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GlaxoSmithKline Response to Compassionate Use For Lotronex

908 Views 12 Replies 8 Participants Last post by  Miss Patience
"Dear Ms. Lewis:We at GlaxoSmithKline appreciate and share your frustration with a process and statements that may be confusing. It is important to understand that Glaxo Wellcome proposed a range of elements to FDA that we believed would adequately and effectively address potential risks with Lotronex (aloesetron HCl). The FDA disagreed as to the adequacy of these programs and proposed more restrictions that would limit the availability of the drug to a very small patient population, and would require us to oversee physicians' prescribing of Lotronex. But we strongly believe that the relationship between a physician and patient should be individualized, private and confidential, and not subject to interference from any pharmaceutical company.We are disappointed that there is confusion concerning the possibility of a compassionate use program.If you have any qustions concerning our company or products, you may call our Customer Response Center at 1-888-825-4249 during our normal business hours, Monday through Friday, 8:00 AM to 8:00 PM EST."At least the response wasn't canned and I can somewhat understand their position.
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sounds like a shuffle to me. of course glaxo doesn't want any restrictions and the doctor-patient relationship is already the basis of the FDA compassionate use policy as note on their web site. glaxo is just trying to divert the blame it sounds like to me,anyone?tom
Glaxo's motive for their response and behavior would seem to be purely profit oriented. I don't mean that word "profit" to be perjoritive - it's just a reality: Glaxo is a business, period. That's what they do - make money. So, if the FDA's proposal to restrict use of the drug would make it no longer profitable, it makes sense that Glaxo would withdraw it. Business-wise it makes sense, that is. For IBS sufferers that benefited from it - NO, the withdrawal doesn't make sense.Now - and I know I'm going to get flamed for this - the FDA's motive would seem to be connected to their apparent mission to protect stupid people. What I'm saying is this: every patient has a responsibility to become aware of the nature and reasons for the treatment they are getting, and to understand as best they can ALL of the risks inherent in that treatment. Then, understanding the risks, you may choose whether or not you want to take them.If this means you have to "learn" how a certain drug behaves and causes side effects (and not necessarily "learn" all of that from a drug companies marketing hype), then that's what you must learn if, in fact, you choose to take that drug. Most folks I've seen on this board seem to know that, and are pretty active in their treatment.But there are some, and these are the ones that the FDA "protects", that have this blind faith in Doctors and if he/she says it's OK, then by God it's OK. BS!!! Doctors, although certainly most are more educated and experienced than patients, are NOT infallible. And you don't have to be a scientist or intellectual to learn enough to make an informed decision. If a doctor is indignant that you should presume to question his opinion, then that' a good sign that you should find another doctor.Bottom line, it's the patients ultimate responsibility to "sign off" on their treatment. If you don't have all the facts, then get them. If you don't understand the facts well enough to render your own opinion, then maybe the risk is too high for you to go further with that selected treatment.So, again, I think the FDA's motive is to protect stupid patients (and Doctors for that matter), and Glaxo's motive is profit, which seems to be expressed between the lines in their response to Sherree here. And, in my opinion, both motives are way out of whack with the problems of IBSers - as a group, they are probably more aware than most about the treatments and drugs available (with the exception, of course, of the ones that need FDA protection), and are not necessarily a good profit center for Glaxo.BJ[This message has been edited by BobJ (edited 01-11-2001).]
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BobJ -No flaming from me. I wholeheartedly agree with you. There are many days I blame both doctors and patients for the withdrawal of Lotronex. The warnings and side effects were very clearly stated. Most of us DO take responsiblity in regard to our bodies, but there are many out there who don't. I can see where "blind faith" played a major role in this whole debacle.
Agreement from me as well, BobJ. On another thread, someone posted a bit from a Lotronex discussion where someone with C was not only TAKING Lotronex, but planning on upping the dose because the constipation wasn't improving. <boggle> IMO, that is part of the reason this drug is gone, and Dr. Woodcock said as much in an article I read recently....that there is responsibility on the part of patients and doctors to use drugs wisely.I don't know about other people, but when a dr says I have "green toe disease", and prescribes "snerktracin" to treat it, you can bet I'm learning all I can about the disease and the treatment. AND I'm reading the drug info that COMES WITH THE DRUG. Reading that info would have IMMEDIATELY told someone with C to STOP Lotronex. Learning about my condition and treatment is MY responsiblity. Colleen
Bob J, totally agree.Anything I read said 2 pills was maximum each day. On this board people talked of taking 3 and 4 daily. Many people did not pay attention to material available.Now we all suffer.Mary Jo
So, here's a logical problem I have with the Glaxo response. Presumably Lotronex, like many other drugs, incurs most of it's cost during research, development and testing of the drug. Once in production, the goal is to recoup those costs. It seems to me, then, that the company would want to sell any amount they could.It seems like the real issue is lawsuits. Have you seen the proliferation of law firms seeking Lotronex cases? Yikes. (Also, I strongly second the rest of the posts here: if doctors and patients take more responsibility for treatment, most of the problems would go away).-Sam
I agree with you totally, Bob J. When my miracle drug Lotronex began working a little too well, I simply cut back on the dosage until I reached total, comfortable control. While my heart goes out to those patients who died, it seems only common sense that what goes in must come out! Duh!And Sherree, I receive the SAME exact return message from Glaxo EVERY DAY--because I e-mail them and the FDA EVERY day. They might as well be as miserable as I am without my Lotronex!
Most place have form letters and form emails for common things. They just hit one or two buttons and the canned reply comes out.If it's a specific email address for Lotronex there may even be a little email bot that just returns the same email to all incoming mails.I've seen that kind of thing when reporting people to thier ISP's for spam. You send to the abuse address and the little canned response comes back usually fairly quickly.It may take a few days before a real person sees it, but they think it makes people feel better to get a quick reponse.K.
From what I read in the letter from Dr. jane Woodcock, the FDA was willing to try such a program, but Glaxo didn't go for it. I'm not sure I know what to make of this...any thoughts from anyone? What can we do? I'm so frustrated, depressed, sad!!!
Bob, what do you make of the research that shows people, pharmacists, doctors, and nurses, apparently can't or don't read. does the fda have to make sure people know how to read before they buy a drug so they don't get sued? sounds to me like congress should look into it.tom
trbell,Boy, I hate to get political on these boards, but...congress, the government, is just who we DON'T want to get mixed up in this thing anymore. They're the ones that helped screw this thing up to begin with.Sammy,I think you are correct - it's probably the potential for the cost of lawsuits that discourages Glaxo from continuing production, or otherwise agreeing to the FDA argument for restricted distribution. Still, the end result is the same - it's not profitable for them to continue trying.AnneMarie,Yes, I don't believe Glaxo held back on the warnings - they were, as you say, very clearly stated.Miss Patience (Colleen),I noticed that thread you spoke of, and it WAS boggling that a C person was taking it, and even considering upping the dose. Duh...Good one with the "green toe disease" example.benjamin (Mary Jo),I wonder if the people upping the dose to 3 or 4 a day were doing it with their Doctor's approval. Not that that would make it OK, but I just wonder how much people consulted with their Doctor about it. If I were wanting to ask advice on upping the dose that much, I think I'd want my Doctor to be VERY familiar with not only IBS but the mechanism of the drug. And even then, I'd probably do some more of my own homework and maybe get a few other opinions from other medical folks familiar with the SPECIFIC CIRCUMSTANCES. Nothing to be taken lightly...AnnieOCFP,Good for you - e-mailing them every day. I like your motive...kmottus,Sounds like Glaxo IS sending out form replies.Janie63,At this point, you might consider looking into other treatment methods or drugs (Remeron?) because I don't think this Lotronex thing is going to be resolved too soon, if ever. Rather than spend your energy in frustration over Lotronex, spend it on finding other ways.All,Thanks for the "no-flame" responses. After I posted, I got to thinking that the use of the word "stupid" was inflammatory, especially on forums like this where sometimes folks take offense at those kinds of words. I was thinking that maybe I should have said "those who refuse to inform themselves" instead of "stupid", but why spend six words where you can save space by using one? Anyway, the enthusiastic agreement was pleasant. Thanks all...**************************I'm not a Lotronex user myself, but I am very concerned about the role the FDA played in this. I think they have a role in setting standards for consistent formulations, so that you know you're getting what you pay for (which you don't in the case of supplements and herbals), but beyond that, they shouldn't have the power over what goes on the market.In fact, there was another thread where someone said they thought the FDA should pull anything off the market that causes even one death. I think it was Jeff, the Forum Administrator, that replied and asked the rhetorical question that would follow that logic: So, the FDA should take aspirin, motrin...[and some other stuff] off the market?? Of course not!!Anyway, caveat emptor and do your own due diligence - that's my angle.BJ[This message has been edited by BobJ (edited 01-12-2001).][This message has been edited by BobJ (edited 01-12-2001).]
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TRBell, I know you directed this question to BobJ, but I'm going to weigh in anyway!
I don't think it's up to the FDA to be a nanny to us. It is up to ME to find out about what I'm being ask the doctor when it's given to me, and to do reserch if I'm not happy with that answer. Not to insult anyone here, but I am ASTOUNDED when someone posts to this board "My doctor just prescribed Bentyl. What is it?" IMO, they are abdicating their responsibility as patients. If I DON'T know what a doc is giving me, I say "what is this? What does it do? What side effects should I look for?" As patients, we just can't take the scrip and not know what it's supposed to do for us. Plus, with the internet, research on this stuff is SO much easier than it's been before.BobJ, I don't think your use of the word "stupid" was wrong. That's bottom line with a lot of "protective" stuff in the protect stupid people from their own stupidity. I am NOT saying that everyone who had problems with Lotronex was stupid. I AM NOT SAYING THAT. I DO think those who don't read package inserts/contraindicatons/warnings on drugs are foolish, at best.Colleen
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