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EpiPen Epinephrine

Story at-a-glance -

  • EpiPen sales brought in $1.2 billion in 2015, the culmination of a 461 percent price increase from 2007 to 2015
  • During that same period, Mylan CEO Heather Bresch enjoyed a 671 percent increase in total compensation, from just under $2.5 million in 2007 to nearly $19 million in 2015
  • The cost of epinephrine in an EpiPen is about $1 but the list price for a two-pack is over $600 in the U.S.
 

EpiPen: Latest Pharma Fiasco

September 07, 2016 | 32,827 views

By Dr. Mercola

If you suffer from allergies to food, insect stings, medications or latex and are at risk of anaphylaxis, an EpiPen could save your life. Anaphylaxis is a life-threatening allergic reaction that may occur just minutes after exposure to an allergen.

In addition to causing itching and swelling of your lips and tongue, anaphylaxis may lead to tightness and closure of your throat along with difficulty breathing that becomes life threatening.

The EpiPen, which is manufactured by Mylan, contains epinephrine, a synthetic form of the hormone adrenaline that counteracts anaphylaxis. It helps to constrict your blood vessels, increasing your blood pressure and also reduces smooth muscles in your lungs to improve breathing.

It also stimulates your heart and helps reduce hives and swelling in your face and lips.1 People at increased risk of anaphylaxis are typically advised to have two doses of epinephrine available at all times and administer the first dose immediately upon experiencing anaphylaxis symptoms.

However, the EpiPen, which contains about $1 worth of epinephrine,2 has become outrageously expensive and Mylan is facing increased public scrutiny for price gouging; the list price for a two-pack of EpiPens is more than $600, up from a little over $100 in 2007.

Mylan Has a Near Monopoly and May Continue to Increase EpiPen Prices

Most of the EpiPen cost increases took place in the last three years, and it was suggested that Mylan may be hiking prices before the introduction of a generic, which was expected out last year.

The U.S. Food and Drug Administration (FDA) rejected the generic version (made by Teva), however, and Sanofi's Auvi-Q, another alternative, was pulled from the market due to problems with dosing.

The New York Times reported, "So rather than a last grasp for profits, Mylan has a near monopoly now, allowing it to continue the price increases for at least another year."3

Mylan has tried to downplay the drug's outrageous cost by saying that most patients have insurance coverage and they offer coupons to help reduce co-payments. People with high deductibles may still end up paying most of the costs out of pocket, however, and as The New York Times continued:4

"Such co-payment assistance is part of the standard playbook for companies selling expensive drugs: The goal is to spare the consumer, who might create a political uproar, and yet still get paid by the insurance company or government health program."

Ultimately, inflated drug costs are often passed down to consumers in the form of higher premiums from insurance companies and higher taxes to cover government health programs.

It should be noted, too, that most people have to purchase new EpiPens every year, even if they don't use them, because they have a one-year expiration date. Some, however, are taking a gamble by keeping their expired EpiPens in lieu of spending hundreds of dollars on a new set.

Mylan CEO's Pay Rose More Than 600 Percent From 2007 to 2015

While there is no open investigation looking into Mylan's pricing structures for EpiPen, there have been multiple calls to do so from politicians like Minnesota Senator Amy Klobuchar and Connecticut Senator Richard Blumenthal.5

EpiPen sales reportedly brought in $1.2 billion in 2015, the culmination of a 461 percent price increase from 2007 to 2015. Meanwhile, during that same period, Mylan CEO Heather Bresch enjoyed a 671 percent increase in total compensation, from just under $2.5 million in 2007 to nearly $19 million in 2015.6

Adding another twist, Bresch is the daughter of West Virginia Senator Joe Manchin III, which could get awkward, to put it mildly, should she be called to testify about the company's seemingly unscrupulous price increases. She's been embroiled in controversy before, however.

After Bresch was named Patriot of the Year by Esquire magazine in 2011, it was revealed that Mylan purchased a European drug company for the purpose of incorporating in the Netherlands in order to pay less in taxes.7

In addition, West Virginia University reportedly gave Bresch an MBA even though she was short of credits. Michael Garrison, the university's president at the time, was a longtime friend of the family and resigned after the scandal.8

Shortly after acquiring the EpiPen, Mylan nearly quadrupled its spending on lobbying efforts, which paid off in the form of industry-friendly legislation. NBC News reported:9

"Legislation that enhanced its bottom line followed, with the FDA changing its recommendations in 2010 that two EpiPens be sold in a package instead of one and that they be prescribed for at-risk patients, not just those with confirmed allergies.

And in 2013 the government passed a law to give block grants to states that required they be stocked in public schools."

Mylan Has Close Ties to US Allergy Advocacy Groups

With EpiPens becoming unaffordable even for many people with health insurance, the number of preventable deaths from anaphylaxis in people with allergies could also rise.

It would seem that U.S. allergy advocacy groups would be chief among those speaking out against Mylan's price gouging, but such groups have been remarkably silent.

"Are these allergy advocacy groups holding back criticism of Mylan's unconscionable price hikes to protect a funding source? Only their leaders really know," Forbes stated, while reporting on Mylan's many financial ties with allergy organizations:10

Mylan is a Corporate Council Member of the Allergy & Asthma Network (AAN) and a sponsor of their 4th annual USAnaphylaxis Summits

Mylan is a national corporate partner of Food Allergy and Education (FARE), a key lobbyist in the bill that encouraged public schools to stock EpiPens; Mylan has also acted as a Premier Sponsor at FARE conferences and summits

Mylan made a cash donation to the Asthma and Allergy Foundation of America (AAFA) for their annual spring fundraiser and has sponsored continuing education for attendees at an AAFA conference as well as other AAFA expos. The company is also a Platinum Sponsor of AAFA's Kids With Food Allergies.

Mylan funded activities at the American Academy of Allergy, Asthma and Immunology (AAAAI) 2016 annual meeting

Mylan Spent $1.7 Million on TV Ads During the Olympics

Despite being embroiled in a price-hike scandal, Mylan didn't shy away from advertising during the 2016 summer Rio Games. During the two-week Olympics coverage, Mylan aired an advertisement 46 times, according to iSpot.tv, a media research firm.11

The ad featured a teenager suffering from anaphylaxis after accidently consuming peanuts and directed viewers to a website to learn more about food allergies.

The ad also suggested people talk to their doctors about a prescription treatment to carry in the event of reactions. The "treatment" section of the website links to the EpiPen website.

The ad is, sadly, an example of reality for people at increased risk of anaphylaxis and their parents. Access to an EpiPen can literally mean the difference between life and death, which pushes the price hikes beyond greed and into the realm of cruel.

Naomi Shulman of Northampton, Massachusetts, who has a daughter with a cashew allergy, told Second Nexus, "It's very wrong … It's gouging parents about their children's lives. It's not like letting them sniffle. It's life or death."12

Mylan Says It Will Offer More Financial Assistance for People in Need of EpiPens

Instead of lowering the inflated cost of EpiPens, Mylan caved in to the public backlash and stated they would offer more financial assistance to those in need of the product.

This would come in the form of additional help with co-payments for people with commercial insurance as well as additional free EpiPens for uninsured patients.

Mylan placed much of the blame not on the EpiPens' exorbitant cost but on "the significant burden on patients from continued, rising insurance premiums and being forced increasingly to pay the full list price for medicines at the pharmacy counter," according to Bresch.13 Many were left unimpressed with Mylan's attempt at damage control. As The New York Times reported:14

" … [T]he total cost [of EpiPens] to the health system, a cost borne largely by insurers, the federal government and school districts, will remain the same.

'Mylan should not offer after-the-fact discounts only for a select few — it should reverse its massive price increases across the board immediately,' Representative Elijah E. Cummings, Democrat of Maryland, who has been investigating rising drug prices, said in a statement."

Get EpiPen for at Least $400 Less in Canada

While Mylan has a near monopoly on the EpiPen market, there is one lower-cost epinephrine injection available in the U.S. — Adrenaclick, made by Impax Laboratories, which administers the medicine using a different method than the EpiPen. Adrenaclick may still cost about $500, while a generic version of the drug may range from $144 to $379 with the use of a manufacturer coupon.15 Adrenaclick and its generic are not as widely available as the EpiPen, however.

Another alternative is to buy the EpiPen online from Canada. The website of the Canadian International Pharmacy Association (CIPA) has a list of online Canadian pharmacies (and more than 60 that sell EpiPens). According to Forbes:16

"You can contact these pharmacies and order a 90-day supply of EpiPens …  [one example] Canada Drugs Online, sells a pair of EpiPens for $133 Canadian; two of them will cost an American shopper $206.55. You'll pay an additional $10 shipping."

It's Not Only the EpiPen That Americans Are Paying More For

Although there have been several high-profile examples, like the EpiPen and Turing Pharmaceuticals' decision to increase the price of a drug used by HIV patients by 5,500 percent, drug prices have been increasing across the board in the U.S. According to research published in Journal of the American Medical Association (JAMA):17

"Per capita prescription drug spending in the United States exceeds that in all other countries, largely driven by brand-name drug prices that have been increasing in recent years at rates far beyond the consumer price index."

In 2013, for instance, per capita spending on prescription drugs in the U.S. was $858 compared with an average of $400 in 19 other industrialized nations. A key part of the problem is the U.S. Food and Drug Administration (FDA), which grants certain new drugs with five- to 12-year windows of exclusivity, during which generic competitors may not come to the market.

Another issue is that Medicare cannot negotiate drug prices with drug companies, a practice that is common in the U.K. and other countries with nationalized health care systems. The JAMA study continued:18

"Another key contributor to drug spending is physician prescribing choices when comparable alternatives are available at different costs. Although prices are often justified by the high cost of drug development, there is no evidence of an association between research and development costs and prices; rather, prescription drugs are priced in the United States primarily on the basis of what the market will bear."

To lower your own drug costs, consider generic equivalents or purchasing your drugs from a reputable Canadian pharmacy whenever possible. Even more important, however, is to take control of your health — the first and best step to reducing your reliance on drugs now and in the future.

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