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Drug Companies and Doctors Battle Over the Future of Fecal Transplants

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“For now, most of the material used in fecal transplants comes from OpenBiome, the public stool bank in Cambridge that embraces its mission with both humor and gravitas. Giant poop emojis decorate its offices, conference rooms are named after sections of the intestinal tract and employee birthday cakes invariably come in one flavor: chocolate.

The organization produces 900 to 1,000 monthly treatments, most of them bottled liquids that are packed in dry ice and sent overnight to clinics across the country. Any unpleasant odors are confined to an airtight production facility, where employees in white hazmat suits gingerly handle clear plastic bags filled with a mud-colored slurry.

The material comes from donors who earn $40 a pop and must pass intensive screenings and regular medical checkups. “It’s harder to become a stool donor than it is to get into M.I.T.,” said Carolyn Edelstein, who runs the organization.

In 2012, Ms. Edelstein created OpenBiome with Dr. Smith, now her fiancé, after her cousin contracted recurrent C. diff and, facing a six-month wait for the procedure, did it at home with a roommate’s stool.

A few months later they started OpenBiome with seed money from a foundation and sent out six treatments that first year. “It’s been a wild ride,” Ms. Edelstein said as she showed off a room full of mammoth freezers that hold thousands of screened stool samples.

But OpenBiome and other stool banks are facing an uncertain future. Drug companies, which have been struggling to funnel patients into the clinical studies that are required for F.D.A. approval, would like federal officials to restrict the stool bank’s ability to distribute fecal matter in the hope that more patients will enroll in their trials.

The F.D.A. has ramped up oversight of OpenBiome’s production, leading to more rigorous testing and higher prices, which will double to $1,600 this month.

Patient advocates expect those prices to jump exponentially should the F.D.A. grant market exclusivity to one of the companies that are in the final stages of testing alternatives to raw stool transplants.”

Fecal matter pills used to treat peanut allergies in Boston study (VIDEO)

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“There's evidence that when someone has a food allergy, gut bacteria send the wrong message about what the body should tolerate. 

‘We looked at babies who were allergic and babies who were not allergic and we analyzed their microbiota and we found significant differences between the babies that were allergic and the babies that were not allergic,’ said Dr. Rachid.

The thought is by transplanting another person's healthy gut bacteria into someone with an allergy, the microbiome can be repaired and send healthy signals to the immune system to tolerate allergens like peanuts.” 

Read More →

A User's Guide to Cheating Death: Germs (VIDEO)

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“Are we too clean? Germ theory and hand washing saved millions of lives, but has the pendulum swung too far in the opposite direction? We talk about everything from regular soap versus anti-bacterial, our microbiome and the role of probiotics, the hygiene hypothesis and the rise of auto-immune diseases, and explore both fecal transplants and helminthic therapy.”

Watch the episode here!

(Requires subscription)

A medical solution aimed at malnourished children

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“The THRIVE (transfer of healthy gut flora for restoration of intestinal microbiota via enema) trial is a small phase 1 study that will investigate whether faecal transplants can help severely malnourished children who fail to develop even after their nutritional needs are met.

Globally, about 35% of children who have severe acute malnutrition fail standard therapy, which includes specially formulated high-calorie food, says UCT’s Shrish Budree, a research fellow at OpenBiome and one of the investigators on the trial.

‘These kids don’t achieve their full growth potential and end up stunted, with an increased risk of infections and mortality,’ he says.

‘In the longer term, they are likely to be less productive adults, which has bigger implications for society at large. There is currently no alternative for the kids who don’t respond to standard therapy.’”

Read more: https://www.businesslive.co.za/bd/life/2018-08-29-a-medical-solution-aimed-at-malnourished-children/

Patients Want Poop Transplants. Here's How to Make Them Safe

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“'The way the regulations are written now, everything is being done under enforcement discretion,' says Diane Hoffman, a professor of health law at the University of Maryland, and first author on the Science paper. The FDA is just choosing to bend the rules for C. diff. patients. But the agency could just as easily unbend them, whenever it wants. Which is why Hoffman and her colleagues are suggesting transplants used for C. diff be regulated as a 'practice of medicine' rather than a drug, when the stool comes from someone the patient or physician knows, i.e. not a stool bank. Then it would only be subject to state, rather than federal regulation. More patients could then access the treatment—which has cure rates above 80 percent—regardless of market winds or agency whims. All other uses of FMT would still be subject to formal clinical trials overseen by the FDA."

Read more.

Vice News (VIDEO)

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"Fecal transplants have the power to revolutionize medicine, but hospitals need raw materials. At Open Biome, the country’s first independent stool bank right outside Boston, donors earn $40 for each sample.  The clinic, however, approves less than 3 percent of applicants. VICE correspondent Thomas Morton visited the stool bank and made a deposit."

Click here to watch the video.