[SteveE]

My local GI contacted me by mail the other day to let me know that his office had been selected to take part in a national study to test a new medication for IBS & if I were interested in participating, I could call for more info.I called this morning & they said I qualify for it, but I'd have to stop drinking the herbal tea that I've found so helpful over the past few months. Plus, given the nature of the way these studies work, there's chance I'd be given a placebo or one of four dosage levels of the new medication (which has NOT been FDA-approved).Since I've been doing a little better...though far from cured, I'm afraid to sacrifice that progress for an experimental substance that might not help at all or might even make me worse. They're going to send me some printed materials about it & then I can make-up mind then.Anyone else ever faced a similar decision/situation?

 

[Anxious]

No SteveE - can't say as I have! And, I, for one, would NOT do it - if I was (which I thought I was, but was wrong) making progress, I definitely would not jeopardize THAT for anything! Not FDA approved - an even better reason to decline!!

 

[Missycat]

Well, maybe you should wait to see the printed materials before you decide? And Maybe you'll get a "wonder drug!" I'm always trying to be optimistic...... I'm actually waiting to hear from a local hospital here who is doing a drug study - it was listed on the link that Jeff posted. Don't know what it's about yet, but I should find out later this week.------------------Fear can hold you prisoner. Hope can set you free.Missycat

 

[Guest]

Hi SteveE - I doubt if I would participate in a trial study because they usually don't want you to take anything else while you are on the trial med. If you get the placebo and you start feeling miserable with your usual symptoms, you have to get through the trial before you can start back on the usual things (such as your herbal tea) to make you feel better. As much as I want to find a cure, I'm hoping some other brave soul who isn't as badly affected by IBS will take my place!Christine

 

[flux]

What drug is it?

 

[Guest]

you know i when i read this i just had to tell you ,2 weeks ago when i was at the doctor i ask him about these new drugs they are talking about for IBS and he was honest when he told me he really didn't know anything about them yet,and i ask what he thought about trying them and he just told me that i was doing good on what i am taking(Phenergan&imodium) and if it's not broke don't try to fix it ,so as long as my treatment is working why give up to try something that might not work at all or even make things worse.[This message has been edited by rockcandi (edited 05-11-99).]

 

[SteveE]

flux--I don't know...and that concerns me.rockcandi--I wouldn't say it ain't broke anymore, but it hasn't been sitting next to the road with the hazard lights on in quite awhile....its kind-of chugging along...

 

[flux]

Perhaps you can ask them for its name.

 

[fbrown627]

It sounds like the Cilansetron study. The makers of Cilansetron had hoped this study would be in Phase 3 by now, but the FDA is making them redo Phase 2 a few more times.(All drugs must go through years of trials under FDA supervision before the government will approve them. That's what these studies are for.) The cilansetron study is a double blind study with the possibility of getting a placebo, 1mg dose, 2mg, 4 mg or 8mg. Many doctors think this is too low. In earlier studies, people taking this drug did see improvement in pain but did not get rid of it completely. While it's true you have to stop taking everything else while in the study, if you start to feel bad, you can always quit and go back to what you were doing before. I was asked to go into this study but turned it down.

 

[Guest]

Is this the drug that has had more sucess in women than men? I think that I remeber seeing something about this -- maybe Missycat had a url link or something? You may want to search on the name. ------------------***Sheeba***

 

[flux]

That drug was Alosetron, but it is reasonable to assume that this might be true for Cilanestron as well. They are both 5HT3 antagonists altered to be more specific for IBS and a possiblity is that female IBS-D is not the same thing as male IBS-D.

 

[SteveE]

Bullseye! Cilansetron it is. I just got the printed material this morning.

 

[marianne]

Look at the front page of the New York Sunday Times, for today, May 16, 1999. There is a major story detailing the amounts of money doctors make for recruiting patients to participate in studies - $1,600 to 3,000 a patient.

 

[SteveE]

You don't have to tell me the figures, I used to help a Ph.D. recruit people to be in smoking research studies. However, I'd like to point-out that the article may be a little deceptive (in terms of the doctors actual cut) depending on how they arrived at that figure. Still, there is no question that each patient/subject/whatever you want to call them is paid for many times over by the agencies financing the studies.