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

- Rogue Medic

I helped a Naturopath kill my son, because I believe in Quackery

tamara-ryan-lovett1

 
Would you kill this kid?

Like clapping for Tinkerbell, killing children for superstition is part of keeping reality at bay.

Am I too harsh?

7 year old Ryan Lovett died of strep, meningitis, and pneumonia. His slow death, over 10 days, is reported to have been extremely painful. His death was also preventable with real medicine, so I am not even remotely harsh.

Ryan Lovett’s mother is a true believer in magic. Defending her irrational beliefs means avoiding everything that has valid evidence of benefit. Oddly, she did call 911, after her son started seizing. Ryan Lovett could not be resuscitated by EMS.

Ryan Lovett’s mother took him to a Naturopathic clinic for an echinacea mixture. Meanwhile, her neighbor, not trained in the deadly art of Naturopathy, was trying to convince Ryan Lovett’s mother to take Ryan to a real hospital.
 

La Pointe (Barbara La Pointe, a former friend of Lovett’s who used to take Ryan to her home on weekends) testified she visited Ryan and his mother the day before he died. She described Ryan as being “in a state of supreme suffering” and offered to take the mother and son to a hospital or doctor, but Lovett refused.[1]

 

Naturopaths claim that they will tell patients to go to a real doctor if the patient has a serious illness, which requires real medicine, not the usual self-limiting illness that patients recover from in spite of the Naturopath’s prescriptions.

Ryan Lovett will tell you that doesn’t work. No, Ryan Lovett can’t tell you, because nobody at Naturopathic clinic did what Naturopaths claim their extensive training in quackery prepares them to do – send the patient to a real doctor.

The neighbor was much smarter than everyone at the Naturopathic clinic, since she does not appear to have been indoctrinated in the death before medicine quackery of Naturopathy.
 

Ryan did not have a birth certificate and had never seen a doctor because his mother “did not believe in conventional medicine,”[1]

 

Evil conventional medicine? Pediatricians use evidence based medicine on their own kids and on themselves. They will even give you copies of research articles that show that their treatments do work. Medicine works even when the manufacturer is not able to influence the results of the research.
 


 

“The court specifically found that Tamara Lovett actually knew how sick he was and simply refused to do something and therefore gambled with his life,” he (Prosecutor Jonathan Hak) told reporters.[1]

 

That is a misunderstanding of medicine and gambling. Medicine is probabilistic. No treatment is 100% successful, so it depends on being prescribed for the right condition, in the right dose, having the fewest side effects, or having side effects that are least likely to make the patient worse, . . . , in order to make it more likely that the patient has a good outcome. That is gambling (putting the odds in the favor of the patient). Medical education is what helps the doctor, PA, NP, nurse, paramedic, EMT to assess the patient in a way that identifies the actual medical condition, to understand the risks and benefits of the available treatments, and to decide what is best for that individual patient.

Evidence-based medical education is better at putting the odds in favor of a good outcome than anything else.

Ryan Lovett’s mother wasn’t gambling, she was praying that her superstition had real magic powers. Maybe Ryan Lovett’s mother was praying that Ryan had a self-limiting illness, which would get better as long as the Naturopathic chemicals did not poison Ryan. Why take Ryan to the Naturopathic clinic at all, if the Naturopathic clinic just sells chemicals that are merely supposed to distract people and make the Naturopath money?
 

Doctors testified the infection would have been treatable had the boy, who also had meningitis and pneumonia, been taken to a doctor and given antibiotics.[1]

 

But this is just one rare case, so it is not fair to criticize Naturopaths for scamming the gullible. The Quack didn’t know the kid would die.
 

Canadians across the country have kept a close eye on the case. It is one of several in southern Alberta involving parents who were charged criminally after their children died of conditions that could have been treated with conventional medicine.[1]

 

Some people just can’t deal with reality.

Reality will eventually kill us, regardless of what we do. In the mean time, we can increase the odds of living a long healthy life by avoiding unnecessary treatment and limiting the treatments we do use to stuff that has valid evidence that it really works.

Footnotes:

[1] Tamara Lovett found guilty of negligence, failure to provide necessaries of life in death of 7-year-old son
By Meghan Grant, Drew Anderson,
CBC News
Posted: Jan 23, 2017 5:00 AM MT
Last Updated: Jan 23, 2017 5:33 PM MT
Article

.

Acute coronary syndrome on Friday the 13th: a case for re-organising services?

ResearchBlogging.orgAcute coronary syndrome on Friday the 13th - a case for re-organising services 1
 
There has been a bunch of research on the likelihood of bad things happening on Friday the 13th. These researchers thought that the big problem with all of the available research is that the populations studied have been too small. The authors took information on over 56,000 patients with acute coronary syndromes, broke them down into 217 day/date combinations (Friday the 1st, Saturday the 1st, . . . ,Wednesday the 31st, Thursday the 31st), and compared the outcomes of those 216 groups with their Friday the 13th group.

Cut to the conclusion –
 

Conclusion: On most days, there was no difference in the 13-year mortality rate for patients admitted with their first ACS from that for “unlucky” Friday the 13th. However, patients admitted on five day/number combinations were 20-30% more likely to survive at 13 years. These findings could be explained by subgroup analysis inflation of the type I error, although supernatural causes merit further investigation.[1]

 

No. Supernatural causes do not merit further investigation, at least, not based on anything in this paper.

The authors used Friday the 13th as their normal date for comparison with every other date, but the outcomes from Friday the 13th are not the true statistical mean. The outcomes on Friday the 13th were just chosen because of the superstition being investigated. Friday the 13th is so close to the statistical mean that this mistake is easy to make.
 

Surprisingly, however, we also identified five potentially “lucky” days on which mortality rates were significantly lower, by 20-30%.[1]

 

When analyzing 217 samples, it is not surprising that some of the data deviate from average by an amount that is expected to produce no more than one significant deviation out of every twenty comparisons. The authors had over 200 comparisons, so we should not have been surprised by up to 11 day/date combinations with p values of less than 0.05. There were only 5. Should anyone go looking for supernatural explanations for statistically normal outcomes?

While Friday the 13th was not the statistical mean, it was very close. Look at the five potentially “lucky” days and how close the ranges are to 1.00. If the range crosses (includes) 1.00, the results are not statistically significant according to the prospectively determined criteria of the authors. Crossing 1.00 is just another way of expressing P <0.05. Sunday the 1st and Monday the 29th each produced outcomes 29% worse than Friday the 13th. Saturday the 31st produced outcomes that were 36% worse. If we compared these with the actual statistical mean, Monday the 29th and Saturday the 31st become significantly “unlucky” using a p value of less than 0.05 and all of the significantly “lucky” days become insignificant.

As we should expect, the most extreme benefit and harm both fall on the 31st. Only 7/12 (58.3%) of months have 31 days, so these days have much smaller sample sizes. With smaller samples, the appearance of deviance is expected to be greater. The actual deviation is less important, because the sample size is smaller.

Friday the 13th is only slightly different from the statistical mean, using the data in this paper, which may be the largest examination of a possible Friday the 13th effect.

Once again, the biggest problem with Friday the 13th is that we end up listening to people promoting superstition.
 

I have also written about this kind of superstition here –

The Magical Nonsense of Friday the 13th – Fri, 13 May 2016

Happy Friday the 13th – New and Improved with Space Debris – Fri, 13 Nov 2015

Friday the 13th and full-moon – the ‘worst case scenario’ or only superstition? – Fri, 13 Jun 2014

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

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

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

Happy Equinox! – Thu, 20 Mar 2008

Footnotes:

[1] Acute coronary syndrome on Friday the 13th: a case for re-organising services?
Protty MB, Jaafar M, Hannoodee S, Freeman P.
Med J Aust. 2016 Dec 12;205(11):523-525.
PMID: 27927150

Protty, M., Jaafar, M., Hannoodee, S., & Freeman, P. (2016). Acute coronary syndrome on Friday the 13th: a case for re-organising services? The Medical Journal of Australia, 205 (11), 523-525 DOI: 10.5694/mja16.00870

.

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

.

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

.

Dr. Kudenchuk is Misrepresenting ALPS as ‘Significant’

ResearchBlogging.org
 

The results of ALPS (Amiodarone, Lidocaine, Placebo Study) are clear. There is no statistically significant difference in cardiac arrest outcomes with amiodarone or lidocaine, when compared with placebo.
 

Conclusions Overall, neither amiodarone nor lidocaine resulted in a significantly higher rate of survival or favorable neurologic outcome than the rate with placebo among patients with out-of-hospital cardiac arrest due to initial shock-refractory ventricular fibrillation or pulseless ventricular tachycardia.[1]

 

This study was very well done, but it was not designed to provide valid information about the effects of amiodarone or lidocaine on witnessed arrests or on EMS Witnessed arrests. Maybe the authors were overconfident.

In resuscitation research, we have abundant evidence that overconfidence is much more common than improvements in outcomes. There is no study that has shown an improvement in neurologically intact survival to discharge with any drug. Leaving the hospital with a working brain is the result that matters most to patients. We give drugs because we have too much confidence in the drugs and we are treating our confidence, not because we are doing anything to benefit the patients.
 

I WANT TO BE DECEIVED version of Domenichino, Virgin and Unicorn 1 copy
 

In ALPS there was a subgroup that might have reached statistical significance, but the researchers never determined what would be statistically significant when setting up the study, so these results are merely post hoc data mining (fitting the numbers to allow for a positive spin).

This is the Texas sharpshooter fallacy. The Texas sharpshooter shoots at the side of a barn, then draws targets around the bullet holes so that the the bullet holes are in the bull’s eyes.
 


 

The Texas sharpshooter didn’t shoot at any target, but he went back later and made it look like he hit the center of the target, because he drew the target around the bullet holes. Science requires that we state our hypotheses ahead of time, so that scientists are kept honest. Science requires that we calculate statistical significance ahead of time, especially for secondary outcomes/subgroup analysis, which may mean decreasing the p value to less than 0.03, or to less than 0.01, or even lower to reach statistical significance, so that scientists are kept honest. You are not permitted to bet on the outcome of a horse race that is already in progress for the same reason.

Why do we need to keep scientists honest? Because, as Dr. Peter Kudenchuk unintentionally demonstrates, scientists are just as biased as everyone else. Scientists need to follow the rules of science to minimize the influence of prejudices, such as overconfidence. When scientists do not follow these rules, they are just as easily fooled as everyone else and they may use that self-delusion, and their reputation, to fool others. Dr. Oz makes a fortune telling people what they want to hear about treatments that do not work.

I don’t claim that Dr. Kudenchuk, or even Dr. Oz, is deliberately fooling others, only that they have fooled themselves and are trying to convince others that their prejudices are accurate representations of reality. Here is what Dr. Kudenchuk has been telling people –
 

Researchers have confirmed that certain heart rhythm medications, when given by paramedics to patients with out-of-hospital cardiac arrest who had failed electrical shock treatment, improved likelihood of patients surviving transport to the hospital.[2]

 

The researchers have not confirmed any such thing.

If Dr. Kudenchuk wants to study whether amiodarone or lidocaine or both improve outcomes for witnessed cardiac arrest patients, or for EMS witnessed cardiac arrest patients, he needs to set up a study with all of the criteria for a positive result specified before the start of the study, because this study did not. The study explicitly states this, so Dr. Kudenchuk should be able to just read the study and see that he is wrong. Here is another statement that contradicts the information that was published.
 

Two groups of patients were pre-specified by the study as likely to respond differently to treatment: those with a witnessed cardiac arrest and those with an unwitnessed arrest. When it was originally designed, the study predicted that because patients with witnessed cardiac arrest are recognized and treated sooner, they would more likely be responsive to effective treatments than unwitnessed arrests. When first discovered, patients with an unwitnessed arrest are more likely to have already sustained irreversible organ damage resulting from a longer “down time” and less likely to respond to any treatment. This is precisely what was seen in the study – a statistically significant 5% improvement in survival to hospital discharge in witnessed arrests, and no effect from the drugs in unwitnessed arrests.[3]

 

Why does the published version of the paper contradict Dr. Kudenchuk? One of our biases is to remember things differently from the way things really happened. This is why eyewitness testimony is so often wrong. Here is what the published paper states about the witnessed arrest results.
 

We observed an interaction of treatment with the witnessed status of out-of-hospital cardiac arrest, which is often taken as a surrogate for early recognition of cardiac arrest, a short interval between the patient’s collapse from cardiac arrest and the initiation of treatment, and a greater likelihood of therapeutic responsiveness. Though prespecified, this subgroup analysis was performed in the context of an insignificant difference for the overall analysis, and the P value for heterogeneity in this subgroup analysis was not adjusted for the number of subgroup comparisons. Nonetheless, the suggestion that survival was improved by drug treatment in patients with witnessed out-of-hospital cardiac arrest, without evidence of harm in those with unwitnessed arrest, merits thoughtful consideration.[1]

 

The authors did not adjust the p value, so the authors do not claim that the witnessed cardiac arrest results are statistically significant. They only state that these results merit thoughtful consideration. In other words, if we want to claim this hypothesis is true, we need to set up a study to actually examine this hypothesis.

One earlier study (also by ROC – the Resuscitation Outcomes Consortium) even has similar results.[4],[5] These results are also not statistically significant, but suggest that with larger numbers the results might be significant. So why did the authors set up such a small study? Overconfidence and an apparent lack of familiarity with their own research.
 


 

The Seattle phenomenon (they claim that their resuscitation rate is the highest in America) seems to be due to excellent bystander CPR rates (apparently the highest in America), but that is only good enough for them to be experts on improving bystander CPR rates. The rest is probably due to defibrillation and chest compressions, which are the only prehospital interventions demonstrated to improve neurologically intact survival.

Why does a bystander CPR specialist focus on drugs? Overconfidence and an apparent lack of understanding of the resuscitation research. Dr. Kudenchuk preaches like Timothy Leary about the benefits of drugs and with just as little evidence. We should give appropriate credit for Dr. Kudenchuk’s work on CPR, but we should not mistake that for a thorough understanding of the resuscitation research, even the research with his name attached.
 

A new podcast reviews ALPS. Dominick Walenczak does not notice the mistakes of Dr. Kudenchuk, but he is not one of the researchers, so that is easy to overlook. The rest of the podcast is excellent. Listen to it here.
 

Episode 8: Conquering the ALPS (Study)
CritMedic – Critical Care Paramedicine Podcast
Dominick Walenczak
April 7, 2016
Podcast page
 

Footnotes:

[1] Amiodarone, Lidocaine, or Placebo in Out-of-Hospital Cardiac Arrest.
Kudenchuk PJ, Brown SP, Daya M, Rea T, Nichol G, Morrison LJ, Leroux B, Vaillancourt C, Wittwer L, Callaway CW, Christenson J, Egan D, Ornato JP, Weisfeldt ML, Stiell IG, Idris AH, Aufderheide TP, Dunford JV, Colella MR, Vilke GM, Brienza AM, Desvigne-Nickens P, Gray PC, Gray R, Seals N, Straight R, Dorian P; Resuscitation Outcomes Consortium Investigators.
N Engl J Med. 2016 Apr 4. [Epub ahead of print]
PMID: 27043165

Free Full Text from NEJM

[2] Antiarrhythmic drugs found beneficial when used by EMS treating cardiac arrest
Press release
For Immediate Release:April 4, 2016
NHLBI (National Heart Lung and Blood Institute)
Press release

[3] Dr. Kudenchuk: Study reveals exciting news about cardiac arrest treatment
Lindsay Bosslet
18 hours ago
Public Health Insider
Article

[4] 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.

[5] Wide variability in drug use in out-of-hospital cardiac arrest: A report from the resuscitation outcomes consortium – Part I
Mon, 17 Sep 2012
Rogue Medic
Article

 
Kudenchuk, P., Brown, S., Daya, M., Rea, T., Nichol, G., Morrison, L., Leroux, B., Vaillancourt, C., Wittwer, L., Callaway, C., Christenson, J., Egan, D., Ornato, J., Weisfeldt, M., Stiell, I., Idris, A., Aufderheide, T., Dunford, J., Colella, M., Vilke, G., Brienza, A., Desvigne-Nickens, P., Gray, P., Gray, R., Seals, N., Straight, R., & Dorian, P. (2016). Amiodarone, Lidocaine, or Placebo in Out-of-Hospital Cardiac Arrest New England Journal of Medicine DOI: 10.1056/NEJMoa1514204

 

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

.

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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Happy Darwin Day 2016

 

Today is the 207th birthday of both Charles Darwin and Abraham Lincoln, two people who were condemned for their great works. One changed the way we treat other members of our species, while the other changed our entire understanding of species.

Lincoln held America together in spite of attempts to divide America into those who used the law to support equal treatment of Americans and those who would start their own country to be able to expand what may be the worst economic system ever seen in America – slavery. We don’t like communism, but when we condemn communism, we use slavery as a metaphor for how bad communism really is. We used to be worse than the communists. Some of us were willing to kill Americans to avoid having to deal with the possibility of giving up the horror that is slavery.

Darwin explained how life evolved into the many different species that exist and into those that no longer exist. The connection among those seemingly unconnected species of animals, plants, fungi, bacteria, . . . is DNA (DeoxyriboNucleic Acid). We can use DNA in a court room to demonstrate that one person is the parent of another person, or that one person had direct (or occasionally indirect) contact with another person and thus may have had the opportunity to commit a crime. Criminal DNA evidence is just a tool and its appropriate use does require judgment, just as with any other evidence. If used without judgment, DNA evidence can be just as unreliable as eyewitness testimony.[1]

DNA is able to tell us how people and species are related. DNA is able to tell us that we are very closely related to other apes. When we trace our ancestry back far enough, we have the same ancestors. If we trace our ancestry back even farther, we have the same ancestors as snails. We have all evolved, over billions of years, to exist in our current temporary state of evolution. Will we humans split into several species or remain just one species until we become extinct?

DNA had not even been identified at the time that Darwin explained evolution in On the Origin of Species, so he did not have the ability to explain how these changes were taking place, but he could show that the changes were taking place and that the changes favored adaptations that increased the probability of survival of the species. He wasn’t right about everything, but science is not perfection. Science is a method of increasing our understanding and Darwin is one of a handful of scientists who dramatically changed the way we understand biology.

Medicine is a branch of biology. We can go practice monkey see, monkey do medicine, but we will cause a lot of harm with our lack of understanding. We can try to understand as much as possible or we can make excuses for rejecting science.

As we learn, science changes. The same is true for everything else. As we learn, we change. Change is unstoppable.

Could over 99% of biologists be wrong about evolution?
 

How Gavin Smythe Broke Science

How Gavin Smythe Broke Science


 
Go see the rest of How Gavin Smythe Broke Science here.
 

If you understand science, Tell Congress to Support Darwin Day 2016.

In addition, House Resolution 548 and Senate Resolution 337:
 

Footnotes:

[1] Apparent DNA Transfer by Paramedics Leads to Wrongful Imprisonment
Fri, 05 Jul 2013
Rogue Medic
Article

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The RAD-57 – Still Unsafe?

ResearchBlogging.org
 

Brandon Oto of EMS Basics and Degrees of Clarity organized The First EMS What-if-We’re-Wrong-a-Thon. I did not participate, because I was taking a break from blogging at the time. Brandon is doing it again, so I decided to look for something I wrote that I have been wrong about to contribute. I thought about Masimo. I had been very critical of Dr. Michael O’Reilly (then Executive Vice President of Masimo Corporation) for being an advocate of bad science. He has since been hired away by Apple.[1] He should be less dangerous with a telephone than he was with the RAD-57. At the time, he wrote –
 

Masimo stands by its products’ performance and knows that when SpCO-enabled devices are used according to their directions for use, they provide accurate SpCO measurements that provide significant clinical utility, helping clinicians detect carbon monoxide poisoning in patients otherwise not suspected of having it and rule out carbon monoxide poisoning in patients with suspected carbon monoxide poisoning.[2]

 

The problem is that there is no evidence that the RAD-57 is safe or effective at ruling out carbon monoxide poisoning in anyone.

There is evidence that the RAD-57 will fail, if used to try to rule out carbon monoxide poisoning. One study showed that the RAD-57 will miss half of the people with elevated carbon monoxide levels.
 

The RAD device correctly identified 11 of 23 patients with laboratory values greater than or equal to 15% carboxyhemoglobin (sensitivity 48%; 95% CI 27% to 69%).[3]

 

What if I was wrong?

Is there any evidence that the RAD-57 is able to rule out covert, but life threatening carbon monoxide poisoning?[4]
 


 
 

Was I wrong?

While there have been several studies of the RAD-57, I could not find any evidence that the RAD-57 is safe or effective at ruling out carbon monoxide poisoning.

There does not appear to be any research on the use of the RAD-57 to screen firefighters to rule out carbon monoxide poisoning, even though advertising shows using the RAD-57 to screen firefighters.

Was I wrong? No. That is why this is not a part of The First EMS What-if-We’re-Wrong-a-Thon.

However, I did find some interesting carbon monoxide poisoning papers –

One shows that we may be causing harm by aggressively providing oxygen. This is not enough of a reason to stop providing oxygen, but if this hypothesis is supported by further research, we will need to change treatment.
 

While CO’s affinity for hemoglobin remains undisputed, new research suggests that its role in nitric oxide release, reactive oxygen species formation, and its direct action on ion channels is much more significant. In the course of understanding the multifaceted character of this simple molecule it becomes apparent that current oxygen based therapies meant to displace CO from hemoglobin may be insufficient and possibly harmful.[5]

 

Another shows that the addition of catalytic converters seems to have dramatically decreased the car exhaust suicide rate and the level of carbon monoxide in survivors of these suicide attempts.
 

RESULTS:
Since 1985, the CDR for suicidal motor vehicle-related CO poisoning has decreased in parallel with CO emissions (R2 = 0.985). Non-fatal motor vehicle-related intentional CO poisoning cases decreased 63% over 33 years (p = 0.0017). COHb levels decreased 35% in these patients (p < 0.0001).
[6]

 

CO is Carbon monOxide.
CDR is Crude Death Rate.
COHb is CarbOxyHemoglobin.

There are still some papers that show that we do not understand what the RAD-57 can’t do –
 

The fact that all the Paramedic Rescue Squads were equipped with medical triage sets and were able to conduct non-invasive measurements of carboxyhemoglobin made it possible to introduce effective procedures in the cases of suspected carbon monoxide poisoning and abandon costly and complicated organisational procedures when they proved to be unnecessary.[1]

 

No. The Magic 8 Ball did not indicate a problem, but that does not mean that it is safe to rule out carbon monoxide poisoning with a Magic 8 Ball. The Magic 8 Ball RAD-57 is not accurate enough to rule out carbon monoxide poisoning.

The RAD-57 is only appropriate for sending more people to the hospital. While the extra cost of these false positives is a problem and will cause people to mock Masimo, this may save some lives or just prevent more serious consequences of carbon monoxide poisoning.

If you use the RAD-57 to determine that someone does not need to go to the hospital, get a lot of very good insurance, because eventually one of those patients will have a heart attack, or a stroke, or die and carbon monoxide will be part of the reason for the bad outcome. Your advice will have contributed.

If you send a firefighter back into a fire because you think you have ruled out carbon monoxide poisoning, eventually you will be the cause of death or disability of firefighters. Don’t do it.
 

CONCLUSIONS:
While the Rad-57 pulse oximeter functioned within the manufacturer’s specifications, clinicians using the Rad-57 should expect some SpCO readings to be significantly higher or lower than COHb measurements, and should not use SpCO to direct triage or patient management. An elevated S(pCO) could broaden the diagnosis of CO poisoning in patients with non-specific symptoms. However, a negative SpCO level in patients suspected of having CO poisoning should never rule out CO poisoning, and should always be confirmed by COHb.
[7]

 

Highlighting in bold is mine.

SpCO is Masimo’s registered trademark for their noninvasive indirect measurement of carbon monoxide using the RAD-57.

Was I wrong? I will find something else to write about, because there is even more evidence that the RAD-57 should not be used to try to rule out carbon monoxide poisoning now than when I originally criticized Masimo.
 

Also read the article by Dr. Brooks Walsh on the RAD-57 and screening for carbon monoxide poisoning in fire fighters – Checking firefighters for carbon monoxide – recent studies, persistent concerns.
 

Here is the rest of what I have written about the Dr. O’Reilly, Masimo, and the RAD-57

The RAD-57 Pulse Co-Oximeter – Does It Work – Part I
Fri, 12 Nov 2010

The RAD-57 Pulse Co-Oximeter – Does It Work – Part II
Wed, 17 Nov 2010

How Not to Respond to Negative Research
Fri, 26 Nov 2010

How Not to Respond to Negative Research – Addendum
Fri, 26 Nov 2010

How TO Respond to Negative Research
Sun, 05 Dec 2010

Bad Advice on Masimo’s RAD-57 – Part I
Fri, 18 Feb 2011

Bad Advice on Masimo’s RAD-57 – Part II
Mon, 21 Feb 2011

Bad Advice on Masimo’s RAD-57 – Part III
Thu, 24 Feb 2011

Bad Advice on Masimo’s RAD-57 – Part IV
Mon, 28 Feb 2011

Performance of the RAD-57 With a Lower Limit – Better?
Wed, 18 May 2011

Accuracy of Noninvasive Multiwave Pulse Oximetry Compared With Carboxyhemoglobin From Blood Gas Analysis in Unselected Emergency Department Patients
Tue, 21 Feb 2012

Mass sociogenic illness initially reported as carbon monoxide poisoning
Wed, 22 Feb 2012

Psychic vs. RAD-57
Thu, 23 Feb 2012

Footnotes:

[1] Apple makes yet another medical field hire for unknown project
By AppleInsider Staff
Thursday, January 30, 2014, 04:04 pm PT (07:04 pm ET)
AppleInsider
Article

[2] Performance of the Rad-57 pulse co-oximeter compared with standard laboratory carboxyhemoglobin measurement.
O’Reilly M.
Ann Emerg Med. 2010 Oct;56(4):442-4; author reply 444-5. No abstract available.
PMID: 20868919 [PubMed – indexed for MEDLINE]

Free Full Text of letter and author reply from Ann Emerg Med.

[3] Performance of the RAD-57 pulse CO-oximeter compared with standard laboratory carboxyhemoglobin measurement.
Touger M, Birnbaum A, Wang J, Chou K, Pearson D, Bijur P.
Ann Emerg Med. 2010 Oct;56(4):382-8. Epub 2010 Jun 3.
PMID: 20605259 [PubMed – indexed for MEDLINE]

Free Full Text Article from Ann Emerg Med.

[4] Accuracy of Noninvasive Multiwave Pulse Oximetry Compared With Carboxyhemoglobin From Blood Gas Analysis in Unselected Emergency Department Patients
Rogue Medic
Tue, 21 Feb 2012
Article

[5] A modern literature review of carbon monoxide poisoning theories, therapies, and potential targets for therapy advancement.
Roderique JD, Josef CS, Feldman MJ, Spiess BD.
Toxicology. 2015 Aug 6;334:45-58. doi: 10.1016/j.tox.2015.05.004. Epub 2015 May 18. Review.
PMID: 25997893

[6] Suicidal carbon monoxide poisoning has decreased with controls on automobile emissions.
Hampson NB, Holm JR.
Undersea Hyperb Med. 2015 Mar-Apr;42(2):159-64.
PMID: 26094291

[7] False positive rate of carbon monoxide saturation by pulse oximetry of emergency department patients.
Weaver LK, Churchill SK, Deru K, Cooney D.
Respir Care. 2013 Feb;58(2):232-40. doi: 10.4187/respcare.01744.
PMID: 22782305

Free Full Text from Respir Care.

Weaver, L., Churchill, S., Deru, K., & Cooney, D. (2012). False Positive Rate of Carbon Monoxide Saturation by Pulse Oximetry of Emergency Department Patients Respiratory Care DOI: 10.4187/respcare.01744

Hampson NB, & Holm JR (2015). Suicidal carbon monoxide poisoning has decreased with controls on automobile emissions. Undersea & hyperbaric medicine : journal of the Undersea and Hyperbaric Medical Society, Inc, 42 (2), 159-64 PMID: 26094291

Roderique, J., Josef, C., Feldman, M., & Spiess, B. (2015). A modern literature review of carbon monoxide poisoning theories, therapies, and potential targets for therapy advancement. Toxicology, 334, 45-58 DOI: 10.1016/j.tox.2015.05.004

Touger, M., Birnbaum, A., Wang, J., Chou, K., Pearson, D., & Bijur, P. (2010). Performance of the RAD-57 Pulse Co-Oximeter Compared With Standard Laboratory Carboxyhemoglobin Measurement Annals of Emergency Medicine, 56 (4), 382-388 DOI: 10.1016/j.annemergmed.2010.03.041

O’Reilly, M. (2010). Performance of the Rad-57 Pulse Co-Oximeter Compared With Standard Laboratory Carboxyhemoglobin Measurement Annals of Emergency Medicine, 56 (4), 442-444 DOI: 10.1016/j.annemergmed.2010.08.016

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