Colds are the bane of a parent’s existence in wintertime, which is pretty much the equivalent of perpetual runny-nose season. The drug manufacturer that can successfully develop a remedy for the sneezing, drippy noses, congestion and coughs that colds convey will hit the jackpot. For now, there’s chicken soup.
Now a Canadian company is in the process of recruiting 500 children to study whether an herbal treatment approved for adults by Health Canada, the equivalent of the U.S Food and Drug Administration (FDA), can help kids recover more quickly from upper respiratory infections.
The company, Edmonton-based Afexa Life Sciences, is so confident of the magical properties inherent in COLD-FX, its North American ginseng-based product, that it’s seeking out the scrutiny of clinical trials. In 2008, research published in Pediatrics – the journal of the American Academy of Pediatrics — showed that the botanical extract had no serious adverse effects in children. (More on Time.com: Can Catching a Cold Make You Fat?)
It works by boosting the immune system, reducing symptoms and duration and helping prevent colds if taken regularly. COLD-FX targets specific immune cells like natural killer cells and macrophages, whose function is to engulf viruses and digest them.
“We know it works for adults,” says Afexa spokesman Warren Michaels.
The research underway is designed to prove that it works in children. It’s got a pretty impressive track record in adults, at least in terms of sales: In Canada, where it’s approved for adults and children 12 and over, COLD-FX outsells name-brand cold meds like Tylenol. Last year, COLD-FX — a sponsor of the Winter Olympics in Vancouver — was anointed as the official cold and flu remedy of the Games.
Although it’s popular in Canada, COLD-FX is not readily available in the U.S., though it can be ordered online at places like candrugstore.com. The company branched out to its southern neighbor a few years ago, but because it didn’t have approval to market itself as a cold remedy from the FDA — a process that can take years — sales didn’t take off and the company pulled out. Eventually, they intend to wind their way through the FDA approval process, with the intent of re-entering the U.S. market.
What’s unusual about COLD-FX’s new study is that it’s seeking out the research limelight in an industry in which children’s cold and flu remedies are largely untested. (COLD-FX is also part of a Wake Forest University trial funded by the National Cancer Institute to see if the remedy can help leukemia patients whose immune systems are weakened as they go through chemotherapy.)
Research has shown that 10% of U.S. children take cough and cold meds each week, yet an FDA report found that fewer than a dozen studies on children’s cough and cold medications were published between 1954 and 2004. (More on Time.com: Got a Cold? Study Says Echinacea Won’t Help Much)
That doesn’t bode well for children; each year, more than 7,000 U.S. kids under 12 head to emergency rooms because of a reaction to cough and cold medicines, according to the U.S. Centers for Disease Control and Prevention.
Acording to the FDA, 54 children died after using decongestants and 69 after using antihistamines between 1969 and 2006. In fact, most medicines given to children haven’t been tested in clinical trials, Dianne Murphy, director of the FDA’s Office of Pediatric Therapeutics, said in a 2009 interview.
“Most OTC products other than those for fever or pain have not actually been studied in children for effectiveness, safety, or dosing,” says Murphy.
For many years, pediatric drugs got the green light based largely on extrapolation of data from adults; kids simply got reduced dosages. More recently, the tide has been changing as many drug companies have withdrawn pediatric cough and cold products in response to FDA recommendations that over-the-counter medications not be used in children under 2. (More on Time.com: How to Lower Your Risk of Catching a Cold: Work Out)
But parents who choose alternative therapies have to be careful, too, according to a new study in the journal Archives of Disease in Childhood that found that giving homeopathic remedies instead of conventional medicines to kids could be deadly, particularly if they’re used in lieu of traditional drugs. “Perhaps the most serious harm occurs when effective therapies are replaced by ineffective alternative therapies,” says Edzard Ernst, a professor of complementary medicine at Peninsula Medical School in England. “In that situation, even an intrinsically harmless medicine, like a homeopathic medicine, can be life-threatening.
In the new COLD-FX trial, researchers will enroll 500 children, with the expectation that 60% will develop an infection and then move into the clinical trial. Children in the trial will receive a pediatric formulation of COLD-FX or a placebo for three days.
“I have two young boys and obviously that is motivating me,” says Jacqueline Shan, who isolated and developed COLD-FX as part of a team of mostly Chinese scientists at the University of Alberta. Shan grew up in China, where she was schooled in herbal remedies by her mother and grandmother. “There’s no evidence to show there’s anything effective for treatment, let alone for prevention. As a parent, I would be so thrilled if I have something safe and effective to reduce my kids’ misery.”