"FDA grapples with oversight of fecal transplants"

OpenBiome was featured in a new story by the Associated Press, published on Fox Business, Bloomberg Businessweek, and other media outlets, examining how to make life-saving fecal transplants available to patients and the deep questions that remain about how to regulate medical stool.  Here's a quote from the piece: 

"With so few providers available, proponents of stool transplantation have come up with innovative solutions. One big hurdle is the high cost of screening a stool sample, which can run up to $1,500 per sample. Insurance typically doesn't cover testing the stool sample because donors are usually healthy without signs of sickness.

Since October 2013, a Boston-based "stool bank" has managed to bring costs down to about $250 per treatment by screening samples in bulk. To date, OpenBiome has shipped over 300 stool samples in ready-to-use frozen preparations to 39 hospitals.

But in March, the FDA released an updated proposal for regulating fecal transplants, saying doctors should only use stool from a donor who is "known" to either the patient or their physician. Some doctors and patients worried the proposal, if finalized, would shutter OpenBiome and a handful of other stool banks, which use anonymous donors and ship to providers hundreds of miles away.

But OpenBiome founder, Mark Smith, says his group continues operating after having several productive discussions with the FDA. Smith says regulators have encouraged him to set up a formal study in which hospitals that work with OpenBiome will contribute data on the safety and effectiveness of fecal transplants."

Read the full story here on Fox or here on Businessweek. 

"Medicine's Dirty Secret"

Mosaic, a new science publication from Wellcome Trust, is writing long form stories on exciting topics in science. Their latest piece, also posted to BBC Future, took a very comprehensive look at fecal transplants, including the role for public stool banks (with comments from us!). Take a look -- here is the opening to the piece:  

"This is how far a mother will go.

Your daughter has been sick for more than four years with a severe autoimmune disease that has left her colon raw with bloody ulcers. After multiple doctors and drugs have failed, you are frantic for her to get better. Then you send her disease into remission, virtually overnight, with a single act of love. “Who wouldn’t do that for their daughter?” you say. It’s like a miracle, you say. “An overnight magic wand.”

You’ve agreed to do it again – twice – for strangers. You’ve seen first-hand how effective it can be and you felt so badly for the patients and their families. Had you donated blood or plasma, no one would blink. But this? You can’t tell anyone else about this because of how they might react.

There are more like you, men and women who have given their loved ones a remarkable reprieve from a group of chronic conditions known as inflammatory bowel disease. There are many more who have cured patients of a potentially fatal bacterium known as Clostridium difficile. This microbe can persist in a cocoon-like spore for up to five months, impervious to nearly everything except bleach. It is fast becoming resistant to every antibiotic thrown at it."

Read the full story here

"MIT Lab Hosts Nation's First Stool Bank, But Will It Survive?"

Last month, Boston's NPR news station, WBUR, featured OpenBiome in a fun piece introducing OpenBiome and the current proposal the FDA is considering for how to regulate FMT.  Here's a bit from the beginning: 

"You walk through a labyrinth of MIT buildings and into what looks like a typical laboratory: white walls and clean counters, the constant buzz of machines, the clutter of pipettes. In the corner, you open the door to a hulking freezer. When the puff of frosty air clears, you see stacks of plastic bottles filled with what looks a little like smoothies — in tawny, rusty colors Odwalla would never market. That’s your first hint of this lab’s unique purpose. Then there’s the giveaway: on the sterile countertop, you see a trophy of a squatting muscleman, labeled “Most Generous Donation.” Welcome to the first national stool bank. It’s like a blood bank, but for fecal matter. And that brown smoothie is actually very healthy stool, parasite-free and loaded with happy bacteria."

And here is an excerpt about the new regulations:

"The FDA is thinking about requiring the patient or the doctor to personally know the donor. But that doesn’t work so well for the stool bank, where the donations come from “Donor One” and “Donor Two.” They are anonymous gifts and soon that might not be allowed."

Here's the full piece. 

"Fecal transplant safety is goal of stool bank"

The Boston Globe featured OpenBiome in a discussion about how to advance safety and research on fecal transplants.  A timely topic, the piece reflects on recent enthusiasm for FMT and the opportunities that exist for advancing our understanding of the treatment. Here is an excerpt:

"The excitement about the successful use of fecal transplants to treat the gastrointestinal infection C. difficile has also led to a premature interest among the general public suffering from ailments for which it is completely unproven and untested. “I have pretty serious concerns about this,” said Mark Smith, a graduate student in microbiology at MIT who co-wrote the paper published in Nature. “It’s an exciting area of research, but it’s not ready for every patient to get their hands on.”

Here's the full piece. 

"Alternatives needed to do-it-yourself feces swaps"

A new piece from ScienceNews' Erika Englehaupt delves into how FMT should be regulated. It features the argument from a Nature piece by OpenBiome's Mark Smith and Eric Alm and Dr. Colleen Kelly.  Providing safe access to FMT is especially important, she argues, given that in the absence of it, people are performing FMTs at home without medical supervision. She writes: 

"Already, instructions for home transplants are available online, with YouTube videos promoting the use of feces from friends and family. “Some have even approached us for advice about using their pets as donors,”  write microbiologist Mark Smith and bioengineer Eric Alm, both at MIT, and gastroenterologist Colleen Kelly of Brown University. Dog poop probably isn’t going to cure you of much, since dogs carry different bacteria than people do, and home procedures with pet or human stool can be dangerous, as I discussed previously. Not to mention that a home enema may not even get the microbes far enough into the digestive tract to be useful in many cases.

On the other hand, people are legitimately eager to treat their serious conditions with a method that has shown success rates of 90 percent and better in published trials treating C. difficile, a bacterium that causes severe diarrhea."

Here's the full piece.

"Cambridge stool bank helps meet growing need for fecal transplants"

A new post by Carolyn Johnson in the Science in Mind section of Boston.com describes the proposal put forth by OpenBiome co-founder Mark Smith, Dr. Colleen Kelly, and Professor Eric J. Alm in Nature that stool for fecal transplants should be regulated not as a drug but similarly to tissue or blood.  Here is an excerpt:

"A group of researchers from the Massachusetts Institute of Technology and the Alpert Medical School of Brown University proposed Wednesday that fecal transplants be regulated similarly to tissue or blood.

In fecal transplants, a slurry of feces containing the gut bacteria from a healthy donor are implanted into the intestine, either through a nasal tube or a procedure similar to a colonoscopy. Official guidelines about how to screen donors and ensure samples are safe will help bring clarity and uniformity to a field that has become something of a Wild West. Researchers are concerned because YouTube videos now offer guidance on DIY fecal transplants for at-home use, and misinformation is abundant. The team that wrote the study has received questions from people suffering from gastrointestinal infections who wonder whether their pets could be used as donors. (They cannot.)"

The full text is here

"Policy: How to regulate faecal transplants"

Today in Nature,  a new comment by Mark B. Smith, Colleen Kelly, and Eric J. Alm makes the case that stool used in medical practice should be regulated like tissue or blood, and not like a drug, as current regulations dictate.  The piece highlights the role for stool banks like OpenBiome in facilitating safe access to material, to avoid circumstances in which patients, with no other alternatives, try to perform fecal transplants themselves.  Here's an excerpt: 

"[The first randomized controlled trial investigating the medical use of human feces] was stopped ahead of schedule because the faecal slurry was more than twice as effective in resolving symptoms as antibiotics alone1. Non-randomized studies, with outcomes collected from hundreds of people suffering from recurrent C. difficile infections and treated with similar procedures, have had typical success rates of around 90% (ref. 2).

First described3 in the scientific literature in 1958, faecal microbiota transplantation (FMT), delivers processed stool from a healthy individual to the gut of a sick person through enema, colonoscopy or other means. The goal is to displace pathogenic microbes from the intestine by re-establishing a healthy microbial community. Interest has surged in the past five years (see 'Stool treatment'). At the same time, new regulatory barriers have made FMT more difficult to study or practice."

Mark is a co-founder of OpenBiome and PhD candidate in microbiology at MIT, Dr. Colleen Kelly is a gastroenterologist and clinical assistant professor of medicine at the Alpert Medical School at Brown University, and Dr. Eric Alm is an associate professor of biological engineering at MIT and OpenBiome team member. 

Read the full piece here

"A New Kind of Transplant Bank"

Peter Andrey Smith featured OpenBiome in The New York Times on Feb 17th (it appears in Feb 18th's paper edition). The story explores the role of stool banks and questions about how to regulate stool for fecal transplantation. Here is an excerpt:

"CAMBRIDGE, MASS. — Around noon on a recent Friday, Donor Five, a healthy 31-year-old, walked across M.I.T.’s frigid, wind-swept campus to a third-floor restroom to make a contribution to public health.

Less than two hours later, a technician blended the donor’s stool into preparations that looked like chocolate milk. The material was separated and stored in freezers at an M.I.T. microbiology lab, awaiting shipment to hospitals around the country. Each container was carefully labeled: Fecal Microbiota Preparation."

Read the full piece here

"Need a fecal transplant? There's a poop bank for that"

Sarah Zhang of Gizmodo covered OpenBiome in a post on February 13th. In the piece, she reflects on the future of the use of stool in medicine. Here's an excerpt: 

"As we increasingly realize the role of the microbiota in just about every aspect of human health, the idea of banking healthy gut microbiota through poop doesn't seem very outlandish. (Note: While there are many associations between differences in the gut microbiota and certain diseases such as obesity and asthma, there's less evidence, at least for the time being, that a fecal transplant can cure diseases aside from C. difficile.) The "Brown Cross" could become part of our public health infrastructure."

Read the full post here

"Introducing the first bank of feces"

Erika Engelhaupt, an editor at Science News and writer for the magazine's Gory Details blog, provides a synopsis of OpenBiome in a post on February 12.  The following line captures the piece:

"A new nonprofit called OpenBiome is hoping to do for fecal transplants what blood banks have done for transfusions. It’s a kind of Brown Cross [emphasis added]."

We loved the new moniker!  In her piece, Erika also suggests that stool banks could provide an important alternative to the risky practice of at-home treatments. The full post is here

The Chronicle of Higher Education covers OpenBiome

M. Scott Brauer for The Chronicle

M. Scott Brauer for The Chronicle

David Glenn from The Chronicle of Higher Education featured OpenBiome in the story, "Student-Led Project Banks on Promise of Fecal Transplants" on February 3rd.  The full article is behind a paywall, but here is an excerpt:

"By the end of the weekend, the two graduate students [Carolyn Edelstein and Mark Smith] and James Burgess—another friend from their Princeton days—had hatched a plan. They would open the world’s first public stool bank, offering prescreened, frozen fecal specimens to hospitals around the country. What the Red Cross has done for blood, their project—known as OpenBiome—would do for feces."

The full text is available here to Chronicle subscribers.

A Q&A with OpenBiome, from the Power of Poop

Our team spoke with Tracy Mac, editor of The Power of Poop, a website that provides resources about fecal transplants "for patients, by patients."  We discussed the origins of OpenBiome, our progress to date, and questions of regulation, safety, efficacy, and research, among others. Here is an excerpt:

US hospitals can now purchase pre-screened frozen fecal microbiota to treat patients with Clostridium difficile. While others have been ignoring the C diff problem, complaining about bureaucracy or lamenting the fact that there’s not enough money in fecal transplants, OpenBiome have been quietly going about fixing the problem.

Q: You mention on your site that one of your family members went through the C diff ordeal. What made you take action – as opposed to just sitting around complaining about it?

A: We couldn’t believe how hard it was for our friend to get treatment given the simplicity of the procedure and the strong clinical evidence supporting its efficacy. He suffered for many months while waiting for a treatment that should have been easy for any gastroenterologist to provide. Thousands are dying and many more are suffering needlessly because this treatment is not yet available for them. So we started off with a feeling that there was a huge problem that needed to be solved. We think everyone who has been involved in FMT has seen that.

In our case we also have had the good fortune of having access to a lot of resources and support at MIT. It’s really an extraordinary place with tremendous resources for biotechnology entrepreneurship. One of our team, Mark Smith, has been deeply involved in microbiome research for many years as a PhD student at MIT. As a result, he was familiar with the technical requirements for implementing our vision and was well positioned to bring together the necessary resources. 

Read the full Q&A here.

Dr. Mike Edmond: "Great news for patients with C. Difficile"

Dr. Edmond is the Richard P. Wenzel Professor of Internal Medicine in the Division of Infectious Diseases at Virginia Commonwealth University. He also holds a faculty appointment in the Department of Epidemiology and Community Health and serves as the Hospital Epidemiologist for the VCU Health System. He posted about OpenBiome on the blog, Controversies in Hospital Prevention. Here is an excerpt:  

Yesterday I stumbled on OpenBiome's website and as I explored it I was nearly euphoric. [...] The company provides processed, frozen human stool from donors that have been carefully selected and screened for multiple infectious diseases at least twice, at a cost that's 1/6 the price of me testing one donor, and 5 to 14-fold cheaper than the drugs that these patients have taken without success. 

Read the full post here.

Dr. Paul Levy: "Will OpenBiome be #1 in the #2 business?"

Dr. Paul Levy is the former President and CEO of Beth Israel Deaconess Medical Center (BIDMC) and author of the blog, Not Running a Hospital. Below is an excerpt from Dr. Levy's post about OpenBiome: 

The folks at OpenBiome will face some interesting and challenging business development issues over the coming months, but their concept is sound and has the potential to bring great value to society.  Keep an eye on this one!

Read the full post here