I was otherwise occupied on May 25, so I missed this article in the New York Times about Miralax, a commonly-prescribed laxative. (Hat tip: Edith Piaf.) The piece is such a shambles, it beggars belief that it was published. It is the worst kind of reporting about a medical issue, creating the appearance of harm where none exists.
Since it was first introduced 13 years ago, a drug called Miralax — an odorless, tasteless laxative that can be easily diluted in orange juice or water — has become a staple in many American households.
But the way many families use Miralax and its many generic equivalents has strayed far from its original intent. The Food and Drug Administration approved the drug for use only by adults, and for only seven days at a time.
Raise your hand if you’ve ever heard of a drug originally approved only for adults being used safely in children. Give yourself a gold star if you knew that just about all medications used in children were initially approved only for use in adults.
Instead, Miralax has become a long-term solution for childhood constipation — a problem that can be troubling not just physically, but also emotionally — rather than a short-term fix so that parents can change their children’s diets to include more fruits and vegetables.
“I’ve had kids on it daily for years,” said Dr. Scott W. Cohen, a pediatrician in Beverly Hills, Calif., adding that he will generally refer them to a specialist in prolonged cases. For children with chronic constipation who are not being helped by dietary changes, “We literally give it like water.”
I have gone to the trouble of bolding the phrases with which the author completely undermines her own point, within the span of two short paragraphs. Yes, it would be fantastic if every parent of a picky child could magically make them eat more fruits and vegetables over the course of one week. Sadly, things often don’t pan out that way. (I say this as both pediatrician and parent.) And there are many, many kids who eat no shortage of roughage yet wind up constipated anyway.
No studies have shown that the drug’s active ingredient — polyethylene glycol 3350, or PEG — has severe side effects. But there is a growing chorus of questions about why it has been used and prescribed for children for so many years.
Not only are there no studies that show any actual severe side effects, nowhere in this pointless article does the author actually describe any real harms done by the medication. I will give you a shiny nickel if you can find anything other than vague allusions to unspecified problems.
Oh, and why has it been used and prescribed for children for so many years? Because it works. Next question.
Last week, for example, the Empire State Consumer Project, a New York consumer group, sent a citizen petition to the F.D.A. on behalf of parents concerned about the increase in so-called adverse events related to PEG that health professionals and consumers have reported to the F.D.A. over the past decade.
And those “so-called adverse events” would be…? Fill me in here, reporter.
In interviews, more than a dozen doctors nationwide, including pediatricians and gastroenterologists, said that they routinely see young patients who have been on Miralax for months and years. Many doctors acknowledged that they have recommended the use of PEG to treat childhood constipation over long periods.
This doctor would be one of them.
Look, do I like my patients to be on Miralax for prolonged periods of time? No. I try to be a therapeutic minimalist to the greatest extent possible. But childhood constipation can be a really tricky problem to fix. It can be related to a whole host of factors (as the author concedes later in the article), none of which lend themselves to a tidy resolution within the space of seven days. In addition, kids who have pain when they go to the bathroom can become reluctant to do so and thus withhold stool, which compounds the problem. It can take a very long time to correct, and as with so many issues can worsen even after periods of improvement. Miralax can be a very effective remedy, and can significantly improve the quality of life of many children who would otherwise have chronic abdominal pain or related problems. Nowhere does the author of this article bother to show how this is genuinely unsafe, and contents herself by gesturing toward the murmurings of others.
But now, of course, concerned parents whose kids are on this medication can come across this article and wonder what insidious damage they have inflicted on their children. Strong work, Grey Lady.
Despite the drug’s popularity, it has never been approved by the F.D.A. for pediatric use. In 1999, when the F.D.A. first approved Miralax, the patient materials included the warning: “Miralax should not be used by children.” In 2009, an F.D.A. drug safety oversight board raised a number of concerns about PEG’s use in children, including the uncertainty of the long-term effects of large doses, but concluded that current evidence does not suggest that PEG causes severe side effects.
This has nothing to do with Miralax per se, and everything to do with how the FDA works. Unless the drug has been specifically developed for and tested on children, then drug companies are required to put stipulations such as the ones above on their labels. If you click through the link to the FDA oversight board meeting (which concluded nothing of import, by the bye), you’ll see that even the guidelines formulated by the Constipation Guideline Committee of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition are not FDA approved. FDA approval and clinical application often do not overlap. But you’d never know that from reading this article, now would you?
“It’s a drug we use long-term; it’s very effective, has a good safety profile,” said Dr. Samuel Nurko, the director of a center for gastrointestinal disorders at Children’s Hospital Boston. “I’m comfortable prescribing it even though it’s not F.D.A.-approved for children.” (Dr. Nurko has done research partially supported by the former maker of Miralax.)
A couple of quick caveats. I don’t think I’ve met Dr. Nurko (though maybe I have), and cannot speak either for him or his colleagues. Further, I know that the plural of “anecdote” is not “data” (an aphorism I’ll never tire of). But for many, many patients I’ve co-managed with one of CHB’s legion of gatroenterologists, Miralax has proven a safe and effective treatment. And I’ve never received a dime from a drug company.
Articles like this are worse than useless. They are actually detrimental. They raise the suspicion of harm without any good evidence to support it. If there is a problem with Miralax (or any other drug), then of course it should be reported. But this piece has nothing to say, and merely contributes to the steady drumbeat of anxiety that makes patient care more fraught than it needs to be. It should never have been published.
I have no quibbles with anything you’ve written here, save a galling word choice on your behalf. You wrote, ” In addition, kids who have pain when they go to the bathroom can become reluctant to do so and thus withhold stool, which compounds the problem.”
How could you not go for the cheap medical humor and use “impacts the problem” rather than “compounds the problem” when it seems so obvious to do so? I’m taking this complaint straight to the top.
You raise a valid complaint. I regret the lapse.
What about the very real danger that kids on a steady diet of ethylene glycol will start to think they’re radiators?
Well, that and dying.
My wife takes two over the counter drugs clearly labeled as not to be taken more than X days at a time.
Why? Her doctor told her to. *shrug*. OTC drugs often have lots of warnings, because while it may fix a problem it might also MASK a problem, and they’re coverring their butts. (Rightly so).
Just so. The primary reason that little time-limit warning is there is to prevent patients from blithely overlooking what may be a serious medical condition. But if said treatment is prescribed by a medical provider, that time limit is essentially meaningless.
So there’s actually no problem with taking more than six regular-strength advil in one day?
Nope. The maximum daily dose is actually the equivalent of 16 regular-strength ibuprofen tablets a day, though I rarely prescribe that much and the risk of side effects obviously increases with the dosage.
[Insert disclaimer about asking your own doctor if you have actual questions about your health here.]
I’ve read that sodium naproxen interferes with the action of aspirin, and vice versa.
Because I’m on low-dose, I don’t take anything other than aspirin as an OTC pain reliever.
I still find it odd that a guy as buff as me would have a weak heart.
I don’t have many patients on aspirin (it’s use is fleetingly rare in children, what with the risk of Reye syndrome), but I do know it’s generally discouraged to use two NSAIDs (such as aspirin, naproxen or ibuprofen) in combination.
I cannot comment authoritatively about your buffness, however.
I wouldn’t just assume that the maximum dosage on an OTC isn’t ‘real’, especially for long-term use.
I know the FDA has certain rules on OTC maximums versus damaging or lethal doses — they obviously don’t want the “no more than X pills per day/hour/whatever” to be anywhere near the “That might kill you” levels, but I think some of the older drugs are grandfathered in.
Tylenol, I think, is an example of a drug whose recommended dosage is far closer to it’s damaging dose levels than is normally tolerated in OTC medicines. I’m basing that off a really hazy mental reference though.
You’re right about Tylenol. For an OTC medication, it has a relatively small therapeutic window. It doesn’t take a particularly high overdose to irreparably damage your liver.
Yikes!
Some suggest that aspirin or particularly acetaminophen would not be approved today (especially for OTC use).
Don’t worry too much, BAMF. If you take it per package instructions, your liver should be just fine.
Have they tried feeding the children jalapenos?
Not in most cases. I will start suggesting it, and report back on how it performs in limited clinical trial.
I believe someone (Chris?) pointed out that the plural of “anecdote” is, in fact, “data”. The problem is generalizing from a small n.
The plural of “anecdote” is “anecdotes.”
But less glibly, the aphorism deals with the usage and connotation of those two words. Most people understand “anecdote” to mean, roughly, “some shit that happened that one time,” and “data” to mean “a mass of reliably collected and interpreted information from which a sound conclusion can be drawn.” Hence, “anecdotal evidence” (which incidentally was the original name I wanted for this blog before I discovered there was already one out there called that) is treated with scorn by medical providers as a source of good decision-making, even though it is technically “evidence.”
I appreciate your explanation, although I’ll say that in the abstract, my reaction to the aphorism is similar to Ryan’s.
Hmmmm. Maybe my love for it is a kind of Stockholm Syndrome after having heard it so many frigging times during residency, uttered approvingly by various attending physicians.
In my case, it’s also partially due to the fact that my best friend is a demographer and loves nothing more than yelling at me when I start talking about how qualitative data isn’t really data.
It’s an enormously common put-down on the Internet. Usually, it goes like: “(generalization), therefore (conclusion favorable to me and unfavorable to my enemies)!” “(counterexample).” “Excsue me but data is not the plural of anecdote.”
The bloom is certainly coming off of that rose.
A laxative dependency is no joke. Big problem on my Dad’s side of the family. After a while, it takes a box of dynamite, an act of Congress and two dozen blasting caps to get their bowels to move. Eventually, it led to irritable bowel syndrome in two of them.
Not all laxatives are created equal, and each has a different risk profile.
Or some Wow-Wow Sauce and a charcoal biscuit.
You should have a stack of this article printed out and sitting on your desk:
http://www.chinasmack.com/2012/stories/zoo-caretaker-licks-monkeys-butt-to-help-it-defecate.html
Remember to sigh and nod gravely when handing them out
“Because it is so precious, the zoo gave it to model worker and high-level expert Zhang Bangsheng to care for and raise.”
A model worker, indeed.
Thank you for your fascinating contribution to the discussion at hand.
“Articles like this are worse than useless. They are actually detrimental.”
Not to the FDA’s long-term goal of cracking down on off-label usage. If it isn’t compulsory, it’s banned; otherwise what’s the point of having a gigantic regulatory bureaucracy?
I think if the FDA were to ban the off-label use of Miralax, it would face a shitstorm of opposition from both parents and providers.
(I’m sorry, I really couldn’t help myself.)
My impression is that banning off-label use is a non-starter, even for the FDA. The shitstorm that would occur would actually draw attention to aspects of the FDA that I do not believe the FDA wants attention drawn to.
I believe the relevant laws state that off-label use is not cause for legal action against the doctor (either criminal or civil).
And you’re right that there are situations where off-label use is endemic because the FDA’s practices make it impossible for anyone to do the required studies for proper usage. See, for example, misoprostol.
YES!
If it isn’t compulsory, it’s banned;
??? This doesn’t follow; “approved as safe by the FDA” doesn’t equate to “compulsory”.