse than himself, he therefore thinks himself. And since he is nothing other than a thinking (v6"qotg), what he thinks of is thinking (vo~loEe0g). "Thinking of thinking," however, is a notion that is as ambiguous in ancient Greek as it is in English. It is just not clear what sort of thing such a reflexively self-thinking mind would be, though it might seem natural to construe the activity of Aristotle's God as somehow an act of pure self-awareness, self-consciousness or self-knowledge. On such an understanding God would be a separately existing consciousness, with himself or his activity as the only object of that consciousness. In 196 9 R. Norman published a paper which disputed this sort of interpretation.' He argued that when one considers Aristotle's theory of, R. Norman, "Aristotle's Philosopher-God," Phronesis 14 (1969): 63-74 (reprinted in Articles on Aristotle, vol. 4, ed. J. Barnes, M. Schofield and R. Sorabji [London, 1979], 93-1o2). While I a-m indebted to Norman's basic approach, my treatment of God's self-thought differs substantially from his in two respects. First, although it isessential to recognize that in Aristotle human thought too thinks itself, this does not justify the conclusion that God's thinking is "of the same kind as our own normal abstract thought" (73). As 1shall argue below in section 4, the characterization of the Prime Mover as v6"qoLgvo~o~t0g is meant specifically to differentiate its activity from the selfthinking of human volSg;human thought could never be characterized as v6"qotgvofioEt0g.Secondly, Norman does not isolate the real source of A.9's argument, which, as l shall argue, is the potential conflict between Aristotle's own physical and psychological theories. M. Wedin, Mind and Imagination in Aristotle (New Haven, 1988), 229-45, also argues against Norman's thesis that human and divine thought are the same in kind. [543] 544 JOURNAL OF THE HISTORY OF PHILOSOPHY 33:4 OCTOBER 1995 volSg from De Anima III.4-8, it is clear that the conception of God as a selfthinking mind does not entail that he engages in self-contemplation in the normal sense of the term. On Norman's interpretation, God thinks himself because he thinks a definite content with which he is numerically identical, according to the well-known Aristotelian doctrine of the unity of vo~g with its object of thought (vo~lx6v). To describe this act simply as self-contemplation belies the fact that its object must have an intelligible content, which in the case of God is not adequately described as his "self," for this self would indeed be nothing more than an act of self-contemplation. While many commentators have followed Norman in recognizing that the description of God as "thinking himself" is drawn from the De Anima's characterization of self-thinking, there has persisted a tendency to interpret Aristotle 's God as engaged in an act of pure self-awareness or under some similar description.' The reason for this persistence is due, I believe, to a crucial difference between chapters 7 and 9 of book A. Whereas both chapters characterize the Prime Mover (PM) as a self-thinker, in chapter 9 he is also said to be ~1 v61]otg vo~loec0g V6tlOtg (the thinking of thinking), which understandably appears to be a much more specific delineation of his thought content. A. 7 tells us that the PM is a vofJg that thinks itself (to72b18-3o); according to De Anima III. 4 that simply is what voa)g does at the highest level of actuality, since it... (shrink)

The authors reject arguments by Professor Joseph Fletcher (author of Situation Ethics) that in some circumstances parents may be held responsible for producing genetically defective offspring, but offer arguments of their own for the same conclusion. Their arguments could, they suggest, justify `wrongful life' claims by the genetically defective infant against the mother. While researching this paper both authors were postdoctoral fellows in medical ethics in the Program on Human Values and Ethics at the University of Tennessee Center for (...) the Health Sciences. (shrink)

The shortage of organs for transplantation by its nature prompts ethical dilemmas. For example, although there is an imperative to save human life and reduce suffering by maximising the supply of vital organs, there is an equally important obligation to ensure that the process by which we increase the supply respects the rights of all stakeholders. In a relatively unexamined practice in the USA, organs are procured from unrepresented decedents without their express consent. Unrepresented decedents have no known healthcare wishes (...) or advance care planning document; they also lack a surrogate. The Revised Uniform Anatomical Gift Act of 2006 sends a mixed message about the procurement of organs from this patient population and there are hospitals that authorise donation. In addition, in adopting the RUAGA, some states included provisions that clearly allow organ procurement from unrepresented decedents. An important unanswered question is whether this practice meets the canons of ethical permissibility. The current Brief Report presents two principled approaches to the topic as a way of highlighting some of the complexities involved. Concluding remarks offer suggestions for future research and discussion. (shrink)

We suggest that policies will be less popular when individuals personally have to pay for them rather than when others have to pay (i.e., a Not Out of My Bank Account or NOMBA effect). Dual process models of persuasion suggest that personally having to pay would motivate scrutiny of persuasive messages making it essential to use effective science communication tactics when using climate science to support climate change policies. A pilot experiment (N = 186) and main study (N = 758) (...) support a NOMBA effect with less policy support (Pilot study) and lower recommended fees (Main study) for a policy that would require participants, rather than another group, to pay a fee for community solar panels. Consistent with dual process models and suggesting systematic processing, only when participants would have to pay the fee, messages using strong (vs. weak) science communication tactics increased support for policies (Pilot study), increased the favorability of thoughts about the policy (Main study) and these thoughts subsequently predicted policy support (Main study). Inconsistent with propositions that information about expert sources would be a heuristic or bolster science messages, expert consensus information did not influence thoughts or policy support in any study condition. Efforts to understand climate change policy support would benefit from attending to research on dual process models of persuasion, including understanding how different types and degree of outcome relevance can alter how people process science information used to bolster support for climate change policies. (shrink)

This book describes the development of the scientific article from its modest beginnings to the global phenomenon that it has become today. The authors focus on changes in the style, organization, and argumentative structure of scientific communication over time. This outstanding resource is the definitive study on the rhetoric of science.

Coping with a relative with a learning disability could be a stressful experience for family members. The present study is aimed at exploring the coping strategies adopted by families in trying to make meaning of their situation. A qualitative study design using focus group discussions was adopted. Ten FGD sessions were held with family members of persons with a learning disability. Findings revealed patterns of family coping to include problem-focused, emotion-focused, and spiritual/religious-focused. Also, coping responses to a learning disability varied (...) based on the level of information available to families about the condition of their relative. In some cases, interspousal relationship was strained due to stress. It was recommended that families of persons with a learning disability need social support and professional help from social workers to facilitate the adoption of more positive-oriented coping strategies by family members. (shrink)

The Johns Hopkins‐Fogarty African Bioethics Training Program (FABTP) has offered a fully‐funded, one‐year, non‐degree training opportunity in research ethics to health professionals, ethics committee members, scholars, journalists and scientists from countries across sub‐Saharan Africa. In the first 9 years of operation, 28 trainees from 13 African countries have trained with FABTP. Any capacity building investment requires periodic critical evaluation of the impact that training dollars produce. In this paper we describe and evaluate FABTP and the efforts of its trainees.Our (...) data show that since 2001, the 28 former FABTP trainees have authored or co‐authored 105 new bioethics‐related publications; were awarded 33 bioethics‐related grants; played key roles on 78 bioethics‐related research studies; and participated in 198 bioethics workshops or conferences. Over the past nine years, trainees have collectively taught 48 separate courses related to bioethics and have given 170 presentations on various topics in the field. Many former trainees have pursued and completed doctoral degrees in bioethics; some have become editorial board members for bioethics journals. Female trainees were, on average, less experienced at matriculation and produced fewer post‐training outputs than their male counterparts. More comprehensive studies are needed to determine the relationships between age, sex, previous experience and training program outputs. (shrink)

In 1960, E. P. Wigner, a joint winner of the 1963 Nobel Prize for Physics, published a paper titled On the Unreasonable Effectiveness of Mathematics in the Natural Sciences [61]. This paper can be construed as an examination and affirmation of Galileo's tenet that “The book of nature is written in the language of mathematics”. To this effect, Wigner presented a large number of examples that demonstrate the effectiveness of mathematics in accurately describing physical phenomena. Wigner viewed these examples as (...) illustrations of what he called the empirical law of epistemology, which asserts that the mathematical formulation of the laws of nature is both appropriate and accurate, and that mathematics is actually the correct language for formulating the laws of nature. At the same time, Wigner pointed out that the reasons for the success of mathematics in the natural sciences are not completely understood; in fact, he went as far as asserting that “… the enormous usefulness of mathematics in the natural sciences is something bordering on the mysterious and there is no rational explanation for it.”. (shrink)

Researchers from diverse disciplines, including organismal and cellular physiology, sports science, human nutrition, evolution and ecology, have sought to understand the causes and consequences of the surprising variation in metabolic rate found among and within individual animals of the same species. Research in this area has been hampered by differences in approach, terminology and methodology, and the context in which measurements are made. Recent advances provide important opportunities to identify and address the key questions in the field. By bringing together (...) researchers from different areas of biology and biomedicine, we describe and evaluate these developments and the insights they could yield, highlighting the need for more standardisation across disciplines. We conclude with a list of important questions that can now be addressed by developing a common conceptual and methodological toolkit for studies on metabolic variation in animals. (shrink)

In this article, we propose the Fair Priority Model for COVID-19 vaccine distribution, and emphasize three fundamental values we believe should be considered when distributing a COVID-19 vaccine among countries: Benefiting people and limiting harm, prioritizing the disadvantaged, and equal moral concern for all individuals. The Priority Model addresses these values by focusing on mitigating three types of harms caused by COVID-19: death and permanent organ damage, indirect health consequences, such as health care system strain and stress, as well as (...) economic destruction. It proposes proceeding in three phases: the first addresses premature death, the second long-term health issues and economic harms, and the third aims to contain viral transmission fully and restore pre-pandemic activity. -/- To those who may deem an ethical framework irrelevant because of the belief that many countries will pursue "vaccine nationalism," we argue such a framework still has broad relevance. Reasonable national partiality would permit countries to focus on vaccine distribution within their borders up until the rate of transmission is below 1, at which point there would not be sufficient vaccine-preventable harm to justify retaining a vaccine. When a government reaches the limit of national partiality, it should release vaccines for other countries. -/- We also argue against two other recent proposals. Distributing a vaccine proportional to a country's population mistakenly assumes that equality requires treating differently situated countries identically. Prioritizing countries according to the number of front-line health care workers, the proportion of the population over 65, and the number of people with comorbidities within each country may exacerbate disadvantage and end up giving the vaccine in large part to wealthy nations. (shrink)

The work of Luciano Floridi lies at the interface of philosophy, information science and technology, and ethics, an intersection whose existence and significance he was one of the first to establish. His closely related concepts of a philosophy of information (PI), informational structural realism, information logic (IL), and information ethics (IE) provide a new ontological perspective from which moral concerns can be addressed, especially but not limited to those arising in connection with the new information and communication technologies. In this (...) paper, I relate Floridi's approach to another novel perspective, namely, that of an extension of logic to complex real processes, including those of information production and transfer. This non-propositional, non-truth-functional logic (logic in reality (LIR)) is grounded in the fundamental dualism (dynamic opposition) inherent in energy and accordingly present at all levels of reality. The LIR description of the dynamics of processes and their evolution is relevant to what Floridi refers to as the possible non-linguistic aspects of information. It suggests answers to some of Floridi's “outstanding problems” in PI related to the ontological status of information and how it is used in cognition. Floridi's IL retains the formal structure of the doxastic and epistemic logics from which he correctly distinguishes it and is the basis for his conceptual PI. However, LIR fulfills Floridi's implied requirement that logic be regarded as a natural phenomenon dealing with other natural phenomena, recovering its original philosophical function. LIR provides a logical foundation for discussion of ethical questions based on kinds of information that complements IL. Both are reconsiderations of logic that, as Marijuan suggests, may be necessary for the advancement of information technology in an ethical direction (cf. also Brenner). IE focuses on entities as constituted by information in an overall strategy that generalizes the concept of moral agents. LIR and its related ontology naturalize critical aspects of Floridi's theses, especially, the moral value of being as such and a non-separable joint responsibility of individuals and groups. I compare IE to other current approaches to ethics and information technology (e.g., phenomenological and social constructivist). Ethical information is defined “ecologically” in process terms as reality in a physical space (cf. Floridi), with an intentional “valence,” positive and negative, in the morally valued interaction between producer and receiver. LIR is neither topic-neutral nor context independent and can support an ethics involving apparently contradictory perspectives (e.g., internalist and externalist). Ethics involves practical reasoning, and unlike standard logics, LIR supports Magnani's approach to abductive reasoning in rational moral decision making. The basis of moral responsibility and the consequent behavior of individuals involved in information and communications technologies is the same logical–metaphysical principle of dynamic opposition instantiated at other levels of reality. The way moral responsibilities are actively accepted (or not) by individuals supervenes on their primitive psychological structure, which in turn reflects an evolutionary development grounded in the fundamental dualism of the physical world. The paper concludes with some suggestions of areas of philosophical research, such as causality, identity, and the ontological turn, where convergence of the Floridi and LIR approaches might be envisaged. Their overall motivation is the same, namely, the development of strategies for reinforcing and increasing ethical sensitivity wherever possible. The ethical information concept outlined in the paper supports the function of IE, assigned to it by Floridi, of potentially determining what is right and what is wrong. (shrink)

In 1931 eminent chemist Fritz Paneth maintained that the modern notion of “element” is closely related to (and as “metaphysical” as) the concept of element used by the ancients (e.g., Aristotle). On that basis, the element chlorine (properly so-called) is not the elementary substance dichlorine, but rather chlorine as it is in carbon tetrachloride. The fact that pure chemicals are called “substances” in English (and closely related words are so used in other European languages) derives from philosophical compromises made by (...) grammarians in the late Roman Empire (particularly Priscian [fl. ~520 CE]). When the main features of the constitution of isotopes became clear in the first half of the twentieth century, the formal (IUPAC) definition of a “chemical element” was changed. The features that are “essential” to being an element had previously been “transcendental” (“beyond the sphere of consciousness”) but, by the mid-twentieth century the defining characteristics of elements, as such, had come to be understood in detail. This amounts to a shift in a “horizon of invisibility” brought about by progress in chemistry and related sciences. Similarly, chemical insight is relevant to currently-open philosophical problems, such as the status of “the bundle theory” of the coherence of properties in concrete individuals. (shrink)

The Johns Hopkins-Fogarty African Bioethics Training Program (FABTP) has offered a fully-funded, one-year, non-degree training opportunity in research ethics to health professionals, ethics committee members, scholars, journalists and scientists from countries across sub-Saharan Africa. In the first 9 years of operation, 28 trainees from 13 African countries have trained with FABTP. Any capacity building investment requires periodic critical evaluation of the impact that training dollars produce. In this paper we describe and evaluate FABTP and the efforts of its trainees.Our (...) data show that since 2001, the 28 former FABTP trainees have authored or co-authored 105 new bioethics-related publications; were awarded 33 bioethics-related grants; played key roles on 78 bioethics-related research studies; and participated in 198 bioethics workshops or conferences. Over the past nine years, trainees have collectively taught 48 separate courses related to bioethics and have given 170 presentations on various topics in the field. Many former trainees have pursued and completed doctoral degrees in bioethics; some have become editorial board members for bioethics journals. Female trainees were, on average, less experienced at matriculation and produced fewer post-training outputs than their male counterparts. More comprehensive studies are needed to determine the relationships between age, sex, previous experience and training program outputs. (shrink)

The left ventricular assist device was originally designed to be surgically implanted as a bridge to transplantation for patients with chronic end-stage heart failure. On the basis of the REMATCH trial, the US Food and Drug Administration and the US Centers for Medicare & Medicaid Services approved permanent implantation of the left ventricular assist device as a destination therapy in Medicare beneficiaries who are not candidates for heart transplantation. The use of the left ventricular assist device as a destination therapy (...) raises certain ethical challenges. Left ventricular assist devices can prolong the survival of average recipients compared with optimal medical management of chronic end-stage heart failure. However, the overall quality of life can be adversely affected in some recipients because of serious infections, neurologic complications, and device malfunction. Left ventricular assist devices alter end-of-life trajectories. The caregivers of recipients may experience significant burden (e.g., poor physical health, depression, anxiety, and posttraumatic stress disorder) from destination therapy with left ventricular assist devices. There are also social and financial ramifications for recipients and their families. We advocate early utilization of a palliative care approach and outline prerequisite conditions so that consenting for the use of a left ventricular assist device as a destination therapy is a well informed process. These conditions include: (1) direct participation of a multidisciplinary care team, including palliative care specialists, (2) a concise plan of care for anticipated device-related complications, (3) careful surveillance and counseling for caregiver burden, (4) advance-care planning for anticipated end-of-life trajectories and timing of device deactivation, and (5) a plan to address the long-term financial burden on patients, families, and caregivers. Short-term mechanical circulatory devices (e.g. percutaneous cardiopulmonary bypass, percutaneous ventricular assist devices, etc.) can be initiated in emergency situations as a bridge to permanent implantation of ventricular assist devices in chronic end-stage heart failure. In the absence of first-person (patient) consent, presumed consent or surrogate consent should be used cautiously for the initiation of short-term mechanical circulatory devices in emergency situations as a bridge to permanent implantation of left ventricular assist devices. Future clinical studies of destination therapy with left ventricular assist devices should include measures of recipients' quality of end-of-life care and caregivers' burden. (shrink)