Hugh A Sampson, MD
Mount Sinai School of Medicine; Jaffe Food Allergy Institute
Food allergy has become a major health problem in westernized countries, now affecting approximately 3.5% of the U.S. population, or about 12 million Americans, and is the leading single cause of anaphylaxis treated in U.S. emergency departments. The standard of care for dealing with food allergies has been to educate patients and their families how to avoid allergenic foods and to recognize and treat allergic reactions if they have an accidental ingestion. In the past 5 years, there has been a growing interest in oral immunotherapy (OIT) for treating food allergy, a practice that was first reported in The Lancet over 100 years ago in an article called “A case of egg poisoning” [Lancet 1908; 1:716]. Considerably more recently, several small clinical trials of OIT for milk, egg and peanut allergies have yielded some promising results, and some practicing allergists have even begun using OIT to treat food-allergic patients.
I certainly can’t fault the desire of patients and patients’ parents to seek relief from the difficulty of managing a severe food allergy (and who pay for these treatments out of pocket). However, I wish to caution that widespread adoption of any OIT methods is premature, and may lead to crushing the hopes of patients, and worse.
Three carefully conducted scientific reviews* of trials have raised serious questions about OIT’s effectiveness, safety and long-term benefits, with the most recent concluding that “the overall low quality of evidence leaves important uncertainty about anticipated effects of immunotherapy due to very serious imprecision of the estimates of effects and the likelihood of publication bias for some of the critical outcomes.” In other words, we can’t judge on the basis of these trials whether it’s really working or not, or whether some researchers are getting the results they want instead of what the data really shows.
Our understanding of the underlying immunologic changes brought about by OIT is very limited and published reports provide inconsistent results. OIT appears to induce “desensitization,” or a clinical state in which the quantity of food required to trigger an allergic reaction is raised while on therapy, in most patients. “Tolerance,” or the long-term loss of allergic reactivity following the discontinuation of therapy, i.e. “a cure,” has been reported in some OIT trials, but most of these trials lack the appropriate controls. Different treatments follow different protocols, creating apples-and-oranges comparisons. In some cases, we can’t distinguish whether improvements with milk are the result of the therapy or whether a child is merely outgrowing the problem, as happens with milk allergies about 80% of the time. In fact, the only OIT trial to date stringently controlling for the natural development of tolerance in food-allergic children failed to find a difference in outcome between treated and control subjects.
In spite of the reservations my colleagues and I have, there are many instances of what we might call “retail OIT” being offered by some practicing allergists. The history of medicine is replete with examples of how premature adoption of new techniques can go wrong. Drugs and technologies that showed “no harm” in trials have often proven to be problematic as they made their way into wider use. We are nowhere near that regulatory threshold with OIT.
Furthermore, administering an experimental therapy creates management problems. Even in a research setting, patients must endure much of the discomfort and reactions that make food allergies a problem to begin with, necessitating a good deal of after-hours support and encouragement; do OIT doctors provide that? And while I trust my fellow allergists to treat emergencies, proliferation of unproven therapies creates more and more probability of mishaps. How long before a patient who believes himself “cured” suffers because he has ignored elementary precautions?
At this time, oral immunotherapy should be considered a promising experimental treatment for food allergy, but proper well-controlled trials are needed to demonstrate that it is safe and effective before the FDA will approve it for general use by practicing allergists.
* [(1)Brozek JL, Terracciano L, Hsu J, Kreis J, Compalati E, Santesso N et al. Oral immunotherapy for IgE-mediated cow’s milk allergy: a systematic review and meta-analysis. Clin Exp Allergy 2012; 42(3):363-74;
(2) Sheikh A, Nurmatov U, Venderbosch I, Bischoff E. Oral immunotherapy for the treatment of peanut allergy: systematic review of six case series studies. Prim Care Respir J 2012; 21(1):41-9; and
(3) Fisher HR, Du TG, Lack G. Specific oral tolerance induction in food allergic children: is oral desensitisation more effective than allergen avoidance?: a meta-analysis of published RCTs. Arch Dis Child 2011; 96(3):259-64]
Dr. Sampson is the Kurt Hirschhorn Professor of Pediatrics and the Dean for Translational Biomedical Research at the Mount Sinai School of Medicine in New York, and the Director of the Jaffe Food Allergy Institute at the Mount Sinai Medical Center. Dr. Sampson’s research interests and publications have focused on food-allergic disorders including the immunopathogenic role of food hypersensitivity in atopic dermatitis and anaphylaxis, characterization of food allergens, and immunotherapeutic strategies for treating food allergies. His research has been funded continuously by a number of grants from the National Institutes of Health and private foundations. Dr. Sampson is the principal investigator of the NIH-sponsored Consortium on Food Allergy Research and an AADCRC program project conducting a number of clinical trials investigating novel therapies for the treatment of food allergy and investigating basic immunologic mechanisms. He has published over 350 articles and 60 book chapters on food-allergic disorders and co-edited four books, and was elected to membership in the Institute of Medicine of the National Academies in 2003 for his research on food allergies. Dr. Sampson is past chairman of the Section on Allergy & Immunology of the American Academy of Pediatrics and past president of the American Academy of Allergy, Asthma and Immunology.
Thank you for clairifying this! I have noticed on many online message boards that people are active in this treatment and I thought it was still in the experimental stages.
People need to know facts when considering treatment options.
Compelling and significant editorial from an eminent food allergy scientist, clinician, academician and leader. Treatment modalities under study need rigorous, longitudinal research as to their safety/effectiveness. There are major differences between patient participation in a clinical research protocol with informed consent of risks versus premature clinical use of therapies not yet fully evaluated. Dr. Sampson’s cogent editorial and precautionary tone is very appreciated.
~ Anne F. Russell BSN, RN
Oral-immunotherapy has an 80-95% success rate. That is unheard of in clinical studies. As a mother with a child in the maintenance phase of desensitization, and the creator of Peanut Anaphylaxis Cure fb group, I would like to share that the private doctors who are offering “retail” desensitization, either set up and ran the clinical studies for years and/or are working with leading allergists who have extensive experience in desensitization–practicing and teaching. They didn’t just fall off the turnip truck yesterday. They are qualified. We have a Desensitization Directory in our fb group, for anyone interested in locating a clinical study or private doctor for desensitization treatment.
My son was diagnosed December 2009, with a life-threatening peanut allergy. He was 4. We were told to avoid peanuts, treenuts, and take great caution with all foods, restaurants, schools, public places where food was present, family and friend’s houses, etc… and keep epipens handy for the inevitable reactions. Every surface in society, every food, drink and smell became a ticking bomb for us. When would the ax fall and would we be ready and able to save him?
We were not willing to sit around and wait for those potentially life-threatening reactions while researchers fiddled around with “what-if” scenarios. We studied the findings of decade-old studies that concluded that OIT is “safe and effective.” That it “.creates a molecular change in the blood and the allergy just goes away.” (Burks). Our only challenge was finding a doctor who would treat him. We needed to make an appointment. Our local allergist referred us to Dr. Scott Nash in Raleigh, NC.
Some folks travel more than 14 hours one-way every week or two, seeking help from the scarce amount of doctors who have risen to the occasion of the millions of children suddenly stuck in this recent food allergy epidemic. We relocated our family to NC for a year to undergo treatment with Dr. Nash. We are not talking discount druggist with a desensitization kiosk at the mall. We checked his qualifications at Duke and Cincinnati Children’s– from which he came highly recommended by the Head of Pediatric Allergy, Asthma and Immunology at CCH who said, “He will probably be able to do it”–(make the allergy go away.)
And do we really want to talk about how doctors get paid? The NIH certainly isn’t handing them millions of dollars to tell the rest of the world to keep “managing” their child’s life threatening medical condition while they plays around with herbs and patches–which to the best of my knowledge, there is no indication from either potential treatment that a person will ever be able to safely ingest their allergen. And who knows the long term effects of the patch, herb, xolair, etc… We have a pretty good idea already and it’s NOTHING compared to eating a peanut that you have become desensitized to–you are not going to develop diabetes because you are eating 8 peanuts a day. There are enough real threats without researchers trying to make us scared of our own shadows. Considering the day you begin oral-immunotherapy, you are all that much better for it, we would have gladly paid double. Thankfully, private desensitization doctors are not in it for the money. I have seen their cars. Some do not even get paid relying on their allergy/asthma practice to pay the bills for the food allergy clinic. They are not opportunists. To their patients, to their mothers and father and siblings, they are heros. And in their modesty, they are only doing their job. They are DOCTORING–measuring doses, spending countless hours with the entire family, waiting, watching–everything that probably happens in the clinical study setting.
The glory of private-practice outpatient service is that treatment is tapered to the individual patient instead of having a strict protocol subject to a review committee with an agenda of collecting data and avoiding lawsuits. Does that explain the animosity from the researchers? Perhaps they are worried that if there were more private practice doctors offering desensitization, no one would join the studies?
Dr. Sampson did not cover it but the way OIT works is they start around 1/1000ths of a peanut (for peanut) and slowly, over time, the doctor increases the dose until the body learns to accept the allergen. That’s it. Again, the success rate is 80-95%, depending on study location. My son has never had a reaction in treatment whereas we are lucky to have him alive considering his reactions before OIT. Of course, it is because Dr. Nash (and the others) know what they are doing. He didn’t suddenly outgrow his allergy. They say only 20% of peanut-allergic children outgrow their allergy.
Prior to desensitization treatment, we requested component testing which indicated that my son’s blood reacts to Ara h1 and Ara h2 proteins of the peanut– two of the 4 “high-risk” peanut proteins associated with the most severe reactions. And two “markers” that indicate he will not outgrow his allergy. In the lab they created anaphylaxis in his blood within 2 minutes. His history of reactions combined with his blood test results were enough to make him a good candidate for desensitization. “The most severe need it more”–because we know what is coming.
My son and hundreds of others are now consuming 8 peanuts a day, or cups of milk, or eggs, that would have once killed them. And they are doing so safely under the supervision of licensed immunologists. The only person who has died in “desensitization” treatment was in a HOSPITAL setting, Jewish-National I believe, when a patient received an injection of a full peanut dose when they should have received the placebo. So kettle, you are black.
Study on researchers. But to discourage and prevent licensed immunologists from doing their job and fulfilling their oath to help their patients, is beyond shameful. To urge doctors and families to wait for FDA approval when there is no financial incentive for FDA approval for oral-immunotherapy so how likely is that to happen? They use applesauce and peanut flour (“off-brand”) so there are no drugs to manufacture. And frankly, we cannot afford to wait. I’m sorry to pop the proverbial profit-bubble, but in this complex and unfair maze of life-threatening food allergies, our only PROMISE for a “cure”/remission, whatever you want to call it, is oral-immunotherapy. We know it works!
Little girls are being picketed as they walk into their schools because the parents of non-allergic children want to pack peanut butter for lunch. Children are getting their faces smashed into lockers with peanut butter sandwiches–just to see what will happen. Children are being excluded from activities and forced to eat lunch alone or with a counselor. So not only is the classroom a danger zone for food-allergic children, because food has become more important than people, the rate of bullying by peers and even teachers, and the psychological and emotional damage that follows is staggering. How can doctors just sit by and not even TRY to help?
So, regardless if it’s Dr. Burks’s protocol or Dr. Wasserman’s protocol, at least it’s something. It’s having an 8-peanut tolerance and no longer being isolated or living in constant fear. It’s having milk spilled on your arm, and not dying. It’s still breathing when 300 bags of peanuts open at the same time on your airplane. It’s not dying on the bathroom floor at the mall because someone placed your sandwich on the same tray used to bake the cookies. It’s good doctoring.
What this article is really doing is dividing the food allergy families when we are all in the same position–at least until we are desensitized and/or have some level of protection. I’m sure somehow someway this all comes down to money. What would you expect, because one doctor says it’s not ready we are all going to quit treatment? Just ask yourselves where you would rather be–at trace amounts can kill my child or he has an 8 peanut tolerance?
Mom of another OIT child here, done with Dr. Wasserman in Dallas. I’m also a doctor and can appreciate Dr. Sampson’s concern for the need for good, reliable, consistent research data. I would love that also. But I was unwilling to wait for it while my contact anaphylactic daughter navigated the world. She was diagnosed in 2003 at 12 months old, and for 8 years lived the very restrictive, sometimes very scary life of keeping her safe despite our culture’s love of food at every event, our school’s refusal to see food in the classroom as a danger, and her constant exclusion from everything from class treats to birthday parties to our trip to China to adopt our son. How to explain thru the language barrier that nothing in her meal can contact peanuts? I wasn’t ready to risk her life trying.
We tried our very best not to be alarmist in our management of her allergy, but when the child at the pool walking around with a Snickers bar poses a physical threat to her, her outlook on life is different than the average child.
My daughter is now 18 months into her maintenance phase of OIT for her peanut allergy. It has been a life changing event for her and our entire family. She is safe. School is safe. Friends’ houses are safe. Travel is safe. She can experience the world without a filter of fear that most adults can’t even imagine. No child should have to live like that, and now she doesn’t.
I understand it may never be a permanent cure. I understand she may need her 8 peanuts daily for life. She, and I, are ok with that. To us, it’s no different than if she had any other medical condition that required daily medication.
I understand OIT is not fully researched. I understand we don’t know the long term ramifications. But as a mother who wanted what was ultimately best for her child, I chose a childhood without fear and exclusions over future unknowns.
Dr. Lori, did your daughter have the uKnow Peanut component test done? Wondering what her results showed. My sons life would be so different if he could tolerate 8 peanuts. WOW. Just thinking about it is like a dream.
No, she hasn’t. I’m not sure it was available when we started.
Yes, life is sooo different. For us, it wasn’t about her being able to eat peanuts, just not be at risk for contact or contamination in food. Truth be told she doesn’t even like peanuts. She takes the equivalent dose of PB and gulps it down with a swig of water.
My daughter says the day she started treatment was the best day of her life. This was an 8 hour day with a blood draw, grape koolaid flavored PN doses every 15 minutes, and a shot of epi at the end for a possible reaction (stomach ache only – I think it was all the grape koolaid.) She still says it was the best day ever.
She went to sleep over camp for a week last summer, and is repeating that this summer, along with a week at my best friend’s house 3 states over. That would have been somewhere between impossible and overwhelmingly nerve-wracking prior to OIT.
We are planning a trip to Europe next summer.
Life changing indeed! 🙂
?”In spite of the reservations my colleagues and I have, there are many instances of what we might call “retail OIT” being offered by some practicing allergists.” Dr. Sampson.
So, I’m guessing, Dr. Baker and his colleagues didn’t ask Dr. Sampson and his colleagues for permission to study and offer OIT? Do you think, by reading Dr. Baker’s bio below, he might know what he is doing? Perhaps he is actually capable of filtering good candidates for OIT, qualified to adminster the treatment, able to educate his patients about “elementary precautions”, provide bedside “after hour support and encouragement?” Wow, he might not even be financially-motivated. His wife might be a doctor and he really doesn’t have to work at all if he doesn’t want to anymore? Maybe he just wants to help his patients?
And if the hospital-based research doctors are concerned about the various protocols used by the private practice physicians, it would be rather easy for them to pick up a phone and discuss it.
Protocols change according to the needs of the individual patient in private practice. One way to ensure that up and coming allergists interested in participating in the ground-breaking treatment for life-threatening food allergies, is to publish a protocol that seems to work for the majority of their subjects.
Getting to know Dr. Baker:
Dr. James W. Baker was born and raised in Wisconsin. He attended the University of Washington where he received a bachelor’s degree in chemistry. After graduating from the University Of Wisconsin School Of Medicine in 1970, he completed a pediatric internship at the University of Vermont then returned to the University of Wisconsin for a pediatric residency. In 1972, Dr. Baker became chief resident and earned The Student Teaching Award. Under Dr. Charles Reed, one of the foremost allergists in the country, Dr. Baker completed an allergy and immunology fellowship before entering into private practice in 1974. For his 36 years of service in the Portland area, his colleagues named him “one of Portland’s finest” physicians.
Dr. Baker is board certified in both pediatrics and allergy and immunology and welcomes all patients seeking treatment for their allergies, asthma, and immunologic disorders.
Being involved in research of medications for the treatment of allergies, asthma, and immunologic disorders keeps Dr. Baker on the cutting edge with the latest treatments and medications.
All of Dr Baker’s well-trained and skilled nurses are RN’s. In addition, Dr. Baker employs a very qualified nurse practitioner.
Dr. Baker; Pediatric Food Desensitization, Allergy & Asthma Research
Baker Allergy Asthma and Dermatology is pleased to announce a new food desensitization program that can provide a long-term solution for patients with peanut, egg, milk, or other food allergies. At the end of this 3-6 month program patients should be able to consume these foods with no allergic reactions.
Video;
https://www.facebook.com/pages/Dr-Baker-Pediatric-Food-Desensitization-Allergy-Asthma-Research/194052480645784
Peanut Anaphylaxis Cure:
https://www.facebook.com/groups/peanutanaphylaxiscure/
Dr. Scott Nash–more than a “retail” clerk.
From http://www.nashallergy.com:
Dr. Nash has been recognized nationally for his research and care of patients with allergic conditions. He has written several articles published medical journals about allergy and immunology. He has also been selected to present frequently at regional and national meeting of allergists and immunologists.
Dr. Nash is a native of North Carolina. He received his undergraduate degree in Zoology from North Carolina State University. He attended medical school at the University of North Carolina at Chapel Hill. Following medical school he received training in Internal Medicine at MCV/VCU in Richmond, VA and then completed a pediatric residency at Cincinnati Children’s Hospital. After residency, he began work at Duke University Medical Center to specialize in Allergy and Immunology.
In the news:
Dr. Nash’s studies and findings on allergy and immunotherapy research have been featured in several national publications and news reports.
Beating Peanut Allergies: Oral Immunotherapy May Desensitize Allergic Children; Skin Test May Predict Who Will Outgrow (CBS News)
Food Allergies: Treatment or Cure? Oral Immunotherapy Offers Hope for a Cure (Suite101.com Media, Inc.)
Oral Immunotherapy Dampens But May Not Cure Peanut Allergy (MedPage Today and allergyware.com)
Food Allergy: Staying safe and looking ahead, presented at the AAAAI Annual Meeting in San Diego, CA (AAAAI)(ImmunoDefence)
Eating A Peck Of Dirt… (Peanut Company of Australia)
I’m glad to see this being publicly debated. I’m not a parent of a food allergic child, but I have, like Drs. Sampson, Nash and others had the privilege of specializing in their care for more than a decade now.
I don’t believe there is any valid reason to doubt that physicians on either side of this question are equally well-intentioned. I am the principal investigator of an active peanut OIT trial and two more, funded by the NIH, due to start this year. I did my fellowship training with Dr. Sampson at Mount Sinai from 2000-03 and was on faculty there until 2009 when I moved to Boston. So you would be correct if you guessed that my opinion is that OIT still belongs in the research setting, and not something available as a fee for service.
But I think that some may be wrong about why I have that opinion. I hold that opinion primarily because I am biased to believe that oral immunotherapy IS effective. It is precisely because of this desire I have to find that OIT is an effective therapy — the same bias that every parent, private practitioner AND researcher currently has — that it is absolutely necessary to conduct impartial and rigorous studies.
Almost everything that has been published on OIT to date consists of case series reports, not randomized clinical trials. The overall numbers are still small and the patient selection highly subject to bias. We do not know that the benefits of OIT outweigh the risks, who is most likely to benefit, who will fail or develop chronic allergic inflammation while taking it, or who would have outgrown the allergy without it but now never will. No scientific review conducted or expert panel convened has concluded that OIT should yet be offered outside of a trial.
I have no doubt that practitioners among us who are offering OIT are setting out to do good. But the data are not yet sufficient to conclude that they will be. Until we have that data, in my opinion nobody should be laying down money for this treatment.
I believe that I understand the desire parents have to do something proactive about as well as anyone who is not personally affected can. My practice and my research are very much informed by that desire. But not only is OIT not ready for prime time, its proliferation outside of the research setting may well undermine our collective capacity to ever determine its efficacy.
Dr. Shreffler, thank you the work you do. With respect, our children’s right to live trumps your need to know. For that matter, you could simple call the doctors offering OIT outside of the study setting and ask for their data.
Here is another mother’s response to Dr. Sampson’s article that she posted in our fb group. She has given permission to use as needed. And just to be clear, we encourage parents to seek treatment in studies and/or private care–whichever is available to them. I will gladly post all studies becoming available. Please provide contact information. The news will be well-received.
From Amy Skinner:
This truly upsets me and I’ll tell you why. As the mother of another OIT child, we have watched first hand this boy who just 15 months ago was so allergic to peanuts that literally going to a Church Christmas party in a building where they knew the precautions necessary for our peanut allergic son, didn’t end well. We got there and oops, someone walks in with a peanut covered cookie, and my son wakes from a sound sleep holding his throat, his next words.. “Mommy, my throat feels funny.” This night ended with a shot of epinephrine and an immediate trip to the ER.
This had not been an uncommon occurrence in our lives, even for people such as us who had been taught “the standard of care for dealing with food allergies has been to educate patients and their families how to avoid allergenic foods and to recognize and treat allergic reactions if they have an accidental ingestion.” We had been taught and taught well, but how about the rest of the planet??
Such occurrences happened regularly, and so, my son’s life was constantly in danger, and as a result, whittled down into this little tiny world that his Mom constantly controlled. A world where the school tried to keep him in a nut free classroom and failed, so they chose to send a teacher to our home to keep him safe. Confined to home, never having been to real school other than the first 6 days with 5 reactions, he had no friends, and even the church we all as a family loved had become off limits because of the number of OTHER PEOPLE who DID NOT UNDERSTAND THE PRECAUTIONS necessary to keep our highly allergic child safe. They had been taught, believe me, but clearly didn’t find it as important as we did, or just didn’t understand the gravity of our situation.
We clearly lived in this little bubble to keep our son breathing and alive, one that everyone told us we needed to get out of until they witnessed reactions for themselves and understood our dilemma.
Our son had so much anxiety surrounding food and social situations that on a journal page he wrote for his teacher, his exact words were “I don’t like to go places,” and “I like to stay at home.” Of course he did, home was his only SAFE place… free of peanuts and shots. Another such journal page started with “I am scared when..” and my son finished that with “when people chase me with peanuts.” Yes, sadly, it happened. Apparently this boy that did the chasing had never been educated in the standard of care for my son’s food allergy.
We heard of the OIT trials, and quickly, had to learn every single thing about them. Our lives and his depended on SOME KIND OF TREATMENT— NOW, or yesterday, not ten years from now when it may be too late. If a trace amount of peanut had come into contact with my son and I wasn’t there, would someone be there who knew what to do?! Could they save his life?
News articles filled my inbox weekly about similar children dying at school, children who HAD AN EMERGENCY PLAN, and whose parents and families had been “taught the standard of care,” and yet died anyway. Those children COULD NOT WAIT for MORE info about OIT, or more research, and my son could not wait either. He was struggling through, as were we.
We were trying to give our daughter some kind of normal life, as well as our son, but clearly, we were not living a normal set of circumstances.
When it came to OIT, even if it was NOT a cure, but could increase our son’s tolerance level enough for him to safely go to school, or karate, or church, enough to go to see family and not have their bird cage send him to the ER… we were interested, and knew there would be risks.
The truth is, we risked his life every time we went to the library, one such time he took a book off the shelf and ended up with hives all over his face.. and later that same day, took a trip to the ER for breathing difficulties. Seriously?? The library?! Our kid couldn’t go get books?!!!
So– with some risk involved, in our minds it was so much less than the very real risk we lived with daily, and so, started our journey.
We ended up at New England Food Allergy Treatment Center in CT in Feb of 2011. I had spoken to Dr. Factor before coming, and I knew there was a chance that our son may be too severe to go through the protocal. By this I mean, he had reacted to touch as well as breathing, his rast scores were greater than 100 several times, and he also has asthma, another complication.
As far as Dr. Sampson’s article.. I must get this out there for everyone who might be considering OIT to understand.. and I’ll quote him here; “there are many instances of what we might call “retail OIT” being offered by some practicing allergists. The history of medicine is replete with examples of how premature adoption of new techniques can go wrong. Drugs and technologies that showed “no harm” in trials have often proven to be problematic as they made their way into wider use. We are nowhere near that regulatory threshold with OIT.”
Dr. Factor, and all of the other Dr’s at this clinic are clearly NOT IN THIS FOR THE MONEY. When Dr. Factor bent down and talked to our 7 yr old, he quickly made a friend for life. He explained things, in terms our son could understand, and our son knew that this Dr, one whom he learned also had a nut allergy that day, WANTED TO HELP HIM.
My son should have been up to 6mg of peanut protein the first day, but, we ended up having to back up, and go forward and back up again. He had some tummy aches and vomiting, and so, we ended up putting him on a histamine blocking medication. As soon as we started this, the dosing got easier and my son was able to complete treatment at a slower pace.
We committed to taking him every other week, which meant a 6 hour drive, a stay at the clinic to be watched after dose, and then, a six hour drive home. We did this every other week for 15 months. He had some issues along the way, and so, a desensitization that should have taken 6 months took 15 months.
Do we care that our son took almost 3 times longer than the “norm,” no, are we thankful that Dr. Factor stuck by us, helping us every step of the way and getting us to the point we are at now? YOU BETTER BELIEVE IT. Do you think Dr Factor charged us three times as much when it took three times as long as other children? HE DID NOT. Clearly NOT a Dr. practicing “Retail OIT.”
Dr. Factor’s nurses loved on our son and family, and Dr Factor himself took calls from us, giving us a number we could always reach him at even when away from the office. I used it at least twice.. did he answer? You bet he did. This is not a man doing “retail OIT,” this is a Dr. giving new hope to patients AND FAMILIES through something he believes in, something we also believe in.
Fast forward to today, and I will say, our son, whom 15 months ago was considered to be severely peanut allergic, whom had been through anaphylaxis, who was afraid of so much in life, is a very different boy. We got to the “eating peanuts” part just 10 days ago, and in 10 days, we have seen this AMAZING, UNBELIEVABLE change in our son and in all of us. They had a party for him at the clinic, complete with ice cream cake and balloons. AGAIN, NOT A DR. IN IT FOR THE MONEY.
Our son has new confidence, and is wanting to go places and do things. We as a family have confidence and a new life!! He is eating peanuts every night, and he’s OKAY, no reaction!!!!!
This summer, he will be able to go to camp.. and in September, his mom will be doing a happy dance at the bus stop when the bus rolls up and he gets on!!!!!!! Will we have an action plan in place, yes. Will we still carry epi’s, yes, of course we will. Will mom and son be terrified of other children or going places.. I can honestly say for the first time ever, NO.
This Dr. and his amazing team have CHANGED THE COURSE of our son’s life as well as our family. Not 10 years from now.. and not when it may have been too late for our son, but for the last 15 months, one baby step at a time… and here we are.
What does my son think of the article? Well, he’s glad he’s never met Dr. Sampson, and thrilled to know Dr. Factor, who we refer to as “our Super Hero.” So, Dr. Sampson, thank you for giving me reason to tell our story and give accolades to a man unafraid to do what his heart tells him and NOT WAIT.
For so many children, the clock ticks as those around them don’t understand, and can’t possibly understand. Is an accident just around the corner… someone who hasn’t been taught what to do, or is there a team of Drs and nurses safely administering minute amounts in OIT to help these kids increase tolerance levels and encourage an amazing quality of life? ~Amy Skinner.
Although we agree with Dr Sampson’s comments that the long term implication of oral immunotherapy to foods is yet to be determined, we disagree with the conclusions and recommendations about the current use of oral immunotherapy. At a dedicated food allergy treatment center, we have been treating patients having peanut allergy using oral desensitization for 18 months and we have enrolled over 160 patients to date. We believe this is the largest single series of patients receiving oral immunotherapy to peanut.
Additionally, we have participated in an IRB approved study on the safety and efficacy of our treatment and have presented data on method, results, and improvement in food-specific quality of life in patients receiving oral immunotherapy to peanut. The quality of life data is now in press. The protocol we have used is very similar to those studied by researchers at Duke University (Burks et al.) and the University of Arkansas (Jones et al.) that are part of the NIH food consortium. We defined as our goal to reduce anxiety of patients as a result of consuming foods containing a small amount of peanut, such as accidental ingestions and contamination. We felt that allowing the patients to eat the equivalent of three peanut M&M’s would accomplish our goal.
Based on the published data, our goal has been to ‘desensitize’ and not inducing ‘tolerance’ (attempt to cure) these patients since the results have not been very convincing in this regard. Our experience with peanut desensitization by board certified allergists at a clinical center devoted to this treatment alone has been very convincing regarding the safety and effectiveness of our treatment.
The protocols we have followed are not without adverse effects. In fact, gastrointestinal symptoms during the build-up phase of our treatment are relatively common. These symptoms are managed by dosing reduction and/or modification. The great majority of these patients have had a resolution of symptoms and are able to achieve the maintenance dose. None of our patients have experienced anaphylactic reactions requiring epinephrine during the build up to maintenance. We have observed more significant reactions requiring epinephrine in 12 cases/76,000 total maintenance doses administered (an incidence of 0.03%). These reactions were associated with specific circumstances such exercising too soon after receiving oral maintenance dose, menses, viral or febrile illnesses. This experience has helped us better manage our patients on maintenance therapy, and hopefully add to the literature in safely treating peanut allergic patients receiving oral desensitization.
The positive effects on perceived and real quality of life have been clinically and statistically significant, for children, adolescents as well as parent perceptions of their children’s experience. There are countless examples of patients’ testimonials who have commented how oral desensitization to peanut has ‘changed their life.’ These experiences are real and poignant, and patients have not had any regret in participating in this treatment. We also know that many patients with peanut allergy suffer from significant psychosocial impairment as a result of this diagnosis. This is of great concern. The positive effects of peanut oral immunotherapy may mitigate these effects.
Any new therapy raises a lot of issues especially in the context of limited controlled clinical studies. This does not mean, however, that a modality of such benefit be set aside until all the requisite assessments are completed. There a many examples of treatment that have not been examined extensively by researchers yet are accepted forms of treatment. Even in our field, treatment such as inhalant immunotherapy and drug desensitization, are examples of this. Furthermore, full understanding of the ‘immunologic changes brought about’ by these treatments has not precluded their effective and accepted use.
I am somewhat taken aback by Dr Sampson’s reference to ‘retail oral immunotherapy’ as if the treating patients with oral immunotherapy as being motivated by some degree of recklessness and greed. This discounts the fact that we truly believe what we are doing is the right thing for our food allergic patients. In the absence of grants or other institutional sources of funding it is necessary to seek payment or reimbursement. It should be noted that the five board certified Allergist who are conducting this study are receiving no monetary remuneration. We assume that Dr. Sampson and his colleagues do receive compensation. Concerning his comments about management problems and ‘after hours support and encouragement ‘, we are all private practitioners and we are very used to providing this for our patients. We don’t have study coordinators or fellows handling these problems. We are available 24 hours a day. In addition all the nurses in our center have children with food allergies and therefore can relate very well to our patients. Concerning the management of severe allergic reactions, I feel that we are just as competent in recognizing and treating mishaps as Dr.Sampson and his colleagues. We too, are working to get a better understanding of these reactions, and how they can be prevented.
We have been doing food challenges, antibiotic challenges and drug desensitization for years. One of our physicians made a significant contribution to the field of penicillin allergy by demonstrating that patients could be tested for penicillin allergy electively, in spite of the recommendations of those in academia that it should not have been done. When he embarked on this venture he was seriously criticized by the experts in the field. Today his approach is the standard of care in the evaluation of this condition.
Although as Dr Sampson points out that ‘the history of medicine is replete with how premature adoption of new techniques can go wrong’ where is the evidence for that thus far? Treatment of food allergies by OIT is still ongoing in much the same way at research centers. It is also true that those who push forward with newer therapies open the door for those who otherwise have limited options.
As Emerson stated, “Do not go where the path may lead, go instead where there is no path and leave a trail”. We believe oral immunotherapy has shown more than just promise in our patients and advocate its ongoing use in clinical practice.
Jeffrey M Factor MD Louis M Mendelson MD
Mitchell R Lester MD Joseph Sproviero MD PhD
Jason O Lee MD