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.