CLICK HERE TO WATCH A RECORDING OF THE WEBINAR

We have had a series of webinars about the disease and cutting edge research.  Now we would like to focus on the future for the patient.  Covid wrecked our plans for SUNN-2, the next step in our plan to eventually screen 1,000,000 patients a year for liver disease, but with vaccines we can begin to think about that future.

I'd like to invite you to a webinar where we will look to the future and some of the tools that are going to help us in our battle with the noncommunicable diseases that have become the scourge of our time. Let me challenge you to step back from COVID for a couple of minutes and think about health more broadly. One small step is to attend this webinar.

I finally got a chance to get the COVID vaccine. As a guy with chronological superiority (fancy talk for I'm older than most) and a high risk category with NASH/cirrhosis this is a big deal.

I keep seeing comments from NASH patients who say they are not going to get the vaccine. That is a risky strategy.  I understand the concern but even beyond the risk of dying from COVID, I personally am concerned about the long Covid symptoms that are being reported. Think about that.  You are dealing with issues now.  As a compromised patient, even if you survive infection, might the odds of lingering problems on top of what you already have be greater. That possibility concerns me and is part of why I want the vaccine.

We are partnering with Johns Hopkins on a COVID-19 project vital to patients with NAFLD/NASH. As you know, we have been critical of the vaccine developers and the CDC for not engaging patients with liver disease. We want to know what to expect from this vaccine and the only way to find out is to do the testing.

We are pleased to announce a clinical trial for patients with diagnosed liver disease. It is very important that we as patients support this effort. It means having several blood tests but we are used to that and most importantly we can find out just how well the vaccine protects us. The link to sign up is below. I urge you to participate.

The times we live in can make discussion difficult. So much of what we see in the news every day is inflammatory and negative emotion stalks the land. I recently wrote about the importance of getting the COVID vaccine and I was not kind in my view of people who advise others not to be vaccinated. I got a bit of criticism for expressing my opinion. Knowledge can sometimes get past emotional responses so fair warning. I'm going to teach a small class here in how this virus and the vaccine really work. Stay with me, it is a really interesting story and matters to your health.

We have all seen these picture of the coronavirus with all the spikes sticking out of the surface. Interesting as an art project but that image only hints at what is going on. In this explanation we are going to dive into what really happens. Don't worry, life is infinitely complex but you can understand this.

Lets look first at those spike proteins. Calling them spikes makes a headline that editors like but they are really more like ugly little mushrooms.

I keep hearing from people who have decided not to get vaccinated or who are fearful of the vaccine and don't know what to do.

I don't know if I can express how sad that makes me for those people and their families or how profoundly angry I am at people who promote fear about the vaccine without evidence.

CLICK HERE TO WATCH A RECORDING OF THE WEBINAR

What is the situation with blood tests for fatty liver disease today?

NON-INVASIVE BLOOD TESTS SOME EXAMPLES

The table above was produced by Fibronostics. We have followed the development of their program for a couple of years and they are supporters of the foundation. The thing that caught my attention back in 2018 was that their test, like the earlier Fibrosure was the result of artificial intelligence studies.  A lot of AI is being done today but those two were early developers and I felt that this would be the future for us as patients.  The downside, of course, is that tests like these are proprietary so the costs are higher so the question of who should use them is more complicated.  For me, as a patient, I wish such tools had been available to me early on in my disease so that I might not have ended up as a cirrhotic.

Everyone writes uplifting letters this time of year. Personally Rosemary and I are doing well and our best hopes are for all of you as we speed toward the next chapter of our lives. The GRAND CONJUNCTION of Jupiter and Saturn reminded me of my youth and the AGE OF AQUARIUS.  Something for those with a few minutes for a bit of nostalgia.

There are a lot of mixed currents in this section of the river of time that we find ourselves.

The CDC COVID-19 vaccine distribution plan likely ignores NASH patients

The CDC is working on a plan for distribution of the COVID-19[1] vaccines once they are approved.  While I am sympathetic to how difficult the challenge is, I’m frustrated that their analysis mostly ignores liver disease patients with NASH. The ACIP COVID-19 Vaccines Work Group slide deck provides a look at how the government is planning the distribution of these critical vaccines.

The strategy which affects the patient community in particular is called 1C.  This group would get vaccines after healthcare workers, long term care residents, and essential workers.  The proposed 1C group would be defined as over 65 or someone with a high-risk medical condition. Since that designation covers well over 100 million people one might think of it as “the rest of the population”. When you consider that the healthcare and essential workers groups are estimated to be 21 and 87 million the proposed “high-risk” groups are fairly far down the priority list.

The medical society that guides the treatment of patients is the American Association for the Study of Liver Disease (AASLD) their annual meeting is this week and it is virtual with a lot of first time patient access.  This is the first time patients have been welcomed so if the state of the art of liver research interests you, here is a link. Join Us!

https://tlmdx.aasld.org/

I am particularly excited by an event that has generally gone unrecognized but it is tremendously important to the patient community. They just don't know it yet.

Madrigal Pharmaceuticals is a small drug developer. They have been quietly doing their work while the pharmaceutical giants get most of the attention.  They have been allowed by the FDA to conduct a phase 3 trial of their drug Resmetirom, called Maestro-NAFLD, without requiring a biopsy.

1 A PATIENT'S VIEW OF THE NASH JOURNEY

When asked to write an article about the patient perspective, it was easy to say yes. Now, looking at this page it is a daunting task. As a cirrhosis patient and Chief Executive Officer (CEO) of the Fatty Liver Foundation, a patient advocacy group, I have my own personal story. My journey from thinking, I was perfectly healthy to facing a terminal illness is common enough but it does not represent what one might describe as the “patient journey.” Through the foundation, we interact with thousands of patients so I hope to provide here a broader glimpse into life as lived by patients.

When we consider patients as a general case in the USA, we see a population that is unwittingly choosing to be ill more often as they age and to die younger and with more difficulty than they expect. Nonalcoholic steatohepatitis (NASH), a disease that was undefined until 1980, has become a leading killer of middle age and older adults. A leading precursor, nonalcoholic fatty liver disease (NAFLD), is steadily increasing in all age groups.

TO READ THE PUBLISHED ARTICLE CLICK HERE

THE PROBLEM: The real liver experts don’t offer effective diet advice

(click here for a pdf with all the science references)

Currently, the experts who treat liver disease, (the specialists of AASLD), do not officially recommend any specific diet for liver health. The reason is because there are not enough well-designed dietary clinical trials focused specifically on the liver to give the organ experts confidence to make official dietary recommendations. This creates a serious dilemma. As patients we don’t have that luxury. We must make choices. We must live every day making food decisions and hope that our diet is a healthy one even if the experts can’t help us. No wonder we see endless variety in dietary advice and “experts” of all persuasions.

OUR GOAL: Design a diet strategy that minimizes the liver workload

Comorbid conditions increase the risk of being infected with COVID.  We hear that all the time but what does it really mean? A study was just released that provides some very important insights. Here is a chart showing the odds ratio, that is a measure of the relative risk compared to a healthy person.  Look closely. This is important. Note that NASH is over 14.

Broadly, these are the elements of metabolic syndrome and fatty liver disease.

Through the Foundation, we interact with a lot of people in pain and going through very difficult fearful things. Stepping away from that part of life and thinking of the things that move us emotionally, if even for a brief time is of great value.

There are so many things to be moved by. Who isn't touched by a baby's laughter? Memories of better times and places have power. I enjoy seeing the rarity of mastery of something. Grace is power perfected. A fan or not, who could deny the artistry of Muhammad Ali in his prime? Do you remember watching Secretariat run? Simone Biles is a breathtaking gymnast. The duet from Lakme always bring tears to my eyes. You don't have to be a fan to appreciate how hard it is to do what Baryshnikov and Kennedy make effortless. Can you imagine what it is like to be able to compete in an Ironman Triathlon? The list is endless and very personal for each of us but worth reflecting on. What moves you?

I was jogging in a park near my home yesterday.  Actually, jogging may be too grand of a term. We have all seen mature folks jogging.  I secretly call it the old guy shuffle, but I say I go jogging.

I was doing well and I heard footsteps behind me.  No surprise, I get passed often so I stayed near the edge.  To my surprise a woman came along side me and bid me a cheery good morning. OK, nice friendly person, but she was WALKING!!!

To give me my due, she was a very fast walker but darn, I am jogging in my accustomed style.

I recently wrote about our concern that the FDA had reset the clock on OCA, obeticholic acid, which is the first potential treatment for advancing fibrosis due to NASH. The core of my objection is that it was done without patient input.  As patients, who face potential terminal illness with no therapies, the prospect of a breakthrough drug is of vital interest.

I hope to not be unfair to the FDA here as I have not seen the actual text of their notice to cancel the planned Adcom meeting and delay a decision on OCA. That said, my understanding is that they stated that based on the data the FDA has reviewed to date, the Agency has determined that the predicted benefit of OCA based on a surrogate histopathologic endpoint remains uncertain and does not sufficiently outweigh the potential risks to support accelerated approval for the treatment of patients with liver fibrosis due to NASH

Don't bother with this if you don't care about liver disease.

The FDA just punted on a decision about the Intercept drug obeticholic acid, or OCA.

It was anticipated that OCA would be the first drug therapy for advancing fibrosis due to NASH.  It was the first drug to meet the FDA defined surrogate endpoints, most importantly the reduction by one stage of fibrosis, in a phase 3 trial.

OCA had been given breakthrough drug status earlier as the first drug that provided benefit to fibrosis patients.

It is being reported that patients who have NAFLD are about twice as likely to have a more serious illness than patients who are obese but do not have NAFLD if infected with COVID.

NAFLD is more likely to result in serious symptoms than obesity without NAFLD. This distinction is important for proper risk stratification.

I know that when you read about the risk factors associated with COVID they rarely mention liver disease. There have been some early reports that essentially say that liver risk is limited.  In the early turmoil of a crisis like the COVID pandemic a lot of information is fragmented and based on very small samples.

A study has just been uploaded to a pre-release server which takes a much more effective look at the question of whether NAFLD should be considered to be a risk factor for hospitalization should you become infected.