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

- Rogue Medic

Happy Play God Day

 
January 9th is Play God Day.

OK. I’ll play. What could possibly go wrong.

I will start before The Beginning. I am everything and I am perfect.

Do I ruin that by creating something other than me? Am I lonely, bored, needy, neurotic, . . . ? What fallibility would inspire me to create creatures to slaughter? According to my biography, this is where I start to screw things up, but it could have been earlier.
 

play-god-day-1
 
Do I ruin perfection by creating something imperfect? Apparently. According to my biography, I do not accept that my far-from-perfect actions are demonstrations of my lack of perfection, but I make the rules, so I will torture you forever for pointing out my failures. It seems fair to me.

Remember that my name is Jealous and It isn’t bad when I do it. I said so. And it seems that I have to say so, because I can’t write. Why can’t I write? Why am I the worst communicator of all time? Remember, I will torture you forever for pointing out my failures.

Why would I choose to create evil and abolish my perfection? I didn’t create evil. Evil created itself and I use the existence of evil so that I can claim that I am better than something else. Don’t expect me to be reasonable. Remember, I will torture you forever for pointing out my failures. If I can create myself out of nothing, why can’t evil? And if I am not as good as I claim to be, maybe evil is not as bad as I claim that it is.

Was I ever perfect, if I can create evil, or let evil be created, or let evil create itself? So what if I get cranky and drown everyone on the planet, except for eight supposedly good people, who weren’t as good as I thought? Was everyone else really evil? What about their innocent fetuses? If I really wanted to get rid of all of the bad people, maybe I should have chosen passengers a little better. Maybe I could have just dealt with them individually. Look at me being surprised by something I didn’t anticipate, again.

Why did I use such an inaccurate weapon? Why not use a laser? That would impress people. A technology that the creators of the Gods did not know about! That would have been much more impressive than a bigger than usual flood. Maybe I should have created better writers.

Why would I want to be such an abysmal failure as the Jewish/Christian/Muslim God? Maybe I just don’t think for myself. Maybe I was just created by people who were not aware of their prejudices and logical fallacies. Richard Feynman has comment on the reports of flying saucers, which I like to modify to apply just as accurately to the Gods.
 

It is not unscientific to make a guess, although many people who are not in science think it is. Some years ago I had a conversation with a layman about flying saucers God — because I am scientific I know all about flying saucers God! I said “I don’t think there are flying saucers Gods”. So my antagonist said, “Is it impossible that there are flying saucers Gods? Can you prove that it’s impossible?” “No”, I said, “I can’t prove it’s impossible. It’s just very unlikely”. At that he said, “You are very unscientific. If you can’t prove it impossible then how can you say that it’s unlikely?” But that is the way that is scientific. It is scientific only to say what is more likely and what less likely, and not to be proving all the time the possible and impossible. To define what I mean, I might have said to him, “Listen, I mean that from my knowledge of the world that I see around me, I think that it is much more likely that the reports of flying saucers God are the results of the known irrational characteristics of terrestrial intelligence than of the unknown rational efforts of extra-terrestrial supernatural intelligence.” It is just more likely. That is all.

 
The Character of Physical Law (1965)
chapter 7, “Seeking New Laws,” p. 165-166: video

 

I could have arranged for good people to be rewarded and bad people to fail. I used to have you believing that I did that and you humans abused people who were different, because that was a sign from me that those people are evil. Many of you haven’t stopped. I love irrational people. Billions of irrational people can’t be wrong, so keep killing each other over the right interpretation of my biography.

If I were going to be a God for a day, I might increase the ability of people to understand. A God capable of communicating in a way that people could agree on would suggest that the God is not made by people, but the only thing that Christians seem to agree on is that they like Jesus. A real God could have communicated a real message, but what should we expect from the guy who wrecked the Tower of Babel, which we have long since surpassed. Ooops.

.

2016 – Amiodarone is Useless, but Ketamine Gets Another Use

amiodarone-edit-1
 

I didn’t write a lot in 2016, but 2016 may have been the year we put the final nail in the coffin of amiodarone. Two major studies were published and both were very negative for amiodarone.

If we give enough amiodarone to have an effect on ventricular tachycardia, it will usually be a negative effect.[1]

Only 38% of ventricular tachycardia patients improved after amiodarone, but 48% had major adverse cardiac events after amiodarone.

There are better drugs, including adenosine, sotalol, procainamide, and ketamine for ventricular tachycardia. Sedation and cardioversion is a much better choice. Cardioversion is actually expected after giving amiodarone.

For cardiac arrest, amiodarone is not any better than placebo or lidocaine. What ever happened to the study of amiodarone that was showing such wonderful results over a decade ago? It still hasn’t been published, so it is reasonable to conclude that the results were negative for amiodarone. It is time to make room in the drug bag for something that works.[2],[3]

On the other hand, now that we have improved the quality of CPR by focusing on compressions, rather than drugs, more patients are waking up while chest compressions are being performed, but without spontaneous circulation, so ketamine has another promising use. And ketamine is still good for sedation for intubation, for getting a patient to tolerate high flow oxygen, for agitated delirium, for pain management, . . . .[4],[5]

Masimo’s RAD 57 still doesn’t have any evidence that it works well on real patients.[6]

When intubating, breathe. Breathing is good. Isn’t inability to breathe the reason for intubation?[7]

Footnotes:

[1] The PROCAMIO Trial – IV Procainamide vs IV Amiodarone for the Acute Treatment of Stable Wide Complex Tachycardia
Wed, 17 Aug 2016
Rogue Medic
Article

[2] Amiodarone, Lidocaine, or Placebo in Out-of-Hospital Cardiac Arrest
Mon, 04 Apr 2016
Rogue Medic
Article

[3] Dr. Kudenchuk is Misrepresenting ALPS as ‘Significant’
Tue, 12 Apr 2016
Rogue Medic
Article

[4] What do you do when a patient wakes up during CPR?
Tue, 08 Mar 2016
Rogue Medic
Article

[5] Ketamine For Anger Management
Sun, 06 Mar 2016
Rogue Medic
Article

[6] The RAD-57 – Still Unsafe?
Wed, 03 Feb 2016
Rogue Medic
Article

[7] Should you hold your breath while intubating?
Tue, 19 Jan 2016
Rogue Medic
Article

.

‘Narcan by Everyone’ Does Not Seem to be Such a Good Idea

 
Now that we have almost everyone giving naloxone (Narcan) to suspected heroin overdose patients, the fatality rate must have dropped. The panacea must have worked. My criticism of the Narcan by Everyone programs must have made me a laughing stock.[1],[2],[3],[4]

No.

Does that mean that I am a prophet and that you should worship me?

No.

Explanations exist; they have existed for all time; there is always a well-known solution to every human problem — neat, plausible, and wrong. H.L. Mencken.

I have been pointing out that the plans assumed that there would not be any unintended consequences. I explained what some of the unintended consequences would be. Many people used logical fallacies to justify ignoring the likelihood of unintended consequences. The reasonable thing to do would have been to study the implementation, so that problems would be noticed quickly.

Misdiagnosis – giving naloxone to people who have a change in level of consciousness that is not due to an opioid (heroin, fentanyl, carfentanyl, . . . ) overdose.
 

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.[5]

Bold highlighting is mine.

 

Failure to ventilate – not providing ventilations to a patient who is not breathing. These patients are often hypoxic (don’t have enough oxygen to maintain life) and hypercarbic (have too much carbon dioxide to maintain life). If the patient is alive, ventilation should keep the patient alive, even if naloxone is not given or if the naloxone is not effective. If the patient is dead, giving naloxone will not improve the outcome.[6]

But . . . But . . . But . . . Narcan is the miracle drug!
 


Image credit.
 

In Akron, a small Ohio city, medical examiner Dr. Lisa Kohler has seen over 50 people die of carfentanil since July. Police Lieutenant Rick Edwards says his officers are “giving four to eight doses of [naloxone] just to get a response.”[7]

 

“Every day our paramedics start CPR on someone surrounded by empty naloxone vials… people give the naloxone and walk away,” she (Ambulance Paramedics of BC president Bronwyn Barter) said in an interview.[7]

 

Where should we start?
 

All patients considered to have opioid intoxication should have a stable airway and adequate ventilation established before the administration of naloxone.[8]

 

We keep making excuses for solutions that are neat, plausible, and wrong. Why don’t we start acting like responsible medical professionals and do what is best for our patients?
 

Thank you to Gary Thompson of Agnotology for linking to this for me.

Go read Response: ‘What happens when drugs become too powerful for overdose kits’

Footnotes:

[1] The Myth that Narcan Reverses Cardiac Arrest
Wed, 12 Dec 2012 20:45:29
Rogue Medic
Article

[2] Should Basic EMTs Give Naloxone (Narcan)?
Fri, 27 Dec 2013 14:00:22
Rogue Medic
Article

[3] Is ‘Narcan by Everyone’ a Good Idea?
Tue, 03 Jun 2014 23:00:38
Rogue Medic
Article

[4] Is First Responder Narcan the Same as First Responder AED?
Wed, 18 Jun 2014 17:15:43
Rogue Medic
Article

[5] Acute heroin overdose.
Sporer KA.
Ann Intern Med. 1999 Apr 6;130(7):584-90. Review.
PMID: 10189329 [PubMed – indexed for MEDLINE]

[6] The Kitchen Sink Approach to Cardiac Arrest
Mon, 16 Feb 2015 16:00:53
Rogue Medic
Article

[7] What Happens When Drugs Become Too Powerful for Overdose Kits?
Dr. Blair Bigham
Oct 4 2016, 12:11pm
Article

[8] Naloxone for the Reversal of Opioid Adverse Effects
Marcia L. Buck, PharmD, FCCP
Pediatr Pharm. 2002;8(8)
Medscape (free registration required?)
Clinical Uses

.

Happy Bill of Rights Day – 225 Years Old

bill-of-rights-hero-lg-1
 

The Bill of Rights was ratified on December 15, 1791, which makes today the 225th anniversary of being signed into law. The Bill of Rights protects the interests of minorities from oppression by tyrannical majorities. This is why we are not really a democracy, but a constitutional republic.

If a majority decides that a minority should not be entitled to the same rights as the majority, or promotes some rationalization of the difference as not being a valid difference, that minority can appeal to the courts for relief. On the other hand, there are no absolute rights, which would invalidate all other rights.

You can be executed for a crime you did not commit, even if you can prove that you are innocent. You have to appeal to the governor or president for intervention. As the Supreme Court decided –
 

Held: Herrera’s claim of actual innocence does not entitle him to federal habeas relief. Pp. 6-28.[1]

 

Due process of law does not require that the innocent be set free. Life, Liberty and the pursuit of Happiness are not to be found in the American Constitution. Life, Liberty and the pursuit of Happiness are not to be found in the Bill of Rights.

Rights also come with responsibilities. We need to respect the rights of others, no matter how much we might think that others cannot be trusted to make those decisions, while we claim to be able to make these same decisions, not just for ourselves, but for others.

If people of different races want to marry, the state governments are not permitted to use their authority to sanction marriages to deprive citizens of their right to marry based on tradition. States rights have limitations, just as individual rights have limitations.

Discriminating against citizens of a politically incorrect group for decades, or even centuries, is not a justification for continuing to deprive them of equal treatment under the law.

Others may use their freedom, which always comes with responsibilities, in ways we do not like, but that is part of the price of freedom.

Even though slavery was legal at the time of ratification of the American Constitution and Bill of Rights, and is still endorsed by the Bible, we have recognized that slavery is bad. Our Constitution caught up with a lot of the rest of the world.

The Bible still endorses slavery and says that I can sell my daughter as a sex slave.

What progress we are making. In the Middle Ages they would have burned me. Now they are content with burning my books. – Sigmund Freud

The Bill of Rights is much better than the Bible. Go blaspheme in celebration of the Bill of Rights, which protects us from those who would burn us, or our writing, or otherwise punish us for being honest.

Footnotes:

[1] Herrera v. Collins (91-7328), 506 U.S. 390 (1993)
Argued October 7, 1992
Decided January 25, 1993
US Supreme Court
Decision

 

In criminal cases, thetrial is the paramount event for determining the defendant’s guilt or innocence. Where, as here, a defendant has been afforded a fair trial and convicted of the offense for which he was charged, the constitutional presumption of innocence disappears. Federal habeas courts do not sit to correct errors of fact, but to ensure that individuals are not imprisoned in violation of the Constitution. See, e.g., Moore v. Dempsey, 261 U.S. 86, 87-88. Thus, claims of actual innocence based on newly discovered evidence have never been held to state a ground for federal habeas relief absent an independent constitutional violation occurring in the course of the underlying state criminal proceedings.

 

.

Flag burning, patriotism, and reality

flagburningtrump2a

Tweet by President-elect Donald Trump on flag burning
 

Is appearance more important than reality?
 

Why do people burn the American flag?

There may be many reasons, but the essence appears to be an attempt to shock people to recognize what the flag burners see as hypocrisy.

What is the purpose of prohibiting burning of the American flag?

Some people place more value in this symbol of America (the flag), than they do in what makes America great (the Constitutional protections of the rights of Americans).

Is President-elect Trump an opponent of the American Constitution? Is President-elect Trump just engaging in a politically correct theatrical display for people who do not seem to understand that the American Constitution doesn’t care if their feelings get hurt?
 


 

In 1798, Congress passed, and President John Adams signed, the Alien and Sedition Acts.[1] These restricted eligibility to vote, restricted immigration, allowed for increased deportation of aliens considered dangerous, and made criticism of the federal government illegal. This is one example of Founding Fathers acting in a way that is contrary to what many consider their original intent.

Recently deceased Supreme Court Justice Antonin Scalia voted in the majority to protect flag burning in 1989.[2] Did Justice Scalia hate America, hate the American flag, or is it more complex than an early morning tweet can express?

In 1943, during World War II, the Supreme Court decided on a variation of this concept. Is it Constitutional to force people to demonstrate patriotism?
 

To believe that patriotism will not flourish if patriotic ceremonies are voluntary and spontaneous instead of a compulsory routine is to make an unflattering estimate of the appeal of our institutions to free minds.[3]

 

Real patriotism is not a politically correct compulsory display.
 

But freedom to differ is not limited to things that do not matter much. That would be a mere shadow of freedom. The test of its substance is the right to differ as to things that touch the heart of the existing order.[3]

 

The American Constitution does not authorize thought crimes.
 

If there is any fixed star in our constitutional constellation, it is that no official, high or petty, can prescribe what shall be orthodox in politics, nationalism, religion, or other matters of opinion or force citizens to confess by word or act their faith therein. If there are any circumstances which permit an exception, they do not now occur to us.[3]

 

What about those who claim that Americans have risked their lives, and even died, to protect the sanctity of the American flag? Does service in any branch of the American military contain any oath to protect the American flag?
 

(a) Enlistment Oath .-Each person enlisting in an armed force shall take the following oath:
“I, ____________________, do solemnly swear (or affirm) that I will support and defend the Constitution of the United States against all enemies, foreign and domestic; that I will bear true faith and allegiance to the same; and that I will obey the orders of the President of the United States and the orders of the officers appointed over me, according to regulations and the Uniform Code of Military Justice. So help me God.”
[4]

 

The So help me God is optional, since there is no truth to the myth that there are no atheists in foxholes and the American Constitution prohibits all religious requirements for service.

The oath is to protect the American Constitution, which protects flag burning. The oath is not to protect the American flag.

Even Jesus stated opposition to this kind of political theater.
 

5 “When you pray, you are not to be like the hypocrites; for they love to stand and pray in the synagogues and on the street corners [a]so that they may be seen by men. Truly I say to you, they have their reward in full. 6 But you, when you pray, go into your inner room, close your door and pray to your Father who is in secret, and your Father who sees what is done in secret will reward you.[5]

 

What does it say about America that we reward theatrical patriotism, rather than respect for the Constitution which makes America great?

Or is President-elect Trump taking initial steps to try to get Citizens United v. Federal Election Commission[6] overturned by expressing that not everything is protected expression? Who can tell with someone who expresses himself in such a vague manner?

Is appearance more important than reality?

Footnotes:

[1] Alien and Sedition Acts
1798
Primary Documents in American History
Library of Congress page

[2] Texas v. Johnson, (1989)
No. 88-155
Argued: March 21, 1989
Decided: June 21, 1989
United States Supreme Court
case

[3] West Virginia State Board of Education v. Barnette (No. 591)
Argued: March 11, 1943
Decided: June 14, 1943
case

[4] §502. Enlistment oath: who may administer
Text contains those laws in effect on November 28, 2016
US Code page

Amended in 1962 – inserted “So help me God” in the oath, and “or affirmation” in text.

[5] Matthew 6:5-6
New American Standard Bible (NASB)
You can go to the site and look up all of the other versions of the Bible or just pick up a Bible and read this.
Bible Gateway
Bible

[6] Citizens United v. Federal Election Commission
2009
case

.

SWAT Fuel – Suing Me to Defend Their Scam

swat-fuel-stop-exposing-our-scam-or-we-will-sue
 

Earlier, I wrote about SWAT Fuel, explaining why SWAT Fuel’s amphetamine-like products are a scam and providing evidence.
 

How to scam the police – SWAT Fuel
 

Now, I am being threatened with a law suit, unless I remove what I wrote, all of the comments (even the fawning SWAT Fuel fanboy comments), and cease writing about SWAT Fuel.

Is SWAT Fuel a scam?

SWAT Fuel, Inc. has not provided any evidence of safety.

SWAT Fuel, Inc. has not provided any evidence of efficacy.

I asked for evidence.

I was threatened with a lawsuit.
 

Will I remove what I wrote? Will I stop criticizing the amphetamine-like products of the SWAT Fuel scam?
 

molon_labe-1a
 

Should I pretend that SWAT Fuel’s amphetamine-like concoctions are safe, when even SWAT Fuel cannot provide valid evidence of safety?

I do not approve of poisoning the police, the military, or anyone else. SWAT Fuel, Inc. needs to provide valid evidence that their amphetamine-like products are safe.

Should I pretend that SWAT Fuel’s amphetamine-like concoctions are effective, when even they cannot provide valid evidence of efficacy?

Amphetamine-like? If we are to believe their advertising, SWAT Fuel is even stronger than amphetamines – SWAT Fuel was described as being like strapping a JATO rocket to your back! SWAT Fuel does not seem to use that terminology any more. I ridiculed that language and they changed. Coincidence? I don’t know, but maybe I can persuade them to develop some ethics and produce some valid evidence.
 

How to scam the police – SWAT Fuel
 

.

FDA bans useless, possibly dangerous, antibacterial soap ingredients

antiseptic soaps safe - qm - WSJ and FDA logo
 

As of September 6, 2017, The FDA (Food and Drug Administration) will ban manufacturers from selling antiseptic soaps over the counter to consumers because the manufacturers could not provide evidence that they work and that they are safe. The list of ingredients is in the footnotes.[1],[2]

In 2013, the FDA gave manufacturers a deadline to provide information about the products they sell to consumers. After decades of use, the manufacturers finally needed to provide evidence that the ingredients in their products are GRAS/GRAE. What does GRAS/GRAE mean?

GRAS = Generally Recognized As Safe
GRAE = Generally Recognized As Effective
GRAS/GRAE = Generally Recognized As Safe and Effective

As a consumer, do we want to spend our money on something that is not safe, is not effective, or is both unsafe and is ineffective?

Does the absence of evidence prove that the ingredients are unsafe or that they are ineffective? No.

The failure to provide evidence shows one of the following –

A. The manufacturers cannot show that the ingredients are safe.
B. The manufacturers cannot show that the ingredients are effective.
C. The manufacturers cannot show that the ingredients are safe and effective.

Those three are the most obvious possibilities, but there are several more possibilities. For example –

D. The manufacturers don’t care enough to find out if the ingredients are safe or effective.

Is it a business decision that the amount of money to be made in this multi-billion dollar market is not worth the amount of money that would be lost, but would any money be lost? Is the failure to provide evidence essentially an admission that the antibacterial soaps are just a marketing gimmick? Have the manufacturers avoided providing evidence? No.

Is there an absence of information? No. There is plenty of evidence, but the evidence does not show benefit or safety.
 

Both sides in the debate have submitted reams of evidence to the FDA supporting their stance, offering up conflicting studies that make it a challenge for the average consumer to make informed decisions.[3]

 

The more conspiratorial would add some other possibilities –

E. The manufacturers can show that the ingredients are not safe.
F. The manufacturers can show that the ingredients are not effective.
G. The manufacturers can show that the ingredients are not safe and not effective.

These are not impossible, but should we assume that manufacturers are intentionally and maliciously marketing dangerous and useless products? Hanlon’s razor addresses this –

Never attribute to malice that which is adequately explained by stupidity.

Stupidity does not appear to be the right word for this situation. There is another version of Hanlon’s razor that seems to be written just for the those who think that a lack of evidence of harm is the same as safety and efficacy.

Don’t assume bad intentions over neglect and misunderstanding.
 

How different is this from medical treatments that have no evidence of efficacy or safety? We stopped using backboards to stabilize the spine, atropine for cardiac arrest, furosemide for CHF, . . . , and we may no longer be able to justify using amiodarone.

Footnotes:

[1] FDA issues final rule on safety and effectiveness of antibacterial soaps – Rule removes triclosan and triclocarban from over-the-counter antibacterial hand and body washes
FDA (Food and Drug Administration)
For Immediate Release
September 2, 2016
FDA News Release

[2] Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use
A Rule by the Food and Drug Administration on 09/06/2016
Final rule.

What ingredients are banned?

Thus, the following active ingredients are not GRAS/GRAE for use as a consumer antiseptic wash:
    *Cloflucarban
    *Fluorosalan
    *Hexachlorophene
    *Hexylresorcinol
    *Iodophors (Iodine-containing ingredients)
○ Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate)
○ Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol)
○ Nonylphenoxypoly (ethyleneoxy) ethanoliodine
○ Poloxamer—iodine complex
○ Povidone-iodine 5 to 10 percent
○ Undecoylium chloride iodine complex
    *Methylbenzethonium chloride
    *Phenol (greater than 1.5 percent)
    *Phenol (less than 1.5 percent)
    *Secondary amyltricresols
    *Sodium oxychlorosene
    *Tribromsalan
    *Triclocarban
    *Triclosan
    *Triple dye
Accordingly, OTC consumer antiseptic wash drug products containing these active ingredients are misbranded, and are new drugs for which approved new drug applications are required for marketing.

IV. Ingredients Not Generally Recognized as Safe and Effective

[3] Are Antibacterial Soaps Safe? Companies say there’s no cause for alarm, but studies suggest they may be dangerous. Now the FDA is preparing to rule.
Wall Street Journal
By Laura Landro
Updated Feb. 15, 2016 11:01 p.m. ET
Article

.

New Illinois state law will allow basic EMTs to inject epinephrine

 
EpiPen 1 from Bloomberg dot com
Image from Bloomberg.com.
 

0.15 mg (0.15 ml of 1 mg/ml epinephrine) for a child.
0.3 mg (0.3 ml of 1 mg/ml epinephrine) for an adult.
Inject deep into the side of the thigh.
This should not be complicated, but . . . .

Paramedics have generally been able to give epinephrine injections for anaphylaxis in Illinois and elsewhere. As of January 1, 2017, basic EMTs (Emergency Medical Technicians) in Illinois, who have been able to use the EpiPen autoinjector, will be able to give epinephrine injections the same way paramedics give epinephrine for anaphylaxis.[1],[2]

Why? The cost of the autoinjector has increased from around $100 to around $600 since 2007, when Mylan bought the EpiPen as part of a group of products from Merck. During that time, the packaging has gone from a single EpiPen to two EpiPens, so that may be one part of the increase.

The EpiPen, which is currently only made by Mylan, used to have competition from Sanofi. On October 30, 2015, Sanofi recalled their Auvi-Q autoinjectors due to the possibility of dosage inaccuracies.[3] Some people are claiming that the increase in cost is due to the withdrawal of this competitor from the market, but I was able to locate two other competitors in the US, so there is competition.

Explanations exist; they have existed for all time; there is always a well-known solution to every human problem — neat, plausible, and wrong. H.L. Mencken.

If only the Sanofi recall caused the price increase, the price would not have been increasing for the past 10 years, but only for the past 10 months. Here is a graph of the price increase before the Sanofi recall.
 

EpiPen 2 from Bloomberg dot com
Graph from September 2015 – before the Sanofi recall – from Bloomberg.com.[4]
 

There are other competitors out there. Adrenaclick by Amedra Pharmaceuticals LLC,[5] and epinephrine injection, USP auto-injector by Lineage Therapeutics Inc.[6] – both located in Horsham, PA and the web sites have the same design, so they may be manufactured in the same facility.
 

The problems with having basic EMTs giving epinephrine injections are that the education has to be very good and the oversight has to be aggressive. As with naloxone (Narcan), doctors, nurses, and paramedics often give the drug inappropriately, so we know that there is a lot of potential for error.

The closest children’s hospital only uses autoinjectors, because they do not allow the nurses to draw up epinephrine for anaphylaxis. They probably do not allow the doctors to either, but I did not ask.

How bad are doctors at diagnosing and treating anaphylaxis?
 

Senior house officers (SHOs) (n=78) at the start of their accident and emergency (A&E) post were given an anonymous five case history questionnaire, containing one case of true anaphylaxis, and asked to complete the medication they would prescribe. In the case of anaphylaxis, 100% would administer adrenaline (epinephrine) but 55% would do so by the incorrect route. In the remaining cases, 10%–56% would be prepared to administer adrenaline inappropriately. Only 5% were able to indicate the correct route and dose of adrenaline according to Resuscitation Council guidelines (UK). This has implications for training as the survey took place before the start of the A&E posting. Anaphylaxis is over-diagnosed and poorly treated despite Resuscitation Council guidelines.[7]

 

That was in 2002. Have things improved?
 

RESULTS:
68 of 107 (64%) junior doctors completed the questionnaire. All recognised the need for adrenaline in anaphylaxis, but only 74% selected the correct intramuscular route, and 34% the correct route and dose. 82% of junior doctors would inappropriately give adrenaline to the patient who had inhaled a foreign body (case 2). A higher percentage of the 2013 cohort indicated the correct route and dose of adrenaline in anaphylaxis than their 2002 colleagues. However, a greater percentage also selected adrenaline treatment inappropriately in non-anaphylactic case scenarios.

CONCLUSIONS:
Despite updated guidelines, junior doctors continue to have poor knowledge about the recognition and management of anaphylaxis, with some still considering inappropriate intravenous adrenaline. More effort should be given to the recognition of anaphylaxis in early medical training.
[8]

 

Other research on doctors shows similar inability to come up with the right diagnosis, the right dose, and/or the right route of administration.[9],[10],[11] There are more. My anecdotal experience is that this is also a problem in the US with experienced paramedics and experienced physicians.

What about the King County epinephrine kit for basic EMTs?
 

King County epinephrine program to replace epipens 1 from Seattle Times
Image from the Seattle Times.
 

With training, EMTs in the program have learned to administer epinephrine efficiently and safely, he said. An EpiPen takes about 45 seconds to administer, start to finish. With the vial and syringe, it’s about 2 minutes, Duren said.[12]

 

As a paramedic, I am not going to be much faster.
 

“That sounds reasonable,” Reiter said. “For all but the most severe cases of anaphylaxis, a one-minute time lag is unlikely to make a difference.”[12]

 

The article suggests that King County is tracking their results carefully, which does not appear to be the case for EMS systems that have first responders giving naloxone. I would still like to see something published in a peer reviewed journal.

Footnotes:

[1] New state law will allow EMTs to inject epinephrine
Dan Petrella
The Southern Springfield Bureau
The Southern Illinoisan
Updated 22 hrs ago
Article

[2] New Ill. law to allow all EMTs to use syringes to administer epinephrine – The new law will allow EMTs with basic-level training to use a syringe to administer epinephrine
By EMS1 Staff
EMS1.com
Yesterday at 12:59 PM
Article

[3] UPDATED: Sanofi US Issues Voluntary Nationwide Recall of All Auvi-Q® Due to Potential Inaccurate Dosage Delivery
FDA (Food and Drug Administration – US)
For Immediate Release
October 30, 2015
Recall notice

[4] How Marketing Turned the EpiPen Into a Billion-Dollar Business – Mylan’s marketing turned the allergy device into a must-have.
Cynthia Koons and Robert Langreth
Bloomberg Businessweek
September 23, 2015 — 10:00 AM EDT
Article

[5] How to use Adrenaclick (epinephrine injection, USP auto-injector)
Adrenaclick by Amedra Pharmaceuticals LLC, Horsham, PA
Web site

[6] epinephrine injection, USP auto-injector
Lineage Therapeutics Inc., Horsham, PA
Web site

[7] Proposed use of adrenaline (epinephrine) in anaphylaxis and related conditions: a study of senior house officers starting accident and emergency posts.
Gompels LL, Bethune C, Johnston SL, Gompels MM.
Postgrad Med J. 2002 Jul;78(921):416-8.
PMID: 12151658

Free Full Text from PubMed Central.

[8] Correct recognition and management of anaphylaxis: not much change over a decade.
Plumb B, Bright P, Gompels MM, Unsworth DJ.
Postgrad Med J. 2015 Jan;91(1071):3-7. doi: 10.1136/postgradmedj-2013-132181.
PMID: 25573132

Free Full Text from Postgrad Med J.

[9] Survey of the use of epinephrine (adrenaline) for anaphylaxis by junior hospital doctors.
Jose R, Clesham GJ.
Postgrad Med J. 2007 Sep;83(983):610-1.
PMID: 17823230

Free Full Text from PubMed Central

[10] Anaphylaxis: lack of hospital doctors’ knowledge of adrenaline (epinephrine) administration in adults could endanger patients’ safety.
Droste J, Narayan N.
Eur Ann Allergy Clin Immunol. 2012 Jun;44(3):122-7.
PMID: 22905594

[11] Treatment of a simulated child with anaphylaxis: an in situ two-arm study.
O’Leary FM, Hokin B, Enright K, Campbell DE.
J Paediatr Child Health. 2013 Jul;49(7):541-7. doi: 10.1111/jpc.12276. Epub 2013 Jun 12.
PMID: 23758136

Free Full Text from J Paediatr Child Health.

 

RESULTS:
Fifty-six junior medical staff participated (90% participation rate). Only 50% of participants administered adrenaline in scenarios of definite anaphylaxis. Adrenaline was more likely to be administered if the scenario included hypotension, where the junior medical officer had previous formal resuscitation training (Advanced Paediatric Life Support) and by medical officers with more years of training.

CONCLUSION:
Anaphylaxis is a life-threatening presentation and requires prompt recognition and appropriate adrenaline administration. Junior medical staff may require more emphasis on recognition and prompt adrenaline administration in both undergraduate and in hospital training and education. Simulated scenarios may provide a platform to deliver this training to ultimately improve patient care.

 

[12] King County drops EpiPen for cheaper kit with same drug
By JoNel Aleccia
Seattle Times health reporter
Originally published January 14, 2015 at 10:05 pm
Updated January 15, 2015 at 7:00 pm
Seattle Times
Article

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