Tuesday, May 16, 2023

Gatekeepers of Extermination: SS Camp Physicians and Their Scope of Action

Author, Article, and Disclosure Information

Abstract

The role of camp physicians of the Waffen-SS (“Armed SS,” military branch of the Nazi Party’s Schutzstaffel) in the implementation of the Holocaust has been the subject of limited research, even though they occupied a key position in the extermination process. From 1943 and 1944 onward, SS camp physicians made the individual medical decisions on whether each prisoner was fit for work or was immediately subjected to extermination, not only at the Auschwitz labor and extermination camp but also in pure labor camps like Buchenwald and Dachau. This was due to a functional change in the concentration camp system during World War II, where the selection of prisoners, which had previously been carried out by nonmedical SS camp staff, became a main task of the medical camp staff. The initiative to transfer sole responsibility for the selections came from the physicians themselves and was influenced by structural racism, sociobiologically oriented medical expertise, and pure economic rationality. It can be seen as a further radicalization of the decision making practiced until then in the murder of the sick. However, there was a far-reaching scope of action within the hierarchical structures of the Waffen-SS medical service on both the macro and micro levels. But what can this teach us for medical practice today? The historical experience of the Holocaust and Nazi medicine can provide a moral compass for physicians to be sensitive to the potential for abuse of power and ethical dilemmas inherent in medicine. Thus, the lessons from the Holocaust could be a starting point for reflecting on the value of human life in the modern economized and highly hierarchical medical sector.


Gatekeepers of Extermination: SS Camp Physicians and Their Scope of Action
Nico Biermanns, MEd
History of Medicine
Abstract: https://www.acpjournals.org/doi/10.7326/M23-0362

Huneke wins grant to research lesbians in the Third Reich


Grant and Award Announcement

GEORGE MASON UNIVERSITY

Samuel Clowes Huneke, Assistant Professor, History and Art History, has been awarded a Sharon Abramson Research Grant from the Holocaust Educational Foundation of Northwestern University. The award will enable him to complete research for his forthcoming book on lesbians in Nazi Germany. 

For many decades after the end of World War II, the fates of queer women were ignored. Because female homosexuality had not been criminalized explicitly, historians long argued that lesbians were not persecuted by the Nazi regime.  

In contrast, Huneke’s book, which is under advanced contract with Aevo-University of Toronto Press, argues that queer women under Nazism faced forms of persecution shaped by misogyny as well as anti-gay animus. The book further contends that in spite of this persecution, queer women sought to carve out spaces of community and tolerance for themselves and that their tenacity in the face of fascism can serve as a model for queer politics in our own time. 

The Holocaust Educational Foundation of Northwestern University awards Sharon Abramson Research Grants annually to support research related to the Holocaust. 

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About George Mason University

George Mason University is Virginia's largest public research university. Located near Washington, D.C., Mason enrolls 38,000 students from 130 countries and all 50 states. Mason has grown rapidly over the last half-century and is recognized for its innovation and entrepreneurship, remarkable diversity and commitment to accessibility. Learn more at http://www.gmu.edu.

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Unique insights into COVID-19 impact on human experience


New book provides insightful perspective on COVID-19 impact on human experience


Book Announcement

BENTHAM SCIENCE PUBLISHERS

Bentham Science’s latest book on COVID-19, COVID-19: Origin, Impact and Management, is now published, offering a comprehensive summary of recent findings on the impact of COVID-19 on various aspects of human life. The book is edited by expert scientists, and features contributions from academicians and scholars from leading institutions in India. It provides readers from science, humanities and commerce backgrounds with a valuable and interdisciplinary perspective on the pandemic.

With a focus on findings from India, the book covers a range of topics including the effects of COVID-19 on physical and psychological well-being, loss of jobs, pay cuts, education, and unpaid caregiving. The book also blends basic and applied research in biology, medicine and social science to offer readers a comprehensive view of the effects of the outbreak.

The book's key features include updated references for advanced readers, and interdisciplinary content making it useful for researchers and working professionals in industry and academia. Its blend of basic and advanced research provides general readers with a broad and insightful perspective on COVID-19's impact on the human experience.

The first part of this book includes interesting topics such as a review on organophosphates and SARS-CoV-2 in connection with severe respiratory disease, the moderating effect of government stimulus programs, psychological distress and COVID-19, the diversified impact of COVID-19 on the development of children, and more.

COVID-19 has affected the lives of people across the globe, and this book offers a valuable resource for those seeking to understand the pandemic's impact. The book is expected to be a valuable addition to the literature on COVID-19 and its effects on human life.

To learn more about COVID-19 and its impact on various aspects of human life, please visit the site.


Experts say it’s not yet time to take off masks in the health care setting

Embargoed News from Annals of Internal Medicine

Peer-Reviewed Publication

AMERICAN COLLEGE OF PHYSICIANS

1. Experts say it’s not yet time to take off masks in the health care setting
Abstract: https://www.acpjournals.org/doi/10.7326/M23-1190
URL goes live when the embargo lifts


A new commentary from infectious disease experts at George Washington University School of Medicine and the National Institutes of Health (NIH) says for patient safety, masking should continue in health care settings. This message conflicts with a recent commentary from authors from 8 U.S. institutions suggesting that the time for universal masking is over. The commentary is published in Annals of Internal Medicine.

Masking has been a controversial mitigation strategy during the COVID-19 pandemic because high-quality evidence of efficacy is lacking and because the topic has become highly politicized. Regardless, real-world experience demonstrates the effectiveness of mask-wearing in clinical settings where data shows that transmission from patient-to-staff and staff-to-patent, when both are masked, is uncommon. Since health care personnel report being driven to show up for work even when they are ill themselves, the argument in support of mask-wearing becomes even more compelling.

Those without symptoms may also transmit respiratory viruses, particularly SARS-CoV-2. While the Omicron strain has been milder, infection could still cause severe or life-threatening disease or prolonged illness if transmitted to at-risk patients, such as the elderly or immunocompromised. With the still-looming risks, now does not seem the time to take off masks in the health care setting. Instead, the authors advocate strongly for continued mask use for infection prevention.

Media contacts: For an embargoed PDF, please contact Angela Collom at acollom@acponline.org. To speak with corresponding author David K. Henderson, MD, please email dhenderson@cc.nih.gov.
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2. Updated evidence suggests masks may reduce risk for SARS-CoV-2 infection in community and health care settings
A beneficial effect of N95 respirators in health care settings could not be ruled out
Abstract: https://www.acpjournals.org/doi/10.7326/M23-0570
Editorial: https://www.acpjournals.org/doi/10.7326/M23-1120
URL goes live when the embargo lifts
The final and major update to a rapid, living review of published evidence suggests that masks may be associated with a small reduction in risk for COVID-19 infection in community settings versus no mask use and both surgical masks and N95 respirators may be associated with similar infection risk in routine patient care settings. However, a beneficial effect of N95 respirators could not be ruled out in the health care setting. The review is published in Annals of Internal Medicine.

In June 2020, Annals published an initial living review of research on mask use which found insufficient evidence to determine effects of masks on COVID-19 infection. The initial review was followed by eight brief updates that found low to moderate strength evidence for an association between mask use and decreased risk for SARS-CoV-2 infection in community settings, but evidence on N95 versus surgical masks in health care settings and risk for COVID-19 infection remained insufficient. This 9th and final review is different because it includes enough evidence to be considered a major update.

Investigators from Oregon Health & Science University reviewed three randomized trials and 21 observational studies to update an evidence synthesis on N95, surgical, and cloth mask effectiveness in community and health care settings for preventing SARS-CoV-2 infection. The authors found that mask use may be associated with a small, reduced risk for COVID-19 infection versus no mask use in community settings. However, they note that that the interventions, settings, and populations included in the reviewed studies varied and adherence was suboptimal, which may have impacted outcomes. The authors note that trial and observational studies of surgical or N95 mask use compared with no mask were imprecise or limited, with evidence on other mask comparisons in health care settings remaining insufficient.

An accompanying editorial by Annals Editor-in-Chief Christine Laine, MD, MPH and Deputy Editor Stephanie Chang, MD, MPH provides important context for understanding why recent evidence reviews do not provide a definitive answer about the benefits of masking. Studies vary widely in what they are designed to determine, such as the effectiveness of masks at preventing viral penetration or the effectiveness of masking recommendations. Because these studies are conducted in the real world where infection risk-reduction strategies also vary, it may be difficult to determine the effectiveness of a single component of that strategy. And finally, the authors say we must be explicit in weighing benefits and harms. While some may consider any evidence of benefit sufficient to justify masking, others believe that inconvenience, discomfort, or communication impedance outweigh small benefits. To get to the truth about masking, the authors say it is imperative to design studies that fill information gaps, interpret the evidence accurately, and are honest about what we do and do not know.

Media contacts: For an embargoed PDF, please contact Angela Collom at acollom@acponline.org. To speak with corresponding author Roger Chou, MD, please contact Erik Robertson at robineri@ohsu.edu.
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3. Adding a single data point to COVID-19 reporting may more accurately convey the real-time burden of infection in health care settings
Abstract: https://www.acpjournals.org/doi/10.7326/M23-0618
URL goes live when the embargo lifts
In a new ‘Medicine and Public Issues,’ authors from Tufts Medical Center, Veterans Affairs Boston Healthcare System, Harvard Medical School and the Massachusetts Department of Public Health advocate for the inclusion of both the total number of COVID-19 hospitalizations daily and the number of inpatients who received dexamethasone at any point during their hospital stay. The authors emphasize that the addition of this data element is an easy and much-needed update to COVID-19 surveillance efforts that may help to more accurately convey the real-time burden of a rapidly changing infection in health care settings. The article is published in Annals of Internal Medicine.

On 10 January 2022, the Massachusetts Department of Public Health (MDPH) began requiring hospitals to expand surveillance to include reports of both the total number of COVID-19 hospitalizations daily and the number of inpatients who received dexamethasone at any point during their hospital stay. This requirement was added because dexamethasone administration had been shown to be highly correlated with disease severity and was sensitive to the changing epidemiology of new immune-evasive COVID-19 variants.

The authors highlight that the purpose of the ongoing requirement by the MDPH to report dexamethasone is not to minimize pandemic impacts, but to instead understand the ongoing burden of the pandemic in the setting of a changing landscape of population immunity and viral variants. The authors point to COVID-19 data collected from all 68 acute care hospitals in Massachusetts between January 2022 and January 2023, which show that the proportion of persons hospitalized for COVID-19 who received dexamethasone decreased from 49.6 to 33 percent. According to the authors, these data have been used to communicate risk and weigh community-level recommendations by health authorities. They also emphasize that their experience highlights the importance of ongoing review and reevaluation to maintain the utility and predictive value of public health surveillance definitions.

Media contacts: For an embargoed PDF, please contact Angela Collom at acollom@acponline.org. To speak with corresponding author Shira Doron, MD, MS, please email Jeremy Lechan at jlechan@tuftsmedicalcenter.org.

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The number of the world's farms to halve by 2100, study shows

Peer-Reviewed Publication

UNIVERSITY OF COLORADO AT BOULDER

New University of Colorado Boulder research shows the number of farms globally will shrink in half as the size of the average existing farms doubles by the end of the 21st century, posing significant risks to the world’s food systems.

Published today in the journal Nature Sustainability, the study is the first to track the number and size of farms year-over-year, from the 1960s and projecting through 2100.

The study shows that even rural, farm-dependent communities in Africa and Asia will experience a drop in the number of operating farms.

“We see a turning point from widespread farm creation to widespread consolidation on a global level, and that's the future trajectory that humanity is currently on,” said Zia Mehrabi, assistant professor of environmental studies at CU Boulder. “The size of the farm and the number of farms that exist are associated with key environmental and social outcomes.”

To evaluate the global state of farming, Mehrabi used data from the UN Food and Agricultural Organization on agricultural area, GDP per capita and rural population size of more than 180 countries to first reconstruct the evolution of farm numbers from 1969-2013 and then to project those numbers through 2100.

His analysis found that the number of farms around the world would drop from 616 million in 2020 to 272 million in 2100. A key reason: As a country’s economy grows, more people migrate to urban areas, leaving fewer people in rural areas to tend the land.

Reap what you sow

A decline in the number of farms and an increase in farm size has been happening in the United States and Western Europe for decades. The most recent data from the U.S. Department of Agriculture indicates there were 200,000 fewer farms in 2022 than in 2007.

Mehrabi’s analysis found that a turning point from farm creation to widespread consolidation will begin to occur as early as 2050 in communities across Asia, the Middle East, North Africa, Oceania, Latin America and the Caribbean. Sub-Saharan Africa will follow the same course later in the century, the research found.

It also shows that even if the total amount of farmland doesn't change across the globe in coming years, fewer people will own and farm what land there is available. The trend could threaten biodiversity in a time where biodiversity conservation is top of mind.

“Larger farms typically have less biodiversity and more monocultures,” Mehrabi said. “Smaller farms typically have more biodiversity and crop diversity, which makes them more resilient to pest outbreaks and climate shocks.”

And it’s not just biodiversity: Food supply is also at risk. Mehrabi’s previous research shows the world’s smallest farms make up just 25% of the world’s agricultural land but harvest one-third of the world’s food.

Moreover, fewer farms mean fewer farmers who may carry with them valuable Indigenous knowledge dating back centuries. As farms consolidate, that knowledge is replaced by new technology and mechanisation.

Building a diverse food portfolio

Just as a diverse investment portfolio performs better than one that is not diversified, having diversity in the world’s food source portfolio is beneficial in the long run, said Mehrabi.

“If you’re investing in today’s food systems with around 600 million farms in the world, your portfolio is pretty diverse,” Mehrabi said. “If there’s damage to one farm, it’s likely the impact to your portfolio will be averaged out with the success of another. But if you decrease the number of farms and increase their size, the effect of that shock on your portfolio is going to increase. You’re carrying more risk.”

There are also upsides to the shift in corporate farm ownership: The paper points out that consolidation in farming can lead to improved labor productivity and economic growth with a larger workforce in non-farm employment and improved management systems.

One of the biggest benefits of farm consolidation, Mehrabi said, is improved economic opportunity for people, and the ability to choose their own career path within our outside of the agricultural sector.

But those future farm workers may need more support as suicide rates in the agriculture industry are among the highest rates by occupation in the U.S.

“Currently, we have around 600 million farms feeding the world, and they’re carrying 8 billion people on their shoulders,” Mehrabi said. “By the end of the century, we’ll likely have half the number of farmers feeding even more people. We really need to think about how we can have the education and support systems in place to support those farmers."

By raising awareness of global agricultural trends, Mehrabi hopes his analysis will lead  to policies that ensure biodiversity conservation, maintain climate resilience, preserve Indigenous knowledge and provide incentives to improve the rural economy in countries around the world.

Investigation raises questions over lack of “substantial evidence” for FDA approved antibiotic

Did new antibiotic meet the legal standard for approval? Are US drug regulatory rules being bypassed?

Peer-Reviewed Publication

BMJ

Drugs approved in the US require “substantial evidence” that they are effective. But an investigation by The BMJ into the recent approval of the antibiotic Recarbrio from Merck suggests that these standards are being bypassed.

Peter Doshi, senior editor at The BMJ, describes how US Food and Drug Administration (FDA) scientists had serious doubts about Recarbrio - a product 40 times more expensive than an existing generic alternative - but the agency approved it anyway.

Did the FDA break its own rules in approving this antibiotic, and what does this case tell us about problems within the agency, he asks? 

Recarbrio is a combination therapy made up of a new beta-lactamase inhibitor (relebactam) and a decades old Merck antibiotic (imipenem-cilastatin) to treat complicated infections. It costs between $4,000 and $15,000 for a course, compared with a couple of hundred dollars for the generic version of Merck’s old antibiotic.

In its FDA application, Merck submitted results from two clinical trials comparing Recarbrio with imipenem in adults with complicated urinary tract infections and in patients with complex intra-abdominal infections.

But FDA reviewers noted that Merck had studied the wrong patient population to evaluate the added benefits of the new drug, and said the trial for urinary tract infections showed that Recarbrio was as much as 21% worse in effectiveness than the older, less-expensive imipenem.

The FDA concluded that “these studies are not considered adequate and well-controlled.” And of a third clinical study, the FDA called it a “very small,” “difficult to interpret” “descriptive trial with no pre-specified plans for hypothesis testing.”

Yet despite all three clinical studies not providing substantial evidence of effectiveness, FDA approved Recarbrio.

“Instead of basing its decision on the clinical trials in Merck’s application, FDA’s determination of Recarbrio’s efficacy was justified on past evidence that imipenem was effective, plus - to justify the new relebactam component - in vitro (lab) studies and animal models of infection rather than evidence from human trials as required by law,” writes Doshi.

Others are concerned that Recarbrio’s approval essentially amounts to a return to a way of regulating medicines that the FDA abandoned a half century ago prior to the agency’s “substantial evidence” standard.

Doshi explains that, under specific circumstances, the Director of the Center for Drug Evaluation and Research (CDER) can waive in whole or in part the FDA’s “adequate and well-controlled studies” approval criteria. But the FDA told The BMJ ”there was no center director memo in the file” for Recarbrio.

And when The BMJ contacted Janet Woodcock, CDER Director at the time, and now the FDA’s Principal Deputy Commissioner, she said she was not aware that the clinical studies of Recarbrio did not provide substantial evidence of effectiveness.

Woodcock was also unable to confirm that approvals of new drugs require at least one clinical study of the drug itself that demonstrates substantial evidence - evidence lacking in the case of Recarbrio.

A spokesperson for CDER told The BMJ that FDA “applied regulatory flexibility” in approving Recarbrio. 

It is unclear whether this regulatory flexibility enabled FDA to conclude Recarbrio had met the legal “substantial evidence” standard without “adequate and well-controlled investigations” of Recarbrio, says Doshi. FDA declined to answer the question, saying “We have no additional information to provide.”

The decline of science at the FDA has become unmanageable, argues David Ross, associate clinical professor of medicine at George Washington University, School of Medicine and Health Sciences, and former FDA medical reviewer, in a linked commentary.

He describes Recarbrio’s approval as “shocking” and says while much of the blame must go to the FDA’s reliance on industry paid user fees for around two-thirds of its annual drugs budget, “the corruption of the FDA’s scientific culture remains the primary culprit driving the deterioration of safety and effectiveness standards.”

To address this “dismal situation” he suggests tapering the FDA’s dependence on user fees and improving public access to the information received by the FDA, its reasoning, and its decisions.

“The Recarbrio approval is a sentinel event, warning of a return to an era when drug effectiveness was an afterthought,” argues Ross. “Although the FDA crowed about this approval, it would have been better advised to remember that “for a successful technology, reality must take precedence over public relations, for nature cannot be fooled,” he concludes.