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There was competitor (Sanofi) but they had a product recall, because it wasn't delivering the right dosage. What people don't seem to understand is - healthcar

There was competitor (Sanofi) but they had a product recall, because it wasn't delivering the right dosage. What people don't seem to understand is - healthcare products are no laughing matter (literally). This isn't like software, where you can release early, release often, and where alpha quality is tolerated (to a degree). For whatever reason, Mylan have done the FDA testing, and perfected a product that works reliably. That is expensive. (I suspect profit factored into it somewhere). There's nothing stopping somebody for designing a different device (like Sanofi) did that does the same job - the devil is in the detail, and making sure you don't f_ck up. Because believe me - the moment you screw up, and deliver the wrong dosage to some kid in anaphylatic shock, and he/she dies...your company is history (or facing a very costly recall and/or potential lawsuit). My daughter recently had a health-scare. That moment, when I looked at her, and honestly thought she wasn't going to make it, was heart-wrenching. So I can tell you, as a parent, if my daughter was allergic to something, and the Epipen was $600, and I needed one around - sure, I'd be bummed about the money, but no, I wouldn't not pay it. And if you told me, these are the only guys so far who have made sure it's reliable, or you can get these cheap 3D printed copy that might work 85% of the time, or she might die but it's only $100 and realy, what's 15%?? What do you think I'm going to go for? If this was like, say, something else that wasn't literally life-saving, then sure, people's risk appetites would probably change dramatically.

FireBeyond 10y ago
As a paramedic: So the issue isn't the epi itself (which is just adrenaline). In fact EMS agencies around the country are moving away from the EpiPen (in my state, all ambulance and fire units are required to carry the pen itself) to drawing up from ampoules. In my relatively small county, Medic One throws away $100,000/yr of EpiPens, because they have a short shelf life. "Wrong dosage", though? Dosing epi isn't a particularly exact science - the adult pen is 0.3mL, the junior 0.15mL. Quite often we will have to use multiple pens on the one patient. Underdose is entirely common - especially in civilian-administered situations. Overdose is typically restricted to acute hypertension and associated symptoms which can largely be managed by EMS (who should be enroute anyway for any admin of epi, for reasons not least of which include that 'need for additional dose').
- victorhooi 10y ago
  Aha, fair enough - I just interpreted what I saw on Sanofi's homepage for the recall: https://www.auvi-q.com/ https://www.auvi-q.com/ > Sanofi US Issues Voluntary Nationwide Recall of All Auvi‑Q® Due to Potential Inaccurate Dosage Delivery > ... > If a patient experiencing a serious allergic reaction (i.e., anaphylaxis) did not receive the intended dose, there could be significant health consequences, including death because anaphylaxis is a potentially life‑threatening condition. As of October 26, 2015, Sanofi has received 26 reports of suspected device malfunctions in the US and Canada. Or is it something that somebody like an EMS would probably not get wrong, but say, a non-medically trained panicked parent could? I've heard the shelf-life complaints about Epipens. For me, I figured it was pretty idiot proof, even for an untrained person in panick mode - take it out, stab it in leg, and that's it, as opposed to trying to drain an ampoule into a syringe. Fortunately, I've never had to face that bad situation....
  - lostlogin 10y ago
    Watching someone with decades of experience in a low stress environment draw up from a glass ampule can be exciting.
  - FireBeyond 10y ago
    Certainly it's worth clarifying that saying that many people need more than one dose doesn't mean that Auvi-Q shouldn't have to "guarantee" that their device delivers the dose that it is intended to. There are some things that can be done to improve the effectiveness of EpiPen/equivalent administration - while the product is designed to be able to be used through clothing, it is better to be removed where possible. Due to the dosage size, post injection site massage is recommended for better uptake from the muscles. When to administer is also another question - arguably by the time the patient is in significant respiratory distress, it should have been administered earlier. This can be a balancing act between a 'sensitivity' and anaphylaxis. Realistically, as soon as there is a deterioration into multi-system response, Epi should be administered. Certainly, other than cost there's no real motivator for the lay person to need to be trained to draw up epi into a syringe. But in terms of ambulances / medic units who stock epi (typically used in cardiac arrest), the requirement to stock EpiPens is an unneeded redundancy, and an expensive one at that.

FireBeyond 10y ago

As a paramedic: So the issue isn't the epi itself (which is just adrenaline). In fact EMS agencies around the country are moving away from the EpiPen (in my state, all ambulance and fire units are required to carry the pen itself) to drawing up from ampoules. In my relatively small county, Medic One throws away $100,000/yr of EpiPens, because they have a short shelf life. "Wrong dosage", though? Dosing epi isn't a particularly exact science - the adult pen is 0.3mL, the junior 0.15mL. Quite often we will have to use multiple pens on the one patient. Underdose is entirely common - especially in civilian-administered situations. Overdose is typically restricted to acute hypertension and associated symptoms which can largely be managed by EMS (who should be enroute anyway for any admin of epi, for reasons not least of which include that 'need for additional dose').

victorhooi 10y ago
Aha, fair enough - I just interpreted what I saw on Sanofi's homepage for the recall: https://www.auvi-q.com/ https://www.auvi-q.com/ > Sanofi US Issues Voluntary Nationwide Recall of All Auvi‑Q® Due to Potential Inaccurate Dosage Delivery > ... > If a patient experiencing a serious allergic reaction (i.e., anaphylaxis) did not receive the intended dose, there could be significant health consequences, including death because anaphylaxis is a potentially life‑threatening condition. As of October 26, 2015, Sanofi has received 26 reports of suspected device malfunctions in the US and Canada. Or is it something that somebody like an EMS would probably not get wrong, but say, a non-medically trained panicked parent could? I've heard the shelf-life complaints about Epipens. For me, I figured it was pretty idiot proof, even for an untrained person in panick mode - take it out, stab it in leg, and that's it, as opposed to trying to drain an ampoule into a syringe. Fortunately, I've never had to face that bad situation....
- lostlogin 10y ago
  Watching someone with decades of experience in a low stress environment draw up from a glass ampule can be exciting.
- FireBeyond 10y ago
  Certainly it's worth clarifying that saying that many people need more than one dose doesn't mean that Auvi-Q shouldn't have to "guarantee" that their device delivers the dose that it is intended to. There are some things that can be done to improve the effectiveness of EpiPen/equivalent administration - while the product is designed to be able to be used through clothing, it is better to be removed where possible. Due to the dosage size, post injection site massage is recommended for better uptake from the muscles. When to administer is also another question - arguably by the time the patient is in significant respiratory distress, it should have been administered earlier. This can be a balancing act between a 'sensitivity' and anaphylaxis. Realistically, as soon as there is a deterioration into multi-system response, Epi should be administered. Certainly, other than cost there's no real motivator for the lay person to need to be trained to draw up epi into a syringe. But in terms of ambulances / medic units who stock epi (typically used in cardiac arrest), the requirement to stock EpiPens is an unneeded redundancy, and an expensive one at that.