Editor’s note: Before introducing peanuts or peanut products to children with known peanut allergies or infants whose allergy status is unknown parents should consult with pediatricians. Immunotherapy is not effective for everyone and uncontrolled exposure to allergens can cause serious reactions in some people.
No, it’s not a cure. But it offers a specific kind of food safety to a subset of the population that includes millions of children.
A new medication for people afflicted with life-threatening peanut allergies may offer them the chance to do something as normal as to walk to the store with friends to get ice cream, go on a class trip, attend a birthday party or a sleepover, or even to travel without fearing an accidental allergic reaction.
This is thanks to Palforzia, the brand name for the first oral immunotherapy candidate for food allergies. On Sept. 13, the Food and Drug Administration’s Allergenic Products Advisory Committee voted 7-2 to approve the treatment. The FDA generally follows the committee’s recommendation. However, the FDA won’t make its final decision until next year. In getting this far, Palforzia, which has been developed to treat children 4 to 17, had to go through the full body of clinical trials.
Good news for the kids
Peanut allergies are the most common food allergies in the United States, where it is estimated that 2.1 million children — or 2.2 percent of U.S. children — are afflicted with this allergy. It is believed that about 25 percent of them outgrow the allergy.
This new drug isn’t a cure for peanut allergies, though. But, it is a tool to reduce the frequency and severity of allergic reactions in children who might accidentally be exposed to peanuts.
Bob Parker, CEO, and president of the National Peanut Board trade association refers to this accidental exposure as “first bite” ingestion. However, some people have reactions to peanut dust in the air and residue on utensils and surfaces.
Sometimes when people allergic to peanuts take just one bite of something containing peanuts, they experience symptoms that include vomiting, stomach cramps, indigestion, and diarrhea.
But, sometimes the symptoms can be more severe, with the most serious reaction being anaphylaxis, which affects the entire body. Trouble breathing, coughing, wheezing, swelling in the throat that can lead to suffocation, rapid heartbeat, fainting, and a drop in blood pressure are the more severe symptoms. For children, especially, this is a very scary experience. For their parents, it’s terrifying.
Generally, the first line of defense for severe reactions is an injection of epinephrine, which can be administered with disposable, pre-filled syringes such as EpiPens. From there, it’s often a trip to the emergency room. Epinephrine is a chemical that narrows blood vessels and opens airways in the lungs.
The sort of severe reaction that requires epinephrine is something that people with peanut allergies live in fear of, said the peanut trade association’s Parker.
“It has a large impact on many people, not just the people with the allergy but also their families,” Parker said.
Considering how many foods are made with peanuts or some form of peanuts, such as peanut butter, peanut paste, and peanut flour, it presents a daunting challenge to protect allergic people from accidental exposure. Something as simple as a cookie or a slice of cake can have traces of peanuts in them. Not to mention staples such as bread and breakfast cereals. All of these products and more can be made with the same processing equipment for foods containing some form of peanuts. Sometimes that information is on the label. Sometimes it is not, despite labeling federal requirements.
The numbers say a lot about how much people in the United States love their peanut butter. According to the National Peanut Board’s sales statistics, people here eat 700 million pounds of peanut butter every year. There’s a jar of peanut butter in 75 percent of the homes in America, the trade association reports.
While it’s estimated that from about 150 to 200 people in the United States die each year from peanut allergies, reporting of these deaths is not required and the statistics are spotty. The Centers for Disease Control and Prevention has officially documented only 13 deaths, including six adults, between 1996 and 2006.
How does the new drug work?
Immunotherapy works by desensitizing people to the food, or foods, they’re allergic to. When someone with a peanut allergy eats a peanut or something made with peanuts, antibodies activate an immune response, which the person experiences as an allergic reaction.
This is entirely different from food poisoning caused by foodborne pathogens such as E. coli, Salmonella or Listeria in food that has been contaminated by these potentially deadly bacteria.
Peanuts, or products containing peanuts, are just one of many foods that have had to be recalled in recent years because of contamination by foodborne pathogens. Tomatoes, cantaloupe, cucumbers, and romaine lettuce are just some of the others that have appeared on the Food and Drug Administration’s recall list.
None of these foods are innately contaminated. Instead, they become contaminated by poor food safety practices in the field, the processing facilities, or even in people’s homes.
Building up tolerance
In the case of Palforzia, treatment begins with a small amount of peanut protein powder in a capsule. From there the dosage is slowly increased to 300 milligrams per day. This is done for about 6 months, after which time patients should be able to safely eat a small number of peanuts or peanut products. About two-thirds of the children undergoing this particular therapy were able to tolerate about 600 milligrams of peanut protein after taking the pills.
Six hundred milligrams of peanut protein is the equivalent of two peanuts, which less than half of one child-sized bite from a peanut butter sandwich.
The drug manufacturer says accidental exposure, such as that first bite, might not be as critical for children who have taken the capsules. The medication could turn what would be a potentially life-threatening situation to one that can be handled with less extreme measures.
Dr. Tina Sindher, an allergist and immunologist with Stanford Health Care, told a reporter that most people who are allergic to peanut butter aren’t hoping to be able to eat the food, but rather to be protected against accidental ingestions. After a year of treatment with Palforzia, most children in a large drug trial were able to tolerate the equivalent of two peanuts.
Steve Tilles, senior director of medical affairs at a biotechnology corporation called Aimmune, told a Washington Post reporter that it is not yet known how long people will need to stay on the drug. But he said he is hopeful that after a few years of treatment, children could discontinue it and remain desensitized to peanuts.
A prescription will be needed, but Aimmune has not yet revealed any information about how much the treatment will cost. The first doses and the increased doses would need to be done in a healthcare facility that’s equipped to treat allergic reactions, just in case any do occur. And all of the children going through treatment would need to carry epinephrine syringes in case they experience an allergic reaction.
While other immunotherapies used by allergists for peanut allergies also build up a tolerance by gradually scaling up the amount of peanut butter, Aimmune Therapeutics describes its new drug as a standardized, pharmaceutical-grade product that employs Good Manufacturing Processes (GMPs). Those practices are designed to ensure that the product is consistently produced and controlled according to industry-recognized quality standards. This, in turn, means that allergists who administer the therapy will be using uniform dosages prepared in the same way.
The peanut trade association’s Parker said the board’s focus for the past three years has been to raise awareness of the value of introducing very small amounts of peanut butter to babies as young as 4 to 6 months old.
According to information on the peanut producers’ website, when the National Institute of Allergy and Infectious Diseases released new guidelines in January for the early introduction of peanut foods to prevent a peanut allergy, it offered hope and help to families everywhere.
And yet, said Parker, research shows that many more parents need information and support before acting.
To bridge the gap, the National Peanut Board has launched a campaign designed to build awareness of the guidelines, provide easy-to-follow resources, and to help parents overcome concerns and fears.
“There’s so much confusion about this,” said Parker on behalf of the peanut industry. “Our farmers want to find a solution. We want to be part of the solution.”
America’s peanut farmers — through the National Peanut Board — have contributed more than $25.3 million for food allergy research, education and outreach since 2001.
The effort is a partnership with the American College of Asthma, Allergy, and Immunology (ACAAI) and Food Allergy and Anaphylaxis Connection Team (FAACT). As such it represents the latest chapter of the board’s work to help create a world free from peanut allergies.
Some people say parents with newborns or who are expecting should begin making plans to introduce peanuts early — around 4 to 6 months of age. For many parents, it’s as simple as introducing baby-safe peanut foods around 6 months of age as often as they’d like.
However, children with severe eczema or an egg allergy or both may be in the “high risk” infant category and parents should consult their pediatricians before introducing peanut foods.
Should a baby have a reaction to the peanut butter, the parents should immediately contact their doctor. If the reaction is severe, they should go to their hospital’s emergency room. Go here (PreventPeanutAllergies.org) to learn more about this campaign.
Another strategy is the immunotherapy patch, which releases small amounts of peanut protein through the skin. Parker said the DVB patch is in trials and getting ready to be presented to the FDA.
Sublingual immunotherapy is another strategy. It involves introducing drops under the tongue.
A complete reversal
Parker of the National Peanut Board said that the trade association’s focus for the past three years has been to raise awareness of the value of introducing very small amounts of peanut butter to babies as young as 4 to 6 months old.
According to information on the board’s website, when the National Institute of Allergy and Infectious Diseases released new guidelines in January discussing the early introduction of peanut foods to prevent peanut allergies, it offered hope and help to families everywhere. It also advises parents that no matter what level of risk an infant falls under, adults should consult a healthcare provider, such as a primary care physician or a board-certified allergist/immunologist, before introducing peanuts into a child’s diet.
Also, according to the guidelines, children in the lowest risk group, with no signs of eczema or food allergy, can be introduced to peanuts when age-appropriate and according to family and cultural preferences.
These guidelines come as a complete reversal from advice new parents had been receiving from doctors in the early 2000s when they were told to avoid feeding peanut products to babies and toddlers. Unfortunately, said Parker, this new information hasn’t been as widespread as would be expected.
“Anything that can help get this information out is so important,” said Parker, adding that the National Peanut Board is actively engaged in doing this.
“There’s so much confusion about this,” said Parker. “Our farmers want to find a solution. We want to be part of the solution.”
America’s peanut farmers – through the National Peanut Board – have contributed more than $25.3 million for food allergy research, education and outreach since 2001.
This recent effort on the part of the board is a partnership with the American College of Asthma, Allergy, and Immunology (ACAAI) and Food Allergy and Anaphylaxis Connection Team (FAACT). As such it represents the latest chapter of the board’s work to help create a world free from peanut allergies.
A new video series features actor Justin Baldoni and documents his experience introducing peanut foods to his young son, Maxwell, to prevent a peanut allergy. The series aims to empower new parents to prevent their children from developing a peanut allergy. Each video shows a different part of the Baldoni family following the new peanut introduction guidelines.
The bull’s eye
“Peanuts are in the bull’s eye of the target of food allergies,” Parker said. “They’re the poster child. Yet the positive in all of this is that most allergy research starts with peanuts.”
Federal law requires declaration labeling on products that contain any of the “major allergens,” which are defined as milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans
“Interesting times are ahead,” Parker said. “We’re all hoping to have a cure for food allergies.”
What about the rest of the world?
While peanut allergies are quite common in Western countries such as the United States and the United Kingdom, they are fairly rare in others. For example, in Greece and Israel, peanut allergies are almost non-existent. This may be partly due to different rates of peanut consumption among different countries.
However, some contend it may also be attributed to the young age babies are introduced to peanut products in some countries. For example, in Israel, babies and children frequently eat Bamba, which is made with peanuts and other ingredients. It has the consistency of corn puffs and some parents use it for teething babies.
The differences in peanut consumption can’t completely explain the differences in the rates of peanut allergies, though.
For example, while peanut consumption is very high in Indonesia and parts of Africa, people in these areas have an extremely low reported incidence of peanut allergies. This may be partly due to different rates of peanut consumption among different countries and different testing and reporting procedures.
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