A Snickers bar triggered the anxiety. It was Halloween 2012, and Mason, then 5 years old, was handed the candy at the second house of the night. Panic set in. He removed his Spider-Man mask and asked his parents to take him back to their Frisco home. The next year, Mason went into anaphylactic shock for the first time. A single peanut sucked the color from his face and caused him to vomit. His father plunged a needle with epinephrine into his thigh.
Mason, like nearly 6 million other American children, has food allergies. Their memories of bright afternoon birthday parties will be dotted with fear or concern. Sleepovers can be off limits. Many will recall sitting at a separate table in the lunchroom. Nearly a third will be bullied about their allergy.
“People who don’t live with food allergies often don’t have an appreciation of how disruptive that is to life,” says Dr. Richard L. Wasserman, the head of DallasAllergyImmunology, a private practice at Medical City Hospital in North Dallas.
That’s why Wasserman, along with colleagues Drs. Robert W. Sugerman and Stacy K. Silvers, asks this question: what is the best way to improve the patient’s quality of life? For them, the answer can be controversial. DallasAllergyImmunology is one of the few clinics in the United States that offers food oral immunotherapy or OIT, which desensitizes patients by having them consume slowly increasing portions of what they are allergic to. Wasserman offers it for milk, egg, peanut, tree nut, and wheat allergies.
To determine whether the treatment is appropriate, the doctors test the blood for the protein marker Immunoglobulin E, IgE, which can reach levels of more than 100 in patients who are allergic to a food. The score marks the likelihood of a reaction, not the severity, so an allergic patient with a level of 2 can go into shock while one with a 12 may get a few hives. The treatment is for food allergic patients, not food intolerant ones, and it is important to note the difference. The intolerant can eat the food and get by with indigestion. The allergic can go into anaphylactic shock and die.
If an OIT patient does not have a clear history of allergic reaction, he or she undergoes a “food challenge,” consuming increasing doses of the allergen until it causes a reaction. Then, for about the next six to nine months, the child takes doses twice daily, 12 hours apart, usually increasing weekly. These can start off as small as 1/10,000th of a peanut. The clinic meticulously weighs the amount prior to issuance. After the patient can consume one full serving of the food twice daily without a reaction—eight peanuts, eight tree nuts, 8 ounces of milk, one egg, one slice of wheat bread—they enter the maintenance period, during which they eat that serving of the food daily to maintain desensitization.
“If we can normalize life by dramatically lowering the risk of a reaction when they’re exposed to the food, and give them the option to incorporate that food into their diet as part of everyday life, that’s our goal,” Wasserman says. “If we can meet that goal, we’re happy. Because that changes life.”
The therapy is still considered experimental (or nonstandard, depending on whom you ask). There is no cure for food allergy, and the chances of a reaction return if the patient stops routinely consuming it. And some recent research has hinted that patients who do not continue to eat the serving wind up at greater risk, says Dr. Robert Wood, chief of pediatric allergy and immunology at the Johns Hopkins Children’s Center in Baltimore.
“The real worry is that people after being treated with OIT have some false sense of security and may just not eat that food for as little as two or three weeks and go from being pretty well-protected to having a dangerous anaphylaxis,” he says. “With that false sense of security, they’re less likely to have their epinephrine with them.”
Wasserman says he’s achieved an 82 percent success rate and, in a journal article published earlier this year, declares it “safe and effective.” The clinic has treated about 351 patients since 2006. Fifty-three of those have dropped out because of reactions, anxiety, disliking the taste, development of eosinophilic esophagitis, or gastrointestinal issues.
The therapy exists in a sort of gray area. The Food and Drug Administration doesn’t have a medication to approve. This makes it tough to fund the large-scale studies that prove its safety for clinical use. Drug manufacturers aren’t confident they can make money off the therapy, so they aren’t sinking money into researching it. The studies that have been published show promise on a small control group, but they haven’t established formal dosing regimens. All weighed the risks of OIT versus avoidance, but Wood says that because of the small sample size, it is hard to draw firm conclusions.
“The risk of fatality is very real,” Wood says. “That’s what we worry about the most.”
When Mason, now 7 years old, went into anaphylactic shock, he was undergoing OIT with a different allergist. The doctor upped the dosage from the equivalent of half of a peanut in flour to a full, single peanut. Mason took the increased dose without incident in the doctor’s office. The third dose at home triggered the reaction.
“Just a few minutes later, he reported he didn’t feel good, his stomach hurt, and his face was white as a ghost,” says his mother, Ewa Miller. She switched to DallasAllergyImmunology after the previous allergist advised Mason to stop the therapy.
Critics point to stories like this as a reason why the treatment isn’t ready for clinical settings. While the risk of an emergency room visit is always high, it can increase if the doses or the frequency are not absolute.
Wasserman first learned of OIT through studies (the oldest report, he says, was published in the 1930s), but he was introduced to its practical application by El Paso allergist Dr. Lyndon Mansfield, who offered it to his patients. Wasserman took Mansfield’s program and “modified his protocol substantially,” Sugerman remembers. What eventually resulted is a 44-page internal operating procedure, detailing the weight of the doses, what to do in an emergency, the frequency, even the distributor of the food. Wasserman believes his homespun protocol makes OIT as safe as possible for those who choose to do it.
In 2013, the Centers for Disease Control and Prevention noted a 50-percent increase in food allergies among children between 1997 and 2011. The cause of that increase could be any number of things: pollution in the environment, increased use of antibiotics. But it’s clearly increasing without a treatment. After treating patients for several years, Wasserman launched a small pilot study in Dallas focusing on quality of life for 31 food-allergic families who underwent OIT. He compared his findings to results from a separate survey of 352 patients who did not have OIT. The post-therapy group reported their quality of life to be about 10 times better. The pediatricians at DallasAllergyImmunology see an opportunity.
“The kind of desensitization that allergists have been doing for over 100 years, i.e., allergy shots, never underwent clinical trials,” Sugerman says. “And that’s the way our specialty was born.”