Archive for the ‘health care’ Category

When This Is Over, We Must Do Better!

Thursday, August 6th, 2020

For decades, we have swept our health care problems under the rug for posterity to trip over.    And right now, posterity is flat on its face.

Let me ask you this: Whether you believe high quality health care is a basic human right or just a privilege to be earned (I argued the former here), what do you think about 5.4 million Americans losing health insurance in the middle of the worst health care crisis in more than 100 years, because they lost their jobs?

One of the many terrible things COVID-19 has done is to expose our health care foundational flaws for all the world to see. For example, if there is ever a time not to lose health insurance it is during a pandemic. Another deep and open wound suddenly exposed to bright light is the abominable, even obscene, way in which COVID-19 has been allowed to impact the African American, Native American and LatinX communities. Health care is neither universal nor applied equally throughout the country.

As far back as 2008, I, along with others, documented the many ways our health care system, if you can call it that, lags behind the rest of the developed world*, in some case far behind. This, despite costing twice as much as the average of the other 36 member countries in the Organization for Economic Cooperation and Development (OECD), 25 of whom are members of the European Union. Since then, except for the passage of the Affordable Care Act (ACA), things have only gotten worse, and the ACA has been flayed, gutted and nearly beaten to death more than once. It should not, but it does to many, come as any surprise that the EU countries are performing significantly better in the battle against COVID-19 than we are, despite having a total population that is 27% greater than America’s. These two charts prove the point:

First, Population – From the World Bank:

Second, COVID-19 cases – from Johns Hopkins University and Statista as of 30 July, seven days ago:

What more does one need to see to conclude America’s response to COVID-19 has been tragically woeful?

Yesterday, I was speaking with a friend, a pulmonologist who has been on COVID-19’s front lines in Massachusetts since March. He and his patients, a number of whom are no longer with us, have been through a lot. His biggest complaint? The lack of “consistent, cohesive and comprehensive leadership from the federal government.” He said, “I’m a God-fearing man, but right now my God is science.”

The rug under which we swept our problems has been pulled up, and bad things have crept out into the light of day. But COVID-19, for all its horror and misery, has presented us with an opportunity. When this is over, and someday it will be, we will have an opportunity, nay, an imperative, to build a better American health care program, less fragmented, less costly, less complicated, and universally provided to every person within the confines of our nation’s borders. If the leaders we elect have even a modicum of courage, if they have entered public service to actually serve the public – all of it – we and they may be able to take the iniquity of this virus and leverage it to the point where health care in this nation, rather than having to be earned as a privilege, available only to people who can afford it, becomes a basic human right for all of us.

* The link is to the conclusion of a 5-part series. For the first four parts, enter “The best health care in the world” in the search box on the right sidebar

 

AstraZeneca And Oxford Surge To The Lead

Monday, July 20th, 2020

Lord knows, good news is hard to come by these days, but, H’Alleluia, we got some this morning.

Researchers from pharmaceutical giant AstraZeneca* and Oxford University’s Edward Jenner Institute for Vaccine Research announced promising results from a Phase 1/2 study of their COVID-19 vaccine candidate, known as AZD1222.

Researchers gave AZD1222 to about 500 volunteers and compared the results to those from around the same number getting a meningococcal vaccine.

For the AZD1222 vaccine, antibodies against the SARS-CoV-2 spike protein peaked by day 28 and remained elevated to day 56, the end of the study, indicating an immune response against the virus. Much has recently also been made of T cells, a type of white blood cell: Here, the vaccine levels of T cells peaked 14 days after vaccination and were still present two months later.

Ages in the study group ran from 18 to 55; the median was 35. This is much younger than the median age of the group that will need it the most: the elderly. Also, nobody in the study group had co-morbidities associated with heightened risk of bad outcomes.

There were side effects, but they were relatively minor: fevers, aches, headaches and fatigue, but acetaminophen, the active ingredient in Tylenol, alleviated these.

Phase 3 trials are now underway in the U.K., Brazil and South Africa and are due to start in the U.S.

The UK has already ordered 100 million doses of the unproven vaccine, which scientists from Oxford’s Jenner Institute have said could be ready for approval in September.

A word or two about the light speed of this vaccine’s development, as well as the roughly 100 others being developed around the world.

First, Oxford has been working toward developing a novel coronavirus vaccine for two or three years. After the 2014 Ebola epidemic, the British government invested  £120 million (about $149 million at the time) to create vaccines aimed at protecting against the 10 or 11 health threats deemed to be the most likely to threaten the country. Coronaviruses were on that list, and the government gave the Jenner Institute some of the money.

Once that happened, Oxford doctors Sarah Gilbert and Adrian Hill pioneered a way to put a bit of a novel coronavirus in a vaccine, but without the part that makes it replicate in humans. At that point it would be safe to inject in people. What Gilbert and Hill created was a platform that theoretically should work for many viruses and has been proven to be safe in vaccines for other diseases. And that methodology, called recombinant adenovirus vector, is what AstraZeneca and Oxford are making the foundation of their COVID-19 vaccine candidate.

So, because of the work of Gilbert, Hill and their Oxford team, Oxford and AstraZeneca had a head start on the COVID-19 vaccine derby. But still, AZD1222 entered its Phase 1 clinical trial the last week in March, 2020. If they succeed and have a vaccine ready for humanity by September, that will be six months from start to finish. This is way beyond unheard of!

Don’t believe me? Typically, and this is anything but, clinical trials go through four phases according to the FDA:

Phase 1: 

Study Participants: 20 to 100 healthy volunteers

Length of Study: Several months (For this example, let’s say 4)

Purpose: Safety and dosage

Result: Approximately 70% of drugs move to the next phase

Phase 2: (AZD1222’s Phase 1 and 2 were done in two months)

Study Participants: Up to several hundred people

Length of Study: Several months to 2 years (Let’s say 4 months to two years)

Purpose: Efficacy and side effects

Result: Approximately 33% of drugs move to the next phase

Phase 3: (This is what AZD1222 is beginning now)

Study Participants: 300 to 3,000 volunteers

Length of Study: 1 to 4 years

Purpose: Efficacy and monitoring of adverse reactions

Result: Approximately 25-30% of drugs move to the next phase

There is a Phase 4 with several thousand volunteers, but it appears the government may be combining Phase 3 and 4 as it did Phase 1 and 2.

If there is one thing Donald Trump and I can agree about it is that this is being done at Warp speed. If you do the math from above, you’ll see the fastest a drug typically makes it through the first three trials is 20 months, not six. Also, by rapid calculus, you’ll note that if we start with 100 drugs going into trials, five make it through Phase 3. We’re dealing with long odds here.

A couple of other things to think about.

First, drug discovery and development involves pre-clinical work that begins with mice, moves on to rats, guinea pigs, rabbits, pigs and non-human primates. Yes, monkeys. After all that, scientists apply for what’s called an Investigational New Drug Award, an NDI. If the FDA approves that, one can move into a Phase 1 trial. None of that has happened here, at least it hasn’t been reported as happening.

Second, even if good results happen from AZD1222’s Phase 3 trial, or one of the other vaccines under development, with such little longitudinal study how certain will we be that long-term immunity will result?

Finally, there are the old folks. One presumes they represent a cohort in the Phase 3 study. What happens if the vaccine succeeds beautifully in young people, but fails miserably in the elderly?

John Milton famously wrote, “Hope springs eternal.” But, frankly, I prefer the advice of my old commanding general in the mountains of Vietnam: “Hope for the best; prepare for the worst.”

 

* AstraZeneca is a British/Swedish company formed from the merger of Astra Pharmaceuticals, a British firm, and Zeneca, a Swedish one, in 1999. It’s headquarters are in Cambridge, England.

 

 

The “K” Factor and EU and USA Cases

Friday, June 26th, 2020

The K Factor

Ever heard of the “K” factor? Neither had I. But in yesterday’s Work Fitness and Disability Roundtable, Dr. Jennifer Christian’s long-running and valuable daily roundup of workers’ compensation medical news and musings, we were introduced.

Turns out the “K” factor could be tremendously important in helping leaders figure out how reopening the economy should proceed.

I thought Jennifer’s Roundtable post was so important I asked her if we could reprint it in the Insider. She gave permission, for which I’m grateful. So, here it is:

Hey, nothing like a fact-based “aha” to sharpen the mind and help point the way forward. A thought provoking article in New York Magazine (https://nymag.com/intelligencer/2020/06/coronavirus-meatpacking-plants-america-labor.html?utm_source=fb&utm_campaign=nym&utm_medium=s1&fbclid=IwAR0jnJXCeUx_zYVQuayha1XSMpMtjT-TSXIv7-RfIFNCDtlrz1hn558Da2w) on the reason for major differences between the COVID-19 experience in meatpacking industries in the USA and Europe brought up the “k” factor in the COVID-19 pandemic.  Ever heard of “k”?

Until yesterday, I hadn’t noticed (or paid attention to) any discussion about the implications for action of SARS-CoV-2’s  “k” factor. The “k” factor is an infecting organism’s observed dispersion behavior. Now is the time to start paying attention to the “k” factor because it points us straight to the main cause of the majority of COVID-19 cases: superspreading events in crowded indoor settings. We’ve all known that a lot of the cases have occurred due to spread on board ships, in prisons, hospitals, nursing homes, nightclubs and meatpacking plants – but to be truthful, I’m not sure we’d gotten the take-home message: SARS-CoV-2 is heavily dependent on crowded indoor spaces for its spread.

So, I did a bit more Googling and found a good Science Magazine article (https://www.sciencemag.org/news/2020/05/why-do-some-covid-19-patients-infect-many-others-whereas-most-don-t-spread-virus-all) that lays it all out quite clearly.  In addition to the R value (the mean number of subsequent new infections resulting from each infected individual), epidemiologists calculate how much a disease clusters. The lower k is, the more transmission is coming from a small number of people. The k value for the 1918 influenza pandemic was estimated at 1.0 – clusters weren’t too important. But during the 2003 SARS and 2012 MERS epidemics the vast majority of cases occurred in clusters, and their calculated k values were therefore low: 0.16 and 0.25 respectively.

In COVID-19, most infected people are not creating any additional cases. Adam Kurcharski from the London School of Hygiene & Tropical Medicine has conducted an analysis of COVID-19 dispersion and says, “Probably about 10% of cases lead to 80% of the spread.” A pre-print of his paper (https://wellcomeopenresearch.org/articles/5-67) has a calculated k value of COVID-19 at 0.1. Previous studies have pegged it just a tad higher than SARS or MERS.

There’s no point in trying to figure out which people are shedding the most viruses – though some of us clearly do disperse more bugs than others.  We professionals need to focus most of our attention on the places and types of events that SARS-CoV-2 needs in order to spread efficiently: loud and crowded indoor spaces, where people are cheek by jowl and raising their voices or breathing deeply: talking, singing, or shouting or aerobically exerting themselves. Ventilation and air flow in these settings also plays an important role.

Almost none of the clusters have resulted from outdoor crowded events.  Chinese studies of the early spread of COVID-19 outside Hubei province identified only one cluster among a total of 318 that originated outdoors. A Japanese study found that the risk of infection indoors is almost 19 times higher than outdoors. And here in the USA people who participated in (largely outdoor) Black Lives Matter protests have not been getting sick. (I also saw some data earlier saying that the virus is almost immediately disabled by sunlight.)

As the Science Magazine article says, the low k factor is …..”an encouraging finding, scientists say, because it suggests that restricting gatherings where superspreading is likely to occur will have a major impact on transmission, and that other restrictions—on outdoor activity, for example—might be eased.” So duh, let’s make the hierarchy of risk much more explicit. We need to make it crystal clear to the public (and patients and workers and employers) that the worst thing a person can do is participate in events in loud, crowded, and  indoor settings without rapid air turnover.

HOWEVER:  Many people are stuck. They live in crowded housing or congregate housing. The places where they live and work (ships, factories, office buildings, and medical facilities) already exist. People need to work, and winter is coming when we have to be inside.

I see this call to action: Are you, personally, confident that you are collaborating with all of the professionals whose input, cooperation, and contributions will be required? Think outside your silo. All of the various types of professionals who do event planning & commercial building design & engineering, industrial hygiene, HVAC, public health, and occupational health & safety need to join up and get deeply and rapidly involved in adapting / redesigning / re-configuring / re-engineering existing places and events to reduce the potential for superspreading.

A look at European Union and U.S. case statistics: Stunning

The following chart from the Johns Hopkins Tracker Project, printed in yesterday’s Statista Daily Alert needs no introduction or even analysis. It puts the period to Dr. Christian’s words.

 

More About The Moderna Vaccine Results

Friday, May 22nd, 2020

Scientists and Wall Street analysts are now beginning to peal the onion of Moderna’s announcement about its Phase One Trial results in which it reported its vaccine candidate had produced antibodies in eight of the study’s 45 participants. Following the announcement, Moderna’s shares rose nearly 30%. A profitable day, indeed.

On Tuesday, I wrote it was way too early to get excited based on this teeny tiny study. Since then, it’s nice to see that Evercore ISI’s Umer Raffat, an analyist Institutional Investor called a Rising Star of Wall Street Research, has added context and perspective. Early Tuesday, Raffat sent a 78-page slide deck to his clients explaining why, while possibly encouraging, Moderna’s announcement  and Monday conference call should not give anyone a serious sense of hope until a lot more work is done and a lot more is known about this particular Phase One Trial.

Getting into the science weeds, Raffat focused his analysis on antibodies and T-Cells.

First, the antibodies. Raffat thinks the most impressive thing about Moderna’s data release concerns “binding” antibodies. These are antibodies that attach to SARS-CoV-2, the virus that causes COVID-19. The concern with Moderna’s announcement is that what’s really important for an effective vaccine is its ability to generate “neutralizing” antibodies that actually prevent the virus from infecting healthy cells, and Moderna provided no information about neutralizing antibodies except to say its neutralizing antibodies “were at or above convalescent serum” collected from people who recovered from COVID-19. Studies have shown that people who have recovered from COVID-19 can generate a wide range of neutralizing-antibodies in their convalescent serum. So, it is unclear just how comparable Moderna’s convalescent serum samples were to samples taken from the trial participants.

The FDA will have to determine what level of neutralizing antibodies are required for an approved vaccine. The Agency has already said that when convalescent serum is used to treat COVID-19 patients the neutralizing antibodies should be high, whatever that means.

Another issue with Moderna’s mRNA-1273 vaccine rests with T-Cells. The level of T-Cell generation is an indicator of the degree to which the immune system is attacking COVID-19. Moderna’s announcement and subsequent call did not address this. Some researchers have shown that a high level of T-Cell generation, even without high levels of neutralizing antibodies, have been found in people who have recovered from COVID-19, leading to speculation that T-Cell generation may be very important for any successful vaccine. However, when asked about this during the conference call, Moderna’s Chief Medical Officer, Tal Zaks, M.D., Ph.D., said  “You would expect that based on the fundamental scientific principles of how an mRNA vaccine works because it teaches the body’s own cells to make the protein from within the cell.”

One last point – The study participants numbered 45. Eight produced binding antibodies. Only four were sampled for neutralizing antibodies. Four.

As I wrote earlier this week, Moderna has made it to the one yard line. Ninety-nine to go.

 

 

COVID-19: Two Updates

Tuesday, May 19th, 2020

Who pays?

The last question asked in our question-filled Post of 13 May was the same as the first question asked, namely: Who’s the guy at the end of the line left holding the bill for COVID-19 workers’ compensation claim costs?

Right now, as we have written here, each state is addressing this in its own way; fifty different plans for one national crisis.Thus far, workers’ compensation is the pot out of which, in one way or another, claims are addressed. Employers do not like this.

Employers of essential workers haven’t wanted to scream too loudly about being the last in line guy, what with so many of their  workers falling ill, even dying, every day. That kind of crass insensitivity would be bad for business. But inwardly, they have to be nervous about getting stuck with the check, the cost of which, as we have documented here, could be enormous.

Employers have already taken a high hard one to the side of the head with the complete and utter devastation COVID-19 has done to their economic well being, and the requirement to pay the workers’ compensation claims which are going to avalanche over the top of them is something with which they strongly disagree. For what it’s worth, I think they have a point.

Back at the state capitals, I would venture, governors don’t really care where the money comes from, just as long as it’s not coming out of their state treasuries.

And throughout history, insurers have resisted paying for occupational disease claims. Witness the 20-year fight to avoid paying the costs of pneumoconiosis, which resulted in the Federal Coal Mine Health and Safety Act of 1969, amended four years later by the Black Lung benefits Act, which created the Black Lung Disability Trust Fund.

So, if the states don’t pay and if insurers don’t pay and if employers don’t pay, who is left?

Brothers and sisters, the federal government is left, which is another way of saying we are left. We will all share the risk and share the costs. If you cannot bring yourself to believe that, you haven’t been paying attention.

In fact, a model exists: The September 11th Victim Compensation Fund, which:

…provides compensation to individuals (or a personal representative of a deceased individual) who were present at the World Trade Center or the surrounding New York City exposure zone; the Pentagon crash site; and the Shanksville, Pennsylvania crash site, at some point between September 11, 2001, and May 30, 2002, and who have since been diagnosed with a 9/11-related illness.  The VCF is not limited to first responders.  Compensation is also available to those who worked or volunteered in construction, clean-up, and debris removal; as well as people who lived, worked, or went to school in the exposure zone.

The wheels are already in motion. Last week, a bipartisan group in the House unveiled the Pandemic Heroes Compensation Act, a plan to compensate essential workers who fall sick or die from COVID-19. The Act is modeled on the September 11th Victim Compensation Act.

Senate democrats are also proposing legislation. Like everything else in D.C. these days, the road from here to eventual victim compensation will be tortuous, but I cannot see any other way of paying for this national catastrophe other than with a national program. Can you?

The Moderna results

For a number of years, I chaired the Board of a BIOTECH pre-clinical Contract Research Organization (CRO). We took compounds, whose makers hoped would become the next blockbuster drugs, and tested them in mice, rats, guinea pigs, rabbits, pigs and non-human primates (that’s right, monkeys). In the biotech business, everyone knows everyone else, and we certainly knew a lot of scientists trying to develop vaccines.

Yesterday, the Boston pharmaceutical company Moderna reported a vaccine it was developing for COVID-19 produced antibodies in humans. In vaccine development, this is the beginning of a Phase One trial, and its purpose is to confirm the vaccine is not toxic. Moderna’s Phase One trial is composed of 45 participants, eight of whom  Moderna says produced the antibodies. We know nothing of the other 37.

While encouraging, you won’t find respected scientists getting too excited yet. They know what Moderna has done is to take the ball out of the end zone and reach the one yard line. Nintey-nine to go.

Two things are exciting, however. First, Moderna was able to get to this point at light speed. What Moderna did in about 70 days usually takes three to four years. That is over the moon fast, but the other ninety-nine yards are going to be increasingly more arduous. Second, there are more than 100 other groups around the world, both pharmaceutical and academic, who are also going hell bent for leather to develop the vaccine that will eradicate COVID-19. Although I have every confidence one of these groups, maybe Moderna,  will cross the goal line at the other end of the field, it will take a miracle on the order of the Raising of Lazarus for this to happen before mid to late 2021.

Until then: Constant vigilance. Complacency will kill you. Really. Please keep this in mind as all the beaches and parks open this coming Memorial Day weekend. It will be highly tempting to revert to former form.

 

How Are States Handling Workers’ Compensation During COVID-19?

Monday, May 11th, 2020

Last week we wrote about Governor Gavin Newsom’s Executive Order implementing a workers’ compensation rebuttable presumption for all essential workers who contract COVID-19 in California.

To review, a rebuttable presumption means an essential worker who contracts COVID-19 does not have to prove work-relatedness. The burden is on the employer to prove the disease was not caused by work.

Writing that other states have also taken action, I noted those actions varied widely across the country. But the monumentality of COVID-19 requires more on this topic. Just what are other states doing? Specifically.

Thirty-nine have either done nothing or have legislation pending. That is, they have taken no action via Executive Order, as Newsom did, or have yet to enact legislation. The District of Columbia is also in this group. Neither, have any of these states declared COVID-19 an occupational disease, although it obviously can be one.

The other 12 states have taken the following actions:

Akaska: On 9 April, Alaska Governor Mike Dunleavy signed legislation declaring a rebuttable presumption for first responders and other health care workers.

Arkansas: On 21 April Governor Asa Hutchinson issued an Executive Order creating a rebuttable presumption for first responders, other health care workers and National Guard personnel assigned to COVID-19 duties.

Florida: The state published a Memorandum saying first responders and health care workers “would be eligible for workers’ compensation benefits under Florida law.” Given the torment COVID-19 is causing throughout society, this is pretty wimpy, don’t you think?

Illinois: On 16 April, Governor J. B. Pritzker issued an Executive Order declaring a rebuttable presumption for first responders and other health care workers. Then, under intense pressure from the business and insurance communities, Pritzker, whose family owns the Hyatt hotel chain, rescinded the order. Obviously, a stand-up guy. So, I guess you could say Illinois now belongs in the camp of the other 38 states that have done nothing.

Kentucky: On 9 April, Governor Andy Beshear issued an Executive Order similar to Newsom’s, creating a rebuttable presumption for all essential workers who contract COVID-19. The business community isn’t happy, but, unlike Pritzker, Beshear has not changed his position.

Michigan: On 30 March, the Workers’ Disability Compensation Agency declared an Emergency Rule creating a rebuttable presumption for all First Response Employees, a term, as Michigan defines it, that includes just about everyone in health care.

Minnesota: On 7 April, Governor Tim Walz signed legislation establishing a rebuttable presumption for first responders, health care workers, correctional officers and child care workers.

Missouri: The Department of Labor and Industrial Relations issued an emergency rule, effective 22 April, declaring a rebuttable presumption for first responders, but, not, perplexingly, for other health care workers exposed to COVID-19. First responders are defined as “a law enforcement officer, firefighter or an emergency medical technician (EMT).”

New Mexico: On 23 April Governor Michelle Lujan Grisham issued an Executive Order creating a rebuttable presumption for state-employed first responders and volunteers to the health care system fighting the disease. Private sector employees are not covered.

North Dakota: On 25 March, Governor Doug Burgum issued an Executive Order creating a rebuttable presumption for all first responders and health care workers. On 16 April, he issued another one to cover funeral directors.

Utah: On 22 April, enacted legislation creating a rebuttable presumption for all first responders.

Washington: On 5 March, Governor Jay Inslee issued an Executive Order  creating a rebuttable presumption for first responders and other health care workers. The order also applies if the workers are merely quarantined.

The majority of states not listed here have some kind of legislation filed awaiting legislative action. But as anyone who has ever wandered the halls of a state capital watching the sausage being made knows, it doesn’t mean a thing until the Governor in the corner office signs it.

Time is wasting.

 

Pandemics: Are We Smart Enough To Learn From Them?

Friday, May 8th, 2020

“As the world becomes more of a global village, infectious disease could by natural transmission become more threatening in the United States. Here monitoring is lax because of a mistaken belief that the threat of infectious disease has been almost wiped out by antibiotics.” American Medical Association conference on infectious disease, 2001, from Norman F. Cantor, In the wake of the plague, 2001, Harper Collins.

Pandemics and the Roman Empire: From glory to gory

History’s first pandemic, the Antonine Plague, struck in AD 165 at the height of the Roman empire, the time Edward Gibbon described as when “the condition of the human race was most happy and prosperous.” Nobody knew, but the Roman Climate Optimum (RCO) was approaching its end. The RCO was an extremely propitious climatological period (BC 400 – AD 250) that allowed the empire to keep all its ~70 million people well fed and relatively healthy, which led to the development of the greatest army the world had ever seen, and would not see again for more than a thousand years. The Antonine Plague, named for the family of Emperor Pius Antoninus, killed at least seven million of the empire’s people, more than 10% of the population.

The greatest physician of the age was Galen (born AD 129). He treated and cured a number of distinguished Romans and extensively documented the spread of the disease in his masterpiece, The Method of Medicine. He said, “Hippocrates showed the path; I made it passable.” Galen didn’t know what caused the Antonine Plague, but he did know that it spread quickly in densely packed pockets of humanity and less quickly when people stayed away from each other.

The Roman Empire survived the Antonine Plague, its imperial fibers frayed, but not broken. The empire recovered its strength. Relative good health returned. Until AD 249, that is, when the Plague of Cyprian ambushed the empire. The Plague, named for the Christian Bishop from Carthage whose writings document the event, was probably smallpox. The Plague of Cyprian lasted 20 years and, at its height, killed about 5,000 people per day in Rome.

Once again, the empire recovered, but now it was weaker with reduced resources. Moreover, the RCO was steadily ending and climate was beginning to turn unfavorable. Egypt, the empire’s breadbasket, began to experience drought, something that had never happened during the RCO. This time, the empire dissolved into anarchy and saw the emergence of the “barracks emperors,” who righted the ship of state once more – for a time. But now, disease was always just over the horizon.

In AD 378, the Roman army suffered its worst defeat ever at Adrianople where 20,000 soldiers were killed, a terrible loss of life, but tiny compared to plague deaths. In 410, the Visigoths sacked the city, the first time an enemy army had ever been inside the the Roman walls. Rome was heading inexorably toward its ruin.

In AD 541, the Justinian Plague landed the knockout punch for the Roman Empire. This greatest of pandemics, until then, anyway, was the pandemic of yersinia pestis, the agent that causes bubonic plague, and it lingered off and on for 200 years. That was when Rome descended into a high-end, Byzantine rump state, its former glory a distant memory. Roman records show the city inhabited by one million people during the time of Marcus Aurelius in AD 165, now housed about 20,000. The world would not see another million person city until London at the end of the 17th century.

Where did all the disease come from? Until the Antonine Plague, Rome had never been struck on such a grand scale. Today, experts believe it hitched a ride with people who travelled more and more in a vast empire. For example, the Justinian Plague is thought to have originated in China, making its way to Rome through trade. Just like today.

The Romans didn’t have the scientifically designed medical therapies to combat infectious disease. But even then mitigation efforts were aimed at running from the disease, creating separation, wherever it manifested. For example, in AD 452 Attila the Hun was plundering all of Italy on his way to Rome, whose soldiers were powerless against him. But then, confounding the Romans, he stopped, decamped and headed for the high ground of the Alps. Why? To get away from the anopheles mosquito. Malaria was suddenly killing his men and his horses. Which proves germs were better at killing than soldiers.

The Black Death of the Middle Ages

In the 14th century, bubonic plague (and probably anthrax, too) struck again causing the greatest pandemic the world has ever seen. The population of England was reduced by ~50% and did not recover until about 1800.

At that time, Edward III, King of England, Wales and one-third of France, was poised to add Spain to his conquests by marrying his 15-year-old daughter, Princess Joan, to Spain’s Prince Pedro. The marriage would change the face of Europe and give Edward control over most of the continent. The year was 1348, and bubonic plague struck as Joan and her large entourage were crossing the channel. They landed at Bordeaux, where the plague was suddenly and viciously cutting down the population leaving bodies stacked in the streets. The stench was terrible. People dealt with it by walking around covering their noses with handkerchiefs drenched in perfume. The 14th century’s version of face masks.

The welcoming committee advised the Princess and her party to get far away from the plague. But the English thought they knew better and settled into Chateau de l’Ombriere, overlooking the Mediterranean and dead smack in the middle of the disease. Within weeks, they were all dead except for one English minister who brought the news back to Edward.

And so the bite of a flea altered the course of history.

The Spanish Flu of 1918/1919

And in the early 20th century we were visited by the Spanish Flu, which carried off 50 million souls worldwide. We told the story of the Spanish Flu here, early in our waltz with COVID-19.

Americans then did what Americans are doing now: they kept apart, stayed home to avoid contact, and wore masks when they moved around in society. At least most of them did, just as most are doing now.

Those Americans had to wait 20 years for a vaccine that only 40% of us now take, and thousands still die every year from the flu.

Conclusion

You may say, “Why is this history, interesting though it may be, even being mentioned? Here in 2020, we’re 2,000 years removed from ancient Rome; 650 years from the death of Princess Joan, and the Spanish Flu was 100 years ago. Why bring this stuff up now?” After all, the combination of more energy, more food, sanitary reform, germ theory, antibiotics and all around jet-propelled science have led to a population boom unlike anything else in the history of the planet. People are living longer and better. So, why look to ancient history in the midst of COVID-19?

Social distancing is nothing new. Throughout history, when societies were confronted with infectious disease on a grand scale, people tried to evacuate the area. Some of them could, most could not. They had no knowledge of the value of hand washing, and hand shaking was as common then as it is now, or at least as it was ten weeks ago, so disease transmittal was rampant.

But beyond all that, although blind luck and more than a little mismanagement contributed to the decline and fall of Rome, infectious disease and climatological degradation were the driving forces. And the Romans were blindsided by both. In the Black Death period, aristocratic hubris and tremendous poverty throughout the population’s underbelly led to death on a massive scale. During the Spanish Flu, many in the U.S. ignored warnings and directives to be “socially distant.” Many chose not to mask in public. Many protested government edicts to contain the spread of the disease. And many died.

Here, during COVID-19, we’ve had:

  • Gross mismanagement from the top, as well as in some of the states;
  • Aristocratic hubris on a massive scale;
  • Profound economic inequality and, consequently, disease in large sections of our urban communities; and,
  • Misguided protesters who endanger themselves and others as they gather together clamoring for the freedom to do just that.

Science and our seeming societal sophistication have led many of us, too many, to believe we actually can plant cut flowers and watch our garden grow.

In the words of that great American philosopher, Pogo, “We have met the enemy, and he is us.”

More COVID-19 Quick Takes

Thursday, May 7th, 2020

Workers’ compensation and the disease

COVID-19 is presenting some interesting and perplexing issues for workers’ compensation. Among them are:

  1. Claims adjusters and Nurse Case Managers are far more familiar with injury claims than disease claims. Occupational disease claims are fuzzy, and work-relatedness is often difficult to determine. A broken arm on the shop floor is ever so much more cut and dried. Yesterday, Governor Gavin Newsom made this moot for California by signing an Executive Order that will make it easier for essential workers who contract COVID-19 to obtain workers’ compensations benefits. His order is in effect for 60 days and is retroactive to 19 March. Note Bene – his order establishes a rebuttable presumption and covers all workers deemed essential during the crisis; e.g., grocery workers, among others, as well as first responders and all health care workers. A rebuttable presumption means an essential worker who contracts COVID-19 does not have to prove work-relatedness. The burden is on the employer to prove the disease could not have been caused by work. California is one of a number of states that have taken action addressing workers’ compensation coverage for essential workers.
  2. But not all states have taken action in the same way. In fact, approaches vary considerably. Two issues treated differently among the states are: first, whether to establish a rebuttable presumption as described above; and, second, just who is essential. Some states say that while a number of occupations have been determined to be “essential” during COVID-19 (see Grocery Workers, above), only first responders and health care workers are essential enough to qualify for workers’ compensation if they come down with the disease. Labor unions say this is an issue of fairness, but since when has workers’ compensation been equally fair in all states? Consider loss of function awards, which vary tremendously across the nation.
  3. NCCI has jumped into the COVID 19 what if debate and projected various loss cost scenarios for the workers’ compensation insurance industry. All scenarios show increased losses, and some of the them are downright grim. In the worst case, 50% of all workers are infected and 60% of all claims are paid, in which case losses increase $81.5 billion, or 250% more than current total loss costs. Ouch! In the best case NCCI presents, there is no rebuttable presumption, only first responders and health care workers are eligible for workers’ compensation benefits, only 5% of them become infected, and only 60% of the claims are paid, which results in an increase in loss costs of $2 billion. The best case scenario is is not going to happen. See 1, above.
  4. And what about the poor employers and insurers who are going to foot the bill? Specifically, what about experience modification? One can almost say COVID-19 comes under the heading: An Act Of God. But the claims are going to be paid, so how does a confused insurer account for that in  the premium it’s going to drop on the head of John Q. Employer with a loud and painful thud?

Update on Long Term Care Facilities

I’ve addressed LTCFs here, here  and here, pointing out that there is no coordinated national reporting of LTCF COVID-19 cases or deaths. “One would think this cries out for federal data tracking conducted in a consistent manner across the nation.” Doesn’t seem to have happened yet.

The logical entity to track this is the Centers for Disease Control and Prevention (CDC), and maybe it is. But, then again, maybe it isn’t, because it won’t say. Yesterday, two Senate Democrats — Ron Wyden of Oregon and Bob Casey of Pennsylvania — called on the Trump administration to close this gap and commit to a timeline to release the information.

“There have been no signs that the Trump administration has an effective plan to address the tragedy that is taking place in America’s nursing homes,” they said in a joint statement.

It’s logical to assume that a disproportionate number of deaths would occur in LTCFs. The vulnerable elderly, many, perhaps most, with a number of comorbid underlying conditions, are packed together and present a breeding ground for the virus. Early on, this should have been apparent to the CDC. Why its talented scientists didn’t dive into this from Day 1 is beyond me.

We’ll continue to follow this.

Are We Learning From History, Or Repeating It?

Throughout history, infectious diseases have crippled societies. They have stymied progress and, in the best cases delayed, in the worst reversed, economic development and prosperity.

How have societies handled infectious disease pandemics throughout history, and are our actions in the midst of COVID-19 any better?

It’s true that our science puts us a quantum leap ahead of historical societies in terms of searching for therapies and a vaccine. Oh, the vaccine will happen, but between now and then are we dealing with our current infectious disease problem better than our ancestors?

Actually, no. Societies have long known that when a killing disease strikes on a grand scale the best thing to do is stay far away from other people. Quite literally, head for the hills. Trouble was, that wasn’t always possible due to urban densities and economic privation. Today, densely packed areas, especially cities, are the immediate hot spots, the poor and African Americans are disproportionately infected, and our mitigation efforts are the same as time immemorial.

Tomorrow, we’ll take a look at the history of pandemics, their societal effects and how we can learn from them as we move through and, we fervently hope, leave behind the scourge of COVID-19.

 

 

Direct Care Workers: Health Care’s Essential Underbelly

Wednesday, April 29th, 2020

First, an update

Yesterday, we wrote about Long Term Care Facilities (LTCF) and the sad COVID-19 experience of Massachusetts’ nursing homes. As of this morning, 303 of the Commonwealth’s 386 nursing homes have had at least 2 cases, for a total of 10,031 cases statewide. Fifty-six percent, or 1,632, of all the Commonwealth’s COVID-19 deaths have happened to nursing home residents or staff.

Governor Charley Baker is a former CEO of Harvard Pilgrim health Care, one of the Commonwealth’s leading HMO  health care plans. So, it’s a given that Baker knows health care. But, even with that background, he, like all our governors, has been living through the tortures of Tantalus as they attempt to work with the administration in all things COVID-19.

Today, the governor announced he’s sending $130 million to help nursing homes deal with the crisis. He’s also enlisting 120 nurses to respond lickety split to nursing home emergencies. Moreover, his administration will be auditing LTCFs for compliance with new care criteria including mandatory testing of staff and residents, a 28 point infectious disease checklist, and PPE requirements. This is all good, but one hopes reality is not that this particular horse has escaped the barn and is now grazing four pastures over.

And what about those caregivers?

They call it “Direct Care.” The care that Certified Nursing Assistants (CNAs), home health aides, and personal care attendants provide America’s elderly and disabled. You’ll find them in nursing homes, residential care homes, hospitals, and plain, ordinary, everyday homes, the kind you and I live in. And they are essential workers.

All told, there are more than 1.3 million of them in the U.S., and the Bureau of Labor Statistics (BLS) projects the direct care industry will grow more than any other over the next decade, with a compound annual growth rate of 4.0. And they are essential workers.

They are also the least compensated workers, by far, in the health care sector. Here’s a graph from the BLS to illustrate the point:

The direct care workers are the pink dots. The isolated pink dot on the lower right refers to Certified Nurse Assistants. According to the Paraprofessional Health Institute (PHI):

The median hourly wage for home care workers in the U.S. is $10.49—a wage that, when adjusted for inflation, has remained virtually stagnant for the last 10 years. In turn, the median annual income for home care workers, most of whom work part-time or only during part of the year, is $13,800.[1]

Twenty-three percent of direct care workers live below the federal poverty line (FPL), as opposed to 7% of the rest of the population (which is abominable in its own right). Some of them might be caring for your parents or grandparents right now. Yes, they are essential workers.

Fifty-two percent of home care workers and 39 percent of nursing assistants rely on some form of public support, such as food and nutrition aid, Medicaid, or cash assistance. Moreover, because of low pay and irregular hours, it’s difficult for direct care workers to qualify or pay for employer-based or individual health coverage. Neither can they afford to stop working during COVID-19. They need the money, such as it is – and they are essential workers.

And what about direct care workers who are immigrants? Researchers from Harvard Medical School studied this in their June 2019 paper, “Care for America’s Elderly and Disabled People Relies on Immigrant Labor.” 

They wrote:

Using nationally representative data, we found that in 2017 immigrants accounted for 18.2 percent of health care workers and 23.5 percent of formal and nonformal long-term care sector workers. More than one-quarter (27.5 percent) of direct care workers and 30.3 percent of nursing home housekeeping and maintenance workers were immigrants. Although legal noncitizen immigrants accounted for 5.2 percent of the US population, they made up 9.0 percent of direct care workers. Naturalized citizens, 6.8 percent of the US population, accounted for 13.9 percent of direct care workers. In light of the current and projected shortage of health care and direct care workers, our finding that immigrants fill a disproportionate share of such jobs suggests that policies curtailing immigration will likely compromise the availability of care for elderly and disabled Americans. (emphasis added)

Nearly 15% percent (14.9%) of the foreign born workforce are college graduates, compared with 8.4% of the native born direct care workforce.

Many foreign born direct care workers are in the country with Temporary Protected Status (TPS), a status provided to nationals of certain countries, ten of them, experiencing problems that make it difficult or unsafe for their nationals to be deported there. In 2018, The Trump administration attempted to terminate the Temporary Protected Status for workers from a number of the designated countries, but courts have enjoined that for now. Nonetheless, that can’t be doing the workers’ mental health much good at the moment. And they are essential workers.

Nobody’s attacking direct care workers during COVID-19. They wouldn’t dare. After all, they are essential workers. But, if we ever get out of this healthcare fiasco, I don’t think it’s a wild stretch of the imagination to think if Donald Trump continues his  fervent anti-immigration polemic direct care workers will be marginalized even more than they already are.

They deserve better. They are essential.

 

The Long Term Care Industry: The Ice Under The COVID 19 Waterline

Tuesday, April 28th, 2020

A sneak attack no one saw coming

The nation has come to realize that Long-Term Care Facilities (LTCF) are the number one breeding ground for COVID 19. To date, the best guess is that about 30% of all deaths from the disease happen in the LTCF world. But, as USA Today discovered when its journalists tried to quantify actual numbers, no one knows for sure. The absence of any coordinated, centralized, and focused effort (by the CDC, perhaps?) to track this data is another in a long list of unfortunate and tragic failures we can lay at the doorstep of 1600 Pennsylvania Avenue.

Some states, for example, Indiana, (where 31% of all COVID 19 deaths have occurred in LTCFs,) and Massachusetts (56%), have begun to try to gather the relevant data and publish it on their COVID 19 dashboards. However, most states have yet to take this step. Massachusetts has gone so far as to list the total of the COVID 19 cases in each of the state’s LTCFs by name – the list runs to five pages, 60 facilities per page.

The story of one such facility in Massachusetts is particularly sad. The Soldiers’ Home in Holyoke labels itself as “a state-funded, fully accredited health care facility that offers veterans quality health care, hospice care, including full-time residential accommodations, an on-site dental clinic, Veterans (sic) assistance center, and a multi-service outpatient department.” The Soldiers Home has always been held in high esteem for its excellent and compassionate care of military veterans. It has been one of God’s finer waiting rooms.

But in late March COVID 19 struck, and it struck hard. Here’s how the Boston Globe described it today:

In late March, when the first resident of the Soldiers’ Home in Holyoke died from the coronavirus, 226 residents lived at the elder care facility. Just over a month later, nearly 30 percent of them have died in one of the nation’s deadliest outbreaks, and another 83 have tested positive.

With 67 deaths linked to the coronavirus, the facility has a greater reported death toll than any other nursing home in New England, New York or New Jersey, or the long-term care facility in Kirkland, Wash., the initial epicenter of the US outbreak, according to a Globe review of cases.

The impact of this disease will be with us for a long time. The wounds to the nation’s physical and mental health will not heal anytime soon. As we flatten the Coronavirus curve, it is tempting to conclude we are at the beginning of the end. Nothing could be further from the truth. This is merely the beginning of the end of the beginning.

Tomorrow, a look at the least compensated people in our healthcare system, the myriad essential workers who care for the nation’s elderly and disabled.