Diana Oh

IR-2/11AP
1/5/18
Turn in Number: 10
Interview #2
Interviewee: Dr. Glenn M. Silber M.D.
Workplace: Allergy & Asthma Center of Central Maryland
Title: Allergist, Medical Doctor
Date of Interview: January 4, 2018

The first few minutes consisted of general greetings and asking for permission to record the
interviewee and the conversation.

DO: My first question is: Do you think oral immunotherapy is worth the risks it comes
with from your point of view?

GS: So I think that the answer is unknown at this point. I think that it is still
controversial and there are some people that are doing it and some who are
actively against it and most people are sitting on the fence waiting for what their
results and studies continue to show.

DO: Ok, so from your perspective, what is making you very hesitant in agreeing that it
is a very good option.

GS: There is several drawbacks, one is the risk of oral immunotherapy in and of itself
with the risk of anaphylaxis, as been associated with some of the studies. The
other concern is that a fair number of patients who get the oral immunotherapy we
have dealt with, have developed eosinophilic, esophagitis; i don’t know if you are
familiar with that but it is esophageal infiltration of eosinophils which is a type of
blood cell, and that causes swelling of obstruction and stricture. And so they can
eat the food, not anaphylax, but then they get another disease which causes them
to stop the food as well. Then, the third thing is there is some group of patients
that although they don’t anaphylax, its still an adverse taste to the patient and so
to stay protected with oral immunotherapy, most studies say that you have to
continue to adjust the food on an ongoing basis. And I have some families who
the kids don’t anaphylax, but they refuse to eat it because even though they are
not having a full systemic reaction, they are having oral throat discomfort and
distaste, so they don’t like it because it doesn’t feel good. So, there are a couple
families where there is a battle: the parents want the kid to eat the peanut or
whatever the food is to become desensitized and the kid refuses to eat it and it
becomes very much a conflict. So basically it’s not proven across the board to be
safe, and is associated with other types of medical illnesses and it can be very
 much a conflict within the family to get the patient to take the food. Now the flip
side of that is, there are people where they have no systemic reactions, and it’s a
Godsend and they think it's the best thing ever. The trouble is knowing who on
the front end doesn’t anaphylax versus the one who is going to anaphylax. Now if
you could do that, that would be much more valuable than it is right now. So I
think most people nationwide are kind of waiting to see what the experts in the
field recommend. Even that’s controversial. Some researchers say its ready for
primetime, and some researchers like Dr. Wood at Hopkins are a little bit more
resistant to doing it due to the known side effects.

DO: Ok. And then, another thing I wanted to ask is, in a very practical and logistic
sense, is it very difficult to carry out the procedures just in clinics?

GS: I can. Offices that aren’t partnered with universities. It is because the risk of the
procedure is anaphylaxis and even though we deal with that… we do allergy
shots, and other things, food challenges that have the risk of it, it’s much easier to
treat if you’re at Johns Hopkins, or a University of Maryland, or a place where
there is a theatiatric ICU right up stairs, and so it is more dangerous to do it in the
office, because you don’t have the medical backup that you have in a research
university setting.

DO: Ok, then, is there any information for you to say that it is an effective treatment;
what information would you want in the future to make that choice.

GS: So, I don’t think that there is much controversy that it can be an effective
treatment. I think the concern is that is it a safe treatment? So you’re looking at
the risk benefits of it and you’re saying, “ok, you could live your entire life
without ever eating peanuts (using peanuts as an example), it’s not essential, it’s
not a nutrient that you have to have.” If one kid dies from oral desensitization, is it
worth it to have 400 who get desensitized? If you put a hundred kids on OIT, and
25 anaphylax, and even if they don’t have a fatality, they have to use the epi and
IV’s and sometimes get transferred to the ICU or to the ER, what is the point
where the number of reactions vs the number of people who don’t react is worth it
to society when this is a food (WOOOOFFFFFFFF) you don’t need to eat, but if
you want to maybe prevent anaphylaxis in the future, but you’re going to incur
the risk of anaphylaxis by using OIT. So you are kind of saying, I don’t want to
anaphylax in the future, so I’m going to go through a procedure now that might
put me to anaphylaxis, and so you can see where I'm saying it’s not like a lot of
things you do where there is only benefit and no risk. And so that is a no brainer,
 if you want to take an inhaled steroid for severe asthma; virtually no problem with
any of the medications being unbelievably unsafe, and the alternative of
uncontrolled asthma is extremely dangerous, here we’re dealing with a problem
that is a potential problem, not a day in day out problem. And the therapy has risk.
So, if you are with the family that anaphylaxes during the oral desensitization,
(WOOOOOOOOF) and most of those people just continue if they anaphylax and
they don’t want to go through that again. Was that worth it to allow 20 other kids
to become desensitized to a food that is not essential for their well-being. That’s
why it’s such a difficult thing. If this was a disease, someone has cancer, and you
do a new chemotherapy, and find that 5% of people die from that chemotherapy,
but 95% survive, but if you don’t do the chemotherapy, you are going to have a
75% fatality rate, within 5 years, well that makes perfect sense. Yes, some people
die from the therapy, but a whole lot more die from the disease. Here you are
giving a therapy that has risk, for a disease that may never be a problem for a
medical condition, and may never be a problem.

DO: This is off the topic of OIT, but do you believe that research should be focused on
finding a treatment or cure for allergies, specifically food allergies, or looking to
find the mechanism, biological mechanism, behind it?

GS: Well i think that they are interrelated. As we know more about the mechanism, we
now have better ideas of ways to block that mechanism. So i think that the basic
science leads to studies in the future and so i think you have to have the basic
science, you have to understand mechanism. You have to understand what’s
influencing the those mechanisms so you can then alter it. It’s kind of like 50-60
years ago, we didn’t know that allergies were caused by an immunoglobulin
called IgE. That was discovered at Hopkins in the 60’s. Now, we have medicine
that blocks IgE. We have xolair and things that can make IgE go away or at least
not permanently, but as long as you take the medicine, we can block it. What we
never known that if someone hadn’t discovered IgE. So, learning the basic science
sometime is essential to having opportunities to have disease changing therapies
whereas sometimes people just get lucky and find stuff fortuitously like penicillin.
But, most of the time, you make a discovery on a mechanism and that gives you
the opportunity to invent a therapy that takes that mechanism and alters it in some
way.

DO: Ok. And then another question I have is, I think on the topic of xolair, I was
talking with Mrs. Mudd about that and she mentioned that there is a black box
warning on it?
GS: Yes, there is a black box warning when in first came out. But, it’s probably a no
consequence. When they did the initial study, 0.5% of people in the control group,
so its less than 1%, had malignancy y in the control group, and 0.9% had a
malignancy in the treatment group. So, there was a black box warning, but when
they took this study to all the cancer doctors, they said that 0.9 is the average, the
normal, the 0.5 in the control group just by chance was a little bit lower than
normal. So that it made it look like there was a difference, but there wasn’t a
difference. There was a following. There are now over 100,000 patients treated
with zoler, and its been in the market for over 10 years, and there’s no evidence of
malignancy, It still carries, the black box warning, but its not a true concern due to
the follow up studies and the number of people that are now on it and the years of
therapy that have been given. So, it’s there but, no one gives it any significant
worry.

DO: Ok, because Mrs. Mudd was mentioning how they use it quite often.

GS: Yes, it's so safe and the FDA recently, it was approved when it came out for ages
12 and above, and the FDA has recently extended that to the use for ages 6 and
above, and they hardly ever pediatric drug less, it has unbelievably great safety.
Because kids with different metabolisms are different and they wouldn’t extend it
to lower ages unless it had very very strong safety. But, I wouldn’t want to worry
about that, but zoler only works as long as you use it. So if you use it for two
years, its great, and if you stop it it comes right back. The other thing about zoler
is that the price, it’s a brand name and there’s no generic, its expensive. And,
there have been some people who have had reactions zoler, because it is a drug
used to prevent allergic disease and some people have had anaphylaxis to zoler.
So, in our office, I bet we have I’m guessing 400 people on zoler, but we are
following 50,000 patients, so where zoler is currently only approved for severe
poorly controlled asthma and chronic urticaria. But it’s not approved for food
allergies. And the reason for that is, there was a study that was started looking at
zoler with food allergy, this is going back about 8 years ago. And, the way the
study was set up, was they were going to do a food challenge and determine the
dose where someone reacted to peanut. And then they were going to put them on
zoler and do another food challenge. After a few months of zoler, and see how
much more peanut they could tolerate before they reacted. But, in the
pretreatment challenges, there were a couple cases of people having near fatal
reactions. So, the company said, wait a minute, this is too dangerous. We don’t
want to continue this study. And we will just forget about trying to get any
 indication for zoler on food allergies. So they went down the path of doing it for
asthma, instead because they didn’t have to do food challenges to get that
indication. And so it came out onto the market for asthma, then eventually came
out on the market for hives. But, even though it blocks all allergies, whether it’s
food or pollen or drug allergy, it blocks it all, but it is only approved for asthma
and hives.

The conversation goes on to speak more on the topic of the future of treatments and
desensitization in general. (WOOFFFFF) indicates an interruption caused by the interviewee’s
pet dog, which caused slight disturbances in the recording.
 Reflection

Overall, this interview had many more “speed bumps” and hold ups, mainly due to the

timing and my allergist’s busy schedule. However, we managed to make things work, and he

made time for me to get my interview in. The interview was very helpful for my project and

outlook on the topic because I was provided a different mindset on oral immunotherapy. My

advisor is a researcher, so her guidance and information is based off a researcher’s point of view.

However, Dr. Silber as an allergist who constantly works with a larger variety children and

patients has a very different view on the risks of the treatment. He knows the practicalities and

logistics of the treatment if it were held in private clinics rather that a large hospitals or

university connected clinics. This gave me a clearer idea of the improvements the treatment

needs before it can be implemented for patient use. This will help guide my paper and my project

in the future.

For my next interview I plan to research more about the concerns of those implementing

the treatment in clinics. I want to ask other nurse and allergists involved in the actual process

how difficult the procedures are to carry out and maintain consistency. Another potential

interview I would like to do is with a parent or a child that is currently participating or has

participated in an oral immunotherapy. This would give me a good view on what people are

expecting and what they need from the treatment itself.

There were a few disturbances during the interview, mainly the interviewee’s dog, which

made his arrival known with many woofs in the background. However, besides that the interview

was very interesting and went fairly smoothly. The information shaped my paper further and

provided a different view of my topic.