Archive for the ‘In the news’ category

Children aren’t professional athletes

September 19, 2016

The Pediatric Insider

© 2016 Roy Benaroch, MD

Daniel K. wrote in a one-line topic suggestion: “The professionalization of Youth Sports and stress level in children”. It’s a big problem – younger and younger children are being expected to behave like professional athletes. They specialize in one sport, train almost as much as a full-time job, and are often expected to “tough it out”, or play through pain. Not only is this bad for kids’ bodies and minds, but it’s bad for their athletic futures. If you want your child to be a star athlete, early specialization and professionalization are not good ideas.

Gone are the days of pick-up games and Ultimate Frisbee on the street. Children and adolescents now play organized sports coached by parents, or sometimes professionals, who may or may not know what they’re doing, and may or may not have the same goals as their players. Kids, overall, want to have fun and compete and play. Coaches want to see their players shine and win. There’s increased pressure to play “for real” in a single-sport, sometimes year-round, and sometimes on multiple teams. That increases the risk of injuries (both serious and minor), and burnout. A kid who gets sick of playing is going to quit – as do 70% of children playing organized sports, by the time they’re 13.

The cold statistics: only 3-10% of high school athletes play at a college level; only 1% receive an athletic scholarship. About .03-.5% of high school athletes make it to the pros. The vast majority of youth sports are played by people who are in it to have fun, stay in shape, and work off stress.

Let’s say your child really does want to take it to the next level. What’s the best way to increase that slim chance of becoming a big-name athlete? It turns out that early specialization is exactly the wrong thing to do. Athletes competing in a wide variety of sports have fewer injuries and continue to play longer than those that specialize early, especially before puberty.

What about that “rule” you may have heard, that athletes need 10,000 hours in their sport to really get good at it? That’s a myth. The number was extrapolated from studies of chess players, and has no empiric evidence in any sport. Many excellent professional athletes start their main sport late, even in college; and most young people who play far more than 10,000 hours of a single sport don’t end up playing for college or the pros. By playing in a variety of sports, young athletes learn the basics of body movement, tracking, reflexes, and teamwork – all skills that can easily transfer to any specific sport, later.

Certain sports do seem to require early specialization for elite competition, probably because the nature of the competition favors bodies that aren’t mature. Figure skating, gymnastics, and diving have long favored young competitors. Still, that’s not necessarily a good thing – female competitors, especially, in these sports are at high risk of overuse injuries and the “female athlete triad” of bone loss, unhealthy energy metabolism, and delayed or absent menstruation. I’ve also been seeing an increasing number of young men with, essentially, eating disorders and related health problems related to similar sports situations.

Youth, as they say, is wasted on the young – but that doesn’t mean we ought to take it away from them. Let your kids be kids, and let them run and play and make up their own games. If they’d like to try organized sports, sign them up for a different sport each season, with a few months of breaks here and there. Later, if they want to, they can specialize and take it up a notch. Children shouldn’t be treated like professional athletes.

Tara Lipinski

USA’s Tara Lipinski performs her routine during the ladies free skating long program at the White Ring Arena on Friday, Feb. 20, 1998, in Nagano, Japan. (AP Photo/Doug Mills)

Epipen alternatives – there are cheaper options

August 30, 2016

The Pediatric Insider

© 2016 Roy Benaroch, MD

Epipens have gotten crazy expensive, yes — $600 for a two-pack. Here are some alternatives that might help you save a few bucks.

#1: Wait a few weeks, and see what Mylan does. Mylan, the company that makes the “Epipen” brand of epinehphrine auto-injector, has been under a lot of pressure lately to back off their unseemly price gouging. They’ve introduced a savings card that claims to lower your out-of-pocket expense to no more than $300 dollars, and say they’ve expanded eligibility for their patient assistance program for their less-wealthy-yet-still-allergic patients. Just yesterday, they accounced a new generic version of their own Epipen, claiming it will be identical to the genuine Epipen, but at half the price. Weird, yes, selling two things that are identical (other than the price), but I suppose stranger things have happened. Give Mylan a few more weeks, and they’ll probably start giving away Epipens in cereal boxes.

#2: Find out if you really need to have an Epipen available for your child. Epipens, until recently, weren’t prescribed for many children. A robust marketing program from Mylan (including appearances by Sarah Jessica Parker on daytime talk shows) along with an expanded FDA indication for people at any risk for allergic reactions turned a niche product into a billion-dollar moneymaker – and that was before they raised the prices through the roof. A reasonable question: are all of those Epipens really necessary? Certainly, those who’ve had a life-threatening allergic reaction to a food or bee sting in the past need one available. And high risk patients (for example, those allergic to peanuts who also have a history of asthma) clearly need them, too. But what about people allergic to other foods, who’ve had multiple reactions in the past, but never anaphylaxis? What about the many people who’ve tested positive for allergic sensitization, but have never actually had any reaction at all? Doctors are loathe to withdraw an Epipen recommendation (better safe than sorry!), but there are times when all of this money could be better spent in another way. If you’re not sure if or why your child needs an Epipen prescription, ask your doctor to review this with you before you refill it.

#3: Hold on to expired Epipens, at least for a little while. Epipens keep at least some potency beyond their expiration dates, especially if they’ve been stored in a cool place. Don’t discard your old Epipens until you’ve purchased new ones – it’s better to use an expired Epipen than to have no epinephrine available when needed.

#4: Consider the Other Brand, “Adrenaclick”. Epipens have pretty much flooded and dominated the market, but there is another epinephrine auto-injector out there, the “Adenaclick.” Instructions for using it are a little different, so if you get one make sure you’re familiar with it. A two-pack lists for $140 less than Epipen, and you can get that price even lower by using a coupon from GoodRx.com. Even better: there is a generic Adrenaclick out there, and it’s even cheaper if you can find it (supplies, I’m told, are limited.) To get an Adrenaclick or the generic version, you need a specific prescription from your doctor listing this by name. In most states, pharmacists cannot substitute Adrenaclick for an Epipen. You’ll want to check your insurance formulary, too – the list prices may not matter as much as what “tier” these products fall under for your plan.

Epinephrine (or adrenaline, if you prefer)

Expired Epipens – Safe to use?

August 29, 2016

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

August 25, 2016

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

Chiropractic’s choice: Quackery or medicine

August 1, 2016

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

Goodbye, Flumist: Why science is important

June 23, 2016

The Pediatric Insider

© 2016 Roy Benaroch, MD

Yesterday the CDC announced that its Advisory Committee on Immunization Practices (ACIP) voted to stop recommending the nasal spray flu vaccine, Flumist, for anyone. Bottom line: it doesn’t work. Though their recommendation against the use of Flumist still has to be approved by the CDC director to make it “official”, it’s pretty much a done deal. The AAP’s president has already endorsed the announcement, too.

Bye, Flumist. We’ll miss the ease of use and the not-scaring-children part, but the data’s clear. The mist doesn’t work. There was a sliver of good news, though—we have solid surveillance data from last year re-confirming that the traditional flu shot does work, with an estimated effectiveness of 63% last year. That’s not outstanding, but it’s pretty good. From a public health point of view preventing 63% of influenza cases can have a huge impact. Remember: every case prevented is one fewer person out there spreading influenza. Effective vaccinations not only help the person who got the vaccine, but the whole family and community.

Older data, at one point, had shown that Flumist was as effective (or even more effective) than the flu shot. For a few years, the mist was even considered the “preferred product” for children, because it seemed to work better.  Last year, Flumist lost its “preferred” status when data emerged showing that it wasn’t looking as good as the shot. Now, enough newer data has accumulated to show that at least against the strains that have been circulating recently, Flumist doesn’t work at all.

There’s going to be a scramble (again!) this year to ensure an adequate supply of injectable flu vaccine. I don’t know if MedImmune will suspend the Flumist program, or if they’ll still try to sell their product – but I am sure that there are a lot of docs out there scrambling this morning, trying to cancel Flumist pre-orders and increase our orders for alternatives. In the long run, that will be better for everyone. In the short run, it’s a problem. Families ought to plan to get their flu shots as early as possible this year, before they run out.

Science isn’t a set of answers, or a body of knowledge etched on a stone somewhere. It is a method of arriving at the truth, involving repeated observations and the continuous re-assessment of data. Estimates of vaccine effectiveness (and safety) are initially based on licensing studies, but they’re then adjusted by real-world data that continues to be collected, year after year. We should always make the best decision we can, based on the best data, even if that means we have to sometimes admit we’ve made a mistake, or that we have to change our minds. That’s not a weakness of science or medicine – that’s a strength. We can’t always promise to get it right, but we’ll keep studying and learning and trying to do it better.

Squirt!

Protect yourself from cell phone radiation journalists

May 31, 2016

The Pediatric Insider

© 2016 Roy Benaroch, MD

The media is agog over a new study, one tailor made for clickbaiting. Staid, boring old Wall Street Journal proclaimed “Cellphone-cancer link found in government study.” Mother Jones called the study “Game Changing”, and NaturalNews’s headline screams “Massive government study concludes cell phone radiation causes brain cancer.” (They also say “On all of these issues, Natural News has always been right!” Google it if you want. I’m not providing a link.)

The new data is from a preliminary release of data from 2,500 rats and mice. It hasn’t been peer-reviewed yet, or scheduled for publication. We have no idea what happened to the mice involved in this study – they weren’t mentioned. Maybe they were busy.

The rats were kept in an underground bunker (which protected them from the sun, a much larger source of radiation exposure.) Special enclosures exposed the experimental rat volunteers to cell phone radiowaves starting at gestation, through the first two years of their lives. Intense radiowaves bathed their entire bodies for 10 minutes on, 10 minutes off, 18 hours a day. For two years. Extrapolating from rat lifespans, that’s equivalent to about 50 human years. Think about that exposure: 50 years, starting before birth, using cell phones mashed up against your entire body for 9 hours a day. I get it, they want to use an absolutely maximal exposure to find even a small signal of increased risk. But does that sound remotely realistic?

Compared to the control rats, male (but not female) exposed rats had small numbers of cancers in their brains and hearts – in most groups, 1 or 2 out of 90. The control rats had zero across all of the subgroups, which is itself a surprise – these were lab rats bred to develop cancers, so cancer-causing exposures could be studied. The control (unexposed) rats also had a weirdly high early death rate (remember, this group didn’t have cell phones. They were bored to death, maybe.) In all seriousness, that seems to be a big flaw. Since cancer takes time to develop, rats in a shortened-lifespan group would almost certainly have fewer cancers at autopsy. Still – zero? Were they looking hard enough?

The new study certainly raises some good questions. How could radiowaves contribute to cancer? There’s no established plausible mechanism at these levels. Why were the results only seen in male rats? What about the mice, were they similarly affected? Why did the non-exposed rats die off early, and could that explain the effect? How do these exposures compare to a typical human way of using a cell phone, holding it in your hand to text or use an app? These are good questions. Too bad journalists covering the study didn’t try to answer them.

Ironically, just a few days earlier, a much larger study (of 45,000 people) showed exactly the opposite. What, you didn’t hear about the huge Australian study that showed no increased risk of brain cancers since the introduction of cell phones 29 years ago? Perhaps the science media is more concerned about rats than Aussies. They’re certainly more eager to get your clicks than to provide accurate or useful information.

A rat.