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In this Thursday, June 19, 2014 photo, technical assistant Eliska Didyk transfers human fecal matter solution into a bottle in an OpenBiome laboratory, in Medford, Mass. With many patients no longer responding to potent antibiotics, stool has emerged as a surprisingly effective treatment for hard-to-treat gut infections. Fecal transplants pose a unique challenge for the Food and Drug Administration, which has been trying to confirm the safety of the new therapy by regulating it as an experimental drug. (AP Photo/Steven Senne)
FDA grapples with oversight of fecal transplants
Regulations » Process uses healthy patient’s stool to fight difficult intestinal infections.
First Published Jun 26 2014 12:28 pm • Last Updated Jun 26 2014 08:04 pm

Washington • Imagine a low-cost treatment for a life-threatening infection that could cure up to 90 percent of patients with minimal side effects, often in a few days.

It may sound like a miracle drug, but this cutting-edge treatment is profoundly simple — though somewhat icky: take the stool of healthy patients to cure those with hard-to-treat intestinal infections. A small but growing number of physicians have begun using these procedures, called fecal transplants, to treat Clostridium difficile, an intestinal infection that causes nausea, cramping and debilitating diarrhea, afflicting a half-million Americans annually and killing about 15,000.

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But fecal transplants pose a challenge for the Food and Drug Administration, which has decided to regulate the treatment as an experimental drug. Stool transplants don’t fit neatly into the agency’s standard framework. And while regulators have shown flexibility in their approach, some critics say the mere presence of government oversight is discouraging many doctors from offering transplants. That’s led some patients to seek out questionable "do-it-yourself" websites, forums and videos.

Most researchers agree that the FDA’s concerns are warranted. Patients can contract HIV, hepatitis and other viruses and parasites from fecal matter that is not properly screened. Additionally, there are no long-term studies on potential side effects of stool transplantation.

FDA officials declined to be interviewed for this story, but said in a written response that the fecal transplantation "shows promise in treating C. difficile infection that has not been responsive to other therapies."

Indeed, with many patients no longer responding to potent antibiotics, fecal transplants have emerged as an effective therapy against drug-resistant strains of the C-diff superbug. The procedure works because the healthy bacteria found in donors’ feces can help the fight off foreign infections.

"We’re dealing with something that is pretty close to miraculous," says Dr. Lawrence Brandt of New York’s Montefiore Medical Center, who has performed over 200 fecal transplants.

Most products reviewed by the FDA spend years in testing before they are submitted to the agency, usually by large drug or medical device developers. Fecal transplants have followed a different path.

In recent years, a handful of doctors have published small case studies on their use of stool to treat C-diff, with many reporting cure rates of about 90 percent. In January 2013, the New England Journal of Medicine published the first rigorous, head-to-head study showing that fecal transplants were superior to antibiotics for patients with recurring C-diff.

The FDA announced last May that it would regulate stool transplants as an experimental drug, meaning doctors could only perform transplants under an FDA-approved research application. The so-called investigational new drug application must include detailed information on the drug to be tested, the study design and safeguards to protect patients. Assembling a single application can take months or years, even for large drugmakers.


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Doctors pushed back, saying the requirement would force them to turn away desperate patients.

"FDA and some others are concerned about the long-term effects," Brandt said. "But my point was these people are getting ready to die now. They are not going to survive long enough to develop the diseases you’re afraid they’re going to get."

A few weeks later, the FDA revised its position, saying it would not enforce the requirement for doctors treating patients with drug-resistant C-diff — provided donors are properly screened and patients are informed that fecal transplants are still experimental.

But regulating stool samples as a drug presents other challenges. While it’s easy to limit access to experimental drugs, everyone has access to stool. And with detailed instructions on websites like thepowerofpoop.com, there’s nothing to stop patients from trying the procedure at home — especially if they can’t find a doctor to perform it.

"Some of these patients are very desperate and they’re not going to take no for an answer," says Dr. Michael Edmond of Virginia Commonwealth University.

Catherine Duff of Carmel, Indiana, says she had no choice but to help herself. In April 2012, she was suffering through her seventh C-Diff. infection, going to the bathroom 20 to 30 times a day and making multiple trips to the hospital due to dehydration.

"My quality of life had gotten to the point where I was beginning to think that it might be better to die," says Duff, 58.

Duff asked three different physicians if she could try a fecal transplant, but none were willing to perform the procedure. Her gastroenterologist did offer to test her husband’s stool to make sure it wasn’t contaminated.

Using instructions found online, Duff and her husband created a solution from his stool sample, mixing it with saline in a blender and administering it via an enema bottle. Four hours later, Duff said she felt good enough to get up and go for a walk.

Today, Duff runs a nonprofit group, the Fecal Transplant Foundation, which aims to raise awareness of the procedure and help patients. Duff says she gets up to 15 emails a day from patients looking for a doctor or a donor. Some even ask if they can use a stool sample from their infants or pets.

Duff says the unresolved status of FDA’s oversight discourages more doctors from offering the treatment. "There are so many doctors who are suspicious that the FDA could change their mind at any given moment and decide to not exercise discretion," Duff says.

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