Doctors target remedies for kids, Urge wider restrictions for cough and cold drugs
BY ROBERT COHEN
STAR-LEDGER WASHINGTON BUREAU
SILVER SPRING, Md. -- A group of leading pediatricians said yesterday the drug industry's recent decision to stop selling over-the-counter cough and cold remedies to children under 2 is inadequate and should be extended to age 6.
"The Food and Drug Administration did not approve these products on the basis of evidence of safety and effectiveness, but FDA has permitted widespread marketing that is not supported by scientific evidence," Maryland Commissioner of Health Joshua Sharfstein told an FDA advisory panel that is holding two days of hearings on the issue.
Sharfstein, a pediatrician by training, said the drug industry spent more than $51 million advertising pediatric cough and cold medications from July 1, 2006, to June 30, promoting them in a "misleading" way as pediatrician-recommended and safe for young children.
He said the over-the-counter medicines are no more effective than placebos, have resulted in serious side effects, including death, because of misuse and should be barred in the "vulnerable" population of children under 6 -- points strongly disputed by the drug industry.
"When a treatment is ineffective, its risks, if not zero, will always exceed its benefits," added Michael Shannon, a professor of pediatrics at Harvard Medical School.
The comments were made to back up a petition by the pediatricians asking the FDA to restrict use of the medicines for children. They said they chose age 6 because of safety concerns, but do not believe they are effective for older children, either.
The FDA advisory panel will vote on recommendations today that could include restrictions on marketing of cough and cold medicines for children under 12, adding warnings to labels and allowing only single-ingredient products. The FDA usually follows the recommendations of its panels, although it is not required to do so.
The panel is meeting a week after Johnson & Johnson, Wyeth, Novartis and Prestige Brands voluntarily recalled 14 nonprescription "infant" cough and cold medicines targeted for children under 2 years of age.
At yesterday's hearing, industry representatives continued to insist the drugs can be used safely and effectively at recommended doses for children 2 and over.
"Reported serious adverse events are very rare when cough and cold medicines are administered at therapeutic doses," said Edwin Kuffner of McNeil Consumer Healthcare, a unit of Johnson & Johnson.
Kuffner said side effects tend to result from overdose or accidental ingestion and represent a very small percentage of the tens of millions of children who effectively use the medicines every year.
The Centers for Disease Control and Prevention reported earlier this year at least 1,500 children younger than 2 suffered complications from cough and cold remedies in 2004 and 2005.
A recent FDA staff review described dozens of cases of convulsions, heart problems, troubled breathing, neurological complications and other reactions, including at least 54 deaths involving decongestants and 69 deaths involving antihistamines from 1969 to 2006.
FDA officials said they believe adverse events from the medicines are greatly underreported.
Richard Dart of the University of Colorado School of Medicine, speaking for the industry, said while more research is needed, there are "some pediatric studies that have shown effectiveness in children even as young as 6 months old ... and we know from adult studies that their medicines work."
Asked later by FDA advisor Leon Dure of the University of Alabama School of Medicine if there is "objective data about the benefits of these drugs," Phil Walson, an industry expert from the University of Cincinnati, said, "Not that I am aware of."
FDA Medical Officer Lolita Lopez also told the panel "published clinical studies in children did not establish efficacy of cough and cold medicines."
Linda Suydam, president of the Consumer Healthcare Products Association, the industry trade group, said the industry wants to strengthen labels to stress "do not use" for children under 2 and "do not use to sedate children." She also said companies will undertake an education campaign to ensure proper use of the drugs.
George Goldstein, an industry consultant on the advisory panel, asked that if the medicines are not effective or safe, "how is the purchase of millions -- hundreds of millions -- of doses by parents explained?"
Dan Levy, president of the Maryland chapter of the American Academy of Pediatrics, said parents buy the medicines for emotional reasons, such as fear and caring. He said he recommends to parents they would get better results by "throwing it down the toilet rather than administering by mouth."