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Everything You Wanted to Know About Expanded Access but Were Afraid to Ask, Part 3

By Alison Bateman-House, Hayley M. Belli, and Sage Gustafson

This series is adapted from a webinar hosted by PRIM&R on August 5, 2021: IRB Review of Expanded Access Protocols that Collect Real World Data: Considerations and Guidance. Read Part 1 and Part 2.

Part 3: What’s an IRB to do?

EA is considered treatment, not research. EA was not established as a means to collect research data, even though certain safety data must be collected and shared with the FDA and the sponsor. But, once sponsors decide to capture/share EA-derived data above and beyond that needed to report SAEs, what should IRBs do when reviewing such plans: view this as research, and thus hold it to (higher) research standards, or continue to view this as treatment?  This distinction is important for patients’ rights and welfare.

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SAINT LOUIS, MO. - August 2, 2021: A protestor holds a sign reading "Evictions Are Violence" at a protest held days after the federal eviction moratorium expired.

U.S. Eviction Policy is Harming Children: The Case for Sustainable Eviction Prevention to Promote Health Equity

By Emily A. Benfer

Without a nationwide commitment to sustainable eviction prevention, the United States will fail the rising number of renter households at risk of eviction. Worse still, the country will set millions of children on the path of long-term scarring and health inequity.

A staggering 14.8% of all children and 28.9% of children in families living below the poverty line experience an eviction by the time they are 15. For children, eviction functions as a major life event that has damaging effects long after they are forced to leave their home. It negatively affects emotional and physical well-being; increases the likelihood of emotional trauma, lead poisoning, and food insecurity; leads to academic decline and delays; and could increase all-cause mortality risk.

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Picture of doctor neck down using an ipad with digital health graphics superimposed

Everything You Wanted to Know About Expanded Access but Were Afraid to Ask, Part 2

By Alison Bateman-House, Hayley M. Belli, and Sage Gustafson

This series is adapted from a webinar hosted by PRIM&R on August 5, 2021: IRB Review of Expanded Access Protocols that Collect Real World Data: Considerations and Guidance. Read Part 1 here.

Part 2: Possible Value of “Real World Data” Collected from Expanded Access

Real world data (RWD) are data relating to patient health status and/or the delivery of health care such as medical bills/claims, electronic health records, and product/disease registries. RWD are derived from sources outside of randomized controlled trials (RCTs). Real world evidence (RWE) may be derived from the analysis of quality RWD.

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Washington, USA- January13, 2020: FDA Sign outside their headquarters in Washington. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.

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

By Ameet Sarpatwari, Liam Bendicksen, Alexander Egilman, andAaron 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 a discussion of opportunities for improving the use of U.S. Food and Drug Administration (FDA) advisory committees, an analysis of the key patents covering drugs recently approved by the FDA, and an examination of high-risk cardiovascular devices approved by the FDA for use in children and adolescents. A full posting of abstracts/summaries of these articles may be found on our website.

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3d render, abstract fantasy cloudscape on a sunny day, white clouds fly under the red gates on the blue sky. Square portal construction.

A Different Future Was Possible: Reflections on the US Pandemic Response

By Justin Feldman

The inadequacies of the early U.S. pandemic response are well-rehearsed at this point — the failure to develop tests, distribute personal protective equipment, recommend masks for the general public, protect essential workers, and take swift action to stop the spread.

But to focus on these failures risks forgetting the collective framing and collective policy response that dominated the first few months of the COVID-19 pandemic. And forgetting that makes it seem as though our current, enormous death toll was inevitable. This dangerously obscures what went wrong and limits our political imagination for the future of the COVID-19 pandemic and other emerging crises.

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pills

Everything You Wanted to Know About Expanded Access but Were Afraid to Ask, Part 1

By Alison Bateman-House, Hayley M. Belli, and Sage Gustafson

This series is adapted from a webinar hosted by PRIM&R on August 5, 2021: IRB Review of Expanded Access Protocols that Collect Real World Data: Considerations and Guidance.

Part 1: What is Expanded Access and How Does it Work?

Expanded Access (EA) is a regulatory mechanism that allows patients, through their physicians, to request the use of an unapproved medical product in a treatment setting.

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Medical Hospital: Neurologist and Neurosurgeon Talk, Use Computer, Analyse Patient MRI Scan, Diagnose Brain. Brain Surgery Health Clinic Lab: Two Professional Physicians Look at CT Scan. Close-up.

Creating Brain-Forward Policies Amid a ‘Mass Deterioration Event’

By Emily R.D. Murphy

COVID-19 will be with us — in our society and in our brains — for the foreseeable future. Especially as death and severe illness rates have dropped since the introduction of vaccines and therapeutics, widespread and potentially lasting brain effects of COVID have become a significant source of discussion, fear, and even pernicious rumors about the privileged deliberately seeking competitive economic advantages by avoiding COVID (by continuing to work from home and use other peoples’ labor to avoid exposures) and its consequent brain damage.

This symposium contribution focuses specifically on COVID’s lasting effects in our brains, about which much is still unknown. It is critical to focus on this — notwithstanding the uncertainty about what happens, to how many, and for how long — for two reasons. First, brain problems (and mental health) are largely invisible and thus overlooked and deprioritized. And second, our current disability laws and policies that might be thought to deal with the problem are not up to the looming task. Instead, we should affirmatively consider what brain-forward policies and governance could look like, building on lessons from past pandemics and towards a future of more universal support and structural accommodation of diminishment as well as disability.

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Abstract glitch with word SCAM on 100 Dollar bill. Concept art for Online scam.

Rethinking Senior Scams?

By James Toomey

Many people, including, it seems, most advocates for law reform, assume that older adults are uniquely vulnerable to scams, and indeed that senior scams are a unique social problem demanding a unique legal solution. But in “The Age of Fraud” (forthcoming in the Harvard Journal on Legislation, winter 2023), about which I’ve blogged here before, I reported the results of an empirical study suggesting that, in fact, younger adults were as much as three times more likely to engage with scammers during the first year of the COVID pandemic than older adults.

One possible implication of this finding — if indeed it is generalizable — which I discuss but don’t commit to in the paper, is that more people are more vulnerable to scams — and the polished tactics of psychological manipulation used by scammers — than has been generally appreciated. But if scams are not a bounded problem of those who are in some sense more psychologically vulnerable (as older adults are thought of in, at least, the popular imagination), we might want to rethink scams — what they are, how we fight them, and how we treat and think about their victims.

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Pile of colorful pills in blister packs

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

By Ameet SarpatwariAviva Wang, Liam Bendicksen, 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 relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of July. The selections feature topics ranging from how Wikipedia pages communicate drug efficacy information, to addressing pharmaceutical industry payments to physicians, to the frequency with which the Food and Drug Administration removes hazardous dietary supplements from the market. A full posting of abstracts/summaries of these articles may be found on our website.

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