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Post Info TOPIC: Rising cost of EpiPens worries Long Island doctors, families
Lawyerlady


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RE: Rising cost of EpiPens worries Long Island doctors, families
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The Lack of EpiPen Competitors is the FDA's Fault

  • EpiPen
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TAGS Big GovernmentHealth

08/24/2016Jonathan Newman

There’s a new bout of outrage over an expensive medicine or medical treatment. While the good in question changes each time, the blame always seems to fall on greedy corporations who just aren’t regulated enough. Free markets and capitalism are the scapegoat, even when nothing remotely resembling unhampered markets in health care is in place in the United States.

This time, it’s the EpiPen, a device that easily and safely injects epinephrine to quickly open up airways for people undergoing severe anaphylaxis because of an extreme allergy. It has saved the lives of countless people who are allergic to bee stings, certain foods, or other drugs because it can be administered on the spot by somebody without any medical training.

EpiPen is sold by Mylan, and the price for a pack of two has increased from about $100 in 2007 to over $600 as of May 2016. Mylan has tried to quell the storm by pointing out that many of their customers pay nothing for the drug because of insurance. Their deflection has been unsuccessful.

The economist looks for competitors in cases like this. A firm cannot just willy-nilly raise their prices without a competing firm leaping in to give consumers what they want at a lower price. As it turns out, Mylan has a great friend who keeps would-be competitors out of the market, or at least makes it so difficult for them that they eventually go out of business. That friend is the FDA.

With the FDA, patents, and cozy insurance relationships, Mylan has been able to steadily increase the price of EpiPens without significant market repercussions. Though, the current backlash may push many patients and doctors to look for alternatives. The only problem is that alternatives are few and far between because of government interventions.

Epinephrine is extremely cheap—just a few cents per dose. The complications come from producing the easy auto-injecting devices. Mylan “owns” their auto-injector device design, so competitors must find work-arounds in their devices to deliver the epinephrine into the patient’s body. This task, coupled with the tangled mess of FDA red tape, has proven to be difficult for would-be EpiPen competitors. It’s like expecting somebody to come up with a new way to play baseball without bases, balls, gloves, or bats, but still getting the game approved by the MLB as a baseball game substitute.

A French pharmaceutical company offered an electronic device that actually talks people through the steps of administering the drug, but it was recalled because of concerns about it delivering the required dose. Just this year, Teva Pharmaceutical’s attempt at bringing a generic epinephrine injector to market in the US was blocked by the FDA. Adrenaclick and Twinject were unable to get insurance companies on board and so discontinuedtheir injectors in 2012.

Adrenaclick has since come back, but it is still not covered by many insurance plans, and the FDA has made it illegal for pharmacies to substitute Adrenaclick as a generic alternative to EpiPen. Another company tried to sidestep the whole auto-injector patent barrier by offering prefilled syringes, but the FDA has stalled them, too.

Mylan has been repeatedly protected from competition, and it has repeatedly (and predictably) increased the price of EpiPens in response. Allowing all of these companies to compete in producing epinephrine auto-injectors would be the best course for all of the many patients who want a cheaper solution for severe allergic reactions.

One thing is for sure: capitalism is not to blame. Government regulations have choked this market and many others. What we need is a big dose of freedom.

Note: An earlier version cited the original 1977 patent for the EpiPen. While it has expired, since 1977 EpiPen producers have been able to secure multiple patents for other aspects and variations of the design and small parts associated with the design. A link to one of these patents has replaced the original link to the 1977 patent, above.



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LGS, what is the policy on these things in your school district?

I'm really curious.

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lilyofcourse wrote:

LGS, what is the policy on these things in your school district?

I'm really curious.

 POSSESSION and USE OF ASTHMA INHALERS/EPI AUTO.INJECTORS Policy 210.1 The Board shall permit students in District schools to possess asthma inhalers and epinephrine auto-injectors and to self-administer the prescribed medication in compliance with state law and Board policy. A student whose parent/guardian completes the written requirements for the student to possess an asthma inhaler or epinephrine auto-injector and to self-administer the prescribed medication in the school setting shall demonstrate to the school nurse the competency for self-administration and responsible behavior in

 

The Board shall permit students in District schools to possess asthma inhalers and epinephrine auto-injectors and to self-administer the prescribed medication in compliance with state law and Board policy. A student whose parent/guardian completes the written requirements for the student to possess an asthma inhaler or epinephrine auto-injector and to self-administer the prescribed medication in the school setting shall demonstrate to the school nurse the competency for self-administration and responsible behavior in use of the medication. Determination of competency for selfadministration shall be based on the student's age, cognitive function, maturity and demonstration of responsible behavior.



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lilyofcourse


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Auto injectors.

That isn't a vial and syringe.

So your "get the vial and syringe" doesn't work in your own school district.



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250px-AutoinjectorMarkI.jpg

download.jpg



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lilyofcourse wrote:

Auto injectors.

That isn't a vial and syringe.

So your "get the vial and syringe" doesn't work in your own school district.

 School Boards WRITE policy Lilly.  It is what we do.  We can reevaluate and change the Policy any time we choose.



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lilyofcourse


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Ok.

And will you be making a motion to rewrite your district's policy to accommodate a student bringing a vial and syringe on campus?



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If a need to do this presents then we will review the current policy.

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lilyofcourse


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So as of now, a child that brings a vial and a syringe onto school property, is violating school policy?

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These things are worked out with the school nurse lilly. Not sure what it is you want me to say.

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lilyofcourse


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Are there school nurses in your schools, each school has a full time nurse?

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Yes we have a school nurse.

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lilyofcourse


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At each school, on campus the entire time kids are at school? Reasonable school hours plus after school care?

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Not sure what you are asking. If a kid had a medical condition that required carrying a syringe then we would look to accomodate that.

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lilyofcourse


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And HOW is it handled with the nurse?

If a student came in with a vial and syringe, would it need to stay in the nurses office?

Is this the same as with an auto injector?

Would the student be violating school policy if the nurse was unaware of the vial and syringe?

Is the nurse aware of every child with an auto injector?

What about field trips? Will the nurse go on field trips with the student who uses the vial and syringe?

Who will be responsible for the vial and syringe on days the nurse isn't there?

 



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Lady Gaga Snerd wrote:

Not sure what you are asking. If a kid had a medical condition that required carrying a syringe then we would look to accomodate that.

 Not sure what I am asking?

Does each of your schools have a dedicated, full time nurse?

 



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We have an elementary school nurse and a high school nurse.

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How many elementary schools and high schools in your district?

Or under your board?



-- Edited by lilyofcourse on Friday 26th of August 2016 09:56:44 PM

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Our county, just on my end, has 5 elementary schools, no nurse at all.



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We have 4 buildings. HS is one building and the Elem nurse travels between buildings. No school has a nurse available 24/7 or after hours or whatever.

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Lady Gaga Snerd wrote:

We have 4 buildings. HS is one building and the Elem nurse travels between buildings. No school has a nurse available 24/7 or after hours or whatever.

 Ok. So what will be done with vial and syringe for student?

 



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I don't know because we haven't dealt with the situation of needing epi and a syringe. If that situation arises it will be discussed inconjunction with Admin and the School Nurse.

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lilyofcourse


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And how long would that take?

Your suggestion of "get the episode and syringe" is pointless.

Because it violates, I'm willing to bet, most school policies.

And IF accommodations could be made, it would be that the vial and syringe stays in a nurse's office. A nurse that ISN'T always available.

So it's a non-solution.

You can't "just get the vial and syringe".


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That isnt what i said at all. Apparently you have your own agenda and choose not to read.



-- Edited by Lady Gaga Snerd on Friday 26th of August 2016 10:46:19 PM

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Uh huh.

Spoken like a true politician.

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Wow. You are being really ignorant.

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Our school nurse administers injections every day. I used to administer injections to my co-worker everyday at work. And you don't necessarily need a vial and syringe, you could have pre-filled syringes that are already dosed properly.

And as stated several times - Epi-pens are not the only option for auto-injectors, either.

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Well the company has come out and stated that they are not going to lower the price even in the midst of the controversy. My guess is they have government contracts that are extremely lucrative. You cannot sell to the government an item at one price and to the public at a lower price so they are willing to lose the other business. Of course, government contracts have a end date so once that date is reached, you will see the cost come down.

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My point is, the flippant remark of "just get the vial and syringe" is not an answer.

It violates policy.

Yes, there could be accommodations made, but how long would it take to implement the accommodations?

What about in the mean time?

What about field trips, or times when the nurse isn't there?

How long will it take for the nurse to respond?

Yes, there are options.

But if the options are not viable in a reasonable length of time, then it isn't an option.

 



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I know what to do_sometimes wrote:

Well the company has come out and stated that they are not going to lower the price even in the midst of the controversy. My guess is they have government contracts that are extremely lucrative. You cannot sell to the government an item at one price and to the public at a lower price so they are willing to lose the other business. Of course, government contracts have a end date so once that date is reached, you will see the cost come down.

 And whoever negotiated the government contract should be fired if it didn't specify the PRICE of the item being bought. 



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Lawyerlady wrote:
I know what to do_sometimes wrote:

Well the company has come out and stated that they are not going to lower the price even in the midst of the controversy. My guess is they have government contracts that are extremely lucrative. You cannot sell to the government an item at one price and to the public at a lower price so they are willing to lose the other business. Of course, government contracts have a end date so once that date is reached, you will see the cost come down.

 And whoever negotiated the government contract should be fired if it didn't specify the PRICE of the item being bought. 

 This is a very good point.  Typically a price per unit is specified so I don't know what happened.  Although given how the whole legislative thing went down, it really does beg for answers.



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lilyofcourse wrote:

My point is, the flippant remark of "just get the vial and syringe" is not an answer.

It violates policy.

Yes, there could be accommodations made, but how long would it take to implement the accommodations?

What about in the mean time?

What about field trips, or times when the nurse isn't there?

How long will it take for the nurse to respond?

Yes, there are options.

But if the options are not viable in a reasonable length of time, then it isn't an option.

 

 Why don't you go run for the Board since you know everything? 



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Lady Gaga Snerd wrote:
lilyofcourse wrote:

My point is, the flippant remark of "just get the vial and syringe" is not an answer.

It violates policy.

Yes, there could be accommodations made, but how long would it take to implement the accommodations?

What about in the mean time?

What about field trips, or times when the nurse isn't there?

How long will it take for the nurse to respond?

Yes, there are options.

But if the options are not viable in a reasonable length of time, then it isn't an option.

 

 Why don't you go run for the Board since you know everything? 

 Guess I hit a nerve....



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I know what to do_sometimes wrote:
Lawyerlady wrote:
I know what to do_sometimes wrote:

Well the company has come out and stated that they are not going to lower the price even in the midst of the controversy. My guess is they have government contracts that are extremely lucrative. You cannot sell to the government an item at one price and to the public at a lower price so they are willing to lose the other business. Of course, government contracts have a end date so once that date is reached, you will see the cost come down.

 And whoever negotiated the government contract should be fired if it didn't specify the PRICE of the item being bought. 

 This is a very good point.  Typically a price per unit is specified so I don't know what happened.  Although given how the whole legislative thing went down, it really does beg for answers.

 I thought it was actually legislation allowing schools to have non-student specific pens rather than a government contract.  I could be wrong.  But the legislation signed by Obama gives states incentives to pass laws allowing for easier access to auto-injecting pens in school.

So the states should just switch to the other pen.  Show the makers of EPI what a free market really means. 

They do not have a monopoly - they just have a better known name.  



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lilyofcourse wrote:
Lady Gaga Snerd wrote:
lilyofcourse wrote:

My point is, the flippant remark of "just get the vial and syringe" is not an answer.

It violates policy.

Yes, there could be accommodations made, but how long would it take to implement the accommodations?

What about in the mean time?

What about field trips, or times when the nurse isn't there?

How long will it take for the nurse to respond?

Yes, there are options.

But if the options are not viable in a reasonable length of time, then it isn't an option.

 

 Why don't you go run for the Board since you know everything? 

 Guess I hit a nerve....

 I don't think so.  Your arguments have ignored salient points to the point of being irrelevant, baseless, and ignorant. 



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Lawyerlady wrote:
lilyofcourse wrote:
Lady Gaga Snerd wrote:
lilyofcourse wrote:

My point is, the flippant remark of "just get the vial and syringe" is not an answer.

It violates policy.

Yes, there could be accommodations made, but how long would it take to implement the accommodations?

What about in the mean time?

What about field trips, or times when the nurse isn't there?

How long will it take for the nurse to respond?

Yes, there are options.

But if the options are not viable in a reasonable length of time, then it isn't an option.

 

 Why don't you go run for the Board since you know everything? 

 Guess I hit a nerve....

 I don't think so.  Your arguments have ignored salient points to the point of being irrelevant, baseless, and ignorant. 

 How?

I've asked valid questions.

None of which have been answered.

 



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lilyofcourse wrote:
Lawyerlady wrote:
lilyofcourse wrote:
Lady Gaga Snerd wrote:
lilyofcourse wrote:

My point is, the flippant remark of "just get the vial and syringe" is not an answer.

It violates policy.

Yes, there could be accommodations made, but how long would it take to implement the accommodations?

What about in the mean time?

What about field trips, or times when the nurse isn't there?

How long will it take for the nurse to respond?

Yes, there are options.

But if the options are not viable in a reasonable length of time, then it isn't an option.

 

 Why don't you go run for the Board since you know everything? 

 Guess I hit a nerve....

 I don't think so.  Your arguments have ignored salient points to the point of being irrelevant, baseless, and ignorant. 

 How?

I've asked valid questions.

None of which have been answered.

 

 Yes, they have.

1.  There is another pen available that also auto-injects.  

2.  Nurses in schools give injections all the time for other health reasons - there is no reason they couldn't be trained to give these.

3.  Each state and/or school district has the right to write their own policies.

 

You simply have some wild ass hair about kids having to use an EPI-pen. Do you own stock in that company or something?  



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Maybe you'll believe Consumer Reports - 

 

http://www.consumerreports.org/drugs/how-to-get-cheaper-epipen-alternative/

 

 

 



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Lawyerlady wrote:
lilyofcourse wrote:
Lawyerlady wrote:
lilyofcourse wrote:
Lady Gaga Snerd wrote:
lilyofcourse wrote:

My point is, the flippant remark of "just get the vial and syringe" is not an answer.

It violates policy.

Yes, there could be accommodations made, but how long would it take to implement the accommodations?

What about in the mean time?

What about field trips, or times when the nurse isn't there?

How long will it take for the nurse to respond?

Yes, there are options.

But if the options are not viable in a reasonable length of time, then it isn't an option.

 

 Why don't you go run for the Board since you know everything? 

 Guess I hit a nerve....

 I don't think so.  Your arguments have ignored salient points to the point of being irrelevant, baseless, and ignorant. 

 How?

I've asked valid questions.

None of which have been answered.

 

 Yes, they have.

1.  There is another pen available that also auto-injects.  

2.  Nurses in schools give injections all the time for other health reasons - there is no reason they couldn't be trained to give these.

3.  Each state and/or school district has the right to write their own policies.

 

You simply have some wild ass hair about kids having to use an EPI-pen. Do you own stock in that company or something?  

 No. I dont.

I'm asking about the flippant "just get the vial and syringe" comment.

It isn't that easy. 

The one member of a school board has presented policy that proves it isn't that easy.

AND the questions have not all been answered.

Will the nurse go on each field trip? What if there are multiple field trips in one day, will a nurse go with each one?

What about days the nurse isn't there? 

I don't care if it's an epipen, a syringe or whatever.

There has be reasonable expectations when an option is given.

For example, there was a child in the same class with my son. Needed an epipen but it had to stay in the nurses office. 

It didn't go on trips with him. 

One of his parents had to go and take another one with them.

It violated the zero tolerance policy.

Now. If the epipen violated this policy, wouldn't a vial and syringe? 

It took a year to get policy rewritten to accommodate the epipen.

If the school uses a vial and syringe, will only a nurse be able to draw and administer? 

If so, what will happen the one day that nurse is off and the kid gets stung or comes in contact with peanut butter?

What will be the contingency plan, rather it's an epipen or syringe, if that happens?

Which would you prefer an untrained teacher administer?

Options have to be practical. 

Call me ignorant all you want.

These are valid questions.

 



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USE THE OTHER DAMN AUTO-INJECTOR.

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lilyofcourse


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Lawyerlady wrote:

USE THE OTHER DAMN AUTO-INJECTOR.

 OK!

MY QUESTIONS ARE ABOUT THE VIABILITY OF THE FLIPPANT RESPONSE OF USE A SYRINGE!

SEE? I CAN GET ALL PISSY, TOO!

THE "USE A SYRINGE" IS A STRAWMAN ARGUMENT. 

 



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lilyofcourse wrote:
Lawyerlady wrote:

USE THE OTHER DAMN AUTO-INJECTOR.

 OK!

MY QUESTIONS ARE ABOUT THE VIABILITY OF THE FLIPPANT RESPONSE OF USE A SYRINGE!

SEE? I CAN GET ALL PISSY, TOO!

THE "USE A SYRINGE" IS A STRAWMAN ARGUMENT. 

 

 
There are two DIFFERENT types of scenarios.  There are the kind that the kids get to keep on their person and administer themselves, and then there are the kind that the school nurse can administer.  

 

Are you telling me a licensed nurse CANNOT administer a dose of epinephrine with a syringe?  What the hell is your basis for that????



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Lawyerlady wrote:
lilyofcourse wrote:
Lawyerlady wrote:

USE THE OTHER DAMN AUTO-INJECTOR.

 OK!

MY QUESTIONS ARE ABOUT THE VIABILITY OF THE FLIPPANT RESPONSE OF USE A SYRINGE!

SEE? I CAN GET ALL PISSY, TOO!

THE "USE A SYRINGE" IS A STRAWMAN ARGUMENT. 

 

 
There are two DIFFERENT types of scenarios.  There are the kind that the kids get to keep on their person and administer themselves, and then there are the kind that the school nurse can administer.  

 

Are you telling me a licensed nurse CANNOT administer a dose of epinephrine with a syringe?  What the hell is your basis for that????

 No.

I'm asking what about when the nurse ISN'T THERE.

 



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Well, duh, the parent. If you have a kid with a deadly allergy and they will not be within help of the school nurse then you 1) chaperone the field trip (which is what happens here) or 2) don't let our kid go.

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She keeps ignoring that there is another brand of auto inject pen. I don't get it.

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LawyerLady

 

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lilyofcourse


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No. I'm not ignoring it.

I don't think any of you are thinking about what I am saying.



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lilyofcourse wrote:
Lady Gaga Snerd wrote:
lilyofcourse wrote:

My point is, the flippant remark of "just get the vial and syringe" is not an answer.

It violates policy.

Yes, there could be accommodations made, but how long would it take to implement the accommodations?

What about in the mean time?

What about field trips, or times when the nurse isn't there?

How long will it take for the nurse to respond?

Yes, there are options.

But if the options are not viable in a reasonable length of time, then it isn't an option.

 

 Why don't you go run for the Board since you know everything? 

 Guess I hit a nerve....

  A nerve?  No.  I work very hard on the local school Board for FREE. I spend a lot of time and effort.  But, what hits a nerve is when you devolve into your personal and snide attacks.  Perhaps you could get your arse off the sofa and go serve as well and maybe you would have some understanding of how Boards work.  If an issue presents, we will  thoroughly discuss it with the parents, school nurse and admin team.  And, we will enact whatever policy is necessary to address the medical concerns of the student.  So, i told you what would happen, but you just want to argue for some reason.



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lilyofcourse


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Snide attacks?

You know, you sound more and more like some of your other buddies every day.



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A flock of flirting flamingos is pure, passionate, pink pandemonium-a frenetic flamingle-mangle-a discordant discotheque of delirious dancing, flamboyant feathers, and flamingo lingo.

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lilyofcourse wrote:

Our county, just on my end, has 5 elementary schools, no nurse at all.

 Well, that's something you should be addressing with your school board. 

 

Our school has a full time dedicated nurse.  She and Jojo are close and she has me on speed dial.  



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You seem intent to prove my point.

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