Health care workers in personal protective equipment attend to a patient.

How Can Policymakers Overcome the Hurdles to Scaling up Antibody Manufacturing?

Cross-posted from Written Description, where it originally appeared on February 18, 2021. 

By Rachel SachsJacob S. SherkowLisa Larrimore Ouellette, and Nicholson Price

In our last post, we introduced some of the clinical evidence supporting the use of therapeutic antibodies against COVID-19—including Regeneron’s casirivimab and imdevimab and Eli Lilly’s bamlanivimab—and analyzed the existing problems in the distribution and administration of those therapies. Even in just the last few weeks, further clinical evidence has supported the use of these technologies, leading the FDA to issue an additional emergency use authorization for Lilly’s bamlanivimab and etesevimab cocktail. In the near future, though, problems in administering our existing supply of these new drugs may give way to problems producing enough of them—a challenge that is also affecting the vaccine rollout. In this post, we consider the difficult manufacturing issues involved in the therapeutic antibody context (a subject we’ve previously explored regarding vaccines), and what might be done to address them.

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Bill of Health - person holds paper cutout of family with two children and parents, adoption, adoption during the pandemic

Maintaining Child Welfare During COVID-19

By Jordan Isern, J.D.

When the pandemic began, states across the U.S. witnessed between a twenty to seventy percent decline in reported cases of child abuse and neglect. However, this is not good news. In fact, it is downright alarming. Indeed, this decrease in reported cases is not because child abuse and neglect have decreased. Rather, the consensus is that this decrease is due to an increase in underreporting.

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These patients’ samples were to be tested for SARS-CoV-2 antibodies, using the Centers for Disease Control and Prevention (CDC) serologic test.

Why Aren’t Therapeutic Antibodies Being Used More to Treat COVID-19?

Cross-posted from Written Description, where it originally appeared on January 29, 2021. 

By Nicholson PriceRachel SachsJacob S. Sherkow, and Lisa Larrimore Ouellette

When former President Donald Trump contracted COVID-19 in fall 2020, he was treated with monoclonal antibodies, touted as potentially miraculous treatments. Unlike other treatments so touted, there is some rigorous evidence to support these assertions: antibody drugs look like the best treatments currently available to prevent COVID cases from progressing to hospitalization. But months later, the drugs are in limited use and seem to be only a moderately important part of the COVID-19 response. Why aren’t antibodies making more of a difference for ordinary Americans?

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phone camera

Deep Phenotyping Could Help Solve the Mental Health Care Crisis

By Justin T. Baker

The United States faces a growing mental health crisis and offers insufficient means for individuals to access care.

Digital technologies — the phone in your pocket, the camera-enabled display on your desk, the “smart” watch on your wrist, and the smart speakers in your home — might offer a path forward.

Deploying technology ethically, while understanding the risks of moving too fast (or too slow) with it, could radically extend our limited toolkit for providing access to high-quality care for the many individuals affected by mental health issues for whom the current mental health system is either out of reach or otherwise failing to meet their need.

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Bill of Health - silhouette of COVID-19 vaccine vile held in front of company logos, cooperation and antitrust in vaccine production

Antitrust: A Barrier or Catalyst to the Vaccine Rollout?

By Jordan Isern, J.D.

In December 2020, health officials administered the first COVID-19 vaccine and President-Elect Biden promised to deliver more than 100 million vaccines in his first 100 days of office. But now that President Biden has assumed office and rollout has begun, the United States must grapple with new limitations, namely: production and distribution.

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Bill of Health - phone in hand doing digital contact tracing, digital contact tracing feasibility

How to Launch a Digital Contact Tracing Application: Key Legal Considerations

By Jordan Isern, J.D.

As previously suggested in Digital Contact Tracing: Hope or Hype?, digital contact tracing, if implemented successfully, can help to control the spread of COVID-19. But the government is not a tech company. Therefore, no state has undertaken an effort to independently develop a digital instrument to conduct contact tracing. Instead, the private sector has underpinned this effort.

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Bill of Health - Women holds red cellphone to her hear, calling domestic violence support, domestic violence support during the pandemic

Staying-at-Home When the Home is Unsafe: The Impact of COVID-19 on Survivors of Domestic Violence (Part 2)

By Jordan Isern, J.D.

This is the second part of a two-part series about the impact of COVID-19 on survivors of domestic violence. Part 1 discussed the surge in domestic violence during the pandemic, new challenges for domestic violence prevention nonprofits, and the federal government’s response. Part 2 will examine the impact of COVID-19 on domestic violence survivors in state court.

A Patchwork Response

The legal processes available to domestic violence survivors are fragmented. When courthouses closed their doors in March, most states implemented statewide court closures, but some states allowed individual counties to determine their own closures and processes in response to the pandemic. This has resulted in multiple new processes and statuses of openness in the court system that can sometimes vary county-by-county.

That said, nearly all courts continued to hear top priority cases in the early stages of the pandemic. This addressed the most urgent concerns of survivors, such as emergency restraining orders, temporary child custody, and domestic violence cases. But the backlog of other cases and new pandemic legal procedures continue to hamstring survivors seeking justice.

Restraining Order Applications

One of the first steps for survivors to seek relief from domestic violence through the legal system is securing a restraining order issued by a municipal court judge. Most states have a criminal and civil process to issue a restraining order. A judge will issue a restraining order through the criminal system when a defendant is charged with a violent crime against a qualifying victim (e.g., a member of the same household) and the court determines he is a threat to the survivor. The civil process, on the other hand, does not require the abuser to be criminally charged with a violent crime. Instead, survivors can apply for emergency and non-emergency restraining orders preemptively. Often, states require survivors to supplement these applications with notarized affidavits and to submit these applications in-person at their local courthouse.

When the pandemic began, many courts automatically extended all emergency restraining orders set to expire during shelter-in-place, though it is unclear whether these extensions remain in effect everywhere. However, not all changes were automatic or straightforward. State and local government pandemic responses also created new legal processes for survivors to navigate when taking this first step toward justice.

Online Restraining Order Applications

Because of the pandemic, many jurisdictions chose to make civil restraining order applications available online or by telephone (rather than require in-person applications) and waived notarized affidavit application requirements, opting instead for fraud disclaimers on application documents. Domestic violence prevention advocates praise this digitization. In fact, advocates in Connecticut filed for the state to continue to make this online process available, even after the pandemic. These advocates herald the online application process for modernizing the courts and helping survivors by reducing transportation costs and increasing their safety.

However, some criticize online applications for dehumanizing a process by which survivors traditionally build trust with court advocates. Moreover, online-only applications can create a barrier for non-English speakers. For example, in some Southern California jurisdictions with large Spanish-speaking populations, online application forms are only available in English. Thus, non-English speaking survivors in these jurisdictions cannot fill out these forms without outside assistance.

In-Person Restraining Order Applications

Still, other states continue to require survivors to submit civil restraining order applications in-person. Some of these jurisdictions expanded the offices through which the applications can be submitted. New Jersey, for example, now allows survivors to submit applications to the police department in addition to the local courthouse.

Notably, even when these applications are submitted in-person, new administrative processes due to the pandemic have sometimes delayed or impeded these restraining orders from going into effect. For example, Louisiana’s stay-at-home guidelines failed to account for several steps in the application process. This created a gap in the process whereby the restraining orders were never registered and, consequently, not enforceable. Additionally, the state orders also failed to account for short-staffing at the courthouse, which slowed the application process and failed to exempt notaries from stay-at-home orders so that survivors could submit the required affidavits for a restraining order.

Courtroom Proceedings

After a court issues a restraining order, states often require a mandatory hearing in the proceeding weeks. Again, states and local governments have varied in whether these proceedings are held in-person or in a virtual courtroom.

In-Person Courtrooms During the Pandemic

Survivors seeking justice face new challenges in jurisdictions that require domestic violence cases to be heard in-person during the pandemic.

First, survivors face new obstacles to appear in court. For instance, survivors must weigh the risk to their health before appearing in court. Further, to get to the courthouse, survivors may have to navigate public transportation systems that run on a reduced schedule due to the pandemic. And, though courthouses remain operational on a limited basis, courthouse daycares are suspended. Therefore, survivors may be unable to access childcare at the time of the court proceedings.

Second, even if survivors are able to appear, they must do so without support. Because courthouses operate at reduced capacity to minimize COVID transmission, survivors cannot bring domestic violence prevention nonprofit staff to support them legally and emotionally throughout court proceedings. This creates added stress for survivors, who often already have difficulty or fear appearing in court.

Finally, because courts dockets are severely backlogged, court dates are often changed, forcing survivors to navigate these barriers on a repeated basis.

Virtual Courtrooms

At the same time, many jurisdictions have begun holding some or all domestic violence hearings virtually. Unlike online restraining order applications, virtual hearings have a mixed impact on survivors. Virtual hearings reduce transportation costs for survivors. Additionally, reporting finds that some survivors feel more safe accessing a virtual courtroom rather than risk travelling to a physical courtroom where they can be harassed or followed. On the other hand, some survivors feel less safe, not knowing who else is in the virtual courtroom. And, some survivors fear they will not be taken seriously in a virtual setting.

Legal Remedies for Survivors

Regardless of forum, the effectiveness of legal remedies in protecting survivors during the pandemic is questionable.

Because of the pandemic, states are seeking to reduce prison populations and many states are reducing bail amounts to achieve this. Though many states[1] have exempted domestic abusers from this reduction in bail, some states, like Connecticut, have not. Therefore, in these states, survivors must await trial while their abuser has been released back into the community.

Moreover, reporting shows that abusers are violating restraining orders at higher rates during the pandemic than they have previously. And, while offenders can be sanctioned for this, they often are not because in some states, survivors must provide proof that the restraining order was violated. This proof can be a police report. But, because of the pandemic, police forces are operating at reduced capacities and have fewer officers to respond to episodes of domestic abuse. Consequently, survivors may be unable to obtain the documentation they need to enforce their restraining orders.

Other Ways the Pandemic Impacts the Legal Posture of Survivors

Despite most state courts continuing to hear criminal and civil domestic violence hearings, the road for a survivor to cut ties with an abuser does not end there. Often, survivors must sort out finances, property, child custody, and divorces with their abusers. However, many of these secondary hearings critical to the health and safety of survivors are virtual, forestalled, or suspended because of the pandemic.

For example, it is unclear whether survivors could get a timely hearing in a landlord-tenant dispute. VAWA and state laws protect survivors from eviction and guarantee access to housing options. But, since the pandemic began, it is questionable whether a survivor could obtain timely recourse if a landlord violated these laws because some courts suspended or delayed landlord-tenant disputes. To provide another example, it may be difficult for survivors to obtain a divorce. The pandemic flooded divorce courts with new filings. One nonprofit reported that it is “nearly impossible to obtain a divorce” during the pandemic and thus, survivors are left in “a kind of limbo.”

Conclusion

The United States has seen a surge in domestic violence during the pandemic. Unfortunately, the new legal structure adopted for the pandemic fails to account for — and, in some cases, further endangers — survivors of domestic violence. Therefore, it is critical for state and local governments to issue new guidelines and stay-at-home orders to ease survivors’ access to justice. Specifically, state and local governments should:

  • Standardize guidelines, procedures, and courtroom formats statewide, but include mechanisms for survivors to request a virtual or in-person format
  • Make information about guidelines, procedures, and courtroom formats more accessible to the public and available in multiple languages
  • Allow online restraining order applications in addition to in-person restraining order applications, and waive notarized affidavit requirements
  • Allow advocates and nonprofit support staff to accompany survivors in the courtroom
  • Provide pandemic funding to nonprofits so that they can continue to support survivors with staff, childcare, and transportation
  • Expedite and prioritize divorce and housing judicial processes related to domestic violence

Resources on this Topic:

[1] For example, in California, Hawaii, Tennessee, and Wisconsin state and local governments introduced formal policies to reduce bail, but exempted domestic violence defendants. Moreover, jails and district attorneys in some states, like Massachusetts, Ohio, and Iowa, have done so informally, by systematically lowering bail amounts and requesting release, but exempt those charged with domestic violence.

This article was originally published on the COVID-19 and the Law blog.

Jordan Isern graduated from Harvard Law School in May 2021.

Bill of Health - Women holds red cellphone to her hear, calling domestic violence support, domestic violence support during the pandemic

Staying-at-Home When the Home is Unsafe: The Impact of COVID-19 on Survivors of Domestic Violence (Part 1)

By Jordan Isern, J.D.

While stay-at-home orders are meant to protect Americans, they can also prove deadly for those facing domestic violence. Under these orders, survivors of domestic violence find themselves confined with their abusers, stripped of support resources, and overlooked by the federal and state governments. This article is the first part of a two-part series about the cataclysmic impact of COVID-19 on survivors of domestic violence. Part 1 provides an overview of the state of domestic violence during the pandemic and analyzes the federal government response. Part 2 examines the impact of COVID-19 on domestic violence survivors in state court.

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Person smoking cigarette.

Should Smokers be Prioritized for COVID Vaccine?

Cross-posted from Harvard Law Today, where it originally appeared on February 2, 2021. 

By Jeff Neal

Should smoking be among the pre-existing health risks that qualify people for priority access to the COVID-19 vaccine? In a Zoom interview with Harvard Law Today, public health expert Carmel Shachar J.D./M.P.H. ’10 says the answer is yes. 

CDC guidelines, which most states are following as they launch mass vaccination programs, say people with certain underlying medical conditions that put them at greater risk for hospitalization or death if they contract COVID-19 (also known as co-morbidities) should receive access to the vaccine before the general population. In Massachusetts, these individuals will be eligible to receive the vaccine in Group 4 of Phase 2 of the state’s vaccination rollout plan. But many have been surprised to see smoking listed among the qualifying conditions, alongside cancer and heart disease.

Shachar, the executive director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, says that smoking is often the result of structural and biological factors that make it more prevalent in historically marginalized communities, and that denying priority access for smokers would reinforce existing inequities. More practically, she says, “every time a person gets vaccinated, it’s good for the community.” 

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Petrie-Flom Center logo.

Call for Applications: Research Fellow for Diagnostic Digital Home Health

Overview

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is hiring a full-time post-doctoral fellow to support its newly launched Diagnostic Digital Home Health initiative. This position will likely be a three year commitment.

This sponsored research project examines the ethical, social, and legal challenges of digital home health products, with a focus on home diagnosis of infectious and chronic conditions. This project will develop scholarship, guidelines, and proposed regulations for the ethical implementation of these products, using focus groups, virtual workshops, and interdisciplinary scholarship, with a focus on considerations of access and equity, social interconnectedness, and patient privacy.

Previous Petrie-Flom Center post-doctoral fellows have used their positions as successful launching pads for tenure-track legal, health policy, and bioethics academic careers. Our most recent post-doctoral fellow has published in leading journals such as JAMA, Science, and the Journal of Law and the Biosciences. She has been interviewed as an expert in biomedical regulation by media outlets such as Forbes and Lancet Digital Health and presented to regulators at the U.S. Department of Health and Human Services.
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