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

- Rogue Medic

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.

.

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

.

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.


.

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.



.

New FDNY Cardiac Arrest Protocol is Reasonable

In New York City, the protocol for cardiac arrest during the coronavirus pandemic has been changed. The protocol now states to pronounce the patient dead after 20 minutes, if there is no return of spontaneous circulation (ROSC). If the patient remains pulseless after full paramedic treatment, the chances of any good outcome have dramatically dropped to zero. However, the dangers of transport and infection are only going to increase with transport for the purpose of pronouncement at the hospital, because that is all that is going to happen. A doctor will probably walk out to the ambulance, ask for a brief report, look at the monitor, and then tell the medics to stop compressions and ventilations.

Is there any reason to believe that an emergency physician, who is already overworked, is going to endanger the other patients in the emergency department, just to “make it look good” for a few more minutes?

Many communities already have these protocols in place. The American Heart Association (AHA) and the International Liaison Committee on Resuscitation (ILCOR) already recommend that resuscitation be terminated with no ROSC after 20 minutes.

FDNY (Fire Department of New York, which run EMS in New York City) has traditionally been, well . . . , very traditional in its approach to cardiac arrest. Cardiac arrest treatment doesn’t require much, but the traditionalists like to do a lot more than is good for the patient. For appearances? For unreasonable optimism?

Unfortunately, the president of the local union is misrepresenting this, in order to make a political point, or to demonstrate a lack of understanding, at a time when he should be trying to explain that this is protecting union members and protecting the public.


This is what the military does. They come. They check your pulse. No pulse – next. You know, we’re going to be leaving bodies behind, which is the exact opposite of what’s the oath we took.[1]


Oren Barzilay EMS Local 2507 President. Also identified by the news as a paramedic. If so he should know better.

What does the protocol state?


TEMPORARY Cardiac Arrest Standards for Disaster Response[2]


NYC REMAC (New York City Regional Emergency Medical Advisory Committee) does need to approve whatever N-95 masks have been donated, if the claim that the masks have not been approved is more accurate than the claim about resuscitation.

The NYC protocol has caught up with what many other states have been doing for decades. It is sad that the union leadership is fighting to keep EMS in the dark ages with misinformation and emotions. Misinformation thrives on emotions, so the emotional appeal is not surprising.

There is another protocol change that seems to escaped the notice of Oren Barzilay EMS Local 2507 President, or that part of the interview was cut. Intubation can be skipped – in favor of an extraglottic airway.


Use of Alternative Airways[3]


There is still no good evidence that the average paramedic is competent at intubation, but many agencies insist on intubation as if it is some sort of magical ability of paramedics. Just wave the laryngoscope and the tube goes into the trachea. Paramedics are not good at intubation, but we are good at whining about having intubation taken away, as if it is something we have earned.

We have not earned the right to make patients hypoxic, to tear up the airway, and to claim that we are improving outcomes. Hypoxia is bad for the patient. Tearing up the airway is bad for the patient. We have no good reason to believe we are providing a benefit to the patient, but we do have plenty of evidence that we are causing harm.

Why do so many of us refuse to practice?

Why do so many of us refuse to behave as if we believe any of the lies we tell about intubation being a life saving procedure?

If intubation really is “life saving”, why do paramedics refuse to engage in more than token intubation practice – and then brag about how much they practice?

Because we do not understand what we are doing and because our arguments are emotional, rather than rational.

We paramedics deserve ridicule for our repeated defenses of incompetence.

Why are we still intubating, when there is no evidence of benefit and we refuse to practice this “skill”?


Here is the only evidence I know of demonstrating benefit from intubation:


Prehospital rapid sequence intubation improves functional outcome for patients with severe traumatic brain injury: a randomized controlled trial.
Bernard SA, Nguyen V, Cameron P, Masci K, Fitzgerald M, Cooper DJ, Walker T, Std BP, Myles P, Murray L, David, Taylor, Smith K, Patrick I, Edington J, Bacon A, Rosenfeld JV, Judson R.
Ann Surg. 2010 Dec;252(6):959-65. doi: 10.1097/SLA.0b013e3181efc15f.
PMID: 21107105


Here is some of the evidence showing either a lack of benefit from intubation or evidence showing harm from intubation:


Misplaced endotracheal tubes by paramedics in an urban emergency medical services system.
Katz SH, Falk JL.
Ann Emerg Med. 2001 Jan;37(1):32-7.
PMID: 11145768

Free Full Text PDF


Rapid sequence intubation for pediatric emergency patients: higher frequency of failed attempts and adverse effects found by video review.
Kerrey BT, Rinderknecht AS, Geis GL, Nigrovic LE, Mittiga MR.
Ann Emerg Med. 2012 Sep;60(3):251-9. doi: 10.1016/j.annemergmed.2012.02.013. Epub 2012 Mar 15.
PMID: 22424653

Free Full Text from Annals of Emergency Medicine.


A is for airway: a pediatric emergency department challenge.
Green SM.
Ann Emerg Med. 2012 Sep;60(3):261-3. doi: 10.1016/j.annemergmed.2012.03.019. Epub 2012 Apr 19. No abstract available.
PMID: 22520991

The article above is a comment on the previous article.


Prehospital intubations and mortality: a level 1 trauma center perspective.
Cobas MA, De la Peña MA, Manning R, Candiotti K, Varon AJ.
Anesth Analg. 2009 Aug;109(2):489-93. doi: 10.1213/ane.0b013e3181aa3063.
PMID: 19608824


Intubation by Emergency Physicians: How Often Is Enough?
Kerrey BT, Wang H.
Ann Emerg Med. 2019 Dec;74(6):795-796. doi: 10.1016/j.annemergmed.2019.06.022. Epub 2019 Aug 19. No abstract available.
PMID: 31439364

The article above is commentary on the article below:

Procedural Experience With Intubation: Results From a National Emergency Medicine Group.
Carlson JN, Zocchi M, Marsh K, McCoy C, Pines JM, Christensen A, Kornas R, Venkat A.
Ann Emerg Med. 2019 Dec;74(6):786-794. doi: 10.1016/j.annemergmed.2019.04.025. Epub 2019 Jun 24.
PMID: 31248674


Effect of a Strategy of a Supraglottic Airway Device vs Tracheal Intubation During Out-of-Hospital Cardiac Arrest on Functional Outcome: The AIRWAYS-2 Randomized Clinical Trial.
Benger JR, Kirby K, Black S, Brett SJ, Clout M, Lazaroo MJ, Nolan JP, Reeves BC, Robinson M, Scott LJ, Smartt H, South A, Stokes EA, Taylor J, Thomas M, Voss S, Wordsworth S, Rogers CA.
JAMA. 2018 Aug 28;320(8):779-791. doi: 10.1001/jama.2018.11597.
PMID: 30167701

Free Full Text from PubMed Central® (PMC)


Effect of a Strategy of Initial Laryngeal Tube Insertion vs Endotracheal Intubation on 72-Hour Survival in Adults With Out-of-Hospital Cardiac Arrest: A Randomized Clinical Trial.
Wang HE, Schmicker RH, Daya MR, Stephens SW, Idris AH, Carlson JN, Colella MR, Herren H, Hansen M, Richmond NJ, Puyana JCJ, Aufderheide TP, Gray RE, Gray PC, Verkest M, Owens PC, Brienza AM, Sternig KJ, May SJ, Sopko GR, Weisfeldt ML, Nichol G.
JAMA. 2018 Aug 28;320(8):769-778. doi: 10.1001/jama.2018.7044.
PMID: 30167699

Free Full Text from PubMed Central® (PMC)


Pragmatic Airway Management in Out-of-Hospital Cardiac Arrest.
Andersen LW, Granfeldt A.
JAMA. 2018 Aug 28;320(8):761-763. doi: 10.1001/jama.2018.10824. No abstract available.
PMID: 30167679


Interruptions in cardiopulmonary resuscitation from paramedic endotracheal intubation.
Wang HE, Simeone SJ, Weaver MD, Callaway CW.
Ann Emerg Med. 2009 Nov;54(5):645-652.e1. doi: 10.1016/j.annemergmed.2009.05.024. Epub 2009 Jul 2.
PMID: 19573949


Association of prehospital advanced airway management with neurologic outcome and survival in patients with out-of-hospital cardiac arrest.
Hasegawa K, Hiraide A, Chang Y, Brown DF.
JAMA. 2013 Jan 16;309(3):257-66. doi: 10.1001/jama.2012.187612.
PMID: 23321764

Free Full Text from JAMA


No evidence for decreased incidence of aspiration after rapid sequence induction.
Neilipovitz DT, Crosby ET.
Can J Anaesth. 2007 Sep;54(9):748-64. Review.
PMID: 17766743

Link to Abstract and Free Full Text PDF Download from Can J Anaesth


The Great Prehospital Airway Debate
August 31, 2018
Emergency Medicine Literature of Note
by Ryan Radecki
Article


EM Nerd-The Case of the Needless Imperative
August 31, 2018
EMNerd (EMCrit)
by Rory Spiegel
Article


Intubation or supraglottic airway in cardiac arrest; AIRWAYS-2
The Resus Room
Podcast with Simon Laing, Rob Fenwick, and James Yates with guest Professor Jonathan Benger, lead author of AIRWAYS-2.
Podcast, images, and notes


Variation in Survival After Out-of-Hospital Cardiac Arrest Between Emergency Medical Services Agencies.
Okubo M, Schmicker RH, Wallace DJ, Idris AH, Nichol G, Austin MA, Grunau B, Wittwer LK, Richmond N, Morrison LJ, Kurz MC, Cheskes S, Kudenchuk PJ, Zive DM, Aufderheide TP, Wang HE, Herren H, Vaillancourt C, Davis DP, Vilke GM, Scheuermeyer FX, Weisfeldt ML, Elmer J, Colella R, Callaway CW; Resuscitation Outcomes Consortium Investigators.
JAMA Cardiol. 2018 Sep 26. doi: 10.1001/jamacardio.2018.3037. [Epub ahead of print]
PMID: 30267053

Free Full Text from JAMA Cardiology


Cardiocerebral resuscitation improves survival of patients with out-of-hospital cardiac arrest.
Kellum MJ, Kennedy KW, Ewy GA.
Am J Med. 2006 Apr;119(4):335-40.
PMID: 16564776


Cardiocerebral resuscitation improves neurologically intact survival of patients with out-of-hospital cardiac arrest.
Kellum MJ, Kennedy KW, Barney R, Keilhauer FA, Bellino M, Zuercher M, Ewy GA.
Ann Emerg Med. 2008 Sep;52(3):244-52. doi: 10.1016/j.annemergmed.2008.02.006. Epub 2008 Mar 28.
PMID: 18374452


Minimally interrupted cardiac resuscitation by emergency medical services for out-of-hospital cardiac arrest.
Bobrow BJ, Clark LL, Ewy GA, Chikani V, Sanders AB, Berg RA, Richman PB, Kern KB.
JAMA. 2008 Mar 12;299(10):1158-65. doi: 10.1001/jama.299.10.1158.
PMID: 18334691

Free Full Text at JAMA


Passive oxygen insufflation is superior to bag-valve-mask ventilation for witnessed ventricular fibrillation out-of-hospital cardiac arrest.
Bobrow BJ, Ewy GA, Clark L, Chikani V, Berg RA, Sanders AB, Vadeboncoeur TF, Hilwig RW, Kern KB.
Ann Emerg Med. 2009 Nov;54(5):656-662.e1. doi: 10.1016/j.annemergmed.2009.06.011. Epub 2009 Aug 6.
PMID: 19660833


Cardiocerebral resuscitation is associated with improved survival and neurologic outcome from out-of-hospital cardiac arrest in elders.
Mosier J, Itty A, Sanders A, Mohler J, Wendel C, Poulsen J, Shellenberger J, Clark L, Bobrow B.
Acad Emerg Med. 2010 Mar;17(3):269-75. doi: 10.1111/j.1553-2712.2010.00689.x.
PMID: 20370759

Free Full Text from Acad Emerg Med.

And more.


That is a big difference. There is nowhere near enough evidence to justify allowing paramedics to intubate.


Footnotes:

[1] Grim New Rules for NYC Paramedics: Don’t Bring Cardiac Arrests to ER for Revival
By Tom Winter
Published April 2, 2020 • Updated on April 2, 2020 at 8:32 pm
nbcnewyork.com
Article with autoplay video

[2] TEMPORARY Cardiac Arrest Standards for Disaster Response
NYC REMAC
Advisory No. 2020-08
Issue Date: March 31, 2020
Effective Date: Immediate
Protocol in PDF format

[3] Use of Alternative Airways
NYC REMAC
Advisory No. 2020-05
Issue Date: March 20, 2020
Effective Date: Immediate
Protocol in PDF format

.

Do Emergency Physicians Intubate Often Enough to Maintain Competency?

 

    There is a study of the frequency of intubation among emergency physicians in the current Annals of Emergency Medicine. This study is accompanied by a discussion, which unfortunately does not question the assumption that intubation improves outcome. There is very little evidence to suggest that intubation improves outcomes. That evidence is only using paramedics with the highest success rates – much higher than your average paramedic.

 
Greater intubation experience in paramedics is associated with improved patient outcomes2; does a similar relationship exist for emergency physicians?[1]
 


Image credit.

The unquestioned assumption is that excellent intubation performance improves outcomes, rather than that excellent intubation performance causes less harm than average intubation performance, or below average performance. We do not have any good evidence to support the wishful thinking that paramedics, or even much more experienced emergency physicians, improve outcomes by intubating patients. We just assume this, because we don’t really want to know. If we decide to be honest and actually find out the effect of intubation, how will we handle it if the results show that we are harming more patients than we are helping?

The Cardiac Arrhythmia Suppression Trial was only started because the proponents of the different antiarrhythmics (encainide, flecainide, and moricizine) wanted to prove that their drug was better than all of the rest. They even agreed to include a placebo arm, although the doctors did not like the idea of depriving patients of such beneficial treatment.

 
CONCLUSIONS: There was an excess of deaths due to arrhythmia and deaths due to shock after acute recurrent myocardial infarction in patients treated with encainide or flecainide.[2]
 

People who had frequent ectopic heart beats – PVCs (Premature Ventricular Contractions) after a heart attack were more likely to die than people who did not have frequent PVCs. The obvious solution – the equivalent of intubation and blood-letting – was to give drugs that will get rid of the PVCs. The problem is that the PVCs were not the problem. The PVCs were just a sign of the problem. The drugs made the actual problem with the heart worse, while making the heart appear to be better. The same is true of blood-letting and may be true of intubation. Abundant evidence for the obvious benefits of blood-letting are quoted in the footnotes.[3]

If intubation is harmful, do we want to know?

If intubation by the average paramedic is harmful, do we want to know?

If intubation by the average emergency physician is harmful, do we want to know?

It isn’t as if we take intubation seriously. If we did take intubation seriously, we would practice much, much more than we do. In stead, we make excuses for failing to practice something that we claim is life-saving, because we are too arrogant to admit that practice is important to develop and maintain any skill.

Practicing on even the most basic mannequin should be done before every shift, whether you are a paramedic or an emergency physician. Unless you have a 99%, or better, success rate on hundreds of patients.

Footnotes:

[1] Intubation by Emergency Physicians: How Often Is Enough?
Kerrey BT, Wang H.
Ann Emerg Med. 2019 Dec;74(6):795-796. doi: 10.1016/j.annemergmed.2019.06.022. Epub 2019 Aug 19. No abstract available.
PMID: 31439364

The article above is commentary on the article below:

Procedural Experience With Intubation: Results From a National Emergency Medicine Group.
Carlson JN, Zocchi M, Marsh K, McCoy C, Pines JM, Christensen A, Kornas R, Venkat A.
Ann Emerg Med. 2019 Dec;74(6):786-794. doi: 10.1016/j.annemergmed.2019.04.025. Epub 2019 Jun 24.
PMID: 31248674

[2] Mortality and morbidity in patients receiving encainide, flecainide, or placebo. The Cardiac Arrhythmia Suppression Trial.
Echt DS, Liebson PR, Mitchell LB, Peters RW, Obias-Manno D, Barker AH, Arensberg D, Baker A, Friedman L, Greene HL, et al.
N Engl J Med. 1991 Mar 21;324(12):781-8.
PMID: 1900101

Free Full Text from N Engl J Med.

[3] Blood-Letting
Br Med J.
1871 March 18; 1(533): 283–291.
PMCID: PMC2260507
 

Physicians observed of old, and continued to observe for many centuries, the following facts concerning blood-letting.

1. It gave relief to pain. . . . .

2. It diminished swelling. . . . .

3. It diminished local redness or congestion. . . . .

4. For a short time after bleeding, either local or general, abnormal heat was sensibly diminished.

5. After bleeding, spasms ceased, . . . .

6. If the blood could be made to run, patients were roused up suddenly from the apparent death of coma. (This was puzzling to those who regarded spasm and paralysis as opposite states; but it showed the catholic applicability of the remedy.)

7. Natural (wrongly termed ” accidental”) hacmorrhages were observed sometimes to end disease. . . . .

8. . . . venesection would cause hamorrhages to cease.
 

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