I was driving to the train station listening to the morning news report on the radio. I almost spit out my coffee when I heard: “Local biotech company secures additional 70 million dollars in capital, on top of 65 million already raised, for development of a novel drug to treat fatty liver disease.”
Whaaa?? There’s already an extremely effective treatment for fatty liver disease, one with zero side effects and multiple additional health benefits. Why would anyone be funding pharma for this disease, when we already have an excellent treatment in existence?
Fatty liver is also called non-alcoholic fatty liver disease (NAFLD), and is a result of fat molecules being stored inside liver cells, causing them to “balloon” (which you can see in the picture). Fatty liver can cause inflammation, which is called non-alcoholic steatohepatitis (NASH for short), which can then progress to scarring called fibrosis and cirrhosis, and then liver failure and cancer. This cascade of events is becoming more common, and currently impacts 30% of adults in the U.S. As a matter of fact, fatty liver is predicted to become the leading reason for liver transplants within the next decade.
Fatty liver is almost always associated with one or all of these diseases: obesity, prediabetes/ diabetes, high cholesterol, and high blood pressure. All are well-known to be caused by a poor diet and inactivity. Here’s the thing though: All are reversible. For fatty liver and NASH, a healthy diet, lifestyle, and weight loss are the only real treatments available, and they work.
The research literature is replete with evidence that simple, safe nutrition and activity approaches work extremely well. An excellent 2017 review article published in The Journal of Hepatology summarizes some of these. Highlights include a 2015 study published in the journal Gastroenterology: 293 patients with biopsy-proven NASH participated in a yearlong diet and lifestyle program, which included a healthy low-fat low-calorie diet, walking for 200 minutes per week, keeping food and activity logs, as well as one-on-one behavioral counseling to help them stick to their goals. Biopsies were repeated at the year-end mark, and the results were impressive. Eighty-eight participants (30%) lost at least 5% of their body weight, and of these, 51 (58%) had complete resolution of NASH. Twenty-nine participants (10%) lost at least 10% of their body weight, and of these, 26 (90%) had complete resolution of NASH. The researchers conclude that “intensive lifestyle modifications must be offered to all patients with NASH”.
The review also dissects studies of weight loss, the Mediterranean diet alone, and all forms of exercise, concluding:
“Lifestyle change, including dietary habits and physical activity, are and should be the first line of treatment in NAFLD and NASH… The question is no longer whether lifestyle is an effective clinical therapy; the question is now how do we implement lifestyle as a therapy in everyday clinical care.”
So why are billions of dollars being poured into drug development, instead?
(You can probably guess, but humor me.)
Oodles of recent biotech news articles detail the fancy drugs being developed “to restore metabolic balance”. Almost all of these describe fatty liver and NASH as “serious and potentially deadly metabolic liver diseases” without any mention at all of the connection to diet and lifestyle.
Looks like some researchers have decided to focus on pharmacology, rather than helping people to live healthier. One recent review article published in Liver International lists many possible chemical pathways that could be targeted for new pharmaceuticals, while pooh-poohing diet and lifestyle approaches:
“While a modest weight loss of about 3% may reduce hepatic steatosis, up to 10% or more is needed to reduce inflammation and for the regression of fibrosis in NASH patients. Even in well-organized settings, only a few patients achieve and sustain a 10% weight loss… Based of the difficulties in applying lifestyle-changing measures alone, the need to combine them with pharmacotherapy will probably remain the norm in NASH management in the foreseeable future.”
And then, there’s the whole profit angle, which is obviously a huge driver of this ridiculous state of affairs. After all, look at the diet and lifestyle interventions that have been tested and work so well: nutrition counseling, physical activity guidelines, diaries, therapy… There’s nothing to patent.
So a bunch of drugs are in development. One drug is “a long-acting fibroblast growth factor analog” and another is “a small molecule thyroid receptor beta agonist“… There are more. Perusing through reports, each has an array of side effects (nausea and vomiting primarily, sounds like). Of course, some will end up being FDA-approved. Of course, patients will end up with more medications, longer meds lists, dangerous interactions, nasty side effects, and none of it addressing the underlying issues.
We should be aggressively studying how to help people live healthier. This includes studying methods of incorporating lifestyle change programs within primary care, and of improving the environment to facilitate healthy lifestyle choices. Not, it’s not patent-able. But it’s the right effing thing to do. Clinical medicine and research should be focusing on wellness and health, not sick care and profits.