Informed Consent: Still Relevant during a Pandemic

What patients seek is not scientific knowledge that doctors hide, but existential authenticity each person must find on her own. Getting too deeply into statistics is like trying to quench a thirst with salty water. The angst of facing mortality has no remedy in probability.

When Breath Becomes Air, by Dr. Paul Kalanithi

The quote above came from a neurosurgeon and the book’s author who learned that he had a terminal brain cancer. He lived the reality of how statistics are sometimes insufficient when one faces their own mortality. This concept seemed to apply to the social contagion of fear during this pandemic as well; statistics were not enough to provide perspective.

During this crisis, an honest discussion was required from authorities and public health institutions, especially when incredibly disruptive public health directives were being enforced. Physicians and scientists appropriately rely on statistics to interpret data and argue their scientific opinions with colleagues. However, statistics and data are often incomplete or not enough. The science is rarely, if ever settled; it evolves. In these circumstances, it is essential to embrace a culture of transparency and encourage an open dialogue with citizens. This concept was not executed well over the last year.

This pandemic represented an important opportunity for an informed consent process to occur with the public. Most people initially trusted authorities and largely gave their consent for a 2-week lockdown in March of 2020 to flatten the pandemic curve. The purpose of this lockdown was to avoid a mismatch between the community’s need for health care access and the health care system’s capacity to deliver it. I didn’t agree with the decision to lockdown or cancel school in our state, but at least, I understood the rationale. Unfortunately, as the goal posts were moved, case counts were emphasized but additional honest, transparent dialogue was lacking. Real harm has occurred because of mitigation policy directives, and many of these mistakes will need to be discussed if we are to learn from them.

An important aspect of informed consent is when physicians must say, “we don’t know at this time”. This usually leads doctors and patients to pause to avoid harm, or at least carefully reconsider the risks and benefits of any proposed action. We should have understood more about this virus before imposing severe mitigation strategies that resulted in the real health, economic and cultural collateral damage. Instead, citizens repeatedly received less than transparent, speculative modeling predictions, overly confident, yet simplified policy solutions from prominent public health officials. At times, these officials dismissed or suppressed dissenting professional opinions, or worse, attacked the dissenting person’s credibility. These actions have negatively impacted public health’s institutional credibility. This is an important point to consider when we are trying to understand vaccine hesitancy.

These institutions did not seem to adequately consider the real harms of the mitigation measures themselves, and the policy did not evolve appropriately as new evidence became available. Instead, we doubled down on every non pharmacologic mitigation weapon in our public health arsenal based on very weak, or even against the prevailing evidence. Some officials within the public health bureaucracy summarily dismissed clinical observations, viral research and population data that did not support their narrative or their mitigation strategies. These acts of evidence and idea suppression occurred to some professionals who were closest to the problem, or even to those with a broader perspective than policy makers. Professionals with contrarian viewpoints included: academic physicians, clinical physicians, virologists, epidemiologists, immunologists, public health scientists, economists, mental health specialists, and others. Citizens were not adequately exposed to valid concerns about the draconian policy decisions being implemented that impacted their personal freedoms to attend school, financially support their families, operate a business, or practice their faith. By June, it was clear to me that the pandemic response had become a political process with much vitriol, when unity and honest communication was needed more than ever.

This experience was incongruent with the process of scientific discovery that I had enjoyed as a physician. During my professional training and beyond, I have observed and participated in morbidity and mortality conferences. These meetings were meant to challenge care that may or may not have contributed to adverse patient outcomes. Physician opinions differed, studies were cited, and robust debate occurred with the central purpose of advancing knowledge and identifying choices that may have led to patient harm. Ideas were never suppressed, but they could be criticized. It was a productive and a mostly respectful process.

Since March of 2020, my aim was to make my community aware of different professional perspectives from very qualified academic epidemiology and infectious disease experts from leading institutions. Many of their viewpoints were consistent with my review of the SARS-CoV-2 population-based data, viral and immunity research, but I also presented viewpoints that were not consistent with my own. These physicians shared research and their rationale that supported their recommendations; most were advocating for a different public health approach.

Many physicians recognized early on that fear and an overly political response to this pandemic could be detrimental to the traditional public health goal of reducing total harm to a population. Unfortunately, many of the current mitigation policies and orders were implemented due to a singular focus and emphasis on case counts. This overly reductionist approach resulted in a neglect of other important public health priorities to reduce total citizen harm. A preventable citizen death is a death whether from undiagnosed cancer, drug overdose, suicide, homicide, or COVID-19. The choice to pursue an extremely narrow focus of daily COVID-19 case counts seemed to be a powerful political incentive to act decisively. This was an unfortunate impulse because viral characteristics, actual case fatality ratios and health care capacity data, as opposed to speculative modeling and case counts, would have suggested a more measured response.

In June of 2020, I proposed a different science-based perspective suggesting a more focused protection plan with less harmful mitigation strategies. (See the Powell COVID Blog posted in July of 2020). Our suggestion was later validated in the Great Barrington Declaration by experts in the fields of epidemiology, immunology, and infectious disease from leading academic institutions. This declaration gained the signatures of over 50,000 world-wide public health, academic and clinical physicians. The proposal has been widely misrepresented by opponents who claim that a focused protection approach would allow the virus to “rip” indiscriminately through a population, a straw man argument. The importance of reaching herd immunity is to reduce a population’s viral transmission rates. Hopefully, most people now understand, herd immunity is not a strategy, it is a desired outcome. The focused protection approach was a strategy to prioritize those who could most safely, acquire natural infection with a goal of attaining herd immunity in a rational fashion. This sustainable strategy would have protected vulnerable people more effectively and would have avoided the degree of collateral damage to the overall health of our population, economy, and cultural unity.

The extensive testing of healthy college students, athletes and asymptomatic individuals has been a tremendous misuse of resources in my view. The athletic COVID protocols in schools, universities and professional sports has not been productive, but it has been costly. Instead of testing asymptomatic elite athletes 3 times a week, contact tracing, quarantining, and isolating this extremely healthy cohort, what if we used the same vigorous testing and isolation in nursing homes instead?

Nursing homes and other assisted living centers would have benefitted from intensive testing, quarantine, isolation, and other mitigation measures where our most vulnerable reside. This is a focused protection strategy. We are doing some of that now, and Oregon fortunately did not follow the leads of New York, Pennsylvania, and other states by discharging patients with COVID-19 to nursing homes. But despite our current mitigation efforts and lockdowns, this virus has already circulated through most of our county care facilities at least once.

Serologic studies have consistently shown that the infection fatality risk is less than 0.1% for those under age 70 and almost 0% under the age of 30. This understanding should have allowed this cohort to weigh their own risk tolerance and resume normal activities without lockdowns, masks, social distancing, contact tracing, isolation, and quarantines. Divisive draconian mitigation measures were increasingly understood to have detrimental effects on educational opportunities, the economy, and other health issues for children and adults.

The ease in which professional and public concerns were dismissed regarding the real harms of prolonged mitigation efforts has been astonishing. Policymakers, media, and public health authorities seemed to be more interested in tabulating cases of Covid or headlining an emotional story about the rare young person with “long Covid”. At the same time, they were less interested in the catastrophic events of increased poverty, homelessness, a mental health crisis, domestic abuse, drug and alcohol abuse, and overdoses that were driven by the closure of schools, “non-essential” businesses and implementation of other mitigation strategies. Evergreen could easily see this parallel story evolving in front of us. Perhaps, this collateral damage data should have been placed in a modeler’s formula? Many citizens did not consent to these prolonged measures. The aggressive “stay home, save lives” advertisement campaign may have been effective, but it did not improve public health or save lives in my opinion.

Our clinical experience as well as other data and research was suggesting that this virus was present earlier than recognized by public health authorities, less virulent for healthy people under the age of 70 than suggested by officials, and increasingly transmissible via airborne and droplet routes. Meanwhile, there was clear evidence in European countries that school children could safely attend schools irrespective of their country’s background viral activity. Sweden’s 1.8 million children attended schools without masks, social distancing, or other complex mitigation measures. At my last review, I am still unaware of a single death related to SARS-CoV-2 in these Swedish children, or evidence of increased viral transmission in teachers. Despite this evidence, I was surprised by the lack of acknowledgement of these observations by policy makers. There must be honest scientific discourse, and less medical tribalism. Delayed publication of extremely relevant research has occurred, and there has been professional pressure to conform to institutional hierarchy and biased policy.

Most pandemic retrospective reviews by the media and even academic articles will emphasize the number of COVID-19 cases and deaths in 2020. They seem to do this to justify the extreme public health measures taken. They often claim that there would have been many more deaths if these steps were not taken. However, there is international and national population evidence that would suggest otherwise.

What is almost never done is to reflect and ask the following important questions:

  1. Did the mitigation measures work?

  2. Were these measures worse than the disease?

  3. What were the missteps, and will we learn from our mistakes?

In times like this, I am reminded of Loeb’s Laws. These laws are attributed to Dr. Robert Loeb who was a well-known professor and chairman of Columbia’s department of medicine in the mid twentieth century.

  1. If what you’re doing is doing good, keep doing it.

  2. If what you’re doing is not doing good, stop doing it.

  3. If you do not know what to do, do nothing.

  4. Never make the treatment worse than the disease.

I’m afraid that we may have violated at least a couple of these laws over the last year, but my hope is that we can learn from our mistakes and avoid violating rule #4 anymore. Going forward, I would hope that we will provide proper informed consent to our citizens. This may require a little more humility and fewer edicts from medical and political leaders, especially when information is incomplete, or there are other valid medical approaches. The individual will then need to understand the lack of professional consensus and make choices based upon their own values and risk tolerance.

John Powell M.D.

The addendum below contains some evidence that calls into question some of our current public health policy.

Oregon Health Authority case fatality data by age as of 4/2/21:

The age severity differential is quite apparent is these data. This important differential was apparent in March of 2020 if actual data would have been elevated over highly publicized, but inaccurate predictive models.

South Korean Case fatality data as of 3/31/21

(source: Korean Disease Control and Prevention Agency)

The CASE fatality rate as defined above for those under the age of 60 is 0.11% (82 divided by 74,707) and for those under the age of 70 the rate is 0.31%. Compare this to an often-quoted infection fatality rate during a standard seasonal flu season of 0.1%.

How did at least 30 more adolescents and teenagers die in Oregon in 2020 as compared to 2019? This represents an over 40% increase in the number of deaths in this demographic. The evidence suggests that the increase was not directly related to SARS-CoV-2. Did the pandemic mitigation strategies contribute to this finding? The question and answer should not be suppressed. The CDC does have some relevant data that speaks to the concern.

Sweden’s Evidence based approach

I have advocated for Sweden’s reasonable approach to mitigate viral transmission. Swedish kids attended schools, businesses remained open, and masks were not mandated. I recommend listening to Dr. Johan Giesecke’s interview that I presented in my blog from April 2020. He is a veteran infectious disease, and epidemiology physician who served as a public health advisor to Sweden and the WHO.

In the interview, he indicated that the virus would sweep over the world, and in the end, there would be very little difference in mortality among countries that resulted due to the degree of lockdowns or severe mitigation policy employed (such as mask mandates). He also correctly predicted that those who did institute draconian mitigation measures would struggle to lift them.

So, let’s look back after a year at some of the data. The graph below demonstrates the seasonal tendencies of SARS- CoV-2.

I draw your attention to the number of deaths per capita at the right-hand column in the tables below as you compare different states and Sweden. Sweden is now listed as 27th country in terms of the number of deaths per capita and the U.S. is 14th. I will acknowledge that there are a lot of factors that impact these numbers including testing availability, but most people who have died in developed countries received a test for Covid for respiratory illnesses by April of 2020.

In terms of deaths per capita, Sweden would be somewhere between Montana and Oklahoma, or number 35 when compared to our 50 states. Sweden’s performance is despite their elderly demographic and public health missteps early in the pandemic. In March, their very large, publicly funded nursing homes and assisted living facilities were inadequately protected. A problem that they identified and corrected because they did not attempt to hide their errors.

Mitigation strategies, Moving the goals posts and Lost Perspectives

In the summer and fall of 2020, do you recall hearing from officials that Oregon citizens needed to maintain public mitigation strategies until the reproduction number (Re) was less than one? In February, the following news release was found on the Oregon Health Authority website.

During this extended mitigation process, we have achieved two goals. We flattened the curve and the replication number has been measured as less than one. Yet, high school kids are still wearing masks outside while competing in sports.

School policies have evolved to appease irrational fears, state mandates, and reduce litigation risk for school districts. Legal immunity should have been granted to schools so that they could truly advocate for the kids. The mental health and educational opportunities should have never been sacrificed to accommodate adult fear. If a parent or student did not feel safe, they should have remained home for virtual learning.

Playing a flute with a slit in the mask and a cloth on the end? This is not science. This is what tyranny looks like in my opinion. Let them play and learn and put the attorneys in timeout.

I will leave you with the following numbers as many consider if the polices implemented during this pandemic were worth it.

  1. 400,000 new deaths last year due to tuberculosis because of the diversion of medical resources.

  2. One hundred and thirty million people with severe food insecurity or starvation due to supply chain disruptions.

  3. Nearly 50% of patients with cancer missed chemotherapy sessions due to altered public health priorities.

  4. An estimated 78% of new cancers were missed or a diagnosis was delayed because of lack of screening opportunities.

  5. Nearly 25% of 18 to 24- year-olds thought about killing themselves in 2020.

  6. A 300% increase in teenage medical visits from teenagers to doctors for self-harm.

  7. 1-4 million died in the influenza epidemics in 1958 and 1968 while the world population was 2.9 billion and 3.5 billion respectively.

  8. As of 4/5/21, the world has confirmed 2.87 million SARS-Cov-2 related deaths in a world population of 7.4 billion since the pandemic began in 2019.

An Informed consent process is important for everyone who is impacted by public policy. This is especially the case when individual life choices and freedoms are affected.

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