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

- Rogue Medic

The March for Science is a March for Honesty and Accountability


 

There were some great signs at the March for Science because the march was about truth and it is difficult to go wrong defending the search for truth. The only time people seem to oppose the search for truth is when truth is seen as a threat to their ideology and/or income.

It is difficult to get a man to understand something, when his salary depends upon his not understanding it! – Upton Sinclair.

Scientists are accused of being arrogant, apparently because scientists don’t waste their time on ideas that cannot be tested or on ideas that repeatedly fail objective testing. Scientists learn by providing the most honest way of assessing the truth – they do everything they can to eliminate bias and to eliminate the effects of anything that is not being tested.

Is that arrogant?

Arrogance would be refusing to allow everyone to criticize your work, but science requires that scientists be open about their work and invite their harshest critics to poke holes in their work.

This means that nonsense will not survive for long. The better hypotheses will survive. Logical fallacies are eventually exposed and we learn the truth.
 


 

This is why science rejects claims that fail experimentation and claims that cannot be tested. These claims are not science.
 

Flat Earth claims are rejected. There is abundant evidence that the Earth is not flat, but people still claim that the Earth is flat. There is no scientific controversy about whether the Earth is roughly spherical in shape.[1]
 

Creationism claims are rejected. Creationism contradicts almost all of the sciences (geology, astronomy, physics, biology, . . .), so Creationism would need to be supported by some very well tested evidence. Creationism is not supported by scientific evidence, but that does not stop Creationists from claiming to be scientists.

The clearest evidence that evolution is real is provided by DNA (DeoxyriboNucleic Acid). When we want to confirm the relationship among different people, we use DNA, because it works. DNA confirms that we are related to baboons, bananas, and bacteria. DNA is able to show how close those relationships are. There is no scientific controversy about whether humans evolved along with the rest of life on Earth.[2]

 

I did not get a clear picture of the sign, but I have not changed the words.

 

Anti-GMO claims are rejected. GMOs (Genetically Modified Organisms) are recognized to be safe, nutritious, important in the prevention of widespread famine, overall much more beneficial than their critics claim, and dramatically better organic foods. Those opposed to GMOs claim that organic foods would not produce a famine, if everyone were to eat organic foods. Those opposed to GMOs claim that modification is bad, even though humans have been modifying crops for over 10,000 years. We even use chemicals and radiation to cause mutations to crops that are still considered organic.
 

From 1930 to 2014 more than 3200 mutagenic plant varieties have been released[1][2] that have been derived either as direct mutants (70%) or from their progeny (30%).[3] [3]

 

There is no scientific controversy about the benefits of GMOs.
 


 

Climate change denial is rejected. Climate change is real and harmful. Some people (not scientists) claim that natural factors are causing the unnatural warming. Some people (not scientists) claim that the unnatural warming is a good thing. Some people (not scientists) claim that the unnatural warming isn’t happening. There is no scientific controversy about the reality of climate change.
 


This chart[4] does not include 2016.

If you are a climate change denier, you were counting on 2016 being something other than the hottest year on record. Three years in a row would be unprecedented. 2017 was hotter than 2016, which contradicts the denier arguments.[5] If you are a climate change denier, you should realize that denying science is not going your way. You have had some political successes, but you can’t deny reality forever. There is no scientific controversy about the reality of climate change.
 

Anti-vaccine claims are rejected. Anti-vaxers claim that vaccines are dangerous and that vaccines do not work. Do vaccines work? We should have eradicated polio by now, but anti-vaxers have discouraged vaccination. If you don’t like your children getting the polio vaccine, blame the anti-vaxers. We did eradicate smallpox in the 1970s. We stopped vaccinating against smallpox. Smallpox was killing 2 million people a year. If you don’t worry about smallpox, thank a scientist. There is no scientific controversy about the safety and efficacy of vaccines.
 

Historical Comparisons of Morbidity and Mortality for Vaccine-Preventable Diseases in the United States – Table 1


 

In response to the evidence in Table 1,[6] anti-vaxers claim that improved sanitation and hygiene. The decrease in cases and deaths due to the various vaccine-preventable illnesses should be the same for all of these diseases, but that is not the case. The diseases have also produced epidemics when the vaccination level drops below herd immunity levels.[7] There is no scientific controversy about the safety and efficacy of vaccines.
 

Science is not perfect, but science is better than all other means of learning the truth.

When science produces mistakes, we learn about it from scientists, not from politicians, not from preachers, not from placebo pushers, not from psychics, and not from any other deniers of science.

Maybe the message of science got through.

Maybe we won’t need another March for Science.
 


🇪🇸Gaby Mérida 🇺🇸‏ @ThatSpanishLady Twitter
Click on the image to make it larger.

Footnotes:

[1] Flat Earth Rising
by Steven Novella
Neurologica
April 6, 2017
Article

[2] Objections to evolution
Wikipedia
Article

[3] Mutation breeding
Wikipedia
Article

[4] The 10 Hottest Years on Record
January 20th, 2016
By Climate Central
Article

[5] 2016 Was the Hottest Year on Record
Both NASA and NOAA declare that our planet is experiencing record-breaking warming for the third year in a row
By Andrea Thompson
January 18, 2017
Scientific American
Article

[6] Historical comparisons of morbidity and mortality for vaccine-preventable diseases in the United States.
Roush SW, Murphy TV; Vaccine-Preventable Disease Table Working Group..
JAMA. 2007 Nov 14;298(18):2155-63.
PMID: 18000199

Free Full Text from JAMA.

[7] “Vaccines didn’t save us” (a.k.a. “vaccines don’t work”): Intellectual dishonesty at its most naked
by David Gorski
March 29, 2010
Science-Based Medicine
Article

.

The Boy Who Cried Terrorist

 
This is the latest comment from Frederick Blum in response to what I wrote about his absurd defense of Dr. Tobinick.[1].[2] As you can see, in labeling appropriate respect for patients as terrorism, Frederick Blum completely lacks perspective.
 

I think a more apt description of what you are is ” Rogue Terrorist ” . Forget ” Rogue Medic. ” It’s not really you. Think about it.[3]

 

Think like Frederick Blum?

That might be torture.

If you honestly think that I am a terrorist, turn me in.

Go ahead.

It may be even worse to not turn in a terrorist, than to treat patients with inadequately tested medications.
 

If you see something, say something 1
 

“War is peace. Freedom is slavery. Ignorance is strength.”[4]

 

What do terrorists do?
 

You hide behind a cowardly mask exactly as terrorists do.[3]

 

Cowardly?

I have allowed Frederick Blum a forum to make baseless accusations.

I have responded with evidence.

I have not made threats.

Frederick Blum calls this cowardly?
 

You fabricate lies about people and assault them with ad hominem attacks, also exactly as terrorists do.[3]

 

Frederick Blum, provide some sort of evidence to support your imaginative accusations.

I have stated that Dr. Tobinick has failed to produce valid evidence of safety.

Do you have any evidence to show that this is not completely true?

I have stated that Dr. Tobinick has failed to produce valid evidence of efficacy.

Do you have any evidence to show that this is not completely true?

I have not lied.

I have criticized Dr. Tobinick for a failure to provide evidence of safety and efficacy. Using safe and effective treatments is an important part of what separates ethical medical practice from alternative medicine.

If people conclude that Dr. Tobinick is unethical because of what I have written, that is only reasonable.

Neither of you have provided even an iota to suggest any other conclusion.

By the way, have terrorists switched from killing people to using honest criticism? I wish it were so.
 

Really, you’re just another unremarkable terrorist.[3]

 

Is your unremarkable remark intentionally ironic?
 

You should change your anonymous cowardly handle to ” Rogue Terrorist. ” At least in doing so you would be honest about yourself.[1]

 

Without valid evidence of safety, we must conclude that Dr. Tobinick cannot honestly demonstrate safety.

Without valid evidence of benefit, we must conclude that Dr. Tobinick cannot honestly demonstrate any benefit.

If Dr. Tobinick’s treatment is safe and effective, why hide the evidence?

Footnotes:

[1] Dr. Edward Tobinick Sues Barbara Streisand – or something equally foolish
Thu, 24 Jul 2014
Rogue Medic
Article

[2] When Minions Attack
Sun, 26 Feb 2017
Rogue Medic
Article

[3] The comment where Blum cried Terrorist
comment on Dr. Edward Tobinick Sues Barbara Streisand – or something equally foolish
Frederick Blum
Comment

[4] 1984
George Orwell
Free Full Text from The University of Adelaide Library

.

When Minions Attack

Minion vampire 1a
Image credit.
 

In the comments to Dr. Edward Tobinick Sues Barbara Streisand – or something equally foolish,[1] Frederick Blum (sometimes Frederick S. Blum) states that he does not like my criticism of Dr. Edward Tobinick for using inadequately tested treatment, on patients.
 

The fact that you’ve censored my comments speaks volumes about the kind of person you are, ” Rogue Medic.”[2]

 

I have not censored Frederick Blum’s comments. All comments are moderated. Not all spam is caught by the spam filter.

Since Frederick Blum’s earlier, similarly absurd, comment was approved and appeared in the comments hours before this comment, what leads Frederick Blum to conclude that this is censorship?
 

What are you afraid of being found out for, that you’re no more than a charlatan ?[2]

 

You chose to use the word charlatan. Since the topic is Dr. Tobinick, is this use of charlatan a Freudian slip?
 

Frederick Blum also obsesses about my use of a pseudonym, although I provide links to valid evidence and Frederick Blum only makes excuses to distract from the absence of valid evidence for Dr. Tobinick’s treatment.

Frederick Blum complains that it is wrong to criticize Dr. Tobinick for his failure to post valid evidence, since Dr. Tobinick uses his real name.

Is valid evidence less valid when I use a pseudonym?

No.

This gullibility is one of the primary reasons scams are so successful.

Bernie Madoff, perhaps the biggest thief of all time, had people, like Frederick Blum, defending his business. A lot of people trusted that con man for the same reason.

What was Bernie Madoff’s motto?
 

Also to his advantage, Madoff was adept at both selfpromotion and client relations. His corporate slogan, “The Owner’s Name Is on the Door,” would reinforce his managerial image, as well as provide his growing list of wealthy clients with a reassuring declaration—a personal acknowledgement of his fiduciary responsibility to them.[3]

 

Is Dr. Tobinick a medical, and much more dangerous, version of Bernie Madoff? Is Dr. Tobinick’s name on the door just a confidence gimmick?
 

You can’t hide the truth about yourself forever. Eventually it is seen for what it really is – the truth.[2]

 

We would be able to determine the truth about Dr. Tobinick, if Dr. Tobinick would adequately test his treatment.

Is the treatment safe, as Dr. Tobinick uses it?

Is the treatment better than a placebo, as Dr. Tobinick uses it?

Is the treatment as good as any adequately tested treatments, as Dr. Tobinick uses it?

The only suppression of the truth is from Dr. Tobinick and his worshipers, such as Frederick Blum.

What is the treatment?
 

The list of conditions for which Tobinick claims or even has patented use of Enbrel include Alzheimer’s, stroke, traumatic brain injury, Parkinson’s disease, carpal tunnel syndrome, brain tumor, spinal cord injury, and back pain. That quite impressive for a doctor who isn’t even a neurologist. Tobinick is an internist who, prior to curing a long list of neurological diseases, specialized in laser hair removal.[4]

 

Why doesn’t everyone go to a laser hair removal specialist for inadequately tested treatments?

I am sure that the FDA and the insurance companies are being unreasonable in wanting evidence of safety and efficacy.
 

And, the truth is that you have devised a falsified and libelous campaign against someone who is not only innocent but a truly great medical scientist with a proven honest intelligence that surpasses almost everybody else in medicine today, Dr. Edward Tobinick, only to further your own loathsome self serving agenda.[2]

A proven honest intelligence? Where did you come up with that nonsense? If an intelligent person uses a dangerous treatment, the treatment is still dangerous.

Go ahead. I dare you, Frederick Blum. Stop making excuses and provide evidence to back up your unsupportable claims.

Footnotes:

[1] Dr. Edward Tobinick Sues Barbara Streisand – or something equally foolish
Thu, 24 Jul 2014
Rogue Medic
Article

[2] Censorship comment by Frederick Blum
comment

[3] Catastrophe: The Story of Bernard L. Madoff, the Man Who Swindled the World
Deborah Strober & Gerald Strober
Kindle Locations 1077-1079
Phoenix Books, Inc.

From the website of Bernie Madoff – http://www.madoff.com on December 15, 2008. In Appendix A (Kindle Locations 2760-2765)
 

The Owner’s Name is on the Door

In an era of faceless organizations owned by other equally faceless organizations, Bernard L. Madoff Investment Securities LLC harks back to an earlier era in the financial world: The owner’s name is on the door. Clients know that Bernard Madoff has a personal interest in maintaining the unblemished record of value, fair-dealing, and high ethical standards that has always been the firm’s hallmark.

 

[4] Enbrel for Stroke and Alzheimer’s
Science-Based Medicine
Steven Novella
May 8, 2013
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

.

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

.

What do you do when a patient wakes up during CPR?

ResearchBlogging.org
 

The return of consciousness without the return of a pulse is still rare, but may be more common with our increased focus on high quality chest compressions. There is still no evidence that interrupting chest compressions, for anything other than defibrillation, improves outcomes.

Is this due to the consistency of the machine? Maybe. Maybe not. We do not have enough evidence to draw that conclusion.

Is this growing population really growing? Maybe. Maybe not. We do not have enough evidence to draw that conclusion, either.

It could be that with the ability to use a cell phone camera to record these instances, there is more credibility to the reports. There is a suggestion that this could be common.
 

Parnia et al. conducted a multi-year, multi-center, prospective study of the frequency of awareness during resuscitation by interviewing cardiac arrest survivors after discharge. They found 55/140 (39%) had perceptions of awareness of being alive and even memories that originated during that time.2 [1]

 

Should we be giving ketamine to these patients?
 

Nebraska EMS CPR Sedation Protocol - ALS
Nebraska CPR Induced Consciousness Sedation Protocol (from the PDF)[1]
 

We should find out how common it is for people to regain consciousness without regaining a pulse. This is clearly an experimental protocol that is not supported by evidence of improved outcomes that matter – just like all of the rest of cardiac arrest treatment that is not compressions or defibrillation.
 

RESULTS: The search yielded 1997 unique records, of which 50 abstracts were reviewed. Nine reports, describing 10 patients, were relevant. Six of the patients had CPR performed by mechanical devices, three of these patients were sedated. Four patients arrested in the out-of-hospital setting and six arrested in hospital. There were four survivors. Varying levels of consciousness were described in all reports, including purposeful arm movements, verbal communication, and resuscitation interference. Management strategies directed at consciousness were offered to six patients and included both physical and chemical restraints.[2]

 

6/1,997 is 0.3% – not anywhere near the 39.3% of 55/140, but it is still a large enough group that we should not ignore them.

Depression and anxiety following resuscitation are significant problems, so this might even be a way to help decrease those resuscitation side effects.
 

CONCLUSION:
One fourth of OHCA-survivors reported symptoms of anxiety and/or depression at 6 months which was similar to STEMI-controls and previous normative data. Subjective cognitive problems were associated with an increased risk for psychological distress. Since psychological distress affects long-term prognosis of cardiac patients in general it should be addressed during follow-up of survivors with OHCA due to a cardiac cause.
[3]

 

The similarity to the outcome of STEMI (ST segment Elevation Myocardial Infarction) patients do not inspire confidence in this approach, but that does not mean that it should not be examined.

It is most important that we not make the mistake that has been made with ventilations, endotracheal tubes, extraglottic airways, antiarrhythmic drugs, pressor drugs, anti-acidosis drugs, antidote drugs, anti-hypoglycemic drugs, et cetera. We should insist that there be valid evidence of some sort of benefit before the ACLS (Advanced Cardiac Life Support) Committee of Failed Treatments adds this to the ACLS algorithms because of an abundance of wishful thinking.
 

This time will be different.
 

This use of ketamine is interesting. Ketamine is a sedative that should not depress vital signs, so it may do what we expect. There may be more benefit than harm, but there may be more harm than benefit, or there may be all harm and no benefit. We will not know until we have valid research.

We have added the other treatments without finding out if they improve outcomes. We continue to remove these treatments as we obtain evidence, because they have one thing in common – they don’t improve outcomes.

These treatments have increased the ignorance of those who work in EMS (Emergency Medical Services) and EM (Emergency Medicine). We keep convincing ourselves that we know what we are doing, but evidence keeps showing that we are lying to ourselves.

Maybe ketamine sedation during compressions will be beneficial. It is such a small patient population, that it will be difficult to study. Introducing a treatment without studying it will always be a mistake. Is Nebraska studying this? Probably, but it is not stated in the paper. Has this been approved by an IRB (Institutional Review Board)? I do not know.

Footnotes:

[1] CPR induced consciousness: It’s time for sedation protocols for this growing population
Rice, D., Nudell, N., Habrat, D., Smith, J., & Ernest, E. (2016). Resuscitation DOI: 10.1016/j.resuscitation.2016.02.013
Free Full Text from Resuscitation.

[2] Return of consciousness during ongoing cardiopulmonary resuscitation: A systematic review.
Olaussen A, Shepherd M, Nehme Z, Smith K, Bernard S, Mitra B.
Resuscitation. 2015 Jan;86:44-8. doi: 10.1016/j.resuscitation.2014.10.017. Epub 2014 Nov 4. Review.
PMID: 25447435

[3] Anxiety and depression among out-of-hospital cardiac arrest survivors.
Lilja G, Nilsson G, Nielsen N, Friberg H, Hassager C, Koopmans M, Kuiper M, Martini A, Mellinghoff J, Pelosi P, Wanscher M, Wise MP, Östman I, Cronberg T.
Resuscitation. 2015 Dec;97:68-75. doi: 10.1016/j.resuscitation.2015.09.389. Epub 2015 Oct 9.
PMID: 26433116

Rice, D., Nudell, N., Habrat, D., Smith, J., & Ernest, E. (2016). CPR induced consciousness: It’s time for sedation protocols for this growing population Resuscitation DOI: 10.1016/j.resuscitation.2016.02.013

Olaussen A, Shepherd M, Nehme Z, Smith K, Bernard S, & Mitra B (2015). Return of consciousness during ongoing cardiopulmonary resuscitation: A systematic review. Resuscitation, 86, 44-8 PMID: 25447435

Lilja G, Nilsson G, Nielsen N, Friberg H, Hassager C, Koopmans M, Kuiper M, Martini A, Mellinghoff J, Pelosi P, Wanscher M, Wise MP, Östman I, & Cronberg T (2015). Anxiety and depression among out-of-hospital cardiac arrest survivors. Resuscitation, 97, 68-75 PMID: 26433116

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The Fatal Flaw in Trial of Continuous or Interrupted Chest Compressions during CPR

ResearchBlogging.org
 

Trial of Continuous or Interrupted Chest Compressions during CPR — NEJM
 

In conclusion, among patients with out-of-hospital cardiac arrest in whom CPR was performed by EMS providers, a strategy of continuous chest compressions with positive-pressure ventilation did not result in significantly higher rates of survival or favorable neurologic status than the rates with a strategy of chest compressions interrupted for ventilation.[1]

 

This is not a study that has a valid control group to determine if there is any benefit from ventilation. There is no group that does not receive ventilations, so it is like a study of one type of blood-letting vs. another type of blood-letting with the researchers taking for granted that blood-letting does improve outcomes. That is not a problem if blood-letting actually improves outcomes.

Should we take it for granted that blood-letting improves outcomes and that the only hypothesis worth studying is which brand to choose?

Should we assume that ventilations are too sacred to ever be doubted?

Should we assume that there are better arguments for ventilations than for blood-letting? That is not true.
 

If we ignore this fatal flaw, the study is very well done. I really like the study design. It is an excellent example of how to study two different versions of an intervention after that intervention has been demonstrated to improve outcomes, but ventilations have never been demonstrated to improve outcomes in adult patients with cardiac causes of cardiac arrest.

Should we have assumed that blood-letting was too sacred to ever be doubted?
 

We do know that outcomes for seizure patients improve when EMS gives benzodiazepines, because some people cared enough to find out.[2]

Assuming that a treatment is too important to study is like building on a foundation in a swamp.
 


 

We still do not know if there is any benefit from including ventilations, because the study design assumes that we don’t want to know.

There is no good reason to believe that ventilations improve outcomes for adult patients with cardiac causes of cardiac arrest. This study has not done anything to change that.

Our patients deserve better. Why aren’t we finding out what improves outcomes?

Footnotes:

[1] Trial of Continuous or Interrupted Chest Compressions during CPR.
Nichol G, Leroux B, Wang H, Callaway CW, Sopko G, Weisfeldt M, Stiell I, Morrison LJ, Aufderheide TP, Cheskes S, Christenson J, Kudenchuk P, Vaillancourt C, Rea TD, Idris AH, Colella R, Isaacs M, Straight R, Stephens S, Richardson J, Condle J, Schmicker RH, Egan D, May S, Ornato JP; ROC Investigators.
N Engl J Med. 2015 Nov 9. [Epub ahead of print]
PMID: 26550795

Free Full Text from NEJM.

[2] A comparison of lorazepam, diazepam, and placebo for the treatment of out-of-hospital status epilepticus.
Alldredge BK, Gelb AM, Isaacs SM, Corry MD, Allen F, Ulrich S, Gottwald MD, O’Neil N, Neuhaus JM, Segal MR, Lowenstein DH.
N Engl J Med. 2001 Aug 30;345(9):631-7. Erratum in: N Engl J Med 2001 Dec 20;345(25):1860.
PMID: 11547716 [PubMed – indexed for MEDLINE]

Free Full Text from N Engl J Med. with link to PDF Download.

Nichol, G., Leroux, B., Wang, H., Callaway, C., Sopko, G., Weisfeldt, M., Stiell, I., Morrison, L., Aufderheide, T., Cheskes, S., Christenson, J., Kudenchuk, P., Vaillancourt, C., Rea, T., Idris, A., Colella, R., Isaacs, M., Straight, R., Stephens, S., Richardson, J., Condle, J., Schmicker, R., Egan, D., May, S., & Ornato, J. (2015). Trial of Continuous or Interrupted Chest Compressions during CPR New England Journal of Medicine DOI: 10.1056/NEJMoa1509139

Alldredge BK,, Gelb AM,, Isaacs SM,, Corry MD,, Allen F,, Ulrich S,, Gottwald MD,, O’Neil N,, Neuhaus JM,, Segal MR,, & Lowenstein DH. (2001). A Comparison of Lorazepam, Diazepam, and Placebo for the Treatment of Out-of-Hospital Status Epilepticus New England Journal of Medicine, 345 (25), 1860-1860 DOI: 10.1056/NEJM200112203452521

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Benzodiazepines are often misused – Part I

 
The most commonly used benzodiazepines in EMS/EM (Emergency Medical Services/Emergency Medicine) are diazepam (Valium), lorazepam (Ativan), and midazolam (Versed). It should be relatively easy to look at the best research and determine –

1. Should benzodiazepines be the first parenteral medication given for seizures?

2. Should benzodiazepines be the first parenteral medication given for agitated delirium/excited delirium (it is a real condition that results in death in custody much more often than intentional police misbehavior)?

3. Should benzodiazepines be the first parenteral medication given for sedation?

In EMS/EM, some of the important things to consider are the time it takes for the drug to take effect, the likelihood that the drug will produce the desired effect, the seriousness of adverse effects and rate at which the most serious adverse effects occur.

Seizures

Is there any evidence that anything works quicker than IM (IntraMuscular) midazolam, when the patient does not already have an IV (IntraVenous line)?

Is there any evidence that an initial dose of 10 mg IM midazolam is too high of an initial dose for an adult (over 40 kg) or that 5 mg is too high of an initial dose for a child (40 kg or less)?

Is there any evidence that this dosing increases the rate of airway compromise above what would occur with lower doses?

The Rampart study[1] strongly suggests that 10 mg of IM midazolam is the best approach for the seizing patient who does not already have an IV, when IM midazolam is available. If midazolam is not available, such as due to poorly written protocols, midazolam is not an option and delaying less effective care to wait for the ideal treatment would be reckless.

There do not appear to be any studies that show any better outcomes with any other benzodiazepoines or with any other doses.
 

What about when an IV is already in place?

Should IV midazolam be used?

Should IV lorazepam be used?

Should IV diazepam be used?

Should some other drug be used?

The evidence is not clear, but is there any reason to believe that lorazepam, or diazepam, works as quickly as midazolam, when given intravenously?

Is there any reason to believe that lorazepam, or diazepam, produce fewer, or less serious, adverse effects than midazolam, when given IV?

I don’t know of any valid evidence to suggest that midazolam is inferior to either diazepam or lorazepam.

There is also the benefit in EMS of a much shorter time of effect for midazolam.

A drug that wears off quickly is going to be the safer EMS drug – unless there is a good reason to use a drug that lasts longer.

I will explain why wearing off quickly is important in EMS treatment of seizures in Part II (not yet posted).

Footnotes:

[1] Intramuscular versus intravenous therapy for prehospital status epilepticus.
Silbergleit R, Durkalski V, Lowenstein D, Conwit R, Pancioli A, Palesch Y, Barsan W; NETT Investigators.
N Engl J Med. 2012 Feb 16;366(7):591-600.
PMID: 22335736 [PubMed – in process]

Free Full Text from N Engl J Med.

I have written about this in Intramuscular Midazolam for Seizures – Part I,
Part II,
Part III,
Part IV,
Part V,
Part VI,
Misrepresenting Current Topics in EMS Research from EMS Expo – RAMPART,
and Images from Gathering of Eagles Presentation on RAMPART.

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