Michael Kaplan traveled from his home in Iowa to Clearwater, Florida to see his father. It was August 2009 and his father, Sheldon Kaplan, had been diagnosed with a liver cancer.
Sheldon Kaplan would live one more month before dying in his modest home where he and his wife lived out his unassuming retirement. During their conversation his son shared that a friend’s child and his own mother in law’s life had been spared using an Epipen. It probably brought a smile to the elder Kaplan’s face.
Sheldon Kaplan was trained as an engineer at Northeastern University and worked at NASA in the 1960’s. He then took a job working on a treatment for nerve agent poisonings with a military contractor and invented the ComboPen to be used in combat.
He then had an idea to modify the ComboPen so that it could deliver a medicine that had been around for decades. Epinephrine, or adrenaline, is naturally produced by the adrenal glands and triggers the “fight or flight” response humans feel when threatened or fearful. It also is the life saving medication for allergic reactions to insect stings and certain foods.
Epinephrine was discovered in 1901. Placed in Sheldon Kaplan’s device, the Epipen was born and patent issued on June 28, 1977.
As an employee of his company, he never made any financial gain from royalties for the EpiPen.
But financial gain has been made in a very large way by the corporate owners of the patent.
Recently Mylan, a pharmaceuticals company, announced that the EpiPen cost was increasing from $400 to $600. This was a peculiar move by the company that owns 85% of the market for epinephrine pens in the United States. Even more so given the fact that the EpiPen was $57 in 2007 when Mylan took over marketing of the product.
It is estimated that the drug epinephrine in the EpiPen cost less than one dollar. One dollar.
Mylan quickly achieved something that is rare in our country nowadays. They united Republicans, Democrats, Hillary Clinton, Donald Trump, Socialist pretending-to-be-Democrat Bernie Sanders, consumer watchdog groups, the American Medical Association, parent/actress Sarah Jessica Parker (ended a publicity campaign with Mylan) and angry parents who have ready access to social media.
Mylan CEO Heather Bresch, the daughter of Democratic Senator Joe Manchin of West Virginia, has tried to spin this media nightmare by saying it isn’t her company’s fault but simply the “broken system” of healthcare in America. Her company, just as I began to write this column, announced a very, very curious “generic version” of the EpiPen available for only $300. It, the generic, is not different from the name brand EpiPen according to Mylan.
Really? You change the label on the same device and drop the price by half and yet still deliver a $1.00 drug in a device that costs $300? Sounds like one of those “I’m sorry if I offended anybody” apologies that never really says “I was wrong.”
This comes in the fortuitous timing of competitor Sanofi’s competing product recall in 2015 and Teva’s generic product approval denied by the FDA in March 2016. Mylan’s 85% market share delivers 1.5 billion dollars and forty percent of their profit. And that was before the competitors were conveniently eliminated.
To be fair, Mylan has been generous with providing EpiPens for schools and athletic programs where students are involved. That’s nice. It looks good in the yearly corporate earnings report.
The names Adrenalina WZF, Altellus, Anapen, Emerade, EpiPen, Fastjekt, FastPen, and Jext may be unfamiliar but are the competing epinephrine pen products in Europe. One report lists a price of $75 for an over the counter device in France.
I believe Heather Bresch is right. It is the fault of the “broken system” of healthcare in America. The “broken system” of healthcare seems to have its roots in one central axis and several supporting spokes: a large, readily influenced by money, controlling governmental bureaucracy and the willing insurance, pharmaceutical, and hospital corporations who are eager to contribute to it.
Physicians clearly are in that mix after sampling the taste of government money in the 1960’s and then becoming addicted to it. Take government money, accept government control.
But somewhere in America some man who was forced to purchase a health care insurance with a high deductible and no pharmacy benefits will need an EpiPen after multiple bee stings while he is working to support his family. Or some child will have a food reaction while camping or at a friend’s house. Both desperately will need the life saving one dollar’s worth of epinephrine. Both may die because they didn’t have the $300 to get it nor the insurance to cover it.
Sheldon Kaplan died shortly after his son traveled to see him. His idea and work likely has saved hundreds of thousands of lives. He died without making a dollar from it. He died with the satisfaction that he had made a difference in this world.
Now, on the other side of billions of dollars in sales, someone may die because access to an invention of a device, not the medicine, is limited by big government, big donors and big influence.
The out of touch world of politicians, bureaucrats, lawyers and their ilk who have generous federal health insurance benefits in the Washington DC Beltway need to wake up to the reality of real America and worry about competition beyond their Nationals’ and Redskins’ teams.
This country was made great on competition. Competition, driven by the medical consumer, can fix a lot of the “broken healthcare” system.
Rest in Peace, Mr. Kaplan.
Eric J. Littleton, M.D. (@DrEricLittleton) is a musician and Family Physician in Sevierville, TN. Topics covered are general in nature and should not be used to change medical treatments and/or plans without first discussing with your physician. Send questions to askdrlittleton@gmail.com