[Jeffrey Roberts]

In a reponse I received from Janet Woodcock concerning the continuingdistribution of accutane under a patient waiver, or what she she callsrestricted drug distribution, she said that this is possible with lotronex.I cannot read into what she wrote; I can only assume that it is apossibility.The following is the offer that the FDA made to GlaxoSmithKline for arestricted drug distribution:This is a quote from the FDA TALK PAPER of January 22, 2001, concerning whatthe FDA offered to GlaxoSmithKline for continued marketing of lotronex:"FDA's view of the options included marketing withdrawal or or a restricteddrug distribution program. The restricted drug distribution program wouldprovide: (1) save use of Lotronex in appropriately informed patients, (2)continued access to Lotronex by severely delibitated IBS patients underclosely monitored conditions, and (3) continued clinical research into thebenefits, risks, and safe and appropriate use of Lotronex. The FDArecognized that the other available treatments for IBS may offer inadequaterelief from a condition that can be severely incapacitating for somepatients."Personally, I think that this is a better alternative for us to persue thanthe compassionate use program because the FDA offered it to GlaxoSmithKlinein January; because Janet Woodcock said it is possible; because it is usedwith accutane at the present time; and because it is much less cumbersomethan than the compassionate use program. However, I don't want to geteveryone confusedand going off in different directions. ANY THOUGHTS ON THIS? I just read WBrown's message that Glaxo will not do a compassionate use program.In light of that, I think that the restricted drug distribution program is a much betteralternative to begin lobbying for.Judy Graves[This message has been edited by Jeffrey Roberts (edited 02-20-2001).]

 

[Bud]

Judy, I noticed the word "restrict" right away and my thoughts were the same as yours in that I thought, "Maybe Restrictive would be less constraining than Compassionate." However, both could really be one of the same. I hope someone can shed some light so we can all better understand.

 

[Jeffrey Roberts]

At the end of this message is a letter you can use to request the restricted drug distribution program for lotronex. In light of the fact that GlaxoSmithKline won't agree to the compassionate use program, we believe that this program is a valid request for several reasons: 1. Janet Woodcock already said it was possible 2. because it is used for accutane at the present time 3. it is the program that the FDA offered to Glaxo in January. Please write your letters or use this one as is or with your own changes. Now is the time to flood Glaxo with our request. US mail or e-mail - either one. Here are the contacts: send to all of them if possible. Eric Carter, Principal Clinician GlaxoSmithKline P. O. Box 13398 Research Triangle Park, N. C. 27709 uscrcweb###GlaxoWellcome.com feedback form at http://www.imgw.com/forms Mr. David Stout, President GlaxoSmithKline US Phaarmaceuticals 5 Moore Drive Research Triangle Park, NC 27709 Dr. Sir: This is a formal request to GlaxoSmithKline to implement the Lotronex Restricted Drug Distribution Program that the FDA offered to you so that hundreds of thousands of IBS sufferers can have their lives again restored by this miracle drug. This program would provide l. safe use of Lotronex in appropriately informed patients 2. continued access to Lotronex by severely delibtated IBS patients under closely monitored conditions and 3. continued clinical research into the benefits, risks, and safe and appropriate use of Lotronex According to the FDA, they "recognize that the other available treaatments for IBS may offer inadequate relief from a condition that can be severly incapacitating for some patients." In light of this fact and the recent statement by Janet Woodcock of the FDA that the Restricted Drug distribution is possible with Lotronex, and on behalf of the hundreds of thousands of IBS sufferers who were successfully treated with lotronex, I request that you voluntarily agree to the FDA terms for a Restricted Drug Distribution Program for Lotronex. I am one of those hundreds of thousands of severely incapacitated IBS sufferers. Most have completely depleted their supplies of Lotronex, and some are now using the last of their supply. Please respond to me and to the Lotronex Action Group at lotronex###yahoogroups.com (At this point, please include your name, e-mail, home address, and home phone number. We want them to see us as real and accessible people. Feel free to change this letter in any way that suits your needs. Judy Graves

 

[Guest]

I am extremely disappointed by this. This is absolutely nothing different than the FDA offered Glaxo in November. Glaxo took the drug off the market rather than continue in this direction.The key word is severely di(something). The post above that says it would help hundred of thousands is wrong.Under this program you would have to prove that you were severely disabled (ie prove no ability to produce income (ie no work) unable to function socially, unable to leave the house etc. While some of us may qualify most of would not.Those of us who have proven that we can function to a limited degree and can cope, with whatever level difficulty, WOULD NOT be eligible for medication under this program.Under this program distribution would be limited to the worst of the worst. The overwhelming majority of us would not be able to participate. This is a program where dozens would be helped not "hundreds of thousands". This is the perfect situation for the FDA, they could appear to be compassionate and allow the drug...but would not allow it for the moderately severe category of IBS patients. Access would be limited to those where the risk of serious complication would be outweighed by the ability to give some functionality to the individual.Under this program further research into like medications (like Cilansetron) would also be effectively handcuffed.My greatest fear is that the FDA will require such a stringent requirement, that very, very, very few of us would be allowed access.I'm concerned that most, if not all, of us would be left out of this program.

 

[Guest]

Sorry the key word is debilitatedHow many of us qualify for this?

 

[Guest]

Here is what I think would be required to meet the debilitated critera.1. On disability2. Prove the inability to provide income to support self/family for some period of time.3. Completely unable to function without immediate access to restroom. I.E. does not leave the house except for emergency/doctor appointment. Cannot shop to provide necessary household supplies. Cannot provide basic care for other dependents.4. Carefully documented clinical history of all other medications indicated for treatment of IBS and clinical history that all such drugs were completely ineffective.5. Carefully documented clinical diagnosis ruling out all possible causes of IBS symptoms and this would have to be current.If you can check off all these blocks than I think you stand a reasonable chance of qualifying under this program. If you cannot you'll be told...SORRY, and to add insult to injury you won't be able to complain because the FDA will then say Lotronex is available, if required. You'll get handed a nice little form letter. This "plan" will effectively take the wind out of LAG sails, appear to be an acceptable compromise to Public Citizen, will make it appear that the FDA is compassionate, will limit the potential for publicity, etc, etc...I do not think this good. And in fact is probably WORSE than the current state.Please know that this only my personal opinion. We need to be very skeptical about any potential program. A compromise which avoilds negative publicity for both the FDA and GSK could truly disarm and handcuff us all. Then again were in no position to dictate any of this.

 

[Bud]

I have to think about this. I feel it's a certainity that my wife would qualify for restrictive or compassionate use, but critchie brings forward some valid points about those that might not qualify under a restrictive program if the guidelines are too restrictive .... Bud

 

[Miss Patience]

Well, isn't debilitation in the eye of the beholder? I'm not trying to be flip, it's a subjective thing. I think many of us have doctors who would go to bat for us, making a case for Lotronex in our individual cases. I have documentation of years of nothing else working for me, as well as two med checks during my use of Lotronex, both of which indicated the efficacy of the drug in my case.Critchie, I've noticed your posts are very pessimistic. Try to have some hope. Our efforts have achieved far more than we thought they would back in November. Being negative isn't going to help.I really do think informed patients and physicians will be a major issue. Think of all the posts to the board that say "my doctor prescribed X. I've been taking it for a week. What does it do?" There's part of the problem right there. Also, the more I've read, it seems that Public Citizen's science is faulty...I cannot believe the FDA wouldn't make an effort to get ACCURATE data on the complications, and whether they were directly caused by the Lotronex.Let's keep the faith and hope we hear good news soon.Colleen

 

[Guest]

Several years ago I was on SSI disability, but got on it because I was able to claim anxiety disorder as the reason...due to the intense anxiety I was unable to leave the house most of the time, etc...! Now that I've had my experience with Lotronex I know that the anxiety came from the IBS, anyway I'm wondering if that would help me to qualify or if it may hurt my chances. Any thoughts? I haven't been able to have a job in over 16 years...theres no way. And I'm back to the point where I'm not leaving my house very much at all-due to the constant D this time, rather than anxiety alone. I don't think it'd be that difficult for me to prove disability.

 

[Guest]

I don't mean to be pessimistic, I am sorry, but on things so important I am very skeptical.While I was taking Lotronex, I was following the early press about criticism of the drug.I became worried the drug would be removed from the market. My doctor said I was crazy, he said there was "no way it would be taken off the market" he said "won't happen, guarantee it, works too well...the problems are over stated, you're worrying too much...relax". Well a couple months later it was pulled and he said "what can I say?"Now when I tell him there's hope that it can come back he says things like "I wouldn't get your hopes up" and again "won't happen, move on".I'm hoping he's wrong twice.There's no way I can determine how restrictive the program could be. I just wanted to make sure that we don't compromise into a situation where we are totally disarmed. Please read about the Propulsid ordeal, many, many people are suffering without Propulsid...to the point of withering away. Less than 200 people are approved for this drug, thousands of others are waiting "in the pattern".I hope the FDA and GSK can do this right. Optimism is good, but I as well as all the rest of have alot riding on the details.

 

[Jeffrey Roberts]

Judy,Let me make sure I understand correctly. We should email the letter to Eric at uscrcweb###GlaxoWellcome.com, and snail mail David Stout. Am I correct?Thanks,Melissa

 

[Guest]

I have my letter to Stout ready to go out tomorrow. The only thing I worry about is will he actually read it and should I have gotten my doctor to write it or another one to go along with mine???

 

[norbert46]

I agree with critchie that we need unrestricted Lotronex use so all could benefit. A signed waiver would be acceptable.My Dupont ins. would not pay even though I told them it worked, so they will still not pay for Lotronex or the gastro.MD or anything else! If anything is to be accomplished we need to all work for a common goal which will help us all. Norb

 

[Miss Patience]

I have been pondering this whole "restricted/debilitated" issue, and I've concluded that if *I* were the drug company, that's what I would be having trouble with. GSK most likely doesn't want Lotronex restricted to the small percentage of IBSers who can't leave the house. They want to MAKE MONEY. And they aren't going to do that if only a few people qualify for the drug. Also, in many of the emails we've received from Dr. Woodcock, she's indicated that the FDA want to make it available again to those who "benefitted so much". So I'm hoping there will be a lenient definition of "severe IBS" and "debilitating".So let's keep the faith!Colleen

 

[Bud]

I'm in agreement with Coleen and Norb. For now, and Nob said it, we need to be focused on a common goal for the sake of unity, thus strength.Additionally, while it's not hurting anything working with these restricted or compassionate use letter/agreement ideas, the reality is that Glaxo and the FDA would develop the final consent agreement that would be used.

 

[Guest]

I am happy to have elicited such a response. I know this may not be what everyone wants.The important thing is that you write to GlaxoSmithKline and tell them of the urgency of getting Lotronex back on the market and tell them your own story and concerns. David Stout, Eric Carter, and the GlaxoSmithKline corporation need to hear our voices. If you can't sent your message US Mail, then e-mail the places I suggested. I have done all four. I have made some corrections and additions to my original letter, and I will post it on lotronex###yahoogroups.com Particularly, I have added a sentence to the last paragraph, asking them for a personal reply rather than a form letter. You might want to do the same on any message of your own. Thanks for the feedback. Keep those messages going to GSK. We want to be heard by them just like we were heard by the FDA. Judy

 

[UnknownSoldier]

I agree with Critchie also that a RESTRICTED use program would not help too many of us. I for example can hold a job, but my QUALITY of life (traveling, going shopping, even grocery shopping, walking around my neighborhood for exercise, etc.) is not so good. I can just make it through 8 hours of work, then come home and 'd' all night and on the weekends. Doesn't leave much time for a REAL life. HOWEVER, a restricted use program is at least a starting point and if that is all we can get then I will still support it. There are others worse off than me, unfortunately.Also, I think Critchie picks up on some really good points and thinks them out well. I appreciate it Critchie!------------------Jocelynjocelyn_t99###yahoo.comThe most absurd and reckless aspirations have sometimes led to extraordinary success. --Vauvenargues