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

- Rogue Medic

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

.

2018 ACLS/PALS/NRP – AHA-ILCOR Guideline questions are being reviewed until 02-21-2017

AHA2015 - 2018
 

In preparation for the 2018 ACLS/PALS/NRP/CPR Guidelines (maybe 2017) the AHA (American Heart Association) and ILCOR (the International Liaison Committee On Resuscitation) are reviewing the questions they ask to examine the evidence, or the lack of evidence, on various interventions addressed by the guidelines for the:
 

First Aid Task Force (Public comment on PICO prioritization has recently closed. PICO categorization public comment period was open from October 10 to 24, 2016)

Advanced Life Support Task Force (Public comment on PICO categorization is NOW OPEN until 12:00 AM CST on February 21st, 2017!)

Basic Life Support Task Force (Public comment on PICO categorization is NOW OPEN until 12:00 AM CST on February 21st, 2017!)

Pediatric Life Support Task Force (Public comment on PICO categorization is NOW OPEN until 12:00 AM CST on February 21st, 2017!)

Education, Implementation and Teams Task Force (Public comment on PICO categorization is NOW OPEN until 12:00 AM CST on February 21st, 2017!)​

Neonatal Life Support Task Force (Public comment on PICO categorization is NOW OPEN until 12:00 AM CST on February 22nd, 2017!)[1]

 

Some questions are obvious and will be continued, such as 428. This is the review of antiarrhythmic drugs for cardiac arrest. Recent research shows no benefit to patients from amiodarone, or lidocaine.[2]

What do the 2015 ACLS Guidelines recommend?
 

Amiodarone may be considered for VF/pVT that is unresponsive to CPR, defibrillation, and a vasopressor therapy (Class IIb, LOE B-R).

Lidocaine may be considered as an alternative to amiodarone for VF/pVT that is unresponsive to CPR, defibrillation, and vasopressor therapy (Class IIb, LOE C-LD).[3]

 

Outside of controlled trials that are large enough to provide useful answers, amiodarone and lidocaine have no place in the treatment of cardiac arrest.
 

Much less obvious is 808, the suggestion that we should ventilate patients in the absence of evidence of benefit from ventilation – at least there is no evidence of benefit for the patient. Hands-only CPR seems to annoy doctors, nurses, paramedics, EMTs, . . . .

Why are we still ventilating adult cardiac arrest patients with cardiac causes of their cardiac arrest in the absence of evidence of safety and in the absence of evidence of benefit?
 

Why is there any question about 788? Results from Paramedic2 should be available next year. Is epinephrine in cardiac arrest better than a placebo?[4]

This is the first time we will have valid evidence to start to decide what to do with a treatment we have been using for over half a century based on the weakest of evidence. Paramedic2 is unlikely to answer many questions, such as which cardiac arrest patients should receive epinephrine and which should not, but it will be a start.
 

Then there is 464Drugs for monomorphic wide complex tachycardia. Considering the recent publication of PROCAMIO and the absence of discussion of tachycardia and bradycardia in the 2015 Guidelines, it is bizarre that this is among the questions recommended for elimination. Since there was no recommendation on treatment of ventricular tachycardia in the 2015 ACLS Guidelines, the recommendation from 2010 continues unchanged.

What did PROCAMIO show? If we give a high enough dose of amiodarone to actually try to treat the arrhythmia, major adverse cardiac events are more common than any benefit.[5]

Are we using amiodarone just to make stable ventricular tachycardia unstable?

Procainamide is safer and more effective.

Cardioversion is safer and more effective.

Adenosine is safer and probably more effective.[6]

Doing nothing is safer and only slightly less effective.

What about blood-letting for stable ventricular tachycardia?

Blood-letting is probably safer and maybe just as effective as amiodarone.[7]

Footnotes:

[1] ILCOR Continuous Evidence Evaluation
AHA (American Heart Association) and ILCOR (the International Liaison Committee On Resuscitation)
ILCOR 2016-2017 PICO categorization and prioritization public comment page

[2] 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 May 5;374(18):1711-22. doi: 10.1056/NEJMoa1514204.
PMID: 27043165

Free Full Text from NEJM

[3] 2015 Recommendations—Updated
Part 7: Adult Advanced Cardiovascular Life Support
2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care
2015 Recommendations—Updated

[4] Paramedic2 – The Adrenaline Trial
Warwick Medical School
About

[5] Randomized comparison of intravenous procainamide vs. intravenous amiodarone for the acute treatment of tolerated wide QRS tachycardia: the PROCAMIO study.
Ortiz M, Martín A, Arribas F, Coll-Vinent B, Del Arco C, Peinado R, Almendral J; PROCAMIO Study Investigators.
Eur Heart J. 2016 Jun 28. pii: ehw230. [Epub ahead of print]
PMID: 27354046
 

The primary outcome, major adverse cardiac events within 40 minutes of infusion initiation, for procainamide vs. amiodarone, was 9% vs. 41%, p = 0.006. Severe hypotension or symptoms requiring immediate direct current cardioversion (DCCV) occurred in 6.3% vs. 31.0%. Results were similar in patients with structural heart disease (n = 49).

 

[6] Adenosine for wide-complex tachycardia – diagnostic?
Thu, 23 Aug 2012
Rogue Medic
Article

[7] Blood-Letting
Br Med J.
1871 March 18; 1(533): 283–291.
PMCID: PMC2260507
 

Physicians observed of old, and continued to observe for many centuries, the following facts concerning blood-letting.

1. It gave relief to pain. . . . .

2. It diminished swelling. . . . .

3. It diminished local redness or congestion. . . . .

4. For a short time after bleeding, either local or general, abnormal heat was sensibly diminished.

5. After bleeding, spasms ceased, . . . .

6. If the blood could be made to run, patients were roused up suddenly from the apparent death of coma. (This was puzzling to those who regarded spasm and paralysis as opposite states; but it showed the catholic applicability of the remedy.)

7. Natural (wrongly termed ” accidental”) hacmorrhages were observed sometimes to end disease. . . . .

8. . . . venesection would cause hamorrhages to cease.

 

.

Does use of Lights and Sirens save lives?

AmboLights
 

A recent Fire Chief Magazine and the current JEMS have some articles on the use of lights and sirens and the effect on patient outcomes. Doug Wolfberg, one of the EMS lawyers who might be trying to defend your choice on use of lights and sirens, states –
 

Few cows are more sacred in fire service based EMS than the ones that flash, wail and yelp. The use of emergency lights and sirens is an inseparable part of everyday EMS life.[1]

 

and –
 

Yet when we look at the actual evidence, a few things become apparent about RLS use. First, it’s proven to be dangerous. Second, it’s not proven to be beneficial.[2]

 

In another article, several of the top medical directors in the country state –
 

Unlike fire emergencies, which can grow exponentially and spread quickly, only a small subset of medical emergencies is truly time sensitive. Most don’t dramatically worsen in the course of a very few minutes, and they don’t spread from person to person.[3]

 

In rare cases, such as those where we are not able to control bleeding, or breathing, and the hospital is close enough that the patient won’t be dead by the time we get there, does use of lights and sirens save lives? In those rare cases? Sometimes.

Wouldn’t it be better to improve the quality of the people treating these patients, rather than increase the speed of transport?

When is the last time you transported a patient to the emergency department for something that needed to be done immediately to save the life of the patient?

Why not do that before transport?

Was it out of your scope of practice, did you not know what was going on, did you not feel comfortable performing the skill, could you not make up your mind about what to do, . . .?

Can’t place an endotraceal tube successfully? Use an LMA (Laryngeal Mask Airway), King Airway, BVM (Bag Valve Mask or resuscitator bag), stimulate the patient to breathe for himself, . . .

Can’t place an IV successfully? The IV is not a life line, but you can place an IO (IntraOssesous) line, apply direct pressure to bleeding, lay the patient flat (Trendelenberg does not improve things for the patient, although it might make you feel like you are doing something good), consider IM (IntraMuscular) or IN (IntraNasal) administration of medication, . . .

But it is an emergency!
 

We used to drive cardiac arrests to the hospital quickly, because we thought that was better.

We were wrong. If we do not resuscitate people prior to arrival at the hospital, they will probably stay dead. Driving fast just increases the odds that we will be as dead as the patient.

There has never been any good evidence to support driving fast.

We need to develop a better understanding of the treatment we provide. We need to provide better assessments (and continue to assess). We need to provide appropriate treatment on scene prior to transport. We need to rush less.
 

Do you believe in frequent lights and sirens transport?

Here is a dare for you.

Keep track of the times you transport with lights and sirens (these should be sentinel events) and document the actual life saving treatment provided in the emergency department in the first 10 minutes.

Keep track of this for a month, or a year.

Do you have anything?

Was it really something that saved the patient’s life?

If you do come up with something, does it amount to more than 1% of lights and sirens transports?

If we have almost always beenwrong about what is going on, should we be endangering everyone on the road to cover for our ignorance?

Footnotes:

[1] Why running lights and sirens is dangerous
Fire Chief
June 5, 2016
By Douglas M. Wolfberg, Esq.
Article

[2] Pro Bono: EMS Use of Red Lights and Siren Offers High Risk, Little Reward
JEMS
Wed, Feb 1, 2017
Doug Wolfberg
Article

[3] The Case Against EMS Red Lights and Siren Responses
JEMS
Wed, Feb 1, 2017
S. Marshal Isaacs, MD, FACEP, FAEMS , Carla Cash, MD , Osama Antar, MD , Raymond L. Fowler, MD, FACEP, DABEMS
Article

.

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

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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

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