*Please note: All factual statements made in this article come from sources that are linked at the bottom of this post.
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You have most likely heard about the new "peanut pill" by Aimmune Therapeutics that is on track to be approved by the FDA in January 2020. Many people have been getting excited by this.
Aimmune is a biopharmaceutical company partly funded and largely supported by food allergy non profit organizations and was founded in order to create a standardized oral immunotherapy product and protocol for the purpose of treating food allergies.
What they created is now known as the peanut pill, which in simple terms, is a pill capsule with slightly roasted peanut flour inside. The capsule is meant to be broken open so that the patient can then mix the peanut flour with a food of choice, such as applesauce or melted chocolate. This is the main product.
As for the protocol, the dose of peanut protein (from the peanut flour) is increased every two weeks to reach a maintenance dose of 300mg daily. Just for reference, 300mg is roughly equal to one peanut. Increasing the dose is known as the updosing process, and once 300mg is reached, that is considered a maintenance dose, which is then required to consume daily for life. This process is known as desensitization.
The main goal of this protocol is to "reduce the frequency and severity of allergic reactions in case the person is accidentally exposed to peanuts". This implies that the goal is not to reach complete tolerance, known as free eating.
According to data published by the New England Journal of Medicine, during one of the clinical trials conducted, 98.7% of patients in the active-dose group had adverse events, meaning that they received the actual peanut flour and had allergic reactions. Symptoms that were not considered to be dose-limiting, which suggests that they were not considered to be severe, included any symptoms related to the gastrointestinal tract, the respiratory tract, or the skin. The trial found that the effects in patients between the ages of 18-55 were not significant, meaning the desensitization had no significant results on this age group. Furthermore, patients with severe or poorly controlled asthma or with chronic gastrointestinal symptoms were excluded for safety reasons.
Thus, the peanut pill is being made available only to patients aged 4-17, and according to the institute for clinical and economic review (ICER) it is expected to cost $4,200 per year.
After reading all of this information, you are probably thinking: this is amazing! Children will be able to gain at least some tolerance to peanuts! This is groundbreaking.
But why are large food allergy organizations spending large amounts to fund and promote protocols like these when there are safer and much more effective treatments for food allergies already available?
With two safe and effective protocols already being used worldwide: private practice oral immunotherapy and the Tolerance Induction Program, questions about why organizations invest in protocols such as Aimmune are brought to attention.
Private practice oral immunotherapy (OIT) has been successfully used to treat patients of all ages - even patients 65 years of age. OIT has been used to treat all food allergies, not only peanuts, and it has helped patients reach a higher tolerance level than what is achieved with Aimmune's protocol. Protocols for private practice OIT vary - although some protocols only get to a level to protect from incidental exposure (i.e. one peanut like Aimmune's peanut pill), more protocols are now moving the patients to a higher level where they do not have to avoid the food any longer.
OIT is being done by hundreds of board certified allergists across the United States, and is also successfully and safely being done in other countries worldwide, such as Israel. Although there are some limitations on who is a candidate, just like there were in the Aimmune clinical trials, OIT treats all ages and all foods.
Another treatment option is the Tolerance Induction Program (TIP) by Dr. Randhawa from the Southern California Food Allergy Institute. The primary goal of TIP is to allow the patient — who is anaphylactic to any food (or multiple foods) – to freely eat unlimited amounts of that food, without any symptoms or side effects. More than 3,000 food-allergic children have graduated from TIP, and the program has more than 10 years of experience with a success rate of over 99%. Keep in mind that this is more than three times the amount of patients that Aimmune has ever treated in their clinical trials.
Unlike Aimmune or OIT, the program (TIP) welcomes all cases, including those with severe asthma or gastrointestinal issues that are not accepted by other protocols. Unlike OIT though, TIP does have an age limit of 21 years old for new patients, meaning that new patients must have their first appointment by the age of 21.
So why are these treatments not approved by the FDA if they are so successful? The short answer is because the FDA only approves drugs and products, they do not approve processes. Desensitization is a process involving food, not a drug. These protocols do as much as they can to be regulated - for example, TIP patients undergo complete biomarker analytics utilizing the clinic's own federally regulated facility.
In order to make desensitization FDA approved, Aimmune took peanut flour and put it in a capsule technically making it a drug. These capsules filled with peanut flour will now be selling for $4,200 per year (as predicted by ICER). For a similar price, you can reach free eating with either OIT or TIP, and for more than one food.
How important is FDA approval truly? Donald Light, a researcher at the Harvard University Center for Ethics, wrote an article just a few years ago about why the FDA should not be trusted as it was in the past. He states, "The bar for “safe” is [equally] low, and over the past 30 years, approved drugs have caused an epidemic of harmful side effects, even when properly prescribed... the FDA has sped up the review process with the result that drugs approved are significantly more likely to cause serious harm, hospitalizations, and deaths. We can no longer trust the FDA to carry out its historic mission to protect the public from harmful and ineffective drugs".
Michael Elashoff, an ex-FDA biostatistician, revealed that "The people in charge [FDA officials] don’t say ‘Should we approve this drug?’ They say ‘Hey, how can we get this drug approved?'"
As a food allergic patient myself (*not a medical professional*), the following thoughts are what I have on Aimmune's peanut pill.
With the cost of Aimmune versus the cost of private practice treatments, I find it difficult to understand why someone would spend a large amount of time, effort and money to be somewhat safe from cross-contamination to peanuts only, when there are programs out there that get the patient to free eating, for all foods, in less than half of the time, with significantly less reactions. You can probably also buy the same peanut flour used in the Aimmune capsules for $5 at Costco.
Another concerning factor is that one of the main goals of the peanut pill is to standardize the protocol. But it is the exact opposite that is responsible for the high safety and effectiveness of OIT and TIP. The fact that these two private practice treatments are successful is in large part because they are highly individualized rather than standardized.
Having a treatment that is approved by the FDA is a huge positive step in the right direction. It opens the doors to more doctors feeling comfortable to offer treatment, which is important. So maybe we as a community need to shift efforts as to what we focus on getting approved by the FDA. I believe that if we are able to find ways to get OIT, as it is currently practiced, and TIP approved by the FDA, this would have a much greater impact.
We also need to remember that peanuts are only one food out of HUNDREDS that people are allergic to. Yes, they are part of the top eight food allergens. But what about the other seven? And what about the hundreds of other foods that millions of people all over the world are allergic to? Although a treatment for peanuts solves some of the problem, we need to focus on an approach that solves the problem as a whole.
Choosing whether or not to pursue treatment for food allergies is a very personal decision, and choosing which specific treatment to pursue is another even more personal decision. At the end of the day, all of us with life-threatening food allergies want the same thing: to be safe. We need to remember that we are a team and that we are here to support each other.
Just remember to do your proper research, get the facts, and decide what is best for you after you have all of the information!
If you want to read an article I wrote a few months ago regarding the five different approaches to food allergies, CLICK HERE.
To watch my food allergy documentary film, Risk At First Bite, CLICK HERE.
To learn more about my personal food allergy story, CLICK HERE.
REFERENCE LINKS TO ALL FACTS STATED IN THIS POST:
DISCLAIMER: I am not sponsored by any type of professional, non profit or medical organization to write this article and share my opinions, including and not limited to the FDA, Aimmune Therapeutics, Food Allergy Research & Education, the Southern California Food Allergy Institute, Business Wire, Harvard University, etc. All facts are taken from the above links and all opinions are my own, as a 25 year old food allergic patient, and not financially influenced by any of the above organizations.
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