Archive for the ‘In the news’ category

MMR litigants’ new target: their own lawyers

July 17, 2014

The Pediatric Insider

© 2014 Roy Benaroch, MD

This would be funnier if it weren’t so sad.

Back in 1998, British gastroenterologist Andrew Wakefield published The Study That Started It All: 12 children he claimed had developed autism as a result of the MMR vaccine. Since then, that execrable “study” has been shown to have been an “elaborate fraud”, with findings faked to support Dr. Wakefield’s own patent application for a competing vaccine. He was also collecting payoffs from plaintiffs’ attorneys suing vaccine manufacturers. It was, simply, always about money.

Now, a British gentleman who was the first plaintiff in a huge, failed class action lawsuit is suing his own attorneys—really, the attorneys hired by his family—for pursuing a claim based on bad science, bilking the British government out of millions of pounds.

Matthew McCafferty, who developed autism three years (!) after receiving the MMR vaccine, is now suing his attorneys for “unjust enrichment as officers of the court by litigating a hopeless claim funded by legal aid by which you profited.” The class action lawsuit fell apart in 2003, after Wakefield’s research was fully discredited (he later lost his medical license because he lied and took advantage of vulnerable children.)

McCafferty’s attorney said:

“The original MMR vaccine litigation was supposed to be worth billions in compensation, not mere millions, but it cost millions in legal aid,” Shaw told the Times. “There was also a huge personal cost for the families involved – all the raised hopes and expectations, driven by the irresponsible media frenzy based on an unsubstantiated health scare and junk science. Not one penny in compensation was obtained for any child. The families are now just beginning to recover and take stock. They are scrutinising the actions of their former lawyers and medical advisers.”

It was supposed to be worth “billions.” Again, it was always about the money. It was never about the health of children.

And yet, here we are. Vaccine-preventable diseases are roaring back. Parents are fearful of one of the safest, most effective public health interventions ever developed. And, the biggest losers of all, millions of families affected by autism, distracted by false hope, lured into distrust by charlatans taking advantage of their children for profit. Just imagine:  if not for all of this manufactured, fake vaccine-worry, how much more progress we could have made developing a better understanding of the real causes of autism, and the best ways to help identify and treat it.

The evidence for the safety of vaccines and the lack of any connection with autism is overwhelming. I suppose the lawyers will continue to fight over the money. Can the rest of us move along now, and work together towards actually helping children?

You and I are your child’s drug dealers

July 7, 2014

The Pediatric Insider

© 2014 Roy Benaroch, MD

Doing drugs no longer requires a dealer on the street corner.

Between the late 1990’s and 2010 sales of narcotic pain medicines quadrupled in the United States. Hydrocodone use increased by 280%, methadone by 1300%, and oxycodone by 900%. As the consumption of these medicines increased, so did ER visits and deaths from overdose– up by about 500%.

A whole lot of these medicines are not going to medical use. And a lot of the abuse is by our children.

And our kids, they know where to get these medicines. 10% of 8th graders and 45% of 12th graders believe they’re easy to obtain. Pain medicines are kept unsecured and unmonitored in about 75% of homes with teenagers. And over 50% of teens who abused narcotic prescription drugs say they got them from their own friends or family, just by opening a pill bottle, usually in their own homes.

Doctors and parents are both to blame. They get the drugs from us. We need to do a better job protecting our own children.

Doctors need to prescribe carefully, and keep track of refills. Pain has to be treated with more than just narcotics (though narcotics have to be part of the treatment of almost all serious pain.) We need to be careful to look for the early signs of dependence, which can develop into addiction and abuse.

Parents, grandparents, and neighbors need to lock up and keep track of these medications. Pain meds, ADHD meds, any kind of meds– they all can be abused. Set a good example by always using medications as directed.

“Leftovers” should be safely discarded, never hoarded. The best way to discard most medications is in your household trash, mixing the pills or liquid into something unpalatable, like coffee grounds or kitty litter. The FDA advises that some medications are best flushed down the toilet, including most narcotics. Alternatively, some pharmacies and doctors are happy to take back unused medicines to put with medical trash for incineration. (We may not legally be allowed to collect “controlled subtances,” including painkillers and ADHD medications.)

Medications, especially narcotics used for pain relief, are a crucial part of the relief of real suffering for many people. But there’s no doubt that a lot of the narcotics prescribed in the US are being abused. You owe it to your kids– don’t become their drug dealer. Keep those medicines safe.

Water versus diet beverages: What’s best for weight loss?

June 16, 2014

The Pediatric Insider

© 2014 Roy Benaroch, MD

A new study gives some support for the use of artificially sweetened drinks as part of a weight loss program for adults.

Researchers randomized 303 adults (mostly women, with an average age of 48) into two groups during a 12-week weight loss program. Both groups received the same behavioral weight loss strategies, but one was told to drink only water. The other group was encouraged to drink non-nutritive, artificially sweetened beverages like diet sodas, iced tea, and flavored water (none with more than 5 calories per serving.)

The average weight loss was better in the diet drink group than among those drinking only water—9 versus 13 pounds. And the people drinking diet beverages were less likely to report feeling hungry than those drinking only water.

Now, all of the study participants were enrolled in a comprehensive weight loss program, and this study only looked at a short-term, 12 week outcome. Diet soda alone is unlikely to help anyone.

There’s some fine print, too. This study was fully funded by “The American Beverage Association”—an organization, I think, that would benefit from increased sales of diet drinks. And 2 of the 9 authors of the paper received consulting fees from The Coca Cola Company. That doesn’t mean that the study is tainted or invalid, but it does mean that we ought to see some collaborative evidence before suggesting that dieters routinely drink Diet Coke or Crystal Light. For now, I’ll suggest that most children stick with water.

Infant recliners kill babies

June 9, 2014

The Pediatric Insider

© 2014 Roy Benaroch, MD

Last time I objected to an infant recliner, I got all sorts of colorful comments*. I was even accused of having a “personal vendetta” against one of them, because I said that they’re not appropriate or safe to use as routine sleepers for babies. Of course, most of the time, having your baby sleep semi-upright in a cushy sling will probably work out fine. Most of the time. Until it doesn’t.

The “Nap Nanny”, sold between 2009 and 2012, was one of those baby recliner-things. It was sold as a way to help babies sleep. Predictably, what happened happened: babies died. Six of them became entrapped or otherwise suffocated in the “Nap Nappy,” or in another version called the “Nap Nanny Chill.” It was recalled last year, but they’re still out there and in use. Another baby just died in it.

We know the safest way for babies to be put down to sleep is flat on their backs, on a firm surface. Not semi-upright, or in a sling-shaped thing. Once babies can roll over on their own, they should be allowed to do so, without straps or other devices to hold them in place. I don’t know how all of the babies died in the Nap Nanny, but the most recent case I linked to seems to have involved entanglement in the straps.

Using a recliner or car seat or similar device as a routine sleep positioner is a mistake. It will probably work fine, most of the time—very much like driving with your child in your lap instead of a car seat. Or not getting vaccines on time. Those decisions, most of the time, will work out fine. Until they don’t.

*Most of the comments objecting to my last article on sleep positioning were from families with babies had specific medical diagnoses, and were told to use a reclined position for sleeping by their docs. I’m not addressing babies with special situations or diagnoses here—I’m talking about ordinary, healthy babies.

 

Got Iodine? An essential nutrient for pregnancy and beyond

May 29, 2014

The Pediatric Insider

© 2014 Roy Benaroch, MD

Iodine is kind of like your pinky finger. You don’t think about it much, but you’d sure miss it if it wasn’t there.

Historically, iodine deficiency caused a swelling of the thyroid gland in the front of the neck, called a goiter. (You will notice we did not link to a Google image search of that term.) The thyroid gland is the only human tissue that requires iodine, which is a necessary component of thyroid hormone. Not enough iodine in the diet means that the precursor molecule of thyroid hormone builds up in the gland, which can grow to quite an impressive size. (Made ya click! But we still didn’t link to a goiter image. We’ve got class, here.)

Insufficient iodine does more than swell up the front of the neck. It also causes low thyroid hormone levels, which can affect the growth and cognitive development of babies and children—even unborn children. And it turns out that pregnant women, in particular, may not be getting enough iodine to keep their babies safe.

In a statement released this week, the American Academy of Pediatrics had underscored the importance of iodine supplementation in pregnant and nursing women.  They estimate that only ~ 15% of this at-risk group gets adequate supplementation, which is putting many babies at risk.

Iodine is found in many foods, including saltwater fish, shellfish, soy products, and many diary products. But for most of us on a diet that doesn’t rely on seafood, the main source of dietary iodine is table salt. Ordinary table salt is almost always “iodized,” meaning fortified with iodine. But salt used in mass-production of processed foods, pickling, and canning is not iodized, and the kosher salt preferred by foodies isn’t, either. Many people may not be able to rely on ordinary salt in the diet to provide iodine, especially those at the most risk for health problems from iodine deficiency.

If you’re pregnant or nursing, you ought to be taking a prenatal vitamin daily. Make sure the one you’re taking contains iodine. It’s a cheap, simple, safe step that might just save your own neck, and your baby’s brain too.

Football and your child’s brain

May 20, 2014

The Pediatric Insider

© 2014 Roy Benaroch, MD

Eat your vegetables. Be good to your momma. Change your underwear.

Good, solid advice. Maybe we need to add: “Don’t damage your brain. You’re going to need it someday.”

More and more evidence is accumulating that football, or at least football as it’s currently being played in high schools and colleges, is causing irreversible brain damage. The latest study was published in JAMA this week. Researchers looked at 25 collegiate football players (who had played in high school), and compared both brain imaging and cognitive performance with students who hadn’t played college. They correlated their findings with the number of years of football experience, and the number of recalled concussions.

Bottom line: concussions correlate with a loss of brain volume in the hippocampus, an area of the brain involved with memory recall and the regulation of emotions. Not only were concussions correlated, but  the number of years playing football also correlated with this change in MRI scans and with deficits in cognitive testing, including tests of reaction time and impulsivity.

The study itself wasn’t large, and relied only on the students’ recall of concussions. And it does not establish causality—maybe people with smaller hippocampi are more attracted to football, or tend to have more concussions (though no other research suggests this). Still, studies like this add to the considerable evidence that the kind of high-impact head trauma that occurs during football is causing real damage to real brains.

What can we do about it? There are steps individual families can make to protect their own children, especially by recognizing and treating concussions when they occur. Beyond that, we’ll have to see if coaches, athletes, and families are willing to risk brain damage to continue traditional football programs. Are the benefits worth the risk? It’s time to talk about it.

Flat head? Helmets aren’t the answer

May 15, 2014

The Pediatric Insider

© 2014 Roy Benaroch, MD

International campaigns to reduce the incidence of Sudden Infant Death Syndrome (SIDS) have been very successful, with reductions of 50% or more in just about every country that’s pursued public education campaigns. Putting babies “back to sleep” is now ingrained in the public psyche. It’s saving lives.

But an unintended consequence has been an increase in babies with flattened heads. Doctors, who need a different word for everything, call this “plagiocephaly”, and it’s almost always caused by prolonged periods of unequal pressure on the growing cranium. If Junior sleeps on his back with his head turned to his right, the back/left of his head will always be pressed down into the bed. Over time, that side will become flatter. Over more time, if steps aren’t taken to correct this, the left ear and the left side of the forehead will shift forward. Viewed from above, the head of a baby with this kind of “positional plagiocephaly” will look like a parallelogram.

This kind of plagiocephaly—caused by pressure on the head, in the shape of a parallelogram—does not cause any developmental or brain problems. The significance is entirely cosmetic. If severe, it can be quite noticeable, but mild to moderate plagiocephaly has minimal if any cosmetic impact and no health consequences whatsoever.

Still, moderate-to-sever plagiocephaly is noticeable, and parents and pediatricians have been eager to find ways to correct it. One treatment that’s become very common is the use of a custom-made, lightweight fiberglass “helmet” that’s worn throughout the day and night. As baby’s head continues to grow, the thinking goes, it will grow into the nice round shape of the inside of the helmet. Problem solved?

But what seems to work, or what you think is likely to work, might not really work. That’s what practicing medicine is all about. We have to test our therapies and ideas, studying them objectively and impassively. We want it to work, it seems like it works, it makes sense that it does work. But does it really make any difference?

Researchers from The Netherlands just published a randomized clinical study, “Helmet therapy in infants with positional skull deformation: randomised controlled trial”. 84 infants who were already enrolled in conservative programs to address moderate-to-severe skull deformity were randomized at 5 months of age to either get fitted with a molding helmet, or to just continue monitoring alone. Helmets were worn for 23 hours a day for six months, with the helmets being re-fashioned and adjusted as the children grew.

Some red flags popped up early on. 403 infants were deemed eligible for the study, but only 21% of their parents agreed to participate—most of the parents did not want to consider joining a study where there child could be randomized to not receiving a helmet. And as the study went on, 100% of the helmet children reported what were considered significant side effects, including skin irritation, pain, decreased cuddling, and unpleasant odors from the helmets.

Still, almost all of the families assigned helmets completed the study and were compliant with therapy, and almost all of them had a full reassessment at 24 months of age to compare helmeted children with those that were just watched. What was found was stark. Use of the helmet made no difference in any measure of head shape. Unbiased observers, who didn’t know which treatment group the children were in, found that measures of head asymmetry were identical. The helmets just didn’t make any difference. Among children who wore a helmet versus those who didn’t, the same degree of improvement was seen, though complete resolution of head asymmetry was seen in only about 24% of patients in both groups. Overall, parents from both groups were equally satisfied with the improvement in their childrens’ head shape.

So what really should be done to deal with positional plagiocephaly? First, a fear of plagiocephaly should not discourage parents from setting their babies down to sleep on their backs. Safe sleeping is preventing thousands of SIDS deaths. But are ways to encourage safe sleep that won’t increase your baby’s risk of a flat head. Rotate the position of sleep, by putting Junior’s head on alternating nights and naps first at one end, then the other end of the crib. Junior will turn his head to look into the room, at the interesting parts. If his head is always on top of the bed, he’ll be looking over the same shoulder all of the time. Sometimes, place him with his head at the bottom of the crib.

Don’t use any sleep positioners—they’re not needed, and make sleep more dangerous. Don’t routinely sleep your child in a car seat, bouncy seat, or sling-shaped positioner—these can all increase the risk of plagiocephaly, and are not safe. Encourage tummy time when infants are young, and upright/sitting play when they’re a little older and ready for it.

Some children with plagiocephaly have a physical problem with the muscles in their necks, which prevents equal rotation to either side. These babies sit with their heads cocked to one side, and sometimes have a thickening you can feel in the muscle along one side of the neck. This is called “torticollis,” and can usually be treated with physical therapy.

If you’re concerned about your child’s head shape, make sure to bring it up with your doctor. Rarely, head shape problems can be a sign of a medical problem that needs to be addressed. Usually, though, a few simple steps at sleep and play times can help head shapes improve—apparently, just as much as an expensive, sweaty, unpleasant head helmet. Sometimes less is more. You don’t have to have your child helmeted for six months to get a fine looking head. Nice to know, and one less thing to worry about!

Antivaccine lunacy: Is The Media finally getting it right?

May 5, 2014

The Pediatric Insider

© 2014 Roy Benaroch, MD

The media likes to report “both sides to a story”—which makes sense, when a story has two legitimate sides. Two political parties arguing over how to fix a problem, or two eyewitnesses who saw two different things.

But there are times when it doesn’t make sense to report “two sides.” Articles about the Holocaust do not have to include the few fringe lunatics who deny it happened; articles about geography do not have to include quotes from people who think the earth is flat. Or at the very least, if fringe beliefs are reported, they ought to be reported in the context of the bigger picture. Yes, some people think fluoride is put in the water so the government can track us via their spy satellites. But those people shouldn’t get half the airtime in an article about dental health.

Apart from the fallacious “two sides” style of reporting, it’s also apparent that traditional media reporting seems to favor the underdog. The colorful side, the side with nothing to lose, the new point of view, the shocking, the people who challenge the establishment—those can be interesting stories, and I understand why journalists like to feature them. Dog bites man versus man bites dog. I get it.

But unfortunately, by uncritically featuring antivaccine conspiracies and lies, the media has contributed to an erosion of confidence in vaccines. The facts show they’re safer than just about any other medical intervention. They’re safe, and they work. There’s no “vaccine controversy” among any legitimate health organization in any corner of the globe. The controversy has been manufactured and propagated, built on fear, lies, and exaggerations.

Now, the good news: it looks to me like the pendulum is swinging. Stories no longer uncritically parrot antivaccine canards. In fact, I’ve seen some stories that are finally telling the truth in the most unvarnished, blunt ways:

If you’re feeling brave, wander through the comments on these articles. Yes, there are plenty of antivaccine posts—but there are even more posts that contradict them. People don’t seem willing to just let the antivaccine claims sit there unanswered. That’s refreshing. And hopeful.

Young people are getting into the act, too. A wonderful new movie has been produced by California high school students, called “Invisible Threat.” (view the trailer) It’s just been released to excellent reviews, and I think images like this will go a long way towards reassuring parents and fighting back against irrational fears.

It’s time to not only push back against antivaccine propaganda, but also to highlight the good news. We need to continue to speak up. Vaccines have saved millions of lives, and there is a whole lot to be happy about and thankful for. Our kids can be safe and protected. It is a time for optimism. Make sure your kids are happy, and healthy, and safe—vaccinate on time. And tell your friends.

Pediatricians can’t always follow FDA medication labels

March 27, 2014

The Pediatric Insider

© 2014 Roy Benaroch, MD

You know those little packets of paper, folded over eight times, written in type that can’t possibly be seen? You’ve seen them glommed onto the side of stock bottles of medications, or shoved into the paper box alongside a tube of prescription ointment. That unreadable thing is the official “product information”, often called the “label”, required for every FDA-approved medication. It contains all sorts of information, including lists of side effects (Nausea! Anal leakage! Growing a tail!) and what a medicine is “supposed” to be used for.

But often, that information isn’t the best information. It’s just what the FDA approved. Science marches on, and new published information is not routinely included in the product insert. Doctors who pay attention know that there’s usually a whole lot of more-reliable, more-specific, and more-accurate information about here than what’s on the label.

The discrepancy is especially stark with babies and children. According to a new AAP report, “Off Label Use of Drugs in Children,” less than 50% of medications have information about pediatric usage in the FDA-approved product labeling. If you have a child who has been prescribed medication, it’s almost certain that at least some of them have been used “off-label,” in a way that is not specifically approved by the FDA.

As the AAP report outlines, using drugs in this way is not incorrect, unethical, or inappropriate:

The absence of labeling for a specific age group or for a specific disorder does not necessarily mean that the drug’s use is improper for that age or disorder. Rather, it only means that the evidence required by law to allow inclusion in the label has not been approved by the FDA.

Those sound like weasel legal words, I know—but it worth understanding what the FDA’s role here is. The FDA is empowered to regulate the manufacturing, labeling, advertisement, and safety of medications. For a drug to be “FDA approved” for sale in the US, a sponsor has to provide information usually including two large, randomized trials to prove that medicine is safe and effective. Safe in the population studied, and effective for the disease studied. The FDA “approves” the drug for sale using specific parameters from these studies, and does not allow the sponsoring company to promote the use of the medication for any other purpose.

But once a drug is approved, a licensed physician can legally prescribe it for any use. The FDA does not regulate the practice of medicine or how doctors use medication (that can be regulated by state medical boards, if a doctor does stupid or unethical things with a prescription pad.) It is up to licensed prescribers to use their own judgment, based on the totality of the evidence, to make prescribing recommendations. Limiting our knowledge to what’s in the product information sheet—which is seldom modified or updated after a drug is approved—would be unethical and foolish.

In most circumstances, using a drug off-label (for an indication or age not explicitly approved in the FDA label) is not “experimental” or “research.” As long as it’s in a patient’s best interests, using a medication this way does not require any specific information be shared with the patient, beyond what we should be talking about with any medication (risks, benefits, side effects, etc.) However, it’s usually best for doctors to talk about the off-label use in cases where off-label prescribing is unusual or cutting-edge. In pediatrics, that’s seldom the case. We write off-label meds every day, in ways that have sometimes been used for decades, and I would bet that most pediatricians don’t even know when they’re doing it.

That’s because the best therapeutic decision making is not based on the label. It’s based on all of the evidence out there: published studies, experience, judgment, and the best interests of the patient.

Does acetaminophen in pregnancy cause ADHD?

March 20, 2014

The Pediatric Insider

© 2014 Roy Benaroch, MD

Kelly and a few other readers contacted me about a recent study that links acetaminophen use in pregnancy to the later development of ADHD in children. Is Tylenol yet another thing pregnant women need to avoid?

The study, titled “Acetaminophen use during pregnancy, behavioral problems, and hyperkinetic disorders” was published this month in JAMA Pediatrics. Dutch researchers looked at about 60,000 children born from 1996-2002. Their parents have been filling out questionnaires and completing phone interviews from pregnancy onward about medication use, illnesses, and many environmental exposures. This study looked specifically at reports of whether mom took acetaminophen during pregnancy, based on multiple phone interviews during pregnancy and six months after each child was born. They also asked about mom’s health during the pregnancy, and about a possible family history of mental disorders. Then, the researches used multiple ways to determine whether these children had ADHD or ADHD-like symptoms at age 7. Parents completed a structured developmental screening tool, and ADHD diagnoses were further collaborated by mining the Danish Psychiatric Central Registry. They also looked at which children had ever filled prescription for a medicine typically used to treat ADHD.

They found that acetaminophen use during pregnancy was correlated with an increased risk all of their ADHD measures—not only the actual diagnosis of ADHD, but ADHD-like behaviors on rating scales and Ritalin prescriptions, too. The risk was increased by 15-40%, depending on the measure; and the risk increased with increasing acetaminophen exposure. Even when the authors factored out the influences of fevers and infections during pregnancy and mom’s mental health, the association remained strong.

So what does this mean? It’s too early to say if acetaminophen caused ADHD. It may be that there was some other factor that drove women to take acetaminophen, such as reduced coping skills or family support. But clearly, there is something going on here, and it is possible that acetaminophen really is the culprit. In this study, 56% of pregnant moms reported taking acetaminophen. Even if the causal factor only increased ADHD risk by a small amount, the net effect would be substantial, given how common acetaminophen use seems to be.

Previous studies have looked at other exposures for pregnant women that might be linked to later ADHD. A 2012 study from New England showed that fish consumption was correlated with a lower risk, and industrial mercury exposure with a higher risk of later ADHD. This study, like the current one, could not prove that these influences were causal, or only associations. But they were statistically valid, and raise important questions about prenatal influences on later mental illness, school, and behavior problems.

If you’re pregnant, I’d think twice about taking any medication, including acetaminophen. While there are times when the risk: benefit ratio of a medicine is clearly justified, medicines should only be taken when there isn’t a more-safe option. Headaches could perhaps first be treated with massage and relaxation time (which I suspect every pregnant woman deserves anyway.) If medicines are used, patients should strive to use the lowest effective dose for the shortest amount of time.

And don’t forget to eat more fish—preferably the kind without any mercury.


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