4/12/01

To Whom It May Concern:

I'm going to chronicle my life without Lotronex in what I'm going to call my "Dear John" diary and share them with you so you will see the difference no Lotronex has made in the lives of people who suffer from IBS-D.

This week alone I've had bowel incontinence episodes 3 days. Sunday I was at home. Tuesday I had saved a student's birthday treat on my desk all day but couldn't resist eating it before I went home. So I was at home that day also. But Wednesday I tried to eat some lunch at school. I had half a BBQ sandwich and some applesauce. The cramps started about 1:45 but I tried to hang in there using some biofeedback techniques but they didn't work well in a class of special needs students one half hour away from a party and one and a half hours away from spring break.

I enjoyed getting to miss the festivities but I don't think my principal and classroom aide felt that way, but as Phoebe Buffet sings on "Friends":

Smelly cat, smelly cat,
It's not your fault.

My goal in this journal would be to impress upon you the seriousness of our plight. This is not a topic that lends itself well to "full disclosure" but I'm going to try so that you may see that we are not going to find another medicine soon to take the place of Lotronex and our suffering without this drug is very real. You see there are hundreds of stories just like mine but it is a hard story to write about and share.

Please try to work out a "win-win" compromise on this. If you're having trouble finding the "win-win" please seek other sources.

Ruth E. R...

4/14/01

Dear John,

It's Saturday afternoon on April 14, 2:30 P.M. We just finished the strip, shower, dress routine one more time this week. My caregiver asked me where I wanted to be now and I answered," My wheelchair, I'm going to write another letter , I guess." My urologist changed my Foley yesterday and asked how I was doing on my current medication.

"OK, for a while, but I've had quite a siege these last 2 weeks again. We are still working on the rerelease of Lotronex. We will not give up, until we get it or another drug like it back."

Last night we kept our granddaughter and I really wanted to go out to breakfast with her this morning. The last time I couldn't go with her because of cramps and diarrhea!

When I write these I'm uncertain whether to use humor, sarcasm, or despair. I guess I feel a mix of all three. I try to run the race that my "higher power" has given me with all the endurance and strength I can, but I can't do it alone anymore.

Until the next time,

Ruth E. R...

_______________________________________________

4/15/01

Dear John,

Today is Easter Sunday and I'm not off to a very good start. My family wanted to eat breakfast out. I took a packet of drink mix I usually do well with and got some hot water. We made it home in time to get part of the dump in the toilet. My system is so messed up now it really doesn't matter any more what I eat or don't eat except if I don't eat there's not so much undigested food particles.

My caregiver is getting tired too, and my legs are getting very weak. I usually try to at least stand up to transfer to the toilet and dress and undress. I hope it won't be much longer. Cookout season is coming. My family does love me and likes me at attendance. We do have most of our gatherings at my house, but we're all getting tired.

Sorry to clog up your mailboxes over vacation with my stories. I wish they were stories of travel and fun in the sun. They can be next Easter break with your support. My doctor is not too keen on using a colostomy for symptom management, but would it be easier to clean up than this?

Until next time

Ruthie

4/16/01

Dear John,

It is Monday, April 16, 3:00 P.M. I am writing this by hand and will type it tomorrow. When I finished my shower Darrel just put me in my comfy recliner instead of getting me dressed again.My niece came to visit and remarked about how much weight I've lost. When I spoke to Public Citizen about my plight he compared my willingness to risk my life for this drug to a woman he had known who felt the same way about Phen-fen. For me, no access to Lotronex is a safer diet, I guess, although most unpleasant.

While I was in my chair with my phone, phone book, and nothing better to do I decided to make a few calls to my GI doc, GSK, and Janet Woodcock. Kathy at the GSK Customer Response Center said they get a lot of Lotronex calls but this was the first to report a bowel incontinence episode. I told her I had been e-mailing them to Ms. Dubose but was going to increase my circulation as my activity level is decreasing and I have nothing better to do. I also called Janet Woodcock's office to see if they had more productive ideas than chronicling my life by defication episodes, because I was starting to feel a little obsessed by this topic. She told me Janet would be returning a call to Corey Miller and I should go through my group for that information. Any ideas?

Until next time,

Ruth E. R...

_______________________________________________

4/21/01Dear John,

I don't feel I'm using the right words to explain this situation, but "failure is not an option" for me, so I must continue to try. It's Saturday, April 21, 10:00 A. M. and Darrel and I have been up since 6:30 A. M. fighting my disease and we're still not done. My catheter is plugged up again with the sediment my IBS medication causes. I did not have any of these side effects with Lotronex.

I got through my work week by fasting but now we will pay the price of that all weekend. People are so kind in my LAG group with their kind words, suggestions, and support. I'm not sure how I would get through this without them. I know I would, I'm a little strong-willed, but it would be hard without the support of everyone including those to whom I send these letters, because I know you're on my side and trying to work the release of Lotronex out.

I've been reading the PC press release trying to make some sense out of it. Lotronex certainly is not a "one size fits all" drug, but its impact on people's lives and future medications that may come from all this controversy and research seem important enough to me to keep fighting for its return.

We appreciate you listening to our group's input on our use of it, its effects, and what we feel society's future could be with this information and the correct handling of it. Like any discovery, including nuclear fission, how society handles their knowledge makes all the difference in how the discovery benefits mankind.

Let's use PC's new data to make things better. Maybe they could even join our fight to benefit mankind. Sometimes there is strength in numbers especially when we can all be on the same side. I know that the FDA and GSK would not take reckless measures in its rerelease of Lotronex. I've comminicated with them too long to believe that. Could this letter go to Mr. Schwetz, too? I don't know how to reach him, and I would appreciate if you could share this with him.

I'm sorry so many people had adverse effects but LAG believes more people had positive effects from those same symptoms. I really believe the decreased blood supply to my colon helped slow things down enough for me to get a handle on my symptoms and control them. I believe the effects of this medicine can be controlled through monitoring by the patient using it. Believe me, severe constipation is a godsend for me, and there may be others for whom manual evacuation was preferable to what we're experiencing now. I found increasing my fiber intake took care of any problems I might have had. It felt so good to me to be able to eat "an apple a day". I felt just like everyone else. There must be a compromise that can be reached to allow the public access to this drug which changed people's lives. We shopped, worked, went out to eat with friends, traveled to see family. My son is graduating from college in Ohio, but I am too afraid to go. I do hope to be able to go to the faculty picnic in the fall and eat a pork chop sandwich, potato salad, and chocolate cake like can only be found in the "heartland" of America.

Until next time,

Ruth E. R...

4/28/01

Dear John,

I wanted to let you know I've had a very good week. My girlfriend sells Shaklee and wanted me to try some alternatives. She gave me Optiflora(a biotic supplement) and EZGest(a plant-derived dietary supplement). The placebo effect mentioned in some of the data I've been reading, I believe, is not a factor in people with severe diarrhea. I feel that those with severe IBS were afraid to participate in trials and give up their current regimen even if it wasn't working well on the chance of getting a placebo. I don't know the numbers, but I do know there were others in our LAG group who tried this new medicine, Lotronex, with great skepticism. Wanting to maintain a good relationship with our doctors(mine is a saint to put up with me) we reluctantly agreed. I was shocked when within a month I was eating anything I wanted, whenever I wanted,and having regular daily bowel movements.

I have hopes my new regimen will work but will still work for the return of Lotronex because of the freedoms it afforded me. I will keep you posted on thoughts and discoveries I have in my search.

Until next time,

Ruth E. R...

5/7/01

Dear John,

Another week incontinence free. It's a very strict regimen but we're surviving. I hope it won't be too much longer. This is not the least restrictive environment, as they would say in educational terms. I saw my GI doc this week and we're treading very carefully (knocking on wood so to say because I've gone several weeks before and then the other shoe drops). That feels like a very self-defeating attitude, but 15 years is a long time. He's anxiously awaiting news, too.

This week wish to speak for others who are too busy raising families. From the stories and letters I see in the LAG group, there are many who are suffering more and many who have suffered for more years than me. Knowing how I feel when my granddaughter's at our house and we have to stop what we're doing so grandpa can help me in the bathroom, I can only imagine what a mother of preschoolers or infants must go through.

If I get through another week I'd like to discuss the economic impact for many who are highly trained or educated but are disabled by this condition. Maybe someone else in my group could do this better than I. I talk to a great deal of businessmen but somewhere I break down when I'm trying to discuss economics.

Until next time,

Ruth E. R...

Monday, May 13,2001

Dear John,

For those of you new to this format, I've chosen to journal my life and thoughts without Lotronex in this journal until it is returned to us and my life is restored. Yesterday was a beautiful day in Illinois and I had a very nice Mother's Day. I did have an "episode" last week and had to come home from work early, but we are not abandoning the new regimen yet. Females with IBS will tell you that symptoms are sometimes cyclical so we will give this one more month.

I also have multiple sclerosis and would like to address some of those symptom improvements while on Lotronex. My bladder spasms were improved and I was able to discontinue Detrol. My depression was improved enough I was able to discontinue Prozac. Muscle spasms became non-existent so I was able to discontinue Baclofen. As I quit all these other medications my fatigue improved and that would have been my next medication to try without. Because of my improved diet (I was able to eat fresh fruits and vegetables) I was exercising more and my blood pressure was dropping. My general health was so improved, not that I was up and walking again, but I certainly did feel better with fewer side effects. Could this drug have any impact for other neurological diseases?

I felt so good while taking Lotronex and feel sometimes like I'm sinking again now. Please put your research to good use and help us. Could you also please give me some more suggestions about the issues we should be addressing? I feel like this is a crap shoot and I need a clearer target. As I look over previous "Dear John" entries my writing appears so random and segmented at times. What is the problem and holdup exactly? I'm not sure I understand.

Until next time,

Ruth E. R...

Wednesday, May 17, 2001

Dear John,

Today I had to leave work at 1:00 P.M. with bowel incontinence. Darrel has a different job now so I just have to sit in it until I can find someone to clean me up. I'm afraid i'm not too comfortable at the moment, but wanted to get this down on paper.

When I was taking Lotronex I could eat ANYTHING, ANYTIME, ANYPLACE. I'm better on my current regimen but we have worked months to find it, and I still have to be so regimented I feel very restricted, especially now that I know what life can really be like with the proper medication.

I really feel miserable and am going to go see what I can do by myself. Please don't make us wait much longer. This is not fun!!!

Until next time,

Ruth E. R...

May 19, 2001

Dear John,

The frequency of these entries means I'll be trying another medicine again. Please make it Lotronex. I know that works. I'm paying for my lovely Mother's Day and this weekend. My son and his girlfriend came for a small, family party to honor his getting his master's from the University of Akron. Her mother always takes lots of pictures for me knowing I can't be there and Amy saves every program she can. He plays tuba and does a lot of performing with symphonies. Even when he was as close as the U of I I had trouble seeing him perform. I would fast for days before so I had nothing in me but as all IBS sufferers know that means nothing sometimes. Somehow our systems seem to find every bit of waste they can to make our lives unpredictable.

Darrel came home from work on his break to strip me and make me comfortable but I'm still sitting here naked writing to you. You can't pay people enough to come over, strip, shower, and dress me again. They have to know and love you because it's a nasty job.

In conclusion, please give me something more constructive to do than write these entries.It's a beautiful Saturday in Illinois. I could tell you all the things I could be doing but it would be too long to read.

Until next time,

Ruth E. R...

June 5, 2001

Dear John,

I have been racking my brain to come up with something new to address in this entry. I got out my ADA manual not because I think it pertains to this medical issue but simply to see if their were any terms that might spark a new line of thinking for me. The terms that stuck out for me were discrimination, attitudes, perceptions, severity and pschoactive substances. Now I'll try to make some new points.

Our group, including me, has been spending a lot of time bombarding as many people as we can with horror stories about the seriousness of our disease. After reading many of the articles being written about this issue it does seem there are a lot of attitudes and perceptions about the severity of this disease. Even my girlfriend/sister of 40 years said she knows now she did not really understand until she helped me clean up one time. However I'm not sure more visual and auditory impact is something we want to get into. I have had times when I've wanted to take my clothing, put it in a box, and ship it to someone, bu then a cooler mind prevails and I reconsider this as a little radical, plus you all are compassionate and educated enough to read our letters and feel our pain through our words. You would not be in the positions you are if you did not have some interpersonal skills.

The term psychoactive substances struck a chord in me because my doctor has just suggested I try a new "happy" pill. He broached the subject treading very carefully because he knows I have very strong feelings on this. I read the messages in our LAG group and see the names of medicines I know are considered controlled, and I see the mood swings in the writing of some of the members, myself included, as we medicine hop again.

I'm starting to feel some new material seeping into my brain for this issue is far from dead. I hope I run out of time before I run out of material, although my "Dear John" file is growing large.

Until next time,

Ruth E. R...

June 12, 2001

Dear John,

It seems our grassroots movement to gain some control over our own lives is experiencing some growth at this time. I'm sorry for everyone that it even had to go this far. We're all missing so many things we will never get back, but if we had not been given the chance to take Lotronex to start with, we might never have known that such bliss could be had again. It is a little selfish on our part to want this so badly we're willing to risk the health of others but hopefully those with more knowledge than I will know how to make it work so we can have the right to make the decision about how we want to live our lives.

I have been thinking about some positives that might come from all this. The longer we wait and the harder we have to fight are producing some good. I have formed some bonds with people I would never have met. This contact is helping me to grow stronger personally and emotionally in ways I don't think I'm able to put into words right now. The longer we wait the stronger we become. Perhaps we will pave the way for stronger patient advocacy and rights. It could help begin some real health reform which we all know is needed desperately.

I still pray I run out of time before I run out of topics but every day just keeps putting more ideas in my head.

I look back on my "Dear John" file and see many things coming out of all this. Even with the return of Lotronex I have a long struggle ahead with multiple sclerosis. It just keeps coming. I do not have the form that is able to be stopped with the new ABC drugs. This fight may give me knowledge and strength for future battles. Remember, FAILURE IS NOT AN OPTION, for IBS can take away your life like an invisible spirit in the night that no one wants to admit they really saw.

Until next time,

Ruth E. R...

7/04/02

Dear John,

I am sitting here once again in feces waiting for someone to come, and decided I must review my past struggles in my "Dear John" diary. I will try to wait until GSK gets everything worked out. I pray every time the pains start for God to help me, but, I guess, this is one of those races for which I pray He gives me the strength to endure, Right now I just want to pray for deliverance from the pain and suffering.

I am grateful for the LAG group, the FDA, and GSK, for sitting down to solve this problem but I am having incontinence almost daily and once again am not sure how long I can endure. I was hoping to try to start school one more time and on those good days believe I can! But after this morning , I feel very discouraged! The other medications available for me are often innefective and make my brain so fuzzy, many were thinking I should not be in a classroom with children.

If your decision to make Lotronex available on a limited basis is firm, please hurry! Can I get on a receiving list as one of the first? I am mailing a copy of my diary to my GI doc. I know he knows how serious I am about this, but I am hoping to deepen his insight into my plight.

Thank you once again for your time and interest. We've come a long way, but still have one more lap to go to finish this race.

Ruth E. R...

7/5/02

July 7, 2002

Dear John,

This morning I transferred on the toilet and my bowels moved and I transferred off, and not ten minutes later, I had cramps and was incontinent before we could transfer me back on the toilet. NOW WHAT WAS THAT!?!

Friday one of my other caregivers was cleaning me up for the third time this week, and she asked if a diary provides any sort of pattern, but we can see none. One time, the pains feel like I'm in labor trying to have a baby. Another time, it's simply nausea and then, BOOM! We can't even see a pattern of trigger foods. They're different every time.

My medicines are completely ineffective now. I think I'm going to quit all medications, and let God do His will. I know that His will is not what I would choose, but I know He's with me every day. Sometimes I feel He's forsaken me.

I shall quit now before I start to wax too philosophical. Someone mentioned that they think this has progressed too far for even Lotronex to do any good, but I'd like to give it one more try. On the positive side, one of my caregivers said they never have to evacuate me manually, like some quads. I'm really more of a tri-. My right hand is still very good.

I did not intend to start this again, but am feeling the need to express my frustrations again, somehow. When will it end? Can I endure?

Ruth E. R...