Home » Infection

Tag: Infection

What is Your Chance of Surviving A COVID-19 Infection?

< 20 years old – 99.98%
20-50 years old – 99.97%
50-70 years old – 99.5%
> 70 years old – 95%

Those numbers are even better if your are following a ketogenic or carnivorous lifestyle.

Sadly, I’ve had patients over age 70 tell me “pneumonia is an old man’s best friend.”  It is very true that pneumonia, the common cold, influenza and COVID-19 can all cause death in the older frail adult.  This is not something new, though if you listen to CNN you may think death should never occur.

But, thousands of physicians and over 200 different journal articles within the last 11 months demonstrate that if you are treated with azithromycin and either hydroxychloroquine or ivermectin plus Zinc, Vitamin D, Niacin, Vitamin C and Melatonin, you improve your risk of survival of a COVID-19 infection by an additional 10-40%.  75% of those studies demonstrated significant improvement even when hydroxychloroquine was started late.  Africa has a mortality rate (1.3 per 100,000) that is 100 percent lower than the US (120 per 100,000) because they have hydroxychloroquine available over-the-counter and many people take it “every Sunday” as preventative medication for malaria.

Mind you, these medications were never FDA approved for treatment with COVID-19.  But, we as licensed physicians have the autonomy to use medication “off-label” as long as we have discussed the risks, side-effects and expectations of these medications and you are aware that they were never FDA approved.

I have treated hundreds of patients with these combinations with great success in my clinic over the last 11 months.

Yet, in the last two weeks Fry’s Pharmacies (Kroger Pharmacies) are now refusing to dispense hydroxychloroquine or ivermectin for any COVID related virus.  Why?  Because they can make a huge profit on the Experimental COVID-19 vaccine.  Why dispense a generic medication when you can make twice the profit from a vaccine?  However, this experimental vaccine’s effectiveness is still yet to be confirmed, and probably less effective on newer strains as stated by the Surgeon General this last week (https://news.yahoo.com/us-surgeon-general-covid-19-184157789.html).

In my opinion, this is malpractice on the part of Fry’s Pharmacy and malfeasance on the part of the pharmacist.

Until they issue a public apology to you and me, I recommending you and I stop using Fry’s Pharmacy all together.  Any company that mandates the use of an Experimental Vaccine with a side effect profile experienced by up to 20% of those who receive it, and at the same time refuses to provide access to proven treatments overseen by a physician should not receive the business or the trust of the public.  If your pharmacist refused to dispense these medications with a valid prescription from your doctor, please let me know.

The pharmacists claim they won’t dispense hydroxychloroquine or ivermectin “because the FDA has not approved their use for viral infections.”  Yet, these drugs are safe enough to be over the counter in many other countries and because of the vaccine, this is all political.  Both of these drugs have been use very safely for decades with millions of people around the world for multiple disease processes.

The FDA issued it’s updated statement on the use of ivermectin.  “Ivermectin is an antiparasitic drug that is approved by the Food and Drug Administration (FDA) for the treatment of onchocerciasis and strongyloidiasis. Ivermectin is not FDA-approved for the treatment of any viral infection. In general, the drug is well tolerated. It is currently being evaluated as a potential treatment for COVID-19.”  These drugs are considered “generally safe” for multiple disease processes used over long periods of time, and yet, the politics and finances of this issue have now become more important than your health.  Neither the FDA or the NIH has stated that these drugs are contrindicated, they just have not been approved, and because of that “they are not recommended.”

As of January 14, 2021, the NIH has stated that ” currently there are insufficient data to recommend either for or against the use of ivermectin for the treatment of COVID-19. Results from adequately powered, well-designed, and well-conducted clinical trials are needed to provide more specific, evidence-based guidance on the role of ivermectin for the treatment of COVID-19.”  Similar statements have been issued on hydroxychloroquine.  However, “well conducted clinical trials” will not occur for some time, as these types of studies take years to be designed, funded and put into place.  Because ivermectin and hydroxychloroquine are generic drugs, there is no incentive for any pharmaceutical company to run these types of studies. The FDA will never change it’s position for this same reason.

Any physician, organization or pharmacy that places politics and finances over your health and wellbeing and tries to get between the doctor and patient should experience you and I protesting with our wallets and our feet.

Two essential things come out of this.  First, the CDC, FDA and NIH have shown us as a nation how untrustworthy they are.  Second, if you and I are not vigilant, mandates for the use of an experimental and potentially dangerous vaccine will be come the “new normal.”

I recommend you go to https://stopmedicaldiscrimination.org/ and sign the petition to prevent travel companies, airlines and other businesses from mandating this and any other experimental vaccine.  And, then tell Fry’s Pharmacy and any other pharmacist that plays politics with your health where they can put the rest of their medications.

Sources:

  1.  Kory P, et al., Review of the Emerging Evidence Demonstrating the Efficacy of Ivermectin in the Prophylaxis and Treatment of COVID-19. FLCCC Alliance; Version 5; Nov 28, 2020.
  2. Rajter JC, et al. Use of Ivermectin is associated with lower mortality in hospitalized patients with corona-virus disease 2019. Chest Journal Open Access Jan 2021; 159(1): 85-92
  3. Guilherme Dias de Melo, Françoise Lazarini, Florence Larrous, Lena Feige, Lauriane Kergoat, Agnes Marchio, Pascal Pineau, Marc Lecuit, Pierre-Marie Lledo, Jean-Pierre Changeux, Herve Bourhy, Anti-COVID-19 efficacy of ivermectin in the golden hamster. bioRxiv 2020.11.21.392639
  4. Vora, Agam, et al. “White paper on Ivermectin as a potential therapy for COVID-19.” Indian Journal of Tuberculosis 67.3 (2020): 448-451.
  5. Gorial, Faiq I., et al. “Effectiveness of Ivermectin as add-on Therapy in COVID-19 Management (Pilot Trial).” medRxiv (2020).
  6. Scheim, David. “Ivermectin for COVID-19 Treatment: Clinical Response at Quasi-Threshold Doses Via Hypothesized Alleviation of CD147-Mediated Vascular Occlusion.” Available at SSRN 3636557 (2020)
  7. Rajter, Juliana Cepelowicz, et al. “ICON (Ivermectin in COvid Nineteen) study: Use of Ivermectin is Associated with Lower Mortality in Hospitalized Patients with COVID19.” medRxiv (2020). medRxiv.org
  8. Chowdhury, Abu Taiub Mohammed Mohiuddin, et al. “A comparative observational study on Ivermectin-Doxycycline and Hydroxychloroquine-Azithromycin therapy on COVID19 patients.” ResearchGate.net
  9. NIH Statement on Ivermectin:  https://www.covid19treatmentguidelines.nih.gov/statement-on-ivermectin/
  10. FDA Statement on Ivermectin: https://www.fda.gov/animal-veterinary/product-safety-information/faq-covid-19-and-ivermectin-intended-animals

 

Coronavirus Risk, Vaccines and Herd Immunity

In order to fully understand the current “pandemic” coronavirus (COVID-19) infection, it is essential that one understands some basics about the immune system.  Second, we will look at how a poor understanding of the immune system has duped many about how the body actually responds to this virus.

Normal functions of the immune system include defense against infections and detection and destruction of malignant or abnormal cells. As our immune system ages and these capabilities decline, there is increased susceptibility to infections and cancer and an increased incidence of autoimmune disorders. The study of age-related changes in immune function is a relatively new area of investigation, which is limited by incomplete understanding of the complexities of immune mechanisms in general.  These age related changes make it clear why COVID-19 is mild in some and severe in others.

July 5, 2020 – ADHS -Data Dashboard – COVID-19 Deaths by Age Group

The coronavirus tends to be more problematic in those over age 55.  In fact, 87% of all deaths in Arizona due to COVID-19 are in those over age 55.  The clinical presentation of infections in older patients may be different from that in younger patients. Older adults with severe infections tend to have fewer symptoms, and fever is absent or blunted in 20 to 30% of those over age 55 years old. This suggests a decreased ability to mount inflammatory cytokine responses (small proteins used as signaling molecules between cell) in the face of infection. Signs of infection in older adults can be nonspecific and include falls, delirium (confusion), anorexia (loss of appetite), or generalized weakness (Norman DC, Clin Infect Dis. 2000;31(1):148).

Immune System & Aging

All immune cells originate from stem cells in the bone marrow, and there is a general decline in the total bone marrow cellular tissue as we age (Geiger H, Rudolph KL. Trends Immunol. 2009;30(7):360). Production of pro-B cells is significantly decreased with aging, resulting in a smaller number of B cells leaving the bone marrow, while T cell precursors seem to be less affected (Cancro MP, Hao Y, Scholz JL, Riley RL, Frasca D, Dunn-Walters DK, Blomberg BB., Trends Immunol. 2009;30(7):313. e-pub 2009 Jun 18). 

The immune system is divided into innate and adaptive immunity. The innate immunity refers to immune responses that are present from birth and not learned, not adapted, and not refined as a result of exposure to micro-organisms/antigens. In contrast, adaptive immunity, which consists of the responses of T and B lymphocytes, is generated and then refined over the lifetime of a person as a result of repeated exposure to antigens from bacteria, viruses or fungi. Aging affects both innate and adaptive immunity, although innate immune mechanisms are better preserved overall (Weiskopf D, Weinberger B, Grubeck-Loebenstein B, Transpl Int. 2009; 22(11):1041).

Innate Immunity

The innate immune system consists of epithelial barriers (skin, gastrointestinal and respiratory protective lining), macrophages, neutrophils, natural killer (NK) cells, natural killer T (NKT) cells, dendritic cells (DCs), and complement proteins. Additional normal defenses include production of mucus in the proper quantity and viscosity, local antimicrobial proteins, and normal sweeping function ciliary cells.

Though some innate immune mechanisms are decreased in the adult over 55 years old, other mechanisms appear to be more active.. The result of these changes is a propensity to develop chronic inflammation. The result of aging of the innate immune system may be most accurately characterized as a state of immune dysregulation characterized by low-grade, chronic inflammatory changes  (Shaw AC, Joshi S, Greenwood H, Panda A, Lord JM, Curr Opin Immunol. 2010;22(4):507).  This is why many of my patients feel that the “Golden Years” are full of lead.

Adaptive Immunity

 Adaptive immunity consists of the functioning of two types of white blood cells: T and B lymphocytes.  T and B lymphocytes mediate control cellular and humoral immune responses, respectively.

Cellular Immune Response and the T Cells

There are several key changes that occur to T cells during aging.

Thymus – The thymus gland is most active early in life, reaches maximum size within the first year of life, and then undergoes a steady decline with age. By age 7, the part of the thymus and it’s activity decrease to less than 10 percent of the total thymic space. The functional thymic cortex and medulla are progressively replaced by fatty tissue. These changes become almost complete some time between the ages of 40 to 50 (Flores KG, Li J, Sempowski GD, Haynes BF, Hale LP. J Clin Invest. 1999;104(8):1031).  As a result, the number of T cells exiting the thymus is significantly decreased and gets progressively lower between the age groups of 40 to 54, 55 to 69, and 70 to 90 (Naylor K, Li G, Vallejo AN, Lee WW, Koetz K, Bryl E, Witkowski J, Fulbright J, Weyand CM, Goronzy JJ. J Immunol. 2005; 174(11):7446).

T Cells Change Over Time – T cell receptors become less divers after age 65.  The production of new T cells is dramatically reduced in the very old. T cell populations are largely composed of persistent long-lived lymphocytes. Age-related defects in the signaling pathways of CD4 T cells have been identified due to changes in T cell receptors (Li G, Yu M, Lee WW, Tsang M, Krishnan E, Weyand CM, Goronzy JJ. Nat Med., 2012 Sep;18(10):1518-24. e-pub 2012 Sep 30).

T Cell Numbers Decrease – There is a decrease in the numbers of (helper) CD4 T cells, an increase in CD8 T cells, and a decrease in CD28 with aging. Reduction in CD28 results in an impaired ability of T cells to proliferate and secrete IL-2, an essential cytokine in promoting growth of T cells (Kaltoft K, Exp Clin Immunogenet., 1998;15(2):84).  Because (helper) CD4 T cells are important in stimulating B cells, the ability of T cells to help B cells grow, expand and produce antibodies diminishes with aging (Haynes L, Maue AC., Curr Opin Immunol, 2009;21(4):414. E-pub 2009 Jun 6).

Decreased Cytokine Signaling – T cells respond specifically to cytokines like IL-2, IL-6, TNF-alpha. With aging over 50 years, production and signaling of these cytokines diminishes and has been found to be directly correlated with degree of frailty in older adults (Marcos-Pérez D, et al., Front Immunol. 2018;9:1056. Epub 2018 May 16).

Humoral Immunity

B Cells – B cells produce their own surface membrane immunoglobulin and differentiate into plasma cells, which then make immunoglobulin for the blood or secretions. These immunoglobulins are the mediators of humoral immunity. B cells respond to antigen exposure (protein markers or flags on the surface of bacteria or viruses) by producing antibodies, which then bind to antigens to fight concurrent infections or prevent future infections.  B cells produce primarily the immunoglobulin IgM. Upon stimulation with and antigen, B cells switch to the production of IgG, IgA, or IgE. The ability of B cells to respond to antigens and produce antibodies is their main job.

The numbers of B cells precursor in the bone marrow (pre-B cells), as well as peripheral B cells, decrease with age.  Immunoglobulin levels (IgM), on the other hand, do not change with aging, and may actually increase (Frasca D, Landin AM, Lechner SC, Ryan JG, Schwartz R, Riley RL, Blomberg BB. J Immunol. 2008;180(8):5283). However, quantities of specific antibodies (ie, those generated by encounters with antigens through infection or vaccination) decline with age (Lazuardi L, Jenewein B, Wolf AM, Pfister G, Tzankov A, Grubeck-Loebenstein B, Immunology. 2005;114(1):37).

Antibody production from vaccination is also noted to be lower in those over age 55.  This is why booster vaccinations are required (Weinberger B, et al, Front Immunol. 2018;9:1035. Epub 2018 May 15).

Memory B & T Cells – The generation of long-lasting protective immune memory is one of the most unique and important characteristics of the adaptive immune system. Memory is essential for individual defense from infections to which you have previously been exposed. As the thymic output declines, individuals rely more on re-expansion of experienced memory cells for defense against infections.

Memory responses from immunoglobulins to previous infections appear to be relatively well-preserved as we get older, compared with new responses of B and T cells. Data suggest that memory B and T cells, once elicited by antigen during youth, are quite resilient to the impact of age (Stacy S, et al, Mech Ageing Dev, 2002;123(8):975Kovaiou RD, et al, Int Immunol, 2005;17(10):1359. Epub 2005 Sep 1).

An example of this  was seen during the 2009 H1N1 influenza pandemic, in which older adults were better protected from H1N1 infection than middle-aged adults, probably because of the persistence of memory lymphocytes producing antibodies generated in response to an H1N1 virus that circulated prior to 1957 (Hancock K, Veguilla V, Lu X, Zhong W, Butler EN, Sun H, Liu F, Dong L, DeVos JR, Gargiullo PM, Brammer TL, Cox NJ, Tumpey TM, Katz JM. N Engl J Med. 2009;361(20):1945). The antibody avidity for 2009 H1 was higher in older adults than in middle-aged adults (Monsalvo AC, Batalle JP, Lopez MF, Krause JC, et al. Nat Med. 2011;17(2):195. E-pub 2010 Dec 5).

Ketogenic Diets Improve T Cell Function

T Cells were found to function more efficiently on fatty acid oxidation, instead of glucose metabolism.  Ketogenic diets have been found to have a protective effect on preservation of T cell immune responses  (Goldberg EL, et al, Sci Immunol Nov 2019 4(41): eaav2026).  The ketogenic diet was found to expand the presence of T cells and improve the inflammatory changes common with aging and diminished immune function (Goldberg EL, Shchukina I, Asher JL, et al. Nat Metab 2020: 2, 50–61).

COVID-19 and the Immune System

Mechanism of COVID-19 infection. ( https://pediaa.com/difference-between-innate-and-adaptive-immunity/)

Information about the coronavirus has dramatically changed in the last six months since it was discovered.  Initially, it was suspected that humoral related antibodies were essential to mount an effective attack against COVID-19.  This is why the focus has been directed at screening for active infection, quarantine and measurement of antibodies.

What we now know is that most individuals with asymptomatic or mild symptoms generate a highly functional T cell response.  In fact, 50% of  those who have been exposed to coronavirus formed a T cell (cellular immunity) response without activation of B cell response (humoral immunity) and had no antibody formation  (Li X, Geng M, Peng Y, Meng L, Lu S. J Pharm Anal. Apr 2020; 10(2): 102-108).

A large Swedish study demonstrated that twice as many exposed family members and healthy individuals who donated blood during the pandemic of COVID-19 generated memory T cell responses (cellular immunity) versus those generating antibody responses (humoral immunity). This imply’s that the seroprevaleance (presence of antibodies like IgG & IgM found on B-cells) as an indicator has grossly underestimated the extent of population level immunity against SARS-CoV-2 (COVID-19). And none of these patients with this type of immune response have experience further episodes of COVID-19 to date (Sekine T, Perez-Potti A, Rivera-Ballesteros O, et al. bioRxiv (Biology) Jun 2020; e-pub:  174888).

What this all means is that 50% of people get exposed and form immunity with T cells, instead of B cells an may never even know they’ve had the virus.

Increased Susceptibility to COVID-19

As you can see above, age over 55 places one at greater risk for severe COVID-19 infection and complications.  This is due to the effect age has on the immune system.

Three additional maladies (hypertensiondiabetes, elevated cholesterol & coronary artery disease) are also significant risk factors for severe COVID-19 infections.  These are also are the four most common medical problems that I see in my clinic, and they affect 85% of the people in my practice.  All four are caused and driven by hyperinsulinemia.

Hyperinsulinemia is defined as an elevated insulin production (2-30 times normal) when ingesting any form of carbohydrate or starch.  It starts 15-20 years before the onset of diabetes and is the cause of hypoglycemia, elevated fasting blood sugar, pre-diabetes, metabolic syndrome, chronic kidney disease, idiopathic neuropathy, hypertension and coronary artery disease.

Elevated insulin, even small elevations, puts a load on the immune system.  The higher your insulin response to starches or sugars, the more likely you are to have hypertension, diabetes and heart disease.  We found that those with elevated insulin levels and those over 45 years old with stressed immune systems are the most susceptible to severe COVID-19 infection.

We know that just four or more hours of elevated blood sugar and insulin increases the cytokine IL-6 significantly.  This has a suppressive effect on T cell immunity.  The body raises insulin chronically to protect itself from the damage caused by chronic elevation in blood sugar.  Chronic elevated blood sugars can lead to severe inflammation and clotting disorders.  The body attempts to raise insulin to protect angainst these issues, however, the chronic elevation in insulin leads to chronic elevation in the cytokines IL-2, IL-6, TNF-alpha, PAI-1, NF-kB, ROS and eventually IL-33.

Innate immunity affected by elevated glucose, insulin and PKC (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3130196/#R56)

Should We Be Waiting For A Vaccine?

As a preface to this section, please be aware that I am a very strong proponent of safe and effective vaccine use.  Because the RNA vaccines are so new, long-term efficacy, safety and adverse reaction studies are essential before these vaccines can be recommended across the board.  It takes at least 4-5 years to 1) bring a vaccine to market and 2) complete adequate safety studies.

Let’s start by looking at the effectiveness of current RNA viral vaccines. The most common RNA vaccine currently in use is the influenza vaccine, quadravalent (four flu strains) and high dose (five flu strains) versions.  Over the last 20 years, the percentage of seniors getting flu shots increased sharply from 15% to 65%. It stands to reason that flu deaths among the elderly should have taken a dramatic dip due to increased flu vaccination each year.

Instead, as you can see above, influenza deaths among the elderly continued to climb. It was hard to believe, so researchers at the National Institutes of Health set out to do a study adjusting for all kinds of factors that could be masking the true benefits of the shots. But no matter how they crunched the numbers, they got the same disappointing result: flu shots had not reduced deaths among the elderly.

It’s not what health officials hoped to find.  I was shocked when I read these studies.  Two studies, here and here, demonstrate that yearly flu vaccine for those over age 65 does nothing to decrease influenza related death. These studies funded by the government in 2005 and 2006 were suppressed and I never heard about them. Yet the CDC still emphasizes to the elderly, “Get your flu shot.”

One reason these vaccines are ineffective is that viruses like influenza and corona-viruses are highly antigenic.  That means that there are hundreds of strains and the virus is changing rapidly.  Influenza has over 600 strains.  Our current high dose vaccine only covers five of these strains.

SARs-CoV-2 (COVID-19) is known to have over 160 strains. “There are too many rapid mutations to neatly trace a COVID-19 family tree.” Said Peter Forster, geneticist at the University of Cambridge.  “We used a mathematical network algorithm to visualize all the plausible trees simultaneously.” (Proceedings of the National Academy of Sciences, 2020).  Dr. Forster’s research identifies 160 genomes within the hundreds of additional variants of the three central COVID-19 strain variants.

A second reason, as stated above, is that 50% of people who are exposed to COVID-19 mount a T cell immune response without ever forming antibodies through B cell immunity.  And, the antibodies that do form only give 3-4 months of protective effect.

Another other very fascinating concern found when making RNA virus vaccines is the potential to increase susceptibility to other viruses.  In a Department of Defense study, looking at 6000 military personal vaccinated in the 2017-2018 season, those who got the influenza vaccine demonstrated an increases susceptibility to corona-viruses by 36%. Those who were vaccinated with the flu vaccine had additional increased susceptibility to non-influenza viruses by 15%, and increased susceptibility to human metapneumovirus by 59%.

second influenza study demonstrated an increased risk of para-influenza virus in adults (increased by 4.6% of vaccinated adults and only 2.6% of un-vaccinated adults.)  Though the researchers dismissed it as calculation error, the p value reflects that the vaccine played some roll (P=0.04) in the increased susceptibility.

Herd Immunity?

As with any other infection, there are two ways to achieve herd immunity: A large proportion of the population either gets infected or gets a protective vaccine. Based on early estimates of this virus’s infectiousness, we will likely need at least 70% of the population to be immune to have herd protection.

If the Penn State study is correct, the up to 50% of the U.S. population may have already been exposed as of the first week in March 2020, and by today, we may already be at Herd Immunity levels.  This may be why we are now seeing continued drop in death rates across the country, despite increase infection counts (due to increased testing frequency).

Should we push for a vaccine?  Do the math on a vaccine that covers only four out of 600+ strains like the quadravalent influenza vaccine.  For a vaccine to create “herd immunity,” currently being touted across the airwaves as the way to return to normal, it would require the average human to be vaccinated every year for 100 years, and would take 200-400 years to create any semblance of herd immunity.  And, that’s after 4-5 years studying the safety of a vaccine in large populations.

Influenza and HPV, the two most widely used RNA vaccines, still have a number of post-market adverse reactions including: Guillain-Barré syndrome (GBS), convulsions, febrile convulsions, myelitis (including encephalomyelitis and transverse myelitis), facial palsy (Bell’s palsy), optic neuritis/neuropathy, brachial neuritis, syncope (shortly after vaccination), dizziness, and paresthesia (tingling of the extremities) (Package-Insert—Gardasil.pdfPackage-Insert—Fluzone High Dose.pdf).  Though these adverse events occur more rarely, it is essential you and I understand the risks of these newer RNA vaccines.  Because it is an RNA virus, any coronavirus vaccine will come with similar risks.

What Can You & I Do?

First, our focus should be continued protection of our elderly and immune-compromised.  Our focus should be placed on improving the immune systems of those at risk through diet, hand washing & quarantine of the ill.  The evidence does not support quarantine of the healthy.  Evidence does not support general public mask wearing.  And there is no evidence that continued business closure is beneficial.

  • Reduce your risk of hyperinsulinemia.  Follow a carbohydrate restricted diet, exercise, control blood sugar, blood pressure, cholesterol and limit risk factors that suppress your immune system. Quit smoking, vaping, etc.
  • For my patients with insulin resistant/hyperinsulinemia, I recommend Berberine 500mg twice daily with meals. (Talk to your doctor before you add any supplements or medications.)
  • Use over-the-counter Zinc 10-30mg once daily – this has been shown to improve T cell control of viral replication.
  • Use over-the-counter Melatonin 5-10mg nightly – this helps in sleep recovery and strengthening the T and B cell immune response.
  • If you have been diagnosed with COVID-19, using Vitamin B3 (Niacin) has been show to be protective on the lungs.  Niacin is found in meat, fish and eggs (there’s reason for that ketogenic diet, again!)
  • Ensure your loved ones, especially the elderly and immune suppressed, understand the truth about their risk of infection.
  • Make a list of the things this pandemic has taught you. What can you do to better protect yourself in the future?
    1. We live in a society with a limited supply chain.
    2. We have become excessively dependent upon foreign business and supply
    3. We have become dependent upon “just-in-time” and over-night delivery systems
    4. We have a number of local and Federal deficiencies in our health care system
    5. How important to your health, personal liberty and constitutional rights is defense of the borders?
    6. How has freedom of speech, freedom of religion and freedom of assembly affected your family and your physical, emotional or spiritual health?

Consider the following poem in all of this:

Don’t be afraid to go outside and be a human being again.  And, pass the bacon.

Much Ado About Ketosis: Are The Adverse Effects Really That Adverse?

I recently read a blog post decrying anyone that would recommend a low carbohydrate / ketogenic diet to their patients.

What?!

In fact, this particular blog outlined a number of “adverse reactions” to a ketogenic diet, and based upon these perceived reactions, the writer advised severe caution with its use in just about anyone.   It is important to note at the outset that most of the data this blogger quotes are from older studies completed in children for the treatment of epilepsy with specific liquid ketogenic dietary meal replacements. (Not what you’d expect in a low-carb / ketogenic diet for the average obese adult today.)

Diet Confusion
Diet Confusion

Thanks to recent misinformation by a number of medical professionals, including the person writing the blog referenced above, a poor understanding of fatty acid metabolism by the general community, and a distinct lack of understanding of human adaptability recorded over the last 5,000-6,000 years, there is still significant confusion about ketogenic diets.

It is important to recognize the crucial fact that the human body is designed to function quite well when supplied any of three macronutrients: carbohydrates, proteins or fats.  It does so through an amazing series of enzymatic reactions referred to as the Krebs (tricarboxylic acid) cycle, producing needed ATP (adenosine triphosphate) required for our muscles to contract, our heart to beat and our diaphragm to expand our lungs.  What’s even more amazing that that the body was designed to recognize the season we are in based up on the food we eat. That is, until we invented refrigerators in 1913. (Now our bodies think it’s year round summer time . . . wait . . . I live in Arizona where it is year round summer time.)

No, this is not a post about unplugging your refrigerator, living on solar, getting off the grid and saving energy.

Our bodies recognize the seasons we are in based upon inherent hormone release.  The key hormone is insulin.  Insulin can be looked at as the seasonal indicator to our bodies.  Insulin production rises and falls based on our intake of carbohydrates (sugar, starches, some fibers).  Insulin, essentially, tells our bodies when it is a “time of plenty” and when it was a “time of famine.”  Why?  You ask.  We didn’t have refrigerators 100 years ago and you were lucky if you had a root cellar.  The body needs to know when to store for the famine (the winter) that was around the corner. Insulin is that signal.

During the summer, potatoes, carrots, corn and other fruits are readily available.  These are all starchy carbohydrates and they all require the body to stimulate an insulin response so that they can be absorbed.  Insulin stimulates fat storage (J Clin Invest. 2000;106(4):473-481. doi:10.1172/JCI10842).  Just like bears, our bodies were designed to store for the winter.

During the winter, when carbohydrates were less prevalent, insulin production could and would decrease to baseline levels. This also is a natural phenomenon that occurs with fasting and even during lactation.  (Kreitzman SN. Factors influencing body composition during very-low-caloric diets. Am J Clin Nutr. 1992;56(l Suppl):217S–23S.Medical aspects of ketone body metabolism. Mitchell GA, Kassovska-Bratinova S, Boukaftane Y, Robert MF, Wang SP, Ashmarina L, Lambert M, Lapierre P, Potier E, Clin Invest Med. 1995 Jun; 18(3):193-216.)

If you think back in history, your grandparents probably used stored meats & cheeses that could be salted or smoked for preserving during this time of year.  Those crossing the plains were commonly found with pemmican, a concentration of fat and protein used as a portable nutrition source in the absence of other food. (Chapter VIII. Narrative of the Life of David Crockett, of The State of Tennessee, Written by Himself, Sixth Edition [E.L. Carey and A. Hart:Philadelphia] 1834, 1837Marcy, The Prairie Traveler, p. 31.) Think about conversations you may have had with your grandmother when she told you that for Christmas, she received an orange.  A single orange for a gift?! Many of my patients drink 12-15 of them in a glass every morning.  The winter diets of our grandparents were very low in starches and carbohydrates.  When carbohydrate intake is low, little insulin is produced.

Again, insulin is the hormone that tells you that you’re in “a time of plenty” and stimulates weight gain and cholesterol production to prepare for winter.  Those prescribing the use of ketogenic diets understand this innate human adaptive trait, and use it to effect changes in weight, cholesterol and other desired metabolic changes.

Ketone_bodies
Three types of ketones. Uptodate.com, May 2015

Now, let’s define the difference between ketosis and keto-acidosis and try to clarify the misinformation that is being spread around the blogosphere.

A ketone is a molecule the body produces from the breakdown of fat and some proteins (amino acids).  There are specifically three types of ketones: beta-hydroxybutyric acid, acetoacetic acid and acetone.  If ketosis was “bad,” then why would our bodies produce these molecules?  They are not bad, and in fact, multiple studies show that the body is often more efficient and effective when it functions on ketones rather than glucose as its primary fuel source.  The body can only supply a limited amount of sugar or glucose for fuel.  If you talk to runners, marathoners or triathletes, they will tell you that after about 45-90 minutes of continuous endurance exercise the glucose supply runs out and they will experience what is termed a “bonk” (have a low-blood sugar or hypoglycemic episode).  Unfortunately, our bodies can only store about 18-24 hours of glucose.

Metobolic Changes of Ketogenic Diet (American Journal of Physiology – Endocrinology and Metabolism Published 1 June 2007 Vol. 292 no. 6, E1724-E1739 DOI: 10.1152/ajpendo.00717.2006)

However, the body can store days upon days of fat in the form of triglyceride in the fat cells.  Triglyceride is broken down into ketones.  If glucose is the “unleaded” fuel, you can think of ketones as the “diesel fuel” that is easier to store and runs longer.

The average body functioning on ketones as the primary fuel will have a ketone level measured in the blood somewhere between 0.4 and 4 mmol/L.  Because of a balance that is created by the use of ketones and a feedback mechanism that kicks in when the ketone level rises, the body will maintain a pH of around 7.4.

Ketoacidosis is dramatically different.  If you are a type I diabetic, you don’t produce any insulin.  The feedback mechanism regulating ketone use is broken and the ketone levels and triglyceride breakdown speeds up because the body can’t access glucose and can’t produce insulin.  The ketone levels spike and the level can rise to > 25 mmol/L.  In the presence of a high blood sugar and high ketone level, the acid level in the blood shifts to a pH of less than 7.3.  This is referred to as metabolic acidosis and can be life threatening as the low pH shuts down the bodies’ enzymatic processes and a person becomes critically ill and without treatment, can die. (Kitabchi AE et al., Clinical features and diagnosis of diabetic ketoacidosis and hyperosmolar hyperglycemic state in adults. www.uptodate.com, May 2015.)

If you’re not a type I diabetic, you have nothing to worry about.  Regardless of what the “ketogenic nay-sayers” blog about, your liver makes approximately 240g of glucose per day, this stimulates a basal release of insulin which keeps the pH in check. It’s also what keeps weight loss at a consistent pace of around 2-10 lbs per month.

If you are a type I diabetic, don’t fret.  Carbohydrate restriction can still be used very effectively.  It just takes some balancing and understanding of your individual metabolism.  Talk to your physician and/or medical bariatrician about how to follow a carbohydrate restricted diet while using insulin.

What about all the other “adverse effects” the blogosphere and other so-called experts claim about ketogenic diets?

Let’s take them on one by one.  Are you ready?

Gastrointestinal (GI) disturbances – Yes. Any time you change your diet you may experience diarrhea, constipation or gassiness.  Most of the time, this is because you are either 1) not eating enough leafy greens (fiber) or 2) you’re using a supplement that contains an artificial sweetener.  Most of the studies on ketogenic diets did not incorporate fiber and the studies used to make this point were on children who used a ketogenic fat supplement shake or liquid preparations containing these artificial sweeteners to make them palatable.  If you have spoken to any bariatrician, they will tell you, the best way to follow a ketogenic diet is to eat real food.  If you want to read about the anecdotal GI effects of sweeteners, read the comment section in Amazon about the Haribo Sugar Free Gummy Bears.

Oh, by the way, 65% of patients in my practice following ketogenic diet see improvement in gastroesophageal reflux (GERD) symptoms. (Austin GL, Thiny MT, Westman EC, Yancy WS Jr, Shaheen NJ. A very low carbohydrate diet improves gastroesophageal reflux and its symptoms: a pilot study. Dig Dis Sci 2006;51:1307–2.)

Hair Loss/Thinning – Really?!  It is important to note that hair loss/thinning can occur with any form of weight loss (Novak MA, Meyer JS. Alopecia: Possible Causes and Treatments, Particularly in Captive Nonhuman Primates. Comparative Medicine. 2009;59(1):18-26.)  This is especially true if you are restricting calories, which was occurring in a number of the ketogenic dietary studies previously published.  You do not and should not need to “restrict calories” if you are following a ketogenic diet correctly, and in fact, most people take in more than 1800 calories on a ketogenic diet. (Shai I, et al., N Engl J Med, 2008; 359:229-241.)

Inflammation Risk – In every patient that I have placed on a ketogenic diet in the last 8 years, all inflammatory markers including CRP, Sedimentation Rate and Uric Acid have all decreased.  Inflammation gets better on an appropriately formulated ketogenic diet. The older studies of ketogenic diets in children contain most of their fat from Omega-6 fatty acids from vegetable oil which will increase inflammation and oxidative stress, spike the cortisol levels and have the secondary effect of actually raising the triglycerides. (Simopoulos AP,The importance of the ratio of omega-6/omega-3 essential fatty acids, Biomed Pharmacother., 2002 Oct;56(8):365-79.)

Kidney Stones/Gout – These (Kidney Stones & Gout) are both commonly caused by spikes in uric acid.  As noted above, I’ve seen multiple cases in my practice where a ketogenic diet lowers uric acid. Only a small clinical trial has been published in the literature (and it wasn’t truely ketogenic), but the results point to the potential for ketogenic diets to lower uric acid. (Dessein PH, Shipton EA, Stanwix AE, et al. Beneficial effects of weight loss associated with moderate calorie/carbohydrate restriction, and increased proportional intake of protein and unsaturated fat on serum urate and lipoprotein levels in gout: a pilot study. Ann Rheum Dis 2000; 59:539-543.)  Ketogenic diets also have the capacity to lower the formation of calcium oxalate stones through a secondary mechanism I won’t go into here. Are these a risk?  Only if you cheat on your carbohydrate restriction.  So, I warn patients.  Don’t cheat.

Muscle Cramps/Weakness – The process of weight loss occurs by burning fat into CO2 and water. We breathe the CO2 out, but the water produced has to follow salts out through the kidneys.  Hence, we lose salts.  This can cause weakness and muscle cramps.  The solution?  Stop restricting salt on a low carbohydrate diet.  We are the only mammal that restricts salt and we do it because low-fat diets cause us to retain water.  Low carbohydrate diets do the opposite.  Use sea salt or sip beef or chicken bouillon broth with your dinner.  The use of yellow mustard also helps (the small amount of quinine in yellow mustard stops the cramping).  If you have congestive heart failure, talk to your doctor about monitoring your salt intake in balance with your diuretic or water pill.

Hypoglycemia – If you read the ketogenic diet research, most of it was done on epileptic children.  The diets called for a period of starvation, then the use of a ketogenic liquid based on the John’s Hopkin’s protocol.  It is a well-known fact in medicine that starvation in children can frequently cause hypoglycemia, especially in children with other genetic or congenital defects leading to forms of epilepsy.  In clinical practice, with ketogenic diet use in adults, hypoglycemia is rare.

Low Platelet Count (Thrombocytopenia) – Again, this was seen in the epileptic children who were placed into starvation first, then introduced a liquid fat replacement shake to stop intractable seizures. These liquids or shakes were often nutrient deficient in other essentials.  Folic acid, B12 and copper deficiency can occur when not eating “real food.” Low platelet counts are rarely seen on ketogenic diets based around “real food.” Many children in the ketogenic studies had been on or were concomitantly on valproic acid for their seizures.  Valproic acid is commonly known to cause thrombocytopenia (Barry-Kravis E et al, Bruising and the ketogenic diet: evidence for diet-induced changes in platelet function. Ann Neurol. 2001 Jan;49(1):98-103.;  Kraut E, Easy Bruising, http://www.uptodate.com, May 2015.)

Impaired Concentration/Mood – A number of patients starting carbohydrate restriction will go through 2-4 weeks of carbohydrate withdrawal.  This can be just as powerful as morphine withdrawal in some patients. Sugar is a drug and effects the same hedonic receptors that morphine does in the brain (Lustig, Robert H, Fructose: Metabolic, Hedonic, and Societal Parallels with Ethanon, Journal of the American Dietetic Association , Volume 110 , Issue 9 , 1307 – 1321.)  Some patients will experience headache, tremor and decreased concentration while “withdrawing” off of starches and carbohydrates. Studies actually show that after a period of adaptation, cognitive function actually improves (Krikorian R, Shidler MD, Dangelo K, Couch SC, Benoit SC, Clegg DJ. Dietary ketosis enhances memory in mild cognitive impairment. Neurobiology of aging. 2012;33(2):425.e19-425.e27. doi:10.1016/j.neurobiolaging.2010.10.006.)

Metabolic Acidosis – As described above, this can occur in a type I diabetic, and metabolic acidosis has also been shown to occur in young children placed on severe carbohydrate and protein restriction, as was the case in some of the ketogenic dietary trials with epileptic patients. (Saxena VS, Nadkarni VV. Nonpharmacological treatment of epilepsy. Annals of Indian Academy of Neurology. 2011;14(3):148-152. doi:10.4103/0972-2327.85870.FreemanThe Ketogenic Diet: One Decade Later, Pediatrics March 2007; 119:3 535543)

Osteoporosis/Osteopenia – If your ketogenic diet is “shake” or “meal replacement” based, you run the risk of mineral deficiency that could lead to Osteoporosis, however, if you are using real food, the opposite is true and most patients have improvement in their Vitamin D levels and bone density. (AG Christina BergqvistJoan I SchallVirginia A StallingsBabette S Zemel, Progressive bone mineral content loss in children with intractable epilepsy treated with the ketogenic dietAm J Clin Nutr December 2008 88: 16781684; doi:10.3945/ajcn.2008.26099)

Easy Bruising – This is usually due to inadequate protein supplementation as was the case in much of the ketogenic literature where protein levels were also restricted. (Kraut E, Easy Bruising, http://www.uptodate.com, May 2015.)

Infections/Sepsis/Pneumonia – These have not been issues in the 8 years I have been using ketogenic diets with my patients.  These issues were seen in the John’s Hopkins protocol with children who had epilepsy and other congenital disorders placed on a diet low in protein and carbohydrate. (Saxena VS, Nadkarni VV. Nonpharmacological treatment of epilepsy. Annals of Indian Academy of Neurology. 2011;14(3):148-152. doi:10.4103/0972-2327.85870.)

Pancreatitis – Patients who are insulin resistant or have impaired fasting glucose commonly have high triglycerides.  Elevation in triglycerides itself is a cause of pancreatitis.  Ketogenic diets lower the triglycerides. However, if a patient has not been following their diet as directed, spikes in the triglycerides can occur placing the person at risk for pancreatitis.

Long QT Intervals/Heart Arrhythmias – The list of things causing Long QT intervals and abnormal heart rhythms is long and variable (Acquired Long QT Syndrome. Berul C et al. www.uptodate.com, May 2015). It is well know that starvation, rapid weight loss and liquid protein diets can cause a delay in the conduction signal in the heart.  Anyone wishing to start any diet should have an electrocardiogram (EKG) through their doctor to ensure that the diet (of any type) doesn’t exacerbate a prolonged QT interval.

Low Carb 71yo male
Three year weight loss and metabolic improvement in a patient on a Low-Carb / Ketogenic diet. Note: Patient admits to not following ketogenic diet during holidays from Nov 2013 – Feb 2014 (see the dramatic changes to the body when cheating happens)

Cardiomyopathy – Prolonged QT intervals have been associated with cardiomyopathy and the former can stimulate the later.  Any diet that has the potential to prolong a QT interval has the potential to cause cardiomyopathy.  Hence the need for regular EKG monitoring on any diet (Acquired Long QT Syndrome. Berul C et al. www.uptodate.com, May 2015).

Lipid/Cholesterol Changes – In the 8 years I have been applying ketogenic diets to patients, I have seen dramatic improvement in the triglycerides and HDL levels.  The only time triglycerides rise over 100 is if the patient is using artificial sweeteners or is cheating on the carbohydrate restriction.  Total cholesterol commonly rises, however, this is indicative of the fact that there is a shift in the LDL particle size and this affects the calculation of both total cholesterol and LDL-C.  In light of this, most of my patients have dramatic improvement in triglycerides and small dense LDL particle number.  I’ve included the common cholesterol changes I seen in my office as a few case reports to demonstrate the effectiveness of a ketogenic diet:

Low Carb 56 yo female
2 year ketogenic dietary labs and weight loss

Myocardial Infarction – It is interesting that one blogger includes this on the list of adverse reactions, however, when you actually read the study, the author of the paper make an “assumption” that there was potential for heart attack due to an elevated total cholesterol, however, a correlation was never made.  Again, in the 8 years I have been using ketogenic diets, I have seen dramatic improvement in cholesterol profiles, inflammatory markers, atherosclerosis and carotid intimal studies (Shai I et al, Circulation 2010; 121:1200-1208).

Low Carb 74 year old male
Three year metabolic history of a Low-Carbohydrate / Ketogenic diet

Menstrual Irregularities / Amenorrhea – It is well known that any diet causing protein or other nutritional deficiency will affect the menstrual cycle first and growth second.  The only time menstrual irregularities occur with a ketogenic or Low-Carb diet is when a patient is not taking in enough protein or is not eating real food.  What amazes me is that a properly applied ketogenic diet causes normalization of the menstrual cycle, and in my practice, I’ve had a number of women successfully be able to conceive after making a ketogenic dietary change.

Death – All cases of death related to ketogenic diets have been documented in children while using liquid formulas for ketosis to treat epilepsy.  These cases revealed the formation of a prolonged QT interval leading to cardiomyopathy due to deficiency in selenium.  This has been solved by the addition of selenium to the ketogenic supplement. (Stewart WA et al., Acute pancreatitis causing death in a child on the ketogenic diet, J Child Neurol. 2001 Sep;16(9):682.;   Bergqvist AG et al, Selenium deficiency associated with cardiomyopathy: A complication of the ketogenic diet. Epilepsia. 2003 Apr;44(4):618-20.;  Kang HC et al., Early and lat onset complications of the ketogenic diet for intractable epilepsy, Epilepsia. 2004 Sep;45(9):1116-23.;  Kang HC et al, Efficacy and Safety of the Ketogenic diet for intractable childhood epilepsy: Korean Multicentric Experience, Epilepsia. 2005 Feb;46(2):272-9.) This does not happen when the diet is based on the use of real food instead of supplementation and has not been seen in adults.

For more details on the nutrient content of a ketogenic diet, see the recent article by a friend of mine, Maria Emmerich.  She’s been creating ketogenic diets for years and has a number of fantastic books my wife and I have been using in our home over the last nine years. She is one among many that can give you some direction on how to devise a healthy, real food based ketogenic diet.  See the page on my website here that will give you some direction in formulating your Ketogenic Lifestyle.

Mothers Day Cheese Cake
Nally Family Low-Carb / Ketogenic Cheese Cake

So, to celebrate Mother’s Day, today, with my family, I am going to indulge in some Low-Carb / Ketogenic Cheese Cake!! Happy Mother’s Day, to all of you and especially to all you mothers out there making a healthy difference in the lives of your families! (You can find the recipe for this delicious cheese cake here)

In the words of Sir William Ostler, “If it were not for the great variability among individuals, medicine might well be a science and not an art.”