When a Pandemic Meets an Epidemic: The Opioid Crisis during COVID-19.

In the last year, the COVID-19 pandemic has collided with the opioid epidemic creating an influx of relapses, overdoses, and deaths. Over 20 million people in the United States have a substance use disorder. As of September 2020, thirty states reported an increase in opioid fatalities since the pandemic started in early 2020. While the overwhelming presence of anxiety, grief, and depression caused by or exacerbated by the pandemic significantly contributed to these numbers, the ongoing isolation continues to prevent individuals suffering from addiction from accessing support systems, hospitals, treatment centers, and other sources of help. Whether it is the fear of contracting the virus from a physician’s office or not having anyone nearby to recognize a dangerous situation, the pandemic has become a severe impediment to the opioid crisis. Luckily, American health organizations are increasingly aware of this rise in substance use disorder and are acting.

In July 2020, the FDA took necessary steps to make naloxone, a medication that can help reverse opioid overdose to prevent death, accessible to the community. To do this, the FDA required opioid manufactures to update package inserts to include recommendations about naloxone and its benefits. This recommendation encourages providers to discuss naloxone with all patients when starting or renewing an opioid treatment. It also urges providers to assess each patient’s need for a naloxone prescription. The FDA plans to implement these changes early this year.

Following agency action, in December 2020, the American Medical Association (AMA) provided recommendations to help states and policymakers support patients with opioid use disorder during the pandemic. These recommendations include ensuring access to care for patients with an opioid use disorder, protecting patients with pain, and utilizing harm reduction efforts to better prevent overdose and the spread of infectious disease. As a result, states like Washington, New Jersey, and Ohio are utilizing curbside and doorstep deliveries of methadone and buprenorphine for quarantined or isolated individuals because of COVID-19 and those in the at-risk population. Additionally, organizations like the American Academy of Physical Medical & Rehabilitation provided COVID-19 specific recommendations and considerations for physicians treating patients with chronic pain.

Increased state and agency responses also influenced the federal government to take action for patients suffering from substance use disorder. In January 2021, the Department of Health and Human Services issued a decision to allow physicians to “prescribe without a waiver highly effective medication for the treatment of patients with opioid use disorder.” This decision allows physicians to work with patients and provide care without worrying about authorization barriers and a strict regulatory regime. This cancellation of the waiver requirement effectively reduces the detrimental stigma and health disparities in accessing treatment. It nevertheless is important to acknowledge the systemic racial and socioeconomic inequities that still plague America’s health care system.

The repercussions of the collision between the opioid epidemic and the COVID-19 pandemic are only starting to show. The increased need for addiction treatment combined with the decreased access to treatment options presents a detrimental problem in the United States. Policy and lawmakers must continue to analyze and reevaluate how organizations delivery health care to its stakeholders, including adapting to the use of telehealth and continuing the use of regulatory waivers. People with substance use disorder should not have to battle addiction alone during and after the pandemic.

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Vaccine Bartering: Israel’s real-world evidence exchange with Pfizer

In the global race to secure COVID-19 vaccines, Israel, the 100th most populous country behind Papua New Guinea and Serbia, is the world leader in COVID-19 vaccine doses administered per capita. In a span of just 7 weeks, Israel, to date, has administered a total of 5.3 million doses, inoculated nearly approximately 30% of its total population, and 80% of citizens 60 years of age and older. In context, Israel has administered 58.9 doses per 100 residents, far exceeding the UK’s 16.5 doses and the US’s 10.6 doses. Which begs the question, how exactly has Israel beat out these bigger countries in the race to secure the coveted COVID-19 vaccine supply?

Israel struck a unique deal with Pfizer – vaccines for health data. On January 7, 2021, it was announced that Israel made an agreement with Pfizer to expedite deliveries of its COVID-19 vaccines so that all citizens over 16 years of age can be inoculated by the end of March 2021 in return for the health data of citizens taking part in the vaccination program. Formally named the “Real-World Epidemiological Evidence Collaboration Agreement,” the deal describes that the Project’s objective is to “measure and analyze epidemiological data arising from the Product [Pfizer-manufactured vaccines] rollout, to determine whether herd immunity is achieved after reaching a certain percentage of vaccination coverage in Israel.” As part of this collaboration, the agreement stipulates that Israel’s Ministry of Health will “use its best efforts to ensure timely reporting [of Project Data] to Pfizer” and “will assure rapid distribution, deployment, and use of the Product.”  In exchange, the Ministry is “relying on receipt of Product doses […] and on the product delivery rate by Pfizer to allow maintaining vaccination rate sufficient to achieving herd immunity and enough data as soon as possible.” Beyond this, however, the exact bargain between Israel and Pfizer is unclear.

As one can imagine, this agreement has instigated fierce debate in Israel among data privacy experts, researchers, and citizens weighing the potential benefits of having highly valuable real-world evidence on vaccination efficacy against the potential abuse of millions of personal medical records. The only solace the agreement offers is in its limited definition of “Project Data” (defined as any de-identified data provided by the Ministry of Health to Pfizer in the framework of the Project) and a 7 item list of the governing regulations concerning data use. Understandably, critics question why the agreement made no mention of what measures Pfizer is taking to keep the data secure or that Pfizer’s use of the data is limited to studying the effects of the COVID-19 vaccine.

Despite engaging in this novel arrangement, Israel is not new to the big data scene. Israeli health plans utilize a universal electronic medical record system and cover about 98% of the population. Although operating independently, Israel’s four HMOs and their affiliated hospitals have for the past two decades used the same electronic medical records platform, with access to patient records available at each point of care as needed. To Pfizer’s delight, this has resulted in a wealth of data about patients, conditions, and treatments. But Israel’s privacy and data protection laws, the same named in the agreement, fall behind those of the surrounding EU, allowing for much more latitude in the use and disclosure of its citizens’ data.

Although we cannot predict if and how Israeli’s health data will be used by Pfizer, or if a precedent has been set encouraging less-wealthy countries to trade citizen privacy for pharmaceuticals, we do know that Israel’s rapid vaccination roll-out (as a result of this agreement) appears to be working – Cases and hospital admissions in Israel are falling steeply among vaccinated age groups. Data collected by Israel’s Ministry of Health show that there was a 41% drop in confirmed COVID-19 infections in that age group and a 31% drop in hospitalizations from mid-January to early February.

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Critical Medical Infrastructure and the Right to Repair: H.R. 7956 and Beyond

In November 2020, Massachusetts approved a ballot measure expanding upon a 2012 “right to repair” law in the state. This law required car manufacturers to let consumers access data on repairs to their vehicles. The amendment went further allowing manufacturers until 2022 to install a standard open data platform which will give independent mechanics access to data typically sent to a remote server.

This win comes as the right to repair movement is gaining ground more widely. The movement backs various legislative initiatives that would prohibit the types of restrictions manufacturers put on product repair; limiting who is permitted to repair things and how available parts are is a common tactic used by manufacturers. From a pro-consumer perspective, repair industry interest groups argue that companies owe information, access, and reparable products to the people supporting them.

“[R]egular consumers should be able to repair the products they’ve purchased[.]” This is the lobbyist stance taken by the movement and consumer interest groups alike––consumer groups like iFixit, a website that makes electronic repair kits accessible for all. Lately, the movement has its sight set on medical equipment: iFixit recently released a comprehensive medical equipment service database in order to assist biomedical engineering technicians in repairing everything from imaging equipment to ventilators.

Making repair files available to repair technicians in hospitals has not been more of a necessary public good than right now. While American medical device makers drastically increased production of ventilators in the summer of 2020 to combat COVID-19 shortages, a problem persists: there aren’t enough specialists to operate, maintain, and monitor these complex machines, especially in rural areas. Additionally, the machines that were mass-produced to equip the Strategic National Stockpile at the height of the crisis were not built to last and require frequent maintenance.

Large device manufacturers shared the design specification “blueprints” for some of their ventilation devices, but this good faith act doesn’t go far enough. In the case of Medtronic, the manufacturer of the Puritan Bennett 560 portable ventilator, the public engineering files are complex, incomplete, and sometimes outdated.

With the United States being the global leader in new––and cumulative––COVID-19 cases, American legislators are taking notes from design guidelines in the European Union which approach right to repair from an energy efficiency perspective. While the legislative focus in the states is combatting the resource strain from the pandemic, legislators should aspire to mirror the zealous advocacy for repair rights seen in the EU.

The first brick was laid in August 2020, when Senator Ron Wyden (D-Ore.) and Representative Yvette D. Clarke (D-N.Y.) introduced H.R. 7965, The Critical Medical Infrastructure Right-to-Repair Act of 2020 (the Act), which would ease technician’s access to the information necessary for maintaining and repairing critical medical infrastructure. This initiative comes after a letter signed by over 300 technicians addressed to California legislators called for manufacturers to stop withholding necessary repair tools. The Act has an intended duration contingent on the life of the COVID-19 medical crisis, but the mechanism for accessible repair of medical equipment should extend beyond the point of crisis.

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Do COVID-19 Restrictions Apply to Religious Ceremonies?

Since the beginning of the pandemic, health experts have urged social distancing practices to mitigate the spread of the COVID-19. Nevertheless, some Americans continue to disregard health experts’ recommendations by both refusing to wear masks and social distance. One common trend across the U.S. that poses a health risk are religious ceremonies with many in attendance and few masks in sight. For example, James River Church in Springfield, Missouri continues to hold multiple Christmas celebrations with thousands of attendees. Additionally, a few thousand Orthodox Jews attended a secret wedding in early November. These events act as “superspreaders” due to the quantity of individuals present, many of whom travel from across the country.

In New York, Governor Cuomo attempted to curb the spread of COVID-19 by restricting social gatherings including limiting indoor religious ceremonies to 10-25 people. The Roman Catholic Diocese of Brooklyn and Agudath Israel of America filed suit against the state arguing that restricting religious gatherings infringes religious freedoms provided under the First Amendment. The New York Supreme Court upheld the COVID-19 restrictions. On appeal however, the U.S. Supreme Court overturned the ruling in a 5-4 decision granting the exemption. The Justices determined that the First Amendment granted religious individuals an exemption from adhering to social gathering restrictions because it infringes the right to freely practice religion.

The plaintiffs further argued that the state’s COVID-19 restrictions targeted religious groups differently than essential businesses that are operating. Similarly, in Employment Division v. Smith, the Supreme Court ruled generally applicable laws that unintentionally burden religious freedoms are not excusable. Furthermore, they declared only laws intended to limit free exercise of religion or violate other constitutional rights must be analyzed in connection to the state’s compelling interests and implemented in the least restrictive means. Therefore, a court may uphold restrictions on religious gatherings if the state can either prove restrictions are generally applicable or that there is a compelling interest such as the health risks posed by COVID-19.

This Supreme Court decision contrasts those prior to Justice Ginsburg’s death wherein restrictions on religious ceremonies in California and Nevada were upheld. This recent case is yet another example of the Supreme Court’s battle with balancing religious freedoms and societal stability. Consistent with the historic trend of conservative SCOTUS majorities, cases concerning one’s “freedom of religion” may inadvertently infringe upon others’ rights to pursue “life, liberty, and the pursuit of happiness.” With the Supreme Court’s ability to impact every American’s life, they play an important role in preserving the health and safety of the public. With nearly 17 million cases this week, this recent decision will undoubtedly delay the urgent attempts to mitigate the spread of COVID-19 in America.

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Racism: America’s Other Pandemic

The rise of COVID-19 reveals many disparitieswithin the United States. Along with mask requirements, lockdowns, and efforts to promote social distancing, our Nation has seen an unprecedented upswing of protests, civil unrest, and riots. While the United States is no stranger to marches and rallies from its most marginalized groups, the 2020 Black Lives Mater Movement is arguably the largest movement in United States history. With numbers ranging between 15 and 26 million people participating in demonstrations all over the country, the notion of rectifying race relations in the United States forged to the forefront of this year’s zeitgeist.

In May 2020, during the same week that multiple news media platforms broadcasted George Floyd’s murder, the American Public Health Association issued a news release asserting that racism is a public health crisis that requires immediate attention. Accepting racism as an urgent public health crisis requires an evaluation of the innumerable ways in which racism effects the health and livelihood of Black people in the United States. Racism not only plays a major role in the U.S. criminal justice system but also effects Black people’s access to education, housing, employment, and medical care.

Though Black people only make up approximately 13% of the U.S. population, they account for 28% of the people killed by police in 2020. Black people are more likely to develop heart disease, diabetes, and mental illness, and Black babies are more than twice as likely to die during their first year of life than white babies. Additionally, the life expectancy of Black people is typically a decade or more shorter than their white neighbors just blocks away. These health disparities are partially created from the stress of being oppressed, marginalized, and targeted for violence. Studies have also shown that experiencing racism and discrimination on a constant basis can cause wear and tear on the body, leading to additional health concerns. Thus, systemic racism not only negatively affects individuals’ social standing but also their overall health.    

Deeming racism a public health issue would be a first step towards repairing race relations in the United States. In May 2019, Milwaukee, which some consider the most segregated city in the country, became the first city to declare racism as a public health crisis. Additionally, on September 3, 2020, Representative Ayanna Pressley (D-MA) introduced the Anti-Racism in Public Health Act. This bill would create programs within the Centers for Disease Control and Prevention (CDC) focused on preventing violence by law enforcement and allocate funds for collecting data and supplying grants focused on researching anti-racist public health interventions and the impact racism has on health.

Moreover, on November 16, 2020, the American Medical Association (AMA) adopted a new policy which declared racism a serious public health threat. This new policy recommends medical education programs to recognize race as a social construct and not a biological determinant. The AMA’s new policy also pushes clinicians and researchers to include the experience of racism and social determinants of health when labelling disease risk factors in hopes of advancing equity in medicine.

Despite the Trump Administration’s claim that systemic racism does not exist in the United States, systemic racism is an issue that has existed since the birth of this nation. In order to achieve health equity between races, policymakers and medical leaders must address social injustice and systemic racism. Effective polices, such as the Anti-Racism in Public Health Act and the AMA’s declaration of racism as a public health threat, create better data and visibility of the health concerns that non-white people face in the United States. Bringing awareness to these issues will generate the tough conversations that we need to combat the longest and strongest pandemic that this country has seen: racism.

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