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

- Rogue Medic

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’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.


.

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

.

Dr. David Price on How to Stay Healthy, While Treating COVID-19 Patients

Here is a quote from 2007, written about the response to the 1918 influenza pandemic.

 

Influenza pandemics have occurred regularly every 30 to 40 years since the 16th century. Today, influenza experts consider the possibility of another influenza pandemic, not in terms of if but when. Due to the high likelihood of an influenza pandemic, planning is underway in many U.S. states and other countries. We reviewed the responses of two neighboring Minnesota cities during the 1918–1919 pandemic to gain insight that might inform planning efforts today.[1]

 

We have chosen to forget what we had already learned. We can expect fewer deaths, this time, but this is a result of the arrogance and complacency that is our willful ignorance.

 

We work with patients who may not know that they have COVID-19 (novel COronaVIrus Disease identified in 2019), but we still have to treat them, just as we do for every other infectious disease. The same is true for patients who have tested positive for COVID-19. We are expected to take care of them, protect our other patients from transmission by us, and protect ourselves from infection.

 

Here is the advice, based on the best available evidence, from Dr. David Price of Weill Cornell Medical Center in New York City, currently the hottest spot of COVID-19 transmission in the world, but that will change. Dr. Price is a pulmonologist, treating COVID-19 patients full time, but he is not worried about becoming sick, because he uses evidence-based practices to protect himself. The quality of the video is not great, but the quality of the information is very high.

 

 

 

 

Some of this is not new. As I already stated, we knew this a century ago. We have chosen to forget how to deal with a pandemic.

 

We need to wash our hands.

 

We need to not touch our faces.

 

The most effective use of a mask may be to train yourself to not touch your face. We should have already been good at that, since we are not supposed to touch our faces, when we are wearing gloves, but many of us do touch our faces with gloves. When we have gloves on, the gloves should be considered to be contaminated, and anything everything we touch with our gloves should also be considered to be contaminated.

 

If you think that you need to be seen by a doctor, call first, because it can probably be handled over the phone.

 

If you think that you need to be seen in the emergency department, you probably do not.

 

Wash your hands before you put gloves on

 

Wash your hands after you take gloves off.

 

Clean everything you touch.

 

Wear an N95 mask, face shield, and a gown, when treating COVID-19 patients.

 

Be considerate of others and do not hoard medical supplies. The medical supplies do not do you any good unless you are treating COVID-19 patients and following these rules.

 

We need more accountability for giving bad dangerously incompetent medical advice.

 

President Trump has been promoting a poorly tested treatment as if he has a financial stake in the drug. A couple followed the “medical advice” of President Trump. One died. The other is in the hospital.[2]

 

In Iran, a bunch of people have consumed methanol to cure/protect against COVID-19. hundreds are reported to have died. Methanol ingestion is something that happens with children, who aren’t old enough to read the warnings on the label.[3]

 

Get your medical advice from a physician who understands evidence-based medicine.

 

We, in America, currently are producing too many new infections each day. We need to control our bad (infection-wise) behaviors in order to protect our patients, our neighbors, our families, and our selves. As health care providers, we should be better at this than everyone else. Too many of us are not.

 

 


Financial Times – Coronavirus: free to read
Click on the link for the full page of the latest graphs from Financial Times or click on the image for a larger version of the graph at the time I wrote this.

 

The countries with the most aggressive spread of COVID-19 are the countries that have not aggressively restricted movement among citizens. Anyone, including President Trump, telling you to ignore the social distancing recommendations is endangering the health of everyone. Most of us will probably become infected. Almost all of us will recover, but the rate of recovery drops if everyone becomes sick at the same time, since we do not have enough ventilators to adequately treat such a dramatic increase in very sick patients. The stock market will recover, although not immediately. The same thing happened a century ago, when dealing with the influenza pandemic.

 


This is a chart of what happened to the stock market before, during, and after the 2018 influenza pandemic.[4] Do not take this as trading advice – maybe if you get your medical advice from science deniers, you should trade, based on this. There are many differences between 2018 and now, such as the size, and importance, of other markets. This isn’t the end of the world, unless you don’t follow safe hygiene practices and get yourself infect. Crying about the economy and worshiping in a “traditional” way should not earn any sympathy for Texas Lt. Gov. Dan Patrick[5], First Things writer R.R. Reno, and Cardinal Raymond Burke.[6] Their promotion of immorality is despicable.

 

Social distancing was effective at limiting the spread of the pandemic.[7]

 

Do not expect a vaccine until 2021 or 2022.

 

Do not expect an effective treatment (something that significantly improves outcomes for patients, rather than just improves the sales for the manufacturers) for several months, at the earliest, because the drug President Trump has been promoting is not supported by good evidence. Ironically, HuffPost, which used to be Huffington Post and used to promote the science denialism of Jenny McCarthy, Dr. Oz, Oprah, and plenty of others, has a good article exposing the problems with the paper being cited by President Trump. Let’s hope that the name change is due to a dramatic change in their approach to reality.[8]

 

Footnotes:

[1] Lessons learned from the 1918-1919 influenza pandemic in Minneapolis and St. Paul, Minnesota.
Ott M, Shaw SF, Danila RN, Lynfield R.
Public Health Rep. 2007 Nov-Dec;122(6):803-10. No abstract available.
PMID: 18051673

Free Full Text from PubMed Central® (PMC)

 

[2] Husband and wife poison themselves trying to self-medicate with chloroquine – An Arizona man is dead and his wife is hospitalized after both of them self-medicated with chloroquine.
By Kimberly Hickok – Reference Editor
3 days ago
Live Science
Article

 

[3] Bootleg Liquor and Why You Should Not Drink Methanol
By Live Science
Staff September 19, 2012
Article

 

[4] Market action a century ago suggests worst could be over for stocks, if not for the coronavirus pandemic
Published: March 19, 2020 at 1:50 p.m. ET
By Shawn Langlois
MarketWatch
Article

 

[5] Texas Lt. Gov. Dan Patrick suggests elderly should die to save economy from coronavirus
By Kate Feldman
New York Daily News
March 24, 2020 | 11:46 AM
Article

 

[6] Editorial: May the lesson be indelibly inscribed — we need one another
Mar 24, 2020
by NCR Editorial Staff
National Catholic Reporter
Article

 

[7] Lessons learned from the 1918-1919 influenza pandemic in Minneapolis and St. Paul, Minnesota.
Ott M, Shaw SF, Danila RN, Lynfield R.
Public Health Rep. 2007 Nov-Dec;122(6):803-10. No abstract available.
PMID: 18051673

Free Full Text from PubMed Central® (PMC)

 

 

Influenza pandemics have occurred regularly every 30 to 40 years since the 16th century. Today, influenza experts consider the possibility of another influenza pandemic, not in terms of if but when. Due to the high likelihood of an influenza pandemic, planning is underway in many U.S. states and other countries. We reviewed the responses of two neighboring Minnesota cities during the 1918–1919 pandemic to gain insight that might inform planning efforts today.

 

Many of the components of current pandemic influenza plans were utilized to some degree in Minneapolis and St. Paul during 1918–1919. Coordination between different levels and branches of government, improved communications regarding the spread of influenza, hospital surge capacity, mass dispensing of vaccines, guidelines for infection control, containment measures including case isolation and closures of public places, and disease surveillance were all employed with varying degrees of success. We focus on medical resources, community disease containment measures, public response to community containment, infection control and vaccination, and communications.

 

[8] The Hucksters Pushing A Coronavirus ‘Cure’ With The Help Of Fox News And Elon Musk – Tucker Carlson, Glenn Beck and more have given a giant platform to a sketchy paper touting chloroquine.
03/20/2020 02:05 pm ET Updated Mar 20, 2020
HuffPost
By Nick Robins-Early
Article

.

Happy Darwin and Lincoln Day 2020


Happy Lincoln-Darwin Day!
 
Today is the birthday of two people considered enemies by the American slavery belt – Charles Darwin and Abraham Lincoln. The slavery belt was so afraid of Lincoln that most of the slave states seceded before Lincoln took office as president.

Charles Darwin wrote a book that exposed the slavery of human beings as immoral. The slaves were just as human as every slave owner. Bible quotations in defense of slavery were regularly provided by slave owners to justify their immorality, but it was not working as well as it used to. To be fair, many of the Founding Fathers opposed slavery, but this was a compromise that will always stain the Constitution. There was even an agreement in the Constitution to allow the importation of slaves at least until 1808.
 

The Migration or Importation of such Persons as any of the States now existing shall think proper to admit, shall not be prohibited by the Congress prior to the Year one thousand eight hundred and eight, but a tax or duty may be imposed on such Importation, not exceeding ten dollars for each Person.[1]

 

There was enough opposition to the importation of slaves that a law prohibiting importation went into effect the first day possible – January 1, 1808.

Opponents of Lincoln continue to make excuses for the treason of the slave states that seceded and made war on the United States of America.

Opponents of Darwin continue to make excuses for rejection of biology, even though genetics and evolution are essential for the understanding of biology. Denial of science has become a tenet of Creationist sects.

Currently the most popular method of denying science is the one made notorious by the exposure of private documents of the cigarette industry. Create the appearance of scientific doubt and scientific controversy, even though the only doubt and controversy is about minor details, rather than the broad conclusions.
 

The most important type of story is that which casts doubt in the cause and effect theory of disease and smoking. Eye-grabbing headlines should strongly call out the point[2]

 

 

Doubt is our product next hit since it is the best means of competing with the “body of fact” that exists in the mind of the general public. It is also the means of establishing a controversy. Within the business we recognize that a controversy exists. However, with the general public the consensus is that cigarettes are in some way harmful to the health. If we are successful in establishing a controversy at the public level, then there is an opportunity to put across the real facts about smoking and health. previous hit Doubt is also the limit of our ” product.” Unfortunately, we cannot take a position directly opposing the anti-cigarette forces and say that cigarettes are a contributor to good health. No information that we have supports such a claim .

Truth is our message because of its power to withstand a conflict and sustain a controversy. If in our pro-cigarette efforts we stick to well documented fact , we can dominate a controversy and operate with the confidence of justifiable self-interest [italic emphasis added]. {2111.01, pp. 4, 5}[3]

 

The point was to create the appearance of honesty, without the substance. This method is used by a lot of other science denialists – anti-vaxers, climate change deniers (both those who deny that climate change is real and those who claim that human activity is not responsible for the dramatic acceleration of global warming), flat earthers, alternative medicine promoters, anti-GMO activists, anti-abortion activists, anti-equality activists, geocentrists, et cetera.

Reality is their enemy.

Reality will always be their enemy.

Footnotes:

[1] Article 1 Section 9
U.S. Constitution
Link to Article 1 Section 9 at constitution.net

[2] Tobacco Explained – The truth about the tobacco industry …in its own words
World Health Organization
Page 11/79 on the pdf counter, but marked as page 7 on the page
Free Full Text in PDF format from WHO
 

Carl Thompson from Hill and Knowlton writes a letter on the best angles for the
industry magazine, Tobacco and Health Research:
“The most important type of story is that which casts
doubt in the cause and effect theory of disease and
smoking. Eye-grabbing headlines were needed and
“should strongly call out the point – Controversy! Contradiction! Other Factors! Unknowns!” 31 (Hill and
Knowlton, 1968)

 

[3] Using Cigarette Ads to Counter Health Information
The Cigarette Papers
Chapter 5 Public Relations in the “Safe” Cigarette Era
Resisting Government Regulation: Advertising Campaigns
Pages 190-191
University of California Press
Link to book with search for “Doubt is our product”

.

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.
 

.