In 2022, students at North American universities with third-dose COVID-19 vaccine mandates risk disenrolment if unvaccinated. To assess the appropriateness of booster mandates in this age group, we combine empirical risk-benefit assessment and ethical analysis. To prevent one COVID-19 hospitalisation over a 6-month period, we estimate that 31 207–42 836 young adults aged 18–29 years must receive a third mRNA vaccine. Booster mandates in young adults are expected to cause a net harm: per COVID-19 hospitalisation prevented, we anticipate at least (...) 18.5 serious adverse events from mRNA vaccines, including 1.5–4.6 booster-associated myopericarditis cases in males (typically requiring hospitalisation). We also anticipate 1430–4626 cases of grade ≥3 reactogenicity interfering with daily activities (although typically not requiring hospitalisation). University booster mandates are unethical because they: (1) are not based on an updated (Omicron era) stratified risk-benefit assessment for this age group; (2) may result in a net harm to healthy young adults; (3) are not proportionate: expected harms are not outweighed by public health benefits given modest and transient effectiveness of vaccines against transmission; (4) violate the reciprocity principle because serious vaccine-related harms are not reliably compensated due to gaps in vaccine injury schemes; and (5) may result in wider social harms. We consider counterarguments including efforts to increase safety on campus but find these are fraught with limitations and little scientific support. Finally, we discuss the policy relevance of our analysis for primary series COVID-19 vaccine mandates. (shrink)

In times of crises, public health leaders may claim that trials of public health interventions are unethical. One reason for this claim can be that equipoise—i.e. a situation of uncertainty and/or disagreement among experts about the evidence regarding an intervention—has been disturbed by a change of collective expert views. Some might claim that equipoise is disturbed if the majority of experts believe that emergency public health interventions are likely to be more beneficial than harmful. However, such beliefs are not always (...) justified: where high quality research has not been conducted, there is often considerable residual uncertainty about whether interventions offer net benefits. In this essay we argue that high-quality research, namely by means of well-designed randomized trials, is ethically obligatory before, during, and after implementing policies in public health emergencies (PHEs). We contend that this standard applies to both pharmaceutical and non-pharmaceutical interventions, and we elaborate an account of equipoise that captures key features of debates in the recent pandemic. We build our case by analyzing research strategies employed during the COVID-19 pandemic regarding drugs, vaccines, and non-pharmaceutical interventions; and by providing responses to possible objections. Finally, we propose a public health policy reform: whenever a policy implemented during a PHE is not grounded in high-quality evidence that expected benefits outweigh harms, there should be a planned approach to generate high-quality evidence, with review of emerging data at preset time points. These preset timepoints guarantee that policymakers pause to review emerging evidence and consider ceasing ineffective or even harmful policies, thereby improving transparency and accountability, as well as permitting the redirection of resources to more effective or beneficial interventions. (shrink)

ABSTRACTDecisions that influence health and access to health care are necessarily a matter of ethics. This paper attempts to examine current budgetary allocations and policy shifts in India from the perspective of global ethical values. It also describes how global economic processes may increase health inequity nationally and argues that they should, therefore, be subject to global health ethics. Public health in India is in a state of crisis from a disinvestment in public health care services and persistent neglect, simultaneous (...) to the global push to enhance privatization. National health policies have remained oblivious to the unacceptably high inequity in access to health care on the one hand, and the cautionary analysis of the experience with currently chosen solutions through public-private- partnership and insurance models, which further marginalize the poorest. Global institutions such as the World Trade Organisation also influence national policies to benefit global business interests but often with detrimental effect upon equitable access to health and health care. The paper argues that the application of ethics must become more visible in the determination of national policies that are led by the dominant global paradigms of economic development to ensure that equitable access to health is prioritized. (shrink)

The COVID-19 vaccine has been a miraculous, life-saving advance, offering staggering efficacy in adults, and was developed with astonishing speed. The time from sequencing the virus to authorizing the first COVID-19 vaccine was so brisk even the optimists appear close-minded. Yet, simultaneously, United States’ COVID-19 vaccination roll-out and related policies have contained missed opportunities, errors, run counter to evidence-based medicine, and revealed limitations in the judgment of public policymakers. Misplaced utilization, contradictory messaging, and poor deployment in those who would benefit (...) most—the elderly and high-risk—alongside unrealistic messaging, exaggeration, and coercion in those who benefit least—young, healthy Americans—is at the heart. It is important to consider the history of COVID-19 vaccines to identify where we succeeded and where we failed, and the effects that these errors may have more broadly on vaccination hesitancy and routine childhood immunization programs in the decades to come. (shrink)

The U.S. Food and Drug Administration's drug advisory committees provide expert assessments of the safety and efficacy of new therapies considered for approval. A committee hears from a variety of speakers, from six groups, including voting members of the committee, FDA staff members, employees of the pharmaceutical company seeking approval of a therapy, patient and consumer representatives, expert speakers invited by the company, and public participants. The committees convene at the request of the FDA when the risks and harms of (...) novel products are not immediately clear, and their final decisions carry significant weight, as most therapies that receive advisory committee approval are subsequently approved by the FDA. In recent years, across a series of diverse publications, the financial conflicts of interest of each category of participants in the meetings have been investigated. Here, we summarize these findings and their ethical implications, focusing on the FDA Oncologic Drugs Advisory Committee, and we suggest ways to move toward more transparent and impartial advisory committee meetings. (shrink)

We thank Leo Lam and Taylor Nichols for their response 1 to our paper ‘COVID-19 vaccine boosters for young adults: a risk–benefit assessment and ethical analysis of mandate policies at universities’. 2 In our paper, we demonstrate that the risk–benefit calculus to mandate boosters for young adults aged 18–29 is a net risk intervention. The authors assert that we have made three inappropriate comparisons of benefits versus risks of the mRNA vaccine booster dose in this age group. We provide our (...) response to each below. We erred on the side of overestimating benefits of the booster dose against severe COVID-19 in this age group and still found net harms to outweigh net benefits. The conclusion of our paper holds, and university booster mandates for young people were—and remain—unethical. COVID-19 hospitalisations prevented versus booster serious adverse events (SAEs) For the first comparison, we weighed predicted hospitalisations prevented... (shrink)

Many physicians are involved in relationships that create tension between a physician's duty to work in her patients’ best interest at all times and her financial arrangement with a third party, most often a pharmaceutical manufacturer, whose primary goal is maximizing sales or profit. Despite the prevalence of this threat, in the United States and globally, the most common reaction to conflicts of interest in medicine is timid acceptance. There are few calls for conflicts of interest to be banned, and, (...) to our knowledge, no one calls for conflicted practitioners to be reprimanded. Contrast our attitudes in medicine with public attitudes toward financial conflicts among government employees. When enforcement of rules against conflict of interest slackens in the public sector, news organizations investigate and publish their criticism. Yet even when doctors are quoted in the media promoting specific drugs, their personal financial ties to the drug maker are rarely mentioned. Policies for governmental employees are strict, condemnation is strong, and criminal statutes exist (allowing for corruption charges). Yet the evidence that conflict is problematic is, if anything, stronger in medicine than in the public sector. Policies against conflicts of interest in medicine should be at least as strong as those already existing in the public sector. (shrink)

Many physicians are involved in relationships that create tension between a physician's duty to work in her patients’ best interest at all times and her financial arrangement with a third party, most often a pharmaceutical manufacturer, whose primary goal is maximizing sales or profit. Despite the prevalence of this threat, in the United States and globally, the most common reaction to conflicts of interest in medicine is timid acceptance. There are few calls for conflicts of interest to be banned, and, (...) to our knowledge, no one calls for conflicted practitioners to be reprimanded. Contrast our attitudes in medicine with public attitudes toward financial conflicts among government employees. When enforcement of rules against conflict of interest slackens in the public sector, news organizations investigate and publish their criticism. Yet even when doctors are quoted in the media promoting specific drugs, their personal financial ties to the drug maker are rarely mentioned. Policies for governmental employees are strict, condemnation is strong, and criminal statutes exist. Yet the evidence that conflict is problematic is, if anything, stronger in medicine than in the public sector. Policies against conflicts of interest in medicine should be at least as strong as those already existing in the public sector. (shrink)

Speaker recognition under mismatched conditions is a challenging task. Speech signal is nonlinear and nonstationary, and therefore, difficult to analyze under realistic conditions. Also, in real conditions, the nature of the noise present in speech data is not known a priori. In such cases, the performance of speaker identification or speaker verification degrades considerably under realistic conditions. Any SR system uses a voice activity detector as the front-end subsystem of the whole system. The performance of most VADs deteriorates at the (...) front end of the SR task or system under degraded conditions or in realistic conditions where noise plays a major role. Recently, speech data analysis and processing using Norden E. Huang’s empirical mode decomposition combined with Hilbert transform, commonly referred to as Hilbert–Huang transform, has become an emerging trend. EMD is an a posteriori, adaptive, data analysis tool used in time domain that is widely accepted by the research community. Recently, speech data analysis and speech data processing for speech recognition and SR tasks using EMD have been increasing. EMD-based VAD has become an important adaptive subsystem of the SR system that mostly mitigates the effect of mismatch between the training and the testing phase. Recently, we have developed a VAD algorithm using a zero-frequency filter-assisted peaking resonator and EMD. In this article, the efficacy of an EMD-based VAD algorithm is studied at the front end of a text-independent language-independent SI task for the speaker’s data collected in three languages at five different places, such as home, street, laboratory, college campus, and restaurant, under realistic conditions using EDIROL-R09 HR, a 24-bit wav/mp3 recorder. The performance of this proposed SI task is compared against the traditional energy-based VAD in terms of percentage identification rate. In both cases, widely accepted Mel frequency cepstral coefficients are computed by employing frame processing from the extracted voiced speech regions using the respective VAD techniques from the realistic speech utterances, and are used as a feature vector for speaker modeling using popular Gaussian mixture models. The experimental results showed that the proposed SI task with the VAD algorithm using ZFFPR and EMD at its front end performs better than the SI task with short-term energy-based VAD when used at its front end, and is somewhat encouraging. (shrink)

The performance of most of the state-of-the-art speaker recognition systems deteriorates under degraded conditions, owing to mismatch between the training and testing sessions. This study focuses on the front end of the speaker verification system to reduce the mismatch between training and testing. An adaptive voice activity detection algorithm using zero-frequency filter assisted peaking resonator was integrated into the front end of the SV system. The performance of this proposed SV system was studied under degraded conditions with 50 selected speakers (...) from the NIST 2003 database. The degraded condition was simulated by adding different types of noises to the original speech utterances. The different types of noises were chosen from the NOISEX-92 database to simulate degraded conditions at signal-to-noise ratio levels from 0 to 20 dB. In this study, widely used 39-dimension Mel frequency cepstral coefficient features were used, and Gaussian mixture model–universal background model was used for speaker modeling. The proposed system’s performance was studied against the energy-based VAD used as the front end of the SV system. The proposed SV system showed some encouraging results when EMD-based VAD was used at its front end. (shrink)

In this article, a new adaptive data-driven strategy for voice activity detection using empirical mode decomposition is proposed. Speech data are decomposed using an a posteriori, adaptive, data-driven EMD in the time domain to yield a set of physically meaningful intrinsic mode functions. Each IMF preserves the nonlinear and nonstationary property of the speech utterance. Among a set of IMFs, the IMF that contains source information dominantly called characteristic IMF can be identified and extracted by designing a zero-frequency filter-assisted peaking (...) resonator. The detected CIMF is used to compute energy using short-term processing. Choosing proper threshold, voiced regions in speech utterances are detected using frame energy. The proposed framework has been studied on both clean speech utterance and noisy speech utterance. The proposed method is used for voice activity detection in the presence of white noise and shows encouraging result in the presence of white noise up to 0 dB. (shrink)