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.