Vegetables super heroes, vector broccoli, squash and avocado, cauliflower and beetroot. Eggplant, chili pepper and pumpkin, spinach, carrot and tomato with cucumber, garlic and radish cartoon veggies.

Fiber: The Hero American Nutrition Deserves

By Jack Becker

Metropolis has Superman. Gotham has Batman. Could America’s nutrition hero be fiber?

Since nutrition can be complicated, consumers need rules of thumb to make more informed decisions without comprehensive nutrition education.

We already have these for what not to eat: the villains of American diets — too much added sugars, saturated fat, and sodium. But we need to be equally clear in identifying a hero. Enter fiber.

Foods that are high in fiber are often nutrient-dense and healthy. So, if someone is struggling to figure out whether a food is healthy, fiber content could be a useful shortcut.

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close up of an open book

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

By Ameet Sarpatwari, Alexander Egilman, Aviva 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 September. The selections feature topics ranging from an analysis of the regulatory outcomes of cancer drugs that received accelerated approval and had negative post-approval trials, to an evaluation of how federal public funding contributed to the development of Pregabalin (Lyrica), to a systematic literature review of the criticisms against the use of the quality-adjusted life-year (QALY) in health technology assessments. A full posting of abstracts/summaries of these articles may be found on our website.

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Concept illustration of DNA and genes.

The Civil Rights Challenge to Gene Patenting

By Jorge L. Contreras

In 2009, the American Civil Liberties Union (ACLU) launched a unique lawsuit against Myriad Genetics, challenging fifteen claims of seven patents covering various aspects of the BRCA1/2 genes and their use in diagnosing risk for breast and ovarian cancer. In mounting this case, the ACLU assembled a coalition of lawyers, scientists, counselors, patients and advocates in an unprecedented challenge not only to one company’s patents, but the entire practice of gene patenting in America. And, against the odds, they won. In 2013, the U.S. Supreme Court ruled in Association for Molecular Pathology v. Myriad Genetics that naturally occurring DNA sequences are not patentable, a ruling that has had repercussions throughout the scientific community and the biotechnology industry.

In The Genome Defense: Inside the Epic Legal Battle to Determine Who Owns Your DNA (New York: Hachette/Algonquin, 2021), I describe the long road that led to this unlikely Supreme Court victory. It began in 2003 when the ACLU hired its first science advisor, a Berkeley-based cellist and non-profit organizer named Tania Simoncelli. At the ACLU, Simoncelli’s job was to identify science-related issues that the ACLU could do something about, from DNA fingerprinting to functional MRI brain imaging. A couple of years into the role, Simoncelli mentioned gene patenting to Chris Hansen, a veteran ACLU litigator who had been involved in cases covering mental health to school desegregation to online porn. At first, Hansen didn’t believe her. How could a company patent something inside the human body? But Simoncelli persisted, showing him articles and statistics demonstrating that, by 2005, more than 20% of the human genome was covered by patents. The realization led to Hansen’s oft-quoted exclamation, “Who can we sue?”

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Illustration of a family and large clipboard with items in a list checked off. All are underneath a large blue umbrella

Churning Point: Lessons from Medicaid Pandemic Policies

By Cathy Zhang

During the COVID-19 pandemic, ensuring widespread health coverage took on a new sense of urgency, leading many states to implement policies to address the longstanding problem of Medicaid churn.

Churn is a persistent problem in the U.S. health care system. Changes in health insurance coverage disrupt care and worsen self-reported health at significant rates, even for individuals who go from one insurer to another with no gap in coverage. Legislation enacted as a stopgap measure during the pandemic may present a path forward for securing more durable Medicaid coverage beyond the public health emergency.

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Researcher works at a lab bench

Scientific Innovation in International Pandemic Lawmaking — Second Symposium Editorial

By Pedro A. Villarreal, on behalf of the editors*

Leer en español.

Lire en français.

Perhaps there is some Utopia where scientific research could immediately provide us all the accurate data on a novel disease´s severity and fatality rate. No doubt some (although not everyone) believe that such an ideal world would include mathematical models that could accurately predict both the disease´s pattern, as well as the effectiveness of the array of medical and non-medical tools to confront it. In this imaginary reality, data could tell us exactly to what extent restrictive public health measures are necessary in a given society to limit the spread of a pathogen, and it would be shared without constraints across the globe. Moreover, in this mythical world, there would be no distance between research and its application, as policymakers would simply need to draw from existing information to “make the right call.” Failsafe mechanisms would be in place to avoid the temptation of either altering scientific data, or using it for partisan motives. And, needless to say, in an ideal world, both research and the products of scientific innovation, including diagnostics, therapeutics and vaccines, would be available to everyone, globally, on the basis of need rather than ability to pay.

No such world is possible because science does not work that way. However, the broken world in which we find ourselves underscores the central imperative of reflecting on how lawmaking can be deployed to advance scientific innovation and equity.

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BETHESDA, MD - JUNE 29, 2019: NIH NATIONAL INSTITUTES OF HEALTH sign emblem seal on gateway center entrance building at NIH campus. The NIH is the US's medical research agency.

The NIH Has the Opportunity to Address Research Funding Disparities

By Leah Pierson

The Biden administration plans to greatly increase funding for the National Institutes of Health (NIH) in 2022, presenting the agency with new opportunities to better align research funding with public health needs.

The NIH has long been criticized for disproportionately devoting its research dollars to the study of conditions that affect a small and advantaged portion of the global population.

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Brown Gavel With Medical Stethoscope Near Book At Wooden Desk In Courtroom.

Most-Cited Health Law Scholars in Westlaw, 2016-2020

By Mark A. Hall and I. Glenn Cohen

A few years ago, to highlight the growth and maturity of the health law field we undertook to measure and rank the scholarly impact of health law professors according to the frequency their work is cited. Our principal ranking followed the methods Gregory Sisk and Brian Leiter have used for many years to rank professors in other fields of law.

Leiter has now included Health Law in the pantheon of ranked legal fields. Accordingly, we will not undertake an independent ranking. Instead, because the data Sisk and Leiter use are restricted to professors with a primary law school appointment, we provide the following modest supplement: We replicate Sisk and Leiter’s citation counting methods for two health law professors known to be highly cited who do not have a primary law school appointment: Aaron Kesselheim and Sara Rosenbaum. (We did the same for several others, but their citation counts in the Westlaw database were below Leiter’s cutoff range). Here is the augmented ranking:

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NEW YORK, NEW YORK - APRIL 05: Emergency medical technician wearing protective gown and facial mask amid the coronavirus pandemic on April 5, 2020 in New York City.

Déjà Vu All Over Again

By Jennifer S. Bard

The COVID-19 pandemic has shown us time and time again that whatever progress we make in curbing transmission of the virus is tenuous, fragile, and easily reversed.

And yet, we continue on a hapless path of declaring premature victory and ending mitigation measures the moment cases begin to fall. We need only look back to recent history to see why relaxing at this present moment of decline is ill-advised.

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Person receiving vaccine.

Should the Seasonal Flu Vaccine Be Integrated into COVID-19 Vaccine Mandates?

By Matt Bauer

As mandates for COVID-19 vaccinations expand, should we consider including the seasonal flu vaccine along with it?

Vaccine mandates

The Biden administrations recently announced its plans to require all employers with 100 or more employees to arrange for their workers to be vaccinated or test regularly. The mandate will likely impact over 80 million workers in the private sector. Health care and federal workers are also subject to new vaccination mandates.

Many universities, colleges, and secondary schools also have vaccination requirements, specifically for enrollment. And these requirements shift in light of changing circumstances:  A 2017 mumps outbreak across the broader Harvard and MIT communities prompted universities to revisit vaccine statuses for mumps (typically included in the MMR vaccine). More recently, many institutions of higher education have implemented COVID-19 vaccination requirements, which have subsequently met legal challenges.

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Los Angeles, California, United States. June 23, 2021: #FreeBritney rally at LA Downtown Grand Park during a conservatorship hearing for Britney Spears.

How Adult Guardianship Law Fails to Protect Contraceptive Decision-Making Rights

By Kaitlynn Milvert

After Britney Spears testified this past summer about her struggle to have her intrauterine device (IUD) removed while under conservatorship, many commentators posed a simple, but critical question: Can conservators (or guardians) make contraceptive decisions for those under their care?

Attempting to answer that question reveals an area of state guardianship law where guardians’ authority is particularly murky and ill-defined. Reform is needed to address the restrictions on reproductive decision-making rights that adults under guardianship currently face.

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