mask

COVID-19 is Still a Crisis for All

By Chloe Reichel

Recently, a narrative that COVID-19 is now a “pandemic of the unvaccinated” has emerged.

Setting aside the callousness of the claim, the biggest problem with this narrative is that it’s wrong. COVID-19 continues to threaten the health and well-being of all, regardless of vaccination status.

As we now know, vaccinated individuals can be infected with and transmit the delta variant. “Breakthrough” infections are not rare — countries with better data collection efforts than the U.S., including Israel and the United Kingdom, estimate vaccine efficacy against infection by the delta variant at around 40-50%.

This isn’t to say that the vaccines are worthless. We should continue to work to promote vaccine uptake, as the vaccines do provide a level of protection against the most severe outcomes.

But we need to understand: We can’t end this pandemic with vaccines alone.

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Traditional countryside scene in the Netherlands with windbreak lane of poplar trees in the wind under summer sky. Ens, Flevoland Province, the Netherlands.

Q&A with Mason Marks on New Psychedelics Law and Regulation Initiative

By Chloe Reichel

On June 30th, the Petrie-Flom Center announced the launch of a three-year research initiative, the Project on Psychedelics Law and Regulation (POPLAR), which is supported by a generous grant from the Saisei Foundation.

The Project on Psychedelics Law and Regulation at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School will advance evidence-based psychedelics law and policy.

In 2017, the FDA designated MDMA a breakthrough therapy for post-traumatic stress disorder, and in 2018 the agency recognized psilocybin as a breakthrough therapy for treatment-resistant depression. These designations indicate that psychedelics may represent substantial improvements over existing treatments for mental health conditions. Many other psychedelics, including ibogaine, ketamine, and dimethyltryptamine, are the focus of ongoing psychiatric research and commercialization efforts.

Despite the proliferation of clinical research centers and increasing private investment in psychedelic drug development, there is a relative lack of research on the ethical, legal, and social implications of psychedelics research, commerce, and therapeutics.

In the following interview, which has been edited and condensed, Senior Fellow and POPLAR Project Lead Mason Marks explains how POPLAR will fill this gap, and previews some of the initiative’s topics of inquiry.

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WASHINGTON, DC - OCT. 8, 2019: Rally for LGBTQ rights outside Supreme Court as Justices hear oral arguments in three cases dealing with discrimination in the workplace because of sexual orientation.

The Many Harms of State Bills Blocking Youth Access to Gender-Affirming Care

By Chloe Reichel

State legislation blocking trans youth from accessing gender-affirming care puts kids at risk, thwarts physician autonomy, and potentially violates a number of federal laws, write Jack L. Turban, Katherine L. Kraschel, and I. Glenn Cohen in a viewpoint published today in JAMA.

So far this year, 15 states have proposed bills that would limit access to gender-affirming care. One of these bills, Arkansas’ HB1570/SB347, already has become law.

This legislative trend should be troubling to all, explained Cohen, Faculty Director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. In an email interview, he highlighted “how exceptionally restrictive these proposed laws are,” adding that they are “out of step with usual medical, ethical, and legal rules regarding discretion of the medical profession and space for parental decision-making.”

Turban, child and adolescent psychiatry fellow at Stanford University School of Medicine also offered further insight as to the medical and legal concerns these bills raise over email.

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Herndon, USA - April 27, 2020: Virginia Fairfax County building exterior sign entrance to Mom's Organic Market store with request to wear face mask due to covid-19 pandemic.

Are Employers That Ditch Mask Mandates Liable for COVID-19 Infections at Work?

By Chloe Reichel

Last week, in response to U.S. Centers for Disease Control and Prevention (CDC) guidance indicating that vaccinated individuals need not wear face coverings indoors, a number of states and businesses swiftly did away with indoor mask mandates.

Widespread criticism followed, focusing on the dangerous policy vacuum that now exists. The CDC has suggested unvaccinated individuals follow an honor system and continue masking — but such an honor system is difficult, if not impossible, to enforce.

In the absence of indoor mask policies, individuals face increased risk of exposure to the virus. And some groups are particularly at risk of contracting the virus now, including immunocompromised individuals, for whom vaccines may not confer protection, and children under the age of 12, for whom a vaccine has not yet been authorized.

To better understand the new guidance and its implications for workers who are no longer protected by mask mandates, I spoke with Sharona Hoffman, an expert in health and employment law. Hoffman is the Edgar A. Hahn Professor of Law, a professor of bioethics, and Co-Director of Law-Medicine Center at Case Western Reserve University School of Law. In our interview, Hoffman explained whether an employer may be held liable if an employee contracts COVID-19 after an occupational exposure, and highlighted other key issues to anticipate regarding COVID-19 and the workplace.

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Fake Vaccine Cards and the Challenges of Decentralized Health Data

By Carmel Shachar and Chloe Reichel

Soon the U.S. will have vaccinated all adults who are not vaccine hesitant. Our next key challenges will be reopening workplaces, restaurants, schools, and other public areas, as well as encouraging vaccine uptake among those who are hesitant or resistant to the vaccine.

Vaccine passports or certifications could be a tool used to address both of those challenges.

But our approach to health care data management may undermine this next stage of the pandemic response.

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Los Angeles, California / USA - May 1, 2020: People in front of Los Angeles’ City Hall protest the state’s COVID-19 stay at home orders in a “Fully Open California” protest.

5 Questions About COVID-19 and Religious Exemptions

By Chloe Reichel

On February 26th, the Supreme Court of the United States issued a shadow docket decision that could foretell sweeping limitations for public health measures, both within and outside the COVID-19 pandemic context.

The Court’s ruling in the case, Gateway City Church v. Newsom, blocked a county-level ban on church services, despite the fact that the ban applied across the board to all indoor gatherings. This religious exceptionalism is emerging as a key trend in recent Supreme Court decisions, particularly those related to COVID-19 restrictions.

To better understand what these rulings might mean for public health, free exercise of religion, the future of the COVID-19 pandemic, and potential vaccine mandates, I spoke with Professor Elizabeth Sepper, an expert in religious liberty, health law, and equality at the University of Texas at Austin School of Law.

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Vial and syringe.

4 Things to Know About Intellectual Property, Patent Pledges, and COVID-19 Vaccines

By Chloe Reichel

High-profile commentators have argued recently that vaccine scarcity needn’t exist. If vaccine manufacturers simply shared their patents with other pharmaceutical companies, supply would quickly ramp up. 

Others have pointed out that numerous bottlenecks exist in the manufacturing process, from the glass vials that hold the vaccine, to the lipids that encase the vaccine’s active ingredient, mRNA.

And even if these bottlenecks didn’t exist, the intellectual property argument may be a straw man.    

In fact, this past October, Moderna made a gesture toward opening access to its intellectual property, by pledging that it would not enforce its patents against “those making vaccines intended to combat the pandemic.” That month, Jorge L. Contreras, a Presidential Scholar and Professor of Law at the University of Utah, covered the patent pledge and its potential implications for Bill of Health.

We checked in with Contreras to ask about the implications of Moderna’s patent pledge now that its vaccine has been proven safe and effective. Here are the highlights from the conversation:

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2020 with second zero filled in with virion.

Bill of Health’s Top 10 Posts of 2020

By Chloe Reichel

In 2020, topics relating to bioethics, health law policy, and biotechnology took center stage in the collective national and global consciousness.

The COVID-19 pandemic has, unfortunately, posed countless urgent bioethical and health law policy questions. The police killing of George Floyd in May 2020 sparked wider awareness of the systemic racial injustice in the U.S., which permeates all aspects of society and has profound detrimental effects on health.

Our contributors have grappled with these issues on the pages of this blog

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White jigsaw puzzle as a human brain on blue. Concept for Alzheimer's disease.

Detecting Dementia

Cross-posted, with slight modification, from Harvard Law Today, where it originally appeared on November 21, 2020. 

By Chloe Reichel

Experts gathered last month to discuss the ethical, social, and legal implications of technological advancements that facilitate the early detection of dementia.

“Detecting Dementia: Technology, Access, and the Law,” was hosted on Nov. 16 as part of the Project on Law and Applied Neuroscience, a collaboration between the Center for Law, Brain and Behavior at Massachusetts General Hospital and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

The event, organized by Francis X. Shen ’06 Ph.D. ’08, the Petrie-Flom Center’s senior fellow in Law and Applied Neuroscience and executive director of the Center for Law, Brain and Behavior at Massachusetts General Hospital, was one of a series hosted by the Project on Law and Applied Neuroscience on aging brains.

Early detection of dementia is a hopeful prospect for the treatment of patients, both because it may facilitate early medical intervention, as well as more robust advance care planning.

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