Archive for the ‘In the news’ category

Beware melatonin supplements – their labels lie

February 27, 2017

The Pediatric Insider

© 2017 Roy Benaroch, MD

About 36 billion dollars will be spent on vitamins and nutritional supplements in the US this year. It is a huge industry, with big advertising and PR budgets. Maybe it’s time for the manufacturers to spend a little money figuring out how to deliver honest and accurate products.

Tests on a variety of supplements have already shown that most of them are contaminated – many with toxic metals, like lead and arsenic. And a new study of one of the most popular supplements, melatonin, shows that most of the brands available have doses far different from what’s on the label.

Researchers in Canada purchased 31 melatonin products from stores in Guelph, Ontario (IKR! I didn’t know there was a Guelph in Ontario!) They analyzed the content of tablets, liquids, and chewables, and found that few of the products contained their labeled dose. 71% of the products were off by more than 10%, with the actual content of melatonin ranging from 17% to 478% of the labeled dose. There was a huge variability even among the same brand, with different bottles varying by 465% in content. Their research was published in the February, 2017 edition of The Journal of Clinical Sleep Medicine.

Potentially worse: 26% of the samples contained serotonin, a contaminant that can cause serious side effects, especially when combined with a variety of medications.

Though these samples were purchased in Canada, there’s no reason to think melatonin products sold in the US would be any more consistent. Neither country has any laws or standards established to regulate, test, or ensure the quality of “dietary supplements” including melatonin, vitamins, or any so-called “natural” or “herbal” products. In other words, there’s no reason to think that you’re getting what you think you’re getting.

There are some voluntary industry standards, and at least that’s a start. The press release about the melatonin study suggested that consumers from the USA look for a “USP Verified” logo certification from the “United States Pharmacopeial Convention.” I could only find one brand on the USP website of melatonin that’s been certified – “NatureMade” (scroll down the bottom, here. Oddly, the Amazon entries for these products don’t indicate that they’re USP certified.)

Many people purchase herbs and supplements for a variety of reasons – and there are some good clinical studies showing that some of them may help (many others, not so much.) But it doesn’t matter what the studies show if what you’re taking isn’t what’s labeled on the bottle. If the supplement manufacturers want to genuinely help people stay healthy, they need deliver a consistent and reliable product. Otherwise, it’s just smoke, mirrors, and empty promises that might make you sick.

Welcome to Guelph

Can vitamin D supplements prevent colds?

February 20, 2017

The Pediatric Insider

© 2017 Roy Benaroch, MD

Linus Pauling was a brilliant scientist. He won the Nobel Prize in Chemistry in 1954 (and, later, a Nobel Peace Prize for his work towards nuclear disarmament.) In the later part of his career, he became convinced that megadoses of vitamins, especially vitamin C, could ward off upper respiratory infections and other ills. Studies have never supported those claims. But maybe he was only off by one letter of the alphabet.

A recent, large study from the BMJ provides solid support for the use of vitamin D – not C, but D – supplementation to prevent ordinary colds and other respiratory infections.

There’s been some inkling that this might be the case. We know that vitamin D, separate from its role in calcium metabolism, has an important part to play in our immune response to infections. It supports the production of built-in antiviral and antibacterial peptides, and helps immune cells make germ-destroying oxygen and nitrogen compounds. Population studies that have shown an increased susceptibility to colds among people who are immune deficient.

What we haven’t had, until now, is a convincing study from an experimental perspective. If we give vitamin D, does that really prevent colds?

What these authors did was impressive. They collected the raw, patient-by-patient data from 25 previous clinical trials of vitamin D, and combined all of that into one mega-study with about 11,000 participants. All of the patients had to have been randomized to either vitamin D or placebo, and rates of respiratory infections tracked going forward. Most of them had blood tests to assess their levels of vitamin D before the trials began.

The bottom line: vitamin D supplementation decreased the risk of a cold by about 12%. That doesn’t sound very high, but on a population level, we’re talking about a lot of infections. And: among those that had low vitamin D levels, the effect size was much larger, about 40%. Vitamin D supplementation was more effective in preventing colds with a daily dose rather than just bolus dosing once in a while.

Who’s low in vitamin D? Based on my experience looking and blood tests from children and teenagers, all of our children are low. Seriously. The only time I see blood tests reflecting a normal or high vitamin D level, it’s in someone already taking a supplement. Our children (us, too) aren’t spending enough time outside to make the vitamin D we need.

The study also found no downsides to ordinary supplements. There were no significant side effects or problems. We’re talking, here, about ordinary doses of probably 400-2,000 IU each day. There’s really no reason to take any more than that, unless there’s a problem with vitamin absorption or some other unique medical issue.

Vitamin C, Airborne, zinc, echinacea – none of these have held up to scrutiny. None of those help prevent people from getting respiratory infections. If you want you and your children to get fewer colds, there are only a few strategies that genuinely work. Stay away from sick people, keep infants out of group care, wash hands frequently, and immunize against influenza and other respiratory pathogens. And, maybe, enjoy a little more time in the sun, or take a vitamin D supplement every day.

l_pauling

How much media use is too much? The AAP weighs in

October 21, 2016

The Pediatric Insider

© 2016 Roy Benaroch, MD

Today, the American Academy of Pediatrics released two new policy statements outlining their official recommendations for media use in children and adolescents. Media, here, means television, video games, tablets, apps – pretty much anything with a screen. We know this kind of entertainment has become a huge part of our lives. How much is too much, and how do we ensure that media is being used wisely and safely? The policy and accompanying technical report rely on hundreds of solid references, providing the best answers based on the best science we know about how children learn and interact with the world of media.

Younger children, less than 2, need exploration and social interactions to learn best. They cannot learn from traditional “media”, at least not on their own. Some learning via electronics can begin by age 15 months, but only via caretakers participating with their children and reteaching the content in an interactive way. By 2 years, we know children can learn word skills by live video-chatting with a responsive adult, or by using apps that reward the child for choosing the right answers.

Preschoolers, aged 3 to 5, can boost their literacy and cognitive skills by watching well-designed TV programs (like Sesame Street.) However, higher-order thinking skills like task persistence, impulse control, and flexible thinking are still best learned during truly social, interactive play – and that’s just not something media can provide.

There are some specific medical concerns raised by media use in young children. Heavy media use increases the risk of obesity, by filling time with sedentary activity and exposing children to unhealthful food advertising. And increased media use directly corresponds to less sleep for children (this is especially true for evening exposures, before bedtime, which interfere with sleep onset, sleep quality, and sleep duration.)

Excessive media use in early childhood is also associated with cognitive, language, and social delays. Some of these associations depend on exactly what’s being watched — switching from violent to pro-social content has been shown to improve preschool behavior, especially in boys. There’s also concern that excessive media use by parents can interfere with other family activities, and may model and reinforce media excess in their children.

With all of this in mind, the AAP has made these specific recommendations for young children and media use:

  • Under 18 months, discourage all media use (other than video chatting with family. Facetime and Skype are OK.)
  • From 2-5 years, limit all media, combined, to a total of less than 1 hour per day of high quality shows. These should be shared together between parents and children.
  • No screens at all during meals and for 1 hour before bedtime.
  • Parents should keep bedrooms, mealtimes, and parent-child playtime screen free.

The AAP had a second policy statement about media use in school aged children and adolescents. There’s good evidence for some benefits of media use at this age, including exposures to new ideas and information, and opportunities for community engagement and collaboration. Social media can help children access support networks, which may be especially valuable for kids with ongoing illnesses or disabilities. Media can provide good opportunities to learn about healthy behaviors, like smoking cessation and balanced nutrition.

But: there’s a down side, too. There are risks for obesity and sleep problems with excessive or untimely media use. Children who overuse online media are at risk problematic, addiction-like media usage, sometimes characterized by a decreased interest in real-life relationships, unsuccessful attempts to cut back, and withdrawal symptoms.

Many teens use media at the same time they’re engaged in other tasks, like homework. They may think they’re learning, but good objective data shows that no one can truly multitask like that. And, of course, though media can deliver positive, healthful information, parents need to be wary of some of the misinformation that’s out there. Information about nutrition, vaccines, and exercise is often misleading or flat-out wrong. Kids can easily find material actually promoting risky health behaviors like eating disorders, sexual promiscuity, and self-mutilation.

There are also significant risks from cyberbullying, sexting, and online solicitation – issues that are especially problematic because the perpetrators may be anonymous. The internet has created some horrifying opportunities for the exploitation of children.

Bottom line, here’s what the AAP recommends for these school aged children and adolescents:

  • Families are encouraged to create their own Media Use Plan. This addresses how media is accessed, both how much and what kind. Consistent limits and a clear and explicit understanding of expectations is crucial. Families should work on these plans together.
  • Children should not sleep with their devices in their bedrooms (parents shouldn’t either.)
  • Media shouldn’t be used during schoolwork, family meals, or other family-designated “media free times.”
  • Parents should engage in selecting and co-viewing media with their kids.
  • There needs to be ongoing discussions of online citizenship and safety.

The AAP’s new policy doesn’t include a specific amount or number of hours of media time is recommended for children and teens. But media use should be limited, so there’s time for exercise, adequate sleep, and other activities. How much media is too much? For teens, when it prevents them from participating in other activities they ought to be doing. Media has become a huge part of all of our lives, but there needs to be time for other things, too.

My hero

Obamacare: Is it working or not?

October 17, 2016

The Pediatric Insider

© 2016 Roy Benaroch, MD

‘Tis a season, fraught and shrill. Volume has replaced thoughtful discourse. I realize many of us have long-ago made up our minds about the Affordable Care Act – and if you already know whether it’s good or it’s bad, this really isn’t the post for you. But if you’re one of the people in the eerie, quiet middle, curious for some context and facts, here’s one doc’s take on the status of what’s typically called “Obamacare.”

 

What are the problems?

There are two big ones, the way I see it. First, the whole program is not sustainable with the current model. When the ACA kicked in, the whole idea was to provide uninsured people with a way to purchase insurance plans, similar to the ones offered by employers. This looked like a big bumper crop of new customers for insurance companies, who initially lined up with all sorts of plans at affordable rates. The costs for consumers, at first, looked especially appealing, because government subsidies made premiums pretty cheap. At first.

But: insurance companies ended up taking a bath on those ACA insurance products. The people who signed up for them turned out to need more health care – to spend more money – than expected. The “young invincibles” who don’t need much health care spending aren’t signing up for these plans, despite having to pay a penalty. (The penalty is still cheaper than the premiums, and they can always sign up later if they develop a health problem. They’re young and invincible, but they’re not stupid.) Insurance companies have had to raise their rates, this year by an average of 10%, and in some areas as much as 55%. Many have exited this part of the insurance market entirely. It’s estimated that when enrollment starts in November, about 20% of people looking for individual plans in the ACA insurance exchanges will have only one plan from which to “choose.” And, of course, areas with fewer plans are seeing the highest rate increases.

Insurance companies would like to hold down rates, but so far their solutions have been both unsuccessful and unpalatable. Smaller “in-network” groups of physicians, hospitals, imaging centers, and labs do reduce costs. But inevitably that means clients – I mean, patients – have to wait longer for services, or travel farther, or navigate endless administrative roadblocks. Another idea to contain insco costs: increased deductibles and copays, which share more of the health care costs with patients.

Which brings us to the second Big Problem: many people are finding that their ACA-compliant plan is costing them, big time, to actually use. Just having health insurance doesn’t guarantee access to affordable health care if you’ve got huge deductibles and out-of-pocket expenses.

 

Have any parts of Obamacare worked?

Yes. The ACA has brought insurance to about 20 million Americans who lacked it, including about 9 million via expansion of state Medicaid programs to low-income families (that number could be much higher, if some states hadn’t refused to participate.) The uninsured rate has fallen from about 16% to 9%. Though deductibles can be high on some plans, people with insurance are at least protected against truly catastrophic costs from a serious hospitalization or chronic illness, like cancer or a heart attack.

Though premiums on the exchanges are rising, they’re actually about $600 a year below what was projected for 2016. And, overall, the rise in national health care costs has been reduced to record-lows, in part from ACA-required hospital cost-control and quality improvement mandates. Overall, federal government spending on health care in 2015 was $2.6 trillion less than it was expected to be – and that’s even with the 20 million more covered people in the system.

 

You’re full of sh*t. Obamacare is (the greatest thing ever)/(a complete disaster for everyone) <–ß you choose!

Yeah, well, see, I was hoping to weed out the partisans with that flowery introductory paragraph. People on either side of this issue seem to have a hard time seeing this from the other point of view. The very idea that “the other side” may have something worth saying and listening to doesn’t seem to jibe with the world of Facebook, Twitter, and the current election cycle. Democracy can be hard, but (I think) it’s the best system out there. Let’s give it a try!

 

OK, Hippie, we’ll try it your way. What do you suggest?

More young people need to sign up. This can be encouraged by increasing subsidies and/or increasing the penalty for non-insurance. Though forbidding insurance from excluding pre-existing conditions is a common-sense provision that needs to be retained, the rules can be tightened. People shouldn’t be allowed to take advantage of this by dropping insurance when they’re well and restarting it only when they get sick.

More flexibility will allow more competition, so people have a choice and premiums can be kept in check. Insurance companies should be allowed to offer products in any state, and regulations requiring certain kinds of coverage for all plans can be relaxed. People should be allowed to choose the kind of coverage they’re willing to pay for.

There are other good suggestions to improve the Affordable Care Act, but it will take a bipartisan congress of adults actually listening to each other to get it done. Their focus needs to be on making quality health care accessible, rather than protecting the profits of the insurance industry.

 

You’ve made some good points! Will you be our next Surgeon General?

I’ll consider it, but I certainly wouldn’t accept that nomination if <REDACTED> wins.

Balance is possible

Is there a link between birth control pills and depression?

October 10, 2016

© 2016 Roy Benaroch, MD

A provocative new study from Denmark supports a link between hormonal contraceptive methods (like birth control pills) and depression. And the association seems to be strongest for adolescent girls.

Huge studies like this are based on huge datasets – in this case, relying the Danish medical system’s longstanding penchant for meticulous and integrated medical records. You just couldn’t do this kind of research in the USA, where medical records systems can’t talk to each other or combine their data in a coherent way.

The researchers started by reviewing the medical records of Danish women, age 15-34, from 2000 through 2013 (excluding women with a preexisting diagnosis of depression or related disorders.) To determine when women took hormonal contraceptives, they relied on a National Prescription Register, which included all prescriptions made and filled for combination contraceptives (these are the ones most commonly used) as well as other medicines and devices (like implants and injected progestin) that rely on hormones to prevent pregnancy. For the purpose of the study, women were considered to be on prescribed hormones for the period of time they filled these prescriptions, plus six months. Over a million women made up the final dataset, followed for an average of 6.4 years each. At any given time, 55% of the women were taking these kinds of contraceptive medications.

The researchers then figured out when all of these women had depression, relying on either their filling a prescription for an antidepressant medication, or when any medical facility made a diagnosis of depression. Overall, during the study period, a total of 133, 178 prescriptions for antidepressants were filled for about 23,000 diagnoses of depression (many of the patients with depression filled more than one prescription.)

Using the data including the timing of contraception usage and depression diagnoses, the study authors could then compare whether depression was diagnosed while the women were either taking or not taking these contraceptives. And it turned out the depression was more common during the on-contraceptive periods. Overall, the increased risk of depression during contraceptive use was about 20% for all women in the study. The increased risk rose to 80% when only adolescent young women from age 15-19 were evaluated. The elevated risks were seen among all the different kinds of hormonal contraceptives examined.

This doesn’t necessarily mean that the contraceptives caused depression. Observational cohorts like these only show a temporal association. It’s possible that women taking contraceptives are more likely to become depressed for reasons unrelated to the medication itself – perhaps relation to the kinds of relationships they were in. Contraceptives are prescribed for many reasons other than contraception, too – to improve menstrual symptoms, or to help with acne. It’s also true that antidepressant medications are prescribed for things other than depression, like anxiety disorders or some chronic pain syndromes.

Still – over a million women in the study, and the effect size (especially among adolescents) was significant. While this study does not mean that women shouldn’t take contraceptives, it does mean that prescribers and their patients should keep depression in mind as a possible side effect, and that women at risk for depression may wish to consider other, non-hormonal means of contraception.

OCPs

 

 

Great news about cancer prevention!

October 6, 2016

The Pediatric Insider

© 2016 Roy Benaroch, MD

The first large, population-based study of real-world changes in cervical cancer screening in the era of HPV vaccination has delivered some great news: the HPV vaccine not only works, but it’s working better than expected.

Researchers looked at rates of CIN, the growth of abnormal cells in the cervix detected by Pap smears, among young women in New Mexico. Even though fewer than 40% of eligible women had received all three doses of the HPV vaccine, rates of these pre-cancerous lesions dropped by over 50%. That’s a huge impact. A safe intervention has cut the incidence of a common cancer by 50%, even in a community where HPV vaccine uptake wasn’t very good. It’s great news, and it hints at even greater news: if we can get more people vaccinated, this cancer-preventer can work even better.

Why did the vaccine work better than expected? There’s a herd effect, where vaccinated individuals help protect everybody by preventing spread of the virus. Plus, the vaccine seems to offer at least some protection against related strains. And it turns out that even women who receive less than the recommended three doses get at least some helpful immunity.

The most-used HPV vaccine in the United States goes by the brand name Gardasil-9, and it protects not only women, but men, too—especially from many cancers of the mouth and throat. Since there’s nothing analogous to a Pap smear for men, it will take longer to see these kinds of cancer-beating effects in the male population, but initial studies relying on rates of infection look very promising.

The HPV vaccine is very safe, and it’s already having a big positive effect in communities. Unfortunately, some parents have been scared away from this vaccine by irresponsible and often flagrantly false internet rumors. Don’t believe the scaremongers. Protect your kids from cancer by making sure they get their HPV vaccines.

Here’s a detailed and well-referenced post from The Skeptical Raptor explaining far more about the Gardasil vaccine, and debunking many of the myths being used to scare parents.

 Q&A from the CDC about HPV and HPV vaccinations

 

MERCK - Merck's HPV Vaccine, GARDASIL®9, now available in Canada

Homeopathic teething pills: Still poisonous

October 4, 2016

The Pediatric Insider

© 2016 Roy Benaroch, MD

In 2010, I wrote about the FDA’s recall of Hyland’s Teething Tablets. It turned out that the tiny little pills, sold to allegedly help babies with teething symptoms, had measurable and potentially toxic amounts of a poisonous plant extract, belladonna. See, they were supposed to not actually have any of that, because homeopathic products aren’t supposed to have any of anything.

One principle of homeopathy works like this: by ultra-super diluting a poison, you get a cure for the poison, or at least relief of the symptoms that the poison would have caused if you ingested it. Which, of course, you shouldn’t do (ingesting the actual poison is discouraged, until it’s ultra-super diluted and isn’t there anymore. That’s what you’re paying for.) Those Hyland’s Tablets turned out to contain the poison that wasn’t supposed to be in there. Oops.

By the way, it’s called “belladonna” from the Italian roots for “beautiful woman”. Belladonna comes from the nightshade plant, and this “natural” chemical will make your pupils dilate (that’s the beautiful part.) It can also cause excessive sleepiness, muscle weakness, difficulty breathing, agitation, and seizures. Those parts are less beautiful.

Last week, on September 30, the FDA updated their 2010 release, warning consumers against using any homeopathic teething tablets or gels. This includes not just Hyland’s products, but those sold at CVS and other retail and online stores.

The bottom line: if they’re manufactured correctly, homeopathic products don’t contain any active ingredients at all. There is nothing in there that could possibly help with teething or any other condition. Oh, sure, there may be other things added to homeopathic products to make you drunk, but that’s not the point. Homeopathic products should be as safe as drinking a little water or swallowing a tiny little sugar pill—because that’s exactly what they’re supposed to be, a little vial of water or a tiny little placebo pill.

That’s if they’re made the way they’re supposed to be made. But homeopathic products, like all of the other alt-med goodies sold next to the real medications, aren’t regulated. There’s no guarantee of purity, and no guarantee that what’s on the label is on the bottle. You’re paying for what you hope is a bottle of literally nothing, but you might accidentally get something that can hurt you.

Funny world, isn’t it? Can you imagine someone complaining to the manufacturer that their placebo was contaminated with a biologically active substance that might actually have an effect on their body? Hey, I paid good money for absolutely nothing, and that’s exactly what I wanted!

Anyway: if your baby seems to be having teething symptoms, try hugs and love or a dose or two of acetaminophen. If that doesn’t help, go see your doctor (it may not be teething at all—those little babies can’t talk yet, and it’s hard to know exactly what’s on their minds. Maybe they got a glimpse of that presidential debate, and they’re understandably worried about the future.) “Homeopathic Teething Tablets” certainly aren’t going to help, and might just make your baby sick.

belladonna