The FDA’s Moment of Truth by Niko Karvounis

Soon we’ll see what the FDA is made of.

Yesterday the AP reported that “doctors told the Food and Drug Administration advisers that the over-the-counter [cough and cold] medicines shouldn’t be given to children younger than 6 because they don’t help them and aren’t safe.” The final recommendation of an advisory panel of outside experts tasked with determining whether or not this is the case is due to the FDA late today.

By “not safe” petitioners don’t necessarily mean that the medicines themselves cause harm, but that they encourage reliance on “quick fixes,” an approach that can mask symptoms of more serious ailments.

This is obviously a problem in and of itself, but becomes an even a bigger deal when one considers that there are no known benefits to the medication. The drugs have never been tested on children—something the FDA has known since 1972. Instead, drug makers “have used extrapolated data from studies in adults to come up with dosing recommendations based on a child’s age or size.” Hardly rigorous medical science.

The threshold for unacceptable risk is a lot lower when a medicine does nothing. Michael Shannon from the Children’s Hospital Boston pediatrician and Harvard Medical School puts it best: “when a treatment is ineffective, its risks — if not zero — always will exceed its benefits.”

So what should worried parents do when their kids have a cold?

Today the AP reported that
Patricia Jackson Allen, of the National Association of Pediatric Nurse
Practitioners, insisted that “watchful waiting for the normal body
defenses to restore health is an appropriate and safe management
strategy for the healthy child with the common cold.” Dr. Joshua
Sharfstein, Baltimore’s health commissioner and a pediatrician offered
an even simpler cure of “love and liquids.”

All of this has, predictably, upset the drug companies (Dimetapp,
Pediacare, Robitussin, and Triaminic—all heavy-hitters). They argue
that the efficacy of their products is proven by the 3.8 billion doses
that children receive a year. Dr. George Goldstein, the nonvoting drug
industry representative on the advisory panel, asks "if these medicines
are allegedly not effective or materially unsafe, how is the purchase
of millions — hundreds of millions — of doses by parents explained?"
Just a thought: maybe it has something to do with the $50 million these
companies spend annually on ads?

As Maggie has often pointed out in her work, consumers of health care
are at a disadvantage relative to other sectors because it’s much more
difficult to be savvy and informed. Parents aren’t physicians—they just
want to make their kids feel better.

As a result, they’re easy targets—something suggested by the panel’s
inquiries, which include an examination of “whether the dizzying array
of medicines that combine multiple ingredients and the sometimes
hard-to-use droppers included in the packaging contribute to parents
unwittingly overdosing their children.”

This is a serious litmus test for the FDA. Think about the picture
before us: medicines that are deeply entrenched in the market and
buoyed by advertising are being used in the billions. They serve little
purpose, have never even been tested on their target demographic, and
have incurred the disapproval of the medical community. If the FDA
caves on this, it will be (yet another) sad statement on the
stranglehold drug companies have over medicine—and over the gatekeepers
of the public interest.

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