Expired Epipens – Safe to use?

Posted August 29, 2016 by Dr. Roy
Categories: In the news, Pediatric Insider information

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The Pediatric Insider

© 2016 Roy Benaroch, MD

The sticker shock for Epipen purchases has some people wondering: Do I really have to buy a new one every year or so? Does it really matter if the drug has aged past its expiration date?

An Epipen is a device that automatically injects epinephrine. It is The Drug for potentially catastrophic allergic reactions to things like foods or bee stings. If someone’s having a bad reaction, epinephrine can save a life. In a medical situation, we’d typically draw up epinephrine from a little vial (which is way cheap, less than 5 bucks) and inject it into an available big muscle. Presto, you’re in the clear (it really can work super-quickly. Quite satisfying.) Since it’s awkward and perilous to draw up epinephrine into a syringe while you or your child is dying of an allergic reaction, for home use an automatically-injecting device is prescribed. Handy! Just remove a cap, press against the skin, and a little spring loaded mechanism fires off, poking out the needle and injecting the medicine in one E-Z step.

Those autoinjectors were first developed by the US military for treating nerve gas attacks. By the mid-1970’s a home version for allergies came out, and though the company that developed it has changed hands, merged, and moved on, the thing that’s currently sold uses pretty much the same technology. The medicine in there, epinephrine, is (and has been) dirt cheap for decades. What makes an Epipen expensive is the device used to inject it, which is currently protected by both patent law and an FDA that seems keen on making sure it’s the only widely available brand. Free from any competition, and with sales buoyed by aggressive marketing, by the manufacturer has been jacking the price through the roof.

Making this even more expensive: a newly purchased Epipen has a manufacturer’s expiration date, typically less than 2 years after purchase. So what happens after that date? Does the medicine really “go bad”?

There aren’t a lot of studies about this. I found two (thanks very much to the Simons, both F. Estelle and Keith, from Winnipeg, Canada – they’re authors on both papers!) In May, 2000, the Simons examined 34 donated Epipen injectors, administering them to 6 New Zealand White rabbits (not at the same time.) The out-of-date injectors delivered less epinephrine, and the drop was proportional to the age past expiration. The older the device, the more it lost its punch. Still, eyeballing their data in Figure 2, devices that were less than 24 months past expiration had between 60-90% of their drug intact, which isn’t terrible. They concluded that as long as the epinephrine wasn’t visibly discolored or damaged, it was better to use an expired Epipen than nothing at all.

Those same authors (with a few extra friends, minus the rabbits) looked at expired Epipens again in 2015, measuring potencies of 80-100% in devices up to three years past their expiration. Again, not too shabby.

Epinephrine is especially vulnerable to breaking down in heat. Epipens stored in car glove boxes aren’t going to last. And the auto-injecting mechanism, while robust, isn’t made for kickboxing practice or roller coaster festivals.

Still, for ordinary households who try to keep their Epipens in a cool, the devices  probably keep at least some potency somewhat past their printed expiration dates. It’s best if families replace them after they expire, to make sure they’re getting a full and reliable dose. But if someone needs a dose of epinephrine, and the only Epipen you’ve got is expired – use it.

And when you do buy a new one, make sure to ask the pharmacist to give you the new stuff, even if she has to reach way in the back. Since they’re so expensive, it might even be worth it to call around a few places, to see whose stock is the freshest.

More about drug expiration dates

I'm Gerald Ford, and you're not.

Epipen price gouging: Sowing, reaping, and a senator’s daughter

Posted August 25, 2016 by Dr. Roy
Categories: In the news, Pediatric Insider information

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The Pediatric Insider

© 2016 Roy Benaroch, MD

Parents, docs, and pundits are fuming. A life-saving, critical medication, used mostly in children, has become just about unaffordable for thousands of families. The Evil Drug Company Mylan has jacked up the price to over $500 over the last several years – this despite no increase in their costs. Congresspeeps, presidential candidates, and the ever-wise Facebook community all agree: Something must be done!

This isn’t the only example of weirdly-high prices for certain older drugs over the last few years. The system seems to be broken. To understand how best to fix it, it would be a good idea to go over just how the system was supposed to work.

After a drug is invented and tested, the company that developed it gets to sell it exclusively, under patent, for a set number of years. During that time the drug is only available as one “Brand Name”. The patent system is in place to reward the company for their innovation, allowing them to recoup their development costs, and make a profit. That encourages them to develop more new drugs, to make more money and to continue to bring new drugs into the marketplace. This part of the system certainly isn’t perfect – you can argue over just how many years drug companies should get exclusive rights to sell the drug they developed, and drug companies seem to be pouring more of their money into marketing and lobbying than into researching and developing new drugs. But the current problem really isn’t about new drugs or new patents.

What’s broken is the step that happens after the drug exclusivity patent expires. That’s when “generic” companies should be able to bring competing products to market. These are the same chemical, but packaged and sold by a different company. When multiple drug companies step in and produce generics, the market price of the drug falls precipitously. Many older drugs that now have multiple generic versions (including many antibiotics, statins, blood pressure, pain, and psychiatric meds) now have generics that are almost “free” – given away by grocery and pharmacy chains as loss-leaders. Yes, you can get a free supply of some antibiotics at Publix. That’s the marketplace at work. When it works, it works.

Except when it doesn’t. That price fall depends on generic companies being able to cheaply and easily bring the generic versions to market. Epinephrine, the medication in Epipen, has been around for decades, and it’s not under a patent. But regulatory issues have thwarted competitors from selling competing versions. One competitor, Auvi-Q, was recalled after a few dozen cases of wrong doses being dispensed by the device (to my knowledge no one was harmed by any of those errors.) In February, 2016 the FDA rejected Teva’s application for a generic epinephrine injector, and in June they delayed another company’s application, calling for expanded patient trials and more studies.

And it’s not just FDA regulations that gum up generic availability. Sometimes, drug manufacturers “pay off” generic makers to delay the introduction of generic medicines. These and other legal anti-competitive shenanigans create a marketplace that’s far from fair, preventing competition from driving down prices.

There is a very similar auto-injecting epinephrine device available, and it’s far cheaper: Adrenaclick. But the packaging and delivery system is different, so it’s not allowed to be freely generically substituted for an Epipen. If you want it, you have to have your prescriber specify that brand.

So: with no generic substitutions in sight, Mylan could freely increase their price. The same thing happens if there’s only one gas station in town, or only one health insurer in a local market. As we all learned from the board game, Monopolies are good for the monopoly, but bad for everyone else.

There’s more to the Epipen story. Mylan has been quietly jacking up the price for years, but no one really noticed until now. Until recently the list prices of medications were largely hidden from consumers. If you had health insurance, they paid the price, and you paid just a copay or whatever. Who cared what the “real” price was? Now that many of us have high deductible plans, those prices become important. Hiding the true cost of things from consumers, in the long run, doesn’t make for a fair or efficient marketplace.

And: you might imagine, with all of this price-gouging talk, you’d hear calls for someone’s head on a platter, in front of congress. Not this time. Mylan’s CEO is Heather Bresch, daughter of Senator Joe Manchin (D-West Virginia.)

The situation with the Epipen will wash out soon. The manufacturer has announced new cost-savings programs, and will almost certainly be lowering the list price shortly. But the regulatory framework that led to this disaster is still there, and until that’s addressed we’re going to be seeing more examples of crazy-priced drugs (and other medical services) soon.

Price Gouging

Is burping really necessary? Grandma versus science!

Posted August 22, 2016 by Dr. Roy
Categories: Guilt Free Parenting, Medical problems

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The Pediatric Insider

© 2016 Roy Benaroch, MD

Ann wrote in: “My baby doesn’t burp easily – sometimes she doesn’t burp at all. Trying to make her burp makes her upset. Do babies really need to be burped after nursing?”

A fair question. Generations of parents have been burping their babies, and it seems like something we probably ought to do. I mean, it’s uncomfortable to have un-burped gas in your belly, right? And gas there probably causes fussiness, and maybe makes babies spit up, right? Not only does it make sense, but that’s what Grandma has been saying. Could Grandma possibly be wrong?

Let’s see what science says. There was a study of this exact question, published in 2014 in the journal Child: Care, Health and Development. A group including nursing and pediatric specialists from Chandigarh, India took on the Grandmas in their publication, “A randomized controlled trial of burping for the prevention of colic and regurgitation in healthy infants.” Their conclusion: “burping did not significantly lower colic events and there was significant increase in regurgitation episodes.” Yikes!

It was a simple study design, the kind I like best. 71 babies were randomly placed into two groups: an “intervention” group, where moms were taught burping techniques and told to burp their babies after meals; and a “control” group, where mom were taught other things about parenting, but were not taught about burping. The babies were all otherwise healthy, ordinary term infants, enrolled shortly after birth. They were followed for three months, with the families recording crying times and the number of spit-ups (regurgitation.)

The results: the amount of crying in each group was about the same. Burping did not prevent “colic”, or excessive crying. When comparing the episodes of spit-up, the “burping” group had approximately twice as many spit up episodes as the non-burped babies. So: burping had no effect on crying, and actually made spitting worse.

There are some important limitations. The study was done in India, and the conclusions might not be the same in babies from other parts of the world. Also, the intervention wasn’t “blinded” – for practical reasons, the parents knew if their babies were in the burping group. Still, the conclusions were statistically strong, and I think they’re probably correct.

Will this convince anyone to stop burping babies? Probably not. But I would say, for Ann, if burping makes your baby upset, there’s no reason to keep doing it. For the rest of you: you’ll have to settle this with Grandma, yourselves. I’m not getting in the middle of it!

Ogre belches are the worst

Die, rumor, die! Offgassing is not the cause of SIDS

Posted August 11, 2016 by Dr. Roy
Categories: Medical problems, Pediatric Insider information

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The Pediatric Insider

© 2016 Roy Benaroch, MD

Leah wrote in: “I was wondering if you could shed some light on mattress wrapping to prevent off gassing and the New Zealand SIDS statistics. If there anything to this?”

Like a zombie rising from the grave to eat your brain, the “offgassing” hypothesis of SIDS is one of those rumors that just won’t stay in its grave. We can thank the internet for its unique ability to keep obviously wrong ideas alive, forever and ever. Every once in a while, someone stumbles on hoary old posts and “news” stories, reposts them on Twitbook or Faceter, and the idea arises again. There has got to be something better for all of us to be doing with our time!

It all started in 1989 when someone claimed that he had figure out the cause of SIDS. It was chemicals (fire retardants) used in crib mattresses, interacting with a fungus that released toxic gases. I’m not linking the sites that claim this, because I have no wish to perpetuate the rumor– if you want to find out more, Dr. Google will be your willing ally for your adventures. You’ll see that there are several sites that all reference each other, rather than any substantial published studies; many sell special mattress wrappings to keep the Evil Gasses at bay. You’ll see claims that no baby ever dies on a specially-wrapped mattress, and that the government and doctors has been hiding these statistics (because, presumably, we’re all in the pocket of “big mattress” and “fire fighters”.) You’ll also see claims, on those same sites, that HIV doesn’t cause AIDS and other, shall we say, “colorful” health beliefs. Seriously, if you do end up Googling this, you’ll want to put on a fresh tin foil hat first.

The facts of the matter are summed up here, in a document from First Candle. They’re a non-profit dedicated to fighting SIDS and providing support for grieving families. They point out some simple facts: the rate of SIDS dropped after “The Chemicals” were added to mattresses to prevent fires;  the fungus claimed to be associated with SIDS is almost never actually present in any mattresses; wrapping mattresses has never been shown to prevent SIDS, babies have in fact died on wrapped mattresses; and SIDS occurs at a similar rate in countries that do and don’t use flame-retardant chemicals in mattresses. There’s more to it, including summaries of multiple, well-funded investigations into the theory, but you get the point: there’s just no evidence, whatsoever, that toxic gasses from unwrapped mattresses are killing babies. Those that support the theory are not telling the truth.

There’s been good progress fighting SIDS in the 25 years since the “offgassing hypothesis” appeared – we now understand a lot of ways families can protect their children, and SIDS rates have fallen dramatically. This idea wasn’t an unreasonable hypothesis when it was proposed, but studies haven’t backed it up. It’s time for the Toxic Gas idea to stay buried and forgotten.

Ironic

Olympic health update: Zika, a broken leg, and bruised athletes swimming in poo

Posted August 8, 2016 by Dr. Roy
Categories: Medical problems

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The Pediatric Insider

© 2016 Roy Benaroch, MD

In case you missed it: in between commercials, NBC has been showing snippets of American athletes kicking butt in Rio. I believe there are other countries competing – I saw them on opening night, warming up for the all-important Taking Selfies event – but multiple health scares have apparently sent many Olympians from non-NBC-watching countries into hiding. And who can blame them? Rio may not be the safest place for anyone right now.

There’s Zika, of course, a virus spread by both mosquitoes and sex. Brazil’s got plenty of both. Gisele looked stunning in her prolonged demonstration of a slinky mosquito-repellent dress.

The swimmers have their own problems to face, especially Michael Phelps (who may be the only swimmer there, as far as we can tell.) Many are covered with round bruises from “cupping”, a skill discovered by countless preschoolers who’ve sucked cups onto their own faces to make funny snouts. Or maybe the marks are from TV producers beating them away from Michael Phelps so they don’t get in the way of the cameramen. Either way, with Michael Phelps on the team, they’re sure to win the men’s relay, sweep the dressage events, and maybe get featured in the next Hardee’s commercial as a burger topping.

There are added challenges for the outdoor swimmers in their featured “sewage” events. Athletes have been told to swim “as fast as possible, without breathing much, clenching shut your mouth and any other possible openings. Including that one.” Fortunately, Michael Phelps has been able to evolve a blowhole.

At the gymnastics arena, the world winced, looked away, and then watched repeated replays of French vaulter Samir Ait Said’s leg bend in a way that a leg should never bend. Is it possible that athletes are being pushed beyond the limits of what a human body can do? Or is it just a lack of enough kinesiology tape and Swarovski crystals? And what does Michael Phelps say about it?

Dotted Phelps

Garlic for ear infections? Think again.

Posted August 4, 2016 by Dr. Roy
Categories: Medical problems, Pediatric Insider information

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The Pediatric Insider

© 2016 Roy Benaroch, MD

Supermouse wanted to know:

One of my sons recently developed an ear infection, and various people have suggested sticking a clove of garlic in his ear, or garlic ear drops. Of course, we took him to the doctor who prescribed Amoxicillin, which worked quickly and well.

I have a hard time believing that garlic is a natural antibiotic that could be substituted for actual antibiotics. I could believe that garlic has antibiotic properties, but that shoving garlic in your ear (besides just being a bad idea to stick things in one’s ear) would be a poor way to access them.

So…does garlic have an antibiotic properties? Could it be used (in some form, drops into/onto the infection or eating it) to cure an infection?

First: does garlic have antibiotic properties? Can it kill or suppress the growth of bacteria? It makes sense that it would. Vegetables and other things that live and grow have evolved elaborate mechanisms to fight back against anything that wants to kill them. Armadillos have those hard shells, poison dart frogs have poison, and manatees have – well, I don’t know what they have, but considering that their natural predator is the speedboat, what they probably need is some kind of rocket harpoon. Plants, too, have elaborate defenses, like spikes on cactuses, or toxic chemicals that prevent them from getting eaten or infected with parasites and bacteria. Yes, your vegetables are literally loaded with toxins, including antibiotics. Elaborate chemical studies that have confirmed this – multiple substances in garlic do fight bacteria.

But does that mean garlic, placed in the ear, can help fight off an ear infection? Nope, it can’t. It’s a simple matter of anatomy. An “ear infection” – more properly called an “otitis media” – is an infection in the middle ear cavity, behind your eardrum. Unless you poke a garlic clove in far enough to pop the drum and push on through (do NOT do that), garlic placed in the ear cannot get to the site of the infection. Putting garlic in your ear to combat an ear infection is like putting oil next to your car engine for lubrication, or putting food near your mouth to eat it. To fight an infection, an antibiotic needs to be where the bacteria are. And an ear infection is internal, on the other side of your eardrum, where garlic or garlic oil pushed into the ear cannot reach.

But, and here’s the rub: if you put garlic in your child’s ear during an ear infection, will he get better? Probably yes. That’s because most ear infections get better on their own, without any antibiotic at all. You can stick garlic in the ear, or margarine, or a banana, or skinny Aunt Lulu – any of those might seem to work, but none of them will make any difference at all. Still, you’ll see it all over The Internets: I put garlic in an ear, and the infection got better, so yeah. Sorry. That doesn’t prove anything.

Side note: there’s another cause of ear pain, called a swimmer’s ear (or “otitis externa”). This is an infection of the ear canal itself, outside of the eardrum. Hypothetically garlic placed in the ear could reach that surface. But I wouldn’t recommend it. Swimmer’s ears hurt, and hurt bad, and pressing a garlic clove in there may make it hurt more.

Garlic steeped in olive oil sounds like a great spread for crostini, and it might keep vampires away. But it’s not going to help anyone with an ear infection.

The weekend ear pain action plan

Count Chocula

Chiropractic’s choice: Quackery or medicine

Posted August 1, 2016 by Dr. Roy
Categories: In the news, Pediatric Insider information

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The Pediatric Insider

© 2016 Roy Benaroch, MD

Can the chiropractic profession evolve and renew itself as a legitimate part of the health care system? Prominent Australian chiropractor Bruce Walker, who is also the editor-in-chief of the Journal Chiropractic and Manual Therapies, has proposed a 10 point plan to ensure that chiropractors create a profession based on science, knowledge, and genuine healing. He makes a strong case that chiropractors need to embrace research, shun “nonsensical elements”, and follow evidence-based practice models. Can this be the spark that leads to genuine reform?

Walker lists several practices that he characterizes as “aberrant” and damaging to the reputation of chiropractic, including over-servicing their patients, pushing “life time” chiropractic care, misleading and deceptive advertising, and an “unhealthy disregard of clinical research.” He singles out two items of special interest to pediatricians, calling for chiropractors to stop their unnecessary treatment of babies and their penchant for anti-vaccination propaganda. (Anti-vax fraud doc Andrew Wakefield is a speaker at this year’s International Chiropractors Association Pediatrics Council.)

“The New Chiropractic,” as Walker calls his plan, relies on a very different model of professional conduct. He calls for improved education and accreditation of chiropractic learning centers, an emphasis on improving public health, and ongoing efforts to improve clinical practice with research and outcomes-based study. Specifically, he says that chiropractors ought to focus on the musculoskeletal system, with a special emphasis on spinal pain – becoming the spinal pain experts.

There’s certainly room for a profession of healers dedicated to the non-pharmacologic treatment of skeletal and back pain. These are common problems, and there’s a growing body of research both in support of alternative treatment modalities for pain and for the potential harms done with the chronic use of pain-killing drugs. But many chiropractors believe their expertise extends far beyond the back, and far beyond pain. There’s no evidence for that, as Walker and his journal have made clear.

For those of you interested in chiropractic care, or in making a career in chiropractic, it’s worth reading Walker’s commentary in full. There’s a lot going on in the chiropractic profession, including disillusionment with the educational expenses, high loan default rates, and a challenging job market for new graduates. Meanwhile, efforts at reining in health care costs are squeezing chiropractors at the payment end. By embracing these changes and demonstrating that chiropractors can be a cost-effective, helpful part of the health care system, chiropractors may yet be able to save themselves a place at the table. We’ll see what they decide.

More info:

A history of chiropractic

What do chiropractors claim to treat?

Does chiropractic work?

A chiropractor


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