How FDA Failures Contributed to the Opioid Crisis

Andrew Kolodny, MD

AMA J Ethics. 2020;22(8):E743-750. 

doi: 10.1001/amajethics.2020.743.

Abstract

Over the past 25 years, pharmaceutical companies deceptively promoted opioid use in ways that were often neither safe nor effective, contributing to unprecedented increases in prescribing, opioid use disorder, and deaths by overdose. This article explores regulatory mistakes made by the US Food and Drug Administration (FDA) in approving and labeling new analgesics. By understanding and correcting these mistakes, future public health crises caused by improper pharmaceutical marketing might be prevented.

Introduction

In the United States, opioid use disorder (OUD) and opioid overdose were once rare. But over the past 25 years, the number of Americans suffering from OUD increased exponentially and in parallel with an unprecedented increase in opioid prescribing. Today, OUD is common, especially in patients with chronic pain treated with opioid analgesics, and opioid overdose is the leading cause of accidental death.

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Oversight Recommendations

While fewer clinicians are initiating long-term opioids, overprescribing is still a problem. According to a recently published report, more than 2.9 million people initiated opioid use in December 2017. The FDA’s continued approval of new opioids exacerbates this problem. Each time a branded opioid hits the market, the company, eager for return on its investment, is given an incentive and, in essence, a license to promote aggressive prescribing. The FDA’s continued approval of new opioids pits the financial interests of drug companies against city, state, and federal efforts to discourage initiation of long-term opioids.

To finally end the opioid crisis, the FDA must enforce the Food, Drug, and Cosmetic Act, and it must act on recommendations from the NAS for an overhaul of its opioid approval and removal policies. The broad indication on opioid labels must be narrowed, and an explicit warning against long-term use and high-dose prescribing should be added. The label should reinforce, rather than contradict, guidance from the CDC, the Department of Veterans Affairs, the Agency for Healthcare Research and Quality, and other public health agencies that are calling for more cautious prescribing.

The information is here.

Can Conspiracy Beliefs Be Beneficial? Longitudinal Linkages Between Conspiracy Beliefs, Anxiety, Uncertainty Aversion, and Existential Threat

Liekefett, L., Christ, O., & Becker, J. C. (2022). 

Personality and Social Psychology Bulletin. 

https://doi.org/10.1177/01461672211060965

Abstract

Research suggests that conspiracy beliefs are adopted because they promise to reduce anxiety, uncertainty, and threat. However, little research has investigated whether conspiracy beliefs actually fulfill these promises. We conducted two longitudinal studies (N Study 1 = 405, N Study 2 = 1,012) to examine how conspiracy beliefs result from, and in turn influence, anxiety, uncertainty aversion, and existential threat. Random intercept cross-lagged panel analyses indicate that people who were, on average, more anxious, uncertainty averse, and existentially threatened held stronger conspiracy beliefs. Increases in conspiracy beliefs were either unrelated to changes in anxiety, uncertainty aversion, and existential threat (Study 2), or even predicted increases in these variables (Study 1). In both studies, increases in conspiracy beliefs predicted subsequent increases in conspiracy beliefs, suggesting a self-reinforcing circle. We conclude that conspiracy beliefs likely do not have beneficial consequences, but may even reinforce the negative experience of anxiety, uncertainty aversion, and existential threat.

From the General Discussion

Are conspiracy beliefs beneficial or harmful for the individual?

In both studies, within-person increases in conspiracy beliefs did not predict reduced anxiety, uncertainty aversion, and existential threat. Increases in conspiracy beliefs were either unrelated to changes in these variables (Study 2) or even predicted increases in uncertainty aversion, anxiety, and existential threat (Study 1). This indicates that conspiracy beliefs are likely not beneficial in this regard. However, we cannot answer conclusively whether conspiracy beliefs, instead, reinforce the negative experience of anxiety, uncertainty, and threat: We observed these harmful effects only in Study 1. It may be that the time intervals in Study 2 were too long to observe these effects. It has been argued that the optimal time intervals to observe longitudinal relations are relatively short, especially for within-person effects (Dormann & Griffin, 2015), and that effect sizes typically decrease as time intervals get larger (Atkinson et al., 2000; Cohen, 1993; Dormann & Griffin, 2015; Hulin et al., 1990). This may explain why we observed only few within-person associations in Study 2.

We did not find within-person consequences of coronavirus-related conspiracy beliefs in Study 2. This may be due not only to long time intervals, but also to opposing effects that cancel each other out: Most coronavirus conspiracy beliefs contain some element that downplays the dangers of the virus, which might relieve distress. Yet, most of them also describe threatening scenarios of malevolent, secret forces, which should increase distress.

We revealed an additional way in which conspiracy beliefs may be harmful for the individual: Both studies found that increases in conspiracy beliefs predicted even further increases in conspiracy beliefs at the next measurement wave. This effect emerged for both short- and long-term distances, and indicates that conspiracy beliefs are part of a self-reinforcing cycle that results in more and more extreme attitudes (Goertzel, 1994; Swami et al., 2010; Wood et al., 2012).

The research is here.

On loving thyself: Exploring the association between self-compassion, self-reported suicidal behaviors, and implicit suicidality among college students

Zeifman, R. J., Ip, J., Antony, M. M., & Kuo, J. R. 

(2021). Journal of American college health

J of ACH, 69(4), 396–403.

Abstract

Suicide is a major public health concern. It is unknown whether self-compassion is associated with suicide risk above and beyond suicide risk factors such as self-criticism, hopelessness, and depression severity. 

Participants: Participants were 130 ethnically diverse undergraduate college students. 

Methods: Participants completed self-report measures of self-compassion, self-criticism, hopelessness, depression severity, and suicidal behaviors, as well as an implicit measure of suicidality. 

Results: Self-compassion was significantly associated with self-reported suicidal behaviors, even when controlling for self-criticism, hopelessness, and depression severity. Self-compassion was not significantly associated with implicit suicidality. 

Conclusions: The findings suggest that self-compassion is uniquely associated with self-reported suicidal behaviors, but not implicit suicidality, and that self-compassion is a potentially important target in suicide risk interventions. Limitations and future research directions are discussed.

Discussion

Clinical implications

Our findings suggest that self-criticism and self-compassion are uniquely predictive of self-reported suicidal behaviors.  Therefore, in addition to the importance of targeting self-criticism, self-compassion may also be an important, and independent, target within suicide risk interventions. Indeed, qualitative analysis of interviews conducted with individuals with borderline personality disorder (a psychiatric disorder characterized by high levels of suicide risk) and their service providers, identified self-compassion as an important theme in the process of recovery.  Interventions that specifically focus on fostering self-compassion, by generating feelings of self-reassurance, warmth, and self-soothing, include compassion-focused therapy and mindful self-compassion. Compassion based interventions have shown promise for a wide range of populations, including eating disorders, psychotic disorders, personality disorders, and healthy individuals.

A pdf of the research is here.

Trolley Dilemma in Papua. Yali horticulturalists refuse to pull the lever

Sorokowski, P., Marczak, M., Misiak, M. et al. 

Psychon Bull Rev 27, 398–403 (2020).

Abstract

Although many studies show cultural or ecological variability in moral judgments, cross-cultural responses to the trolley problem (kill one person to save five others) indicate that certain moral principles might be prevalent in human populations. We conducted a study in a traditional, indigenous, non-Western society inhabiting the remote Yalimo valley in Papua, Indonesia. We modified the original trolley dilemma to produce an ecologically valid “falling tree dilemma.” Our experiment showed that the Yali are significantly less willing than Western people to sacrifice one person to save five others in this moral dilemma. The results indicate that utilitarian moral judgments to the trolley dilemma might be less widespread than previously supposed. On the contrary, they are likely to be mediated by sociocultural factors.

Discussion

Our study showed that Yali participants were significantly less willing than Western participants to sacrifice one person to save five others in the moral dilemma. More specifically, the difference was so large that the odds of pushing the tree were approximately 73% smaller for a Papuan in comparison with Canadians.

Our findings reflect cultural differences between the Western and Yali participants, which are illustrated by the two most common explanations provided by Papuans immediately after the experiment. First, owing to the extremely harsh consequences of causing someone’s death in Yali society, our Papuan participants did not want to expose themselves to any potential trouble and were, therefore, unwilling to take any action in the tree dilemma. The rules of conduct in Yali society mean that a person accused of contributing to someone’s death is killed. However, the whole extended family of the blamed individual, and even their village, are also in danger of death (Koch, 1974). This is because the relatives of the deceased person are obliged to compensate for the wrongdoing by killing the same or a greater number of persons.

Another common explanation was related to religion. The Yali often argued that people should not interfere with the divine decision about someone’s life and death (e.g., “I’m not God, so I can’t make the decision”). Hence, although the reason may suggest an action as appropriate, religion suggests otherwise, with religious believers deciding in favor of the latter (Piazza & Landy, 2013). In turn, more traditional populations may refer to religion more than more secular, modern WEIRD populations. 

The research is here.

Can Brain Organoids Be ‘Conscious’? Scientists May Soon Find Out

Anil Seth

Wired.com

Originally posted 20 DEC 21

Here is an excerpt:

The challenge here is that we are still not sure how to define consciousness in a fully formed human brain, let alone in a small cluster of cells grown in a lab. But there are some promising avenues to explore. One prominent candidate for a brain signature of consciousness is its response to a perturbation. If you stimulate a conscious brain with a pulse of energy, the electrical echo will reverberate in complex patterns over time and space. Do the same thing to an unconscious brain and the echo will be very simple—like throwing a stone into still water. The neuroscientist Marcello Massimini and his team at the University of Milan have used this discovery to detect residual or “covert” consciousness in behaviorally unresponsive patients with severe brain injury. What happens to brain organoids when stimulated this way remains unknown—and it is not yet clear how the results might be interpreted.

As brain organoids develop increasingly similar dynamics to those observed in conscious human brains, we will have to reconsider both what we take to be reliable brain signatures of consciousness in humans, and what criteria we might adopt to ascribe consciousness to something made not born.

The ethical implications of this are obvious. A conscious organoid might consciously suffer and we may never recognize its suffering since it cannot express anything.

The info is here.

Latent motives guide structure learning during adaptive social choice

van Baar, J.M., Nassar, M.R., Deng, W. et al.

Nat Hum Behav (2021). 

https://doi.org/10.1038/s41562-021-01207-4

Abstract

Predicting the behaviour of others is an essential part of social cognition. Despite its ubiquity, social prediction poses a poorly understood generalization problem: we cannot assume that others will repeat past behaviour in new settings or that their future actions are entirely unrelated to the past. We demonstrate that humans solve this challenge using a structure learning mechanism that uncovers other people’s latent, unobservable motives, such as greed and risk aversion. In four studies, participants (N = 501) predicted other players’ decisions across four economic games, each with different social tensions (for example, Prisoner’s Dilemma and Stag Hunt). Participants achieved accurate social prediction by learning the stable motivational structure underlying a player’s changing actions across games. This motive-based abstraction enabled participants to attend to information diagnostic of the player’s next move and disregard irrelevant contextual cues. Participants who successfully learned another’s motives were more strategic in a subsequent competitive interaction with that player in entirely new contexts, reflecting that social structure learning supports adaptive social behaviour.

Significance statement

A hallmark of human cognition is being able to predict the behavior of others. How do we achieve social prediction given that we routinely encounter others in a dizzying array of social situations? We find people achieve accurate social prediction by inferring another’s hidden motives—motives that do not necessarily have a one-to-one correspondence with observable behaviors. Participants were able to infer another’s motives using a structure learning mechanism that enabled generalization.  Individuals used what they learned about others in one setting to predict their actions in an entirely new setting. This cognitive process can explain a wealth of social behaviors, ranging from strategic economic decisions to stereotyping and racial bias.

From the Discussion

How do people construct and apply abstracted mental models of others’ motives? Our data suggest that attention plays a key role in guiding this process. Attention is a fundamental cognitive mechanism as it affords optimal access to behaviorally relevant information with limited processing capacity. Our findings show how attention supports social prediction. In the Social Prediction Game, as in everyday social interactions, there were multiple cues that could be predictive of another’s behavior, from the player payoffs S and T to the order of the games or even the initials of the player. Structure learning allowed participants to disregard superficial cues and attend to information relevant to the players’ latent motives. Although this process facilitated accurate social prediction with limited effort if the inferred motives were correct, incorrect structure learning caused counterproductive attention on irrelevant information. For example, participants who did not consider risk aversion failed to shift their attention to the sucker’s payoff (S) during the Pessimist block and instead kept looking at the temptation to defect (T), thereby missing out on information predictive of the player’s choices. This suggests that what we can learn about other people is limited by our expectations.

A pdf of the research is here.

Neural computations in children’s third-party interventions are modulated by their parents’ moral values

Kim, M., Decety, J., Wu, L. et al.

npj Sci. Learn. 6, 38 (2021). 

https://doi.org/10.1038/s41539-021-00116-5

Abstract

One means by which humans maintain social cooperation is through intervention in third-party transgressions, a behaviour observable from the early years of development. While it has been argued that pre-school age children’s intervention behaviour is driven by normative understandings, there is scepticism regarding this claim. There is also little consensus regarding the underlying mechanisms and motives that initially drive intervention behaviours in pre-school children. To elucidate the neural computations of moral norm violation associated with young children’s intervention into third-party transgression, forty-seven preschoolers (average age 53.92 months) participated in a study comprising of electroencephalographic (EEG) measurements, a live interaction experiment, and a parent survey about moral values. This study provides data indicating that early implicit evaluations, rather than late deliberative processes, are implicated in a child’s spontaneous intervention into third-party harm. Moreover, our findings suggest that parents’ values about justice influence their children’s early neural responses to third-party harm and their overt costly intervention behaviour.

From the Discussion

Our study further provides evidence that children, as young as 3 years of age, can enact costly third-party intervention by protesting and reporting. Previous research has shown that young children from age 3 enact third-party punishment to transgressors shown in video or puppets9,10. In the present study, in the context of real-life transgression experiment, even the youngest participant (41 months old) engaged in costly intervention, by hinting disapproval to the adult transgressor (why are you doing that?) and subsequently reporting the damage when being prompted. During the experiment, confounding factors such as a sense of ‘responsibility’, were avoided by keeping the person playing the ‘research assistant’ role out of the room when the transgression occurred. Furthermore, when leaving the room, the ‘research assistant’ did not assign the children any special role to police or monitor the actions of the ‘visitor’ (who would transgress). Moreover, the transgressor was not an acquaintance of the child, and the book was said to belong to a university (not a child’s school nor researchers), hence giving little sense of in-group/out-group membership11,60. Also, the participating children would likely attribute ‘power’ and ‘authority’ to the visitor/transgressor, as an adult26. Nevertheless, in the real-life experimental context, 34.8% of children explicitly protested to the adult wrong-doer.

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It should be emphasized that parent’s cognitive empathy was not implicated in the child’s neural computations of moral norms or their spontaneous intervention behaviour. However, parents’ cognitive empathy had a positive correlation with a child’s effortful control and their subsequent report behaviour. This distinct contribution made by two different dispositions (cognitive empathy and justice sensitivity) suggests that parenting strategies necessary to enhance a child’s moral development require both aspects: perspective-taking and understanding of moral values. 

The research is here.

Psychopathy and Moral-Dilemma Judgment: An Analysis Using the Four-Factor Model of Psychopathy and the CNI Model of Moral Decision-Making

Luke, D. M., Neumann, C. S., & Gawronski, B.

(2021). Clinical Psychological Science. 

https://doi.org/10.1177/21677026211043862

Abstract

A major question in clinical and moral psychology concerns the nature of the commonly presumed association between psychopathy and moral judgment. In the current preregistered study (N = 443), we aimed to address this question by examining the relation between psychopathy and responses to moral dilemmas pitting consequences for the greater good against adherence to moral norms. To provide more nuanced insights, we measured four distinct facets of psychopathy and used the CNI model to quantify sensitivity to consequences (C), sensitivity to moral norms (N), and general preference for inaction over action (I) in responses to moral dilemmas. Psychopathy was associated with a weaker sensitivity to moral norms, which showed unique links to the interpersonal and affective facets of psychopathy. Psychopathy did not show reliable associations with either sensitivity to consequences or general preference for inaction over action. Implications of these findings for clinical and moral psychology are discussed.

From the Discussion

In support of our hypotheses, general psychopathy scores and a superordinate latent variable (representing the broad syndrome of psychopathy) showed significant negative relations with sensitivity to moral norms, which suggests that people with elevated psychopathic traits were less sensitive to moral norms in their responses to moral dilemmas in comparison with other people. Further analyses at the facet level suggested that sensitivity to moral norms was uniquely associated with the interpersonal-affective facets of psychopathy. Both of these findings persisted when controlling for gender. As predicted, the antisocial facet showed a negative zero-order correlation with sensitivity to moral norms, but this association fell to nonsignificance when controlling for other facets of psychopathy and gender. At the manifest variable level, neither general psychopathy scores nor the four facets showed reliable relations with either sensitivity to consequences or general preference for inaction over action.

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More broadly, the current findings have important implications for both clinical and moral psychology. For clinical psychology, our findings speak to ongoing questions about whether people with elevated levels of psychopathy exhibit disturbances in moral judgment. In a recent review of the literature on psychopathy and moral judgment, Larsen et al. (2020) claimed there was “no consistent, well-replicated evidence of observable deficits in . . . moral judgment” (p. 305). However, a notable limitation of this review is that its analysis of moral-dilemma research focused exclusively on studies that used the traditional approach. Consistent with past research using the CNI model (e.g., Gawronski et al., 2017; Körner et al., 2020; Luke & Gawronski, 2021a) and in contrast to Larsen et al.’s conclusion, the current findings indicate substantial deviations in moral-dilemma judgments among people with elevated psychopathic traits, particularly conformity to moral norms.

The research is here.

Network Structure Impacts the Synchronization of Collective Beliefs

Vlasceanu, M., Morais, M. J., & Coman, A. 

(2021). Journal of Cognition and Culture.

Abstract

People’s beliefs are influenced by interactions within their communities. The propagation of this influence through conversational social networks should impact the degree to which community members synchronize their beliefs. To investigate, we recruited a sample of 140 participants and constructed fourteen 10-member communities. Participants first rated the accuracy of a set of statements (pre-test) and were then provided with relevant evidence about them. Then, participants discussed the statements in a series of conversational interactions, following pre-determined network structures (clustered/non-clustered). Finally, they rated the accuracy of the statements again (post- test). The results show that belief synchronization, measuring the increase in belief similarity among individuals within a community from pre-test to post-test, is influenced by the community’s conversational network structure. This synchronization is circumscribed by a degree of separation effect and is equivalent in the clustered and non- clustered networks. We also find that conversational content predicts belief change from pre-test to post-test.

From the Discussion

Understanding the mechanisms by which collective beliefs take shape and change over time is essential from a theoretical perspective (Vlasceanu, Enz, Coman, 2018), but perhaps even more urgent from an applied point of view.  This urgency is fueled by recent findings showing that false news diffuse farther, faster, deeper, and more broadly than true ones in social networks (Vosoughi, Roy, Aral, 2018), and that news can determine what people discuss and even change their beliefs (King, Schneer, White, 2017). And given that beliefs influence people’s behaviors (Shariff & Rhemtulla, 2012; Mangels, Butterfield, Lamb, Good, Dweck, 2006; Ajzen, 1991; Hochbaum, 1958), understanding the dynamics of collective belief formation is of vital social importance as they have the potential to affect some of the most impending threats our society is facing from pandemics (Pennycook, McPhetres, Zhang, Rand, 2020) to climate change (Benegal & Scruggs, 2018). Thus, policy makers could use such findings in designing misinformation reduction campaigns targeting communities (Dovidio & Esses, 2007; Lewandowsky et al., 2012). For instance, these findings suggest such campaigns be sensitive of the conversational network structures of their targeted communities. Knowing how members of these communities are connected, and leveraging the finding that people synchronize their beliefs mainly with individuals they are directly connected to, could inform intervention designers how communities with different connectivity structures might respond to their efforts. For example, when targeting a highly interconnected group, intervention designers could expect that administering the intervention to a few well-connected individuals will have a strong impact at the community level. In contrast, when targeting a less interconnected group, intervention designers could administer the intervention to more central individuals for a comparable effect. 

The research is here.