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Testimony of Patricia (Patti) D. Costa, Executive Director, HGF, and her daughter, Nicole Costa, on Tuesday, June 10, 2003, at the meeting of the FDA Endocrinologic and Metabolic Drugs Advisory Committee, which recommended the FDA (Federal Food and Drug Administration) approve Eli Lilly and Company's (Lilly) supplemental new drug application (sNDA) 19-604/S-033 for the use of recombinant growth hormone by non-growth hormone deficient children. Nicole's testimony follows Patti's.
I am Patricia Costa, the Executive Director of the Human Growth Foundation located at 997 Glen Cove Avenue, Glen Head, New York. The Human Growth Foundation is a non-profit organization that has been in existence for 38 years. Our mission statement is: The Human Growth Foundation helps children and adults with disorders related to growth or growth hormone through education, research, support and advocacy.
We receive our funding from Membership dues, the Combined Federal Campaign, United Way, health care providers, pharmaceutical companies including Eli Lilly, several private foundations and many individual donors.
O n May 9th, I read an email from one of our members on the HGF Peds List, which is one of our Internet List Support Groups. In her email, this member stated that her child's pediatric endocrinologist had told her that a new drug application for rGH was being considered for use in children who were not growth hormone deficient. Prior to viewing this communication from one of our members, I had been made aware of this application at a meeting from a doctor at Eli Lilly. Our List Administrator looked further into the matter. He found additional information and posted his finding along with the FDA website on this list. I then spoke with several of our Board Members who felt that it was important for us to have a presence here today, to speak on behalf of children who would benefit from this application.
When I started to prepare this statement, I knew that all the clinical data, studies, and the testimonies of the experts in the field of growth would have already been heard and recorded. I am here today to ask all of you not only to consider the medical data before you, but also when making your decision on this application to measure the psychosocial well being of these children of short stature. Every year we receive hundreds of inquiries from parents who are concerned about their child's height. Inevitably, in the course of our conversation, these parents make reference to their child's low self-esteem. They speak of the teasing, bullying, and isolation that their child deals with because of their abnormal stature. During this initial conversation, we explain the normal protocol that is necessary for their child to be diagnosed. We send them our educational booklets (these are medical booklets on the various growth disorders that have been written for a non-professional to be able to comprehend.) We advise them of the HGF Ped's List; a place where they can communicate with other parents who share the same concerns. This first communication usually prompts two or three additional calls from these parents. They call not only to inform us of their child's diagnosis, but also to receive the assurance that they will be able to give their child the daily shot and that quickly this will become a normal pattern in their every day life. The next call is the joyous one. The one where the parent informs us that not only has their child grown, but he or she is happier. One mother told me about the conversation she and her son had as they left the doctor's office after his first three-month visit. Her son told her how happy he was because someday he was going to be the same size as his friends. The mother then became emotional and said to me, “Patti, I never heard the words 'my Friend' come out of my son's mouth before.”
However, all of our calls do not have such a happy ending. For parents whose children are abnormally short and their problem could not be identified, these parents now have dual concerns: their child's short stature and their child's self-esteem that is plummeting. We have heard of children who have become withdrawn, coming home from school, staying alone in their rooms; the child has now become the “bullied” or is being labeled the “Class Clown.” On rare occasions we hear, as one father informed us: “Every morning my kitchen has become a battlefield with my daughter crying and refusing to go to school because everyone laughs at her because she is so tiny.”
How can we continue to justify to these children that we know the solution but since we cannot pinpoint the problem--they do not have the right to it? We all know that at sometime in every child's life, they look up to somebody. It might be a movie star, a baseball player, or the President of the United States and we all recognize this as normal. What should also be normal is for these children looking eye-to-eye with everyone else.
You have a recommendation before you that, the denial of which, will result in a lifetime sentence for these children. These children are our future. Please allow them to grow to their full potential, To grow up to be adults who believe in a system that works and more importantly, in themselves.
I am Nicole Costa and I live in Glen Head, NY. All of my expenses to be here today were paid for by my parents. They knew that I felt it was important not only for you to hear my story but for you to see with your own eyes the results of the application that is before you today.
Before I share my story with you, I would like to thank you for giving me the opportunity to participate in this hearing and to let you know how lucky I feel to be able to stand in front of you without the aid of a box. This result is due to the wisdom of my endocrinologist. According to my parents, I had always been on the very bottom of the growth chart. I never reached the 5th percentile, that magical number that says you are normal. When I was 3 years old, my pediatrician told my parents to take me to a Pediatric Endocrinologist because of my short
stature. At that initial appointment, my height and weight were taken; my head, torso and limbs were also measured. My growth chart from the pediatrician was observed and my parents' history of their height and development was recorded. We left the doctor's office with prescriptions for several blood tests, a test to karyotype for Turner Syndrome and an appointment for me to have a Growth Stimulation test.
Two months later, we returned having completed all the tests. The doctor told us that the tests were all normal. From the test results she could not tell us the reason for my slow growth pattern. The doctor told us to come back in six months so she could monitor my growth. We continued these six-month visits for three and a half years. By then I was six and a half years old. The doctor, after watching my growth for 3 1/2 years estimated my adult height would be approximately four foot eight. It was at that appointment that my doctor recommended growth hormone therapy to see if this would change my growth pattern. After being on growth hormone for three months we returned to the doctor's office. I had grown 3/4 of an inch. On a good year for me, that was my growth for an entire 6 months. I continued on growth hormone therapy for almost 7 years. It was then that my bones fused together. I reached the height of 5'2”.
I can't honestly tell you what my life would have been if I was only 4'8”. However, I do know I would never have been able to go into a department store and buy something off the rack. I would not be able to reach the items on the upper shelves of supermarkets. And, most definitely, I would never be able to drive a normal size car.
What I can share with you are some of the experiences that I went through because of my short stature. I was not able to reach the kindergarten water fountain when I was thirsty. No one on the playground chose me to be on their team because in their words quote, “you can't run fast enough because your legs are too short.” How lonely I felt sitting on the park bench at the amusement park waiting for my peers to get off a ride, a ride that I was not allowed to go on because I was too small.
When it came time for my “First Communion” my mother said that it was a special day and it required a special dress. We went to a dressmaker to have it handmade. Neither of us ever mentioned the real reason, which was--there wasn't a manufacturer who made a communion dress small enough for me to wear.
In second grade the teacher required that everyone's feet had to touch the ground when we were seated at our desks. They had to bring in a chair from the kindergarten class for me to meet that requirement. You can imagine how embarrassed I felt. I always loved sports and wanted to play. However, because of my height, I was restricted in my choices.
I began my comments by saying how lucky I was that I was given the opportunity to reach my full growth potential. I hope that by the end of this day, after listening to my story and seeing the positive results of the drug application that is before you, this opportunity is made available to all the children who are now walking in the shoes that I outgrew. This drug application will make a world of difference to these children. It will make their world a different place. |
