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

- Rogue Medic

Merit Badge Courses, Amiodarone, and tPA

At EP Monthly, there is an interesting article – Merit Badge Courses: Who Benefits?

This is the second part from me. First was the quality of the merit badge courses. This is the honesty of the evidence presented. I am not claiming that what the AHA (American Heart Association) does is dishonest.

I am claiming that the AHA does not do enough to demonstrate that they are objective.

Oh, but look at all of the conflict of interest documentation!

Very nice paperwork – paperwork that makes a bureaucrat wet at night, but that does nothing for the patients – at least nothing good.

Is this chain of survival broken?

Jan Shoenberger, MD writes –

The huge stroke chapter seems to cater to emergent tPA-based treatment of acute stroke despite the fact that scientific controversy continues regarding this issue. Lawsuits have been mounted against EPs both for giving tPA and for failing to give tPA. In 2009, the AHA accepted over $17 million from pharmaceutical companies and device manufacturers. This does little to reassure EPs that the standards are purely evidence based.

Since I write mainly for EMS, I am going to leave tPA alone, at least for now. However, . . .

Consider amiodarone.

Now amiodarone is off patent, but amiodarone was made the first line drug for everything arrhythmic when it was still an expensive drug only available from Wyeth. $1/mg and 300 mg/dose with 2 doses not being uncommon. Hundreds of thousands of cardiac arrests treated by EMS and emergency departments. A large percentage of them presenting with VF/pulseless VT (Ventricular Fibrillation/Pulseless Ventricular Tachycardia).

VF and pulseless VT are both treated with epinephrine, then $300 of amiodarone, then epinephrine, then $300 of amiodarone again as long as the patient does not have a pulse. What if the patient gets a pulse back (ROSC – Return Of Spontaneous Circulation) before the patient is given any amiodarone? Just in case, we give them a bunch of prophylactic amiodarone to prevent them from going back into VF/pulseless VT.

A lot of EMS agencies never switched from lidocaine to amiodarone. They said that they couldn’t afford to. Many did.

Why?

Guidelines are Gospel.

This is the Cinderella Gold Standard – at least until the midnight when the new guidelines are released and the spectacular new Gold Standard has its coronation.

But –

Antiarrhythmics
There is no evidence that any antiarrhythmic drug given routinely during human cardiac arrest increases survival to hospital discharge. Amiodarone, however, has been shown to increase short-term survival to hospital admission when compared with placebo or lidocaine.[1]

Let me repeat what the AHA states about amiodarone and survival to discharge –

no evidence

How much evidence?

no evidence

Ironically, at the time, I argued with the people who claimed that amiodarone only increased the number of patients dying in the hospital. My point was that there had not been enough research done to make the claim that amiodarone definitely does not improve survival, any more than the claim that amiodarone should be given to all VF/pulseless VT patients – yet.

There were studies underway and the only honest thing to do was to wait for the evidence before making any kind of definitive statement.

That was a decade ago.

Where are the results of those large enough to show a difference in outcome studies? I think that it is fair to conclude that there was nothing positive in the large enough to show a difference in outcome studies.

In other words amiodarone does only increase the number of patients dying in the hospital.

Where are the results of these survival studies we were told to wait for?

If the research had been positive, would Wyeth not advertise it?

I haven’t seen anything positive about amiodarone in cardiac arrest.

Nothing.

Amiodarone is just another over-hyped ineffective drug that has become a part of the standard of care nonsense that we use to harm patients.

If I wanted to practice alternative medicine I could make more and I wouldn’t even need to have any education. I could just claim to be anything I want – except a real doctor. I could use magic words like Quantum, Qi or other Q words.

No.

I have no desire to be a fraud. The AHA needs to stop imitating the alternative medicine frauds and start acting like a science-based medicine organization.

Epinephrine – no evidence of improved outcomes that matter.

Amiodarone – no evidence of improved outcomes that matter.

We need to stop abusing patients with the wishful thinking of alternative medicine.

The new AHA ACLS guidelines are coming out next month. what are the chances that they reflect reality, rather than wishful thinking?

Our patients deserve better.

Footnotes:

[1] Management of Cardiac Arrest
2005 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care
Part 7.2: Management of Cardiac Arrest
Medications for Arrest Rhythms
Free Full Text from the AHA

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Comments

  1. So, will you soon be making your own evidence based, alternative to ACLS? That would be so awesome and you might get more people on board than you’d think. That being said, are you going to address vasopressin in this series? Just a thought.

  2. Rogue,
    I agree 100%! Ten years ago, I was one of those medics who was screaming about just this! A lot of GOOD medics were (but were told to follow the new guidlines because obviously, the AHA knew better-HA!). As a result of the changes (that I gave a fair chance too, but didn’t believe in) I challenged docs and others to prove to me that Amiodarone that was better than Lidocaine or other drugs. I have YET to see any good/believable research on it. Sounds like the truth is finally coming out, thankfully.
    Life is a learning process. By getting things wrong, we hope to get things right (by learning from our mistakes). What is good for the goose, isn’t always good for the gander. However, if we don’t do research, we’ll never figure it out. Kudos to those like you who are research minded.
    I’ve been saying “prove it” for the last 10 years, glad to see they finally are or aren’t!

    • Melinda,

      As a result of the changes (that I gave a fair chance too, but didn’t believe in) I challenged docs and others to prove to me that Amiodarone that was better than Lidocaine or other drugs.

      There was some research showing that amiodarone was better than lidocaine at increasing hospital admissions, but none that showed that amiodarone was better than anything at improving survival to discharge.

      Amiodarone as compared with lidocaine for shock-resistant ventricular fibrillation.
      Dorian P, Cass D, Schwartz B, Cooper R, Gelaznikas R, Barr A.
      N Engl J Med. 2002 Mar 21;346(12):884-90. Erratum in: N Engl J Med 2002 Sep 19;347(12):955.
      PMID: 11907287 [PubMed – indexed for MEDLINE]
      http://www.ncbi.nlm.nih.gov/pubmed/11907287

      CONCLUSIONS: As compared with lidocaine, amiodarone leads to substantially higher rates of survival to hospital admission in patients with shock-resistant out-of-hospital ventricular fibrillation.

      As compared with lidocaine, but only to hospital admission. Not real survival. that was from 2002. Where is the survival study?

      Amiodarone for resuscitation after out-of-hospital cardiac arrest due to ventricular fibrillation.
      Kudenchuk PJ, Cobb LA, Copass MK, Cummins RO, Doherty AM, Fahrenbruch CE, Hallstrom AP, Murray WA, Olsufka M, Walsh T.
      N Engl J Med. 1999 Sep 16;341(12):871-8.
      PMID: 10486418 [PubMed – indexed for MEDLINE]
      http://www.ncbi.nlm.nih.gov/pubmed/10486418

      CONCLUSIONS: In patients with out-of-hospital cardiac arrest due to refractory ventricular arrhythmias, treatment with amiodarone resulted in a higher rate of survival to hospital admission. Whether this benefit extends to survival to discharge from the hospital merits further investigation.

      I agree. Where is the further investigation of the possible survival benefit?

      Both papers have links from PubMed to the free full text of the articles at NEJM.

      Life is a learning process. By getting things wrong, we hope to get things right (by learning from our mistakes). What is good for the goose, isn’t always good for the gander. However, if we don’t do research, we’ll never figure it out. Kudos to those like you who are research minded.

      Without the research to show improved real survival, this is just a continuation of an unauthorized uncontrolled experiment.

      I’ve been saying “prove it” for the last 10 years, glad to see they finally are or aren’t!

      We will find out on October 18 if they are going to follow the research or if they are going to follow tradition.

  3. Rogue,

    I think part of the problem with the ACLS Guidelines is that the book given out in the course has minimal information in it. In my opinion it amounts to here is the cookbook, go forth. I think it should be required to go to the AHA website and actually read the entire standard. It is an eye opener for most people when they find out how little much of ACLS has been proven. I love what they say about atropine use in cardiac arrest.

    Keep up the good work in making people think about what they are doing and why they are doing it.

    • Jeff,

      Thank you.

      All of the students are supposed to receive the most recent full textbook, which should be the same as what is on the web site. If the course also hands out a pocket-sized copy of the guidelines, that is OK, but I think that is included in the text book.

      I used to bring the book along with me to show people where the AHA clearly wrote that there is no evidence of any improved survival to discharge with any drugs or invasive procedures.

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