Public Health

Everything’s Bigger in Texas, Including Power Outages

Madeline Vavricek, MJLST Staffer

On last week’s episode of “now what?”, Texas was experiencing massive power shortages following a winter storm, leaving hundreds of thousands of Texans without power and water. An estimated 4.3 million Texans were rendered without power for up to a week as the cold snap that swept the nation caused Texas’s power grids to fail. Though the power grid is back up and Texas has returned to its regularly scheduled spring temperatures, last month’s empty grocery store shelves and power shortages have yet to melt from many Texans’ memories. As massive electric bills arrive in citizens’ mailboxes (hello, surge pricing!), lawsuits levied against power companies, and bankruptcies filed by energy companies, one might ask why Texas, far from being the coldest part of the United States that week, was so thoroughly and singularly felled by the winter weather. The answer, perhaps unsurprisingly, is both political and economic, and requires a history lesson as well.

Nearly half a century after Thomas Edison’s 1880 invention of the light bulb, the advent of the power grid was gaining traction in the nation’s cities and becoming less of a luxury and more of a necessity. This created a highly profitable market for electricity where previously no market had existed, and the expansion of the industry only shed light on ways that electric companies were utilizing the novel market to their advantage. This expansion eventually lead to the passage of the 1935 Public Utility Holding Company Act (PUHCA) under President Franklin D. Roosevelt. The Act outlawed the “pyramidal structure” of interstate utility holding companies, preventing holding companies from being more than twice removed from their operating subsidiaries, and required companies with a ten percent stake or greater in a utilities market to register with the Securities and Exchange Commission for monitoring. Essentially, this legislation was to prevent energy companies from operating as monopolies in the relatively new energy market, a move met with vehement opposition by the utility companies themselves; the bitter feeling was mutual, with FDR notably calling the holding companies “evil” in his 1935 State of the Union address.

While PUHCA inconvenienced these villainous utility companies’ interstate operations, there was one loophole left available to them: their “evil” was left unregulated within the state, allowing holding companies that operated within a single state unregulated under PUHCA.  While the Act was effective, decreasing the number of holding companies from 216 to 18 between 1938 and 1958, creating a “a single vertically-integrated system which served a circumscribed geographic area regulated by either the state or federal government.” It was following the 1935 passage of PUHCA that Texas power companies decided to band together within the state rather than submit to the federal regulation at hand. By only operating within state lines, Texas companies effectively skirted federal regulation and interference, politically maneuvering itself to an energy independence largely made possible through Texas’s energy-rich natural resources.

In the late sixties, the federal government created two main power grids to serve the country: the Eastern Interconnection and the Western Interconnection. Texas opted out of this infrastructure, choosing instead to form its own grid operator, called the Electric Reliability Council of Texas, or ERCOT. The ERCOT grid “remains beyond the jurisdiction of the Federal Energy Regulatory Commission,” the federal entity that regulates the power grid for the rest of the nation. ERCOT took on additional power following the 1999 move to deregulate the energy economy in Texas, an effort to create a completely free market for electricity in the state to benefit both consumers and companies. This independence had most Texans’ ardent approval . . . until the cold front rolled in late February 2021, obstructing the flow of the state’s natural gas and leading to the failure of 356 electric generators state-wide. While other Southern states relied on the national power grid to maintain their electricity, Texas had no one but itself to fall back on, and was quite literally left out in the cold.

While some argue that the independent electrical grid was not to blame for Texas’s misfortunes, insisting that the cold temperatures in the rest of the nation meant there wouldn’t be much energy to spare anyway, it is undeniable that the deep freeze has called attention to many cons of Texas’s pro-deregulation energy market. Though there is what could be considered an “instinctive aversion to federal meddling” in avoiding federal regulation, as well as sensible reasons for a state of Texas’s size and natural resources to remain separate from the other 47 continental United States, the reality remains that many Texans suffered at the hands of its own power grid. As the bills pile up and Texans increase the water bottles they have in their pantry at any given time, one can see how some might favor the security of a more regulated system over the freedom that lead to surge pricing, dry faucets, and dark homes.  However, as with all government regulation, there is a price to pay, and perhaps the Lone Star State prefers to stay “lone” for that very reason. Either way, Texas, now warmer and well-lit, is no doubt grateful to return to our 2021 definition of “normal” and hoping that their lives stop sounding like a verse of a beloved Bill Joel song (no, not Piano Man).


How the U.S. Government Broke Its Treaty Obligations Before the Pandemic Struck: COVID-19 illuminates how the U.S. government have failed Native communities

Ingrid Hofeldt, MJLST Staffer

As COVID-19 first began to ravage Native American tribal lands, the U.S. government’s treaty-solidified responsibility to protect tribes against external disasters was triggered. However, Native American communities’ reluctance to receive vaccinations showcases how the U.S. government’s treaty obligations require it to take proactive steps to ensure the advancement of healthcare on tribal lands and to attempt to mend the longstanding medical trauma of Native communities and resulting friction with the U.S. government.

Healthcare Disparities Before COVID-19

Since the invasion of Europeans, Native American communities have faced health crises. The European invaders both inadvertently spread smallpox, measles, and the flu, and launched biological warfare against Native communities. Around 90% of Native peoples were murdered or died through the spread of disease. Even after the most egregious periods of the genocide against Native Americans, indigenous communities continued to experience disparities in health outcomes. During the 1918 pandemic, the influenza struck Native populations with four times the severity of the general population, which resulted in 2% of Native peoples dying, and the near extinction of entire villages. 

Today, Native American communities continue to face disparities in health outcomes. Native Americans  have above average rates of immunocompromising diseases including diabetes, asthma, heart disease, cancer, respiratory diseases, hypertension, PTSD, and other mental health disorders. Native Americans are 600 times more likely than non-Native people to die of tuberculosis and 200 times more likely to die of diabetes. These rates exist in part because of the lack of resources available on reservations, which are home to 50% of the U.S. Native American population. Limited healthcare services, overcrowded housing, and lack of access to running water, proper sewage, and broadband internet[1] on reservations all contribute to reduced healthcare outcomes. A burgeoning elderly population, a quarter of whom lack health insurance, also adds to the difficulties facing Native healthcare services and tribal governments. 

The Crisis of COVID-19 for Native American communities and Reservations

Unsurprisingly, COVID-19 has spread across reservations like wildfire. Navajo Nation has had more deaths per capita than any state in the country. While Native Americans comprise 3% of Wyoming’s population and 6% of Arizona’s, they represent 33% and 16% of COVID-19 cases respectively. These disparities have emerged for a variety of reasons, from the higher rates of pre-existing conditions discussed above, which each exacerbate the severity and lethality of COVID-19, to lack of healthcare resources. Reservations experience the same shortages of doctors, hospitals, and medical resources common among rural areas. Additionally, limited grocery stores and multigenerational housing increase the risk of COVID-19 spread.

Beyond these existing disparities and lack of resources, the federal government’s mismanagement of resources designated for Native American communities has worsened the crisis of COVID-19 on reservations. While Congress distributed $80 million in COVID-19 relief funds to the Indian Health Services, 98% of tribal clinics have still not received their funds because of the federal government’s failure to properly disperse the funds. Testing has been largely absent from reservations, which causes cases to go unreported. Additionally, the federal government used census data, rather than tribal enrollment data,  to calculate distribution of resources in reservations. Because Native people are hugely undercounted in the census, reservations have received inadequate supplies of PPE, cleaning supplies, and tests. For example, the Sault Ste. Marie Tribe of Chippewa Indians only received 2 test kits for a population of 44,000. Meanwhile, the Seattle Indian Health Board was sent body bags in lieu of medical supplies

The U.S. Government’s Responsibility to Tribes

The U.S. government’s actions and inactions run afoul of multiple treaties, established case law, and the central tenants of Indian law. Numerous treaties between the U.S. government and tribal nations established tribes as sovereign political nations that the U.S. government must protect from external threats, ranging from foreign invasion to natural disasters. The Supreme Court has affirmed the dual sovereignty of tribal nations and the U.S. government’s obligations to tribes. 

Treaties between tribes and the U.S. government have both established this broad principle of the government’s responsibility to ensure the health and wellbeing of Native peoples and provided specific responsibilities requiring the U.S. government to provide vaccines, medicine, and physicians to Native peoples on reservations. In theory, the land tribes ceded to the U.S. government was a form of pre-payment for adequate healthcare. In 1955, the U.S. government established the Indian Health Services (IHS), to ensure that the U.S. government met its implied responsibility to ensure the adequate healthcare of Native peoples. Congress has also conceded that the U.S. government has a responsibility to “improve the services and facilities of Federal Indian health programs and encourage maximum participation of Indians” in those programs, which “the Federal Government’s historical and unique legal relationship with, and resulting responsibility to the American Indian people” requires. Congress has recognized that the current unmet health needs of tribes are “severe” and implicate “all other Federal services and programs in fulfillment of the Federal responsibility to Indians” which are “jeopardized by the low health status of the American Indian people.” 

How the U.S. Government Has Violated Its Treaty Obligations During the COVID-19 Crisis

As the U.S. government charges forward with the COVID-19 vaccination program, the COVID-19 healthcare disparities and the long history of medical trauma in Indian country compound one another. Many Native Americans living on reservations express skepticism over the vaccine program given the genocide committed against Native peoples through medicine and the government’s current mishandling of the COVID-19 crisis. Currently, an estimated 50% of people on the Spirit Lake Reservation do not plan to receive vaccinations. While the government spent centuries committing biological warfare against Native peoples, the medical community has enacted great harm against Native people relatively recently. Within the past 100 years, the U.S. government has conducted testing of radioactive iodine on Alaska Natives and widely distributed vaccines that proved less effective or ineffective for Native people. In the 1970’s, the U.S. government mass sterilized Native Americans without their consent. Further, in 2009, the U.S. government mishandled the H1N1 crisis on reservations, exacerbating this existing lack of trust. 

The tenuous relationship between tribes and the government has only worsened during the COVID-19 crisis as a result of the mismanagement of tribal healthcare. Many Native people worry that the federal government is withholding the risks of the COVID-19 vaccine. Native healthcare providers stress that the U.S. government must work to cultivate community support for its healthcare initiatives and ensure informed consent from each Native person for any medical procedure. The longstanding, positive relationship between Johns Hopkins University medical researchers and the Navajo people is a testament to the benefits of long standing relationships between tribes and researchers built on trust.

In light of the long history of healthcare issues and violations on reservations, the current mishandling of the COVID-19 crisis on reservations, and the fear of vaccination in many tribal communities, it becomes clear that the U.S. government’s treaty obligations related to healthcare must be rethought, recalibrated, and redefined. The U.S. government should not merely intervene when a pandemic strikes, but should take proactive, constructive steps before crisis strikes to ensure that Native peoples will receive adequate healthcare during both normal times and widespread calamities. It was no secret to the government that a pandemic would prove disastrous for tribes: public health experts have long foreshadowed the severity of a pandemic for tribal populations. Merely throwing money at tribes once disaster strikes will not solve the longstanding health and healthcare issues on reservations that complicate the virus. 

 Funds alone cannot solve the complex, socio-political healthcare issues complicated by historical trauma. Beyond dispersing funds through IHS, the U.S. government should consider organizing focus groups on reservations between elders, traditional healers, tribal government leaders, and immunologists from the CDC and public health officials to discuss steps moving forward. Additionally, to ensure treaty obligations, the U.S. government must tackle the more difficult long standing issues such as the lack of agency tribes hold over medical research and the distrust between the federal government and Native communities. To achieve equitable healthcare for tribes, Native people cannot merely be pushed to the sidelines as participants or involved minimally as nurses and doctors but not as researchers. The federal government should use funds to ensure that young Native Americans have available programming on science, STEM careers, and pathways into medicine. While not a conclusive end to the medical trauma Native communities have experienced, providing partnerships in medical research to researchers from Native communities will hopefully both shed a spotlight on healthcare disparities within Native communities and rebuild the frayed and broken trust between Native communities and medical researchers. 

Regardless of what steps are taken, the strength and organizing of Native communities during the COVID-19 pandemic deserves recognition. In the words of Jonathan Nez, Navajo Nation president, “We are resilient . . . our ancestors got us to this point . . .  now it is our turn to fight hard against this virus.”

 

[1] 13% of American Indian/Alaska Native homes lack running water or sewage compared to 1% of homes nationwide. In the Navajo Nation, ⅓ of homes lack running water.


COVID-19 Vaccination: Pervasive Skepticism and Employer Mandates in the United States

Drew Miller, MJLST Staffer

On December 31, 2019, the COVID-19 pandemic began when the World Health Organization’s (WHO) Chinese office picked up a media statement by the Wuhan Municipal Health Commission regarding cases of “viral pneumonia.” Nearly a year later, despite the protective measures instituted on a global scale to slow the spread, COVID-19 has claimed the lives of nearly 1,500,000 people worldwide) and shows no sign of slowing down. All hope is not lost; scientists and biopharmaceutical companies have worked diligently throughout the crisis, and a large-scale vaccination release seems imminent. However, given the prevalence of anti-vaccination sentiment in the United States, it may be difficult to distribute the vaccine to enough people; employer-mandated vaccines likely offer the best chance for widespread vaccination, but the standards governing such mandates remain unclear.

Anti-Vaccination Sentiment in the US

Whether the vaccine will provide outright immunity or simply partial protection, it will regardless be a critical step toward ending the pandemic. However, vaccines are obviously only effective if people agree to get the shot, and that may prove to be a significant barrier in the United States. Vaccine doubt and anti-vaccination movements continue to grow in popularity for a variety of reasons. Social media’s unique ability to bring together like-minded individuals across the globe inevitably results in the creation of insular groups; anti-vaccine support from celebrities such as Jenny McCarthy and Jim Carrey provide a degree of validation to “regular” people who feel the same way; and general government distrust, which has sharpened considerably under the tumultuous and polarizing Trump presidency, heightens suspicions surrounding FDA testing and approval processes. Finally, as noted by Dr. Paul A. Offit, an infectious disease expert and co-inventor of a vaccine for rotavirus, “Vaccines are a victim of their own success. We have largely eliminated the memory of many diseases.”

Moreover, skepticism regarding the safety and efficacy coronavirus vaccine is not entirely unfounded. The vaccine development process typically takes a decade, whereas this one began under a year ago. A group of researchers at the Johns Hopkins Center for Health Security and the Texas State University anthropology department writes, “If poorly designed and executed, a COVID-19 vaccination campaign in the U.S. could undermine the increasingly tenuous belief in vaccines and the public health authorities that recommend them – especially among people most at risk of COVID-19 impacts.” The results of a poll conducted by Pew Research Center in September indicates the consequences of all these factors: just over half (51%) of U.S. adults definitely or probably would get a COVID-19 vaccine if it were available today—a 21% drop from 72% in May.

Employer-Mandated Vaccines

With skepticism at an all-time high, the responsibility for raising vaccination rates in the U.S. may fall to employers. The U.S. Occupational Safety and Health Administration (OSHA) allows employers to legally impose an influenza vaccine requirement on their workers, but there are several requirements and exceptions that make such a mandate more difficult to impose.

First, employees are entitled under the Americans with Disabilities Act (ADA) to request medical and disability exemptions. This exemption requires proof of an underlying disability or medical condition that renders an employee essentially unable to safely get the vaccine. Second, employees may also claim religious exemptions to avoid an employer-mandated vaccine. However, Title VII of the Civil Rights Act of 1964 states that an employee must have a “sincerely held religious belief” against vaccination. In 2020, the Third Circuit Court of Appeals held that an employee’s “holistic health lifestyle” and personal belief that vaccines are harmful were insufficient to trigger protection under the Civil Rights Act. See Brown v. Children’s Hosp. of Philadelphia, 794 Fed. Appx. 226 (3rd Cir. 2020). The court wrote, “[I]t is not sufficient merely to hold a ‘sincere opposition to vaccination’; rather, the individual must show that the ‘opposition to vaccination is a religious belief.’” Id. (citing Fallon v. Mercy Catholic Med. Ctr. of Southeast Pa., 877 F.3d 487, 490 (3rd Cir. 2017)).

There are two primary standards governing the situations in which employers may legally require vaccinations regardless of religious or medical exemptions. Title VII does not require employers to make “reasonable accommodations” for medical or religious reasons if it would pose an undue hardship, which it defines as “more than de minimis cost” to the operation of the business. The ADA standard is stricter, requiring reasonable accommodation barring undue hardship, which it defines as an “action requiring significant difficulty or expense.”

Finally, because vaccinations are “medical examinations” under the ADA, the COVID-19 vaccine would need to be deemed “job-related, consistent with business necessity or justified by a direct threat, and no broader or more intrusive than necessary.” Although the Equal Employment Opportunity Commission (EEOC), which is responsible for enforcing federal anti-discrimination laws in employment, has labeled COVID-19 as a “direct threat” to the workplace and stated that employers are allowed under the ADA to “bar an employee from physical presence in the workplace if he refuses to have his temperature taken or refuses to answer questions about whether he has COVID-19, has symptoms associated with COVID-19, or has been tested for COVID-19,” it has not yet stated whether employers will have the right to make a vaccine mandatory.

Conclusion

As such, the rights of employers to legally impose COVID-19 vaccination requirements on employees are uncertain and, absent clear direction or regulation, will likely require case-by-case analysis to determine the validity of each exemption and the corresponding hardship to business. Consequently, even if employers do have the legal right, protracted legal battles are the only remedy, and given the pervasive fear of vaccinations in today’s social climate, there are likely to be a great many of them. Meanwhile, the COVID-19 pandemic will continue to ravage the nation.


Becoming “[COVID]aware” of the Debate Around Contact Tracing Apps

Ellie Soskin, MJLST Staffer

As COVID-19 cases continue to surge, states have ramped up containment efforts in the form of mask mandates, business closures, and other public health interventions. Contact tracing is a vital part of those efforts: health officials identify those who have been in close contact with individuals diagnosed with COVID-19 and alert them of their potential exposure to the virus, while withholding identifying information. But traditional contact tracing for a true global pandemic requires a lot of resources. Accordingly, a number of regions have looked to smartphone-based exposure notification technology as an innovative way to both supplement and automate containment efforts.

Minnesota is one of the latest states to adopt this approach: on November 23rd, the state released “COVIDaware” a phone application designed to notify individuals if they’ve been exposed to someone diagnosed with COVID-19. Minnesota’s application utilizes a notification technology developed jointly by Apple and Google, joining sixteen other states and the District of Columbia, with more expected to roll out in the coming weeks. The nature of the technology raises a number of complex concerns over data protection and privacy. Additionally, these apps are more effective the more people use them and lingering questions remain as to compliance and the feasibility of mandating use.

The joint Apple/Google notification software used in Minnesota is designed with an emphasis on privacy. The software uses anonymous identifying numbers (“keys”) that change rapidly, does not solicit identifying information, does not provide access to GPS data, and only stores data locally on each user’s phone, rather than in a server. The keys are exchanged via localized Bluetooth connection operating in the background. It can also be turned off and relies wholly on self-reports. For Minnesota, accurate reports come in the form of state-issued verification codes provided with positive test results. The COVIDaware app checks daily to see if any keys contacted within the last 14 days have recorded positive test results. Minnesota policymakers, likely aware of the intense privacy concerns triggered by contact tracing apps, have emphasized the minimal data collection required by COVIDaware.

The data privacy regulatory scheme in the United States is incredibly complex, as there is no single unified federal data protection policy. Instead, the sphere is dominated by individual states. Federal law enters into the picture primarily via the Health Insurance Portability and Accountability Act (“HIPAA”), which does not apply to patients voluntarily giving health information to third parties. In response to concerns over contact tracing app data, multiple data privacy bills were introduced to Congress, but even the bipartisan “Exposure Notification Privacy Act” remains unpassed.

Given the decentralized nature of the internet, applications tend to be designed to comply with all 50 states’ policies. However, in this case, state-created contact tracing applications are designed for local use, so from a practical perspective states may only have to worry about compliance with neighboring states’ data privacy acts. The Minnesota Government Data Practices Act passed in 1974 is the only substantive Minnesota state statute affecting data collection and neighboring states’ (Wisconsin, Iowa, North Dakota, and South Dakota) laws have similarly limited or dated schemes. In this specific case, the privacy-focused Apple/Google API that forms the backbone of COVIDaware and the design of the app itself, described briefly above, likely keep it complaint. In fact, some states have expressed frustration at the degree of individual privacy afforded by the Apple/Google API, saying it can stymie coordinated public health efforts.

Of course, one solution to even minimal data privacy concerns is simply not to use the application. But the efficacy of contact tracing apps depends entirely on whether people actually download and use them. Some countries have opted for degrees of mandatory use: China has mandated adoption of its contact tracing app for every citizen, utilizing unprecedented government surveillance to flag individuals potentially exposed, and India has made employers responsible for ensuring every employee download its government-developed contact tracing app. While a similar employer-based approach is not legally impossible in the United States, any such mandate would be legally complex, and anyone following the controversy over mask mandates should instinctively recognize that a mandated government tracking app is a hard sell (to put it lightly).

But mandates may not even be necessary. Experts have emphasized that universal compliance isn’t necessary for an app to be effective: every user helps. Germany and Ireland have not mandated use, but have download rates of 20% and 37% respectively. Some have proposed small, community-focused launches of tracking apps, similar to successful start-ups. With proper marketing and transparency, states need not even enter the sticky legal mess that is mandating compliance.

Virtually every policy response to COVID in the United States has been met with heated controversy and tracking apps are no different. As these apps are in their infancy, legal challenges have yet to emerge, but the area in general is something of a minefield. The limited and voluntary nature of Minnesota’s COVIDaware app likely places it out of the realm of significant legal challenges and significant data privacy concerns, at least for the moment. The general conversation around contact tracing apps is a much larger one, however, and has helped put data privacy and end user control into the global conversation.

 

 

 

 

 


FDA Approval of a SARS-CoV-2 Vaccine and Surrogate Endpoints

Daniel Walsh, Ph.D, MJLST Staffer

The emergence of the SARS-CoV-2 virus has thrown the world into chaos, taking the lives of more than a million worldwide to date. Infection with SARS-CoV-2 causes the disease COVID-19, which can have severe health consequences even for those that do not succumb. An unprecedented number of vaccines are under development to address this challenge. The goal for any vaccine is sterilizing immunity, which means viral infection is outright prevented. However, a vaccine that provides only partially protective immunity will still be a useful tool in fighting the virus. Either outcome would reduce the ability of the virus to spread, and hopefully reduce the incidence of severe disease in those who catch the virus. An effective vaccine is our best shot at ending the pandemic quickly.

For any vaccine to become widely available in the United States, it must first gain approval from the Food and Drug Administration (FDA). Under normal circumstances a sponsor (drug manufacturer) seeking regulatory approval would submit an Investigational New Drug (IND) application, perform clinical trials to gather data on safety and efficacy, and finally file a Biologics License Application (BLA) if the trials were successful. The FDA will review the clinical trial data and make a determination as to whether the benefits of the therapy outweigh the risks, and if appropriate, approve the BLA. Of course, degree of morbidity and mortality being caused by COVID-19 places regulators in a challenging position. If certain prerequisites are met, the FDA as the authority to approve a vaccine using an Emergency Use Authorization (EUA). As pertaining to safety and efficacy, the statutory requirements for issuing an EUA are lower than normal approval. It should also be noted that an initial approval via EUA does not preclude eventual normal approval.  Full approval of the antiviral drug remdisivir is an example of this occurrence.

In any specific instance, the FDA must conclude that a reason for using the EUA process (in this case SARS-CoV-2):

can cause a serious or life-threatening disease or condition . . . based on the totality of scientific evidence available . . . including data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that . . . the product may be effective in diagnosing, treating, or preventing [SARS-CoV-2] . . . the known and potential benefits of the product, when used to diagnose, prevent, or treat [SARS-CoV-2], outweigh the known and potential risks of the product . . . .

21 USC 360bbb-3(c). On its face, this statute does not require the FDA to adhere to the full phased clinical trial protocol in grating an EUA approval. Of course, the FDA is free to ask for more than the bare minimum, and it has wisely done so by issuing a set of guidance documents in June and October. The FDA indicated that, at the minimum, a sponsor would need to supply an “interim analysis of a clinical endpoint from a phase 3 efficacy study;” that the vaccine should demonstrate an efficacy of at least 50% in a placebo controlled trial; that phase 1 and 2 safety data should be provided; and that the phase 3 data “should include a median follow-up duration of at least two months after completion of the full vaccination regimen” (among other requirements) in the October guidance.

It is clear from these requirements that the FDA is still requiring sponsors to undertake phase 1, 2, and 3 trials before FDA will consider issuing an EUA, but that the FDA is not going to wait for the trials to reach long term safety and efficacy endpoints, in an effort to get the public access to a vaccine in a reasonable time frame. The Moderna vaccine trial protocol, for example, has a study period of over two years. The FDA also has a statutory obligation to “efficiently review[] clinical research and take[] appropriate action . . . in a timely manner.” 21 USC § 393(b)(1).

One method of speeding up the FDA’s assessment of efficacy is a surrogate endpoint. Surrogate endpoints allow the FDA to look at an earlier, predictive metric of efficacy in a clinical trial when it would be impractical or unethical to follow the trial to its actual clinical endpoint. For example, we often use blood pressure as a surrogate endpoint when evaluating drugs intended to treat stroke. The FDA draws a distinction between candidate, reasonably likely, and validated surrogate endpoints. The latter two can be used to expedite approval. However, in its June guidance, the FDA noted “[t]here are currently no accepted surrogate endpoints that are reasonably likely to predict clinical benefit of a COVID-19 vaccine . . . .  [and sponsors should therefore] pursue traditional approval via direct evidence of vaccine safety and efficacy . . . .” This makes it unlikely surrogate endpoints will play any role in the initial EUAs or BLAs for any SARS-CoV-2 vaccine.

However, as the science around the virus develops the FDA might adopt a surrogate endpoint as it has for many other infectious diseases. Looking through this list of surrogate endpoints, a trend is clear. For vaccines, the FDA has always used antibodies as a surrogate endpoint. However, the durability of the antibody response to SARS-CoV-2 has been an object of much concern. While this concern is likely somewhat overstated (it is normal for antibody levels to fall after an infection is cleared), there is evidence that T-cells are long lasting after infection with SARS-CoV-1, and likely play an important role in immunity to SARS-CoV-2. It is important to note that T-Cells (which coordinate the immune response and some of which can kill virally infected cells) and B-Cells (which produce antibody proteins) are both fundamental, and interdependent pieces of the immune system. With this in mind, when developing surrogate endpoints for SARS-CoV-2 the FDA should consider whether it is open to a more diverse set of surrogate endpoints in the future, and if so, the FDA should communicate this to sponsors so they can begin to build the infrastructure necessary to collect the data to ensure vaccines can be approved quickly.

 


It’s a Small World, and Getting Smaller: The Need for Global Health Security

Madeline Vavricek, MJLST Staffer

The word “unprecedented” has been used repeatedly by every news organization and government official throughout the last several months. Though the times that we live in may be unprecedented, they are far from being statistically impossible—or even statistically unlikely. Based on the most recent implementation of the International Health Regulations released by the World Health Organization (WHO) in 2005, more than 70% of the world is deemed unprepared to prevent, detect, and respond to a public health emergency. The reality of this statistic was evidenced by the widespread crisis of COVID-19. As of September 29, 2020, the global COVID-19 death toll passed one million lives, with many regions still reporting surging numbers of new infections. Experts caution that the actual figure could be up to 10 times higher.

The impact of COVID-19 has made pandemic preparedness paramount in a way modern times have yet to experience. While individual countries look inward towards their own national response to the coronavirus, it is apparent now more than ever that global issues demand global solutions. The ongoing COVID-19 pandemic indicates a need for increased resiliency in public health systems to manage infectious diseases, a factor known as global health security.

The Centers for Disease Control and Prevention (CDC) defines global health security as “the existence of strong and resilient public health systems that can prevent, detect, and respond to infectious disease threats, wherever they occur in the world.” Through global health security initiatives, organizations such as the Global Health Security Agenda focus on assisting individual countries in planning and resource utilization to address gaps in health security in order to benefit not only the health and welfare of the individual countries, but the health and welfare of the world’s population as a whole. The Coronavirus has been reported in 214 countries, illustrating that one country’s health security can impact the health security of dozens of others. With the ever-increasing spread of globalization, it is easier for infectious diseases to spread more than ever before, making global health security even more essential than in the past.

Global health security effects more than just health and pandemic preparedness worldwide. Johnson & Johnson Chief Executive Officer Alex Gorsky recently stated that “[g]oing forward, we’re going to understand much better that if we don’t have global public health security, we don’t have national security, we don’t have economic security and we will not have security of society.” As demonstrated by COVID-19, failure to adequately prevent, detect, and respond to infectious diseases has economic, financial, and societal impacts. Due to the Coronavirus, the Dow Jones Industrial Average and the Financial Times Stock Exchange Group saw their biggest quarterly drops in the first three months of the year since 1987; industries such as travel, oil, retail, and others have all taken a substantial hit in the wake of the pandemic. Unemployment rates have increased dramatically as employers are forced to lay off employees across the majority of industries, amounting in an estimated loss of 30 million positions in the United States alone. Furthermore, Coronavirus unemployment has been shown to disproportionally affect women workers and people of color. The social and societal effects of COVID-19 continue to emerge, including, but not limited to, the interruption of education for an estimated 87% of students worldwide and an increase in domestic violence rates during shelter in place procedures. The ripple effect caused by the spread of infectious disease permeates nearly every aspect of a nation’s operation and its people’s lives, well beyond that of health and physical well-being.

With a myriad of lessons to glean from the global experience of COVID-19, one lesson countries and their leaders must focus on is the future of global health security. The shared responsibility of global health security requires global participation to strengthen health both at home and abroad so that future infectious diseases do not have the devastating health, economic, and social consequences that the coronavirus continues to cause.

 


A Cold-Blooded Cure: How COVID-19 Could Decimate Already Fragile Shark Populations

Emily Kennedy, MJLST Staffer

Movies like Jaws, Deep Blue Sea, and The Meg demonstrate that fear of sharks is commonplace. In reality, shark attacks are rare, and such incidents have even decreased during the COVID-19 pandemic with fewer people enjoying the surf and sand. Despite their bad, Hollywood-driven reputation sharks play a vital role in the ocean ecosystem. Sharks are apex predators and regulate the ocean ecosystem by balancing the numbers and species of fish lower in the food chain. There are over 500 species of sharks in the world’s oceans and 143 of those species are threatened, meaning that they are listed as critically endangered, endangered, or vulnerable. Sharks are particularly vulnerable because they grow slowly, mature later than other species, and have relatively few offspring. Shark populations are already threatened by ocean fishing practices, climate change, ocean pollution, and the harvesting of sharks for their fins. Sharks now face a new human-imposed threat: COVID-19.

While sharks cannot contract the COVID-19 virus, the oil in their livers, known as squalene, is used in the manufacture of vaccines, including COVID-19 vaccines currently being developed. Shark squalene is harvested via a process known as “livering,” in which sharks are killed for their livers and thrown back into the ocean to die after having their livers removed. The shark squalene is used in adjuvants, ingredients in vaccines that prompt a stronger immune response, and has been used in U.S. flu vaccines since 2016. Approximately 3 million sharks are killed every year to supply squalene for vaccines and cosmetic products, and this number will only increase if a COVID-19 vaccine that uses shark squalene gains widespread use. One non-profit estimates that the demand for COVID-19 vaccines could result in the harvest of over half a million sharks.

Sharks, like many other marine species, are uniquely unprotected by the law. It is easier to protect stationary land animals using the laws of the countries in which their habitats are located. However, ocean habitats largely ungoverned by the laws of any one country. Further, migratory marine species such as sharks may travel through the waters of multiple countries. This makes it difficult to enact and enforce laws that adequately protect sharks. In the United States, the Lacey Act, the Endangered Species Act, and the Magnuson-Stevens Fishery Conservation and Management Act govern shark importation and harvesting practices. One area of shark conservation that has gotten attention in recent years is the removal of shark fins for foods that are considered delicacies in some countries. The Shark Conservation Act was passed in the United States in response to the crisis caused by shark finning practices, in addition to the laws that several states had in place banning the practice. The harvest of shark squalene has not garnered as much attention as of yet, and there are no United States laws enacted to specifically address livering.

Internationally, the Convention on the Conservation of Migratory Species of Wild Animals (CMS) and the International Plan of Action for the Conservation and Management of Sharks (IPOA) are voluntary, nonbinding programs. Many of the primary shark harvesting nations have not signed onto CMS. The Convention on International Trade in Endangered Species of Wild Flora and Fauna (CITES) is binding, but there are loopholes and only 13 shark species are listed. In addition to these international programs, some countries have voluntarily created shark sanctuaries.

Nations that have refused to agree to voluntary conservation efforts, that circumvent existing international regulations, and lack sanctuaries leave fragile shark species unprotected and under threat. The squalene harvesting industry in particular lacks transparency and adequate regulations, and reports indicate that protected and endangered shark species end up as collateral damage in the harvesting process. A wide array of regional and international interventions may be necessary to provide sharks with the conservation protections they so desperately need.

Research and development of medical cures and treatments for humans often comes with animal casualties, but research to development of the COVID-19 vaccine can be conducted in a way that minimizes those casualties. There is already some financial support for non-animal research approaches and squalene can also be derived and synthesized from non-animal sources. Shark Allies, the conservation group that created a Change.org petition that now has over 70,000 signatures, suggests that non-shark sources of squalene be used in the vaccine instead, such as yeast, bacteria, sugarcane, and olive oil. These non-animal adjuvant sources are more expensive and take longer to produce, but the future of our oceans may depend on such alternative methods that do not rely on “the overexploitation of a key component of the marine environment.”


COVID-19: Detrimental to Humans, Beneficial to the Environment?

Janae Aune, MJLST Staffer

No one is a stranger to the virus that has quickly changed life from recognizable to socially distanced and isolated. COVID-19, generally known as coronavirus, has gripped the world since the end of 2019 when it was first discovered. The virus has caused cities and countries to shut down, people to self-isolate, and Purrell to experience an increase in demand like never before. With so many negative consequences of the virus, are there are any possible positives that could come from this? Some argue yes –look at the environment.

COVID-19 Generally

Coronaviruses are not uncommon or unknown in the world. Every person has likely had one type of coronavirus in their life as these viruses are responsible for the common cold. The novel coronavirus currently gripping the world is not like other common coronaviruses’ however. The CDC has dubbed the disease COVID-19 because of the novelty and its discovery in 2019. Common symptoms of COVID-19 are fever, dry cough, and shortness of breath. Because these symptoms are similar to other coronaviruses and common allergies, many have experienced difficulty in properly detecting early COVID-19 symptoms. COVID-19 becomes even harder to accurately detect because some who have been infected or exposed to the disease are asymptomatic and may never know they had the virus.

COVID-19 was first discovered in Wuhan, China back in November 2019. Many other people recognize the area of discovery from the SARS outbreak back in the early 2000’s. Both of the diseases have been traced back to the wet markets in China housing wild animals being sold for food. For more information on the background of these markets in China see the short Vox documentary discussing these markets and the roots within Chinese society. While the first case was discovered in China, the disease has now spread across the world affecting every continent except Antarctica.

Spread of COVID-19

Much of the spread of COVID-19 around the world is  attributed to international travel. Since the discovery of the virus, many countries have gone on social distancing and lockdown orders to slow or prevent community spread of the disease. Even with these measures, some countries like the United States have yet to hit their peak number of cases. Countries like Spain and Italy have been hit the hardest in the European Union, however the situation is hoped to be improving soon. South Korea was hit particularly early, however given the government’s intense response with testing the country was relative successful in slowing the spread of the disease. The travel industry has taken a large hit from the disease with many not traveling and some countries shutting down airports and banning flights from certain areas of the world.

Within the United States in particular some states have yet to practice social distancing effectively. Big cities like New York City, Los Angeles, and Washington D.C. have been on shelter-in-place orders for multiple weeks with little sign they will end soon. New York City in particular has been hit hard with deaths increasing every day and hospitals becoming over capacity. This week (April 6, 2020) is expected to be the peak week of deaths, however some experts speculate the number will continue to grow after this week. Many have been critical of the response of the government in the United States in not taking the disease seriously when it was first discovered and properly preparing the country, while others have found the government’s response adequate.

Does the environment benefit from COVID-19?

COVID-19 has dramatically changed human life from what it was at the beginning of the year, and usually for the worst. COVID-19 has not only changed human life however. With most of the world being told to stay inside or practice social distance, environments, cities, and ecosystems around the world have experienced an abrupt departure from how life used to be. The canals of Venice have cleared up with fish returning. Goats have roamed back into cities in Europe where tourists usually dominate. City skylines previously blocked by smog are now clearly visible. Research shows the changes big cities have experienced due to the decrease in air travel with major cities like Los Angeles having dramatically different air pollution rates. Is it possible that COVID-19 will have a lasting positive impact for the environment? The answers are split.

In addition to these obvious positive impacts, some argue the benefits extend beyond the cosmetic. Lower levels of CO2 in the air can contribute to decreasing how often people experience diseases. Greenhouse gasses suppress the atmosphere and air around people and decreasing those levels can improve air quality and, in turn diminish how often people experience some diseases.

Even given the positive impacts, some worry the impact will only be temporary. UN officials argue exactly that. While the rebuilding efforts have not begun, one UN official argues once they do, sweeping environmental policy changes are needed in order to maintain the positive impact. Without these radically different policies, the positive impacts currently happening will be fleeting and unsustainable. Additionally, the official argues sweeping policy changes and increased spending for green energy and technology will lower the possibility of diseases spreading like this again in the future.

While some argue the deadly disease has created positive consequences for the environment, others feel very differently. Many states and countries have put their recycling programs on hold to contain the spread of the virus. Additionally, many retailers, grocery stores, gas stations, etc. have banned the use of reusable cups to eliminate the amount of potential contamination. This means more plastic, Styrofoam, etc. is being used on a daily basis around the world. Even online retailers have arguably contributed to the negative environmental causes by shipping more than usual due to people being at home and shipping things in multiple containers rather than consolidating into fewer boxed. Finally, many legislatures and governments have put serious climate legislation on the backburner to deal with the COVID 19 crisis. This could stall progress and cause delays in legislation and projects that had been started prior to the pandemic.

 


Boeing Bailout: 737 Max Crashes and the Coronavirus

Bernard Cryan, MJLST Staffer

Boeing Overview

Boeing plays a major role in the aerospace industry—both domestically and internationally. Boeing employs over 160,000 people worldwide and had a revenue of $76 billion in 2019. According to Forbes’ 2019 Fortune Global List, Boeing is ranked as Fortune 100 company. In fact, Boeing is America’s largest manufacturing exporter. Boeing’s business operations are organized into three units: Commercial Airplanes; Defense, Space & Security; and Boeing Global Services. Boeing’s Commercial Airplanes division is responsible for producing “almost half the world fleet” with more than 10,000 Boeing-built jetliners in service worldwide and “about 90% of the world’s cargo is carried onboard Boeing planes.”

737 Max Crashes

Boeing’s popular commercial airplane—the 737 Max—was recently involved in two deadly crashes. In October 2018, 189 passengers were killed on a Lion Air flight taking off from Indonesia. Again, in March 2019, 157 passengers were killed on an Ethiopian Airlines flight just minutes after takeoff. In response, Boeing grounded all 737 Max airplanes around the world and created a $100 million relief fund “to meet the family and community needs of those affected by the accidents.” Nevertheless, Boeing has received harsh criticism and scrutiny over deficiencies in its product and training. The 737 Max airplanes are still not cleared to fly causing Boeing customers to revise or even cancel orders. Certain airlines have also demanded compensation from Boeing for flight cancellations that resulted from the grounding of 737 Max airplanes. Boeing’s stock price fell after the crashes and Boeing’s revenue fell from $101 billion in 2018 to $76 billion in 2019. Boeing even replaced its CEO after he was unable to stabilize the company following the crashes. In sum, the 737 Max crashes have forced Boeing into a vulnerable financial position.

Coronavirus

The recent COVID-19 outbreak has posed additional challenges for Boeing and the entire aerospace industry. Boeing has publicly acknowledged the struggles of the entire industry caused by the coronavirus. For example, coronavirus’ impact on travel has forced American Airlines to fly its first cargo-only flight in 36 years. Boeing is directly impacted by the coronavirus because struggling airlines are not currently in the position to place orders for new airplanes.

Government’s Response

Although there is fierce competition amongst airlines, there is little competition in the manufacture of commercial airplanes. Boeing and Airbus, a European company, are the two main global suppliers of large commercial aircraft and have almost complete market power. President Trump has recognized Boeing’s indispensable role in keeping America competitive in the global industry and has recently stated, “Yes, I think we have to protect Boeing. We have to absolutely help Boeing.” Boeing has publicly expressed support for the government’s plan to bailout the aerospace industry.

Boeing is requesting a bailout of the aerospace industry in the amount of $60 billion. Boeing has suspended paying dividends and CEO Dave Calhoun has given up his pay temporarily. Additionally, United Airlines has threatened to cut jobs if the bailout relief is not passed by Congress. The aerospace industry wants help from the government. Some, however, caution against using the term ‘bailout’ for this type of situation because the airlines did not cause the hardship resulting from the coronavirus. Although Boeing and the airlines are not responsible for the coronavirus, they are at least partly responsible for their current inability to survive through these challenging times—Boeing and the airlines have spent billions of dollars in recent years buying back their own stock. For example, airlines have spent $42.5 billion on buy backs between 2014 and 2019 which is almost identical to the amount the industry is now requesting from the government.

The Bailout and The Takeaway

A government bailout can be in the form of legislation providing money or resources to a company or even an industry to help that company or industry avoid bankruptcy. For example, Congress approved a $15 billion bailout to the airlines in response to the 9/11 terrorist attacks. Another example is the Emergency Economic Stabilization Act of 2008 where the government provided bailout relief to banks after the mortgage crisis. AIG initially received an $85 billion loan (later receiving more money totaling $150 billion) from the Treasury in exchange for 79.9% equity in AIG. The loan was to be repaid with interest; the U.S. government and taxpayers eventually made $22.7 billion from interest payments.

A government bailout of the aerospace industry appears imminent. Boeing is likely to be considered “too big to fail.” The main questions are how much money will go to Boeing and the aerospace industry, in what form, e.g., debt or equity, and what strings will be attached to that money. Will the government acquire some ownership of Boeing as they did with AIG? Boeing CEO has said Boeing may reject any relief from the government if the government demands stake in the company. Will Boeing be required to change any of its Commercial Airplane division business practices? Will there be more government oversight of Boeing’s operations? Will Boeing be required to cut emissions from its planes to help protect the environment? The aerospace industry bailout will be interesting to monitor as things should come together quickly in the next few weeks, or even days.


Can the Legal System Help Combat COVID-19

Amanda Jackson, MJLST Staffer

As the novel coronavirus, COVID-19, continues its global rampage, the United States has been hard hit.  Now third with respect to number of new cases, there is little evidence to show that the case count will decrease any time soon.  If Italy provides any indication of what is to come, the United States is only going to be hit harder by the life-threatening virus.  Both federal government and local governments have taken drastic measures to combat the spread of COVID-19, including state-wide shelter-in-place orders, closing schools and universities, banning dining in at bars and restaurants, and moving non-essential businesses to work-from-home models.

As the confirmed cases continue to rise, so does uncertainty and uneasiness among the nation and the world as a whole.  What will fix this crisis?  How long will these measures be in place?  How many more people will get sick and potentially pass away from the virus?  What will happen to the economy?  Will my loved ones be okay?  The questions never seem to end.  Luckily, however, there are some answers as to how different laws, administrative agencies, and regulations in place in the United States can aid in the fight against the quickly spreading coronavirus.

First, the Defense Production Act (DPA) can alleviate shortages in medical equipment.  As concern about the novel virus itself grows, concern for the availability of necessary supplies and equipment also seems to grow at record speeds.  A lack of masks and other personal protective equipment for healthcare workers, a shortage in ventilators and beds for sick patients, and even a need for healthcare workers and hospital space are becoming more prevalent as the COVID-19 crisis continues.   The DPA, a Korean War-era law, enables the federal government to require private companies to provide for the needs of national defense.  The DPA may not be able to satisfy the need for healthcare workers and hospital space, but it can allow the federal government to direct manufacturers to produce the desperately needed medical equipment for healthcare workers and patients.  However, the President must invoke the DPA in order for it to make a difference, and as of right now, the DPA has not been invoked to aid in the fight against coronavirus.  Although some companies have increased or altered production to help restock the necessary equipment, it remains unclear whether that alone, without invoking the DPA, will be enough to meet the needs of the United States in the coming weeks.  Even so, the DPA provides a robust option to fulfill the needs of the nation in the fight against the pandemic.

Second, the Federal Drug Administration’s (FDA) and the National Institute of Health’s (NIH) ability to fast track vaccines and therapeutic drugs can speed up development of a COVID-19 vaccine or therapy.  Called an Emergency Use Authorization (EUA), the FDA is able to authorize emergency use of an unapproved product or an unapproved use of an approved product under a declaration of a public health, domestic, or military emergency, or a material threat.  The evidence required for approval of an EUA is that the product “may be effective” to treat, diagnose, or prevent the conditions associated with the declaration.  This is a lower standard than the “effectiveness” standard used for typical FDA approvals, a process that takes on average twelve years to go from a new drug in a laboratory to a drug on a pharmacy shelf.  In determining whether to approve the EUA, the Commissioner has to determine that the known and potential benefits of the product outweigh the risks associated with the product, while also considering the threat prompting the emergency declaration.  Fortunately, the FDA has already issued multiple EUAs with respect to the novel coronavirus, such as for tests to detect COVID-19.  The FDA has also instituted flexible measures outside of EUAs that enable states to take a more prominent role than typically allowed.  For example, the FDA is now allowing states to approve COVID-19 tests without requiring FDA approval or an EUA.  Moreover, NIH is also fast-tracking development of a coronavirus vaccine, with a Phase I clinical trial of the vaccine candidate having already begun.

Third, declarations of major disaster areas will open up emergency funds to help states and local governments respond to an outbreak.  Major disaster area declarations are often requested when a disaster exceeds the response capabilities of state and local governments under extremely severe circumstances.  Major disaster area declarations enable a wide range of federal assistance for both individuals and public infrastructure.  With respect to coronavirus, the President has already declared New York and other hard-hit states as major disaster areas, the first time in United States history that a major disaster has been declared for a public health threat.  The declaration enables the federal government to pay for a majority of the states’ costs and mobilize the Federal Emergency Management Agency (FEMA) to deploy assistance in the state, among other methods of assistance.

Fourth, shelter-in-place orders by local governments may reduce the spread of the virus.  Shelter-in-place orders mandate that residents stay in their homes, except for essential trips (e.g., to the grocery store or a pharmacy).  Many shelter-in-place orders also force all non-essential businesses to close.  These orders are generally constitutional under a state’s police power.  At least eight states and many cities have issued shelter-in-place orders as a means to flatten the curve and reduce the impact of coronavirus on society and the healthcare system.  Some law enforcement officials appear to be taking the orders very seriously, breaking up parties in violation of the shelter-in-place rules or stating that the orders will be “strictly enforced.”

Moreover, there are multiple bills working their way through the federal government that will hopefully provide some more answers and relief for the American people.  Although those options are only a few of the tools in the government’s toolbox, if used properly, they can help the nation combat COVID-19.