Fecal transplant results for UC sound great - so why aren't doctors jumping on board on this?

Or maybe they are and I just haven't found it. But when I read this. .

http://en.wikipedia.org/wiki/Fecal_bacteriotherapy#Effectiveness

Somebody said...
While its effects on ulcerative colitis have not yet been adequately researched, small case-studies report positive effects. A recent article by Borody et al. that details 6 cases of severe chronic ulcerative colitis treated using Fecal bacteriotherapy suggests that the procedure may be extremely successful in these cases as well. Complete reversal of symptoms was achieved in all patients by 4 months post-HPI, by which time all other UC medications had been ceased. At 1 to 13 years post-HPI and without any UC medication, there was no clinical, colonoscopic, or histologic evidence of UC in any patient.[10

I wonder what better news could there possibly be?

Well, what I should have said was, why arent there large scale tests going on to get it FDA approved? (or are there and I just dont know it?)

And arent there nonprofit organizations that should be pushing for the research of unprofitable but promising treatments like this? CCFA, for example? And if not, does anyone know why not? Are there organizations that would do this if someone just gave them the funding?

This kind of helps to explain it:

"Though the procedure has been used in the treatment of C. difficile infections for a number of years, the body of literature examining its efficacy currently consists only of observational studies, and no randomized controlled trials.[7][8][9] Benefits of fecal bacteriotherapy include reducing the risk of cultivating antibiotic-associated resistance in the pathogenic bacteria displaced by the colonization and its purported effectiveness when antibiotic resistance is already in place. It is still considered a "last resort" therapy due to its relative invasiveness compared to antibiotics, the inherent risks of infection, lack of Medicare coverage for donor stool screening and instillation procedure, and the absence of any effective means of ensuring that the donor stool is itself free of pathogens.

While its effects on ulcerative colitis have not yet been adequately researched, small case-studies report positive effects."


Observational studies mean nothing when randomized controlled trials have not been done. It may have been a particular group of people that responded well. It may only be that people of European or Asian descent respond well, or only people who also have the gene for blue eyes (okay, crazy example). Effects also need to measured in the long term, not the short term. They also need to be researched over a wide group of varied people. On average, the process to approve a new drug can take upwards of twelve years; see this website for more details: http://www.drugs.com/fda-approval-process.html. It's also unbelievably expensive, and typically, something has to be shown to be very effective before they'll pass this on.

What it also comes down to is the fact that you are transplanting fecal matter. That carries a whole host of risks on its own.

Finally, it's another therapy that people can try, but might cause more harm than good for some...we just don't know. Obviously, for many people this may be their last option, and that's fine. But, things like this are often a double-edged sword. Have they tested this in people whose symptoms are milder? What happens then? What about with people who are immuno-compromised? We need to be cautious in this, as in everything else, as it could have horrific side effects that we know nothing about. Obviously medication can have the same risks, but, I honestly trust the medication more than this. I think that a lot more research is needed, and yes, it's not exactly the most profitable for pharma companies, but sadly, that's the game.

@Subdued: But we have birth control, condoms, spermicide, etc. Sex has been occurring for far longer, and we're far more knowledgeable about the "side effects" (I don't know whether that's the right wording haha, but I guess pregnancy is a side effect of sex!). I'm not denying that it's not money (I know it is), but we cannot deny that there is a lot of unknown yet. I'm not stating that we shouldn't be doing more research, etc, but it's a lot of time and money spent for something that might be difficult to regulate (how do you test the poo? who can donate? etc.). I took a class on infectious diseases during my undergrad, and we talked about the FDA approval process. Many things aren't approved by the FDA, however, people still use them because of the length of time they've been around. Maybe once the procedure is 10 years plus out the gate, then it will become more acceptable, but it won't happen overnight. Big pharma plays a role, but so do people's personal fears. Not everyone is going to be comfortable with that sort of procedure, so it's going to be longer for it to catch on. Also, and I believe this is key: it only improves the lives of a small number of people. It isn't economically feasible to push something like this through when there are many more people who need cancer drugs, AIDS/HIV drugs, etc.

Animals are made up differently than we are...there are animals that can eat things that are poisonous to us and be perfectly fine. So, I disagree that we should be thinking of it in the same manner.

I'm not trying to say that big pharma doesn't haven't a big hand here, but, there are also other reasons that I rarely see addressed in people's posts.

If you are worried about getting some disease from your donor's poo, then get it tested first. My donor is my granddaughter. I'm quite confident her poo is safe.

And then, "because stool is not yet a marketable biologic product, the procedure is not federally regulated."

http://classic.the-scientist.com/news/display/57795/

http://www.foxnews.com/health/2011/01/19/scientists-perform-fecal-transplant-treat-hospital-infection/

http://www.youtube.com/watch?v=FDEkKGrC7R0

Post Edited (subdued) : 9/11/2011 4:28:08 AM (GMT-6)