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How ineffective children’s drugs stayed on store shelves for years

November 7th, 2007 by Dawn Mefford

“If you are a desperate parent at 10 or 11 o’clock at night on a Saturday and your kid has a cold, what do you do?  You go to the drugstore and see all this stuff on the shelves with pictures of babies and assume it must work.”—Wayne R. Snodgrass, professor of pediatrics at the University of Texas Medical Branch. 

In a October 11 blog posting on this site, it was discussed that various  pharmaceutical companies had finally pulled from store shelves cold medications marketed for very young children.  The post also highlighted the ongoing debate over the effectiveness of cold medications in young children. 

The controversy regarding children’s cold medications begs the question: “If the drugs weren’t effective, why did they stay on the shelves for decades?”

A recent story in the Washington Post provides some insight into the processes and decisions that allowed drug manufacturers to market medications to parents that carried a risk of overdose, while providing no relief to children.  The story, entitled “Children’s Cold Remedies Raised Questions for Years” appeared on the front page of the paper’s October 26, 2007 issue, authored by Rob Stein. 

Stein noted that over-the-counter (OTC) cold medications had been sold for decades before the Food and Drug Administration (FDA) was given the authority to regulate those, and all other drugs, in 1962.  Once it got regulation power, the FDA had the huge task of reviewing hundreds of products and hundreds of ingredients. 

As the FDA began working through the list of drugs already on the market, it gave priority to prescription drugs.  OTC drug review languished for years.  In 1972 the FDA organized a panel of experts to review the ingredients that made up cough and cold meds.  The panel endorsed 35 of the 92 ingredients then being sold, and it made its endorsements based on studies performed on adults. 

In 1976, it was considered unethical to test products on children.  So the panel made the crucial decision to base its recommendations for treating children with those medicines from the results of the adult studies.  Despite reviews of the adult dosages in the years since, recommendations for children’s doses never receive any kind of scrutiny. 

In the meantime, the pharmaceutical industry began marketing numerous products that claimed to fight coughs and colds in young children.  And it was big business.  Drug companies spend over $50 million a year to market the products to parents. 

Criticism of these products started as long ago as 1993, when researchers began testing cold medicines on children and found that there was no good evidence that the medicines worked.  Another 2004 study came to a similar conclusion.  As a result of such findings, in 1997 the American Academy of Pediatrics adopted a policy that declared the products ineffective.  The American College for Chest Physicians made a similar statement nine years later.  Despite these warnings, the doctors groups were no match for the drug industry’s powerful marketing machine.  And while some doctors recommended parents avoid the medicines, others still did not. 

About two-thirds of the drugs currently marketed to children have still never been tested on children.  The long-simmering frustration of pediatricians finally developed into a campaign to get the FDA to take a serious look at cold medicines for children.  That campaign has led to an FDA panel to recommend last month that the products not be used in children under the age of 6. 

That panel’s decision will now be considered by the FDA, who can determine whether the medications need new warning labels, whether they should be pulled from the shelves, or whether the directions on the medicines simply need a clarification.  Unfortunately, a final FDA decision could be years away. 

Those doctors who are supporting the campaign to get the drugs pulled point to a Centers for Disease Control study that reported more than 1500 children had bad reactions to the medicines in 2004 and 2005.  Three of those children died in that two year period alone. 

As Peter Lurie, of Public Citizen’s Health Research Group, one of the experts quoted in Stein’s story, put it, “It really is unbelievable.  You’re just left scratching your head about how this could go on for so long.”

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