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Fecal Transplants: Is Regulation Limiting Access To Health?

Clostridium difficile bacteria is shown under a magnification in this undated...

Credit: Courtesy of the Center For Disease Control and Prevention

Above: Clostridium difficile bacteria is shown under a magnification in this undated photo.

Robert Hyde Sr. was first diagnosed with Clostridium Difficile, called C. diff, in 2013. He fought the infection, caused by a drug-resistant bacterium, for four years, vomiting almost every time he ate and suffering from debilitating diarrhea.

“This is a disease that I never even heard of, and yet I’m so sick. The doctor, before the stool test came back, told me that if something didn’t happen I was going to die,” said Hyde, age 77.

The spores are highly contagious and can live on surfaces for months. Robert and Nadine, his wife, used separate bathrooms and cleaned areas of their home each day with hospital-grade bleach wipes.

Hyde said this includes “bathrooms, door knobs, toilet seats, light switches, everything. And I am so afraid she is going to get it. I’m going to kill my own wife.”

The Centers for Disease Control and Prevention calls C. diff an “urgent threat to the United States.” The bacterium is estimated to cause half-a-million infections each year, killing tens of thousands of people within the first 30 days of diagnosis. The infection is more deadly than HIV/AIDS.

Photo credit: Courtesy of Nadine Hyde

Robert Hyde Sr. holds a bottle containing his fecal transplant at Sharp Grossmont Hospital on April 7, 2017.

Doctors prescribed antibiotics for Hyde but the infection kept returning, mutating with each relapse and growing more resilient each time. The cost of Vancomycin, a standard antibiotic therapy for C. diff, was not covered by insurance, making their out-of-pocket costs $400 for a 2-week supply.

“We felt it was better to take care of burial matters because we thought Bob had little time to live,” Nadine said.

But then doctors suggested another treatment option. It’s called Fecal Microbiota Transplantation, or FMT.

Historical records show a similar practice was used as early as the 4th century by an alchemist named Ge Hong, who used “yellow soup” to treat patients with intestinal conditions.

Through an endoscopic procedure, human stool from a healthy donor is inserted into the colon of the sick patient. Transplants can also be done through an enema, or even given in a capsule form that is triple coated then swallowed. The healthy bacteria colonizes the colon, eventually killing the persistent infection.

Dr. Michael Lajin, Gastroenterologist and Intervention Endoscopist at Sharp Grossmont Hospital, said FMT has a 90% success rate for curing persistent C. diff infections.

“Fecal transplantation for treatment of C. diff can be life-saving, especially in people who have severe illness, severe colitis, and it can save them from death. It can save them from surgery where the whole colon has to be removed," Lajin said.

Dr. Fadi Haddad is an infectious disease specialist, also at Sharp Grossmont Hospital. He likens C. diff to weeds growing on a lawn.

“You can opt to kill the weed by giving it an antibiotic or by getting rid of the whole lawn and putting in a new lawn. And that’s what we’re doing,” Haddad said. “Rather than using a drug to target the bad bacteria, we can use bacteria to fight bacteria.”

Photo by Kris Arciaga

Dr. Fadi Haddad at Sharp Grossmont Hospital on February 2, 2018.

But the use of FMT has been greatly limited.

In 2013, the Food and Drug Administration issued strict regulations on the use of fecal matter. Fecal matter, as it’s used in FMT, is defined as a drug under the FDA Glossary of Terms because it is used to treat and prevent disease.

The use of FMT first required an Investigational New Drug (IND) application to be used in FDA-approved clinical trials. But several months later, the FDA announced they would provide “enforcement discretion” in the case of C. diff patients not responding to standard therapy.

FMT could be used to treat C. diff without the restriction of an IND, with certain usage conditions. For Robert Hyde, this meant his insurance would cover the cost and the hospital would perform the procedure.

“When I had the fecal transplant in the hospital my bill was zero,“ Robert said.

Fighting the limits on FMT

Today the use of FMT remains controversial, especially among people who believe it should be used more broadly for conditions other than C. diff.

Joel Sprechman runs an intestinal health community resource called “One Great Gut” in San Diego. However, because he suffers from Inflammatory Bowel Disease, and not C. diff, he couldn’t get the fecal transplant in the United States that he believed would be beneficial.

“I love my country, but if I can’t get the treatment I need here, I have to go elsewhere,” Sprechman said.

Photo by Kris Arciaga

Joel Sprechman uses infrared therapy to ease symptoms of Inflammatory Bowel Disease at his home in Del Mar on January 30, 2018.

He traveled to Australia where he received a series of 10 transplants, costing him more than $13,000, on top of travel expenses. He said he has never experienced such potent medicine so quickly. But the financial burden was too great to continue therapy. His condition worsened, at one point his weight dropped to 115 lbs. He said he imagined suicide.

“I’ve had many stool tests, just to see what’s going on to check it out. And every time I hope that I have C. diff because then I can get it paid for. I can get the fecal transplant, which can be very helpful. Fortunately, or unfortunately, I’ve never had C. diff,” he said.

A grainy ten-year-old video shows Dr. Mark Davis examining an elderly patient, complaining of stomach problems, in his Maryland practice. Before the FDA issued the new guidelines, Davis, a naturopathic doctor, used FMT for people with chronic intestinal conditions, including inflammatory bowel disease and irritable bowel syndrome.

He said he is no longer able to prepare or administer it for those patients, even though he said FMT is safer than any drugs and more effective.

In early 2018, he traveled to Baja California where he consulted at a retreat that offers medically supervised fecal transplants for patients who could not legally get them in the U.S.

“The people that go to these retreats are people who feel like they don’t have any other option, they are people who feel like they have tried everything in conventional medicine, and often people who feel like they have tried everything in alternative medicine,” Davis said.

At his practice in Maryland, the IBD Specialty Center, Davis said patients who could not afford retreats plead with him for help, in spite of FDA rules.

“I have had people try and bribe me, or say can we skirt the law somehow. I don’t love the law but I follow it,” Davis said.

He said there is something he can legally do to help patients who aren’t candidates for FMT in the United States and who can’t afford the high cost of an FMT retreat abroad.

“I say, ‘Hey look, is there somebody in your friend or family community who is healthy and we can screen to make sure they are really healthy, and who you can ask that weird question: Can I use your poop as medicine?.’ Then you can do it at home,” he said.

Photo by Kris Arciaga

Dr. Mark Davis talks with Maya Trabulsi at KPBS on January 19, 2018.

He provides a health questionnaire and writes laboratory orders to screen donors for illness. Once donors are cleared, patients can self-administer the transplant by following a step-by-step guide he supplies that teaches patients how to prepare the stool as an enema at home. He said “it’s not really harder than following most kitchen recipes at home.”

But some conventional clinicians argue this is not a safe option. Dr. Michael Lajin said rigorous trials are in place for good reason.

“I don’t think it’s a good idea to do it outside what’s approved by the FDA,” Lajin said.

“We have to go through vigorous and rigorous screening. So there are certain labs that screen the donors and they go through detailed history and they go through blood test and fecal test and less than 5% of donors are accepted.”

Other doctors argue there is not enough evidence that FMT is safe to use for any condition, except what is currently approved by federal standards. Dr. Fadi Haddad said using the treatment outside of classical textbook application could result in unintended consequences.

Photo by Kris Arciaga

Dr. Michael Lajin demonstrates the endoscopic procedure for administering a fecal transplant at Sharp Grossmont Hospital on February 2, 2018.

“We don’t have to rush to a conclusion by just saying that FMT works in every condition. We have to take our time and get the right studies, the right research, the right donors, the right bacteria, and make the right conclusions,” Haddad said.

Internationally, dozens of FMT clinical trials are being conducted for conditions that range from pancreatitis to anxiety. However, it could be years before FMT is approved in the U.S. for these and other conditions.

Mark Davis said FMT is in a state of limbo as it is classified as a drug but can never be licensed as such because the FDA requires every drug to be identical from one dose to the next.

“FMT is not that and it will never be that,” he said, “so they defined it as a drug but a drug that could never be approved.”

Davis said one solution, suggested by other clinicians, would be to reclassify it as a tissue, like blood or bone marrow — something that treats and prevents disease but is never the same in every batch. But, he said, since the product is not composed of human cells, but rather bacterial cells, it couldn’t be defined as tissue by the FDA.

“What I would like the FDA to do is to say, ‘You know what? FMT is not a drug, it’s something else’,” Davis said. “And we should classify it as its own unique thing and give clinicians some more latitude to be able to treat patients with a variety of conditions.”

Robert Hyde Sr. was first diagnosed with Clostridium Difficile, called C. diff, in 2013. He fought the infection, caused by a drug-resistant bacterium, for four years, vomiting almost every time he ate and suffering from debilitating diarrhea.


Part 2: Patients in San Diego and across the country urge the FDA to expand the legal use of fecal microbiota transplantation.


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