In June, after a patient died and another became ill with a fecal transplant containing drug-resistant bacteria, the Food and Drug Administration intervened and set new guidelines for the procedure.
The guidelines stated that both donors and their faeces should be tested for "multidrug-resistant organisms". They were included in a signal issued by the agency stating that the two patients who became ill had weakened their immune systems and that the donor feces they had received had not been tested for the specific superstorm that made them sick.
However, no additional information was provided on cases, such as how the faeces were treated, how they were given to patients, or what was used for treatment.
Communication raised more questions than answers. Chief among them: What exactly happened in both cases? And given the growing threat of drug-resistant bacteria, why haven't these guidelines been implemented anymore?
To the disappointment of many physicians, the FDA remains a mum on case details. In addition to the brief safety alert, the agency did not provide additional information, possibly because patients were part of a clinical trial, which means the information was privileged.
As to the question of why there was no guidance, which requires a look back at the long history of the procedure. Faecal Transplant History
Until a few years ago faecal microbiota or FMT transplants were completely unregulated. The procedures are thought to fall under the heading "medical practice", a heading that allows doctors to use treatments that are not approved and may not even have very long experience.
But in reality FMT, have a long experience. As early as the 1950s, doctors in the United States began transplanting stools from healthy donors to patients with life-threatening diarrhea caused by an infection with a nasty bacterium called C. difficile. The transplants worked and the patients improved.
The reason for the success of the procedure is what led patients to become ill in the first place: they all have a history of extensive antibiotic treatment.
"Doctors believe that the problem is that antibiotics have killed the normal gut that resides in the gut, and that somehow disrupts the normal ecosystem there, allowing bad bacteria to thrive," says Dr. Alexander Horutz, a gastroenterologist, professor of medicine at the University of Minnesota. "They thought maybe this could be reversed by adding [gut bacteria] from healthy people through enemas.
The word for the success of treatment began to spread and doctors throughout the country began using the technique, although there were no clinical trials to prove its value.
That changed in January 2013 when a study published in the New England Journal of Medicine found that FMT was so effective in treating C. diff that researchers had to stop enrolling new patients for their trial, because as it would be unethical to have a control group that did not receive
In the meantime, specialists begin to work out how the donated chair is handled. "Essentially food, fiber and other materials are filtered out and all that's left is fluid with bacteria," says Dr. Daniel Uslan, clinical director of infectious disease at UCLA Health.
These days FMT can also be given by mouth: Doctors have refined the process so much that the bacteria can fit into a capsule that patients can swallow.
By 2012, a non-profit company called Open Biome began collecting and processing donor feces, selling its "product" to gastroenterologists who did not want to do it themselves.
However, the FDA has not yet established any guidance on what doctors should look for in donors and stools before transplanting. To be sure, many providers have checked for certain pathogens, but there was also the suggestion that if the donor is healthy, their feces are likely to be free of dangerous bacteria.
Purpose of the drug
Following the publication of a New England Article in the Journal of Medicine, the FDA intervened.
A seminar was convened by the agency in February 2013, which ultimately concluded that the best way to proceed was to designate FMT as a study drug that could only be used in clinical trials. (Until approved by the FDA, it can only be used in clinical trials.)
The decision elicited a reaction from specialists who knew that many patients in need of treatment would not be able to participate in these trials .  In response, the FDA retreated slightly. The agency decided to allow the use of FMT outside of clinical trials for a specific group of patients: patients with C. diff infections who did not switch to standard antibiotic treatment. Doctors, for their part, had to make sure they explained the potential risks of the procedure.
At that time, no one, including the FDA, knew exactly what those risks could be – indeed this was always a problem with unexplored and unproven treatment – but according to Horutz, the major concern from the FDA's point of view was the risk of infection.
Despite the discretion of law enforcement, many professionals were unhappy to see the treatment defined as a medicine because it meant that in the future, companies would be able to develop products marketed as microbiome substitutes and then charge so much that some patients will not be able to afford it. (Still, current treatments can be expensive: Open Biome, for example, charges between $ 1595 and $ 1950 for their feces processed.)
An alternative, Horut argues, would be to approach FMT as an organ transplant. This means that doctors will continue to treat patients, some will even do their own research, but without FDA regulation and the medical company are less likely to enter the picture.
However, from the FDA's point of view, prescribing the drug was only one way to maintain sections of the rapidly expanding area.
"We decided it made the most sense to regulate it as a biological medicine," explained Dr. Peter Marx, director of the FDA's Center for Biological Assessment and Research. , "And in many ways it looks like a drug. Is it the perfect analogy? I will be the first to admit that it is not perfect. "
With drug prescribing, therapy was more likely to be tested in rigorous clinical trials, Marx said. In these trials, both its efficacy and safety will have to be evaluated and scientists can explore the best ways to
"There are many things in the history of medicine where preliminary data looked good, but when there were randomized controlled trials, they turned out not to help people and potentially harm them," Marx told NBC News "We want e while protecting public health while encouraging people to receive the treatment they need. "
There is no doubt that the popularity of FMT has increased in recent years. There are more than 300 registered studies on clinitrials.gov that examine FMT for a wide variety of conditions. many of which go beyond their original purpose, including transplant rejection, obesity and cancer, as well as some of the more anticipated gastrointestinal disorders such as irritable bowel syndrome and ulcerative colitis.
It is better for Dr. Ari Greenspan to monitor, especially after FMT-related death.
"It is my assumption that many of us in this area were a little cavalier with our use of it," said Greenspan, associate professor of medicine at the Gastroenterology Department at Icahn Medical School in Mount Sinai. "This is a bit like bleeding in the 80's when we didn't know we had to check for hepatitis B or HIV."
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