U.S. Patent and Trademark Office building

Visualizing the Growing Intersection of Life Sciences and Computing Patents in the US from 1976-2021

By Matthew Chun

With its leadership in drug development, biotechnology, and computing technologies, the United States touts itself as being “the most innovative economy in the world.”

But when did the U.S. rise to its position as a global leader in these areas? Which regions of the country have led the charge? And what is the next frontier of American innovation?

To begin exploring these questions, I analyzed 45 years of publicly available patent data to map the growth of U.S. innovation in the life sciences and computing fields from 1976-2021. I also mapped the recent growth of patented “hybrid” inventions, which are closing the gap between these historically disparate fields. In particular, the hybrid inventions explored in this project represent interdisciplinary advances in areas including bioinformatics, cheminformatics, artificial intelligence, and quantum computing.

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ACCRA, GHANA: April 23, 2020 - The testing of samples for the coronavirus in a veterinary lab in Accra, Ghana.

Does It Really Matter How the COVID-19 Pandemic Started?

By Barbara Pfeffer Billauer

Throughout the COVID-19 pandemic, much air time and social media space has been allocated to the lab leak vs. natural spillover dispute regarding the origins of SARS-CoV-2.

To summarize briefly, the question is whether the pandemic was caused by a leak from a biosafety level (BSL) four lab in Wuhan, China, or whether it arose naturally as a consequence of a virus jumping from a bat to an animal and then to humans.

Given that the “truth” will likely never be known, and certainly not provable, the question becomes: is it important to seriously consider the lab leak theory?

The answer, I suggest, is an unabashed yes — but not for the reason you might think. The question is important prospectively, not retrospectively. Debating the origins of the COVID-19 pandemic is a fool’s errand. Considering laboratory accidents writ large, however, is important, as they remain a potent threat to international biosecurity.

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Medical student textbooks with pencil and multicolor bookmarks and stethoscope isolated on white.

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

By Ameet Sarpatwari, 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 November. The selections feature topics ranging from an analysis of the approval and marketing of biosimilars with skinny labels and their associated savings to Medicare, a discussion of the Philips Respironics recall and the need for reforms to medical device regulation, to a review of price negotiation processes in peer countries and potential lessons for Medicare price regulation. A full posting of abstracts/summaries of these articles may be found on our website.

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Black and white photo of a woman with phone in hand; phone has color retouched image of her face on it.

The Filter Effect: What Does Comparing Our Bodies on Social Media Do to Our Health?

By Sarah Gabriele

Filters on social media apps such as Instagram and TikTok are great to take silly pictures alone and with friends, and they often give us a good laugh. However, as Dr. Christine Stabler from Penn Medicine writes, they also create an illusion, a perfection that we struggle to live up to every day. This is the case even if almost everyone is well aware that pictures are filtered and carefully selected, and that pictures do not always represent reality.

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Businessman's hands typing on laptop keyboard in morning light

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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