Irritable Bowel Syndrome and Digestive Health Support Forum banner
1 - 16 of 16 Posts

·
Registered
Joined
·
385 Posts
Discussion Starter · #1 ·
Did everyone who plans to speak at the FDA meeting get their e-mail from Tom Perez today with instructions and time limits? The 11 people who were listed on the e-mail I got were each given 4 minutes. The list did not include Corey or Jeff, so I'm hoping that means they each got more than 4 minutes.
 

·
Registered
Joined
·
496 Posts
Hi Julia
Yes I did receive the Email and was curious about The senior representatives (Jeff, Corey etc) time allotment. I hope they are allowed adequate time to vocalize! In fact Im so nervous, I wish someone else could speak for me
GOOD LUCK to us all, I cant think about anything but this trip as days get closer...and closer. Julia - my Email server or laptop is bottlenecking - impeding my inbox email reception!! Of all the rotten timing, I wrote you - so just in case you dont hear from me via Email, you'll know why. I can go to the LAG site and read messages for the interim, until This laptop completely fizzles out on me. Any Tech support pros here?? I still have to "compose" the speech??? and be composed
This is nervewracking but worth every ibs tear. stay as well as can be folks. Lisa K
 

·
Banned
Joined
·
7,295 Posts
Corey and I received a separate note. We were allotted 7 minutes.=> 11*4 = 44 (11 people ### 4 minutes)The email I got: 7*5 = 35 (5 people ### 7 minutes)=> 79 minutes!(Hmm, that doesn't equal 1 hour?)
 

·
Registered
Joined
·
179 Posts
I received an e-mail from Perez limiting me to 4 minutes-- e-mailed him back saying lawyers can't even get started in 4 minutes (humor) requesting more time. He e-mailed right back saying too bad. I hope he doesn't give PC more than 4 minutes.If he does someone ought to holler! Bill
 

·
Registered
Joined
·
326 Posts
I received the "4-minute" email. Someone in our group has backed out - Cynthia Huschles, so maybe they can give us her time too.Maria
 

·
Registered
Joined
·
179 Posts
Jeff, Maria, Corey, et.al-- I posted an e-mail on the lag site, but repeating it here. Considering Wolfe's statement in today's USAToday, it looks as if he is going to go after us to the death. I think someone should devote their 4 minutes solely to rebutting his remarks. His "research" if you can call it that, is flawed; he has no evidsence from autopsies that the women who died had a connection with lotronex; at best it was mis-prescribed. Also it's a fact that many people have lost their jobs because lotronex was unavailable. It all boils down to the physician/patient relationship. Remember also tha thte mewdia will probably be thewre, and I don't mind one bit calling Wolfe a QUACK to the NYTimes, WSJ, etc. He is a tool of the Naderites trying to bring down the pharmaceutical industry-- just a part of "Uncle Ralph'S" trying to kill corporate America. We should not shy away from the media, if asked our opinions, but not rant and rave as I just did. Bill
 

·
Registered
Joined
·
126 Posts
I am proud of all of you attending the meeting. I just wish I could also go, but I would disrupt everything with too many BR visits. Anyway, I have read all the media, and listened to the responses, etc. I just can't get a handle on what the members think will happen with Lotronex--not that we aren't all "hopeful", but more than that, is there a concrete general "feel" to how this will go? Also, if we do see a return, when will that decision be made? At the meeting? Will they go give their decision at a later date? When would production begin on Lotronex? I know this is a lot of questions, just wondering out loud, I guess. I want to be able to get a script written on 4/24--how's that? No, I wouldn't think of "rushing" into this!!! I want it back, and I want it now--I was the "perfect" patient on it. Anyway, thanks for any input. I appreciate all that LAG is doing for alot of people. Hope someone uses the analogy that IBS-D is like taking an overdose of ex-lax then going to a business meeting or out to dinner or the movies, then OOOOOPS in your pants!!! K.K.
 

·
Registered
Joined
·
496 Posts
Bill Brown - Ive been very curious in finding evidentiary coorelation btwn Lotronex and "death" and Ischemic Colitis. It has been reported etc... but the HOW's and Why's were never answered. The ones who died, how did they die? from Ischemic colitis complications due to lotronex or from other diseases/disorders they may have had while on lotronex? Searched online, asked GI Doctors, nobody knows actual evidence or causation, only a strong link to Lotronex. Wolfegang has been quoted to support the restrictive use of lotronex for pre-existing consumers, I didnt think he had "any" heart at all. Lotronex should not be just available to past consumers, that would be absurd and unfair to many who are waiting to try this medication with all its potential risks. oh no Im getting too upset. Spent all night/day revamping my 4 minute briefing...I cant believe how little you can say in 4 mins
Kitty Kat - you had a bundle of interesting questions there, I wish I had concrete answers for you tho. Only speculation and hopeful thinking on my part. On the LAG, I believe Jeff & Corey had posted, that generally following an FDA advisory meeting, some preliminary "verdict" is provided (re recommendations to GSK to follow through etc..) I don't know if a decision will be made in regards to Lotronex being fully restored or denied on that day. Even if Lotronex is restored under any compassionate usage, GSK rep advised that it will take a while before its actually distributed again. If so, how long I asked, but no definitive time frame was given. I cant wait for 4/23, harrowing and all, some good luck is going to ensue, I just feel it in my skinny bones
Keep eachother posted and Here we go! Safe and Bowel Safely. Lisa K PS Jeff - I cant compute either. but Im also happy that you and Corey were allowed more time.
 

·
Registered
Joined
·
326 Posts
Lisa and others,All I can say is that by lowering their initial prescribing dosage, Glaxo will be doing everyone a HUGE favor including themselves. That step alone should curtail, if not eliminate, the severe constipation and IC problems associated with the higher dosages "in some people." As with any drug, the higher the dosage,the more prevalent the side effects. Why doesn't common sense prevail here with these people? Then again, maybe now we've enlightened them.Also, I have a suspicion, and it's really only speculation, that Glaxo will wait to see what happens with Cilansetron before they make their move. They may wait to hear the final results of the Cilansetron study - since they have gone ahead and lowered their study dosage from what it was originally being studied at during Phase I and II. If this is the case, we won't be seeing Lotronex until sometime in 2003. I hope I'm wrong. I hope they, at the very least, let those of us who have previously used it get it back before then.Maria
 

·
Registered
Joined
·
179 Posts
I've always said Wolfe and company are quacks and have no hard evidence of a relationship between ischemic colitis and lotronex. It has been said that the women who diecd had the colitis before receiving lotronex. There are NO indications of autopsy reports linking these deaths to lotronex, just a supposition. I would love to cross-examine Wolfe, but this will never happen. Begin with his credentials, maybe the purpose of PC, its employees, Wolfe's medical praqctice, etcMy position is that you will be libeling Wolfe if you call him a "quack" or other endearing terms, HOWEVER if the media, such as NYTimes, USATooday, Post, etc. want to interview me, or others it's probably OK for you to say "IN MY OPINION Wolfe is a quack serving a Naderite organization with a vision to bring down corporate America and the pharmaceutil companies" since this is your "opinion". The politics of this in the media is OK. We get our turn and hopefully can damage Wolfe's comments. Don't forget that the FDA andthe politicians are wary of the media, and alot gets done through the press, such as pressure on the FDA. They are all worried about their "image". Let's talk about this as a part of the game plan Monday night in Wasahington. For heaven's sakes, though, don't say anything like this at the hearing on Tuesday.
 

·
Registered
Joined
·
116 Posts
Just a note to say that I am behind you all. I have waited patiently for this day, since I heard of the meeting back in January. sorry I cannot attend, I am in NY. I have again recently sent letters to Perez and GSK, just to "keep on the pressure," hope others do so....My support for all. I will be watching, and trying to get the "webcast" --- Dan
 

·
Registered
Joined
·
1,077 Posts
Good luck, good luck, good luck!!!!I can't believe it's almost here. I am so grateful to all of you who are going and speaking on our behalf. Yes, use the media to your advantage. I hope this raises awareness for our cause, and makes people wonder if Public Citizen is looking out for our best interests after all. (Which we of course know they aren't in this case.)Go get 'em!! I commend ALL of you for doing this on behalf of us all!!!
 

·
Registered
Joined
·
172 Posts
i hope there's at least one of our younger members joining everyone in DC, but i suspect not.if time allows it, don't forget to mention all the kids and young adults who can't go to school, or struggle with it, because of ibs.good luck to all of you there. you have all of us ibs-ers behind you.-methical
 

·
Registered
Joined
·
43 Posts
im only 17, i think it would be great to have someone there my age 2, sorry im to sick to go. ive had ibs since the age of 12 and had to drop out of school in only the 8th grade cause things got so bad, i wish they would understand what its really doing to our lives, i also had to quit my job, so now im 17, and have no choice to be a prisoner in my own home without any type of edjucation, wish they knew just how many out there have the same story as me, i really wish i could be there, is there any where in particular that people will be telling us whats going on?-kel-
 
1 - 16 of 16 Posts
Top