“EpiPen” is a patented delivery system for Epinephrine injection to alleviate anaphylactic shock, a life-threatening allergic reaction, most commonly to bee stings. It has become the subject of controversy and is prototypical for much of what is wrong with America today.
The device was patented in June 2005 which is remarkable as 69 other such devices have had patent applications since 1976 with all unsuccessful. As a US Patent holder who files original applications, we are surprised the patent was granted as we have had rejections for much less reason than we see in the EpiPen application. For openers, the illustrations appear to have been drawn by an adolescent on ruled paper! Generally, patent application illustrations are very carefully, professionally prepared, drawings. As well, the language in the document is below standard. Patent language is a blend of legal and technical verbiage designed to keep that club small. This applicant was very confident said patent would be granted.
The EpiPen device is a spring-loaded “gun” that projects a small cylinder with a fine, hollow needle for injecting of a few milliliters of water containing 300 micrograms, 0.0003 grams, of Epinephrine, a synthetic version of the hormone, into a muscle so it will diffuse, enter a bloodstream slowly, as the full shot in a vein would cause a heart attack where a small, timed release is life-saving. Such “intramuscular” injections are easier to do than those requiring finding a vein and inserting the needle properly, thus such devices are possible for field use by the general public.
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This issue has brought into focus the fact the field of medicine has become a playground of buccaneers, scoundrels and shysters. The hormone in the EpiPen cost one Dollar and the mechanics of device another Dollar, but they charge $600 retail for it. It had been $56.45 until recently, but the CEO of Mylan, Mrs. Heather Bresch, the daughter of US Senator Manchin, Democrat of West Virginia, was awarded with a considerable boost in her pay package that had been $2,453,456 in 2007 and now totals $19 million!
While it is easy to understand how the Board of Directors could think it was “pretty spiffy” for Heather to come up with a high price it is more likely her awards have been for finding a way to naked greed. It is probably no coincidence that while other such devices have been developed here and abroad all have been batted down in the US Patent Office or kept off the market by the FDA! Many are sold in other countries for $30, but we are to pay $600 thanks to the efforts of Senator Manchin’s daughter.
French pharmaceutical maker Sanofi, the only competitor of Mylan, pulled it’s Epinephrine injecting device, “Auvi-Q,” under FDA pressure in 2015 citing problems with inaccurate dosing and pricing after having been on the market with no problems! It would seem solving such a problem would be preferred to leaving the market and since when is pricing an FDA problem or for a device delivering one Dollar’s worth of chemical when it sells for over $50 and they now make no beef over a $600 price for a virtually identical device? No other Sanofi products have been challenged! Dare we wonder why?
Meanwhile, Mylan employees and their PAC contributed $60,750 to Senator Manchin between 2011 and 2016, according to the Center for Responsive Politics. Apparently, these employees knew from where their livelihood came and how to keep it going. How many such companies have their own PAC for one US Senator?
We have questions about the US Patent Office granting this patent. The withdrawing of a similar device by a foreign maker with large donations to a US Senator by a company CEO’ed by the Senator’s daughter plus the rationale for the price increase on a simple device delivering one Dollar’s worth of chemical for $600 when the device technology is comparable to that in a one Dollar pen, which it resembles! However, the problem runs much deeper and is in the billions of Dollars in American health care.
If you spend a day in an American hospital you will get a bill for thousands of Dollars including $320 for one aspirin, $1,000 for a bed in a ward with other people. $7,000 for 15 minutes in an operating room, needing paint and having equipment that belongs in a museum and on through a nightmare of charges apparently designed to give you a heart attack and a trip back! American medicine is the new Spanish Main of pirates in white coats having exchanged swords for scalpels.
Medical professionals justify this saying insurance companies, Federal and State government will not pay what they must have to offer their services so they have to over-bill to continue. The problem is that the innocent premium and taxpayer do not make the problem and should not be involved to the point of receiving such bills as they are very upsetting. And, some will pay them!
Here is the reason for medical over-billing! Say a hospital puts out 100 outrageous bills, which are each ten times what they should be, and sometimes more! Suppose only one of five patients pays! They will receive 2.8 times as much as they would have by billing correctly given what insurance companies and government will pay. No wonder they pay their administrators million Dollar a year compensation packages. These are the guys promoting this scam!
What to do when you are hit by this fraud? Do a search on the Internet for a “master study” of the price for the services you received. We did this when billed $20,000 for one cataract operation by a northern California hospital chain. We found two “master studies,” which are studies of studies, usually 100, with a summary of the findings. Both master studies concluded that the national average price for a “cataractectomy” was $2,000! And, one noted the trend was declining such that they expected the price to be $1,600 by 2020 AD while the other master study noted the price for an identical operation in India, Mexico or Panama was $40.
We put all this in a letter to our District Attorney, copy to the hospital, noting that in our opinion such billing was criminal fraud. We have heard nothing from the hospital or the District Attorney for two years. Corruption runs long, deep and wide in America.
Fighting back can take several forms: Cary Turner, an EMT coordinator of the Salt Lake City Fire Department, came up with solution to evade the cost of EpiPen. Turner devised a kit containing a small vial of Epinephrine, and a small syringe, got it approved for EMT agents to use. The price of Turner’s kit is $3.50.
Turner trained his EMT agents on how to properly administer Epinephrine. Turner uses an orange to demonstrate how to do an injection, but if you are or have a loved one allergic to bee stings, as did I when my son was young and allergic to bee stings, you only need to find a medical pro to show you how to fill a syringe with the required dose, insert it in a thigh or butt muscle, push and you have saved your loved one from death by anaphylactic shock. There have been no problems with Mr. Turner’s kit and trainings as the free market once again becomes the savior of America.