Epinephrine (also known as “adrenalin”) is a hormone produced primarily by the adrenalin glands that sit atop each of your kidneys. Certain neurons located throughout your body can also produce this hormone. It plays an important role in the ‘fight or flight’ response in humans. You probably know that.
You may also know that epinephrine is used frequently as a medication to reverse severe allergic reactions (anaphylactic shock). Situations where not having this medication on hand for immediate use can result in death in just minutes, think people allergic to bee stings, people with peanut allergies. Epinephrine can administered to patients in multiple ways: inhalation, subcutaneous injection (under the skin), intravenously, and intramuscular injection. One of those methods has dual distinctions of being the most effective route of administration and often the only one available during emergency anaphylactic situations: intramuscular injection.
Epinephrine costs pennies on the dollar to synthesize. Wholesale cost for a vial of the medication is usually less than a dollar. Vials of epinephrine do next to no good for anyone experiencing anaphylaxis, as they would have to open the vial, then a syringe, then a needle, attach the needle to the syringe, draw up a 0.3mg dose and then jam it into their thigh. Not exactly a time-saving method in an emergency.
That’s where the ingenious invention called the “EpiPen Auto-Injector” comes in. A descendent of anti-nerve agent auto-injectors used by the military to protect soldiers from chemical agent attacks, the EpiPen is a self-contained injection apparatus that merely requires the user to press the device against their thigh to trigger a spring loaded needle and syringe to inject exactly 0.3mg of epinephrine into the thigh muscle. If you have ever witnessed the effects of an EpiPen injection in use, you know exactly how amazing, and critical, this device is.
First introduced in the 1970s, the device has become a ‘must-have on hand’ for anyone with severe allergic reactions to common things like peanuts, bee stings, or eggs. It is the most commonly dispensed epinephrine auto-injection device on the market (~85% of market share). EpiPen’s contain approximately $1.00 worth of epinephrine.
Merck owned the rights to produce and distribute EpiPens until 2007 when the rights were acquired by generic drug manufacturing giant Mylan. At the time of acquisition, EpiPen’s annual sales figure was right around $200 million at a wholesale cost of $100 for each device. Shortly thereafter Mylan, headed by CEO Heather Bresch, launched a massive marketing campaign designed to increase awareness of the dangers of anaphylaxis coupled with a successful congressional lobbying effort to enact legislation permitting EpiPens to be available in public places in exactly the same fashion as the automatic external defibrillator devices (AEDs) were made available in public places. EpiPens are now often found in school nurses’ offices, childcare centers, sports complexes, and many other places where life threatening allergic reactions can kill a person before emergency medical services has time arrive on scene.
In 2013, the wholesale price for an EpiPen was $263.
In 2015, the wholesale price for an EpiPen was $460
In 2016, the wholesale price for an Epipen is $600
EpiPen, with an 85% market share, accounts for nearly 40% of Mylan’s profits. Still to this day, the EpiPen contains approximately $1.00 of medication.
The technology of the EpiPen itself has changed little since 2007. The cost of epinephrine has fluctuated somewhat due to difficulties in supply keeping up with demand, however it is still pennies on the dollar to manufacture.
Mylan bears no cost burden for the research, development, or clinical trialing of epinephrine as it has been around for medicinal use since the early 1900s.
Mylan bears no significant cost burden associated with breaking a newly approved product into a competitive drug market.
Why has the cost of EpiPen risen over 500% in the last 9 years? Because Mylan and their CEO decided to excessively profit off of the sale of a dirt-cheap medication and relatively cheap delivery technology that routinely saves peoples’ lives, including young children. They knew with an 85% market share of this type of device, there was little risk in raising the price of the product over the last 9 years. They knew with the repeated troubles of competitors bringing similar devices to market, they would rake in cash left and right by raising the prices. They raised the price because they could. What else are you going to do if a bee sting can kill your child in mere minutes? Just go without an EpiPen and hope EMS gets to you in time? Of course not. Heather Bresch and Mylan knew that. Are people who have prescription insurance that covers most of the increasing cost the only ones that are allergic to bee stings, peanuts, or eggs? Of course not. Heather Bresch and Mylan knew that. Are people going to gamble with their own lives or their child’s life and forgo purchasing this medication? Of course not. Heather Bresch and Mylan knew that too.
You know the name Martin Shkreli. Now you know the name Heather Bresch.