December 24, 1998 The New York Times Children’s Medicine BY DANA CANEDY Drug companies, trying a new approach in treating children, are selling over-the-counter remedies that are as tasty and chewy as soft candy and bubble gum or could be mistaken for ordinary lollipops. These products, though, are not meant to treat a sweet tooth but instead are for ailments like colds, sore throats and even asthma. The maker of Children’s Tylenol now makes a chewy version of its widely used pain reliever in bubble gum, fruit and grape flavors. Another company is introducing Kids-eeze bubble gum (yes, it actually makes bubbles) next month for relief of cold symptoms. A unit of American Home Products is selling Get Better Bear lollipops for sore throats. There is even a product called Lolliasthma for sucking during an asthma attack. More of these products are showing up on drugstore and supermarket shelves next to the cough medicine and baby aspirin. Manufacturers say they are the next generation of easy-to-take remedies for the young. And the child-friendly formulas, manufacturers and some doctors say, enable parents to medicate more easily a toddler with a fever or a hacking cough. “It’s kind of like the Mary Poppins thing – a spoonful of sugar does help the medicine go down,” said Sid Good, president of Good Marketing Inc., which specializes in marketing to children. Critics of these products take a far more skeptical view, contending that while some, like the chewy Tylenol, have clear medicinal value, others offer no more therapeutic benefit than, say, chicken noodle soup. Among them are Kids-eeze bubble gum, which promises in some promotional material to cut the severity of a common cold, and Get Better Bear, which the manufacturer says soothes sore throats. As important, some doctors and child health specialists say that treating any medicine as if it were candy is confusing and potentially dangerous for children. Teaching youngsters that medicine tastes good, they fear, could lead them to reach for the valium or codeine in the bathroom cabinet just as they would the lollipops or jelly beans in the kitchen cabinet. “This is a very dangerous trend and precedent,” said Dr. Sara O’Heron, a maternal child health specialist at Emory University in Atlanta. “The problem is, on one hand we are trying to make kids distinguish between medicine and candy or food, and now we’re blurring that distinction. I think it’s a good marketing ploy but it’s scary.” She and other critics also say some of the medicines contain potent ingredients that can be harmful to children who mistake them for candy and take too much. Certainly, companies have been adding cherry flavor to cough syrup and aspirin for years, but the new products go further, making medicines so fun and flavorful that youngsters look forward to taking them. Take, Greyson Goodwin, a 3-year-old who once had to be force-fed medicine. The last time he had a cold his mother gave him Get Better Bear, lollipops for sore throats that taste so much like candy that the toddler later faked a coughing fit to get more, his mother, Carolyn Goodwin, said. “It’s kind of like having to weigh the lesser of two evils,” said Mrs. Goodwin, an executive at the CBS television affiliate in Tucson, Ariz. “Do you get medicine he absolutely won’t take or stuff that he just loves?” The choice is one that many parents will find themselves making more often as a growing number of candy-like children’s remedies come to market. Parents may wonder if they are confusing their children on the differences between medicine and candy or whether such products are the most effective among over-the-counter treatments. The problem, critics say, is that the marketing muscle behind these remedies may cloud the issues in the minds of many consumers. Drug makers “are exploiting the market and consumer reasoning,” said Dr. Sumner J. Yaffe of the National Institute of Child Health and Human Development in Bethesda, Md. Sales of children’s remedies are growing slightly faster than the $17 billion over-the-counter drug market in general. While the overall market is growing at a sluggish 2 percent a year, according to David Buck, an analyst with Sands Brothers & Company, an investment firm, the children’s category, fueled by product innovation, is growing at 3 to 4 percent or more. Like all over-the-counter drugs, the children’s remedies are regulated by the Food and Drug Administration, which requires that the packages list active ingredients, recommended doses and warnings. Beyond that, manufacturers are mostly free to promote products for proven relief of specific symptoms, no matter how minimal the medicinal benefit. And some of the remedies, like Kids-eeze and Coughco Inc.’s Cough Pops for colds, are classified as herbal or natural dietary supplements because they include natural ingredients such as zinc or compounds derived from plants. All dietary supplements are regulated by a looser set of standards than nonprescription medication because the passage in 1994 of the Dietary Supplement Health and Education Act stripped the F.D.A. of most of its authority to regulate this class of products. Before then, manufacturers were prohibited from making claims about the potential benefits of their products. But the revised guidelines now allow companies to advertise the health effects of the products – without having to prove their effectiveness – so long as the wording does not suggest that the products cure or prevent a disease. As a result, companies have a wide latitude in what they can promote. Bubble gum for a cold, and lollipops for a sore throat? The maker of Lolliasthma, Energique Inc. in Woodbine, Iowa, promotes that product as a homeopathic medical treatment for young asthma sufferers that is “for the temporary relief of constriction of the chest or asthma.” And Whitehall-Robins Healthcare, a unit of American Home Products that makes Get Better Bear, uses the name recognition of its cough medicine to remind parents that the lollipop was “from the makers of Dimetapp.” Johnson & Johnson’s McNeil Consumer Healthcare unit, which recently introduced Tylenol SoftChews, says in promotions to customers that they “taste so great and dissolve so fast that kids won’t mind taking this medicine. And the Quigley Corporation, the company behind Kids-eeze, the zinc-based cold gum, contends that the product reduces the duration and severity of the common cold. The gum is being manufactured for Quigley by Amurol Confections – a candy company and unit of the Wm. Wrigley Jr. Company. Manufacturers, which are promoting the products in commercials and magazine and newspaper ads as well as on Web sites, say the remedies are serious medicine that should be taken only with adult supervision. “We truly wanted to create a more palatable delivery system for kids and adolescents,” said Guy Quigley, the chief executive of Quigley. “But it will definitely be on the cough and cold cure aisle because it is not candy.” As such, parents should treat them like any other products that should be kept out of the reach of children, manufacturers and health care professionals caution. Indeed, while an overdose of products like Coughco’s Tummypops, essentially an antacid on a stick, may do little more than cause further stomach upset, Energique’s Lollicough pop contains belladonna, a plant derivative that can be toxic in large quantities, said Dr. Robert Ward, chairman of the American Academy of Pediatrics’ committee on drugs. How seriously some of these products should be thought of as remedies is another matter, however. Dr. Yaffe of the National Institute of Child Health and Human Development criticized Get Better Bear, saying that promoting it as a Dimetapp product falsely suggests to parents that it offered the same medicinal value as cough medicine. “It’s like saying ‘buy this car, it’s from the maker of Cadillac,'” Dr. Yaffe said. But Dimetapp contains ingredients that are clinically proven to suppress coughs, he said, while Get Better Bear, whose package boasts “Soothing Relief for your Child’s Sore Throat,” is simply sugar and pectin – the same ingredients in jelly beans. Whitehall-Robins contends that unlike Dimetapp, Get Better Bear is not marketed for coughs, but that advertising reminds parents it is from a company they know and trust. The pectin in the lollipop, the company adds, coats the throat; therefore, “we are positioning it for soothing the throat, not positioning it for giving to children as candy,” said Carol Dornbush, a company spokeswoman. In the case of zinc-based children’s cold medicine, a recent study concluded that zinc was “not effective in treating cold symptoms in children and adolescents.” The study, conducted by the Cleveland Clinic and the University of Pittsburgh Medical School, used lozenges provided Quigley – the same company that markets Kids-eeze. Quigley and the distributor of Cough Pops, which also contain zinc, say the lozenges used in the study contained too little zinc and that the study was riddled with procedural errors. One of the doctors who worked on the research, Dr. Michael Macknin, the chairman of the department of general pediatrics at the Cleveland Clinic, said the lozenges did contain a lower dose of zinc than is in Kids-eeze, but said the study was not flawed and that he stood by the results. Despite questions over their benefits, products like child zinc gum or pectin lollipops are generally harmless, according to the American Academy of Pediatrics. What is troubling. the academy and the N.I.H.’s child health unit say, are products that promise relief of symptoms of serious medical conditions, in particular, Lolliasthma. “Not a single one of those ingredients are active ingredients used to treat asthma,” Dr. Ward of the American Academy of Pediatrics said of the herbal compounds in the lollipop. “I would be very concerned that they are making a claim of treating a medical disorder.” The manufacturer stands by its various medicinal lollipops, saying they are safe and contain effective homeopathic ingredients. “They are quite powerful,” said Joyce Beach, a co-owner of Energique. “They should be treated as medicine.” The F.D.A. does not take a position on these remedies, as long as they adhere to labeling requirements. But agency officials acknowledge that consumers often have a false sense of security about them, wrongly assuming that if the products are on the market they are guaranteed to be safe and effective. “What we advise consumers to do is to talk to a health care professional, whether it’s a doctor, pharmacist or nurse,” said Tom McGinnis, deputy associate commissioner of health affairs at the F.D.A. and also a pharmacist. “A health care professional will be able to see what’s in there.” Copyright 0 1998 by The New York Times
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