Why Didn’t They Tell Us?

by Stacey

Although it was news to parents, pediatricians have known for years that cough and cold medicines for kids were a waste of time and money. According to this article in the Washington Post, some doctors even learned about it in medical school.

“When I was trained as a pediatrician, it was just accepted that these products had no role. This was known in the profession,” [Baltimore Health Commissioner Joshua] Sharfstein said. “It’s a fair question why there wasn’t a strong regulatory challenge by the profession. They could have justified one.”

Sharfstein has led the campaign to end the use of over-the-counter cold medicines in children under the age of six. Last week an advisory panel to the Food and Drug Administration agreed. The meeting followed mounting reports of possible dangers of the drugs, the article says. The federal Centers for Disease Control and Prevention reported in January, for example, that more than 1,500 children, including three who died, had suffered adverse reactions to the medications in 2004 and 2005.

The case has also raised many questions: How could the products remain on the market for so long without proof they work? Why didn’t the FDA act sooner? Why didn’t the medical establishment warn parents? Are there other medications in a similar situation?

About two-thirds of drugs prescribed to children have not been tested in kids, the article says. Until recently, the FDA did not require drug makers to test drugs in children, and in fact, it was considered unethical to do so. Now doctors know that drugs work differently in children’s bodies and that data from studies involving kids is crucial to safety.

The article describes the history of pediatric drug regulation, which if you’re interested is worth reading. But what I want to focus on is, how come we didn’t know about all this business with the cold meds?

Research has been published on the ineffectiveness of cold medicines going back as far as 1993, the article says. That year, the Journal of the American Medical Association published an analysis that concluded there was no good evidence that the medications worked. Then in 2004, The Cochrane Collaboration, an independent international project that regularly evaluates medical therapies, reached a similar conclusion.

Although many pediatricians were aware of the mounting doubts and began urging their patients not to use the products, some doctors continued to counsel their patients that they could, and the products remained a mainstay.

In addition, the American Academy of Pediatrics has had a policy since 1997 stating that cough products are ineffective, and the American College of Chest Physicians produced a similar statement in 2006. The article says that other groups, such as the American College of Family Physicians, never issued any formal guidance to doctors, and no major medical groups ever officially questioned the class of products or campaigned against their use.

Peter Lurie, from the consumer advocacy group Public Citizen’s Health Research Group says, “there was a vacuum in leadership on this issue by the professional societies.” Others defend the medical groups, the article says, saying policy statements from doctors’ groups can do only so much, especially against the aggressive marketing by large pharmaceutical companies, which spend more than $50 million a year to sell the products. AAP’s Wayne R. Snodgrass, who chairs the group’s committee on drugs says the companies and the FDA share the blame.

So while everyone’s busy pointing their fingers, no one seems to be thinking about the parents who for all these years have been trudging out to the drug store in the middle of the night seeking relief for their coughing, sneezing, stuffy-headed children and finding a plethora of grape and cherry-flavored potions that promised to help and in the end, could only hurt. We’re the last stop for safety for our children and we needed to know the facts. Shame on all of you.

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Filed under children's health, drugs, family, kids, parenting, safety

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