Archive for the ‘health care’ Category

News You Might Have Missed

Wednesday, May 26th, 2021

Immunity Passports and Herd Immunity

As time passes, we are learning more and more about SARS-CoV-2, the virus that causes COVID-19. One of the things we are learning is how much we have yet to learn.

For example, a current and pervasive meme involves antibodies an infected person’s immune system makes to combat COVID-19.

Following his bout with the virus in October, 2020, during which he was given an “antibody cocktail,” Donald Trump famously said, “Now you have a president who doesn’t have to hide in a basement like his opponent. You have a president who is immune. Which is a very important thing, frankly.” Although the disgraced former president also said he wasn’t sure how long his “immunity” would last, the cult-of-Trump within the American public heard his “now I’m immune” message loud and clear.

Even before Trump’s “I’m immune” message, six months before, actually, his White House Rasputin, Scott Atlas, from Stanford’s Hoover Institute, told Fox’s Tucker Carlson it was “good news that the virus spreads widely and without risk to the vast majority of people. That’s good news, because we have a better chance of developing population immunity.” He went on to say this “would allow people to develop their own antibodies, and eventually enough people would develop their own antibodies to block the network of contagion.”

Herd immunity from having had the disease is a belief that won’t die. Two months ago “Health Coach” Christian Elliot published a mega-viral blog post entitled Eighteen Reasons I Won’t Be Getting A Covid Vaccine. One of the reasons? “I already had Covid.”

Reputable journals, newspapers and website have published fact-based research debunking this “I’m immune because I had it” drivel. As far back as 24 April 2020, around the same time Scott Atlas was mythologizing with Tucker Carlson, The World Health Organization (WHO) tried to put the matter to rest when it published Immunity Passports in the context of COVID-19. From the beginning of the article:

Some governments have suggested that the detection of antibodies to the SARS-CoV-2, the virus that causes COVID-19, could serve as the basis for an “immunity passport” or “risk-free certificate” that would enable individuals to travel or to return to work assuming that they are protected against re-infection. There is currently no evidence that people who have recovered from COVID-19 and have antibodies are protected from a second infection.

For the article, the WHO reported on 17 studies investigating whether having had COVID-19 produces antibodies (it does) that prevent recurrence of the disease (unknown). Seventeen studies, and not one reporting having had COVID-19 prevents short or long term reinfection.

To make it even clearer, further on the WHO said:

As of 24 April 2020, no study has evaluated whether the presence of antibodies to SARS-CoV-2 confers immunity to subsequent infection by this virus in humans.

But none of this stopped Donald Trump from perpetuating the medical myth the following October after his recovery.

This Alice-down-the-rabbit-hole thinking just confirms once again there has never been a fact that Trumped a deeply held belief.

Fifty-three percent, eh?

The Gallup organization made news this week with its latest poll in which it reported 53% of Republicans believe Donald Trump was cheated out of the presidency. This has been confirmed over and over again in the six months since the election—an election Joe Biden won by more than seven-million votes. Makes it seem as if a big swath of the country thinks a fraudster sits in the Oval Office.

But does it really? Let’s look a little deeper.

For decades, Gallup has surveyed the party affiliation of Americans, that is, U.S. adults identifying with the Democratic Party or who said they are independents leaning toward the Democratic Party; and, U.S. adults identifying with the Republican Party or who said they are independents who lean toward the Republican Party. In recent years, the gap between the two, a Democratic advantage, has been between four and six percentage points. In the first quarter, 2021, that gap grew to nine percentage points.

In Gallup’s Q1 survey, 25% of U.S. adults identified as Republicans and 15% as Republican-leaning Independents, for a total of 40%. This compares with 30% identifying as Democrats and 19% as Democratic-leaning Independents, totaling 49%. Thus, the nine point gap.

Now, back to the 53% of Republicans who believe Trump was cheated. Fifty-three percent of 25% is 13.25%. Fifty-three percent of 40% is 21.2%. Presuming not every, single Republican-leaning Independent believes Biden stole the election, we can say somewhere between 13.25% and 21.2% of U.S. adults believe the stolen election Big Lie. I’m betting it’s closer to the bottom number.

And that, my friends, is Donald Trump’s true base.

Who needs an independent commission?

The last time a violent mob invaded Washington, D.C. was 24 August 1814 during the War of 1812 when the British set fire to the White House and the U.S. Capitol, destroying the Senate Chamber and the Library of Congress. They burned most everything to the ground. Only torrential rains stopped the blaze. President James Madison wasn’t at the White House when this occurred, but his wife Dolly was. She took command and rescued everything she could. After that, with American soldiers escorting her, she was able to make her escape.

Two-hundred-seven years later, on 6 January 2021, a weaponized and organized mob of our fellow citizens stormed the Capitol in a violent insurrection. Five people died and the mob trashed the place to the tune of $30 million, according to the Architect of the Capitol. President Donald Trump wasn’t in the Capitol when the mob arrived, but his Vice President Mike Pence was. With the mob chanting, “Hang Mike Pence,” the Secret Service, like the soldiers who helped Dolly Madison, spirited Pence and his retinue out of the building to safety.

Thus far, 494 people have been arrested and charged for participating in the insurrection. They are from all parts of America and from all levels of society. Knowing the who, what, how, and why of this national obscenity seems to me to be a not too radical idea, the responsible thing to do. However, Republicans in Congress maintain that, because congressional committees are looking into the matter, an independent commission is unjustified and a waste of time and taxpayer money. They say the country needs to look forward, not back.

Being kind about this type of argument, I have to say it is full of what makes the grass grow green and tall. Perhaps the summit of Republican silliness was reached last night when Mitch McConnell, calling the whole thing a “purely political exercise,” told reporters that democrats, “would like to continue to debate things that occurred in the past,” as if investigating an assault on Democracy during which a violent mob was trying to find the Vice President of the United States in order to kill him was something akin to investigating how a new city parking lot strangely came to be on the corner of 6th and 7th. McConnell couldn’t even call the insurrection what it was; for him, it’s now just a “thing in the past.”

It is a tremendously sad commentary on our current society that the U.S. Senate, because of Republican opposition, will most likely not  approve an investigation by an independent commission into the 6 January insurrection. People, what have we come to?

History will not be kind to us in this moment. It will give us what we deserve.

A Day For Gloating!

Tuesday, April 27th, 2021

In early 2003, I was honored to be part of a group that wanted to bring better health care to some of the neediest citizens of the Commonwealth of Massachusetts. Dr. Bob Master, former Commissioner of the state’s Medicaid program, had the idea that if a number of us put our collective heads together we could actually do that. With him leading the effort, we created Commonwealth Care Alliance (CCA), an HMO dedicated to serving people who were dually eligible for both Medicare and Medicaid. These were the Commonwealth’s sickest of the sick and poorest of the poor. Paradoxically, their health care was woebegone, but the cost of providing it was astronomical.

CCA was a Dual Eligible Special Needs Plan, known in the business as a D-SNP. D-SNPs were created by the Medicare Modernization Act of 2003 (MMA), and are overseen by the Centers for Medicare and Medicaid Services (CMS). The potential afforded by the MMA was what intrigued Bob Master. He realized that if correctly harnessed, the power of the MMA could do a world of good for people at the lower end of the health care totem pole. And he was right.

Over the years, CCA took on the persona of The Perils Of Pauline, going from crisis to crisis. Our Board, comprised mostly of academics and clinicians, constantly fought above its weight. But, thanks to health care leaders in Massachusetts who saw the value of what we were trying to do, we were always rescued from our own folly. With their help, we grew and thrived—precariously.

In November, 2015, after Bob Master retired as CEO, the Board made the best decision in its history, hiring Chris Palmieri to take over the reins. Chris was a health care executive possessed of zeal, deep dedication to the cause and profound intelligence. Under his leadership CCA  for three years running was ranked number one in its class of health care providers nationally. I chaired the Board during this time and had a ring-side seat to the growth and respect CCA achieved.

During this time, the Board was deeply concerned about the diversity of our employees. We wanted them to look like the thousands of members we served. Great effort went into making that happen. It wasn’t easy, but management established protocols and stuck to them.

My term as Board Member and Chair ended 31 December 2019, but, as you can imagine, I have avidly followed the organization, especially as it navigated the terrible 2020 COVID-19 pandemic. During the last year, under Chris’s leadership, CCA has continued to perform at a superior level. I never doubted that it would.

Today, though, is special. Today, the Boston Globe published its rankings for diversity in hiring of all Massachusetts firms. When I saw that CCA ranked Number One in the Commonwealth!, I thought my chest would burst with pride. This is a remarkable achievement, brought about by the entire organization taking to heart the idea that all of us, working together, are better than some of us, working in ethnic, gender, racial and demographic silos.

Slowly, America is moving to a more inclusive society. After the darkness of the last four years, we are coming into the light. Although much work remains, diversity accomplishments and the recognition that comes with them, as demonstrated by Commonwealth Care Alliance, will propel us toward becoming all that we can be, not what we have been.

It’s Always Been Tough Being A Nurse. Now It’s Worse.

Thursday, April 22nd, 2021

The OSHA Incidence Rate of work injuries (cases per 10,000 workers) for nurses is 12.7; for all other industries, it’s 3.8. Moreover, 40.8% of all nurse injuries involve physically dealing with patient needs, like moving, turning and lifting them, resulting in the highest rate of sprains and strains of all professions.

That nurses experience high rates of injuries is nothing new. Lynch Ryan’s very first client, the year was 1984, was a community hospital where injuries to nurses caused the hospital’s workers’ compensation insurance experience to be nearly three times worse than its peers in Massachusetts. We solved that by creating the concept of modified duty, returning injured employees to work with physician-specified physical restrictions prior to complete recovery.

What is less well known is that America’s health care workers, principally nurses, are victims of violence in the workplace at three times the rate of all other industries, including manufacturing and construction. Among registered nurses, what the Bureau of Labor Statistics (BLS) calls “violent events” make up 12.2% of all occupational injuries; for all other industries it’s 4.2%. Clearly, nursing has been a challenging profession since the time of Florence Nightingale.

The COVID-19 pandemic has made things even worse. A new Washington Post – Kaiser Family Foundation Poll reveals roughly three out of ten health care workers are considering leaving the profession and more than half report being “burned out” due to the overwhelmingly horrific year they’ve just spent trying, and often failing, to save the lives of COVID inflicted patients.

Couple this potential decrease in health care workers with the BLS’s projection (as of 9 April 2021) that health care jobs will be the fastest growing segment of the economy from 2019 to 2029:

Employment in healthcare occupations is projected to grow 15 percent from 2019 to 2029, much faster than the average for all occupations, adding about 2.4 million new jobs. Healthcare occupations are projected to add more jobs than any of the other occupational groups. This projected growth is mainly due to an aging population, leading to greater demand for healthcare services.

So, we were already facing a future serious shortage of health care professionals. Now, the pandemic threatens to thin the ranks even more. Despite this, enrollment in baccalaureate nursing programs increased nearly 6% in 2020, to 250,856, according to preliminary results from an annual survey of 900 nursing schools by the American Association of Colleges of Nursing. In order to hit the BLS projection of 2.4 million new jobs, nursing enrollment will have to grow at this rate every year. That is a tall order.

Meanwhile, occupational injuries, violence events, and, now, illnesses due to the pandemic will continue to plague the health care sector. Try as I might, I have been unable to find any kind of cohesive national strategy to confront and deal with this looming health care catastrophe.

Just another example of our sweeping a coming disaster under the rug for posterity to trip over.

This Is Madness

Friday, November 13th, 2020

Let’s start with the numbers.

Global Cases

Global COVID-19 cases are rising and the rise is accelerating, as documented by the Johns Hopkins Coronavirus Resource Center. There have been nearly 53 million cases around the world, 660 thousand yesterday. There have now been about 1.25 million deaths, and the death rate is also rising.

U.S. Cases

According to the New York Times Latest Map and Case Count, America’s case rate is surging faster than at any time in the pandemic.

Consider these four points from the above chart:

Since the beginning of COVID-19 in the U.S., the health care community has made tremendous gains in treating the disease, that is, in preventing deaths. However, no one yet knows the extent of long-term complications due to contracting the virus. Although COVID-19 primarily affects the lungs, it can damage many other organs as well. This organ damage may increase the risk of long-term health problems. Regardless, deaths are once again rising.

With respect to keeping safe, absolutely nothing has changed since the beginning of the pandemic. Hand washing/sanitizing, social distancing, mask wearing, and testing are, to this day, the only things we can do to control the disease. At some point in the future, perhaps by mid-spring, the vaccine cavalry will come charging over the hill. But until then, we’re on our own. COVID-19 is the enemy, the opposition, and we have to outlast it. Everyone needs to put on the moral cloak of responsibility.

It would be nice if that moral cloak were to become moral leadership from the White House, but the Trump Administration, obscenely obsessed with fighting the will of the majority, has gone AWOL, once again leaving the states to fight the disease by themselves, and most are now fully engaged.

Consider Ohio, where Republican Governor Mike DeWine is doing everything he and his team can to drive home the need for masks, hand washing and social distancing. Case in point: His Department of Health created a compelling video to illustrate the value of social distancing.

One of the most tragic things I have ever observed is going on right now across America. Millions of people have been persuaded the washing, wearing and distancing things are lies meant to steal the soul of the nation in a socialistic, Mephistophelean conspiracy. They believe government is trampling on their “rights.” Meanwhile, many of them get sick, some of them die, and they bring great harm to their neighbors who are trying to do the right thing. This is madness.

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 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.

Sisyphus Must Have Felt Like This

Wednesday, September 16th, 2020

The COVID-19 boulder, full of facts, lies, information, misinformation, disinformation, and just plain delusional thinking keeps rolling back down the mountain. Try as we might, it’s certainly difficult to make sense of COVID-19. But we keep trying, anyway. As in:

Unions during COVID-19

I have written previously about the perplexing case of union participation in America. In 1960, about a third of hourly workers belonged to unions. In January of this year, the BLS reported that number had dropped to 10.3%. Yet, in the same press release, the BLS reports:

Nonunion workers had median weekly earnings that were 81 percent of earnings for workers who were union members ($892 versus $1,095).

Right now we won’t get into why this puzzling paradox exists, except to say we now have another log to throw on the pyre.

A new study authored by researchers at George Washington University, the University of Pennsylvania Perelman School of Medicine and the Boston University School of Medicine, published in Health Affairs, found that having a unionized workforce at a nursing home greatly reduces the likelihood that residents or staff will die from COVID-19. From the study’s Abstract:

Health care worker unions were associated with a 1.29 percentage point mortality reduction, which represents a 30% relative decrease in the COVID-19 mortality rate compared to facilities without health care worker unions.

The study analyzed data from more than 300 nursing homes in New York from March 1 through May 31. The authors conclude the unionized health care workers in the nursing homes were able to negotiate for more PPE, higher pay, and better working conditions.

During the pandemic, New York has suffered nearly 7,000 nursing home deaths, more than any other state except New Jersey.

My take on this? If you have loved ones who may be headed for a nursing home, it might be a good idea to ask if the staff is unionized.

Avoiding medical care during COVID-19

Since early in COVID-19, we’ve known that many people, fearful of the disease, have put off getting routine, or, in some cases, emergency medical care. What we have not known is what demographic groups are doing that and to what degree. Now, the CDC has put a full stop period to that issue.

In its 11 September weekly Morbidity and Mortality Report, the CDC published a comprehensive analysis concluding 40.9% of U.S. adults delayed or avoided medical care as of June 30. This includes urgent or emergency care (12%) and routine care (32%). Regarding what population segments are doing this, the study had this to say:

The estimated prevalence of urgent or emergency care avoidance was significantly higher among the following groups: unpaid caregivers for adults versus non-caregivers (adjusted prevalence ratio [aPR] = 2.9); persons with two or more selected underlying medical conditions† versus those without those conditions (aPR = 1.9); persons with health insurance versus those without health insurance (aPR = 1.8); non-Hispanic Black (Black) adults (aPR = 1.6) and Hispanic or Latino (Hispanic) adults (aPR = 1.5) versus non-Hispanic White (White) adults; young adults aged 18–24 years versus adults aged 25–44 years (aPR = 1.5); and persons with disabilities§ versus those without disabilities (aPR = 1.3).*

So, Mary, taking care of her aged mother at home, foregoes either emergency or routine care at nearly three times the rate of Sarah, her next door neighbor who is not burdened with an aged relative, because she doesn’t want to bring COVID-19 home to Mom. Even more troubling is that people with two or more co-morbidities forego care at nearly two times the rate of people without such underlying conditions.

The CDC’s paper advises that, “… urgent efforts are warranted to ensure delivery of services that, if deferred, could result in patient harm.”

Enough said.

*By way of example for the statistically challenged, an adjusted prevalence ratio of 2 means that the prevalence of cases among a study group is 2 times higher than among the control subjects. It’s calculated through a series of regression analyses. There. Now you know.

U. S. life expectancy

COVID-19 has sucked all the air out of any national attempt at healthcare reform, while revealing in sharp detail the foundational flaws in the current system. Eventually, however, America is going to have to confront this issue in a meaningful manner. Healthcare cost in America is still twice the average of all 37 member countries of the Organization for Economic Cooperation and Development (OECD), and Americans still have poorer health and lower life expectancy than the average of the member countries (78.7 versus 79.5)

In its latest Health At A Glance publication, the OECD updated its life expectancy data, as shown here:

There are many cracks in our healthcare house that Jack built. Ignoring them is not a strategically viable plan for improvement, improvement that all citizens deserve.

To quote the venerable A. E. Housman, “Terrence, this is stupid stuff.” Another example of our woebegone healthcare system.

Trump’s Nevada rally

Last night, during an ABC-TV Town Hall Meeting President Trump once again pilloried cities and states run by Democrats and blamed their leaders for any problems with the response to COVID-19.

A little contextual background is required here. On 14 April, Trump asserted “absolute authority” to control the nation’s response to the pandemic, saying, “When somebody is president of the United States, your authority is total.” He made it clear he would be in charge and the states would have to fall in line.

Two days later, he reversed himself on a call with all the governors, telling them, “I’ve gotten to know almost all of you, most of you I’ve known and some very well. You are all very capable people, I think in all cases, very capable people. And you’re going to be calling your shots.”

Since then, he has repeatedly repeated the “You’re on your own” line. The result, of course, has been that we have seen 51 different plans and approaches  with varying degrees of success.

Nevada, one of the “you’re on your own” states, is still in the midst of a tough fight against the disease with a Daily Positivity Rate of 7.1% and a Cumulative Positivity Rate of 10.2% as of 10 September.

On 24 June, Nevada Governor Steve Sisolak imposed certain restrictions, among them the requirements that all Nevada residents wear masks when in public and that no more than 50 people, socially distanced, congregate in one place.

Enter Donald Trump and his the-sky-is-the-limit indoor rally of last Sunday evening at Xtreme Manufacturing in Henderson, Nevada. Fire officials estimated the size of the crowd was 5,600 people, nearly all of whom were maskless (except for the people right behind Trump who were constantly on full TV view).

Just as we saw in Tulsa after his previous rally, we’ll probably see a spike in cases in Nevada in two to three weeks.

Beyond the nonchalant and willful endangerment to peoples’ lives, what bothers me most of all about this event is Donald Trump’s cavalier and metaphorical raising high of his two middle fingers to Nevada’s scientifically-based efforts to keep its citizens alive. After repeatedly telling the nation’s governors they should do what they think they need to do to combat COVID-19, this “law and order” president, without compunction of any kind, imperiously violates the law while telling his large crowd Nevada’s Governor Sisolak is “a hack” and “weak.”

Allow me to close with Joseph Welsh’s question to Senator Joe McCarthy on 9 June 1954: “Have you no decency, sir?”

 

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.

 

 

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