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

- Rogue Medic

Do Drug Shortages Really Impact EMS? – Answer 1



Here is part 1 of the details from the points I raised in commenting on the discussion of the drug shortages and the way these affect EMS. I already gave the short answers in Do Drug Shortages Really Impact EMS? – EMS Office Hours. These will be a bit longer, so I broke it up by answer. There are many points covered for a podcast that lasts less than 40 minutes. Do Drug Shortages Really Impact EMS?

1. Do the drugs help patients?

I have recently written about why these drugs are inappropriate here, here, here, and here.

These drugs are based on either, or both, of 2 bad ideas.

First – Expired expert opinion. Opinion that is not supported by good research. When the research has been done, the research has not supported these treatments.

By expired, I do not mean that the expert has expired, but that the opinion has been kept in use long past any possible justification. If this were canned food in your cupboard, the can would be bulging at both ends from the disgusting growth on this very dead opinion.

Second – Not just expired expert opinion, but opinion that is not based on any research. There is the possibility that research will someday demonstrate that these treatments are effective, if anyone ever appropriately studies these ideas. It is also possible that the parts of the moon that have not been examined actually are made out of cheese. This is the morass of Class IIb level of evidence.

Class II: Conditions for which there is conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of a procedure or treatment.

IIa. Weight of evidence/opinion is in favor of usefulness/efficacy

IIb. Usefulness/efficacy is less well established by evidence/opinion.[1]

There is no requirement for any evidence.

The highlighting is mine, but the wording is 100% ACC/AHA (American College of Cardiology/American Heart Association). The people who thought antiarrhythmics were the answer to everything, until research showed an antiarrhythmic fatality rate several times higher than placebo.[2]

Oopsy.

Perhaps I am putting too positive a spin on the Class II levels of evidence. Some of what is classified as IIa is not much different from IIb, because there is still the allowance for expert opinion. Any reading of this research should be preceded by the words, Wouldn’t it be nice if . . .

However, that is not the way to decide what chemicals to test on a patient.

Let’s be honest. That is all we are doing. We are testing chemicals and/or procedures on patients. We are not treating patients, because treatment implies some sort of concern for the patient. This is just a bunch of large scale never-to-be-published, uncontrolled, unregistered, unreasonable experiments on patients who are not informed of their guinea pig status.

I want to know the real risks and benefits of this treatment.

Wouldn’t it be nice if . . .

How far do we need to go to demonstrate that bad ideas really are bad ideas?

We need to demand that medical directors base their EMS protocols on research.

Why are medical directors ignoring what is best for their patients?

Why are medical directors ignoring what is best for our patients?

Why should we tolerate this ignorance?

I’m a doctor.

Wouldn’t it be nice if . . .

Continued in –
Do Drug Shortages Really Impact EMS? – Answer 2
Do Drug Shortages Really Impact EMS? – Answer 3
Do Drug Shortages Really Impact EMS? – Answer 4

Footnotes –

[1] Manual for ACC/AHA Guideline Writing Committees
Methodologies and Policies from the ACC/AHA Task Force on Practice Guidelines
Section II: Tools and Methods for Creating Guidelines
Step Six: Assign Classification of Recommendations and Level of Evidence
Free Full Text Article

[2] C A S T and Narrative Fallacy
Rogue Medic
Article

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Comments

  1. Rogue (notice I’m spelling it right now!) I can’t begin to voice my support for your frustration in regards to these medications. The fact that research is coming out of Europe which shows that traditional cardiotonic drugs do nothing to improve patient outcome in cardiac arrest merely adds to my frustration. As I understand it, these studies are unlikely to be reproduced in the US because medications like epinephrine are considered “the standard of care” and standard care may not be withheld from patients as part of a study. So ultimately these standards, which are not based on research are keeping us from performing research which may show that these standards are inappropriate (see also: cervical spine immobilization).

    I’ll be interested to see the new recommendations when AHA releases them, but I don’t hold out too terribly much hope. I wonder what it will take for us to start adopting research performed elsewhere, especially when it calls into question our treatment decisions and consequently patient outcomes.

    • The fact that research is coming out of Europe which shows that traditional cardiotonic drugs do nothing to improve patient outcome in cardiac arrest merely adds to my frustration.

      They help us to get a pulse back.

      As much as that would seem to be important for improved long term survival, there is no improvement in outcomes.

      They help us.

      They do not appear to help the patient.

      The question is, How much harm are we doing, just to be able to say we got a pulse back?

      There may be specific indications for epinephrine, but if we never compare it with placebo, we will never know how much harm we are doing.

      As I understand it, these studies are unlikely to be reproduced in the US because medications like epinephrine are considered “the standard of care” and standard care may not be withheld from patients as part of a study.

      The standard of care may be withheld, but it requires a competent IRB (Institutional Review Board) to approve such a study. In stead we have a bunch of bureaucrats, who feel that they will never get in trouble by saying, No.

      So ultimately these standards, which are not based on research are keeping us from performing research which may show that these standards are inappropriate (see also: cervical spine immobilization).

      Joseph Heller could have been writing about EMS research.

      I’ll be interested to see the new recommendations when AHA releases them, but I don’t hold out too terribly much hope.

      There is a saying about science only progressing when the scientists holding the traditional views die off. At least if the traditionalists are treated with their own medicine, they should be dead pretty soon.

      I wonder what it will take for us to start adopting research performed elsewhere, especially when it calls into question our treatment decisions and consequently patient outcomes.

      Ridicule.

      Lots

      and

      lots

      of

      ridicule.

      We might have to point out the research over and over, but eventually doctors, who understand medicine and science, will be in positions to influence what we do to patients in the name of tradition medicine.

    • I just wrote something brief on a related topic.

      Most Survive with Mystery Treatment for Cardiac Arrest.

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  1. […] have also covered these drug shortages here, here, here, here, here, here, here, and […]

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  4. […] the way these affect EMS. Do Drug Shortages Really Impact EMS? – EMS Office Hours and followed by Do Drug Shortages Really Impact EMS? – Answer 1. This is broken up by answer. There are many points covered for a podcast that lasts less than 40 […]

  5. […] the way these affect EMS. Do Drug Shortages Really Impact EMS? – EMS Office Hours and followed by Do Drug Shortages Really Impact EMS? – Answer 1, then by Do Drug Shortages Really Impact EMS? – Answer 2, and that is followed by Do Drug […]

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