I read Melissa's post about her son. So I did a search to find someone doing something like that in our area.
I found that Children's Hospital in Los Angeles is doing the Xolair trials. I contacted them and we have an appointment on Monday 9-26 to meet with the Dr.
We are nervous, yet excited. Emily is thinking that this means she will get to be "normal". I think she is more for this than we are. By the way, she just turned 7.
We have a few concerns about the fact that 1/2 of the patients will be on placebo. Hopefully my husbands concerns are addressed. He has a stack of papers a couple of inches thick that he has been researching this with!
Today we saw the allergist, and spoke about all of our concerns. She knows about Xolair and is excited for us. (Side note: the doctor's child is also PA).
The allergist did another skin test on Em, since we hadn't had one in awhile. Also, the Doctor know's about Dr. Sampsons finding thats 20 percent are "outgrowing" the allergy. We were all hoping and praying. Unfortunately Emily is still a 4+ out of 4 on the scale. [img]http://uumor.pair.com/nutalle2/peanutallergy/frown.gif[/img]
For those of you that pray, I have a request. Pray that our entire family submits to God's will. And that we do the right thing for Emily.
On Sep 22, 2005
I think that you will make the right decision for her.
Praying for you!
On Sep 23, 2005
Wow am I familiar w/ the way you're feeling...I stressed so much that we would make the wrong choice...we researched and researched, "tried" to find something negative about Dr. Burks and couldn't, went through a phase where I talked myself out of it, and finally one day it hit me that if we didn't try it, I would be very disappointed, and that I DID feel ok w/ it...there have been a couple of bumps in the road where I second guessed myself (like when he had mysterious hives for 2 weeks about a month into the study) but no matter what the end result (still PA or not) I know we've done something good for him and potentially good for all PA kids and adults. DS isn't old enough for a Xolair trial, so I don't know how I'd react to that decision. I do know there are some folks here who have seen amazing changes w/ Xolair. I wish you the best of luck w/ your decision...use us as a sounding board if need be. I've gotten so much support during this study here and it has helped tremendously. Melissa
On Sep 23, 2005
Whatever your decision I wish your family all the best and you can count on our prayers...
On Sep 23, 2005
Thanks for the well wishes all.
Melissa, I saw the support you got. I am counting on it for us. I thank you for sharing your second thoughts. I am having third, fourth and fifth thoughts right now! [img]http://uumor.pair.com/nutalle2/peanutallergy/wink.gif[/img]
Emily still had a bump and itchiness last night from the skin test. I almost told my husband that I wanted to forget the whole thing. I am going to try going down to L.A. on Monday with as open of a mind as I can.
Will let you all know on Tuesday how it went.
On Sep 30, 2005
We decided to sign Emily up for the study. She has a 1 in 3 chance of being on Placebo. We talked and prayed with Emily in the exam room before signing papers. Emily was all for everything except the part involving needles! Ultimately we let Emily be the one to say yes. It was awesome that the Doctor had Em sign a "contract".
The terms are that we can drop out at any time we want to. That made me feel better. Emily will be in for a shot every 4 weeks (unless IgE is high, then it is every 2 weeks). At the beginning she does a food challenge, and another at the end. We have always been interested in a food challenge. But with the risk factors, didn't want to try it.
Emily goes down on the 10th and 11th of October for her first two challenges. 1 day will be peanut, the other is wheat. We won't know what is being given. I know that we will figure it out after reactions begin with the peanut one.
Emily had to have another skin test on Monday. They had to have the numbers for the study. She had peanut and wheat tested. They had to make sure she wasn't allergic to wheat. Her peanut reaction was quite big. Bigger than the skin test a few days prior.
After the skin test Emily wanted to know if she was "curd" (she is saying that instead of cured!). We had to explain that this study isn't a cure. It's a study for making the reactions not as severe.
When they took her blood for the tests that need to be ran (RAST and others), she broke down. Her Daddy held her face and had her count with him. In between numbers she cried that she didn't want to do it. DH reminded her that she had prayed to God for "courage" and she said that Jesus wasn't helping right then. When DH told her it was all done and asked if it hurt she said no, but she didn't want them to use needles.
As a Mommy I don't want Emily to go through any of that again. But.... as a Mommy I want her to be safe. Is that confusing? It is to me.
Please keep us in your thoughts and prayers. I will keep this updated. Promise! [img]http://uumor.pair.com/nutalle2/peanutallergy/smile.gif[/img]
[This message has been edited by EmilysMom (edited September 30, 2005).]
On Sep 30, 2005
It is not confusing, it totally makes sense to me... You want the results but it is hard to see her struggle to get there...
We faced some challenges with our son when he was diagnosed with a mild form of autism and we tried a metabolic approach - blood tests and injections included. So I know exactly how you feel...
All I can say is that your family is doing something remarkable and please tell Emily she is a very special and brave little girl.
I will keep checking the thread.
All the best!
On Sep 30, 2005
Emily's mom ~ I will definitely be praying for Emily. The Xolair has truely changed our lives. Please do a search with my user name and Xolair to read DS's experiences with it if you haven't read it already. He started it when he was 7, also. DS's IgE levels are such that he really should get shots every 2 weeks, but the every 4 weeks are working great for him. Since he's so small (53 lbs.) his doctor doesn't want to dose him more frequently if he doesn't have to.
FYI, the shots are very terrible - I'm not sure I could handle them [img]http://uumor.pair.com/nutalle2/peanutallergy/frown.gif[/img]. The needles are large because the medicine has the consistency of pudding - it has to be injected pretty slowly, too. You really must have Emily prepared ahead of time mentally. Also come armed with distractions. We use "magic cream" on DS's arms (his Xolair dose is so large and he is so small they have to give him 2 shots at once) and the nurses also freeze the area before they begin. The "magic cream" is a prescription called Emla and numbs the area - it needs 30-45 minutes to take effect. There is an OTC numbing cream called LMX (pronounced elemax). It works more quickly, but does not numb as deeply and is pretty expensive. We also have DS play a GameBoy to distract him and then just as the needles go in, we pop a piece of gum in his mouth so his focus is on chewing. These things seem to help him get through it. Also, they have two nurses do the shots at the same time so he doesn't have to go through it twice.
Good luck! Rebekah
P.S. From what I've heard, it's easy to tell if you're getting the placebo because the shots aren't nearly as bad...
On Oct 1, 2005
This is the study I looked into for my son but I was told that everyone gets the Xolair.
What made us decide to not do this was that they HAD to go into Anaphylaxis in order to start the study.
I do not mean to make you uncomfortable but that was the one thing holding us back.
Good luck with your decision. We are in Westchester and our allergist recommended this study if we were interested.
On Oct 2, 2005
I was told the child just had to react to find out at what point they start to react to establish a threshold level. They need this information to know how much more they can tolerate after the Xolair. This could be a few hives or a bunch of sneezes.
On Oct 2, 2005
Emilys mom, If your beginning criteria for the study is the same as ours was (not Xolair as you know) the child does have to react, does have to actually get to that point of having some sort of reaction; it does not have to be anaphylactic and I think that out of the 12 or so kids in our study my DS was the only "lucky" one to experience an anaphylactic reaction...others had hives, or vomiting, or a cough, but I think we were the "worst" ones...his probably would not have been that bad had his IV not kinked up and we could have gotten Benadryl in it...so, while it is a possibility that anaphylaxis will occur, I don't think it "has" to happen, if you know what I mean. I would run this by the study folks to ease your mind. Melissa
On Oct 4, 2005
Thanks for the support all.
Luisa, I will tell Em that there are people in the world that think she is brave. In fact I will just print part of your post for her!
Rebekah, thanks for the heads up. The shot thing is now really freaking me out. I am terrible with needles myself and thought Emily didn't know. She probably has felt my tension in the past and now got this way. I will check for your existing threads. Thanks!!!
Peggy, LuvMyKids and Melissa are correct. As far as I am aware Em just has to have some type of reaction. I was told they do it in a hospital setting just in case of anaphylactic reaction. I will double check. You are so right in holding back. If I thought that they HAD to put Emily into shock, I would run as fast as I could the other way!
I have to tell you all that I am very comfortable with the Doctor and all the ladies involved with this study. They just really seemed to love on Em. Thats one of the most important things to me.
[This message has been edited by EmilysMom (edited October 04, 2005).]
On Oct 12, 2005
We did the first two food challenges Monday and yesterday (Tuesday). Day one was wheat, day two was the peanut.
Em started manifesting reactions to the 5mg (less than a 1/4 of a baby aspirin) dose of peanut. But I kept dismissing it because all she said was that her tummy hurt. She had said that the day before with the wheat because she was hungry.
The dose that was the kicker was the 100mg dose (1/4 of a peanut). She started crying about her tummy and her face got flushed with one hive. The doctor immediately pulled the plug on the test and the nurse administered the Benadryl, Epinephrine and one other drug that I can't remember the name of. When the drugs were administered, the reaction was immediately reversed.
I am so glad that my husband was there. I completely lost it. Started feeling guilt because "I" had put my baby through it!
Emily was under observation for quite awhile after the reaction. She got cold, then she said that her feet were itchy (we think it was like her feet fell asleep), and then she slept while Daddy held her.
Emily is much better today. We talked to her last night at dinner and asked if she still wanted to go through with all of the study and she said yes.
I on the other hand am thinking..... Lets run! Run far away, and never go back. But that is just my Mommy fears.
We go back next week for the first shots (I think). Will keep you all up to date.
Wendi --- Emily's Mom
On Oct 12, 2005
Wendi, I am glad that Emily is feeling better now.
I can't imagine how nervous you might have been, good that your husband is supportive and the 3 of you are so together on this. I totally understand your feelings and doubts.
I am also truly amazed at her for saying she wants to keep going. That shows a lot of strength...
Best of luck on the next visit and I hope things only get easier!
On Oct 12, 2005
Thanks for the well wishes Luisa
On Oct 12, 2005
Dear emily's mommy,
Wow, you sure have been through alot. After reading this whole post, the one thing that we want to say to your family is thank you. We are thankful that you are doing this because all of us will benefit. We will definitely be praying for your little emily, and look forward to hearing how things go. God bless you all, emily's mommy
On Oct 14, 2005
Thank you so much for posting everything and letting us share in your journey. I will pray for your family and pray that experiences like yours can help families like mine and thousands of others.
I do have to ask, since my ds has a wheat allergy, what is the connection with the wheat allergy and the medication/testing?
On Oct 14, 2005
Thanks for the prayers emily's mommy and mistey.
As for your question mistey....
This study is called a double-blind study. Meaning on one day you will get a wheat-pill and the other day is a peanut one. We don't know until after the food challenge which pill was given on either day.
The other blind part of the study is that Emily has a 1 in 3 chance of being on placebo medication. Nobody (Doctors, Nurses, my family) knows who gets the placebo. That part bugs me a bit. BUT, if this study helps Emily in the future.... I say let's go for it!
They skin tested Em on wheat and peanut before we went back for the challenge. They had to make sure she wouldn't react to wheat. The wheat pill is given to prove that there is no reaction based on "thinking" that you are being given the peanut pill. At least that is how I understand it.
I am assuming that with the protocol of this study, your DS wouldn't be able to participate. But I may be wrong. They might be able to use something else for your son.
On Oct 19, 2005
Wendi- sorry I am so late responding; I've been sick w/ some bug for about a week and haven't been on the computer much. The feelings you had after Emily's food challenge are exactly the same as mine after Justin's ana reaction on the first day of the study...I did not want to go back the next day. If my DH hadn't been w/ me I would have chickened out. And the same thing after Justin developed 2 weeks of massive hives about a month into the study (no cause was ever determined)...I second guessed myself a million times. I am not sure why I stuck w/ it b/c I am usually a "quick to get out" kinda gal, if you know what I mean. But I trusted Dr. Burks and that meant everything. I also talked to our local allergist about it and she helped me feel better. You just have to go w/ your gut, and I know that's hard sometimes. If it doesn't feel right, there's a reason; but if it feels like it might be the right thing to do, stay w/ it. We still don't know what will happen w/ our study...all I know is that he eats the equivalent of a peanut everyday w/ no reaction, and i hope that helps somewhere down the road. Keep us posted here...this will be your best place for support and understanding (although I do credit my 2 friends at church whose children have the same allergies w/ a lot of support throughout this study as well). Melissa
On Oct 20, 2005
Thanks for clearing that up! I wondered if having a wheat allergy somehow made it more difficult to outgrow PA [img]http://uumor.pair.com/nutalle2/peanutallergy/smile.gif[/img] Glad to hear that's not the case!!
On Nov 3, 2005
Wendi, I've been thinking about you and wondering how Emily is doing...any updates? Melissa
On Nov 19, 2005
Wow, I just saw this thread because we were talking about Xolair studies on the Main Board. Dd`s allergist asked me about putting dd in this study awhile back, but I did not do it. I think it is wonderful that you are doing it. I had no idea you were in the L.A. area. We are also. Can you email me? My email is [email]firstname.lastname@example.org[/email] Thanks!
[This message has been edited by Carefulmom (edited November 19, 2005).]
On Nov 28, 2005
I am SO sorry that I have not updated this post. A lot of personal stuff has been going on in our lives. I know that is no excuse, but that is what has been keeping me from the net.
Thank you for sharing your feelings about the food challenge.
The study is going GREAT. DH used Rebekahs idea about the gum and the shots are not so bad. The last time we were there I stayed out of the room and never heard a cry at all. I asked DH and Em when was she going to get the shots and I was told she already had them! Emily feeds off my fears I guess! [img]http://uumor.pair.com/nutalle2/peanutallergy/smile.gif[/img]
Carefulmom, we are in Bakersfield. I will email you soon.
Today we go for some shots again. I promise to keep you all posted better than I have been.
On Nov 30, 2005
I am SO excited! We have the possibility of staying on the drug after the study.
Emily did wonderful again. When we told her that she might continue getting the shots after the study is over she basically said "No". We asked her why and she said that the gum we use during the shots would be all gone! [img]http://uumor.pair.com/nutalle2/peanutallergy/smile.gif[/img] When she found out that we could buy more gum, she was all for staying on the drug!
I can't wait til this is approved for all of the PA kids. This is going to open a whole new world for them.
I can't even remember the last time Emily had cake from a bakery. Or donuts that weren't Krispy Kreme (which by the way went out of business in our city! [img]http://uumor.pair.com/nutalle2/peanutallergy/frown.gif[/img]) We could go to the local Chinese restaraunt. After church on Sundays we wouldn't have to stop and recall if someplace is "safe"! Or is it something that we are taking a chance with.
We won't feed Emily peanuts on purpose, she won't ever eat a PB&J sandwich, or peanut butter cookies. But, we won't worry about every miniscule thing anymore!
On Nov 30, 2005
I have been following your thread in detail, and I really appreciate your family's contribution to this study, and your sharing.
But am I missing something in the thread? Were you able to guess that Emily is not getting the placebo based on something. Is she showing signs of being less allergic to peanuts now?
On Dec 1, 2005
forJacob.... Oooops. So sorry. Didn't realize I might have confused someone.
We don't know for sure if Emily is getting the drug. We haven't even guessed either way.
Emily has never manifested any airborne allergic reactions. Hers have all been contact, ingestion reactions. At this point we have no idea how much she could tolerate. We have not exposed her.
We had to agree that Emily would practice strict avoidance (just like before) to be part of the study. Emily had to know that she still could have reactions because of the possibility of being on the placebo.
The thing about staying on the drug is this: Even if Emily is on the placebo right now, she will be given the Xolair after the study is over.
On Dec 1, 2005
Oh, I get it, now! That's great news that Emily will be getting Xolair after the study!
On Dec 1, 2005
That is great news and more than fair for all her hard work!
On Dec 13, 2005
Emily had blood work and shots yesterday. She did wonderful with the blood draw.
The first shot - not so well. I was in the room and she freaked.
The second shot - she did awesome. I left the room real quick and watched through the peephole. Not one tear.
I have come to the realization that she feeds off my fears and anxiety.
I keep thinking that she is on placebo. She doesn't complain much about the pain of the shots. We will see in March.
On Dec 13, 2005
How much medicine is in each shot? Logan gets 2.8 cc total - so 1.4 in each shot. How large are the needles? The Xolair is like pudding consistency and they have to use a large guage needle (22 or 23 guage) and inject slowly to get it into him. They push the needle in really far and then as they inject the meds they also pull the needle further out so it doesn't leave a big lump in one spot. Kind of hard to explain - I guess like making a line of meds under his skin instead of a pool.
Maybe that will give you some clues whether she's on the placebo - hopefully she's not!! Rebekah
On Dec 14, 2005
Would you mind if I emailed you? I have some questions.
On Dec 14, 2005
Rebekah - I don't know how much in each shot. I will have to ask next time. My husband said that they are using larger needles now so that they don't have to go quite as slow.
I was told that they have made the placebo look and feel as close to the real drug as possible. So that we can't guess what Em is on.
Peggy ---- My email is on my profile. You can email me anytime.
On Dec 28, 2005
Well, we got the call that I have never wanted to hear, last night.
The plug has been pulled from the study. What amounts to someone not following protocols. None of the patients were to have asthma, and a couple got through.
Nothing dramatic happened to those patients. The food challenge was nothing too drastic from what I understand, but there was wheezing, and that made the oversite committee recomend canceling the study.
I am so heart-broken. I had put a lot of faith in this being the "cure". I guess this was something to knock me off my soap box. Darn it!!!!
One ray of hope. The company had the approval to give all the patients the Xolair after their portion of the study was over. So now we just have to wait for further approval and Emily will possibly get it while waiting for FDA approval for the general public. Not putting too much stock in it though!
I guess a lot of my disappointment is in not having Emily treated by Dr. Ferdman, and his wonderful staff. Teresa the project director was amazing. As was the rest of the nurses.
I am sorry... I am just so sick about this. I guess I will sit here on my pity pot for awhile longer.... [img]http://uumor.pair.com/nutalle2/peanutallergy/frown.gif[/img] [img]http://uumor.pair.com/nutalle2/peanutallergy/frown.gif[/img] [img]http://uumor.pair.com/nutalle2/peanutallergy/frown.gif[/img] [img]http://uumor.pair.com/nutalle2/peanutallergy/frown.gif[/img] [img]http://uumor.pair.com/nutalle2/peanutallergy/frown.gif[/img] [img]http://uumor.pair.com/nutalle2/peanutallergy/frown.gif[/img]
On Dec 29, 2005
I havent followed this much...
And Im naive on the whole 'xolair' project.
First, sorry you are disappointed.
We were in the Pre-FDA approval for Elidel. Had it for MONTHS... worked REAL well...
Then it ended, and it was approved, and we still used it (til the black box incidents)
Thats how we met our Doc (and NP) at BCH.
I find the study interesting, but for situation, and I'll guess on Erik's now (as he is sort of in the same boat as Ann) -- I find it less useful than others.
Ann's been PA all her life. She avoids nuts. If she comes across something that MAY contain nuts, she avoids it. Its not so hard for her, as shes been doing it for 30+ yrs... Sure, shes reacted to things... and she carrys benadryl with her...
She lives quite a normal life, per se, with PA.
If she had to shell out out-of-pocket expense ($$$) for shots monthly, she probably wouldn't. If insurance covered it? Probably not.
We were ASKED to be in 'some' study (Ann AND Caitlin) - We declined.
I'm glad people WERE in the study, but it just wasn't for .
Im sorry it didnt work out.
------------------ [b]* Obsessed * [/b]
On Jan 4, 2006
Originally posted by EmilysMom: [b]The plug has been pulled from the study. What amounts to someone not following protocols. None of the patients were to have asthma, and a couple got through. [/b]
Noooooooooooooo!!!!!! How could this happen?! I'm so devasted. I've been following your posts and hoping for the best. I just can't believe it. How could they let this happen!
Please keep us posted if you hear more.