12 INVESTIGATES: FDA crackdown on fecal transplants - NBC12 - WWBT - Richmond, VA News On Your Side

12 INVESTIGATES: FDA crackdown on fecal transplants

RICHMOND, VA (WWBT) -

The Food and Drug Administration (FDA) is cracking down on doctors performing a gross but potentially life-saving procedure. NBC12 first told you about fecal transplants in February. Now one of the only doctors in Virginia doing the procedure has stopped, and patients are going underground to get what they need.

"Oh God, it's awful. It really is awful," said Leah Rubenstein. After battling uterine cancer, one dose of an antibiotic sent Rubenstein's body into a tailspin.

"It's a horror. It really is. It takes away your life."

Clostridium Difficile, also called C-Diff, nearly killed her. The infection clears your gut of healthy bacteria, causing severe diarrhea. It's estimated to kill 14,000 people a year. She spent two weeks in isolation in the intensive care unit.

"We didn't think she was going to make it," said her husband, Rob Rubenstein.

Six months later, antibiotics would not work. She was stuck with debilitating diarrhea.

"You're afraid to walk out of house because you want to be near a bathroom," said Leah.

As a last resort, she turned to an unusual procedure. She had a fecal transplant.

"We take a stool sample from a healthy individual and we give it to the patient who has C-Diff," said Dr. Michael Edmond. He's an infectious disease specialist with the VCU Medical Center.

Dr. Edmond inserts a tube into your nose, down your throat and into your stomach. He then take a healthy stool sample from a donor - usually a family member. The sample is mixed in a blender, passed through coffee filters, and put into a syringe.

"I'm living proof. C-Diff nearly killed me and this gave me back my life. Within a few days, I had energy. I was able to eat like a normal human being," said Leah.

Now, finding a doctor who's doing these transplants is nearly impossible. That's because the FDA wants to regulate the procedure.

From now on, physicians and researchers have to get special approval from the FDA before they can perform a stool transplant.

"It's very frustrating. It's very frustrating when you know that a therapy is as effective as it is," said Dr. Edmond. He was one of the only doctors in Virginia doing the procedure.

"I had 10 patients scheduled for the procedure that we had to cancel," said Edmond.

He's had to stop and says patients are getting desperate, going online to learn how to do a fecal transplant at home - which means the stool donor is not screened for diseases.

"The end result might be that we've made the procedure less safe than more safe, which was the intent," said Dr. Edmond.

"Aside from anger, there's fear in my mind. God forbid, she had developed it again, knowing right now that we couldn't get the procedure scares me completely," added Rob.

"It's mind boggling. It really is. here you have something that this is simple, so basic that will cure a patient and they're not doing it," said Leah.

An FDA spokesman told NBC News:

"Our intention is not to interfere with life saving treatment, but to assure that patient's rights and safety are protected."

The agency says it's just trying to standardize the treatment. In the meantime, C-diff cases continues to spike across the country.

Copyright 2013 WWBT NBC12.  All rights reserved.

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