view of Chicago

What Two Neighborhoods in Chicago Show About Disparities During COVID-19

By Michael Atalla

Minorities, especially African-Americans in metropolitan areas, are being infected with and dying from COVID-19 at higher rates than their white counterparts.

This phenomenon is occurring in many large cities like New York, Detroit, and New Orleans. This piece focuses on Chicago — arguably the most segregated city in all of America. Comparing two zip codes within Chicago city limits with similar population sizes but divergent racial composition, the disparities are striking.

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cruise ship

Old and New Ways of Coping with COVID-19: Ethics Matters (Part I)

By Leslie Francis and Margaret Pabst Battin

This post is part I of a two-part series on pandemic control strategies in response to COVID-19.

Your life and the lives of many others may depend now on isolation, quarantine, cordon sanitaire, shelter in place, or physical distancing.

These terms have entered the public consciousness rapidly. Though general awareness has increased, the important practical and ethical differences between these practices require further explanation.

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Graph with number of biosimilar approvals on the X axis and years from 1970 until 2018 on the Y axis. The line on the graph represents a generally upward trend.

The Rise of Biosimilars: Success of the BPCIA? (Part III)

By Jonathan Darrow

This is Part III in a series exploring the history, challenges, and opportunities in the regulation of biosimilars, or biologic medical products that are very similar to already approved biological medicines.  Part III considers a path forward in the regulation of biologics.  For Part I, click here.  For Part II click here.

A Path Forward

The small number of biosimilar approvals compared to generic drug approvals cannot establish the failure of the BPCIA due to differences in industry familiarity with each follow-on pathway, the number of reference products available for copying, patient population sizes, patent barriers, and drug costs. The later arrival of US laws and guidance documents—not inadequate legal design—is the most straightforward explanation of why the first US biosimilar approvals were delayed compared to those in Europe.

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Graph with number of biosimilar approvals on the X axis and years from 1970 until 2018 on the Y axis. The line on the graph represents a generally upward trend.

The Rise of Biosimilars: Success of the BPCIA? (Part II)

By Jonathan Darrow

This is Part II in a series exploring the history, challenges, and opportunities in the regulation of biosimilars, or biologic medical products that are very similar to already approved biological medicines.  Part II covers some key considerations and factors that impact the biologics market and regulation.  For Part I, click here.

Reference Products Available for Copying in 1984

Because most post-1962 drugs enjoyed a 17-year patent term (changed to 20 years in 1995), there was little need for an abbreviated pathway in the years immediately following the Kefauver-Harris Amendments. But as patents expired, increasing numbers of post-1962 drugs became available for copying yet were ineligible as reference products under the 1970 ANDA regulations. On the eve of the Hatch-Waxman Act, Congress estimated that approximately 150 post-1962 drugs were off-patent but had no generic equivalent. This backlog of available reference products produced a surge in ANDA approvals following enactment of the new law (Exhibit 1).

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Graph with number of biosimilar approvals on the X axis and years from 1970 until 2018 on the Y axis. The line on the graph represents a generally upward trend.

The Rise of Biosimilars: Success of the BPCIA? (Part I)

By Jonathan Darrow

This is Part I in a series exploring the history, challenges, and opportunities in the regulation of biosimilars, or biologic medical products that are very similar to already-approved biological medicines.  This Part briefly covers the history of American regulation of biologics and touches briefly on the European experience.

The Biologics Price Competition and Innovation Act (BPCIA), part of the 2010 Affordable Care Act, sought to drive down prices for biologics, much as the 1984 Hatch-Waxman Act did for small-molecule drugs. By allowing manufacturers of follow-on products to rely in part on the clinical data of the brand-name reference product, both laws were designed to lower development costs and attract competitors.

Since the BPCIA’s enactment, however, scholars have compared it unfavorably to the Hatch-Waxman Act, criticized its pathway as “obstructed” and lacking in sufficient incentives, lamented the scarce approvals it has produced, and recommended that it be “abandoned.” Although criticisms of the law are not without basis, their collective implication—that the BPCIA is irredeemably defective and will never yield robust competition—may be wrong.

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Ambassador-at-Large Deborah Birx giving a speech from a podium with an American flag and PEPFAR banner in the background

One of the Biggest Public Health Initiatives in History: PEPFAR and HIV

By Daniel Aaron

In October, the Petrie-Flom Center hosted a conference of world-leading experts in HIV/AIDS to discuss one of the biggest public health successes in history: PEPFAR, the President’s Emergency Plan for AIDS Relief. PEPFAR was launched in 2003 in response to a burgeoning global epidemic of HIV. The program offered $2 billion annually, rising to about $7 billion in 2019, to surveil, diagnose, treat, and reduce transmission of HIV around the world.

PEPFAR prevented what could have become an exponentially growing epidemic. It is estimated to have saved more than 17 million lives and avoided millions of new HIV infections. As a result, the speakers at the conference were quick to extol the virtues of the program. Professor Ashish Jha called it an “unmitigated success”; Professor Marc C. Elliott named it a “historic effort”; Dr. Ingrid Katz described PEPFAR as “nothing short of miraculous.”

However, several undercurrents within the conference, as well as more explicit points made by several panelists, suggested the importance of enlarging the discussion beyond PEPFAR itself to include other policies that impact HIV and AIDS, and even other diseases.

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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

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

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 Mediacult 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

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

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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