We are there for the good of the patient, not for the good of the protocol, not for the good of the medical director, and not for the good of the company.

- Rogue Medic

The crisis in evidence-based medicine

 
Are there crises in EBM (Evidence-Based Medicine)?

If so, what are the crises and what can we do to make things better?

John wrote this in the comments to We all rely on evidence. The important difference is __________.[1]
 

I wonder what you think about this:

http://theincidentaleconomist.com/wordpress/the-crisis-in-evidence-based-medicine/

 

The article, The crisis in evidence-based medicine,[2] references a BMJ article[3] that I will try to write about soon, since it provides an excellent description of what EBM (Evidence-Based Medicine) is and how EBM is misused.

What many of the opponents of EBM (I am not including Bill Gardner) seem to ignore is that the problems that affect the application of high quality evidence to patient care are even greater with the application of the lowest quality evidence anecdotal experience to patient care. For example, multimorbidity makes it even more difficult to draw conclusions based on anecdotes, than based on evidence prospectively collected in a way that is designed to minimize the complications produced by the many conditions not being studied, while anecdotalists rely on experience, that is more likely to be irrelevant than the research and they rely on their memories. One thing that objective evidence shows us is that our memories are not accurate.[4]

However, Bill Gardner is looking at the ways we can avoid making mistakes with EBM, rather than making excuses for ignoring EBM. I recommend reading the BMJ article first, then going back and reading his article and the other articles at The Incidental Economist on EBM.

There is a weak point in Bill Gardner’s solution, and he is aware of it. At what point does the quality of the data become so low that the massive quantity is not able to provide useful information?

The NTDB® (National Trauma Data Bank®) is a great idea. We objectively collect as much data on as many trauma patients as possible and mine that data for signals that stand out from the noise. I have pointed out some of the problems with the application of this approach several times.[5],[6],[7]

Eventually, we should become much better at acquiring data, but so far we have demonstrated that even data prospectively collected by the experts can be GIGO (Garbage In = Garbage Out). The same is true for EBM. If we use low quality data, we should expect low quality results. Eventually, we should find better ways to filter out the noise, but we are not there, yet.

The Framingham Heart Study[8] is an example of using massive amounts of data to find evidence that several risk factors lead to significantly shorter lives.

As with anything else, the problems are not a reason to abandon hope, but a reason to use caution. We will learn as we go, while the acolytes of anecdotalism will continue to promote misunderstanding and continue to discourage progress.

We need to learn more about how to use science and how not to be misled by science, rather than to abandon science. Here is just a start to learning how not to get fooled by bad science.
 


Image credit. Click on the image for a much larger version (1754×1280).
 

While the perfect is often the enemy of the good, that does not mean that good is not good, or that we should reject anything that is not perfect in favor of the alternative (not good or bad or much worse). It means that we need to keep improving. Science does keep improving.

-

Footnotes:

-

[1] We all rely on evidence. The important difference is __________.
Tue, 24 Jun 2014
Rogue Medic
Article

-

[2] The crisis in evidence-based medicine
June 23, 2014
Bill Gardner
The Incidental Economist
Article

-

[3] Evidence based medicine: a movement in crisis?
Greenhalgh T, Howick J, Maskrey N; Evidence Based Medicine Renaissance Group.
BMJ. 2014 Jun 13;348:g3725. doi: 10.1136/bmj.g3725. No abstract available.
PMID: 24927763 [PubMed - in process]

Free Full Text from BMJ.

-

[4] Who you gonna believe, me or you own eyes?
Dr. Mark Crislip
July 12, 2013
Science-Based Medicine
Article

Or listen to the audio version in MP3 format by Dr. Mark Crislip –
121: Who you gonna believe, me or your lying eyes

-

[5] Correction to Spine Immobilization in Penetrating Trauma: More Harm Than Good
Tue, 15 Mar 2011
Rogue Medic
Article

-

[6] Prehospital Intravenous Fluid Administration is Associated With Higher Mortality in Trauma Patients – Part III
Tue, 01 Mar 2011
Rogue Medic
Article

-

[7] Flawed Helicopter EMS vs Ground EMS Research – Part II
Thu, 19 Apr 2012
Rogue Medic
Article

-

[8] Framingham Heart Study
Home page

.

We all rely on evidence. The important difference is __________.

 
There are many people who will tell us that we should not demand evidence as the basis for our decisions, but what is the basis for their decisions?

Evidence, not logic.

We all rely on evidence. The important difference is the quality of the evidence we rely on.

We should not listen to those who are devoted to low standards that can support any bias at all.
 

Yes, you may have dozens of impressive anecdotes, but an anecdote is just the retelling of events with most of the variables ignored. The reader is encouraged to come to the conclusion that is being promoted. Anecdotes should be viewed as advertising – promotion of a product that hides reality.

When we see advertising for a big, juicy burger, we are being presented with evidence. When we go to buy that big, juicy burger, we are being presented with reality. The advertising used evidence to get us to buy their product. The actual sale was when we were presented with the evidence that we are easily fooled and manipulated by those who make money off of our low standards for evidence.
 

Medicine/EMS is just as susceptible to advertising biased promotion of a favored treatment.

Is it logical to choose a treatment (which can harm and/or help) based on weak evidence?

If we are going to risk harming our patients, why are so many of us in favor of such low standards?

Why are we so arrogant that we assume that unintended consequences do not affect our patients?

Maybe our treatments really can’t be tested.
 


 
Image credit.

Or we claim that a treatment is too important to study

For example, epinephrine (Adrenaline) in cardiac arrest.
 

This study was designed as a multicentre trial involving five ambulance services in Australia and New Zealand and was accordingly powered to detect clinically important treatment effects. Despite having obtained approvals for the study from Institutional Ethics Committees, Crown Law and Guardianship Boards, the concerns of being involved in a trial in which the unproven “standard of care” was being withheld prevented four of the five ambulance services from participating.[1]

 

In addition adverse press reports questioning the ethics of conducting this trial, which subsequently led to the involvement of politicians, further heightened these concerns. Despite the clearly demonstrated existence of clinical equipoise for adrenaline in cardiac arrest it remained impossible to change the decision not to participate.[1]

 

Or spinal immobilization.
 

Perhaps it has not been demonstrated safe but it has never been demonstrated unsafe either. Better stay with the known than go to the unknown. If you want to develop a research project, please go ahead and do it. But without proof that they are bad, we cannot just assume that they are bad.

 

That could be the clap for Tinkerbell speech.[2] It could be Dr. Oz justifying his fraud,[3] but it isn’t. This defense of recklessness is from a surgeon who controls trauma policy in EMS.

This was a serious response to my criticism of the lack of evidence of benefit of spinal immobilization. He has studied the effect of oxygen on trauma patients, so he does not apply this Dark Ages thinking to everything.

We pretend that we are not harming patients, rather than find out how much harm we are doing. Everything we do is harmful, but when the benefits outweigh the harms, only then it is appropriate to use the harmful treatment.

We choose to pretend that we are not causing harm.

We can’t even be honest with ourselves.

-

Footnotes:

-

[1] Effect of adrenaline on survival in out-of-hospital cardiac arrest: A randomised double-blind placebo-controlled trial
Jacobs IG, Finn JC, Jelinek GA, Oxer HF, Thompson PL.
Resuscitation. 2011 Sep;82(9):1138-43. Epub 2011 Jul 2.
PMID: 21745533 [PubMed - in process]

Free Full Text PDF Download of In Press Uncorrected Proof from xa.yming.com

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[2] Tinkerbell effect
Wikipedia
Article
 

The Tinkerbell effect is an American English expression describing things that are thought to exist only because people believe in them. The effect is named for Tinker Bell, the fairy in the play Peter Pan who is revived from near death by the belief of the audience.

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[3] Dr. Oz Shows How He Lies with Bad Research
Tue, 17 Jun 2014
Rogue Medic
Article

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Is First Responder Narcan the Same as First Responder AED?


Image credit.
 

Are these the same?

If one works, does the other work?
 


Image credit.
 

The idea that first responders can safely give naloxone (Narcan) is popular, but only based on things that we want to be true. Dr. Oz would love it.

It has been suggested that giving first responders naloxone is the same as giving them AEDs (Automated External Defibrillators).[1] AEDs are defibrillators that can deliver the same shock as a manual defibrillator, but AEDs do not require all of the education needed to become a paramedic, nurse, PA, NP, or doctor.

Unlike naloxone, AEDs are designed to do almost all of the assessment for the first responder. The AED is only supposed to be attached to a pulseless patient, so assessment for responsiveness and the presence of a pulse is expected by the first responder. Is naloxone assessment that simple?

When a patient actually has an opioid overdose, it can be that simple, but -

Not all patients who respond after naloxone, respond because of naloxone.

This is the concept that is difficult to explain to the advocates of first responder naloxone programs.

1. Some advocates deny that this happens, even though it is documented.

2. Some advocates claim that we already know all that we need to know about naloxone.

3. Some advocates also claim that we should not study this because we already know all that we need to know.

Since there is overlap among the groups, the failure to understand the problem of improper assessment, especially among paramedics, nurses, and doctors is a huge problem. If we do not understand naloxone, with all of our education in pharmacology, how can we expect first responders to understand naloxone without any education in pharmacology?

What kind of education can prevent mistakes? How do we know?

If we listen to those who don’t know, but claim that they know all that they need to know, we will be ignoring the possibility of unintended consequences and assuming that we are too smart to make mistakes. Is that reasonable?

Do AEDs save lives?
 

CONCLUSION:

Addition of AEDs to this EMS system did not improve survival from sudden cardiac death. The data do not support routinely equipping initial responders with AEDs as an isolated enhancement, and raise further doubt about such expenditures in similar EMS systems without first optimizing bystander CPR and EMS dispatching.[2]

 

The problem is not that AEDs do not work.

The problem is not that AEDs are not safe.

The problem is thinking that AEDs are a simple solution to a problem that is not as simple as some would like us to believe.
 

The concept of equipping as many emergency responders as possible with AEDs has been widely adopted,2 and 31 but it should not be blindly adopted without improving the EMS system at all levels. This decision should be individualized to each EMS system based on all of the variables in EMS response. As an isolated enhancement, it is doubtful that addition of AEDs will provide a measurable survival benefit.[2]

 

If first responder naloxone were limited to people found with needles in their arms, less thought would be required. As the presentation of overdose changes to prescription opioids, there is less clear evidence of overdose and more of a need for a good assessment and understanding of pharmacology.

First responder naloxone may save lives, when it is administered appropriately. We should study this before implementation. Discouraging us from studying the safety and efficacy of this type of use of naloxone is bad medicine.
 

Also see –

Is ‘Narcan by Everyone’ a Good Idea?

Should Basic EMTs Give Naloxone (Narcan)?

The Myth that Narcan Reverses Cardiac Arrest

To Narcan or not Narcan

What About Nebulized Naloxone (Narcan) – Part I

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Footnotes:

-

[1] I’ve heard that PA is looking to follow down the “Narcan for everyone” route, in allowing PD and BLS folks to give intranasal naloxone. . . .
Facebook
Narcan post

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[2] EMT defibrillation does not increase survival from sudden cardiac death in a two-tiered urban-suburban EMS system.
Sweeney TA, Runge JW, Gibbs MA, Raymond JM, Schafermeyer RW, Norton HJ, Boyle-Whitesel MJ.
Ann Emerg Med. 1998 Feb;31(2):234-40.
PMID: 9472187 [PubMed - indexed for MEDLINE]

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Dr. Oz Shows How He Lies with Bad Research


 

These pictures show the same thing – abuse of trust.
 


 

Today, Dr. Oz was questioned by Sen. Claire McCaskill of the Senate Commerce subcommittee on Consumer Protection, Product Safety and Insurance. Watch how Dr. Oz spins nonsense to defend his promotion of treatments that do not work. Fortunately, Sen. McCaskill does not fall for his propaganda. The video is embedded at the end.
 

Dr. Oz – These are the five papers. These are clinical papers. We can argue about the quality of them, very justifiably. I could pick apart the papers that show no benefit, as well.[1]

 

Translation – People do not understand science, so I, Dr. Oz, can easily fool them.
 

Dr. Oz – It is remarkably complex to figure out what works for most people in a dietary program.[1]

 

Translation – I almost don’t have to lie, but I just can’t help myself.
 

Dr. Oz – I don’t think this ought to be a referendum on the use of alternative medical therapies, because if that’s the case, I’ve been criticized for having people come on my show talk about the power of prayer. Now, as a practitioner, I can’t prove that prayer helps people survive an illness.

Sen. McCaskill – It’s hard to buy prayer.

Dr. Oz – That’s the difference.[1]

 

Translation – I would sell prayer if I could, but the real point of my comment was to try to change the subject and make it seem like I am defending prayer. I am defending fraud.
 

Dr. Oz – My show is about hope.[1]

 

Translation – Hope sells.

You can rape people who are desperate, but as long as you give them hope, it is OK.
 

Dr. Oz – I actually do personally believe in the items that I talk about on the show. I passionately study them. I recognize that, often times, they do not have the scientific muster to present as fact,[1]

 

Translation – There is no good reason to believe in this stuff.

I believe in this stuff.

My ratings depend on my belief.
 

Sen. McCaskill – The scientific community is almost monolithic against you in terms of the efficacy of the three products you described as miracles.[1]

 

Translation – You are a taking advantage of your position to deceive your audience.
 

Sen. McCaskill – When you call a product a miracle, and it’s something you can buy, and it’s something that gives people false hope, I just don’t understand why you needed to go there.[1]

 

Translation – Don’t you have any integrity?
 

Dr. Oz – My job on the show is to be a cheerleader for the audience.[1]

 

My job on the show is to be a cheerleader for the audience Big Placebo – the companies that make billions of dollars off of the audience.

Translation – No. I don’t have any integrity.
 

We need to stop making excuses for those who endanger patients with treatments that do not work and have not been demonstrated to be safe.

We need to be consistent in applying this to alternative medicine and conventional medicine.
 

-

Footnotes:

-

[1] Weight-Loss Product Advertising – Witnesses testified on ways to protect consumers from false and deceptive advertising of weight-loss products.
June 17, 2014
C-SPAN
Page with embedded video.

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Friday the 13th and full-moon – the ‘worst case scenario’ or only superstition?


 
Today we get hit with a double whammy – Friday the 13th and a full moon. This will not happen again until August of 2049.

Is there anything about Friday the 13th, or the full moon, or the combination that would make today worse than usual?

Let’s look at the evidence.

The last combination of Friday the 13th and a full moon was in October 2000. Somebody decided to compare patient volumes by category against other full moon days and also against the average volume.
 

One of the oldest superstitions is about Friday, the number 13, and a full moon. There exists a very popular belief in the relationship between the number 13 and Friday as well as the moon’s phase and the incidence of bad luck. Among the emergency department “folklore” belongs the theory that shifts on such dates are always busy ones.[1]

 

We compared the number of overall admissions divided into medical, nontrauma-related surgical emergencies, mild and moderate trauma, multiple injured patients, and attempted suicides, on the full moon days and nights from February 2000 to Friday, October 13, 2000 with the average admission rate per day during this period.[1]

 

Here are the numbers.
 


 

Nothing unusual there.
 


 

Still nothing unusual.
 


 

A higher number of non-trauma surgical emergencies on Friday the 13th with the full moon, but this is the only one category. Does anything else suggest a connection?

Trauma will clearly show the power of this double hex day to do harm.
 


 

That seems to be beneficial. That can’t be right.
 


 

That, too.

This is downright depressing.
 


 

Worse than depressing – even the suicides were not increased.
 

The data analysis showed no significant difference between Friday the 13th of October compared with our average full moon admission rate (Table 2).

Even fewer trauma patients were seen on this day compared with other full moon days and nights. Furthermore, the present study could not show any difference in the admission rate on days with a full moon, compared with a normal day, disappointing once again a lot of believers in “hospital folklore.”[1]

 

It isn’t proof, but there is plenty of other evidence against full moon superstition and others.

Maybe someone will collect data on the volumes from today and compare them with normal days and with normal full moon days.

I have written about full moon superstitions before.
 

Blue Moon 2012 – Except parts of Oceanea – Fri, 31 Aug 2012

2009’s Top Threat To Science In Medicine – Fri, 01 Jan 2010

T G I Friday the 13th – Fri, 13 Nov 2009

Happy Equinox! – Thu, 20 Mar 2008

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Footnotes:

-

[1] Friday the 13th and full-moon: the “worst case scenario” or only superstition?
Exadaktylos AK, Sclabas G, Siegenthaler A, Eggli S, Kohler HP, Luterbacher J.
Am J Emerg Med. 2001 Jul;19(4):319-20. No abstract available.
PMID: 11447523 [PubMed - indexed for MEDLINE]

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Would a Taser Have Made a Difference in the Outcome?


Investigators on the scene of a deadly shooting by San Mateo County Sheriff’s deputies. (CBS)
 

What kind of response should EMS have when a person is reported to be acting violently and carrying a knife? We stage around the corner, or a few blocks away.

What about the police? They need to try to disarm the person and control things without anyone getting hurt, but that is not always possible.

According to the various articles in the news, two deputies arrived and confronted Yanira Serrano-Garcia, an 18 year old woman who had not been taking her medication.
 

Two deputies responded to the Moonridge Housing Complex at Miramontes Point Road, east of Highway 1, where the woman lived, Rosenblatt said. The family told dispatchers the woman was mentally ill and was located down the block with a knife, and that she refused to put the weapon down when asked.[1]

 

However, another article states that the police were provided with different information.
 

The information received by emergency personnel who responded to the incident was that the woman was acting erratically and violently and had a knife. The woman’s family asked her to put the knife down, and when she didn’t comply, family members called the fire department for medical assistance, Rosenblatt said.[2]

 

Another states –
 

The family told dispatchers the woman was mentally ill and was located down the block with a knife, and that she refused to put the weapon down when asked.[3]

 

No recordings of 911 tapes are quoted, but the information that was provided to the responding deputies might change how they approached her.

Should the family have tried to get unarmed EMS to respond to care for a violent armed patient? No.

Were they just trying to protect her? Probably.

What happened?

The two deputies confronted Yanira Serrano-Garcia and shot her at least once. She was pronounced dead on scene.
 

“I don’t know why they couldn’t have done better things instead of getting a bullet through her and trying to shoot her,” said Saul Miramontes, Serrano-Garcia’s cousin. “She was kind of sick — you know, at least they could have Tasered her or at least tackled her.”[1]

 

Tackling someone who has a knife is a very bad idea for everyone. It had Darwin award written all over it.

A Taser may be appropriate, but it should involve at least two armed people, one with the Taser and one backup with a firearm that is drawn and aimed at the person to be taken down. It is not considered appropriate to just drive up and use the Taser without making some attempt to get the person to put down the knife voluntarily.

One problem with the use of the Taser is that if you are close enough to use the Taser, and the person with the knife lunges toward you, you may be stabbed without being able to hit the person with the Taser.
 


Download YouTube Video | YouTube to MP3: Vixy | Replay Media Catcher
 

Did either deputy have a Taser out? We do not know from any of the articles.

Why did only one deputy shoot? It may be that they were not positioned well and when the deputy who did shoot moved, he moved into the line of fire of the other deputy. Maybe the other deputy froze. Maybe the other deputy did not think that a shot was the appropriate response for the circumstances. There can be many other reasons. We do not know.

Was there some other reason that the deputy felt the need to shoot quickly (the shot is reported to have taken place within a minute of arriving on scene)?

There is another bit of information that has not been included in the more recent news reports. This is from a cached copy of one article.
 

Dyanna Ruiz, 12, said she had been walking to a friend’s house when she saw the deputy running away from a woman who had her arm raised and was chasing him with what appeared to be a knife.

“I saw the girl running at him with something in her hands,” Dyanna said. “I didn’t know what was happening. I was really scared about what to do.”

The deputy saw Dyanna, stopped and yelled at Serrano-Garcia, the girl said. When Serrano-Garcia kept coming at him, the deputy fired, Dyanna said.[4]

 

The deputies may have had a plan for controlling the situation that may have seemed reasonable with just the two of them and the person with the knife at risk. With a child/adolescent also at risk, the plan may fall apart. That is pure speculation on my part, but I have a lot of experience with plans falling apart, as does anyone who deals with emergencies.

Why was the statement of this witness removed from more recent versions of the article? I do not know.

Will a Taser always work? No. Sometimes, in spite of reasonable attempts to do everything right and protect lives, bad outcomes still happen.

-

Footnotes:

-

[1] Half Moon Bay woman, 18, fatally shot by deputy after lunging at him with knife, authorities say
By Erin Ivie eivie@mercurynews.com
Posted: 06/04/2014 05:56:45 AM PD Updated: 6 Days ago
Contra Costa Times News
Article

-

[2] Officer Who Killed Woman Felt His Life Was in Danger
Joan Dentler (BCN)
Friday June 06, 2014 – 09:51:00 AM
Page One
The Berkely Daily Planet
Article

-

[3] Half Moon Bay woman, 18, fatally shot by deputy after lunging at him with knife, authorities say
By Erin Ivie
eivie@mercurynews.com
Posted: 06/04/2014 05:56:22 AM PDT Updated: 6 Days ago
San Jose Mercury News
Article

-

[4] Woman, 18, shot dead by San Mateo sheriff’s deputy
Henry K. Lee and Kurtis Alexander
Updated 5:07 pm, Wednesday, June 4, 2014
SFGate.com
Cached version of the article. It is a snapshot of the page as it appeared on Jun 5, 2014 00:40:18 GMT.

Woman, 18, wielding knife shot dead by San Mateo deputy
Henry K. Lee and Kurtis Alexander
Updated 8:46 pm, Friday, June 6, 2014
Article at the same link, but when I last checked at 18:00 6/10/2014, the part I quoted was not in the article.

.

Emergency Cardiovascular Care Update (ECCU) 2014 Conference – What Will We Get?

 

What should we expect from the Emergency Cardiovascular Care Update (ECCU) 2014 Conference?

The brochure suggests that the next version of the guidelines will be based more on science than the current guidelines, but that is always the suggestion.
 


 

Will the AHA (American Heart Association) actually limit treatments to those that work?

Or will we get more wishful thinking-based guidelines?

There is an examination of the research that will affect the next decade of BLS (Basic Life Support) resuscitation.
 


 

There is also a session where questions are encouraged.
 


 

Will we continue to harm patients with ventilations?

There is still no evidence of benefit from ventilations prior to ROSC (Return Of Spontaneous Circulation). We would still ventilate those who arrested secondary to respiratory causes and children.
 

That format is repeated for ALS (Advanced Life Support).
 


 

And a session where questions are encouraged.
 


 

Will we still be giving eye of newt?

While eye of newt has not been shown to increase the rate of ROSC, it has not been studied, so we do not know if eye of newt does increase the rate of ROSC.

Epinephrine (Adrenaline in Commonwealth countries) is slightly more evidence-based than eye of newt, because it has been shown to increase the rate of ROSC, but who cares?

ROSC is not the goal.

Resuscitation of the heart and brain is the goal.

Epinephrine has failed to demonstrate improved resuscitation.
 

What works?

Teaching CPR effectively works.

Ventilations impair outcomes and impair education.
 


 

What can we do to improve the quality of CPR?
 


 

What can we do to improve the quality of EMS?

EMS resuscitation is not an ALS treatment.

EMS resuscitation is about keeping the medics out of the way of the people providing compressions and defibrillations.
 


 

Resuscitation does not come in a syringe, so prehospital therapeutic hypothermia is not going to be done with chilled IV fluids.

We know that does not work.
 


 

Stutter CPR looks promising, but we are not there, yet.
 


 

What do we do after ROSC?

Higher pressures seem to lead to higher resuscitation rates, but is that just an association of healthier hearts producing higher blood pressures, is it something we can improve with pressors (epinephrine, norepinephrine, phenylephrine – but probably not with dopamine), or is it something that we will make worse with pressors?
 


 

There is even a discussion of mechanical Compression devices.

Should we teach excellent chest compressions to bystanders, while we abandon quality EMS compressions to machines?

If quality is a problem, we should give the machines to bystanders and demand high quality from EMS.

Or is it possible that the machines can act as prehospital ECMO and improve outcomes? We do not know – yet.
 


 

It looks interesting.

I hope the results are a dramatic improvement over the current (2010) guidelines.

The 2005 guidelines made a big difference in compression quality and the resuscitation rates followed.

2015 could cause us to focus on what really works.

If it doesn’t work when we study it, then we were just fooling ourselves about whether it works. If it doesn’t work when we study it, it does not work.
 

Emergency Cardiovascular Care Update (ECCU) 2014 Conference

.

Is ‘Narcan by Everyone’ a Good Idea?


Image credit.
 

My friend Jonathan Blatman asks the following question about naloxone (Narcan) on Facebook –
 

I’ve heard that PA (Pennsylvania) is looking to follow down the “Narcan for everyone” route, in allowing PD and BLS folks to give intranasal naloxone.[1]

 

The problem is not that basic EMTs, or first responders, or police are stupid people.

The problem is that all people are stupid people.

Doctors, nurses, and paramedics do not understand naloxone, so we need to improve the understanding of pharmacology among doctors, nurses, and paramedics, before we increase the ranks of ignorant people inappropriately administering the drug.

Naloxone itself is very safe.

A quack once challenged me to take 1,000 times the dose of any medicine I chose, while he would do the same with some natural product. I accepted and chose naloxone, with the condition that he first take 1,000 time the daily recommended dose of one of something he considered completely safe and natural – water.

The quack had it pointed out to him that this dose of all natural water would be deadly. The quack backed out. Whether naloxone’s standard dose is 0.4 mg (it should not be more than this) or the dose more popular in areas with frequent fentanyl overdoses (2.0 mg) does not matter. Naloxone has been demonstrated to be relatively safe at massive doses.
 

Adult Patients
In one small study, volunteers who received 24 mg/70 kg did not demonstrate toxicity.
In another study, 36 patients with acute stroke received a loading dose of 4 mg/kg (10 mg/m2/min) of naloxone hydrochloride injection followed immediately by 2 mg/kg/hr for 24 hours. Twenty-three patients experienced adverse events associated with naloxone use, and naloxone was discontinued in seven patients because of adverse effects. The most serious adverse events were: seizures (2 patients), severe hypertension (1), and hypotension and/or bradycardia (3).
[2]

 

400 mg (0.4 mg dose x 1,000) or 2,000 mg (2.0 mg x 1,000) would be higher than the doses tested in these patients, but would still be much safer than 1,000 times the recommended daily dose of water, even though water is safe and essential for life. It does not matter if there is fluoride in the water for it to be lethal, but we should fluoridate water, because only conspiracy theorists think that fluoride is dangerous in drinking water.
 


Download YouTube Video | YouTube to MP3: Vixy | Replay Media Catcher
 

We engage in magical thinking about the drugs we give.

The problem is not with the drug. The problem is with the actions of the people giving the drug – us.

We still have a big push for giving fibrinolytics (tPA – tissue Plasminogen Activator) to patients with acute ischemic stroke, even though most of the improvement may be due to the transience of stroke symptoms in some stroke patients (TIS – Transient Ischemic Attack). Fibrinolytics do not appear to be beneficial for acute ischemic stroke and there is no reason to give them for a TIA.

There is weak beneficial evidence in only two out of eleven studies (only 18% of studies) – and increases in death in most studies of fibrinolytics for acute ischemic stroke.[3] The problem is not with the drug. The problem is with the actions of the people giving the drug. Most of the evidence shows death increased, but we ignore that.

Naloxone and tPA are both given based on a rush to treatment and a fear of not giving the standard of care – the Yuppie Nuremberg Defense.
 

Everyone’s got a mortgage to pay. [inner monologue] The Yuppie Nuremberg defense.[4]

 

Will this be a matter of providing naloxone, rather than providing ventilations?
 

An epidemic of naloxone-resistant heroin overdoses due to fentanyl adulteration has led to significant morbidity and mortality throughout the central and eastern United States. According to records of the Philadelphia County Medical Examiner’s office, at least 250 overdose deaths have been associated with fentanyl between April 1, 2006, and March 1, 2007.[5]

 

What about people who take more than one drug?

If the opioid is reversed, will there be problems?
 

All were initially lethargic and became agitated and combative after emergency medical service (EMS) personnel treated them with parenteral naloxone, which is routinely used for suspected heroin overdose to reverse the toxic effects of opioids (e.g., coma and respiratory depression). All patients received diazepam or lorazepam for sedation, and signs and symptoms resolved during the next 12-24 hours.[6]

 

Will we identify the patients who have other medical conditions that may respond after naloxone, but not because of naloxone, such as hypoglycemia, stroke, seizures, clonidine overdose, arrhythmia, head trauma, dehydration, syncope, et cetera?
 

Six of the 25 complete responders to naloxone (24%) ultimately were proven to have had false-positive responses, as they were not ultimately given a diagnosis of opiate overdose. In four of these patients, the acute episode of AMS was related to a seizure, whereas in two, it was due to head trauma; in none of these cases did the ultimate diagnosis include opiates or any other class of drug overdose (which might have responded directly to naloxone). Thus, what was apparently misinterpreted as a response to naloxone in these cases appears in retrospect to have been due to the natural lightening that occurs with time during the postictal period or after head trauma.[7]

 

The problem is not with the administration of naloxone, but with the faulty assumption that because a patient wakes up after naloxone, the patient woke up because of naloxone.

Doctors, nurses, and paramedics do not do a good job of identifying the difference currently. We need to educate them, rather than encourage others to replicate their mistakes.

Pharmacology is poorly understood by people with medical education.
 

The documented indication for nebulized naloxone administration was suspected opioid overdose in 70 patients (66.7%), altered mental status in 34 patients (32.3%), and respiratory depression in one patient (0.9%).[8]

 

The indication for naloxone is respiratory depression.

The treatment for respiratory depression is to supplement oxygen and/or ventilations. We have decided to give naloxone in stead.

Naloxone was used appropriately in fewer than 1% of patients.

How good bad will our naloxone by everyone education be?

Don’t wait with bated breath – someone my administer naloxone.
 

Also read –

Should Basic EMTs Give Naloxone (Narcan)?

The Myth that Narcan Reverses Cardiac Arrest

To Narcan or not Narcan

What About Nebulized Naloxone (Narcan) – Part I

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Footnotes:

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[1] I’ve heard that PA is looking to follow down the “Narcan for everyone” route, in allowing PD and BLS folks to give intranasal naloxone. . . .
Facebook
Narcan post

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[2] NALOXONE HYDROCHLORIDE injection, solution
[Hospira, Inc.]

DailyMed
Adverse reactions
Overdosage
FDA Label

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[3] The Guideline, The Science, and The Gap
Wednesday, April 17, 2013
Dr. David Newman
Smart EM
Article

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[4] Thank You for Smoking
Movie, based on the book by Christopher Buckley
Wikiquote
Quote page

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[5] Heroin: what’s in the mix?
Muller AA, Osterhoudt KC, Wingert W.
Ann Emerg Med. 2007 Sep;50(3):352-3.
PMID: 17709054 [PubMed - indexed for MEDLINE]

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[6] Scopolamine Poisoning among Heroin Users — New York City, Newark, Philadelphia, and Baltimore, 1995 and 1996
MMWR (Morbidity and Mortality Weekly Report).
Vol 45, No 22;457;
Free Full Text from the Centers for Disease Control and prevention.

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[7] The empiric use of naloxone in patients with altered mental status: a reappraisal.
Hoffman JR, Schriger DL, Luo JS.
Ann Emerg Med. 1991 Mar;20(3):246-52.
PMID: 1996818 [PubMed - indexed for MEDLINE]

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[8] Can nebulized naloxone be used safely and effectively by emergency medical services for suspected opioid overdose?
Weber JM, Tataris KL, Hoffman JD, Aks SE, Mycyk MB.
Prehosp Emerg Care. 2012 Apr-Jun;16(2):289-92. doi: 10.3109/10903127.2011.640763. Epub 2011 Dec 22.
PMID: 22191727 [PubMed - indexed for MEDLINE]

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