The only reason we get away with giving such large doses of epinephrine to these patients is that they are already dead.

- Rogue Medic

The Media are Just As Bad at Ethics As They are at Science

 
There is another article about the adrenaline (epinephrine in non-Commonwealth countries) vs. placebo in cardiac arrest trial that is about to start in England.[1] Media sites no longer seem to want to spend money to get valid information on science or ethics. Forbes provides another example of the writer completely missing the obvious.
 

It’s one thing to treat an incapacitated emergency patient without consent, when you’re administering a standard therapy already proven to be beneficial.[2]

 

Nobody is being deprived of anything that has been adequately tested on humans. Why assume that the untested and unknown standard treatment is beneficial?

The active drug (adrenaline) is an unknown. There is no good evidence that adrenaline improves outcomes.

If you disagree, provide some evidence that shows that adrenaline is better than placebo at anything that matters.

Adrenaline is an unknown because it has never been adequately studied. The only study that has tried to compare it to placebo was limited by politicians and the media – the people who know the least about how science works.

This is like being told that you will be put in a room with either a killer or a mannequin. Which one do you want. Except that we do not know if adrenaline is a killer. We do not have enough information. The only way to find out is to study it.

The research so far is negative. Is that because the adrenaline is given too late? Is that because too much adrenaline is given? Is that because we give it to everyone still dead after a few minutes?

We do not know.

We treat adrenaline like snake oil – Able to cure all kinds of cardiac arrest. Step right up and get your magic elixir. Cures baldness, too!
 


Image credit.
 

When the sales pitch is that the drug fixes everything, we should be very suspicious.

Cardiac arrest due to blood loss?   Give adrenaline.

Cardiac arrest due to slow heart rate?   Give adrenaline.

Cardiac arrest due to fast heart rate?   Give adrenaline.

Cardiac arrest due to irritated heart?   Give adrenaline.

Cardiac arrest due to not enough stimulus to the heart?   Give adrenaline.

Cardiac arrest due to drug over-dose?   Give adrenaline.

Cardiac arrest due to drug under-dose?   Give adrenaline.

Cardiac arrest due to diabetes problem?   Give adrenaline.

Cardiac arrest due to infectious disease?   Give adrenaline.

Cardiac arrest due to lightning strike?   Give adrenaline.

Cardiac arrest due to drowning?   Give adrenaline.

Cardiac arrest due to asthma?   Give adrenaline.

Cardiac arrest due to stroke?   Give adrenaline.

Cardiac arrest due to cancer?   Give adrenaline.

Cardiac arrest due to adrenaline overdose?   Give adrenaline.

We do not discriminate. We just give adrenaline. All of the other drugs have failed to produce a benefit, but we still believe in adrenaline without good evidence. We have been using adrenaline for over half a century on unsuspecting people and we still have no evidence that it works.
 

However, the more important issue is what you as a patient think. Should scientists be able to enroll you in a life-or-death medical experiment without your consent?[2]

 

Adrenaline has worked in laboratory animals, but every drug that is tested in humans is supposed to have worked in animals. Why doesn’t adrenaline work in humans? If it does work, where is the evidence?

The standard of care is an experiment that is not controlled and not even acknowledged. The guidelines clearly state that we do not know what works and that we should only consider adrenaline, but that we do not have any good evidence that adrenaline improves outcomes for anyone.

The ethical failure is that we have failed to find out if what we are giving is harmful.
 

We have only improved outcomes when we have ignored the drugs and paid attention to chest compressions and defibrillation.
 

We are lying to patients when we tell them that we know what works in cardiac arrest.

How much worse than placebo is adrenaline? We don’t know. Failing to find out is what is unethical.

Footnotes:

[1] Does a Placebo vs. Adrenaline Study Deprive Patients of Necessary Care According to the Resuscitation Guidelines?
Wed, 27 Aug 2014
Rogue Medic
Article

[2] UK To Experiment on Cardiac Arrest Patients Without Their Consent
8/27/2014 @ 3:55PM
Paul Hsieh – Contributor
Forbes
Article

.

Dextrose 10% in the Treatment of Out-of-Hospital Hypoglycemia

ResearchBlogging.org
 

Is 50% dextrose as good as 10% dextrose for treating symptomatic hypoglycemia?

If the patient is disoriented, but becomes oriented before the full dose of dextrose is given, is it appropriate to continue to treat the patient as if the patient were still disoriented? If your protocols require you to keep giving dextrose, do the same protocols require you to keep giving opioids after the pain is relieved? Is there really any difference?

50% dextrose has problems.
 

Animal models have demonstrated the toxic effect of glucose infusions in the settings of cardiac arrest and stroke.2 Experimental data suggests that hyperglycemia is neurotoxic to patients in the setting of acute illness.1,3 [1]

 

Furthermore, extravasation can cause necrosis.
 


Image credit.[2]
 

I expect juries to look at this kind of image and say, Somebody has to take one for the 50% dextrose team. We can’t expect EMS to change.

Is 10% dextrose practical?
 

Won’t giving less concentrated dextrose delay treatment?
 

The median initial field blood glucose was 38 mg/dL (IQR = 28 mg/dL – 47 mg/dL), with subsequent blood glucose median of 98 mg/dL (IQR = 70 mg/dL – 135 mg/dL). Elapsed time after D10 administration before recheck was not uniform, with a median time to recheck of eight minutes (IQR = 5 minutes – 12 minutes).[1]

 

If that is going to slow your system down, is it because you are transporting patients before they wake up?

Did anyone require more than 10 grams of 10% dextrose, as opposed to 25 grams of 50% dextrose?
 

Of 164 patients, 29 (18%) received an additional dose of intravenous D10 solution in the field due to persistent or recurrent hypoglycemia, and one patient required a third dose.[1]

 

18% received a second dose, which is 20 grams of dextrose and still less than the total dose of 25 grams of dextrose given according to EMS protocols that still use 50% dextrose.

Only one patient, out of 164 patients, required a third dose. That is 30 grams of dextrose.

Only one patient, out of 164 patients, received as much as we would give according to the typical EMS protocol, which should be a thing of the past. If we are routinely giving too much to our patients, is that a good thing? Why?
 

Maybe the blood sugars were not that low to begin with.
 


 

The average was 38 mg/dL, which is not high.
 

Maybe the change in blood sugar was small after just 10 grams of dextrose, rather than 25 grams.
 


 

The average (mean) change was 67 mg/dL, which is enough to get a patient with a blood sugar of 3 up to 70.
 

Maybe the blood sugar was not high enough after just 10 grams of dextrose, rather than 25 grams.
 


 

The average (mean) repeat blood sugar was 106 mg/dL, which is more than enough.
 

Maybe it took a long time to treat patients this way.
 


 

The average (mean) time was 9 minutes, which is not a lot of time.
 

Is this perfect?
 

Three patients had a drop in blood glucose after D10 administration: one patient had a drop of 1 mg/dL; one patient had a drop of 10 mg/dL; and one patient had a drop of 19 mg/dL.[1]

 

All patients, even the three with initial drops in blood sugar (one had an insulin pump still pumping while being treated) had normal blood sugars at the end of EMS contact.

10% dextrose is cheaper, just as fast, probably less likely to cause hyperglycemia, probably less likely to cause rebound hypoglycemia, probably less likely to cause problems with extravasation, less of a problem with drug shortages, . . . .

Why are we still resisting switching to 10% dextrose?
 

Other articles on 10% dextrose.

Footnotes:

[1] Dextrose 10% in the treatment of out-of-hospital hypoglycemia.
Kiefer MV, Gene Hern H, Alter HJ, Barger JB.
Prehosp Disaster Med. 2014 Apr;29(2):190-4. doi: 10.1017/S1049023X14000284. Epub 2014 Apr 15.
PMID: 24735872 [PubMed – indexed for MEDLINE]

[2] Images in emergency medicine. Dextrose extravasation causing skin necrosis.
Levy SB, Rosh AJ.
Ann Emerg Med. 2006 Sep;48(3):236, 239. Epub 2006 Feb 17. No abstract available.
PMID: 16934641 [PubMed – indexed for MEDLINE]

Kiefer MV, Gene Hern H, Alter HJ, & Barger JB (2014). Dextrose 10% in the treatment of out-of-hospital hypoglycemia. Prehospital and disaster medicine, 29 (2), 190-4 PMID: 24735872

Levy SB, & Rosh AJ (2006). Images in emergency medicine. Dextrose extravasation causing skin necrosis. Annals of emergency medicine, 48 (3) PMID: 16934641

.

The Controversy of Admitting ‘We Do Not Know What Works’

ResearchBlogging.org

 

There are several news articles today criticizing a study because the patients might be deprived of a drug that has not been adequately studied in humans. This criticism is coming from journalists – the people who publicized the fraudulent vaccines research by Andrew Wakefield, who was trying to sell his competing vaccine and was being paid to produce negative research by lawyers suing the vaccine companies.[1]

The real controversy is that this untested drug became the standard of care with no evidence that it improves outcomes that matter.

Is it controversial to give a placebo, rather than a drug not yet adequately tested in humans?

No.

We are not informing patients that there is no evidence that the standard treatment is effective. We are not obtaining consent to give the unproven drug – epinephrine (Adrenaline in Commonwealth countries). How are the ethics different when we substitute a placebo for a mystery medicine?

What is less ethical than continuing the tradition of giving an inadequately studied drug to people who cannot consent to treatment?

Are we depriving patients of effective medicine or are we depriving them of witchcraft?

If you think that epinephrine is effective medicine at improving survival to discharge, provide the evidence and stop this study. The reason the study is being done is that evidence of benefit does not exist.
 

Click on image to make it larger.[2] The studies are in the footnotes.[3],[4],[5],[6],[7],[8],[9],[10]
 

Is Adrenaline beneficial in cardiac arrest?

Probably, but only for some patients and we do not know which patients benefit.

Is Adrenaline harmful in cardiac arrest?

Probably, but only for some patients and we do not know which patients are harmed.

What is the right dose of Adrenaline in cardiac arrest?

Pick a number – any number. We do not know the right dose.
 

 

Even the patients who only received the minimum dose – 1 mg – had worse outcomes.[11]

Wrong timing? Wrong dose? Wrong drug?

We do not know.
 

We have used this untested treatment for half a century and not bothered to find out if it works. A recent study shows that epinephrine produces worse outcomes when given by EMS later,[12] but that does not mean that the outcomes are good when epinephrine is given early. The study had no placebo group, so like a study comparing different doses of cyanide, just because one dose is not as bad as another dose, the results do not suggest that cyanide is beneficial.
 


 

This is comparing three different treatments HDE (High-Dose Epinephrine), SDE (Standard-Dose Epinephrine), and NE (NorEpinephrine). The lines for the HDE and NE are so close to each other, that you may not be able to see the gold line.[13] Other studies produce similar results.[3],[14],[15],[16],[17] Only one study showed better ROSC with standard dose epinephrine.[18]
 

Epinephrine does produce more ROSC (Return Of Spontaneous Circulation – at least a temporary pulse) than placebo, but high dose epinephrine produces even more ROSC than standard dose epinephrine, so why do we give the standard dose that only produces middling ROSC?

Is ROSC the goal? No.

For the guidelines (ACLS and ILCOR), ROSC is the basis for giving standard dose epinephrine, but it would make more sense to give high dose epinephrine if the goal is ROSC. More ROSC, but no more survivors leaving the hospital. If all we want is put the patient in a coma long enough to run up a big hospital bill, then the drugs are great.

If we want people to leave the hospital alive, then We Do Not Know What Works.
 

The guidelines are based on wishful thinking and rationalization. They are not based on improved survival. A lot of research is cited (hundreds of papers), but the research does not show improved survival with any drug(s).

Will the guidelines be revised to remove epinephrine? Maybe.
 

The exciting development is that these data create equipoise about the current standard of resuscitation care. The best available observational evidence indicates that epinephrine may be harmful to patients during cardiac arrest, and there are plausible biological reasons to support this observation. However, observational studies cannot establish causal relationships in the way that randomized trials can.[19]

 

Some cocktails have produced better results than epinephrine in tiny studies. It is too probably too early to tell if these are just statistical aberrations. I will write about them later.

Continued in Does a Placebo vs. Adrenaline Study Deprive Patients of Necessary Care According to the Resuscitation Guidelines?

Footnotes:

[1] “Piltdown medicine” and Andrew Wakefield’s MMR vaccine fraud
Science-Based Medicine
Posted by David Gorski
January 6, 2011
Article
 

In a mere decade and a half, several decades of progress in controlling this scourge had been unravelled like a thread hanging off a cheap dress, all thanks to Andrew Wakefield and scandal mongers in the British press.

[2] Vasopressors in cardiac arrest: a systematic review.
Larabee TM, Liu KY, Campbell JA, Little CM.
Resuscitation. 2012 Aug;83(8):932-9. Epub 2012 Mar 15.
PMID: 22425731 [PubMed – in process]
 

CONCLUSION: There are few studies that compare vasopressors to placebo in resuscitation from cardiac arrest. Epinephrine is associated with improvement in short term survival outcomes as compared to placebo, but no long-term survival benefit has been demonstrated. Vasopressin is equivalent for use as an initial vasopressor when compared to epinephrine during resuscitation from cardiac arrest. There is a short-term, but no long-term, survival benefit when using high dose vs. standard dose epinephrine during resuscitation from cardiac arrest. There are no alternative vasopressors that provide a long-term survival benefit when compared to epinephrine. There is limited data on the use of vasopressors in the pediatric population.

[3] High dose and standard dose adrenaline do not alter survival, compared with placebo, in cardiac arrest.
Woodhouse SP, Cox S, Boyd P, Case C, Weber M.
Resuscitation. 1995 Dec;30(3):243-9.
PMID: 8867714 [PubMed – indexed for MEDLINE]

[4] Adrenaline in out-of-hospital ventricular fibrillation. Does it make any difference?
Herlitz J, Ekström L, Wennerblom B, Axelsson A, Bång A, Holmberg S.
Resuscitation. 1995 Jun;29(3):195-201.
PMID: 7667549 [PubMed – indexed for MEDLINE]

[5] Survival outcomes with the introduction of intravenous epinephrine in the management of out-of-hospital cardiac arrest.
Ong ME, Tan EH, Ng FS, Panchalingham A, Lim SH, Manning PG, Ong VY, Lim SH, Yap S, Tham LP, Ng KS, Venkataraman A; Cardiac Arrest and Resuscitation Epidemiology Study Group.
Ann Emerg Med. 2007 Dec;50(6):635-42. Epub 2007 May 23.
PMID: 17509730 [PubMed – indexed for MEDLINE]

Free Full Text Download in PDF format from prdupl02.ynet.co.il

[6] Intravenous drug administration during out-of-hospital cardiac arrest: a randomized trial.
Olasveengen TM, Sunde K, Brunborg C, Thowsen J, Steen PA, Wik L.
JAMA. 2009 Nov 25;302(20):2222-9.
PMID: 19934423 [PubMed – indexed for MEDLINE]

Free Full Text from JAMA

[7] Outcome when adrenaline (epinephrine) was actually given vs. not given – post hoc analysis of a randomized clinical trial.
Olasveengen TM, Wik L, Sunde K, Steen PA.
Resuscitation. 2011 Nov 22. [Epub ahead of print]
PMID: 22115931 [PubMed – as supplied by publisher]

[8] 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
 

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.

 

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.

 

[9] Prehospital epinephrine use and survival among patients with out-of-hospital cardiac arrest.
Hagihara A, Hasegawa M, Abe T, Nagata T, Wakata Y, Miyazaki S.
JAMA. 2012 Mar 21;307(11):1161-8. doi: 10.1001/jama.2012.294.
PMID: 22436956 [PubMed – indexed for MEDLINE]

Free Full Text from JAMA.

[10] Impact of early intravenous epinephrine administration on outcomes following out-of-hospital cardiac arrest.
Hayashi Y, Iwami T, Kitamura T, Nishiuchi T, Kajino K, Sakai T, Nishiyama C, Nitta M, Hiraide A, Kai T.
Circ J. 2012;76(7):1639-45. Epub 2012 Apr 5.
PMID: 22481099 [PubMed – indexed for MEDLINE]

Free Full Text from Circulation Japan.

[11] Wide variability in drug use in out-of-hospital cardiac arrest: A report from the resuscitation outcomes consortium.
Glover BM, Brown SP, Morrison L, Davis D, Kudenchuk PJ, Van Ottingham L, Vaillancourt C, Cheskes S, Atkins DL, Dorian P; Resuscitation Outcomes Consortium Investigators.
Resuscitation. 2012 Nov;83(11):1324-30. doi: 10.1016/j.resuscitation.2012.07.008. Epub 2012 Jul 31.
PMID: 22858552 [PubMed – indexed for MEDLINE]

Free Full Text from PubMed Central.

[12] Time to administration of epinephrine and outcome after in-hospital cardiac arrest with non-shockable rhythms: retrospective analysis of large in-hospital data registry.
Donnino MW, Salciccioli JD, Howell MD, Cocchi MN, Giberson B, Berg K, Gautam S, Callaway C; American Heart Association’s Get With The Guidelines-Resuscitation Investigators.
BMJ. 2014 May 20;348:g3028. doi: 10.1136/bmj.g3028.
PMID: 24846323 [PubMed – in process]

Free Full Text from BMJ.

[13] A randomized clinical trial of high-dose epinephrine and norepinephrine vs standard-dose epinephrine in prehospital cardiac arrest.
Callaham M, Madsen CD, Barton CW, Saunders CE, Pointer J.
JAMA. 1992 Nov 18;268(19):2667-72.
PMID: 1433686 [PubMed – indexed for MEDLINE]

[14] A comparison of standard-dose and high-dose epinephrine in cardiac arrest outside the hospital. The Multicenter High-Dose Epinephrine Study Group.
Brown CG, Martin DR, Pepe PE, Stueven H, Cummins RO, Gonzalez E, Jastremski M.
N Engl J Med. 1992 Oct 8;327(15):1051-5.
PMID: 1522841 [PubMed – indexed for MEDLINE]

Free Full Text from NEJM.

[15] Standard doses versus repeated high doses of epinephrine in cardiac arrest outside the hospital.
Choux C, Gueugniaud PY, Barbieux A, Pham E, Lae C, Dubien PY, Petit P.
Resuscitation. 1995 Feb;29(1):3-9.
PMID: 7784720 [PubMed – indexed for MEDLINE]

[16] A comparison of repeated high doses and repeated standard doses of epinephrine for cardiac arrest outside the hospital. European Epinephrine Study Group.
Gueugniaud PY, Mols P, Goldstein P, Pham E, Dubien PY, Deweerdt C, Vergnion M, Petit P, Carli P.
N Engl J Med. 1998 Nov 26;339(22):1595-601.
PMID: 9828247 [PubMed – indexed for MEDLINE]

Free Full Text from NEJM.

[17] High dose versus standard dose epinephrine in cardiac arrest – a meta-analysis.
Vandycke C, Martens P.
Resuscitation. 2000 Aug 1;45(3):161-6.
PMID: 10959014 [PubMed – indexed for MEDLINE]

[18] High-dose epinephrine in adult cardiac arrest.
Stiell IG, Hebert PC, Weitzman BN, Wells GA, Raman S, Stark RM, Higginson LA, Ahuja J, Dickinson GE.
N Engl J Med. 1992 Oct 8;327(15):1045-50.
PMID: 1522840 [PubMed – indexed for MEDLINE]

Free Full Text from NEJM.

[19] Questioning the use of epinephrine to treat cardiac arrest.
Callaway CW.
JAMA. 2012 Mar 21;307(11):1198-200. doi: 10.1001/jama.2012.313. No abstract available.
PMID: 22436961 [PubMed – indexed for MEDLINE]

Link to a free 6 1/2 minute recording of an interview with Dr. Callaway about this paper.

On the right side of the page, to the right of the First Page Preview, is a section with the title Multimedia Related by Topic. Below that is Author Interview. Below that is some information about the edition, . . . , and below that is an embedded recording of the interview. Press on the arrow to play. That has the recording of the interview with Dr. Callaway.

The interview with Dr. Callaway is definitely worth listening to.

Larabee TM, Liu KY, Campbell JA, & Little CM (2012). Vasopressors in cardiac arrest: a systematic review. Resuscitation, 83 (8), 932-9 PMID: 22425731

Woodhouse SP, Cox S, Boyd P, Case C, & Weber M (1995). High dose and standard dose adrenaline do not alter survival, compared with placebo, in cardiac arrest. Resuscitation, 30 (3), 243-9 PMID: 8867714

Herlitz J, Ekström L, Wennerblom B, Axelsson A, Bång A, & Holmberg S (1995). Adrenaline in out-of-hospital ventricular fibrillation. Does it make any difference? Resuscitation, 29 (3), 195-201 PMID: 7667549

Ong ME, Tan EH, Ng FS, Panchalingham A, Lim SH, Manning PG, Ong VY, Lim SH, Yap S, Tham LP, Ng KS, Venkataraman A, & Cardiac Arrest and Resuscitation Epidemiology Study Group (2007). Survival outcomes with the introduction of intravenous epinephrine in the management of out-of-hospital cardiac arrest. Annals of emergency medicine, 50 (6), 635-42 PMID: 17509730

Olasveengen, T., Sunde, K., Brunborg, C., Thowsen, J., Steen, P., & Wik, L. (2009). Intravenous Drug Administration During Out-of-Hospital Cardiac Arrest: A Randomized Trial JAMA: The Journal of the American Medical Association, 302 (20), 2222-2229 DOI: 10.1001/jama.2009.1729

Olasveengen TM, Wik L, Sunde K, & Steen PA (2011). Outcome when adrenaline (epinephrine) was actually given vs. not given – post hoc analysis of a randomized clinical trial. Resuscitation PMID: 22115931

Jacobs IG, Finn JC, Jelinek GA, Oxer HF, & Thompson PL (2011). Effect of adrenaline on survival in out-of-hospital cardiac arrest: A randomised double-blind placebo-controlled trial. Resuscitation, 82 (9), 1138-43 PMID: 21745533

Hagihara A, Hasegawa M, Abe T, Nagata T, Wakata Y, & Miyazaki S (2012). Prehospital epinephrine use and survival among patients with out-of-hospital cardiac arrest. JAMA : the journal of the American Medical Association, 307 (11), 1161-8 PMID: 22436956

Hayashi Y, Iwami T, Kitamura T, Nishiuchi T, Kajino K, Sakai T, Nishiyama C, Nitta M, Hiraide A, & Kai T (2012). Impact of early intravenous epinephrine administration on outcomes following out-of-hospital cardiac arrest. Circulation journal : official journal of the Japanese Circulation Society, 76 (7), 1639-45 PMID: 22481099

Glover BM, Brown SP, Morrison L, Davis D, Kudenchuk PJ, Van Ottingham L, Vaillancourt C, Cheskes S, Atkins DL, Dorian P, & the Resuscitation Outcomes Consortium Investigators (2012). Wide variability in drug use in out-of-hospital cardiac arrest: A report from the resuscitation outcomes consortium. Resuscitation PMID: 22858552

Donnino, M., Salciccioli, J., Howell, M., Cocchi, M., Giberson, B., Berg, K., Gautam, S., Callaway, C., & , . (2014). Time to administration of epinephrine and outcome after in-hospital cardiac arrest with non-shockable rhythms: retrospective analysis of large in-hospital data registry BMJ, 348 (may20 2) DOI: 10.1136/bmj.g3028

Callaham M, Madsen CD, Barton CW, Saunders CE, & Pointer J (1992). A randomized clinical trial of high-dose epinephrine and norepinephrine vs standard-dose epinephrine in prehospital cardiac arrest. JAMA : the journal of the American Medical Association, 268 (19), 2667-72 PMID: 1433686

Brown CG, Martin DR, Pepe PE, Stueven H, Cummins RO, Gonzalez E, & Jastremski M (1992). A comparison of standard-dose and high-dose epinephrine in cardiac arrest outside the hospital. The Multicenter High-Dose Epinephrine Study Group. The New England journal of medicine, 327 (15), 1051-5 PMID: 1522841

Choux C, Gueugniaud PY, Barbieux A, Pham E, Lae C, Dubien PY, & Petit P (1995). Standard doses versus repeated high doses of epinephrine in cardiac arrest outside the hospital. Resuscitation, 29 (1), 3-9 PMID: 7784720

Gueugniaud PY, Mols P, Goldstein P, Pham E, Dubien PY, Deweerdt C, Vergnion M, Petit P, & Carli P (1998). A comparison of repeated high doses and repeated standard doses of epinephrine for cardiac arrest outside the hospital. European Epinephrine Study Group. The New England journal of medicine, 339 (22), 1595-601 PMID: 9828247

Vandycke C, & Martens P (2000). High dose versus standard dose epinephrine in cardiac arrest – a meta-analysis. Resuscitation, 45 (3), 161-6 PMID: 10959014

Stiell IG, Hebert PC, Weitzman BN, Wells GA, Raman S, Stark RM, Higginson LA, Ahuja J, & Dickinson GE (1992). High-dose epinephrine in adult cardiac arrest. The New England journal of medicine, 327 (15), 1045-50 PMID: 1522840

Callaway, C. (2012). Questioning the Use of Epinephrine to Treat Cardiac Arrest JAMA: The Journal of the American Medical Association, 307 (11) DOI: 10.1001/jama.2012.313

.

IAFF’s Jack Reall faces discipline for delaying a 911 call in order to protest research he does not like


 

One of the advantages of fire department-based EMS is that there is a clear chain of command and that discipline is not a problem. The exceptions to this may be rare enough that they make headlines. Here is one.
 

A Columbus Fire battalion chief could face discipline for insubordination after an internal investigation found that he disrupted a pilot program intended to more efficiently respond to emergencies.[1]

 

The first oddity is that the Battalion Chief (Jack Reall) is also the president of Local 67 of the International Association of Fire Fighters. A management position and a union position – and not just any union position, but president. Jack Reall apparently cannot keep his priorities in order.

The fire department is studying whether 911 calls should receive an initial response from one paramedic with a basic EMT or from a pair of paramedics. There is no evidence that sending one paramedic and one EMT causes any kind of harm, or that two paramedics provide better care, so there is no basis to claim that anyone is being in any way endangered by this pilot program.

If there were a legitimate concern, then the time to address that was when the pilot program was being considered. It appears that Jack Reall is not happy with that and his union boss persona delayed a 911 response in violation of fire department rules.
 

The Fire Division launched a pilot program that morning to reduce the number of paramedics who respond to routine calls, allowing the division to disperse medics elsewhere. Instead of two paramedics on a truck, there would be one medic and a basic emergency-medical technician, or EMT.[1]

 

Is it possible that this was a complete surprise to Battalion Chief/Union President Jack Reall?

I don’t know what kind of preparations were made by the fire department, but I suspect that they began well in advance of BC/Pres. Jack Reall’s attempt at sabotage.

It is appropriate to study things when there is a state of equipoise about which is best.

Equipoise is just a fancy word for We do not know which is best.

When we do not know what is best, we should find out, rather than arrogantly assume that we know all that we need to know to force an uninformed opinion on others. That is the alternative – I don’t know, but I am going to force my opinion on everyone else because I am certain my opinion is more important than learning the truth.

Research means we learn more, even if we never learn the whole truth. Opposing research is opposing learning more – especially if the truth disagrees with opinion.

Equipoise means that we cannot be certain, because we do not know enough to be certain.
 

Reall was against the plan from the start and said fewer paramedics meant lower-quality service.[1]

 

The fire department and the union probably have worked out procedures for resolving these differences of opinion. They probably do not include delaying 911 responses to make a point.

If Jack Reall were behaving responsibly, he would have raised these concerns at an appropriate time and place.
 

Reall said the plan was not presented well to firefighters and paramedics and was “not well thought out.”[1]

 

He did raise them at the appropriate time, but he did not get what he wanted.

When I don’t get what I want, as a responsible adult, I should throw a tantrum.

True or False?

A Battalion Chief is supposed to be a person to turn to to resolve confusion, not to create confusion. One part of the job is to make a clear decision (such as to protect the interests of a patient) and to take responsibility for that decision.

It appears that Reall was doing the opposite.

Footnotes:

[1] Firefighters-union chief faces discipline from Fire Division
By Lucas Sullivan
The Columbus Dispatch
Wednesday July 9, 2014 5:51 AM
Article

.

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

[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.

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

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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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No Apologies, Because America is a Victim Nation


 

Scott (MedicSBK – EMS in the New Decade) posted a few tweets about the infamous news reporting by Andrea Isom and Fox2-Detroit – Responsible Reporting and Credibility.
 

That’s right; an Emmy Award Winning reporter told me to “STFU.” While, with that simple statement, she lost all credibility in my eyes, I engaged in a lengthy 140 character at a time discussion with her that ended with her telling me I should contact the station if I was so upset. I took Ms. Lue’s advice and sent the following e-mail to Kevin Roseburger at Fox 2.

 

Is it cyber bullying to point out that people did something wrong?

Is it cyber bullying to point out that a news organization did something wrong?

Is it cyber bullying to use Twitter to attack someone for pointing out that people did something wrong?

Is it cyber bullying to use Twitter to attack someone for pointing out that a news organization did something wrong?

Is pointing out unethical behavior unethical?

Is it television bullying (I have no idea what the politically correct term would be) to use the media to attack someone without any valid basis – then refuse to apologize for that unethical behavior?
 

Go read Scott’s full letter to the station manager.
 

Follow Scott’s directions to –
 

If you would like to contact Fox 2 in Detroit in a professional manner, head over to Dave Statter’s article where you will find all of the contact information that you need.

 

All over a refusal to apologize for presenting a baseless and defamatory interpretation of what is going on in this picture.

 


 

I also wrote about this in –

Does Ignorance Lead to Faulty Assumptions?

Irresponsible Posing? Absolutely.

Here is some of what others have written –

Don’t rely on Dave Statter

UPDATE: TV station pulls report but fails to apologize & explain why it aired bogus story about smiling EMS crew

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The Ethics of Intervention – 1


Image credit. Is the Give tPA propaganda loud enough?
 

Many of us in medicine want to be more aggressive in treating patients with untested/poorly tested treatments.

We’ve got to do something!

What we ignore is the harm that comes from being aggressive with wishful thinking.

Dr. Ryan Radecki points out that we still have no effective way to manage post-thrombolysis intracranial hemorrhage. This is a real problem that is ignored by many proponents of tPA (tissue Plasminogen Activator – Alteplase).
 

If the widespread proponents of tPA would like to subject ever-increasing numbers of patients to this complication, perhaps they ought to put as much energy into developing new treatments for hemorrhage as they do vilifying tPA skeptics?[1]

 

Why don’t we clamor for a treatment for the problems caused by tPA aggressive intervention with tPA?
 


Image credit.
 

We recite the usual platitudes –

If it helps just one patient . . . .

Yet, if it harms more than it helps – it is bad.

Why is that math so difficult?

An intervention that cannot be shown to be beneficial should be assumed to be harmful until after there is evidence to the contrary. If that evidence never exists, it will be just one more dangerous treatment avoided.

Why?

Because almost every treatment that has been tried has been more harmful than beneficial.

There is no reason to assume that this does not also apply to the treatments based on a modern understanding of pathophysiology.

Why does expert opinion seem only to favor the experts who are hopelessly optimistic pro-interventionists?

Why doesn’t critical judgment support pro-interventionist expert opinion?

Why doesn’t history support pro-interventionist expert opinion?

Why doesn’t reality support pro-interventionist expert opinion?

Is reality biased against endangering our patients in the absence of valid evidence that our treatments are safe and effective?

Yes.

Reality doesn’t care what we want.

If reality cared, the patient would not have the medical condition to begin with.

Reality is neutral, but we are biased in favor of thinking that we know what is best for others.

We consistently provide evidence that we are wrong, then we ignore that evidence and make lame excuses that it wasn’t our fault.

We need to grow up and admit that it is our fault when we harm patients with expert opinion.

Footnotes:

[1] tPA ‘Em & Let ‘Em Bleed
Monday, April 28, 2014
Posted by Ryan Radecki
Emergency Medicine Literature of Note
Article

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