Statement by
Jennifer Merenda, RN
(410) 344-1058
To the Food
and Drug Administration Pulmonary-Allergy Drugs Advisory Committee
Re: BLA
103976, XOLAIR Omalizumab (Humanized Monoclonal Antibody to Human IgE) by
Genentech, Inc., for the treatment of allergic asthma
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Good afternoon. Thank you for your time today on this very
important issue and thank you for allowing me to testify before your
Committee. My name is Jennifer
Merenda. I am a registered nurse with
the R. Adams Cowley Shock Trauma hospital in
I have been waiting three very long years to tell you my story.
Since
birth, I have had restricted airway problems.
I spent the first two weeks of my life in the hospital because of
breathing difficulties. I spent most of
my early childhood years restricted in my activities, as medication to treat my
chronic symptoms was not available.
Instead, avoidance was supposed to be the best treatment, which was good
in theory but was not practical in real life, especially for a child. I awakened many nights suffering with
shortness of breath and made frequent retreats to my parents’ room for
assistance. I spent every Wednesday
afternoon and every Saturday morning in my doctor's office for a minimum of one
and a half hours while I received my allergy serum injection. I endured tenderness and swelling at the site
that resembled an egg beneath the skin surface.
Winter nights were spent in my bedroom with a vaporizer and frequent
chest physiotherapy. I would be sent
home from school because I "looked" like I was having too much
trouble breathing, even as I pleaded to stay.
I
stopped allergy injections in my early teens as there did not seem to be any
real benefit. I began to use Primatine
Mist as that was the most useful over-the-counter medication at the time. I grew tired of the doctor’s office. As I grew into my late teens my breathing and
allergies worsened. I was tired of
medicine. I was tired of reading every
food label. I was always taught to deal
with my health problems and not use asthma as an excuse. I didn’t want sympathy from anyone. I would rather enjoy life, wheeze, take my
inhaler and move on. I guess that was
part of being a teen.
At
the age of 17, I finally realized that my asthma was not controlled. I began my allergy injections again and was
prescribed Theopholine twice a day with Ventolin for breakthrough wheezing. While both drugs certainly helped my asthma,
I experienced several side effects.
Eventually I changed to a sustained release form of the Theopholine and
had more control, but again, not without the side effects. Along came Serevent, and though I
continued to have my problems, I felt it was under control. Little did I know what control could be,
however, until a friend of mine with asthma told me about a new clinical trial.
When
I joined the Xolair trial in August of 1998, I was told the FDA did not yet
approve the drug being tested, but that if I got the drug instead of placebo I
would most certainly see improvement.
Truth is, I didn’t feel like I had anything to
lose and my expectations were quite low.
To qualify for the trial, I had to stop current medications. This was the most difficult part, as I had to
restrict my activities because of shortness of breath. I couldn’t even walk a flight of stairs.
I
can’t emphasize enough for you my surprise with this miracle injection I began
to receive. I did not experience any local
effects at the injection site and my asthma symptoms were completely
alleviated. While I received the Xolair
injections, I experienced the life of a normal person. I say this because prior to Xolair, people in
my life would say "you're breathing heavy again" or "I can hear
you coming around the corner before I see you."
With
Xolair, I stopped clearing my throat and coughing frequently. I could go anywhere without the fear of
losing my inhaler. I was no longer
concerned about needing to have an inhaler in every coat, in every pair of
pants, in my car, or in a relative’s home.
I was not afraid to go on vacation and be without a nebulizer
machine. I did not make noise breathing. I slept quietly. I did not walk around with my mouth
open. I did not have to worry about
restrictive clothing. My nose worked and
was no longer what I refer to as "purely cosmetic...serving no
function." I was truly free. For the first time in my life, I felt like
everyone else did not have his or her "eyes of concern" focused on
me.
I
told you in the beginning that I’ve waited three long years to tell you my
story. That’s because when the Xolair
clinical trial ended three years ago, I immediately returned to a life of daily
asthmatic symptoms. I felt I had something
great and now it’s gone. I am a
registered nurse. I work in a center
that is known worldwide. I continue to
praise this miracle drug to physicians and colleagues that I work with
daily. I field questions from other
patients about the drug that once relieved me from the misery of my
asthma.
And
as a nurse, I’ll be the first to say that prevention is where health care
starts. Prevention is what Xolair is all
about as far as I'm concerned. The fact
is, it is difficult for patients to understand why a
drug that has demonstrated so much promise has not been approved yet. I continue to be asked by my colleagues, and
by my family and friends, about where the drug is currently in the approval
process. I not only think of myself
though. I think about how many emergency
room visits for people with asthma could be eliminated. I think of my son and the potential for his
life to be free from continuous medication and constant fear. I look to the future and hope that many more
people with asthma will know what it means to lead a normal life. I sincerely believe Xolair can provide that
freedom. I urge you today to recommend
that this drug be approved.
Again, thank you for your time and for allowing me to share my story.