EpiPens have become a model for ‘prescription injustice’
It was in the early 90s when my ED had two near-misses with epinephrine dosing—one in a child and one in an adult. It was easy to mix up the drug dose when trying to make a quick mental conversion between epi for cardiac arrest (1:10,000, 0.1mg/ml) and epi in vials for sq administration (1:1000, 1mg/ml).
By converting entirely to the use of pediatric and adult dose epipens for the ED treatment of anaphylaxis and angioedema we were able to eliminate such medical errors.
EpiPens are necessary treatment tools, but financial distortions led to a 500% U.S. price increase in the past nine years, landing epi-pens on the front page of the news.
Let’s start at the beginning. Jokichi Takamine (1854-1922), a Japanese chemist, isolated ‘adrenaline’ in his New York laboratory, and in 1900, ‘adrenaline’ became the very first ‘natural substance’ to be patented (US Patent No 730196-730198). He also trademarked the name ‘Adrenalin’.
Fast-forward to the 1960-70s. Sheldon Kaplan, a biomechanical engineer, at Survival Technology, Inc in Bethesda, was approached by the US Department of Defense to create an autoinjector for the military, as an easy battlefield method for self-injection of chemical warfare antidotes. He did develop the device, for auto injection of a variety of substances, and it was called the ComboPen. Development was funded by the Pentagon. Dr. Kaplan never received royalties for his invention, and lived a modest life in Florida until his death in 2009.
Survival Technology merged with Meridian Medical Technologies, Inc in 1996, and Meridian is still the contract manufacturer of the EpiPen. After a number of passes, Mylan Pharmaceuticals acquired the rights to market and distribute the EpiPen in the US in 2007. In 2007, a single EpiPen cost $50.00 in the US. Today, goodrx.com lists the price of a pair at around $635.00. My own hospital pays nearly $600/per twin pack of. 3mg. The coupons I was able to find (as of 8/29/2016) were for about $50. In Europe, an EpiPen costs about $85 USD. In Canada, the cost is C$120. ($92 USD). The shelf-life is reported to be one year.
Heather Bresch, chief of Mylan, is proud of her achievements. ‘I am a for-profit business’. * There are reports of an alternative device currently in development by other companies, and Ms. Bresch now says she can make a generic Epipen available, but still at an exorbitant price.
What’s wrong with this picture?
Is it fair to US taxpayers, to have paid for the initial development (through the Pentagon), and still pay an exhorbitant cost for use of the product? Mass production, quality control, and distribution are additional costs after initial product development. Still, what is a ‘reasonable cost’ for the product today? Is egregious profit reasonable just for marketing without innovation or invention?
Is there ‘profit’ that is good and ‘profit’ that is bad? Mylan’s behaviors focus on corporate profit. Why isn’t there a place for corporate behaviors that can positively impact the health of the population, that work for the common good, and that should be balanced with, rather than outweighed by, profit?
The EpiPen story is a model of ‘prescription injustice’**. Should products that are ‘immediate lifesavers’ be somehow treated differently in terms of development, manufacture, distribution and cost than other agents? EpiPen is not the only example of ‘prescription injustice’. Albuterol (no longer available as $4 generic) and lantus insulin are two life-sustaining products that are moving out of affordable reach for many. Do life-savers and life-sustainers both need protection from this injustice?
Deaths from anaphylaxis are rare: Canada reported 92 deaths in Ontario from 1986-2011; Australia reported 324 deaths from 1997 to 2013; the UK reports 20 deaths a year. In North Carolina in 2015, there were 16,598 ED visits (out of nearly 5 million overall ED visits) for anaphylaxis/angioedema. However, the anticipatory needs for a drug like EpiPen far outweigh the mortality/morbidity numbers. In the US, schools are required to have Epipens on site. Homes, offices, clinics, hospitals, EDs, wilderness groups, trekkers, EMS systems, all need access to adrenalin. Our local EMS systems cannot afford Epipens. They still draw up epinephrine from vials, as the cost is about $2.00 for the vial and $1.00 for the syringe.
Do patients see physicians as part of the same machine—hospitals, drug companies, insurance companies? Do we need to do more to show them we are on their side? We emergency physicians, and our societies—ACEP, ACOEP, SAEM, AAEM – need to call attention to ‘prescription injustice,’ and use our combined voices to right a terrible wrong.
* Katie Thomas, ‘Villain? Mylan’s Chief Says She’s No Such Thing’ New York Times, Sat Aug 27, 2016, B3.
** Credit for coining the term ‘Prescription Injustice’, to Anne Tintinalli, MD.
I couldn’t agree more, but would suggest that there is more than just greed afoot.
Why is only 1 company licensed to make the epipen?
If a second company made the epipen, what would the competitive price be?
We have an overpowered regulatory agency (THE FDA) creating monopolies in a free market environment.
Monopolies (of anything) are dangerous to the consumer and we shouldn’t be surprised that somebody will take advantage. Too much regulation (“THE FDA is here to protect you”) is just as harmful as not enough.
We need to restore the balance to the marketplace.
This article neglects to mention that Heather Bresch, Chief of Mylan, is the daughter of US Senator Joe Manchin (D-WV).
It would be common sense to allow multiple companies to produce meds like this but common sense has never been a hallmark of the FDA.
Hopefully the media exposure this has received will allow other “monopolies” to be addressed.
You did not mention, that in 2015, Heather Bresch was paid 19 million dollars.
Unfortunately, no one, including the author, has mentioned that there are several alternatives in the United States to Epipen. One is Adrenaclick and the other is the Adrenaclick generic. A simple call to any pharmacy or a simple Google search confirms this. All the anti-corporate backlash should, instead, be focused on promoting the generic Adrenaclick or Adrenaclick. Also, where is all the anger at the well-publicized patent office approval that was lobbied heavily for by the makers of Epi-pen? This patent was approved by one person in the patent office who was essentially bullied to approve an extended patent which should not have been approved. Multiple news agencies including CBS and NBC news have reported on this.
Instead of criticizing the greedy corporation, just take your business elsewhere or direct the venom toward the government, who is squawking the loudest, but most responsible?