Without evidence of benefit, an intervention should not be presumed to be beneficial or safe.

- Rogue Medic

Mask vs. Vaccine – Which is More Effective?

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.

“I might even go so far as to say that this face mask is more guaranteed to protect me against COVID than when I take a COVID vaccine, because the immunogenicity may be 70%,” Redfield said in testimony before a Senate appropriations committee. “And if I don’t get an immune response, the vaccine is not going to protect me. This face mask will.”[1]

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.

**********************

.

Footnotes:

.

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

.

[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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The Oleandrin Scam Exposes Incompetent Doctors

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.

The mouse over text states: Now, if it selectively kills cancer cells in a petri dish, you can be sure it’s at least a great breakthrough for everyone suffering from petri dish cancer.

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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What Does the Approval of a Russian Vaccine Mean?



Today, after testing on a grand total of 76 people, President Putin announced the approval of a vaccine in Russia, Sputnik-V, to prevent COVID-19.

We knew another pandemic was coming, because we understand evolution. We should have been prepared. We were prepared under the Bush administration. We were prepared under the Obama administration. The current administration chose to stop wasting money on being prepared.

There are three human phases of testing generally required before the approval of a vaccine or drug, after testing in other animals. Phase I is testing in humans for common adverse effects, dosing ranges, and to generally learn how the body reacts. For the most discussed vaccine trial, Moderna had 45 people (three groups of 15 people each receiving different doses of vaccine) in their Phase I trial.

Phase II expands the use to people who are not as healthy as the people in Phase I and to a more people. Phase III is refining this, based on the results of the earlier trials. Phase I and II are being combined in some vaccine trials. Phase II and II are being combined in others.

The Moderna Phase III trial of mRNA-1273 (mRNA is messenger RiboNucleic Acid – the stock ticker for Moderna, Inc. is also MRNA) is expected to enroll 30,000 people who have no evidence of previous COVID-19 infection.[1] Half will get mRNA-1273 and half will get a meningitis vaccine as a placeboish control. While a placebo often means inert, a saline solution injection would not produce the temporary fever, soreness, and/or redness to the site at the same rate as an actual vaccine. This is expected to keep the volunteers from being able to tell which they have received and it provides a benefit to those in the placebo group.

Russia has enrolled 76 people in Phase I and President Putin has announced that Phase III will happen at the same time as the mass vaccination of the people most likely to be exposed to infection. This is Phase IV – post approval study.

Russia has not announced any challenge testing, which might have been a more ethical approach than skipping Phase III. Challenge testing has not being announced anywhere for COVID-19 vaccine testing, because of the ethical concerns. With an expected 1/2% to 1% fatality rate, a much higher rate of serious complications, and an unknown rate of long term complications that appear to be related to COVID-19, it is difficult to justify intentionally exposing people to infection with a vaccine of unknown ability to protect the people being exposed. Thousands of people dying each day, thousands more developing serious complications each day, and thousands more developing long term complications each day. Where is the line drawn between approving challenge testing and not approving it? Where is the line drawn between challenge testing and skipping Phase III trials?

When will the Russian vaccine be given to people? Some time in October.

What could go wrong?

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]

Will this be just another political intervention, like hydroxychloroquine? Only time will tell.

What would indicate that the United States has a safe and effective vaccine?

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.

The pandemic was not at all a surprise. The conspiracy theorists will misrepresent this video, because of their lack of understanding of what they are hearing. If it doesn’t support their prejudices, they don’t seem to hear anything at all, as if they have been programmed to ignore valid evidence and logic.

Pandemic Preparedness in the Next Administration: Keynote Address by Anthony S. Fauci – Feb. 14, 2017 – Almost 3 years before COVID-19, but the medically competent audience understood that this was a reasonable prediction to make in 2017. If you don’t understand that, watch the whole video.



Every reasonable person should have known there would be another pandemic, but we have media that discourage understanding, especially about science.


Late addition – 10:55 – 8/12/2020 – For further information, Carl Zimmer has an article in The New York Times going into more detail. A couple of important quotes from the article are below.

‘This Is All Beyond Stupid.’ Experts Worry About Russia’s Rushed Vaccine
August 11, 2020
by Carl Zimmer. Andrew Kramer and Katherine J. Wu contributed reporting.
The New York Times
Article

“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.

Footnotes:

[1] Phase 3 clinical trial of investigational vaccine for COVID-19 begins – Multi-site trial to test candidate developed by Moderna and NIH.
Monday, July 27, 2020
NIH (National Institutes of Health)
News Release

[2] Coronavirus: Putin says vaccine has been approved for use
Analysis by Fergus Walsh, Medical correspondent
BBC
Article

.

Is Hydroxychloroquine Effective Against COVID-19?

     
As with any popular treatment, there are plenty of people who want us to ignore the research, or to focus on giving people hope. That is not a reasonable, or ethical, approach to medicine. That is not even a medical approach to medicine. If we lower our standards enough, we can claim that everything works, but that would kill a lot more people than only using treatments based on EBM (Evidence Based Medicine). Should we make excuses for lowering our standards, and killing people, or should we insist on raising our standards?

There is currently a pandemic, so there is a bit of a rush to find something that works, which some people mistake for a need to provide hope. If you want hope, you can pray and there should not be any harmful effects of praying. However knowing that you were being prayed for by others has been associated with a significantly higher incidence of complications. In other words, praying for yourself or others is fine, but telling others that you are going to pray for them is probably harmful, even though your intent is to help.[1]

The reasonable way to look at taking medicine is take only those treatments that have been demonstrated to improve outcomes for people with the studied diagnosis, when you have that diagnosis. Everything else is a crap shoot, where you don’t even know the risks – and there probably is no benefit.

Why do I state that the risks to the person taking the treatment are unlimited, but the benefits probably do not exist?

That is the history of the study of treatments. Almost everything proposed as a treatment has been more harmful than beneficial. It would be nice if this were not true, but reality doesn’t care about being nice. All of alternative medicine falls into the category of probably more harmful than safe and unlikely to be of any benefit, other than a benefit to the finances of the person selling the alt med.

Is hydroxychloroquine alternative medicine? Hydroxychloroquine is approved as real medicine for malaria, lupus erythematosus, and rheumatoid arthritis.[2] For these diagnoses, hydroxychloroquine is not alternative medicine. For everything else, the use is off-label, which is a legal way of saying alternative medicine, as far as the FDA (Food and Drug Administration) is concerned. Sometimes off-label use can be supported by good evidence, but the treatment has not been submitted to the FDA for approval for that diagnosis, but that is not the case with hydroxychloroquine. The FDA issued an EUA (Emergency Use Authorization) for hydroxychloroquine limited 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.[3]

Why are those limitations important?

1. If a treatment is effective, diverting patients from clinical trials will delay learning that the treatment is effective, which will significantly decrease the number of lives saved.

2. If a treatment is not effective, diverting patients from clinical trials will delay learning that the treatment is not effective, which will significantly decrease the number of lives saved, because patients are receiving a useless distraction from effective treatment.

3. If a treatment is harmful, which is much worse than just being not effective, diverting patients from clinical trials will delay learning that the treatment is harmful, which will significantly increase the number of patients killed.

All of those results – and those are the possibilities – are ignored by those who reject research. No treatment, however good, will be purely beneficial. All treatments have adverse effects. however, the reverse of that is not true. A treatment that is harmful often does not provide any benefit.

The odds are always against the patient. Any doctor trying to just do something is endangering patients. Kitchen sink medicine (throwing everything at the patient, just in case) has always been bad medicine.

There is a good discussion of the evidence in two podcasts:

15. Covid-19: Is There a Case for Hydroxychloroquine?
Stimulus with Rob Orman, MD (who also hosts the ERCast)
July 30, 2020
Podcast page

Dr. Orman does not specifically mention the Arshad study, which claims to show a benefit in patients treated with HCQ (HydroxyChloroQuine), AZM (AZithroMycin), and HCQ+AZM (HydroxyChloroQuine + AZithroMycin), but that does not change the conclusion of an examination of the evidence.[4]


COVID-19 Treatment Update: Can We Just Stop Wasting Time on Hydroxychloroquine
Written by Salim Rezaie
July 6, 2020
Podcast page

Here is the most important point from Salim Rezaie about the outcomes from the Arshad study:

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


Dr. Rezaie concludes: This study should not change clinical practice of not prescribing these medications.

The Arshad study is being used by proponents of hydroxychloroquine alternative medicine to try to contradicting higher quality research, which is the reason it is not real medicine. When there is only low quality evidence, we should be cautious in recommending any treatment. When the high quality evidence shows that the low quality evidence is misleading, we should ignore the low quality evidence until there is high quality evidence to support the findings of the low quality evidence. Don’t expect that to happen.

The reason most medical research is overturned is the reliance on low quality evidence.[5], [6], [7], [8]


Footnotes:

[1] Study of the Therapeutic Effects of Intercessory Prayer (STEP) in cardiac bypass patients: a multicenter randomized trial of uncertainty and certainty of receiving intercessory prayer
Herbert Benson 1, Jeffery A Dusek, Jane B Sherwood, Peter Lam, Charles F Bethea, William Carpenter, Sidney Levitsky, Peter C Hill, Donald W Clem Jr, Manoj K Jain, David Drumel, Stephen L Kopecky, Paul S Mueller, Dean Marek, Sue Rollins, Patricia L Hibberd
Am Heart J. 2006 Apr;151(4):934-42. doi: 10.1016/j.ahj.2005.05.028.
PMID: 16569567

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.



[2] Hydroxychloroquine Sulfate tablet
INDICATIONS AND USAGE
Daily Med
FDA Label


[3] Frequently Asked Questions on the Revocation of the Emergency Use Authorization for Hydroxychloroquine Sulfate and Chloroquine Phosphate
FDA
Page as PDF download

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.



[4] Treatment with hydroxychloroquine, azithromycin, and combination in patients hospitalized with COVID-19
Samia Arshad,a Paul Kilgore,b,c Zohra S. Chaudhry,a Gordon Jacobsen,e Dee Dee Wang,d Kylie Huitsing,a Indira Brar,a George J. Alangaden,a,c Mayur S. Ramesh,a John E. McKinnon,a William O’Neill,d Marcus Zervos,a,c,⁎ and Henry Ford COVID-19 Task Force1
Int J Infect Dis. 2020 Aug; 97: 396–403.
Published online 2020 Jul 2. doi: 10.1016/j.ijid.2020.06.099
PMID: 32623082

PMCID: PMC7330574 (Free Full Text from PubMed Central)


[5] Why Most Published Research Findings Are False
John P. A. Ioannidis
PLoS Med. 2005 Aug; 2(8): e124.
Published online 2005 Aug 30. doi: 10.1371/journal.pmed.0020124
PMID: 16060722

PMCID: PMC1182327 (Free Full Text from PubMed Central)

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.



[6] Evidence-based de-implementation for contradicted, unproven, and aspiring healthcare practices
Vinay Prasad and John PA Ioannidis
Implement Sci. 2014; 9: 1.
Published online 2014 Jan 8. doi: 10.1186/1748-5908-9-1
PMID: 24398253

PMCID: PMC3892018 (Free Full Text from PubMed Central)

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.


[7] Observational studies often make clinical practice recommendations: an empirical evaluation of authors’ attitudes
Vinay Prasad 1, Joel Jorgenson, John P A Ioannidis, Adam Cifu
J Clin Epidemiol.
2013 Apr;66(4):361-366.e4.
PMID: 23384591   DOI: 10.1016/j.jclinepi.2012.11.005

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.



[8] Contradicted and initially stronger effects in highly cited clinical research
John P A Ioannidis
JAMA. 2005 Jul 13;294(2):218-28. doi: 10.1001/jama.294.2.218.
PMID: 16014596   DOI: 10.1001/jama.294.2.218

Free Full Text from JAMA

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



.

What is the Evidence Supporting the Protesters Grievances?


I could post the video of a white man kneeling on the neck of a black man, while others help hold the black man down, but everybody is familiar with that video. That video shows what black men expect from the police in America. White America continues to be more upset about property damage by a tiny portion of protesters, than about the lives of people too frequently harassed, arrested, and killed because of their skin color.


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


.

What’s the Good News on Hydroxychloroquine?

Hydroxychloroquine is a darling of the media and of politicians, but what about the evidence? Well, the evidence on the use of hydroxychloroquine to treat humans with COVID-19 (COronaVIrus Disease identified in 2019) is either negative (hydroxychloroquine is worse than homeopathy, acupuncture, naturopathy, prayer, . . . ) or the evidence is neutral (hydroxychloroquine is just as useless as homeopathy, acupuncture, naturopathy, prayer, . . . ).


But what is the good news?


The good news is that all of the research on hydroxychloroquine is of low quality or of very low quality. This is exactly the kind of evidence that frauds use to sell their fly by night panaceas.


The “best” news for the frauds is that one study showing harm from hydroxychloroquine has been retracted by most of the authors, due to problems with the data.[1],[2] The researchers contracted out the data acquisition and analysis to Surgisphere Corporation, a private company that appears to have promised to be able to deliver more than it can deliver.


If the negative paper has been retracted, why am I calling the promoters of hydroxychloroquine the frauds?


I am not referring to any of the researchers as frauds, not even the ones from the company that provided the retracted information. The frauds are the people promoting hydroxychloroquine without any evidence that hydroxychloroquine is safe or effective to treat COVID-19 in our species. These people are recklessly and irresponsibly endangering people for their own apparently political reasons.


We still do not have any valid evidence that hydroxychloroquine is safe to use in any humans to treat COVID-19.


We still do not have any valid evidence that hydroxychloroquine is effective at improving any outcomes for any humans with COVID-19.


Experimentation on humans should be limited to well controlled research studies.


The WHO (World Health Organization) appropriately, and only temporarily, paused research on hydroxychloroquine to re-examine the safety data available. The enrollment of patients in the WHO research has resumed.[3]


For those who claim that this retraction is evidence that science doesn’t work – It is amusing to see you trying to cite evidence to support your rejection of evidence, every time you do it. May you never tire of demonstrating the validity of the Dunning-Kruger effect.


This is like using a stopped clock to tell you the time. The stopped clock does not provide any useful information about the actual time, but it does provide useful information about the person claiming it provides useful information about the time.



This was pre-print – not yet peer reviewed, which was retracted by most of the authors, because of questions raised about the data. It may turn out that the outcomes for patients were better than represented in the paper. It may turn out that the outcomes for patients were the same as than represented in the paper. It may turn out that the outcomes for patients were worse than represented in the paper. We won’t know until the full information is independently analyzed, which might not happen. The failure to provide access for independent analysis was the reason for the retraction.


Late addition (6/08/2020 at 15:08): Dr. Steven Novella has a more detailed description of this at Neurologica, written on 6/08/2020 after I posted this on 6/06/2020:


The Surgisphere Fiasco



Footnotes:


[1] Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis.
Mehra MR, Desai SS, Ruschitzka F, Patel AN.
Lancet. 2020 May 22:S0140-6736(20)31180-6. doi: 10.1016/S0140-6736(20)31180-6. Online ahead of print.
PMID: 32450107


Free Full Text from PubMed Central.


[2] Retraction—Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis
Mandeep R Mehra, Frank Ruschitzka, Amit N Patel
Published:June 05, 2020
DOI:https://doi.org/10.1016/S0140-6736(20)31324-6


[3] “Solidarity” clinical trial for COVID-19 treatments
WHO (World Health Organization)
Information page.


Update on hydroxychloroquine


Originally posted 27 May 2020, updated 4 June 2020


Having met on 23 May 2020, the Executive Group of the Solidarity Trial decided to implement a temporary pause of the hydroxychloroquine arm of the trial, because of concerns raised about the safety of the drug. This decision was taken as a precaution while the safety data were reviewed by the Data Safety and Monitoring Committee of the Solidarity Trial.


On 3 June 2020, WHO’s Director-General announced that on the basis of the available mortality data, the members of the committee have recommended that there are no reasons to modify the trial protocol.


The Executive Group received this recommendation and endorsed the continuation of all arms of the Solidarity Trial, including hydroxychloroquine.


The Data Safety and Monitoring Committee will continue to closely monitor the safety of all therapeutics being tested in the Solidarity Trial.



.

Hydroxychloroquine – The More You Know, The Worse It Looks



Do you want to use a drug that was never based on any good evidence, but only a hunch? Try hydroxychloroquine. The president says, What have you got to lose?


Kitchen sink medicine is a remnant of the Dark Ages, but it has not been eliminated from medicine. It is the argument from ignorance. If you can’t prove that the treatment is harmful, the treatment is wonderful. If you can prove the treatment is harmful, you are part of a conspiracy.


This is further evidence that hydroxychloroquine is harmful. The higher the quality of the evidence about hydroxychloroquine, the worse hydroxychloroquine looks.


Today, Lancet published this study comparing almost 15,000 patients receiving several different experimental treatments with about 80,000 patients not receiving any of the experimental treatments. This should convince reasonable people that there is no justification for treating patients with hydroxychloroquine outside of a well controlled randomized trial.


The comments on articles about the study are full of the usual anti-science, anti-vax, alternative medicine propaganda. Their religion has failed, but they keep preaching.


After controlling for multiple confounding factors (age, sex, race or ethnicity, body-mass index, underlying cardiovascular disease and its risk factors, diabetes, underlying lung disease, smoking, immunosuppressed condition, and baseline disease severity), when compared with mortality in the control group (9·3%), hydroxychloroquine (18·0%; hazard ratio 1·335, 95% CI 1·223–1·457), hydroxychloroquine with a macrolide (23·8%; 1·447, 1·368–1·531), chloroquine (16·4%; 1·365, 1·218–1·531), and chloroquine with a macrolide (22·2%; 1·368, 1·273–1·469) were each independently associated with an increased risk of in-hospital mortality.[1]


The evidence shows that you are twice as likely to die if you receive hydroxychloroquine.


Don’t listen to anti-science, anti-vax, anti-medicine preachers, because they are not interested in your health.


What have you got to lose?


What are you treating, you politics/religion or your health?


If your goal is to treat your religion, go ahead and use the magic elixir and maybe you will not be harmed by it.


If your goal is to treat your health, avoid magic claims about treatments, regardless of the treatment. Use treatments that work in the real world.


What have you got to lose?


You are twice as likely to lose your life. Among survivors, the significant adverse effect rate was much higher in the hydroxychloroquine groups. This is the highest quality research so far and there is no good news for the hydroxychloroquine.


Read the full paper and think for yourself. Don’t listen to those making excuses to promote their agenda. Your health has never been important to those who reject science.


It is unfortunate that we do not have some treatment that works well, but that is not a good reason to bet your life on bad medicine. More people survive with better health with conventional treatment.



Footnotes:


[1] Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis
Prof Mandeep R Mehra, MD, Sapan S Desai, MD, Prof Frank Ruschitzka, MD, Amit N Patel, MD
Lancet. Published:May 22, 2020
DOI:https://doi.org/10.1016/S0140-6736(20)31180-6


Free Full Text from Lancet.


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Interim Guidance for Basic and Advanced Life Support in Adults, Children, and Neonates With Suspected or Confirmed COVID-19 – April 9, 2020

All of the revised guidelines are at the end.

Treatment of cardiac arrest in the time of a pandemic requires changes to the ACLS (Advanced Cardiac Life Support), PALS (Pediatric Advanced Life Support), and NRP (Neonatal Resuscitation Program) guidelines. These were written specifically for COVID-19, but would apply just as well to any other pandemic with the possibility of aerosolized respiratory transmission.

Who is making these recommendation?

From the Emergency Cardiovascular Care Committee and Get With the Guidelines®-Resuscitation Adult and Pediatric Task Forces of the American Heart Association in Collaboration with the American Academy of Pediatrics, American Association for Respiratory Care, American College of Emergency Physicians, The Society of Critical Care Anesthesiologists, and American Society of Anesthesiologists: Supporting Organizations: American Association of Critical Care Nurses and National EMS Physicians[1]

Why are these recommendations being made?

Hypoxemic respiratory failure secondary to acute respiratory distress syndrome (ARDS), myocardial injury, ventricular arrhythmias, and shock are common among critically ill patients and predispose them to cardiac arrest,5-8 as do some of the proposed treatments, such as hydroxychloroquine and azithromycin, which can prolong the QT.9 With infections currently growing exponentially in the United States and internationally, the percentage of cardiac arrests with COVID-19 is likely to increase.

Healthcare workers are already the highest risk profession for contracting the disease.10 This risk is compounded by worldwide shortages of personal protective equipment (PPE). Resuscitations carry added risk to healthcare workers for many reasons. First, the administration of CPR involves performing numerous aerosol-generating procedures, including chest compressions, positive pressure ventilation, and establishment of an advanced airway. During those procedures, viral particles can remain suspended in the air with a half-life of approximately 1 hour and be inhaled by those nearby.11 Second, resuscitation efforts require numerous providers to work in close proximity to one another and the patient. Finally, these are high-stress emergent events in which the immediate needs of the patient requiring resuscitation may result in lapses in infection-control practices.[1]

Will the changes decrease chances of successful resuscitation?

Yes. That is unavoidable, but DNRs (Do Not Resuscitate orders) and POLSTs (Physicians Orders for Life Sustaining Treatment) also decrease the chances of successful resuscitation. These changes are still the right thing to do.

How do these changes decrease the chances of successful resuscitation?

There is more focus on successful intubation – at the expense of continuous chest compressions. Chest compressions definitely improve outcomes, while there is no evidence that intubation improves outcomes – and there is evidence that intubation decreases successful resuscitation.

Prioritize oxygenation and ventilation strategies with lower aerosolization risk

● Use a HEPA filter, if available, for all ventilation
● Intubate early with a cuffed tube, if possible, and connect to mechanical ventilator, when able
● Engage the intubator with highest chance of first-pass success
● Pause chest compressions to intubate
● Consider use of video laryngoscopy, if available
● Before intubation, use a bag-mask device (or T-piece in neonates) with a HEPA filter and a
tight seal
● For adults, consider passive oxygenation with nonrebreathing face mask as alternative to bagmask device for short duration
● If intubation delayed, consider supraglottic airway
● Minimize closed circuit disconnections[1]

The AHA is now telling us to stop compressions to help minimize the number of intubation attempts, but not because intubation is going to improve outcomes for the patient. This is to protect everyone near the patient from aerosolized infectious material. An endotracheal tube with a HEPA filter is not an absolute protection, but intubation with a HEPA filter is probably best at preventing spread of aerosolized infectious material than other methods of ventilation and probably even better than passive ventilation (compression only resuscitation with a mask over the patient’s mouth).

Because our patients will now have a lower chance of a good outcome (being resuscitated with good brain function), we should also be more selective about whom we attempt to resuscitate. Too many of us have only been going through the motions, because we have refused to recognize futility, or our medical directors have refused to let us recognize futility.

Even though this lower chance of a good outcome is still better than before we focused on chest compressions, more patients should not have resuscitation attempted.

Consider resuscitation appropriateness

● Address goals of care
● Adopt policies to guide determination, taking into account patient risk factors for survival [1]

The other import consideration is the transport of family members.

Transport

o Family members and other contacts of patients with suspected or confirmed COVID-19 should not ride in the transport vehicle.
o If return of spontaneous circulation (ROSC) has not been achieved after appropriate resuscitation efforts in the field, consider not transferring to hospital given the low likelihood of survival for the patient,17 balanced against the added risk of additional exposure to prehospital and hospital providers.[1]

Unfortunately, footnote 17 is to page 16 of CARES (the Cardiac Arrest Registry to Enhance Survival), which is about using CARES in Ohio. I suspect that this was meant to refer to something else, so the wrong citation was provided in the rush to get new guidelines on line quickly.

17. CARES: Cardiac Arrest Registry to Enhance Survival. 2018 Annual Report.

https://mycares.net/sitepages/uploads/2019/2018_flipbook/index.html?page=16



Below are all of the new AHA algorithms (they are also available in PDF format at
https://www.ahajournals.org/doi/pdf/10.1161/CIRCULATIONAHA.120.047463



AHA – COVID-19 Recommendations – BLS Healthcare Provider Adult Cardiac Arrest Algorithm [1]

Click on the image for full size.



AHA – COVID-19 Recommendations – ACLS Cardiac Arrest Algorithm [1]

Click on the image for full size.



AHA – COVID-19 Recommendations – BLS Healthcare Provider Pediatric Cardiac Arrest Algorithm for 2 or More Rescuers [1]

Click on the image for full size.



AHA – COVID-19 Recommendations – BLS Healthcare Provider Pediatric Cardiac Arrest Algorithm for the Single Rescuer [1]

Click on the image for full size.



AHA – COVID-19 Recommendations – PALS Pediatric Cardiac Arrest Algorithm [1]

Click on the image for full size.



Footnotes:



[1] Interim Guidance for Basic and Advanced Life Support in Adults, Children, and Neonates With Suspected or Confirmed COVID-19: From the Emergency Cardiovascular Care Committee and Get With the Guidelines®-Resuscitation Adult and Pediatric Task Forces of the American Heart Association in Collaboration with the American Academy of Pediatrics, American Association for Respiratory Care, American College of Emergency Physicians, The Society of Critical Care Anesthesiologists, and American Society of Anesthesiologists: Supporting Organizations: American Association of Critical Care Nurses and National EMS Physicians.
Edelson DP, Sasson C, Chan PS, Atkins DL, Aziz K, Becker LB, Berg RA, Bradley SM, Brooks SC, Cheng A, Escobedo M, Flores GE, Girotra S, Hsu A, Kamath-Rayne BD, Lee HC, Lehotzky RE, Mancini ME, Merchant RM, Nadkarni VM, Panchal AR, Peberdy MAR, Raymond TT, Walsh B, Wang DS, Zelop CM, Topjian A.
Circulation. 2020 Apr 9. doi: 10.1161/CIRCULATIONAHA.120.047463. [Epub ahead of print]
PMID: 32270695

Free Full Text from the American Heart Association in PDF format

This page is the abstract from the American Heart Association. It has a tab for PDF/EPUB, but the link only provides the PDF link above.



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