FDA has scheduled an adcom (advisory committee meeting) for Intercept's candidate drug to be the first approved treatment for NASH.

This is the public's opportunity to provide input to FDA as part of its deliberations about approving a drug. If you would like to have a chance to add your views to the discussion, this is how you do it.

I know what it is to be unwell, but I need you to think about this result from our State of Care Survey. Only 16% of you reported feeling like you got enough information from your doctors.

posted anonymously with the patients permission

Thumbs up at the ER.

I had to take an ambulance today. Scary stuff happened and I was home alone. Big thank you to my bro-man for staying on call with me, helping rein in my anxiety as I listened to the sirens pull up.

Firemen came. Fedex got here at same time, awkward, but fire men brought my packages in. Nice. Ambulance did EKG, was ok. Ambulance wanted to give me benedryl on the way because my hives were SO bad this time - but then the EMT realized they were out of benedryl. Neat. They said ER would get me some at check in. They didn't. Neat-o. They let me keep the blanket. Appreciated. So I curled up in one of those wide seats with my puke bag and waited. At one point I was crying, all alone like a weirdo. Closed my eyes and tried to rest anyway.

Then opened my eyes because the absolute sweetest old Mexican grandma lady with little English asked if she could go get me water, I was too red all over, and handed me some tissues from the desk that I'd been in too much pain to go get. I cried even harder because she was so nice to me. And this lady, you guys--- she sang to me and sat next to me. I will love her for the rest of my life.

I invite you to read the report of the 2022 State of NAFLD/NASH Care in America Survey. This survey looks at the experiences of patients from the perspective of their day to day lived experience. Many of the results are disturbing as they highlight how poorly liver disease is managed in the broader community.  There are certainly pockets of excellence and patients fortunate enough to live in their footprint are well served. For many, the path is more difficult than it should be.  We hope this work leads to progress in the care of the patient community at large.  To read the report click on the image below.

People who are lost can walk in a circle and get back to where they started. It is a bit like that for the patient community.  In 2020 we were getting ready for the FDA to hold an adcom meeting on the Intercept drug Ocaliva. Adcom is where they take public testimony and as patients we wanted to speak. This was to be the first drug that had met the targets set by FDA for a NAFLD/NASH therapy. We all knew it wasn't a perfect solution but when there is no therapy at all it was a place to start and we were very hopeful.

Posted anonymously with the author's consent

Trying to sleep. My legs ache, my mind is running on the anxiety hamster wheel, i just don't feel good.

Thinking about what kind of home and life I want.

I want the only people who walk in these doors to be the safe kind. I want to sing barefoot in the kitchen while I cook mediocre dinners because that's the best I know how. I never want a man to yell at me because the floors aren't clean enough and the laundry isn't finished. I want art, and poetry, and music, and so much love you feel it the instant you come to visit.

My grandson asked about our family tree for a school project and I found myself thinking about the changing character of our society and wondering how we have become so dysfunctional.

I have been fortunate to have lived in a region that may be one of the last parts of the country to have retained aspects of the society that settled the West in the 1800's.  Both sides of my family were part of the wagon train movement that came west and settled in Idaho.

The new guidance for managing NAFLD/NASH has been officially published. This is the official guidance by the American Association for the Study of Liver Disease (AASLD) and it is intended to provide primary care and other providers with the information they need to provide care for their patients. A key element for us is that it supports early intervention for high risk patients and provides clear guidance for how to risk stratify and to determine who needs referral to a specialist.

Marcia R. Cohen, 94, formerly of Wynnewood, one of the oldest liver transplant recipients in the world, died Friday, Dec. 24, of heart failure at her son’s home in New York.

Mrs. Cohen was 74 when she received a liver transplant in March 2002 at the Hospital of the University of Pennsylvania, and she surprised doctors and her family over the years by not only outliving expectations because of her advanced age but also thriving.

WILMINGTON, Del. — John Manser, 70, a veteran journalist, died Tuesday, Nov. 24, 2020, in Christiana Hospital of complications from the liver disease NASH (non-alcoholic steatohepatitis).

James Redford, a filmmaker, activist and son of actor Robert Redford,  died October 2020. He was 58. A reminder that youth or fame are not protection against liver disease

His wife, Kyle, confirmed in an interview with the Salt Lake Tribune that her husband died from bile-duct cancer in his liver. Robert Redford’s publicist, Cindi Berger, said in a statement that the elder Redford is mourning with his family during this “difficult time.”

Kyle Redford said that her husband’s liver disease returned in 2019 and that the cancer was discovered in November of 2019 while he waited for a liver transplant.

Marcia R. Cohen, one of the oldest liver transplant patients dies at 94
Posted by Wayne Eskridge · February 05, 2023 5:45 PM

John Manser, 70, a veteran journalist, Nov. 24, 2020 of NASH
Posted by Wayne Eskridge · February 05, 2023 5:30 PM

James Redford died of liver cancer in 2020
Posted by Wayne Eskridge · February 05, 2023 5:20 PM

The is a service of the foundation.  You may donate in memory of but it is not required.

Very few parents would say that they wouldn't take risks to save their child.  In fact many people would try to protect unrelated children from harm. These impulses are just part of our nature. But what are the limits to that? At what point do we stop being concerned about harm to our own or other children?

OK, this is a really strange question for a patient health blog but stay with me for a little while.

When I was a newly diagnosed patient with cirrhosis, one of the things that offended me was that my doctors had followed practice guidelines that said not to screen for asymptomatic disease. I had to be hospitalized before I learned anything about my liver getting sicker for at least a decade. Many of you can relate to that, as you have told your stories in the groups.

It hasn't been officially published yet, but the new guidance by the American Association for the Study of Liver Disease (AASLD) will soon release new practice guidance. Here is a summary slide of the key points.

We have been asked by a colleague to help distribute this study on stigma to the patient community. Please find below information about this opportunity to share your thoughts and contribute to NAFLD research by completing an anonymous survey:

INTERCEPT RESUBMITS NEW DRUG APPLICATION TO FDA FOR OBETICHOLIC ACID IN PATIENTS WITH LIVER FIBROSIS DUE TO NASH

A SURPRISE CHRISTMAS PRESENT FOR PATIENTS WITH FIBROSIS. IF YOU WOULD LIKE TO READ THE PRESS RELEASE CLICK HERE.

A bit of history may be helpful to many. Obeticholic Acid (OCA) was filed with FDA in 2019 but FDA didn't go through with a planned patient meeting called an adcom and instead issued what they called a complete response letter in June of 2020 and raised questions about safety.  They did not reject the application they just punted.  The department was going through some reorganization at the time and from a patient perspective we did not believe the sequence was proper but we were stuck with it.  Most companies would have abandoned the effort at that point.  To their great credit Intercept believed in the drug and continued their studies to answer the safety questions that had been raised.  Now they have much more data and good evidence of safety which we believe should resolve that issue.

Patients who have been on this journey with me over the years know my story, but for the new folks, I've been a test dummy and I've been able to track my progress with my darned cirrhotic liver over the years. Here is a chart of my progress through June of 2020. Notice that I've confirmed my progress with both Fibroscan and MRE and I have progressed from a Fibroscan of 21.5 at diagnosis to 9.6 in 2020. Technology is advancing and I recently had an opportunity to get a Velacur test, a new kid on the block offering liver tests.