These guys just slapped a sticker on an Autoject 2, a design by Owen Mumford (who is a sort-of competitor to my employer)
This is a Very Very well designed device, and I understand it is great for diabetics.
However, this is stupid for anyone who actually needs an emergency injection of epinepherine. Seconds count in live-threatening allergic anaphalactic attacks- if you have already drawn a syringe full of epinephrine - why are we putting it in a device? GIVE YOURSELF THE SHOT!!!
What the Epipen does is provide a sterile injection in 2 quick steps. 1) pull of safety, 2) push to inject - no fiddling with syringe and vial., no worrying about sterility or stable drug (despite its short shelf life)
Sure looks simple putting it together in a video. Now factor in the panic of a life-threatening moment.
You cant just walk around with the syringe pre-loaded in the device- its no longer sterile, and Epinepherine, which is very difficult to preserve is no longer in a sealed container.
That would seem to be the key issue. This is essentially people “compounding” a sterile drug in a non-sterile environment. Compounding pharmacy Imprimis is looking to do something similar to create a cheaper alternative to Epi pen brand overcharging, but they can do it in a sterile environment.
This is patently false. Active or Passive sharps protection is required on all autoinjectors by the FDA Guidance on Pen Injectors, 2009& 2013, FDA passive sharps guidance 2005 and ISO 11608.
On the epi pen in particular, the orange cover extend over the needle after the injection
This is emphatically not an equivalent to a commercial epinephrine auto-injector.
Point 1: The Autoinject 2 used in the instructions is made to inject at a different depth than the epinephrine injectors (subcutaneous vs intramuscular). This will change the effect of the medication administered.
Point 2: Epinephrine solution cannot be drawn up manually into a syringe and left for use at an indefinite future date. Nursing team advice recommends discarding manually pre-loaded syringes within 12-24 hours (to say nothing of the difficulties of maintaining proper sterile technique).
And finally, Point 3 (which was a red flag to me): “Doctor” Michael Laufer (as he refers to himself in the video) is not an MD. His PhD is in mathematics. He says as much on the site where the “Epipencil” instructions are hosted (fourthievesvinegar.org/faq) and admits it freely on Twitter as well. He does not have the health care experience to appropriately advise use of this device.
Use a different company’s commercially available epinephrine auto-injector - AFAIK they’re pretty much all cheaper and work nearly as well. Or for maximum savings (albeit with some increased risk) one could have a relative train in how to properly draw up and administer an epinephrine dose in an emergency.
This works better for chemo and insulin-dependent diabetes because it can safely be assumed that those doses will be drawn up and used immediately. Setting this up with epinephrine and then just leaving it aside for future use could have all kinds of bad effects, up to and including death.
Also, the Four Thieves reference? Also concerning in the way that Laufer calls himself “Doctor.” It was a medieval nostrum that claimed to ward off plague infections when one was exposed - pretty much pseudoscience and wishful thinking. https://en.wikipedia.org/wiki/Four_thieves_vinegar
There’s a difference between regularly and carefully injecting yourself with insulin and OH SHIT I CAN’T BREATHE MY THROAT IS CLOSING SHUT INJECT ME THE FUCK RIGHT NOW!!!
Legit, except it might fail to stop an anaphylactic reaction (several different ways), which could leave you dead, or give you a nasty infection if that doesn’t happen. But yeah, otherwise legit, I guess…?
Not having $600 can also leave you dead. Which is worse? Lifesaving medication isn’t a human right in this country. But refusing to allow others to manufacture lifesaving devices is a privilege savagely defended.
If you watch the video, all of the stuff he’s using is commercially-available medical products. Syringes come in sterilised packages, the injector part is a thing that’s specifically designed for this purpose (turning a normal syringe into an auto-injecting) and he repeatedly emphasises the importance of keeping all the components sterile.
Medicine stuff always seems scary, until you realise its just science
As a licensed compounding pharmacy, filling individual prescriptions using FDA approved components, I don’t think they need any additional FDA approval. It’s a stopgap measure, but better than nothing.
You’re raising some serious issues. I am curious, I know about epinephrine’s decomposition to adrenochrome from a chemical perspective, do “pocketable” autoinjectors sheath the tip of the needle? Does it come crashing through a sterile membrane or sheath when you use one?
There’s a standoff and a sterile membrane that’s punctured by the needle. When you release pressure from the epipen from against your body the standoff slides over the needle again to prevent sticks.
The scare quotes around “Doctor” are interesting to me.
Doctoris a title bestowed upon academic accomplishment, that has been extendedas a courtesyto physicians, in recognition of the medical trade’s contribution to humanity. It is intended to indicate that physicians have the samesocial rankas distinguished academics.
The original “Doctors” were the learned doctors of the church - essentially, teachers who weren’t necessarily preachers. But when the great universities of Europe began to escape domination by church hierarchies, the requirement of religious conformance was accordingly weakened, and doctors of theology became distinguished from doctors of philosophy, which distinction was followed shortly by division into increasingly fine academic regimens such as Natural History and Mathematics. Much later (in fact almost a century later) doctors of medicine were recognized, and more recently surgeons have also been awarded the title of doctor (despite the objections of some physicians).
So complaining that someone isn’t a real doctor because they have a Maths Doctorate is extremely amusing to historians. A person with a Phd in Mathematics has a greater historical and etymological claim to the title than any physician, but in truth they are both real doctors.
Those are legitimate concerns if you were buying one of these pre-assembled, but making your own as an alternative to just having a loaded syringe for your own use or to use on your kids makes total sense. Before epipens, you would have been doing the same loading of the syringe with the correct dose anyway.
