Wednesday, November 13, 2013

FMT & How This Treatment Will Evolve

Another report on poop that's not that shitty.  The only stuff that smells in this article is the way the AMA and FDA have responded (or lack thereof) to FMT's.  This post is about good ol' FMT's or otherwise known as - Fecal Matter Transplant's, if you're not familiar with the abbreviation. I prefer FMT when talking about this.  
So yeah, this is an article that I found on a local CA online publication. It provided a lot of information, so I decided to do a blog on this.  I read a lot of articles about FMT's, with some that have produced study data and some that do not. There's not much data out there to be found, that's probably why.  All of the articles that I have read however, have been on the positive side in regards to the results with FMT's. This is the first article that I have read to date that reports an extensive {if you want to even go that far as to call it "extensive"} follow-up with patients who had received a FMT.  This information is super important in order to show the effectiveness of the procedure and to give people the confidence to consider such a treatment.  People get grossed, they just do. It's the way our culture handles stuff like this. The point I want to make here is that because of the lack of testing and trials for FMT's, being able to know if this procedure is effective and safe, is to follow-up with patients that have been treated with FMTs. Those patients, in a sense, will provide helpful and needed information that cannot be found in clinical trial data because the data doesn't exist.   This procedure is so new {well,to us Westerners that like to deny and refuse anything "natural"} and not tradition, the patients receiving this treatment are essentially the trial subjects. Seriously, there should be a consent that patients must sign before they receive this treatment that allows the doctors to use their information anonamously, especially follow up data, so it can be published for learning purposes.  To have that information available is crucial.  We are talking about working with US FDA here! As we have seen and continue to see, the FDA doesn't always make the most logical/reasonable decisions in the best interest of the people.  To be able to show data that makes a difference, will make this life saving treatment available to people that would otherwise die. There is no reason why there should be  hundred of thousands of people suffering from c-diff, thousands who end up dying and BILLIONS of dollars spent on ineffective treatments!  That's insanity when there's a treatment that has shown to be 90% effective.  
A patient that suffered from c-diff states the following -  "It's a beast that keeps storming back," he said. "It affects the mind and emotions, too — 90 percent of serotonin is in the gut. You worry quite a lot."  The doctors in this article state that the infection disrupts a person's life.  Doctor Stollman states that FMT's are "the most patient-driven treatment he's encountered in his twenty-plus years of practicing medicine".  It's not surprising that when you have a condition that won't go away, no matter how many rounds of treatment you take, that people end up seeking out the strange and unusual if it means being healthy again.  
The AMA needs to make a billing code !  Doctors need to get paid for treating people AND  doctors need to consider offering FMT's as an option that they know they will get paid for.  After all, the FDA has allowed people with a difficult case of c-diff to get treated with this procedure.  Which means = if you're most likely going to die from c-diff, THEN you can receive the treatment. *smh* Yup, only if you have suffered long, spent a lot and have no more fight in you, will you be able to get an effective treatment.  Does this make any sense whatsoever?  
One last point.  The 4 patients out of the 77 that were followed up with after the FMT who had developed one of the health issues listed (I highlighted the paragraph in purple), in my opinion probably has no relationship to the FMT.  People could have other health issues brewing that just happen to appear after this procedure.  The 4 health conditions are all very different from each other which also leads me to believe that these illnesses weren't brought on by the FMT.  I just feel that as long as the sample donor is screened and cleared for all the diseases that could make a donor  not qualified, then the chances of something negative happening is probably very low.  It's like receiving blood.  The benefit of getting it is high (because if you're getting a blood transfusion, there's a need for it) and the risk is low. Whether it's in a form of transplant or pill, if  it makes people better, this should start to be considered THE most effective treatment rather than the alternative when all else fails.  That's my take on it. 




The Future of Feces | Feature | Oakland, Berkeley & Bay Area News & Arts Coverage:

The Future of Feces 

Fecal transplants are being heralded as a simple cure for a dangerous and growing intestinal infection. But their future is uncertain.

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Jennifer spent the better part of 2009 in a hospital due to a stomach condition called gastroparesis. According to the Sacramento resident, that's where she contractedClostridium difficile (C. diff for short), a nasty and potentially life-threatening bacterial infection that's often spread in health-care settings. She said it began with bloody diarrhea, and multiple courses of expensive antibiotics didn't help. After suffering with the affliction for years, Jennifer (whom the Express agreed to identify by her first name because of privacy concerns) was desperate to find a cure. "I was living on Imodium during the day because I didn't want to have problems at work," she said, adding that she lost several jobs as a result of her sickness.
The answer to her woes, it turns out, was feces.
A year and a half ago, Jennifer's mother began researching alternative solutions online. That's when she discovered Oakland gastroenterologist Dr. Neil Stollman.
For the past five years, Stollman, whose office is tucked inside the historic Rotunda building in Frank Ogawa Plaza, has been treating sufferers of C. diff with a procedure known as fecal microbiota transplantation. It involves taking a stool sample from a healthy donor (usually a spouse or relative, or someone the patient trusts) and mixing it with saline to create a "milkshake-like" consistency, which is then delivered via enema into the C. diff patient's gastrointestinal tract. (It can also be administered via colonoscopy or nose tube.) The bacteria in the donor's stool restore the patient's balance of healthy bacteria. According to studies, the procedure's effectiveness in treating severe or recurring C. diff is higher than 90 percent.
After a consultation with Stollman, Jennifer was deemed suitable for the procedure, and her mother was identified as a healthy donor. In the week leading up to it, Jennifer's mother ate prunes every night to regulate her bowel movements for stool donation. The results of the fecal transplant were almost immediate. Within a week, Jennifer felt better. "Stools were normal. My lower abdomen cramps were gone. It was amazing," she said. After suffering from C. diff for four painful years, Jennifer said she has gained ten pounds and been able to return to work full-time. "I was sick for so long," said the veterinarian. "It was the best thing, really."
According to Stollman, of the approximately 75 patients he has treated, all have been cured — quickly and at a fraction of the cost of antibiotic treatment. The concept of fecal transplants dates back to the 4th century when people with food poisoning ingested feces as a treatment in China. They have also been popular among veterinarians, who have used them to treat diarrhea in large animals such as horses. But only recently has Western medicine embraced them as more studies (including ones by Stollman) have been published in scientific journals. In January, The New England Journal of Medicine published the first study showing the effectiveness of fecal transplants compared to standard antibiotic therapy in patients with severe or recurring C. diff. **It showed transplants cured fifteen of sixteen people, whereas antibiotics effectively treated three of thirteen people. **Media outlets like The New York TimesWIRED, Gawker, and the radio program Radiolabpicked up the story, touting the healing powers of poop.
It's possible that fecal transplants could help tens of thousands of patients, according to Stollman. In recent years, incidences of C. diff have become more frequent, severe, and difficult to treat. The infection is usually treated with antibiotics — Vancomycin being the most commonly prescribed — and while that method's initial success rate is higher than 90 percent, C. diff recurrence rates range from 15 to 35 percent. In a recently released report, the Centers for Disease Control and Prevention (CDC) stated that the threat level of C. diff infections is now considered "urgent." C. diff debilitates more than 250,000 Americans and kills an estimated 14,000 every year, costing at least $1 billion in medical expenses. Symptoms can include diarrhea, fever, loss of appetite, abdominal pain, and nausea. According to the CDC, people can become infected if they touch surfaces that are contaminated with feces that contain the bacteria and then touch their mouth or mucous membranes. The elderly and people who have illnesses that require prolonged use of antibiotics have a greater risk of acquiring C. diff, because antibiotics kill the gut bacteria required to fight the infection. It's often spread from health-care workers to patients and is classified as a "healthcare-associated infection."
Recently, more doctors have begun offering fecal transplants. Locally, Kaiser Permanente's Walnut Creek and Antioch Medical Centers have been treatingC. diff patients with fecal transplants for the past year. Stanford Hospital and UCSF will also soon offer the treatment.
But demand has far outpaced availability. Until recently, Stollman was the only doctor in California to offer fecal transplants. Although no official data or registry exists, Stollman estimates that only about one hundred doctors in the United States offer the procedure, citing the fact that it is labor-intensive, potentially high-risk, and is poorly compensated (there is currently no billing code for fecal transplants, so how doctors bill for it varies, as does what health insurance companies agree to pay for, if anything).
Meanwhile, fecal transplants are increasingly being viewed as a "miracle cure." Stollman said his office fields hundreds of calls every month from people who want fecal transplants for everything from autism to acne. (Stollman said he only uses the treatment as a "last resort" for C. diff patients who have already tried multiple courses of antibiotics.) Meanwhile, clinics promising quick cures have begun sprouting up, aiming to capitalize on the newfound demand for poop. In a story published last year by the Portland alt-weekly Willamette Week, a fecal clinic promised to treat autoimmune diseases, eczema, asthma, multiple sclerosis, and depression — starting at $4,000 for a five-day "colon health retreat." The clinic's doctor said he was "self-taught."
The potential for scams seems particularly risky because, thus far, there have been no established guidelines on how to perform fecal transplants, or how to screen donors.
**Earlier this year, the Federal Drug Administration issued a letter noting that fecal microbiota falls within the definition of a biological product and drug, and therefore any doctor performing a fecal transplant would need to fill out a lengthy Investigational New Drug (IND) application and wait thirty days for approval. The announcement forced doctors to stop performing the procedure, and the ensuing backlash prompted the FDA to revise its stance. In July, it issued a statement that doctors could continue to perform fecal transplants in cases of severe C. diff, as long as the patient provided informed consent and was made aware of potential risks. A spokesperson from the FDA said trials are currently underway to test the safety and effectiveness of fecal transplants for C. diff.**
For now, the question remains of just how fecal transplants will be regulated, and whether the patients who need them most will be able to have access to them.

Between 2001 and 2010, the incidence of C. diff infections nearly doubled, according to data from National Hospital Discharge Surveys. It was during this time, around 2008, that Stollman and three fellow gastroenterologists — Seattle-based Christina Surawicz, New York City-based Lawrence Brandt, and Oklahoma City-based Mark Mellow — started talking about what could be done. Surawicz was the first to suggest fecal transplants as a potential treatment, though she had never performed the procedure herself.
"It seemed weird, strange, and bizarre," Stollman recalled. Surawicz had an especially desperate C. diff patient in the Bay Area and encouraged Stollman to test the treatment on her. "I think I said 'no' at first," he said. "This is not traditional Western medicine, but I'm a traditional doctor." But, realizing the patient had run out of other options, Stollman decided to try it and found success; by 2009, all four doctors were offering the procedure.
"We completely made it up," Stollman said, regarding how they determined the amount of feces required, how to test donors, and how to administer the transplant. "There are no guidelines and there were no studies."
That soon changed. In 2010, Stollman, Surawicz, and Dr. Faith Rohlke introduced the concept in one of the first papers about the procedure, "Fecal Flora Reconstitution for Recurrent Clostridium difficile Infection: Results and Methodology." In 2012, Stollman, Surawicz, Rohlke, Brandt, and Mellow, plus four other doctors, contributed to the more extensive paper "Long-Term Follow-Up of Colonoscopic Fecal Microbiota Transplant for RecurrentClostridium difficile Infection," which tested 77 patients anywhere from 3 to 68 months after a fecal transplant. It showed that the primary cure rate for C. diff was 91 percent, with none of those patients reporting any new infectious diseases following the treatment. Although four patients developed new disorders, including peripheral neuropathy, Sj√∂gren's syndrome, idiopathic thrombocytopenic purpura, and rheumatoid arthritis, Stollman said there is no way to determine whether the fecal transplants and the immune disorders are connected.    
Because the treatment is so new, the American Medical Association still hasn't regulated what doctors can charge for fecal transplants. Stollman only bills his patients for the cost associated with testing a donor's stool sample, which starts at $100, and the colonoscopy that's required of the patient before the procedure, which is about $700. Stollman screens donors for HIV, hepatitis, syphilis, parasites including giardia, and C. diff, which can be dormant in healthy patients.
Kaiser gastroenterologist Theodore Levin said he was skeptical of the treatment at first, but he was also concerned about the many patients he was seeing with recurring C. diff. "It's really hard to get rid of," Levin explained. "These patients are destroyed. People's lives are completely disrupted. They become dependent on the Vancomycin, but as soon as they stop, the symptoms come back with a vengeance."
But without an assigned AMA billing code, Kaiser was hesitant to offer fecal transplants. So Levin, who is friends with Stollman and has closely monitored his success rate, began sending severe C. diff cases his way. "I kept hearing back from patients and I became more convinced it was valuable," Levin said.
As demand for fecal transplants increased, Levin questioned how best to work through hospital policies. Finally, one of Kaiser's infectious disease specialists came to him and said, "Please do this." "That made me go, 'Oh, other people think this is a good idea,'" Levin said.
In June 2012, Kaiser started offering fecal transplants to C. diff patients. Levin said its medical centers in Antioch and Walnut Creek have treated ten patients so far with positive results. "It's striking the impact you can make on their lives, and that becomes a reinforcing factor," Levin said. "One day people are sick and a few days later they are apparently cured."

Bob Frost, 58, had been thinking about having a fecal transplant since May. The local freelance writer (who, full disclosure, has contributed to theExpress) contracted C. diff in December 2012 after a minor surgical procedure required him to take antibiotics. The symptoms started with diarrhea that lasted ten days.
"I couldn't keep any food in," Frost said, adding that in the nine months he was sick with C. diff, he lost fifteen pounds.
Frost tried multiple courses of antibiotics, but the infection kept returning. "It's a beast that keeps storming back," he said. "It affects the mind and emotions, too — 90 percent of serotonin is in the gut. You worry quite a lot."
When Frost first read about fecal transplants in an online C. diff forum, he recalled thinking, "That's the grossest thing ever." But after six months of suffering, he decided he wanted to try it. That happened to be right when the FDA cracked down on the procedure, so both Stollman and Kaiser ended up denying him.
Frost said a fecal transplant would have been far cheaper compared to antibiotics — without insurance, Vancomycin runs about $1,800 for a fourteen-day treatment. That fact made him suspicious of the FDA's interference: "The FDA is in bed with conventional medicine. The drug companies won't support it because it doesn't benefit them."
Frost said he even considered doing a fecal transplant himself — there are many do-it-yourself instructions on the web — but ultimately decided against it. "There's too much potential of something going wrong," he said.
In July, when the FDA backed down on regulating fecal transplants, Frost was approved to have the treatment, but he's glad he waited; in August, his C. difffinally cleared up on its own. "It took me nine months to heal," Frost said. "With a fecal transplant, it might have taken nine days or nine hours."
Stollman said when the FDA initially announced restrictions on fecal transplants, he and his colleagues were worried that patients would attempt DIY transplants or seek treatment from the black market. But even though the FDA has eased its stance, there are still concerns about a fecal transplant black market catering to people who don't have C. diff.
"There are charlatans out there," said UC Davis Department of Microbiology and Immunology professor Jonathan Eisen, who has been researching microbial populations for twenty years and follows developments regarding fecal transplants on his blog The Tree of Life. "It appeals to scam artists. Google search for 'fecal bacteria clinic.' It's amazing how many people offer it [fecal transplants], and I don't trust many of them."
Stollman said that although there are a handful of doctors in the Bay Area who now perform the treatment, there are still not enough. "I'm still way backed up and can't keep up with demand," he wrote in an email.
The biggest barrier to patients getting treatment is doctors themselves, Stollman continued. Long before fecal transplants became the subject of media attention, almost all of his patients found him through online forums, where C. diff sufferers would commiserate and search for solutions. He called the procedure the most patient-driven treatment he's encountered in his twenty-plus years of practicing medicine. These days, Stollman said about three-quarters of his patients come to him due to their own initiative, and it often involves convincing their doctors.
In addition, the risks, amount of labor, and lack of compensation associated with fecal transplants deter doctors who might be open to performing the procedure. "There's still a whole debate about whose insurance company should be paying for the screening of the donor," Levin said. "If the donor is a Kaiser member, it's covered. Otherwise, we just handle case-by-case."
Eisen stressed that fecal transplants should not be used for conditions that are not yet proven to benefit from the treatment. Kaiser's Levin said he has performed the procedure for two patients with ulcerative colitis, an inflammatory bowel syndrome, but didn't find the results compelling enough to try again. "It didn't seem to work," Levin said. "With C. diff, it's strikingly beneficial."
Still, there are many aspects of fecal transplants that are unknown. "Infections are diverse and people themselves are incredibly diverse," Eisen said. "How do you regulate a treatment like this where everyone is so different from everyone else? We don't know how to estimate the risks. That's what we should be most concerned about."
Eisen said one person's stools can contain hundreds to thousands of different types of bacteria — most of which are unknown before a transplant takes place — meaning there could be a risk of getting an infection. So far, there have been no documented cases of such a thing happening, but long-term studies about the effects of taking on another person's bacteria don't yet exist.

As doctors wait to see how the FDA will regulate fecal transplants, they are left to speculate about the future of the procedure. Stollman and Levin believe the FDA will eventually require them to submit an IND application, which is why they've both starting filling them out. "It's been fairly laborious process," Levin said, adding that Kaiser is close to submitting its paperwork. Stollman, however, said he's not sure when his small staff will be able to complete the complicated application: "It's basically like a pharma company applying for a new drug," he said.
What is likely to change in the coming years is the donation process. Levin said he hopes regulation on how to screen donors will be enforced to ensure patients are getting healthy feces. "I think there are still some places that don't have clear policies on how donors are getting screened," he said.
While regulation would make stool donation safer, Stollman said increased testing requirements will also make the procedure more expensive, and may limit patient access if it requires the use of a more advanced lab.
Donor banks may eventually replace feces from friends and family. Stollman said both Stanford Hospital and UCSF are considering building donor banks, which would make pre-screened stools available for emergencies, and Levin said Kaiser has also considered it.
Eventually, synthetic stools could replace human donation. Eisen said researchers at the Human Microbiome Project at the National Institutes of Health are currently working on technology that would allow scientists to map our microorganisms, similar to how DNA is analyzed, which would then allow doctors to create transplant bacteria based on a patient's specific needs.
The transplant aspect may also take on a new form. During last month's IDWeek, an infectious diseases conference in San Francisco, Canadian researchers unveiled a new "poop pill" to treat C. diff. The pill does not contain actual poop, but rather the healthy bacteria from a donor's feces. Like standard fecal transplants, the stool would be donated by a family or friend and tested before its bacteria are extracted in a lab. The bacteria is then condensed into 24 to 34 triple-coated gel capsules, which a patient is required to take in one sitting. So far, 27 patients have reported being cured of C. diffafter taking the pills.
As fecal transplants evolve, Stollman said his practice might not be able to keep up with the technology required to offer them. "Fecal transplants — as we know it — will not be a forever solution," he said. But until then, he's dedicated to continue offering them: "This is a very inelegant solution with elegant results," Stollman said. "It treats a population who has no other solution."

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