As a child, I was allergic to everything – or so it seemed.
I had to watch myself. My brother had it worse – if exposed to certain allergens, he would basically vapor lock and require some type of emergency treatment. His was the only air-conditioned room in our house for several years.
We both went weekly to the local pediatrician for shots until we were 12 or so. For me, the specter of allergies is now limited to those 3 weeks in mid-Spring when pollen is really flying out there, and my sinuses respond by filling with goo. That and goose down.
Some kids I knew had it worse. One or two had dangerous reactions to bee stings. I don’t remember encountering anyone with a serious food allergy when I was a kid.
For kids today, that no longer appears to be the case. CNN reported in 2010 that “the number of kids with food allergies went up 18 percent from 1997 to 2007, according to the U.S. Centers for Disease Control and Prevention. About 3 million children younger than 18 had a food or digestive allergy in 2007.”
The hygiene hypothesis states that excessive cleanliness interrupts the normal development of the immune system, and this change leads to an increase in allergies. In short, our “developed” lifestyles have eliminated the natural variation in the types and quantity of germs our immune system needs for it to develop into a less allergic, better regulated state of being.
A CDC report in 2013 added credence to this thinking:
Food and respiratory allergy prevalence increased with income level. Children with family income equal to or greater than 200% of the poverty level had the highest prevalence rates.
Does it follow that more cleanliness equals more sensitivity? The jury is still out.
In any event, Epinephrine is the first, best treatment for a life-threatening reaction. Delivery of this drug in emergency situations was simplified in the late 1970’s with the invention of the EpiPen. This device is marketed by Pittsburgh area-based Mylan.
With the increasing propensity of food allergies among children came some serious efforts at advocacy. Food Allergy Research and Education (FARE) is one such organization that started out as two separate groups.
FARE has done well to leverage donations and corporate sponsorship money to advance their cause, and it would seem that those supporting them are poised to reap the benefits – and that’s not limited to children with severe food allergies.
It’s not really surprising that FARE’s top two “Corporate Partners” are Mylan and Sanofi – two companies that stand to benefit the greatest from any legislative mandates concerning their products.
FARE scored a modest success a year ago when President Obama signed legislation that would give states that passed laws requiring schools to stock epinephrine injectors priority for federal grants to treat childhood asthma. Pennsylvania has taken a sort of leap toward this goal.
Last month, Senator Matt Smith (D-Mt. Lebanon) announced the passage of House Bill 803 by both the Pa. House and Senate. This is a compromise measure from Senate Bill 898, which Sen. Smith introduced and has championed for at least the last year or so. Governor Corbett signed the bill into law on October 31.
“The essential change was to allow epi-pens in schools rather than have it be a requirement. I still believe it should be a ‘shall’ rather than a ‘may,’ but that compromise allows schools to have these pens in place when a student or faculty member goes into anaphylactic shock,” Smith said.
Over the last year or so, I provided feedback to Sen. Smith’s staff about the need to make sure that Emergency Medical Services are notified whenever an EpiPen is used by school personnel to treat an allergic emergency.
Language to this effect appeared in both the House and Senate versions – the operative requirement now is that school staff, upon receiving a report of someone having an anaphylactic reaction, “shall contact 911 as soon as possible”.
I like this simple, direct language. It’s been my experience that many schools would rather quietly notify only the parents of a medical issue, or if needed do an end around the system to keep things quiet. HB 803 now makes this illegal, not just ill-advised.
There are a couple of concerns about this legislation that need to be considered. One is whether or not all schools will choose to take the initiative to stock this medication and train their staff. If you consider the use of an EpiPen as a life-saving treatment for airway compromise, similar to using an AED to potentially reverse circulatory compromise, then to not make this treatment available may end up creating more liability in the long run.
In researching the increasing popularity of these devices, what seems to be going along hand-in-hand is a precipitous increase in the cost of these devices.
I located several posts from epinephrine users who were lamenting both the increase in cost and short half-life of the injectors. One of these bloggers provided information on a program that pays up to $100 of the insurance deductible on EpiPen. This comes from an online discount site, and doesn’t seem to be readily available as common public knowledge.
Perhaps the most inventive post came from In These Times, which chronicled two women as they tried to make sense of what they saw as price gouging, and made a Michael Moore-esque trip into Canada to prove their point. A couple of quotes seemed to do this rather well:
First synthesized in 1904, epinephrine…is now a dirtcheap generic. If your doctor prescribed it, says Vermont pharmacist Rich Harvie, you could buy a pre-loaded syringe of epinephrine for under $20. But the more foolproof delivery device—the pen in EpiPen—was patented in 1977, meaning that Mylan, the U.S. marketer, and Pfizer, the manufacturer, have a license to gouge.
EpiPens used to be cheap—just $35.59 wholesale in 1986. Harvie now pays $333 for a two-pack—the only option.
Tim Golding of Sen. Matt Smith’s staff directed me to some helpful information about programs that provide free EpiPens and training materials to school staff. Sanofi also has a similar program for Auvi-Q, and there are discount copay cards for this option available on at least one online savings site.
I should mention here the results of those ladies and their excursion north in search of cheap EpiPens, which, by the way, are available over-the-counter in Canada.
“I’d like to buy an EpiPen,” I told the pharmacist. “Have you a prescription, madam?” (the pharmacist) asked. “But I was told it was over-the-counter.” “Yes, but without [an insurance-backed] prescription, it will be so extremely expensive: US $94.”
This is yet another example of the disturbing nature of American health care, especially as it relates to pharmaceuticals. Big Pharma, with legislative assistance orchestrated by a quasi-Astroturf advocacy group, creates a market for the proprietary delivery system of a cheap generic medication, which can have life-saving effects in the pre-hospital setting. They will give the schools what they need, but maximize their profit on the backs of ordinary Americans.
There are obviously good reasons to assure that children with serious allergies have access to emergency treatment when needed. In response to increasing numbers of children with these conditions, adding epinephrine to the public arsenal is much like having an AED available in commercial buildings – or better yet, have a citizenry that takes CPR certification seriously.
As disturbing as it is to see children becoming more susceptible and sensitive to what are commonplace components of our food chain, it is of greater concern that we may never really know why this happens. The theoretical combination of culture, environment and genetics can be devastating to the families of children with serious health problems, or who lose a child to cancer or other illnesses.
It’s not much comfort that the most effective treatment has been made a commodity, at least in this country, in response to these trends.
Have a good month ahead.