In an election season where indignation and outrage are the postures du-jour, comes EpiPen, a medical device manufactured by Mylan drug company. A Facebook post yesterday, capsulized a headline from the website “Uncut”, “Big Pharma’s dirty secret: EpiPen was developed entirely with taxpayer money”, placed under the words, “CLASS WAR”.
I have no way of knowing if this story was concocted out of total ignorance or if the web site was simply waving a ‘ME TOO’ flag to the outrage crowd. You can read the complete story at http://usuncut.com/class-war/epipen-taxpayer-money/
For those who have been on a moon voyage for the past week while this device was filling air time on news shows between commercials, it was developed as a hand held device for fast injection of epinephrine into someone headed into anaphylactic shock.
(DISCLAIMER: This is not intended as any vindication of big pharma; they have their own highly paid PR folks who do that.)
Something just didn’t sit right, so I decided to chase it down and learned the following:
- It was invented by Sheldon Kaplan while employed by Survival Technology, Inc. in the early 70’s. He didn’t make a dime in royalties off of it.
- Mylan acquired EpiPen in a purchase of the generic drug division from Merck in 2007.
- Prior to that it sold for $57 each. Current price tag is in the mid 600’s depending upon which web site discount coupon you select.
- Mylan CEO, Heather Bresch, is a daughter of West Virginia U.S. Senator, Joe Manchin. She began her career at Mylan as a secretary.
- Sales took a huge upturn following President Obama’s signature on a law making federal funds available to schools who purchased a supply of EpiPens in 2013.
Since the device is not patented, I went searching for competition and learned that Teva Pharmaceuticals failed in their first attempt to obtain regulatory approval for a competitive product and Sanofi recalled its product because it may be delivering an incorrect dosage.
- FDA approvals take years and are required for sales of generic drugs as well as patented medicines.
- Mylan was extremely fortunate to be the only company with a product ready to go upon execution of the 2013 law. Absent that law, you would have never heard of EpiPens. Imagine whatever political influence you want.
- The pricing may be unconscionable but a CEO’s responsibility is to the shareholders who may take a different position when they analyze the PR damage it has done to their company. As for CEO salary, that’s between the CEO and the board of directors.
- It was not developed at taxpayer expense.
This experience points up two big weaknesses in our medical delivery systems.
- Extraordinary time and expense to complete the FDA approval process.
- Total lack of incentive for patients to shop for best prices.