In my last blog I talked about my fall.  When I fell I did quite a bit of damage and have 3 compression fractures to show for it. I've been surprised by the number of people who have commented about falling and most have had no problems and dismissed the event. Perhaps its time we took a closer look.

This is an MRI of my back after the fall.

In my last blog I talked about falling and how bad that was for old folks.  I mention that frequently in my communication with members of the foundation and I was disgusted that I tripped at night and had a hard fall.

My hepatologist and every other doc always emphasized don't fall. I fell.

Last week, In the middle of a midnight bathroom run, I tripped and fell.

Not a terrible fall as nothing broken and no head impact but a big setback in my recovery from the back spasm.  NASH patients tend to become riskier to falls as the disease progresses. That one of the reasons for keeping an exercise routine.

Did you ever feel defeated by liver disease? Sarah Larsen decided to fight back.  We are giving her a special blog space where she will document her training journey from patient to athlete training to compete in the World Senior Games.

People who promote something, like politicians or health advocates, and then don't practice what they preach get my goat.

Madrigal Pharmaceuticals has released news that it has completed its filing for approval by FDA of its NASH drug candidate Resmetirom.

If you would like to read the official announcement, here is a link to it

Madrigal Pharmaceuticals Completes Submission of New Drug Application Seeking Accelerated Approval of Resmetirom for the Treatment of NASH with Liver Fibrosis | Madrigal Pharmaceuticals.

There are hinge points in society which alter things in ways that fundamentally change how society works.  The domestication of fire may have been the first. The development of projectile weapons and the efforts of the first farmers are examples.  They can be large structural change like the development of the city/state or a knowledge engine like the invention of the printing press. They may be instantaneous like the explosion of the first atomic bomb or aspirational like the Magna Carta, but in all cases society changes as a result.

Join us for a webinar about AI and machine learning.

About a month ago, I shared some of my thoughts on the recent hysterics over AI. We know that panic and fear sells, so the media often plays on these emotions to garner more exposure and views. Unfortunately, these stories often fail to provide us with any meaningful information that might alleviate our concerns and instead leave us feeling more panicked and afraid than before we turned on the TV.

The makers of the first NASH drug that has met the goals set by FDA, Ocaliva by Intercept, have once again been told that if they spend another billion dollars they can apply again. Intercept is beaten and will withdraw.

My doctor divorced me. A new kind of care is being forced upon us.

It is an old story.  They think we don't know, but we know. We get the little messages, "I wonder if we should see other people". We hear the office chatter, "Did you see the big ones that just came in"? "Sure a lot of newbies here lately." "There sure are a lot of young ones."

We're here to mark a time in history when the Allied armies of science and medicine joined in battle to defeat the silent scourge of NAFLD/NASH. For decades, much of humanity has been under a terrible shadow. Countless faceless victims mourned only by their families have fallen to NASH, a disease of modern society. As the the medical world became aware of the killer stalking their patients the word went out from a few pioneers seeking answers. Even though the early researchers were largely ignored and the spotlight fell on the stars of heart and cancer they persevered.

As I reported earlier, this was the outcome of the FDA meeting on the first drug candidate to successfully meet the FDA's requirement of reducing fibrosis by at least one stage.

The FDA advisory panel voted to reject Intercept's application for OCA as a treatment for NASH

Despite meeting the goals set by FDA, of reducing fibrosis by at least one stage, the GIDAC panel today voted against approval of obeticholic acid as a treatment for NASH.

The FDA advisory panel voted to reject Intercept's application for OCA as a treatment for NASH

Despite meeting the goals set by FDA, of reducing fibrosis by at least one stage, the GIDAC panel today voted against approval of obeticholic acid as a treatment for NASH.

As a patient, I'm very concerned by this decision.  The concern expressed by the panel was that there was an increased risk of bile duct disease in a small number of patients in the clinical trial.  The exact statistics will be published but we believe that the number is small compared to the number of people who will die from the disease if untreated Personally, I'd like to be able to have a chance to decide that risk for myself.  I believe that most hepatologists know how to manage those risk factors.

The FDA is finally going to act on the first drug for treatment of NASH

The FDA staff does not support approval - you can watch the meeting live if you care

Click this link to join the meeting 9:00 AM EST Friday May 19th

A little background. The Intercept drug obeticholic acid or OCA is the first drug to meet the FDA requirement of reducing NASH fibrosis by at least one stage. There is no therapy for NASH and it is a serious unmet need.  We all know that and the meeting tomorrow will end with a vote of whether to recommend approval. 

It is a public meeting and I invite you to watch. If you have NASH this could be significant for you. They have a brief window for public comment and I get 4 minutes to speak on our behalf as patients.

I am both amused and appalled by all of the stories about AI that are pummeling us lately. This is the latest fashion doing the walk down the breaking news parade route.

OK Wayne, just stop. You might know a little about liver disease but this is serious. I heard all the billionaires say its awful.

Maybe we could just take a breath. We need to remember that the world today runs on media exposure and audience. In the long ago we used to see cartoons about the guy in the public square with a sign saying "The World Is About To End".  That was good for a chuckle. Today it's someone in a suit on TV with a new book or available for speaking tours. We have upgraded our doomsayers but now they are very successful at provoking our fear.

IN BRIEF: ICER HATES obetacholic acid, and dislikes resmetirom

THE UGLY-- ICER voted 14 to 1 not to recommend obeticholic acid as a treatment for NASH

                     ICER voted 8 to 7 to reluctantly recommend resmetirom

A question that I found to be very distressing personally was defeated 9 to 6. The question: Would having a treatment for NASH have any effect on caregivers? Unbelievable

New drugs are coming for liver disease, but will we be able to get them approved by insurance?

In a few weeks the FDA will have its public comment meeting for obetacholic acid for treatment of NASH. This is in response to an application by Intercept for approval.  If FDA gives it a go ahead, the issue of the cost of the drug will be the next big thing. 

Remember this, the insurance company is not actually in business for your health. They don't get bonuses because you were cured. Their job is to not spend all of the premium money so they carefully manage what they are willing to pay for.

With drugs coming soon, I REALLY NEED YOUR HELP!!!!!!

In the 2022 survey only about 10% of the patients contacted bothered to help. We need to do better. Here are links.

2023 Care Survey English

2023 Care Survey Spanish

The FDA will consider two drugs for treatment of NAFLD/NASH this year. I know we have been saying that therapy is coming for several years only to be disappointed. It is easy to be a little cynical about the prospects. This is a government agency and it seems like delay is what all agencies do best, but I do believe we will finally have a chance to move forward.

I've been seeing ads for butt crack deodorant and I've wondered what societal changes have made that a "thing". I've been soooooo tempted to write an April Fool blog about all the things that could go wrong if sniffing replaces fist or elbow bumps as the way we greet people in an age of pandemic fear. But, I'll leave those imaginings to you. I want to talk about doctors who are clueless about liver disease.

If you are like I was, I knew that our life expectancy in this country had declined recently, but I had no idea. I was shocked by this report by NPR.

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.

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.

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.

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: