For many, the choice to abandon quality and reason was easy. The reward was immediate and was reinforced by people who were selling us those bad ideas. What could possible go wrong?

The answer to that question may be painful for some of the people selling immediate gratification.

Who would have thought that a corrupt dictator would be surrounded by similarly corrupt people, who are supported by other similarly corrupt people? That’s never happened before. When attempts to isolate a country for invasion fail and the military has to fight people defending their homes, that your dream army’s erosion by corruption becomes inescapable. Reality is looking as if it will provide abundant evidence of the effects of corruption to a lot of people who have been benefiting from corruption.

A lot of people have died and more will die before that happens, so that’s not really a Happy New Year, but it should reinforce that reality doesn’t care what we believe. It is a better new year.

Some people seem to never learn, no matter the amount and/or quality of the evidence.

The extreme rejection of evidence and rejection of rationality result in a former comedian (Volodymyr Zelenskyy) to exposing the corruption of a dictator (Putin), who has surrendered a lot of his country’s ability to corrupt influence other countries.

Putin’s actions are not funny. The actions of the science deniers (not ironically, often promoted by the Kremlin) are also not funny. Reasoning with the killers has not worked, but mocking them may help to encourage people to be more reasonable.

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Will pardoning simple possession of marijuana do anything to let violent criminals out of prison? No.

Will anti-American politicians claim that laws against non-violent crimes are essential to protect Americans from violence? Liars will continue to lie, but maybe voters will do a better job of rejecting the lies.

Is it reasonable to pretend that non-violent American citizens are violent, because some politicians (and some media) don’t care how many American citizens their laws hurt? No.

Currently, 37 states and the District of Columbia have legalized medical marijuana, and 19 states have legal adult-use marijuana. Five states are voting on recreational cannabis legalization in the 2022 midterms: Missouri, Arkansas, North and South Dakota, and Maryland.

Biden pardons marijuana offenses, calls for review of federal law – Politico

Americans are refusing to continue to allow their elected representatives to spend citizens’ taxes dollars to lock up their non-violent neighbors for something that is none of the business of the politicians.

Should marijuana be on the schedule of controlled substances or should marijuana just be in a more appropriate place, reflecting the lack of harm compared to alcohol and tobacco, both of which are entirely legal for adults to possess and use?

What about driving while intoxicated/impaired by marijuana? That is already illegal, as it should be.

Harm reduction has been claimed to be the goal of tough criminal laws, but the increase in overdose deaths of Americans shows that tough criminal laws cause harm, not benefit.

Supervised injection sites produce the genuine reductions in harm that criminalization does not.

Results: Seventy-five relevant articles were found. All studies converged to find that SISs [Supervised Injection Sites] were efficacious in attracting the most marginalized PWID [People Who Inject Drugs], promoting safer injection conditions, enhancing access to primary health care, and reducing the overdose frequency. SISs were not found to increase drug injecting, drug trafficking or crime in the surrounding environments. SISs were found to be associated with reduced levels of public drug injections and dropped syringes. Of the articles, 85% originated from Vancouver or Sydney.

Conclusion: SISs have largely fulfilled their initial objectives without enhancing drug use or drug trafficking. Almost all of the studies found in this review were performed in Canada or Australia, whereas the majority of SISs are located in Europe. The implementation of new SISs in places with high rates of injection drug use and associated harms appears to be supported by evidence.

Supervised injection services: what has been demonstrated? A systematic literature review – PubMed

That is from a 2014 meta-analysis of some of the research showing that supervised injection sites are urgently needed to slow down, or reverse, the rate of overdose deaths of Americans. The research since then continues to show the benefits of supervised injection sites, while the morgues continue to show the harms of criminalization the war on drugs, reminiscent of the war on alcohol.

Research makes it clear that supervised injection sites save lives, but the people opposed to supervised injection sites tend to reject evidence and reason, in favor of feelings.

Mike Tyson said he was afraid before every fight, but he didn’t let that fear stop him. We need to accept that fear and recognize that this fear is irrational. We need to stop allowing politicians to use our fear to manipulate us into harming Americans who aren’t harming anyone else.

The NPR radio show/podcast called On Point recently had a segment on supervised injection sites in New York City. While the show and site have similar names, they are not connected (OnPoint NYC). Behind supervised injection sites: A controversial solution to overdose deaths (transcript and link to podcast)

Statement from President Biden on Marijuana Reform – White House

Why ‘Perhaps the End of the Beginning’ on Harm Reduction for Americans? It is not a reference to the 1937 Seán O’Casey play, but to part of the 1942 speech given by Winston Churchill following the victory by the Allies at El Alamein. “This is not the end. It is not even the beginning of the end. But it is, perhaps, the end of the beginning”. That speech indicated that the violently anti-fascist Allies were now fighting an offensive war.

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Welcome to Banned Books Week, which ends today, but can be celebrated all of the time – not celebrating that books are banned to punish thought crime, but to read something we might not otherwise read – to expand our awareness of what other people think – to be independent.

Some politicians claim that censorship is wrong, while using the government to prevent citizens from reading unapproved books. These politicians claim that they are protecting citizens from harm, because those citizens are students and too young to think for themselves in the schools that are supposed to teach these students to think for themselves.

The book banning politicians do not want the students to grow up to be voters who think for themselves, but want to control the information that is allowed to students, so that when they are adults, these citizens will do as they are told without questioning what they are told.

This is not new. Banning books has been around for hundreds of years and has always failed.

What is it about Toni Morrison that must be kept from students?

In 1616 the Catholic Church banned Galileo from even thinking about the Copernican hypothesis, because the Copernican hypothesis is a thought crime. In 1632 Galileo took a creative approach to the ban. Galileo wrote a dialogue discussing the superiority of the geocentric system and the heliocentric system, in spite of the evidence.

The evidence that the Earth does not move was that, if the Earth moved, we would feel it and we would be able to observe stellar parallax (when a star is viewed from one extreme of the Earth’s orbit to another, it will appear to have moved). These are common sense arguments, but common sense also tells us that the Earth is flat.

The evidence that must be ignored centered on a book written by Copernicus in 1543, later work by Johannes Kepler, and on evidence produced by Galileo with his telescopes beginning in 1609. Galileo had not invented the telescope, but had improved on it so much that he had the best telescopes in the world at that time. Using the telescope Galileo was able to show that the Earth was not the center of everything in the universe, since the moons of Jupiter revolve around Jupiter, not Earth. The existence and movement of Sun spots supported the Copernican system. The strongest argument was that Venus has phases, just like our Moon, but not consistent with revolution around Earth. Galileo was wrong about the tides, and should have known that he was wrong, but that was not an essential part of heliocentric theory.

After being threatened with torture and execution 69 year old Galileo recanted what he wrote and was sentenced to house arrest for the rest of his life. Giordano Bruno had been tortured for 7 years before being burned alive in public as an example to those who would think for themselves. Bruno was convicted of the same charge as Galileo – Heresy, which is thought crime.

The Church banned On the Revolutions of the Celestial Spheres by Copernicus (unless edited to mean the opposite of what Copernicus meant), and the books of Galileo, Kepler, and other books that provide evidence that the Earth revolves around the Sun. Some of those prohibitions lasted until 1835.

Only 45 years after the death of Galileo, long before there was evidence of stellar parallax, Isaac Newton ignored the prohibition on thought crime in his explanation of gravity. The theory of gravity requires the Earth to revolve around the Sun. If someone can show that the Sun revolves around the Earth, they can disprove gravity. Those who ban books would be ecstatic.

In 1992 Pope John Paul II gave a partial apology for the actions of the Church to punish thought crimes, but was criticized for going too far. The Catholic Education Resource Center still promotes disingenuous arguments to support the actions of the Church. Ironically, the Catholic Church does not oppose evolution (perhaps because their treatment of Galileo was so pathetically bad), but some Protestants, especially Evangelicals, do. Maybe they view evolution denial as their chance to grab their own science denial award – a Darwin Award, given to people who kill themselves through extreme stupidity.

In history, there are also books that are banned, because the evidence presented in the books may make the reader feel bad. This is not out of concern that the reader will feel bad about being lied to by their parents, teachers, and politicians. This is of a desire to protect the lies told by parents, teachers, and politicians.

The American Civil War was started by parts of America deciding to take all of their people and their land and all of the federal government land in their states and declare themselves a separate country, in order to protect slavery from the not yet elected Abraham Lincoln. This was when the Republicans were the radical progressive party and the Democrats were the unapologetic white supremacist party promoting slavery.

The dishonest historical claim is that the Civil War was fought over states’ rights, but before the war the slave states insisted that the Fugitive Slave Act be enforced everywhere in America, even though it completely violated the rights of the states that prohibited slavery. Why would they lie about something that is so easy to show to be false? Because if you are taught that thinking is a crime, you won’t check the facts. If you do check the facts, you are easier to target as a thought criminal.

Another example of the dishonesty of the claim that the Civil War was not fought to expand Christian slavery. Christian slavery does not mean slavery of Christians, although some did convert enslaved people, but slavery by Christians. Christians were the first people to enslave people based on the color of their skin. Slavery has been around probably as long as people have been around, but it was only when Europeans started exploring other parts of the world, that the business of slavery of people for looking different became established. Greece, Rome, the Ottoman Empire, . . . had slavery, but they did not have the racial slavery that Christianity created in the Age of Exploration, justified by the Bible.

Article I, Sec. 9, “(4) No bill of attainder, ex post facto law, or law denying or impairing the right of property in negro slaves shall be passed.” – Constitution of the Confederate States; March 11, 1861

Article IV, Sec. 3, “(3) The Confederate States may acquire new territory; and Congress shall have power to legislate and provide governments for the inhabitants of all territory belonging to the Confederate States, lying without the limits of the several Sates; and may permit them, at such times, and in such manner as it may by law provide, to form States to be admitted into the Confederacy. In all such territory the institution of negro slavery, as it now exists in the Confederate States, shall be recognized and protected be Congress and by the Territorial government; and the inhabitants of the several Confederate States and Territories shall have the right to take to such Territory any slaves lawfully held by them in any of the States or Territories of the Confederate States.” – Constitution of the Confederate States; March 11, 1861

The states also give their reasons for their insurrection:

A Declaration of the Immediate Causes which Induce and Justify the Secession of the State of Mississippi from the Federal Union.

“In the momentous step which our State has taken of dissolving its connection with the government of which we so long formed a part, it is but just that we should declare the prominent reasons which have induced our course.

Our position is thoroughly identified with the institution of slavery– the greatest material interest of the world.”

Confederate States of America – Declaration of the Immediate Causes Which Induce and Justify the Secession of South Carolina from the Federal Union

“We affirm that these ends for which this Government was instituted have been defeated, and the Government itself has been made destructive of them by the action of the non-slaveholding States. Those States have assume the right of deciding upon the propriety of our domestic institutions; and have denied the rights of property established in fifteen of the States and recognized by the Constitution; they have denounced as sinful the institution of slavery; they have permitted open establishment among them of societies, whose avowed object is to disturb the peace and to eloign the property of the citizens of other States. They have encouraged and assisted thousands of our slaves to leave their homes; and those who remain, have been incited by emissaries, books and pictures to servile insurrection.

For twenty-five years this agitation has been steadily increasing, until it has now secured to its aid the power of the common Government. Observing the forms of the Constitution, a sectional party has found within that Article establishing the Executive Department, the means of subverting the Constitution itself. A geographical line has been drawn across the Union, and all the States north of that line have united in the election of a man to the high office of President of the United States, whose opinions and purposes are hostile to slavery. He is to be entrusted with the administration of the common Government, because he has declared that that “Government cannot endure permanently half slave, half free,” and that the public mind must rest in the belief that slavery is in the course of ultimate extinction.

This sectional combination for the submersion of the Constitution, has been aided in some of the States by elevating to citizenship, persons who, by the supreme law of the land, are incapable of becoming citizens; and their votes have been used to inaugurate a new policy, hostile to the South, and destructive of its beliefs and safety.

On the 4th day of March next, this party will take possession of the Government. It has announced that the South shall be excluded from the common territory, that the judicial tribunals shall be made sectional, and that a war must be waged against slavery until it shall cease throughout the United States.”

Most of the Confederate states declared that they were not American before Lincoln was president. South Carolina, in the statement of their reasons does not sound much different from those claiming that Obama was going to close all of the churches and take everyone’s guns. President Obama never tried to do either one, in spite of the promises of his enemies. That is one of the reasons for banning books – to keep people from knowing the truth.

As with the memory holes in 1984, “The Party told you to reject the evidence of your eyes and ears. It was their final, most essential command.” George Orwell condemned authoritarians on the left and on the right. An important part of that condemnation is the way they try to prevent citizens from having access to information, as we see in so many states with book bans.

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The management of Vanderbilt University Medical Center created the system that killed the patient and the Nashville District Attorney’s Office is an accomplice after the fact.

Yes, the nurse, RaDonda Vaught, is was dangerous as a nurse, but that was fixed by taking away the license to work as a nurse. That doesn’t come close to bringing back the patient killed, but the patient was killed by a system that teaches incompetence. Vanderbilt University Medical Center, which should have prevented this death, rather than causing this death.

This is an example of the Dunning-Kruger effect being promoted by the hospital management. The management put a nurse, who does not know enough to safely administer sedation, in the position of teaching new nurses to sedate patients without monitoring the patients and to leave the patients in the care of people possibly even less qualified to monitor sedated patients.

How can anyone be less qualified than a nurse who killed a patient?

It may not be part of the training of the radiology technician to recognize and address (by calling for help, at a minimum) excessive sedation, so less qualified. On the other hand, the technician is working for the same hospital that put the dangerous nurse in the position of training other nurses to be dangerous.

The hospital management is telling patients that they have hired competent people, that the management values the lives of patients, and that the management is taking reasonable steps to provide the best care to patients, but the management is lying.

Accidents do happen, which is why there are rules for the administration of sedatives to protect patients.

Vanderbilt University Medical Center has repeatedly declined to comment on Vaught’s trial or its procedures.

Just as the nurse administered the wrong drug, and did not monitor the patient appropriately even for the drug that was supposed to be given, the Nashville District Attorney’s Office is prosecuting the wrong killer. If anyone should be prosecuted, it should be the people responsible – the management of Vanderbilt University Medical Center.

However, prosecuting doctors, PAs, NPs, nurses, paramedics, technicians, … for medical errors is the kind of abuse of power that harms patients. When medical professionals cannot report medical errors, without fear of being charged with crimes, more patients will die, because the errors will be covered up.

The Nashville District Attorney’s Office is telling medical professionals to cover up errors. If medical professionals do not report errors, we do not learn to avoid errors. We learn to hide errors.

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Who has created this problem? It isn’t the nurses, who are overworked, underpaid, and abused by some of their patients.

But a nurse makes more than a paramedic, so they shouldn’t complain! A nurse generally has more education and more responsibility than a paramedic, so why shouldn’t a nurse make more? Before the pandemic, I told people not to go into EMS, because there are few options in what you do for work and the standards are low.

A quick way of eliminating people, while claiming to be making things better, is to put a pay cap on the people actually doing the work. But which people do we lose with a pay cap?

With a pay cap, we lose the people who hit the pay cap, which means the highest paid people. If pay is supposed to have something to do with ability, we will lose the best employees first – and it is not likely to stop with just a few people, because this is a system that has been failing for a long time.

The increased demands of the pandemic and the attacks from the people who demand that doctors, nurses, paramedics, EMTs, … put up with abuse from the least educated, because of the “Freedom” of the least intelligent, there are not many reasons to stay. We keep telling the best nurses, that it is time to find some other way to make a living, because we don’t want competence – we only want compliance.

The way to make healthcare better is not to cap the pay of the people who do the work.

Why aren’t we limiting at the pay of the people who run things and did a lot to get us into this mess?

If we want to decrease the number of people in beds in the hospitals, we should promote vaccination, masking, and social distancing. The corruption of some politicians, partying without masks, is not a reason to avoid wearing masks, but a reason to enforce the rules without exceptions for the politically powerful.

COVID-19 has killed millions with the help of the anti-vaxers and the anti-maskers. We shouldn’t be part of the group sickening/killing our neighbors, our families, or ourselves.

Vaccines and masks are safe and effective and save lives, if we are smart enough to use them.

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There are some doctors, who do not understand the difference between good research and garbage, and are promoting bad research because they really really believe – and they were right lucky about steroids before the evidence was clear. Therefore they must be right about everything.

Except, reality does not care what you believe.

They believed in steroids before there was good evidence that steroids work, but their belief was based on wishful thinking and willful ignorance, not on good science. That they were right was purely coincidence. We have seen doctors kill tens of thousands of patients with antiarrhythmic drugs, because the drugs were widely prescribed without high quality evidence of safety and efficacy.

CAST – The Cardiac Arrhythmia Suppression Trial (the high quality evidence that was agreed to in order to prove which drug saved more lives) showed that the doctors fooled themselves, and killed their patients, by believing in something that only appeared to be an improvement in outcomes. Tens of thousands of deaths were not an improvement in outcomes.

If we have a story that seems to make sense, it is much easier to convince ourselves that we are not killing patients. After all, we mean well. At least some of us do. This is an example of misleading ourselves with a narrative fallacy. C A S T and Narrative Fallacy. Rudyard Kipling called these Just So Stories.

Dr. Pierre Kory (president of the Frontline COVID-19 Critical Care Alliance – FLCCC, which is different from the extreme quackery of America’s Frontline Doctors) may be a true believer, but if Dr. Kory really believes ivermectin works, he should be demanding large scale randomized double blinded placebo controlled research, rather than making excuses for low quality research.

Dr. Kory’s claims are so bad that even PolitiFact can’t find any truth in Dr. Kory’s claim – and PolitiFact tries to be as fair to every claim as possible.

What about the science? The promoters of ivermectin have claimed that the odds are over 2 trillion to 1 that the results of the latest meta-analysis are due to chance low quality research methods. Their research methods are almost as bad as their math.

Ivermectin meta-analyses:

1) Most of the studies are poorly designed and don’t provide datasets. No way to demonstrate replicability.

2) Grouping observational studies and RCTs with different populations, control groups, dosing, and outcomes: unreliable due to heterogeneity. https://t.co/PQEyyqTtrv

— MJ (@mjaeckel) June 19, 2021

Dr. David Gorski has written a long article that goes into detail about the problems with this latest paper. Ivermectin is the new hydroxychloroquine, take 2. Read the whole article, but here is a sample:

In fairness, the authors don’t actually say that meta-analyses of crappy studies do make good evidence, at least not in the paper. However, ivermectin advocates touting the study fans are certainly making that claim, and Dr. Kory sure did seem to me to imply the same in his interview with Bret Weinstein. In any event, one large, well-designed rigorous double-blind clinical trial for prevention, along with one large, well-designed rigorous clinical trial for treatment, could trump this entire meta-analysis.

Indeed, Gideon Meyerowitz-Katz did a reanalysis of the studies analyzed by the BIRD Group that shows that if you leave out the two studies that are as yet only preprints, are very small, and actually appear to have been miscategorized as higher quality than they are, the results are very different:

This basically shows that without those two studies, the analysis demonstrates no benefit for ivermectin at all compared to placebo, with a confidence interval that includes everything from a big benefit to a large harm from the drug.

If the study really had a 2 trillion to 1 chance of the results being by chance alone, it would not rely of such low quality research (preprints, tiny studies, studies without placebos, studies that are not double blinded, . . .).

There is no good reason to look at any research on treatment for COVID-19 that is not randomized placebo controlled and double blinded.

There are millions of patients to study, so the only reasons to avoid using the highest quality of research is a lack of confidence in the treatment.

As with promoters of alternative medicine, the actions of the promoters of ivermectin do not demonstrate confidence that what they are selling will survive high quality research.

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If the mRNA (messenger RiboNucleic Acid) vaccines really work, how is it possible for someone to get COVID-19 after receiving both the first and second shot of the Pfizer/BioNTech vaccine?

The results of the research submitted to the FDA (Food and Drug Administration) for an EUA (Emergency Use Authorization) show that the vaccine is much more effective than was expected. Originally, the efficacy goal for a vaccine was to prevent at least 50% of disease. The Pfizer/BioNTech vaccine research shows that it prevents 95%.

For participants without evidence of SARS-CoV-2 infection prior to 7 days after Dose 2, VE [Vaccine Efficacy] against confirmed COVID-19 occurring at least 7 days after Dose 2 was 95.0%. The case split was 8 COVID-19 cases in the BNT162b2 group compared to 162 COVID-19 cases in the placebo group (Table 6).

Link to research – Efficacy Results – Primary Endpoint (Evaluable Efficacy Population)

95.0% is more precise than anyone should be using, even if it is mathematically correct to calculate it that way. The paper does admit this: “The 95% credible interval for the vaccine efficacy was 90.3% to 97.6%, . . .” As more people are vaccinated, the numbers reported will more accurately represent the true protection from disease.

Here is where things start to get complicated. Protection from “disease”, in the case of vaccine approval, means not developing symptoms. Symptoms are what the person experiences – cough, shortness of breath, weakness, aches, et cetera. Signs are things that the person might not feel, such as an elevated heart rate or hypoxia (hypoxia is a low oxygen saturation). Hypoxia is a particular problem with COVID-19, since many patients have been hypoxic, but have not experienced any difficulty breathing or other respiratory symptoms. It is easy to miss hypoxia in COVID-19 patients, if we are not measuring oxygen saturation.

If the person does not have any symptoms, does that mean that the person is not infected? No.

Is that a problem? Probably not. It would be best, if the vaccines provide sterilizing immunity – immunity that prevents the transmission of infection. Often an infection is asymptomatic, so the person is not aware of being infected. Measuring the rate of infection requires frequently testing everyone, but that was not the goal of this research. The goal was for the vaccine to decrease the spread of disease (an infection that is causing symptoms), when compared with placebo. We do not yet know if any COVID-19 vaccines prevent transmission of infection. The Pfizer/BioNTech vaccines, which is what US Rep. Stephen Lynch received two doses of, prevents development of symptoms 95% better than placebo (not receiving any active vaccine doses). That also means that a small percentage (5%) of the people who are vaccinated will be expected to become symptomatic.

A statement from the South Boson congressman’s office says Lynch isn’t displaying any symptoms of COVID-19.

Link to article in MassLive

Since he is not reported to be experiencing any symptoms, Rep. Lynch is still considered to be asymptomatic, therefore probably in the 95% protected from disease (symptoms). It is possible that Rep. Lynch would have developed an asymptomatic infection, if he were not vaccinated, but we do not know. At 65 years old, Rep. Lynch is not expected to develop an asymptomatic infection. That is much more likely to occur in much younger people, but there are no guarantees.

Why did the researchers only look at symptoms? Because it would be a lot more work, and money, and could discourage people from volunteering for the study, since participants would have to get tested for COVID-19 every few days to determine if they had infection, rather than only getting tested after developing symptoms. Is it possible that more people became infected in the vaccine group, than in the placebo group? Yes, but it is unlikely and more infections in the vaccine group, with 95% less disease, would not indicate that vaccination is a problem. Why?

In the final analysis of the evaluable efficacy population (7 days), four participants had severe COVID-19 disease at least 7 days after Dose 2 (one subject who received BNT162b2 and three participants who received placebo). The vaccine recipient who had severe COVID-19 disease met the severe case definition because oxygen saturation at the COVID-19 illness visit was 93% on room air. The subject was not hospitalized, did not seek further medical care, and did not have risk factors for severe disease. The three placebo recipients who had severe COVID19 disease met the severe case definition for the following reasons: one subject had an oxygen saturation of 92% on room air without other severe disease criteria, one subject was hospitalized for noninvasive positive pressure ventilation with bilateral pneumonia, and one subject had an oxygen saturation of 92% and ICU admission for heart block. One of these placebo recipients with severe disease also had a body mass index > 30 kg/m2 as a risk factor, while the other two participants did not have any risk factors for severe disease. The vaccine efficacy of this secondary efficacy endpoint is shown in Table 11.

The worst outcome, among those vaccinated, was an oxygen saturation that dropped to 93%. It does not describe if symptoms resulted in testing, or if it was due to an exposure, or something else, but the reason this person is categorized as severe disease is an oxygen saturation of 93%. One of the three patients in the placebo group was also considered to have severe disease is for a similar oxygen saturation (92%), which is essentially the same as 93% for treatment purposes.

Has the protection provided by vaccine decreased since the EUA approval for the vaccine? No. There have not been any reports of decreasing efficacy of either mRNA vaccine. Any reasonable person, who does not have a medical reason for not getting vaccinated (severe allergies seems to be the only consideration), should receive both shots of vaccine.

You can develop immunity naturally, with about a 1% chance of death and about a 15% chance of severe disease (depending on age, co-morbidities, …), or you can obtain immunity by vaccination, with the possibility of some side effects, which are reported to be less severe for older people.

The only reason Rep. Lynch found out that he was infected was testing after a member of his staff tested positive for COVID-19. He is not reporting any symptoms. A vaccine that prevents symptoms, even if it allows infection, is still a successful vaccine. Preventing disease and preventing death are both very important benefits of vaccines.

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The 9 AM December 10 meeting is available by video conference at this link. Since we are seeing record rates of infection, there should be a lot more cases of infection, with the same difference in numbers between the placebo group and the vaccine candidate group. There are two important questions.

We may not be be able to answer either one, yet. How long does the vaccine candidate protect recipients. We know there are cases of people developing COVID-19 after recovering from an earlier case. Since there are no coronaviruses that have provided long term immunity, how often will we need to get vaccinated? Every six months? Every year? Every other year?

Usually, reinfection results in a less serious infection, but there is already evidence that this may not be the case with COVID-19.

The patient had two positive tests for SARS-CoV-2, the first on April 18, 2020, and the second on June 5, 2020, separated by two negative tests done during follow-up in May, 2020. Genomic analysis of SARS-CoV-2 showed genetically significant differences between each variant associated with each instance of infection. The second infection was symptomatically more severe than the first.

Genomic evidence for reinfection with SARS-CoV-2: a case study

He was reinfected two months later and the second infection was more severe.

The other important thing that we may not be able to know depends on the amount of information obtained by the study. Did the study require tracking of the close contacts of the participants to see if there is a difference in infection rate?

If there is no difference, that means the vaccine candidate does not prevent transmission, even though it prevents the vaccinated people from becoming noticeably sick. This would still be an effective vaccine, but would require a higher rate of vaccination to control the pandemic.

The higher the rate of vaccination needed, the more likely it is that the anti-vaxers will keep the pandemic from being stopped for years, if not forever. Anti-vaxers have prevented the eradication of polio, so we have to continue to vaccinate our children against polio. Successful vaccines put themselves out of business. Anti-vaxers require vaccination for ever.

Fortunately, anti-vaxers failed to protect smallpox, so we no longer have to vaccinate children against smallpox.

Vaccines are probably the safest and most effective medical intervention available, but anti-vaxers oppose that.

Vaccines save millions of lives every year – mostly the lives of children – but anti-vaxers oppose that.

. ]]> https://roguemedic.com/2020/11/update-on-the-moderna-vaccine-candidate/ Mon, 30 Nov 2020 21:30:44 +0000 https://roguemedic.com/?p=26749

Today Moderna issued another press release to update the information available on their vaccine candidate. The results are consistent with the previously released results and will be followed by a much more detailed release of information at an FDA advisory panel meeting, expected to be on December 17, 2020.

The new cases are more than double the 95 cases from the November 16 press release. The total is now 196 symptomatic cases – 185 in the placebo group and 11 in the mRNA-1273 group – efficacy of 94.1%. There were 30 severe cases, including 1 death, in the placebo group and no severe cases in the mRNA-1273 group.

We do not know how many asymptomatic cases are in either group, so this route of transmission by vaccinated people is still a possibility.

Another part of the press release raises different questions.

Efficacy was consistent across age, race and ethnicity, and gender demographics. The 196 COVID-19 cases included 33 older adults (ages 65+) and 42 participants identifying as being from diverse communities (including 29 Hispanic or LatinX, 6 Black or African Americans, 4 Asian Americans and 3 multiracial participants).

But . . .

The study includes more than 11,000 participants from communities of color, representing 37% of the study population, which is similar to the diversity of the U.S. at large.

The minority rate in the study is stated to match the 37% minority rate of America, but the symptomatic infection rate among American minorities in the study is 42 out of 196 (21.4%), but according to a meta-analysis of over 18 million patients in the Lancet, the symptomatic infection rate among minorities is significantly higher than 37%:

Patients from ethnic minority groups are disproportionately affected by Coronavirus disease (COVID-19). We performed a systematic review and meta-analysis to explore the relationship between ethnicity and clinical outcomes in COVID-19.

How is this study of randomized volunteers, who are allegedly representative of the American population, producing symptomatic infection rates that are much less than half of what is expected among minorities?

The November 18 Pfizer/BioNTech vaccine candidate press release only states:

Efficacy was consistent across age, gender, race and ethnicity demographics.

I did not find any details of the actual numbers in the press release, nor in any of the links. The Moderna press release has a similar statement, even though the numbers provided disagree with that statement: “Efficacy was consistent across age, race and ethnicity, and gender demographics.” Is the Pfizer/BioNTech statement more trustworthy, because it does not provide any numbers? No, but this is something that needs to be addressed for all of the vaccine candidates.

What are the Pfizer/BioNTech numbers for minorities? The FDA meeting for Pfizer/BioNTech is scheduled for December 10, so we should learn a lot more from that open to the public by video FDA meeting.

Why does the Moderna press release list such disproportionate numbers, but not mention that they are disproportionate? There is no reason to expect that a placebo would provide this kind of disproportionate protection.

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There was a press release from AstraZeneca at 7 AM today. It includes two different dosing methods with two dramatically different rates of efficacy. One group received half a dose, followed by a month later by a full dose. The other group received a full dose, followed by a month later by another full dose.

One dosing regimen (n=2,741) showed vaccine efficacy of 90% when AZD1222 was given as a half dose, followed by a full dose at least one month apart, and another dosing regimen (n=8,895) showed 62% efficacy when given as two full doses at least one month apart. The combined analysis from both dosing regimens (n=11,636) resulted in an average efficacy of 70%. All results were statistically significant (p<=0.0001). More data will continue to accumulate and additional analysis will be conducted, refining the efficacy reading and establishing the duration of protection.

Usually, the result of the differences in dosing is to use the lowest effective dose, in order to minimize any side effects, which are usually dose related. A higher dose is expected to be more effective, but also to have more side effects.

The part people are having a hard time explaining is that the 90% efficacy is in the smaller dose group. This does not seem to make medical sense, but this is what people who understand statistics expect.

Why?

Daniel Kahneman explains this in his excellent book, Thinking, Fast and Slow. He uses the following example as an introduction:

A study of the incidence of kidney cancer in the 3,141 counties of the United States reveals a remarkable pattern. The counties in which the incidence of kidney cancer is lowest are mostly rural, sparsely populated, and located in traditionally Republican states in the Midwest, the South, and the West. What do you make of this?

This is known informally as the Law of Small Numbers. Intuitively, we can come up with many different explanations about a healthy rural lifestyle, or something else. Kahneman follows that with the statistics on counties with the highest incidence of kidney cancer, which are also mostly rural, sparsely populated, and located in traditionally Republican states in the Midwest, the South, and the West.

The important factor is not lifestyle, not politics, and not geography. The important factor is that these are all sparsely populated counties, which means that the number of cases of kidney cancer will be disproportionately affected by the addition/subtraction of a tiny number of cases.

The small sample size is the most likely explanation for the 90% efficacy in the half dose, then full dose group. When more cases of COVID-19 are diagnosed among those who have received the half dose, then the full dose, expect the estimate of benefit to drop closer to 70%. The 70% efficacy is also based on small numbers, but those numbers (including the 90% sample) are more than four times the size of the 90% sample. This is not certain. This is statistical probability. A reasonable person should feel comfortable in placing a wager on the results dropping to near 70%.

In other words, the news is worse than expected, although still good news. There is another vaccine candidate that, based on the preliminary numbers, meets the approval criteria of better than 50% efficacy.

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I had thought that the vaccine studies would only be recruiting people up to 55 years old, which was the age limit on the phase 1 studies, but there is significant representation of people over 65 and people with serious comorbidities. This is excellent news.

According to one press release from Moderna:

The COVE study includes more than 7,000 Americans over the age of 65. It also includes more than 5,000 Americans who are under the age of 65 but have high-risk chronic diseases that put them at increased risk of severe COVID-19, such as diabetes, severe obesity and cardiac disease.

The other important concern I had was the need to store the vaccine at around -80 degrees C, which would limit access for a lot of people, even in America. From another press release, dated 4 minutes earlier, Moderna:

today announced new data showing that mRNA-1273, its COVID-19 vaccine candidate, remains stable at 2° to 8°C (36° to 46°F), the temperature of a standard home or medical refrigerator, for 30 days. Stability testing supports this extension from an earlier estimate of 7 days. mRNA-1273 remains stable at -20° C (-4°F) for up to six months, at refrigerated conditions for up to 30 days and at room temperature for up to 12 hours.

There is an excellent analysis of the press release on preliminary efficacy results at STAT News, which has been ahead of the rest of the media in recognizing the serious nature of this pandemic.

It is important to remember that a press release, even about something this serious, is a commercial, intended to promote the company’s product. The information provided by Moderna in the press releases has not been peer reviewed. The numbers may change as mistakes are caught and conclusions are examined. That is OK, because there will be thorough analysis of the results before any vaccine candidate is approved for use outside of these experiments.

How will we know when a vaccine is safe and effective? I provided my criteria in August, when I wrote about a vaccine approved by President Putin, based on inadequate research:

I want to see recommendation of a vaccine by the people who know the most about vaccines – Paul Offit, Michael Osterholm, Peter Hotez, and Anthony Fauci. They need to be able to see all of the evidence. The only reasonable conclusion about a refusal to share the evidence with any of them is that there is something bad being hidden. These are not politicians. None of these medical experts have shown signs of being influenced by political pressure.

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Now that President Trump’s attempts to prevent himself from developing COVID-19 have failed, for the president and for many of those around him, will the president continue to reject science, when it comes to treatment?

Currently, mask vs. vaccine is an easy answer. Masks are 100% more effective than something that is not available. Eventually, mask plus vaccine may be the best answer.

According to the evidence, the the masks decrease the amount of virus that is able to be detected on the other side of the mask, regardless of whether the mask is being worn by an infectious person trying to avoid infecting others or the mask is being worn by a healthy person trying to avoid becoming infected.

The dose of virus does seem to matter in transmission of disease.

This does not mean that vaccines will not help, assuming that a safe and effective vaccine is eventually available. The stated cut off level to be applied for approval of a vaccine is currently at least 50% effective. Masks are already more than 50% effective.

That statement was later contradicted by President Trump, but that statement was not contradicted by any credible scientist and was not contradicted by any credible physician. Oddly, the article title suggests that Dr. Redfield walked back his statement, although the article never states that. This may be because the headline is often not written by the person writing the article, but by an editor, looking to get more clicks.

Masks work.

Vaccines are not available and probably will not be available until sometime next year.

If we want the economy to recover, we need to be aggressive about wearing masks to protect others and to protect ourselves.

This is from a paper written in 2009 about influenza, which is transmitted the same way SARS-CoV 2 is transmitted. These were people with influenza, wearing masks, and coughing. The results with an N95 mask and a surgical mask show that both decreased the amount of virus, that would be spread by a cough, to the undetectable level.^[2]

Masks do not protect your eyes, so you should consider wearing eye protection. Masks also do not protect your hands, so wash your hands. Typhoid Mary might not have killed anyone if she had washed her hands.

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Footnotes:

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^[1] CDC Chief Walks Back Masks v. Vaccine Comments
By Ralph Ellis
WebMD
Article

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^[2] A Quantitative Assessment of the Efficacy of Surgical and N95 Masks to Filter Influenza Virus in Patients with Acute Influenza Infection
D. F. Johnson, J. D. Druce, C. Birch, M. L. Grayson
Clinical Infectious Diseases, Volume 49, Issue 2, 15 July 2009, Pages 275–277, 
https://doi.org/10.1086/600041 Published: 15 July 2009

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President Trump has made another medical recommendation. This one is more dangerous than the last. As long as a lot of physicians are willing to harm patients in order to promote their political agenda, President Trump is willing to keep playing doctor and providing them with ways to harm patients. We can hope that the FDA (Food and Drug Administration) takes action to protect patients from such doctors.

Hydroxychloroquine was supported by low-quality research, but some physicians couldn’t wait to promoted it. That is alternative medicine – the opposite of competent medicine.

When high-quality evidence on the use of hydroxychloroquine in humans with COVID-19 was published, these physicians insisted that the research was politically motivated, each time a new high-quality study was published. That is the argument used by alternative medicine, not real medicine. Every high-quality study shows that there is no benefit from hydroxychloroquine for COVID-19 patients. The risks are greater than the potential benefits. Competent and ethical physicians should limit the use of hydroxychloroquine to well-controlled research.

Now we have a more extreme danger to patients from alternative medicine and promoted by President Trump. Oleandrin is an extract of the oleander plant and is not supported by any research in humans. The only research supporting oleandrin as a COVID-19 treatment is in test tubes, which means that this is not even as well tested as the vaccine approved by President Putin earlier this month. If there is any use in humans, it would be in a Phase 1 trial. Not even that level of research has been done, yet.

The obvious image to use to explain this is from xkcd.

Oleandrin, and thousands millions of other chemicals, kill coronaviruses in petri dishes. Killing cells in petri dishes does nothing to help patients.

For more detailed information read this article or this article or listen to this podcast.

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Meanwhile the Moscow-based Association of Clinical Trials Organizations (Acto), which represents the world’s top drug companies in Russia, urged the health ministry to postpone approval until after phase-three trials.

Acto executive director Svetlana Zavidova told the Russian MedPortal site that a decision on mass vaccination had been carried out after a combined first- and second-phase tests on 76 people, and that it was impossible to confirm the efficacy of a drug on this basis.^[2]

“This is all beyond stupid,” said John Moore, a virologist at Weill Cornell Medical College in New York City. “Putin doesn’t have a vaccine, he’s just making a political statement.”

Dr. Nicole Lurie, a former assistant secretary for preparedness and response at the U.S. Department of Health and Human Services and currently an adviser at the Coalition for Epidemic Preparedness Innovations, said the lesson that the U.S. government should draw from Mr. Putin’s announcement is clear.

“This is exactly the situation that Americans expect our government to avoid,” she said.

As most patients in this trial receiving HCQ or HCQ + AZM received steroids and the patients receiving AZM alone or neither therapy had far fewer patients receiving steroids, the likely mortality benefit of this trial is due to the steroids and not the HCQ or HCQ + AZM

Our study had 2 main findings. First, intercessory prayer itself had no effect on whether complications occurred after CABG. Second, patients who were certain that intercessors would pray for them had a higher rate of complications than patients who were uncertain but did receive intercessory prayer.

Q. Why did FDA grant the EUA for hydroxychloroquine sulfate (HCQ) and chloroquine phosphate (CQ) for the treatment of COVID-19 initially?
A. On March 28, 2020, BARDA requested and FDA issued an Emergency Use Authorization (EUA) for emergency use of oral formulations of chloroquine phosphate (CQ) and hydroxychloroquine sulfate (HCQ) for the treatment of COVID-19. Based on the scientific information available to FDA as of that date, the Agency determined that CQ and HCQ may be effective in treating COVID-19 and that the known and potential benefits of CQ and HCQ outweighed the known and potential risks for this use. The agency limited the use of authorized products to adults and adolescents who weigh 50 kg (approximately 110 pounds) or more, who were hospitalized with COVID-19, and for whom participation in a clinical trial was not available, or participation was not feasible.

The probability that a research claim is true may depend on study power and bias, the number of other studies on the same question, and, importantly, the ratio of true to no relationships among the relationships probed in each scientific field. In this framework, a research finding is less likely to be true when the studies conducted in a field are smaller; when effect sizes are smaller; when there is a greater number and lesser preselection of tested relationships; where there is greater flexibility in designs, definitions, outcomes, and analytical modes; when there is greater financial and other interest and prejudice; and when more teams are involved in a scientific field in chase of statistical significance.

Abandoning ineffective medical practices and mitigating the risks of untested practices are important for improving patient health and containing healthcare costs. Historically, this process has relied on the evidence base, societal values, cultural tensions, and political sway, but not necessarily in that order. We propose a conceptual framework to guide and prioritize this process, shifting emphasis toward the principles of evidence-based medicine, acknowledging that evidence may still be misinterpreted or distorted by recalcitrant proponents of entrenched practices and other biases.

It is common to see new studies contradict previous adopted standards of care [25,26]. Even the results of highly cited studies can be refuted [7], and the replication rate tends to be low for claims made from observational designs [7]. We have previously noted that the most common correlate for reversal of standards of care was the original adoption of a practice based on nonrandomized evidence alone [27]. The studies examined here offer many recommendations that may be precarious or erroneous. If adopted, such practices may need to be reversed in the future after having been detrimental to health, health finances, and the reputation of medical science.

Of the 45 eligible highly cited studies with efficacy claims (Table 2), 7 (16%) were contradicted by subsequent research, and another 7 (16%) were found to have initially stronger effects. In all these 14 cases (BOX 1), subsequent studies were either larger or better controlled (randomized vs a nonrandomized original study). The findings of 20 highly cited articles (44%) were replicated (also with a larger sample size in subsequent research compared with the original highly cited study) and 11 (24%) had remained largely unchallenged.^58-78

Many white Americans seem to be telling the rest of America to get over it and let things go back to normal – after all, acknowledging that we are complicit would require honesty – and that appears to be asking too much.

You can’t make an omelette without kneeling on a few necks? Right?

What has changed? The smart phone, which includes the ability for almost anyone to broadcast high quality video to the world. We no longer have to rely on the kind of evidence that most often leads to the conviction of people who were not at all guilty. That evidence is eyewitness testimony.

Why is eyewitness testimony so bad?

Eyewitness testimony relies on our perception, which has evolved in a way that reinforces our prejudices. Our perception definitely does not objectively and accurately observe events. The fictional film Rashomon^[1] does a great job of demonstrating different views of the same event by four different people involved in that event. All have different prejudices influencing their perceptions.

One product of the availability of high quality video is the ability to show that UFO (Unidentified Flying Object) sightings require the lowest quality video, in order to be believed, because as we have more and more high quality video of things that are real, the video of UFOs continues to be of the lowest quality and fail to support the claims of those insisting that UFOs are aliens.^[2]

The opposite is true about the claims unjustified police violence. The increasingly high quality of the videos confirms what the victims have been saying all along. There are a lot of bad cops.

This video is of the Buffalo ERT (Emergency Response Team) in action against a white 75 year old peaceful, if vocal, protester.

For those of you with any kind of medical training, after falling and apparently hitting his head out of view of the video, the blood coming out of the ear can indicate a serious head injury. According to the news, the man is still reported to be in serious condition in the hospital.

The entire ERT responded to the suspension of bad cops by resigning from the ERT, not from the police force, in solidarity with their criminal brothers. Fire, EMS, and other police also rallied in support of their criminal brothers, because that is what is expected of good cops?

If the police cannot recognize criminal behavior, should they be police?

The excuse for the violence by the police is that the guy presented a threat to them, so it is acceptable to knock him down and walk away, because that is the kind of police force we should want. If he is a threat, what do they do when presented with a real threat? He appears to be merely a threat to their dominance, which has become the point for President Trump, Sen. Tom Cotton, and others, who are more worried about appearances than about law; more worried about appearances and about lives.

If there is such widespread opposition to law enforcement (supporting bad cops is not supporting law enforcement) how will the police survive?

When the police refuse to do their job refuse to enforce the law and require an oath of Omerta^[3], how are the police any different from the Mafia, or any other criminal organization?

This is America in 2020.

If you are a black man, you can expect to be stopped for no reason other than being black, even though this is prohibited by the Constitution. You can expect to be searched for no reason other than being black, even though this is also prohibited by the Constitution. You can expect to know some other black man who has been killed by the police for being black at the wrong time in America.

What about the reports submitted by the police involved in these incidents? The reports do not include the truth.^[4]

If you are someone who peaceably assembles to protest criminal behavior by the police, you can expect to be attacked for peaceful protest, even though this is prohibited by the Constitution.

There is a famous poem that describes the conditions that discourage us from protecting our rights from authoritarian abuse.

First they came for the socialists, and I did not speak out— Because I was not a socialist.

Then they came for the trade unionists, and I did not speak out— Because I was not a trade unionist.

Then they came for the Jews, and I did not speak out— Because I was not a Jew.

Then they came for me—and there was no one left to speak for me.^[5]

This was written by Martin Niemöller, a German Christian pastor, in part to atone for his willing participation as an anti-communist. Eventually, Niemöller spoke out about the non-communists being sent to concentration camps. Martin Niemöller was arrested in 1937 and remained in a concentration camp until the end of the war.

We can always make excuses for why some people do not deserve equal citizenship. Moral people do not do this. Jesus didn’t make these excuses. Jesus was killed for upsetting the people.

Footnotes:

^[1] Rashomon
Wikipedia
Article

^[2] Pentagon UFO Video
Published by Steven Novella
Neurologica
Article

^[3] Omerta
Lexico
Definition

o·mer·tà /ōˈmertə/ noun (as practiced by the Mafia) a code of silence about criminal activity and a refusal to give evidence to authorities. “loyal to the oath of omertà”

^[4] When the Police Lie
New York Times
By David Leonhardt
June 8, 2020, 6:37 a.m. ET
Article

^[5] First they came …
Wikipedia
Article

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