-by Dr. Lee RogersAnaphylaxis is a deadly reaction to an allergy. After exposure to an allergen, a person breaks out in hives, lips swell, has difficulty breathing, and wheezes, which can eventually lead to shock and death. It has happened to as many as 1 in 50 Americans. Yet, it is one of the simplest emergencies to treat. The initial life-saving treatment is injecting epinephrine (adrenalin) into the fat or muscle, followed by care from a medical professional.Epinephrine is a hormone produced by the adrenal glands. The body releases it during the “fight-or-flight” response. It increases the heart rate, improves blood flow to muscles, dilates the bronchioles in the lungs (to increase air exchange), and constricts other blood vessels (to shunt blood to vital organs). As a hormone, it a product of nature and cannot be patented.Seems pretty straight forward, right? Well, not any more. Mylan Pharmaceuticals, the manufacturer of the most commonly used device to deliver epinephrine, called the EpiPen, just jacked up the price of the medication over 400% and there doesn't seem to be any better reason than... “because they could.”EpiPen has been around since 1977, but Mylan acquired the product in 2007 when the it cost about $57. Now according to many media outlets and the prescription drug price comparison website www.GoodRx.com, the price has skyrocketed to $640. Fortunately for Mylan, EpiPen has an expiration date of one year, causing the company to bank on an annuity of more than $600 from families who need the life-saving medication, a vast majority of which go unused every year.The price of epinephrine hasn’t increased in the past 10 years. In fact the epinephrine inside EpiPen costs less than $1. I doubt the price to manufacture EpiPen’s autoinjectors has changed. So what has changed? There are two recent events that help explain. First, EpiPen’s only major competitor, Auvi-Q made by Sanofi, underwent a voluntary recall due to possible dosage miscalabrations. And secondly, this year the FDA rejected an application, which would have been much cheaper, perhaps costing only $10-20, however not auto injected. That opened the door for Mylan to price-gouge consumers into paying outrageous fees for their life-saving medications.Just in case you might be susceptible to the “poor pharmaceutical company argument,” EpiPen, just one of the products Mylan sells, brings in $1 billion a year and which boosted the company’s 2nd quarter numbers in 2016.Déjà vu?If any of this sounds familiar, that’s because it is. We all remember Martin Shkreli, the former CEO of Turing Pharmaceuticals, the sole manufacturer of Darapim, who notoriously raised the price of the generic HIV medication from $14 to $750. Shkreli faced tremendous public scrutiny and was referred to by the media as “the most hated man in America.” Eventually, he was subpoenaed to testify before Congress, charged with securities fraud, and resigned as CEO of Turing.Now there’s something wrong when even this man, Martin Shkreli, recently called the executives at Mylan “vultures” for their slimy move!Who is Shkreli referring to? None other than Mylan CEO Heather Bresch. Bresch isn’t some ordinary greedy pharmaceutical executive. She’s the daughter of US Senator Joe Manchin (D-WV). She finished her BA in political science at West Virginia University (WVU) and was hired by Mylan in 1992 after her powerful father spoke to former CEO Milan Puskar. She rose through the ranks at Mylan, eventually serving at Director of Government Relations from 2002-2005, while her father was WV Secretary of State. In 2008, there was a controversy at WVU after she claimed to have an MBA. The university initially disputed the claim, but then awarded her an MBA despite only completing 22 of 48 credits required. After public embarrassment, WVU rescinded her degree and the university president, a former consultant and lobbyist for Mylan, resigned in disgrace.
In 2011, just after her father was elected to replace the late Robert Byrd as US Senator, she spearheaded the effort in Congress to pass the Generic Drug User Fee Act, making it more difficult for foreign generic drug makers to import into the United States. In 2012, she became CEO of Mylan Pharamceuticals. Fortune Magazine named her as one of the “50 Most Powerful Women in Business in 2012 and 2013.”Then in 2015, Mylan purchased Abbott’s generic drug division located in the Netherlands. At that point,Bresch led Mylan through complex and controversial corporate tax inversion to base Mylan’s headquarters (domicile) in the Netherlands in an effort to avoid paying US corporate taxes. The corporate executives still live in the US and run the company from the US. The tax inversion is expected to reap the company an additional 10% in profits. The move wasn't good for everyone. Normally there are no tax implications from a corporate merger for shareholders. But with tax inversions, investors have to pay capital gains tax on the difference between the stock price at their initial investment and what the new company’s stock price would be. Some shareholders were advised to sell their shares at a loss to offset tax capital gains taxes they’d have to pay.All of this may cause political problems for Bresch’s father, Sen. Manchin. Sen. Bernie Sanders (I-VT) has been very critical of the price hike, taking to Twitter to decry the move. Sen. Amy Klobuchar (D-MN), who was an advocate for getting EpiPens into schools, is now breathing fire over this decision by Mylan. In a recent statement, she said:
"This outrageous increase in the price of EpiPens is occurring at the same time that Mylan Pharmaceutical is exploiting a monopoly market advantage that has fallen into its lap,” said Klobuchar. “Patients all over the U.S. rely on these products, including my own daughter. Not only should the Judiciary Committee hold a hearing, the Federal Trade Commission should investigate these price increases immediately. The Commission should also report to Congress on why these outrageous price increases have become common and propose solutions that will better protect consumers within 90 days."
Hauling a fellow Senator’s daughter into Congressional Hearings a la Pharma Bro Martin Shkreli would certainly not be good for Senate Democrats, not to mention the embarrassment to Senator Manchin casting light on his daughter’s actions during her tenure as CEO of Mylan.Additionally, Bresch’s actions may win her a new title, next to Shkreli as the “most hated woman in America.”What Can Patients Do?I agree, the EpiPen’s design makes delivering a life-saving drug as simple and as effective as possible. But if you can’t afford to be price-gouged for $600, there are alternatives that are still just as life-saving.A 1 mL ampule of epinephrine costs less than $5. The dose of epinephrine for anaphylaxis is 0.3 to 0.5 ml delivered subcutaneously (in the fat) or intramuscularly (in the muscle). If patient and family members are comfortable with drawing up their own medication and injecting (no more difficult than using insulin), they can request a prescription from their doctor for the vial and syringes. An example of how the prescription would read is below. This would cost about $10.Prescription:Rx: Epinephrine 1:1000, 1 mL ampule Rx: 1 cc syringe with 25g 1.5 cm needle Instructions: For severe allergic reaction, break ampule and fill syringe with 0.3 mL of epinephrine, inject under the skin. Call 911 or go to the nearest emergency room.* *specific instructions will differ, always confer with your doctor.Owen Mumford makes an auto-injector called Autoject which costs $28. This could be used instead of the syringe if autoinjetion is desired. It is more complex than the EpiPen and above method.Another alternative is the Adrenaclick epinephrine autoinjector which is closest to the EpiPen. It costs approximately $200.I always recommend patients price shop for their medication. The GoodRx website is a good place to start. A pharmacist can also help find certain coupons or incentives might be available that lower the out-of-pocket costs.Dr. Lee Rogers is board certified podiatrist, author, and national speaker. He ran for US Congress in California’s 25th district in 2012 and 2014 where he was endorsed by the LA Times, Blue America, and the Democratic Congressional Campaign Committee (DCCC), mostly for his leadership on healthcare issues.
