The FDA and my goat OCA

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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

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THE FDA HAS GOT MY GOAT

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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.

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NAFLD probably increases your risk if you get COVID

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. 

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Thinkin Bout Things, not COVID for a change, but salt

With a bit of time, even things like the COVID virus are accommodated by our fears and broader concerns bubble back up.  One of the challenges faced by a lot of people with serious chronic illness is that they are alone physically or emotionally.

As I think about these past weeks and staying at home I realize that I am so very fortunate. My wife Rosemary makes my days in isolation a joy rather than a burden but I see messages in our patient forums that break my heart from people who are literally dying deaths of despair.  If you are well enough, reach out to those you know who are lonely. Chronic illness is difficult enough without having to do it alone.

Click the picture below for a link to a bit of fun on the subject of introspection. Many of you are old enough to remember this but it may be meaningful to our younger folks as well. (The picture isn't related, I just like it)

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You have liver disease, what next under COVID

We are reaching the end of the beginning of the COVID pandemic. As society tries to return to some kind of normal the challenge is how, as an individual, to manage being a part of society if you have a medical issue.

If we look at some recent data from New York the issue is very clear.

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Clearly, about 96% of the deaths are people older than 45. We have to remember that anyone can get it, but while it is hazardous for mature adults, most younger people will be OK. What that actually means is that it takes about 40 years for a typical person to develop some kind of chronic illness which puts them at risk.

That is all very interesting, but as part of the "at risk" population how do we think about the near term future? There aren't many good models but it is probably wise to keep a perspective even in the face of horrific news every day.

 

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How will the value of a life under COVID by calculated?

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We are getting past the peak of the COVID deaths and we have used the strategy of social distancing and shutdown to try to prevent our hospitals from being overwhelmed. We all understand the tragedy of death by virus but the figure of merit that drove decisions by the government was ultimately ventilator supply and ICU occupancy. It really was an exercise in statistics.

Before you get mad at me, this discussion is about how our society makes decisions in the face of crisis. If you are a patient, or someone who may die some day, the way the system works is important so stick with me here. The way these processes work, in the back rooms and basements where real policy is made, matter to your life and you should understand it.

It is a fair analogy to think of this pandemic as a war. It is an invasion by a force which is hazardous and for which we have no defense. You might think of New York City as similar to the sinking of the Arizona at Pearl Harbor. We respond to the emergency with a host of defenses as we try to understand what we face. Some things work, some don't, but that is the nature of crisis.

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Into the Valley of Death - COVID - a perspective

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As I watch the COVID tragedy unfold in the language of death rates and cytokine storms I find that Tennyson's poem, The Charge of the Light Brigade, which speaks of courage under fire despite the failures of command, comes to mind.

Forward, the Light Brigade!
Was there a man dismay'd?
Not tho' the soldier knew
Some one had blunder'd:
Their's not to make reply,
Their's not to reason why,
Their's but to do and die:
Into the valley of Death
Rode the six hundred.

In the manner of all armies, the healthcare workers and all of those that support them join the battle because it is theirs to do. Those of us who are high risk targets of COVID or are "non-essential" can but be humbled by the courage that is the definition of that profession.

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COVID-19 is it like the flu? NO NO NO my friend

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How serious is this bug really?

We still see people arguing that this epidemic is overhyped and that we should not be closing the country down to fight it. Do they have a point?

One advantage of socialized medicine is that you get a consolidated database. Data from the Intensive Care National Audit and Research Center in London offers some perspective on how COVID-19 compares to the flu.

A recent report compares 2249 recent COVID-19 patients, whose mean age at admission was 60 years, compared to 4759 patients with non-COVID-19 viral pneumonia, most of them caused by flu with an average age of 58, who were hospitalized over the three complete years 2017-2019.

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COVID-19 a broad view from the patient perspective

The Kabuki theater reveal is nearly here. The poorly orchestrated government response to COVID-19 is being forced to throw off the kimono.  We have watched the ratcheting up of the warnings for several weeks now and the step by step escalation of responses.  It is just the way of it I guess.  The government knew this information in late January. We wait too long for proof and consensus before we will take a difficult step.

The first thing to understand is the epidemiological facts about the virus. The big number is we should plan for a health crisis about 10 times as big as the flu.  The knee jerk announcements you are seeing today are in recognition of the risk.

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COVID-19 A perfect storm

Did you know that 20,000,000 Americans don't know they have asymptomatic liver disease?

Did you know that disease called COVID-19 is caused by the virus SARS-CoV-2?

Did you know that COVID-19 or SARS-2 is more dangerous to society than SARS-1.0 which hit in 2003 and killed 9.6% of those infected?

Did you know that if you have advancing fatty liver disease without any symptoms your risk of death from SARS-2 is higher than average?

I have some concern about writing this.  When we face a crisis, panic and reactions driven by fear can do great harm.  I do not wish to contribute to that, however, as an advocate for people faced with chronic illness, such as liver disease, I feel compelled to inform my community about the details.

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Coronavirus, a Fashionable way to die? Medical care in America

Terminal illness is a fate that awaits us all. We know not the pathways of our personal  journey only that we will take one of those paths in a time not of our choosing.

I live in the land of the chronically ill. It is that time between health and end stage disease. The Foundation's niche is fatty liver disease but chronic illnesses of many kinds are passengers on the same train.

I deal with the newly diagnosed who are frightened and confused. I scheme ways to hold the devil back with stalwart warriors who fight for life. I comfort those for whom the journey is too hard and who are dying a death of despair. I walk with people who are triumphant after they receive liver transplants. I see the length and breadth and depth of this disease and as a society I see that we manage it badly.

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Hashimoto's Thyroiditis and Fatty Liver: What's the Connection?

In many cases where patients struggle with a heightened blood sugar level and/or excess weight and have Hashimoto’s thyroiditis; their blood tests reveal a fatty liver - with high liver enzymes. As you may know, there aren’t any overtly obvious symptoms when it comes to a fatty liver; but it can be quite dangerous. If someone’s liver is filled with excess fat, it will struggle with its detoxification role, result in higher inflammation - and in turn, a higher risk of a heart attack. But did you know that Hashimoto’s hypothyroidism may also play a role in your liver becoming fatty? We’ll explore the connection here in order to inform potential patients suffering from such issues.

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CBD OIL a triumph of hope over reason? Does it affect the liver?

My poor inbox groans under the weight of CBD articles and pitches. I've hesitated to jump into this pit again but I get a steady stream of questions from patients about using it.

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We need to be clear about this issue.  CBD oil is biologically active. However, that doesn't mean it is good or bad for you. In reality we just don't know enough yet to have a valid opinion.

Let's be clear.  I'm not part of the debate about this plant.

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Can NASH/cirrhosis progression be stopped by diet

This time of year I get a lot of questions about whether it is possible to manage NASH/cirrhosis entirely with diet and can a stage 4 liver fibrosis improve.  Most people say no.  Once you have cirrhosis it is hopeless. Is that necessarily true?

There are a lot of new year resolutions about better health and diet but what really matters? What is possible? I changed my lifestyle as my personal therapy and the question is does it work? Here is a chart of my results since diagnosis.

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A message from SUNN

What have we learned from the SUNN Study?

As members and friends of the Foundation, you know about our efforts to promote early screening for advancing liver disease.  We believe it is morally wrong to allow people with advancing liver disease, but with no symptoms, to go untested until they develop stage 4 NASH, otherwise known as cirrhosis. Remember, that is the standard guidance of the medical profession. We believe that end stage liver disease is too late in the process to discover the problem. As a way to advance the argument we sponsored the SUNN Study (Screening for Undiagnosed NAFLD and NASH).

 

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The recruitment Phase of SUNN Study (Screening for Undiagnosed NAFLD and NASH) has been completed

The Foundation (FLF) announced today it has successfully completed participant recruitment in the SUNN study, a proof-of-concept study of screening for undiagnosed nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) in a self-selected, at-risk population within non-traditional, community-based settings. SUNN study has completed recruitment of 1,006 participants across various communities in South Houston and Galveston, Texas. Full results of SUNN study are anticipated to be released in early 2020.

“Completing recruitment for this proof-of-concept study is another important step forward for FLF’s ongoing community outreach, education and advocacy efforts toward proactive screening for advancing liver disease among at-risk populations for NAFLD and NASH,” commented Wayne Eskridge, FLF’s Co-Founder and Chief Executive Officer.

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Exercise and NAFLD

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Image credit: Vegan Liftz

What Type of Workout should People with Fatty Liver Disease Complete?

Non-alcoholic fatty liver disease (NAFLD) is the most common chronic liver disease, owing in no small part to the increasingly high rates of obesity in the American population. In a 2019 study published in Gene Expression: The Journal of Liver Research, researchers found that physical exercise could benefit people with NAFLD - including those who had the disease in its most inflammatory form - nonalcoholic steatohepatitis (NASH). In their study, they relied on a moderate exercise routine lasting 20-to-60 minutes for four to seven days a week. The routine included both aerobic and weights/resistance training. Their results showed that the positive effects of exercise were observed whether or not participants lost weight.

Both Aerobics and Strength Exercises are Key

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The Link between Gestational Diabetes and Fatty Liver

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Around one in seven births are affected by gestational diabetes - a severe threat to maternal and child health - as stated by the International Diabetes Foundation. Gestational diabetes is one of the reasons why maternal programs include careful testing and control of glucose levels. The disease can have long-term health effects for mothers and their children, heightening the risks of obesity, diabetes, hypertension, and kidney problems in children. However, one consequence many women do not know about, is that of fatty liver disease.

A 2019 Study Showing the Link between Gestational Diabetes and Fatty Liver

A recent study by Sarah R. Donnelly et al found that women with gestational diabetes mellitus (GDM) have an increased risk of fatty liver disease nine to 16 years after giving birth. This is the case because chronic hyperglycemia is a risk factor for liver fat accumulation and potential liver dysfunction. Specific liver enzymes are created at

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Doctors may underestimate patient pain, But Why?

I was recently asked to talk about the patient view of liver disease by a group known as ICER, A nonprofit group that studies fair drug pricing.  They are working on how drugs for #NAFLD and #NASH might be priced.  The team includes a wide range of expertise which includes some doctors and during the discussion I talked about the fear people experience when diagnosed with cirrhosis or stage 4 NASH.

I was surprised when a primary care doc reported that he didn't see that much fear in his practice which made me wonder why our views of the average patient response was so different.

I think the answer lies in the nature of the relationship.  When we go to a doctor we are dealing with a power figure.  We hope for solutions to our  troubles and we want the doctor to think well of us and to help us.  We want to be a "good" patient and we are more likely to do our best to present our problems and to listen respectfully to what the doctor has to say.  It is a process which engages our attention. Most of us, even if we express our fears, will be reluctant to try to describe or act them out in front of the physician so it has an element of intellectual control even if fear grips us in the doctor's presence.

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Red Meat good - bad ? Another health information debacle

Big news, red and processed meats are now OK.  Another example of how the news and the drive of researchers to publish is making us crazy.  We all remember the butter bad, margarine good mess or eggs bad, no eggs ok.  Health news is designed to be something for everyone.  You can find support for anything you think you might like to try.  Entertaining I suppose and lots of jobs are created but if you are a patient, particularly a liver patient, this is all dangerous.

Here is the latest bombshell that all the talking heads are exploding over.

Red and processed meat are OK to eat, controversial new guidelines claim.

Since you are here you must be interested in liver disease so keep that in mind.  One of the irritating aspects of so much research is they speak about heart, diabetes, and cancer then generalize the comments as though the information is good for everyone.

A major issue here is saturated fat and the claim it is not an issue.  Well, for what they studied that is true.  The heart, for example burns almost nothing but fat and does pretty well with any of them.  Diabetes is a sugar issue and cancer is vastly complex but liver cancer is kind of in a class by itself and they don't address that.

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