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Discussion Starter · #1 ·
IBS-C seems to be most common in women, yet being a male sufferer I find it frustrating that there is a a treatment that has had moderate success with women yet not with us 'lowly' men.
Is it simply the case that Zelnorm hasn't yet been tested on men, or HAS it been tested and found to be ineffective?If so, here's hoping for a treatment for us IBS-C suffering guys too.
Thanks
 

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This is fall out from the discoveries of the 1980's and 1990's that some drugs tested on men only and approved for everyone do not work on woman and some drugs that didn't get approved because they were tested on men only worked really well on woman.ALL DRUGS in the US at least MUST be tested in BOTH genders up until Phase II (the test a few people with the disease and see if it does ANYTHING...Phase I is give to healthy people to see what dose people can tolerate, if any).At the end of Phase II testing BY LAW they have to do a gender bias analysis. Phase III can ONLY be done in subgroups where it worked in Phase II (and this is where ALL the "They NEVER tested it" stuff comes from...NO ONE lookes at the Phase II to see that they COULD NOT test it in certain groups...drives me buggy
)No one really knows all that well what they underlying gender bias is...they aren't making drugs to ONLY work in one gender, they are making drugs to work at all and then finding out they only work in one gender.So, while I feel for you...I really do...just remember the VAST majority of drugs are only proven to work in men...when they don't work for woman we are problem patients
More drugs are in the pipeline, hopefully some of the other drugs will work in men. IBS is a funny disease and a lot of the drugs that work in woman don't work in men...but then many of the drugs that treat heart disease in men do NOT work well in woman, so it isn't some BIAS against MEN in the Drug industry...trust me...they want drugs they can sell to as many people as possible, but hey better to get approved for one subgroup than not be able to sell it or get it approved at all (which most of the IBS drugs pre-1990 would have NEVER made it to market at all, and people would still say nothing can be done to treat it.)K.
 

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PS...the does not work for subgroup means there is no statistical increase in the GROUP as a WHOLE when compared to placebo.So if 20% got better for no reason only like 20% got better on the drug.There do seem to be INDIVIDUALS that do not follow the group trend for most of these gender biased drugs.There was one in Lotronex that showed for a very small subgroup of men (not enough to change the group results) Lotronex when you look for a physiological indication it did something does in fact in a few men do the same thing it routinely does to woman (but not all woman, no drug ever works in 100% of people).It is just hard to find out what is the 1 or 2% of a sub-group that it might work for, and sometimes it doesn't work in anyone...K.
 

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Discussion Starter · #4 ·
Thanks for the info. I didn't think it was anything 'against' men, just curious really why Zelnorm wasn't applicable to men.Does it not work AT ALL for men?
 

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Zelnorm does work on men. My roommate has IBS-C as do I. For him it works. Well enough to almost "fix" him. He just has to watch what he eats and keep up the fiber and he lives a fairly normal existence. Before he had pretty severe constipation. I, on the other hand, get very little, if any, results from it. More than likely I'm responding to a placebo effect but I haven't been able to take the time off work to test that theory. Currently my insurance is still helping me with the cost, but that may change soon as its not approved for men. Although I'm not positive I believe the reason it has not been approved for men was the study was F'd up on the male side. They gave the drug to an IBS-D sufferer and they died of dehydration. Thereby killing the study for the men. And being that men are small part of a small market they may not have gotten around to starting again. Also I think the manufactures of Zelnorm are working a new drug with much better results: low dose Naltrexone (I think I spelled that right)which is in phase III tests. Hope that helps.
 

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Not 100% positive but I wouldnt be surprised if one reason why IBS meds arent "approved" or tested on men is that IBS affects more women than men so the drug companies make more money on women.
 

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ONE MORE TIME!!The were FORCED to BY LAW to test Zelnorm and Lotronex AND EVERY other drug on the planet that has undergone testing since the mid 1990's upto Phase II in both genders in sufficient numbers to get statistical relevance on does it do anything at all (and in phase I can we even give it to people at all). I did a clinical trial under these laws with diet and we were FORCED to include men because even though BREAST cancer was the main thing of interest colon cancer was in there, and since MEN get colon cancer we had to include them. Doesn't matter that the dietary factors were predominately targetted for a womans disease if there was ANYTHING that MEN got at all in any concievable way then MEN had to be included.Does NOT matter who you are marketing it to. We don't know enough at this time to design a drug to work only in one gender. In the past ONLY MEN were tested. The found out, eventually, that men and woman do not react the same to drugs (pain meds heart meds, and now IBS drugs are included in this...so the FORCED EVERY ONE EVER TESTING A DRUG AGAIN TO TEST IN BOTH GENDERS UP TO PHASE 2 AND SUBMIT THE GENDER ANALYSIS. IF IT ONLY WORKS IN ONE GENDER YOU CAN ONLY DO PHASE 3 IN THAT GENDER OTHERWISE YOU ARE FORCED TO BY LAW INCLUDE BOTH GENDERST IN PHASE 3...must calm down
Zelnorm was tested against enough men to show that STATISTICALLY it was no different from giving men placebo (if anything it trended to it does more harm than good in men).BUT THAT IS AS A GROUP Like they have shown for lotronex even when it doesn't help enough men to make the treated group different from the placebo you can sometimes if you look hard enough at the right endpoints show that some people respond like the other gender (for unknown reasons at this time).K.
 
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