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Federal Government Considering Plunge into Regulating Stool

03/05/19 10:03 AM


C. difficile is a thorny problem for hospitalized patients because physicians have generously prescribed progressively stronger broad spectrum antibiotics, killing off good bacteria, making it easier for the bad bacteria to proliferate.

The condition affects 500,000 Americans each year and takes 30,000 lives.

When yogurt and standard probiotics don’t stop the diarrhea (and there is evidence to suggest they may be good first line treatments), some have turned to fecal matter transplants (FMT) to rebuild the good bacteria.

How does it work?

The treatment transfers fecal matter from healthy donors to the bowels of sick patients. Transfer can be via mouth or colonoscopy. Before you judge, the treatment by mouth requires processing to make it palatable.

The question before the FDA is whether fecal microbiota should be considered a drug. Or are fecal microbiota analogous to organs, tissues, and blood products transferred from the healthy to the ill?

Let’s go back in time. In 2013, the FDA announced a draft decision to regulate FMT as a new drug. They stated they would study the matter. Almost 6 years later, a decision is expected soon.

Some entities, such as practicing gastroenterologists and patient groups, want the FDA to butt out. Others (such as biotechnology and pharmaceutical companies) want the FDA to regulate. The conflict is turning into a s*%tstorm.

In a summary of the conflict, the NY Times reported:

Dr. Alexander Khoruts, a gastroenterologist at the University of Minnesota, said he feared the F.D.A. was favoring the interests of what he calls the “poop drug cartel,” a group of companies seeking approval for new ways to deliver the active ingredients in transplanted feces. Three of the companies, Rebiotix, Seres Therapeutics and Vedanta Biosciences, have raised tens of millions of dollars from investors and they recently formed an association to advance their interests with the F.D.A.

“An obscene amount of money is being thrown around by companies trying to profit off of what nature made,” said Dr. Khoruts. “I don’t think there are clear villains here, but I worry that the regulators are not caught up on the latest science and that the interests of investors may be exceeding those of patients.”

“The first principle of medicine is do no harm, and at the moment we don’t have a long-term track record of F.M.T.’s adverse effects,” said Dr. Sahil Khanna, an associate professor of gastroenterology at the Mayo Clinic who has conducted industry-funded clinical trials on fecal transplants. “We also need to move away from transferring poo from one person to another.”

Experts in the field of bioethics and many doctors are pressing the F.D.A. to come up with a new regulatory category that reflects the groundbreaking nature of microbiota therapies.

In 2012, around the time the FDA released its draft, a microbiologist at MIT, Mark Smith, founded OpenBiome as a non-profit stool bank. That entity now supplies the lion’s share of fecal matter for transplants in the US. Since its founding, tens of thousands of patients have been treated and cured with FMT. Some patients feel relief within hours of being treated.

The FDA is in a holding pattern and has adopted a wait and see approach for FMT for patients who have failed conventional treatments for C. difficile. Desperate patients has resorted to taking shortcuts with a relative’s stool , saline, and an enema.

Ms. Duff, the head of the C. diff patients group, credits her own recovery from the disease to a homemade concoction her husband created with his own stool in the kitchen blender.

I hope that blender was thoroughly washed before being used again. The larger point is that the number of effective treatments are few; and FMT is so effective. The FDA should make it easier to obtain access.

Insurance companies are also in a holding pattern waiting for FDA guidance. Until the FDA decides, most carriers are not reimbursing for FMT.

So, what does farm to table (or, more accurately, bench to bedside) look like:

The organization (OpenBiome) 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.

From the pharmaceutical companies’ perspective, if patients can buy a treatment directly from OpenBiome for a modest sum, then no one will enroll in a clinical trial. They are arguing that they have invented a novel means of delivering FMT and they should be able to extract a premium price if it passes formal regulatory approval.

Who knows how this will come out in the end? Let us know your thoughts. And if you’ve found yourself in a medico-legal bind, use the form below to connect with us.

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ABOUT THE AUTHOR

Jeffrey Segal, MD, JD

Dr. Jeffrey Segal, Chief Executive Officer and Founder of Medical Justice, is a board-certified neurosurgeon. In the process of conceiving, funding, developing, and growing Medical Justice, Dr. Segal has established himself as one of the country’s leading authorities on medical malpractice issues, counterclaims, and internet-based assaults on reputation.

Dr. Segal holds a M.D. from Baylor College of Medicine, where he also completed a neurosurgical residency. Dr. Segal served as a Spinal Surgery Fellow at The University of South Florida Medical School. He is a member of Phi Beta Kappa as well as the AOA Medical Honor Society. Dr. Segal received his B.A. from the University of Texas and graduated with a J.D. from Concord Law School with highest honors.

Dr. Segal is also a partner at Byrd Adatto, a national business and health care law firm. With over 50 combined years of experience in serving doctors, dentists, and other providers, Byrd Adatto has a national pedigree to address most legal issues that arise in the business and practice of medicine.

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EasyE

F.M.T. sounds like a crappy idea. If restoration of normal flora is the mechanism, Why not try a probiotic enema? Empty 3 capsules, or 150 billion organisms into an empty Fleet bottle and add warm water. Sounds like a more reasonable approach for “microbiome” restoration. Thank you.