Interchangeability of biosimilars: A study of expert views and visions regarding the science and substitution

Healthcare systems have reached a critical point regarding the question of whether biosimilar substitution should become common practice. To move the discussion forward, the study objective was to investigate the views of experts from medicines agencies and the pharmaceutical industry on the science underpinning interchangeability of biosimilars. We conducted an empirical qualitative study using semi-structured interviews informed by a cross-disciplinary approach encompassing regulatory science, law, and pharmaceutical policy. In total 25 individuals with experience within biologics participated during September 2018–August 2019. Eight participants were EU national medicines authority regulators, and 17 had pharmaceutical industry background: five from two originator-only companies, four from two companies with both biosimilar and originator products, and eight from seven biosimilar-only companies. Two analysts independently conducted inductive content analysis, resulting in data-driven themes capturing the meaning of the data. The participants reported that interchangeability was more than a scientific question of likeness between biosimilar and reference products: it also pertained to regulatory practices and trust. Participants were overall confident in the science behind exchanging biosimilar products for the reference products via switching, i.e., with physician involvement. However, their opinions differed regarding the scientific risk associated with biosimilar substitution, i.e., without physician involvement. Almost all participants saw no need for additional scientific data to support substitution. Moreover, the participants did not believe that switching studies, as required in the US, were appropriate for obtaining scientific certainty due to their small size. It is unclear why biosimilar switching is viewed as scientifically safer than substitution; therefore, we expect greater policy debate on biosimilar substitution in the near future. We urge European and UK policymakers and regulators to clarify their visions for biosimilar substitution; the positions of these two frontrunners are likely to influence other jurisdictions on the future of biosimilar use.

The Origin of the SARS‑CoV‑2 in the United States as a Biological Weapon

Introduction: The SARS-CoV-2 virus was first reported in Wuhan China in Dec 2019, since then 279 million have been infected and 5.4 million have died. This has raised the question where did the SARs-CoV-2 virus originate? Methodology: In this study, the literature was reviewed, and the scientific and intelligence evidence assessed. Interviews were made with scientists and victims involved in the creation of the virus in both the United States and China. Results: The evidence suggest that the SARs-CoV-2 virus began as bat virus which was then manipulated in the lab via gain of function research in the United States funded by the National Institutes of Health under Dr. Fauci. This proto-biological weapon was then given to the Chinese and passed through Uighur prisoners. It is hypothesized that the modest common Altaic ancestry between American Native Americans and the Uighur from North Central Asia may in part account for the increased death rates of Native Americans in the United States. Conclusion: The SARS- CoV-2 virus with near scientific certainty originated in the United States as a proto-biological weapon which was further clinically developed in China in a collaborative effort as a biological weapon to target ethnic and racial minorities by both China and the United States.

Joseph Ratzinger’s Argument for the Epistemological Seriousness of Faith

Christianity, and the Christian faith, seems to be losing when confronted with scientific reason and scientific certainty. Christianity needs new arguments for the epistemological seriousness of its faith. Those could be found in Joseph Ratzinger’s writings, providing new insights into fundamental theology. The subject of faith as an element that is crucial to him (and to Christianity) pervades all his works. This paper aims at proving that Ratzinger has worked out an original epistemological way of defending the Christian faith. It is an attempt to recreate his argument on the basis of his entire intellectual output. The present research leads to the conclusion that Ratzinger’s way of argumentation is quite unique. In classical fundamental theology, the Christian faith (comprehended mostly as an individual act of faith) is placed at its end point, while in Ratzinger’s fundamental theology, faith (understood mostly as a historical and communal act) is practically a point of departure. From the beginning of his reasoning Ratzinger (due to his meta-faith perspective) persuades that the Christian faith is epistemologically very serious. Faith may not only manifest its presence alongside other serious attitudes to reality, but also be capable of demonstrating its foundation, rationality, originality, uniqueness, and even absoluteness (definitiveness).

Alfred Newton’s second-hand histories of extinction: hearsay, gossip, misapprehension (William T. Stearn Student Essay Prize 2020)

The study of extinction was rooted in Victorian naturalists’ practices of observation and collection, but presented a challenge to the discipline’s increasing emphasis on empiricism and precision. This paper traces the role of witness testimony and hearsay accounts in early studies of extinction, as preserved in the notebooks of Cambridge zoology professor, Alfred Newton. Beginning in 1850s, Newton and his collaborators sought to trace the histories of suspected extinct species such as the British great bustard and the great auk of Iceland. With its subject absent by definition, the study of extinction relied on hearsay and rumour as well as evidence gleaned from past published accounts. Through methodical attempts to collate diverse and contradictory sources, from eyewitnesses to newspapers to local folklore and gossip, Newton demonstrated the inextricability of human activities from the practice of studying extinction. These attempts to resolve social evidence into scientific certainty were time and again frustrated by the uncertain epistemic status of his sources.

The management of post-consumer pharmaceutical waste: a comparison between British Columbia and Ontario programs

The presence of pharmaceutical waste in the environment is an emerging concern. The challenges of achieving high levels of scientific certainty concerning its impacts has motivated jurisdictions to adopt medications return programs (MRPs) to safely manage the public’s post-consumer pharmaceuticals (i.e. unused/expired drugs). There are several variables for governments to consider when implementing MRPs, particularly when based on extended producer responsibility (EPR). This comparative policy analysis examined regulatory MRPs in British Columbia and Ontario as cases to compare and evaluate. It developed 12 criteria for an optimal MRP consistent with EPR practices, including key performance measures, and applied them to evaluate the British Columbia and Ontario programs. It then explored Ontario’s revised MRP, launched in 2013, to determine if the positive and negative indicators from British Columbia’s long-standing program have been incorporated, and analyzed if policy lesson-drawing or policy convergence occurred in practice.

The management of post-consumer pharmaceutical waste: a comparison between British Columbia and Ontario programs

The presence of pharmaceutical waste in the environment is an emerging concern. The challenges of achieving high levels of scientific certainty concerning its impacts has motivated jurisdictions to adopt medications return programs (MRPs) to safely manage the public’s post-consumer pharmaceuticals (i.e. unused/expired drugs). There are several variables for governments to consider when implementing MRPs, particularly when based on extended producer responsibility (EPR). This comparative policy analysis examined regulatory MRPs in British Columbia and Ontario as cases to compare and evaluate. It developed 12 criteria for an optimal MRP consistent with EPR practices, including key performance measures, and applied them to evaluate the British Columbia and Ontario programs. It then explored Ontario’s revised MRP, launched in 2013, to determine if the positive and negative indicators from British Columbia’s long-standing program have been incorporated, and analyzed if policy lesson-drawing or policy convergence occurred in practice.

Effect of COVID 19 on thyroid gland function

The pandemic caused by the new Coronavirus (SARS-CoV-2) and the disease induced by it (Coronavirus Disease or COVID-19) has been filling the pages of newspapers, television news and websites for days. It is a new virus, which until a few months ago probably lived only in bats, about which there is little scientific certainty about humans. The few evidences, however, are constantly updated and evolving. It is therefore not uncommon to come across information from unreliable sources and / or without any scientific basis. As far as possible, I will try to shed some light on the possible relationships between the new SARS-CoV-2 coronavirus and the endocrinological system. This article, therefore, is the result of a completely personal research carried out in scientific journals, international scientific research sites and on the opinion of experts in the sector (expert opinions). It does not presume to be exhaustive, as the current certainties are very few and in any case must be interpreted dynamically since the scientific framework is constantly evolving. In essence, the information reported at the time of writing this article is based on what is currently known about the COVID-19 infection, but could be outdated in the coming months, based on the finding of new scientific evidence. Keywords: Effect, COVID 19, thyroid, gland, function

Tenuous relations: Ethnic–racial cultural and police disrespect in Finland

The relationship between ethnic–racial cultural communities and the Finnish police is evolving, and relatively little research is available within the criminal justice system that highlights police practices and behaviour towards ethnic and racial cultural in Finland. There is also a lack of scientific certainty about how to assess ethnic and racial cultural’ experiences of fair, unfair and impolite treatment by the police. The available research suggests that the experiences of Black and other ethnic–racial cultural groups in the criminal justice system differs from that of the ethnic majority population, and this tends to increase the tense relationship between the police and ethnic–racial cultural communities. The data on which this article is based were collected between April 2013 and July 2015 among ethnic and racial cultural groups from three different sites to explore ethnic cultural perceptions of legal authority in Finland. The experiences of 205 people with a cultural ethnic background were used to examine ethnic–racial cultural views on four types of police behaviour—respect, fairness, politeness and courtesy—in deciding whether to trust or distrust the police. We compared adverse encounters between members of ethnic and racial cultural communities and the police using a mixed-methods approach to procedural justice in a questionnaire and face-to-face interviews. The study indicates that hostile police humour contributes to a negative attitude, fear and lack of trust towards the police, whereas every respectful interaction brings about a positive attitude.

Early Lessons of COVID-19 for Governance of the North American Great Lakes and the Baltic Sea

The commitment to advance the protection of the North American Great Lakes and the Baltic Sea continues during the COVID-19 pandemic. The resilience of the research community was displayed as policy decisions were made for the first virtual conferences this year to share scientific findings and expertise in both regions. As this pandemic continues to challenge the world, countries have responded to the threat and continue to deal with the uncertainties of this wicked transboundary problem in many different ways. This article discusses key governance and policy issues that have been revealed thus far that can inform the governance of the transboundary North American Great Lakes and the Baltic Sea. Key lessons from the pandemic include waiting for total scientific certainty to act can lead to fatal consequences and our symbiotic connection with nature. Further insights from the pandemic include the importance of context, science-based leadership, institutional accountability, and acknowledging that nature knows no borders.

Towards an Expanded Conception of Publication Bias

This short essay argues for an expanded conception of publication bias. In addition to consideringthe selective publication of results, I argue that we need to also consider the selective publicationof epistemic by-products—observations and knowledge that scientists accumulate incidentallyin the process of carrying out their work. There are three reasons why we should be concernedabout the exclusion of epistemic by-products from the published literature: first, because theyplay an important role in robust replication attempts; second, because their absence can resultin misplaced scientific certainty; and third, because they contribute to a holistic understandingof natural phenomena. However, identifying and addressing publication bias against epistemicby-products and other undervalued forms of knowledge is more difficult than identifying biasagainst quantitative findings. I argue that scientific pluralism and making data publicly accessibleare two potential remedies for addressing this form of publication bias.