cacman
10 years ago

And allergy shots are different than epi pens. Mine happen to be .5. They are administered by a nurse or doctor and the dose is adjusted to me.

teedubbya wrote:


I never stated EpiPens where adjustable. Nor did you mention until now that your allergy medication was different than Epinepherine. But you do state and corroborate my point that the dose is adjusted to you. The same with Epinepherine. The correct dose has to be calculated for you before the medication is drawn from the ampule. The needle itself does tell you how much your dose should be, it only measures it. Your dose will most likely be slightly different than someone else's. In a crisis situation you can't trust the layman to draw the correct dose even if they know beforehand what that dose should be. People sue over a cup of hot coffee. Regardless of how simple fixing a needle is to you, me, or an old insulin patient, are you really going trust these other "hot coffee suing people" to fix their own set? My comments against the Ampule/Needle combo is only in response to someone else stating that this is a viable option available from your doctor instead of an EpiPen. I simply stated that it is not, and the reasons why.

But hey, I don't know sh|t right. Only lived with EpiPens for 18yrs with my son. Had to give him an EpiPen shot once, which was then followed with an additional dose measured from an ampule at the ER, then supported with benedryl afterwards. Just like my wife does in an emergency at facility she works at - Epinepherine dose is calculated for the individual based on age, weight and severity of reaction, measured from an ampule then administered. Of course they don't use an EpiPen for dosing. I never stated they did, and it was wrong of you to surmise that from my statement. We're basically saying the same thing, but maybe in different ways. Get it now sneezy?


Mylan Launching Generic Version of EpiPen
http://abcnews.go.com/Health/wireStory/mylan-launching-generic-version-epipen-41713529 

At least two companies are trying to get U.S. approval to sell a rival brand or generic version of EpiPen. None is likely to hit the U.S. market until well into next year.

Numerous members of Congress and other politicians have called for congressional hearings on Mylan's pricing, an investigation by the Federal Trade Commission and action by the Food and Drug Administration to increase competition by speeding up approvals of any rival products.

Shares of Mylan NV slipped 34 cents to $42.69 in morning trading Monday, while broader indexes rose slightly

---
A drug monopoly created by the same guberment that is supposed to stop monopolies. Ma Bell would be so happy.
cacman
10 years ago

From the PDR

teedubbya wrote:


That's for the EpiPen only, as it is clearly oversimplified.

Here... I can copy & paste too.
http://www.pdr.net/drug-summary/Adrenalin-epinephrine-3036 
---

Adrenalin (epinephrine)
THERAPEUTIC CLASS: Sympathomimetic catecholamine

DEA CLASS: RX

ADULT DOSAGE & INDICATIONS
Emergency Treatment of Type I Allergic Reactions
Includes anaphylaxis, which may result from allergic reactions to insect stings, biting insects, foods, drugs, sera, diagnostic testing substances, and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis

0.3-0.5mg (0.3-0.5mL) of undiluted epinephrine IM/SQ; may repeat inj every 5-10 min as necessary
Max: 0.5mg (0.5mL)/inj

Ocular Surgery
Induction and Maint of Mydriasis During Intraocular Surgery:
1mL Vial:

Must be diluted prior to intraocular use

Dilute 1mL of epinephrine 1mg/mL (1:1000) in 100 to 1000mL of an ophthalmic irrigation fluid to create a concentration of 1:100,000 to 1:1,000,000 (10mcg/mL to 1mcg/mL); use the irrigating sol prn for the surgical procedure

After dilution in an ophthalmic irrigating fluid, may also be injected intracamerally as a bolus dose of 0.1mL at a dilution of 1:100,000 to 1:400,000 (10mcg/mL to 2.5mcg/mL)

PEDIATRIC DOSAGE & INDICATIONS
Emergency Treatment of Type I Allergic Reactions
Includes anaphylaxis, which may result from allergic reactions to insect stings, biting insects, foods, drugs, sera, diagnostic testing substances, and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis

<30kg:
0.01mg/kg (0.01mL/kg) of undiluted epinephrine IM/SQ; may repeat inj every 5-10 min as necessary
Max: 0.3mg (0.3mL)/inj

≥30kg:
0.3-0.5mg (0.3-0.5mL) of undiluted epinephrine IM/SQ; may repeat inj every 5-10 min as necessary
Max: 0.5mg (0.5mL)/inj

Ocular Surgery
Induction and Maint of Mydriasis During Intraocular Surgery:
1mL Vial:

Must be diluted prior to intraocular use

Dilute 1mL of epinephrine 1mg/mL (1:1000) in 100 to 1000mL of an ophthalmic irrigation fluid to create a concentration of 1:100,000 to 1:1,000,000 (10mcg/mL to 1mcg/mL); use the irrigating sol prn for the surgical procedure

After dilution in an ophthalmic irrigating fluid, may also be injected intracamerally as a bolus dose of 0.1mL at a dilution of 1:100,000 to 1:400,000 (10mcg/mL to 2.5mcg/mL)

HOW SUPPLIED
Inj: 1mg/mL [1mL single-use vial, 30mL multi-dose vial]

WARNINGS/PRECAUTIONS
Not recommended for inj into or near muscles smaller than the vastus lateralis (eg, deltoid) due to possible differences in absorption. Do not repeat inj at the same site; may cause tissue necrosis. Do not inject into buttock; may not provide effective treatment of anaphylaxis and has been associated w/ development of gas gangrene. Do not inject into digits, hands, or feet; may result in loss of blood flow and tissue necrosis if accidentally injected into these areas. Rare cases of serious skin and soft tissue infections including necrotizing fasciitis and myonecrosis caused by Clostridia reported; do not inject into the buttock to decrease the risk of Clostridium infection. Caution in patients w/ hyperthyroidism, Parkinson's disease, diabetes mellitus (DM), or pheochromocytoma, or who are pregnant or elderly. Caution w/ heart disease; may precipitate/aggravate angina pectoris or produce ventricular arrhythmias. Contains sodium bisulfite; associated w/ corneal endothelial damage when used in the eye at undiluted concentrations (1mg/mL) and may also cause mild to severe allergic reactions including anaphylaxis or asthmatic episodes in susceptible individuals. 30mL Vial: Not for ophthalmic use; contains chlorobutanol that may be harmful to the corneal endothelium. 1mL Vial: Must be diluted before intraocular use.

ADVERSE REACTIONS
Anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, N/V, headache, respiratory difficulties.

DRUG INTERACTIONS
May cause additive effects w/ other sympathomimetics; coadminister w/ caution. Monitor for cardiac arrhythmias w/ cardiac glycosides, digitalis, diuretics, quinidine and other antiarrhythmics, or halogenated hydrocarbon general anesthetics (eg, halothane). Effects may be potentiated by TCAs (eg, imipramine), MAOIs, levothyroxine sodium, and certain antihistamines (eg, diphenhydramine, tripelennamine, dexchlorpheniramine). Cardiostimulating and bronchodilating effects are antagonized by β-blockers (eg, propranolol). Vasoconstricting and hypertensive effects are antagonized by α-adrenergic blocking drugs (eg, phentolamine). Ergot alkaloids may reverse pressor effects. Do not use to counteract circulatory collapse or hypotension caused by phenothiazines; may result in further lowering of BP.

PREGNANCY AND LACTATION
Pregnancy: Category C. Caution during labor and delivery; may result in uterine vasoconstriction, decreased uterine blood flow, and fetal anoxia.
Lactation: It is not known if epinephrine is excreted in human milk; caution in nursing.

MECHANISM OF ACTION
Sympathomimetic catecholamine; acts on α-adrenergic receptors and lessens the vasodilation and increased vascular permeability that occurs during anaphylaxis. Acts on β-adrenergic receptors, causing bronchial smooth muscle relaxation. Also may alleviate GI and genitourinary symptoms associated w/ anaphylaxis due to relaxer effects on smooth muscle of the stomach, intestine, uterus, and urinary bladder.

ASSESSMENT
Assess for sulfite sensitivity, heart disease, DM, hyperthyroidism, Parkinson's disease, pheochromocytoma, pregnancy/nursing status, and possible drug interactions.

MONITORING
Monitor for angina pectoris, ventricular arrhythmias, allergic reactions, serious skin and soft tissue infections, and other adverse reactions. Monitor for severity of the allergic reaction and potential cardiac effects of the drug.

PATIENT COUNSELING
Advise about the common adverse reactions of therapy and inform that these symptoms usually subside rapidly, especially w/ rest, quiet, and recumbent positioning. Warn patients w/ good response to initial therapy about the possibility of recurrence of symptoms and instruct to obtain proper medical attention if symptoms return. Warn diabetic patients that they may develop increased blood glucose levels following epinephrine administration. Instruct to seek immediate medical care if signs/symptoms of an infection develop at the inj site.

STORAGE
20-25°C (68-77°F). Protect from light and freezing. Discard vials 30 days after initial use.
Buckwheat
10 years ago

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

dstieger wrote:



Don't forget that the political action sections (i.e. PACS) of large corporations were also granted nearly unlimited ability to give large amounts of money to politicians to make laws that favor allowing them to continue to do pretty much what ever they want. I'm all in favor of free enterprise and capitalism on an even playing field but that is not what we currently have. 🌫
teedubbya
10 years ago
cacman we have been discussing the epipen and your comment specifically stated the epipen.... so of course it was for the epipen only. My comments even addressed indivifual dosing (non-epipen). It is/was sort of the point.

What you are cutting and pasting has nothing to do with the epi pen and is really what you were correctly taking issue with originally then morphed. Go back and read things in order. If you need to save face I get it. Don't go back and read it and just believe you were right. it's cool.


As for the topic as a whole go back and research the food drug and cosmetic act of 1938 basically causing some of the mess we have right now. You can partially blame Massengil. I did a three part paper on it in graduate school covering the political resistance to FDA powers and requirement for scripts, the events changing the political winds (Massengil was a yuge part) and the implementation and modification since. I did the paper during the heart of the AIDS crisis and the need to fast track and reduce pricing was evident then. Interesting stuff.
teedubbya
10 years ago
For a more current interesting read try reading about Thomas A. Scully and his time in the Bush admin and following his departure.
Stinkdyr
10 years ago

Communists...

victor809 wrote:




vicky is correct, this is how Corrupt Commie gubments operate!

but yep, you know, it is necessary ....... to........


......wait for it..............



protect the children!

🍺
cacman
10 years ago

If you need to save face I get it. Don't go back and read it and just believe you were right

teedubbya wrote:


What face is there to save? Again, someone had stated that a bottle of epinephrine and a needle was a viable option instead of the EpiPen. I argued that it is not an option, a doctor will not prescribe it and a reasons why - one being calculating the correct dose in a crisis situation, not just the simple .3mg with the EpiPen. You argued that it was possible for someone draw the correct dose and give themselves an epinephrine shot. I don't dispute the possibility, only that in a crisis situation it is not recommended. So whatever. Hold you chest out high in pride of proving & winning nothing while waving a piece of tissue paper in the air. 😣

Now, go to your doctor and ask him to prescribe you a bottle of epinephrine or whatever your allergy medication, a bag of needles, and instructions on doing it yourself in a crisis situation and see what he says. Then argue with him Sneezy.

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.

Gene363 wrote:



The above is not an option. Ask your own doctor.
teedubbya
10 years ago
cacman
10 years ago
EpiPen main ingredient costs 'less than a Big Mac'
http://money.cnn.com/2016/08/30/investing/epipen-alternative-100-dollars/ 
http://money.cnn.com/video/news/2016/08/30/interview-with-imprimis-ceo-mark-baum.cnnmoney 

Mark Baum believes the relentless EpiPen price hikes are "shameful" and his company is plotting a $100 alternative for the lifesaving allergy treatment.

Baum, known for offering a $1 substitute for the $750 AIDS drug Daraprim, told CNNMoney on Tuesday that his company Imprimis Pharmaceuticals (IMMY) has been quietly working on a compounded version of EpiPen for months. The company hopes to have it ready by the end of the year.

The plans come amid the latest price gouging scandal over the 400% increase in EpiPen prices by Mylan (MYL). The drug maker and its CEO Heather Bresch have become the newest faces of corporate greed. In response to the outcry, Mylan took the unusual step of announcing a fast-track launch of its own $300 generic EpiPen.

But Baum says his version of EpiPen would cost very little to make. He pointed that one milligram of epinephrine, which is three times more than what's needed in an EpiPen, costs just a few bucks.

"The cost of epinephrine is literally less than a Big Mac," he said of EpiPen's main ingredient.

The auto injector is available for between $3 and $7. He believes he can make a customizable version of EpiPen and sell it profitably for less than $100, without gouging the public.

"We don't have the desire to charge the public even $300, for something that costs so little," Baum said.
"That's not how I want to live my life."

Imprimis has already had success in taking on expensive branded drugs with cheaper compounds. Last year, the company launched a $1 alternative to Daraprim, the AIDS drug that overnight saw an incredible 5,000% price increase from the company led by the infamous Martin Shkreli [currently under Federal Fraud charges].

Today, Imprimis has captured 20% of the market for this critical AIDS drug, producing more than 17,000 doses of its alternative, Baum told CNNMoney's Paula Newton.

So how does it work? As a compounder, Imprimis takes items already approved by the FDA and repackages them to create the drug. Baum thinks this process can easily be replicated with EpiPen.

Imprimis CEO Mark Baum has already taken on Turing and its $750 AIDS drug. Now his company is planning a $100 compounded alternative to EpiPen.

Another factor is that tiny Imprimis doesn't have nearly the same costs that big drug companies do. Baum's $52 million company is located in a modest office park in the outskirts of San Diego and has just 112 employees. By comparison, Mylan is a $23 billion giant with a workforce of nearly 35,000.

Compounded drugs may be a tougher sell because of safety concerns. In 2012, a meningitis outbreak caused by a Massachusetts compounding pharmacy led to the deaths of 64 people.

Baum insists that Imprimis focuses on quality and has a deep understanding of epinephrine. "We understand how the drug works and can make it effectively and affordably," he said.

The Imprimis CEO offered a mixed take on Bresch, the controversial Mylan boss. He applauded her for being "honest" about serious problems in the opaque pharmaceutical supply chain that encourage higher prices.

Given Mylan's near-monopoly in the EpiPen space, Baum explained that Bresch would have been fired had she not raised prices.

"It would be CEO malpractice if she didn't," he said.

But Baum said he would not have raised the price as much.
"I don't need to make $19 million a year," Baum said, referring to the big pay package Bresch took home last year.
"Tonight when I go home I'm going to eat a nice piece of fish and the fish I eat isn't any better or worse than what she is going to eat."

---

Imprimis (IMMY) stock is roughly $4.15/share compared to Mylan at $41.90. Since I din't have to pay the average $609 per set for 2 EpiPen sets required by my son's school (they will not accept or assume responsibility for an ampule of epinephrine and needles, nor will his doctor prescribe it), I threw $100 into the Imprimis stock. Less than a box of cigars
cacman
10 years ago

"It would be CEO malpractice if she didn't, [raise the price]" he said.

Mark Baum wrote:



---

EpiPen CEO could score $28 million payday thanks to price hikes
http://money.cnn.com/2016/08/31/news/companies/epipen-ceo-pay-bonus/index.html 

Heather Bresch, the CEO of EpiPen manufacturer Mylan, could score a $28 million payday in a couple of years if she pushes the company's profits and share price high enough.

And four other top executives at the company could pocket nearly $50 million between them.

Mylan is under fire after a series of 15 price hikes over the last seven years for the lifesaving allergy treatment, which together have lifted the price 400%. But Bresch and other top executives at Mylan (MYL) have a large financial incentive to keep pressing for higher prices and profits at the drug maker.

The company established an unusual one-time bonus plan in 2014 to get the top five executives focused on aggressively raising profits. If Mylan's profits hit the target of $6.00 per share by 2018, they're each entitled to a one-time bonus likely to be worth millions.

If they miss that earnings targets, they lose out on the bonus.

The stock price will also have to rise for the executives' bonus program to pay off. Bresch's bonus would be $1.4 million dollars for every dollar the stock price goes above $53.33, up to a price of $73.33. So if shares goes to $73.33 or higher, her bonus would be $28 million. But if they don't reach $53.33 -- they're currently trading at about $42 -- there's no bonus.

That would be a huge windfall for Bresch, who earned $13.1 million last year.

Company President Rajiv Malik could get as much as $24 million, while executive chairman Robert Coury could get $20 million and Chief Financial Officer John Sheehan is eligible for a $5 million bonus. That brings the maximum bonus for the top five execs to a total of $77 million. More than 100 lower ranking executives would also get bonuses if the targets are met.

Hitting the profit target isn't a sure thing. It would represent a 40% increase from last year's annual earnings-per-share of $4.30.

But it's not that much of a reach based on recent performance and current forecasts. Keep in mind that Mylan's profits rose 66% between 2012 and 2015. The price hikes for the EpiPen and other products produced a healthy gain in revenue.

Wall Street analysts are forecasting earnings-per-share to rise to nearly $5.00 this year and to $5.85 in 2017.
The company describes the 2014 bonus plan as "innovative," and part of its "robust pay-for-performance philosophy," designed to enhance shareholder value.

A huge one-time time payout like this is unusual, said Dan Marcec. director of content at Equilar, a firm that specializes in executive compensation. Executive bonuses tied to various performance targets are common at almost all public companies, he said, but "it's unusual to have one large goal tied to one single metric like this. When you have that large an award, there's going to be a laser focus on that one part of the business."
cacman
10 years ago
Some believe the recent EpiPen prices are not only the result of the "monopoly" created by the guberment agencies, but also a reaction to the recent SCOTUS ruling in favor of Teva Pharmaceutical. The decision allows the Israel-based company to keep its exclusive rights to Copaxone until September, delaying generic competition from Mylan and the other companies. And it gives Teva more time to shift patients to a longer acting version that won't face competition until 2030.

Mylan loses Supreme Court fight over multiple sclerosis drug
http://triblive.com/business/headlines/7602490-74/court-drug-teva 
Stinkdyr
10 years ago

Some believe the recent EpiPen prices are not only the result of the "monopoly" created by the guberment agencies, but also a reaction to the recent SCOTUS ruling in favor of Teva Pharmaceutical. The decision allows the Israel-based company to keep its exclusive rights to Copaxone until September, delaying generic competition from Mylan and the other companies. And it gives Teva more time to shift patients to a longer acting version that won't face competition until 2030.

Mylan loses Supreme Court fight over multiple sclerosis drug
http://triblive.com/business/headlines/7602490-74/court-drug-teva 

cacman wrote:




Expect more of the same with Hitlery as your President. She is firmly in the pockets of Israel and Wall St.
Follow the $.

🌫
MACS
10 years ago
Papa Murphy's should get into the epi-pen business. Everyone knows they'd be the best, if they made epi-pens. 🇨🇮





Someone had to say it. 🌫
DrMaddVibe
10 years ago
Why can't they just use heroin like everyone else?
tonygraz
10 years ago
Maybe the rules for generic competition should change, particularly for life saving and necessary drugs. Some people are very anti-regulation until they find out regulation are necessary.
cacman
10 years ago
EpiPen maker Mylan's school program draws anti-trust scrutiny
http://money.cnn.com/2016/09/06/news/companies/mylan-schneiderman-investigation/index.html 

Mylan's program to distribute its troubled EpiPens in schools are drawing antitrust allegations.

Senators Richard Blumenthal and Amy Klobuchar asked the Federal Trade Commission Tuesday to look into whether the company took illegal steps "to protect its EpiPen product from competition."

"As the cost of EpiPens skyrocketed, schools seeking relief turned to Mylan's 'EpiPen4Schools' program, which offered a significant discount for the lifesaving drug," a statement from the senators reads. "Some of these schools were required to sign a contract agreeing not to purchase any products from Mylan's competitors for a period of 12 months."

The FTC confirmed receipt of the letter, but declined to indicate whether the commission intends to take action.

Attorney General Eric Schneiderman's office also said Tuesday that he's looking into Mylan's EpiPen school distribution program.

"No child's life should be put at risk because a parent, school, or healthcare provider cannot afford a simple, life-saving device because of a drug-maker's anti-competitive practices," Schneiderman said.

Mylan's EpiPen4Schools program gives free injectors to about 65,000 schools nationwide, and the company issued a statement Tuesday denying the claims its contracts included non-compete agreements.

"There are no purchase requirements for participation in the program, nor have there ever been to receive free EpiPen Auto-Injectors," the company said.

EpiPens, a life-saving treatment for allergic reactions, made headlines when it came to public attention that Mylan hiked the price of the drug 400% over the course of seven years. It was also revealed last week that Heather Bresch, the CEO, was promised a $28 million bonus in a couple of years if she boosts the company's profits and share price.

Maylan responded to outrage by offering a cheaper, generic version of the drug and promising to make EpiPen more affordable. But the company has attempted to pin the blame on a "broken" health care system that "incentivizes higher prices."

In Washington, the House Oversight Committee has also begun an investigation into Mylan's pricing for EpiPens.
Various companies have come under fire for hiking the price of life-saving drugs, which has come to symbolize corporate greed.

The topic captured national attention about a year ago when Turing Pharmaceuticals lifted the price of Daraprim -- a drug that treats AIDS and transplant patients -- about 5,000% overnight. (The CEO of Turing is facing unrelated federal trader fraud charges)
Covfireman
10 years ago
Nothing will happen they own congress. The 300 percent price increase will stand .
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