Medical-Grade Merde, Ctd

Emily Eakin covers the increasing popularity of fecal transplants. The logic behind them:

It’s possible that no Americans have gut microbiomes that are truly healthy. Evidence is mounting that over the course of human history the diversity of our microbes has diminished, and, in a recent paper, Erica and Justin Sonnenburg, microbiologists at Stanford, argue that the price of microbial-species loss may be an increase in chronic illness. Unlike our genes, which have remained relatively stable, our microbiome has undergone radical changes in response to shifts in our diet, our antibiotic use, and our increasingly sterile living environments, raising the possibility that “incompatibilities between the two could rapidly arise.”

In particular, the Sonnenburgs stress the adverse effects of a standard Western diet, which is notoriously light on the plant fibre that serves as fuel for gut microbes. Less fuel means fewer types of microbes and fewer of the chemical by-products that microbes produce as they ferment our food. Research in mice suggests that those by-products help reduce inflammation and regulate the immune system. Noting that rates of so-called Western diseases—including heart disease and autoimmune disorders, all of which involve inflammation—are thought to be much lower in traditional societies, the Sonnenburgs write, “It is possible that the Western microbiota is actually dysbiotic and predisposes individuals to a variety of diseases.”

Currently, OpenBiome, “a nonprofit stool bank founded last year by graduate students at M.I.T., ships more than fifty specimens each week to hospitals in thirty-six states.” But that might not last:

In the past year, orders for OpenBiome’s stool have increased at a rate of about eighteen per cent a month. Its success has unnerved biotech companies that are developing stool-based enemas and capsules—or, as they’re known in the field, “crapsules”—for eventual sale on the commercial market. “OpenBiome is selling an unapproved drug without any kind of F.D.A. clearance, so in my opinion they’re breaking the law,” Lee Jones, the C.E.O. of Rebiotix, a company in Minnesota that is developing an enema for the treatment of C. difficile, told me. “They may parade as a nonprofit, but what they’re doing is selling a product to be used on patients.”

When, in a year or two, Rebiotix submits its enema to the F.D.A. for approval, it will have spent tens of millions of dollars on research and trials—costs that are typically factored into a drug’s retail price. OpenBiome charges two hundred and fifty dollars for a treatment, which just covers its costs. “This is a highly unusual situation,” Peter Safir, the lawyer, said. “There’s no question that in the United States we want our drugs approved. We want the F.D.A. to say a product is safe, effective, and is manufactured according to good practices, and that costs a lot of money. But here you’ve got an almost identical competitor that is virtually giving it away, without F.D.A. approval.” Once a company like Rebiotix obtains approval to sell its stool therapy, he went on, it could pressure the F.D.A. to shut down OpenBiome.

Previous Dish on fecal transplants here.