FAA changes name of Antidepressant Protocol to...

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GoFlightMed

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Today the FAA published the newest AME guide and made some big updates to the depression/antidepressant protocol.

In addition to three new antidepressants [duloxetine (Cymbalta) venlafaxine (Effexor), desvenlafaxine (Pristiq)] being added to the 'conditionally approved' (requires special issuance) list, they changed the name of the entire process.

The new name is..."The Antidepressant Protocol" (it was formerly the SSRI Protocol but the new meds aren't technically SSRI's).

Thoughts?
 

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...and all the evaluations remain the same. However I would not expect many to make stds on Duloxetine, nor pristiq. Effexor- MAYBE.
 
bbchien said:
...and all the evaluations remain the same. However I would not expect many to make stds on Duloxetine, nor pristiq. Effexor- MAYBE.
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Bruce, would you expect people on those meds to perform better than when they were untreated (and likely unreported)?
 
We noticed 18 years ago in the lab that duloxetine was just a BRAIN clamp and performance in the lab suffered. Desvenlafaxine, less so, Effexor was in the same ranks as Bupropion. So in order to get a proposal through we proposed just the orignal four...
 
bbchien said:
We noticed 18 years ago in the lab that duloxetine was just a BRAIN clamp and performance in the lab suffered. Desvenlafaxine, less so, Effexor was in the same ranks as Bupropion. So in order to get a proposal through we proposed just the orignal four...
Click to expand...

Is there any documentation regarding the performance of people with depression or anxiety who are not taking any medication?
 
No, because in the American System, we don't do testing on folks who "don't have an issue". Try getting insurors to pay for that(?!)
 
bbchien said:
...and all the evaluations remain the same. However I would not expect many to make stds on Duloxetine, nor pristiq. Effexor- MAYBE.
Click to expand...
Effexor is common to treat hot flashes for men on treatment for prostate cancer and women for breast cancer. A bit surprised it was approved. Men on it describe a side effect as brain zaps where they feel like they just recovered from an electrical shock.
 
Half Fast said:
How do they ever test a med without a control group taking a placebo?
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They compare a group with the proposed new treatment for that whatever with the traditional treatment. .....think for a moment about the ethics of a "No treatment" group........they're not gonna do it......
 
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bbchien said:
They compare a group with the proposed new treatment for that whatever with the traditional treatment. .....think for a moment about the ethics of a "No treatment" group........they're not gonna do it......
Click to expand...
Yeah….that wouldn’t play too well in front of a MRB.
 
It slows the speed at which the forebrain communicates with the other parts, limiting speed, flexibilty and also PAIN and mood swings.
It's neurospcych profile is such that I'm not expecting anyone on it to be able to pass.

All of which is this former pain doc's way of saying (and we use it a lot to tamp down pain!) the FAA did not give much away with it's April expansion.

And Clip 4 is partially correct about effexor. It is a ADRENERGIC antidepressive. one of the manifestation is frequently the diarrhea is just intolerable.
 
bbchien said:
It slows the speed at which the forebrain communicates with the other parts, limiting speed, flexibilty and also PAIN and mood swings.
It's neurospcych profile is such that I'm not expecting anyone on it to be able to pass.

All of which is this former pain doc's way of saying (and we use it a lot to tamp down pain!) the FAA did not give much away with it's April expansion.

And Clip 4 is partially correct about effexor. It is a ADRENERGIC antidepressive. one of the manifestation is frequently the diarrhea is just intolerable.
Click to expand...
So they basically made it look like they were doing something, but in reality they allow some of the worst ones it sounds like.
 
Sierra1 said:
So they basically made it look like they were doing something, but in reality they allow some of the worst ones it sounds like.
Click to expand...
Not sure I'd agree with that. I've had at least 3 patients who were very well controlled on Cymbalta and once we tried changing them to one of the OG 'conditionally approved' antidepressants, these patients symptoms returned. Ultimately they had to give up on their pursuit of aviation. But now, the door has been cracked open for them and many others.
 
GoFlightMed said:
Today the FAA published the newest AME guide and made some big updates to the depression/antidepressant protocol.

In addition to three new antidepressants [duloxetine (Cymbalta) venlafaxine (Effexor), desvenlafaxine (Pristiq)] being added to the 'conditionally approved' (requires special issuance) list, they changed the name of the entire process.

The new name is..."The Antidepressant Protocol" (it was formerly the SSRI Protocol but the new meds aren't technically SSRI's).

Thoughts?
Click to expand...
When the voices make up their mind I’ll get back with my thoughts
 
GoFlightMed said:
Not sure I'd agree with that. I've had at least 3 patients who were very well controlled on Cymbalta and once we tried changing them to one of the OG 'conditionally approved' antidepressants, these patients symptoms returned. Ultimately they had to give up on their pursuit of aviation. But now, the door has been cracked open for them and many others.
Click to expand...
Cracked open is better than nothing I guess. I just wish they would do more for those with these situations.
 
bbchien said:
They compare a group with the proposed new treatment for that whatever with the traditional treatment. .....think for a moment about the ethics of a "No treatment" group........they're not gonna do it......
Click to expand...
Sure they do. Most trials include a placebo, aka "no treatment," group.

This discusses placebo controlled trials of Cymbalta: https://pubmed.ncbi.nlm.nih.gov/19480470/
 
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In some cases that is bioethically permissible but more often the exception that proves the rule.....'Most' is a big statement. I'll bet you never served on a bioethics board.....of course, everybody here is a doc an ame an attorney...etc. etc. etc.
 
bbchien said:
In some cases that is bioethically permissible but more often the exception that proves the rule.....'Most' is a big statement. I'll bet you never served on a bioethics board.....of course, everybody here is a doc an ame an attorney...etc. etc. etc.
Click to expand...
I provided a link to an article discussing four placebo-controlled trials on the drug under discussion. :dunno:
 
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