Will I Always Face The Threat Of A Peanut-Laden Kiss Of Death?
Whenever I see a report touting possible new peanut allergy treatments, I devour it. I can鈥檛 help it. It鈥檚 an occupational hazard for any health journalist whose reporting specialty and medical history intertwine.
I write about the business of health care, focusing on how consumers interact with the system 鈥 what we pay, what we get and why American care costs so much. But in this particular instance, I have another kind of authority: 26 years of life-threatening allergies to nuts and peanuts.
So last month, when California-based Aimmune Therapeutics sparked optimistic headlines after releasing clinical trial results that its allergy product, AR101, would reduce the risks linked to an accidental exposure to peanuts, I received the usual wave of questions from friends, co-workers and my parents: Would you try it? Could this help?
Aimmune is just one company eyeing the prize. Childhood peanut allergy diagnoses increased in the United States from 2010 to 2017. The global market for relief is worth as much as $2 billion. The French drugmaker DBV Technologies is also working to commercialize a peanut allergy patch. , including industry giant , are following their .
If any one of them succeeds, it could change my life.
My friends call nuts 鈥淪hefali poison.鈥澛燤y allergies first surfaced when, as a 15-month-old, I picked Thai noodles off an aunt鈥檚 plate and developed hives on my face, and then a few months later when I tasted my mom鈥檚 kaju barfi 鈥 an Indian dessert with cashews 鈥 and ended up in the hospital. Nobody in my family had ever heard of peanut allergies.
I鈥檝e carried epinephrine since I was 7 years old. My friends are trained to inject it in my leg, the standard procedure for an emergency allergen exposure. though I luckily haven鈥檛 had to take a shot of it since I was 4. (Another child in my Montessori class had a peanut butter sandwich for lunch.)
My mom also recalls another incident when she had to pick me up early from day care because the class was making peanut butter bird feeders. And I spent too many years of pre-adolescence eating lunch at the designated 鈥減eanut-free table.鈥 Now, I can only dream of flying to visit my parents for Christmas without worrying about whether my seatmate鈥檚 snacks might induce anaphylaxis. And yes, who has just eaten peanut butter would put my life in danger.
But are these pills and patches a true breakthrough for people like me?
I approached the question as I would any other assignment. I read the research, called immunologists, and spoke with economists and drug pricing experts about whether these treatments offer meaningful benefit.
One of the first things I heard: 鈥淲e are still in the infancy of these treatments,鈥 said Dr. Corinne Keet, a pediatric allergist at Johns Hopkins University.
Shefali Luthra (second from right), pictured in the seventh grade with her school math team, carried epinephrine in a fanny pack as a child, in case she had an allergic reaction. (The fanny pack, thankfully, has since been replaced with a purse.)(Courtesy of the Luthra family)
Medically, there鈥檚 a lot we don鈥檛 know about the risks, how much these drugs could help and how long any effects would last.
鈥淣one of these treatments have been shown to prevent fatal reaction,鈥 Keet emphasized.
The idea behind them is to desensitize people. Aimmune鈥檚 鈥減eanut pill鈥 is modeled on the oral therapies some specialists use to wean allergic kids back on to nuts. This approach has gained popularity in recent years, especially for children with multiple allergies, or when it鈥檚 a substance particularly hard to avoid.
A colleague鈥檚 young daughter, who was born with multiple allergies, used that very treatment, as did a younger cousin of mine who, for the first several years of her life, was allergic to 鈥 not joking 鈥 almost everything but fruits and vegetables. In my case, this therapy came into vogue after I was too old to have a good chance of it weakening my sensitivities.
How it works: Kids ingest tiny, escalating doses of peanut protein. They then stay on peanut protein 鈥 Aimmune recommends the pill, though other doctors I spoke to suggested a little bit of peanut 鈥 as a maintenance drug.
But it鈥檚 unclear how much the new therapies would improve upon that ad hoc oral immunotherapy allergists are already offering. Instead of drugs, they use store-bought peanut protein, usually de-fatted peanut flour available online for as little as $1 a pound. This method isn鈥檛 approved by the Food and Drug Administration, and often isn鈥檛 covered by insurance 鈥 though doctors鈥 visits can be billed as 鈥渇ood challenges鈥 or other visits that are typically covered.
In contrast, Aimmune鈥檚 product to cost between $5,000 and $10,000 for the first six months of use, and $300 to $400 per month after. DBV鈥檚 will cost more than $6,000 for a year鈥檚 supply, though the company says it has not yet determined a price. DBV, Aimmune鈥檚 chief rival, has come up with a wearable skin patch that would transmit tiny, desensitizing protein doses. It declined to estimate a price, but it does not view oral immunotherapy as a competitor, said Joseph Becker, a company spokesman.
鈥淭here鈥檚 excitement, there鈥檚 caution and a lot of unanswered questions,鈥 warned Dr. Erwin Gelfand, a pediatrics and immunology professor at the University of Colorado.
According to Aimmune鈥檚 results, published in the prestigious , two-thirds of allergic children could ingest 600 milligrams of peanut without harm after going through treatment.
To be clear, even with Aimmune鈥檚 help, someone like me still couldn鈥檛 safely eat PB&J. But it would desensitize me enough that I could taste a friend鈥檚 wine even if he recently ate pad thai.
Still, the treatment comes with caveats.
While 496 children started the trial, only 372 completed it. Of the 20 percent who backed out, half did so because of adverse events. About 14 percent of kids getting treatment still had to take epinephrine, and one experienced anaphylaxis, a severe reaction that can involve rashes, vomiting, a tightening throat and difficulty breathing. (For an allergic kid, even the possibility is maybe one of the most terrifying things you can imagine.)
Children who completed the regimen still had to take small doses of peanut protein daily, either the Aimmune drug or a controlled peanut serving. Statistically significant benefits were clear only in patients through age 17, though Dr. Daniel Adelman, the company鈥檚 chief medical officer, said Aimmune plans to do a follow-up trial for adults.
And the results don鈥檛 indicate who is likely to benefit, or how long improvements would last. That鈥檚 impossible to know, Adelman said, though he suggested accidental peanut exposure is scary enough 鈥 and pure avoidance ineffective enough 鈥 that the treatment is still worth it.
But all this means that anyone who has gone through Aimmune鈥檚 regimen would still want to carry epinephrine, and try to avoid peanuts.
鈥淣ot everybody responds well,鈥 Gelfand said. When you factor in those details, the results are 鈥渘ot all that impressive,鈥 he argued.
Dr. Tina Sindher, a pediatric allergist at Stanford University, pointed out that the Aimmune pill is a repackaged, clinically tested version of that homegrown oral therapy many allergists have already been using. DBV鈥檚 peanut patch, Viaskin, to a lesser extent, is the same 鈥 more convenient, perhaps, and more regulated, but still a variation on the existing medical approach.
鈥淭his concept has been around for a long time,鈥 she said.
What鈥檚 new is the addition of labor, standardization and federal oversight 鈥 which companies then say demonstrates increased value.
It highlights a pattern I鈥檝e noticed from my reporting: Drugmakers develop medication that refines a low-tech remedy, run a clinical trial to secure FDA approval, and then sell it at a higher price. For pharma, it鈥檚 a logical way to profit. But it puts patients in a bind.
鈥淭he hard outcome is we have these new products and they鈥檙e just about as good or slightly better than what we have,鈥 said Nicholson Price, an assistant professor at the University of Michigan Law School, who studies drug pricing. 鈥淎nd they鈥檙e a lot more expensive.鈥 He noted: 鈥淭hat鈥檚 when the choices get hard, and we鈥檙e not good at making hard choices.鈥
Also skeptical? The closest authority I know: my mother, who raised me with peanut allergies when they were more or less unheard of, and is now doing it all over again for my 10-year-old brother. (My other brother, my twin, was allergy-free until about a year ago.)
鈥淚t鈥檚 not worth it,鈥 my mom told me. Her concern? Getting any of us to maintain a peanut dose 鈥 without knowing how long that reduced sensitivity would last 鈥 could induce what she called 鈥渁 false sense of security.鈥
This thinking isn鈥檛 out of line, Sindher suggested. The way these studies are touted, she said, often 鈥済loss over the fact that there鈥檚 a lot we don鈥檛 know.鈥
So for now, I鈥檒l have to maintain my distance from the newsroom stash of Reese鈥檚 Pieces. My epinephrine and I aren鈥檛 parting ways anytime soon.