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Emergencies Have Always Been The Pretext On Which The Safeguards Of Individual Liberty Have Been Eroded - Friedrich Hayek, Nobel Prize for Economics laureate.
- US Wants to Track Americans Over Coronavirus; Thermal cameras pushed as 'threat detection'
- Israel Joins Totalitarian States Using Coronavirus To Spy On Citizens. Iran and China, too, are turning powerful intelligence-gathering networks on their own people. Is the U.S. next?
- The Tories just revealed the most terrifying part of their coronavirus plan
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According to the latest data of the Italian National Health Institute ISS, the average age of the positively-tested deceased in Italy is currently about 81 years. 10% of the deceased are over 90 years old. 90% of the deceased are over 70 years old.
80% of the deceased had suffered from two or more chronic diseases. 50% of the deceased had suffered from three or more chronic diseases. The chronic diseases include in particular cardiovascular problems, diabetes, respiratory problems and cancer.
Less than 1% of the deceased were healthy persons, i.e. persons without pre-existing chronic diseases. Only about 30% of the deceased are women.
The Italian Institute of Health moreover distinguishes between those who died from the coronavirus and those who died with the coronavirus. In many cases it is not yet clear whether the persons died from the virus or from their pre-existing chronic diseases or from a combination of both.
The two Italians deceased under 40 years of age (both 39 years old) were a cancer patient and a diabetes patient with additional complications. In these cases, too, the exact cause of death was not yet clear (i.e. if from the virus or from their pre-existing diseases).
The partial overloading of the hospitals is due to the general rush of patients and the increased number of patients requiring special or intensive care. In particular, the aim is to stabilize respiratory function and, in severe cases, to provide anti-viral therapies.
(Update: The Italian National Institute of Health published a statistical report on test-positive patients and deceased, confirming the above data.)
The doctor also points out the following aspects:
Northern Italy has one of the oldest populations and the worst air quality in Europe, which has already led to an increased number of respiratory diseases and deaths in the past and is likely an additional risk factor in the current epidemic.
South Korea, for instance, has experienced a much milder course than Italy and has already passed the peak of the epidemic. In South Korea, only about 70 deaths with a positive test result have been reported so far. As in Italy, those affected were mostly high-risk patients.
The approximately twelve test-positive Swiss deaths so far were also high-risk patients with chronic diseases, an average age of 80 years and a maximum age of 90 years, whose exact cause of death, i.e. from the virus or from their pre-existing diseases, is not yet known.
Furthermore, according to a first Chinese study, the internationally used virus test kits may give a false positive result in some cases. In these cases, the persons may not have contracted the new coronavirus, but presumably one of the many existing human coronaviruses that are part of the annual (and currently ongoing) common cold and flu epidemics. (1)
Thus the most important indicator for judging the danger of the disease is not the frequently reported number of positively-tested persons and deaths, but the number of persons actually and unexpectedly developing or dying from pneumonia (so-called excess mortality).
According to all current data, for the healthy general population of school and working age, a mild to moderate course of the Covid-19 disease can be expected. Senior citizens and persons with existing chronic diseases should be protected. The medical capacities should be optimally prepared.
(1) Zhuang et al., Potential false-positive rate among the ‚asymptomatic infected individuals‘ in close contacts of COVID-19 patients, Chinese Medical Association Publishing House, March 2020.
(2) Grasselli et al., Critical Care Utilization for the COVID-19 Outbreak in Lombardy, JAMA, March 2020.
(3) WHO, Report of the WHO-China Joint Mission on Coronavirus Disease 2019, February 2020.
Important reference values include the number of annual flu deaths, which is up to 8,000 in Italy and up to 60,000 in the US; normal overall mortality, which in Italy is up to 2,000 deaths per day; and the average number of pneumonia cases per year, which in Italy is over 120,000.
Current all-cause mortality in Europe and in Italy is still normal or even below-average. Any excess mortality due to Covid-19 should become visible in the European monitoring charts.
March 17th 2020
- According to press reports, some Swiss emergency units are already overloaded simply because of the large number of people who want to be tested. This points to an additional psychological and logistical component of the current situation.
- The mortality profile remains puzzling from a virological point of view because, in contrast to influenza viruses, children are spared and men are affected about twice as often as women. On the other hand, this profile corresponds to natural mortality, which is close to zero for children and almost twice as high for 75-year-old men as for women of the same age.
- The younger test-positive deceased almost always had severe pre-existing conditions. For example, a 21-year-old Spanish soccer coach had died test-positive, making international headlines. However, the doctors diagnosed an unrecognized leukemia, whose typical complications include severe pneumonia.
- The decisive factor in assessing the danger of the disease is therefore not the number of test-positive persons and deceased, which is often mentioned in the media, but the number of people actually and unexpectedly developing or dying from pneumonia (so-called excess mortality). So far, this value remains very low in most countries.
- According to official figures, there are currently about 1850 test-positive patients in intensive care in Italy, most of them in northern Italy. There is no official data on the age and disease profile of these patients. The occupancy rate of the North Italian ICUs in the winter months is typically already 85 to 90%. Some or many of these existing patients could also be test-positive by now. However, the number of additional unexpected pneumonia cases is not yet known.
- Italian immunology professor Sergio Romagnani from the University of Florence comes to the conclusion in a study on 3000 people that 50 to 75% of the test-positive people of all ages remain completely symptom-free – significantly more than previously assumed.
- A hospital doctor in the Spanish city of Malaga writes on Twitter that people are currently more likely to die from panic and systemic collapse than from the virus. The hospital is being overrun by people with colds, flu and possibly Covid19 and doctors have lost control.
- A new epidemiological study (preprint) concludes that the mortality of Covid19 even in the Chinese city of Wuhan was only 0.04% to 0.12% and thus rather lower than that of seasonal flu, which has a mortality rate of about 0.1%. As a reason for the overestimated mortality of Covid19, the researchers suspect that initially only a small number of cases were recorded in Wuhan, as the disease was probably asymptomatic or mild in many people.
- Chinese researchers argue that extreme winter smog in the city of Wuhan may have played a causal role in the outbreak of pneumonia. In the summer of 2019, public protests were already taking place in Wuhan because of the poor air quality.
- New satellite images show how Northern Italy has the highest levels of air pollution in Europe, and how this air pollution has been greatly reduced by the quarantine.
- A manufacturer of the Covid19 test kit states that it should only be used for research purposes and not for diagnostic applications, as it has not yet been clinically validated.
The Italian National Health Institute ISS has published a new report on test-positive deaths:
- The median age is 80.5 years (79.5 for men, 83.7 for women).
- 10% of the deceased was over 90 years old; 90% of the deceased was over 70 years old.
- At most 0.8% of the deceased had no pre-existing chronic illnesses.
- Approximately 75% of the deceased had two or more pre-existing conditions, 50% had three more pre-existing conditions, in particular heart disease, diabetes and cancer.
- Five of the deceased were between 31 and 39 years old, all of them with serious pre-existing health conditions (e.g. cancer or heart disease).
- The National Health Institute hasn’t yet determined what the patients examined ultimately died of and refers to them in general terms as Covid19-positive deaths.
- A report in the Italian newspaper Corriere della Sera points out that Italian intensive care units already collapsed under the marked flu wave in 2017/2018. They had to postpone operations, call nurses back from holiday and ran out of blood donations.
- German virologist Hendrik Streeck argues that Covid19 is unlikely to increase total mortality in Germany, which normally is around 2500 people per day. Streeck mentions the case of a 78-year-old man with preconditions who died of heart failure, subsequently tested positive for Covid19 and thus was included in the statistics of Covid19 deaths.
- According to Stanford Professor John Ioannidis, the new coronavirus may be no more dangerous than some of the common coronaviruses, even in older people. Ioannidis argues that there is no reliable medical data backing the measures currently decided upon.
- According to the latest European monitoring report, overall mortality in all countries (including Italy) and in all age groups remains within or even below the normal range so far.
- According to the latest German statistics, the median age of test-positive deaths is about 83 years, most with pre-existing health conditions that might be a possible cause of death.
- A 2006 Canadian study referred to by Stanford Professor John Ioannidis found that common cold coronaviruses may also cause death rates of up to 6% in risk groups such as residents of a care facility, and that virus test kits initially falsely indicated an infection with SARS coronaviruses.
- Spain reports only three test-positive deaths under the age of 65 (of a total of about 1000). Their pre-existing health conditions and actual cause of death are not yet known.
- Italy reported 627 nationwide test-positive deaths in one day. By comparison, normal overall mortality in Italy is up to 2000 deaths per day, some of which may now be test-positive, esp. since Italy and all of Europe have had a very mild flu season in 2019/2020.
- Bloomberg highlights that "99% of Those Who Died From Virus Had Other Illness, Italy Says“
- The Japan Times asks: Japan was expecting a coronavirus explosion. Where is it? Despite being one of the first countries getting positive test results and having imposed no lockdown, Japan is one of the least-affected nations. Quote: „Even if Japan may not be counting all those infected, hospitals aren’t being stretched thin and there has been no spike in pneumonia cases.“
- Italian researchers argue that the extreme smog in Northern Italy, the worst in Europe, may be playing a causative role in the current pneumonia outbreak there, as in Wuhan before.
- In a new interview, Professor Sucharit Bhakdi, a world renowned expert in medical microbiology, says blaming the new coronavirus alone for deaths is „wrong“ and „dangerously misleading“, as there are other more important factors at play, notably pre-existing health conditions and poor air quality in Chinese and Northern Italian cities. Professor Bhakdi describes the currently discussed or imposed measures as „grotesque“, „useless“, „self-destructive“ and a „collective suicide“ that will shorten the lifespan of the elderly and should not be accepted by society.
Regarding the situation in Italy: Most major media again falsely reported that Italy yesterday had 797 deaths from the coronavirus. In reality, the president of the Italian Civil Protection Service stressed that these are deaths „with the coronavirus and not from the coronavirus“ (minute 03:30 of the press conference). In other words, these persons died while also testing positive.
As world renowned Professors Ioannidis and Bhakdi have shown, countries like South Korea and Japan that introduced no lockdown measures have experienced near-zero excess mortality in connection with Covid-19, while the Diamond Princess cruise ship experienced an extrapolated mortality figure in the per mille range, i.e. at or below the level of the seasonal flu.
Current test-positive death figures in Italy are still less than 50% of normal daily overall mortality in Italy, which is around 1800 deaths per day. Thus it is possible, perhaps even likely, that a large part of normal daily mortality now simply counts as „Covid19“ deaths (as they test positive). This is the point stressed by the President of the Italian Civil Protection Service.
However, by now it is clear that certain regions in Northern Italy, i.e. those facing the toughest lockdown measures, are experiencing markedly increased daily mortality figures. It is also known that in the Lombardy region, 90% of test-positive deaths occur not in intensive care units, but instead mostly at home. And more than 99% have serious pre-existing health conditions.
Professor Sucharit Bhakdi has called lockdown measures „useless“, „self-destructive“ and a „collective suicide“. Thus the extremely troubling question arises as to what extent the increased mortality of these elderly, isolated, highly stressed people with multiple pre-existing health conditions may in fact be caused by the weeks-long lockdown measures still in force.
If so, it may be one of those cases where the treatment is worse than the disease.
- In Switzerland, there are currently 56 test-positive deaths, all of whom were „high risk patients“ due to their advanced age and/or pre-existing health conditions. Their actual cause of death, i.e. from or simply with the virus, has not been communicated.
- The Swiss government claimed that the situation in southern Switzerland (next to Italy) is „dramatic“, yet local doctors denied this and said everything is normal.
- According to press reports, oxygen bottles may become scarce. The reason, however, is not a currently higher usage, but rather hoarding due to fear of future shortages.
- In many countries, there is already an increasing shortage of doctors and nurses. This is primarily because healthcare workers testing positive have to self-quarantine, even though in many cases they will remain fully or largely symptom-free. March 22, 2020 (III)
- A model from Imperial College London predicted between 250,000 and 500,000 deaths in the UK „from“ Covid-19, but the authors of the study have now conceded that many of these deaths would not be in addition to, but rather part of the normal annual mortality rate, which in the UK is about 600,000 people per year. In other words, excess mortality would remain low.
- Dr. David Katz, founding director of the Yale University Prevention Research Center, asks in the New York Times: „Is Our Fight Against Coronavirus Worse Than the Disease? There may be more targeted ways to beat the pandemic.“
- According to Professor Walter Ricciardi, scientific adviser to the Italian health minister, in Italy „all the people who die in hospitals with the coronavirus are deemed to be dying of the coronavirus“, although „only 12% of death certificates have shown a direct causality from coronavirus.“
- A new French study in the Journal of Antimicrobial Agents, titled SARS-CoV-2: fear versus data, concludes that „the problem of SARS-CoV-2 is probably overestimated“, since „the mortality rate for SARS-CoV-2 is not significantly different from that for common coronaviruses identified at the study hospital in France“.
- An Italian study of August 2019 (https://www.ijidonline.com/article/S1201-9712(19)30328-5/fulltext) found that flu deaths in Italy were between 7,000 and 25,000 in recent years. This value is higher than in most other European countries due to the large elderly population in Italy, and much higher than anything attributed to Covid-19 so far.
- In a new fact sheet, the World Health Organization WHO reports that Covid-19 is in fact spreading slower, not faster, than influenza by a factor of about 50%. Moreover, pre-symptomatic transmission appears to be much lower with Covid-19 than with influenza.
- A leading Italian doctor reports that „strange cases of pneumonia“ were seen in the Lombardy region already in November 2019, raising again the question if they were caused by the new virus (which officially only appeared in Italy in February 2020), or by other factors, such as the dangerously high smog levels in Northern Italy.
- Danish researcher Peter Gøtzsche, founder of the renowned Cochrane Medical Collaboration, writes that Corona is „an epidemic of mass panic“ and „logic was one of the first victims.“
- Former Israeli Health Minister, Professor Yoram Lass, says that the new coronavirus is „less dangerous than the flu“ and lockdown measures „will kill more people than the virus“. He adds that „the numbers do not match the panic“ and „psychology is prevailing over science“. He also notes that „Italy is known for its enormous morbidity in respiratory problems, more than three times any other European country.“
- Pietro Vernazza, a Swiss infectious disease specialist, argues that many of the imposed measures are not based on science and should be reversed. According to Vernazza, mass testing makes no sense because 90% of the population will see no symptoms, and lockdowns and closing schools are even „counterproductive“. He recommends protecting only risk groups while keeping the economy and society at large undisturbed.
- The President of the World Doctors Federation, Frank Ulrich Montgomery, argues that lockdown measures as in Italy are „unreasonable“ and „counterproductive“ and should be reversed.
- Switzerland: Despite media panic, excess mortality still at or near zero: the latest testpositive „victims“ were a 96yo in palliative care and a 97yo with pre-existing conditions.
- The latest statistical report of the Italian National Health Institute is now available in English.
- The UK has removed Covid19 from the official list of High Consquence Infectious Diseases (HCID), stating that mortality rates are „low overall“.
- The director of the German National Health Institute (RKI) confirmed that they count all test-positive deaths, irrespective of the actual cause of death, as „coronavirus deaths“. The average age of the deceased is 82 years, most with serious preconditions. As in most other countries, excess mortality due Covid19 is likely to be near zero in Germany.
- Beds in Swiss intensive care units reserved for Covid19 patients are still „mostly empty“.
- German Professor Karin Moelling, former Chair of Medical Virology at the University of Zurich, stated in an interview that Covid19 is „no killer virus“ and that „panic must end“.
- In Italy, overall national mortality of the 65+ age group until March 7 still remained below the level of earlier years, especially due to the rather mild winter (see red line in chart below).
- German immunologist and toxicologist, Professor Stefan Hockertz, explains in a radio interview that Covid19 is no more dangerous than influenza (the flu), but that it is simply observed much more closely. More dangerous than the virus is the fear and panic created by the media and the „authoritarian reaction“ of many governments. Professor Hockertz also notes that most so-called „corona deaths“ have in fact died of other causes while also testing positive for coronaviruses. Hockertz believes that up to ten times more people than reported already had Covid19 but noticed nothing or very little.
- The Argentinean virologist and biochemist Pablo Goldschmidt explains that Covid19 is no more dangerous than a bad cold or the flu. It is even possible that the Covid19 virus circulated already in earlier years, but wasn’t discovered because no one was looking for it. Dr. Goldschmidt speaks of a „global terror“ created by the media and politics. Every year, he says, three million newborns worldwide and 50,000 adults in the US alone die of pneumonia
- Professor Martin Exner, head of the Institute for Hygiene at the University of Bonn, explains in an interview why health personnel are currently under pressure, even though there has hardly been any increase in the number of patients in Germany so far: On the one hand, doctors and nurses who have tested positive have to be quarantined and are often hard to replace. On the other hand, nurses from neighbouring countries, who provide an important part of the care, are currently unable to enter the country due to closed borders.
- Professor Julian Nida-Ruemelin, former German Minister of State for Culture and Professor of Ethics, points out that Covid19 poses no risk to the healthy general population and that extreme measures such as curfews are therefore not justified.
- Using data from the cruise ship Diamond Princess, Stanford Professor John Ioannidis showed that the age-corrected lethality of Covid19 is between 0.025% and 0.625%, i.e. in the range of a strong cold or the flu. Moreover, a Japanese study showed that of all the test-positive passengers, and despite the high average age, 48% remained completely symptom-free; even among the 80-89 year olds 48% remained symptom-free, while among the 70 to 79 year olds it was an astounding 60% that developed no symptoms at all. This again raises the question whether the pre-existing diseases are not perhaps a more important factor than the virus itself. The Italian example has shown that 99% of test-positive deaths had one or more pre-existing conditions, and even among these, only 12% of the death certificates mentioned Covid19 as a causal factor.
- USA: The latest US data of March 25 shows a decreasing number of flu-like illnesses throughout the country, the frequency of which is now well below the multi-year average. The government measures can be ruled out as a reason for this, as they have been in effect for less than a week.
- Germany: The latest influenza report of the German Robert Koch Institute of March 24 documents a „nationwide decrease in activity of acute respiratory diseases“: The number of influenza-like illnesses and the number of hospital stays caused by them is below the level of previous years and is currently continuing to decline. The RKI continues: „The increase in the number of visits to the doctor cannot currently be explained either by influenza viruses circulating in the population or by SARS-CoV-2.“
- Italy: The renowned Italian virologist Giulio Tarro argues that the mortality rate of Covid19 is below 1% even in Italy and is therefore comparable to influenza. The higher values only arise because no distinction is made between deaths with and by Covid19 and because the number of (symptom-free) infected persons is greatly underestimated.
- UK: The authors of the British Imperial College study, who predicted up to 500,000 deaths, are again reducing their forecasts. After already admitting that a large proportion of test-positive deaths are part of normal mortality, they now state that the peak of the disease may be reached in two to three weeks already.
- UK: The British Guardian reported in February 2019 that even in the generally weak flu season 2018/2019 there were more than 2180 flu-related admissions to intensive care units in the UK.
- Switzerland: In Switzerland, the excess mortality due to Covid19 is apparently still zero. The latest „fatal victim“ presented by the media is a 100-year-old woman. Nevertheless, the Swiss government continues to tighten restrictive measures.
- Sweden: Sweden has so far pursued the most liberal strategy in dealing with Covid19, which is based on two principles: Risk groups are protected and people with flu symptoms stay at home. „If you follow these two rules, there is no need for further measures, the effect of which is only marginal anyway,“ said chief epidemiologist Anders Tegnell. Social and economic life will continue normally. The big rush to hospitals has so far failed to materialize, Tegnell said.
- German criminal and constitutional law expert Dr. Jessica Hamed argues that measures such as general curfews and contact bans are a massive and disproportionate encroachment on fundamental rights of freedom and are therefore presumably „all illegal“.
- The latest European monitoring report on overall mortality continues to show normal or below-average values in all countries and all age groups, but now with one exception: in the 65+ age group in Italy a currently increased overall mortality is predicted (so-called delay-adjusted z-score), which is, however, still below the values of the influenza waves of 2017 and 2018.
- Italy: According to the latest data published by the Italian Ministry of Health, overall mortality is now significantly higher in all age groups over 65 years of age, after having been below average due to the mild winter. Until March 14, overall mortality was still below the flu season of 2016/2017, but may have already exceeded it in the meantime. Most of this excess mortality currently comes from northern Italy. However, the exact role of Covid19, compared to other factors such as panic, healthcare collapse and the lockdown itself, is not yet clear.
- France: According to the latest data from France, overall mortality at the national level remains within the normal range after a mild influenza season. However, in some regions, particularly in the north-east of France, overall mortality in the over-65 age group has already risen sharply in connection with Covid19 see figure below
- France also provides detailed information on the age distribution and pre-existing conditions of test-positive intensive care patients and deceased patients see figure below:
The average age of the deceased is 81.2 years.
78% of the deceased were over 75 years old; 93% were over 65 years old.
2.4% of the deceased were under 65 years of age and had no (known) previous illness
The average age of intensive care patients is 65 years.
26% of intensive care patients are over 75 years old; 67% have previous illnesses.
17% of intensive care patients are under 65 years of age and have no previous illnesses.
The French authorities add that „the share of the (Covid-19) epidemic in overall mortality remains to be determined.“
- USA: Researcher Stephen McIntyre has evaluated the official data on deaths from pneumonia in the US. There are usually between 3000 and 5500 deaths per week and thus significantly more than the current figures for Covid19. The total number of deaths in the US is between 50,000 and 60,000 per week. Note: In the graph below, the latest figures for March 2020 have not yet been fully updated, so the curve is slumping
- Great Britain: Neil Ferguson of Imperial College London now assumes that the UK has sufficient capacity in intensive care units to treat Covid19 patients. John Lee, Professor Emeritus of Pathology, argues that the particular way in which Covid-19 cases are registered leads to an overestimation of the risk posed by Covid19 compared to normal flu and cold cases.
- A preliminary study by researchers at Stanford University showed that 20 to 25% of Covid19-positive patients tested additionally positive for other influenza or cold viruses.
- The number of applications for unemployment insurance in the US skyrocketed to a record of over three million. In this context, a sharp increase in suicides is also expected.
- The first test-positive patient in Germany has now recovered. According to his own statement, the 33-year-old man had experienced the illness „not as bad as the flu“.
- Spanish media report that the antibody rapid tests for Covid19 only have a sensitivity of 30%, although it should be at least 80%.
- A study from China in 2003 concluded that the probability of dying from SARS is 84% higher in people exposed to moderate air pollution than in patients from regions with clean air. The risk is even 200% higher among people from areas with heavily polluted air.
- The German Network for Evidence-Based Medicine (EbM) criticises the media reporting on Covid19: „The media coverage does not in any way take into account the criteria of evidence-based risk communication that we have demanded. () The presentation of raw data without reference to other causes of death leads to an overestimation of the risk“.
Immunity Certificates: an introduction and Q&A from your friendly neighborhood virologist
My doctoral thesis was on antibody responses against emerging viruses like Ebola, Hanta, and Zika. So you can imagine how much I care about getting this stuff right.
Recently, I've seen how often the topic of “immunity certificates” has come up. So I decided to write a longform introduction and answer a few questions.
The explanation is long, but worth the read! I promise!
Q: Are "immunity passes" really a good idea?
A: It's complicated, and I'm sorry for how complicated it is.TL;DR--A lot of things will need to happen correctly for this to be a good idea: specific criteria for who gets tested & making sure that a positive on the test means you're truly immune to reinfection. Why? Because of the fundamental science of the test. But if it works, it could be a really good thing.
(If you've never heard the term "immunity pass," check out this link)
(Important point: IgG serological tests are evaluating whether or not you've already had the virus and have gotten better. Not whether or not you currently have it. That is a different thing, often called a "molecular test." For more info, check out this link)
Why no test is perfect: Harry Potter and the paradox of Positive Predictive Value (PPV)To answer this question, we need to understand antibody tests and clinical testing in general. These tests are not infallible. NO TEST IS PERFECT.
Good tests can, however, predict whether or not people are immune to the virus.
(if our understanding so far of reinfection holds true <-- and that's a big if, keep reading)
Any test, of any kind, has what's called a "Positive predictive value" i.e. If you test positive, how likely is it that you're a true positive? In this case, a true positive is someone who was already infected and has gotten better.
Even the best antibody test we have right now only has a PPV of ~18% in the general population. Meaning if I just go out and test 10,000 random people, and 300 of them come up positive, 246 of those people will be "false positives" -- they didn't actually get infected and it wouldn't be safe to have them go back to normal life.
For more on this math, here's an excellent thread from @taaltree (I cannot overstate to you how good this thread is at explaining True and false positives/negatives, PPV, NPV. I don't get into it here with as much detail but it's very useful knowledge)
Think about PPV when you see studies where they use serological testing to estimate the extent of viral spread. They will often test everyone indiscriminately, meaning their results are less accurate. And that's okay! Because they're not using the test to decide who can go back to work or w/e. They're using it to estimate the extent of disease in the general population. Different purpose. And they often correct for these sources of error, calculating that % of infected by only taking the proportion that are likely “true” positives. Remember that, if they don’t correct for false positives, their results could be way off! 82% off even! Because of this PPV problem.
Clinical tests are hard to make! A few reasons why:And why is the PPV so low for general use? Because making good clinical tests is hard!
One reason for this is because of how the testing works. These are some of the most ubiquitous clinical assays in the world. We use them all the time in the lab and in the clinic. Ever wondered how they check if your mumps or rubella vaccine worked when you were a kid?
They did an IgG serology test!
An IgG serology test takes a certain CoV protein and puts it on a plate. Then it puts a part of your blood (called "serum") on top of those CoV proteins and asks "Do any of the antibodies in this serum bind this CoV?" If enough do (and with enough strength), then you've got a positive!
IgG = A very specific antibody type called "Immunoglobulin G"
The problem is that antibodies are sticky. They're supposed to be sticky. It's their job. They stick to bad things in your blood/lungs so you don't get sick. So when we're trying to figure out if you have a certain antibody in your serum, we need to figure out how to detect that specific antibody and get it to stick to our SARS-2 “bait” without catching any of the other thousands of antibodies you have in your serum. Especially if you have any antibodies against other related viruses (like SARS-CoV-1 (the 2003 virus) or MERS-CoV, or any of the ones that cause a common cold). All of those antibodies could pose a problem. They do stuff like wash the plate with saline to make all those other sticky non-SARS-CoV-2 antibodies fall off. But it's not perfect.
Get the idea?
It's especially hard to, with a quick and repetitive test, catch all the right sticky CoV antibodies (be "highly sensitive"), but also as few of the wrong sticky non-CoV antibodies as possible (be "highly specific"). It's a little more complicated than that, but that's the basic idea.
As a result, it's difficult to make high PPV tests.
The influence of % infected on PPVThe other reason is something that has nothing to do with the test itself: how many people are actually infected in the population! The % infected! This is the single most influential statistic on PPV. The lower the % infected in the group you're testing, the lower the PPV. And the opposite is also true: higher prevalence, higher PPV.
Said another way:
Fewer infected, more false positives. More infected, fewer false positives.
With 1% infected, there will be ~82% false positives w/ Cellex's FDA-approved test.
If we get to ~10% infected in the population, then all of a sudden the test becomes much better: only around 30% false positives!. Corresponding visuals are from twitter user @LCWheeler9000.
These images are not CoV-specific, though the math works out similarly.
Between those two images, nothing about the actual test has changed. Nothing about the chemicals or the way we do it in the lab has changed. The only thing that has changed is the % infected in the population.
For a different visual explanation, check out this video.
Here is a graph of PPV vs prevalence for the Cellex test.
Okay, so how screwed are we?Fortunately, there are things we can do to increase PPV!
- If we only test people that have had symptoms, PPV goes up.
- If we use more than one test in a row, with different mechanisms, the PPV goes up.
- Retesting only positives with a new sample increases PPV.
- If you only test people if they're in NY or WA, the PPV goes up.
- If we only test people who were hospitalized, PPV goes WAY UP!
- Et cetera.
If you combine these things as criteria, but only require one of them, you get a mixed bag between the worst and best criteria. If you combine these things, and require all of them to administer the test, then the test is really good, but almost nobody gets to have it done! That's also a problem.
There are basically zero tests that we give to anyone/everyone, regardless of clinical questionnaire. HIV is close, but even then we use multiple tests, ask about exposure, etc. to increase PPV.
(If you're a virgin, and you've never used IV drugs or gotten a blood transfusion, much harder to get an HIV test. The same is likely gonna be true for people in low-risk CoVID areas with no recent travel or symptoms.)
Ultimately papers will be published and clinical reviews written by panels of experts that debate what the best methods for testing CoV immunity are going to be. Same thing happened in HIV. They weigh the pluses and minuses of having more or less strict criteria for who gets the test, and then they settle on the best combo. And that's usually what the CDC and FDA end up recommending.
After that, we have the test! (yay!) but we will still continually have to reassess how that test is performing in use. Forever, while it's being used, we need to know if it's being used correctly and if it's still doing its job.
How does this connect back to immunity certificates?We then need to figure out what relationship that "positive test result" actually has to "reinfection risk." I said on a previous post that it's really unlikely that the recovered can be reinfected (in the short term).
And I still believe that's true! But I also need to tell you that "really unlikely" is just plain not good enough for this kind of decision. We need to keep checking and check in better and more innovative ways, and determine that a "positive test result" makes reinfection very very very unlikely.
note I didn't say " antibodies " or " immunity " I said " positive test result ."*
I did this because when you're making these difficult decisions, you only have test results, not objective knowledge. You're viewing reality through a glass, darkly.
Reactive vs Neutralizing vs Protective antibodiesThe other complication to this is that antibodies on their own, are not enough. You need to have a certain type of antibodies and in large enough quantities in your blood in order to actually be protected against reinfection. This is the part we really need to investigate further before this is safe.
A “reactive” antibody is one that just binds to the protein it’s been made against. It would be useful in detecting the virus in a lab test, but not very useful in helping you avoid getting sick.
A “neutralizing” antibody is one that binds the virus in a very special way, that prevents the virus from getting into your cells. These are the antibodies we need to see in your blood. And we actually need to see them in high enough amounts as well. This is what is called a correlate of protection.
Normally, for most viral diseases, what we do is we get a big group of animals (usually mice, but sometimes ferrets or monkeys), and we vaccinate them, and figure out how much of the second kind of antibody (neutralizing) they have in their blood. Then we try our hardest to infect them. And we figure out at what level of neutralizing antibody they stop getting sick. This is then called the “protective antibody titer” (titer meaning “count”).
We have just drawn a “correlate of protection.” By correlating protection (not getting infected) with something we can measure (neutralizing antibody level in the blood).
This can take a long time to be accepted in the scientific community. For CoV, since it’s a problem right now, it may be done differently, by statistically analyzing huge groups of humans, but will also likely be done in animals like I just described at some point down the road. But in the next section I get into more detail about epidemiologically proving immunity.
* Oxford University has an article on the complexities of this if you want more detail.
How are we actually going to do this? Clinical Trials!What's likely going to happen, is researchers here and in other countries are going to do some small scale trials, with the best possible methods, to try and figure out who is immune. And whether those immune individuals are unable to get reinfected.
We need to do both molecular (in the lab) and epidemiological (in huge groups of humans) studies about this and figure out if and how we can evaluate immunity.
Germany is already starting to test the waters. Based on both objective (i.e. were you in the hospital) and subjective (did you have symptoms) criteria, they give you the test. Only some people actually get it. And that's not necessarily because we won't have enough, although there will likely also be supply chain issues. It's also because a test doesn't work as well if we give it to anyone and everyone (as I said above).
And then after they do all that testing, they're going to do one of two things:
(different countries will likely do A or B, depending on their ethical appetite for A)
A) involves what are called challenge studies where they actually straight up try their hardest to infect the people who have a positive IgG test.
And I recognize this is not super palatable to a lot of people. Purposely infecting humans?? Knowing that some might get sick??
Well they would only do this in young people (18-40) with very low risk for death or disability. And they only do it in the extremely safe environment of a clinical trial where you're being closely monitored and given the best medical care money can buy.
And it's done for the good of society! The needs of the many outweigh the needs of the few, etc. We give people money to participate, make sure they understand the risks, and so on.
(A may be less likely in the US, given the government’s risk aversity, though it could be done safely [in young people] in my opinion.)
B) involves giving a bunch of people this best possible testing regimen (multiple tests, pre-screen, w/e) and then you separate them into two groups.
Group 1 was positive on the test, Group 2 was negative. You let both groups go about their lives and then you continually monitor them extremely closely (swabbing their noses once or twice a day) and figure out if they're getting reinfected or capable of spreading virus.
If Group 1 (IgG+ via the test) gets the virus less often than Group 2 ( IgG- via the test), and to a degree that we're all comfortable with (let's say 100x less often, again panels of experts and a few lay people will decide this), then we let the positives go do their thing in society.
(Note: there's always lay people on these panels for the public perspective! Don't let anyone say that America doesn't respect the opinion of the common man.)
A>B in terms of proof of immunity = no reinfection. Option A also requires fewer people than B. Option B will likely need many thousands to be properly "powered" (statistical term meaning capable of telling with reasonable confidence) to answer the question of reinfection risk. But A can probably be done with a few hundred people.
And if it turns out that reinfection risk is less common in the test + group, then we let this test + group go back to patronizing businesses and possibly helping with relief efforts, go back to work, etc.
The role of PPV and Herd Immunity in this rolloutAnd we'll have to develop a second PPV, let's call it PPV2. PPV1 is "how likely was it that you had the virus, given a positive test result?" PPV2 is "how likely is it that you are immune and unable to get reinfected, given a positive test result?"
Two separate questions, two separate PPVs.
PPV2 needs to be high enough for "immunity certificates" to be possible.
Exactly how high is probably a factor of herd immunity. If we can be confident that 70ish% of these people are true positives, then herd immunity could be enough. This needs to be modeled based on the R0.
R0 is a number called "infectivity." -- basically means: If I'm infected, how many people do I spread the virus to? Estimates for CoV's R0 vary widely, between 2.5 at the lowest and 6 at the highest. It's a living and breathing number that factors in how well we are "sheltering in place."
But we can't just count the population we tested, we'd have to also count the essential workers those tested people will have to interact with, who may not have gotten the test, and may not have antibodies! It would have to be 70% of ALL PEOPLE who aren't in self-isolation to be true positives for that to work.
70% = (True positives)/(all the positives + all essential workers)
But even if we do issue these "immunity certificates," we have to keep checking, continually, to make sure that their immunity is still holding true. We can let all the positive people go back to higher risk activities, but then we need to keep doing B continually, and checking to make sure the positives are not at higher risk.
And so even if we do A at first, we often end up doing B afterwards on a rolling basis. We need to make sure these "immune" people aren't getting reinfected at a higher rate than the sheltered-in-place. Or at least at not at too much higher of a rate. If they are getting reinfected too often, it won't be worth it to let them return to businesses, help out with relief efforts, etc. They would pose too great a risk to everyone else.
If the numbers aren't good, then we're SOL until a better testing regimen comes along, or until we get a vaccine. But there is a chance at present that this will play out in our favor.
But if it does work, and the IgG+ are incapable of reinfection for the most part, then they could help slowly restart our economy and slowly help society return to normal...
This is probably one of the most complex, annoying, and counterintuitive parts of medical statistics, clinical pathology, etc. And it's not easy for people to understand, even doctors and scientists have trouble with this!
Other things to consider:
- We need national legislation making it illegal to discriminate against WFH, or in any way restrict WFH (work from home) in non-essential industries/jobs. We cannot let the disabled or the elderly get the short end of the stick just because the immune healthy people get to go back to work IRL.
- The testing would need to be offered for free or at low cost via the local health department, so it doesn't make worse inequities among the haves and have-nots.
- It needs to be prioritized for healthcare workers and other essential workers, so we are protecting the non-immune ones from infection as much as possible. These essential workers are a resource, as much as ventilators and medicines. We need to conserve them and keep them healthy!
- We need to be careful about intentional infection (CoVID Parties). The only way to implement something like this is slowly and methodically. We would have to do two things:
A) Examine how other countries do it and how it’s going (Because I think Americans, for example, are individualistic and crazy enough to lick doorknobs, but I’m not sure they’re that much crazier or desperate than, say, Germans, French, or Italians);It may not even be intentional infections that are the issue! People could forge certificates.
B) Do it slowly, and study the prevalence of these “negative internalities” (figure out how much bad shit is actually happening as a result of the certificates).
All of these costs would need to be measured, and compared to the benefits. Things like more jobs, fewer bankruptcies, improved mental health, fewer suicides, etc. If negative effects outweigh positive ones, then we probably shouldn’t implement it.
If we’re going to act like scientists, in a conversation about public policy & public health, then we need to do so free from inherent biases or preconceived notions. We need to put all the cards on the table, see which ones work, and then play them.
“Immunity certificates” is just one card in that hand.
The NIH is starting a serosurvey!Also check out this study from the NIH and consider participating if you qualify.
(Email [email protected] to participate)
They're testing only people with no history of a prior result (+ or -). If you've ever been tested, you can't sign up. But for everyone else, go for it! These studies will help improve the models we have and help us understand the test itself! By getting a better estimate of overall % infected and recovered.
But remember this essay, bookmark it, and come back and reread it when you see the NIH study's results. And think about how PPV and prevalence are directly linked. Lower % infected, more false positives.
And remember also that these studies are not yet designed to figure out if these people are actually immune to reinfection. They’re trying to figure out who has already been infected. Different questions. Different approaches. Different studies.
Here are some other good articles, explainers, videos:
- The WHO put out a statement about this! And it agrees with pretty much everything I’ve said here. One big caveat I would make is that WHO says there is no evidence of immunity. That’s misleading. We have some evidence that people recovered from severe CoVID cases should form protective immunity, but it’s far from conclusive.
- Twitter thread from @taaltree (I cannot reiterate enough how good this thread is at explaining TP, FP, PPV, NPV. I didn't get into it here but it's very useful knowledge)
- ProPublica article on serological tests
- This ~10 min clip about CoV Clinical Tests from the Skeptic’s Guide to the Universe Podcast #772
- This very well written article in The Atlantic by Ed Yong
- MIT Technology Review article on immunity certificates
- MGH FLARE Review of the evidence for immunity against SARS-CoV-2 (subscribe here!) (This listhost is run by a bunch of Boston MDs and summarizes CoVID stuff daily)
- Oxford University article on the complexities of serological testing and reinfection (I didn't get that deep into the topic of neutralizing vs protective vs just reactive antibodies, which is another layer to this. We need the first two, not just the third)
- Khan Academy video on HIV testing
- Published review talking about different test statistics
- An academic review on PPV and how to optimize it