Pandemics and Placebos in Health Care
By Craig B. Garner
Founder
Garner Health Law Corporation
Original Publish Date: June 6, 2023
“Much unhappiness has come into the world because of bewilderment and things left unsaid.” -- Fyodor Mikhailovich Dostoevsky
The Paradox of Placebos and the Hippocratic Oath
A paradox is nothing new to medical science, much like the use of a placebo in treating patients. Richard Cabot combined both in 1903 when he struggled to balance the placebo’s deceptive nature with the unethical practice to avoid a treatment that actually heals. In 1920 T.C. Graves defined the “placebo effect”, writing in The Lancet about the impact drugs have in manifesting psychotherapeutic healing, real or perceived.
Since the 1960s, the path in approving new medications commonly includes a placebo, albeit with more success in subjective conditions such as pain and anxiety, and often differentiating between individuals. Even the word “obecalp” exists to make the use of a placebo less transparent to a patient.
The 1947 Nuremberg Code and its principles by which medical research must be conducted, including informed consent, lack of coercion and general beneficence, resulted from the reliance upon barbaric human experimentation within Germany’s Third Reich. The 1964 Declaration of Helsinki transitioned to physician self-regulation and away from doctrines imposed upon these health care practitioners. In 2002, the World Medical Association clarified the Declaration of Helsinki to ensure patients participating in drug-trials know that a placebo may be used.
A Snafu from Technology
In an effort to improve communications during the Cold War, in 1969 the ARPA Network (ARPANET) created an infrastructure by which computers could send and receive messages. By 1973, academic, military and research leaders connected Hawaii, Norway and the United Kingdom. A year later, transmission-controlled protocol (TCP/IP) helped computers to speak a common language. By the time ARPANET ended, the Internet began to shine. As ordinary individuals discovered the Internet, between 1994 and 1996 the number of websites blossomed from 130 to 100,000. By 1995 Netscape Navigator alone had approximately 10 million users around the world.
Today the Internet hosts more than 5 billion active users world-wide (more than 63% of the world population). While pornography accounts for approximately 35% of all Internet downloads, health care’s use of the World Wide Web is hardly insignificant, and WebMD alone boasts of more than 130 million monthly visitors. Even if medical websites do not cure patients, they certainly offer the possibility of diagnosis, right or wrong. Indeed, the Internet offers multiple and often conflicting answers for just about any symptom, not to mention myriad reasons, conspiracies or otherwise for the cause of most illness.
The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) mentions Internet Gaming Disorder, the persistent and recurrent use of the Internet to engage in games, often with other players, leading to clinically significant impairment or distress as indicated by certain systems, as a condition for further study. For those suffering from DSM-5, 301.0 (paranoid personality disorder), the Internet can be treacherous path, presenting either the cause of or solution for pervasive distrust and suspiciousness of others such that their motives are interpreted as malevolent. Indeed, even the indexed portion of the World Wide Web can be a dark place.
A Global Pandemic in the Modern Era
When the World Health Organization declared COVID-19 a global pandemic in 2020, few believed the entire world would shut down for such an extended period of time. As the weeks turned to months, New Year’s Eve 2020 offered little hope with no end in sight. The global economy existed on the cusp of ruin, society on the brink of collapse, and for many, death by COVID-19 waited just around the corner.
Meanwhile, on December 14, 2020, a nurse in New York nurse became the first American outside of clinical trials to receive a COVID-19 vaccine. On December 22, 2020, the CDC published its suggested model for efficient and equitable vaccination distribution. By December 24, 2020, more than 1 million people in the U.S. received a COVID-19 vaccine dose, a number that almost tripled a week later.
On March 2, 2021, the Biden-Harris Administration directed all states to make pre-K through 12 teachers, school staff, and childcare workers eligible for COVID-19 vaccinations. On March 8, 2021, the CDC recommended that fully vaccinated individuals could safely gather with other fully vaccinated individuals indoors and without masks. On March 11, 2021, the Biden-Harris Administration announced its plans to vaccinate all eligible adult Americans by May 1. In early March, more than 100 million individuals received COVID-19 vaccine doses in the U.S., increasing to 200 million by April 21, 2021.
COVID-19’s Mandatory Measures
In the following months the number of vaccinated individuals in the U.S. increased as the recommended age for eligibility decreased, landing at ages 5 to 11 in November 2021. Two months before, the Biden-Harris Administration announced the federal mandate requiring COVID-19 vaccination for certain entities, including health care workers in institutions receiving Medicare and Medicaid funds. As early as July 2021, however, private and government employers implemented vaccination mandates for their workforces, as did colleges and universities for its students. Even Anschultz Entertainment Group and Live Nation Entertainment required vaccination at their venues in October 2021. By November 8, 2021, the federal government required all non-citizens travelling to the U.S. to provide proof of vaccination status before entering the country.
In 2022 many of these mandates faced constitutional challenges in state and federal court, with limited clarification and relief for the private sector. Health care workers, however, received no relief from the vaccination mandates, absent an exemption for medical or religious reasons. While the medical exception provided objective criteria for implementation, no similar assistance accompanied the religious counterpart, resulting in inconsistent results throughout health care facilities. The moral conundrum of punishing those who held firm at the front lines during COVID-19’s first year clashed with the federal government’s directive to enforce vaccination as a means to protect the public. The subject of vaccination polarized the nation, some of whom took issue with any requirement to inject a liquid created in record-breaking time and without any historical hindsight, while others cast aspersions on those refusing vaccination, blaming them for the extending a pandemic longer.
Water Under the Bridge
At the beginning of May 2023, the Biden-Harris Administration declared: “Today, we are announcing that the Administration will end the COVID-19 vaccine requirements for Federal employees, Federal contractors, and international air travelers at the end of the day on May 11, the same day that the COVID-19 public health emergency ends. Additionally, [U.S. Department of Health and Human Services (HHS)] and DHS [Department of Homeland Security] announced today that they will start the process to end their vaccination requirements for Head Start educators, CMS-certified healthcare facilities, and certain noncitizens at the land border.”
On May 11, 2023, the Federal Government terminated the public health emergency (PHE) known as COVID-19. HHS stated: “Based on current COVID-19 trends, [HHS] is planning for the federal [PHE] for COVID-19, declared under Section 319 of the Public Health Service (PHS) Act, to expire at the end of the day on May 11, 2023. Our response to the spread of SARS-CoV-2, the virus that causes COVID-19, remains a public health priority, but thanks to the Administration’s whole of government approach to combatting the virus, we are in a better place in our response than we were three years ago, and we can transition away from the emergency phase.”
The U.S. Centers for Disease Control and Prevention (CDC) also published: “May 11, 2023, marks the end of the federal COVID-19 PHE declaration. After this date, CDC’s authorizations to collect certain types of public health data will expire. The United States has mobilized and sustained a historic response to the COVID-19 pandemic. As a nation, we now find ourselves at a different point in the pandemic – with more tools and resources than ever before to better protect ourselves and our communities.”
While COVID-19 has not miraculously disappeared, the impact the pandemic had on the nation’s infrastructure and day-to-day existence effectively is now gone. Even as COVID-19 continues to take lives and will most likely do so for decades to come, the nation enters a cross-roads where COVID-19 related questions may outnumber new fatalities from the virus.
Back to DSM-5, 301.0 and Placebos
COVID-19’s legacy stretches far and wide, although the pandemic’s effect on mental health exists in the early stages of a deadly variant. As scientists research and debate the ultimate cause of an overall decline in mental health, the symptoms are hard to ignore. Conspiracy theories, social anxiety, damaged relationships, empty office buildings and an unfortunate decline in public and private educational institutions expose just a handful of the many ways in which COVID-19 compromised society’s overall mental health.
Albeit paranoid and delusional at times, society’s reaction to the COVID-19 vaccine, if nothing else, has been liberating. With or without choice, by May 2023 Americans received over 676 million vaccine doses. Medical science still needs considerable time to determine the efficacy of the vaccine on prevention as well as mitigation, not to mention the possibility that the vaccine caused unintended, life threatening health care concerns. The list of possible side effects from the COVID-19 vaccine runs deep, and the Internet provides an unprecedented source of energy to ensure existing and future theories, irrespective of plausibility, remain for decades to come.
Some also believe the vaccine was a placebo, which if true would be an egregious violation of medical ethics. Nevertheless, the COVID-19 vaccine treated psycho and somatic concurrently, a challenging feat for medical sciences on its best day. COVID-19 introduced a threat to society like no other, comparable only in recent history to the Second World War and its aftermath. The need to break the rules of engagement out of desperation is well documented in the nation’s history books. Only time will determine when and if the nation reconciles COVID-19 and its profound impact on society, including the “whys” and “hows” of the pandemic. Nevertheless, nothing can change the federal government’s May 11, 2023 directive. COVID-19, at least as the nation understood the pandemic after three long years, is finally over.
Craig Garner is the founder of Garner Health Law Corporation, as well as a healthcare consultant specializing in issues pertaining to modern American healthcare. Craig is also an adjunct professor of law at Pepperdine University School of Law. He can be reached at craig@garnerhealth.com.