Antera Therapeutics is a Boston-based biomedical startup led by a former Pfizer biochemist, funded by Big Pharma alumni, and linked with Harvard’s iLab incubator, and it has the hallmarks of a sterling upstart. But its flagship product Aralyte, intended to help prevent peanut allergy, has dubious utility, medical experts warn, and could fleece parents out of hundreds or even thousands of dollars.
Aralyte is a kit of individual capsules filled with liquid peanut protein designed to be fed to infants on a strict schedule to prevent an allergy from developing. Its least expensive formulation is $180 for a three-month supply. Aralyte is the first in a line of what Antera Therapeutics plans to be numerous early introduction products to prevent allergies.
Peanut allergies among children in Westernized countries have risen sharply in recent years, with evidence suggesting that they may now be three times as prevalent among children in the United States as they were 10 to 15 years ago. As many as 1 in 50 primary-school-age children in the US, Canada, UK, and Australia are estimated to be allergic; those allergies can have serious consequences such as anaphylaxis (a dangerous systemic reaction) and, rarely, even death. In the late 1990s and early 2000s many doctors advised parents, particularly those with a family history of the allergy, to avoid exposing infants to peanut protein. About a decade later the official advice changed, saying instead that avoidance wasn’t necessary. Last year, with the publication of an influential study in the New England Journal of Medicine, the recommendation went a step further, saying not only that you didn’t need to avoid peanut but that it should actively be given. The Learning Early About Peanut allergy study, known as LEAP, gave doctors strong evidence that early introduction of peanut protein to "high risk" children actually lowered the incidence of allergy.
In the study, more than 600 high-risk infants either ate at least six grams of peanut protein every week over the course of three or more meals, or avoided peanut products entirely. (High risk was defined as the child having an existing egg allergy and / or severe eczema.) The researchers found that early exposure reduced the rate of peanut allergy in at-risk infants by up to 80 percent. An extension of the study, published in the NEJM this spring, further cemented these findings by showing that the protection afforded to at-risk infants by early peanut consumption persists even after a one-year period of avoiding peanut products.
Capitalizing on LEAP’s findings, Antera says Aralyte’s precisely dosed kit is modeled on the study’s regimen. Aralyte’s marketing materials and its website overtly feature endorsements by Harvard Medical School physicians. And the product is intended to be ordered through doctors’ offices as if it were a prescription medication. (It’s also available directly through its website.) The company claims you may even be able use your flexible spending account to pay for it. For parents who want to prevent their infants from developing peanut allergies but are nervous about how to do so safely, Aralyte seems to be a perfect resource.
But there’s a problem with that reasoning: the LEAP study, on which Aralyte is based, didn’t use a precisely dosed kit. Further, plain old peanut butter "can safely and easily be given to children as young as four months" when mixed with formula or soft foods, and later by itself, says Carina Venter, chair of the International Network of Diet and Nutrition in Allergy. A specialized liquid version of peanut protein is not necessary. In fact, in the LEAP study the infants were fed Bamba, a packaged puffed corn and peanut snack (akin to a peanut butter Cheeto), or plain peanut butter.
Aralyte’s precisely dosed regimen also comes with the hefty $180 price tag for a three-month supply. The equivalent amount of store-bought peanut butter would cost about $2. The Aralyte website indicates that the minimum schedule for low-risk children is three months, but that "doctors agree that use for 24 months confers maximum protection to all children." At that duration, parents will spend a staggering $1,440 on Aralyte. Another way to look at the cost: if Aralyte were sold as typical peanut butter it would cost over $400 per jar. (The only active ingredient in Aralyte is peanut protein.) How does Antera justify this price? The words "safe" or "safety" appear 11 times on the consumer-directed pages of the product’s website. "Early introduction can be scary" the website notes, but with "doctor recommended" Aralyte early introduction is easy, "infant-friendly, and stress-free." The company knows that many parents may feel that introducing allergens to an infant is dangerous, and "difficult to get right," requiring the utmost precision. Indeed, Aralyte’s raison d’être is based on this notion. The problem is that it’s untrue.
the words "safe" or "safety" appear 11 times on the consumer site There is no evidence that parents of typical children need to follow an exact dosing regimen. The dosing doesn’t have to be so specific, says David Fleischer, a pediatric allergist and director of the Food Challenge Unit at Children’s Hospital Colorado. He’s also an author of the Consensus Statement following the LEAP study, a statement that represents 11 pediatric and allergy organizations around the world, and an author of the forthcoming National Institutes of Health’s best practices for early introduction of peanuts. According to Fleischer, the key point is getting some amount of peanut protein in a child’s diet, with some consistency, not to "make it like a prescription for an antibiotic." Even the LEAP study itself allowed for variation. In the trial infants were fed "at least 6 grams of peanut protein per week, distributed in three or more meals per week" [emphasis mine]. "Weaning is a normal developmental process in life," Venter added, and Aralyte "is medicalizing something that should be natural." In fact, the common casual consumption of Bamba by Israeli infants was what inspired the LEAP the study in the first place.
According to Antera Therapeutics CEO Clarence Friedman, Aralyte’s dosing schedule "reduces the risk of adverse reactions." In the conversations he’s had with pediatric allergists, "the recurrent theme is that parents are not doing early introduction for issues of safety and convenience," he says. While doctors can recommend and educate parents about early introduction, parents are fearful of uncontrolled amounts of peanut protein. "Parents are worried about so many things in the early years of their child’s life and are always looking for easy, safe ways to ensure their infants are healthy," Friedman says. "Aralyte addresses this need." And he seemed agnostic about whether Aralyte was meant for normal, non high-risk children, saying that the decision to administer the supplement was that of the families and physicians.
Getting parents and doctors used to new medical guidelines can take time, Fleischer says. That’s certainly been the case for changes in recommendations for earlier introduction of highly allergenic foods. But he doesn’t think that Aralyte would reduce parental stress. Venter agrees. "I don’t think it is a case of parents not complying," she says. Later this year the National Institutes of Health is expected to issue new and clear advice for parents, she says. "It should not be difficult to just give diluted peanut butter, mashed up Bamba, or peanut powder mixed with a suitable puree."
While Aralyte is available direct-to-consumers on its website, it’s also being marketed heavily to physicians. The company’s roll out plan is to have the product available in "150 of the most prestigious pediatric allergy clinics" this year. Beyond being "prescribed" via physicians, part of Aralyte’s claim to safety is that it offers the option of having the first dose administered in a doctor’s office. But an initial exposure could be done with a peanut butter solution in a doctor’s office as well if a physician deemed it necessary. Two Harvard Medical School physicians are featured in Aralyte’s promotional materials touting the product. One of them, Caroline Sokol, is quoted on the product’s site: "I would recommend it to every child." Sokol has a nonstatutory stock option in Antera Therapeutics, she told me. Her financial interest, however, is not disclosed on the website or in promotional materials. (Sokol said she would not be involved if she didn’t believe in the product.)
I emailed and called a second Harvard Medical School physician, Wayne Shreffler — who was also originally on the website offering a testimonial — posing questions about Aralyte and asking if he had a financial stake in Antera Therapeutics, but didn’t receive a reply. A few days later, his presence was erased from the site. When asked about it, Friedman said the doctor wanted to be more private. I later reached out to Shreffler one more time, seeking comment on his removal from Aralyte’s site. He replied that he wasn’t comfortable with the potential conflict of interest and asked to be taken off. He said he now doesn’t "have any relationship to them financial or otherwise."
Sokol told me that with her second child she was "too scattered and hurried to take the time to make special purees with peanut butter." A product like Aralyte would have been helpful for her, she says, but as an issue of "convenience, not clinical necessity." But can Aralyte even be seen as an easier option, as Sokol and the company suggest? This notion runs counter to the opinions of Fleischer and Venter about the normalcy and relative ease of natural weaning for infants who aren’t at high risk of developing the allergy. In fact, Fleischer didn’t see how Aralyte made early introduction any less stressful.
Aralyte can be a help in a home where a family member already has a peanut allergy, Sokol says. By using individual disposable packages, she and the company claim, it makes cross-contamination less likely. Nevertheless, Aralyte’s marketing materials are unambiguously aimed at general population families.
Because Aralyte is a liquid, it can be ingested at a younger age whereas parents need to wait until their child is older and able to eat pureed foods to safely ingest diluted peanut butter. One location on Aralyte’s website indicates that an infant can begin the product at three months; in other sections the starting age is listed as between four and 11-months-old. According to Fleischer, there’s no real data suggesting parents have to start that early; in the LEAP study itself none of the participants were as young as three months. There is probably plenty of time to just use peanut butter with typical weaning foods such as fruit purees, Fleischer explained.
Aralyte is also fortified with various vitamins, but a child will exceed the RDA for these vitamins when the product is taken at the recommended dosage with a regular diet, Venter points out. And if an infant is also drinking fortified formula, that risk likely increases. In reply to these concerns, Friedman says that Antera worked with pediatric allergists and nutritionists, and the company is "confident the product is nutritious and safe."
It’s not just nervous parents who should worry about Aralyte’s cost. When I first viewed it, Aralyte’s website said the product could be purchased through your Flexible Spending Account. This would mean that not only would its cost be borne by its purchasers, but also, indirectly by all of us (taxes aren’t paid on money contributed to your FSA). If someone knew she was going to pay for Aralyte and added a corresponding amount of dollars to her FSA to cover the expense, that is money taken from the tax base. According to the IRS’s guidelines FSA accounts may be used to pay for a variety of medical expenses, including everything from prescription medication to oxygen equipment to psychoanalysis. However, medicines not requiring a prescription are not eligible. When questioned about the FSA inclusion Friedman initially said, "We’re consulting with our advisors for the exact classification," and that he’d send me their response "as soon as we have it."
I spoke with a representative from the IRS and an accountant versed in the topic, who explained the manufacturer of a new product doesn’t determine what expense is eligible based on the IRS guidelines; the insurance company or administrator of an FSA does. After three and a half weeks of silence, I emailed Friedman’s publicist, again asking for clarification about their claims on FSA eligibility and noted what I was told by the accountant and IRS rep. Five days later I checked the Aralyte site and saw the text about FSAs had been revised to read, in part: "We have no determination at this point if Aralyte is FSA-eligible." That same day I received this reply: Thank you for following up with us on this. The information that was originally on our website was based on an earlier classification that we were seeking when Antera was founded. However, based on our current FDA classification as a Food for Special Dietary Use, we have no determination at this point if Aralyte is FSA-eligible. We have updated the language on our new website, which goes live this week and for the first time allows parents to purchase Aralyte. We apologize for any confusion this might have caused, and look forward to keeping you updated as Aralyte starts to become available in pediatric clinics later this summer and fall.
Whether society will bear some of the cost of Aralyte indirectly through FSAs or not, perhaps there is a different social cost to be considered. Aralyte seems to take advantage of our culture’s broader inclination toward solving health issues with a pill, or in this case a capsule, rather than education. If parents today are afraid to follow the consensus recommendations of allergy experts, as Friedman suggests, then maybe education campaigns are a better option than pricey supplements. Until then, though, companies like Antera will exist to soothe frightened parents — at a cost, of course.
"It is perfectly normal to be scared when introducing potential allergens into your child’s diet," the product’s website explains. "That’s the reason Aralyte exists."