By Dr. Paul Ehrlich
Only yesterday, food allergy advocates spent hours testifying before a California legislative committee on behalf of an access-to-epinephrine bill for school children. It is a scene that has been repeated in state after state, with favorable legislative results and even more notable health outcomes. I have nothing against this process, which seems to be a rare instance of widespread bi-partisanship at the state level, in the wake of President Barack Obama’s endorsement of the principle and his announcement that one of his children is allergic to peanuts.
Still, I was somewhat surprised to see in this morning’s New York Times that the FDA is moving at lightning speed (for a federal agency) to approve access to a device to rescue addicts who are overdosing.
“The hand-held device, called Evzio, delivers a single dose of naloxone, a medication that reverses the effects of an overdose, and will be used on those who have stopped breathing or lost consciousness from an opioid drug overdose. Naloxone is the standard treatment in such circumstances, but until now, has been available mostly in hospitals and other medical settings, when it is often used too late to save the patient.”
The device is even compared to an EpiPen autoinjector, although the report describes EpiPens as used for insect stings and omits food allergies.
I did most of my medical training at Bellevue Hospital in the 1970s. I know what it’s like to treat a heroin overdose. It didn’t take the death of Philip Seymour Hoffman to alert me to the tragedy of opioid abuse, either heroin or prescription drugs that flow all-too-freely into the hands of addicts, which now account for half of overdoses. I was struck by the statistics in the Times article: “Deaths from opioids have quadrupled in 10 years to more than 16,500 in 2010, according to federal data.”
As a matter of public health, however, fast-tracking life-saving medication shouldn’t depend on body counts. Epinephrine auto-injectors are safe, effective, and convenient. They should be in all schools and teachers should be trained in their use (and by the way schools should let children carry their own asthma medicine, too). Putting them there shouldn’t depend on grinding it out in state capital after state capital.
One of the most frustrating things for me is that so many of the state school epi laws permit but do not mandate them. I’m not naive and know that is one of the compromises that gets legislation passed. The real world effect of this is that here in Florida you will find epis only in school districts where parents have resources to advocate for them. My son has an Epi-Pen on his body with backup in the (unstaffed) nurse’s office. The child who is undiagnosed or whose parents can’t afford them is out of luck. This is wrong on so many levels.
Elizabeth Goldenberg says
I agree with you 100% Dr. Ehrlich. Although there are 10x more deaths from overdose than from anaphylaxis, does that mean that the 150 people who do die in the USA each year from allergic reactions fall into the level of acceptable risk thus not requiring legislative attention? Also, while most legislators will agree that children in schools with known allergies should have life saving medication and trained rescuers on site, the rules surrounding its administration in schools are often ungainly (for example if the child having the reaction has not been formally diagnosed as allergic, only the school nurse can administer the epinephrine, he or she may not be on site, and the child must wait for treatment until rescue crews arrive), should we not improve the safety of ALL people at risk of anaphylaxis, at ALL the places they go, not only kids in schools? There has to be a better way, and I would like to see an Anaphylaxis Survival Act exactly like President Clinton’s Cardiac Arrest Survival Act, which would make epinephrine kits as common as defibrillators not only in schools, but in municipal buildings, transportation centers, arenas, universities etc and save harmless from liability any one who administers it.
I’m not familiar with naloxone and when it is to be administered, but I must point out that not all emergency medicines are the same. Unlike naloxone, which is used only on those who have stopped breathing or lost consciousness from an opioid drug overdose, to have the best chance of survival, epinephrine should be given within 1 to 5 minutes from the start of an allergic reaction well before the patient loses consciousness or stops breathing.
Lynda Mitchell says
Are we are comparing apples to apples here? What is the FDA actually fast tracking – prescribed use, correct?