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Epipen Pricing, Capitalism gone wrong or Not!
Gene363 Offline
#1 Posted:
Joined: 01-24-2003
Posts: 30,814
Capitalism gone wrong or Not!

The Mylan company CEO is making excuses for for raising the price 400% and talking about discounts for lower income buyers, but nothing about lowering the price. She babbles about insurance causing patients to pay retail, what a crock. The production cost is about $3 per pen.

Video here: https://static01.nyt.com/video/players/offsite/index.html?videoId=100000004610924

http://www.nytimes.com/2016/08/27/business/painted-as-a-villain-mylans-chief-says-shes-no-such-thing.html

The real root of the problem is the FDA, they have dragged their feet and played fifty questions with other companies trying to market a competing product. As long as they don't have a competitor, it not capitalism and the cause is government inefficiency or willful blocking of a competing product.

The content of the pen is simple, epinephrine (adrenaline) is commonly available and can be administered by a simple injection. There are other existing auto injectors it's just the combination that the FDA needs to approve.

In the video it is crystal clear how business get legislation issued to their business advantage.

Finally, Heather Bresch, chief executive of Mylan is the daughter of a democrat Senator, she might get guidance from her father, but I don't see anything sinister.
DrafterX Offline
#2 Posted:
Joined: 10-18-2005
Posts: 98,548
well, she did get a 671% raise.... Mellow
Gene363 Offline
#3 Posted:
Joined: 01-24-2003
Posts: 30,814
DrafterX wrote:
well, she did get a 671% raise.... Mellow


I am sure, it was all about need, like her discussion of the need for all parents and schools to have their epi pens. Or that word that rhymes with need... RollEyes
victor809 Offline
#4 Posted:
Joined: 10-14-2011
Posts: 23,866
Communists...
sd72 Offline
#5 Posted:
Joined: 03-09-2011
Posts: 9,600
I just got replacements for mine and they were $30. Total cost, but they are generic, not sure where the idea is coming from that there's no alternative. The military used to supply a kit with a syringe, and a bottle of epinephrine in neat little case to its members needing them.
dstieger Offline
#6 Posted:
Joined: 06-22-2007
Posts: 10,889
And yet, we shake our heads and wonder why so many young people were 'Bern-ing'.....too easy to make the leap that capitalism NEEDS regular intervention
Gene363 Offline
#7 Posted:
Joined: 01-24-2003
Posts: 30,814
sd72 wrote:
I just got replacements for mine and they were $30. Total cost, but they are generic, not sure where the idea is coming from that there's no alternative. The military used to supply a kit with a syringe, and a bottle of epinephrine in neat little case to its members needing them.


If you don't mind, what is the name on the Generic?

If it is Auvi they had problems: https://www.auvi-q.com/

As for the net cost to the patient, it depends on where you buy, what your insurance company has negotiated and your out of pocket status. Our last set cost $87.00 and they are out of date, but I keep[ them cool and dark so the expiration date is not as critical.

There is more background on the FDA here: http://www.wsj.com/articles/anaphylactic-political-shock-1472078239

Quote:
Thus EpiPen should be open to generic competition, which cuts prices dramatically for most other old medicines. Competitors have been trying for years to challenge Mylan’s EpiPen franchise with low-cost alternatives—only to become entangled in the Food and Drug Administration’s regulatory afflatus.

Approving a generic copy that is biologically equivalent to a branded drug is simple, but the FDA maintains no clear and consistent principles for generic drug-delivery devices like auto injectors or asthma inhalers. How does a company prove that a generic device is the same as the original product if there are notional differences, even if the differences don’t matter to the end result? In this case, that means immediately injecting a kid in anaphylactic shock with epinephrine—which is not complex medical engineering.

But no company has been able to do so to the FDA’s satisfaction. Last year Sanofi withdrew an EpiPen rival called Auvi-Q that was introduced in 2013, after merely 26 cases in which the device malfunctioned and delivered an inaccurate dose. Though the recall was voluntary and the FDA process is not transparent, such extraordinary actions are never done without agency involvement. This suggests a regulatory motive other than patient safety.

Then in February the FDA rejected Teva’s generic EpiPen application. In June the FDA required a San Diego-based company called Adamis to expand patient trials and reliability studies for still another auto-injector rival.
Gene363 Offline
#8 Posted:
Joined: 01-24-2003
Posts: 30,814
dstieger wrote:
And yet, we shake our heads and wonder why so many young people were 'Bern-ing'.....too easy to make the leap that capitalism NEEDS regular intervention


You are correct about Bern-ing, but not about capitalism; it isn't capitalism if competitors cannot bring a competing product to market. (See highlighted text post #7 above.)
dstieger Offline
#9 Posted:
Joined: 06-22-2007
Posts: 10,889
Matters not. Facts have NO place in mainstream political conversations. Did away with them decades ago.
Its all about the optics, baby.
MACS Offline
#10 Posted:
Joined: 02-26-2004
Posts: 79,773
sd72 wrote:
I just got replacements for mine and they were $30. Total cost, but they are generic, not sure where the idea is coming from that there's no alternative. The military used to supply a kit with a syringe, and a bottle of epinephrine in neat little case to its members needing them.


That was atropine and 2 pam chloride. Used for combating nerve agents. I believe they still have them, but I don't know if they would work for allergic reactions.
MACS Offline
#11 Posted:
Joined: 02-26-2004
Posts: 79,773
dstieger wrote:
And yet, we shake our heads and wonder why so many young people were 'Bern-ing'.....too easy to make the leap that capitalism NEEDS regular intervention


I get it. I do support capitalism, but I do not support fleecing people because you can. Make a tidy profit, sure... make a killing off of someone else's misfortune (allergies) is wrong. I think most folks feel this way. Which is why we all dislike car salesmen. They take advantage of ignorance for profits' sake.

Lets hope the future leaders of our country can find a balance between supporting capitalism, and ensuring companies do what's right.
victor809 Offline
#12 Posted:
Joined: 10-14-2011
Posts: 23,866
^communist.

Why do you want the terrorists to win?
dstieger Offline
#13 Posted:
Joined: 06-22-2007
Posts: 10,889
No simple answers.....I'm a laissez-faire sort, but my philosophy presupposes that businesses will naturally have individual and consumer rights in mind to ensure long-term success (and profits.) The age of shareholders and short sighted visions have corrupted the capitalism that I always imagined. I still want less govt in business, but I've lost a lot of faith in business to act appropriately most of the time...I don't have any real answers...just an unbridled enthusiasm to complain about the state of ....well, most everything
victor809 Offline
#14 Posted:
Joined: 10-14-2011
Posts: 23,866
Gene363 wrote:
You are correct about Bern-ing, but not about capitalism; it isn't capitalism if competitors cannot bring a competing product to market. (See highlighted text post #7 above.)


It's capitalism if Mylan met the same stringent FDA requirements which the competitors are seemingly unable to meet at this time.

Notice the part in your highlighted statement where the words "26 cases in which the device malfunctioned and delivered an inaccurate dose". That is the sort of thing that kills a product who's entire job is to deliver an accurate dose. Just because the author put the word "merely" in front of it doesn't mean the FDA considers that few.

More importantly, in this era of rampant litigation, no company would continue forward with a product in which there is evidence they know it is delivering inaccurate dosages on occasion... All it takes is someone to die or get sick from an inaccurate dose of epinephrine and that company will be on the hook for some ridiculous sum... what was the last one, 700million or something asinine like that for one death? The lawyers proved that there had been known issues in clinical trials which were ignored, and Wyeth (or was it Merck?) got nailed.

If you want more drugs cheaper, we as a society have to be ok with some people dying occasionally. Since we are very litigious and very risk averse, both the private companies, and the government agencies are going to make it very challenging to get drugs and medical devices to the market.

You made your bed, now lay in it.
DrafterX Offline
#15 Posted:
Joined: 10-18-2005
Posts: 98,548
they are one dose pens right..?? so, you're not gonna overdose if it malfunctions... and I understand not enough can be bad too... Mellow
gummy jones Offline
#16 Posted:
Joined: 07-06-2015
Posts: 7,969
this certainly isnt true capitalism

if no one else can bring a product to market without endless regulations then monopolies on products are created



victor809 Offline
#17 Posted:
Joined: 10-14-2011
Posts: 23,866
The original manufacturer had to go through the same regulations. It is the like the FDA was put in place yesterday. Manufacturing quality is constantly monitored by the FDA as well. On first blush this just sounds like communists and liberals like gene and macs whining about their drug costs being too high.
ajerrils Offline
#18 Posted:
Joined: 07-27-2016
Posts: 179
Interesting article. I know they aren't out yet but there are a few who are close. Isn't like people aren't trying bring the prices down.

https://www.statnews.com/2016/07/07/epipen-monopoly-mylan-windgap-medical/
rumraider Offline
#19 Posted:
Joined: 08-05-2012
Posts: 727
I think the better question is "is it immoral?" This isnt Air Jordans we're talking about. Law and justice are two very different things.
Gene363 Offline
#20 Posted:
Joined: 01-24-2003
Posts: 30,814
victor809 wrote:
The original manufacturer had to go through the same regulations. It is the like the FDA was put in place yesterday. Manufacturing quality is constantly monitored by the FDA as well. On first blush this just sounds like communists and liberals like gene and macs whining about their drug costs being too high.


Someone must have stepped in a puddle of urine or perhaps feces. Fear not, no one is trying to replace you.

Funny, I don't recall saying anything about their profits, it's the lack of competition. If you read over what the FDA is doing they have no standard so they are making it up as they go along. Perhaps if the bureaucrats quoted the Bible you might react differently. IDGAF At least the FDA bureaucrats know you are their friend.
bgz Offline
#21 Posted:
Joined: 07-29-2014
Posts: 13,023
Well, Hillary threw some damage control rhetoric out there probably to ease some of the negative publicity about it to make it easier for users to swallow a 200% hike instead of 400%.

They are a pretty hefty donor to the Clinton foundation, so they probably called in the favor.
victor809 Offline
#22 Posted:
Joined: 10-14-2011
Posts: 23,866
Gene... I'm not a friend of the FDA, I've had to defend my work to their auditors on a couple occasions (successfully I'm might add.. To brag a little)....

But you can't have it both ways. FDA regulations are burdensome and expensive, but their not arbitrary, and they aren't acting to protect a market for one company.
victor809 Offline
#23 Posted:
Joined: 10-14-2011
Posts: 23,866
.... Sorry, almost forgot... Commie!
jjanecka Offline
#24 Posted:
Joined: 12-08-2015
Posts: 4,334
Vic is right, if you think either the FDA or big Pharma would ever be lax on compliance and regulatory, you're mistaken. There's some serious amount of cost that goes into clinical trials, legal work, et cetera just for the pills you pop or the pen that prevents an alleric reaction. It takes an entire division of regulatory and compliance people on both sides just to ensure that these products are safe and reliable.for the consumer.

No CEO or Congressman would even think about tampering with that. The media backlash alone would be catastrophic.
tonygraz Offline
#25 Posted:
Joined: 08-11-2008
Posts: 20,247
Perhaps it will soon be time to look at how the Germans have brought down pharma costs in their health system.
danmdevries Offline
#26 Posted:
Joined: 02-11-2014
Posts: 17,365
To me, it just means another company has an open door to the market that's been cornered by the epi pen for years.

Patent running out?
Covfireman Offline
#27 Posted:
Joined: 09-03-2015
Posts: 809
victor809 wrote:
Gene... I'm not a friend of the FDA, I've had to defend my work to their auditors on a couple occasions (successfully I'm might add.. To brag a little)....

But you can't have it both ways. FDA regulations are burdensome and expensive, but their not arbitrary, and they aren't acting to protect a market for one company.



You're right they aren't just protecting the market for one company .there are only 2 left anyhow .


The part that bothers me is that the company lobbied for and received legislation in several states requiring differnt public places to carry these pens then the company jacked the price up . You people are just looking at the tree step ba k and see the whole forest .
cacman Offline
#28 Posted:
Joined: 07-03-2010
Posts: 12,216
Just another fuqing Obamacare failure!!
Insurance rates going up because people are using their insurance, the cost of drugs are sky-rocketing, insurance companies are dropping out of the exchanges left and right, and we as slaves to the guberment are forced to buy into this broken system or pay hefty fines. It's total bullsh|t. This instance with Mylan is no different than the other scumbag drug company that raised their price amongst national ridicule. Finally they dropped their price as their CEO was brought up on unrelated criminal charges.

We are required to keep EpiPen 2 sets - 1 my son carries, and another set required at his school, Fortunately my wife is a nurse and was able to get them for practically nothing compared to the $400/set the pharmacist wanted.

Vic is NOT right! There is no excuse for life-saving medicine to go up so much in price that the people whose lives depend on it can't afford to buy it, especially after being forced to buy into the bull**** ponzi scheme called Obamacare. The medication has been around for a long time. There's nothing new here in regards to research or development. It cost pennies to make.

I'm still waiting for my insurance costs to go down $2,500 as the lying POS in the White House promised. Instead insurance costs have risen a lot more than $2,500/yr.
tailgater Offline
#29 Posted:
Joined: 06-01-2000
Posts: 26,185
We should eliminate profit.
That way we'll truly enjoy the benefits of new developments and technology and stuff.


The epi pen story is a case of "perfect storm" and bad timing.

The storm is the competitive failures in a time of need. Every other kid out there has a "deadly" allergy and "needs" these pens. But nobody but Mylan has done it right.
I read somewhere that costs did increase in order for the increased production, and even though it's likely the two weren't comparable you can begin to understand the situation.


But the kicker was the CEO.
She gave herself an $18MM raise during this sh*t storm.


A large customer of mine once drove in his brand new BMW the day after 30% of the workforce was laid off.

Mylan is doing the same thing.
gummy jones Offline
#30 Posted:
Joined: 07-06-2015
Posts: 7,969
tailgater wrote:
We should eliminate profit.
That way we'll truly enjoy the benefits of new developments and technology and stuff.


The epi pen story is a case of "perfect storm" and bad timing.

The storm is the competitive failures in a time of need. Every other kid out there has a "deadly" allergy and "needs" these pens. But nobody but Mylan has done it right.
I read somewhere that costs did increase in order for the increased production, and even though it's likely the two weren't comparable you can begin to understand the situation.


But the kicker was the CEO.
She gave herself an $18MM raise during this sh*t storm.


A large customer of mine once drove in his brand new BMW the day after 30% of the workforce was laid off.

Mylan is doing the same thing.


she and her entire family are corrupt

remember when she faked a degree from wvu?
cacman Offline
#31 Posted:
Joined: 07-03-2010
Posts: 12,216
Although Mylan is reaping huge profits with the recent sale of the EpiPen, their stock is taking a beating and dropped approx 40% since April 2015. It's cheaper to buy their stock than their medication.

The only thing "new" about the EpiPen medication is the method of delivery. The medication itself has remain unchanged.
Gene363 Offline
#32 Posted:
Joined: 01-24-2003
Posts: 30,814
Just a note to those that need this device:

If you have a person that needs an eppy pen, you can get an ampule of epinephrine and a syringe to give the same life saving dose. The pen is just easy for anyone to use. Your doctor can prescribe the drug and train you on it's use, although, a nurse might be better for actual injection training.

OK, back to the usual argument.
tailgater Offline
#33 Posted:
Joined: 06-01-2000
Posts: 26,185
That's good info.
All I have to do is carry some ephedrine. It's easy to find a syringe down at the playground or at the beach...
Gene363 Offline
#34 Posted:
Joined: 01-24-2003
Posts: 30,814
tailgater wrote:
That's good info.
All I have to do is carry some ephedrine. It's easy to find a syringe down at the playground or at the beach...


And you won't ever be accepted for blood donations. d'oh!
Mr. Jones Offline
#35 Posted:
Joined: 06-12-2005
Posts: 19,421
Those military morphine injectors "that fell off
The Convoy trucks" every once and a while
Were always a good time ...in the 70's...
Musta been Nam' leftovers that "got lost" out of the
New Cumberland Army Depot...

^^^ you know...N.C.A.D....WHERE :

"The TOP SECRET FUSION CENTER "

Is for Homeland Security.....

The sprawling complex with all the fishing ponds and rusted out fencing with holes you can walk upright through without ducking..,, near the Rt. 83 PA turnpike exit.
frankj1 Offline
#36 Posted:
Joined: 02-08-2007
Posts: 44,221
gummy jones wrote:
she and her entire family are corrupt

remember when she faked a degree from wvu?

if your gonna fake a degree, why wvu? That's like a fake Cuban Quintero.



calm down gumpster. it's a joke.
ZRX1200 Offline
#37 Posted:
Joined: 07-08-2007
Posts: 60,599
And who is her dad?
cacman Offline
#38 Posted:
Joined: 07-03-2010
Posts: 12,216
Gene363 wrote:
If you have a person that needs an eppy pen, you can get an ampule of epinephrine and a syringe to give the same life saving dose. The pen is just easy for anyone to use. Your doctor can prescribe the drug and train you on it's use, although, a nurse might be better for actual injection training.

The problem with this statement is that most doctors will not prescribe an ampule of epinephrine, even to a parent who is a RN, period.

When you go into Anaphylactic Shock in layman's terms the blood flow is wide open. Epinephrine in it's basics restricts the blood flow and too much can result in cardiac problems - heart-attack or stroke. By giving an ampule of epinephrine to the layman there is too much of a risk of over dosing in the calculation of the correct dose in a crisis situation, compared to the controlled environment in the ER or doctor's office where there is a double-check by another RN or PH before the dose is given. Ampules are measured in kilograms, which then has to be converted to milligrams based on a person's weight, and then converted again to milliliters for the proper injection dose. As a parent facing a possible crisis situation the last thing I want to do is math to calculate conversion for the proper dose. At that time I don't care if there is an App for that. I don't have a cell-phone, and we we may be in an area without cell service.

Plus, most school policies require that you supply a set of EpiPens. I would not trust the school "nurse" to calculate the correct dose of Epinephrine from an ampule to give to my child. And the schools do not want that responsiblitity or liability. Most school "nurses" aren't even licensed or allowed to give out aspriprin, let alone calculate a and give a shot.

I blaze up another fat one while being reminded how much Obamacare and big pharm has done for my family.
victor809 Offline
#39 Posted:
Joined: 10-14-2011
Posts: 23,866
Did you just say there's a need to make sure the dosage is correct?

I believe the communists want you to have cheap epipen knock offs which may or may not give you an accurate dose...
Gene363 Offline
#40 Posted:
Joined: 01-24-2003
Posts: 30,814
victor809 wrote:
Did you just say there's a need to make sure the dosage is correct?

I believe the communists want you to have cheap epipen knock offs which may or may not give you an accurate dose...


No, we want you to have them. Not talking
victor809 Offline
#41 Posted:
Joined: 10-14-2011
Posts: 23,866
Commie...
teedubbya Offline
#42 Posted:
Joined: 08-14-2003
Posts: 95,637
epipens are .3 mg and the dose doesn't change. So there is no real calculation and you simply draw in to the syringe, no need to convert measurements back an forth. My allergy shot is .5ml. You simply draw to .5 ml on the syringe. I get mine at the employee health unit with nurses that make school nurses look like heart surgeons. The ampule could weigh 5 tons and it would be irrelevant.

The calculations and conversions are irrelevant. The convenience and difficulty effing it up is relevant. You can carry them everywhere with little danger of breaking them, poking someone else (they have a safety) or having difficulty pulling them out when panicked (they are huge). They also let you just plunge them in your leg in one action rather than having to insert needle then work plunger. And where I agree with my sickle cell averse friend in the dosing is the need to draw the .3 when self administering (not having someone else around let alone a nurse) while in shock. Draw, inject, plunge vs remove blue cap and stab.

They are definitely better than ampule/ syringe and a great invention.

I get my epi pens for free luckily.
teedubbya Offline
#43 Posted:
Joined: 08-14-2003
Posts: 95,637
Does the Czech Republic make an epi pen
Gene363 Offline
#44 Posted:
Joined: 01-24-2003
Posts: 30,814
cacman wrote:
The problem with this statement is that most doctors will not prescribe an ampule of epinephrine, even to a parent who is a RN, period.

When you go into Anaphylactic Shock in layman's terms the blood flow is wide open. Epinephrine in it's basics restricts the blood flow and too much can result in cardiac problems - heart-attack or stroke. By giving an ampule of epinephrine to the layman there is too much of a risk of over dosing in the calculation of the correct dose in a crisis situation, compared to the controlled environment in the ER or doctor's office where there is a double-check by another RN or PH before the dose is given. Ampules are measured in kilograms, which then has to be converted to milligrams based on a person's weight, and then converted again to milliliters for the proper injection dose. As a parent facing a possible crisis situation the last thing I want to do is math to calculate conversion for the proper dose. At that time I don't care if there is an App for that. I don't have a cell-phone, and we we may be in an area without cell service.

Plus, most school policies require that you supply a set of EpiPens. I would not trust the school "nurse" to calculate the correct dose of Epinephrine from an ampule to give to my child. And the schools do not want that responsiblitity or liability. Most school "nurses" aren't even licensed or allowed to give out aspriprin, let alone calculate a and give a shot.

I blaze up another fat one while being reminded how much Obamacare and big pharm has done for my family.


I hear you, but you can just duplicate the pen dose, it doesn't do any adjustments for size and weight. While this approach is not suitable for all applications, , e.g., the school you mentioned and requires some degree of *training, it is doable. A given number of CCs from an ampule of a given strength.

* My RN wife has trained many families to do various procedures including injections, wound care and IV maintenance when she was a home health nurse.

IMO, pharma is raising prices for the same reason colleges have raised their prices, available cash, insurance/Obamacare/Medicare/Medicaid money for the former and easy student loans for the latter.
teedubbya Offline
#45 Posted:
Joined: 08-14-2003
Posts: 95,637
Gene for awhile my mom needed an expensive IV antibiotic at home. It was $1000 a month as prescribed or $100ish a month in ampules where my dad needed to draw the dose and administer. He did just fine.

It can be done.
Gene363 Offline
#46 Posted:
Joined: 01-24-2003
Posts: 30,814
teedubbya wrote:
epipens are .3 mg and the dose doesn't change. So there is no real calculation and you simply draw in to the syringe, no need to convert measurements back an forth. My allergy shot is .5ml. You simply draw to .5 ml on the syringe. I get mine at the employee health unit with nurses that make school nurses look like heart surgeons. The ampule could weigh 5 tons and it would be irrelevant.

The calculations and conversions are irrelevant. The convenience and difficulty effing it up is relevant. You can carry them everywhere with little danger of breaking them, poking someone else (they have a safety) or having difficulty pulling them out when panicked (they are huge). They also let you just plunge them in your leg in one action rather than having to insert needle then work plunger. And where I agree with my sickle cell averse friend in the dosing is the need to draw the .3 when self administering (not having someone else around let alone a nurse) while in shock. Draw, inject, plunge vs remove blue cap and stab.

They are definitely better than ampule/ syringe and a great invention.

I get my epi pens for free luckily.


Yup, we have Epi pens for the same reason, allergy shots for my wife and myself. Those pens are not "free" someone is paying for them.
Gene363 Offline
#47 Posted:
Joined: 01-24-2003
Posts: 30,814
teedubbya wrote:
Gene for awhile my mom needed an expensive IV antibiotic at home. It was $1000 a month as prescribed or $100ish a month in ampules where my dad needed to draw the dose and administer. He did just fine.

It can be done.


Yes it can. My wife often had a family member say something like, "Oh no way, I cannot do that!" until they found out the cost would not be covered.
teedubbya Offline
#48 Posted:
Joined: 08-14-2003
Posts: 95,637
I didn't say they are free. I get mine for free meaning I don't pay at the point of sale. You are right, someone pays.

It's sad really. Epi pen has a program that covers the copayment for those with insurance. Those that have get a break, those that don't don't.
teedubbya Offline
#49 Posted:
Joined: 08-14-2003
Posts: 95,637
I had to inject my wife with anticoagulants for a few weeks after her surgery. Each injection was in a pre measured snap safety syringe. Epi could go this way too for pennies a shot. It just wouldn't be convenient or arguably as save.

Then there is the cultural thing. I'd be allowed to send an epi pen on the bus with my child but not an unopened prepackaged syringe.
teedubbya Offline
#50 Posted:
Joined: 08-14-2003
Posts: 95,637
Gene363 wrote:
Yes it can. My often had a family member say something like, "Oh no way, I cannot do that!" until they found out the cost would not be covered.



The sad part is they through as much away every day as they used and it was still 1/10 the price.
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