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MALIBU, Calif., Nov. 13, 2019 /PRNewswire/ — Several doctors spoke before the FDA in Washington D.C. on November 4, advocating for C.diff treatment improvements. Among those in attendance were gastroenterologists Paul Feuerstadt (Yale), Colleen Kelly (Brown), Sahil Khanna (Mayo Clinic), Jessica Allegretti (Harvard), Zain Kassam (Finch), and Sabine Hazan (Progenabiome). They continue to collaborate in hopes of finding answers.
Challenging C.diff Beliefs
Clostridioides difficile infection (CDI) burdens millions worldwide, causing symptoms from diarrhea to life-threatening colon inflammation. With recurrence rising despite existing treatments, CDI kills 41 individuals daily in the US alone.
“What if we were wrong about C.diff?,” questions Progenabiome CEO Dr. Sabine Hazan. “What if the bug killing thousands every year doesn’t spread in hospitals but develops by what we put in our body?” After her lab found non-toxigenic C.diff in 100% of 121 random asymptomatic patients, Hazan wonders if hand-to-mouth transmission of bacteria actually causes CDI. She argues for further clinical investigation.
FDA Hearing on Use of FMT to treat CDI
Providers, scientists, industry, and patients provided testimony at the FDA hearing:
- Openbiome says enforcement discretion serves patients; shows 79% FMT success rate with their product
- Rebiotix expresses concerns of costs of clinical trials, delayed drug development and decreased study enrollment as a result of stool banks
- Amanda Kabage (Univ. of Minnesota) says FMT saves tens-of-thousands, many excluded from clinical trials
- Diane Hoffmann, JD (Univ. of Maryland) says costs will limit access if enforcement discretion discontinues with FDA drug approval
- Paul Feuerstadt, MD says limited access can be dangerous, as individuals have tried to perform FMT on themselves
While some speakers argue for increased studies to show definitive efficacy, several doctors show existing data to support FMT.
- Colleen Kelly, MD shares post-FMT data:
- 75% (263 respondents) “sustained cure” in 3-year multi-center follow-up study
- 95% (152 “initially cured” patients) remained cured 6 months post-FMT
- Sahil Khanna, MD shares recurrence rates:
- 8-16% rCDI post-FMT vs. 50-60% rCDI after antibiotic treatment
- Paul Feuerstadt, MD looks forward to data from active phase 3 trials; high-quality data-supported therapies are essential
- Byron Vaughn, MD no longer questions FMT effectiveness
- Sabine Hazan, MD emphasizes patient rights above all; with provider guidance and informed consent, patients should have a choice
Doctors Working Together for Progress
Abovementioned Drs. Feuerstadt, Kelly, Khanna, Allegretti, Kassam, and Hazan, will join others including Thomas Borody (CDD), Neil Stollman (UCSF), as well as NIST and NIH representatives to continue the conversation about C.diff, FMT, and other microbiome topics at the Malibu Microbiome Meeting on March 28-29, 2020.
Additionally, Progenabiome hopes to unite doctors worldwide for a global microbiome clinical study in hopes of finding more answers about the role of the gut flora in C.diff and other diseases.
Contact: Stephanie Davis, firstname.lastname@example.org
Here is something that will change healthcare and make us more aware of our gut microbiome
Progenabiome, a physician-owned genetic sequencing laboratory, found cutting-edge data on Clostridium difficile (C.diff), a disease burdening 500,000+ Americans yearly. They will present a validated, verified, and reproduced C.diff Assay at The American College of Gastroenterology (ACG) 2019 Annual Scientific Meeting on Monday, Oct. 28, 2019 in San Antonio.
“This data will change healthcare and make us more aware of our gut microbiome,” said Dr. Sabine Hazan-Steinberg, CEO and Founder of Progenabiome. “2500 years later, we’re proving Hippocrates right…everything starts in the gut.”
Dr. Hazan, a Malibu-based gastroenterologist, has 20+ years experience leading clinical trials, many for C.diff. When trials failed, she used fecal microbiota transplant (FMT), following advice from friend Dr. Neil Stollman, gastroenterologist at UCSF and East Bay Center for Digestive Health. She also followed great work by Dr. Thomas Borody, FMT pioneer and Centre for Digestive Diseases founder. Success post-FMT for recurrent C.diff suggested the microbiome holds many answers.
Knowing the C.diff microbe has existed for 10 million years, she questioned why it now takes 50,000 lives annually.
Dr. Sydney Finegold, infectious disease specialist who researched Autism/microbiome for 50 years, recommended she acquire a next-generation sequencer. When he passed in 2018, his books went to Hazan, hoping she could continue his legacy.
In January, she joined pathologist Dr. Brad Barrows and scientific director Dr. Andreas Papoutsis to launch Progenabiome. Their first run found non-toxigenic C.diff in every sample, including those not diagnosed with the disease. Preliminary data shows the C.diff microbe is not transmitted hand-to-mouth as previously believed. It is already in the gut and becomes toxic when something ingested triggers it.
Progenabiome will present this groundbreaking discovery at ACG 2019 (Poster 1027 / Booth 1931) and the 7th Annual International C.diff Conference November 6-7, 2019 in St. Louis.
Progenabiome is investigating the role of the gut flora in various diseases through 11 studies overlooked by New England IRB. Progenabiome’s Mission: to better understand, prevent, and treat diseases by analyzing specific genetic codes of 40 trillion gut microbes. Dr. Hazan believes the art of Medicine lies in our ability to see outside the box and recognize that all microbes and humans are unique.
Contact: Stephanie Davis, email@example.com
Nigeria is Africa’s top oil producer, yet it’s in the middle of a fuel crisis. The missing link: oil refineries. To address this massive disconnect, billionaire businessman Aliko Dangote is building an oil refinery right outside Lagos.
A developer in Kansas is building and pre-selling high-end survival condos, but banks aren’t helping interested buyers finance these unique properties
Everyone has heard the headlines: the retail apocalypse is here; online shopping has replaced traditional stores. But it turns out that’s not what’s actually going on.
In 2019, the US saw roughly 9,300 retail stores close; a 61% uptick from the previous year according to Coresight Research. Concerning? Yes. But if you look a little closer, you get a bit of a different picture. For instance, Payless, the discount shoe retailer, accounted for nearly a quarter of those store closures. In fact, out of the 12 companies that each closed more than 200 stores, 9 had filed for bankruptcy in recent years.
The narrative has been that, as e-commerce rises, traditional brick-and-mortar stores decline. Is that really the case? Not quite. In fact, research shows that the two can have a symbiotic relationship. That’s thanks to a shift in consumer behavior. Shopping today doesn’t always happen all online or all in-store; it’s often a hybrid experience, such as buying a product online and then picking it up in-store.
When do you visit a physical store? How does the ‘hybrid’ shopping experience apply to you?
Let us know in the comments below.
Producer: John General
Senior Producer: Logan Whiteside
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