books

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet SarpatwariBeatrice Brown, Alexander EgilmanAviva Wang, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues.

Below are the citations for papers identified from the month of August. The selections feature topics ranging from an overview on the evolution of medical device regulation in the United States, to an analysis of the impact of the disclosure of expanded access policies mandated by the 21st Century Cures Act, to an evaluation of how litigation has impacted the success of the Biologics Price Competition and Innovation Act.

A full posting of abstracts/summaries of these articles may be found on our website.

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FLINT, MICHIGAN January 23, 2016: City Of Flint Water Plant Sign In Flint, January 23, 2016, Flint, Michigan.

Digging Deep to Find Community-Based Health Justice

By Melissa S. Creary

Public health interventions aimed at Black and Brown communities frequently fail to recognize that these communities have, over and over, been made sick by the systems that shape their lives.

When we fail to recognize that these problems are happening repeatedly, we are likely to address the most recent and egregious error, ignoring the systemic patterns that preceded it. Public health and technological policy responses that do not address these underlying structural and historical conditions are a form of bounded justice, i.e., a limited response sufficient to quiet critics, but inadequate to reckon with historically entrenched realities.

By only responding to the acute crisis at hand, it is impossible to attend to fairness, entitlement, and equality — the basic social and physical infrastructures underlying them have been eroded by racism.

To achieve health justice, we must move beyond bounded justice. Rather than simply recognizing the existence of underlying social determinants of health, we must do the hard work to create and re-create systems, interventions, policies, and technologies that account for that erosion and offer high-grade reinforcements.

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U.S. Supreme Court

There’s No Justice Without Health Justice

By Yolonda Wilson

Last month the U.S. Supreme Court struck down the eviction moratorium issued by the Centers for Disease Control (CDC). The Court reasoned that, among other things, the eviction moratorium was an overreach by the CDC. That is, even in light of a global pandemic where being unhoused increases one’s risk of acute COVID-19 infection and subsequent serious illness, the Court rejected the CDC’s argument for the connection between housing justice and health justice. The Court raised several telling rhetorical questions in their decision that were intended to show the potentially troubling slippery slope that would commence if the moratorium were allowed to stand:

Could the CDC, for example, mandate free grocery delivery to the homes of the sick or vulnerable? Require manufacturers to provide free computers to enable people to work from home? Order telecommunications companies to provide free high-speed Internet service to facilitate remote work?

Whereas the Court viewed the eviction moratorium as an overreach that would lead to unthinkably absurd consequences for other sectors of social and economic life, a Black feminist conception of justice, as expressed, for example, in the historic statement of the Combahee River Collective, is necessarily grounded in a sense of the importance of community, rather than as a mere collection of individuals who may have little to no connection with or obligations to one another. Though the Court prioritized the interests of landlords and real estate agents, a Black feminist conception of justice foregrounds the needs of the overall community, such that if the well-being of the community depended on free grocery delivery to the sick and vulnerable, then so be it. The community rises and falls together, and so justice must account for the whole, not merely the well-heeled. Implicit in this conception of justice is an understanding that the community can only thrive, can only aspire to a Black feminist conception of justice, to the degree that the community is well or ill.

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yellow capsules on a blue background.

Fatty Acids, Skinny Labels: Fish Oil Patent Battle Back in Court

By Gregory Curfman

An ongoing patent battle over omega-3 fatty acids, colloquially known as as fish oils, may have broad implications for the marketing of generic drugs.

Icosapent ethyl (Vascepa®) is an omega-3 fatty acid preparation used to treat high triglycerides.  It was explicitly designed to be different from most other omega-3 fatty acid preparations — instead of containing a mixture two fatty acids (docosahexaenoic acid and eicosapentaenoic acid), it is a purified preparation of just the latter, and it is a much higher dose than what is typically used.

On the basis of the ANCHOR and MARINE clinical trials, in 2012 the Food and Drug Administration (FDA) approved Vascepa for the treatment of persons with severe hypertriglyceridemia.

In 2015, Hikma Pharmaceuticals, a generic drug company, filed an abbreviated new drug application (ANDA) for its generic formulation of icosapent ethyl.

The manufacturer of branded Vascepa, Amarin Corporation, promptly filed a patent infringement lawsuit citing six method of use patents (the ‘728, ‘715, ‘677, ‘652, ‘560, ‘929 patents) on Vascepa that the company believed were infringed by Hikma’s ANDA.

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abortion protest outside supreme court.

Pregnancy Loss, Abortion Rights, and a Holistic Reproductive Justice Movement

The Health Law, Policy, Bioethics, and Biotechnology Workshop provides a forum for discussion of new scholarship in these fields from the world’s leading experts. Though the Workshop is typically open to the public, it is not currently, due to the COVID-19 pandemic. However, many of our presenters will contribute blog posts summarizing their work, which we are happy to share here on Bill of Health.

By Greer Donley and Jill Wieber Lens

In the summer of 2020, celebrity Chrissy Teigen shared her son’s stillbirth with her tens of millions of followers on social media, including photos of her agony at her son’s simultaneous birth and death.

Teigen and her husband, John Legend, are noted supporters of abortion rights. After Jack’s death, Planned Parenthood tweeted its condolences: “We’re so sorry to hear that Chrissy Teigen and John Legend lost their son, and we admire them for sharing their story.”

Backlash was swift, accusing both Teigen and Planned Parenthood of hypocrisy, questioning how one could believe abortion involves only a “clump of cells,” yet grieve a pregnancy loss.

This anecdote perfectly highlights the perceived conflict between pregnancy loss and abortion rights — that any recognition of loss in the context of stillbirth or miscarriage could cause a slippery slope to fetal personhood.

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Symbol of law and justice, banknote of one dollar and United States Flag.

Saving Lives and Decreasing Costs: The Economic Case for Health Justice

By Wendy Netter Epstein

Most proponents of health justice will tell you that health is a fundamental human right. They will say that there is a moral imperative to eliminate health inequities and to give all people equal opportunity to lead a healthy life. And they will be correct. Health justice as a framework is driven by this narrative — the laudable goals of health equity and social justice.

What you aren’t as likely to hear from health justice advocates, however, is that health justice is economically efficient. To the contrary, most health justice advocates see its framework as an alternative to the markets, efficiency, autonomy, and individual responsibility that are the hallmarks of conservative ideology.

Yet, there is no question that health inequities are costly to the individuals that bear them, in higher health care expenses, missed days of work, and fewer years lived. There are also significant costs to society — both direct and indirect. According to one analysis, disparities lead to $93 billion in excess medical care costs and $42 billion in lost productivity per year.

Making the economic case for health justice, and noting how it is inextricably linked to the moral case, is crucial. Because not only is the framework bolstered by notions of both fairness and efficiency, but also, as a practical matter, getting legislative and regulatory buy-in to fund initiatives to address health inequities requires making the economic case.

If health inequities could be ameliorated, government health spending and other safety net spending would be drastically reduced, workforce productivity would increase, and even healthy and wealthy Americans — who are the most likely to oppose the health justice framework — would benefit.

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globe.

Whose Global Health Security?

By Aeyal Gross

The current discussion within the World Health Organization (WHO) of a “pandemic treaty” aims at better solutions to “health emergencies.”

But, if this focus on “emergencies” comes at the expense of chronic and underlying issues, including the overall status of health systems, we risk replicating, with this legal instrument, the colonial legacy of international health supposedly left behind with the shift to “global health.” This points to the urgent need to rethink what is considered a “crisis” or an “emergency,” as part of the effort to “decolonize global health,” including global health law (GHL).

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Work-life balance. flat design style minimal vector illustration.

Shortening Medical Training Would Help Trainees Balance Family and Career

By Leah Pierson

In my junior year of college, my pre-medical advisor instructed me to take time off after graduating and before applying to medical school.

I was caught off guard.

At 21, it had already occurred to me that completing four years of medical school, at least three years of residency, several more years of fellowship, and a PhD, would impact my ability to start a family.

I was wary of letting my training expand even further, but this worry felt so vague and distant that I feared expressing it would signal a lack of commitment to my career.

I now see that this worry was well-founded: the length of medical training unnecessarily compromises trainees’ ability to balance their careers with starting families.

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Petrie-Flom Center student fellows 2021-2022.

Petrie-Flom Welcomes 2021-2022 Student Fellows

(Clockwise from top left: Matt Bauer, Jack Becker, Bailey Kennedy, Cathy Zhang, Leah Pierson, Kaitlynn Milvert)

We are so excited to welcome a new group of Student Fellows to the Petrie-Flom Center family. These six students are a fantastic cohort of health law policy, biotechnology, and bioethics scholars who join us from across Harvard.

They each will undertake a year-long research project with mentorship from Center faculty and affiliates, and also will blog here at Bill of Health regularly. Keep an eye out for their bylines!

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Emergency room.

Truth and Reconciliation in Health Care: Addressing Medical Racism using a Health Justice Framework

By Amber Johnson

Healing processes, such as the truth and reconciliation process, can operationalize the three components of the health justice framework — community empowerment, structural remediation, and financial and structural supports — to address the trauma of medical racism. Structural remediation and institutional change is a long and slow process; however, changing the way we interact with each other — through healing processes — can lead to swift, radical changes. Consider, for example, interpersonal racism in patient/provider health care interactions.

Interpersonal racism in patient/provider interaction can determine whether a patient’s needs are met, and can be the deciding factor between survival or death. From communication between a provider and a patient, to diagnosis and treatment, to follow-up care and pain management, the patient/provider interaction is integral to obtaining access to quality health care. When interpersonal racism is at play, the quality of care is substandard and health outcomes are negatively impacted.

Interpersonal racism is one aspect of patient/provider interaction(s) that has massive implications for health outcomes, and it is also one that hospitals and medical staff have the direct agency, resources, and time to change. But this must be done at least partially on an individual level — neither patients nor providers can eradicate racism without acknowledging the truth of the harm caused and healing from the harm.

Acknowledging the truth may be achieved through a truth and reconciliation commission (TRC), a process whereby parties who have been harmed and parties who have caused harm are able to share their experiences and revise ahistorical narratives, so that they reflect the truth and seek justice in the form of reconciliation, reparations, or some form of resolution.

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