Tag Archives: Testing

The Favored Cause of Death

19 Monday Oct 2020

Posted by in Coronavirus, Public Health

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The CDC changed its guidelines on completion of death certificates on April 5th of this year, and only for COVID-19 (C19), just as infections and presumed C19 deaths were ramping up. The substance of the change was to broaden the definition under which death should be attributed to C19. This ran counter to CDC guidelines followed over the previous 17 years, and the change not only makes the C19 death counts suspect: it also makes comparisons of C19 deaths to other causes of death unreliable, since only C19 is subject to the new CDC guidance. That’s true for concurrent and historical comparisons. The distortions are especially bad relative to other respiratory diseases, but also relative to other conditions that are common in mortality data.

The change in the CDC guidelines was noted in a recent report prepared for the Florida House of Representatives. It was brought to my attention by a retweet by Justin Hart linked to this piece on Andrew Bostom’s site. Death certificates are divided into two parts: Part 1 provides four lines in which causes of death are listed in reverse clinical order of events leading to death. Thus, the first line is the final clinical condition precipitating death. Prior clinical events are to be listed below that. The example shown above indicates that an auto accident, listed on the fourth line, initiated the sequence of events. Part 2 of the certificate is available for physicians or examiners to list contributing factors that might have played a role in the death that were not part of the sequence of clinical events leading to death.

The CDC’s change in guidelines for C19, and C19 only, made the criteria for inclusion in Part 1 less specific, and it essentially eliminated the distinction between Parts 1 and 2. The following appears under “Vital Records Criteria”:

“A death certificate that lists COVID-19 disease or SARS-CoV-2 as a cause of death or a significant condition contributing to death.”

How much difference does this make? For one thing, it opens the door to C19-attributed deaths in cases of false-positive PCR tests. When large cohorts are subject to testing — for example, all patients admitted to hospitals — there will always be a significant number of false positives even when test specificity is as high as 98 – 99%.

The elimination of any distinction between Parts 1 and 2 causes other distortions. A review of the Florida report is illustrative. The House staff reviewed almost 14,000 certificates for C19-19 attributed deaths. Over 9% of those did not list C19 among the clinical conditions leading to death. Instead, in those cases, C19 was listed as a contributing factor. Under the CDC’s previous guidelines, those would not have been counted as C19 deaths. The Florida House report is conservative in concluding that the new CDC guidelines inflated C19 deaths by only those 9% of the records examined.

There are reasons to think that the exaggeration was much greater, however. First, the Florida House report noted that nearly 60% of the certificates contained information “recorded in a manner inconsistent with state and national guidance”. In addition, almost another 10% of the fatalities were among patients already in hospice! Do we really believe the deaths of all those patients whose diseases had reached such an advanced stage should be classified as C19 fatalities? And another 1-2% listed non-C19 conditions as the immediate and underlying causes.

Finally, more than 20% of the certificates listed C19 alone as a cause of death despite a range of other contributing conditions or co-morbidities. This in itself may have been prompted by the change in the CDC’s guidelines, as the normal standards often involve a “comorbidity” as the initial reason for hospitalization — in that case a clinical event ordinarily listed in Part 1. The high rate of errors and the fact that roughly two-thirds of the deaths reviewed occurred in the hospital, where patients are all tested and often multiple times, raises the specter that up to 20% more of the C19 deaths were either erroneous and/or misclassified due to false positives.

(An exception may have occurred in New York, where an order issued in March by Governor Andrew Cuomo to return C19-positive residents of nursing homes (including suspected C19 cases) back to those homes, The order was made before the change in CDC guidelines and wasn’t rescinded until later in April. There is reason to believe that some of the C19 deaths among nursing home residents in New York were undercounted.)

All told, in the Florida data we have potential misclassification of deaths of 9% + 9% + 2% + 20% = 40%, or inflation relative to actual C19 deaths of up to 40%/60% = 67%! I strongly doubt it’s that high, but I would not consider a range of 25% – 50% exaggeration to be unreasonable.

We know that reports of C19 deaths lag actual dates of death by anywhere from 1 to 8 weeks, sometimes even more. This is misleading when no effort is made to explain that difference, which I’ve never heard out of a single journalist. We also know that false positive tests inflate C19 deaths. The Florida report gives us a sense of how large that exaggeration might be. In addition, the Florida data show that the CDC guidelines inflate C19 deaths in other ways: as a mere contributing factor, it can now be listed as the cause of death, unlike the treatment of pneumonia as a contributing factor, for instance. The same kind of distortion occurs when patients contract C19 (or have a false positive test) while in hospice.

There is no doubt that C19 led to “excess deaths” relative to all-cause mortality. However, many of these fatalities are misclassified, and it’s likely that a large share were and are lockdown deaths as opposed to C19 deaths. That’s tragic. The CDC has done the country a massive disservice by creating “special rules” for attributing cause-of-death to C19. If reported C19 fatality rates reflected the same rules applied to other conditions, our approach to managing the pandemic surely would have inflicted far less damage to health and economic well being.

Coronavirus Framing #7: Second Wave Uncertainty

19 Friday Jun 2020

Posted by in Pandemic

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We’re now said to be on the cusp of a “second wave” of coronavirus infections. It’s become a new focus of media attention in the past week or so. Increased infections have been reported across a number of states, especially in the south, but I’m not especially alarmed at this point for reasons explained below. Either way, the public policy response will certainly be different this time, at least in most areas. We’ve learned that a more targeted approach to managing coronavirus risk is far less costly, which means eschewing general lockdowns in favor of focusing resources on protecting the most vulnerable. That approach is supported by research weighing the costs and benefits of the alternatives (also see here and here).

The targeted approach I’ve advocated does not call for any less caution on the part of individuals. That means avoiding prolonged, close contact with others, especially indoors. I don’t mind wearing a mask when inside stores or public buildings, but I believe it should be voluntary. I do my best to stay out of close proximity to most others in public places anyway, masked or otherwise. This is voluntary social distancing. I also believe public health authorities should be more active in disseminating information on known correlates of coronavirus severity, such as Vitamin D deficiency, high LDL cholesterol, and the “reverse seasonal effect” caused by low humidity in air-conditioned spaces. I would also strongly agree that the effort to identify and mass produce vaccine candidates, known as Operation Warp Speed, should be ramped up considerably, with heavier funding and more than five vaccine candidates.

We’ve seen a continuing increase in coronavirus testing since my last “framing” post about a month ago. Testing has increased to a daily average of almost 500,000 over the past two weeks. At present we appear to have an excess supply of testing capacity in many areas, as Rich Lowry notes:

“The problem with testing nationally is becoming less a shortfall of availability of the tests and more a shortfall of people showing up to get tested. An insider in the diagnostics industry says that laboratories are reporting that they are ‘sample starved’ — i.e., they aren’t getting enough specimens. He notes, ‘We have all seen stories about sample-collection sites in some regions not seeing that many patients.’

An HHS official says that in May there was the capacity to do twice as many tests as were actually performed, calling it a function of ‘allocation and efficiency, but more just demand.’ Says Giroir, ‘We really see areas in the country now that there’s more tests available than people who want to get tested or the need for testing.'”

Before turning to some charts, a word about the data in the charts I’ve been using throughout the pandemic. Some of the nationwide information was directly from the CDC or the Johns Hopkins dashboard. In other cases, I’ve reported state level data and some nationwide data published by The COVID Tracking Project (CTP) and the COVID Time Series (CTS) dashboard, which uses state data from CTP. I first noticed a few discrepancies in the national totals in April, which have become larger with growth in the counts of cases and deaths. Here is a key part of CTP’s explanation:

“For many states, the CDC publishes higher testing numbers than the states themselves report, which raises questions about the structure and integrity of both state and federal data reporting. … Another point of contrast between the CDC’s new reporting and the official state data compiled by The COVID Tracking Project is that the CDC has not released historical, state-level testing data for the first three months of the outbreak.”

Thus, the CDC currently reports almost 120,000 U.S. deaths, while CTP reports about 112,000. Nevertheless, I will continue to report numbers from both sources for the sake of continuity, and I will try to remember to note the source in each case.

The first chart below shows the number of daily tests from CTP; the second chart shows the number of daily confirmed cases (CTP). Since mid-May, daily testing has increased by more than 50%, calculated on a moving average basis, and is now approaching half a million per day or more than 3 million per week. Pooled testing is coming, which will ultimately increase testing capacity several-fold. Daily confirmed cases have been hovered just above 20,000 since around Memorial Day, with a recent turn upward to around 24,000.

Early in the pandemic, I made the mistake of focusing too heavily on case numbers. Yes, I adjusted for population size and was aware that the initial shortage of tests was restraining diagnoses. Still, I did not foresee the great expansion in testing we’ve witnessed, the great transmissibility of the virus in some regions, nor the large number of asymptomatic cases that would ultimately be diagnosed.

The daily percentage of positive tests (CTP), which is smoothed in the chart below using a seven-day moving average to eliminate within-week variability, has declined gradually since early April to about 4% before the uptick in the last few days. Still, that’s a drop of about 75% from the peak when tests were in very short supply. Those were days when even heavily symptomatic individuals were having trouble getting tested.

We’d hope to see a resumption in the decline of the positive percentage as testing continues to grow, but even with a relatively constant positivity rate, the number of daily confirmed cases must grow as testing expands. There may be several reasons the positivity rate has remained stubbornly near 5% over the past few weeks. One is the obvious reversal in social distancing as states have opened up. People became less fearful about the virus in general, and protesters jammed the streets after the George Floyd murder in Minneapolis. Another reason is that there are new areas of focus for testing that might be picking up cases. For example, hospitals in some states are now testing all admissions for COVID-19. This will tend to pick up more infections to the extent that individuals with co-morbidities are hospitalized at higher rates in general and are also more susceptible to the coronavirus. Finally, testing more broadly is likely to pick up a larger share of asymptomatic cases even as the “true rate” of infection declines.

The daily death toll (CTP) attributed to coronavirus has continued to decline. See below. It is now running at about a third of the peak level it reached in mid-April. There are several reasons for the decline. One is the lower number of active cases, changes in which lead deaths by a few weeks. Awareness and testing capacity have undoubtedly led to earlier diagnosis of the most severe cases. There is also the strong possibility that the virus, having felled some of the most susceptible individuals, is now up against more hosts with effective immune responses. An ongoing degree of social distancing, more humid weather, and more direct sunlight have probably reduced initial viral loads from those experienced early-on, when the case load was escalating. Finally, treatment has improved in multiple ways, and there are now a few medications that have shown promise in shortening the duration and severity of infection.

The course of the pandemic has varied greatly across countries and across regions of the U.S. The New York City area was especially hard hit along with several other large cities, as well as Louisiana. CTS shows that states with the highest cumulative number of coronavirus deaths (New York (blue line), New Jersey (green), Massachusetts, Illinois, and Pennsylvania in the charts below) have experienced downward trends in positive cases per day (the first chart below), leading daily deaths downward in May and early June (the second chart — NY’s downtrend began earlier). I apologize if the charts below are difficult to read, but they have resisted my efforts at resizing. Note: I’m mainly focused on trends here, and I have not shown these series on a per capita basis.

More recently, almost two dozen states have begun to see higher daily case diagnoses. Several of these had more favorable outcomes in the early months of the pandemic and were in more advanced stages of reopening. The charts below (CTS) show results for Arizona, Florida, Georgia, and Texas. The new “hot spots” in these states are mostly urban centers. It’s not clear that the reopenings are to blame, however. The protests after George Floyd’s murder may have contributed in cities like Houston, though no increase in New York is apparent as yet. The states in the chart are all in the south or southwest, so the increases have occurred despite sunny, warm conditions. It’s possible that hot weather has prompted more intensive use of air conditioning, which dries indoor environments and can promote the spread of the virus. These southern states have not yet experienced a corresponding increase in deaths, though that would occur with a lag. 

Missouri has seen an slow upward trend in its daily positive test count over the past four weeks, even though the state’s positive rate has trended down slowly since early May. I show MO’s confirmed cases per day below (in green) together with Illinois’ (because my hometown is on the border and the two states are a nice contrast). IL is much larger and has had a much higher case load, but the downward trend in new cases in IL is impressive. Coronavirus deaths per day are shown in the second chart below, with seven-day averages superimposed. Deaths have also trended down in both states, though MO has experienced a few bad days very recently, and MO’s case fatality rate is slightly higher than in IL.

We’ll know fairly soon whether we’re really headed for a second major wave. However, the case count, in and of itself, is not too informative. Testing has increased markedly, so we would expect to see more cases diagnosed. The percent of tests that are positive is a better indicator, and it has flattened at a still uncomfortable 5% for about a month, with a slight uptick in the past few days. Even more telling will be the future path of coronavirus deaths. My expectation is that more recent infections are likely to be less deadly, if only because of the lessons learned about protecting the care-bound elderly. I also believe we’re not too far from what I have called effective herd immunity. 

The pandemic has taken a heavy toll, especially among the aged. In fact, total deaths in the U.S. have now exceeded both the Hong Kong flu of the late 1960s and the Asian flu of the late 1950s. Unfortunately, risks will remain elevated for some time. However, any reasonable estimate of the life-years lost is considerably less than in those earlier pandemics due to the differing age profiles of the victims. In any case, the coronavirus pandemic has not been the kind of apocalyptic event that was originally feared and erroneously predicted by several prominent epidemiological models. It can be tackled effectively and at much lower cost by focusing resources on protecting vulnerable segments of the population. 

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Trump and Coronavirus

26 Tuesday May 2020

Posted by in Pandemic, Public Health, Risk Management, Stimulus, Trump Administration

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It’s a bit early to fully evaluate President Trump’s performance in dealing with the coronavirus pandemic, but there are a number of criteria on which I might assign marks. I’ll address some of those below, but in so doing I’m reminded of Jerry Garcia’s quip that he was “shopping around for something no one will like.” That might be how this goes. Of course, many of the sub-topics are worthy of lengthier treatment. The focus here is on the pandemic and not more general aspects of his performance in office, though there is some unavoidable overlap.

General “Readiness”

Many have criticized the Trump Administration for not being “ready” for a pandemic. I assign no grade on that basis because absolutely no one was ready, at least not in the West, so there is no sound premise for judgement. I also view the very general charge that Trump did not provide “leadership” as code for either “I don’t like him”, or “he refused to impose more authoritarian measures”, like a full-scale nationwide lockdown. Such is the over-prescriptive instinct of the Left.

Equally misleading is the allegation that Trump had “disbanded” the White House pandemic response team, and I have addressed that here. First, while the NSC would play a coordinating role, pandemic response is supposed to be the CDC’s job, when it isn’t too busy with diseases of social injustice to get it done. Second, it was John Bolton who executed a reorganization at the NSC. There were two high profile departures from the team in question at the time, and one one was a resignation. Most of the team’s staff remained with the NSC with the same duties as before the reirganization.

Finally, there was the matter of a distracting impeachment on false charges. This effort lasted through the first three years of Trump’s administration, finally culminating in January 2020. Perhaps the Administration would have had more time to focus on what was happening in China without the histrionics from the opposition party. So whatever else I might say below, these factors weigh toward leniency in my appraisal of Trump’s handing of the virus.

Messaging: C

As usual, Trump’s messaging during the pandemic was often boorish and inarticulate. His appearances at coronavirus briefings were no exception, often cringeworthy and sometimes featuring misinterpretations of what his team of experts was saying. He was inconsistent in signaling optimism and pessimism, as were many others such as New York Governor Andrew Cuomo and New York City Mayor Bill De Blasio. It shifted from “the virus is about like the flu” in February to a more sober assessment by mid-March. This was, however, quite consistent with the messaging from Dr. Anthony Fauci over the same time frame, as well as the World Health Organization (WHO). Again, no one really knew what to expect, so it’s understandable. A great deal of that can be ascribed to “the fog of war”.

Delegation and Deference: B

Trump cannot be accused of ignoring expert advice through the episode. He was obviously on-board with Fauci, Dr. Deborah Birx, Dr. Robert Redfield, and other health care advisors on the “15 Days to Slow the Spread” guidelines issued on March 16. His messaging wavered during those 15 days, expressing a desire to fully reopen the nation by Easter, which Vice President Michael Pence later described as “aspirational”. Before the end of March, however, Trump went along with a 30-day extension of the guidelines. Finally, by mid-April, the White House released guidelines for “Opening Up America Again“, which was a collaboration between Trump’s health care experts and the economic team. Trump agreed that the timeline for reopening should be governed by “the data”. There is no question, however, that Trump was chomping at the bit for reopening at several stages of this process. I see value in that positioning, as it conveys an intent to reopen asap and that people should have confidence in progress toward that goal.  

International Travel Bans: A

If anyone wonders why the world was so thoroughly blindsided by the coronavirus, look no further than China’s failure to deliver a proper warning as 2019 drew to a close. Wuhan, China was ground zero; the virus spread to the rest of the world with travelers out of Wuhan and other Chinese cities. The White House announced severe restrictions on flights from China on January 31, including a two-week quarantine for returning U.S. citizens. In retrospect, it wasn’t a minute too soon, yet for that precaution, Trump was attacked as a racist by the Left. In early February, WHO actually said travel bans were unnecessary, among other missteps. Other bans were instituted on entry from Iran and Brazil, as well as entry from Europe in early March, as countries around the globe closed their borders. Trump’s actions on incoming travelers were prescient, so I’ll score this one for Trump. Some of these travel restrictions can and should be eased now, and certainly that is expected in coming months, so we’ll see how well that process is managed.

Deference to States: A-

As a federalist, I was pleased that Trump and his team left most of the specifics on closures and bans on public gatherings up to state and local governments. That allowed more targeted mitigation efforts as dictated by local conditions and, to some extent, public opinion. This is a classic case of “laboratory federalism” whereby the most effective policies can be identified, though as we’ve seen, there’s no guarantee less successful states will emulate them. I grade Trump well on this one.

On reopening, too, Trump has been a consistent advocate of allowing flexility where local conditions permit, though he wrongly claimed he had “total authority” over ending social distancing rules. It’s hard to square that remark with his general stand on the issue of autonomy except as a tactic to strong-arm certain governors on other points.   

CDC/FDA Snafus: D

I applaud the Administration for its emphasis on the salutary effects of deregulation, but Trump went along with some major pieces of “expert advice” that were not only poor from regulatory perspective, but an affront to federalism. One was a directive issued by the CDC to delay “all elective surgeries, non-essential medical, surgical, and dental procedures during the 2019 Novel Coronavirus (COVID-19) outbreak“. (See my post “Suspending Medical Care in the Name of Public Health“.)

This is exactly the kind of “one size fits all” regulatory policy that has proven so costly, sacrificing not just economic activity but lives and care for the sick, creating avoidable illnesses and complications. The idea was to assure that adequate health care resources were available to treat an onslaught of coronavirus patients, but that was unneeded in most jurisdictions. And while the contagion was in it’s early “exponential” phase at the time, a more nuanced approach could have been adopted to allow different geographic areas and facilities more discretion, especially for different kinds of patients, or perhaps something less than a complete suspension of care. In any case, the extensions into May were excessive. I must grade Trump poorly for allowing this to happen, despite what must have been extreme pressure to follow “expert advice” on the point and the others discussed earlier.

That’s not the only point on which I blame Trump for caving to the CDC. In a case of massive regulatory failure, the CDC and FDA put the U.S. well over a month behind on testing when the first signs of the virus appeared here. Not only did they prohibit private labs and universities from getting testing underway, insisting on exclusive use of the CDC’s own tests, they also distributed faulty tests in early February that took over a month to replace. The FDA also enforced barriers to imported N95-type masks during the pandemic. Trump tends to have a visceral understanding of the calcifying dangers of regulation, but he let the so-called “experts” call the shots here. Big mistake, and Trump shares the blame with these agencies.  

Health Resources: B-

Managing the emergency distribution of PPE and ventilators to states did not go as smoothly as might have been hoped. The shortage itself left FEMA with the unenviable task of allocating quantities that could never satisfy all demands. A few states were thought to have especially acute needs, but there was also an obligation to hold stockpiles against potential requests from other states. In fact, a situation of this kind creates an incentive for states to overstate their real needs, and there are indications that such was the case. Trump sparred with a few governors over these allocations. There is certainly blame to be shared, but I won’t grade Trump down for this.

Vaccines and Treatments: C+

 

The push to develop vaccines might not achieve success soon, if ever, but a huge effort is underway. Trump gets some of the credit for that, as well as the investment in capacity now to produce future vaccine candidates in large quantities. As for treatments, he was very excited about the promise of hydroxychloraquine, going so far as to take it himself with zinc, a combination for which no fully randomized trial results have been reported (the recent study appearing in the Lancet on HCQ taken by itself has been called into question). Trump also committed an unfortunate gaffe when the DHS announced the results of a study showing that sunlight kills coronavirus in a matter of minutes, as do bleach and other disinfectants. Trump mused that perhaps sunlight or some form of disinfectant could be used as a treatment for coronavirus patients. He might have been thinking about an old and controversial practice whereby blood is exposed to UV light and then returned to the body. Later, he said he used the term “disinfectant” sarcastically, but he probably meant to say “euphemistically” …. I’m not sure he knows the difference. In any case, his habit of speculating on such matters is often unhelpful, and he loses points for that.

Fiscal Policy: B

The several phases of the economic stimulus program were a collaboration between the Trump Administration and Congress. A reasonably good summary appears here. The major parts were the $2.3 trillion CARES Act in late March and a nearly $500 billion supplemental package in late April. These packages were unprecedented in size. Major provisions were direct cash payments and the Paycheck Protection Program (PPP), which provides loans and grants to small businesses. The execution of both was a bit clunky, especially PPP, which placed a burden on private banks to extend the loans but was sketchy in terms of qualifications. The extension of unemployment compensation left some workers with more benefits than they earned in their former jobs, which could be an impediment to reopening. There were a number of other reasonable measures in these packages and the two smaller bills that preceded them in March. A number of these measures were well-targeted and inventive, such as waiving early withdrawal penalties from IRA and 401(k) balances. The Trump Administration deserves credit for helping to shape these efforts as well as others taken independently by the executive branch. 

Trump’s proposal to suspend payroll taxes did not fly, at least not yet. The idea is to reduce the cost of hiring and increase the return to work, if only temporarily. This is not a particularly appealing idea because so much of the benefits would flow to those who haven’t lost their jobs. It could be improved if targeted at new hires and rehires, however.

Trump’s proposal to grant liability waivers to reopened private businesses is extremely contentious, but one I support. Lockdowns are being eased under the weight of often heavy public and private regulation of conduct. As John Cochrane says in “Get Ready for the Careful Economy“: 

“One worry on regulation is that it will provide a recipe for a wave of lawsuits. That may have been a reason the Administration tried to hold back CDC guidance. A long, expensive, and impractical list of things you must do to reopen is catnip when someone gets sick and wants to blame a business. Show us the records that you wiped down the bathrooms every half hour. A legal system that can sue over talcum powder is not above this.”

Indeed, potential liability might represent a staggering cost to many businesses, one that might not be insurable. Accusations of negligence, true or false, can carry significant legal costs. Customers and employees, not just businesses, must accept some of the burden of risks of doing business. I give Trump good marks for this one, but we’ll see if it goes anywhere.

Some of the proposals for new stimulus legislation from democrats are much worse, including diversity initiatives, massive subsidies for “green” technologies, and bailouts for state and local government for unfunded pension liabilities. None of these has anything to do with the virus. The burden of pension shortfalls in some states should not fall on taxpayers nationwide, but on the states that incurred them. The Trump Administration and congressional Republicans should continue resisting these opportunistic proposals.

The Grade

Without assigning weights to the sub-topics covered above, I’d put the overall grade for Trump and his Administration’s handling of matters during the pandemic at about a B-, thus far. When it comes to politics, it’s often unfair to credit or blame one side for the promulgation of an overall set of policies. Nevertheless, I think it’s fair to say that Trump, could have done much better and could have done much worse. We will learn more with the passage of time, the continued evolution of the virus, the development of treatments or vaccines, and the course of the economy.