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.”
Imagine the reaction in the United States if Russia detonated cluster munitions over Miami Beach, killing and wounding more than one hundred, including children. The American people would demand a strong response. Well, that is exactly what is happening now in Russia….
Cardiovascular diseases (CVDs) are major causes of mortality around the world. High blood pressure (BP) or hypertension is one of the most significant predisposing factors to CVDs. Ketogenic diets (KDs) have been the center of attention for their possible health benefits. The aim of this analysis is to study the impact of KDs on BP through the existing literature.
Data synthesis
We investigated the impact of KDs on systolic and diastolic blood pressures (SBP and DBP) conducted in the format of randomized controlled trials (RCTs). Four online databases (PubMed/Medline, SCOPUS, Cochrane Library, and Google Scholar) were searched from inception up to November 2022. Subgroup analyses were carried out to find the sources of heterogeneities.
Twenty-three RCTs with 1664 participants were identified. KDs did not exert any significant impacts on SBP (WMD: −0.87 mmHg, 95% CI: −2.05, 0.31) nor DBP (WMD: −0.11 mmHg, 95% CI -1.14, 0.93). Subgroup analyses did not reveal any further information. Also, non-linear dose-response analysis could not detect any associations between the percentage of calorie intake from fat in the KD format and BP levels.
Conclusion
KDs do not seem to be effective in improving BP. Nonetheless, further investigations are recommended to examine the proportion of fat intake needed to induce favorable clinical impacts.
Posted onJune 17, 2024|Comments Off on New Drug Rezdiffra for Liver Disease
Stages of liver damage. Healthy, fatty, liver fibrosis and cirrhosis
DiabetesDaily informed me of a new drug available for treatment of a liver disease that affects “up to 20% of people with diabetes. But by no means is the disease limited to diabetics (er, “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 an open mind.
I’m not sure, but it appears that candidates for the drug will need a liver biopsy showing fibrosis (scarring).
Posted onJune 12, 2024|Comments Off on I Told You So: 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.
Regarding the fish above…. I was eating at a fancy French restaurant in Pensacola, FL, about 30 years ago and a table mate ordered fish (du poisson?). When it arrived with head ON, she immediately demanded it be taken back to the kitchen for removal of the head!
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.
A large number of Americans still think that Russia is the Soviet Union, that the country is a crumbling wreck and the people are atheists and miserable. Boy, are they wrong. I received the following note this morning from a friend who exemplifies this mistaken prejudice. He wrote:
“I have been in Russia a few years ago before any wars, and the standard of living even for well educated people remains quite low. So, they may have a bigger better economy than we all know, but it is not translating to a much better life for its citizens compared to the EU or America. Relative to what it was before Putin it is very much better, but compared to the west or Japan it is still far behind. What will 500,000+ dead and wounded and 100,000 more fleeing and a very low birth rate in a rapidly declining demographic, do for the economy. Nothing good.”
Wrong, wrong, wrong!!!! Although I have only visited the two largest cities in Russia — Moscow in the winter and St. Petersburg on the cusp of summer — I can report that the average Russian appears to be living as well, if not better, than their counterparts in the United States or Japan. Especially when it comes to quality of life. Unlike the big cities in the United States, you can stroll along the streets and boulevards of Moscow or St. Petersburg without worrying about getting mugged or stumbling over some homeless addict sprawled on the sidewalk. The streets are clean. No used needles or face masks. Try explaining to Russians a “poop” map. They cannot grasp the concept.
With the threat of nuclear war higher than it’s ever been in my lifetime (and I was alive during the Cuban missile crisis), I’ve been thinking more about Russia. Unlike most of our national (U.S.) politicians, I don’t hate Russia or the Russian people. (Same goes for China.)The more I learn about Russians, the more I like and admire them.
Posted onMay 7, 2024|Comments Off on Why Do Women Live Longer Than Men?
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.
Advanced Mediterranean Diet 