Various kinds of alcohol and drug testing, such as preemployment, routine, and for-cause testing, are commonly performed by employers. While healthcare organizations usually require preemployment drug testing, they vary on whether personnel will be subjected to further testing. Recently, a call has gone out for postincident testing among physicians who are involved in serious, preventable events, especially ones leading to a patient's death. This article will offer a number of counterarguments to that proposal (...) and discuss an alternate approach: that health institutions can better improve patient safety and employees’ well-being by implementing an organizational policy of “speaking up” when system operators notice work behaviors or environmental factors that threaten harm or peril. The article will conclude with a description of various strategies that facilitate speaking up, and why the practice constitutes a superior alternative to mandatory alcohol and drug testing in the wake of serious, harm-causing m.. (shrink)

As drug testing has become increasingly used to maximize corporate profits by minimizing the economic impact of employee substance abuse, numerous arguments have been advanced which draw the ethical justification for such testing into question, including the position that testing amounts to a violation of employee privacy by attempting to regulate an employee's behavior in her own home, outside the employer's legitimate sphere of control. This article first proposes that an employee's right to privacy is violated (...) when personal information is collected or used by the employer in a way which is irrelevant to the terms of employment. This article then argues that drug testing is relevant and therefore ethically justified within the terms of the employment agreement, and therefore does not amount to a violation of an employee's right to privacy. Arguments to the contrary, including the aforementioned appeal to the employer's limited sphere of control, do not account for reasonable constraints on employee privacy which are intrinsic to the demands of the workplace and implicit in the terms of the employment contract. (shrink)

By some estimates one-third of American corporations now require their employees to be tested for drug u se. The se requ iremen ts are com patible with general employment law while prom oting the public's in terest in figh ting drug use. Mo reover , the Unite d State s Supreme Court has ruled that drug tes ting prog rams a re cons titutionally p ermiss ible within both the public and the private sectors. It appears (...) m andatory drug tes ting is a permanent fixture of American corporate life. (Bakaly, C. G., Grossman, J. M. 1989) The legal roots of m anda tory drug testing are found in the com mon la w doctrin e of "employment at will." That doctrine states that either party to an employment contract can termina te the contract for any reason, at any time, unless the contract specifies otherwise. As the Court h eld in Adair v. United States (208 U.S. 161, 175-6, 1908), the employer "was at liberty, in his d iscretion , to discha rge [the e mploy ee] from service w ithout givin g any reason for so do ing." In unqualified form, this doctrine would give employers effective control over employees. Employers could establish any requirements they wished for prospective and current employees. Not only could they decline to hire employees who will refuse drug tests, they could likewise decline to hire people with characteristics, beliefs, or behavior they dislike. Employees must endure these requirements or seek emplo yment elsewhere. However, since m ost peo ple hav e limited job opp ortunities , they will be forced to "a ccept" these require ments , no ma tter how objection able. Courts and legislatures have since recognized the abuses this 283 284 Drugs, Morality, and the Law.. (shrink)

In this article I attempt to examine the justification for the mandatory drug testing of employees. The justification commonly assumes the form of the productivity argument which states that an employer has a proprietary right to regulate the purchased time of the employee. Since the employer may be rightfully concerned with the employee''s productive output, so this argument goes, the employer retains the right to motivate production. By extension, the employee''s behavior outside of the workplace which affects his (...) or her productive capacity may also be regulated, including drug use which may affect this capacity. Thus it is claimed that the employer has the right to test employees for drug use and to impose sanctions when it is discovered.I argue that the implications of the productivity argument lead to unacceptable consequences and thus must be rejected. The productivity argument can be examined in light of a thought-experiment in which the reader is asked to imagine the discovery of two drugs, both of which enhance employee productivity. Calling these drugs hedonine and pononine, I imagine the first to be pleasurable to the employee while the second is accompanied by a degree of pain and discomfort. Since the mandated use of both of these imagined drugs would be consistent with the productivity argument, I maintain that the productivity argument thereby fails and so must be rejected. As employee drug testing is justified by this argument, it must also be rejected. (shrink)

Employers and governments are interested in the use of serological testing to allow people to return to work before there is a vaccine for SARS-CoV-2. We articulate the preconditions needed for the implementation of antibody testing, including the role of the U.S. Food & Drug Administration.

In late May 1984, Irish citizens were perturbed to hear that a thirty-one year old man died while participating, as a paid volunteer, in a clinical drug trial at the Institute of Clinical Pharmacology in Dublin. At the inquest, held in September 1984, the State Pathologist, Dr John Harbison, affirmed that the cause of death was the reaction of the trial drug Eproxindine 4/0091 with a major tranquillizer which had been given less than fifteen hours earlier as part (...) of regular treatment for a psychiatric disorder. The mixture of the two drugs, he went on to say, increased their effect by between twenty and thirty times their normal strength, and the volunteer had died of cardiac depression. (shrink)

In late May 1984, Irish citizens were perturbed to hear that a thirty-one year old man died while participating, as a paid volunteer, in a clinical drug trial at the Institute of Clinical Pharmacology in Dublin. At the inquest, held in September 1984, the State Pathologist, Dr John Harbison, affirmed that the cause of death was the reaction of the trial drug Eproxindine 4/0091 with a major tranquillizer which had been given less than fifteen hours earlier as part (...) of regular treatment for a psychiatric disorder. The mixture of the two drugs, he went on to say, increased their effect by between twenty and thirty times their normal strength, and the volunteer had died of cardiac depression. (shrink)

The proposed article provides an overview of European and North American states’ legislation, which regulates the procedure for pre-clinical research, clinical trials and state registration of medicinal products, as well as responsibility for its violation, analysis of the problems and prospects of adaptation of the national legislation to European legal space, particularly in the field of criminal and legal regulation of relations in the sphere of pre-clinical trials, clinical trials and state registration of medicine. The emphasis is put on the (...) matter that inclusion of Article 321-2 into the Criminal Code of Ukraine leads to a false concurrence with other provisions of the Code. The author proposes to introduce recent EU legislation (Acquis Communautaire) on legal regulation of clinical trials and circulation of medicine into the law of Ukraine, clarify terminology related to Fundamentals of Ukrainian Legislation on Health Protection and the Special Part of criminal law, introduce criminal liability for legal entities that will provide effective control over negative effects of research centers’ activity. It is suggested to develop legislative proposals to improve the provisions of the Criminal Code of Ukraine, which provide legal protection of relations arising in connection with pre-clinical research, clinical trials and state registration of medicinal products. (shrink)

Book reviewed in this article: Ethical Issues in Drug Testing, Approval and Pricing: The Clot‐Dissolving Drugs. By Baruch Brody.

Although testing for substance abuse can be intrusive, inaccurate, and ineffective at ferreting out those who are a threat to others, it can be morally justified in certain carefully circumscribed cases.

Programs of drug testing welfare recipients are increasingly common in US states and have been considered elsewhere. Though often intensely debated, such programs are complicated to evaluate because their aims are ambiguous – aims like saving money may be in tension with aims like referring people to treatment. We assess such programs using a proportionality approach, which requires that for ethical acceptability a practice must be: reasonably likely to meet its aims, sufficiently important in purpose as to outweigh (...) harms incurred, and lower in costs than feasible alternatives. In the light of empirical findings, we argue that the programs fail the three requirements. Pursuing recreational drug users is not important in the light of costs incurred, while dependent users who may require referral are usually identifiable without testing and typically need a broader approach than one focussing on drugs. Drug testing of welfare recipients is therefore not ethically acceptable policy. (shrink)

Issues of privacy and employee health screening rank as two of the most important ethical concerns organizations will face in the next five years. Despite the increasing numbers of social scientists researching personal privacy and the current focus on workplace privacy rights as one of the most dynamic areas of employment law, the concept of privacy remains relatively abstract. Understanding how the courts define privacy and use the expectation of privacy standards is paramount given the strategic importance of the (...) law as a legal socializing agent. This article reports on two federal court decisions involving employer drug and HIV testing whose determinations relied on assumptions about the psychological dimensions of privacy. How the courts define privacy, the outcome of this definition and the ethical ramifications as it affects the employee/employer relationship are discussed. (shrink)

Most of the debate about drug testing in the workplace has focused on the right to privacy. Proponents of testing have had to tackle difficult questions concerning the nature, extent, and weight of the privacy rights of employees. This paper examines a different kind of argument — the claim that because corporations are responsible for harms committed by employees while under the influence of drugs, they are entitled to test for drug use. This argument has considerable (...) intuitive appeal, because it seems, at least at first glance, to bypass the issue of privacy rights altogether. The argument turns, not on rights, but on the nature and conditions of responsibility. We may therefore call it an ought implies can argument.In spite of its initial appeal, however, the argument does not succeed in circumventing the claims of privacy rights. Even responsibility for the actions of others does not entitle us to do anything at all to control their behavior; we must look to rights, among other things, to determine what sorts of controls are morally permissible. In addition, the argument rests on unjustified assumptions about the connection between drug testing and the prevention of drug-related harm. (shrink)

There is consensus that children have questionable decisional capacity and, therefore, in general a parent or a guardian must give permission to enroll a child in a research study. Moreover, freedom from duress and coercion, the cardinal rule in research involving adults, is even more important for children. This principle is embodied prominently in the Nuremberg Code (1947) and is embodied in various federal human research protection regulations. In a program named "SATURN" (Student Athletic Testing Using Random Notification), each (...) school in the Oregon public-school system may implement a mandatory drug-testing program for high school student athletes. A prospective study to identify drug use among student-athletes, SATURN is designed both to evaluate the influence of random drug testing and to validate the survey data through identification of individuals who do not report drug use. The enrollment of students in the drug-testing study is a requirement for playing a school sport. In addition to the coercive nature of this study design, there were ethically questionable practices in recruitment, informed consent, and confidentiality. This article concerns the question of whether research can be conducted with high school students in conjunction with a mandatory drug-testing program, while adhering to prevailing ethical standards regarding human-subjects research and specifically the participation of children in research. (shrink)

It is common for physicians who prescribe opioids for chronic pain to have their patients sign an opioid contract in order to receive opioid therapy. A vast majority of these contracts contain a stipulation requiring patients to submit to random drug testing which screens for both licit and illicit drugs. Physicians who prescribe opioids may be concerned about prosecution and disciplinary actions; medication abuse and misuse; and addiction. Steven Passik et al. write, “…physicians still fear the risk of (...) abuse or addiction as well as the potential legal consequences of their prescribing.”Issues surrounding OC/RDT need a closer look with a focus on enforceability and efficacy of the opioid contract; accuracy and complications of drug screens and their interpretation; and the importance of trust between patient and physician. In addition, it is vital to dispel fears with facts regarding prosecutions, nonmedical use of prescription opioids, and addiction. (shrink)

In recent years, the biopharmaceutical industry has seen an increase in the development of so-called orphan drugs for the treatment of rare and neglected diseases. This increase has been spurred on by legislation in the United States, Europe, and elsewhere designed to promote orphan drug development. In this article, we examine the drivers of corporate social responsibility (CSR) activities in orphan drug markets and the extent to which biopharmaceutical firms engage in these activities with a strategic orientation. The (...) unique context of orphan drugs constitutes a research opportunity to test the applicability of existing theoretical perspectives on CSR and strategic CSR. Using Schwartz and Carroll’s (Bus Ethics Q, 13(4):503–530, 2003) three-domain approach to CSR and the literature on strategic CSR as a theoretical background, we employ a combination of semi-structured interviews and a quantitative website content analysis to study practices of biopharmaceutical firms in the United States and European Union. Our findings show that both US- and EU-based companies engaged in orphan drugs development perceive their involvement as a responsible business activity beyond the economic dimension of CSR. However, for the majority of these companies their CSR activities do not qualify as strategic according to the criteria established in the literature. We also find significant differences between larger and smaller firms in their use of CSR. Based on these findings, we make several suggestions regarding orphan drug legislation and other measures that might help firms exploit strategic CSR benefits. (shrink)

Background and objectivesThe study of brain functional connectivity alterations in children with Attention-Deficit/Hyperactivity Disorder has been the subject of considerable investigation, but the biological mechanisms underlying these changes remain poorly understood. Here, we aim to investigate the brain alterations in patients with ADHD and Typical Development children and accurately classify ADHD children from TD controls using the graph-theoretical measures obtained from resting-state fMRI.Materials and methodsWe investigated the performances of rs-fMRI data for classifying drug-naive children with ADHD from TD controls. (...) Fifty six drug-naive ADHD children and 56 age matched TD controls were included in this study. The graph measures extracted from rs-fMRI functional connectivity were used as features. Extracted network-based features were fed to the RFE feature selection algorithm to select the most discriminating subset of features. We trained and tested Support Vector Machine, Random Forest, and Gradient Boosting using Peking center data from ADHD-200 database to classify ADHD and TD children using discriminative features. In addition to the machine learning approach, the statistical analysis was conducted on graph measures to discover the differences in the brain network of patients with ADHD.ResultsAn accuracy of 78.2% was achieved for classifying drug-naive children with ADHD from TD controls employing the optimal features and the GB classifier. We also performed a hub node analysis and found that the number of hubs in TD controls and ADHD children were 8 and 5, respectively, indicating that children with ADHD have disturbance of critical communication regions in their brain network. The findings of this study provide insight into the neurophysiological mechanisms underlying ADHD.ConclusionPattern recognition and graph measures of the brain networks, based on the rs-fMRI data, can efficiently assist in the classification of ADHD children from TD controls. (shrink)

George Will, the well-known pundit, once observed: “A society's recreation is charged with moral significance. Sport—and a society that takes it seriously—would be debased if it did not strictly forbid things that blur the distinction between the triumph of character and the triumph of chemistry.” In opposition, Dan Duchaine, the highly publicized “steroid guru” and counter-culture columnist, declared: “There comes a time for many in competitive athletics where winning is more important than those initial goals of health, recreation, and relaxation.” (...) The parallels of these two philosophies to life in general are patent simply by substituting “sports” and “winning” for “career” and “success,” respectively.This paper will review the basis for banning anabolic steroids in athletics, and consider especially the recent medical findings that support this prohibition. This survey leads into a discussion of the available deterrents, and the secondary, but essential, role of random drug testing as a final safeguard. (shrink)

George Will, the well-known pundit, once observed: “A society's recreation is charged with moral significance. Sport—and a society that takes it seriously—would be debased if it did not strictly forbid things that blur the distinction between the triumph of character and the triumph of chemistry.” In opposition, Dan Duchaine, the highly publicized “steroid guru” and counter-culture columnist, declared: “There comes a time for many in competitive athletics where winning is more important than those initial goals of health, recreation, and relaxation.” (...) The parallels of these two philosophies to life in general are patent simply by substituting “sports” and “winning” for “career” and “success,” respectively.This paper will review the basis for banning anabolic steroids in athletics, and consider especially the recent medical findings that support this prohibition. This survey leads into a discussion of the available deterrents, and the secondary, but essential, role of random drug testing as a final safeguard. (shrink)

There is consensus that children have questionable decisional capacity and, therefore, in general a parent or a guardian must give permission to enroll a child in a research study. Moreover, freedom from duress and coercion, the cardinal rule in research involving adults, is even more important for children. This principle is embodied prominently in the Nuremberg Code (1947) and is embodied in various federal human research protection regulations. In a program named "SATURN" (Student Athletic Testing Using Random Notification), each (...) school in the Oregon public-school system may implement a mandatory drug-testing program for high school student athletes. A prospective study to identify drug use among student-athletes, SATURN is designed both to evaluate the influence of random drug testing and to validate the survey data through identification of individuals who do not report drug use. The enrollment of students in the drug-testing study is a requirement for playing a school sport. In addition to the coercive nature of this study design, there were ethically questionable practices in recruitment, informed consent, and confidentiality. This article concerns the question of whether research can be conducted with high school students in conjunction with a mandatory drug-testing program, while adhering to prevailing ethical standards regarding human-subjects research and specifically the participation of children in research. (shrink)

There is consensus that children have questionable decisional capacity and, therefore, in general a parent or a guardian must give permission to enroll a child in a research study. Moreover, freedom from duress and coercion, the cardinal rule in research involving adults, is even more important for children. This principle is embodied prominently in the Nuremberg Code and is embodied in various federal human research protection regulations. In a program named "SATURN", each school in the Oregon public-school system may implement (...) a mandatory drug-testing program for high school student athletes. A prospective study to identify drug use among student-athletes, SATURN is designed both to evaluate the influence of random drug testing and to validate the survey data through identification of individuals who do not report drug use. The enrollment of students in the drug-testing study is a requirement for playing a school sport. In addition to the coercive nature of this study design, there were ethically questionable practices in recruitment, informed consent, and confidentiality. This article concerns the question of whether research can be conducted with high school students in conjunction with a mandatory drug-testing program, while adhering to prevailing ethical standards regarding human-subjects research and specifically the participation of children in research. (shrink)

Employers seeking to control employee behavior outside of working hours is nothing new. However, recent developments have extended efforts to control employee behavior into new areas, with new significance. Employers seek to control legal behavior by employees outside of working hours, to have significant influence over employee’s health-related behavior, and to monitor and control employee’s social media, even when this behavior has nothing to do with the workplace. In this article, I draw on the work of political theorists Jon Elster, (...) Gerald Gaus and Michael Walzer, and privacy scholars Daniel Solove and Anita Allen, to show what is wrong with this extension of employer control of employee’s outside of work behavior. I argue that there are ethical limits on the controls that employers may put on their employees’ out of work behavior, and that many of these limits should be enshrined into legal protections which would prevent employers from conditioning employment on the regulations criticized. -/- (Please note that the version of this paper on SSRN is a pre-publication version. Please cite and refer to the published version when possible.). (shrink)

This balanced and thorough study of the loyalty programs reviews the history of prosecutions and the dismissals under them, and makes detailed proposals for their revision.--R. F. T.

Business in Ethical Focus is a compilation of classical and contemporary essays on business ethics. Approximately 50 essays are organized into five units: Corporate Social Responsibility; Rights and Obligations of Employees and Employers; Justice and Fair Practice; Distributive Justice; and Advertising, Marketing, and the Consumer. Readers will become acquainted with seminal ideas from important thinkers such as Milton Friedman on corporate social responsibility and Amartya Sen on whether business ethics makes economic sense. They will also find classic readings on distributive (...) justice by Thomas Hobbes, John Locke, Karl Marx, John Rawls, and Robert Nozick. Other topics include drug testing, sexual harassment, environmental responsibility, bribery, and ethical issues in advertising and marketing. The editors provide thoughtful commentary, case studies, and study questions for each unit, enabling readers to clearly understand the growing discipline of business ethics. (shrink)

The University of Tehran English Proficiency Test (UTEPT) is a high-stakes entrance examination taken by more than 10,000 master’s degree holders annually. The examinees’ scores have a significant influence on the final decisions concerning admission to the University of Tehran Ph.D. programs. As a test validation investigation, the present study, which is a bias detection research in nature, utilized multistep logistic regression (LR) procedure to examine the presence of gender differential item functioning (DIF) in the UTEPT with a sample of (...) 6,555 examinees who took the test in November 2006. Specifically, the LR DIF two-degree of freedom Chi-squared test of significance was employed to test the significance of DIF. Following what has been recently suggested in the literature, the test of significance for DIF was accompanied by a measure of magnitude, namely the R-squared effect size for LR DIF, for the interpretation of which the two widely accepted classification schemes were used comparatively. The results reveal that 39 of the 100 items in the test display significant gender differences. However, these group differences are viewed as “negligible” based on both of the schemes. Accordingly, it could be argued that the UTEPT is a gender DIF-free test, though the Reading Comprehension section of the test remains in need of further analysis as it seems that the general trend of DIF indices at the item level may hint at an inclination towards males. (shrink)

As a clinical geneticist I have been amazed at the speed of discovery over the past 20 years. The specific genetic causes of thousands of rare genetic conditions have been defined due to improvements in genomic sequencing, computing power and international collaborations to phenotype individuals with similar clinical features. This knowledge has resulted in an increased ability to make accurate molecular diagnoses which informs optimal treatment and clinical care, can remove the need for unnecessary investigations and informs reproductive decision-making. However (...) for any given individual, this genetic testing can often take weeks or months before the initial genetic diagnosis is made within a family. Occasionally genetic information is required more quickly to define a clinical action. For years point of care testing has been a mainstay of clinical care, for example, in confirming pregnancy or monitoring blood glucose. I had been keen to explore scenarios where a genetic POCT could be employed in clinical practice. To me, an obvious example appeared to be neonatal testing to avoid gentamicin-induced hearing loss. Here was a situation where we had known about the genetic …. (shrink)

Even after several decades of human drug development, there remains an absence of published, substantial, comprehensive data to validate the use of animals in preclinical drug testing, and to point to their pr...

Despite recent advances in ways to prevent transmission of HIV from a mother to her child during pregnancy, infants continue to be born and become infected with HIV, particularly in southern Africa where HIV prevalence is the highest in the world. In this region, emphasis has shifted from voluntary HIV counselling and testing to routine testing of women during pregnancy. There have also been proposals for mandatory testing. Could mandatory testing ever be an option, even in (...) high-prevalence settings? Many previous examinations of mandatory testing have dealt with it in the context of low HIV prevalence and a well-resourced health care system. In this discussion, different assumptions are made. Within this context, where mandatory testing may be a strategy of last resort, the objections to it are reviewed. Special attention is paid in the discussion to the entrenched vulnerability of women in much of southern Africa and how this contributes to both HIV prevalence and ongoing challenges for preventing HIV transmission during pregnancy. While mandatory testing is ethically plausible, particularly when coupled with guaranteed access to treatment and care, the discussion argues that the moment to employ this strategy has not yet come. Many barriers remain for pregnant women in terms of access to testing, treatment and care, most acutely in the southern African setting, despite the presence of national and international human rights instruments aimed at empowering women and removing such barriers. While this situation persists, mandatory HIV testing during pregnancy cannot be justified. (shrink)

Genetic testing in the workplace is a technology both full of promise and fraught with ethical peril. Though not yet common, it is likely to become increasingly so. We survey the key arguments in favour of such testing, along with the most significant ethical worries. We further propose a set of pragmatic criteria, which, if met, would make it permissible for employers to offer (but not to require) workplace genetic testing.

Despite recent advances in ways to prevent transmission of HIV from a mother to her child during pregnancy, infants continue to be born and become infected with HIV, particularly in southern Africa where HIV prevalence is the highest in the world. In this region, emphasis has shifted from voluntary HIV counselling and testing to routine testing of women during pregnancy. There have also been proposals for mandatory testing. Could mandatory testing ever be an option, even in (...) high‐prevalence settings? Many previous examinations of mandatory testing have dealt with it in the context of low HIV prevalence and a well‐resourced health care system. In this discussion, different assumptions are made. Within this context, where mandatory testing may be a strategy of last resort, the objections to it are reviewed. Special attention is paid in the discussion to the entrenched vulnerability of women in much of southern Africa and how this contributes to both HIV prevalence and ongoing challenges for preventing HIV transmission during pregnancy. While mandatory testing is ethically plausible, particularly when coupled with guaranteed access to treatment and care, the discussion argues that the moment to employ this strategy has not yet come. Many barriers remain for pregnant women in terms of access to testing, treatment and care, most acutely in the southern African setting, despite the presence of national and international human rights instruments aimed at empowering women and removing such barriers. While this situation persists, mandatory HIV testing during pregnancy cannot be justified. (shrink)

An increasing number of drugs removed from the market because of unacceptable toxicity raises concerns regarding preapproval testing of drug safety. In the present paper it is postulated that the non-inferiority type of trial should be abandoned in favor of the superiority trial with active controls and less stringent (p<0.1, both for efficacy and toxicity) statistics. This approach will increase sensitivity of detection of drug-induced adverse effects at the expense of increasing false positive results regarding the difference (...) in efficacy between the tested and reference drug. Such a move will increase the protection of future patients. In addition, the proposed design is far more acceptable from the clinical (e.g. no need to specify the statistically expected “unimportant” number of deaths) and ethical points of view, as well as being favored by the strong incentive of involved parties. In the second part of this paper arguments are presented in favor of the hypothesis that placebo (still used in some superiority trials) does not induce adverse effects. The assertion that placebo may induce adverse effects is probably biased by the nature of the clinical experiment. Such a conclusion is supported by studies indicating that placebo-induced adverse effects are disease — and treatment — specific. The modification of clinical trials according to the proposed changes may increase the trials’ sensitivity at detecting adverse effects of drugs. (shrink)

John Worrall and Nancy Cartwright have both argued that randomized controlled trials are “testing the wrong theory.” They claim that RCTs are designed to test inferences about the causal relationships in the study population, but this does not guarantee a justified inference about the causal relationships in the more diverse population in clinical practice. In this article I argue that the epistemology of theory testing in trials is more complicated than either Worrall’s or Cartwright’s accounts suggest. I illustrate (...) this more complex theoretical structure with case studies in medical theory testing from Alzheimer’s research and anticancer drugs in personalized medicine. (shrink)

Rational drug design is a method for developing new pharmaceuticals that typically involves the elucidation of fundamental physiological mechanisms. It thus combines the quest for a scientific understanding of natural phenomena with the design of useful technology and hence integrates epistemic and practical aims of research and development. Case studies of the rational design of the cardiovascular drugs propranolol, captopril and losartan provide insights into characteristics and conditions of this integration. Rational drug design became possible in the 1950s (...) when theoretical knowledge of drug-target interaction and experimental drug testing could interlock in cycles of mutual advancement. The integration does not, however, diminish the importance of basic research for pharmaceutical development. Rather, it can be shown that still in the 1990s, linear processes of innovation and the close combination of practical and epistemic work were interdependent. (shrink)

Rational drug design is a method for developing new pharmaceuticals that typically involves the elucidation of fundamental physiological mechanisms. It thus combines the quest for a scientific understanding of natural phenomena with the design of useful technology and hence integrates epistemic and practical aims of research and development. Case studies of the rational design of the cardiovascular drugs propranolol, captopril and losartan provide insights into characteristics and conditions of this integration. Rational drug design became possible in the 1950s (...) when theoretical knowledge of drug-target interaction and experimental drug testing could interlock in cycles of mutual advancement. The integration does not, however, diminish the importance of basic research for pharmaceutical development. Rather, it can be shown that still in the 1990s, linear processes of innovation and the close combination of practical and epistemic work were interdependent. (shrink)

Industrial drug design methodology has undergone remarkable changes in the recent history. Up to the 1970s, the screening of large numbers of randomly selected substances in biological test system was often a crucial step in the development of novel drugs. From the early 1980s, such ‘blind’ screening was increasingly rejected by many pharmaceutical researchers and gave way to ‘rational drug design’, a method that grounds the design of new drugs on a detailed mechanistic understanding of the drug (...) action. Surprisingly, however, the chance-based method of random screening returned to center stage of industrial drug development in the 1990s in the form of ‘high-throughput screening’ (HTS). I will argue in this paper that this to-and-fro in the prominence of random screening comes with fundamental changes in the epistemic significance of chance experiments in pharmaceutical development. While up to the 1970s, random screening used to be chosen as an empirical search strategy primarily because suffi- cient knowledge of the mechanistic basis of drug action was lacking, it has turned with high-throughput screening into an experimental method that employs chance variation and testing to illuminate this mechanistic basis. As a consequence, research into the underlying mechanisms of drug action and the development of new drugs have become closely integrated. The rise of HTS therefore not only shows how chance experiments have assumed a new epistemic role in drug development. It also allows for a detailed study of the much debated emergence of a new relationship between scientific understanding and the development of technological artifacts. (shrink)

Predictive genetic testing is now routinely offered to asymptomatic adults at risk for genetic disease. However, testing of minors at risk for adult-onset conditions, where no treatment or preventive intervention exists, has evoked greater controversy and inspired a debate spanning two decades. This review aims to provide a detailed longitudinal analysis and concludes by examining the debate's current status and prospects for the future. Fifty-three relevant theoretical papers published between 1990 and December 2010 were identified, and interpretative content (...) analysis was employed to catalogue discrete arguments within these papers. Novel conclusions were drawn from this review. While the debate's first voices were raised in opposition of testing and their arguments have retained currency over many years, arguments in favour of testing, which appeared sporadically at first, have gained momentum more recently. Most arguments on both sides are testable empirical claims, so far untested, rather than abstract ethical or philosophical positions. The dispute, therein, lies not so much in whether minors should be permitted to access predictive genetic testing but whether these empirical claims on the relative benefits or harms of testing should be assessed. (shrink)

I welcome with great enthusiasm Meling and Scheidegger’s (2023; henceforth “M&S”) timely contribution to advance an enactive approach to psychedelic therapy, especially to the complex causality involved. Their two main research questions concerned:(i) the causal interaction between the psychedelic molecule and brain activity; and (ii) the causal interaction between brain activity and the psychedelic experience. While I largely agree with and celebrate much of what is proposed by M&S, especially their employment of key enactive concepts to advance our understanding (...) of the first research question, in the following, I will present some worries regarding their answers to the second. Although I agree that there is probably a two-way reciprocal relationship between neural activity and experience, I have several points of contention regarding M&S’s proposal. My hope is to stimulate discussion on M&S’s important contribution, and to help advance a much-needed enactive science of psychedelics. (shrink)