What happened to those pain-killing ear drops?

Posted August 14, 2017 by Dr. Roy
Categories: Pediatric Insider information

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The Pediatric Insider

© 2017 Roy Benaroch, MD

MJ wrote in about her daughter. In the past, she used to use a prescription drop called Auralgan (benzocaine plus antipyrine) for ear pain, but it’s been taken off the market. What happened to it? Was it unsafe? Can she start buying it from Canada? What other options are there?

The FDA got tough on Auralgan and several other similar ear drops – AB Otic, Aurodex, Auroto, and other brands – in 2015. To my knowledge, there wasn’t any specific incident or allegation that these products caused any problems. But they’ve never been shown to be safe, and they’ve never been shown to be effective.

For many years these and other older “grandfathered” drugs were cheerfully sold alongside other prescriptions. But all new drug applications submitted to the FDA must include proof of both safety and effectiveness – that’s been the law since 1938, though what’s passed for “proof” has varied. Many older drugs, like these ear drops, slipped though when things were less stringent. But the FDA has always had the right to ask for more proof from the manufacturers.

I don’t really know why these drops got the FDA’s attention. It is true that there’s never been any proof of effectiveness. A German study cited in the non-discontinued products’ insert showed that children given Auralgan for earache did improve – but they didn’t compare the responses with a placebo, and we know that ear aches get better on their own, anyway. There was also a study from Pittsburgh in 1997 – the authors say they showed that topical Auralgan was “likely to provide additional relief” when given along with acetaminophen. But their study showed no statistical difference in pain scores at 3 of the 4 time periods, meaning that Auralgan was equivalent to their placebo (olive oil drops.)

There’s also no science reason to even think these drops would work. The two ingredients, benzocaine and antipyrine, are not effective when applied to the skin – they only work when injected or swallowed. Benzocaine has some activity when rubbed onto a mucus membrane, like on your tongue or gums, but that’s not what’s inside your ears. And: it makes absolutely no sense to use these to treat middle ear pain (like an ear infection, or the pain you get in an airplane), because drops in your ear canal don’t get into your middle ear. That’s like treating stomach pain by pulling on a finger. OK, bad example (ref: grandpa). Anyway, you get the idea.

Real Drugs are only supposed to be marketed in the USA with FDA approval, which requires proof of safety, effectiveness, and quality control manufacturing standards. For ear pain, if you want to stick with a Real Drug, acetaminophen is a pretty good choice. MJ asked about buying Auralgan from Canada – it looks like it’s still on the market up there. I found one place selling it for $142. That’s one expensive placebo.

Or, MJ could wander outside of the realm of Real Drugs. The 1997 study used olive oil as a placebo, and that’s safe – and you could use the leftovers in a salad. Or you could look in the alt-med, “alternative medicine” section of the drug store – there are ear drops there, but they’re not FDA regulated, so purveyors can sell whatever they’d like. You don’t know what you’re getting in those bottles, and there’s no reason to think they’d work any better than olive oil, pickle brine, or ranch dressing.

 

Competition can’t reduce health care costs if the prices are a secret

Posted August 8, 2017 by Dr. Roy
Categories: Pediatric Insider information

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The Pediatric Insider

© 2017 Roy Benaroch, MD

Competition often works. Competing dry cleaners or donut shops must either improve the quality of their product or keep their prices low, or customers will go somewhere else for their cruller fix. In time, the better businesses – the ones that provide tastier pastries at a lower price, – will thrive, and less-good, more-expensive businesses will go away. In the long run, all customers benefit from competition between businesses.

That’s how it’s supposed to be in the American marketplace. But the reality in health care is that it’s not a free market, and it can’t be a free market, and we cannot rely on competition to keep prices down. One big reason: health care prices are a secret.

 You know how much a donut costs. If it’s too much, you’ll take your business elsewhere. Or eat a croissant, or (God forbid) a gluten-free muffin. But can you shop around to find  better health care costs?

A quick story: I use a CPAP machine at night. (Apparently, if I don’t, I stop breathing. I’m told that’s bad.) I get billed $140 a month from the CPAP company, which is magically transformed into $42 a month on the insurance statement, which I pay towards my deductible. I called today to find out from the CPAP company what the total cost will be (it’s a rent-to-own deal, and eventually the machine will be paid off.) They wouldn’t tell me the total, but suggested I call my insurance company. Who also wouldn’t tell me the total, but assured me that if the CPAP company went over their “contractual rate”, the insurance company would stop paying. (How this helps me, I don’t know, but isn’t it nice to know that my insurance company won’t overpay? I might get hosed, but thankfully the good people at Aetna are protected from CPAP price gouging.) That “contractual rate”? It’s a secret (their computer knows, I was assured, but they can’t tell me.)

Even if I wanted to shop around for a less-expensive CPAP device, I couldn’t, because no one will tell me the price. Not that I would shop around, honestly – after those two phone calls, I’d rather poke a fork in my eye, or just stop breathing at night and let my wife shake me awake (which has always worked before. Maybe I need to start paying her that $42 a month.) Secret pricing and means that competition and comparison shopping just aren’t possible for many medical services.

There are other reasons that health care doesn’t abide by free-market principles:

Hospitals and emergency departments have to provide care to everyone, even if they can’t pay. Imagine running a grocery store where sometimes you had to give the food away. To stay in business, you’d have to jack up the prices on the paying customers to cover the non-payers. Now: emergency departments are not grocery stores, and I agree that it is morally unacceptable to turn sick people away. But someone has to pay for this. Emergency departments cannot be run like an ordinary competitive business.

The “barriers to entry” are too high to ensure competition. If a donut shop offers crappy, expensive donuts, another shop can open up across the street. But opening up a hospital is very expensive – and requires government clearance for a “certificate of need” and all sorts of other hoops. Pharmaceutical companies, device manufacturers – these are also very, very expensive companies to start up, and that stifles competition. Legal wrangling also gets in the way. There is no fair playing field to even out or control prices for the biggest-ticket medical expenses.

On the other hand, it’s relatively inexpensive to open up another walk-in or urgent care center – that’s why there’s one on every corner. At least in wealthy neighborhoods. You’d think that would create competition and lower prices – but that won’t happen, not unless their customers can comparison shop for price and quality. (By the way: judging the quality of medical care is also fraught.)

Many people don’t pay their own health care bills. We’ve come to expect health care to be covered by insurance (though that’s changing, with more high-deducible plans and cost-sharing). Many of us don’t even think to comparison shop. But if no one cares about the prices charged, “competition” doesn’t work.

Health care is often “purchased” under duress. When you’ve got crushing chest pain, you don’t call your insurance company to find an “in-network” hospital or ambulance service. And you shouldn’t have to.

The biggest problem with health care is that it costs too dang much. Providing better access to insurance and doctors is morally the right thing to do, but – and this is important, here – better access does not control costs. Competition, alone, won’t work. We’d better come up with some better ways to get costs under control, or there won’t be any money left over for those tasty donuts.

Bedwetting in a pre-teen

Posted August 3, 2017 by Dr. Roy
Categories: Medical problems

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The Pediatric Insider

© 2017 Roy Benaroch, MD

Josh wrote in about his 12 year old daughter – they’ve tried everything, specialists and medications, and she still wets the bed every night:

We have done everything. Waking her, withholding fluids, buzzer. She has taken the highest dosage of desmopressin allowed, to no avail. She has been to an endocrinologist and tested thoroughly, seen her pediatrician many times, had abdominal X-rays and ultrasounds, and been examined for psychological issues. Nothing. The next step our doctor suggests is a urologist. She currently wears a diaper to bed, and we are very straightforward and sympathetic with her. Only positive reinforcement, but she is frustrated with herself at this point.

Josh, about 3% of 12 year olds still wet the bed, at least sometimes (though most of those are boys). It’s not crazy-uncommon for your daughter to be doing this, but I know she wants to stop. Trouble is: bedwetting happens when you’re asleep, and what you want or don’t want doesn’t really matter. Positive reinforcement won’t hurt, but it probably won’t help much, either. What might hurt is encouraging her to “try harder” – this is something that isn’t about trying or practice or rewards. It’s about neurologic maturity.

What supposed to happen: past a certain age, even while we’re asleep we can still pay attention to signals from our bladders. When it’s full, or getting full, we tighten up our pelvic muscles to hold in the urine, without waking up. A good trick, that is, and babies can’t do it, and young children can’t do it. People who are heavier sleepers find it harder to do this, too – and that makes sense. Sleeping like a rock means it’s more likely that you’ll wake up like a, well, wet rock. And there’s not much you can do to “lighten” someone’s sleep cycle.

What *might* work – and I know Josh’s daughter has already tried some of these, but just for completeness:

Drinking more in the morning I know, the usual advice is to drink less at night – but it turns out that’s really difficult to do. If you’re thirsty, you’re thirsty, and not drinking when you’re thirsty is nigh impossible. Instead: stay well hydrated the rest of the day, especially the morning, so you don’t feel like drinking in the evening.

Don’t hold urine during the day I know, some people suggest “bladder stretching” by day to hold more at night. But the problem isn’t a small bladder – it’s that the sleeping child doesn’t notice that their bladder is full. It turns out that holding by day gets the brain “used to” the feeling of a full bladder. It dampens (sorry) the nerve signals, so you don’t get as strong a feeling of a full bladder. This is exactly what you do not want. Frequent, relaxed daytime emptying can help a child stay dry at night.

Treat constipation Constipation leads to holding which leads to less awareness of a full bladder; it also inadvertently strengthens muscles you don’t want strengthened, making it difficult to empty the bladder. At 12, if bedwetting is an issue, I suggest treating constipation even if you don’t think your child is constipated. Just try it. It might work.

Consider medication Two meds have wide use to help with bedwetting: desmopressin and imipramine. Either or both are worth a try, especially if the child is concerned about this.

Don’t make this about trying or not trying I said this before, but let me repeat it: kids don’t wet the bed because they want to wet, and don’t stop wetting the bed because they want to stop. Josh mentioned looking into psychological contributors, which may be a good idea, but don’t create a bigger problem by blaming or by implying that kids can solve this problem by trying harder. That’s not fair and won’t be helpful.

See a urologist At some point, I think it’s a good idea – to rule out very rare anatomical issues, and make sure all medical contributors have been addressed.

And, finally: Focus on the positive. I agree, Josh’s daughter has every right to be upset about this and to want it to stop. And it will stop. I’d pursue some (or all) of the ideas above, while at the same time keeping the conversation positive, non-blamey, and focused on things she does well.

Just because a chemical is present doesn’t mean you have to worry about it

Posted July 31, 2017 by Dr. Roy
Categories: Guilt Free Parenting, In the news, The Media Blows It Again

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The Pediatric Insider

© 2017 Roy Benaroch, MD

Advocacy groups have been busy lately with their fancy-pants chemicalz detection science instruments, and their press releases have made it into the news. But is there news here, and are these chemicals something parents really need to worry about?

First it was a big lead from the New York Times called “The Chemicals in your Mac and Cheese.” The article started:

Potentially harmful chemicals that were banned from children’s teething rings and rubber duck toys a decade ago may still be present in high concentrations in your child’s favorite meal: macaroni and cheese mixes made with powdered cheese.

Oh noes, not high levels! The chemicals they’re talking about are from a family called “phthalates,” which sounds scary and difficult-to-pronounce. (Words shouldn’t start with four consonants. On this we should all agree.) Phthalates have been in wide use for over 80 years in plastics and other compounds. Though they’re not added to cheese, they’re on the coatings of tubes and platforms and whatever else is used in the machinery to make Magic Orange Cheese Powder. Foods with a high surface area (like a powder) are going to come in more contact with it, and a teeny bit of a trace of a few molecules are going to transfer over.

Important point: these chemicals have been in our food for many, many years. What’s changed is that we’ve now got fancy equipment to measure it. The Times story is quoting a kind of press release – not a medical study, or even anything published in the medical journal. It’s a “study” done by a consortium of food advocacy groups. It’s being promoted by an organization called “KleanUpKraft.Org” (Cutesy misspellings are at least as bad as starting words with four consonants, K?) And their “high levels” are in tiny parts per billion, at levels that are very low compared to amounts that cause adverse effects in animal studies.

Just because you can detect a chemical as present doesn’t mean there’s enough of it to hurt you. Mercury and arsenic are part of the natural world around us, and any food tested with equipment that’s sensitive enough will find at least traces of these and many other chemicals. It is not possible to get the values of phthalates or arsenic or many other chemicals down to zero in our foods.

Speaking of chemicals, this week another food advocacy organization announced that they’d found traces of an herbicide (glyphosate, found in Round-Up) in Ben & Jerry’s Ice Cream. And in every flavor tested, too, except Cherry Garcia, which is kind of nasty-tasting anyway (I’m sticking with Chunky Monkey, which wasn’t even tested.) But: their press release didn’t even reveal the levels that they found, only that they found it. Maybe it was one part in a zillion. Who knows? But: Do you think if the value were genuinely high they’d hide it like this? No way. It’s there in some kind of teeny amount, and they’re trying to scare you.

Don’t fall for all of this “The Sky is Falling, There’s Chemicals in My Food” hype. Just because something is hard to pronounce doesn’t make it dangerous, and just because something is present doesn’t mean it’s going to kill you. We’ve all got enough to worry about without being scared of Mac and Cheese and Ice Cream. In fact, a little comfort food in these troubled times would probably be good for all of us. Maybe even the grumps at KleanUpKraft.org.

By the way, I don’t disagree with one thing – homemade Mac n Cheese is at least as good as that boxed orange stuff. Though sometimes, I won’t deny it, the orange stuff sure does hit the spot…

Vaxxed versus unvaxxed children: What a real study shows

Posted July 26, 2017 by Dr. Roy
Categories: Guilt Free Parenting, In the news

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The Pediatric Insider

© 2017 Roy Benaroch, MD

You may have seen it on Facebook: A published study claiming to be “The First Ever” comparing vaccinated and unvaccinated children supposedly showed that vaccinated children are more likely to have a number of health problems. Let me promise you: there’s nothing to worry about here. The study is one of those garbage-in-garbage-out whackjobs that’s almost indescribably bad and unreliable. And: a much better study of the same thing – children who are vaccinated, versus children who are not vaccinated – shows that there are not any worrisome risks. The long-term health of vaccinated children is just fine, and even better than unvaccinated kids (because they don’t have to suffer through vaccine-preventable diseases.)

Let’s cover the good study, first. It was published in 2011, and tracked over 13,000 randomly selected children in Germany, tracking their health status and correlating that with their documented vaccine histories. The authors could find no examples of any increased risks of infectious or allergic diseases in the vaccinated children.

And now, this more-recent, execrable study. They didn’t use randomly selected children. What it actually compared were the 666 children of homeschoolers who chose to complete the survey (which was promoted on antivaccine websites), using their self-reports of vaccine histories and health status. Of these, 40% hadn’t been vaccinated, at least according to the surveys. No attempt was made to track who received the survey, what percentage of respondents completed it, and what kind of respondents completed it. Do you think it’s possible that a high proportion of vaccine-distrusting parents would complete a survey like this? Hint: if you did a survey of musical tastes at a Justin Bieber concert, you’re not going to find many Cab Calloway fans.

The “study” was really just a survey, and a biased one at that – a survey among people who were guaranteed to say exactly what the study authors wanted them to say. It had already been retracted, once previously (and, laughably, by a bottom-feeding journal that looks like it requires authors to pay to publish their studies. This isn’t the way legit journals work.)

Vaccines are safe, and they save lives. Make sure your kids are fully vaccinated. Don’t believe the Facebook rumors, or idiocy dressed up like science – what the real science shows is what parents should feel confident about. There’s no need to worry about vaccines.

A more detailed evaluation of this fakakta survey is here, and here’s more information about reliable vaxxed versus unvaxxed studies. Yes, they’ve been done before. Yes, they consistently show that vaccines are safe and that vaccinated children are healthy.

26

Republican and democratic lawmakers: Grow up and do your jobs

Posted July 20, 2017 by Dr. Roy
Categories: Medical problems

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The Pediatric Insider

© 2017 Roy Benaroch, MD

Health – /helTH/ – The state of being free from illness or injury

Care – /ker/ – The provision of what is necessary for the health, welfare, and protection of someone or something.

System – /’sistəm/ – A set of things working together as parts of a mechanism or an interconnecting network.

It’s not keeping us Healthy, it doesn’t seem to Care, and it’s certainly no kind of System. What we’re got is more about hostile parties protecting their turf and income than a system that’s working together. The docs fight the insurance companies to get things covered; the patients fight the hospitals over inflated, inscrutable bills; the insurance companies fight the pharmaceutical companies over the eye-popping prices of new drugs. The people least suited to fight end up losing the most – that’d be the “patients.”

Meanwhile: the peeps we’ve hired to fix this mess are too busy trying to make each other look bad – which, by the way, is like shootin’ fish in a barrel these days, amirite? – to pass some kind of legislation to even begin to help fix this fine mess. Ever get hired to do a job that you don’t do for 2 or 4 or 8 or 20 years? Didja keep that job? Mind: boggled.

OK, in the spirit of angering everyone involved, so I can bask in the flames of democrats and republicans alike, I will now specifically criticize the approach of both parties. Those of you with strong loyalties may want to skip the next (democratic) or following (republican) paragraphs, lest you be exposed to a worldview that’s not aligned with your own. But for the few of you left who are still capable of seeing two sides of an issue, start here:

Democrats: Obamacare has problems. The insurance marketplaces in many places are collapsing, and premiums are going thru the roof. Even people who have “insurance” often have huge deductibles that they can’t afford. In short: just having “insurance” isn’t the same as “having access to health care.” Obamacare didn’t do a thing to rein in the biggest problem: health care costs too much, and too many people (sorry, “market stakeholders”) are chewing up huge slices of the pie without contributing anything useful to helping patients. I know you’re feeling hurt that you lost the last election, but can you please grow up, talk to the other side, and come up with some common ground to start to address the problems?

Republicans: The free market, alone, cannot save health care. The barriers to entry are too huge (it’s hard to become a doctor, harder to open up a company to manufacture medicines, and even harder to open up a hospital) – which means competition is artificially stunted, and won’t pop up automatically to reduce prices. Also, Emergency Departments are required, by law, to offer care to people who cannot pay – that’s morally the right thing, and don’t even think about removing this safety net. Health care choices are also difficult and fraught, and often made under the duress of pain and worry. People cannot be expected to call around to different ambulance companies to check their prices when they’re experiencing crushing chest pain. You have to admit: health care is unique, and you can’t depend on free market principles, alone, to fix it. The solution is going to include regulations and guidelines and (gasp) some guarantees of coverage, and might even require ways to rein in insco, hospital, doctor, and pharmaceutical profits. I know you’re feeling giddy that you won the last election, but can you please grow up, talk to the other side, and come up with some common ground to start to address the problems?

It’s not easy, I know – but at this point, it’s clear that members of both parties aren’t keeping their eyes on the ball. Your job isn’t about re-election, and payback, and “If you play with Susie than you can’t be my friend anymore.” This isn’t kindergarten, and we don’t really care who plays with Susie – we just want Susie and her family to have access to affordable, good health care. Congresspeople, it’s time to grow up and do your jobs.

Vaccines: We’re all in this together

Posted July 17, 2017 by Dr. Roy
Categories: Medical problems

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The Pediatric Insider

© 2017 Roy Benaroch, MD

When we work together, great things can happen.

Polio has been around since ancient times – there are depictions of it in art thousands of years old. Improved sanitation helped, but it was vaccines that have nearly eradicated polio from the world. This is a disease that paralyzed over 21,000 people in the US in 1952. There are still plenty of people around living with deformities and chronic pain from polio they suffered through years ago. Our children will never have to face this, because our parents and grandparents were sure to get us vaccinated.

Smallpox – gone.

Rinderpest – gone, too, though you may not have known what it was. It’s a neat story. Rinderpest was also known as cattle plague or steppe murrain, and may have been one of the biblical plagues. Our livestock no longer have to worry about it (I’m not sure they ever did, really. That’s livestock for you. But for farmers & pastoral nomads, rinderpest was a big deal.)

Measles – another ancient disease, and a serious one that continues to kill people – was almost eradicated from the western world. It’s no longer endemic (constantly circulating) in the USA, though pockets of certain populations can still support local outbreaks. And that exactly what happens, when vaccine rates fall. Measles cases rapidly return. It’s happening in Europe, and it’s happening in communities in Minnesota who’ve fallen for the lies of the antivaccine propagandists.

Have you or your kids had tetanus, lately? Diphtheria? No. And it’s not because you’re lucky. It’s, again, because our parents and grandparents got us vaccinated, and almost all of us continue to vaccinate our children.

Most parents get it, that vaccines protect not only our children, but everyone else’s children – especially babies too young to get their immunizations, or children who have cancer or other immune problems. Elderly people, adults on medicine for their psoriasis or rheumatoid arthritis, or in chemotherapy – all of us, in every community, benefit when parents vaccinate their children.

And when parents don’t vaccinate, bad things quickly happen. The diseases will wait, patiently, until we let our guard down and invite them back into our homes. They’re not busy. They’re waiting.

There’s a choice, here. Live in fear – fake fear, made-up fear, fear based on lies and propaganda and the same stuff that tries to fool you into e-mailing your bank routing number to a Nigerian prince. You’re not getting that $26 million (or $43 million), and your doctors and the CDC and governments all over the world are not trying to poison your children. Honestly. Let us protect your kids. Great things can happen when we all vaccinate. Protect your children, your community, and yourself.

Bonus! Another example – great things can happen when we all work together. Or, in this case, sing together. Listen, it’ll give you goosebumps.