Fecal Transplantation "war"

Tristan's article said...
Inspired by the success of fecal transplants for C. diff, scientists are racing to develop similar treatments for an array of ailments and disorders, among them obesity, autism, ulcerative colitis, and Alzheimer’s and Parkinson’s diseases.

Such exuberance is a far cry from what researchers experienced when they first tried to sell the curative power of human feces.

Mark Smith, a microbiologist at M.I.T., was halfway through his pitch with a group of pharmaceutical executives when one of them interrupted to ask if the meeting was a prank. “I can’t believe you wasted my time with this crazy idea,” the man said, Dr. Smith later recalled.

DBwithUC - I'm assuming your ongoing argument that FMT will only be a valid treatment when it's an augmented pharmaceutical product refers to conditions outside of c. diff - colitis, crohn's and autism being the most widely studied right now. FMT efficacy for these conditions right now in clinical trials is showing about 30%-60%. Would certainly be nice to have a reliable pharmaceutical product to replace the raw material, and hopefully offer better results, but in the meantime it's still a promising treatment for those who have run out of options. Officially ruling fecal matter as a drug would make it more difficult for people to access the treatment while we wait for an approved product.

The more pressing issue with the FDA ruling is in regards to c.diff, for which FMT has a 90% cure rate after 1 single transplant, and is estimated to be more like 98% with 2 doses. What would be the benefit in denying this treatment to c.diff patients while we wait for a pharmacological product? Who knows if it's possible to recreate the exact mechanism of human stool in a lab, and if it is possible, how long it will take? While researchers attempt to work this problem out many desperate patients may be stuck waiting, denied this life saving treatment. Once there is a product, the price will certainly be much higher than what it is now with the availability of stool banks like openBiome, and who know if it will even be as effective as the natural route. Many people will likely still opt for the DIY method because it is extremely effective for c. diff, and is extremely safe providing there are no laws preventing doctors helping patients find and screen donors, monitor the patient before and after the treatment, etc.

The argument of the article is not about it's current efficacy for conditions like colitis. The argument is how will it be manufactured and distributed in a way that is safe and beneficial for patients. The dilemma is that this material doesn't fit in the current "drug" vs "tissue" model. There is certainly a lot of money to be made in this field and in the case of c. diff it is not based on "unscientific hype aimed at quick market profit".

I just don't see how the FDA making a strict "drug" ruling would benefit anyone other than pharmaceutical companies.

The article itself is pretty short and didn't really include a whole lot new. I believe a lot of folks are injecting his/her personal opinion into it. So let's keep this thread nice and polite

I don't think poop is a drug or should be treated like an organ transplant. It's really another, 3rd category and shouldn't be regulated as tightly as either others are.

Be best if they can isolate the helpful bacteria from all the rest of the crap lol. Safer, and would be an easier pill to swallow. Essentially be a more effective probiotic, a cocktail of good bacterium we need.

@MariaMaria. I agree some wider use of an FMT (likely screened or donor-optimized) will likely occur where it shows promise before microbe-only preparations become available. These may occur in medical settings under FDA regulation, or may occur in non-medical spa and DIY settings if regulation is slow and clumsy.

It may overstate my point to say it is about "validity". I am drawing attention to the microbial nature, and the fact that most medical reports note that the future needs to be consistently manufactured scientifically based microbes and not raw or semi-raw FMT. I perceive some to be suggesting that a free low-cost thing is on the horizon, because poop is everywhere. Few studies, especially UC, have found efficacy anywhere near the c.diff success rate. Some of this is the anerobic issue. Some is likely that with c.diff there is a microbe to kill, and with UC there is a pattern of immune response to the commensal microbes that needs altering. The 1st is easier than the 2nd.

I resist the idea that people don't want to research this because there is no money in it. I think there will be quite a lot of money in it. I think some of the research has been slow because of ick factor, but some because of limited success beyond c.diff.

I think the future of a lot of treatments for UC (and possibly other conditions) will target the gut microbes.

I also think that historically there have been a number of hyped up supplements and home remedies that did not work and may have prevent people from seeking working alternatives. Often because the active ingredient needs to be concentrated or rendered chemically available in some way, or something beyond the DIY capabilities. Just look at the hype around various diets, yet only a few have any scientific support. Remember laetrile, a naturally occurring chemical compound, famous for falsely being promoted as a cancer cure?

I think research should go forward, and I would support some sort of regulatory access to "off label" use of this c.diff treatment. I would prefer it in medical settings where results and adverse events can be tracked. I am unclear how it would come about that medical settings are going to start trying non-medicines. This requires doctors to be researchers in a way they are typically not. This would expose practitioners to lots of liability if they work outside of "standard of care".

the article said...
openBiome, the nonprofit stool bank that now supplies most of the fecal matter for transplants in the United States.

Over the past decade, tens of thousands of Americans with C. diff have been cured through fecal transplants, often with a single dose that can bring patients back from the brink of death.

The material comes from donors who earn $40 a pop and must pass intensive screenings and regular medical checkups. “It’s harder to become a stool donor than it is to get into M.I.T.,” said Carolyn Edelstein, who runs the organization.

MariaMaria said...
The more pressing issue with the FDA ruling is in regards to c.diff, for which FMT has a 90% cure rate after 1 single transplant, and is estimated to be more like 98% with 2 doses.

I just don't see how the FDA making a strict "drug" ruling would benefit anyone other than pharmaceutical companies.

I'm afraid that I have to agree with you. The FDA has often sided with the drug companies in the past and I would be pleasantly surprised (astonished actually) if this time were different:

the article said...
openBiome and other stool banks are facing an uncertain future. Drug companies... would like federal officials to restrict the stool bank’s ability to distribute fecal matter...

Critics fear that designation would allow a drug company to gain the exclusive right to sell a fecal transplant treatment for up to 12 years, a move they say would stymie innovation.

The F.D.A. has ramped up oversight of openBiome’s production, leading to more rigorous testing and higher prices, which will double to $1,600 this month.

Patient advocates expect those prices to jump exponentially should the F.D.A. grant market exclusivity to one of the companies that are in the final stages of testing alternatives to raw stool transplants.

Hi Maria Maria...thanks for being so open...my son was in remission for 1 year and uc came back, i did not do the maintenance and i am so mad at my self,,,here in Quebec Canada fmt are not very popular, you don t talk about fmt you look weid loll so we are all alone ..we look at internet and here ...this web site help me ...please tell me Maria if it was a rollercoaster for you wen you did fmt...its been 25 days and 16 fmt ..my son have cramps in the morning very bad cramps ans blood no blood liquide no liquide its not always the same ...are first time was not that hard...i read on Sky that help her son... i know that she said that that the symptome can be positive that the bactéria is very busy reproducing...it work before my son was well but the maintenance is so importante...please telle me your experience with fmt ..tried to talk to somebody ..and Micheal Hurst look well he travels he is on facebook...he do not talk about fmt on facebook...wen we need help we have not alot to turn to ...but here ...people say by my book ..all i want is your experience..it took how manny fmt before it was a little well..did you use 1 ore 2 ore 3 doners..can we use me and my husban one time him one time me ...sory for my english ,,thank you so so so much to all of you...take care..

It is possible that once the key microbes are identified that they will be available as a supplement, or medical food, as VSL was. As further safety is established, I can see some identified superdonors supplying material for culture and large cultured supplies sold as a supplement or medical food.

Unless openBiome has a proprietary process, I think others may manufacture as markets open.

I have recommended FMT to folks here when they needed options, or might have had c.diff comorbid. It is certainly worth a try before surgery. With reported remission rates as low as 22 to 30 percent, and most of those due to a particular donor, it is likely remission rates for general donors will be just a few percent.

Even a few percent is worth a try at some point. But, it is not a good option to used instead of treatments that have much much higher success rates. It should be used in addition.

Time will tell what happens. Everything else is just pure speculation. Plenty of reasons to be very optimistic or very pessimistic depending on one's own point of view on the matter. I just hope that reason wins (but I am an obvious optimist)...

Good question. Had to do some googling, it seems that blood has it's own "bespoke" rules according to this article at least. Would be nice if fecal matter had the same rules but apparently the fact that fecal matter is "excreted from the body" puts it in another category. https://www.wired.com/2014/02/fecal-transplants-regs/

We've never been able to recreate blood so it gets special treatment. Could we extract, manipulate and formulate the beneficial part of stool and transform it into a drug? No one knows yet. We still don't know why it works so well. It might not just be a few bacterial strains doing the work, it could be the ecosystem as a whole which would be very hard for scientists to imitate and recreate.

"The FDA regulates blood, cartilage, bone, skin and egg cells as human tissues or under similar customized statutes. Transplanting these products into people requires meticulous record-keeping and screening for communicable diseases. These are exactly the safety precautions that should be taken with FMT. Under current US law, products that are excreted from the body or that depend on living cells from non-relatives are excluded from this category, disqualifying faeces. Exceptions have been made for semen, which is a tissue product, and blood, which has its own bespoke rules. In our view, statutes should be changed so that faeces too can be regulated as a tissue, not a drug. Risks can be reduced by rigorous screening, and the potential for clinical benefit is substantial."