Tag: Side Effects

June 26, 2022

Infertility after Pfizer Vaccination

I’ve been ridiculed, censured and I’ve been reprimanded recently that I am not strongly supporting vaccination of everyone 6 months old and older with one of the COVID-19 vaccinations. Yet today, even more proof appears in support of my concerns . . . (mind you that it shows up on a weekend when no one in the news cycles will see it).

The Pfizer vaccine decreases male sperm count over 25% for up to six months post vaccination, “but it returns to normal after six months.” That’s the findings this week from Andrology.

Hmmm . . . ? Are we actually sure about that?

Last June in JAMA, we were reassured that two doses of the vaccine are “safe and there was no problem with fertility of any kind.” Any legitimate questions about COVID-19 vaccination affecting fertility were dismissed using the perverse rhetoric of “there’s no evidence” (it’s dependent upon the advocates of a universally distributed medical product to prove it’s safe, not the other way around).

After the publication of the study and positive support from the scientific community, hospital systems, the US Military and medical societies around the country, all male fertility concerns were brushed aside. Anyone who dared question the parameters of the study or the other longer-term effects like increase in associated miscarriage’s was relegated to the status of a conspiracy theorist or quack.

Meanwhile, White House COVID-19 Response Coordinator Dr. Ashish Jha made a contrary statement, saying that vaccines for children down to 6 months or older “have been thoroughly tested. Millions of children above the age of 5 have gotten these vaccines. They’re exceedingly safe,” Jha told CBS News in a June 20 interview.

The CDC last Saturday, June 18th, 2022, signed off on giving both Moderna’s and Pfizer’s COVID-19 mRNA vaccines to infants and children between 6 months and 5 years old. It came after the Food and Drug Administration (FDA) advisory panel unanimously voted to authorize the use of the vaccines.

Jha also said while the majority of children likely have natural immunity, getting the vaccines will help keep children out of the hospital if they get it again.

The White House is echoing the FDA and CDC’s message to get young children vaccinated.

And, yet today, buried in the weekend news, a longer term study find out that these vaccines cause a 25% reduction in sperm counts in males . . .

My concern, and the concern of many others, is the small initial studies on these vaccines only looked at sperm counts before the first dose and 70 days after the second. What happens after two months remained a mystery. What about after a 3rd for 4th booster? What about sperm counts in infant males receiving the vaccination prior to puberty? What about males in puberty an their sperm counts at 1 year, 5 years and 10 years? All of these answers are still a mystery, but a mystery not worth worrying about as we were told.

“Thoroughly tested” is a blatant bold-faced lie.

If a child or an adult has an adverse reaction to the vaccine, that child’s parents or family could not sue for damages because the emergency use authorization prevents the companies from being held liable.

The vaccines are experimental by definition. A product that’s being used under emergency use [EU] authorization definitionally is investigational. The EU authorization gives these vaccine companies blanket liability protection.

Will reduction in sperm counts be longer than six months? Will reduction in sperm counts be different in those who receive the vaccine as children versus those who receive it as adults? Who knows? Only time will tell. But, the White House, FDA, CDC and most medical societies don’t seem to think that is important.

I remember taking an oath as a physician to, first, do no harm? Yet, I’m a conspiracy theorist for asking the question and not towing the line?

May 22, 2021

Urgent Open Letter from Doctors Around the World

Over the last 14 months, I’ve been face-to-face (mask-to-mask when required by the government) with over 350 positive COVID-19 patients. Thankfully, the majority of these patients only had mild to moderate symptoms of illness. Those with severe or prolonged symptoms were aggressively treated with combinations of antibiotics, steroids, ivermectin and/or hydroxychloroquine. Our office has seen the whole gambit of symptoms with this virus, but fascinatingly, control of blood sugar and insulin levels has been the key to our patient’s staying healthy and/or recovering quickly. I’m really not worried about this virus any longer. I’m worried about the intentional confusion of my patients, of the populous of the country and of the people around the world.

A patient showed up in my office this week with thrombocytopenia (low platelets) and profound fatigue 5 days after receiving COVID vaccination that he felt pressured to get in order to keep his job. He is not the first to show up with these concerns.

A second patient showed up with identical low platelets and bruising over her body after a positive COVID infection lasting three weeks. Her concern was that everyone around her, including her employer, was telling her she should now be vaccinated for COVID-19.

These are two of many people presenting to medical offices like mine, after being given “medical direction” by their employers and governments without the patient or their doctors fully understanding the potential risks of these therapeutics. And, we can’t and won’t really know what the risks are until these vaccines have been under clinical trial for at least two years.

I have some serious concerns regarding these COVID-19 vaccines. I have been openly vocal about COVID-19, masks and vaccine use and many of these concerns in various posts on Youtube, Facebook and Instagram. Because of this, I have been ridiculed by other physicians, “experts” and people who I thought were trustworthy friends in the field of science, now towing the vaccine line. But, towing the line or remaining silent would to me be death by 1000 cuts.

As I have stated before, I am NOT an anti-vaxxer. I support new medical interventions which are appropriately developed and deployed, after which safety, efficacy and informed consent can be appropriately given to the patient receiving these treatment. This support includes vaccines.

My biggest concern with the COVID-19 vaccine is that it has the largest propaganda push I’ve ever seen in the 51 years of my life, being stoked by politicians and pharmaceutical companies around the globe. This push comes AFTER the U.S. and most countries were no longer under severe threat of being medically overwhelmed, as a majority of the population of the world had been exposed and the worse of the pandemic had abated.

Second, in light of research to the contrary, this push is now being levied upon young children, teenagers and young adults, all of whom have little to no risk of severe illness if they contract COVID-19, assuming they haven’t already been exposed to this virus in the last 14 months. 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). We know that those who have had or been exposed to the virus have 2-4 years of T-cell immunity. You can learn more about effectiveness of recent vaccines, T-cell and B-cell immunity in my coronavirus posts here.

To date, other than the continuously running “ticker tape of death” on CNN and multiple other news stations around the world, no conclusive evidence was presented to any of us in the medical community that an actual emergency still existed requiring emergent authorization of three vaccines – all three vaccines have yet to complete Phase IV clinical trials.

After 14 months, COVID-19 has a 99.7% survival rate. 95% of all COVID-19 deaths have comorbid conditions associated with the severity of the infection. And, the average age of those dying with COVID-19 is 78 years old. This data all comes from the CDC. Oh, by the way in case you were wondering as you read that information, the global life expectancy for the average women is 75 years old, and for men it is 70 years old. That doesn’t leave you with any questions, does it?!

I, and many collegues in the medical community, have serious concerns that premature and reckless approval of these COVID-19 vaccines occurred AFTER the severe threat had abated. We know that the vaccines only decrease the severity of infection, they don’t actually prevent the infection in a statistically large enough group to be curative. The push and marketing of vaccination with three products that do not actually prevent COVID-19 infection, are not actually curative, and to date pose greater risks of side effects than any other vaccine on the market constitute “human experimentation” on a world stage. Additionally, pushing these products from a governmental bully pulpit is propaganda of a dispicable nature. This push has created situations between employers and employees that violate individual liberties and are violations of the Nuremberg Code.

In February, 2021, an open letter was written to the European Medicines Agency (EMA) by many concerned physicians and scientists from around the world with these an other concerns that have yet to be answered. Neither the EMA or the CDC has addressed any of these issues for the medical community. You can find the letter at Doctors For COVID Ethics.

I post a copy of that letter below:

Emer Cooke, Executive Director, European Medicines Agency, Amsterdam, The Netherlands 28 February 2021

Dear Sirs/Mesdames,

FOR THE URGENT PERSONAL ATTENTION OF: EMER COOKE, EXECUTIVE DIRECTOR OF THE EUROPEAN MEDICINES AGENCY

As physicians and scientists, we are supportive in principle of the use of new medical interventions which are appropriately developed and deployed, having obtained informed consent from the patient. This stance encompasses vaccines in the same way as therapeutics. We note that a wide range of side effects is being reported following vaccination of previously healthy younger individuals with the gene-based COVID-19 vaccines. Moreover, there have been numerous media reports from around the world of care homes being struck by COVID-19 within days of vaccination of residents. While we recognize that these occurrences might, every one of them, have been unfortunate coincidences, we are concerned that there has been and there continues to be inadequate scrutiny of the possible causes of illness or death under these circumstances, and especially so in the absence of post-mortems examinations. In particular, we question whether cardinal issues regarding the safety of the vaccines were adequately addressed prior to their approval by the European Medicines Agency (EMA). As a matter of great urgency, we herewith request that the EMA provide us with responses to the following issues:

1. 1. Following intramuscular injection, it must be expected that the gene-based vaccines will reach the bloodstream and disseminate throughout the body [1]. We request evidence that this possibility was excluded in pre-clinical animal models with all three vaccines prior to their approval for use in humans by the EMA.
  2. If such evidence is not available, it must be expected that the vaccines will remain entrapped in the circulation and be taken up by endothelial cells. There is reason to assume that this will happen particularly at sites of slow blood flow, i.e. in small vessels and capillaries [2]. We request evidence that this probability was excluded in pre-clinical animal models with all three vaccines prior to their approval for use in humans by the EMA.
  3. If such evidence is not available, it must be expected that during expression of the vaccines’ nucleic acids, peptides derived from the spike protein will be presented via the MHC I — pathway at the luminal surface of the cells. Many healthy individuals have CD8-lymphocytes that recognize such peptides, which may be due to prior COVID infection, but also to cross-reactions with other types of Coronavirus [3; 4] [5]. We must assume that these lymphocytes will mount an attack on the respective cells. We request evidence that this probability was excluded in pre-clinical animal models with all three vaccines prior to their approval for use in humans by the EMA.
  4. If such evidence is not available, it must be expected that endothelial damage with subsequent triggering of blood coagulation via platelet activation will ensue at countless sites throughout the body. We request evidence that this probability was excluded in pre-clinical animal models with all three vaccines prior to their approval for use in humans by the EMA.
  5. If such evidence is not available, it must be expected that this will lead to a drop in platelet counts, appearance of D-dimers in the blood, and to myriad ischemic lesions throughout the body including in the brain, spinal cord and heart. Bleeding disorders might occur in the wake of this novel type of DIC-syndrome including, amongst other possibilities, profuse bleedings and hemorrhagic stroke. We request evidence that all these possibilities were excluded in pre-clinical animal models with all three vaccines prior to their approval for use in humans by the EMA.
  6. The SARS-CoV-2 spike protein binds to the ACE2 receptor on platelets, which results in their activation [6]. Thrombocytopenia has been reported in severe cases of SARS-CoV-2 infection [7]. Thrombocytopenia has also been reported in vaccinated individuals [8]. We request evidence that the potential danger of platelet activation that would also lead to disseminated intravascular coagulation (DIC) was excluded with all three vaccines prior to their approval for use in humans by the EMA.
  7. The sweeping across the globe of SARS-CoV-2 created a pandemic of illness associated with many deaths. However, by the time of consideration for approval of the vaccines, the health systems of most countries were no longer under imminent threat of being overwhelmed because a growing proportion of the world had already been infected and the worst of the pandemic had already abated. Consequently, we demand conclusive evidence that an actual emergency existed at the time of the EMA granting Conditional Marketing Authorization to the manufacturers of all three vaccines, to justify their approval for use in humans by the EMA, purportedly because of such an emergency.

Should all such evidence not be available, we demand that approval for use of the gene-based vaccines be withdrawn until all the above issues have been properly addressed by the exercise of due diligence by the EMA. There are serious concerns, including but not confined to those outlined above, that the approval of the COVID-19 vaccines by the EMA was premature and reckless, and that the administration of the vaccines constituted and still does constitute “human experimentation”, which was and still is in violation of the Nuremberg Code. In view of the urgency of the situation, we request that you reply to this email within seven days and address all our concerns substantively. Should you choose not to comply with this reasonable request, we will make this letter public.

This email is copied to: Charles Michel, President of the Council of Europe Ursula von der Leyen, President of the European Commission. Doctors and scientists can sign the open letter by emailing their name, qualifications, areas of expertise, country and any affiliations they would like to cite, to Doctors4CovidEthics@protonmail.com

- - References

[1] Hassett, K. J.; Benenato, K. E.; Jacquinet, E.; Lee, A.; Woods, A.; Yuzhakov, O.; Himansu, S.; Deterling, J.; Geilich, B. M.; Ketova, T.; Mihai, C.; Lynn, A.; McFadyen, I.; Moore, M. J.; Senn, J. J.; Stanton, M. G.; Almarsson, Ö.; Ciaramella, G. and Brito, L. A.(2019).Optimization of Lipid Nanoparticles for Intramuscular Administration of mRNA Vaccines, Molecular therapy. Nucleic acids 15 : 1–11. [2] Chen, Y. Y.; Syed, A. M.; MacMillan, P.; Rocheleau, J. V. and Chan, W. C. W.(2020). Flow Rate Affects Nanoparticle Uptake into Endothelial Cells, Advanced materials 32 : 1906274. [3] Grifoni, A.; Weiskopf, D.; Ramirez, S. I.; Mateus, J.; Dan, J. M.; Moderbacher, C. R.; Rawlings, S. A.; Sutherland, A.; Premkumar, L.; Jadi, R. S. and et al.(2020). Targets of T Cell Responses to SARS-CoV-2 Coronavirus in Humans with COVID-19 Disease and Unexposed Individuals, Cell 181 : 1489–1501.e15. [4] Nelde, A.; Bilich, T.; Heitmann, J. S.; Maringer, Y.; Salih, H. R.; Roerden, M.; Lübke, M.; Bauer, J.; Rieth, J.; Wacker, M.; Peter, A.; Hörber, S.; Traenkle, B.; Kaiser, P. D.; Rothbauer, U.; Becker, M.; Junker, D.; Krause, G.; Strengert, M.; Schneiderhan-Marra, N.; Templin, M. F.; Joos, T. O.; Kowalewski, D. J.; Stos-Zweifel, V.; Fehr, M.; Rabsteyn, A.; Mirakaj, V.; Karbach, J.; Jäger, E.; Graf, M.; Gruber, L.-C.; Rachfalski, D.; Preuß, B.; Hagelstein, I.; Märklin, M.; Bakchoul, T.; Gouttefangeas, C.; Kohlbacher, O.; Klein, R.; Stevanović, S.; Rammensee, H.-G. and Walz, J. S.(2020). SARS-CoV-2-derived peptides define heterologous and COVID-19-induced T cell recognition, Nature immunology. [5] Sekine, T.; Perez-Potti, A.; Rivera-Ballesteros, O.; Strålin, K.; Gorin, J.-B.; Olsson, A.; Llewellyn-Lacey, S.; Kamal, H.; Bogdanovic, G.; Muschiol, S. and et al.(2020). Robust T Cell Immunity in Convalescent Individuals with Asymptomatic or Mild COVID-19, Cell 183 : 158–168.e14. [6] Zhang, S.; Liu, Y.; Wang, X.; Yang, L.; Li, H.; Wang, Y.; Liu, M.; Zhao, X.; Xie, Y.; Yang, Y.; Zhang, S.; Fan, Z.; Dong, J.; Yuan, Z.; Ding, Z.; Zhang, Y. and Hu, L.(2020). SARS-CoV-2 binds platelet ACE2 to enhance thrombosis in COVID-19, Journal of hematology & oncology 13 : 120. [7] Lippi, G.; Plebani, M. and Henry, B. M.(2020).Thrombocytopenia is associated with severe coronavirus disease 2019 (COVID-19) infections: A meta-analysis, Clin. Chim. Acta 506 : 145–148. [8] Grady, D. (2021). A Few Covid Vaccine Recipients Developed a Rare Blood Disorder, The New York Times, Feb. 8, 2021. Yours faithfully, Professsor Sucharit Bhakdi MD, Professor Emeritus of Medical Microbiology and Immunology, Former Chair, Institute of Medical Microbiology and Hygiene, Johannes Gutenberg University of Mainz (Medical Doctor and Scientist) (Germany and Thailand) Dr Marco Chiesa MD FRCPsych, Consultant Psychiatrist and Visiting Professor, University College London (Medical Doctor) (United Kingdom and Italy) Dr C Stephen Frost BSc MBChB Specialist in Diagnostic Radiology, Stockholm, Sweden (Medical Doctor) (United Kingdom and Sweden) Dr Margareta Griesz-Brisson MD PhD, Consultant Neurologist and Neurophysiologist (studied Medicine in Freiburg, Germany, speciality training for Neurology at New York University, Fellowship in Neurophysiology at Mount Sinai Medical Centre, New York City; PhD in Pharmacology with special interest in chronic low level neurotoxicology and effects of environmental factors on brain health), Medical Director, The London Neurology and Pain Clinic (Medical Doctor and Scientist) (Germany and United Kingdom) Professor Martin Haditsch MD PhD, Specialist (Austria) in Hygiene and Microbiology, Specialist (Germany) in Microbiology, Virology, Epidemiology/Infectious Diseases, Specialist (Austria) in Infectious Diseases and Tropical Medicine, Medical Director, TravelMedCenter, Leonding, Austria, Medical Director, Labor Hannover MVZ GmbH (Medical Doctor and Scientist) (Austria and Germany) Professor Stefan Hockertz, Professor of Toxicology and Pharmacologym, European registered Toxicologist, Specialist in Immunology and Immunotoxicology, CEO tpi consult GmbH. (Scientist) (Germany) Dr Lissa Johnson, BSc, BA(Media) MPsych(Clin) PhD, Clinical Psychologist and Behavioural Scientist, Expertise in the social psychology of atrocity, torture, collective violence and propaganda, former member, professional body Public Interest Advisory Group (Psychologist) (Australia) Professor Ulrike Kämmerer PhD, Associate Professor of Experimental Reproductive Immunology and Tumor Biology at the Department of Obstetrics and Gynaecology, University Hospital of Würzburg, Germany, Trained molecular virologist (Diploma, PhD-Thesis) and Immunologist (Habilitation), Remains engaged in active laboratory research (Molecular Biology, Cell Biology (Scientist) (Germany) Associate Professor Michael Palmer MD, Department of Chemistry (studied Medicine and Medical Microbiology in Germany, has taught Biochemistry since 2001 in present university in Canada; focus on Pharmacology, metabolism, biological membranes, computer programming; experimental research focus on bacterial toxins and antibiotics (Daptomycin); has written a textbook on Biochemical Pharmacology, University of Waterloo, Ontario, Canada (Medical Doctor and Scientist) (Canada and Germany) Professor Karina Reiss PhD, Professor of Biochemistry, Christian Albrecht University of Kiel, Expertise in Cell Biology, Biochemistry (Scientist) (Germany) Professor Andreas Sönnichsen MD, Professor of General Practice and Family Medicine, Department of General Practice and Family Medicine, Center of Public Health, Medical University of Vienna, Vienna (Medical Doctor) (Austria) Dr Wolfgang Wodarg, Specialist in Pulmonary and Bronchial Internal Medicine, Hygiene and Environmental Medicine, Epidemiology, and Public Health; Honorary Member of the Parliamentary Assembly of the Council of Europe and former Head of the Health Committee of the Parliamentary Assembly of the Council of Europe; former Member of Parliament, German Bundestag; Initiator and Spokesman for the study commission ‘Ethics and Law in Modern Medicine’; Author and University Lecturer (Medical Doctor) (Germany) Dr Michael Yeadon BSc (Joint Honours in Biochemistry and Toxicology) PhD (Pharmacology), Formerly Vice President & Chief Scientific Officer Allergy & Respiratory, Pfizer Global R&D; Co-founder & CEO, Ziarco Pharma Ltd.; Independent Consultant (Scientist) (United Kingdom)

May 13, 2021

Vaccine Propaganda

Let’s call it what it is – propaganda. Over the last few months, as I drive down the freeway, I continue to see Arizona Department of Transportation signs and other media advertising the number of people vaccinated, and how we are supposedly “saving our country by getting a shot.” This morning at 7 am the message board on the 303 freeway loop stated:

“5.4 MILLION DOSES AND COUNTING. GET VACCINATED”

Now colleges & universities are considering mandating vaccination before allowing students to return to class. Travel companies and international airlines have actually already mandated vaccination. I am actually horrified that our state officials pay for and support this type of propaganda. The scientific evidence to support this type of health propaganda does not exist. I’ve scoured the medical literature for it and it just doesn’t exist.

In fact, my patients are showing up in my office after being told by their cardiologists and gastroenterologists that they need their COVID vaccine. I can guarantee that many of these specialists have never read the vaccine literature and have no idea of the side effect profile and/or risks of this or any other vaccine.

Let me start by stating up front that I am a strong proponent of vaccines. We have many tried and true, fully vetted vaccines to prevent many diseases. The science states that if you’ve already had the virus, you have two to four years of immunity. We know the vaccine doesn’t prevent the virus, it just decreases likelihood of severity for 4-6 months. In fact, I’ve already had four patients in my office get a full blown COVID-19 infection post vaccination. However, this and seven other essential points are being blatantly ignored by governments, churches, college campuses and other organizations encouraging, propagandizing and even “requiring” vaccination.

Young adults are a healthy and immunologically competent and vibrant group that is at “extraordinary low risk for COVID-19 morbidity and mortality.”
Even though the FDA granted Emergency Use Authorization (EUA) for three COVID-19 vaccines, they are not FDA approved to treat, cure or prevent any disease at this time.
The COVID-19 vaccines on the market in the U.S., produced by Moderna, Pfizer, and Johnson & Johnson, have been associated with serious side effects. These adverse reactions result in absence from school and work, hospital visits, and even loss of life. More than 2,300 deaths have been reported to the Vaccine Adverse Event Reporting System (VAERS) as of April 20, 2021.
Students who have recovered from COVID-19 already likely have protective immunity, and vaccination of these groups significantly increases risk of autoimmune reactions.
Protections expressed by the Nuremberg Code require individuals “to be able to exercise free power of choice, without the intervention of any element of force.”
Informed consent is the standard for all medical interventions. The FDA fact sheet for the healthcare provider reads: “The recipient or their caregiver has the option to accept or refuse [the] vaccine.”
College-age women may be at unique risk for adverse events following administration of the experimental COVID vaccinations currently available. According to the CDC, all cases of life-threatening blood clots subsequent to receiving the J&J vaccine have so far occurred in younger women. In addition, “women are reporting having irregular menstrual cycles after getting the coronavirus vaccine,” and 95 miscarriages have been reported to VAERS following COVID vaccination as of April 24, 2021.

This is the position of the Association of American Physicians and Surgeons and it is my position. This push for vaccination when these questions still remain may appear prudent in an emergency situation to those who have been selected and elected to lead us, however, after five months of availability to evaluate this approach it is actually coercive and blatantly ignores the science that supports these points. This course of action is, in my opinion, an egregious lack of insight, or if done knowingly is actually malevolent.

As a family physician, whose job revolves around vaccination of children and adults, and one who is given the mission of providing appropriate preventative medical care to his community, I cannot in good conscience support the propaganda behind this vaccine.

May 10, 2015

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

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, 1837; Marcy, 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.

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 CO₂out, 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.; Freeman, et al., The Ketogenic Diet: One Decade Later, Pediatrics March 2007; 119:3 535–543)

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 Bergqvist, Joan I Schall, Virginia A Stallings, Babette S Zemel, Progressive bone mineral content loss in children with intractable epilepsy treated with the ketogenic dietAm J Clin Nutr December 2008 88: 1678–1684; 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.

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:

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).

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.

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.”