Change My Mind: Pfizer COVID-19 Vaccine Fails to Prevent Death Over Six Months

Posted on August 9, 2021 | 2 comments
Alea iacta est

I ran across a pre-print placebo-controlled scientific study looking at results of Pfizer-BioNTech vaccination over the course six months. The primary take-home point for me is that the vaccine did not prevent death. Mysteriously, the study authors didn’t discuss the lack of death prevention by the vaccine; I found the data in Figure 1. The vaccine did prevent severe COVID-19 disease.

The scientific name for this particular vaccine is BNT162b2.

Remember that Big Pharma and the CDC have been telling us since November 2020 that the COVID-19 vaccines are highly effective (~90% or better) in preventing severe disease and death.

The study at hand looked at 22,000 folks who got two doses of the vaccine and another 22,000 who got a saline placebo. There were 16 deaths in the vaccine group, 15 in placebo.

Thirty-one participants met the CDC’s definition of severe COVID-19; 30 of these were in the placebo group. So the odds of developing severe COVID-19 over six months if not vaccinated were 0.136%. Or one in 735. (Tell me if my math is wrong.) I fully expect the odds are higher if elderly, lower if young.

Among the vaccinated, 77 developed COVID-19. The placebo group had 850 cases. The report doesn’t state a definition of a “COVID-19 case.” I presume a positive PCR nasal swab and one or more of the usual symptoms. Maddeningly, when the mainstream media mentions a case count, the number may include folks with a positive PCR swab but no symptoms.

Most participants were enrolled between August and October 2020. IIRC, the U.S. had a major spike in cases in January 2021. The data cut-off date for this study was March 31, 2021, so many of the participants had significant exposure. Median age for both groups was 51. 76% of participants were in the U.S.

The authors note that the risk of developing COVID-19 in the vaccinated tended to rise over time. Vaccine effectiveness declined about 6% every two months. A booster vaccination might be recommended at some point. Pfizer’s CEO revealed this a couple months ago.

For all I know, the linked-to pre-print article above is a hoax. These data are not going to help Pfizer sell more vaccine! If the pre-print is legit, I assume Pfizer was somehow compelled to publish the results.

This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice.

Steve Parker, M.D.

h/t The Last Refuge

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Glucagon for Hypoglycemia Unawareness

Posted on August 7, 2021 | Comments Off on Glucagon for Hypoglycemia Unawareness

Diabetes Daily has in important interview with Dr Steven Edelman on hypoglycemia (particularly in type 1 diabetes) and the need for injectable glucacon to treat it. This could easily apply also to type 2 diabetes that’s treated with insulin or other drugs that can cause hypoglycemia. Folks with type 1 diabetes seem to be more prone to hypoglycemia unawareness. That is, the blood sugar is dangerously low, but not recognized or treated promptly, potentially resulting death. Dr Edelman notes that dangerous hypoglycemia has been significantly reduced by the use of continuous glucose monitoring (CGM).

Note that CGM measure glucose levels in the the fluid in between the cells of subcutaneous tissue (AKA interstitial fluid). Your familiar fingerstick glucose is measuring capillary fluid levels. Capillaries are tiny blood vessels at the end of arteries. After going through the capillaries, blood enters veins for the return trip to the lung and heart. Glucose levels in the interstitial fluid and capillaries may not be the same as in the large arteries delivering glucose to the brain. Most CGM devices will provide the user with an alert when the glucose level drops too low, so that remedial action can be taken.

An excerpt from Diabetes Daily:

What are some ways that the CGM can most effectively help avoid hypos?

Well, one of the things I do in clinic is to really check where people set their upper and lower alerts. I had a patient yesterday in clinic who has had type 1 for 60 years. Her A1C is unbelievable, but she does have hypo unawareness and her lower alert was 65. You have to convince people that the extra alerts are worth it to you.

A lot of people said they put their lower alert at 65 and they don’t realize this situation called the “lag time.” So, when your blood sugar is dropping, even if you have a diagonal arrow down compared to, even worse, one arrow down or two arrows down, looking at the Dexcom arrows, they don’t realize that the glucose in your circulation is probably much lower than it appears on the Dexcom monitor or your phone. Because the Dexcom sensor and other sensors too, they measure the glucose in the subcutaneous tissue, and there’s a lag between the subcutaneous tissue and the circulation.

When your Dexcom goes off or when your CGM goes off at 65, and if your trend arrow’s going down, you could be 45 or 40. So that’s really an important issue, especially for people that their symptoms aren’t as obvious anymore. You could be caught off guard. And I had multiple patients that has occurred with. And then unfortunately, as you know, the majority of T1Ds in this country do not wear a CGM and that’s the topic of a whole other story.

Does this lag time issue apply to a regular glucometer as well?

Yes. If your blood sugar is dropping, your meter or CGM may be perfectly accurate of the subcutaneous tissue at 65. If you checked your blood sugar with a meter, it’s still going to say 65, but your circulation that’s going to your brain might be 45. So, the lag time is key. You could have the most accurate meter or CGM in the world, it doesn’t affect the lag time.

Click for my five-year-old article on drugs that can cause diabetes.

Click for my brief article on hypoglycemia unawareness.

Click for my general article on recognition and treatment of hypoglycemia.

Steve Parker, M.D.

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Finerenone: New Drug to Prevent Chronic Kidney Disease and Cardiovascular Death in Type 2 Diabetes

Posted on July 28, 2021 | 1 comment

Verbatim from the FDA press release:

FDA has approved Kerendia (finerenone) tablets to reduce the risk of kidney function decline, kidney failure, cardiovascular death, non-fatal heart attacks, and hospitalization for heart failure in adults with chronic kidney disease associated with type 2 diabetes.

Diabetes is the leading cause of chronic kidney disease and kidney failure in the United States. Chronic kidney disease occurs when the kidneys are damaged and cannot filter blood normally. Because of defective filtering, patients can have complications related to fluid, electrolytes (minerals required for many bodily processes), and waste build-up in the body. Chronic kidney disease sometimes can progress to kidney failure. Patients also are at high risk of heart disease.

The efficacy of Kerendia to improve kidney and heart outcomes was evaluated in a randomized, multicenter, double-blind, placebo-controlled study in adults with chronic kidney disease associated with type 2 diabetes. In this study, 5,674 patients were randomly assigned to receive either Kerendia or a placebo.

The study compared the two groups for the number of patients whose disease progressed to a composite (or combined) endpoint that included at least a 40% reduction in kidney function, progression to kidney failure, or kidney death. Results showed that 504 of the 2,833 patients who received Kerendia had at least one of the events in the composite endpoint compared to 600 of the 2,841 patients who received a placebo.

The study also compared the two groups for the number of patients who experienced cardiovascular death, a non-fatal heart attack, non-fatal stroke, or hospitalization for heart failure. Results showed that 367 of the 2,833 patients receiving Kerendia had at least one of the events in the composite endpoint compared to 420 of the 2,841 patients who received a placebo, with the treatment showing a reduction in the risk of cardiovascular death, non-fatal heart attack, and hospitalization for heart failure.

Side effects of Kerendia include hyperkalemia (high levels of potassium), hypotension (low blood pressure), and hyponatremia (low levels of sodium). Patients with adrenal insufficiency (when the body does not produce enough of certain hormones) and those receiving simultaneous treatment with strong CYP3A4 inhibitors should not take Kerendia.

Kerendia received priority review and fast track designations for this application.

FDA granted the approval of Kerendia to Bayer Healthcare.

Click for prescribing information.

Parker here.

Just offhand, finerenone doesn’t look like a great drug. Helpful, maybe. Chronic kidney disease can end up at ESRD (end stage renal disease), which requires thrice weekly hemodialysis if the patient wants to stay alive. (Yes, peritoneal dialysis is an alternative.) Preventing ESRD is an incredible benefit for an individual.

Finerenone seems to be a well-tolerated daily pill. The main adverse effect is elevated blood potassium level, which can cause palpitations, and death infrequently. Less commonly, the drug can cause low blood pressure.

The ultimate role of finerenone in our armamentarium against disease and suffering will probably depend on cost and the number needed to treat.

Steve Parker, M.D.

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Another Estimate of Paleolithic Man’s Diet

Posted on July 18, 2021 | 1 comment
Not many edible leafy greens around this time of year

I see no reason to disagree with this abstract.

Abstract

We review the evolutionary origins of the human diet and the effects of ecology economy on the dietary proportion of plants and animals. Humans eat more meat than other apes, a consequence of hunting and gathering, which arose ∼2.5 Mya with the genus Homo. Paleolithic diets likely included a balance of plant and animal foods and would have been remarkably variable across time and space. A plant/animal food balance of 40-60% prevails among contemporary warm-climate hunter-gatherers, but these proportions vary widely. Societies in cold climates, and those that depend more on fishing or pastoralism, tend to eat more meat. Warm-climate foragers, and groups that engage in some farming, tend to eat more plants. We present a case study of the wild food diet of the Hadza, a community of hunter-gatherers in northern Tanzania, whose diet is high in fiber, adequate in protein, and remarkably variable over monthly timescales. Expected final online publication date for the Annual Review of Nutrition, Volume 41 is September 2021. Please see http://www.annualreviews.org/page/journal/pubdates for revised estimates.

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Dietary Salt Restriction Lowers Blood Pressure in Type 2 Diabetes

Posted on July 16, 2021 | 2 comments
A pinch of salt may cut the bitterness in a cup of coffee

Yes, according to an article in Nutrition, Metabolism & Cardiovascular Disease. The systolic pressure lowering is 5-6 points, but only 1-2 points on average for diastolic pressure. This degree of BP lowering is not dramatic, but might prevent an escalation of antihypertensive drug dosing or initiation of an additional drug.

Steve Parker, M.D.

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Posted in Heart Disease

Is the Paleo Diet the Easiest to Stick With?

Posted on July 14, 2021 | 2 comments
I’ve never eaten rabbit, but would try it. A patient in Florida cooked squirrel for me. Tastes like chicken, as I recall.

An article at Public Health Nutrition suggests that, yes, the paleo diet is one of the last to be abandoned. I’m not paying the $35 for access to the full article, so I don’t know which diets were considered. I assume all the popular ones.

Abstract

Objective: To use Internet search data to compare duration of compliance for various diets.

Design: Using a passive surveillance digital epidemiological approach, we estimated the average duration of diet compliance by examining monthly Internet searches for recipes related to popular diets. We fit a mathematical model to these data to estimate the time spent on a diet by new January dieters (NJD) and to estimate the percentage of dieters dropping out during the American winter holiday season between Thanksgiving and the end of December.

Setting: Internet searches in the USA for recipes related to popular diets over a 15-year period from 2004 to 2019.

Participants: Individuals in the USA performing Internet searches for recipes related to popular diets.

Results: All diets exhibited significant seasonality in recipe-related Internet searches, with sharp spikes every January followed by a decline in the number of searches and a further decline in the winter holiday season. The Paleo diet had the longest average compliance times among “new January dieters” (5.32 ± 0.68 weeks) and the lowest dropout during the winter holiday season (only 14 ± 3 % dropping out in December). The South Beach diet had the shortest compliance time among NJD (3.12 ± 0.64 weeks) and the highest dropout during the holiday season (33 ± 7 % dropping out in December).

Conclusions: The current study is the first of its kind to use passive surveillance data to compare the duration of adherence with different diets and underscores the potential usefulness of digital epidemiological approaches to understanding health behaviours.

Steve Parker, M.D.

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Introducing the “Paleo Ratio” as an Assessment of Paleo Diet Compliance

Posted on July 13, 2021 | 2 comments

The study at hand did not find an improvement in hemoglobin A1c in type 2 diabete after 12 weeks of intervention. I’m surprised. I haven’t read the whole report yet.

Abstract

This study is a secondary analysis of a randomized controlled trial using Paleolithic diet and exercise in individuals with type 2 diabetes. We hypothesized that increased adherence to the Paleolithic diet was associated with greater effects on blood pressure, blood lipids and HbA1c independent of weight loss. Participants were asked to follow a Paleolithic diet for 12 weeks and were randomized to supervised exercise or general exercise recommendations. Four-day food records were analyzed, and food items characterized as “Paleolithic” or “not Paleolithic”. Foods considered Paleolithic were lean meat, poultry, fish, seafood, fruits, nuts, berries, seeds, vegetables, and water to drink; “not Paleolithic” were legumes, cereals, sugar, salt, processed foods, and dairy products. A Paleo ratio was calculated by dividing the Paleolithic calorie intake by total calorie intake. A multiple regression model predicted the outcome at 12 weeks using the Paleo ratio, group affiliation, and outcome at baseline as predictors.

The Paleo ratio increased from 28% at baseline to 94% after the intervention. A higher Paleo ratio was associated with lower fat mass, BMI, waist circumference, systolic blood pressure, and serum triglycerides at 12 weeks, but not with lower HbA1c levels. The Paleo ratio predicted triglyceride levels independent of weight loss (p = 0.046). Moreover, an increased monounsaturated/saturated fatty acids ratio and an increased polyunsaturated/saturated fatty acids ratio was associated with lower triglyceride levels independent of weight loss. (p = 0.017 and p = 0.019 respectively).

We conclude that a higher degree of adherence to the Paleolithic diet recommendations improved fat quality and was associated with improved triglyceride levels independent of weight loss among individuals with type 2 diabetes.

Source: Using a Paleo Ratio to Assess Adherence to Paleolithic Dietary Recommendations in a Randomized Controlled Trial of Individuals with Type 2 Diabetes – PubMed

Steve Parker, M.D.

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Paleo Diet Effect on Athletes

Posted on June 28, 2021 | 1 comment
hunter, hunting, prehistoric, paleo diet, caveman, saber-toothed tiger, cavewoman

Judging from the article abstract below, it looks like the researchers didn’t find any major impact of the paleo diet on athletic performance, compared to “healthy” control diets. The title of the scientific report is “Paleolithic Diet-Effect on the Health Status and Performance of Athletes?” That sure made me think they were going to look at athletic performance. Here’s one of two sentences in the abstract that refer to athletic performance: “Lower positive impact of paleo diet on performance was observed it the group without exercise.” What does that even mean? Looks like even scientific journals are using click-bait now.

Before you read the abstract, remember that higher blood triglycerides, total cholesterol, and LDL cholesterol are linked in some studies to cardiovascular disease. Also, lower plasma glucose (sugar) and insulin levels are linked in some studies to less risk of cardiovascular disease. So the paleo diet may be healthful since it shifts those numbers in the right direction.

The aim of this meta-analysis was to review the impact of a Paleolithic diet (PD) on selected health indicators (body composition, lipid profile, blood pressure, and carbohydrate metabolism) in the short and long term of nutrition intervention in healthy and unhealthy adults. A systematic review of randomized controlled trials of 21 full-text original human studies was conducted. Both the PD and a variety of healthy diets (control diets (CDs)) caused reduction in anthropometric parameters, both in the short and long term. For many indicators, such as weight (body mass (BM)), body mass index (BMI), and waist circumference (WC), impact was stronger and especially found in the short term. All diets caused a decrease in total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and triglycerides (TG), albeit the impact of PD was stronger. Among long-term studies, only PD cased a decline in TC and LDL-C. Impact on blood pressure was observed mainly in the short term. PD caused a decrease in fasting plasma (fP) glucose, fP insulin, and homeostasis model assessment of insulin resistance (HOMA-IR) and glycated hemoglobin (HbA1c) in the short run, contrary to CD. In the long term, only PD caused a decrease in fP glucose and fP insulin. Lower positive impact of PD on performance was observed in the group without exercise. Positive effects of the PD on health and the lack of experiments among professional athletes require longer-term interventions to determine the effect of the Paleo diet on athletic performance.

Reference: https://pubmed.ncbi.nlm.nih.gov/33801152/

Click for the full text article. The article title and abstract were so poorly written that I’m not wasting time on the full text. Let me know if you find anything interesting. Furthermore, this “research” was a meta-analysis, so I’m even more skeptical about any conclusions on athletic performance.

Steve Parker, M.D.

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Paleo Diet Reduced Body Fat and Waist Circumference

Posted on June 15, 2021 | 1 comment
Paleolithic populations weren’t plagued by overweight and obesity

An extremely small study of only seven healthy inactive experimental subjects (BMI 29.4. so almost obese, average age 32) found a drop in BMI to 27.7 but no change in the measured adipokines while following a paleo diet for eight weeks. The investigators write, “Adipokines are considered a class of biomarkers indicative of health and metabolic disease. They are secreted from adipose tissue and act in an autocrine, paracrine, or endocrine manner and have been implicated in the regulation of metabolic health and eating behaviors.”

Here’s a link to the full text article in International Journal of Exercise Science. The abstract:

The Paleolithic diet, characterized by an emphasis on hunter-gatherer type foods accompanied by an exclusion of grains, dairy products, and highly processed food items, is often promoted for weight loss and a reduction in cardiometabolic disease risk factors. Specific adipokines, such as adiponectin, omentin, nesfatin, and vaspin are reported to be dysregulated with obesity and may respond favorably to diet-induced fat loss. We aimed to evaluate the effects of an eight-week Paleolithic dietary intervention on circulating adiponectin, omentin, nesfatin, and vaspin in a cohort of physically inactive, but otherwise healthy adults.

Methods: Seven inactive adults participated in eight weeks of adherence to the Paleolithic Diet. Fasting blood samples, anthropometric, and body composition data were collected from each participant pre-and post-intervention. Serum adiponectin, omentin, nesfatin, and vaspin were measured. Results: After eight weeks of following the Paleolithic diet, there were reductions (p<0.05) in relative body fat (−4.4%), waist circumference (− 5.9 cm), and sum of skinfolds (−36.8 mm). No changes were observed in waist to hip ratio (WHR), or in adiponectin, omentin, and nesfatin (p>0.05), while serum vaspin levels for all participants were undetectable.

Conclusions: It is possible that although eight weeks resulted in modest body composition changes, short-term fat loss will not induce changes in adiponectin, omentin, and nesfatin in apparently healthy adults. Larger, long-term intervention studies that examine Paleolithic diet-induced changes across sex, body composition, and in populations with metabolic dysregulation are warranted.

Steve Parker, M.D.

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High Blood Pressure: How Low Should You Go?

Posted on June 13, 2021 | 1 comment
Not a bad monitor

First, remember that blood pressure is reported as two numbers: systolic and diastolic. E.g., 135/92. The first number is the systolic number. A systolic pressure goal of under 120 mmHg may be better than the traditional goal of under 140, at least if you’re “at increased risk for cardiovascular disease.” The study at hand excluded folks with diabetes or prior stroke.

We randomly assigned 9,361 participants who were at increased risk for cardiovascular disease but did not have diabetes or previous stroke to adhere to an intensive treatment target (systolic blood pressure, <120 mm Hg) or a standard treatment target (systolic blood pressure, <140 mm Hg). The primary outcome was a composite of myocardial infarction, other acute coronary syndromes, stroke, acute decompensated heart failure, or death from cardiovascular causes. Additional primary outcome events occurring through the end of the intervention period (August 20, 2015) were adjudicated after data lock for the primary analysis. We also analyzed post-trial observational follow-up data through July 29, 2016.

RESULTS

At a median of 3.33 years of follow-up, the rate of the primary outcome and all-cause mortality during the trial were significantly lower in the intensive-treatment group than in the standard-treatment group (rate of the primary outcome, 1.77% per year vs. 2.40% per year; hazard ratio, 0.73; 95% confidence interval [CI], 0.63 to 0.86; all-cause mortality, 1.06% per year vs. 1.41% per year; hazard ratio, 0.75; 95% CI, 0.61 to 0.92). Serious adverse events of hypotension, electrolyte abnormalities, acute kidney injury or failure, and syncope were significantly more frequent in the intensive-treatment group. When trial and post-trial follow-up data were combined (3.88 years in total), similar patterns were found for treatment benefit and adverse events; however, rates of heart failure no longer differed between the groups.

Click for article abstract at NEJM.

Steve Parker, M.D.

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Posted in Heart Disease, Longevity, stroke