Jeffrey Dach's Blog, page 13
September 6, 2020
Vitamin D for Corona Virus Instead of a Vaccine ?
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Vitamin D for Corona Virus Instead of a Vaccine ?
by Jeffrey Dach MD
Jim and his wife Cynthia are old friends and long time patients in my office. Last week, Jim called the office to report Cynthia was not feeling well, and where should she go for a Corona Virus test? I explained to Jim the testing is unreliable, and we no longer use the testing for Corona Virus. There is nothing in medicine worse than an unreliable test.
Boosting the Immune System with vitamin D3
Instead, our approach is to boost the immune system with Vitamin D and a few other things such as Zinc, (which Cynthia was already taking). Cynthia had no fever, and only mild symptoms which could be related to almost anything. Rather than immediately go for the big guns, the Z-pack and Hydroxychloroquine, I suggested boosting her immune system with additional Vitamin D, C, and A. We also started her on Chinese Skullcap (Baicalin) , an excellent anti-viral botanical. Since it was after hours, I invited Jim to stop over at the house to pick up everything. After all, Jim and Cynthia were old friends, so I was happy to share from my personal supply. On the way out the door, Jim said “thanks for the vitamins, but do you have any experience treating COVID-19 ?” This is the typical type of question I usually get, so I am prepared for it.
Testing for Vitamin D and Vitamin C
I then explained to Jim that we come into contact with hundreds of viruses on a regular basis. They are floating around in the air. We do not get sick because our immune systems defend us from viral disease.
So, our approach to Corona Virus is the same as all the other viruses, we boost our immune systems with supplements. Vitamin D3 is probably the most important one. In my office, we routinely test for Vitamin D levels on every patient, and give vitamin D supplements for everyone found vitamin D deficient. Similarly, we also test for and supplement with Vitamin C (ascorbate). Perhaps this is the explanation for why our office practice has had no patient require hospitalization for upper respiratory viral disease over the last 8 months of the “pandemic”. NO ONE !!! The following day, Jim calls in the report Cynthia is feeling much better.
Anti-viral benefits of Vitamin D3 has been extensively studied over the years. (1-24) In my opinion, the main benefit is on the immune system as an immuno-modulator which prevents the dreaded “cytokine storm” responsible for admission to the intensive care unit. In one randomized study by Dr. Castillo on corona virus patients hospitalized in Spain, the administration of vitamin D3 reduced admission to the intensive care unit from 50% to 2% !!! There were no deaths in the Vitamin D treated patients !!! Dr Castillo writes:
“Based on a pilot study, oral calcifediol (Vitamin D3) may be the most promising approach.” (16-17)
Supplementing Vitamin D3 Levels in Nursing Homes
A number of studies have shown that the thousands of elderly nursing home deaths from corona virus were in patients with vitamin D deficiency. Simply by testing for and supplementing with vitamin D3 in this population would have been preventive.(2)(30-35)
Unreliability of Coronavirus PCR Testing
Jim had another question that was coming up frequently. His cousin Betty who was 40 years old just arrived from New York and was staying with them for few weeks. Betty had recovered from a corona virus infection back in March along with everyone else in New York and tested positive back in March. Betty recovered uneventfully with only mild upper respiratory symptoms, and has been feeling fine since then. However, just to be on the safe side, Betty repeated the Corona Virus PCR test last week, and it was still positive !! Jim wanted to know what to do with Betty’s positive test. I explained to Jim that this was a “false positive test”, meaning the test is detecting dead viral genetic material with no infectious capability. Recent study by Dr. Lu shows that up to 14% of Corona Virus patients continue to test positive after recovering from the viral illness, and are no longer infectious. This is one of the reasons the testing is unreliable. Dr Lu writes:
“Re-positive SARS-CoV-2 cases do not appear to be caused by active reinfection and were identified in ~14% of discharged cases.”(27)
Masks and Social Distancing for the Kids ??
The next question Jim asked was what about masks for the kids? Why do they need to wear masks at school ?? According to the Toronto Hospital for Sick Children Expert Report, kids should be allowed to attend school as normally as possible without masks or social distancing. Kids are at very low risk for corona virus says Dr Scott Atlas who is on the White House Corona Virus Advisory Panel. Dr Atlas agrees with the Toronto Hospital Report, and advises that kids do not need to wear masks or social distance at school. Children are not at risk, and have asymptomatic or only mildly symptomatic bouts with corona virus.
If We Have Vitamin D, Hydroxychloroquine and Zinc, Why Do We Need A Vaccine ?
The next question Jim asked me is, “if we can boost the immune system with Vitamin D, and take anti-virals such as Zinc, Hydroxychloroquine, Z-Pack (azithromycin) and Chines Skullcap (Baical), transforming corona virus into a mild illness (like in children) , then why do we need a vaccine?” Why do we need a rushed vaccine with no testing for efficacy, and only limited safety testing, with vaccine manufacturers who deny any responsible if you are injured by their vaccine product? Unlike all other manufacturers in the U.S., you can not sue the vaccine maker if you are left paralyzed or dead after vaccine injection. This is because of the 1986 Vaccine Act of Congress which made vaccine makers exempt from product liability. When people ask me if I will take the corona virus vaccine, my response is to say: “You First” !! (36)
Conclusion: Effective viral prevention and treatment involves boosting the immune system with Vitamin D3. Instead of spending billions of dollars on research and development for a corona virus vaccine, we could be using Vitamin D3 testing and supplementation for the population instead. Hastily rolling out an untested, questionable vaccine product is a recipe for disaster, especially when we already have excellent immune boosting anti-viral strategies. The last time the government did this during the 1976 Swine Flu epidemic was a complete disaster, causing hundreds of cases of Guillan Barre syndrome (paralysis) and terminated the vaccine program.(29)
Articles With related Interest
Hydroxychloroquine Efficacy Against Corona Virus
Effective Early Treatment for Corona Virus
Stop Vitamin D, Are You Joking ?
Jeffrey Dach MD
7450 Griffin Road Suite 180/190
Davie, Florida 33314
954-792-4663
Link and References
Header Image courtesy of Wikimedia Commons
1) https://www.ncbi.nlm.nih.gov/pmc/arti...
Grant, William B., et al. “Evidence that vitamin D supplementation could reduce risk of influenza and COVID-19 infections and deaths.” Nutrients 12.4 (2020): 988.
The world is in the grip of the COVID-19 pandemic. Public health measures that can reduce the risk of infection and death in addition to quarantines are desperately needed. This article reviews the roles of vitamin D in reducing the risk of respiratory tract infections, knowledge about the epidemiology of influenza and COVID-19, and how vitamin D supplementation might be a useful measure to reduce risk. Through several mechanisms, vitamin D can reduce risk of infections. Those mechanisms include inducing cathelicidins and defensins that can lower viral replication rates and reducing concentrations of pro-inflammatory cytokines that produce the inflammation that injures the lining of the lungs, leading to pneumonia, as well as increasing concentrations of anti-inflammatory cytokines. Several observational studies and clinical trials reported that vitamin D supplementation reduced the risk of influenza, whereas others did not. Evidence supporting the role of vitamin D in reducing risk of COVID-19 includes that the outbreak occurred in winter, a time when 25-hydroxyvitamin D (25(OH)D) concentrations are lowest; that the number of cases in the Southern Hemisphere near the end of summer are low; that vitamin D deficiency has been found to contribute to acute respiratory distress syndrome; and that case-fatality rates increase with age and with chronic disease comorbidity, both of which are associated with lower 25(OH)D concentration. To reduce the risk of infection, it is recommended that people at risk of influenza and/or COVID-19 consider taking 10,000 IU/d of vitamin D3 for a few weeks to rapidly raise 25(OH)D concentrations, followed by 5000 IU/d. The goal should be to raise 25(OH)D concentrations above 40–60 ng/mL (100–150 nmol/L). For treatment of people who become infected with COVID-19, higher vitamin D3 doses might be useful. Randomized controlled trials and large population studies should be conducted to evaluate these recommendations.
2) McCartney, Daniel M., and D. G. Byrne. “Optimisation of vitamin D status for enhanced Immuno-protection against Covid-19.” Ir Med J 113.4 (2020): 58.
Vitamin D deficiency (serum 25(OH)D
Vitamin D and Covid-19
Correction of vitamin D deficiency is thought to suppress CD26, a putative adhesion molecule for Covid-19 host cell invasion. Vitamin D may also attenuate interferon gamma (IFNγ) and interleukin-6 (IL-6) inflammatory responses, both potent predictors of poorer outcome in critically-ill ventilated patients including those with Covid-19.
Vitamin D Requirements
Irish adults require 25-30μg/d of vitamin D3, an intake not achievable by diet alone, to reliably maintain serum 25(OH)D levels >50nmol/l. Supplementation with doses up to 100μg/d has been shown to be safe for adults, and many agencies and expert groups now advocate supplementation in older adults, albeit at lower levels than this.
Conclusions and Recommendations
Vitamin D deficiency is common and may contribute to increased risk of respiratory infection including Covid-19. We recommend that all older adults, hospital inpatients, nursing home residents and other vulnerable groups (e.g. those with diabetes mellitus or compromised immune function, those with darker skin, vegetarians and vegans, those who are overweight or obese, smokers and healthcare workers) be urgently supplemented with 20-50μg/d of vitamin D to enhance their resistance to Covid-19, and that this advice be quickly extended to the general adult population.
3) https://www.ncbi.nlm.nih.gov/pmc/arti...
Rhodes, Jonathan M., et al. “low population mortality from COVID‐19 in countries south of latitude 35 degrees North supports vitamin D as a factor determining severity.” Alimentary pharmacology & therapeutics 51.12 (2020): 1434-1437.
There are considerable experimental data showing that vitamin D is important in regulating and suppressing the inflammatory cytokine response of respiratory epithelial cells and macrophages to various pathogens including respiratory viruses. 9 Evidence that vitamin D might protect against infection is modest but it is important to note that the hypothesis is not that vitamin D would protect against SARS‐CoV‐2 infection but that it could be very important in preventing the cytokine storm and subsequent acute respiratory distress syndrome that is commonly the cause of mortality. 10
4) https://www.ncbi.nlm.nih.gov/pmc/arti...
Ebadi, Maryam, and Aldo J. Montano-Loza. “Perspective: improving vitamin D status in the management of COVID-19.” European Journal of Clinical Nutrition (2020): 1-4.
Vitamin D is a secosteroid that has a wide spectrum of immunomodulatory, anti-inflammatory antifibrotic, and antioxidant actions. Expression of inflammatory cytokine [e.g., IL-1α, IL-1β, tumor necrosis factor-α] was inhibited by vitamin D and its insufficiency was associated with overexpression of Th1 cytokines [4]. We have recently found that severe vitamin D deficiency (
5) Laird, E., J. Rhodes, and Rose Anne Kenny. “Vitamin D and inflammation: potential implications for severity of COVID-19.” Ir Med J 113.5 (2020): 81.
Background
Recent research has indicated that vitamin D may have immune supporting properties through modulation of both the adaptive and innate immune system through cytokines and regulation of cell signalling pathways.
We hypothesize that vitamin D status may influence the severity of responses to Covid-19 and that the prevalence of vitamin D deficiency in Europe will be closely aligned to Covid-19 mortality.
Methods We conducted a literature search on PubMed (no language restriction) of vitamin D status (for older adults) in countries/areas of Europe affected by Covid-19 infection. Countries were selected by severity of infection (high and low) and were limited to national surveys or where not available, to geographic areas within the country affected by infection. Covid-19 infection and mortality data was gathered from the World Health Organisation.
Results
Counter-intuitively, lower latitude and typically ‘sunny’ countries such as Spain and Italy (particularly Northern Italy), had low mean concentrations of 25(OH)D and high rates of vitamin D deficiency. These countries have also been experiencing the highest infection and death rates in Europe. The northern latitude countries (Norway, Finland, Sweden) which receive less UVB sunlight than Southern Europe, actually had much higher mean 25(OH)D concentrations, low levels of deficiency and for Norway and Finland, lower infection and death rates. The correlation between 25(OH)D concentration and mortality rate reached conventional significance (P=0.046) by Spearman’s Rank Correlation.
Conclusions Optimising vitamin D status to recommendations by national and international public health agencies will certainly have benefits for bone health and potential benefits for Covid-19. There is a strong plausible biological hypothesis and evolving epidemiological data supporting a role for vitamin D in Covid-19.
6) Alipio, Mark. “Vitamin D Supplementation Could Possibly Improve Clinical Outcomes of Patients Infected with Coronavirus-2019 (COVID-19).” Available at SSRN 3571484 (2020).
In this paper, a multinomial logistic regression was used to predict clinical outcomes of patients infected with COVID-2019 based on 25-hydroxyvitamin D [25(OH)D] levels, the barometer for Vitamin D status. A retrospective multicentre study of 212 cases with laboratory-confirmed infection of SARS-CoV-2 was conducted. Data pertaining to clinical features and serum 25(OH)D levels were extracted from the medical records. For statistical analysis, Mann-Whitney U and χ² testswere usedto compare differences in the clinical outcomes. Multinomial logistic regression was used to explore the association between serum 25(OH)D level and clinical outcomes of the cases. Frequency and percentage were used for categorical variables. Mean was used for continuous variables. A p-value below 0.01 was considered statistically significant. Of the 212 cases of COVID-2019, majority had ordinary clinical outcome. Mean serum 25(OH)D level was 23.8 ng/ml. Serum 25(OH)D level was lowest in critical cases, but highest in mild cases. Serum 25(OH)D levels were statistically significant among clinical outcomes. Majority had insufficient Vitamin D status, most of them were not severe. Vitamin D status is significantly associated with clinical outcomes. A multinomial logistic regression analysis reported that for each standard deviation increase in serum 25(OH)D, the odds of having a mild clinical outcome rather than a severe outcome wereincreasedapproximately 7.94 times (OR=0.126, p
7) Rhodes, Jonathan M., et al. “Perspective: Vitamin D deficiency and COVID‐19 severity–plausibly linked by latitude, ethnicity, impacts on cytokines, ACE2, and thrombosis (R1).” Journal of internal medicine (2020).
Background: SARS-CoV-2 coronavirus infection ranges from asymptomatic through to fatal COVID-19 characterized by a ‘cytokine storm’ and lung failure. Vitamin D deficiency has been postulated as a determinant of severity.
Objectives: To review the evidence relevant to vitamin D and COVID-19.
Methods: Narrative review.
Results: Regression modelling shows that more northerly countries in the Northern Hemisphere are currently (May 2020) showing relatively high COVID-19 mortality, with an estimated 4.4% increase in mortality for each 1 degree latitude north of 28 degrees North (P = 0.031) after adjustment for age of population. This supports a role for ultraviolet B acting via vitamin D synthesis. Factors associated with worse COVID-19 prognosis include old age, ethnicity, male sex, obesity, diabetes and hypertension and these also associate with deficiency of vitamin D or its response. Vitamin D deficiency is also linked to severity of childhood respiratory illness. Experimentally, vitamin D increases the ratio of angiotensin-converting enzyme 2 (ACE2) to ACE, thus increasing angiotensin II hydrolysis and reducing subsequent inflammatory cytokine response to pathogens and lung injury.
Conclusions: Substantial evidence supports a link between vitamin D deficiency and COVID-19 severity but it is all indirect. Community-based placebo-controlled trials of vitamin D supplementation may be difficult. Further evidence could come from study of COVID-19 outcomes in large cohorts with information on prescribing data for vitamin D supplementation or assay of serum unbound 25(OH) vitamin D levels. Meanwhile, vitamin D supplementation should be strongly advised for people likely to be deficient.
8) Liu, Guoqiang, Tianpei Hong, and Jin Yang. “A Single Large Dose of Vitamin D Could be Used as a Means of Coronavirus Disease 2019 Prevention and Treatment.” Drug Design, Development and Therapy 14 (2020): 3429-3434.
Abstract: we hypothesize that a single large dose of vitamin D (Vit D) could be an option for trial in COVID-19. Vit D deficiency or insufficiency is very common in the general population as well as in patients with COVID-19. It has been shown that low Vit D level is associated with viral infection, and Vit D supplementation is beneficial for people infected with viruses, such as HIV and hepatitis C virus. Although COVID-19 is a respiratory disease, the morbidity and mortality of this disease are driven by coagulopathy. Clinical studies have shown that Vit D can exert anticoagulant effects. Vit D, a lipid-soluble vitamin, can be administered as a draught. Vit D supplementation is safe and has rare toxic events. In addition, the cost of Vit D is fairly low. Based on these observations, we speculate that a single dose of 300,000 IU Vit D may have a role in the prevention and treatment of COVID-19.
9) https://www.ncbi.nlm.nih.gov/pmc/arti...
Martineau, Adrian R., and Nita G. Forouhi. “Vitamin D for COVID-19: a case to answer?.” The Lancet. Diabetes & Endocrinology (2020).
Interest in a potential role for vitamin D in the prevention or treatment of acute respiratory infections dates back to the 1930s, when cod liver oil was investigated as a means to reduce industrial absenteeism due to the common cold. Meta-analyses of randomised controlled trials conducted from 2007–20 reveal protective effects of vitamin D against acute respiratory infections, albeit these effects were of modest size and with substantial heterogeneity.1 The striking overlap between risk factors for severe COVID-19 and vitamin D deficiency, including obesity, older age, and Black or Asian ethnic origin, has led some researchers to hypothesise that vitamin D supplementation could hold promise as a preventive or therapeutic agent for COVID-19.
10) https://www.maturitas.org/article/S03...
Shakoor, Hira, et al. “Immune-boosting role of vitamins D, C, E, zinc, selenium and omega-3 fatty acids: could they help against COVID-19?.” Maturitas (2020).
COVID-19 affects the immune system by producing a systemic inflammatory response, or cytokine release syndrome. Patients with COVID-19 have shown a high level of pro-inflammatory cytokines and chemokines. There are currently no effective anti-SARS-CoV-2 viral drugs or vaccines. COVID-19 disproportionately affects the elderly, both directly, and through a number of significant age-related comorbidities. Undoubtedly, nutrition is a key determinant of maintaining good health. Key dietary components such as vitamins C, D, E, zinc, selenium and the omega 3 fatty acids have well-established immunomodulatory effects, with benefits in infectious disease. Some of these nutrients have also been shown to have a potential role in the management of COVID-19. In this paper, evidence surrounding the role of these dietary components in immunity as well as their specific effect in COVID-19 patients are discussed. In addition, how supplementation of these nutrients may be used as therapeutic modalities potentially to decrease the morbidity and mortality rates of patients with COVID-19 is discussed.
A number of nutrients have been associated with improved outcomes for patients with COVID-19.
Vitamin D is associated with both decreased rates of infection and improved outcomes for patients.
Vitamin C may shorten the course of the disease and decrease the severity of the symptoms.
Vitamin E, zinc and selenium are known to assist with recovery from viral infection, and may have efficacy in COVID-19.
11) https://link.springer.com/article/10....
Ilie, Petre Cristian, Simina Stefanescu, and Lee Smith. “The role of vitamin D in the prevention of coronavirus disease 2019 infection and mortality.” Aging Clinical and Experimental Research (2020): 1-4.
WHO declared SARS-CoV-2 a global pandemic.
The present aim was to propose an hypothesis that there is a potential association between mean levels of vitamin D in various countries with cases and mortality caused by COVID-19. The mean levels of vitamin D for 20 European countries and morbidity and mortality caused by COVID-19 were acquired. Negative correlations between mean levels of vitamin D (average 56 mmol/L, STDEV 10.61) in each country and the number of COVID-19 cases/1 M (mean 295.95, STDEV 298.7, and mortality/1 M (mean 5.96, STDEV 15.13) were observed. ”
Vitamin D levels are severely low in the aging population especially in Spain, Italy and Switzerland. This is also the most vulnerable group of the population in relation to COVID-19.
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12) https://www.ncbi.nlm.nih.gov/pmc/arti...
Silberstein, Morry. “Vitamin D: A simpler alternative to tocilizumab for trial in COVID-19?.” Medical Hypotheses (2020): 109767.
There is anecdotal evidence that tocilizumab, an immunosuppressant drug, may be a potential therapeutic option for patients with severe manifestations of coronavirus disease 2019 (COVID-19). Like tocilizumab, Vitamin D appears to modulate the activity of an interleukin (IL-6), which may explain the seasonal variation in prevalence of influenza. While most cases of COVID-19 have, thus far, occurred in the Northern Hemisphere winter, limiting the ability to assess seasonal variation, there remains substantial variation in the severity of this condition that has yet to be explained. A retrospective comparison of Vitamin D levels in previously obtained blood samples between survivors and confirmed fatalities could establish a rationale for implementation of widespread Vitamin D supplementation. This would be far cheaper and simpler than tocilizumab as a therapeutic option to trial.
13) https://www.medrxiv.org/content/10.11...
Panagiotou, Grigorios, et al. “Low serum 25-hydroxyvitamin D (25 [OH] D) levels in patients hospitalised with COVID-19 are associated with greater disease severity: results of a local audit of practice.” medRxiv (2020).
Subject to the inherent limitations of observational (non-trial) audit data, analysed retrospectively, we found that patients requiring ITU admission were more frequently vitamin D deficient than those managed on medical wards, despite being significantly younger.
14) Daneshkhah, Ali, et al. “The possible role of Vitamin D in suppressing cytokine storm and associated mortality in COVID-19 patients.” MedRxiv (2020).
15) Trovas, George, and Symeon Tournis. “Vitamin d and covid-19.” Hormones (2020): 1-2.
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16) Castillo, Marta Entrenas, et al. “Effect of Calcifediol Treatment and best Available Therapy versus best Available Therapy on Intensive Care Unit Admission and Mortality Among Patients Hospitalized for COVID-19: A Pilot Randomized Clinical study.” The Journal of Steroid Biochemistry and Molecular Biology (2020): 105751.
The vitamin D endocrine system may have a variety of actions on cells and tissues involved in COVID-19 progression especially by decreasing the Acute Respiratory Distress Syndrome. Calcifediol can rapidly increase serum 25OHD concentration. We therefore evaluated the effect of calcifediol treatment, on Intensive Care Unit Admission and Mortality rate among Spanish patients hospitalized for COVID-19.
Design
parallel pilot randomized open label, double-masked clinical trial.
Setting university hospital setting (Reina Sofia University Hospital, Córdoba Spain.)
Participants 76 consecutive patients hospitalized with COVID-19 infection, clinical picture of acute respiratory infection, confirmed by a radiographic pattern of viral pneumonia and by a positive SARS-CoV-2 PCR with CURB65 severity scale (recommending hospital admission in case of total score > 1).
Procedures: All hospitalized patients received as best available therapy the same standard care, (per hospital protocol), of a combination of hydroxychloroquine (400 mg every 12 hours on the first day, and 200 mg every 12 hours for the following 5 days), azithromycin (500 mg orally for 5 days. Eligible patients were allocated at a 2 calcifediol:1 no calcifediol ratio through electronic randomization on the day of admission to take oral calcifediol (0.532 mg), or not. Patients in the calcifediol treatment group continued with oral calcifediol (0.266 mg) on day 3 and 7, and then weekly until discharge or ICU admission. Outcomes of effectiveness included rate of ICU admission and deaths.
Results: Of 50 patients treated with calcifediol, one required admission to the ICU (2%), while of 26 untreated patients, 13 required admission (50%) p value X2 Fischer test p
Multivariate Risk Estimate Odds Ratio for ICU in patients with Calcifediol treatment vs Without Calcifediol treatment ICU (adjusting by Hypertension and T2DM): 0.03 (95%CI: 0.003-0.25).
Of the patients treated with calcifediol, none died, and all were discharged, without complications. The 13 patients not treated with calcifediol, who were not admitted to the ICU, were discharged. Of the 13 patients admitted to the ICU, two died and the remaining 11 were discharged.
Conclusion Our pilot study demonstrated that administration of a high dose of Calcifediol or 25-hydroxyvitamin D, a main metabolite of vitamin D endocrine system, significantly reduced the need for ICU treatment of patients requiring hospitalization due to proven COVID-19. Calcifediol seems to be able to reduce severity of the disease, but larger trials with groups properly matched will be required to show a definitive answer.
17) https://www.ncbi.nlm.nih.gov/pmc/arti...
Quesada-Gomez, Jose Manuel, Marta Entrenas Castillo, and Roger Bouillon. “Vitamin D Receptor stimulation to reduce Acute Respiratory Distress Syndrome (ARDS) in patients with Coronavirus SARS-CoV-2 infections: Revised Ms SBMB 2020_166.” The Journal of Steroid Biochemistry and Molecular Biology (2020): 105719.
The major complication of coronavirus disease 2019 (COVID-19), the Acute Respiratory Distress syndrome (ARDS), is due to a variety of mechanisms including cytokine storm, dysregulation of the renin-angiotensin system, neutrophil activation and increased (micro) coagulation. Based on many preclinical studies and observational data in humans, ARDS may be aggravated by vitamin D deficiency and tapered down by activation of the vitamin D receptor. Several randomized clinical trials using either oral vitamin D or oral Calcifediol (25OHD) are ongoing. Based on a pilot study, oral calcifediol may be the most promising approach.
18) Benskin, Linda. “A Basic Review of the Preliminary Evidence that Covid-19 Risk and Severity is Increased in Vitamin D Deficiency.” Benskin LL (2020).
19) Brenner, Hermann, Bernd Holleczek, and Ben Schöttker. “Vitamin D Insufficiency and Deficiency and Mortality from Respiratory Diseases in a Cohort of Older Adults: Potential for Limiting the Death Toll during and beyond the COVID-19 Pandemic?.” Nutrients 12.8 (2020): 2488.
Abstract: The COVID-19 pandemic goes along with increased mortality from acute respiratory disease. It has been suggested that vitamin D3 supplementation might help to reduce respiratory disease mortality. We assessed the prevalence of vitamin D insufficiency and deficiency, defined by 25-hydroxyvitamin D (25(OH)D) blood levels of 30–50 and 9548 adults aged 50–75 years from Saarland, Germany.
Vitamin D insufficiency and deficiency were common (44% and 15%, respectively). Compared to those with sufficient vitamin D status, participants with vitamin D insufficiency and deficiency had strongly increased respiratory mortality, with adjusted hazard ratios (95% confidence intervals) of 2.1 (1.3–3.2) and 3.0 (1.8–5.2) overall,
4.3 (1.3–14.4) and 8.5 (2.4–30.1) among women, and 1.9 (1.1–3.2) and 2.3 (1.1–4.4) among men. Overall, 41% (95% confidence interval: 20–58%) of respiratory disease mortality was statistically attributable to
vitamin D insufficiency or deficiency.
Vitamin D insufficiency and deficiency are common and account for a large proportion of respiratory disease mortality in older adults, supporting the hypothesis that vitamin D3 supplementation could be helpful to limit the burden of the COVID-19 pandemic, particularly among women.
20) Lau, Frank H., et al. “Vitamin D insufficiency is prevalent in severe COVID-19.” medRxiv (2020).
VDI was defined as serum 25OHD < 30 ng/mL.10
Results Twenty COVID-19 patients with serum 25OHD levels were identified; 13 (65.0%) required ICU admission. Overall, few significant differences were identified between ICU and floor patients (Table 1) but statistical analysis was limited by the small number of subjects. Lactate dehydrogenase on admission was significantly higher among ICU patients (441.8 vs. 223.0, p=0.001), consistent with previous reports. No patients were diagnosed with stroke, myocardial infarction, or pulmonary embolus. Two patients (10%) died during the study period.
Among ICU subjects, 11 (84.6%) had VDI, vs. 4 (57.1%) of floor subjects.
Strikingly, 100% of ICU patients less than 75 years old had VDI (n=11; Table 2). Among these,64.6% (n=7) had critically low 25OHD (
The baseline prevalence of VDI amongst ICU patients is 30-40%.12 In this study, we found that 84.6% of COVID-19 ICU patients had VDI, vs. 57.1% of floor patients. Strikingly, 100% of ICU patients less than 75 years old had VDI. We also found that 62.5% had CAC, and 92.3% had lymphopenia.
Given these data, we hypothesize that VDI enhances COVID-19 severity via 1) its prothrombotic effects and 2) its derangement of the immune response
21) https://www.ncbi.nlm.nih.gov/pmc/arti...
Meltzer, David O., et al. “Association of Vitamin D Deficiency and Treatment with COVID-19 Incidence.” medRxiv (2020).
Importance: Vitamin D treatment has been found to decrease incidence of viral respiratory tract infection, especially in vitamin D deficiency. It is unknown whether COVID-19 incidence is associated with vitamin D deficiency and treatment. Objective: To examine whether vitamin D deficiency and treatment are associated with testing positive for COVID-19.
Design: Retrospective cohort study Setting: University of Chicago Medicine
Participants: Patients tested for COVID-19 from 3/3/2020-4/10/2020. Vitamin D deficiency was defined by the most recent 25-hydroxycholecalciferol
Main Outcomes and Measures: The main outcome was testing positive for COVID-19. Multivariable analysis tested whether the most recent vitamin D level and treatment changes after that level were associated with testing positive for COVID-19 controlling for demographic and comorbidity indicators. Bivariate analyses of associations of treatment with vitamin D deficiency and COVID-19 were performed.
Results: Among 4,314 patients tested for COVID-19, 499 had a vitamin D level in the year before testing. Vitamin D status at the time of COVID-19 testing was categorized as likely deficient for 127(25%) patients, likely sufficient for 291(58%) patients, and uncertain for 81(16%) patients. In multivariate analysis, testing positive for COVID-19 was associated with increasing age (RR(agebeing likely vitamin D deficient (deficient/treatment-not-increased:RR=1.77,p
predicted COVID-19 rates in the vitamin D deficient group of 21.6%(95%CI[14.0%-29.2%] ) versus 12.2%(95%CI[8.9%-15.4%]) in the vitamin D sufficient group.
Vitamin D deficiency declined with increasing vitamin D dose, especially of vitamin D3. Vitamin D dose was not significantly associated with testing positive for COVID-19.
Conclusions and Relevance: Vitamin D deficiency that is not sufficiently treated is associated with COVID-19 risk. Testing and treatment for vitamin D deficiency to address COVID-19 warrant aggressive pursuit and study.
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19 vs 20 ???????????
22) https://www.ncbi.nlm.nih.gov/pmc/arti...
Merzon, Eugene, et al. “Low plasma 25 (OH) vitamin D level is associated with increased risk of COVID‐19 infection: an Israeli population‐based study.” The FEBS journal (2020).
The study population included the 14,000 members of Leumit Health Services who were tested for COVID‐19 infection from February 1st to April 30th 2020, and who had at least one previous blood test for plasma 25(OH)D level. “Suboptimal” or “low” plasma 25(OH)D level was defined as plasma 25‐hydroxyvitamin D, or 25(OH)D, concentration below the level of 30 ng/mL.
Results Of 7,807 individuals, 782 (10.1%) were COVID‐19‐positive, and 7,025 (89.9%) COVID‐19‐negative. The mean plasma vitamin D level was significantly lower among those who tested positive than negative for COVID‐19 [19.00 ng/mL (95% confidence interval [CI] 18.41‐19.59) vs. 20.55 (95% CI 20.32‐20.78)].
Univariate analysis demonstrated an association between low plasma 25(OH) D level and increased likelihood of COVID‐19 infection [crude odds ratio (OR) of 1.58 (95% CI 1.24‐2.01, p
Conclusion Low plasma 25(OH)D level appears to be an independent risk factor for COVID‐19 infection and hospitalization.
Keywords: Vitamin D, COVID‐19, risk of infection, low plasma 25(OH) vitamin D level, Israeli population study
23) Jesenak, Milos, et al. “Immune parameters and COVID-19 infection-associations with clinical severity and diseases prognosis.” Frontiers in cellular and infection microbiology 10 (2020): 364.
24) Sparavigna, Amelia Carolina. “Vitamin D for Covid-19?.”
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No Masks for Kids in Schools Scott Atlas MD
25) https://dailycaller.com/2020/06/29/st...
Stanford’s Dr. Scott Atlas: There Is ‘No Science Behind Having Children Not Attend Schools’
Dr. Scott Atlas told “Tucker Carlson Tonight” Monday that there is “no science” behind the notion that children should not attend schools in the fall because of coronavirus.
Atlas, a senior fellow at Stanford’s Hoover Institution and the former chief of neuroradiology at Stanford University Medical Center was reacting to the recent surge in coronavirus cases among young people as well as the American Academy of Pediatrics’ recommendation that students return physically to the classrooms.
“We expected more cases with more social mingling and of course, as you are showing and others have seen, we had a lot of social mingling in the last few weeks,” Atlas told Fox News host Tucker Carlson.
“As the American association of pediatrics pointed out, as the Hospital for Sick Kids in Toronto, one of the world’s best hospitals, pointed out when they recommended full opening, no masks, no distancing,” Atlas said. “There is no science behind having children not attend schools. There is zero science for having children wear masks or have spacing when they have zero risk from the disease.”
26) Toronto Children’s Hospital Recommends Back to School without Masks or Social Distancing. Detailed Report
By John C. A. Manley Global Research, September 06, 2020 First published by Global Research on July 21, 2020
Toronto’s Hospital for Sick Children (aka Sick Kids) has released a detailed report on “the harms of school closure on [children’s] physical and mental health.”
Harms included: “Increased rates of depression, trauma, drug abuse and addiction and even suicide can be anticipated.”
The Sick Kids report reassures parents that there is “strong evidence that the majority of children who become infected with SARS-CoV-2 are either asymptomatic or have only mild symptoms…. There have been no paediatric deaths reported in Canada to date.”
Even more heartening is that Sick Kids Hospital recommends:
“Non-medical and medical face masks are not required or recommended for children returning to school.”
They point out that “if worn incorrectly, it could lead to increased risk of infection and it is not practical for a child to wear a mask properly for the duration of a school day.”
They also state the oft-ignored fact that:
“There is a lack of evidence that wearing a face mask prevents SARS-CoV-2 transmission in children.”
=========================================
Covid PCR testing Unreliable
27) Lu, Jing, et al. “Clinical, immunological and virological characterization of COVID-19 patients that test re-positive for SARS-CoV-2 by RT-PCR.” EBioMedicine 59 (2020): 102960.
Some COVID-19 cases test positive again for SARS-CoV-2 RNA following negative test results and discharge, raising questions about the meaning of virus detection. Better characterization of re-positive cases is urgently needed.
Methods: Clinical data were obtained through Guangdong’s COVID-19 surveillance network. Neutralization antibody titre was determined using microneutralization assays. Potential infectivity of clinical samples was evaluated by cell inoculation. SARS-CoV-2 RNA was detected using three different RT-PCR kits and multiplex PCR with nanopore sequencing.
Findings Among 619 discharged COVID-19 cases, 87 re-tested as SARS-CoV-2 positive in circumstances of social isolation. All re-positive cases had mild or moderate symptoms at initial diagnosis and were younger on average (median, 28). Re-positive cases (n = 59) exhibited similar neutralization antibodies (NAbs) titre distributions to other COVID-19 cases (n = 218) tested here. No infectious strain could be obtained by culture and no full-length viral genomes could be sequenced from re-positive cases.
Interpretation
Re-positive SARS-CoV-2 cases do not appear to be caused by active reinfection and were identified in ~14% of discharged cases. A robust NAb response and potential virus genome degradation were detected in almost all re-positive cases, suggesting a substantially lower transmission risk, especially through respiratory routes.
28) https://academic.oup.com/cid/advance-...
Rhee, Chanu, et al. “Duration of SARS-CoV-2 Infectivity: When is it Safe to Discontinue Isolation?.” Clinical Infectious Diseases (2020).
Chanu Rhee, MD, MPH (crhee@bwh.harvard.edu)Department of Population Medicine Harvard Medical School
Early in the pandemic, most hospitals required two negative RT-PCR tests before discontinuing isolation inpatients with Covid-19.
Many patients, however, have persistently positive RT-PCR tests for weeks to months following clinical recovery and multiple studies now indicate that persistently positive RT-PCRs generally do not reflect replication-competent virus.
Defining the duration of infectivity of SARS-CoV-2 has major implications for public health and infection control practice in healthcare facilities. Early in the pandemic, most hospitals required two negative RT-PCR tests before discontinuing isolation in patients with Covid-19. Many patients, however, have persistently positive RT-PCR tests for weeks to months following clinical recovery and multiple studies now indicate that persistently positive RT-PCRs generally do not reflect replication-competent virus.
SARS-CoV-2 appears to be most contagious around the time of symptom onset and infectivity rapidly decreases thereafter to near-zero after about 10 days in mild-moderately ill patients and 15 days in severely-critically ill and immunocompromised patients. The longest interval associated with replication-competent virus thus far is 20 days from symptom onset. This review summarizes evidence-to-date on the duration of infectivity of SARS-CoV-2 and how this has informed evolving public health recommendations on when it is safe to discontinue isolation precautions.
29) Swine flu ‘debacle’ of 1976 is recalled By Shari Roan April 27, 2009
30) Van der Wielen, Reggy PJ, et al. “Serum vitamin D concentrations among elderly people in Europe.” The Lancet 346.8969 (1995): 207-210.
31) Gloth, F. Michael, et al. “Vitamin D deficiency in homebound elderly persons.” Jama 274.21 (1995): 1683-1686.
32) Arnljots, Rebeka, et al. “Vitamin D deficiency was common among nursing home residents and associated with dementia: a cross sectional study of 545 Swedish nursing home residents.” BMC geriatrics 17.1 (2017): 1-8.
33) Tanabe, Shota, et al. “Physical inactivity and vitamin D deficiency in hospitalized elderlies.” Journal of bone and mineral metabolism 37.5 (2019): 928-934.
34) Mueangpaisarn, Pattranid, and Sumapa Chaiamnuay. “A randomized double-blinded placebo controlled trial of ergocalciferol 40,000 versus 100,000 IU per week for vitamin D inadequacy in institutionalized postmenopausal women.” Aging Clinical and Experimental Research 32.1 (2020): 41-48.
35) Pilz, Stefan, et al. “Low 25-hydroxyvitamin D is associated with increased mortality in female nursing home residents.” The Journal of Clinical Endocrinology & Metabolism 97.4 (2012): E653-E657.
36) Cheffers, John. “Entrusting Foxes with the Hen House: How a Bad Law Pits Big Pharma and the Federal Government against Vaccine-Injured Children.” Ave Maria L. Rev. 18 (2020): 194.
Published on September 6th, 2020 by
Jeffrey Dach MD
The post Vitamin D for Corona Virus Instead of a Vaccine ? appeared first on Jeffrey Dach MD.
August 11, 2020
My Bioidentical Hormone Creams Are Killing Me !
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My Bioidentical Hormone Creams Are Killing Me !!!
by Jeffrey Dach MD
With the publication of the NASEM report July, 2020, I was astonished to learn that for the past 20 years, compounded bioidentical hormones have been killing every one.(1) If only we had used FDA approved hormone pills and patches manufactured by the Pharmaceutical Industry, everything could have been so much better.
This is All Nonsense
Of course, this is all nonsense, because over the past 20 years of prescribing compounded bio-identical hormones to thousands of patients, I can attest to good outcomes in patients on compounded bioidentical hormones, with relief of menopausal symptoms and good quality of life (QOL). Of course, adverse side effects can occur, most commonly related to excess hormone dosage. These are easily managed by adjusting dosage under the supervision of a knowledgeable physician. .
Evidence Does Not Support Clinical Utility of Compounded Bioidentical Hormones
Here is the conclusion of the NASEM Report:
“Evidence does not support the clinical utility of compounded bioidentical hormone therapies and their use should be limited to patients who cannot use products approved by the US Food and Drug Administration (FDA),” (1)
Endocrine Nonsense Society ?
This NASEM report reminds me of the last time this came up in 2016 when the Endocrine Society advised doctors against using compounded bioidentical hormones. Four years ago, I wrote an article suggesting the organization should change their name to the “Endocrine Nonsense Society”. Similarly, NASEM which stands for National Academy of Science Engineering and Medicine should change its name to the ” National Academy of Nonsense, Engineering and Medicine“.(2)
Compounded Bioidentical Hormones Are on the Chopping Block
The Drug Industry has a long history using unethical and illegal activities including “dirty tricks” to advance its financial interests. Indeed, the Drug industry has paid out 35 Billion Dollars in penalties for Criminal and Civil Violations. One of the “dirty tricks’ over the years is the seeding of medical literature with “Ghost Written” articles disparaging bioidentical hormones and promoting their own patented synthetic hormones.(5-7)
Pharmaceutical Industry as Organized Crime Syndicate
Books by two eminent physicians Drs. Peter Gotsche, and Marcia Angell have documented the enormous corruption of the Pharmaceutical industry. Dr. Peter Gotsche has gone so far as to compare the Pharmaceutical Industry with an organized crime cartel which has captured our legislative bodies, regulatory agencies, medical societies, medical meetings, medical research, and the mainstream media, thus wielding enormous power over our society. (5-7)
Insidious New Campaign to Eliminate Compounded Hormones
With the publication of the NASEM Report, the Pharmaceutical Industry has launched an insidious new campaign to eliminate compounded bioidentical hormones. This campaign is based on the NASEM report claim that only randomized placebo controlled trials represent “medical evidence”. The FDA, an agency captured by the drug industry, funded a report by the NASEM (National Academy of Science Engineering and Medicine) to come up with the predestined conclusion: Since there is no evidence for efficacy or safety for bioidentical hormones, therefore bioidentical hormones should be placed on the FDA “Difficult to Compound List”, a regulatory move which essentially bans compounded bioidentical hormones, eliminating a major economic competitor. It’s just business. Two consequences will be:
1) Post Menopausal women will have no access to the compounded hormone creams they are currently using.
2) Compounding pharmacies across the nation will go out of business.
The Old Gimmick Used by the Pharmaceutical Industry
The basis for the FDA funded NASEM report is an old gimmick used over and over again by the drug industry to eliminate competing natural substances, and thereby gain market share. According to patent law, natural substances such a bioidentical hormones can not be patented, so there is no money for expensive clinical trials.
The Only Acceptable Evidence
The old gimmick is to “declare” that the only acceptable “evidence” is the randomized double blind placebo controlled drug trial of the the type required for FDA new drug approval. Although the Randomized Double Blind Placebo Controlled Trial is considered the gold standard for FDA drug approval, this type of drug trial is not practical for natural substances which can not be patented, nor for Off-Label drug use. The reason patent protection is required is the cost involved in a randomized trial is prohibitively expensive in the range of 100 to 250 million dollars. No drug company in their right mind would incur this expense without patent protection to guarantee profits on the back end. The same is true for most Off-Label drug use, usually involving Off-Patent drugs, meaning these are old drugs with expired patents.
Using a False Claim to Defeat the Competition
To make the claim that the only acceptable “evidence” is a randomized placebo controlled drug trial is not only false, it is standard gimmick or ploy used by the pharmaceutical industry for decades. Off-Label prescribing is in the same boat, since there are no randomized placebo controlled trials to support Off Label use of an old drug. So, such an attack on compounded hormone preparations is also an attack on Off-Label prescribing, comprising 20% of all presciptions
The Privilege of Off-Label Prescribing
New drugs are FDA approved for a specific “indication”, a medical condition placed on the drug label. However, about twenty percent (one fifth) of all drug prescriptions are prescribed Off Label.(1) This means the drug is prescribed for a different indication unrelated to the original FDA approval.
Prescribing an Antibiotic for Cancer Off-Label
An example of “Off-Label” use is the prescribing of Clarithromycin for Multiple Myeloma by Dr. Tomer Mark of Cornell as a repurposed anti-cancer drug for Multiple Myeloma. Clarithromycin’s original FDA approved indication is an antibiotic to treat bacterial infection, not as a repurposed anti-cancer drug. (3-4)
This common medical practice of “Off-Label Use” of a drug has always been accepted by all medical societies and regulatory agencies as a prerogative and privilege of the prescribing physician. Since twenty percent of prescriptions are not based on a randomized double blind placebo controlled trial (typically used for FDA new drug approval), the next obvious question is: What other types evidence are used to justify Off-Label prescribing of drugs?
Other Types of Evidence for Prescribing Drugs Off Label
Doctors rely on many other types of evidence such as in-vitro and in-vivo animal studies, human observational trials, and registry trials. Another powerful and highly accepted type of medical evidence called challenge, rechallenge, which proves drug causality. Challenge-Rechallenge is accepted by medical science as well as our legal system (a court of law), and is used in medical research to show causality of a drug or treatment.
Of course, the doctor must understand the physiology, the basic science showing the mechanism of action of the drug. The importance of this cannot be over-emphasized, as it provides confidence that the drug is effective and can be used, or ineffective and should not be used.
NASEM Committee Rejects All Other Types of Medical Evidence
All of these other perfectly valid types of medical evidence have been rejected by the esteemed doctors of the NASEM committee who came to their ridiculous conclusion, that there is no evidence of clinical utility of compounded bioidentical hormones. Needless to say this amounts to a form of scientific deception and fraud which, in a free society, should not be tolerated. This erosion of scientific integrity is real, and if unchecked by a grass roots movement of enraged post-menopausal women, this insidious campaign against compounded hormone replacement is likely to prevail, resulting in catastrophic consequences for millions of post menopausal women, and their compounding pharmacies..
FDA Approved Bioidentical Hormones Preparations:
All the hormones used in compounded preparations have been FDA approved and are used OFF-Label in compounded preparations. Here is a partial list of FDA approved hormone preparations for Estradiol, Progesterone and Testosterone:
Hormone Product Year of FDA Approval Manufacturer
——————————————————————————-
Alora (estradiol): FDA approved 1996 Watson Labs
Climara (estradiol): FDA approved 1994 Bayer
FemPatch : (estradiol) FDA approved 1997 Parke Davis
Vivelle-Dot (estradiol): FDA approved 1994 Novartis
Estraderm: (estradiol) FDA approved 1986 Novartis
Esclim: (estradiol) FDA approved 1998 Women’s First Healthcare
Estrace (estradiol): FDA approved 1993 Bristol Myers Squibb
Estring: (estradiol) FDA approved 1996 Pharmacia UpJohn
Prometrium (progesterone): FDA approved 1998 Solvay Pharmaceuticals
Crinone: (progesterone) FDA approved 1997 Columbia Labs
AndroGel (testosterone): FDA approved 1999 Unimed / Abbott
Testim (testosterone): FDA approved 2002 Auxilium
Compounded Bioidentical Hormones Are a Form of OFF-Label Use
As you can see with the above chart, the bioidentical hormones, Estradiol, Progesterone and Testosterone have all been FDA approved for specific indications on the basis of randomized placebo controlled trials. Off-Label use of these drugs and other drugs is a common physician practice. Compounded formulations of combinations of these three hormones is a form of Off-Label use and as such, the NASEM report requirement of placebo controlled randomized trial for each compounded formulation is a ridiculous proposal, and in fact is has never been required in the history of medicine for OFF-Label prescribing by a physician.
Medical Evidence Supporting Off Label Use of Bioidentical Hormones
The next obvious question is where is all this medical evidence excluded by the NASEM Report supporting the clinical utility, safety and efficacy of bioidentical hormones for Off Label prescribing ? This evidence is abundant in the medical literature. For starters, I refer the reader to two excellent review articles by Drs. Kent Holtorf, Erika Schwartz and David Brownstein. (8-9) There are many others.(10-18) A Google Scholar search for the key words, “bioidentical hormones” yields 5,200 articles in the scientific literature. Go take a look.
Here are two of my articles on the safety and efficacy of bioidentical hormones:
The Safety of Bioidentical Hormones
The Importance of Bioidentical Hormones
Hormone Replacement is Not a Stand Alone Program
The one pill, one clinical trial, one FDA indication mentality of the drug industry is inadequate for the complexities of actual clinical practice prescribing bioidentical hormones for the typical post menopausal patient. A Bioidentical Hormone Program should not be considered a stand alone medical intervention. A more holistic, integrative approach is required to achieve the best results. A complete patient evaluation which addresses micro-nutrient deficiencies, thyroid function, and gluten sensitivity is included in the program. I would recommend adding a cancer prevention program, as well, with testing for and supplementation with Iodine, vitamin D3, Selenium and DIM (Di-Indole Methane).
Subservience to the Pharmaceutical Industry
In most of the NASEM Reports, subservience to the pharmaceutical industry agenda is not so obvious. This one is very blatant. This NASEM “Decree” reminds me of a scene in a Woody Allen movie, “Bananas”. The little island of San Marcos has a new Dictator, and his first proclamation is: “All subjects are to wear their underwear on the outside”. Oh well, Just another day for George Orwell’s “Ministry of Health and Truth”. America, it’s a Great Country..(3) See video below:
Conclusion:
In the 1940’s an obscure Penn State chemist by the name of Russell Marker devised the Marker Degradation Process which opened the door for manufacturing bioidentical hormones inexpensively in large volumes. Russell Marker gave this “Process” as a gift to the world, declining to obtain a patent for his chemical formulation. Since the 1940’s, bioidentical hormones have been prescribed by physicians for the betterment of human life, specifically to relieve post-menopausal symptoms. The FDA is seeking to change that by using a fraudulent NASEM report to ban the use of compounded bioidentical hormones. This is the most evil, despicable thing I have seen in a long time. Where is the outrage?
Jeffrey Dach MD
7450 Griffin Road Suite 180/190
Davie, Florida 33314
telephone 954-792-4663
www.jeffreydachmd.com
Articles with Related Interest:
Click Here for Bioidentical Hormone Articles by Jeffrey Dach MD
Links and references
1) National Academies of Sciences, Engineering, and Medicine. 2020. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. https://doi.org/10.17226/25791.
2) Santoro, Nanette, et al. “Compounded Bioidentical Hormones in Endocrinology Practice: An Endocrine Society Scientific Statement.” The Journal of Clinical Endocrinology & Metabolism 101.4 (2016): 1318-1343. Nanette Santoro, Glenn D. Braunstein, Cherie L. Butts, Kathryn A. Martin, Michael McDermott, and JoAnn V. Pinkerton
3) Mark, Tomer M., and Morton Coleman. “It’s time to take clarithromycin seriously in multiple myeloma.” Acta haematologica 135.2 (2016): 101-102.
4) Mark, Tomer M., et al. “Phase 2 study of clarithromycin, pomalidomide, and dexamethasone in relapsed or refractory multiple myeloma.” Blood advances 3.4 (2019): 603-611.
5) Fugh-Berman, Adriane J. “The haunting of medical journals: how ghostwriting sold “HRT”.” PLoS Med 7.9 (2010): e1000335. The haunting of medical journals how ghostwriting sold HRT Fugh-Berman Adriane J PLoS Med 2010
6) Angell, Marcia. The truth about the drug companies: How they deceive us and what to do about it. Random House Incorporated, 2005.
“The combined profits for the ten drug companies in the Fortune 500 ($35.9 billion) were more than the profits for all the other 490 businesses put together ($33.7 billion) [in 2002]. Over the past two decades the pharmaceutical industry has moved very far from its original high purpose of discovering and producing useful new drugs. Now primarily a marketing machine to sell drugs of dubious benefit, this industry uses its wealth and power to co-opt every institution that might stand in its way, including the US Congress, the FDA, academic medical centers, and the medical profession itself.”
7) Gøtzsche, Peter. “Deadly medicines and organised crime.” How Big Pharma has corrupted healthcare. London: Radcliffe (2013).
PRESCRIPTION DRUGS ARE THE THIRD LEADING CAUSE OF DEATH AFTER HEART DISEASE AND CANCER. In his latest ground-breaking book, Peter C Gotzsche exposes the pharmaceutical industries and their charade of fraudulent behaviour, both in research and marketing where the morally repugnant disregard for human lives is the norm.
The research literature is distorted by scientific misconduct through trials with flawed designs and analysis, selective publication of trials and data, and ghostwritten papers.
The author states on page 39, “Almost every type of person who can affect the interests of the industry has been bribed: doctors, hospital administrators, cabinet ministers, health inspectors, customs officers, tax assessors, drug registration officials, factory inspectors, pricing officials, and political parties.”
8) Schwartz, Erika T., and Kent Holtorf. “Hormones in wellness and disease prevention: common practices, current state of the evidence, and questions for the future.” Primary Care: Clinics in Office Practice 35.4 (2008): 669-705.
9) Holtorf, Kent. “The bioidentical hormone debate: are bioidentical hormones (estradiol, estriol, and progesterone) safer or more efficacious than commonly used synthetic versions in hormone replacement therapy?.” Postgraduate medicine 121.1 (2009): 73-85.
10) Ruiz, Andres D., et al. “Effectiveness of compounded bioidentical hormone replacement therapy: an observational cohort study.” BMC women’s health 11.1 (2011): 27.
This study demonstrates that compounded BHRT improves mood symptoms. Larger studies are needed to examine the impact on vasomotor symptoms, myocardial infarction and breast cancer.
11) Martins, Vera, et al. “Compounded bioidentical HRT improves quality of life and reduces menopausal symptoms.” Journal of Prescribing Practice 2.7 (2020): 384-390.
12) De Lignieres, B., et al. “Combined hormone replacement therapy and risk of breast cancer in a French cohort study of 3175 women.” Climacteric 5.4 (2002): 332-340.
13) De Lignieres, B. “Effects of progestogens on the postmenopausal breast.” Climacteric 5.3 (2002): 229-235.
14) Fournier, Agnes, et al. “Breast cancer risk in relation to different types of hormone replacement therapy in the E3N‐EPIC cohort.” International journal of cancer 114.3 (2005): 448-454.
15) Wood, Charles E., et al. “Effects of estradiol with micronized progesterone or medroxyprogesterone acetate on risk markers for breast cancer in postmenopausal monkeys.” Breast cancer research and treatment 101.2 (2007): 125-134.
These findings suggest that oral micronized progesterone has a more favorable effect on risk biomarkers for postmenopausal breast cancer than medroxyprogesterone acetate.
16) Hargrove, Joel T., et al. “Menopausal hormone replacement therapy with continuous daily oral micronized estradiol and progesterone.” Obstetrics and gynecology 73.4 (1989): 606-612.
17) L’Hermite, M. “Custom-compounded bioidentical hormone therapy: why so popular despite potential harm? The case against routine use.” Climacteric 20.3 (2017): 205-211.
HT can be optimized by continuously combining transdermal estradiol with progesterone (when required).
18) Thompson, Jennifer Jo, Cheryl Ritenbaugh, and Mark Nichter. “Why women choose compounded bioidentical hormone therapy: lessons from a qualitative study of menopausal decision-making.” BMC Women’s Health 17.1 (2017): 97.
This study finds that women draw upon a range of “push” and “pull” motivations in their decision to use CBHT. Importantly, we find that women are not only seeking alternatives to conventional pharmaceuticals, but alternatives to conventional care where their menopausal experience is solicited, their treatment goals are heard, and they are engaged as agents in managing their own menopause. The significance of this finding goes beyond understanding why women choose CBHT. Women making menopause treatment decisions of all kinds would benefit from greater shared decision-making in the clinical context in which they are explicitly invited to share their experiences, priorities, and preferences. This would also provide an opportunity for clinicians to discuss the pros and cons of conventional HT, CBHT, and other approaches to managing menopause.
——————————————————————————————-
Expert review warns against compounded bioidentical hormone therapies
======================================
FDA: Bioidenticals are “Public Health Concern;” Ban Likely July 9, 2020
FDA Turns Its Back on Women July 23, 2020 Category: War On Natural Medicine
FDA Rigs Process Against Estriol, Other Bioidenticals
November 7, 2019
==============================================
https://a4pc.org/APC/Advocacy/Federal...
APC is still reviewing the report, but a few preliminary points are worth noting:
The NASEM study committee was populated by esteemed healthcare professionals, but there was not a pharmacist with patient-facing experience, much less a pharmacy compounder, in their number. Neither was there a physician with substantive experience in bioidentical hormone therapy. Likewise, the peer reviewers for the study included few compounders — but did include one former FDA employee (and current FDA contractor) who is a long-time, well-known opponent of pharmacy compounding.
Although compounded drugs are exempt from the new drug approval process because they are prepared to meet individual patient needs, the foundation of NASEM’s analysis seems to focus on the absence of new-drug-caliber studies of compounded meds. The report makes an illogical leap by effectively deeming cBHT unsafe unless it can mirror drug manufacturing in terms of safety and effectiveness data, labeling, AE reporting, pharmacokinetic data, and scale of clinical trials.
NASEM said it based its recommendations in large part on a review of literature, but identifies only 13 studies as having, in the judgment of the committee, suitable “rigor and relevance” — these, out of literally hundreds of studies out there, not to mention abundant patient outcomes data that could and should have been considered and weighed.
The report calls for restricting use of cBHT to patients with allergies to FDA-approved drugs, despite the fact that many FDA-approved therapies may not meet the dosing needs of patients — a point not addressed by the report’s recommendations.
The recommendations seem to suggest that a prescriber’s medical judgment and a patient’s preferences should play no role in determining a proper course of treatment — a stunning assertion that is applied to no other aspect of medicine or pharmacy care. Women’s needs are much more complex than the cookie-cutter approach offered by current FDA-approved drugs. Individualized therapy is the result of a balanced approach between prescriber, patient and pharmacist assessing each patient’s unique needs.
The NASEM study seems to suggest that states that do not adopt USP and chapters in whole, without question or amendment, are somehow under-regulating compounders, yet it provides no evidence of patient harm that has resulted in states that adhere to different standards.
The report cites concerns over bioavailability. However, many compounders or prescribers perform saliva or serum testing to confirm cBHT is appropriate therapy. Yet how many prescribers routinely check levels of FDA-approved products?
The report sends mixed messages. Individualized therapy is a part of FDA’s newly established goal of creating personalized therapies to target each patient. Factors such as age, weight, genetics, past medical history all contribute to appropriate treatment and dosage selection. Yet these NASEM recommendations seem to assert that FDA-approved drugs are always superior to compounded therapies.
The following drug products were withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective. The following drug products may not be compounded under the exemptions provided by section 503A(a) or section 503B(a) of the Federal Food, Drug, and Cosmetic Act:
https://casetext.com/regulation/code-...
Last updated on August 13th, 2020 by
Jeffrey Dach MD
The post My Bioidentical Hormone Creams Are Killing Me ! appeared first on Jeffrey Dach MD.
My Bioidentical Hormone Creams Are Killing Me
[image error]
My Bioidentical Hormone Creams Are Killing Me !!!
by Jeffrey Dach MD
With the publication of the NASEM report July, 2020, I was astonished to learn that for the past 20 years, compounded bioidentical hormones have been killing people.(1) If only I had prescribed FDA approved manufactured hormone preparations, patented by the pharmaceutical industry, thousands of patients would have been spared all that agony and suffering. Because of course, we all know that FDA approved patented hormone tablets made by the Drug Industry NEVER have any side effects and are perfectly safe. Of course, this is all nonsense, because over the past 20 years of prescribing compounded bio-identical hormones to thousands of patients, I can attest to good outcomes in patients on compounded bioidentical hormones with relief of menopausal symptoms and restoration of good quality of life. Of course, adverse side effects can occur, most commonly related to excess dosage. That is why the program is managed by a knowledgeable physician who can adjust dosage and monitor for side effects. In reality, adverse side effects related to hormone replacement are easily managed by the physician.
Evidence Does Not Support the Clinical Utility of Compounded Bioidentical Hormones
Here is the conclusion of the NASEM Report:
“Evidence does not support the clinical utility of compounded bioidentical hormone therapies and their use should be limited to patients who cannot use products approved by the US Food and Drug Administration (FDA),” (1)
Endocrine Nonsense Society ?
This NASEM report reminds me of the last time this came up in 2016 when the Endocrine Society advised doctors against using compounded bioidentical hormones. Four years ago, I wrote an article suggesting the organization should change their name to the “Endocrine Nonsense Society”. Similarly, NASEM which stands for National Academy of Science Engineering and Medicine should change its name to the ” National Academy of Nonsense, Engineering and Medicine“.(2)
Compounded Bioidentical Hormones Are on the Chopping Block
The Drug Industry has a long history using unethical and illegal activities including “dirty tricks” to advance its financial interests.Indeed, the Drug industry has paid out 35 Billion Dollars in penalties for Criminal and Civil Violations. One of the “dirty tricks’ over the years is the seeding of medical literature with “Ghost Written” articles which disparage bioidentical hormone and promote their own patented synthetic hormones.(5-7)
Pharmaceutical Industry as Organized Crime Syndicate
Books by two eminent physicians Drs Peter Gotsche , and Marcia Angell have documented the enormous corruption of the Pharmaceutical industry. Dr. Peter Gotsche has gone so far as to compare the Pharmaceutical Industry with an organized crime cartel which has captured our legislative bodies, regulatory agencies, medical societies and meetings, medical research, mainstream media, thus wielding enormous power over our society. (5-7)
Insidious New Campaign to Eliminate Compounded Hormones
With the publication of the NASEM Report, the Pharmaceutical Industry has launched an insidious new campaign to eliminate or ban compounded bioidentical hormones. This campaign is based on the NASEM report claim that only randomized placebo controlled trials represent “medical evidence”. The FDA, an agency captured by the drug industry, funded a report by the NASEM (National Academy of Science Engineering and Medicine) to come up with the predestined conclusion: There is no evidence for efficacy or safety for bioidentical hormones, and therefore bioidentical hormones should be placed on the FDA “Difficult to Compound” List, a regulatory move which essentially bans compounded bioidentical hormones, eliminating a major economic competitor. It’s just business. Two consequences are:
1) Post Menopausal women will have no access to the hormone treatment they are currently using.
2) Compounding pharmacies across the nation will go out of business.
The Old Gimmick Used by the Pharmaceutical Industry
The basis for the FDA funded NASEM report is an old gimmick used over and over again by the drug industry to eliminate competing natural substances, and thereby gain market share. According to patent law, natural substances such a bioidentical hormones can not be patented, so there is no money for expensive clinical trials.
The Only Acceptable Evidence
The old gimmick is to “declare” that the only acceptable “evidence” is the randomized double blind placebo controlled drug trial of the the type required for FDA new drug approval. Although the Randomized Double Blind Placebo Controlled Trial is considered the gold standard for FDA drug approval, this type of drug trial is not practical for natural substances which can not be patented, nor for Off-Label drug use. The reason patent protection is required is the cost involved in a randomized trial is prohibitively expensive in the range of 100 to 250 million dollars. No drug company in their right mind would incur this expense without patent protection to guarantee profits on the back end. The same is true for most Off-Label drug use, usually involving Off-Patent drugs, meaning these are old drugs with expired patents.
Using a False Claim to Defeat the Competition
To make the claim that the only acceptable “evidence” is a randomized placebo controlled drug trial is not only false, it is standard gimmick or ploy used by the pharmaceutical industry for decades. Off-Label prescribing is in the same boat, since there are no randomized placebo controlled trials to support Off Label use of an old drug. So, such an attack on compounded hormone preparations is also an attack on Off-Label prescribing, comprising 20% of all presciptions
The Privilege of Off-Label Prescribing
New drugs are FDA approved for a specific “indication”, a medical condition placed on the drug label. However, about twenty percent (one fifth) of all drug prescriptions are prescribed Off Label.(1) This means the drug is prescribed for a different indication unrelated to the original FDA approval.
Prescribing an Antibiotic for Cancer Off-Label
An example of “Off-Label” use is the prescribing of Clarithromycin for Multiple Myeloma by Dr. Tomer Mark of Cornell as a repurposed anti-cancer drug for Multiple Myeloma. Clarithromycin’s original FDA approved indication is an antibiotic to treat bacterial infection, not as a repurposed anti-cancer drug. (3-4)
This common medical practice of “Off-Label Use” of a drug has always been accepted by all medical societies and regulatory agencies as a prerogative and privilege of the prescribing physician. Since twenty percent of prescriptions are not based on a randomized double blind placebo controlled trial (typically used for FDA new drug approval), the next obvious question is: What other types evidence are used to justify Off-Label prescribing of drugs?
Other Types of Evidence for Prescribing Drugs Off Label
Doctors rely on many other types of evidence such as in-vitro and in-vivo animal studies, human observational trials, and registry trials. Another powerful and highly accepted type of medical evidence called challenge, rechallenge, which proves drug causality. Challenge-Rechallenge is accepted by medical science as well as our legal system (a court of law), and is used in medical research to show causality of a drug or treatment.
Of course, the doctor must understand the physiology, the basic science showing the mechanism of action of the drug. The importance of this cannot be over-emphasized, as it provides confidence that the drug is effective and can be used, or ineffective and should not be used.
NASEM Committee Rejects All Other Typos of Medical Evidence
All of these other perfectly valid types of medical evidence have been rejected by the esteemed doctors of the NASEM committee who came to their ridiculous conclusion, that there is no evidence of clinical utility of compounded bioidentical hormones. Needless to say this amounts to a form of scientific deception and fraud which in a free society should not be tolerated. The erosion of medical freedom and scientific integrity is real, and if unchecked by a grass roots movement of enraged post-menopausal women, this insidious campaign against compounded hormone replacement is likely to prevail, resulting in catastrophic consequences.
FDA Approved Bioidentical Hormones Preparations:
All the hormones used in compounded preparations have been FDA approved for other indications, and are in fact used OFF-Label in compounded preparations. Here is a partial list of FDA approved hormones:
Hormone Product Year of FDA Approval Manufacturer
——————————————————————————-
Alora (estradiol): FDA approved 1996 Watson Labs
Climara (estradiol): FDA approved 1994 Bayer
FemPatch : (estradiol) FDA approved 1997 Parke Davis
Vivelle-Dot (estradiol): FDA approved 1994 Novartis
Estraderm: (estradiol) FDA approved 1986 Novartis
Esclim: (estradiol) FDA approved 1998 Women’s First Healthcare
Estrace (estradiol): FDA approved 1993 Bristol Myers Squibb
Estring: (estradiol) FDA approved 1996 Pharmacia UpJohn
Prometrium (progesterone): FDA approved 1998 Solvay Pharmaceuticals
Crinone: (progesterone) FDA approved 1997 Columbia Labs
AndroGel (testosterone): FDA approved 1999 Unimed / Abbott
Testim (testosterone): FDA approved 2002 Auxilium
Compounded Bioidentical Hormones Are a Form of OFF-Label Use
As you can see with the above chart, the bioidentical hormones, Estradiol, Progesterone and Testosterone have all been FDA approved for specific indications (On-Label) on the basis of randomized placebo controlled trials. Off-Label use of these drugs and other drugs is a common physician practice. Compounded formulations of combinations of these three hormones is a form of Off-Label use and as such, the NASEM report requirement of placebo controlled randomized trial for each compounded formulation is a ridiculous proposal, and in fact is has never been required in the history of medicine for OFF-Label prescribing by a physician.
Medical Evidence Supporting Off Label Use of Bioidentical Hormones
The next obvious question is where is all this medical evidence excluded by the NASEM Report supporting the clinical utility, safety and efficacy of bioidentical hormones for Off Label prescribing ? This evidence is abundant in the medical literature. For starters, I refer the reader to two excellent review articles by Drs. Kent Holtorf, Erika Schwartz and David Brownstein. (8-9) There are many others.(10-18) A Google Scholar search for the key words, “bioidentical hormones” yields 5,200 articles in the scientific literature. Go take a look.
Hormone Replacement is Not a Stand Alone Program
The one pill, one clinical trial, one FDA indication mentality of the drug industry is inadequate for the complexities of actual clinical practice prescibing bioidentical hormones for the typical post menopausal patient. A Bioidentical Hormone Program should not be considered a stand alone medical intervention. A more holistic, integrative approach is required to achieve the best results. A complete patient evaluation which addresses micronutrient deficiencies, thyroid function, and gluten sensitivity is included in the program. I would recommend adding a cancer prevention program, as well, with testing for and supplementation with Iodine, vitamin D3, Selenium and DIM (Di-Indole Methane).
Subservience to the Pharmaceutical Industry
In most of the NASEM Reports, subservience to the pharmaceutical industry agenda is not so obvious. This one is very blatant. This NASEM “Decree” reminds me of a scene in a Woody Allen movie, “Bananas”. The little island of San Marcos has a new Dictator, and his first proclamation is: “All subjects are to wear their underwear on the outside”. Oh well, Just another day for George Orwell’s “Ministry of Health and Truth”. America, it’s a Great Country..(3) See video below:
Jeffrey Dach MD
7450 Griffin Road Suite 180/190
Davie, Florida 33314
telephone 954-792-4663
www.jeffreydachmd.com
Articles with Related Interest:
Click Here for Bioidentical Hormone Articles by Jeffrey Dach MD
Links and references
1) National Academies of Sciences, Engineering, and Medicine. 2020. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. https://doi.org/10.17226/25791.
2) Santoro, Nanette, et al. “Compounded Bioidentical Hormones in Endocrinology Practice: An Endocrine Society Scientific Statement.” The Journal of Clinical Endocrinology & Metabolism 101.4 (2016): 1318-1343. Nanette Santoro, Glenn D. Braunstein, Cherie L. Butts, Kathryn A. Martin, Michael McDermott, and JoAnn V. Pinkerton
3) Mark, Tomer M., and Morton Coleman. “It’s time to take clarithromycin seriously in multiple myeloma.” Acta haematologica 135.2 (2016): 101-102.
4) Mark, Tomer M., et al. “Phase 2 study of clarithromycin, pomalidomide, and dexamethasone in relapsed or refractory multiple myeloma.” Blood advances 3.4 (2019): 603-611.
5) Fugh-Berman, Adriane J. “The haunting of medical journals: how ghostwriting sold “HRT”.” PLoS Med 7.9 (2010): e1000335. The haunting of medical journals how ghostwriting sold HRT Fugh-Berman Adriane J PLoS Med 2010
6) Angell, Marcia. The truth about the drug companies: How they deceive us and what to do about it. Random House Incorporated, 2005.
“The combined profits for the ten drug companies in the Fortune 500 ($35.9 billion) were more than the profits for all the other 490 businesses put together ($33.7 billion) [in 2002]. Over the past two decades the pharmaceutical industry has moved very far from its original high purpose of discovering and producing useful new drugs. Now primarily a marketing machine to sell drugs of dubious benefit, this industry uses its wealth and power to co-opt every institution that might stand in its way, including the US Congress, the FDA, academic medical centers, and the medical profession itself.”
7) Gøtzsche, Peter. “Deadly medicines and organised crime.” How Big Pharma has corrupted healthcare. London: Radcliffe (2013).
PRESCRIPTION DRUGS ARE THE THIRD LEADING CAUSE OF DEATH AFTER HEART DISEASE AND CANCER. In his latest ground-breaking book, Peter C Gotzsche exposes the pharmaceutical industries and their charade of fraudulent behaviour, both in research and marketing where the morally repugnant disregard for human lives is the norm.
The research literature is distorted by scientific misconduct through trials with flawed designs and analysis, selective publication of trials and data, and ghostwritten papers.
The author states on page 39, “Almost every type of person who can affect the interests of the industry has been bribed: doctors, hospital administrators, cabinet ministers, health inspectors, customs officers, tax assessors, drug registration officials, factory inspectors, pricing officials, and political parties.”
8) Schwartz, Erika T., and Kent Holtorf. “Hormones in wellness and disease prevention: common practices, current state of the evidence, and questions for the future.” Primary Care: Clinics in Office Practice 35.4 (2008): 669-705.
9) Holtorf, Kent. “The bioidentical hormone debate: are bioidentical hormones (estradiol, estriol, and progesterone) safer or more efficacious than commonly used synthetic versions in hormone replacement therapy?.” Postgraduate medicine 121.1 (2009): 73-85.
10) Ruiz, Andres D., et al. “Effectiveness of compounded bioidentical hormone replacement therapy: an observational cohort study.” BMC women’s health 11.1 (2011): 27.
This study demonstrates that compounded BHRT improves mood symptoms. Larger studies are needed to examine the impact on vasomotor symptoms, myocardial infarction and breast cancer.
11) Martins, Vera, et al. “Compounded bioidentical HRT improves quality of life and reduces menopausal symptoms.” Journal of Prescribing Practice 2.7 (2020): 384-390.
12) De Lignieres, B., et al. “Combined hormone replacement therapy and risk of breast cancer in a French cohort study of 3175 women.” Climacteric 5.4 (2002): 332-340.
13) De Lignieres, B. “Effects of progestogens on the postmenopausal breast.” Climacteric 5.3 (2002): 229-235.
14) Fournier, Agnes, et al. “Breast cancer risk in relation to different types of hormone replacement therapy in the E3N‐EPIC cohort.” International journal of cancer 114.3 (2005): 448-454.
15) Wood, Charles E., et al. “Effects of estradiol with micronized progesterone or medroxyprogesterone acetate on risk markers for breast cancer in postmenopausal monkeys.” Breast cancer research and treatment 101.2 (2007): 125-134.
These findings suggest that oral micronized progesterone has a more favorable effect on risk biomarkers for postmenopausal breast cancer than medroxyprogesterone acetate.
16) Hargrove, Joel T., et al. “Menopausal hormone replacement therapy with continuous daily oral micronized estradiol and progesterone.” Obstetrics and gynecology 73.4 (1989): 606-612.
17) L’Hermite, M. “Custom-compounded bioidentical hormone therapy: why so popular despite potential harm? The case against routine use.” Climacteric 20.3 (2017): 205-211.
HT can be optimized by continuously combining transdermal estradiol with progesterone (when required).
18) Thompson, Jennifer Jo, Cheryl Ritenbaugh, and Mark Nichter. “Why women choose compounded bioidentical hormone therapy: lessons from a qualitative study of menopausal decision-making.” BMC Women’s Health 17.1 (2017): 97.
This study finds that women draw upon a range of “push” and “pull” motivations in their decision to use CBHT. Importantly, we find that women are not only seeking alternatives to conventional pharmaceuticals, but alternatives to conventional care where their menopausal experience is solicited, their treatment goals are heard, and they are engaged as agents in managing their own menopause. The significance of this finding goes beyond understanding why women choose CBHT. Women making menopause treatment decisions of all kinds would benefit from greater shared decision-making in the clinical context in which they are explicitly invited to share their experiences, priorities, and preferences. This would also provide an opportunity for clinicians to discuss the pros and cons of conventional HT, CBHT, and other approaches to managing menopause.
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Expert review warns against compounded bioidentical hormone therapies
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FDA: Bioidenticals are “Public Health Concern;” Ban Likely July 9, 2020
FDA Turns Its Back on Women July 23, 2020 Category: War On Natural Medicine
FDA Rigs Process Against Estriol, Other Bioidenticals
November 7, 2019
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https://a4pc.org/APC/Advocacy/Federal...
APC is still reviewing the report, but a few preliminary points are worth noting:
The NASEM study committee was populated by esteemed healthcare professionals, but there was not a pharmacist with patient-facing experience, much less a pharmacy compounder, in their number. Neither was there a physician with substantive experience in bioidentical hormone therapy. Likewise, the peer reviewers for the study included few compounders — but did include one former FDA employee (and current FDA contractor) who is a long-time, well-known opponent of pharmacy compounding.
Although compounded drugs are exempt from the new drug approval process because they are prepared to meet individual patient needs, the foundation of NASEM’s analysis seems to focus on the absence of new-drug-caliber studies of compounded meds. The report makes an illogical leap by effectively deeming cBHT unsafe unless it can mirror drug manufacturing in terms of safety and effectiveness data, labeling, AE reporting, pharmacokinetic data, and scale of clinical trials.
NASEM said it based its recommendations in large part on a review of literature, but identifies only 13 studies as having, in the judgment of the committee, suitable “rigor and relevance” — these, out of literally hundreds of studies out there, not to mention abundant patient outcomes data that could and should have been considered and weighed.
The report calls for restricting use of cBHT to patients with allergies to FDA-approved drugs, despite the fact that many FDA-approved therapies may not meet the dosing needs of patients — a point not addressed by the report’s recommendations.
The recommendations seem to suggest that a prescriber’s medical judgment and a patient’s preferences should play no role in determining a proper course of treatment — a stunning assertion that is applied to no other aspect of medicine or pharmacy care. Women’s needs are much more complex than the cookie-cutter approach offered by current FDA-approved drugs. Individualized therapy is the result of a balanced approach between prescriber, patient and pharmacist assessing each patient’s unique needs.
The NASEM study seems to suggest that states that do not adopt USP and chapters in whole, without question or amendment, are somehow under-regulating compounders, yet it provides no evidence of patient harm that has resulted in states that adhere to different standards.
The report cites concerns over bioavailability. However, many compounders or prescribers perform saliva or serum testing to confirm cBHT is appropriate therapy. Yet how many prescribers routinely check levels of FDA-approved products?
The report sends mixed messages. Individualized therapy is a part of FDA’s newly established goal of creating personalized therapies to target each patient. Factors such as age, weight, genetics, past medical history all contribute to appropriate treatment and dosage selection. Yet these NASEM recommendations seem to assert that FDA-approved drugs are always superior to compounded therapies.
The following drug products were withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective. The following drug products may not be compounded under the exemptions provided by section 503A(a) or section 503B(a) of the Federal Food, Drug, and Cosmetic Act:
https://casetext.com/regulation/code-...
Published on August 11th, 2020 by
Jeffrey Dach MD
The post My Bioidentical Hormone Creams Are Killing Me appeared first on Jeffrey Dach MD.
August 2, 2020
Hydroxychloroquine Efficacy Against Corona Virus
[image error]Challenge, Re-challenge Evidence for Hydroxychloroquine Efficacy Against Corona Virus
by Jeffrey Dach MD
Although the Randomized Double Blind Placebo Controlled Trial is considered the gold standard for FDA drug approval, this type of drug trial is not practical for off label drugs and natural substances which can not be patented. The reason patent protection is required is the cost involved in a randomized trial is prohibitively expensive in the range of 100 to 250 million dollars. No drug company in their right mind would incur this expense without patent protection to guarantee profits on the back end.
The Privilege of Off-Label Prescribing
About twenty percent (one fifth) of all drug prescriptions are prescribed Off Label.(1) This means the drug is prescribed for a different indication unrelated to the original FDA approved indication. An example of “Off-Label” use is the prescribing of Hydroxychloroquine (Plaquenil) for systemic lupus erythematosis (SLE). The drug was originally FDA approved for treatment of malaria which has nothing to do with systemic lupus. This common medical practice of “Off-Label Use” of a drug has always been accepted by all medical societies and regulatory agencies as a prerogative and privilege of the prescribing physician.
Since twenty percent of prescriptions are not based on randomized double blind placebo controlled trials typically used for FDA new drug approval, the next obvious question is: What other types evidence are used ?
Other Types of Evidence for Prescribing Drugs Off Label
Doctors rely on many other types of evidence such as in-vitro and in-vivo animal studies, human observational trials, registry trials, and challenge, rechallenge studies. Of course, the doctor must understand the basic science studies showing the mechanism of action of the drug. The importance of this cannot be over-emphasized, as it provides confidence that the drug is effective and can be used, or ineffective and should not be used.
The Sad Story of Procrit
For example, if basic science shows that a drug stimulates cancer cell growth, then obviously, this drug would not be suitable for the oncology patient. Such was the case with Procrit, a form of erythropoeitin manufactured with the new recombinant DNA technology. The drug was FDA approved to increase (RBC) Red Blood Cell count in anemic patients. Anemia is a common side effect of chemotherapy, and the drug was used for many years on oncology wards to increase blood counts in cancer patients. This was carried out for many years until it was finally discovered the drug increased the mortality from cancer by stimulating cancer growth. Basic science studies showed that many cancer cell types have erythropoetin receptors that stimulate the cancer cell with growth signals.(3-4)
Drug Challenge Rechallenge
Another form of evidence which proves drug causality accepted by medical science as well as our legal system (a court of law) is called drug challenge, rechallenge. This is used throughout medical research to show causality of a drug or treatment.
Challenging Rhesus Monkeys with SARS-Cov-2 Virus
For example, a recent 2020 study by Dr. Chandrashekar, nine rhesus monkeys were challenged with SARS-Cov-2 virus by inoculating their nasal passages with the virus.(2) The challenged monkeys developed a mild upper respiratory disease with viral RNA detected in nasal samples. Additional blood testing showed the nine monkeys developed humoral and cellular immunity to the virus with both neutralizing antibodies and T-Cell immunity. On day 35 after the monkeys had recovered, they were re-challenged with the same dose of the SARS-Cov-2 virus, finding the monkeys were now immune and did not get sick. Thus, proving the title of the publication: “SARS-CoV-2 infection protects against rechallenge in rhesus macaques”. In other words, infection with the virus creates protective immunity which then prevents re-infection after re-exposure. This is the same idea of “herd immunity” in a population when enough people have protective immunity, the virus has no place to go and fizzles out. In this above example, the principle of challenge , re-challenge was used in a medical research study to show causality, infection with the virus causes protective immunity. Of course, rhesus monkeys are not humans so one might argue the findings may not hold true in humans. A study to verify these same finding in humans is easy enough and should be done.
Challenge Rechallenge for Hydroxychloroquine (HCQ)
What if we did a challenge/ rechallenge experiment on a population exposed to circulating Corona Virus (Sars-Cov2). What if we challenged the population with a drug, then dechallenged by stopping the drug, and then rechallenged by restarting the drug ? This is exactly what was unintentionally done in Switzerland where hydroxychloroquine (HCQ) was freely available. Use was temporarily suspended for three weeks, and then reinstated representing challege, dechallenge and rechallenge. See below chart.
[image error]
Horizontal red line is Swiss mortality data from COVID-19. Black Vertical Line: May 27 HCQ suspended. Blue Vertical Line HCQ reinstated. Red Vertical Line Increased Mortality from Covid-19 during window when HCQ use was suspended. This is highly significant !!!! Courtesy of Johns Hopkins University.
Hydroxychloroquine had been available and widely used in Switzerland until use was suspended on May 27, 2020 a few days after the negative May 22 Lancet study that prompted the WHO to suspend its drug trials. However, this Lancet study was found to be fraudulent, and was retracted on June 4. And, one week later on June 11, Switzerland reinstated use of Hydroxychloroquine. During this 20 day window, a dramatic increase in mortality from COVID-19 is observed (RED ARROW), showing challenge/rechallenge evidence indicating causality that removing the drug caused increased mortality from the virus.
Comparing CFR Case Fatality Rate to HCQ Use by Country
Folks if the above data from Switzerland doesn’t convince you, then look at this next chart, Covid-19 (CFR) Case Fatality Rate by HCQ use. The bar chart shows countries with no HCQ use (red), mixed use (orange) and free use (green). Left axis is CFR (case fatality rate).
[image error]
Covid-19 (CFR) Case Fatality Rate Correlates with HCQ Use
Red bar chart: NO HCQ use.
Orange Bar Chart: Mixed Use
Green Bar Chart /: Unrestricted Free HCQ Use – Much Lower Mortality Rate
This represents an observational study clearly demonstrating the efficacy of HCQ Hydroxychloroquine for reducing case fatality rate (CFR) for SARS-Cov-2 (COVD-19).
One Tenth the Mortality Rate in Countries Using HCQ
General Counsel Andrew Schlafly of the AAPS (American Association of Physicians and Surgeons) filed a court case against the FDA regarding restrictions on use of hydroxychloroquine. Mr. Schlafly says:
“The mortality rate from COVID-19 in countries that allow access to HCQ is only one-tenth the mortality rate in countries where there is interference with this medication, such as the United States….. In some areas of Central America, officials are even going door to door to distribute HCQ….These countries have been successful in limiting the mortality from COVID-19 to only a fraction of what it is in wealthier countries.” (12) End Quote Andrew Schlafly, General Counsel AAPS. (12)
Why Dr Fauci Insists on A Double Blind Placebo Controlled Study Before Endorsing HCQ for Covid19
Above White House News Conference from March 20, 2020
Remember the above exchange between President Trump and Dr Fauci during a white house Corona Virus Press Briefing (March 20, 2020)? President Trump said he had a “good feeling” about HCQ. However, Dr Fauci disagreed, claiming we need a randomized placebo controlled trial before recommending HCQ for Covid-19. This answer does indeed reveal that Dr Fauci represents the financial interests of the drug/vaccine industry, same as all other regulatory agencies, the CDC, FDA and NIH all captured by the drug industry many years ago. This is old news. In addition, Dr. Fauci knows that if President Trump ever “requests his resignation”, a lucrative job with the Gates Foundation, Merck, Pfizer or others is waiting with a paycheck at least ten fold greater than his current one, same as former FDA commissioner Dr. Scott Gottlieb who is now a board member for Pfizer, and biotech company Illumina. Same as Dr. Julie Gerberding, former director of the CDC (Centers for Disease Control and Prevention) , who is now president of Merck’s vaccine division.
Using a False Claim to Defeat the Competition
To make the claim that only a randomized placebo controlled drug trial can be accepted as “evidence” is not only a false claim, it is standard gimmick or ploy used by the pharmaceutical industry for decades. This claim maintains the only acceptable “evidence” is a randomized placebo controlled trial typically used for new drug FDA approval. Just by coincidence this excludes off-label repurposed drugs as well as natural substances that can not be patented.
Compounded Bioidentical Hormones Are Also on the Choppng Block
By the way, this includes bioidentical hormones since they can not be patented. The Pharmaceutical Industry has launched an insidious new campaign to ban compounded bioidentical hormones based on this same argument, namely the claim that only randomized placebo controlled trials represent “medical evidence”. The FDA which has been captured by the drug industry funded a report by the NASEM (National Academy of Science Engineering and Medicine) to come up with the predestined conclusion they wanted, that there is no evidence for efficacy or safety for bioidentical hormones, and therefore should be placed on the FDA “Difficult to Compound” List, a regulatory move which essentially bans compounded bioidentical hormones, eliminating a major economic competitor. It’s just business. Two consequences are 1) women will have no access to the hormone treatment they are currently using. 2) Compounding pharmacies across the nation will go out of business (13-14)
Dr Fauci Represents the Interests of the Drug Industry
As we discussed above, Dr. Fauci knows all this, including the fact that no drug company will ever fund such an expensive drug trial without the guarantee of profits through patent protection. If such a study is done by the drug industry or the government, it will be done with the express purpose of discrediting the drug. In the case of HCQ, this drug is especially odious to the drug industry since it competes with the potential billion dollar windfall in vaccine development and sales. The rush to discredit HCQ prompted studies published in the Lancet and NEJM that were so sloppy and fraudulent that both were retracted, an embarrassment unprecedented in the history of medicine. These fraudulent studies were funded for the express purpose of discrediting HCQ in order to eliminate the financial competition to the future Sars-Cov2 vaccines in the pipeline.(5-8)
A commonly cited failed HCQ study is a 2020 study in JAMA by Dr. Borba in Brazil obviously intentionally designed to discredit the HCQ drug by using lethal, highly toxic doses of HCQ in patients on ventilators. (9) Similarly, other unethical medical studies around the globe used lethal doses of the drug given to end stage ventilator patients.(15) HCQ is best used early in the disease course at lower dosage, safely used for decades for malaria and auto-immune disease. Efficacy is enhanced in combination with Zinc and Azithromycin (Z-Pack). Oral intake of Vitamin D3, Vitamin A, and Vitamin C to bowel tolerance enhance the immune system. Botanicals such as Elderberry, Chinese Skullcap, and Licorice have known antiviral activity.
Censorship of Physicians Having Good Outcomes Prescribing HCQ for Covid-19
I have personally seen good outcomes with the use of Hydroxychloroquine, Z-pack (azithromycin) and Zinc for upper respiratory infection attributed to Corona Virus, Sars Cov-2 (Covid -19). In addition, many physicians are coming forward stating they have had considerable success with this drug combination with good patient outcomes. Here is one such group of “Front Line” physicians speaking in front of the Supreme Court. Their video received 17 million views before it was deleted by You Tube, Google, Facebook and Twitter in a bizarre act of censorship. You can watch this video here:
Doctor’s Press Conference Drs. Simone Gold, Bob Hamilton, Stella Immanuel, Dan Erickson, James Todaro, Joe Ladapo on the steps of Supreme Court, Washington DC talking about HCQ, Z pack and ZINC for Covid 19. This video was censored/deleted by FB, U tube and Twitter.(10-11)
America’s Frontline Doctors SCOTUS Press Conference Transcript of above video press conference.
Governors in Five States Interfere with HCQ Prescribing by Physicians
Governor Steve Sisolak (D-NV)
Gov. Gretchen Whitmer (D-MI) (later reversed)
Gov. Cuomo (D-NY)
Gov. Mike DeWine (R-Ohio) (later reversed)
Gov. Doug Ducey (R-Arizona)
In an unprecedented move, Governors of 5 states including Gov. Cuomo of New York have issued executive orders banning or restricting the use of hydroxychloroquine for Covid-19. This is unprecedented in the history of medicine that a Government official would use their office to “Practice of Medicine without a License” and interfere with the doctor patient relationship. Needless to say, this interferes with the long standing off- label prescribing practices of physicians. How many lives have been sacrificed by the misguided executive orders of government agencies? These criminal acts should be held accountable by the Inspector General, the Attorney General and the Department of Justice.
Conclusion: The Challenge Rechallenge Data from Switzerland, and the comparative country data on CFR (Case fatality rate) with HCQ and without HCQ shows impressive efficacy of HCQ for reducing case fatality rates CFR. The use of HCQ should be liberalized and made OTC Over-The-Counter. Government officials and agencies should halt any interference in physician Off Label prescribing of Hydroxychloroquine, or be held accountable by the Attorney General.
Censorship Unprecedented in our History
Board certified physicians are standing up at great personal risk to inform the American People of the efficacy of hydroxychloroquine (HCQ). The fact these physicians are being censored and deleted by the Big Tech social media giants is simply astounding, and undoubtedly has caused unnecessary suffering and loss of life. The social media giants involved in this irresponsible censorship campaign should be held accountable and should pay a price for their negligence.
Jeffrey Dach, MD
7450 Griffin Road Suite 180/190
Davie, Fl 33314
telephone: 954 792-4663
Effective Early Treatment for Corona Virus (Covid-19)
Covid-19 Once in a Century Fiasco in the Making
Corona Virus How to Protect Ourselves
Links and References:
1) Radley, David C., Stan N. Finkelstein, and Randall S. Stafford. “Off-label prescribing among office-based physicians.” Archives of internal medicine 166.9 (2006): 1021-1026.
2) Chandrashekar, Abishek, et al. “SARS-CoV-2 infection protects against rechallenge in rhesus macaques.” Science (2020).
3) Elliott, Steve, and Angus M. Sinclair. “The effect of erythropoietin on normal and neoplastic cells.” Biologics: targets & therapy 6 (2012): 163.
4) Cao, Yihai. “Erythropoietin in cancer: a dilemma in risk therapy.” Trends in Endocrinology & Metabolism 24.4 (2013): 190-199.
5) (RETRACTED) Mehra, Mandeep R., et al. “Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis.” The Lancet (2020). May 22, 2020
6) (Retracted) Mehra, Mandeep R., et al. “Retraction: Cardiovascular Disease, Drug Therapy, and Mortality in Covid-19. N Engl J Med. DOI: 10.1056/NEJMoa2007621.” (2020).
7) Lancet, NEJM retract studies on hydroxychloroquine for COVID-19
Publish date: June 4, 2020 By Marcia Frellick
The Lancet announced today that it has retracted a highly cited study that suggested hydroxychloroquine may cause more harm than benefit in patients with COVID-19. Hours later, the New England Journal of Medicine announced that it had retracted a second article by some of the same authors, also on heart disease and COVID-19.
8) Iacobucci, Gareth. “Covid-19: Validity of key studies in doubt after leading journals issue expressions of concern.” (2020).
9) Borba, Mayla Gabriela Silva, et al. “Effect of high vs low doses of chloroquine diphosphate as adjunctive therapy for patients hospitalized with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection: a randomized clinical trial.” JAMA network open 3.4 (2020): e208857-e208857.
10) Doctors Break Down COVID Response and the Demonization of HCQ, DOCTORS TELL ALL July 1, 2020 Julie Carr The Ohio Star
In this interview, Dr. Simone Gold and Dr. Dan Wohlgelernter discuss the country’s failure to protect the elderly from the coronavirus and also sort out information around Hydroxychloroquine.
11) The Key to defeating Codi19 Harvey Risch MD
“I am usually accustomed to advocating for positions within the mainstream of medicine, so have been flummoxed to find that, in the midst of a crisis, I am fighting for a treatment that the data fully support but which, for reasons having nothing to do with a correct understanding of the science, has been pushed to the sidelines. As a result, tens of thousands of patients with Covid-19 are dying unnecessarily. Fortunately, the situation can be reversed easily and quickly. I am referring, of course, to the medication hydroxychloroquine. When this inexpensive oral medication is given very early in the course of illness, before the virus has had time to multiply beyond control, it has shown to be highly effective, especially when given in combination with the antibiotics azithromycin or doxycycline and the nutritional supplement zinc.”
—Harvey A Risch, MD, PhD, Professor of Epidemiology in the Department of Epidemiology and Public Health at the Yale School of Public Health and Yale School of Medicine
12) July 22, 2020 More Evidence Presented for Why Hydroxychloroquine Should be Made Available, in a New Court Filing by AAPS
“The mortality rate from COVID-19 in countries that allow access to HCQ is only one-tenth the mortality rate in countries where there is interference with this medication, such as the United States,” explains Andrew Schlafly. “In some areas of Central America, officials are even going door to door to distribute HCQ,” Andrew Schlafly adds. “These countries have been successful in limiting the mortality from COVID-19 to only a fraction of what it is in wealthier countries.”
Not using HCQ, Z-pack, and Zinc ??? That would really help to reduce the volume, work load and the mortality they are talking about…
13) FDA Turns Its Back on Women Action Alert Alliance for Natural Health July 23, 2020
As we recently reported, the FDA is gearing up to issue a ban on compounded bioidentical hormone replacement therapy. The newest development is a report from the National Academies of Sciences, Engineering, and Medicine (NASEM), which falsely concluded that these critical medicines used by millions of women are a “public health concern.” We must use every avenue available to fight the FDA and prevent a ban on estriol, progesterone, and other compounded bioidentical hormones.
14) What’s at Stake in FDA’s Hormone Attack Action Alert Alliance for Natural Health January 23, 2020
15) Dr. Meryl Nass Discovers Hydroxychloroquine Experiments Were Designed to Kill COVID Patients – How Many Were Murdered?
Aug 3 , 2020 Health Impact News
Published on August 2nd, 2020 by
Jeffrey Dach MD
The post Hydroxychloroquine Efficacy Against Corona Virus appeared first on Jeffrey Dach MD.
July 5, 2020
Covid-19 A Once in a Century Fiasco in the Making
[image error]
Covid-19, A Once in a Century Fiasco in the Making
by Jeffrey Dach MD
Back in March at the beginning of the COVID 19 outbreak, the highly respected Stanford Epidemiologist John Ioannidis drew heavy criticism for expressing his view that governments were making decisions without reliable data. On March 17, 2020, Dr. John Ioannidis writes:
“The current coronavirus disease, Covid-19, has been called a once-in-a-century pandemic. But it may also be a once-in-a-century evidence fiasco.“(1)
The Data Has Accumulated and Dr. John Ioannidis was RIGHT !!
Infection Fatality Rate of ZERO for under 45 yrs of age !!
In a recent interview June 27, 2020, Dr Ioannidis spells out the accumulated data which is now available. Sadly, he was right all along. Regarding the infection fatality rate, remarkably, Dr John Ioannidis says for people younger than age 45, the infection fatality rate is ZERO !!! And, for people age 45 to 70, the infection fatality rate is probably about 0.05-0.3%, historically similar to other seasonal respiratory viruses. However, fatality rate for frail nursing home patients may be as high as 25%.
What is the IFR (infection fatality rate) ? Dr. Ioannidis replies:
“0.05% to 1% is a reasonable range for what the data tell us now for the infection fatality rate, with a median of about 0.25%. The death rate in a given country depends a lot on the age-structure, who are the people infected, and how they are managed. For people younger than 45, the infection fatality rate is almost 0%. For 45 to 70, it is probably about 0.05-0.3%. For those above 70, it escalates substantially, to 1% or higher for those over 85. For frail, debilitated elderly people with multiple health problems who are infected in nursing homes, it can go up to 25% during major outbreaks in these facilities.”
Draconian Lockdown Consequences: “Financial Crisis, Unrest, and Civil Strife.”
When recently asked about the consequences of the Lockdowns, Dr Ioaninidis said he was saddened that his projections were verified: Dr. Ioannidis replies:
“I feel extremely sad that my predictions were verified. “Major consequences on the economy, society and mental health” have already occurred. I hope they are reversible, and this depends to a large extent on whether we can avoid prolonging the draconian lockdowns and manage to deal with COVID-19 in a smart, precision-risk targeted approach, rather than blindly shutting down everything. Similarly, we have already started to see the consequences of “financial crisis, unrest, and civil strife.” I hope it is not followed by “war and meltdown of the social fabric.”
Draconian Lockdowns put 1.1 Billion at Risk of Starvation
Dr. Ioannidis replies:
“Globally, the lockdown measures have increased the number of people at risk of starvation to 1.1 billion, and they are putting at risk millions of lives, with the potential resurgence of tuberculosis, childhood diseases …, and malaria. I hope that policymakers look at the big picture of all the potential problems and not only on the very important, but relatively thin slice of evidence that is COVID-19.”
Polarized Society Driven by Fear
We now live in a polarized society of two types of people. On one hand we have people obediently watching the nightly news who believe what they hear and see on the television. These people are fearful of viruses and want government protection with “security measures” that coincidentally abolish constitutional rights and liberties. For example, the right to work and make a living, and the right to assemble in a house of worship are among many that have been abolished. These “fearful” people are not concerned about the economic consequences of 40 million people collecting unemployment payments. Or the soon to be millio[image error]ns living out of cardboard boxes on the sidewalk because they can not pay their rent.
Celebrating Freedom on Independence Day
On the other hand, there are people who understand the views of Dr Ioannidis, who are not fearful, and who do not watch the nightly news. These people do not want government protection from a virus. These people want the government to stop interfering in their right to work and make a living to support their families. They want to have their constitutional rights and liberties restored. That is what we are celebrating on July 4th Independence Day.
Latest Data Chart From Covid Tracking Project
[image error]
While “cases” are increasing (Blue Arrow), deaths are decreasing (Red Arrow).
Conclusion: Our country is teetering on a precipice. Are we sheep to be ruled by fear ? Or are we brave men and women standing up for freedom, liberty and the American way? If we are worried about the mortality rate from a virus, just think about this: What is the mortality rate from living out of a cardboard box on the sidewalk?
Articles with Related Content:
Early Effective Treatment for Corona Virus
Coronavirus How to Protect Ourselves
Jeffrey Dach MD
7450 Griffin Road, Suite 190
Davie, Fl 33314
954-792-4663
www.jeffreydachmd.com
Links and References
1) A fiasco in the making? As the coronavirus pandemic takes hold, we are making decisions without reliable data. By John P.A. Ioannidis March 17, 2020 once-in-a-century evidence fiasco.
2) Up to 300 Million People May Be Infected by Covid-19, Stanford Guru John Ioannidis Says. By Patricia Claus – Jun 27, 2020
Dr. Ioannidis: 0.05% to 1% is a reasonable range for what the data tell us now for the infection fatality rate, with a median of about 0.25%. The death rate in a given country depends a lot on the age-structure, who are the people infected, and how they are managed. For people younger than 45, the infection fatality rate is almost 0%. For 45 to 70, it is probably about 0.05-0.3%. For those above 70, it escalates substantially, to 1% or higher for those over 85. For frail, debilitated elderly people with multiple health problems who are infected in nursing homes, it can go up to 25% during major outbreaks in these facilities.
Dr. Ioannidis: I feel extremely sad that my predictions were verified. “Major consequences on the economy, society and mental health” have already occurred. I hope they are reversible, and this depends to a large extent on whether we can avoid prolonging the draconian lockdowns and manage to deal with COVID-19 in a smart, precision-risk targeted approach, rather than blindly shutting down everything. Similarly, we have already started to see the consequences of “financial crisis, unrest, and civil strife.” I hope it is not followed by “war and meltdown of the social fabric.”
Globally, the lockdown measures have increased the number of people at risk of starvation to 1.1 billion, and they are putting at risk millions of lives, with the potential resurgence of tuberculosis, childhood diseases like measles where vaccination programs are disrupted, and malaria. I hope that policymakers look at the big picture of all the potential problems and not only on the very important, but relatively thin slice of evidence that is COVID-19.
3) Stanford’s John P.A. Ioannidis — co-director of the university’s Meta-Research Innovation Center and professor of medicine
response to the coronavirus pandemic may be “a fiasco in the making” because we are making seismic decisions based on “utterly unreliable” data. The data we do have, Ioannidis explains, indicates that we are likely severely overreacting.
“The current coronavirus disease, Covid-19, has been called a once-in-a-century pandemic. But it may also be a once-in-a-century evidence fiasco,”
4) Ioannidis, John. “The infection fatality rate of COVID-19 inferred from seroprevalence data.” medRxiv (2020).
Jeffrey Dach MD
7450 Griffin Road, Suite 190
Davie, Fl 33314
954-792-4663
www.jeffreydachmd.com
www.drdach.com
Heart Book by Jeffrey Dach
www.naturalmedicine101.com
www.bioidenticalhormones101.com
www.truemedmd.com
Click Here for: Dr Dach’s Online Store for Pure Encapsulations Supplements
Click Here for: Dr Dach’s Online Store for Nature’s Sunshine Supplements
Web Site and Discussion Board Links:
jdach1.typepad.com/blog/
disc.yourwebapps.com/Indices/244066.html
disc.yourwebapps.com/Indices/244067.html
http://sci.med.narkive.com/covV2Qo2/jeffrey-dach-book-announcment-natural-medicine-101
The reader is advised to discuss the comments on these pages with his/her personal physicians and to only act upon the advice of his/her personal physician. Also note that concerning an answer which appears as an electronically posted question, I am NOT creating a physician — patient relationship. Although identities will remain confidential as much as possible, as I can not control the media, I can not take responsibility for any breaches of confidentiality that may occur.
Copyright (c) 2020 Jeffrey Dach MD All Rights Reserved. This article may be reproduced on the internet without permission, provided there is a link to this page and proper credit is given. See Repost Guidelines.
FAIR USE NOTICE: This site contains copyrighted material the use of which has not always been specifically authorized by the copyright owner. We are making such material available in our efforts to advance understanding of issues of significance. We believe this constitutes a ‘fair use’ of any such copyrighted material as provided for in section 107 of the US Copyright Law. In accordance with Title 17 U.S.C. Section 107, the material on this site is distributed without profit to those who have expressed a prior interest in receiving the included information for research and educational purposes.
Serving Areas of: Hollywood, Aventura, Miami, Fort Lauderdale, Pembroke Pines, Miramar, Davie, Coral Springs, Cooper City, Sunshine Ranches, Hallandale, Surfside, Miami Beach, Sunny Isles, Normandy Isles, Coral Gables, Hialeah, Golden Beach ,Kendall,sunrise, coral springs, parkland,pompano, boca raton, palm beach, weston, dania beach, tamarac, oakland park, boynton beach, delray,lake worth,wellington,plantation
Published on July 5th, 2020 by
Jeffrey Dach MD
The post Covid-19 A Once in a Century Fiasco in the Making appeared first on Jeffrey Dach MD.
May 31, 2020
Effective Early Treatment for Corona Virus
[image error]Effective Early Treatment for Corona Virus
by Jeffrey Dach MD
If you have symptoms of fever, malaise, headache, and cough and runny nose, one might entertain the diagnosis of corona virus. Alternatively your symptoms could be due to one of hundreds of other “influenza-like” viruses. Contrary to what you are being told in the mainstream media, there is a very effective treatment for corona virus and the others when treated early as discussed in a previous newsletter.
Dr. Harvey Risch Yale Medical School
Perhaps the best discussion comes from Yale Professor, Dr. Harvy Risch in the May 27 2020 American Journal of Epidemiology: “Early Outpatient Treatment of Symptomatic, High-Risk Covid-19 Patients that Should be Ramped-Up Immediately as Key to the Pandemic Crisis.”
Dr. Harvy Risch has amazing credentials. He is Professor of Epidemiology in the Department of Epidemiology and Public Health at the Yale School of Public Health and Yale School of Medicine. Dr. Risch’s MD degree University of California and PhD from the University of Chicago.
Five Studies
Dr Risch writes that five studies have shown significant outpatient efficacy for the combination of hydroxychlorquine and azithromycin when used to treat corona virus. He says the combination is safe and “These medications need to be widely available and promoted immediately for physicians to prescribe.”(1):
Here is the quote from his article:
“Five studies, including two controlled clinical trials, have demonstrated significant major outpatient treatment efficacy. Hydroxychloroquine+azithromycin has been used as standard-of-care in more than 300,000 older adults with multicomorbidities, with estimated proportion diagnosed with cardiac arrhythmias attributable to the medications 47/100,000 users, of which estimated mortality is
Dr. Phillip Carlucci NYU Medcical Center
Phillip Carlucci at NYU hospital writes the addition of Zinc massively improves efficacy of this combination, reduces mortality of hospitalized patients by 50% (fifty per cent):
The early addition of zinc to the hydroxychloroquine and azithromycin adds significant benefit to the protocol in hospitalized COV-19 patients according to a recent study by Phillip Carlucci at NYU hospital. Dr. Carlucci studied the hyroxychloroquine/azithromycin protocol with and without added zinc. The addition of zinc reduced the mortality or transfer to hospice by approxinately 50%. (2)
Dr Carlucci writes:
“zinc sulfate increased the frequency of patients being discharged home, and decreased the need for ventilation, admission to the ICU, and mortality or transfer to hospice for patients who were never admitted to the ICU….After adjusting for the time at which zinc sulfate was added to our protocol, an increased frequency of being discharged home (OR 1.53, 95% CI 1.12-2.09) reduction in mortality or transfer to hospice remained significant (OR 0.449, 95% CI 0.271-0.744).”(2)
Preventive Measures:
For prevention of flu-like illness, high doses of Vitamin A, Vitamin D3, Vitamin C are recommended by many integrative physicians such as David Brownstein MD.
Should I Wear a Mask ?
During my medical training years, I spent many long days and nights in the operating room wearing a mask, and gloves, and gown. Of course we followed an elaborate process of “scrubbing in” before donning the mask, gloves and gown in preparation for entering the sterile environment of the operating room. It was not unusual for the chief surgeon to change his gloves multiple times during an operation. All of this clothing was strictly removed and placed in the garbage upon leaving the operating room. Similarly, on the hospital floors, the masks and gloves are immediately removed and disposed of after leaving each patients room.
Re-Using the Same Mask and Gloves
This is quite different from the re-used makeshift masks and gloves of the corona virus pandemic. People are re-using and not disposing of the mask and gloves after leaving each place of business. This leads me to question this practice as being “inherently unhealthy”. The re-used gloves become contaminated with microbes and viruses, which are then spread around town. The mask wearer may have pathogenic microbial organisms in the oral cavity which recirculate from the mask back into the respiratory system, causing worsening symptoms for the mask wearer. Improperly discarded masks on the roadway or sidewalk become a biohazard.
Mask Fatigue
People who wear masks for a long time (including doctors) experience “mask fatigue”, and find themselves pulling at the mask to get better air flow. A quote on “mask fatigue” from Dr. Cheng (10)
“a factor contributing to non-adherence is “mask fatigue.” Most people (including some health professionals) cannot tolerate wearing a mask all day; others can but quickly develop resistance to using it further.”(10)
Masks by Administrative Emergency Order
During the height of the corona virus pandemic, I think it made sense for people to wear a mask in public in heavily populated cities, on a voluntary basis, at the discretion of the use. However, I do not think this practice should ever have been mandated by government order as was done in Broward County (where I live). An Administrative Emergency Order by Bertha Henry on May 21, 2020 mandated wearing mask while shopping in essential businesses (among other things) . This is a typical response for a government administrator who is only trying to do the right thing with limited knowledge and understanding of medical science.
Masks Should be Voluntary, Not Mandatory
In my opinion, at this stage in the timing of the corona virus outbreak, we are at the end of the outbreak. Therefore, the use of masks should not be mandatory. They should be voluntary for individual people who wish to do so. Some may have underlying health conditions posing greater risk, and may wish to wear a mask in public in buses, trains and planes etc.as a preventive measure. For healthy people, wearing a mask in public should be at the discretion of the individual, not mandated by emergency order from a local county administrator.
Face masks to prevent community transmission of viral respiratory infections: Masks, “Available Evidence is Equivocal”
Here is a quote from Dr. Olga Perski:
“Available evidence from RCTs (randomized trials) is equivocal as to whether or not wearing face masks in community settings results in a reduction in clinically- or laboratory-confirmed viral respiratory infections. No relevant studies concerned SARS-CoV-2 or were undertaken in community settings in the UK.” (8)
Five Facts from JB Handley Blog (12)
Fact #1: The Infection Fatality Rate for COVID-19 is somewhere between 0.07-0.20%, in line with seasonal flu.
Fact #2: The risk of dying from COVID-19 is much higher for older people and those with co-morbidities, and much lower for younger healthy people, and nearing zero for children.
Fact #3: People infected with COVID-19 who are asymptomatic (which is most people) do NOT spread COVID-19. (11)
Fact #4: Emerging science shows no spread of COVID-19 in the community (shopping, restaurants, barbers, etc.)
“There is no significant risk of catching the disease when you go shopping. Severe outbreaks of the infection were always a result of people being closer together over a longer period of time…” Quote from – Professor Hendrick Streek , University of Bonn
Fact #5: Published science shows COVID-19 is NOT spread outdoors.
Fact #6: Science shows masks are ineffective to halt the spread of COVID-19, and The WHO recommends they should only be worn by healthy people if treating or living with someone with a COVID-19 infection.
Conclusion: The Latest Outrage: In the opinion of Dr Harvey Hirsch, Professor of Medicine at Yale, highly efficacious treatment is available for early corona virus symptoms as described above. The mass media has been suppressing this information, the result of which is causing untold suffering and death in the American Population. This is an outrage.
At this stage of the pandemic, makeshift face masks used by the public may be causing more harm than good, should be changed to voluntary, and emergency mandates rescinded.
Articles with related interest: Coronavirus , How to Protect Yourself from Covid–19
Jeffrey Dach MD
7450 Griffin Road
Suite 180/190
Davie, Fl 33314
954-792-4663
www.jeffreydachmd.com
References
1) Risch, Harvey A. “Early Outpatient Treatment of Symptomatic, High-Risk Covid-19 Patients that Should be Ramped-Up Immediately as Key to the Pandemic Crisis.” American Journal of Epidemiology (2020).
2) Carlucci, Philip, et al. “Hydroxychloroquine and azithromycin plus zinc vs hydroxychloroquine and azithromycin alone: outcomes in hospitalized COVID-19 patients.” medRxiv (2020).Hydroxychloroquine azithromycin plus zinc in hospitalized COVID19 patients Phillip Carlucci 2020
3) Mask mystery: Why are U.S. officials dismissive of protective covering? By BEN SCHRECKINGER 03/30/2020 08:30 PM EDT
4) Should Americans Wear Masks Outside The House? Dr. Anthony Fauci Now Says Maybe Marley Coyne Marley Coyne Forbes Staff Business
5) Masks Don’t Work: A review of science relevant to COVID-19 social policy. Technical Report (PDF Available) · April 2020 D. G. Rancourt Ontario Civil Liberties Association
6) Javid, Babak, Michael P. Weekes, and Nicholas J. Matheson. “Covid-19: should the public wear face masks?.” (2020).
7) Howard, Jeremy, et al. “Face masks against COVID-19: an evidence review.” (2020).
8) Perski, Olga, et al. “Face masks to prevent community transmission of viral respiratory infections: A rapid evidence review using Bayesian analysis.” Qeios (2020).
Conclusions: Available evidence from RCTs is equivocal as to whether or not wearing face masks in community settings results in a reduction in clinically- or laboratory-confirmed viral respiratory infections. No relevant studies concerned SARS-CoV-2 or were undertaken in community settings in the UK.
9) Greenhalgh, Trisha, et al. “Face masks for the public during the covid-19 crisis.” Bmj 369 (2020).
10) Cheng, Sheung-Tak. “Covid-19: are face masks a good long term strategy?.” BMJ 369 (2020).
a factor contributing to non-adherence is “mask fatigue.” Most people (including some health professionals3) cannot tolerate wearing a mask all day; others can but quickly develop resistance to using it further.
11) Gao, Ming, et al. “A study on infectivity of asymptomatic SARS-CoV-2 carriers.” Respiratory Medicine (2020): 106026.
455 contacts who were exposed to the asymptomatic COVID-19 virus carrier became the subjects of our research. They were divided into three groups: 35 patients, 196 family members and 224 hospital staffs. We extracted their epidemiological information, clinical records, auxiliary examination results and therapeutic schedules.
Results The median contact time for patients was four days and that for family members was five days. Cardiovascular disease accounted for 25% among original diseases of patients. Apart from hospital staffs, both patients and family members were isolated medically. During the quarantine, seven patients plus one family member appeared new respiratory symptoms, where fever was the most common one. The blood counts in most contacts were within a normal range. All CT images showed no sign of COVID-19 infection. No severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections was detected in 455 contacts by nucleic acid test.
Conclusion In summary, all the 455 contacts were excluded from SARS-CoV-2 infection and we conclude that the infectivity of some asymptomatic SARS-CoV-2 carriers might be weak.
Unquestionably, all cases tested negative for SARS-CoV-2 nucleic acid. This fact illustrated that there had been no cases of infection in a relatively dense space.
The result of this study may alleviate parts of the public concern about asymptomatic infected people.
12) J B Handley Blog Lockdown Lunacy
Published on May 31st, 2020 by
Jeffrey Dach MD
The post Effective Early Treatment for Corona Virus appeared first on Jeffrey Dach MD.
April 1, 2020
Coronavirus, How to Protect Ourselves
[image error]Coronavirus, How to Protect Ourselves
by Jeffrey Dach MD
Corona Virus Has Changed the World as We Know It
The arrival of the corona virus pandemic has changed the world. Many of these changes are obvious as we practice social distancing, and wear gloves and mask in public. Our routines at the gym, tennis and golf course, workplaces and places of worship are all disrupted, as many of these have closed their doors to prevent large social gatherings which could spread the virus. Many businesses are suffering from the economic slow down and have drastically reduced income. The markets are undergoing a series of spasmodic gyrations not seen in years.
[image error] How to Protect Ourselves From the Corona virus
First of all I would direct you to a very good video by Dr David Price from Weill Cornell Hospital in New York who explains basic measures how to protect ourselves from the coronavirus.
1) Always know where your hands are and keep them clean…
2) use Purell hand sanitizer…
3) wash hands …
4) do not touch your face after coming into contact with outside objects such as door handles, shopping carts, gas pump handle, surfaces etc…
5) wear a mask to prevent oneself from touching face. does not need to be a medical mask
6) know your hands are clean. do not touch face. …
7) distance between people..stay away 3-6 from people..reduce the size of your social circle.
Boosting the Immune System with Supplements
Secondly, I would direct you to Dr. David Brownstein’s recommendations for boosting the immune system with supplements to prepare for dending against a viral infection:
Dr. David Brownstein writes:
“At the first sign of any illness, I suggest my patients take:
100,000 U of vitamin A (NOT beta-carotene),
50,000 U of vitamin D3
5-10,000 mg of vitamin C per day for four days.
Pregnant women should not take high doses of vitamins A and D. Vitamin C can be increased to bowel tolerance” end quote Dr. Brownstein.
Link to full article on Dr. Brownstein’s Blog
Dr. Zelenko’s Recommendations
Thirdly I would refer you to Dr. Zelenko’s for his recommendations. My son, Benjamin lives in New Jersey with his family and knows Dr. Zelenko, a local MD who has successfully treated more than 700 patients for coronavirus with repurposed drugs and supplements.
1) Hydroxychloroquine (Plaquenil requires prescription) 200 mg tabs one tab twice a day for 5 days.
2) Azithromycin (Z-Pak 250 mg tabs two tabs first day and one tab daily for next four days.)
3) Zinc sulfate (at the vitamin store)
Dr. Vladimir Zelenko has now treated 699 coronavirus patients with 100% success using Hydroxychloroquine Sulfate, Zinc and Z-Pak
FDA Issues Emergency Use Authorization for Hydroxychloroquine
On March 29, 2020, the FDA issued an Emergency Use Authorization for hydroxychloroquine as treatment for COVID-119.
Mechanism of Drug Action Against Corona Virus
Both Hydroxychloroquin and Azithromycin are autophagy inhibitors which alter the acidity in lysosomes. The virus uses lysosomes for replication. By altering acidity in the lysosomes, corona virus replication is prevented. This is explained in this article:Yang, Naidi, and Han-Ming Shen. “Targeting the Endocytic Pathway and Autophagy Process as a Novel Therapeutic Strategy in COVID-19.” Int J Biol Sci 16.10 (2020): 1724-1731.
To See Coronavirus Drug Treatment References Click Here.
Antiviral Herbals
Stephen Buhner is the world’s expert on antiviral herbals, and in his book, recommends :
1) Chinese Skullcap (Baicalin)
2) Licorice Root Extract
3) Quercetin
For more on this see this article on Antiviral Herbals
[image error]Intravenous vitamin C for Severe Cases
For those unfortunate enough to develop viral pneumonia and require treatment in the ICU on a ventilator, many of these patients can be saved by intravenous vitamin C. Intravenous vitamin C is being used in these severe corona virus ventilator patients in New York Hospitals with success. Demand your doctor give your family member I.V. vitamin C in the hospital. It can save a life.
See this article: Intravenous Vitamin C Saves Man Dying of Viral Pneumonia
Articles with related Interest:
Intravenous Vitamin C Saves Man Dying of Viral Pneumonia
Vitamin D Prevents Viral Influenza
Images courtesy of Wikimedia commons in public domain:
Jeffey Dach MD
7450 Griffin Road, Suite 190
Davie, Fl 33314
954-792-4663
www.jeffreydachmd.com
www.drdach.com
Heart Book by Jeffrey Dach
www.naturalmedicine101.com
www.bioidenticalhormones101.com
www.truemedmd.com
Click Here for: Dr Dach’s Online Store for Pure Encapsulations Supplements
Click Here for: Dr Dach’s Online Store for Nature’s Sunshine Supplements
Web Site and Discussion Board Links:
jdach1.typepad.com/blog/
disc.yourwebapps.com/Indices/244066.html
disc.yourwebapps.com/Indices/244067.html
http://sci.med.narkive.com/covV2Qo2/jeffrey-dach-book-announcment-natural-medicine-101
The reader is advised to discuss the comments on these pages with his/her personal physicians and to only act upon the advice of his/her personal physician. Also note that concerning an answer which appears as an electronically posted question, I am NOT creating a physician — patient relationship. Although identities will remain confidential as much as possible, as I can not control the media, I can not take responsibility for any breaches of confidentiality that may occur.
Copyright (c) 2020 Jeffrey Dach MD All Rights Reserved. This article may be reproduced on the internet without permission, provided there is a link to this page and proper credit is given. See Repost Guidelines.
FAIR USE NOTICE: This site contains copyrighted material the use of which has not always been specifically authorized by the copyright owner. We are making such material available in our efforts to advance understanding of issues of significance. We believe this constitutes a ‘fair use’ of any such copyrighted material as provided for in section 107 of the US Copyright Law. In accordance with Title 17 U.S.C. Section 107, the material on this site is distributed without profit to those who have expressed a prior interest in receiving the included information for research and educational purposes.
Serving Areas of: Hollywood, Aventura, Miami, Fort Lauderdale, Pembroke Pines, Miramar, Davie, Coral Springs, Cooper City, Sunshine Ranches, Hallandale, Surfside, Miami Beach, Sunny Isles, Normandy Isles, Coral Gables, Hialeah, Golden Beach ,Kendall,sunrise, coral springs, parkland,pompano, boca raton, palm beach, weston, dania beach, tamarac, oakland park, boynton beach, delray,lake worth,wellington,plantation
Published on April 1st, 2020 by
Jeffrey Dach MD
The post Coronavirus, How to Protect Ourselves appeared first on Jeffrey Dach MD.
January 1, 2020
How to Avoid Heart Disease Interview with Jay Campbell
[image error]How to Avoid Coronary Calcification Heart Disease with Jeffrey Dach MD, and TOT Revolution Jay Campbell
I was pleased and honored to accept Jay Campbell’s invitation for a video interview. Here is the video Interview (above) with the two of us discussing a range of topics including my recent book, Heart Book, on coronary calcium score and heart disease, the use of Clomid for low testosterone, and the topic of va((i-nation .
Below: These are Jay’s notes posted on You Tube with the Interview
Infection in the body leads to calcification, which eventually leads to heart disease. Are there measures we can take to prevent it? What are the common causes of calcification? Do statin medications have any benefits? On this episode, I’m joined by legendary physician, heart disease and testosterone expert, and author, Dr. Jeffrey Dach. He shares his insights on calcification, and the attack on our biological systems.
Three Takeaways
1) The two common causes of calcification are a leaky gut and dental disease.
2) In order to move medicine forward, we need disruptive science; studies which cause paradigm shifts of established patterns and economic interrupt patterns.
3) The benefits of statin drugs are not lowering cholesterol, they are actually pleiotropic effects which include the reduction of inflammation.
Guest Bio – Dr. Jeffrey is a Specialty Board Certified in Diagnostic and Interventional Radiology and has 25 years experience serving the Memorial Healthcare System in Hollywood, Florida, with Radiology Associates of Hollywood. He is also the author of The Heart Book. For more information, visit https://jeffreydachmd.com/
Articles with Similar Interest:
[image error]
Clomid for Low Testosterone Part One
Jeffrey Dach MD
7450 Griffin Road Suite 180/190
Davie, Florida 33314
954-792-4663
Published on January 1st, 2020 by
Jeffrey Dach MD
The post How to Avoid Heart Disease Interview with Jay Campbell appeared first on Jeffrey Dach MD.
November 24, 2019
Vaccine Injury Epidemic VIE Event Washington DC Nov 14, 2019
[image error]
Vaccine Injury Epidemic VIE Event Washington D.C. Nov 14, 2019
Our broken vaccine system is creating a massive vaccine injury epidemic, the greatest tragedy of modern history. The VIE Event in Washington DC, Nov. 2019, features some of the luminaries of the vaccine safety movement. This event is only one of many pushing back against the medical tyranny of the pharmaceutical industry in bed with the government. This is a video recording of the entire 4 hour VIE program. I suggest you watch it in short 30 min segments during your free time.
VIE Speaker List:
Hillary Simpson
Barbara Loe Fisher, NVIC
Del BigTree, Informed Consent Action Network
James Lyons Weiler, PhD, IPAK
Mary Holland ESQ, NYU School of Law
Dr Bob Sears MD, Pediatrician
Rep Heidi Sampson Republican Maine 21st District
Dr Jim Meehan MD
Dr Sherri TenPenny DO
Sen. Robert Foley R. Maine District 34
Dr Shiva Ayyadurai PhD, MIT
Mark Blaxill, Chairman Canary Party
Kari Bundy, Son Died After Vaccination
Andrew Wakefield, MD Gasteroenterologist
Robert F Kennedy Jr, Children’s Health Defense
Ameer Hamideh, Special Needs Child
Kevin Barry, Esq. First Freedoms
Messianic Rabbi Henry Morse, Shofar Blowing Demo
Father Michael Copenhagen
Charmaine Rusin, Religious Leader
Dr Peter Aaby – DPT Vaccine Associated with 5-10 Fold increase in Mortality
Peter Aaby at the Symposium about Scientific Freedom, Copenhagen, 9 March 2019. Published study of Vaccinated vs. Un-vaccinated children shows the DPT vaccine causes a 5 to 10-fold increase in mortality.(1-3)
Conclusion: Our broken vaccine system is creating a massive vaccine injury epidemic, the greatest tragedy of modern history. In peer reviewed published study, Dr Aaby shows the DPT Vaccine is associated with a 5-10 fold increase in mortality compared to the unvaccinated. (1-3)
Jeffrey Dach MD
7450 Griffin Road Suite 180/190
Davie, FL 33314
954-792-4663
References
1) Mogensen, Søren Wengel, et al. “The Introduction of Diphtheria-Tetanus-Pertussis and Oral Polio Vaccine Among Young Infants in an Urban African Community: A Natural Experiment.” (2017).
Among 3–5-month-old children, having received DTP (± OPV) was associated with a mortality hazard ratio (HR) of 5.00 (95% CI 1.53–16.3) compared with not-yet-DTP-vaccinated children. Differences in background factors did not explain the effect. The negative effect was particularly strong for children who had received DTP-only and no OPV (HR = 10.0 (2.61–38.6)). All-cause infant mortality after 3 months of age increased after the introduction of these vaccines (HR = 2.12 (1.07–4.19)).
2) DTP Vaccine Increases Mortality 5-Fold, In Study Without Healthy User Bias
3) April 24, 2017 DTP Vaccine Increases Mortality in Young Infants 5 to 10-Fold Compared to Unvaccinated Infants
4) Thysen, Sanne M., et al. “Out-of-sequence DTP and measles vaccinations and child mortality in Guinea-Bissau: a reanalysis.” BMJ open 9.9 (2019): e024893.
5) Aaby, Peter, et al. “Evidence of Increase in Mortality After the Introduction of Diphtheria–Tetanus–Pertussis Vaccine to Children Aged 6–35 Months in Guinea-Bissau: A Time for Reflection?.” Frontiers in public health 6 (2018): 79.
Although having better nutritional status and being protected against three infections, 6–35 months old DTP-vaccinated children tended to have higher mortality than DTP-unvaccinated children. All studies of the introduction of DTP have found increased overall mortality.
Link to Dr Aaby’s Publications on PubMed
VIE Event Video Recording Courtesy of ICAN.
Header Image Courtesy of CrazyMothers and Renegrade Tribune
Published on November 24th, 2019 by
Jeffrey Dach MD
The post Vaccine Injury Epidemic VIE Event Washington DC Nov 14, 2019 appeared first on Jeffrey Dach MD.
October 17, 2019
Open Letter to Fla State Legislature Opposing SB64
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Open Letter to All Florida State Legislators
Re: Senate Bill SB 64: Exemptions from School-entry Health Requirements: Referred to Health Policy; Education; Rules
Dear Senator _____________ .
I am a board certified physician licensed in the State of Florida since 1980. I served the South Broward Hospital District, Memorial Hospital for 25 years as a Diagnostic and Interventional Radiologist from 1981 to 2006, and from 2006 to the present, resumed outpatient clinical medicine in Davie Florida.
The reason for this email is to express to you my opposition to Senate Bill SB64 which repeals the religious exemption to vaccination and further restricts medical exemptions, creating a de facto “mandatory vaccination” for child entry to schools. There are two areas of concern.
The first: Mandatory vaccination laws violate various civil rights, religious freedoms, and personal freedoms such as the right to decline a medical procedure without coercion. As you may know, California and New York, both heavily Democratic states, have already passed similar draconian legislation. In recent Court challenges in New York, the Courts have ruled in favor of the State, confirming the State’s authority to remove religious exemptions and/or impose compulsory vaccination “to protect the public health”. The failure of these Court challenges brings a sense of urgency to oppose SB64.
My second area of concern about SB64 as well as vaccine legislation in general is the obvious one. Our nation has a “broken vaccine system” beginning with the 1986 Vaccine Act which removed liability from the Vaccine Makers, replacing it with a Federal Vaccine Court, which created VAERS ( the vaccine adverse event reporting system). One might then ask the next obvious question: Instead of “protecting the public health”, could it be possible our “broken vaccine system” is paradoxically harming it? The answer to this heretical question, unfortunately, remains elusive because we do not have the proper long term placebo controlled clinical trials of the entire 72 dose recommended CDC vaccine schedule. (16 vaccines). Our surveillance system (VAERS) in woefully inadequate and cannot provide accurate information on each and every adverse event following a vaccination.
And yes, I am familiar with the AMA recent policy statement advocating elimination of Non-Medical Vaccine Exemptions. The AMA says: “The overwhelming scientific evidence shows that vaccines are among the most effective and safest interventions to both prevent individual illness and protect the health of the public.” and the CDC says: “Vaccination is one of the “Ten Great Public Health Achievements in the 20th Century.” However, both organizations have been captured by the pharmaceutical industry, and are merely serving as mouthpiece for them.
I have listed below an alternative legislative agenda with the same goal in mind, “to protect the public health”, by fixing our “broken vaccine system”. Perhaps this agenda could be discussed among the Health Committee members, and hopefully lead to legislative initiatives as in other states.
Suggested Legislative Agenda to Fix our “Broken Vaccine System” and “Protect Public Health”:
1) Repeal 1986 Vaccine Act, Restore Liability to Vaccine Makers for Product Injury.
2) Reclassify Vaccines from Biologics to Drugs Requiring Placebo Controlled Randomized Trials for Approval and Licensing same as any other Drug.
3) Vaccine Adjuvants such as Aluminum are to be classified as New Drugs, which require separate placebo controlled safety testing for the adjuvant.
4) Replace or Update VAERS so it captures 100% of all vaccine injuries and deaths, using a team of trained health professionals to track all vaccine events which are followed for at least one year, with 100% of all adverse events entered into the database.
5) Ban Direct Consumer Drug Television Advertising as all other industrialized countries have done (with the exception of New Zealand)
6) Ban Financial Kickbacks to Pediatricians from insurance companies for childhood vaccinations. Enforce existing laws, Anti-Kickback Statutes and Anti-Physician Self-Referral Laws (Stark law) which prohibit financial kickbacks for medical procedures.
7) Ban the practice of payments to hospitals for vaccination quotas for patient vaccinations.
8) Ban the practice of using Flu Vaccination status as a prerequisite for employment for hospital nursing staff and other health professionals.
9) CME’s: Health professionals such as Pediatricians, and Pediatric Nurses will require 1 hour CME in recognizing and reporting vaccine adverse effects, the history of past discontinued (failed) vaccines etc.
10) Mandate Serologic-Genotype Testing for all viral disease cases to determine if the “epidemic” is caused by a vaccine strain virus which is not a “public health emergency”.
11) Ban the use of vaccines during pregnancy unless the vaccine has been prospectively tested for safety and efficacy in Pregnant Women.
12) Ban the use of the Hepatitis B vaccine in newborns unless the mother tests positive for hepatitis B. Hepatitis B is transmitted through IV drug use or sexual contact, none of which is capable for newborns.
13) Pass resolutions condemning censorship on the Internet by Google, Facebook, and other social media of discussions questioning vaccines. We need a free and open debate.
14) Open a Congressional Inquiry into William Thompson Whistle-blower at the CDC claiming fraudulent manipulation of Data in the DeStefano 2004 MMR study. Reference: DeStefano, Frank, et al. “Age at first measles-mumps-rubella vaccination in children with autism and school-matched control subjects: a population-based study in metropolitan Atlanta.” Pediatrics 113.2 (2004): 259-266.
15) Open a Congressional Inquiry into the Andrew Zimmerman MD, pediatric neurologist and expert witness for the federal vaccine court. Dr Zimmerman’s expert testimony, “That Vaccines Can Cause Autism in some cases” was suppressed and fraudulently misrepresented by federal vaccine court lawyers.
16) Open a Congressional Inquiry on “Why USA has Highest Infant Mortality Rate and Japan Lowest ?” Japan Banned the Hepatitis B Shot for newborns. In, Japan, vaccination is entirely voluntary, having no vaccine requirement for school entry.
17) Ban the “Revolving Door” practice by prohibiting top officials at the CDC and FDA from rotating from government job to executive for the drug industry and vice versa.
In closing, our nation is poised at a historic crossroads. Hanging in the balance is the question: Will we preserve the individual right to decline unwanted medical procedures, or will we descend into the tyranny of a medical police state? I respectfully request your opposition to SB64, and your support for the above Legislative Agenda to Fix our “Broken Vaccine System” and and thereby “Protect the Public Health”.
Please feel free to contact me for more details, references charts, etc. I am available to meet formally with the committee or informally in the office setting at your convenience for further discussions.
Useful Links:
Link to my vaccination page with more of my articles:
warmest regards,
Jeffrey Dach MD
7450 Griffin Road Suite 180/190
Davie, Florida 33314
954-792-4663
www.jeffreydachmd.com
header image: US Capitol Building courtesy of Wikimedia Commons.
Published on October 17th, 2019 by
Jeffrey Dach MD
The post Open Letter to Fla State Legislature Opposing SB64 appeared first on Jeffrey Dach MD.
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