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Discussion Starter · #2 ·
for those who have had trouble keeping up with the number of messages and what has beend one:as a group we have accomplished a lot but for right now we need to focus on one crucial issue -there are people who are out of lotronex or about to run out.glaxo is not responding to the group or members of the group on this issue even though there are a lot of us and we have support from the public and professionals.two possible courses are1. a congressional hearing2. a protest at next week's investor meeting.other possibilities?now is the time to be heard. keep doing what you are doing as we are making progress, and as jeff said, fill out that form.tom
 

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Discussion Starter · #3 ·
good question. i thought the FDA and GSK met last week but haven't heardanything. I assume it will either be in Washington or North Carolina.sombody might be able to find this information out using the Freedom ofInformation Act and there is a manual on how to do this on the PublicCitizen webpage. http://www.citizen.org/ tom
 

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I could be wrong, but I don't think public input is allowed at the the Investor's Meeting. I know that meeting is pre-scripted and that the board normally only does questions and answer related to finances and financial and product outlooks. In order to be best heard, I think it would be best to request that our issues be an agenda item at their next regular board meeting. Normally, but not always, if an item is requested to be on the agenda, it usually makes it.
 

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Discussion Starter · #5 ·
If we can't get enough people out there to protest, not exactly an option for some of us, why not keep calling the office all day long with comments? You know, keep their phone lines VERY busy. All we need to to is just try and find the right phone number. When you call Glaxo HQ in NC, I think they give you a phone directory option. So, how about Mr. Stout's office or Ramona Dubose's or whomever else we should be calling. We could leave them LOADS of messages! Even if they didn't get to see them personally, someone on their staff would. I'm sure they'd get wind of it somehow. Maybe we could start doing this the day before the meeting.Maria Z
 

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Discussion Starter · #6 ·
Maria:Capital idea - re: calling the key folks at Glaxo - I tried this for weeks after the drug was w/d. Not sure if my message ever got thru but I certainly annoyed several secretaries.If we all called with of those big wigs 10x's + they might get the hint.Cindy W.
 

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Discussion Starter · #8 ·
Tom in response to several of yours--- 1st- your respomse to Wolfe is accurate and well-reasoned. Bravo! 2nd- what else? How about the letter I mailed Saturday, regarding compassionate use? Two questions, though-- does the doctor or the patient make the request of Glaxo, and to whom at Glaxo is the request sent?WWB
 

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Discussion Starter · #9 ·
Maria:I called the main #, and filtered my way through their voice mailsystem, and numerous secretaries to get to the secretary of thepresident David Stout, and their main research guy - don't recall hisname. That's where I got stuck, tho I did speak with her and expressedmy desire to protest against their recent actions, and did specificallyask for him to return my call (ha - what drug was I not on) and then gottossed back to the drones in Customer Support.Not sure if this accomplished anything.Sorry - not to be more helpful!Cindy
 

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Discussion Starter · #10 ·
william, if everyone does the compassionate use thing it will just jam up the fdabut maybe that's not bad. you might want to either post to the list or havejeff put on the site directions on how to do it? this would avoid a lot ofemails i think. as far as who actually makes the request to GSK i'm notsure. it might take some legal research?tom
 

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Discussion Starter · #11 ·
Tom- re your last e-mail: I would ask Jeff to look into wheter the compassionate use letter has to be signed by the MD or the patient, and to whom addressed. He may have more contacts than I. In addition, I think I saw on the Ibs BB. a letter of rejection for compassionate use mailed to Glaxo by soneone. Probably got sent to the wrong person at Glaxo-- the reponse from Glaxo was essentially "we dont do that". This wont jam up FDA, because the letter is to be written to Glaxo, not the FDA. Time to put the screws to Glaxo, I thinkWWbrown
 

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Discussion Starter · #12 ·
let's not leave it up to Jeff. he's buried in emails as i am. maybesomeone from the list can look into it or has the info. it seems like itshould be available but might have to wait for a phone call tomorrow. ifanyone knows or finds out please post the info here and on the bb to saveduplication of effort.tom
 
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I printed out the requirements for a compassionate-use request....under "Informed Consent Statement" it mentions an Institutional Review Board (IRB). It also states that there are some IRBs that have specific procedures for approving emergency requests. I wonder if thats who/where the requests should be sent?! Sometimes I feel as though I am grasping at straws and that may be the case here, but I think I'll call Glaxo tomorrow and ask if they have such a board and how one(or a group) might contact them directly.BTW, I got the above mentioned info from the link that William sent out in the digest...the FDA's page concerning physician request for a single patiant IND compassionate or emergency use.
 

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Jeff: I've been a member of our Hospital's IRB (Institutional Review Board) for 10 years. There's a format that must be followed for Compassionate Use Protocols. They must be submitted by the prescribing physician. It's not a very complicated process and most do get approved. It could be a burden if your GI doc is really busy (as mine is) and he/she gets a lot of requests for Compassionate Use. Let's just hope that Lotronex becomes available without the Compassionate Use requirement.echris
 

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Discussion Starter · #15 ·
thanks for the info, julia. i think jeff is trying to move some of thesethreads over to the bb so we can get out from under the piles of emails.what is a formal or offical request to the drug company? any ideas any one?tom
 

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Discussion Starter · #16 ·
William, Tom, and everyone else, Regarding compassionate use: I am not an expert by any means, but I can tell you how it works at the hospital where I am employed part time. A physician initiates the request on behalf of a patient. The request next must be approved by the Institutional Review Board (every hospital has one of these, although it may have different names in different places), which is a panel of doctors set up by the hospital ot protect human subjects of research (because compassionate use only has to be requested if the drug can't be obtained by other -legal- means, it is considered a research item). If the IRB approves, and it usually does, since doctors tend to ask only in extraordinary circumstance, the formal request is made to the pharmaceutical company that makes the drug. I presume that every drug company has its own equivalent of an IRB to review these requests. If the pharmaceutical company agrees to compassionate use, it supplies the drug to the requesting physician, who supervises the patient who is going to get the drug. If the pharmaceutical company refuses, there is probably an appeal mechanism, but I am unfamiliar with it. The hospital makes these requests rarely, and usually in life and death situations. Maybe someone on this list (like the Glaxo person who monitors it) can fill in the blanks about what happens when a request is turned down. And maybe a doctor in private practice can fill in the blanks about how these requests are handled in the non-hospital world. Finally, I don't know how to move this discussion to the BB, where there are probably at least 100 people who can answer the questions, but I'm sure Jeff will get it over there in the proper place. Julia
 

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Discussion Starter · #17 ·
Guys, regarding Julia's compassionate use info - All I know is what my Gastro doctor told me what he's been going through with Propulsid (upper GI drug that was pulled off market and has "compassionate use" status); yes, they are allowing compassionate use, but (and I quote) "you can't get it anyway." So, he's resorted to getting a similar drug from Canada. I guess the point here is that even though they say "sure, we'll allow compassionate use" they probably make it so difficult to obtain that it just ain't gonna happen.Maria Z
 

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Discussion Starter · #18 ·
Maria, please be specific when you use 'we' it looks pretty clear that they(the FDA) allow it but they (GSK) won't give it out. People could getconfused if you're not specific here. can you say what 'similar' drug yourdoctor is talking about?tom
 

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Discussion Starter · #19 ·
Tom re: Compassionate use and what my Gastro doctor told me:I wasn't even talking about Glaxo. Propulsid is manufactured by another pharmaceutical company altogether. I was merely notifying you all that with the compassionate use program there appear to be some glitches, at least with his inability to get Propulsid for his patients. He's being told, yes there is a program, but you can't get the drug anyway. Why? He didn't go into it. He has now resorted to getting a medication that is similar to Propulsid from Canada, otherwise his patients would be suffering just like we are in that they do not have an alternative to Propulsid. It was the only drug of it's kind marketed in the U.S. At least they have an option, we don't. If Glaxo ends up allowing compassionate use, I'm just hoping that their reps don't go around telling doctors that the program exists but you can't get the drug anyway - like they are doing with Propulsid. Maybe they just make the whole process too difficult for doctors to conform too. Just my observation, and I don't know how this would play out with Glaxo if they allowed it. Hopefully, it would be an easier scenario. Did I explain that any better?Maria
 
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