Covid-19 Vaccine?: Maybe, Maybe Not

professor, equations
The governments “top men” are working on it

Peter Doshi, an associate editor at British Medical Journal, is not favorably impressed with the recent vaccine trial announcements. “90% effective.” “95% effective!”

Coronavirus guru Anthony Fauci assures us that a coronavirus vaccine will only be FDA-approved if it’s “safe and effective.”

From Doshi:

But what will it mean exactly when a vaccine is declared “effective”? To the public this seems fairly obvious. “The primary goal of a covid-19 vaccine is to keep people from getting very sick and dying,” a National Public Radio broadcast said bluntly.

Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston, said, “Ideally, you want an antiviral vaccine to do two things . . . first, reduce the likelihood you will get severely ill and go to the hospital, and two, prevent infection and therefore interrupt disease transmission.”

Yet the current phase III trials are not actually set up to prove either. None of the trials currently under way are designed to detect a reduction in any serious outcome such as hospital admissions, use of intensive care, or deaths. Nor are the vaccines being studied to determine whether they can interrupt transmission of the virus.

Will COVID-19 vaccines save lives? Current trials aren’t designed to tell us.
elderly man, face mask
Do you ever wonder why we didn’t see widespread use face masks during a typical flu season in the past?

Switching gears to the flu vaccine for a minute. The flu vaccine’s been a godsend in preventing influenza death among the frail elderly, right? Not so fast there, pardner. Doshi again:

But the truth is that the science remains far from clear cut, even for influenza vaccines that have been used for decades. Although randomised trials have shown an effect in reducing the risk of symptomatic influenza, such trials have never been conducted in elderly people living in the community to see whether they save lives.

Only two placebo controlled trials in this population have ever been conducted, and neither was designed to detect any difference in hospital admissions or deaths.

Moreover, dramatic increases in use of influenza vaccines has not been associated with a decline in mortality.

The Moderna and Pfizer trials enrolled 30,000 and 44,000 participants, respectively. That sounds like a lot of people to be vaccinated. But they only vaccinate half the folks. The other have serve as a control group. Next, the investigators track the occurrence of coronavirus events over time, then compare the two groups. An “event” may be anything from a cough plus positive COVID-19 PCR test, to hospitalization or death. Of course, they also look at potential adverse effect of vaccination, comparing the two groups.

The trials aren’t going to give us good information on COVID-19 hospitalizations and death rates because those outcomes are so infrequent. Most people with symptomatic COVID-19 experience only mild symptoms; there are relatively few cases of serious disease in a general population of 30,000.

Who needs a safe and effective vaccine the most?

  • Those over 60-65
  • Anybody seriously immunocompromised (i.e., a poor immune system too weak to fight infection).

Immunocompromised people are excluded from the seven ongoing trials. So these trials focus on those over 60, right? Wrong. The Moderna trial eligibility started at age 18. Pfizer’s accepted 12-year-olds.

Surely the vaccine trials will have some participants over 60-years-old. There just may not be enough to generate clinically meaningful data on serious disease outcomes and adverse effects in the elderly.

Steven Novella says Moderna developed their vaccine with a grant from the U.S. government. Pfizer funded themselves. Each vaccine has cost over two billion dollars to develop. They will be the first ever mRNA vaccines approved by the FDA. Our other vaccines are based on different technology. Both vaccines require two shots, 28 days apart.

Steve Parker, M.D.

PS: I am not generally anti-vaccination.

Some Prehistoric Women Were Big-Game Hunters

caveman, saber-toothed tiger, cavewoman, hunter, hunting, prehistoric, paleo diet
OK, but does she also cook and clean?

From Science Advances:

Sexual division of labor with females as gatherers and males as hunters is a major empirical regularity of hunter-gatherer ethnography, suggesting an ancestral behavioral pattern. We present an archeological discovery and meta-analysis that challenge the man-the-hunter hypothesis. Excavations at the Andean highland site of Wilamaya Patjxa reveal a 9000-year-old human burial (WMP6) associated with a hunting toolkit of stone projectile points and animal processing tools. Osteological, proteomic, and isotopic analyses indicate that this early hunter was a young adult female who subsisted on terrestrial plants and animals. Analysis of Late Pleistocene and Early Holocene burial practices throughout the Americas situate WMP6 as the earliest and most secure hunter burial in a sample that includes 10 other females in statistical parity with early male hunter burials. The findings are consistent with nongendered labor practices in which early hunter-gatherer females were big-game hunters.

Source: Female hunters of the early Americas | Science Advances

Steve Parker, M.D.

What’s the Best Fitness Tracker?

I don’t know. It partially depends on your needs.

ConsumersAdvocate.org has an article comparing and contrasting some of the available fitness trackers:

young woman, exercise, weight training, gym
You go, girl!
HOW WE FOUND THE BEST FITNESS TRACKERFEATURES

We checked for fitness trackers with diverse features that users could choose to best match their lifestyle and goals. This includes multiple health and activity monitoring options.

CONNECTIVITY

Many fitness trackers sync with smartphones or Bluetooth to receive calls, get message notifications, and send data to their corresponding fitness apps. We looked at trackers that were easy to connect.

COST

Regular fitness trackers can range from $50 to $200, while hybrid smartwatches can cost over $400. We compared prices to special features to make sure consumers get the most out of their investment.

CUSTOMER EXPERIENCE

Fitness trackers should be durable, lightweight, and comfortable. We interviewed customers and read dozens of reviews and testimonies for thorough feedback on each product.

Source: The Best Fitness Trackers For 2020

Click through for details. I use none of these trackers, so have no dog in this fight.

Steve Parker, M.D.

Reduce Insulin Resistance with Resistance Training

Didn’t we already know this? The study at hand involved 10 overweight young men.

Insulin is a blood-borne hormone that the pancreas gland secretes in order to keep blood sugar levels from getting too high. (Insulin does many other things, but table that for now.) Insulin triggers certain body cells to absorb glucose from the bloodstream. “Insulin resistance” means that these cells don’t respond to insulin as well as they should, so either the pancreas secretes even more insulin (hyperinsulinemia) or blood sugar levels rise. Insulin resistance is a harbinger of type 2 diabetes mellitus. Most overweight or obese type 2 diabetics have insulin resistance. Many experts think hyperinsulinemia causes disease by itself, regardless of blood sugar levels. So it may be best to avoid insulin resistance and hyperinsulinemia.

The aim of the study was to investigate the effects of 6 weeks of resistance exercise training, composed of one set of each exercise to voluntary failure, on insulin sensitivity and the time course of adaptations in muscle strength/mass. Ten overweight men (age 36 ± 8 years; height 175 ± 9 cm; weight 89 ± 14 kg; body mass index 29 ± 3 kg m−2) were recruited to the study. Resistance exercise training involved three sessions per week for 6 weeks. Each session involved one set of nine exercises, performed at 80% of one‐repetition maximum to volitional failure. Sessions lasted 15–20 min. Oral glucose tolerance tests were performed at baseline and post‐intervention. Vastus lateralis muscle thickness, knee‐extensor maximal isometric torque and rate of torque development (measured between 0 and 50, 0 and 100, 0 and 200, and 0 and 300 ms) were measured at baseline, each week of the intervention, and after the intervention. Resistance training resulted in a 16.3 ± 18.7% (P < 0.05) increase in insulin sensitivity (Cederholm index). Muscle thickness, maximal isometric torque and one‐repetition maximum increased with training, and at the end of the intervention were 10.3 ± 2.5, 26.9 ± 8.3, 18.3 ± 4.5% higher (P < 0.05 for both) than baseline, respectively. The rate of torque development at 50 and 100 ms, but not at 200 and 300 ms, increased (P < 0.05) over the intervention period. Six weeks of single‐set resistance exercise to failure results in improvements in insulin sensitivity and increases in muscle size and strength in young overweight men.

Source: The effect of short‐duration resistance training on insulin sensitivity and muscle adaptations in overweight men – Ismail – 2019 – Experimental Physiology – Wiley Online Library

Steve Parker, M.D.

For How Long Did Neanderthals Breast-Feed?

For 5-6 months.

Now aren’t you glad you read this blog? Where else you gonna get this vital info?

The discovery is based on dental analysis of a whopping three Neanderthals found in Italy.

The early onset of weaning in modern humans has been linked to the high nutritional demand of brain development that is intimately connected with infant physiology and growth rate. In Neanderthals, ontogenetic patterns in early life are still debated, with some studies suggesting an accelerated development and others indicating only subtle differences vs. modern humans. Here we report the onset of weaning and rates of enamel growth using an unprecedented sample set of three late (∼70 to 50 ka) Neanderthals and one Upper Paleolithic modern human from northeastern Italy via spatially resolved chemical/isotopic analyses and histomorphometry of deciduous teeth. Our results reveal that the modern human nursing strategy, with onset of weaning at 5 to 6 mo, was present among these Neanderthals. This evidence, combined with dental development akin to modern humans, highlights their similar metabolic constraints during early life and excludes late weaning as a factor contributing to Neanderthals’ demise.

Source: Early life of Neanderthals – PubMed

Steve Parker, M.D.

Chronic Proton Pump Inhibitor Use Linked to Type 2 Diabetes

prilosec, proton pump inhibitor
Neither the cited study nor I implicate Prilosec in particular

Regular use of proton-pump inhibitors (PPIs) increases patients’ risk of developing type 2 diabetes mellitus (T2DM) by 24%, an observational study published in Gut has suggested.

Source: Regular use of PPIs linked with increased risk of type 2 diabetes, study suggests | News | Pharmaceutical Journal

Proton pump inhibitors are widely used in the U.S. to treat esophageal reflux, ulcers, and dyspepsia. They are among the most widely prescribed drugs. You can also get them over-the-counter. Brand names include Protonix, Prilosec, and Nexium.

The study at hand defined “regular use” as at least twice per week. The study was an epidemiological one observing participants for 10-12 years. The more years of regular use, the greater risk of diabetes developing. Nearly all participants were White, so results may not apply to other ethnicities.

Note that this study doesn’t prove that PPIs cause diabetes. They just found a statistical linkage. As you know, correlation does not equal causation. We don’t know how PPIs could cause T2 diabetes. From the article:

According to the study, the possible mechanism for the association could be related to gut microbiota, as previous studies have shown that PPI use is associated with reduced diversity of gut microbiome and consistent changes in the microbiota phenotype.

Steve Parker, M.D.

Managing Diabetes on Sick Days

home glucose monitor, diabetes
How old is this device?

For folks taking insulin, Diabetes Daily has a good article by endocrinologist Dr Francine Kaufman. An excerpt:

Everyone with diabetes who takes insulin needs to have a sick day plan. This is something you develop with your healthcare professional to help you manage the high and low sugar levels that can be associated with an illness. The following advice applies to people with type 1 diabetes and people with type 2 diabetes who take insulin – the advice may be different if you have type 2 diabetes and do not take insulin.

Here’s what’s covered in the article:

  • Track your important numbers in a sick log
  • Glucose levels
  • Ketone levels
  • Temperature
  • Fluid intake
  • Urination
  • Vomiting, diarrhea, and dehydration
  • Insulin, amount and time
  • Medications

Key messages from Dr. Kaufman

When you get sick, you are at risk of becoming dehydrated from poor intake or from excessive loss of fluids due to nausea, vomiting, diarrhea, and fever (your body may lose more water when you have a high temperature). In addition, dehydration is common in diabetes because high glucose levels (above 180-200 mg/dL) cause sugar to enter your urine, dragging an excess amount of fluid with it. Illness also puts you at risk of developing ketones, which when coupled with high glucose levels can lead to diabetic ketoacidosis (DKA), a very serious condition. How do you know if you have ketones? Good question, click here!

The purpose of your sick day plan is to try to keep your glucose levels in a safe range – to avoid dehydration and to prevent ketones from rising to a dangerous level.

Source: Zoning in on Sick Day Management: Practical Tips, Strategies, and Advice – Diabetes Daily

Steve Parker, M.D.

PS: Avoid the medical-industrial complex by getting and staying as healthy as possible. Let me help:

How to Save $ on Your Diabetes Drugs

This Shrimp Salad is low-carb. Use the search box for recipe.

Christine Fallabel has an article at Diabetes Daily that may save you beaucoup bucks on your diabetes care, whether or not you have insurance coverage.

If you live in a country like the United States, where the majority of health insurance is privatized and there is no strong social safety net, it can feel as though managing a chronic disease like diabetes requires nothing but lots of money. And it does. As of 2017, diabetes cost the United States a staggering $327 billion dollars per year on direct health care costs, and people with diabetes average 2.3x higher health care costs per year than people living without the disease.

Diabetes is also devastatingly expensive personally: the cost of insulin has risen over 1200% in the past few decades, with no change to the chemical formula. In 1996, when Eli Lilly’s Humalog was first released, the price for a vial of insulin was $21. In 2019, that same vial costs around $275. Studies show that 1 in 4 people ration insulin simply due to cost. Diabetes Daily recently conducted a survey study, with almost 2,000 participants, of which an overwhelming 44% reported  struggling to afford their insulin.

So where does this leave patients who don’t have tons of money to spend on insulin and supplies, or who don’t have adequate health insurance coverage for the technology to help prevent complications? Can you manage diabetes well without lots of money? The short answer is yes. The long answer is a bit more complicated.

Source: Can You Manage Diabetes Well Without Lots of Money? – Diabetes Daily

Steve Parker, M.D.

PS: A low-carb paleo diet will also reduce your drug costs. 

PPI Drugs Linked to Doubled Risk of #COVID19

Click for details.

You should assume there’s a good reason or two why we have acidic stomach juice. One reason is to prevent infection.

I see two many patients who are put on these drugs are a good reason, but they keep taking them after the drug has finished it’s job.

An “as needed” H2 blocker like Pepcid may be a reasonable substitute for PPIs. Check with your personal physician.

I have nothing against Prilosec in particular. It can be very helpful. It’s one of several PPIs on the market.

Steve Parker, M.D.

Click pic to purchase book at Amazon.com. E-book versions available at Smashwords.com.

Are We Eff’d Up Due to Electric Light at Night?

No electricity

From the Journal of Pineal Research:

Key to the transition of humans from nomadic hunting-gathering groups to industrialized and highly urbanized societies was the creation of protected and artificially lit environments that extended the natural daylight hours and consolidated sleep away from nocturnal threats. These conditions isolated humans from the natural regulators of sleep and exposed them higher levels of light during the evening, which are associated with a later sleep onset. Here we investigated the extent to which this delayed timing of sleep is due to a delayed circadian system. We studied two communities of Toba/Qom Argentina, one with and the other without access to electricity. These communities have recently transitioned from a hunting-gathering subsistence to mixed subsistence systems and represent a unique model in which to study the potential effects of the access to artificial light on sleep physiology. We have previously shown that participants in the community with access to electricity had, compared to participants in the community without electricity, later sleep onsets and shorter sleep bouts. Here we show they also have a delayed dim light melatonin onset (DLMO). This difference is present during the winter but not during the spring when the influence of evening artificial light is likely less relevant. Our results support the notion that the human transition into artificially lit environments had a major impact on physiological systems that regulate sleep timing, including the phase of the master circadian clock.

Source: Access to electric light is associated with delays of the dim light melatonin onset in a traditionally hunter-gatherer Toba/Qom community – PubMed

Steve Parker, M.D.

Click pic to purchase book at Amazon.com. E-book versions available at Smashwords.com.