Saturday, September 26, 2020

Coronavirus Links

Here are the links for my virus posts:

I try to update this as often as possible. It has hyperlinks to the original source. Events such as elections, press conferences, etc. are in green. Quotes are in orange (Trump) and agua for others. I've limited editorial comment by others (in aqua) to things that I think explain something in context. 

(Last year I started database on the pandemic and its origins. It quickly became overwhelming so I followed it up with a series of posts that I characterized as a post mortem on Trump's failed response to the coronavirus. The links to each post are set out below. This is a compilation of those posts, all written before Trump actually came down with the disease and, obviously, prior to the election.)

A diagnosis of what amounts to a self-inflicted wound is not just about incompetence borne of inexperience, but a malaise exacerbated by an etiology of inaction, conceit, negligence, petulance, impetuosity gilded with ignorance, penchants for infantile and happy talk, dogged insistence and actions by force of will, an indolence and unwillingness to study or work at the tasks before him, and an imperviousness to harsh and obvious realities.

January closed with the country having now reported its first cases. We had a tenuous lock down travel plan and we had an able and prestigious team of medical professionals. But that was it. There was no real plan, just the administration intuitively caroming side to side along ad hoc courses of action that they often rescinded, retracted or contradicted.

But no one was at the helm. Or, rather, not only was the person who was theoretically in charge not paying any real attention, he was betting against the house. Despite the repeated warnings and health alerts from the WHO, the warnings from our intelligence agencies and daily briefings, including the January 28 briefing and the President’s own February 7 taped interview with Woodward regarding the perniciousness of the disease, the administration began playing a shell game with the public. Testing, or rather, the data it would reveal, somehow perceived as a negative, was the key component of this guile.

This would soon devolve into finger pointing between the governors and the President, mostly around the availability of testing and PPE and the question about who bore the responsibility for obtaining them. By mid-April, a full-on range war had developed, involving even governors from his own party. Trump called them complainers. The critiques, first enunciated in pre-pandemic assessments concerning the confusion about intergovernmental and agency roles would soon prove much too true.

What was obvious in the back-and-forth of what would become a daily made-for-television political soap opera was Trump’s insistence that it was his way or the highway, science be damned. Fauci was but just one of the pieces in his reality show. Others on the task force attempted to walk the tightrope of fulfilling their ethical duties, avoiding Trump’s political machinations, and trying to effectively face what would become the President’s political backfires.

There it was; the emperor had no clothes. From bickering with his experts to finally scotching the task force “indefinitely”, he moved to appoint Atlas who was, although a doctor, mismatched in medical expertise, a Fox News commentator, and a member of a Libertarian think tank pushing the discredited “government is bad” theory of herd immunity. The President had left the building.

Nor is there walk-back from his obvious lies or sorties into weird science misadventures. Who to believe, the President who would brag that he had a predisposition toward science because of his ‘super genius’ uncle and who praised his own “natural ability” to grasp scientific theories, or the man who had made the suggestion about injecting bleach as a corona virus countermeasure?





Friday, September 25, 2020

Postmortem Part VII: No-confidence Vote

   [ED NOTE: Some months ago, bewildered by the amount of oncoming data and information - and its misapplications - I started putting together a coronavirus database. That can be found here. Much of the information in this piece is taken from there.]

POSTMORTEM: Too Early?

Part VII

by Domingo Soto

And reality. In the President’s alternate universe view the virus had run its course or was, at least, on the ropes. He, if not the country, was back to business as usual. Rallies were being held. Safety protocols were no longer just ignored but now vilified. So, too, anyone that followed them. Help, he assured, was well on the way, a vaccine would soon be available, thanks to his masterful handling of the situation. He gave himself an “A” for a job well done.

But the public had by now little confidence in anything the President said. He had a history of palpably false statements, happy talk, and crazy thinking and it wasn’t limited to just his handling of the pandemic. His political capital was spent. Even if, charitably, one were to accept his claims (belatedly and as a result of Woodward’s revelation) that his positive spins were for the public’s confidence and sense of well-being, how to explain that as recently as late September, Trump was still spewing his voodoo medicine, only to be corrected by Dr. Fauci? 

The President would tell a rally that “Now we know it affects elderly people. Elderly people with heart problems and other problems. If they have other problems, that’s what it really affects. That’s it. You know, in some states thousands of people— nobody young — below the age of 18, like nobody — they have a strong immune system — who knows?....Take your hat off to the young, because they have a hell of an immune system. But it affects virtually nobody. It’s an amazing thing.”

Nor is there walk-back from his obvious lies or sorties into weird science misadventures. Who to believe, the President who would brag that he had a predisposition toward science because of his ‘super genius’ uncle and who praised his own “natural ability” to grasp scientific theories, or the man who had made the suggestion about injecting bleach as a corona virus countermeasure? 

It was not lost on the public that he had outrageously ridden the hydroxychloroquine horse into the ground. He had seized on yet another lifeline, beginning with a cheerleader’s tweet that said “HYDROXYCHLOROQUINE & AZITHROMYCIN, taken together, have a real chance to be one of the biggest game changers in the history of medicine. The FDA has moved mountains - Thank You! Hopefully they will BOTH (H works better with A, International Journal of Antimicrobial Agents)....."

Characteristically he would dismiss a hydroxychloroquine study that undermined him as a “Trump enemy statement”. “I worked with doctors,” he would say. “If you look at the one survey, the only bad survey, they were giving it to people that were in very bad shape, they were very old, almost dead. It was a Trump enemy statement.” 

It would prove to be a dead end, even drawing a reprimand shutting down his precious Twitter account for a short period of time. Not chastened, he would continue, moving on to a succession of snake oil remedies and hopeful panaceas, at each point rejecting the advice of one of the world’s most prestigious medical staffs. But what’s new?

Operation Warp Speed, designed to cut through the normal state of regulation of drugs, in this case the vaccine, had been a deft and incisive move. But over the months, the speed of the response and the President’s insistence that a vaccine would soon be available, now touted as a vindicating one-two punch, became a liability. The President had initially declared that COVID-19 would simply vanish. “I feel about vaccines like I feel about tests. This is going to go away without a vaccine. It’s gonna go away, and we’re not going to see it again, hopefully, after a period of time.”

He soon shifted gears, announcing that a vaccine would be available soon. At times it was by election day. Others before the end of the year. The medical experts reasoned otherwise, charitably opining that “it could happen.” But “probably not” hung in the air. Suspicious of the obviously heavy political undercurrents, the public showed resistance to taking the vaccine even before it was available. 

The medical and pharmaceutical establishments bucked the President, publicly addressing the notion that the process had been tainted by political interference. No one will interfere with the efficacy of their standards, FDA’s Hahn (and others) would state. 

That’s our current state: the reputations of our most celebrated institutions have been unnecessarily smeared, called into question, and - like the rest of the country - in conflict with each other; metrics, science and solutions, now tribal, seem without footing; and worse yet - even if one can condone the late start and misfires as just part of a learning curve - we are, nine months later and over 200,000 lives lost, dead in the water and without a real game plan, led by a man in whom we have no trust.

(CLICK HERE FOR THE ENTIRE SERIES)


Thursday, September 24, 2020

Postmortem Part VI: The Emperor Has No Clothes

  [ED NOTE: Some months ago, bewildered by the amount of oncoming data and information - and its misapplications - I started putting together a coronavirus database. That can be found here. Much of the information in this piece is taken from there.]

POSTMORTEM: Too Early?

Part VI

by Domingo Soto

There it was; the emperor had no clothes. From bickering with his experts to finally scotching the task force “indefinitely”, he moved to appoint Atlas who was, although a doctor, mismatched in medical expertise, a Fox News commentator, and a member of a Libertarian think tank pushing the discredited “government is bad” theory of herd immunity. The President had left the building.

It was now mid-August. Save for the declaration of victory, there was no real plan of action. Quite the contrary, the medical experts had been essentially side-lined, muzzled, and exiled, now fighting, apparently, internal turf wars with Atlas. Whatever, battle discipline there had been was totally gone.

Or, more accurately, Trump had thrown his hands up in the air, seemingly banking on happenstance and luck. “It is,” he had said in a July interview “what it is.” He openly abandoned discipline. His worked at cross purposes to the safety protocols like social distancing and masks. He welcomed his coterie to question the dangerousness of the virus, its size, its potentiality, the numbers, the science and engaged in rabbit trails, like herd immunity (or “herd mentality” to use the President’s malaprop).  

How Did We Get Here?

Nine months later, we are dead in the water and drifting. How did we get to the point that not only do we not have a plan, we lack confidence in the process or the players? Whether the President was ill-qualified for the task is clearly a valid question. Regardless, the main reason we are here is his “quirky” personality, his overblown self-image, chaos complicity, and his fatalistic positivism. 

As a result of this outlook (some call it narcissism), nothing he has done is wrong or worthy of explanation. It is always the fault of others. While it’s easy to recognize the overt victims of his approach, in the long run it was the President’s credibility that suffered and, like the virus, what infected the entire process. Rather than fighting the pandemic, we are now at war with each other.  

Early on, Trump sought the alibi of inactions and mistakes of others. He chastised the WHO, eventually cutting financial ties, publically calling their work and motives into question and refusing to participate in the launch of a global effort on vaccines and drugs. China? Obviously. Obama? Well, hell yeah! “The system is starting to work out very well but we had to break a system like breaking an egg because the system we had was obsolete and didn’t work and that was the system we inherited.” 

Trump even pondered whether health care workers were responsible for the shortage of protective masks. By late April, he was floating the idea of withholding financial assistance to “poorly run” (Democratic) states. As the fiasco worsened and the issue of the proper course forward became more and more politicized, he would continue to double-down on this notion of “us” and “them”. Statistics became blue or red.

His main targets, however, were the health care professionals who were used, like his Miss Universe models, as not much more than hand candy or expedient foils. Not that they were all that compliant. Overall, they remained true to their disciplines even if, at times they appeared to cave to the pressure.  Dr. Birx, a woman of impeccable forensic credentials, would praise the President’s grasp of scientific literature and data details, words I'm sure she will some day regret. "He’s been so attentive to the scientific literature and the details and the data....I think his ability to analyze and integrate data that comes out of his long history in business has really been a real benefit during these discussions about medical issues.”

Dr Fauci, Redfield, Hahn, and the United States Surgeon General were forced to dance with the drunk in the room, right there on television, in front of God and everyone. At times their shame was palpable and at other times their pluck was a beauty to behold.

The CDC, one of the world’s most admired and professional organizations also walked the line looking like a Sunday morning stroll of shame: Granting authorizations for medicines and treatments at the President’s insistence; changing guidelines in at least the appearance of political interference. Solid evidence that would subsequently be revealed. 

With Atlas’ appointment even the meager subtleties fell by the wayside. The administration played fast and loose with an agency they now perceived as in their way. Those numbers, a Trump obsession, were tweaked. Efforts were made to retroactively change morbidity and mortality reports. Command and control of the CDC was moved to the White House so that even well-meaning mistakes or changes in situation became suspect to Trump’s Machiavellianism.

Not content with that, Trump minions would continue the practice of attacking  these doctors but amped it up quite a bit, accusing the "health care deep state" of engaging in “sedition” and being part of “left-wing hit squads” determined to undermine Trump and “preparing for armed insurrection after the election.” The government declared war on itself. 

[TO BE CONTINUED]


Wednesday, September 23, 2020

Postmortem Part V: Breakdown of Trust

  [ED NOTE: Some months ago, bewildered by the amount of oncoming data and information - and its misapplications - I started putting together a coronavirus database. That can be found here. Much of the information in this piece is taken from there.]

POSTMORTEM: Too Early?

Part V: Breakdown of Trust

by Domingo Soto

As the conflicting interests between the economy versus public safety played out, now daily, the President was less an arbiter and more a provocateur, his thumb on the scale favoring the economy as the cure-all panacea. An intentional saboteur would not have been more pleased with the damage done - in the end, to the process - but as it played out, also to the players, the national and global institutions, and the country’s ability to short circuit the pandemic.

Health Professionals

It’s the ones on the front lines that take the first hits, here it was the healthcare experts. Not one for subtleties, the President, even though the Vice President was at its head, subsumed the task force’s managerial role via daily television briefings. There were immediate stress lines and, eventually, a fracture with a bully not merely at odds with the medical knowledge, but in battle with its purveyors.

There is perhaps no better metaphor for what might seem like a David versus Goliath struggle than Dr. Fauci, not just in physical size, but in temperament, ego, style, intellect, and professionalism. He would come to gain the nation’s confidence as the point man for the task force, often adding “nuance” to the President’s analysis. 

What was obvious in the back-and-forth of what would become a daily made-for-television political soap opera was Trump’s insistence that it was his way or the highway, science be damned. Fauci was but just one of the pieces in his reality show. Others on the task force attempted to walk the tightrope of fulfilling their ethical duties, avoiding Trump’s political machinations, and trying to effectively face what would become the President’s political backfires. 

In mid-April, Trump would rebuff Fauci’s concern that the country was lagging in its coronavirus testing, saying publicly, “I don’t agree with him.” The day before, the President contradicted CDC Director Robert Redfield’s comments of a second wave, saying “It may not come back at all” and later claiming that Redfield had been "totally misquoted". To his comment that "You may not even have corona coming back," Fauci would respond that "We will have coronavirus in the fall. I am convinced of that because of the degree of... transmissibility that it has, the global nature." The honeymoon was just about over.

At the end of April, it was announced, contrary to what the medical experts suggested, that the federal guidelines on social distancing would not be renewed. Concerned, Congress sought Fauci’s testimony. On May Day the White House blocked him from testifying before a House panel. Much more happened that day: a watchdog who identified critical medical shortages was replaced; NIH abruptly cut coronavirus research funding for a Chinese bat study; and the Administration rejected CDC reopening guidelines as "overly prescriptive" and later that week, task force members were barred from accepting invitations to appear before congressional panels without White House Chief of Staff Mark Meadows’.

The daily televised briefings ended on May 4. The following day the White House announced that it was considering winding down the task force, the Vice President saying that it was "a reflection of the tremendous progress we've made as a country. We are bringing our country back." Facing clap back, Trump soon reversed himself, saying the task force would continue “indefinitely”. The task force lay essentially dormant until mid-August when Dr. Scott Atlas was named the new head of the task force. Putsch accomplished.

[TO BE CONTINUED]


Tuesday, September 22, 2020

Postmortem Part IV: Action Plan

  [ED NOTE: Some months ago, bewildered by the amount of oncoming data and information - and its misapplications - I started putting together a coronavirus database. That can be found here. Much of the information in this piece is taken from there.]

                                        POSTMORTEM: Too Early?

                                                            Part IV

by Domingo Soto

Action Plan

By early March it appeared that the Administration team was in full attack mode. HHS announced its intention to purchase 500 million N95 masks and plans to distribute them over the next 18 months. CDC would get $35 million to help state and local communities. The FDA granted the CDC’s request for emergency use authorization (EUA) so as to allow health care personnel to use certain unregulated (but NIOSH-approved) respirators. 

The FDA granted Roche AG an emergency approval for automated coronavirus testing kits and issued an emergency approval to Thermo Fisher for a coronavirus test within 24 hours of receiving the request. HHS announced funding for the development of two new rapid diagnostic tests, which would be able to detect coronavirus in approximately 1 hour.

Agriculture announced a partnership between USDA, Baylor University, McLane Global, and Pepsi Co. to provide one million meals per week to rural children in response to widespread school closures. Treasury contributed ten billion dollars through the economic stabilization fund to the Federal Reserve’s commercial paper funding facility. DOD announced it would make available to HHS up to five million respirator masks and 2,000 ventilators. The administration sought out public-private partnerships to develop drive-through testing collection sites.

By mid-March, the President had declared a national emergency and in the process accessed $42 billion in existing funds. He issued safety orders and signaled his intention to invoke the Defense Production Act, which he did two weeks later.

"My administration is recommending that all Americans, including the young and healthy, work to engage in schooling from home when possible. Avoid gathering in groups of more than 10 people. Avoid discretionary travel. And avoid eating and drinking at bars, restaurants and public food courts. If everyone makes this change or these critical changes and sacrifices now, we will rally together as one nation and we will defeat the virus. And we're going to have a big celebration all together. With several weeks of focused action, we can turn the corner and turn it quickly."

Plan, What Plan?

That statement, now six months later, is emblematic of how we went from an all-out (if somewhat belatedly) assault to capitulation and a hollow declaration of victory. It bears parsing out. It shows that while he was on the right track and knew what he had to do, his assessment of the strength of the problem and the duration of a campaign was, at best, naive and in the end, insufficient. 

Nor, did he have the resolve, or perhaps the ability, to follow a definitive and concrete action plan, to stay the course. Almost contemporaneously with his statement and the actions that signaled that he was leading the charge, the President was mixing his message. He appeared to balk at the chore before him. He immediately shifted responsibility to the state governors. On March 19, he suggested that obtaining medical equipment should be up to individual governors because “we’re not a shipping clerk.”

This would soon devolve into finger pointing between the governors and the President, mostly around the availability of testing and PPE and the question about who bore the responsibility for obtaining them. By mid-April, a full-on range war had developed, involving even governors from his own party. Trump called them complainers. The critiques, first enunciated in pre-pandemic assessments concerning the confusion about intergovernmental and agency roles would soon prove much too true.

This rift, as well as the one that would develop between the political and the medical operatives, would exacerbate what was already an overboiling pot. In early April, an exasperated Dr. Fauci cautioned states to stop allowing any exemptions to social-distancing guidelines. Forcing people to stay home is the “only thing we have”, he said. Later that month, though, the White House would issue guidelines on reopening and the President would declare that state governors should make their own decisions about when to restart.

The Role Model

While the medical and organizational mechanics of fighting the pandemic were crucial, the problem of optics, of confidence in the process and the players was constantly on life support, prey to what appeared to be an ad hoc, often contradictory and always quirky approach which no one could rationally call a game plan or, for that matter, a rational manner of governance. In the end, it was not just a matter of being rudderless. There was an untrained and irresponsible pilot at the wheel.

Trump continued to criticize governors for ‘unreasonable’ lock downs and engaged in what are, by now all-too-familiar fantastical declarations minimizing the potential of this disease. By the end of April, even though he was now having to admit the earlier death projections were wrong and might reach as high as 60,000 to 70,000, he was claiming that "the worst days" were over. Now rejecting his earlier warnings, he suggested that perhaps blanket testing was not necessary. "You'll see some astonishing numbers -- I don't know that all of that's even necessary." For all of his rosy cheerleading, Trump, a multi-front confrontationalist, found time to not only paint expansive day-glo pictures of optimism, he would scattershot blame and did so almost immediately.

At a time unity was needed, he plowed division, abetted by media friends like Ingraham and Hannity who claimed the virus was overblown and a Democratic Party gimmick meant to undermine his election.  “LIBERATE MINNESOTA!” “LIBERATE MICHIGAN!”“LIBERATE VIRGINIA, and save your great 2nd Amendment. It is under siege!”, the roiler President would tweet in mid-April. And, while attacks on the opposing party in the middle of an election campaign might pass as appropriate, he did so in such an equal opportunity and far ranging manner, that he damaged more than just confidence in the process.

[TO BE CONTINUED]


Saturday, September 19, 2020

Time to double down

This scenario, the passing of RGB and the wreckage it leaves behind, might be a surprise to some but it was predicted by many of us during the last presidential campaign as the principal worry and the main reason to get your ass out there and vote.  The loss of the Supreme Court and the federal judiciary has always been in play and we keep under-estimating the will of these jokers to play by any means necessary. 

Right now we're fighting a rearguard action on this. Let's hope that Trump's list that includes maniacs like Tom Cotton, Ted Cruz, and Jeanine Pirro is just red meat doggerel. Hopefully, Trump will be compelled to appoint a woman and that will probably be Amy Barrett who is at least legally well qualified. But-for her religious baggage there really wouldn't be any objection to her in normal times. 

Putting her on the Supreme Court, which, realistically speaking is our best shot at maintaining any level of overall political sanity - and kind of maintains the integrity of our highest court - packs the Supreme Court with seven Catholic jurists, at least four of whom are extreme religious zealots.

Everyone needs to take their colander and use it to put out their hair; it's on fire. This is a shock. It's a terrible loss. Mitch McConnell is despicable. The whole thing is hypocritical. 

Center. 

Put this angst to some constructive use. Send money, call politicians, sign petitions, whatever makes you feel good. But I don't have a lot of faith in any of that. (I do send money.) I don't want to go all Mother Jones but, don't mourn organize. Finish paying your respects to this fine lady and then get out there and show you really mean it. Call your local party office and volunteer to do some work. That will be the best tribute.


Tuesday, September 15, 2020

Postmortem Part III: Testing

 [ED NOTE: Some months ago, bewildered by the amount of oncoming data and information - and its misapplications - I started putting together a coronavirus database. That can be found here. Much of the information in this piece is taken from there.]

POSTMORTEM: Too Early?

Part III

by Domingo Soto

Testing

Testing is the basic first baby step of diagnosis and treatment. As the head of the WHO warned "You cannot fight a fire blindfolded. And we cannot stop this pandemic if we don't know who is infected...We have a simple message for all countries: test, test, test. Test every suspected case." In the US testing got off to a bad start and continues to limp along.

The manufacturing errors caused delay, and, the CDC initially restricted tests to those with respiratory symptoms, those who had traveled to China, or persons who had close contact with an infected person. By Valentine’s Day, the CDC and state labs had only tested just under 2,200 samples. South Korea - a much smaller country that had also marked its first case as beginning on January 21 - was testing around 20,000 people per day by early March and would eventually test nearly 500,000 people. 

The CDC announced that it would begin screening in what it perceived to by the five high-risk cities of New York, Chicago, Los Angeles, San Francisco and Seattle. An agency official said it could provide “an early warning signal to trigger a change in our response strategy.”  The plan failed, however, as most of the cities lacked the resources to carry it out.

This failure is seen by the health professionals as a critical reason for the disease’s spread. “Had we had done more testing from the very beginning and caught cases earlier, we would be in a far different place,” Dr. Jennifer Nuzzo, of Johns Hopkins, would tell the New York Times. The administration, she said, had an “incredibly limited” view of the disease’s potentiality.

The absence of robust screening until it was “far too late” revealed failures across the government, said Dr. Thomas Frieden, the former CDC director. Jennifer Nuzzo, an epidemiologist at Johns Hopkins, said the Trump administration had “incredibly limited” views of the pathogen’s potential impact. Dr. Margaret Hamburg, the former commissioner of the FDA, said the lapse enabled “exponential growth of cases.”

But no one was at the helm. Or, rather, not only was the person who was theoretically in charge not paying any real attention, he was betting against the house. Despite the repeated warnings and health alerts from the WHO, the warnings from our intelligence agencies and daily briefings, including the January 28 briefing and the President’s own February 7 taped interview with Woodward regarding the perniciousness of the disease, the administration began playing a shell game with the public. Testing, or rather, the data it would reveal, somehow perceived as a negative, was the key component of this guile.

At a campaign rally during the second week of February, Trump suggested that the virus would be gone by April, a claim he would frequently repeat. On Valentine’s Day, he would boast that "We have a very small number of people in the country, right now, with it. It’s like around 12. Many of them are getting better. Some are fully recovered already. So we’re in very good shape."

His cavalier attitude continued throughout the month. “We pretty much shut it down coming in from China,” he would say. By the end of the month, with the stock market bringing on the bears and his administration asking for emergency aid, he would tweet that the virus "is very much under control" and the stock market "starting to look very good to me!". 

By February 25, Mardi Gras Day, a holiday that will become a significant spreader event, testing was still foundering and the task force was, like the blind man in the cave, trying to figure out what animal they had before them. 

But the band played on. Azar would hold a press conference, maintaining that “Thanks to the president and this team’s aggressive containment efforts, the novel coronavirus is contained.” Abetting him was director of the US National Economic Council, Larry Kudlow, who would hit the news shows to assure the country that the Coronavirus would not be an economic tragedy. “I won't say airtight but pretty close to airtight."

Contemporaneously, the WHO would announce its findings; new data from China confirmed that the coronavirus had a high fatality rate and the CDC our first community transmission of the virus. Trump, however, would boast that aggressive public health containment measures and travel entry restrictions had successfully limited the spread. He touted the efforts of his team. “CDC and my Administration are doing a GREAT job of handling Coronavirus....I think that's a problem that’s going to go away… They have studied it. They know very much. In fact, we’re very close to a vaccine....The 15 (cases in the US) within a couple of days is going to be down to close to zero....We're going very substantially down, not up.” Claiming that the country was "really prepared", he places Pence in charge of the White House task force. Despite all of these details from this momentous day (and what he has admitted to Woodward), the President would continue to claim that “This is a flu. This is like a flu....It’s going to disappear. One day — it’s like a miracle — it will disappear.”

The health professionals, however, were not quite so sanguine. Dr. Nancy Messonnier, Director of the CDC’s National Center for Immunization and Respiratory Diseases, followed up on Trump’s February 25 remarks. “It’s not so much of a question of if this will happen anymore, but rather more of a question of exactly when this will happen.” She said that hospitals and schools should begin preparing for an outbreak, and that she had even spoken with her own family about “significant disruption of our lives.”

During this time, a cruise ship, some of whose passengers had become infected with the virus, were shunted around the globe. Like the passengers of Leon Uris’ novel, they were seen as a pariah. Denied entry elsewhere, the ship returned home and waited in a bureaucratic limbo off the California coast. Although he would eventually relent, the President’s considerations were not about the 2,000 trapped souls. He preferred, he said, that the passengers stay on board the ship. “I like the numbers being where they are. I don’t need to have the numbers double because of one ship." 

By early March, the system finally started paying attention to testing, if with somewhat mixed results. FDA Commissioner Hahn would claim that the nation would have the capacity to test a million people by the end of the week, an assertion immediately challenged by the labs. The CDC lifted the restrictions on coronavirus testing, allowing coronavirus testing, “subject to doctor’s orders.” A short time later, the FDA authorized state-developed tests.

Trump claims that “Anybody right now, and yesterday, anybody that needs a test gets a test. They’re there. And the tests are beautiful....the tests are all perfect like the letter was perfect. The transcription was perfect. Right? This was not as perfect as that but pretty good.” He would be forced to walk that claim back.

Even with the the government’s fourth quarter rally, the crucial issue of testing continued to limp along, impeded by the President’s hostility to it. As late as April 9, his position on a widespread COVID-19 testing program to assess whether workers can safely return to their workplaces was that it was "never going to happen" even though the following day the US would mark its deadliest day and become the first country to hit 2,000 deaths in 24 hours.

Although Dr. Fauci maintains that the US should increase its testing even more, by early May, the country had reached some modicum of success with the issue of testing. He estimated that the US is conducting approximately 1.5 to 2 million Covid-19 tests per week, but noted that "testing is an important part, but it's not the only part."

As reported by the New York Post, the CDC’s Anne Schuchat’s mea culpa places the blame on a lack of testing and a delay in travel alerts for contributing to the spread of the disease. The government, she notes, was slow to react to the looming coronavirus pandemic as it spread from Europe, which led to the rocketing rates of infection and death here.

“We clearly didn’t recognize the full importations that were happening....The extensive travel from Europe, once Europe was having outbreaks, really accelerated our importations and the rapid spread...I think the timing of our travel alerts should have been earlier.”

TO BE CONTINUED


Monday, September 14, 2020

Postmortem Part II: Isolation and Quarantine

 [ED NOTE: Some months ago, bewildered by the amount of oncoming data and information - and its misapplications - I started putting together a coronavirus database. That can be found here. Much of the information in this piece is taken from there.]

POSTMORTEM: Too Early?

Part II

by Domingo Soto

Isolation and Quarantine

Keeping the disease far from our shores, as Obama had done with the Ebola virus, was a botched attempt, again, partially the result of Chinese politics and of the WHO’s global considerations, but due mainly to the machinations and conflicts within the administration; actions, failures to timely act and missteps were fed by a presidential indolence that amounts to political negligence.

To be fair, the question initially was how to lock down a country as large as ours, not to mention, China. These were not relatively isolated African countries but two teeming nations with mobile and transient populations. Again, fiscal considerations came to dominate. The President, according to media reports, was resistant to reading reports, even the daily briefings on issues more obviously on the plate. A pandemic was even further removed. He refused to center on the gravity of the virus situation even after the early warning signals of mid January. That left no one with ultimate authority pushing the pandemic panic button or, even, manning the helm. 

Given that, the NSC’s proposal of restricting flights from China, met resistance from other cabinet-level agencies who were concerned about the effect of a lock down on the stock market.  China’s trade importance was certainly lost on no one, least of all the President. “Do you trust that we're going to know everything we need to know from China?”, he was asked. “I do. I do. I have a great relationship with President Xi. We just signed probably the biggest deal ever made. It certainly has the potential to be the biggest deal ever made.” 

Again, some measure of blame must be ascribed to the WHO’s macropolitical views. By late January they were still advising against travel restrictions and maintaining that there was no person-to-person danger. The iceberg looming, the band played on. The debate over the scope of the lock-down raged much longer than necessary. The country was in no way, as Trump would tell his media chum Hannity, “shut down”. 

The compromise had become medical screenings for only Wuhan travelers and then at just three international airports. This was expanded to twenty US airports by the end of January. Travel restrictions applied only to foreign nationals traveling to the United States after visiting the China, with specific exemptions for travelers coming from the Special Administrative Regions of Hong Kong and Macao. US citizens and permanent residents were also exempt from the restrictions, and incoming flights did not stop landing at US airports until several weeks later.

Even these halfway measures were met with criticisms from the political opposition. Nancy Pelosi and New York Mayor Bill de Blasio would see them as more of the President’s anti-immigrant inclinations; the pyromaniac has matches, they would warn. On March 11 Trump announced a Europe travel ban targeting “foreign nationals”. The following day, travel from countries in the European Union was prohibited. One week later, a temporary closure of the US-Canada border to non-essential traffic was announced.

Meanwhile in Wuhan, a city of 11 million was completely locked down by the first week of January. Starting within hours of the announcement, transport into and out of the city was closed, with no exceptions even for personal and medical emergencies.

Trump’s happy talk is by now well known. Some measure of empathy has to be given to the reality that these public servants, in dealing with a novel catastrophic monster were dancing on the two-edged sword of also maintaining public confidence in their efforts. HHS’ Azar would assure the public early on that the “potentially serious” coronavirus "was one for which we have a playbook.” Yet, this public face was belied by reports that his advisers, amongst them Azar, were having difficulties getting Trump to take the matter seriously.

Trump acknowledges receiving intelligence briefings on the coronavirus by late January but claims that the warnings were minimized. "On January 23, I was told that there could be a virus coming in, but it was of no real import. In other words, it wasn't, 'Oh, we've got to do something, we've got to do something.' It was a brief conversation...said it very matter-of-factly, and it was not a big deal." That it was of no concern is belied by the fact that at the State Department, our China diplomats and their families were being brought home on chartered planes.

That was recently belied by the assertions found in Rage, Bob Woodward’s latest book. As he reports it, On January 28, he received a briefing from National Security Adviser Robert O’Brien  who told him that the virus would be “the biggest national security threat you face in your presidency. This is going to be the roughest thing you face.” Trump's head "popped up," Woodward writes. As late as May 3, Trump would repeat his assertion that intelligence officials did not raise the coronavirus with him until late January and that they did it in a casual manner.

Also in mid-January, media reports claim that “White House aides huddled with then-acting chief of staff Mick Mulvaney in his office, trying to get senior officials to pay more attention to the virus. Joe Grogan, the head of the White House Domestic Policy Council, argued that the administration needed to take the virus seriously or it could cost the president his reelection, and that dealing with the virus was likely to dominate life in the United States for many months.” 

In a subsequent interview with Woodward, Trump acknowledges what must have been, at least by February 7, the realization of the magnitude of the problem. “This is deadly stuff....You just breathe the air and that’s how it’s passed,” Trump said in a Feb. 7 call. “And so that’s a very tricky one. That’s a very delicate one. It’s also more deadly than even your strenuous flus.” And, while it finally moved the President to take the action of shutting down international travel access, January and part of February slipped by without any meaningful treatment plan. Indeed, what did develop was a roll-your-own process that served only to undermine its efficacy.

A Treatment A-Team

By January’s end, the White House had formed the Coronavirus Response Task Force. To deal effectively with what was perceived to be an oncoming catastrophic scourge - especially if one expected compliance from a host body of an usually pampered citizenry - there would have to be a confidence in the course of action. To get there the universal guidepost would have to be: let the medical professionals handle the crisis and do nothing to get in the way.

There is no quarrel with the makeup of this team. The group, consisting of approximately 25 agency and administration bureaucrats, included some of the country’s most esteemed health professionals: HHS’ Azar; Anthony Fauci, the Director of the National Institute of Allergy and Infectious Diseases; AIDS expert Deborah Birx who would serve as the White House Coronavirus Response Coordinator; Jerome Adams, the country’s Surgeon General; Seema Verma, Administrator of the Centers for Medicare and Medicaid Services; Ben Carson, Secretary of HUD; Stephen Hahn, Commissioner of Food and Drugs; and Francis Collins, Director of the National Institutes of Health.

What had been just stress lines in the process started looking more like a fracture and it was immediately evident in the months that followed as a tango played out, the political machine bending the health professionals into near contortions to their lead. 

Almost immediately the meddling started. Azar, who had declared a Public Health Emergency at the end of January and had, along with the task force been preparing for what he feared was a looming health crisis, had his role downsized. He was replaced by the Vice President, supposedly because the President and his advisers thought Azar too “alarmist”. Pence was not only a politician but had some troubling healthcare and religious baggage. It would be the first of many conflicts between the professionals and the politicians, tensions often played out in national press conferences.

Others thought it was the administration’s mind set that was fanciful. The President’s men declined an offer of early congressional funding assistance. The officials, including Azar, said they “didn’t need emergency funding, that they would be able to handle it within existing appropriations.” Senator Chris Murphy would tweet: “Just left the Administration briefing on Coronavirus. Bottom line: they aren't taking this seriously enough. Notably, no request for ANY emergency funding, which is a big mistake. Local health systems need supplies, training, screening staff etc. And they need it now.”

January closed with the country having now reported its first cases. We had a tenuous lock down travel plan and we had an able and prestigious team of medical professionals. But that was it. There was no real plan, just the administration intuitively caroming side to side along ad hoc courses of action that they often rescinded, retracted or contradicted. Other afflicted countries met the disease with aggressive and forceful courses of actions that included closures, quarantines, testing, and contract tracing. But here what we had for the better part of February - and by now we had our first fatalities - was a nightmare of dithering missteps. Trust and transparency were the crucial first victims and would infect every action along the way.

[TO BE CONTINUED]


Sunday, September 13, 2020

Postmortem Part I: Intro

 [ED NOTE: Some months ago, bewildered by the amount of oncoming data and information - and its misapplications - I started putting together a coronavirus database. That can be found here. Much of the information in this piece is taken from there.]

Postmortem: Too Early?

by Domingo Soto

PART I

Like the cloud of the upcoming November election - the assessment of this administration’s response to the coronavirus pandemic looms ever large. This scourge has not just maimed the body politic, killing thousands in the process, it may have terminally wounded Donald Trump’s election hopes, its prognosis now grim.

A diagnosis of what amounts to a self-inflicted wound is not just about incompetence borne of inexperience, but a malaise exacerbated by an etiology of inaction, conceit, negligence, petulance, impetuosity gilded with ignorance, penchants for infantile and happy talk, dogged insistence and actions by force of will, an indolence and unwillingness to study or work at the tasks before him, and an imperviousness to harsh and obvious realities.

Prior History

Novice or not, there is little substance to the idea that “no one saw this coming.” In 2004, George W. Bush, while leafing through an advance copy of a book, had an epiphany which soon turned into an obsession; Something like the 1918 pandemic could reoccur, he thought. 

It was probably no great leap for the man who had just shepherded the country through 9/11 to imagine yet another doomsday scenario. “It may not happen on our watch, but the nation needs the plan,” he told an aide and set about prioritizing health preparedness at a time when the nation’s attention was focused on terrorism. “If we wait for a pandemic to appear, it will be too late to prepare.”

And it was no half measure. His was a full-court press. By the latter part of 2005, he had instigated a comprehensive and ambitious plan involving the top echelons of government and  health officials, the World Health Organization and the United Nations. The President’s plan was essentially war preparedness, calling for international working relationships, the stockpiling of medicines, development of new vaccines and antiviral drugs, and the establishment and placement of federal and state emergency plans. 

He signed the Pandemic and All-Hazards Preparedness Act (PAHPA) in 2006, beefing up HHS’ preparedness and response activities and establishing a new Assistant Secretary for Preparedness and Response (ASPR). The act provided new authorities for a number of programs, including the advanced development and acquisition of medical countermeasures and the establishment of a quadrennial National Health Security Strategy. 

They also established BARDA (Biomedical Advanced Research and Development Authority), tasking it with securing the nation from chemical, biological, radiological, and nuclear (CBRN) threats, as well as from pandemic influenza (PI) and emerging infectious diseases (EID). That agency supported the transition of medical countermeasures such as vaccines, drugs, and diagnostics from research through advanced development towards consideration for approval by the FDA and inclusion into the Strategic National Stockpile. 

Taking responsibility for preparedness was now seriously on the table. Myriad reports and assessments from just about every American sector were generated. Global Trends 2025 the fourth installment in the National Intelligence Council-led effort to identify key drivers and developments likely to shape world events was published in 2008. “The emergence of a novel, highly transmissible, and virulent human respiratory illness for which there are no adequate countermeasures could initiate a global pandemic,” the authors warned. The threat, they added, would likely emerge “in an area marked by high population density and close association between humans and animals, such as many areas of China and Southeast Asia.”

The following year, Dennis Blair, then the Director of National Intelligence (DNI), presented his Annual Threat Assessment to the Senate Select Committee on Intelligence. “The most pressing transnational health challenge for the United States is still the potential for emergence of a severe pandemic, with the primary candidate being a highly lethal influenza virus,” he told them. 

Blair reiterated that warning the following year. “Lack of consistent surveillance and diagnostic capability for diseases in animals undermines the United States’ ability to identify, contain, and warn about local outbreaks before they spread.” Two years later and only a few months into the Obama administration’s first term, the Swine Flu (H1N1) pandemic hit, forcing the young President to declare a national emergency later part that year. 

The House of Representatives, also, was sounding the alarm. It’s “Subcommittee on Emergency Preparedness, Response, And Communications, Committee on Homeland Security” issued Taking Measure of Countermeasures, Part 3: Protecting the Protectors, a report that set out the parameters then being taken in countermeasure development, including the development of next-generation portable ventilators.

Then-DNI James Clapper's Worldwide Threat Assessment warned the following year that “an easily transmissible, novel respiratory pathogen that kills or incapacitates more than one percent of its victims is among the most disruptive events possible. Such an outbreak would result in a global pandemic....This is not a hypothetical threat,” he warned.

Within a few mere months into his new administration, Obama had been forced to grapple with yet another head on the hydra of major problems. Added to the meltdown of the financial economy and the weight of a costly and ineffective healthcare system, was the issue of an emerging pandemic, the H1N1 (Swine Flu) which took over 1,000 lives. Obama, now totally on board, proceeded to shore up the safety system. 

His efforts were somewhat stymied by some political back and forth with the sequestration cost cutters. But by the end of 2014, the country now faced a second disease outbreak, the Ebola virus. The dangers and the need for mechanisms with which to deal with airborne diseases was obvious and Obama was firmly on board. “We have to put in place an infrastructure,” he said “that allows us to see it quickly, isolate it quickly, respond to it quickly… "If and when a new strain of flu, like the Spanish flu, crops up five years from now or a decade from now, we've made the investment and we're further along to be able to catch it," he said. "It is a smart investment for us to make. It's not just insurance; it is knowing that down the road we're going to continue to have problems like this - particularly in a globalized world where you move from one side of the world to the other in a day."

Obama’s approach was proactive. He brought the Ebola fight to Africa, its source, and in the process limited its reach and impact here. Prioritizing the effort as one of national security, personnel - international and American, civilians and military - were deployed to West Africa to fight the scourge at its source. Locally, they encouraged and developed prophylactic countermeasures such as screening travelers, diagnoses, isolation, testing and treatment. As a result, only 11 people were treated for Ebola in the U.S. during the 2014-2016 epidemic.

Prepping for Change

Three days prior to the Trump inauguration, Dr. Anthony Fauci, a noted epidemiologist we would all soon come to know, spoke at a forum on pandemic preparedness at Georgetown University and warned that the new administration would not only be challenged by ongoing global health threats such as influenza and HIV, but also by a surprise disease outbreak.

That same week, the outgoing Obama administration held a briefing regarding the real potential for a pandemic and the need to coordinate a simultaneous international and domestic response. The National Security Council (NSC) prepared a 69-page, color-coded document, the Playbook for Early Response to High-Consequence Emerging Infectious Disease Threats and Biological Incidents

And it was with good cause that they warned the new guys. By the end of his term, the now-not-so-young President knew the full implications of health crises. Obama’s mettle had been tested, forged, along with everything else, in the crucible of two pandemics. It had been a lesson learned the hard way. The H1N1 (Swine Flu) epidemic, like the Asian Flu epidemic of 1957, had cost thousands of lives and impacted the economy but the lessons learned on his watch would guide his successful efforts at stemming the Ebola pandemic years later. Preparedness and action were the keys.

Just some few months into the new Trump regime, experts in health and national security were raising concerns that crucial public health positions across the government were not being filled. The nation was being left “ill-prepared to face one of its greatest potential threats: a pandemic outbreak of a deadly infectious disease,” a report said.

Perhaps sensing where the Administration’s true priorities lay, Daniel Coats, the new DNI, soon highlighted the World Bank’s assessment that a pandemic would cost the world around 5% of GDP. “The United States and the world will remain vulnerable to the next flu pandemic or large-scale outbreak of a contagious disease that could lead to massive rates of death and disability, severely affect the world economy, strain international resources, and increase calls on the United States for support.”

The Trump administration’s cost-cutting agenda, a large part of its political mandate, was not lost on the Centers for Disease Control and Prevention (CDC). It started downsizing its epidemic prevention activities in 39 out of 49 countries. The agency would focus on 10 priority countries, including China. Congress would eventually step, avoiding the CDC cuts. But the downsize momentum was having its effect. The government reduced $15 billion in national health spending, cut the global disease-fighting operational budgets, and quashed the government’s $30 million Complex Crises Fund.

Heads, also, would roll. Homeland Security adviser, Tom Bossert, who had called for a comprehensive biodefense strategy against pandemics and biological attacks, was fired. Rear Adm. R. Timothy Ziemer, the Trump administration's senior director for global health security and biodefense at the National Security Council left his post abruptly and the global health security team he oversaw was disbanded as part of a reorganization under national security adviser John Bolton. A few months later, medical epidemiologist Linda Quick’s Beijing position as trainer of Chinese field epidemiologists was eliminated.

To the winners go the spoils. Trump won the election, in no small part by championing cost-cutting and the deregulation of government. Up to this point, the backdrop is merely our bad luck and the misfortune of a failed myopic ideology that can only be criticized using 20/20 hindsight. 

The perfect storm included errors by others, initially, the CDC. The Chinese had almost immediately isolated and completed the genome sequencing. The development of a test to detect the presence of the virus was the crucial next step. A German test had been immediately available and shipped to 120 countries. Normal quality control standards, however, called for the US to develop and deploy it’s own, which it rapidly did. 

HHS Secretary Alex Azar praised the CDC for developing a coronavirus test in one week. "This was really a historic accomplishment."  “That’s our prime mission,” Dr. Redfield of the CDC said, “to get eyes on this thing.” Unfortunately, manufacturing errors delayed the viability of the tests for more than a month.

Warnings Unheeded

Intentional or not, Trump ignored the foundational work of his predecessors and in many ways worked at cross purposes with the safeguards, standards, systems, and protocols that had been put in place by past administrations. With Obama as his wolf bane, that’s not surprising. But the warnings weren’t limited to those of prior administrations. There were ruminations from those within his own administration, the medical community, of course, but also the intelligence community and, even, the military. The warnings were constant and continuous and consisted of reports from every sector of the government and, even, from his closest advisors.

The White House itself had issued National Biodefense Strategy and Presidential Memorandum on the Support for National Biodefense, warning that “the evolving biological threat landscape requires a comprehensive approach.” The Worldwide Threat Assessment issued in early 2019 warned - For the third year in a row - that the U.S. will “remain vulnerable to the next flu pandemic or large-scale outbreak of a contagious disease that could lead to massive rates of death and disability, severely affect the world economy, strain international resources, and increase calls on the United States for support.”

“We assess that the United States and the world will remain vulnerable to the next flu pandemic or large-scale outbreak of a contagious disease that could lead to massive rates of death and disability, severely affect the world economy, strain international resources, and increase calls on the United States for support,”

That was followed a few months later by a Biodefense Summit. Attended by Azar and Tim Morrison, then a Special Assistant to the President and Senior Director for Weapons of Mass Destruction and Biodefense on the National Security Council. The meeting’s agenda was to “engage the biodefense stakeholder community to inform national biodefense enterprise efforts to counter biological threats, reduce risk, prevent, prepare for, respond to, and recover from biological incidents.”

"Of course, the thing that people ask: 'What keeps you most up at night in the biodefense world?' Pandemic flu, of course. I think everyone in this room probably shares that concern," Azar said, before listing efforts to mitigate the impact of flu outbreaks.

The year was replete with more of these conferences and internal reports, all warning of the need to be prepared. FEMA, for example issued  a National Threat and Hazard Identification and Risk Assessment, identifying the “greatest threats and hazards” to the United States and warning concerning the social, economic and personal devastation that a pandemic could cause, foreseeing current impacts, including overwhelmed hospitals and disruptions in essential services.

Some short time later, HHS concluded its last phase of an  8-month-long simulated pandemic exercise. The exercise, code named “Crimson Contagion,” had eerie and prophetic similarities to the current real-life coronavirus pandemic. Officials from more than a dozen federal agencies, several states and hospitals were engaged in a scenario in which a pandemic flu had begun in China, was being spread by international tourists and was deemed a pandemic 47 days after the first outbreak.

The simulation’s report concluded that the federal government lacked sufficient funding to respond to a severe pandemic; that agencies lacked clarity on the roles of different federal agencies, and what information was important to pass along to its federal partners; that there was confusion in the chain of command; that production capacity to meet the demands for protective equipment and medical devices such as masks and ventilators imposed by a pandemic was insufficient; and that states were unable to efficiently request resources due to the lack of a standardized request process.

Even the White House Council of Economic Advisers joined the harpy chorus, estimating that 500,000 deaths and economic devastation could flow from an influenza-like pandemic.

In November, just a few months before the world would be turned upside down, a bipartisan group of lawmakers and experts were worried enough to formally recommend that the health security leadership on the NSC be restored. It is perhaps no accident that the first case of the coronavirus had been reported that week. Indeed, our military was apprised of the situation, issuing a confidential report warning of a contagion sweeping through Wuhan, China and assessing it as a possibly “cataclysmic” event. According to media accounts, that report was briefed to the National Security Council, the Pentagon and the White House, but the Defense Secretary, Mark Esper, denies any awareness of it.

It’s even harder to buy the idea that the crisis was a complete surprise. There are media reports of repeated warnings posted in the President’s Daily Brief, warnings relayed by the Office of the DNI, the CIA and other intelligence agencies, warnings that especially started heating up at the end of January. 

One week after the first reported US case of the coronavirus, 

DNI Coats testified at the Senate Intelligence committee’s annual worldwide threats hearing. That very day, Peter Navarro, Trump’s trade adviser, wrote a memo warning that the coronavirus crisis could cost the United States trillions of dollars and put millions of Americans at risk of illness or death. He called for "an immediate travel ban on China."

“The lack of immune protection or an existing cure or vaccine would leave Americans defenseless in the case of a full-blown coronavirus outbreak on U.S. soil....This lack of protection elevates the risk of the coronavirus evolving into a full-blown pandemic, imperiling the lives of millions of Americans.”

He would follow up with another memo a few weeks later in which he warned that "There is an increasing probability of a full-blown COVID-19 pandemic that could infect as many as 100 million Americans, with a loss of life of as many as 1-2 million souls."

He set out the need for an "immediate supplemental appropriation of at least $3 billion", anticipating the need for "Personal Protective Equipment" for health care workers. "We can expect to need at least a billion face masks, 200,000 Tyvek suits, and 11,000 ventilator circuits, and 25,000 PAPRs (powered air-purifying respirators)”, he said. 

Keeping Secrets

As the year 2019 closed, a vector loomed in China. Health authorities were now aware of a mysterious and stealthy disease centered in the metropolitan city of Wuman. The World Health Organization issued a warning. By New Year’s day, Chinese authorities would order the closing and cleaning of the Wuhan Seafood Market, the suspected source.

The Chinese bear some measure of complicity for the spread of the virus beyond it’s borders. Instead of treating the matters as a health crisis with global implications, it was handled  preliminarily as a political matter, a treatment plan that is eerily reminiscent of the approach taken by Trump. As the disease progressed alarmingly, the Wuhan health officials had dutifully reported their findings. The head of China’s disease control agency immediately informed his US counterpart CDC Director Robert Redfield of the rampaging disease. 

Their candor was rewarded by authorities with an information lock-down. China’s Institute of Virology reminded the Wuhan lab; disclosure of information is prohibited. Eight doctors, including the first whistle blower, were punished for “rumor-mongering” via a broadcast on China’s national television. As it has here, the counterproductive interplay between the apparatchiks and the health officials continued. A People's Liberation Army biological weapons expert soon assumed control of Wuhan's P4 lab.

Behind closed doors, the highest levels of government pondered the situation, finally reaching the assessment that it was grim with far-reaching implications. In typical fashion for a government with complete control of the apparatus of authority, they sent out medical shock troops, assigned top health officials to working groups, trained health workers, collected data, did field investigations and supervised laboratories. Soon thereafter, they ordered a complete shutdown of the city and built two treatment hospitals nearly overnight.

As insular and secretive as they are, though, the country’s outbreak had been hard to underplay. There were people dying, literally, on their streets. The cat had been belled. Asia went on full alert. The Lunar New Year, they all worried, would see many workers going back to their home cities. Taiwan, Hong Kong, South Korea, Thailand and the Philippines set up quarantine and scanning zones for passengers from China.

But the Chinese health officials had not abandoned their Hippocratic duties. By the first week of the year, they had isolated and completed the genome sequencing, reported it to the National Health Commission, suggested preventative measure recommendations, and sent a genetic map of the viral DNA to the world community.

The WHO, caught, perhaps as Trump insists, in a political undertow, cautioned caution. Like the Chinese playing their cards too close to their chests, they added to the problem. With a world view not tethered to one country, they advised against travel restrictions to China “based on the current information available on this event." Although internal documents show that the higher echelons of the Chinese government were concerned that the disease had human-to-human transmission capabilities, they fudged on that. As late as January 23, a few days after the first reports of a case in the United States and other world centers, the head of the WHO still resisted calling the outbreak a public health emergency of international concern. 

It would not be until the end of January, now facing the harsh realities of a worldwide meltdown, that the WHO would reconvene to consider whether the outbreak amounted to a global health emergency. Declaring it now a pandemic, Dr. Mike Ryan, head of the WHO's Health Emergencies Programme, said, "The whole world needs to be on alert now. The whole world needs to take action and be ready for any cases that come from the epicenter or other epicenter that becomes established." The WHO's Tedros announced that the outbreak had become a "public health emergency of international concern over the global outbreak of novel coronavirus."

The agency advised countermeasures. "Countries should be prepared for containment, including active surveillance, early detection, isolation and case management, contact tracing and prevention of onward spread of 2019-nCoV infection, and to share full data with WHO.”

In early January, the CDC had created an “Incident Management System” for the coronavirus and advised travelers to Wuhan to take precautions. That was followed by a warning from the Chinese President himself that the outbreak “must be taken seriously” and every possible measure pursued. On January 21, the same day the WHO declared the virus risk as globally “high”, the first US case was reported. If a pandemic “Operation Overlord” had been envisioned by other administrations - whatever systems, protocols, or actions might have been prescribed - they were MIA, allowing the disease essentially unfettered entry. 

Instead of an affirmative and measured response, the administration acted in a dilatory, inept, and counterproductive fashion. The coronavirus had us up the creek; Trump not only threw away the paddles, he shot holes in the bottom of the boat. Those lynchpins of pandemic prophylaxis, the standards and protocols recommended by the WHO, the CDC, and others, were not just ignored, they were countermanded. Missing was the steady and firm hand at the till, there were no actions borne of competence and confidence. Instead, it was a reverse play book - testing, contract tracing, quarantines, travel lock downs, the placement of respected medical professions, isolating the process from the appearance of political interference, working to instill public confidence - were all upended. Medical knowledge and its experts was impugned and ultimately sidelined in favor of fanciful elixirs, shamans, mendacity, and magical thinking.

[TO BE CONTINUED]


Wednesday, September 09, 2020

MIA

 I pass this Trump flag every morning as I go to work. It hangs there, in the front of a haggard-looking house a few yards from the railroad track that crosses Old Government. The flag, too, is ragged. Did this probably-strapped-for-cash person actually purchase this Made-in-China rag or is it a a leftover totem? Was it a "rescue" flag left over from some nativist beat down? I can't tell if the residence is rental property or someone who has lived there all of their life. Are they Black? All of those could be. I add that to the list of things - like his evangelical support, Trump flotillas and regattas, a Trump store - that shake me, that puzzle me. 

But not for long. 

Traffic, and the day, loom.

But today that flag reminded me of the MIA flag, and it centered me on the news that Trump's "suckers" remarks had now been compounded by his supposedly having said some horrible things about MIAs. I try not to give too much credit to unsubstantiated things, going even so far as to ignore the hundreds of things that Trump has said in the past that tend to corroborate this, if true, his latest outrage. I can't say I can make a lot of sense out of a lot of this. How can anyone disparage us for being veterans? For being captured! For dying in the name of our country!

It offends me of course. I think about my cousin Noel who was MIA for so many years, both of his parents grieving and passing without ever getting any closure. The irony of it adds to my sadness and confusion. Noel, like so many other veterans I know, would have been one of his biggest boosters. He was gung-ho for the war. He was gung-ho for this country. His kids and half of my Puerto Rican family support Trump still. 

It goes far beyond my umbrage, though, this mystery. Can he really have said that? Well, sure, history supports that notion. But he'll be gone soon enough. Of all of the awful things the year 2020 has brought, its the harsh reality that even though it flies in the face of common sense and their most cherished beliefs and interests, it's my neighbors who continue to defend the indefensible. That cuts to the quick even more. 


Wednesday, July 29, 2020

Take the hydroxychloroquine challenge!


[Originally published on July 29, updated 8/13/20]

Take the hydroxychloroquine challenge!

Well, it looks like we are back to talking about hydroxychloroquine. Here's what I know about this issue. Mind you, this is just about hydroxychloroquine and not the rest of the craziness with which we have been living. For context with all of the rest of the insanity, check out my database.

Part One

Our latest reincarnation of the issue is really part 2. The first part began in March with a Fox report of a small French study that touted the effectiveness of the drug. Almost immediately Trump vowed to make it more widely available. “It’s shown very encouraging – very, very encouraging early results,” he said at a press conference. “And we’re going to be able to make that drug available almost immediately. And that’s where the FDA has been so great. They – they’ve gone through the approval process; it’s been approved. And they did it – they took it down from many, many months to immediate.”

At the same press conference, FDA administrator Hahn said regulators were taking “a closer look.” “That’s a drug that the president has directed us to take a closer look at, as to whether an expanded-use approach to that could be done to actually see if that benefits patients.”

Another report, this time from the U.K. seemed to lend support to that view by finding "positive effects among COVID-19 patients who take a combination of hydroxychloroquine and the antibiotic azithromycin". Although the study garnered international attention, cooler heads cautioned not to make too much of a non-controlled study with a small sample size (26 people).

Nonplussed, Trump tweeted on 3/21/20 that "HYDROXYCHLOROQUINE and AZITHROMYCIN, taken together, have a real chance to be one of the biggest game changers in the history of medicine. The FDA has moved mountains - Thank You! Hopefully they will BOTH (H works better with A, International Journal of Antimicrobial Agents)....."

The CDC, following suit, immediately issuing an Information for Clinicians on Treatment Options for COVID-19 Patients. The document describes possible prescription information for coronavirus patients, while at the same time proposing hydroxychloroquine and chloroquine as a restricted option in coronavirus treatment.

The American Medical Association, American Pharmacists Association and American Society of Health-System Pharmacists cautioned against it use, issuing a joint statement on ordering, prescribing or dispensing COVID-19 medications. "We are aware that some physicians and others are prophylactically prescribing medications currently identified as potential treatments for COVID-19 (e.g., chloroquine or hydroxychloroquine, azithromycin) for themselves, their families, or their colleagues; and that some pharmacies and hospitals have been purchasing excessive amounts of these medications in anticipation of potentially using them for COVID-19 prevention and treatment. We strongly oppose these actions.

Regardless, the FDA granted Hydroxychloroquine and chloroquine, previously anti-malarial drugs, EAU (emergency use authorization).

A very short time afterwards, a paper in Annals of Internal Medicine, “Use of Hydroxychloroquine and Chloroquine During the COVID-19 Pandemic: What Every Clinician Should Know” warned that “data to support the use of HCQ and CQ for COVID-19 are limited and inconclusive.”


See also:








On 4/21/20, a panel of experts convened by the National Institute of Allergy and Infectious Diseases recommended against doctors using a combination of hydroxychloroquine and azithromycin for the treatment of COVID-19 patients because of its potential toxicities.

The FDA followed suit, cautioning against the use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems.

Trump, however dismissed the hydroxychloroquine studies, telling reporters that he has been taking the drug.

“I worked with doctors,” he began. “If you look at the one survey, the only bad survey, they were giving it to people that were in very bad shape, they were very old, almost dead. It was a Trump enemy statement.

A short time later, on 5/22/20, a Lancet Article claimed that the malaria drugs hydroxychloroquine and chloroquine did not help coronavirus patients and may have done harm; People who received the drugs were more likely to have abnormal heart rhythms.

Part Two

The issues of the efficacy of the drug resurfaced anew on July 2nd when the Henry Ford Health System report was published in the International Journal of Infectious Diseases, a peer-reviewed, open-access online publication of the International Society of Infectious Diseases shows that treatment with Hydroxychloroquine  cut death rate significantly in COVID-19 patients.

That, and the 5/27/20 article published in the American Journal of Epidemiology entitled: “Early Outpatient Treatment of Symptomatic, High-Risk Covid-19 Patients that Should be Ramped-Up Immediately as Key to the Pandemic Crisis” concerning the work of Yale professor of epidemiology Harvey S. Risch, reignited this debate. He concluded that theoretical fears of cardiac events were not borne out in real-world usage and were vastly overshadowed by lives saved.

[ED. NOTE: 
On 8/4/20, some Yale Faculty members, writing with "grave concern", responded to Dr. Risch's "ardent advocacy". 

While minority opinions, anecdotal evidence, novel interpretations and challenges to orthodoxies in a field can be important, at some point, the application of the scientific method generating evidence from multiple, well-designed clinical trials and observational studies does matter and should be heard over the noise of conspiracy theories, purported hoaxes, and the views of zealots.


You will see that people who want to push this drug cite either or both of these. They rarely bother to go digging any further. 

Without belaboring Dr. Risch's work, feel free to investigate for yourself. For example, a 6/2/20 article "Hydroxychloroquine Misinformation Can Be Deadly: Let Patients Decide" speaks directly to his comments. And this  article seriously critiques Dr. Risch's work. A few days after the publication of his comments, yet another study found no clinical benefit from use of hydroxychloroquine in patients hospitalized with COVID-19.

However, things seriously kicked off around the Fourth of July holiday. Days after the Henry Ford Health System report was published, Trump was tweet-touting the drug again. While Trump has his reasons for kicking the anthill, you might want to take a look at "A flawed Covid-19 study gets the White House’s attention — and the FDA may pay the price" for what the experts say is wrong with that study.  Researchers have severely criticized the Henry Ford study as not meeting the standards set for medical research. One researcher set out the problems he saw for an assessment that the the flaws in the analysis made the conclusions reached invalid. In "Clarifying the record on hydroxychloroquine for the treatment of patients hospitalized with COVID-19" University of Albany researchers also made observations critical of the Henry Ford study. Asked to comment on the efficacy of the study during his Congressional testimony, Dr. Fauci's comments mirrored those criticisms.

Faced with this barrage of detractors claiming heresy, Henry Ford issued a statement: "We've acknowledged the varying conclusions multiple studies have reached, along with the limitations of our retrospective [hydroxychloroquine] study as well as those of other published studies on the topic."

Regardless of whether it's the initial phase of this debate or the more recent Henry Ford/Breitbart-video, the science guys always come down on "don't do this".

For example, as recently as 7/23/20 "Hydroxychloroquine with or without Azithromycin in Mild-to-Moderate Covid-19" was published in the New England Journal of Medicine finding that "among patients hospitalized with mild-to-moderate Covid-19, the use of hydroxychloroquine, alone or with azithromycin, did not improve clinical status at 15 days as compared with standard care". See also.

We are now caught in what is essentially a counterproductive force of will and personality. While it seems like a century ago, it was only two days ago that the video with “America's Frontline Doctors”, along with a push from the president, managed to convince apparently many to abandon logic and science. Dr. Stella Immanuel, a primary care physician in Houston, declared that no one need fear the coronavirus that has so far killed more than 150,000 people in the United States and more than 650,000 worldwide. "This virus has a cure. It is called hydroxychloroquine, zinc, and Zithromax."

In addition to her comments, also in attendance was Dr. Simone Gold, who claimed to head the group,an organization comprised of "some doctors" and others involved in the anti-vaccination movement. Dan Erickson, one of the two YouTube Bakersfield doctors, also spoke at the news conference.
In spite what caution would dictate, the following day Trump doubled down on hydroxychloroquine. “Many doctors think it is extremely successful, the hydroxychloroquine coupled with the zinc and perhaps the azithromycin,”


Dr. Deborah Birx subsequently joined him in this assessment that scientific evidence does not support claims that hydroxychloroquine is effective in treating COVID-19, despite its touting by President Donald Trump.

"It's not productive or helpful for me to be making judgments on right or wrong but what I can say is what I've said all along, that the overwhelming body of data from trials that were well run, randomized placebo controlled trials, indicate that hydroxychloroquine is not effective in treating coronavirus disease," Fauci recently told Congress.

On 7/29/20 Scott Gottlieb, former Trump FDA head went on one of the Sunday shows and said that "We can definitively say hydroxychloroquine doesn't work".

https://www.axios.com/hydroxychloroquine-coronavirus-scott-gottlieb-trump-a7b60575-91db-4239-8c86-59b993c55358.html Following him closely was  White House coronavirus testing czar Adm. Brett Giroir who said that he “can't recommend” hydroxychloroquine to treat COVID-19. While hydroxychloroquine “looked very promising” at first, he noted that five studies had found that the anti-malarial drug does not help COVID-19 patients. 

“At this point in time, there's been five randomized-controlled, placebo-controlled trials that do not show any benefit to hydroxychloroquine, so at this point in time, we don't recommend that as a treatment.”  
 

[ED NOTE: 
On 8/7/20 Newsweek ran a story about a report claiming that more than 100 People had died in U.S. while taking Hydoxychloroquine for COVID-19

In the first half of 2019, 3,251 adverse events were recorded in patients taking hydroxychloroquine or its derivatives, with over 2,441 said to be serious as the individual was hospitalized, disabled or died. In the first half of this year, 6,588 adverse events were recorded, with 6,233 designated serious.


As of today, the debate isn't about the development of other drugs and vaccines, things that are actually positive and moving in the right direction. No, while we're ostensibly debating about the efficacy of a drug, what is happening is more tribalization and factionalism. We're looking at this health issue through a political prism, focused on whether we like what the medical professionals and scientist say and we're doing it at a time of utmost peril.