Letters: Oral Immunotherapy for Peanut Allergies ‘Is More Than Worth the Risk’

The U.S. Health-Care System Found a Way to Make Peanuts Cost $4,200

In September, James Hamblin wrote about the pharmaceutical company Aimmune, which had petitioned the FDA to approve a new oral-immunotherapy drug for peanut allergies. The treatment, which uses peanut flour to try to reprogram a patient’s immune system, is both costly and dangerous, Hamblin argued:

“Oral immunotherapy with peanuts is considered experimental, and no professional organization recommends that parents give any peanuts to an allergic person. Even though some practitioners have concocted homespun protocols, most doctors feel unsafe overseeing any such attempts. Given the potential for a fatal reaction, some believe that no one should yet be trying out the approach outside of a research setting.”

My daughter is one of the youngest patients on the Aimmune peanut-immunotherapy protocol. She has had minimal reaction to the powder. Based on skin testing, she has gone from virulently allergic to not allergic. Some patients have experienced adverse events; most have not.

My daughter’s first allergic reaction to peanuts happened two months after she was exposed to solid food. She nearly went to the emergency room. The notion that more kids are allergic to peanuts these days because of lack of early exposure is a cruel falsehood. The threefold increase in peanut allergies from 1997 to 2010 is more than can comfortably be explained by parental caution.

Further, focusing on the cost of Aimmune’s new treatment is wrong. Aimmune was formed to get peanut protein through FDA approval. Once the drug is approved, the company will have a 20-year window to recoup its expenses. I expect generics to flourish and other companies to bootstrap their research to provide competitive therapies, so the actual window is shorter than 20 years. Compare and contrast the cost of Aimmune to that of the EpiPen—which I am required to have in every vehicle, in every place of recreation, and in every school or day care. My insurance will pay for only two EpiPens a year, yet according to our allergist, we should have six. (Any actual use of an EpiPen usually requires an ambulance ride to the emergency room, a $25,000 to $30,000 expense that insurance rarely reimburses.)

It’s easy to point to the exorbitant expense of pharmaceuticals without acknowledging that this is a consequence of our licensing and vetting procedures. They’re what saved the United States from thalidomide and, when subverted, exposed the United States to Vioxx. Simply put, exposing my daughter to peanut powder in a controlled clinical environment is not possible without a billion-dollar pharmaceutical company doing the job.

Seth Talley
Seattle, Wash.

James Hamblin’s conclusion—“Patient advocates are not patient advocates if they push for approval of a drug that does more harm than good”—reveals an ignorance of what it’s actually like to live with a life-threatening food allergy. His single-minded focus on the 14 percent of patients who experienced anaphylaxis belies the drug’s very real, life-changing benefits for the majority of participants, namely the peace of mind they gain knowing that accidental exposure to the food is far less likely to result in death.

Those with severe food allergies—myself included—understand the risks of oral immunotherapy. But we already take even deadlier risks three meals a day, seven days a week, 52 weeks a year, for years on end. For the children and adults whose survival depends on practicing strict avoidance, Palforzia offers the strong potential of an added layer of protection, and ultimately a better quality of life. That is more than worth the risk.

Jessica Marcus
Former Outcomes Research Advisory Board Member, Food Allergy Research & Education (FARE)*
New York, N.Y.

James Hamblin replies:

I completely agree with the need for extensive clinical research. That was the point of the story, which I hope came across. I wish that kind of research had happened here. Unfortunately, all we have to go on is a small, short-term trial without a clinical end point. I wanted this therapy to work! But the kids who took the drug had more severe allergic reactions during the study, not fewer. I’m not suggesting that the idea should be abandoned. But taking it to market without understanding why it made kids worse off would be irresponsible. I want them to have peace of mind, of course. That’s why they should know about the facts of the study.

*Editor’s Note: FARE helped found Aimmune.