April 7, 2009 -- The U.S. Food and Drug Administration is investigating the claims of a new product intended to treat allergies naturally and without the need for physician supervision.
But some allergy experts dismissed the treatment, called Allertherapy, fearing that people with allergies could fall prey to false hope and increase their risk for life-threatening allergic reactions.
Allertherapy is a homeopathic treatment for seasonal and food allergies available for purchase online, according to the company Web site. The medication, which consists of diluted quantities of dozens of allergens, is applied under the tongue and is meant to help the body "quickly build immunity and reduce targeted allergies," according to a press release from ProActive Remedies, the company that manufactures Allertherapy.
But many allergists, homoeopaths and people with allergies are not impressed with Allertherapy's treatment rationale or lack of evidence showing its safety and efficacy.
"A legitimate [pharmaceutical company] has to spend $1 million to get a drug approved by the FDA, and these people can make these outrageous claims without any required testing," said Dr. Harold Nelson, an allergist and professor of medicine at National Jewish Health in Denver. "The system is seriously flawed."
While the FDA considers homeopathic medications "drugs" and provides guidelines for manufacturing and testing them via the Homeopathic Pharmacopeia of the United States, rules concerning what is and is not a medication are not as stringent as for a typical drug.
Homeopathy is a healing technique that uses highly diluted substances to cure ailments that those same substances, at toxic levels, would produce. "Official" homeopathic drugs are those whose ingredients are part of the Homeopathic Pharmacopeia, a compendium of substances proven to have a homeopathic effect, and are available over the counter.
"Non-official" homeopathic drugs, whose ingredients are not part of the Homeopathic Pharmacopeia, are also available over the counter. Many of the ingredients in Allertherapy's food allergy mix, which includes fruits, vegetables, grains, dairy, fish, shellfish, nuts and meat, are not listed in the Homeopathic Pharmacopeia.
"Medicines not contained in the pharmacopeia are not necessarily illegal or unofficial or non-homeopathic," said Mark Land, president of the American Association of Homeopathic Pharmacists. "It's up to the manufacturer to show that it truly is a homeopathic product."
The manufacturers must offer proof of safety and efficacy -- in the form of clinical trial data -- for examination by the FDA and the Federal Trade Commission.
"But generally, manufacturers are not going to make that information available to consumers," said Land, adding that someone who wanted such information would have to contact the manufacturer directly.
Allertherapy does raise safety concerns because people with severe allergies can react to allergens in quantities as small as one part per million -- the dosage of each allergen in the Allertherapy cocktail.
"Under a physician's care I'm fully in support of exploring your options," said Gina Clowes, founder of AllergyMoms.com, who has tried homeopathic remedies for seasonal allergies on herself with no discernable results. "But buying it and trying it at home with something as volatile as a food allergy? Absolutely not."
Homeopathy has a good safety record for most ailments, according to Dana Ullman, author of "The Homeopathic Revolution," because the active ingredients are present in such minute quantities. But without reputable vetting for Allertherapy, "one cannot rely on the 200 years of safety that homeopathic history stands on," Ullman said.
ProActive Remedies acknowledged the risks of unsupervised ingestion of food allergens from the company's food allergy spray.
"Although the active ingredients are extremely diluted, it is possible to have side effects after taking the treatment -- including allergic reactions," said Connie Williams, spokesperson for ProActive Remedies. "For this reason, anyone with any serious health condition, including but not limited to allergies, must consult a doctor before treatment. Those with serious allergies should only commence treatment under the supervision of a doctor, so that proper medical treatment is available should a serious allergic reaction occur."
Questioning Allertherapy's Effects
But the possibility that Allertherapy, which costs $119 for a kit, could have no effect at all was a bigger issue for some than safety.
"They've covered, in a way, the safety," said Nelson, pointing out the miniscule amounts of allergens in the treatment and the company's warning to those with severe allergies. "I'm not concerned with the safety as much as the almost certain inefficacy of it. Things like this shouldn't be offered ... It's terrible to have money wasted on ineffective treatments."
ProActive Remedies attempted to bolster Allertherapy's legitimacy by citing recent research from Duke University showing that some children with peanut allergies were able to build a tolerance after being given small amounts of peanuts for a period of time, as well as the principles of immunotherapy, in which small amounts of allergens are introduced to the body to decrease the immune response and increase tolerance.
But while homeopathy may seem to parallel the Duke study or immunotherapy, its mechanism is less clear cut. Homeopathic treatments do not stimulate an immune response. The active ingredient dosages are much smaller, and their efficacy is subjective in that they work for some people and not for others.
"Quoting legitimate scientific studies and pretending to be in the same league is just bogus," Nelson said.
Yet, despite a lack of abundant clinical research, it appears that the popularity of homeopathy is on the rise in the U.S. In a 2006 report, American Association of Homeopathic Pharmacists Regulatory Committee Chairman J.P. Borneman estimated the sales of homeopathic drugs in the U.S. in 2003 between $300 million and $450 million. The report further stated that these sales were increasing at an average of 8 percent per year.
"I can understand a spray for pollen but I don't understand the food allergy stuff," said Dr. Natalie Stern, a pediatric homeopath at the Continuum Center for Health and Healing at Beth Israel Medical Center in New York, who has found homeopathy useful in treating people with seasonal allergies. "I wouldn't dare be giving [Allertherapy] to somebody I know with anaphylactic shock with peanuts."
Concerns about Allertherapy prompted the Food Allergy and Anaphylaxis Network (FAAN) medical advisory board to release a statement April 1, criticizing the product and its methodology and cautioning people against attempting to treat their allergies without medical supervision, particularly since there is no proven cure for food allergies.
"Our message to everyone is that this is a homeopathic therapy that is unproven scientifically," said Anne Munoz-Furlong, founder of FAAN. "People may spend their money on this product and find that it doesn't work at all, or worse, that reactions occur."