Brave Pioneers: The Families in Food Allergy Trials

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in Features, Food Allergy
Published: February 18, 2016

Life-Changing Results for Some

P3130018Josh Mandelbaum on the tennis court.

In March 2015, Stirling made his last clinic visit and graduated from his trial. He needs to eat the peanuts (which he still doesn’t like) daily to maintain the tolerance he’s gained. So every day, Sherry Cope counts out 17 peanuts and stirs them into chocolate she has melted to create clusters for her son. “I haven’t gotten used to the fact that he’s eating the peanut. We still go into restaurants and say my son has a life-threatening allergy to peanuts and tree nuts,” says Cope.

It’s not that Stirling can now eat a peanut-butter sandwich or enjoy a Reese’s Peanut Butter Cup – that was never the hope. But, Cope thinks that Stirling might be able to eat ice cream, something he’s never had, or other products that have been produced in a facility with peanuts. “It protects him from the worry of cross-contamination,” says his mother.

When Josh was tested at the beginning of the peanut-patch trial, he was able to eat just 44 milligrams of peanut before having a reaction. After the second year, he ate just under 440 milligrams, the equivalent of two peanuts, before reacting. “That’s a huge difference,” says Mandelbaum. But she takes issue with media articles that portray positive results from clinical trials as a “cure” for food allergies. “At two peanuts, Josh was vomiting, his blood pressure dropped, and he said somebody was strangling him,” says Mandelbaum. “He is not cured.”

Still, life is easier. Josh competes in tennis, and shaking hands after tennis matches was always a stressful experience as some people were eating peanut M&M’s or candy bars. “He doesn’t worry about that anymore. As long as he washes his hands he’s not going to get two peanuts’ worth,” says Mandelbaum. “In that sense, it has changed his life tremendously.”

The Cope family and the Mandelbaum family have both seen some success from their trials, some validation that all the inconvenience and worry were worth it. But not all patients see favorable results. “In oral immunotherapy, we know that 10 to 15 percent of patients just aren’t going to be able to tolerate it,” says Sampson. “For them, it’s a fair bit of burden with no benefit.”

It is still unclear if Ewan’s quality of life will improve from being in the study. When he had his first reaction in the clinic back in July 2014, he had eaten just 150 milligrams or half a peanut. In the following months the doctors ramped up his intake, and he is now on a maintenance dose that he will stick to for another two years. But Diamond doesn’t know for certain whether he’s taking a dose of peanut or a placebo. This made her skeptical about the study at first.

“I was hesitant to put my child through an anaphylactic situation, then have him be on a placebo for close to three years and at the end of it be really disappointed.” Knowing that at the least she would be helping doctors develop therapies for other kids, the family forged ahead with it.

But at the end of the two-and-a-half-year first phase, she’ll have another decision to make. Because the study is designed to find out if patients can gain actual tolerance from their allergen – that is, to not eat peanut every single day and still not react – the second part of the trial would involve taking Ewan off his maintenance dose for six months to see if he retains his protection. “This is when some people leave the trial,” she says. “If they are certain their child is on peanut medicine, then they will continue and give their child actual peanuts,” she says.

Sampson says most of the families he’s encountered in his trials are, like the Diamonds, taking part in the hope of benefiting their children, but also with an eye to a better future for all children with allergies. “They are all clearly involved because they think it might help other people,” he says.

That’s certainly true for the Cope family. “Any research that we could have been involved in to help others, that wasn’t going to hurt our child in anyway, we were definitely interested in,” says Cope. “It’s crazy what we’ve been through. Stress from allergies is unbelievable on families.”

As any allergy family knows, that anxiety comes from what you can’t control: a bite from the wrong cupcake at a birthday party; a mistake in a restaurant kitchen; a family member forgetting to read a label. Now, because of all the families who are taking risks and making sacrifices for food allergy research, there is hope for a future where that stress will be diminished. A future where families who are dealing with allergies will be able to breathe out knowing, at the very least, that if their child eats a small bite of an allergen, there will be no consequence.

If you live in the U.S. and you’re interested in participating in a trial, visit Clinicaltrials.gov to see studies and locations.