A therapy using fecal matter to combat a bad bug in the gut will now be regulated by the federal government, to the consternation of some physicians.
The bug is Clostridium difficile, or C. diff, and the therapy involves infusing a watered-down bit of a donor's feces into the patient's digestive tract through a tube down the mouth or nose or into the colon.
The Food and Drug Administration announced this spring that it hasn't approved fecal transplantation for therapeutic use and that doctors must apply for permission to deploy it as an “investigational new drug.”
This may lead to paperwork before and after use of the therapy and could have a chilling effect on an excellent treatment, said Dr. Mark Rupp, chief of the division of infectious diseases at the University of Nebraska Medical Center.
“Unfortunately, it puts up a major regulatory hurdle and barrier for doctors” who want to use it, Rupp said.
Dr. Dan Diekema, director of the University of Iowa's infectious diseases division, agreed with Rupp's assessment: “I'm concerned about it because I'm worried that it will limit people's access to this critically important procedure.” He said he was unaware of any adverse events from using the procedure.
The treatment had been used increasingly to combat C. diff, a bacteria that has presented a growing challenge and is a classic example of the potential problems that come with antibiotic use. Scientists say the use of antibiotics for dental procedures and other purposes sometimes clears many forms of bacteria out of the gut and opens the digestive tract to invasion by C. diff.
C. diff causes repeated bouts of bloody diarrhea and can bring on dehydration, damage the colon and even lead to death. The federal Centers for Disease Control and Prevention says C. diff is “at historically high levels” and is linked to 14,000 deaths annually in the United States.
Although physicians typically conquer the bug in a patient with specific antibiotics, in some cases C. diff is antibiotic-resistant. Rupp and other Nebraskan physicians happily reported early last year that they were defeating antibiotic-resistant C. diff by infusing into the patient's gut fecal matter watered down by saline solution. Typically that fecal matter, which is a brown liquid by the time it's infused, is obtained from a spouse or other loved one.
The FDA maintains that “controlled trials are needed to demonstrate the safety and effectiveness” of the fecal therapy. The FDA said the treatment also is being considered for use against inflammatory bowel disease and other disorders.
Dr. Alex Hewlett, a UNMC assistant professor of medicine, said his institution has used the fecal therapy on 17 patients for whom antibiotics against C. diff failed. Fecal therapy worked for 15, a success rate of 88 percent.
Hewlett, who monitors fecal therapy at UNMC, said he hopes the FDA clarifies what must be done. He has three patients scheduled to receive fecal transplants within the next three weeks, he said, and he'll probably have to delay them.
The FDA has offered an emergency phone number for doctors to use in cases in which patients desperately need the therapy. It's not clear what the FDA will require, though, for approval.
At UNMC and the University of Iowa, fecal donor blood and stool samples are tested to make sure they don't have hepatitis, HIV, C. diff, salmonella or other diseases. UNMC's Hewlett said testing and obtaining results can take one or two days.
Dr. Daniel DeMarco, director of digestive disease technology at the Baylor Health Care System in Texas, said his institution stopped doing fecal transplants late last year when it became aware the FDA was looking into it. DeMarco said he was disappointed when he had to stop, but understood the FDA's concerns. He had used the therapy with five patients, and four overcame C. diff, he said.
“I think the FDA's doing their job,” said DeMarco, who is a governor with the American College of Gastroenterology. He said the FDA doesn't want fecal transplants “done everywhere by everybody” for unconventional reasons.
DeMarco said he believed the FDA could approve a therapy as an investigational new drug within a couple of hours, and the paperwork could come later. But it's extra work, he said, and some institutions might not have the resources to go through the additional steps.
Dr. Marvin Bittner, infectious disease specialist at the Creighton University School of Medicine, said he hasn't used that form of therapy, but believes physicians should be able to evaluate treatments without FDA regulations and delays.
The literature supporting fecal transplant's effectiveness is impressive, he said. Costs associated with fecal transplants are only several hundred dollars, he said, while a high-powered drug to fight C. diff, fidaxomicin, can cost $3,000 to $4,000. There are less expensive drugs, too, that are frequently effective.
But Bittner pointed out that Omaha investor Warren Buffett said last weekend that health care costs in the United States make up more than 17 percent of the American economy, a higher share than in other nations.
“Maybe in the United Kingdom they aren't as interested in regulating a person's stool,” Bittner said.
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