Archive for the ‘Research’ Category

Like BBs In A Boxcar

Monday, October 12th, 2020
Turning and turning in the widening gyre   
The falcon cannot hear the falconer;
Things fall apart; the centre cannot hold;
Mere anarchy is loosed upon the world….
The best lack all conviction, while the worst   
Are full of passionate intensity.
          The Second Coming, by William Butler Yeats

 

One thing COVID-19 has certainly done is to expose many of the foundational flaws in America’s healthcare house that Jack built, the house that “cannot hold.” From the Trump administration’s helter-skelter response, to the unequal treatment of Blacks and Latinos, to the near total reliance on China for PPE, to the exacerbating plight of rural hospitals, to jaw-dropping surprise bills, to something as granular as the price of insulin, and the list goes on.

To illuminate the dire situation even more, the Kaiser Family Foundation last week published its annual Employer Health Benefits Survey, which showed the average annual premium for a family of four has grown 4% over the last year, more than doubling the rate of inflation, and has now reached $21,342, with worker contributions averaging $5,588. Add in the average deductible of $4,000, along with copays of $40, and employees get their hair-raising, once-a-year healthcare sticker shock.

In 2020, the U.S. is spending 18% of GDP on healthcare, according the Office of the Actuary within the CMS. For years, I’ve been quoting Herb Stein’s Law: “If something cannot go on forever, it will stop.” And for years, I’ve been wrong. This cannot be sustainable, but so far it has been.

A distant second-most-costly-country-in-the-world is Switzerland, at 12.1% (which is what the U.S. spent 30 years ago in 1990). The Swiss, as do many other OECD countries, have a decentralized system similar to ours, a blend of public and private-pay healthcare, with two important differences: First, since 1996, government, wanting to spread the pool, has required the Swiss people to purchase healthcare insurance, similar to the Affordable Care Act’s individual mandate (which Congress eliminated when it passed the Tax Cuts and Jobs Act of 2017, effective 1 January 2019). The result is for more than 20 years the Swiss have nearly 100% participation, but not the U.S.; our rate of the uninsured is going up, not down, made worse, much worse, by job, and consequently health insurance, losses due to the pandemic. Second, government plays a large role in establishing prices, especially for pharmaceuticals.

I think we can say with total certainty that, regardless of what you hear or read, nobody knows what healthcare in America will look like a year from now. If Trump wins reelection and republicans hold the senate, the ACA, or what’s left of it, could find itself buried deep beside Davy Jones’s locker at the bottom of the ocean, and what would come after that? Back to square one. People, our fellow citizens, our friends and relatives with chronic conditions, would once again find themselves walking down the edge of an economic razor blade.

There are four possible outcomes:

  1. Trump wins and republicans hold the senate, as above;
  2. Trump wins and democrats take the senate, resulting in stalemate, but the Trump reality show continues;
  3. Biden wins and democrats take the senate, in which case big changes are coming; and,
  4. Biden wins and republicans hold the senate, resulting in stalemate, but we’re saved from Trump’s histrionics (one hopes).

Options three and four spare us the president’s governing style, which is to say, chaos. For four years we have been subjected to his whipsawing and dangerous administration. His policies, personality and pronouncements seem to bounce around like BBs in a boxcar. Never more so than in the last few weeks. Things change by the hour. Nothing is predictable, except unpredictability.

We are moving inexorably into the winter of our continuing discontent. God help us all.

COVID-19 Analysis from Jennifer Christian, M.D., M.P.H.

Monday, September 21st, 2020

I have written before of my great admiration for Dr. Jennifer Christian and for her Work Fitness and Disability Roundtable (WFDRoundtable@groups.io). The Roundtable is a mainstay for clinicians and other health care professionals.

I thought this morning’s Roundtable post by Jennifer to be particularly thoughtful and thought-provoking, so I asked her if she would allow us to republish the post in its entirety here at the Insider. She very kindly gave permission.

I think Jennifer is one of those brilliant three or four folks I’m lucky enough to know who think around corners. Her mind makes intuitive leaps where others (like mine) plod along.

Here is Jennifer’s post:

How many people have some pre-existing immunity to COVID-19

There is growing uncertainty about what this fall and winter is going to look like with regard to the COVID-19 pandemic.  Are we going to have a second, and possibly even bigger wave of worldwide infections — or is the biggest part of this pandemic over and done with once each geographic area has had its first wave?

A new review from the British Medical Journal says researchers may have been paying too much attention to antibodies and too little attention to a second part of the human immune system that protects against and reacts to infections:  T cells.   More on this in a moment…..

But first, a reminder.  We are in the middle of the first large-scale pandemic with a new and highly contagious respiratory pathogen since the field of immunology was born!   Immunology is still quite young compared to other specialty areas in biological science and medicine.  It was only in the mid-20th century that advances in cell biology started making it possible to study the detailed processes that make up the immune response in detail.  That has led to much deeper understanding of the mechanisms by which vaccines work, to the development of the first cancer chemotherapy agents that selectively killed rapidly-proliferating immune cells, and to the development of immune-modulating drugs, which enable the transplantation of organs by muting the body’s natural rejection of foreign tissues.

The appearance of HIV/AIDS in the 1980’s again precipitated huge leaps in funding for research to increase our understanding of the immune system, which in turn highlighted the function of T cells and other previously unrecognized aspects of it.   However, in comparison to other bodily systems and organs, our knowledge of the human immune system is still primitive — it’s obvious there is much left to learn — and some of what we don’t know may seem very basic!

If you’re an immunologist, virologist, epidemiologist — or a public health officer trying to figure out how to protect and guide your local population — this is the overwhelming challenge of a lifetime.  Personally, I hope that the media and the general public will remember that this pandemic has attacked our society at the very edge of what is known.  All of those professionals are working at a feverish pace to observe carefully, assemble enough data to be confident they have enough to detect a real pattern if it’s actually there, make sense of what they are seeing, and then figure out the implications for action.  Let’s agree to be forgiving of the fact that “the facts” have not all been revealed to us yet, and “the scientists” simply don’t yet know everything we wish they did.

Back to the T cell story.   Researchers have shown that people with the most severe cases of COVID-19 (the ones in ICU and who are most likely to die) often have low T cell levels.  But some other puzzling data has appeared. For example:

  • some countries — and especially some areas within those countries that had bad initial outbreaks — have not seen widespread new infections despite having relaxed protective restrictions; and,
  • blood tests in a noticeable fraction of people with no record of exposure to SARS-CoV-2 virus show some of the T cells reacting weakly to it anyway — indicating a potentially partial immune response.

This has led scientists to start wondering whether we really know enough about the human immune system’s ability to develop partial T cell “cross-reactivity” to families of closely-related viruses and whether that might predictably and reliably reduce the severity of illness or even reduce the likelihood of getting ill at all when a new-but-related virus appears.   And, that, of course, raises some possibilities that need to be investigated:

  1. Does cross-reactivity explain why some geographic areas that had first pandemic peaks are not seeing second ones — because the people who got sick had no immunity and were more susceptible, and most of the remaining ones have some limited immunity which is protecting them?
  2. Does cross-reactivity explain some of the disparity between people who get deathly sick from COVID-19 and people who are exposed to the virus but never get infected, or, if they do, remain asymptomatic or have only mild illness?  Note that there are two  possibilities:  Cross-reactivity could be making the illness worse or it might be making it less severe — we don’t know yet.
  3. How could cross-reactivity be protective if it develops after prior exposure to coronaviruses, because children are the least likely to get a severe case of the disease and adults are the most susceptible to severe COVID-19 illness and death?  (Children have not had a lifetime of colds, and thus less opportunity to be exposed to coronavirus and develop partial-immunity to SARS-CoV-2)

In short, my best advice as of 21 September 2020 is:

  1. Stay tuned for further developments in the factual realm – both changes in case counts and new research results;
  2. Hope for the best but prepare for the worst as autumn approaches and we all retreat indoors.

COVID-19 Update

Friday, September 18th, 2020

To close out your week we offer a few items that may have flown nap-of-the-earth under your radar.

The AstraZenica/Oxford vaccine bump in the road

On 8 September AstraZenica (AZ) halted its Phase 3 study, because one of its study participants came down with Transverse Myelitis, a neurological condition affecting the spine and caused by infection, immune system disorders or other disorders that can damage or destroy myelin, the fatty tissue that protects nerve cell fibers.

The UK has allowed AZ to restart its study there (AZ is a UK-based company), but as of this writing, the U.S. has not. In fact, in an interview with Kaiser Health News, the National Institute for Neurological Disorders and Stroke’s Avindra Nath said “the highest levels of NIH are very concerned.” According to Nath, the NIH has yet to access tissue or blood samples from the patient, who was part of the U.K. portion of AZ’s Phase 3 study. NIH believes AZ is being far too coy with its data. Nath called for the company “to be more forthcoming,” adding that “we would like to see how we can help, but the lack of information makes it difficult to do so.”

Given this halt in the U.S. study, it is not inconceivable that, if the AZ vaccine, known as AZD1222, proves efficacious and safe in the UK, regulators there could approve it for general use well before the U.S. does. This would not make our Commandeer in Chief happy.

The Mask versus Vaccine dust up

Speaking of the Commander in Chief, he recently took CDC Director Dr. Robert Redfield for a quick walk to the woodshed for suggesting during testimony to a Senate subcommittee, “Masks are more guaranteed to protect me against COVID-19 than a vaccine.”

President Trump, who is not a doctor, but repeatedly plays one on TV, took exception to this. He publicly chastised Redfield for his comments and said a vaccine could be available in weeks and go “immediately” to the general public. Diminishing the usefulness of masks, despite a wealth of scientific evidence to the contrary, he said his CDC chief was “confused.”

Well, no, he wasn’t. Redfield told subcommittee members that if everyone in the U.S. would wear masks in public the pandemic could be under control within 12 weeks. His issue with a vaccine lies in its degree of immunogenicity, which he suggested would be in the area of 70%, meaning if 100 vaccinated people are exposed to the virus, 30 of them will have insufficient protection to ward it off. Those 30 will probably be comprised of groups who are most susceptible to the vaccine now, like the elderly.

People, masks will be with us for a long time.

Health insurance losses

Before the pandemic, 49% of Americans got health insurance through employer sponsored insurance (ESI). COVID-19 has reduced that percentage, because 6.2 million of our neighbors have lost their jobs and, consequently, their health insurance. When you factor in spouses and children, the number of people who have been shoved out the door into the COVID cold becomes 12 million.

Researchers at the Economic Policy Institute (EPI) have recently documented the losses in a new study. Researchers Josh Bivens and Ben Zipperer write:

  • Extreme churn after February 2020 has led to very large losses in ESI coverage. In March and April, for example, new hiring led to 2.4 million workers gaining ESI coverage each month, but historically large layoffs led to 5.6 million workers losing coverage each month. This rate of lost coverage—over 3 million workers—dwarfs a similar calculation for the number of workers losing coverage each month during the biggest job-losing period of the Great Recession (September 2008–March 2009). Our analysis using the monthly, high-quality measure of the total number of jobs in the economy from the Current Employment Statistics (CES) program of the Bureau of Labor Statistics (BLS) is consistent with 9 million workers having lost access to ESI in March and April 2020 but 2.9 million workers having gained coverage between April and July 2020.

Bivens and Zipperer say about 85% of those who lost ESI coverage were able to gain at least some coverage either through a spouse’s plan, the Affordable Care Act or state Medicaid programs, but that still leaves about a million laid off workers and their familes with nothing. Bivens, Zipperer and others argue the job losses have only worsened the public health crisis created by COVID-19.

Of course, recognizing that millions of people losing employer sponsored health insurance is a public health crisis is not the same as fixing the system to prevent it from happening again. However, as I have written before, having exposed gross inadequacies in the nation’s health care system, COVID-19 also provides opportunities for improvement. What is needed now is the determined motivation and will to make that happen. That is a Herculean task about which I wish I were more optimistic.

The Pledge, AstraZenica’s Hiccup, An Important WCRI Study, And An Homage To Bourbon!

Wednesday, September 9th, 2020

Having put The Insider on pause for a few weeks to have some fun researching pandemics in earlier times (they were awful) and to improving my tennis game (it’s pretty good), we now dive back into the blogging fray. Today, we get a running start.

The Pledge

At a press conference on 24 August, President Trump and FDA Commissioner Stephen Hahn trumpeted (pun very much intended) the FDA’s Emergency Use Authorization (EUA) of blood plasma to treat COVID-19 patients.  The Trump/Hahn announcement came less than a week after officials at the National Institutes of Health (NIH) had put a hold on releasing the EUA, saying randomized trials were needed before such an action could occur. The President disagreed, saying, “There are people in the FDA and actually in your larger department [HHS] that can see things being held up and wouldn’t mind so much — its my opinion, a very strong opinion — and that’s for political reasons. We are being very strong and we are being very forthright, and we have some incredible answers, and we’re not going to be held up.”

In yet another example of Olympian Hyperbole, a disease to which Mr. Trump seems to be terminally infected, he also called the EUA a “truly historic announcement,” which puts it alongside something like the Emancipation Proclamation.

Like most of Trump’s hyperbolic pronouncements, the blood plasma EUA created quite the controversy, especially when the FDA released the comments of one of its own scientists tasked with reviewing the appropriateness of the same blood plasma EUA. That scientist— displaying far less enthusiasm than Trump and Hahn, and whose name was redacted from a memo released by the agency — wrote that the data:

 “…support the conclusion that [convalescent plasma] to treat hospitalized patients with COVID-19 meets the ‘may be effective’ criteria for issuance of an EUA. Adequate and well-controlled randomized trials remain nonetheless necessary for a definitive demonstration of … efficacy and to determine the optimal product attributes and the appropriate patient populations for its use.”

After the 24 August press conference, it took about 1.5 nanoseconds for Joe Biden and many media pundits to accuse Trump and Hahn of politicizing the EUA to influence the coming election.

Which brings us to The Pledge.

On 8 September, wanting to get out of firing range, the CEOs of all the leading Western developers of COVID-19 vaccines vowed to only file for FDA approval after demonstrating safety and efficacy in their Phase 3 trials. Their Pledge and descriptions of all nine trials can be found here.

The Pledge also promises all the developers will share some, but not all, of their data to propel their vaccines to the finish line. However, although every CEO wants their vaccine to be the first approved, not one of them wants to get there only for the world  to discover they’ve cut corners and now endanger humanity. These are people who want to go down in history for the right reason.

Mr. Trump will push, prod and kick these vaccine developers to get one of their efforts approved before 3 November. But I have a 95% confidence level none of them will buckle under that pressure. I sure hope I’m right.

AstraZenica’s Hiccup

In an example of the caution just described, yesterday AstraZenica announced  it was putting its Phase 3 vaccine trial on hold, due to a suspected serious adverse reaction in a participant in the United Kingdom.

This is not an uncommon happening in vaccine development, but it does show how fraught with uncertainties these trials can be. It proves that AZ’s data and safety monitoring group is doing its job, and that’s what is supposed to happen. I previously wrote about all the leading COVID-19 vaccine candidates, as well as ChAdOx1, the one being tested by AstraZenica in partnership with the University of Oxford’s Jenner Institute.

It is entirely possible we will experience more bumps in the road before one of the developers wins FDA approval.

An Important, New WCRI Study Is Released

Low back pain (LBP) is something that has afflicted humanity since Homo Sapiens decided to stand straight and walk upright. And it’s been the bane of claims adjusters since Otto von Bismarck, Germany’s Iron Chancellor, created the first workers’ compensation program in the 1880s.

Back injuries are the leading cause of all musculoskeletal claims, which are the leading cause of all workers’ compensation claims, and have been since it seems forever. If you’ve ever looked at a workers’ compensation loss run for any hospital in America, you’ll know what I mean.

One of the myriad treatment modalities for these claims is physical therapy (PT). However, it’s always been a bit of a crap shoot as to when to prescribe PT for a patient beset by a work injury resulting in low back pain.

Now, the Workers’ Compensation Research Institute (WCRI) has produced a study that convincingly puts the matter to rest. The study’s conclusion: the earlier PT is begun, the better.

The study, The Timing of Physical Therapy for Low Back Pain: Does It Matter in Workers’ Compensation?, is based on a review of  nearly 26,000 LBP-only claims with more than seven days of lost time from 27 states, with injuries from 1 October 2015, through 31 March 2017, and detailed medical transactions up through 31 March 2018.

One of the many reasons this study is important is that PT can sometimes be the last resort, not the first, in many cases being recommended only after opioids and other invasive procedures have been tried.

The WCRI study found:

  • Later timing of PT initiation is associated with longer temporary disability (TD) duration. On average, the number of TD weeks per claim was 58 percent longer for those with PT initiated more than 30 days post-injury and 24 percent longer for those with PT starting 15 to 30 days post-injury, compared with claims with PT within 3 days post-injury.
  • Workers whose PT treatment started more than 30 days post-injury were 46 and 47 percent more likely to receive opioid prescriptions and MRI, respectively, compared with those who had PT treatment initiated within 3 days of injury. The differences between PT after 30 days post-injury and PT within 3 days post-injury were 29 percent for pain management injections and 89 percent for low back surgeries.
  • The average payment for all medical services received during the first year of treatment was lower for workers with early PT compared with those with late PT. For example, the average medical cost per claim for workers who had PT more than 30 days post-injury was 24 percent higher than for those who had PT within 3 days post-injury.
  • Among claims with PT treatment starting more than 30 days post-injury, the percentage with attorney involvement was considerably higher (27 percent compared with 13–15 percent among those in the early PT groups) and workers received initial medical care much later (on average 18 days compared with 2–3 days in the early PT groups).

If you’re a claims adjuster wary of incurring the cost of sending injured workers with resultant low back pain to PT, this study should make you press the “Reset” button in your mind.

And, finally, an homage to bourbon (which is also good for low back pain)

In the constant sea of terrible, divisive, set-your-hair-on-fire news, we now row to a bipartisan safe harbor: Bourbon.

In the halls of Congress, bipartisanship seems to have gone the way of the Woolly Mammoth. But, reader, that is not the case in the case of Bourbon! That’s because on 2 August 2007, Congress ratified a bill designating September as National Bourbon Heritage Month. More notable, however, is that it passed unanimously. Thus, history shows that amid the countless issues and places and opinions that divide us, nothing unites Americans like bourbon.

And that aint all. A 1964 act declared bourbon “America’s Native Spirit,” making it the only spirit distinctive to the United States, if you don’t count the “spirits” the QAnon folks are worried about.

So, although I can’t stand the stuff, on this first day after 2020’s Labor Day as we all get sucked along the giant tube of political rigarmarole, you might want to consider the nationally endorsed benefits of America’s Native Spirit. Things will still be dire, the President will continue his hyperbolic rants, many of your fellow Americans will continue to “choose liberty” over masks, but you? You’ll hardly notice any of it.

 

 

COVID-19 Update And Promising Vaccine Reports

Monday, August 10th, 2020

An alarming and disquieting milestone

Yesterday, we passed the five million mark. Five million confirmed cases of COVID-19 in America since January. To put this in a better perspective consider this: If you took every one of those five-million people and stood them shoulder to shoulder, the line would extend from Canada to the Mexican border. About 2,200 miles.

As for deaths, we have reached 163,000, and still rising with no end in sight. That number is more than three times the number of American soldiers who died in World War 1. More than three times the number of American soldiers killed during the 16-year Vietnam War.

This continuing death spiral is happening as Congress and the Administration are, as legendary Boston sportscaster Johnny Most used to say, “fiddling and diddling.” And all this fiddling and diddling is going on while millions of our fellow citizens watch their livelihoods and their dreams of a better life for them and their children dissolve into thin air.

We deserve better than this. Fiddling and diddling with a human tragedy of this magnitude is an obscene abomination.

Vaccine update

In the pre-clinical biotech world, we call them non-human primates. To everyone else, they’re monkeys, usually rhesus monkeys.

We have reported, and I’m sure you’re aware, that a number of companies have entered Phase 3 clinical trials testing their vaccines on thousands of people. Until COVID-19, that always followed years of pre-clinical work that usually began with mice. But because regulators have compressed and redesigned the vaccine development process, companies and institutions are running their pre-clinical and clinical trials simultaneously, in parallel.

Now, four groups have reported promising results with non-human primates, those rhesus monkeys. All of the approaches are different, but they settle into two methodologies:

  • Attacking SARS-CoV-2, the virus that causes COVID-19, through Messenger RNA.
  • Using a replication-deficient chimpanzee adenovirus to deliver a SARS-CoV-2 protein to induce a protective immune response.

You don’t really need to understand the science. What is important to know is all four groups reported that their vaccines have shown promising results in monkeys. The critical thing here is this: Three or four weeks after vaccinating the monkeys, each of the groups put SARS-CoV-2 into the monkeys’ noses. Each of the vaccines offered protection for the monkeys. Three of the four groups gave the vaccine in two shots, a prime followed weeks later by a booster.

The team of Oxford University and AstraZenica injected with one shot. Their results presented some concerns. While their vaccine prevented the monkeys from developing pneumonia, it did not clear the virus, indicating the vaccinated monkeys remained infected and able to spread the disease. It should be noted that the scientists infected the monkeys with ten times the viral load that a person would experience. Still, the group said protection might have been significantly enhanced had they given two shots.

These monkey trials are tremendously important, because scientists can give the monkeys their vaccine and then infect them with SARS-Cov-2, something they cannot do with their human volunteers in their Phase 3 trials.

The four groups are:

  • Moderna, working with the Swiss company Lonza, New Jersey-based Catalent and the National Institutes of Health. Its vaccine, mRNA-1273, contains snippets of viral mRNA, a molecule with instructions for making proteins. Moderna packs the mRNA inside a slippery pod made of lipids, so it can slide easily into the cells.
  • Oxford University’s Jenner Institute, working with AstraZenica. Its vaccine, ChAdOx1, uses a replication-deficient chimpanzee adenovirus to deliver a SARS-CoV-2 protein to induce a protective immune response. Their approach has been successful before as the first Ebola vaccine.
  • Pfizer, working with BioNTech, a German biotechnology company. Their vaccine, BNT162b2, also takes the mRNA route encoding an optimized version of the whole spike protein, which we wrote about here.
  • Johnson & Johnson, working with Beth Israel Deaconess Medical Center in Boston. Its vaccine candidate, Ad26.COV2.S, delivers the SARS-CoV-2 spike protein into cells using an inactivated common cold virus as the delivery vehicle. J & J gave a single shot of Ad26.COV2.S, and that provided significant immunity to COVID-19. But previous J & J studies showed giving a second booster shot raised the antibody response by tenfold in both animals and people.

All of this is promising, indeed. It is evidence we should be optimistic that we’ll have one or more effective vaccines by early 2021. However, it is worth noting that the road to a successful vaccine is littered with the decaying carcasses of failures.

 

 

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.

 

 

The Continuing Saga Of COVID-19 In Long Term Care Facilities And New Research

Thursday, May 21st, 2020

We have written about the ongoing death spiral in LTCFs four times – herehere, here, and here.

We’ve done this, because for three months authorities have known that LTCF’s were lethal hot spots, the most lethal in the country, actually. And to this day the federal government has devoted nothing more than lip service to it. Don’t believe me? Read on.

Last Thursday, OSHA issued COVID-19 Guidelines, not Requirements, for nursing homes. The Guidelines recommend screening residents and staff for symptoms, keeping everyone six feet apart and creating alternatives to group activities. I challenge anyone to read the Guidelines and find the word, “must.” OSHA has become the quintessential paper tiger. Remember, it only took three months to produce these groundbreaking recommendations.

And it is now exactly one month since CMS Administrator Seema Verma, to much ballyhoo, announced new COVID-19 reporting requirements for nursing homes. Specifically, CMS was requiring:

…nursing homes to inform residents, their families and representatives of COVID-19 cases in their facilities. In addition, as part of President Trump’s Opening Up America, CMS will now require nursing homes to report cases of COVID-19 directly to the Centers for Disease Control and Prevention (CDC).  This information must be reported in accordance with existing privacy regulations and statute. This measure augments longstanding requirements for reporting infectious disease to State and local health departments. Finally, CMS will also require nursing homes to fully cooperate with CDC surveillance efforts around COVID-19 spread.

So, how has that worked out? Keep in mind that, as reported by the New York Times, “While just 11 percent of the country’s cases have occurred in long-term care facilities, deaths related to Covid-19 in these facilities account for more than a third of the country’s pandemic fatalities.” As of 9 May, the Times reported the death toll in Long Term Care Facilitites (LTCF) was 28,100. Those are the ones we know of.

Unfortunately, that number is probably low, because we are still waiting for the CMS reporting requirement to produce anything. And now, it appears CMS’s plan has changed. On 14 May, one week ago, Administrator Verma said data from LTCFs would not be posted on the CDC website. Rather, it will be reported by the end of this month somewhere on Medicare’s website Nursing Home Compare.

Nursing Home Compare is exactly what the name suggests. It is a site where, by inputting a zip code, one can compare what Medicare calls Health Deficiencies in specific nursing homes within the relative geography chosen. It includes a humongously large database containing a number of datasets devoted to health deficiencies. This may be the place one would search for nursing home data regarding COVID-19. But we won’t know that until “the end of this month.” Maybe.

We shall see.

By the way, Verma’s announcement of one month ago began with this:

Today, under the leadership of President Trump, the Centers for Medicare & Medicaid Services (CMS) announced new regulatory requirements that will require nursing homes to inform residents, their families and representatives of COVID-19 cases in their facilities.

“Leadership.” Really?

Research on what is most effective to stop COVID-19 transmission

Two new research papers look into the effectiveness of the measures governments have either required or recommended for slowing the spread of the virus.

The first, Strong Social Distancing Measures In The United States Reduced The COVID-19 Growth Rate, published in Health Affairs on 14 May, investigated the efficacy of four social distancing policies taken by most state and local governments: Shelter-in-place orders (SIPOs), public school closures, bans on large social gatherings, and closures of entertainment-related businesses. Specifically, the researchers were trying to estimate the relationship between social distancing policies and the exponential growth rate of confirmed COVID-19 cases using an event-study regression with multiple treatments.

There were surprising results.

First, from the Paper:

Adoption of government-imposed social distancing measures reduced the daily growth rate by 5.4 percentage points after 1–5 days, 6.8 after 6–10 days, 8.2 after 11–15 days, and 9.1 after 16–20 days. Holding the amount of voluntary social distancing constant, these results imply 10 times greater spread by April 27 without SIPOs (10 million cases) and more than 35 times greater spread without any of the four measures (35 million). Our paper illustrates the potential danger of exponential spread in the absence of interventions,…

Second, only two of the policies produced statistically significant impacts on the growth rate at the 95% confidence level: SIPOs and the closures of entertainment-related businesses.

In contrast, the researchers found no evidence that bans on large social gatherings or school closures influenced the growth rate. That is not to say there was no influence on the growth rate due to these measures, just that whatever influence was there, it was not statistically significant.

The school closure finding is important as school boards and college trustees ponder whether to reopen in the fall. Yesterday, Boston College, where I spent some of my youth, announced that the campus would be open for classes for the fall semester.

The second PaperFace Masks Against COVID-19: An Evidence Review, “synthesized the relevant literature to inform multiple areas: 1) transmission characteristics of COVID-19, 2) filtering characteristics and efficacy of masks, 3) estimated population impacts of widespread community mask use, and 4) sociological considerations for policies concerning mask-wearing.”

The verdict of the researchers: “The preponderance of evidence indicates that mask wearing reduces the transmissibility per contact by reducing transmission of infected droplets in both laboratory and clinical contexts. Public mask wearing is most effective at stopping spread of the virus when compliance is high. The decreased transmissibility could substantially reduce the death toll and economic impact while the cost of the intervention is low.” In otherwords, masks work.

This paper carried the following supplemental tidbit:

While the focus of this article is on preventing the spread of COVID-19 disease through public mask wearing, many countries face concurrent epidemics of contagious respiratory diseases like tuberculosis and influenza. Tuberculosis kills 1.5 million people globally per year, and in 2018, 10 million people fell ill. Face covering has been shown to also reduce the transmission of tuberculosis. Similarly, influenza transmission in the community declined by 44% in Hong Kong after the implementation of changes in population behaviors, including social distancing and increased mask wearing, enforced in most stores, during the COVID-19 outbreak.
This could be important when one considers that an effective vaccine for tuberculosis exists: the Bacillus Calmette-Guérin vaccine. It isn’t usually given to infants in the U.S., because the disease isn’t a widespread problem here. However, when we eventually have a vaccine for COVID-19, we’re going to have to face the fact that getting it to people around the world is not going to be easy.
And, God help us, we’ll also have to deal with the anti-vax cult living among us here at home.

 

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.

 

Still More Covid 19 Quick Takes

Monday, April 27th, 2020

The age problem

“You know you’re getting old when you stoop to tie your shoelaces and wonder what else you could do while you’re down there.” ― George Burns

Question: When will elderly people, say over the age of 70, dare to venture out of their present tightly-wrapped cocoons and back into general society?

Answer: I will go out on a very fat limb and suggest not anytime soon.

Today marks the 118th day since 31 December 2019, the day the World Health Organization (WHO) reported the first case of a “pneumonia of unknown cause” in Wuhan, China. It’s the 47th day since 11 March 2020, the day the WHO officially declared the newly named COVID 19 a pandemic. And it’s the 53rd day since 5 March 2020, the day the Workers’ Compensation Research Institute (WCRI) convened its annual conference in Boston.

John Ruser, WCRI’s President and CEO opened the conference by advising everyone to avoid shaking hands; elbow bumps were the order of the day, but social distancing was non-existent, about two feet was typical.

I mention the WCRI’s just-before-the-deluge conference because of one chart shown during it. This chart:

WCRI’s injury database shows about 40% of injured workers over the age of 60 have two or more comorbidities, which increase inexorably with age. Sort of like the way those of us who still have it have been watching the steady growth of the stuff on top of our heads over the last five or six weeks. My hair hasn’t been this long since 1980.

I thought of that chart this morning as I was beginning my new daily routine: studying various COVID 19 dashboards (more about that below). I was struck by two charts from the Commonwealth of Massachusetts that put the problem the elderly now face into stark relief. Here they are:

Massachusetts is not unique; COVID 19 does not respect state boundaries. One realizes this as one attempts to quantify the disease’s impact in the nation’s 15,600 nursing homes housing 1.4 million elderly and disabled people. A difficult task, as USA Today discovered when its journalists tried to investigated the issue (article dated 13 April):

At least 2,300 long-term care facilities in 37 states have reported positive cases of COVID-19, according to data USA TODAY obtained from state agencies. More than 3,000 residents have died.

The numbers eclipse those previously disclosed by the Centers for Disease Control and Prevention (CDC), which in late March estimated that 400 facilities had reported cases of the virus. But the new totals still represent an incomplete accounting due to the ongoing lack of widespread testing for the virus and inconsistent record-keeping from state to state. On the federal level, neither the CDC nor the Centers for Medicare and Medicaid Services is tracking the number of U.S. nursing homes with COVID-19 cases, or the number of total cases and fatalities in those facilities.

In Massachusetts, 56% of COVID 19 deaths have occurred in long-term care facilities. One would think this cries out for federal data tracking conducted in a consistent manner across the nation. One would think.

About those dashboards

Where are you getting your information on the daily spread of COVID 19? Where do you think most Americans are getting theirs? Could the answer be Twitter? Or Facebook? How about the daily White House Coronavirus Task Force briefings (Randy Rainbow beautifully summed up last Thursday’s, which was highly controversial and chock full of more than ordinary mediocrity)?

If you’re thinking of the CDC’s dashboard, you’ll find the data in a few places, not all in one, easy to navigate spot. For example, go here; or here; or here. You get the point. A lot of information, but you really have to dig.

There are national dashboards, which are organized well and highly informative. Two that I recommend are the Coronavirus Resource Center at Johns Hopkins University and the New York Times’s Coronavirus in the U.S.: Latest Map and Case Count. Updated frequently, at least daily, each is excellent. The Johns Hopkins dashboard is global in scope; the Time’s focuses on the U.S.

The Massachusetts dashboard is the best state-maintained dashboard I’ve found. Disclosure: I live in Massachusetts. However, the dashboard is truly exceptional. Take a look. Scroll through it. I think you’ll agree this should be a model for all others.

Where one gets information about COVID 19 matters, because of all the disinformation and outright lies being thrown up against the wall every day. Some of it will always stick, and this is too serious for that. The more we know about this disease, the more we ought to realize how much we really don’t know. Ignorance is not bliss. Benjamin Franklin said, “It is in the religion of ignorance that tyranny begins.”