Monthly Archives: April 2020

Act of War or of Criminal Incompetence?

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Was the Covid-19 pandemic due to criminal incompetence or an act of war?

The preponderance of evidence, at this time, suggests that SARS-CoV occurred naturally. While China claims the outbreak in late 2019 occurred naturally at a “wet market”, most western experts believe that it was stored in a virology laboratory near Wuhan China after discovery in 2013. US intelligence reported safety problems with at least one of two such laboratories about a year before human infection and spread began around December 1, 2019. Chinese government officials covered up an unknown number of details and lied about others as the epidemic raged in Hubei province where 56 million people live. In January, all domestic travel in and out of Hubei was halted. Six days later, aided by the World Health Organization, all international travel was also halted.

Chinese individuals, including at least one physician, who tried to warn the rest of the world about the gravity of the situation, disappeared. Misinformation poured from government sources and the WHO. Non-governmental voices were censured. It is objectively impossible to trust any information about this issue from any source in China including, in my opinion, professional medical publications. It is inarguable that the government has launched a campaign of propaganda to, at best, try to regain stature in the international community. At worst, the intent is to further the political and socioeconomic upheaval caused by the pandemic. Intent is difficult to clarify and often has several aspects.

China either failed to contain the virus, likely by virtue of bureaucratic ineptitude, or it intended to allow its spread. The latter, as evidenced by the six day window of continued international travel, would be tantamount to an act of war.

A perfect act of war is one that is subtle, seemingly natural, and arguably accidental. It results in devastation of enemies far and near. Such an act would bring no immediate military response, no critical resolution from the United Nations, and no harmonious chorus of condemnation. Victim countries would be torn by between those who see the infection as a hostile act and apologists that promote the perpetrator’s propaganda. If a dominant fraction of apologist media exists, public support of the notion that this was an act of war may never rise above a murmur.

What would China gain by release of virus worldwide? For one, while it harmed their internal economy, it has created for them an economic explosion of exports, both legal and blackmarket. They are selling products to affected countries faster than they can be produced at prepaid prices that approach astronomical. As a result, these countries go deeper into debt to make these purchases. Viral containment efforts in most western nations have resulted in economic contraction and widespread unemployment unlike any period in almost a hundred years. With much lower tax revenue and profligate bailouts, the budget deficit of the US, for example, from April 1, 2020 to March 31, 2021 could exceed four trillion dollars. It is plausible—a notion voiced by Senator Tom Cotton—that China didn’t want to be the only country to suffer economically and found it preferable that the world suffer with it. Again, it is almost impossible to have certainty about intent.

Economic collapse is typically followed by political chaos. Chaos creates opportunity for hegemony. Wars are fought to expand territory, control, power and/or influence. Every objective observer of history knows this.

The failure to contain international travel, the pervasive obfuscation and mendacity, the governmental culture of dominance, still cannot confirm that this was an act of war. If not, however, it was an act of genocide, a crime against humanity, and criminal negligence for which China owes every country in the world recompense. Their intent is irrelevant with respect to their debt to all.

Keeping  with the China theme, there is a Karma in life. In striving for the yang of the cheapest source, we reaped the yin of a decimated capacity of US manufacturing, making us dependent on others, including hostile powers. For the yang of shared commerce, we harvest the yin of cowering in place from yet another Chinese virus and panicking over toilet paper while simpering politicians dismantle our own economy.

The US recently became energy independent from the mideast. At the very least, this second (or third?) epidemic from China should serve as notice that it is time to be independent from them in every way. But first, don’t forget that they owe us trillions of dollars in damages suffered by us from their criminal attack.

The Eyewash Station

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I stepped into a remodeled cardiac catheterization lab and saw a new contraption on the faucet of the scrub sink. As I donned my lead apron, the manager explained it was an eyewash station. The more I learned, the more I came to see it as a symbol of how government increases healthcare costs while decreasing quality.

The gadget is designed to shoot water into both eyes in the event of something bad splashes in them. What hazardous liquids are found in a cardiac cath lab, you might ask, since every such substance is approved by our Food and Drug association for medical use, either topically or injected, and should be safe. Yes, iodine can sting the eyes. Yes, blood can and rarely does splash in the eyes, despite the Occupational Safety and Health Administration requirement to use eyewear.  Blood is sterile in the vast majority of patients and when blood contains germs, studies show that infection of the unfortunate recipient is virtually immediate. There is typically an eyewash station in the emergency room within a minute or two of virtually all cath labs but that’s not adequate for regulators. Getting to an eyewash station in twenty seconds is not superior to two minutes for any liquid one could acquire on an eyeball in the cath lab, yet the room must have one.

The station interferes with the normal operation of the faucet and increases contamination hazard, should one attempt a sterile scrub.  Leaks are common and lead to a wet floors with a subsequent fall risk, not to mention damage to the building. 

But the story gets better. To ensure compliance with OSHA guidelines, accrediting organizations, create reporting requirements for hospitals. A weekly audit of the device is required. The person assigned to this task often must complete hours of education. A record of the weekly assessments must be made, to include inspection of the nozzle dust caps position and functionality, water temperature and pressure, and whether the pathway to the station is clear and unobstructed. If weekly assessments are not properly recorded in the correct form, inspectors issue a black mark against the institution, jeopardizing Medicare payments. 

While the inspection method and parameters are highly structured, neither OSHA nor accreditors require teaching people how to operate the device. These appliances do nothing to improve safety or quality but they drain hospitals of money. Eyewash stations are aptly named.

Government involvement has used good intent to pave the road to high cost, low quality medical care. Prime examples are government run, single payer systems of Indian Health and Veteran’s healthcare (neither of which are a topic in this article.) The government (and everyone else) wants to prevent fraud in taxpayer funded activities. In this spirit, bureaucrats adopted a wasteful, costly, and arcane medical billing system developed by a communist commune in Chicago, also known as the American Medical Association.  In it, every physician I know has committed fraud. That sounds awful. I shall explain.

Medicare pays for Evaluation and Management services. A history and physical or a doctor visit is such. There are three to five levels of payments for E&M codes. Higher levels of payment require more data points of minutia in the note that documents the service. Insurance gnomes count the data points to make sure no one cheats. The feds also require compliance officers to do the same work inside the hospitals. Doctors are not stupid. They developed a workaround using pre-filled forms to insert the required data into the electronic health record.

The result of this in real life springs out of a discharge summary on a patient who died during a procedure that I read recently.  It listed eight drugs the (dead) patient was prescribed at discharge. (Would the mandated discharge planner need a seance to follow up on compliance?) As this patient was dying, a consulting physician rushed in to help. The patient was being resuscitated but, according to his note, she had a completely normal physical exam including normal heart exam (the patient was in cardiac arrest) and was “alert and oriented” when she was essentially dead. The note hit all the points required in order to collect payment. Accuracy was optional.

Notes that were once concise now obfuscate details in five pages of useless copy-and-paste to achieve higher payment. On the other hand, physician orders that were once illegible doctor scribble are crystal clear. That sounds valuable, however, my experience is that the orders often get lost in a morass of cyber confusion. When I see a patient hours after a procedure, it’s not uncommon to find the IV fluid that I ordered stopped is still flowing rapidly into a poor soul gurgling in excess water. Computerized healthcare is the law. It costs, I have read, over $50,000 per year per physician to create this unsafe and confusing debacle. I sometimes cynically opine that the EHR is a governmental solution to global warming in that has shortened life expectancy in the US.

In order for the practice or hospital to get maximal payment, coders send me their irritations about my documentation every week. (“I can’t bill a level three because you were two items short on your review of systems. Can you go back and edit your note?”) A coder is a person who has been to coding school, (an entity that also funds the aforementioned communists in Chicago) and received a certificate. There are levels of coders in this artificial industry, and certificates in various specialties from oral surgery to proctology. I chose these specific specialties on purpose because this malicious micromanagement is flavored with idealistic intent but excreted as *** (insert preferred scatological reference here. Or, more politely, “eyewash.”)

Elimination of most of of regulations and systems that govern Medicare medical billing would result in a large drop in healthcare costs, probably improving quality of service and care at the same time.

Another accelerator of cost which is at least as bad as the regulations on providers is the FDA. Before costs are addressed, consider its abysmal record of failure with drugs. Around seventy thousand people die in the US of illicit drug use annually. Additionally, thousands more die of drug misadventures in healthcare settings. Tens of thousands more die from infections that result from antibiotic misuse.

Perhaps to overcompensate for its incompetence, the FDA creates expensive piles of *** (see above)  through which companies must slog to bring new drugs and devices to market. By requiring far more data than is needed in any other country, it may cost as much as eight times more to gain approval for drugs and devices in the US than in Europe. Because of this, the US is usually last to gain access to new drugs and technology when they are finally approved. Yet, healthcare is no safer here than in Europe. 

Combine the onerous FDA requirements with a twenty year patent duration, that begins years before the drug is approved, and it is no wonder that new pharmaceuticals are unaffordable. Politicians seem to create problems that they use for their own political gain. They rail against the high cost of drugs, a problem of their own creation.

A far lower cost solution is to accept European Union approval for drugs and devices for the US.  This would eliminate a giant swath of costly bureaucracy at the FDA making drug and device costs much lower. If the EU asks us to help fund their approval process, we could agree to do so when every country in the EU meets their NATO obligation. (Is that quid pro quo  impeachable?)

Some call for more generics and shorter patents. The latter would harm the pharmaceutical industry. Generic drugs have looser standards of purity. Reports of lower efficacy are mounting. Many generics come from China. These low cost, less pure drugs, along with a host of other sweat-shop non-medical products, force Americans to support a communist regime that aspires to eliminate our way of life. But I digress.

A Negative Test For Covid-19 Can Kill

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A test that is positive for coronavirus, aka Covid-19, confirms the presence of infection, if you have clinical signs and symptoms of infection. If you don’t, it doesn’t. Alternatively, a test that is negative is helpful in looking at a large, healthy population but it means much less for someone who is ill. Even worse, negative tests in sick people result in infection and death of healthcare providers and family. Confusing? Yes. 

There has been a lot of discussion and concern about the late arrival of testing for Covid-19. In order to shed a little light on this issue, let’s look at the current understanding of the test currently in use for detection of the disease. The test is properly done by sampling mucus from the nasopharynx, the back of the nasal cavity above the uvula, the little “punching bag” seen at the back of the mouth. The RNA of the virus is amplified by the polymerase chain reaction until there is enough to measure. The test is highly dependent on two things, amount of virus in the site sampled and sampling the correct site with sufficient (meaning unpleasant) vigor. 

Machines are tested on standard positive and negative samples. The machine characteristics must deliver accurate results 99% of the time or higher. However, samples submitted are not like the standards.

Data from Covid-19 testing in a real life scenario are few. A study published in the journal Radiology looked at testing done in China on about a thousand patients who presented with symptoms typical of the Covid-19 infection. 600 PCR tests were positive and 900 chest CT scans were positive in this group. It could be assumed that 300 PCR tests were false negatives and that the CT scans were highly accurate.

Using this data set as a springboard, let’s look at two vastly different uses of testing to detect infection.  First, consider a cohort similar to the one published, with a 90% prevalence of disease and a test that has a specificity of 99% and a sensitivity of 70%. A 4 x 4 plot of true positives, false positives, and true and false negatives would look like this:

Test + Test – Total  (Key)

Disease present 600 300 900 TP FN

Disease absent 1 99 100 FP TN

The positive predictive value in this situation (TP/TP+FP) is 99.8. The negative predictive value (TN/TN+FN) is 0.25. Thus a positive test is helpful but a negative test clearly does not exclude disease and is useless in changing any aspect of management when the prevalence is high. In this scenario, the false negatives may result in infection of many others including care providers.

Now look at a second cohort with a prevalence of disease of 0.1%. This would be using the test to screen for disease. (At this writing, the number of cases in the US is almost 300,000 in a nation of 330,000,000, or roughly 0.1%) In this case, let us screen 100,000 people with the same test, of whom 100 will be infected.  The 4 x 4 plot follows.

Test + Test – Total  (Key)

Disease present 70 30 100 TP FN

Disease absent 1,000 98,900 99,900 FP TN

The positive predictive value here is 70/1,070 = 0.07, which in ordinary English means that only 7% of the positive results occur in people with infection.  The negative predictive value is 98,900/99,200 = 99.7.  Suppose a leader proposed isolating all people with a positive test in this situation.  93% of those isolated would not have the disease and would be isolated unnecessarily. Further, testing for infection in screening vastly overestimates the prevalence of disease, in this case by about ten fold. (100 with disease but testing positive in 1,070) In the US, if we tested about one third of the country, one hundred million, we would quarantine a million people unnecessarily. This might be acceptable to some governments but a lot less so to Americans who understand these numbers. We would not sentence 1,000,000 innocents to a month in jail to ensure that 70,00 criminals did time for their crime. Additionally, there is a growing suspicion that about 25% of those infected are asymptomatic or minimally symptomatic yet spread virus for weeks. We have no idea how accurate that figure is because false positives are blended with the silently infected.

The CDC and the FDA cooperate to an extent on development of tests for epidemics. Considerable regulation exists with the intent of ensuring high quality and accurate performance of laboratory testing. With this coronavirus epidemic, the hue and cry of the masses (mob?) has forced the suspension of many of the procedures that foster accuracy, just so a test is available. We will soon have tests flying off the shelves to be used to diagnose this condition. It is extremely unlikely that these instantly created machines will have better operational characteristics than the existing tests. It appears that the likely less accurate results will be ready a lot sooner.

On a more positive note, there are tests that measure antibody to the virus, a protein that shows up weeks following infection. These tests are generally more accurate with far fewer false negatives. This testing can give a better notion of the prevalence of disease but after the fact. It will help clarify the false positives versus asymptomatic carrier question.

The late appearance of testing for Covid-19 in the US began as a consequence of false statements from China that led to a misunderstanding of the characteristics of the viral transmission and underestimation of the problem, and obstructive regulations in place for years that might be acceptable in times of health but fail in times requiring an urgent response. Federal health agencies could adopt a more functional approach to respond to epidemics, one that provides a nimble response and production of testing mechanisms by private industry that is both massive and as accurate as possible, recognizing the limitations and strengths of acute testing. On the other hand, testing for viral presence in the nasopharynx will always have the limitations noted here. An argument could be made that such testing is of limited value in containing an epidemic and that the focus should be in changing behaviors and practices that limit spread until a vaccine can be developed a year or two later. Numbers from testing certainly help the news media industrial complex while giving many people anxiety and provoking other psychiatric reactions. Fear is a double edged sword. It motivates many to comply with infection control measures while it stimulates fraud and crime in others. It’s impossible to say at this point—or at any point—what effect on infection and mortality rates has been derived from government-dictated termination of selected business activities as opposed to a lighter touch with enhanced guidelines regarding occupation limits, spacing, masks, cleaning, etc. Just like we will know more about infection rates a year from now, we might better understand how devastating government actions have been on the economy, provided we have control states or economies where the restrictions have been less onerous.

Coronavirus will not be the last epidemic. All epidemics will not necessarily be viral as there is a rapidly expanding list of antibiotic resistant bacteria. Microbes owned our planet for two billion years. They want it back.