The data indicate that for Men AS A GROUP Lotronex is not statistically different from giving a similar group of men placebos.The approval process is based on AS A GROUP. You cannot do statistics on an individual very easily (although there are cross-over studies that can do that in some cases).Now ANECDOTAL evidence suggests that for at least a FEW individual men Lotronex works well, but the % of men that it works for is similar to the % of men that get better with a sugar pill.So I expect that it may work well for a FEW men but certainly not MOST men.K.
The problem is *not* that it never helped any man ever, the problem is the percentage of men that it helps is too low to be statistically better than being cured simply from being in the clinical trial.I don't want you thinking I said that it never helped any man ever, the problem is that to be APPROVED for EITHER gender in the clinical trials (usually Phase II level) it has to do better than just getting treated well (they want you to complete the study) and getting a sugar pill.NOTHING is EVER approved based on a sample of ONE person, no matter how well the drug worked for that ONE person.It doesn't matter really, what condition you have some people will be cured simply from being in the clinical trial (either it was their time for remission or being treated well is enough to get them to heal themselves).They just did a surgery study for arthrits. All you gotta do to make a knee better is put them out lightly make a couple of small holes and bandage them up, STATISTICALLY AS A GROUP. That "sham" surgery did NO BETTER than the actually go into the knee and clean it out. So we do not KNOW for certain that cleaning out the inside of the knee is any different than just doing SOMETHING, ANYTHING.Now it is possible that for a few of the people the ACTUAL surgery made a differnece, but we cannot PROVE it made a difference. Because not cleaning out the knee but making people think they had surgery does JUST as well.It is very difficult to prove that X helped person Y. It is compelling evidence when X helps 80% of people where getting a sugar pill only helps 10% of the people. but clinical trials are usually not that clear cut.15 years ago Lotronex would have never been put on the market because ALL drugs were ONLY tested in MEN.Now that you HAVE to test ALL drugs in BOTH men AND woman I suspect we will see over time a goodly number of MEN only drugs as well as WOMAN only drugs across the board of ALL Drugs.FWIW pretty much everything you buy OTC, or buy generically REALLY should ONLY be prescribed to MEN as there is for most thing NO evidence what-so-ever that it is either safe for woman or effective in woman. And lack of data proves NOTHING.K.
K Mottus and others. Statistics lie. I am proof of the need to look at the individual case. Lotronex made a dramatic difference for me ( a male) , after many, many years of suffering from IBS and D. As some of you know, I have been one of those fighting for its re-introduction, and am awaiting the day, hopefully in the next few months, when I can try it again....Dan
There are a lot of men that were helped by lotronex and zelnorm will probably help some, too. they just aren't developing any new meds for men because drug company investors know the money is in drugs for women.tom
DIGESTDAN!LOL __________________________________"K Mottus and others. Statistics lie." __________________________________I have a sign on the wall of my office where everyone that enters to see me can see IT first: ____________________________Numbers DO Lie.But not as Convincingly as People. ____________________________
Just to gently redirect, in the simpest possible terms, all KM is doing is explaining the rules of the "new drug game", and rules that have been generally accepted as to how to assess the OVERALL OUTCOMES of a drug, surgery or other modality, thats all.Nobody contends that the drug(s) do not help siome men, just that the population is/was small. The minority. And since the spread on Zelnorm, even on women, is only (depends what you read 5% to 11% compared to placebo, and you get tachyphylaxis in a large % of the population that uses it, it is just not an earth shattering soluition. Step in the right direction, though.Another saying about statitstics I think you will like is: _____________________________"If you torture the statistics long enough you can make them say whatever you want." _____________________________TR does make an interesting point as well. I will be lurking around from time to time just to see who, if anyone, challenges it.
No I don't keep a file, but I do get a little irritated by the "whining"
Gee the first time that woman actually ARE included in clincial trials they get a drug that is just for them and then ALL the men ###### about it ceaselessly.ALSO I DO research so I understand EXACTLY where the "It doesn't work for men" comes from. AND I was on a research project once where we HAD to include both genders even though most of the benefit was about BREAST cancer, but because a minor benefit might be colon cancer we had to include men because of the new regulations BANNING gender specific clinical trials UNLESS there was VERY SOLID EVIDENCE (like woman do not have prostates
) that the genders are VERY different.The numbers were something like this (memory is pretty clear on about what they were, but not entirely clear) in the PHASE II (BY LAW MUST MUST MUST DO BOTH BOTH BOTH Genders REGARDLESS OF ANY POTENTIAL MARKETING STRATEGYWoman, placebo 30% got betterWoman, Lotronex, 45% got betterMen, placebo, 30% got betterMen, Lotronex, It was either 30% got better, or 32% got better, but not enough to be able to tell between the two groups.(PS...for Zelnorm it was fewer men got better on Zelnorm than on the placebo so even though it helped woman it seemed to AS A GROUP make men worse off than if they did nothing)That is HOW they do the tests.No matter how well it works for ANY SINGLE PERSON AND I NEVER SAY IT DOESN'T HELP SOME MEN, JUST NOT ENOUGH TO BE STATSITICALLY DIFFERENT FROM MEN ON PLACEBOS....SIGH that doesn't matter.It is how it effects the GROUP.Part of the arguement for banning Lotronex is even for the woman, for whom it WAS statistically significant, it didn't help THAT many of them, so it's benefits appear iffy FOR THE GROUP REGARDLESS OF HOW WELL IT WORKS FOR ANY GIVEN INDIVIDUAL K.<the medical profession IGNORE's woman's health for generations....no drugs are actually proven to be EITHER safe OR effective for ANY of us unless it is for parts men do not have and the first frigging time we get ONE frigging drug that works better for us all the men get their boxers tied up in knots>BELIVE ME IF THE NUMBERS WERE REVERSED IT WOULD BE APPROVED FOR MEN ONLY NO MATTER THAT IT HELPED A COUPLE OF WOMAN ALONG THE WAY.
K, I'm not sure why the need to label compaining as 'whining' and 'bitching' but those are words my doctor uses. there is nothing available for men right now and i don't think anything is in the works. It's true that it's basically our fault because not many of us have come forward in the past: it's not considered okay for men to go see a doctor and complain. tom
Because in the reverse, woman would certainly be getting the exact same label...but no we were supposed to put up with the fact the medicine IGNORED us and the gender differences for ever. So what if heart medications and pain medications DO NOT usually work for woman. But heaven forbid there be ONE area where medication for woman is taking the lead.JUST ONE....It is like the world is coming to an end.NO AMOUNT of men going to doctors to tell them that they have X symptom (or woman dying of heart attacks or having totally uncontrollable pain for that matter) will change in any way that SOME drugs work better for ONE gender or the other. The only thing we can do is test drugs in BOTH genders and approve them for the people they will help most. Heaven knows how many woman have died from drugs that do not work for us, or have different side effects for us that we get prescribed to us EVERY day because there ARE no alternatives that are proven EITHER SAFE or EFFECTIVE for woman. Drugs that work JUST GREAT in men....but we just whine and ###### that the medication that the doctor gave us MUST BE working... it works for MEN who take it after all, it doesn't kill MEN who take it.....sigh.I AM SURE that drug companies are not shelving research on IBS drugs because, OOPS in the Phase II clinical trials it helped more men than woman.We DO NOT know enough to be able to from the get go design a drug that works in a given gender because we DO NOT know WHAT causes the gender differences. So there is no way they went (we only want IBS drugs for woman....if you have any clue it works for a man kill the project, kill it now.....no men with IBS and if they have it they must suffer till the end of time
[evil scientist laughter]We just recently ADMITTED that there MAY be gender differences.May be we should go back to the old days where ONLY men are tested for drugs and only drugs that work in men are approved.Because the way things are there is likely to be more drugs over the next couple of decades that are MEN only or WOMAN only and heaven forbid there be ANY more WOMAN only drugs released. Every drug must now be tested in both genders...I wish it and zelnorm worked better in men but they barely work for woman, either, but helping some people is better than helping none.
First off, I need a definition a word MNL used, "tachyphylaxis". Thanks
K, that was an interesting commentary on the role of gender in medical studies. Has anyone gone back and tested established drugs in women to see if they actually are effective in women?? Or if the doses are appropriate? I've often wondered about doses...even disregarding gender differences, I would expect a 300 lb. person and a 100 lb. person to need different doses of medication.One person commented that Lotronex worked right away from him... I can't help but wonder if it was a placebo effect or coincidence that it worked that quickly. I don't think it worked immediately for me. And it really was a miracle drug for me! (And I'm female, in case you were wondering.)
K, I would hope that when they get around to developing new drugs they base their work on hormonal or psychological factors which are likely to be present in ibs rather than on past injustices. But there's no need to take my comments personally. I'm not attacking you or the bb and I don;t think any of the other men intended that. I just think it's a fact of life today that drug companies are after major shares of the market and selling stock by developing things they think will sell well in TV ads.tom
Kmottus"15 years ago, Lotronex would have never been put on the market because ALL drugs were ONLY tested in MEN.""No, I don't keep a file, but I do get a little irritated by the "whining.""Gee, the first time that women actually ARE included in clinical trials, they get a drug that is just for them, and then ALL the men ###### about it ceaselessly.""BELIEVE ME, IF THE NUMBERS WERE REVERSED, IT WOULD BE APPROVED FOR MEN ONLY NO MATTER THAT IT HELPED A COUPLE OF WOMEN ALONG THE WAY.""...Medicine IGNORED us (women) and the gender differences forever.""Heaven forbid there be ONE area where medication for women is taking the lead.""It is like the world is coming to an end.""Maybe we should go back to the old days where ONLY men are tested for drugs and only drugs that work in men are approved."Luna"One person commented that Lotronex worked right away for him...I can't help wonder if it was a placebo effect or coincidental that it worked that quickly."Kmottus, Vere76 wanted to know if it worked for men. It does. Take a Midol.Luna, it worked for me the day I took it. It bound me up instantly -- and I loved it. I'd been taking four Immodium a day for years. I quit Immodium after the second day of Lotronex. I remember a lot of women were confused about all the men on the board who had GREAT success with Lotronex, when they did not. They were frustrtated. I'm back to taking my four Immodium a day or I'd blow water.
KM I'm glad I asked you that question, at least now I know where you are coming from. Not that I agree with it. I don't want to make this a political subject, but I don't think I or any other person should be banged because of how things were done in the past. I personally never owned a slave, took land from the Indians or tested drugs for men only. Get over it. PS: I never caused the line to the ladies room to be three to four times slower than the line to the mens room, hence the long lines. If I designed a public restroom facility I think I could fix that problem. Because that's what engineers do! Call it whining or whatever you want, but I'm and I'm sure many women and men are glad that people like Jeff Roberts has organized the whining.
One point that I cannot get *ANYONE* (well none of the men that seem to post things that sound like there is a conspiracy to keep all men with IBS in complete and total pain for ever) to understand is LOTRONEX WAS NOT ORIGINALLY DEVELOPLED TRYING TO MAKE A DRUG JUST FOR WOMAN It just happens that like A LOT of drugs for A LOT of conditions there ARE gender differences. As much as everyone tried to ignore that forever. They DID NOT MAKE LOTRONEX A DRUG THAT JUST WORKS IN WOMAN TO FIX PAST INJUSTICES. THEY HAPPENED TO FIND A GENDER DIFFERENCE BECAUSE THE ARE FORCED TO TEST ALL NEW DRUGS IN BOTH MEN AND WOMAN. If we KNEW how to make a drug that works in one gender or another they would probably have a "male only Lotronex clone" in the works.As time progresses we will probably get quite a few drugs for many things that are gender specific. But we JUST started it so everyone thinks it is a BAD and WRONG thing that it happened with Lotornex, rather than some other drug/disease. (Esp. on this board....I doubt men here would be all up in arms if a new drug for heart disease was for woman only)We DO NOT in any way know enough about what CAUSES these gender differences to design a Heart, or IBS, or pain med or etc SPECIFICALLY for either a MAN or a WOMAN.Maybe someday we can. But right now the "state of the science" is NOT that advanced.Now it appears that IBS *is* a disease where there *are* gender differences and *one* of the ways we *found* that out was that they actually *tested* drugs in BOTH genders.Otherwise we would not have figured that out or had ANY drugs for IBS coming to market at this time.But everyone seems to think that Lotronex was either specifcially designed for woman to screw men out of a treatment for one reason or another or that the data about how this drug effects men AS A GROUP in the clinical trials was doctored or faked or something to screw men out of being able to get Lotonex, Zelmac, etc.What is funny is one of the very old antidepressants that by definition must cure depresssion in MEN because that is all they tested it for way back then, so it DOES do SOMETHING in men does not with any regularity (again the not statistically significant as a group) help men with IBS.Why it fixes the brain and not the gut is a mystery and it certainly wasn't DESIGNED to work only in woman with IBS.Luna--there isn't money to go back and test all drugs in woman. It just isn't going to happen. The best you can really hope for is that your doctor will work with you for dosing and which prescription based on what works for you. A few things probably are being retested if there is a specific reason for it, but most things will never be. I can't remember the name of who wrote it, but there is a book where someone compiled lower doses for many drugs that have been proven to work, but I csn't remember what it was called, but that info is out there.K.
K, I think this is a 'system' problem. no one is attcaking you or women. drug develoment and research is driven by money and selling stocks and what goes over well on TV spot ads. Let's work on changing the system rather than biting each others' heads off?tom
Vere, Lotronex worked great for me from the first dose. Actually caused a little constipation, something I had never experienced. No placebo effect, I have tried most all meds that were supposed to help with little success. I totally agree with Tom's earlier statement about the money being in selling it to women. I communicated with two males who were in the trials and they said the drug maker didn't want enough males in the study to get approval and most everyone they knew was getting relief. I have stopped my IBS/D with Mike's tapes and will not be returning to Lotronex but it is sure worth a try for you. Only problem is since it is not approved you will not be covered by insurance like the females and have to pay a high price outta your pocket- $160/month was the previous cost! Norb
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