Category: History

Photograph of a person holding an e-cigarette in one hand and traditional cigarettes in the other hand.

FDA’s Warning Letter to Juul & the First Amendment

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By Daniel Aaron

On September 10, 2019, the Food and Drug Administration (FDA) issued a warning letter to Juul asserting that the vaping manufacturer had violated federal law by illegally marketing its e-cigarettes as safer than other products. Citing evidence uncovered at a July 2019 House Subcommittee hearing as well as industry documents, FDA claims that Juul marketed its products as modified-risk tobacco products (MRTPs) without an FDA order allowing the product to be marketed as such. Therefore, FDA concluded, Juul’s products are adulterated.

At first blush, this seems like a heavy-hitting letter. FDA warning letters are an effective enforcement tool because they intimidate regulated entities and carry the threat of further enforcement. FDA likely hopes Juul will bring itself into compliance with federal law by ceasing to market its products as lower-risk.

However, enforcement letters carry no legal weight in and of themselves. Should Juul continue to market its products as lower-risk, there may be a long legal battle implicating the First Amendment.

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US servicemembers pictured from behind, saluting

“Homecoming” to a History of Servicemember Experimentation

Jennifer Oliva 1 Comment

Much ado has been made about Amazon’s new hit, “Homecoming,” which recently received three Golden Globe nominations, including one for best drama series. The psychological thriller, directed by “Mr. Robot” creator Sam Esmail and starring Julia Roberts, has been characterized as “an irresistible mystery-box drama” and “the good kind of ‘what the hell is going on here?’ TV.” Tim Goodman described the show, which was adopted from Eli Horowitz and Micah Bloomberg’s Gimlet Media “cult hit” podcast of the same moniker, as a “dazzling” play “on memory, the military industrial complex, conspiracy and unchecked government privilege.”

The series revolves around novice caseworker Heidi Bergman’s (Roberts) experiences administering the Tampa, Florida-based Homecoming Transitional Support Center (HTSC). HTSC is a privately-run, Department of Defense (DoD) contract facility, which purports to assist combat-traumatized servicemembers readjust from the battlefield and reintegrate to civilian life. Indeed, Bergman opens the drama’s aptly-titled pilot, “Mandatory,” by explaining to her “client,” three-tour-combat-veteran Walter Cruz (Stephan James), that the treatment facility is “a safe space for you to process your military experience and re-familiarize yourself with civilian life in a monitored environment, which, just means getting you situated now that you’re back home, rear-wise, health-wise, basically, I just work for you.” Read More

Bioethics in Islam: Principles, Perspectives, Comparisons

ylenfest 2 Comments

An important questions in Islam, recurrent across time and space, is whether Islamic political theory recognizes rights claims against the state as distinct from rights claims against other members of the community. This continues to be an important subject today, intersecting the fields of law, religion, and moral philosophy. The classical tradition is divided on the matter, with the legal theory of the Shafi’i school of jurisprudence saying that rights are to be accorded viareligious authority, while the Hanafi school emphasized the universality of the notion of human inviolability (dhimma)—and the innate rights that derive from it—as God-given, universal, and applicable to all societies from the beginning of time.

Whereas in Western law there is generally a separation between law and ethics, in the Islamic tradition, there is more of a dialectical tension between the two: Where religious inwardness is more highly developed, attitude and intention are weighed more heavily, whereas in its absence however formalism and legalism are advanced as the ethical ideal.

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Religion, Health, and Medicine: the Dialectic of Embedded Social Systems

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The philosopher in me understands that there are universal principles in logic, mathematics, and in basic scientific tenets such as the law of gravity. Be that as it may, the historian in me recognizes that we inherit epistemologies and ways of thinking from those before us, and from our own historical and cultural contexts. Certain ideas dominate the world; and, while some are indeed universal, especially those based on science, the fact remains that a number of other concepts are only seemingly universal. The concepts of personhood, divinity, self, and even society as we tend to understand them today are largely inherited from a Western, Christian worldview. As these ideas have wrestled with philosophical inquiry throughout history, they have either been decoupled from their origins in religious thought, or they have been secularized and rationalized a la Kantian categorical imperatives or the like—and then disseminated in universities, institutions, cultures, and literatures.

On one level, to speak of the Western world as “secular” is, as the philosopher Charles Taylor notes, to say that “belief in God, or in the transcendent in any form, is contested; it is an option among many; it is therefore fragile; for some people in some milieus, it is very difficult, even ‘weird’” (Taylor: 2011, 49). But on another and much deeper level, this very possibility was only ever tenable on account of two major factors: “First, there had to develop a culture that marks a clear division between the ‘natural’ and the ‘supernatural,’ and second, it had to come to seem possible to live entirely within the natural” (Taylor, 50). This was only possible because of a unique philosophical climate that actively sought to dislodge the old form of moral order and social “embeddedness” in an attempt to establish a “purely immanent order.” Taylor’s groundbreaking work, A Secular Age argues that secularism is part of a grand narrative in the West and shows that its historical and cultural foundations are in fact thoroughly Christian and European. He pushes back against Max Weber’s secularization thesis that religion diminishes in the modern world and in the wake of increasing developments in science and technology—and instead gives a different account of what secularism might mean: one that has deep implications for morality, politics, and philosophy.

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Medicine and Ethics: Religious or Secular?

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By Yusuf Lenfest

There is no lack of controversy when talking about religion and medicine in America today. Medicine is studied, practiced, and firmly rooted in the corporal world while religion draws inspiration from texts, traditions, and the incorporeal. Yet from an historical perspective, religious pasts do shape the present, particularly in the realm of ethics and moral reasoning. Indeed, whatever one’s spiritual or philosophical predilections, religion continues to play a major role in the dialogue on medicine and health care in Western society.

Bioethics in particular has become a topic of growing interest in America, but there has been little critical discussion about its contextual underpinnings, which stem largely from a Western Christian perspective. This is not to say that another religion would arrive at radically different system of morals. While differences do exist amongst religious traditions, across both space and time, experience and common sense tell us that diverse religious traditions do in fact share in much of the same moral principles and foundations. So what might other religious traditions say about, or contribute to, the discourse on bioethics? Should religion even be included in the conversation, especially given that health care and healing belong to the sphere of medicine?

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“There are millions of people who are living below subsistence”: Black Panther Party Founder Bobby Seale as Public Health Activist

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By Wendy S. Salkin

Picture it: Tuesday, February 14, 2017. It is four o’clock and the Tsai Auditorium of the Center for Government and International Studies is packed to the gills, abuzz with energy. Harvard faculty, students, staff, and community members fill every seat, line the steps, and stand shoulder-to-shoulder in the back. They are turning would-be attendees away at the door. The occasion for such excitement is this: The Hutchins Center for African & African American Research here at Harvard hosted the event, “Bobby Seale in Conversation with Jim Sidanius.”

Jim Sidanius is the John Lindsley Professor of Psychology in memory of William James and of African and African American Studies. His work spans broadly across both decades and areas of inquiry. He and his co-author Felicia Pratto are famously responsible for formulating social dominance theory, “a general model of the development and maintenance of group-based social hierarchy and social oppression.” He has also pioneered work in other areas of political psychology, including such research areas as “political ideology and cognitive functioning, the political psychology of gender, group conflict, institutional discrimination and the evolutionary psychology of intergroup prejudice.”

And Bobby Seale, as you may know, co-founded the Black Panther Party for Self Defense (BPP). I had never before seen Bobby Seale speak and did not know what to expect. And, ultimately, I am pleased not to have watched any of his interviews in advance, as I was able to have the experience with fresh eyes. (It’s worth noting that many of his interviews and speeches are easily accessible on YouTube. It’s worth watching them, including his 2015 New York Times interview with R&B artist D’Angelo.) His energy and enthusiasm captivates his audience, as when, during his talk last week, he recited from the Declaration of Independence, and while so doing impersonated both John Wayne and Rev. Dr. Martin Luther King, Jr. He recited this passage:

“[W]hen a long train of abuses and usurpations, pursu[ed] invariably…evinces a design to reduce [a people] under absolute Despotism, [then it is the] right [of the people]…to [alter and change that] Government, and [] provide new Guards for their future security.”

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New twist in debate over resident duty hours (Part I)

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By Brad Segal

Amidst a roller-coaster presidential campaign, on November 4th the Accreditation Council for Graduate Medical Education (ACGME) presented a plan to change resident duty hour limits. That the specifics have largely flown under the radar is perhaps unsurprising given the current news cycle. But the understated revision to, “Resident Duty Hours in The Learning and Working Environment” is the latest twist in a relatively contentious issue within medical education (see 2016 NEJM op-ed vs. responses). The proposal is currently undergoing requisite comment period until December 19. This week I’ll briefly lay out the history of duty hours to help explain the significance of ACGME’s proposal, and I will then go through general empirical arguments for and against such a change. My next post will examine how well these argument hold in light of the most recent data available.

Today the physicians’ training experience immediately following medical school is no longer the whir of dangerous sleep deprivation lampooned in the House of God. Amid mounting evidence that resident sleep deprivation caused medical errors, and under threat of federal legislation, in 2003 the ACGME first introduced national guidelines restricting resident work hours to 80 hours per week (averaged over 4 weeks), and capped residents to 30 hours of continuous in-house call. Then in 2009 the Institute of Medicine (IOM) released a 427-page report reviewing scientific evidence on resident work hours, sleep deprivation, and fatigue-related errors. The evidence overwhelmingly suggests that sleep deprivation significantly impairs most aspects of cognition. Hence the IOM ultimately recommended that residents not exceed 16 hours of continuous work before dedicated rest.

The ACGME subsequently modified duty hour guidelines in 2011 and limited first-year residents (‘interns’) to working 16-hour stretches. The reason ACGME’s most recent proposal is curious, though, is that it back-tracks on the 2011 intern duty-hour limits, raising their in-house cap to 28 hours. In response to this proposal a national advocacy group, Public Citizen, claimed it, “would expose residents, their patients and the general public to the risk of serious injury and death.” Read More

Legal Levers for Health Equity through Housing: A New Research Project

Temple University Center for Public Health Law Research Leave a comment

Health equity in housing can be defined as the absence of disadvantage to individuals and communities in health outcomes, access to health and social services, and quality of health and social services based on a person’s dwelling or neighborhood.

Lack of housing access, poor housing conditions, and income or racial segregation all have been shown empirically to cause negative health outcomes. Law has a pervasive role in housing, and has for a long time. Law was instrumental in creating and maintaining segregation through mechanisms like red-lining, restrictive covenants and zoning. The Civil Rights movement brought an end to explicitly discriminatory policies, and new finance and inclusionary zoning policies helped create millions of units of affordable housing, but we still have a long way to go. As Matthew Desmond’s work shows, drastic improvements are needed in how governments enforce housing codes and balance the rights of landlords and tenants. The bottom line is that too many of our people have trouble affording decent housing in neighborhoods with the amenities for healthy living, and too many of our neighborhoods are still segregated.

Our team at the Center for Public Health Law Research has been selected as a research hub in the Robert Wood Johnson Foundation’s Policies for Action Program. For the next 20 months, we will be using empirical research and legal scholarship to analyze the housing crisis through the lens of law. We know that law shapes environments and behaviors, so we are searching for the links between laws, their intended and unintended effects on the housing market, and the health outcomes that follow. We will be bringing a focus on law and its mechanisms to a field rich in policy research. Our aim is to investigate how law influences health equity in housing, and offer recommendations about how it can be a lever for greater equity. We hope to engage the community of non-profits, advocacy groups, policy think-tanks, and social scientists who are working on identifying problems and finding solutions, as well as the community of legal scholars and litigators working on housing issues. In our recommendations we plan on both identifying steps to incrementally advance housing equity through existing law, and envisioning creative changes to the legal framework itself.

We are excited to engage the housing policy and the law community in a discussion about legal levers for health equity through housing. We also look forward to sharing our work with you as we go, here and on the Policies for Action website. Please stay tuned!

If you are interested in continuing this discussion please reach out to Abraham Gutman at Abraham.gutman@temple.edu

Organs and Overdoses: The Numbers (Part I)

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By Brad Segal

The surging opioid epidemic is a threat to the nation’s public health. This year the CDC reported that mortality from drug overdose reached an all-time high, with the annual death toll more than doubling since 2000. Yet in the backdrop of this epidemic, the country also faces ongoing shortages of a different sort–too few organs for transplantation. Every day, approximately 22 people die while waiting for an organ to become available. To some it is not a surprise–or at least not inconceivable–that the fastest-growing source of organ donors is being fueled by the national spike in drug overdoses. This first post will help delineate the scope and scale of the situation. My follow-up will discuss the ethical considerations and ramifications for public policy.

To start: the numbers. The Organ Procurement and Transplantation Network (OPTN) makes domestic transplant data publicly available online, which currently extends from 1994 to September 30th, 2016. Two decades ago, 29 organ donors died from a drug overdose.* In just the first nine months of this year, that number has climbed to 888 donors. Even with a quarter of the calendar year left to be counted, 2016 has already surpassed previous record set in 2015 (Figure 1).

figure-1
Figure 1

One might question whether this trend is an illusion–perhaps a rise in the incidence of donors who had overdosed reflects an increasing number of transplants. But the data suggest the opposite. Also plotted in Figure 1, the percentage of total organ donors who died from overdose (maroon diamonds, right-sided Y axis) has not remained constant–instead, the percentage has steadily increased. Two decades ago, overdose caused the deaths of 0.6% of all organ donors; this year, it is the cause of death among 12.0% of organ donors nationwide. The rising percentage means that not only are more victims of drug overdose donating organs, but that the pool of organ donors is increasingly composed of such individuals. Read More

Health Care Politics in the US South

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by Emma Sandoe

Courtesy of Vanderbilt Center for Medicine, Health, and Society https://www.vanderbilt.edu/mhs/the-politics-of-health-in-the-u-s-south/

This month I attended the Politics of Health Care in the US South conference held at Vanderbilt. This conference was cosponsored by the Anna Julia Cooper Center at Wake Forest. Instead of a lengthy conference summary, I’ll attempt to capture some of the key lessons I learned to better understand the politics of the South.

What is the South?

There is no other region of the country with such a strong personal identification and complex emotional reaction as the South. Californians don’t identify as “Westerners;” “New Englander” inspires connotations of sleepy scenes of snow and hot chocolate; and while you may get a rare character that strongly identifies as a “Midwesterner,” there is a clear difference in the passion that a Minnesotan speaks of their homeland compared to a Tennessean. But despite the fact that the words “the South” strikes passion in its residents, historical and modern important moments in our nations conversation on race, and a specific cultural identity, there is really no common definition of the geographic South. Modern politics make the inclusion of Maryland and DC counter to our understanding of the deep red political vote. Texas and Florida have their own unique identities and their vast populations often skew any analysis of the region. Each unique issue in the South first requires a definition of what geographic region you are discussing.

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