Friday, June 5, 2020

Certificates of Immunity in America?

Adm. Giroir, the COVID-19 testing czar,[1] has stated that “tens of millions”[2] of antibody tests would be in the pipeline, soon; but they come with many uncertainties about what that will mean. There is no clear evidence that having antibodies to COVID-19 will protect you from getting the disease again, and to the extent we can believe it, reports from China were that people were being reinfected after recovering from the viral infection.[3] There are several strains of COVID-19 that could complicate the antibody tests, and the level of antibodies necessary to confer immunity is another measure we do not have.[4] We are relying on decades of studies and the very scientific underpinning for vaccines that tell us that antibodies from a COVID-19 infection should make us immune to COVID-19. Even that basic medical principle is challenged by COVID-19.
The concept of “herd immunity” is at least part of the recovery plan for Sweden, where they believe more than 30% of the population has antibodies to COVID-19,[5] creating an antibody environment that would slow transmission. But some experts believe it takes closer to 60% of the population with immunity to achieve the herd immunity effect.[6] We, in the U.S., are far from this standard, today.
So assuming we answer these scientific questions, and certificates of immunity, an idea discussed in April by the U.S. public health leadership are considered?[7] What are the legal issues?
The first reaction to certificates of immunity has been to reference the idea as a dystopian plot for a novel. Labeling and stigmatization of individuals is the fear. The second, and far more damaging reference, was to use the term “suspend individual rights” in order to reopen America. We do not, let me repeat, we do not, suspend individual rights, ever, under our Constitution. For those of you who are planning on government collapse, you may be disappointed because we have a well-practiced, continuity of government (COG) plan in place (and now ready) should government be even slightly diminished in function.
We also have a prohibition against military governance, the Posse Comitatus Act, passed after reconstruction following the U.S. Civil War, because we saw it was a very bad idea to have a military-civilian law enforcement relationship. So any “suspension” of individual rights is clearly prohibited by law.
The U.S. Constitution is still our guaranteed protection against tyranny. The Bill of Rights ensures, without suspension, how those rights are balanced against the interests of the American society and its protection against invasion from outside the nation and crime, public health and property protection, from inside the country.
So how do we balance the need to reopen the economy and allow individuals to pursue work and life? A certificate of immunity is one idea to safely govern the return to work, school and play, but it must not burden individual rights and protections more than it benefits and serves the needs of the American people – in Constitutional law language, it is the compelling government interest in reopening the economy and protecting public health that must outweigh the burden on individual rights. The balance is making sure it is worth the burden placed on individual protection and rights.
Now let us examine the individual rights that would be “burdened” by a certificate of immunity, again, assuming we find a reliable diagnostic test on which to base such a certification.
First, the U.S. Supreme Court has opined that the U.S. Constitution guarantees the right of privacy. This is found not in the word “privacy” anywhere in the text of the Constitution, but collectively found from the 3rd, 4th, 5th, 10th and 15th Amendments of the U.S. Constitution. That is settled law. That means your health information is a privacy interest of every individual, and Congress has ensured it is protected through the HIPAA protection that is afforded patients of healthcare providers. However, HIPAA does provide for the revealing of that information to public health authorities in a public health emergency, which is considered a burden that is not too great on individual privacy rights, in that narrow circumstance of a public health emergency. As of this writing, there is a declared national public health emergency and all fifty states have issued public health emergency proclamations or the equivalent. Your privacy right would weigh less in the balance of these set of facts and circumstances.
Second, equal rights for every individual is guaranteed by the 14th Amendment, and discrimination against an immutable characteristic is prohibited – meaning something you cannot change, like gender, race, etc. Immunity is not an immutable characteristic and can even be changed with a vaccination. That said, individuals with immuno-compromised conditions and other risk factors that would make attempts at gaining immunity from the disease or a vaccination prohibitive, warrant special consideration. Part of a certificate of immunity policy would have to plan for how this class of individuals might return to work without discrimination based on these characteristics that they cannot change.
Third, workplace discrimination is prohibited by genetic information, and there is some indication that genetic information could be correlated with immunity for a more reliable immunity determination. Workplace discrimination based on genetics is prohibited by federal law,[8] the Genetic Information and Nondiscrimination Act (GINA) of 2008.[9] Congress would have to adopt an amendment to GINA to allow the use of genetic information as part of a certificate of immunity. However, workplace discrimination has been held to be likely enough for a federal district court to issue an injunction against a hospital where a group of nurses refused a smallpox vaccination as a condition of continuing in their jobs in the hospital in Washington State.[10] This was a federal district court order, but it is an indication of how the law might be applied, if tested, in other courts, with certificates of immunity as a condition to return to work. Remember, this is also a balancing test, and this conflict occurred almost one year after the passage of the Smallpox Protection Act in response to the threat posed by the anthrax attacks of 2001. That law called for taking the precautionary step of vaccinating frontline workers with the smallpox vaccine. In 2003, the threat was still very real, but by 2004, the threat had largely passed in terms of public perception and the balancing of the risk of the smallpox vaccine against the likelihood of a smallpox attack (the compelling government interest being to protect the nation) no longer seemed balanced. For now, the balance of a certificate of immunity for COVID-19 weighed against the need to safely return the American workforce to work may be a much more acceptable balance. As circumstances and conditions change with regard to COVID-19, so too, would the balancing test.
Fourth, safety in the workplace where personal protective equipment is required by the employer, as a condition of employment, can be bolstered by the employer relying on state and federal recommendations and protocols.  
Finally, how different is a certificate of immunity from a vaccination record that is required to attend public school and public universities? Requiring vaccinations for public school has been found to be consistent with our Constitution[11] where exceptions can be made for those unable to have vaccinations. This policy is driven by the susceptibility of children to these childhood diseases balanced by its narrow application to public school attendance and the compelling government interest of preserving the lives of many more children by using vaccinations.
The unintended consequences of such a policy must also be considered. Such a policy might drive those who vitally need to return to work to sustain themselves and their families to infect themselves to obtain immunity,[12] perhaps with deadly consequences. In fact, just the mention of certificates of immunity may have triggered some individuals to get a “head start” on the policy. (We already have a network of “chicken pox parties” in Facebook groups who plan intentional infections of the childhood disease for their children with the dangerous and perverse logic that it will help them.[13] It is not an unreasonable assumption that the same network might be developed for COVID-19.)
Will such a policy create a stigmatized group of individuals? Not if we plan accommodations in the policy for those who are unable to obtain immunity and thus the certificates of immunity. Even without certificates of immunity, there are already classes of individuals that should not return to work where the risk of infection is high, like the risk group of 65 and older. There may be stigmatization against young adults who are largely identified as the population that can spread the disease with no symptoms, potentially making them a stigmatized group.
The balance of the government interest against the burden on individuals having to prove such immunity with certificates to return to work, school and play could very well be constitutionally balanced, now, in these times and circumstances. It does not mean this will always be the balance, because when the threat subsides, and the burden becomes unwarranted by the compelling government interest to keep us safe from COVID-19, certificates of immunity will no longer be warranted.
Finally, despite the increasing use of Executive Orders when Congress will not act to carry out the policies of a duly elected President (exercised by Presidents of both political parties), certificates of immunity would be considered a “rulemaking” meaning that it would have a legal impact on individuals. At a minimum, such a policy would require an authorizing statute giving broad authority to make such a rule, but it would also require notice and comment for 60 days, which could be repeated until the rule/law is final. In an emergency, the certificates of immunity could be instituted, while a rulemaking is underway. Rather than the Executive Branch risking a judicial review of the legality of a certificate of immunity requirement, a certificate of immunity could be made voluntary for employees and employers, but that would leave employers who demand the certificates as an absolute condition of employment exposed to litigation without the authority of a federal requirement as a per se defense.   
Certificates of immunity would create two general groups: those who can work, study and play and those who still have access to these activities in a more protected way. If we do not have certificates of immunity, the likelihood of stigmatizing groups known to be vulnerable (older adults), and groups known to be spreaders without symptoms (younger adults) is a certainty, which will raise Constitutional issues to resolve.
So, if science can give us a reliable test with predictability, a certificate of immunity can be managed with no suspension of the Constitution or individual rights. The Constitution will operate the way it was designed, with principles of freedom, democracy and dignity and protected rights for the individual.

[9] Pub.L. 110–233, 122 Stat. 881 (May 21, 2008).
[10] Washington State Nurses Assoc. v. Virginia Mason Medical Center, (W.D. Wash., Oct 1, 2004).
[11]  Jacobson v. Massachusetts, 197 U.S. 11 (1905) also citing several state cases that upheld the authority to require school vaccinations.

Saturday, April 25, 2020

China's contempt for compliance with international law calls for rethinking public health diplomacy

The International Health Regulations have been around since the 1960s and agreed to by the World Health Assembly, binding all members of the World Health Organization. But the IHR of 1969 was weak, at best, in terms of obligations on members. There were only four reportable diseases, one being smallpox which dropped off the list in the late 1970s and the remaining diseases, Yellow Fever, Cholera and Plague were not frequent epidemics and all of them had treatment protocols that would contain any outbreak.

The SARS pandemic, often called the first pandemic of the millenia, started in Guangdong, China in November 2002, and was kept quiet by the Chinese government. But in February 2003, a doctor brought the virus to Hong Kong, and began the worldwide spread that resulted in more than 8,000 infections and 800 deaths in 26 countries before it was contained or just disappeared as it evolved. The World Health Organization had only the IHR of 1969 and no obligation for China to report a novel coronavirus, only one of the three reportable diseases. While it had been clear for some time that the IHR of 1969 needed to be updated, the shameful failure of China to report the outbreak and allow it to spread beyond its borders before allowing help to arrive in identifying the virus, pushed the revision of IHR to the top of the WHO Agenda.

So immediately after the spread from China to Hong Kong, and the refusal of China to cooperate with outside scientists, the World Health Organization assembly of members, the World Health Assembly, passed a resolution, WHA 56.29, May 28, 2003, that urged WHO member states to take eleven specific actions to enhance, support, and strengthen national, regional, and international efforts to address the SARS outbreak. But most significantly, they also passed resolution WHA 56.28, to begin revision of the IHR, urging member states to give “high priority” to revising the IHRs 1969 and “to provide the resources and cooperation necessary to facilitate the progress of such work.”
Most importantly, WHA56.28 granted the WHO power to intervene by sending WHO teams to independently investigate and conduct “on-the-spot studies” to determine whether national authorities are taking “appropriate control measures.”

The Washington Post reported that the actions by the World Health Assembly “mark the first significant expansion of WHO power in more than three decades.”  They wrote that WHA56.28 “frees [the] WHO from having to wait until a country officially reports an international health threat before beginning countermeasures . . . and gives the agency the authority to begin ground inspections without a formal invitation.” [Rob Stein, WHO Gets Wider Power to Fight Global Health Threats, Wash Post A15 (May 28, 2003)]. Everyone knew why WHO was granted to the power to enter a country without invitation, and it was clear that China had paved the way for such a sovereignty-infringing regulation and making it acceptable to WHO Members.

China was silent, while WHO tried diplomacy to gain access for scientists to diagnose the disease. After gaining access to enter China around March, by April WHO was threatening to leave and withdraw resources because of lack of cooperation by China. 

Meanwhile, the revision of the IHR was underway and a final draft was signed by the Members of WHO in 2005 and the regulations became effective (and binding) June 2007. China was a signatory, and they agreed to be bound by the new regulations that required reporting within 24 hours of confirming a disease with certain charateristics that would add up to threating global public health, identifed as a Public Health Emergency of International Concern (PHEIC).

Now, twelve years after the IHR went into effect, in 2019, another coronavirus emerges within China's borders; and again, China sat silent, even punishing those who would dare to speak out about the novel deadly coronavirus. But the IHR anticipated this type of secrecy and so it also provided for reports to come from reporters or individuals directly to WHO, alerting WHO of a disease coverup. The country is notified for a response. This is the legal mechanism that allowed WHO to pursue the COVID-19 reports followed by the obligatory response of China based on individual reports leaked from the country. So China failed to comply with its simpliest requirement to send a notification to the WHO within 24 hours of determining they had a disease that met the definition of a PHEIC.  Years of diplomacy to ensure the problem child of the international public health community, China, would comply with regulations so clearly triggered by China's failures during SARS.

So the difference between SARS and COVID-19 for China is clear. For SARS, China was just a morally and ethically bad global citizen. For COVID-19, China violated international law by all accounts and should be accountable in an appropriate judicial or diplomatic forum. Ideally, the IHR violations should trigger the WHO or even the UN Security Council to sanction China for violating international norms and regulations.

What does this say for the value of international law if China is given a pass by the WHO for this history of violating international norms and rules? It makes all international law, weaker.

Maybe WHO as an international diplomatic mechanism is something that is time to rethink, and maybe withholding dues to an organization that has done nothing to enforce its IHRs is not so unreasonable.

Saturday, April 11, 2020

Has anything really changed with our way of coping with pandemics in human history?

An excerpt from an 11-year old's journal in 1912 about a smallpox epidemic in her town and how it affects her family was published by a relative in the Coeur d'Allene newspaper today, and the observation that I have to make is that we are dealing with COVID-19 about like we did with smallpox in 1912, without a lot of advancement. Quarantine and isolation is in use, but with slightly less constitutional due process, and family social-distancing is practiced. The same family factors are still important --the father is missing work, and the extended family is buying groceries and leaving them on the doorstep for the sick family.

Let's not stop with the analogy, and continue to travel back in time.

The year is 1350, and the black plague is in full force in Europe. Without any knowledge of germ theory, social distancing is still practiced and is the rule of the day. Some towns are completely quarantined and no one enters or leaves. Some houses are boarded shut -- with the residents inside, who were destined to pass on from the plague. The religious leaders said the pandemic was punishment from God, and flagellating zealots wandered from town to town in hopes of redeeming society, and bringing a close to the largest wave of death ever seen by Europe (in recorded history). Doctors and everyone who could afford a mask, wore one. By the time the plague arrived again in the 1400s, King HenryVI banned kissing in England; and in the 1600s, the iconic doctor's mask with a large beak, made of leather and stuffed with fragrant flowers, was the standard of personal protective equipment.

Nothing much has changed. We seem to be coping with the pandemic much the same way we did with the same tools since the 1300s, with incremental improvements from century to century. Quarantine and isolation are still are best tools to fight COVID-19; masks and "face coverings" are the standard of personal protective equipment for leaving your home, if you can; and some religious leaders are suggesting the world is being punished for its sins. I am not disputing the truth of that, I am simply saying we are still saying the same things and doing the same things in response to a pandemic, as we did since the beginning of recorded history, despite the industrial revolution, the physics revolution and now the biotechnology revolution.

So what, if anything, has changed?

Hope that we can cure it -- a realistic hope. As a society we are not panicked because we know that in infectious diseases of the past, we have followed a process of researching and using vaccines to combat viral infectious diseases, including childhood diseases, and yes, that scourge of smallpox. We also have the benefit of centuries of data on the epidemiological curves (a mid-19th century discovery) and have some imperfect projection of how we will reach a peak, how high the peak might be, and when we can expect to see changes to the infection and death rate. Yes, it is imperfect, but it gives us an edge on predictability, that we didn't have in 1352, or even 1912. There was such a complete lack of hope during the Black Plague, and many thought the end of the world was coming, that there was wild drunkenness and orgies in defiance of the expected coming end of the world.

One other notable similarity -- our counts of deaths during the Black Plague in Europe are fairly accurate; yet, we have no accurate information about the true number of deaths in Asia from the Black Plague. Some things never change.

The compliance and calm has been strikingly successful, leaving us with the final observation that we have a realistic hope for a way to win in this war against COVID-19, in a way, our human predecessors did not. We are also able to adapt to our isolation through the humanity-changing technology, with our worldwide interconnection through the internet. Many (not all) are able to continue working online, ordering food online, and learning online. We are incrementally less disrupted, by these incredible changes to the way that humans connect.

Will this change us when COVID-19 subsides? If the changes after 9/11 and the anthrax attacks are any indication, we will be changed by this forever, in some major ways and some subtle ways. Will we move farther into cyberspace to connect, and thereby be less disrupted by the next pandemic?

Almost certainly. 

Wednesday, April 1, 2020

Ethics of Selecting who gets a ventilator

This is not a shocking new idea, although it is the next step that we will have to take while we simultaneously try to flatten the curve of the infections.

The predicted shortage of ventilators has raised the question of how hospitals will select who gets a ventilator, and essentially, who lives and who dies?

Some considerations for ventilator distribution is first, to what cities should the stockpiles be sent? Should this be on a per capita basis, or on the actual, not predicted, cases? Now that directives on how to use a ventilator on two people have been discussed, that should be the first consideration before making any choices. Looking to the ethical guidance issued during the vaccine shortage of 2003-4, reveals some of the key considerations for similar respiratory distress risk groups.

During the bird flu outbreak the flu vaccine was in short supply because the U.S. supply had been sourced from a vaccine facility in France that had a contamination incident, and no shipment could be made to the U.S.. The second reason was a shortage of eggs that are used to make vaccine. Bird flu meant a lot of birds were destroyed creating an egg shortage, as well as a concern of contaminated eggs.

The New York Times reported on October 7, 2004, that the U.S. will receive only about 55 of the 110 million doses of flu vaccine ordered.

This led the CDC to convene its Advisory Committee for Immunization Practices (ACIP) to determine who would get the flu vaccine, since not everyone would have access to it.

Although CDC wrote that each group had the same priority, the listing had the effect of suggesting a priority in this order:
1. infants
2. elderly
3. chronically-ill
4. front-line medical workers

Many were critical at the time that front-line medical workers should have been at the top of the list rather than at the bottom. CDC was planning to revisit the hierarchy and mercifully, the flu season ended without being as bad as expected. In 2005, CDC made recommendations again, and healthcare workers were near the top of the list.

Since 1990, flu vaccinations in the U.S. nearly tripled in the 1990s, making the 2004 shortage a real issue (see graphic).

When the ACIP or ethics board gathers to consider who gets a ventilator, let's hope that healthcare workers are at or near the top, because the preservation of life (without question) is directly dependent on healthcare workers.

Thursday, March 19, 2020

The Trajectory of COVID-19 cases in Select Countries

The trajectory of COVID-19 shows a very different rate of reported new cases.

The trajectory for Italy is strikingly more steep than for South Korea. Some epidemiologists are offering the analysis that there are more elderly people Italy (23% over 65 yrs)  than in South Korea (13% over 65 yrs) as the primary reason for the difference. 

I would like to suggest it was more related to the policy decisions made to stop the spread of the virus, which included immediate isolation and quarantine as well as some methods that would be unacceptable in the U.S. or Europe, such as contact tracing through cellphone records. The government had data about every contact each individual with a cell phone had, enabling the government of South Korea to reach those contacts of infected individuals immediately to contain the spread by isolating or quarantining those that had come in contact with the infected individual. In contrast, according to CGTN (China Global Television Network) the "Mayor of Florence Dario Nardella has suggested residents hug Chinese people to encourage them in the fight against the novel coronavirus."  That was good in spirit, but resulted in a lot more than hugging one individual, where several people would embrace each other at once -- not recommended public health practice. By having groups of 3-4 people hugging each other, it was the opposite of WHO recommendations to practice social distancing. 

The analysis of public health measures will continue to unfold as the escalation of cases continues. But there is hope with the Italy trajectory. Yesterday, there was a drop in cases, that we hope indicates the end of the second peak that is typical in a highly infectious event. There may even be a third peak, but predictably lower.

Saturday, March 14, 2020

"Self-isolation" vs. "self-quarantine". What's the difference?

I have been asked these questions, including the question in the title of this post. I thought it would be useful to share the answers, here.

How do “self-isolation” and “self-quarantine” differ? 

The short answer is “quarantine” is for anyone who does not show symptoms but may have been exposed to a contagious diseases; whereas, “isolation” is for anyone already infected or likely to be infected due to an exposure. Both are done to prevent transmission of the disease to others.

The recommended definitions for “isolation” and “quarantine” in the Model Public Health Act (that is not law unless it is adopted by a state legislature or a form of it) may have been adopted by any state in their public health laws. Keep in mind, every state has their own public health law, these are just recommended standard definitions, not law.

(30) “Isolate,” “Isolated,” or “Isolation” means the physical separation and confinement of an individual or groups of individuals who are infected or reasonably believed to be infected with a contagious or possibly contagious disease from non-isolated individuals, to prevent or limit the transmission of the disease to non-isolated individuals.
(53) “Quarantine” means the physical separation and confinement of an individual or groups of individuals, who are or may have been exposed to a contagious or possibly contagious disease and who do not show signs or symptoms of a contagious disease, from non-quarantined individuals, to prevent or limit the transmission of the disease to non-quarantined individuals.

The World Health Organization also similarly defines these terms in the International Health Regulations (IHR), but includes articles and animals as well as humans, unlike the Model Act definitions:

“quarantine” means the restriction of activities and/or separation from others of suspect persons who are not ill or of suspect baggage, containers, conveyances or goods in such a manner as to prevent  the possible spread of infection or contamination;
“isolation” means separation of ill or contaminated persons or affected baggage, containers, conveyances, goods or postal parcels from others in such a manner as to prevent the spread of infection or contamination;

·  What do we know about the risk of people going out once they are told to self-isolate? How likely are they to spread it? 
Our system of quarantine/isolation has always been based on the concept of the “social compact” that means the government gives you the maximum amount of freedom to protect public health in exchange for your agreement to restrict/burden your own freedom to the degree required to do that. So ethical people agree to this “social compact”. The problem occurs when people do not keep that agreement, that happens more often than you would think. For example. Tuberculosis patients agree to come in everyday for antibiotic treatment in exchange for going about their day with complete freedom of movement. However, TB patients often do not show up for their antibiotics especially if they are drug addicts, so eventually, the court will agree to an order after giving them significant due process to comply with the “social compact”. The consequences of someone with COVID-19 violating their ”social compact” has high consequences. This may indicate a higher likelihood of court ordered isolations or quarantines because when balanced against the harm, the burden on the individual will be reasonable to prevent that harm. But our constitutional due process requires that we give a reliable patient the maximum freedom to self-isolate in their home with only the minimum amount of confinement necessary to protect the public health.
The infection rate is about the same as flu and SARS although with different consequences.

·  Do public health officials have any way of keeping up with all of the people who have been asked to self-isolate or quarantine? Is a court order, required?
Canada did a remarkable job of self-isolation and self-quarantine of people with symptoms or exposure to SARS in 2003-4, when they identified these travelers and sent them home and asked them to call in each day with a reading of their temperature. They communicated via telephone or Skype. This is human resource intensive, but they allowed people to enter their temperature online each day, reducing the human resource burden near the end of the cycle of SARS. We should be able to do that. If someone missed calling in, a human followed up with a phone call or a visit.

The U.S. is asking its citizens to honor the social compact and use social distancing even if it is inconvenient, both for the safety of the individual and the safety of others. The U.S. or its states may even ask for self-isolation or self-quarantine of particular individuals, again asking them to honor the social compact. We can do it.

Friday, March 13, 2020

What is a pandemic vs. an epidemic?

The World Health Organization (WHO) on March 11, finally issued the official decree -- COVID-19 is now a "pandemic".

The WHO has criteria for phases of pandemic influenza and they have applied that criteria to Bird Flu and even SARS. There are three criteria that must be met, which you can see from the WHO graphic. First, that the disease is contagious to humans or animals; second, there must be a sustained human to human transmission; and third, it must have "widespread human infection". Even after 34 countries were reporting cases of human to human transmission of COVID-19, WHO had not yet determined this met the "widespread human infection" criteria and many were wondering what it took to meet that criteria, if not 34 countries?

It took 114 countries. 

The WHO Director-General in his remarks, said that "In the past two weeks, the number of cases of COVID-19 outside China has increased 13-fold, and the number of affected countries has tripled."  Further, " we are deeply concerned both by the alarming levels of spread and severity, and by the alarming levels of inaction."

This graphic shows the decision-framework WHO uses to assess where we are in the phases before and after a pandemic. The announcement on March 11 is the Phase 5-6/ Pandemic phase. Look for WHO to next consider "post peak" status, hopefully in the near future. Since China and the Republic of Korea have 90% of the cases and have now shown declines in new cases, that's a good sign for the rest of the world. The move toward "post peak" for these two major nation contributors to the number infected indicates other countries should follow that drop in reported cases in the coming weeks depending on the controls and government interventions. 

Let's hope for the post peak announcement this spring.