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Fecal Transplant Cures Antibiotic Resistant Infections – Will FDA Stop it?

Will "poop" soon become such a valuable commodity for some that they will not want to flush it away?
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Will "poop" soon become such a valuable commodity for some that they will not want to flush it away?

Health Impact News Editor

A recent study published in the New England Journal of Medicine on fecal transplants curing Clostridium difficile bacteria made news across the nation recently. 14,000 people a year in the U.S. die from C. difficile, which is generally caused by the overuse of antibiotics which kills off all of the gut flora, including the beneficial bacteria all of us need to survive. C. difficile is typically treated with more antibiotics, which for many people do not work.  C. difficile is becoming epidemic in hospitals and nursing homes. Fecal transplant therapy puts fecal matter from a person with good gut flora directly into the colon of the sick person. That may not sound appealing to most of us, but if you know anyone who has ever been afflicted with C. difficile and cannot stop the diarrhea, and who is slowing dying from losing weight, this therapy is a literal life-saver.

So while fecal transplants are not new, the fact that a study was conducted with amazing results on C. difficile is huge news. Up until now, the reports of fecal transplants were all testimonial-based, and not considered “scientifically valid” to those in the medical community. All of that has changed now, with this study being conducted in the Netherlands at the Hagaziekenhuis hospital in The Hague.

The study found that fecal transplants cured 15 of 16 people who had recurring infections with C. difficile bacteria, while only seven of 26 patients in two control groups were cured with antibiotics. Researchers at The Hague studied adults who had had at least one relapse of C. difficile after antibiotics. They randomly assigned them to three groups. Sixteen people took the antibiotic Vancomycin for four days and had fecal transplants. Thirteen people had their intestines rinsed then took Vancomycin for 14 days. The third group, also 13 people, had only Vancomycin.

In the first group that received fecal transplants, 13 of the 16 were cured after the first transplant, and two of the remaining three were cured after repeat transplants. Only seven of the 26 in the other two groups were cured after taking antibiotics. The others relapsed and 18 of them were then given fecal transplants, and 15 of them were cured. The New York Times reports [2] that the study was originally meant to include more patients, but it had to be cut short because the antibiotic groups were faring so poorly compared with the transplant patients that it was considered unethical to continue.

The New York Times and other major new media sites interviewed doctors across the country who have successfully used fecal transplants to cure their patients. It is not a new procedure, being first used in the United States reportedly by Dr. Ben Eiseman, of the University of Colorado, in 1958. Reports of its use in China date back to the 4th century. The New York Times article [2] reports that Dr. Alexander Khoruts, a gastroenterologist at the University of Minnesota, has performed the transplants in more than 100 patients with C. difficile. He said that it worked the first time in 90 percent, and that the other 10 percent were cured with a second treatment. The St. Louis Post-Dispatch [3] reports that Dr. Matthew Ciorba, assistant professor of gastroenterology at Washington University, was excited by the study’s findings because he and other physicians at Washington University had been preparing to begin using fecal transplants for patients with recurrent C. difficile this spring:

“We’re going to start offering it because it works,” he said. “It’s been shown to work across different countries, different centers, different investigators and different populations. The success rate is 80 to 90 percent, which is unheard of.”

“Contrary to popular belief, stool has no waste in it – it’s a mass of good bacteria,” says Professor Thomas Borody, director of the Centre for Digestive Diseases [4], who does one to six transplants a week in his Five Dock clinic in Sydney Australia.  “The incoming bacteria are capable of killing bad bacteria and recolonising your gut, restoring your body’s balance and leading to a resolution of your symptoms. In my experience, with a single treatment there’s a 95 per cent cure rate of C. diff. With a double treatment, the recovery comes so close to 100 per cent that you may as well call it 100 per cent.” (Story here [5].)

According to the St. Louis Post-Dispatch [3], the fecal matter is infused into the colon either through a colonoscope, enema or a tube inserted through the nose and into the colon. Some patients have even been instructed on how to do it at home.

Will The FDA Stop Fecal Transplants?

A major concern of doctors who are seeing tremendous success with this therapy is that it is not approved by the FDA, and they believe that the FDA may step in and try to stop doctors from performing the procedure. The New York Times [2] reports that Dr. Lawrence J. Brandt, a professor at the Albert Einstein College of Medicine in New York, said that the Food and Drug Administration had recently begun to regard stool used for transplant as a drug, and to require doctors administering it to apply for permission.

The St. Louis Post-Dispatch [3] reports that the Food and Drug Administration doesn’t regulate the transplants, because fecal matter is organic, but that this might be changing:

“We don’t know yet,” Dr. Ciorba says. “This could put a whole new wrench in things for physicians and the patients who would benefit from the procedure.”

The FDA routinely issues warning letters to companies that sell food or supplements that make health claims, warning them that they are selling “unapproved drugs” since they view themselves as the sole authority for health claims. If one does not take corrective actions in the way a product is marketed according to their unpublished standards, they can (and do) send in federal marshals to seize a company’s inventory and shut them down. This happens all the time all across the U.S., as was done to a Kansas winery selling elderberry wine (story here [6].) This story was interesting because an FDA “associate commissioner for regulatory affairs” actually gave a reason why the FDA felt this product was so “dangerous”:

“Products with unapproved disease claims are dangerous because they may cause consumers to delay or avoid legitimate treatments.” (Full story here [6].)

“Legitimate treatments” obviously are only treatments the FDA approves, and only drug companies who can patent a product and get a return on their many millions of dollars they must invest to get a product approved by the FDA, market products that are “legitimate.”

In the stories I read from major media outlets regarding the fecal transplant study, nobody was able to get a comment from the FDA on this matter. However, the Center for Disease Control (CDC) did weigh in on the topic on their blog [7] (I offer my comments in italics):

Author – Clifford McDonald MD [8]
Prevention and Response Branch Chief
CDC’s Division of Healthcare Quality Promotion

Transplanting feces from one human to another may sound repulsive, but for patients suffering from recurrent, debilitating diarrhea caused by Clostridium difficile [9], a fecal transplant offers a ray of hope.

(Comment: A “ray” of hope?! Doctors reports, now confirmed by this study, are near miraculous! What other procedure currently exists with a 90% success rate??)

It increasingly appears that fecal transplants are effective in treating recurrent CDI. Though we await randomized controlled trials to confirm signs of efficacy, we at CDC are heartened by this potential treatment.  Also, we are encouraged by our rapidly increasing understanding of the human microbiome, a term that refers to the entire population of microorganisms living on or inside us and all the genetic information possessed by these microorganisms.

(Comment and translation: Since much of the current funding in drug research revolves around “genetics,” we will figure out the “genetic information” and create drugs to do the same thing which we can approve. Current health claims cannot be approved because a person’s feces cannot be patented and no one will pay us the money needed to approve it. So until we find someone who can patent this and pay us a lot of money, we’ll use our standard excuse of “we need to wait for more research to confirm this.”)

In a recent paper [10] in Clinical Infectious Disease [11]s, Dr. Pritish Tosh [12] and I lay out a framework for the importance of a healthy intestinal microbiome to fight off a large and growing number of multidrug-resistant organisms (MDROs).  We believe that the main effect of antibiotics resulting in drug-resistant organisms is “selective pressure on the human microbiome.” When antibiotics wipe out the good bacteria of the microbiome, those bacteria are replaced by organisms that survived the antibiotic treatment, namely MDROs.  Once colonization with resistant organisms has occurred, these bad bugs can multiply and, in some cases, cause untreatable or severe infections.  These infections include colitis from C. difficile, in addition to bloodstream infections, pneumonias and other serious infections caused by MDROs.

(Comment and translation: We finally get it that our drugs messed up and killed the good guys (bugs) too. So we’re going to develop new drugs that are “selective” and only kill the bad guys (bugs.) But drugs are still the only hope for the future.)

Restoring a person’s inner population of normal bacteria holds promise for sufferers of CDI and for preventing MDRO infections. We need to know more about fecal transplants and the role of a healthy microbiome to bring this science to the bedside.  To speed this process, CDC is working with other government agencies, the NIH and FDA, to translate microbiome science into practical infection prevention. While that technology may be several years away from common use, it holds promise as one more tool we can use to protect patients from the increasing threat of these difficult to treat infections.

(Comment and translation: you can forget about us approving of fecal transplants, no matter how effective you think they are, so you are just going to have to wait for us to develop drugs that can be patented and approved by us, and that may take a few years to do.)

Read the CDC blog here [7] and offer your comments.

Will Healthy “Poop” in the Future Create A Lucrative Black Market?

If there is one thing that Americans have proven in recent years, it is that information will continue to flow as long as the Internet is still free, and that products good for our health but not approved by the government will flourish in a kind of “black market.” We are seeing that today mainly in the raw milk movement, as the FDA spends inappropriate massive resources to go after small family farmers who dare to provide raw milk to those who want it and benefit from it.

Currently, there is a clinic in Portland, Oregon, that offers fecal microbial transplantation (FMT) for conditions other than just C. difficile, including “autoimmune disease, eczema, asthma, multiple sclerosis and depression.” (Story here [13].) The key to this kind of therapy, however, is finding people with a healthy gut flora, who have not been on antibiotic therapy. The Willamete Week [13] ran a story about a 13-year old boy that was supplying his feces to this medical clinic in Portland, who was selected “because of his good diet, and because his parents never allowed him to take antibiotics.” He reportedly earns $50-a-pop job as a feces donor, more than he could make by baby sitting or raking leaves.

Given the lack of people who exist in our culture that eat healthy and have not taken antibiotics, one can imagine how “healthy poop” could come in high demand if FMT therapy starts to really become popular. And if the FDA and the government decide to ban it? You can almost guarantee two things will happen: A “black market” will develop because sick and dying people are desperate for cures that work, and poorer countries like Mexico will offer it across the border to lure patients into their “medical tourism” which is becoming lucrative in many places around the world. This is already happening with many effective therapies that are practiced in Europe and other places, in some cases successfully for hundreds of years, but are not available in the U.S. due to the government’s belief that only drugs, and drugs they approve, can make health claims.

There is a reason why the United States ranks #1 in money spent on healthcare (more than twice as much as any other nation), but only ranks 29th in life expectancy (story here [14].) Be educated, and take control of your own health. An improper faith in pharmaceutical drugs is largely responsible for creating the C. difficile epidemic, and it looks like a natural, unapproved, non-drug procedure offers the best cure!

References

1. Fecal Microbiota Transplantation — An Old Therapy Comes of Age [15] – New England Journal of Medicine

2. Risk and rewards of fecal transplants [16] – Canadian Medical Association Journal

3. Successful colonoscopic fecal transplant for severe acute Clostridium difficile pseudomembranous colitis [17] – Divisions of Gastroenterology, Mayo Clinic in Arizona

4. Systematic Review of Intestinal Microbiota Transplantation (Fecal Bacteriotherapy) for Recurrent Clostridium difficile Infection [18] –  McGill University, Department of Epidemiology

5. Quick, inexpensive and a 90 percent cure rate [19] – Mayo Clinic

6. Fecal microbiota transplantation for relapsing Clostridium difficile infection in 26 patients: methodology and results [20]. – Women and Infant’s Hospital, Brown University Alpert School of Medicine

7. Endoscopic Fecal Microbiota Transplantation: “First-Line” Treatment for Severe Clostridium difficile Infection? [21] – Journal of Clinical Gastroenterology

8. Treating Clostridium difficile Infection With Fecal Microbiota Transplantation [22] – Clinical Gastroenterology and Hepatology

9. Clinics and Doctors Who Perform Fecal Microbiota Transplantation [23]

10. Bright Medicine Clinic [24] in Portland Oregon

 

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