Cold medicines, weasels, and a flaming piano

Captain Joe visited the site, and posted: “What’s Dr. Roy’s take on the recent announcement by the FDA and drug companies that children under 4 should not be given over-the-counter cough and cold remedies?”

Joe, what’s happened was a sneaky end-around by a very clever industry. You’ve got to give them credit for coming up with a truly weasely way of handling what would have soon become a sales nightmare for them. And they did it in a way that will hamstring the FDA and keep the money rolling in.

First, some background: in an older post I reviewed the best current evidence: so called “cold medicines” do not work. These include “cough suppressants”, “expectorants”, “decongestants”, and “antihistamines” used to treat the symptoms of the common cold. Almost all of the well designed studies looking at these products have shown that they don’t work in children; the few studies that have shown effectiveness were done decades ago in adults, and have serious design flaws.

The only reason we think these products work is because we’ve been hoodwinked by their manufacturers. Years of pervasive advertising have reinforced the image of a caring mommy offering a sniffly child Dimetussiminic, with dad hovering, concerned, nearby. Doctors have contributed to this, too, by prescribing and suggesting prescription and OTC meds that most of us know are just expensive placebos.

What changed a few years ago wasn’t new science showing the meds don’t work—we already knew that—it was a series of reports of serious and sometimes deadly side effects. Now, we couldn’t just look at these products as benign placebos. Genuine side effects can happen, and can kill.

Almost all of these side effects occurred with overdoses in children less than two. Many of the overdoses occurred because so many of these products actually contain multiple ingredients that are hard to figure out from the labels. So a dad might give three “cold medicines”, not realizing that they all contain the same ingredient. A triple dose lands Junior in the Emergency Room, or worse.

A few years ago, the FDA starting looking critically at the data, and in 2007 an advisory committee concluded that because there was zero evidence that these medicines worked, and considerable evidence of their potential harm. The FDA advisory committee recommended banning the sale of cold medicines to children less than SIX years of age.

The FDA didn’t take that step. In conjunction with industry leaders, an interim decision was made to stop marketing and selling cold medicines to children under two, and to allow a time period for further input before taking further steps. The FDA scheduled public hearings, the most recent of which was October 2, 2008, to consider input regarding the best way to proceed—that is, whether to take the advisory committee’s suggestion to extend the ban up to age SIX.

Over a year has passed since the advisory committee’s recommendation. Knowing that the FDA would eventually follow its advisory committee, the pharmaceutical industry realized that having at least part of a money-making pie was better than losing the whole thing. Rather than wait for the FDA’s decision, they voluntarily announced that they will change their labels to say that the products shouldn’t be used under age FOUR. Of course, until the new labels are made, existing products won’t be pulled.

Now, what would you do if you were in the FDA’s shoes? They had to announce that they support this industry decision—doing less would make them seem less concerned about children than the drug sellers. But now, can they really come back in a few months and raise the age to six? If they do, they’ll look ridiculous. It will seem to most people that the FDA has no idea what they’re doing: after all, didn’t “they” just announce you shouldn’t take these meds less than four? And now it’s less than six?

Clever.

To summarize:

Serious reactions can occur if “cold medicines” are used in children, especially under age 2.
For older kids, they’re pretty harmless as long as the correct doses are used.
They don’t work.
The companies that sell them are apparently staffed by clever weasels.

The Pediatric Insider