COVID-19: FDA Gets Bitch-Slapped By Appeals Court for Statements on Ivermectin

artist rendition of coronavirus
Artist conception of the dreaded virus

From The Tennessee Star:

Dr. Mary Talley Bowden, Dr. Paul E. Marik and Dr. Robert L. Apter sued the FDA in June of 2022, asking the court to: “Hold unlawful and set aside any FDA actions directing or opining on whether ivermectin should be used for certain off-label purposes, including treatment of COVID-19.”

“After nearly two years and a resounding rebuke by the Fifth Circuit Court of Appeals, the FDA has agreed to remove its misleading social media posts and consumer directives regarding ivermectin and Covid-19,” said Bowden.

The Appeals Court had written in its decision: “The FDA is not a physician. It has authority to inform, announce, and apprise—but not to endorse, denounce, or advise.”


That last line is beautifully written.

Steve Parker, M.D.

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New Drug Resmetirom for Non-Alcholic SteatoHepatitis

Stages of liver damage. Healthy, fatty, liver fibrosis and cirrhosis. Vector illustration

DiabetesDaily informed me of a new drug available for treatment of a liver disease that affects “up to 20% of people with diabetes. The disease is MASH: metabolic dysfunction-associated steatohepatitis, something else I’d never heard of. (Shouldn’t the acronym be MDASH?) The drug is resmetirom, sold in the U.S. as Rezdiffra. Click for the FDA announcement. MASH can lead to liver scarring (fibrosis), which then qualifies the patient for resmetirom. The DiabetesDaily article is well-written and includes alternatives to this new drug.

I’ve long been aware of NASH: non-alcoholic steatohepatitis). THIS is the liver disease target according to the FDA announcement, which states “Rezdiffra is a partial activator of a thyroid hormone receptor; activation of this receptor by Rezdiffra in the liver reduces liver fat accumulation.” Furthermore:

The most common side effects of Rezdiffra included diarrhea and nausea. Rezdiffra comes with certain warnings and precautions, such as drug-induced liver toxicity and gallbladder-related side effects. 

There may be potential significant interaction of this new drug with others, particularly statin cholesterol-lowering drugs.

Color me skeptical. If only because the drug was on the “accelerated approval pathway.” But I’ll keep and open mind.

I’m not sure, but it appears that candidates for the drug will need a liver biopsy showing fibrosis (scarring).

Steve Parker, M.D.

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Does a Ketogenic Diet Prevent Cardiovascular Disease?

In July, 2023, the journal Nutrients published a review of literature on the effect of ketogenic diets on cardiovascular disease. The abstract mentions potentially beneficial changes blood lipids, inflammation, blood pressure, etc., without going where the rubber meets the road: the effect on mortality and incidence of cardiovascular events in live humans. Click the link to see the entire article.

The Abstract:

“The most common and increasing causes of death worldwide are cardiovascular diseases (CVD). Taking into account the fact that diet is a key factor, it is worth exploring this aspect of CVD prevention and therapy. The aim of this article is to assess the potential of the ketogenic diet in the prevention and treatment of CVD. The article is a comprehensive, meticulous analysis of the literature in this area, taking into account the most recent studies currently available. The ketogenic diet has been shown to have a multifaceted effect on the prevention and treatment of CVD. Among other aspects, it has a beneficial effect on the blood lipid profile, even compared to other diets. It shows strong anti-inflammatory and cardioprotective potential, which is due, among other factors, to the anti-inflammatory properties of the state of ketosis, the elimination of simple sugars, the restriction of total carbohydrates and the supply of omega-3 fatty acids. In addition, ketone bodies provide “rescue fuel” for the diseased heart by affecting its metabolism. They also have a beneficial effect on the function of the vascular endothelium, including improving its function and inhibiting premature ageing. The ketogenic diet has a beneficial effect on blood pressure and other CVD risk factors through, among other aspects, weight loss. The evidence cited is often superior to that for standard diets, making it likely that the ketogenic diet shows advantages over other dietary models in the prevention and treatment of cardiovascular diseases. There is a legitimate need for further research in this area.”


Steve Parker, M.D.

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Filed under coronary heart disease, Heart Disease, Stroke

I Was Right! Mediterranean Diet Prevents Cardiovascular Disease

Branzino, aka European Bass, live in Mediterranean waters

Yet another epidemiologic study supports the contention that the Mediterranean diet reduces cardiovascular disease. The higher the adherence to the Medi diet, the less cardiovascular disease over the next 20 years. I scanned the report down to the Discussion section and, surprisingly, didn’t catch their definition of cardiovascular disease. It usually refers to heart attacks, strokes, angina, congestive heart failure, and hypertension. Some would include aneurysms. The study at hand was done in Greece. You can read the whole thing.

Abstract

Background and aims

Only few studies have assessed longitudinal dietary trends in relation to cardiovascular disease (CVD) risk. We aimed to evaluate the association between adherence to the Mediterranean diet, both baseline and longitudinal, and 20-year CVD incidence.

Methods and results

This was a prospective study among 1988 Greek adults (50% men, age: 45 ± 14years). Adherence to the Mediterranean diet was evaluated at baseline and 10 years through the MedDietScore, based on which longitudinal Mediterranean diet trajectories were identified. CVD incidence was recorded at 20 years. Each one-unit increase in baseline MedDietScore was associated with an 8% reduction in 20-year CVD incidence. Compared to subjects in the lowest tertile of baseline MedDietScore, those in the highest exhibited a 44% lower 20-year CVD risk (relative risk: 0.56, 95% confidence interval: 0.32, 0.97) adjusted for age, sex, baseline body mass index, smoking, physical activity, presence of hypercholesterolemia, hypertension and diabetes mellitus, and family history of CVD; further adjustment for high-sensitivity C-reactive protein, uric acid and estimated glomerular filtration rate attenuated this association. Results were similar in models adjusted for longitudinal changes in body weight, physical activity and smoking, and 10-year medical status. Mediterranean diet trajectory analysis revealed that 24.7%, 8.6%, 45.8% and 20.9% of participants longitudinally sustained a low adherence, moved closer, moved away or sustained a high adherence, respectively; among those, the corresponding CVD incidence was 63.3%, 65.5%, 28.1% and 9.4% (p-value<0.001).

Conclusion

The Mediterranean diet offers long-term protection against CVD, part of which is mediated by inflammation, uricemia and renal function.


Steve Parker, M.D.

PS: The study is in Nutrition, Metabolism & Cardiovascular Disease: “Mediterranean diet trajectories and 20-year incidence of cardiovascular disease: The ATTICA cohort study (2002–2022),” published in January 2024.

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Filed under coronary heart disease, Health Benefits, Heart Disease, Stroke

What About Ketogenic Diet for Kids?

Diabetes Daily has in interesting article that addresses that question. A snippet:

In October 2023, the American Academy of Pediatrics (AAP) published a report examining low-carbohydrate diets like keto in children and adolescents. You probably won’t be surprised that the authors are concerned. Despite the increasing popularity of carbohydrate restriction, evidence to support the benefits of low-carb diets in young people under 18 with obesity or diabetes is very limited. And though diabetes authorities have acknowledged that carb restriction has “the most evidence” for improving blood sugar levels, the American Diabetes Association has only endorsed low-carb eating as one of multiple possible eating patterns.

And yet, there are many people in the diabetes community who believe in the effectiveness of low, even very-low, carbohydrate diets for their children. There’s at least one study that supports their advocacy


I’m not a pediatrician and never treat children in my hospital practice, not even 17-year-olds. Nor have I reviewed the pertinent pediatric scientific literature. So I’ve never been comfortable writing about keto diets for children. The linked DD article was reviewed by Anna Goldman, M.D.

Steve Parker, M.D.

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Leap Year Customs and Superstitions

Jan over at The Low Carb Diabetic has a fun post regarding Feb 29.

Read about marriage proposals, gloves, leap day babies, bad luck, and St. Oswald’s Day, all from an occidental perspective.

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Does Vitamin D Prevent Dementia?

Dr. John Campbell is “totally convinced” that high-dose vitamin D supplementation would prevent many cases of dementia, particularly Alzheimer dementia, which is 75% of all dementia cases. He takes 4,000 IU of vitamin D/day plus 100 mcg of vitamin K2. Unclear to me if that’s year-round or only in fall and winter, when there’s less sunshine in the northern hemisphere. I assume it’s oral vitamin D3 (there are several types of vitamin D). Dr. Campbell didn’t say why he takes the K2. Click for a brief review of K2. In contrast to his vitamin D dose of 4,000 IU/day, U.K. health authorities recommend a tenth of that — 400 IU — in autumn and winter.

Several observational studies link higher risk of dementia with blood levels of vitamin D that are deficient or insufficient. Blood levels of 25-hydroxy-vitamin D under 25 mg/ml are particularly linked to dementia. Dr. Campbell admits that it’s difficult to prove that adequate vitamin D supplementation would prevent Alzheimer dementia.


  Steve Parker, M.D.

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Male Versus Female Longevity

Working on powerlines is dangerous and it’s mostly men who do it.
Photo by Ana-Maria Antonenco on Pexels.com

Jim Goad is one of my favorite living cultural commentators. On par with a young P. J. O’Rourke, who died in 2022 at age 74. Last year Goad wrote a thoughtful and thought-provoking article on why women outlive men. A sample:

This disparity is not exclusive to the United States. In fact, it’s worse elsewhere. Worldwide, women outlive men by an average of seven years. According to a 2001 report, the only five countries on Earth where men outlived women were the flea-bitten open-air latrines we call Afghanistan, Nepal, Papua New Guinea, Namibia, and Zimbabwe. But a report from 2017 says there’s no longer any country on the planet where men outlive women.

It wasn’t always this way.

According to data from developed countries, men lived longer than women throughout most of the 1800s, only for the longevity stats to tip in favor of females during the 1890s — an advantage that women have held ever since. Women are supposedly more vulnerable than men to infectious diseases, but once male scientists got a grip on the microbes and brought those pesky critters to heel, women started living longer than men.

As far as I know, women have never thanked men for it.

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For another example of Goad’s work, check out his valentine, Why I Never Gave Up On Women.


  Steve Parker, M.D.

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Red Meat and Diabetes Risk

Photo by Malidate Van on Pexels.com

Red meat consumption — whether processed or not — was linked to onset of type 2 diabetes in the U.S. according to a 2023 article in American Journal of Clinical Nutrition. The research was a long-term observational study by mostly Harvard-based scientists. Among the authors that might be familiar to you are Walter Willett, Frank Hu, and Frank Sacks. Click the link for the deets.

This doesn’t prove that red meat consumption causes diabetes. But if you enjoy a fair or high amount of red meat, you might benefit by cutting back, especially if diabetes runs in your family. I’d also suggest regular exercise and avoiding overweight and obesity to reduce your risks of type 2 diabetes. The author suggest red meat alternatives: nuts, legumes, dairy foods.

In the same journal issue is a commentary by Daan Kremer. Some snippets:

The current observational study is unlikely to end the discussion on whether red meat intake increases risk of type 2 diabetes and even less likely to end the epistemological debates on how to grade quality of observational evidence when many efforts are made to reduce bias and confounding.

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All in all, the study by Gu et al. may arguably be the best evidence to date on the relation between red meat intake and type 2 diabetes. Yet somehow, I feel that the books have not been closed.

  Steve Parker, M.D.

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Faster Walking Speed is Linked to Lower Risk of Type 2 Diabetes

Photo by James Wheeler on Pexels.com

You probably want to shoot for a speed of 3 miles per hour or higher. Or 4.8 kilometers/hr or faster.

The British Journal of Sports Medicine published an article by researchers based in Iran. They analyzed 10 cohort studies that looked at average habitual walking speed and the incidence of type 2 diabetes. Study subjects were not in Iran, but in the U.S., U.K., and Japan.

An easy, casual walking speed is 2 miles per hour (mph) or less. Brisk walking speed is 3-4 mph. The researchers found that a habitual walking speed of even 2.5 mph was linked to a slightly lower risk of type 2 diabetes compared to the casual walkers. A more definitive reduction of diabetes incidence (25%) was seen in those who walk at 3 to 4 mph.

For those of you who think in terms of km/hr: An easy, casual walking speed is 3.2 km/hr or less. Brisk walking speed is 4.8-6.4 km/hr. The researchers found that a habitual walking speed of even 4 km/hr was linked to a slightly lower risk of type 2 diabetes compared to the casual walkers. A more definitive reduction of diabetes incidence (25%) was seen in those who walk at 4.8-6.4 km/hr.

This doesn’t necessarily mean that you’ll cut your risk of developing type 2 diabetes if you increase your habitual walking speed from an easy stroll to 3 mph or higher. But it is suggestive and there is physiological science to support that suggestion. The problem is that this study was observational. Which means it’s possible that faster walkers are simply overall healthier than slower ones. They walk faster because they’re healthier and are just constitutionally (genetically?) less prone to illness. To prove that faster walking speeds prevent some cases of type 2 diabetes, you’d have to take 2,000 slow walkers and somehow motivate 1,000 of them to walk faster habitually, while making sure the slow-pokes stay slow for 5-10 years. Keep everything else the same for all 2,000. After 5-10 years, you compare the incidence of diabetes. That study will not, probably cannot, be done.

  Steve Parker, M.D.

h/t to Diabetes Daily for a well-written article on this.

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Filed under Causes of Diabetes, Exercise