Jeffrey Dach's Blog, page 17
February 19, 2018
Anti-Cancer Vaccine with Embryonic Stem Cells
Anti-Cancer Vaccine with Embryonic Stem Cells
What if I told you a simple vaccine could prevent or cure cancer? Would you laugh at such a ridiculous idea ? You might be surprised to know that a group at Stanford reported a successful anti-cancer vaccine in a animal breast cancer xenograft model.(1)(6-7) Instead of embryonic cells, Dr Wu used adult cells induced to form pluri potent stem cells, which are very similar to embryonic stem cells.(1)(6,7) Others have created similar successful vaccines against colon, ovarian and lung cancer.(2-3)(8-9) Remarkably, these vaccines have no toxicity to the host animal.
Cancer Cells Are Remarkably Similar to Embryonic Stem cells
It was recognized all the way back in 1906 by Schöne that injection of embryonic/fetal tissue stimulates rejection of transplanted tumors in animals.(5) More recent work has shown that cancer cells share many features of embryonic stem cells, including genetic signature and surface protein markers called epitopes which can be recognized by the immune system. These protein markers these include HCG and CEA.(5) HCG (human chorionic gonadotropic is a pregnancy test, and also a cancer test. The carcinoembryonic antigen (CEA) is a well known test for cancer cells by virtue of detecting an embyronic antigen released by cancer cells.(5)
Similarities between trophoblast (placental) cell and cancer cell behavior has been reported for over 100 years. More recently, Dr. C. Ferretti in 2006 found similarities in the molecular circuits relating to the proliferative, invasive and migratory capacities of both types of cells.(10) So it is not surprising that they should share surface antigens.
Circumventing Ethical Issues with Fetal Cell Research
Because of ethical concerns, fetal stem cell research was halted a few years ago. To circumvent this issue, Dr Wu’s group has converted adult cells into plui-potent stem cells which can serve in place of embryonic stem cells.
Conclusion: Anti-cancer vaccines derives from pluri-potent stem cells in animal models are quite effective. It may take a few more years to iron out the wrinkles and translate to human use.
Jeffrey Dach MD
Related Articles:
Nicholas Gonzalez MD and the Trophoblastic Theory of Cancer
Links and References:
Header Image Embryonic Stem Cells Courtesy of Wikimedia Commons
Breast Cancer Xenograft animal model
1) Autologous iPSC-Based Vaccines Elicit Anti-tumor Responses In Vivo Kooreman, Nigel G. et al. Cell Stem Cell , Volume 0 , Issue 0 ,
our data show the feasibility of creating broad tumor immunity against multiple cancer types using an iPSC-based vaccine that presents the immune system with large quantities of tumor antigens. Compared to current immunotherapy strategies, our iPSC vaccine is capable of reactivating the immune system to target cancers without therapy-associated adverse effects and can be created within a few weeks after diagnosis. These beneficial properties make this iPSC vaccine a potential option for personalized adjuvant immunotherapy shortly after conventional primary treatment of cancer.
Colon Cancer
2) Int J Cancer. 2018 Apr 1;142(7):1453-1466. Vaccination with human amniotic epithelial cells confer effective protection in a murine model of Colon adenocarcinoma.
Tabatabaei M1, Mosaffa N1, Ghods R2,3, Nikoo S4, Kazemnejad S5, Khanmohammadi M5, Mirzadeghan E5, Mahmoudi AR4, Bolouri MR4, Falak R4, Keshavarzi B1, Ramezani M6, Zarnani AH4,7.
As a prophylactic cancer vaccine, human amniotic membrane epithelial cells (hAECs) conferred effective protection in a murine model of colon cancer. The immunized mice mounted strong cross-protective CTL and antibody responses. Tumor burden was significantly reduced in tumor-bearing mice after immunization with hAECs. Placental cancer immunotherapy could be a promising approach for primary prevention of cancer. In spite of being the star of therapeutic strategies for cancer treatment, the results of immunotherapeutic approaches are still far from expectations. In this regard, primary prevention of cancer using prophylactic cancer vaccines has gained considerable attention. The immunologic similarities between cancer development and placentation have helped researchers to unravel molecular mechanisms responsible for carcinogenesis and to take advantage of stem cells from reproductive organs to elicit robust anti-cancer immune responses. Here, we showed that vaccination of mice with human amniotic membrane epithelial cells (hAECs) conferred effective protection against colon cancer and led to expansion of systemic and splenic cytotoxic T cell population and induction of cross-protective cytotoxic responses against tumor cells. Vaccinated mice mounted tumor-specific Th1 responses and produced cross-reactive antibodies against cell surface markers of cancer cells. Tumor burden was also significantly reduced in tumor-bearing mice immunized with hAECs. Our findings pave the way for potential future application of hAECs as an effective prophylactic cancer vaccine.
Ovarian Cancer
3) Asian Pac J Cancer Prev. 2012;13(9):4295-300.
Human embryonic stem cells–a potential vaccine for ovarian cancer.
Zhang ZJ1, Chen XH, Chang XH, Ye X, Li Y, Cui H.
To investigate the therapeutic potential of human embryonic stem cells (hESCs) as a vaccine to induce an immune response and provide antitumor protection in a rat model.
METHODS: Cross-reactivity of antigens between hESCs and tumour cells was screened by immunohistochemistry. Fischer 344 rats were divided into 7 groups, with 6 rats in each, immunized with: Group 1, hESC; Group 2, pre-inactivated mitotic NuTu-19; Group 3 PBS; Group 4, hESC; Group 5, pre-inactivated mitotic NuTu-19; Group 6, PBS; Group 7, hESC only. At 1 (Groups 1-3) or 4 weeks (Groups 4-6) after the last vaccination, each rat was challenged intraperitoneally with NuTu-19. Tumor growth and animal survival were closely monitored. Rats immunized with H9 and NuTu- 19 were tested by Western blot analysis of rat orbital venous blood for cytokines produced by Th1 and Th2 cells.
RESULTS:hESCs presented tumour antigens, markers, and genes related to tumour growth, metastasis, and signal pathway interactions. The vaccine administered to rats in Group 1 led to significant antitumor responses and enhanced tumor rejection in rats with intraperitoneal inoculation of NuTu-19 cells compared to control groups. In contrast, rats in Group 4 did not display any elevation of antitumour responses. Western blot analysis found cross-reactivity among antibodies generated between H9 and NuTu-19. However, the cytokines did not show significant differences, and no side effects were detected.
CONCLUSION:hESC-based vaccination is a promising modality for immunotherapy of ovarian cancer.
4) Kwiatkowska-Borowczyk, Eliza P., et al. “Immunotargeting of cancer stem cells.” Contemporary Oncology 19.1A (2015): A52.
Cancer stem cells (CSCs) represent a distinctive population of tumour cells that control tumour initiation, progression, and maintenance. Their influence is great enough to risk the statement that successful therapeutic strategy must target CSCs in order to eradicate the disease. Because cancer stem cells are highly resistant to chemo- and radiotherapy, new tools to fight against cancer have to be developed. Expression of antigens such as ALDH, CD44, EpCAM, or CD133, which distinguish CSCs from normal cells, together with CSC immunogenicity and relatively low toxicity of immunotherapies, makes immune targeting of CSCs a promising approach for cancer treatment. This review will present immunotherapeutic approaches using dendritic cells, T cells, pluripotent stem cells, and monoclonal antibodies to target and eliminate CSCs.
5) Exp Mol Pathol. 2009 Jun;86(3):192-7. Embryonic vaccines against cancer: an early history. Brewer BG1, Mitchell RA, Harandi A, Eaton JW.
Almost 100 years have passed since the seminal observations of Schöne showing that vaccination of animals with fetal tissue would prevent the growth of transplantable tumors. Many subsequent reports have affirmed the general idea that immunologic rejection of transplantable tumors, as well as prevention of carcinogenesis, may be affected by vaccination with embryonic/fetal material. Following a decade of intense research on this phenomenon during approximately 1964-1974, interest appears to have waned. This earlier experimental work may be particularly pertinent in view of the rising interest in so-called cancer stem cells. We believe that further work – perhaps involving the use of embryonic stem cells as immunogens – is warranted and that the results reviewed herein support the concept that vaccination against the appearance of cancers of all kinds is a real possibility.
5) Vinnitsky, V. “The development of a malignant tumor is due to a desperate asexual self-cloning process in which cancer stem cells develop the ability to mimic the genetic program of germline cells” Intrinsically disordered proteins 2.1 (2014): e29997-e29997.
Immunization against cancer using embryonic material has a history of more than 100 years. Oncodevelopmental antigens were reported to have been identified by transplantation as early as 1906 when Schone148 SchöneG. Untersuchungen uber Kakzinomimmunitat bei Mausen. Munch Med Wochenschr1906; 53:2517 – 9 [Google Scholar] found that tumor transplants that would kill normal mice would be rejected by mice that had previously been immunized with fetal tissue; immunization with adult tissue was ineffective.149 SellS, BeckerFF, LeffertHL, WatabeL. Expression of an oncodevelopmental gene product (alpha-fetoprotein) during fetal development and adult oncogenesis. Cancer Res1976; 36:4239 – 49; PMID: 61804 [PubMed], [Web of Science ®], [Google Scholar] In the following decades, many reports affirmed the general idea that immunization of an individual with fetal tissue, including placental tissue, can result in immunologic rejection of transplantable tumors, as well as prevention of the development of chemically-induced tumors.150
We consider the development of effective cancer vaccines using tumor-embryo cross-reacting antigens for early-life immunization as a new research strategy aimed at creation of life-long immunity against cancer.
6) Induced pluripotent stem cells could serve as cancer vaccine
Date: February 15, 2018 Source: Stanford Medicine
Summary: Induced pluripotent stem cells, or iPS cells, are a keystone of regenerative medicine. Outside the body, they can be coaxed to become many different types of cells and tissues that can help repair damage due to trauma or disease. Now, a study in mice suggests another use for iPS cells: training the immune system to attack or even prevent tumors.
7) Induced pluripotent stem cells could serve as cancer vaccine Priming the immune system with induced pluripotent stem cells prevented or slowed the development of cancer in mice, Stanford researchers found. (Stanford News Release)
Lung Cancer
8) Dong, Wei, et al. “Administration of embryonic stem cells generates effective antitumor immunity in mice with minor and heavy tumor load.” Cancer immunology, immunotherapy 59.11 (2010): 1697-1705.
The history of immunizing animals with fetal tissues to generate an antitumor response dates back a century ago. Subsequent reports supported the idea that vaccination with embryonic materials could generate cancer-specific immunity and protect animals from transplantable and chemically induced tumors. In our study, we found C57 BL/6 mice vaccinated with embryonic stem cells (ESCs) received obvious antitumor immunity, which protected them from the formation and development of lung cancer. Furthermore, we investigated the antitumor effects of administration of ESCs in mice with minor and/or heavy tumor load. The tumor growth was monitored, the proliferation of lymphocytes and secretion of cytokines were examined, and finally the tissue sections were approached by immunohistochemical and apoptosis staining. The results suggested that mice injected with ESCs received obvious tumor inhibition and retardation due to significant lymphocyte proliferation and cytokine secretion, which help to rebuild the host’s immunity against cancer to some extent and comprise the main part of antitumor immunity. Moreover, mice with minor tumor load received stronger antitumor effect compared with mice with heavy tumor load, may be due to relatively intact immune system. Thus, besides their function as prophylactic vaccines, administration of ESCs could be a potential treatment for cancer, which obviously prevent and control the proliferation and development of malignant tumors.
9) Yaddanapudi, Kavitha, et al. “Vaccination with embryonic stem cells protects against lung cancer: is a broad-spectrum prophylactic vaccine against cancer possible?.” PloS one 7.7 (2012): e42289.
The antigenic similarity between tumors and embryos has been appreciated for many years and reflects the expression of embryonic gene products by cancer cells and/or cancer-initiating stem cells. Taking advantage of this similarity, we have tested a prophylactic lung cancer vaccine composed of allogeneic murine embryonic stem cells (ESC). Naïve C57BL/6 mice were vaccinated with ESC along with a source of granulocyte macrophage-colony stimulating factor (GM-CSF) in order to provide immunostimulatory adjuvant activity. Vaccinated mice were protected against subsequent challenge with implantable Lewis lung carcinoma (LLC). ESC-induced anti-tumor immunity was not due to a non-specific “allo-response” as vaccination with allogeneic murine embryonic fibroblasts did not protect against tumor outgrowth. Vaccine efficacy was associated with robust tumor-reactive primary and memory CD8(+) T effector responses, Th1 cytokine response, higher intratumoral CD8(+) T effector/CD4(+)CD25(+)Foxp3(+) T regulatory cell ratio, and reduced myeloid derived suppressor cells in the spleen. Prevention of tumorigenesis was found to require a CD8-mediated cytotoxic T lymphocyte (CTL) response because in vivo depletion of CD8(+) T lymphocytes completely abrogated the protective effect of vaccination. Importantly, this vaccination strategy also suppressed the development of lung cancer induced by the combination of carcinogen administration and chronic pulmonary inflammation. Further refinement of this novel vaccine strategy and identification of shared ESC/tumor antigens may lead to immunotherapeutic options for lung cancer patients and, perhaps more importantly, could represent a first step toward the development of prophylactic cancer vaccines.
10) Ferretti, C., et al. “Molecular circuits shared by placental and cancer cells, and their implications in the proliferative, invasive and migratory capacities of trophoblasts.” Human reproduction update 13.2 (2007): 121-141. Molecular circuits shared by placental and cancer cells implications in proliferative invasive migratory trophoblasts Ferretti C Human repro upd 2007
11) Erenpreisa, Jekaterina, et al. “The “virgin birth”, polyploidy, and the origin of cancer.” Oncoscience 2.1 (2015): 3.
Recently, it has become clear that the complexity of cancer biology cannot fully be explained by somatic mutation and clonal selection. Meanwhile, data have accumulated on how cancer stem cells or stemloids bestow immortality on tumour cells and how reversible polyploidy is involved. Most recently, single polyploid tumour cells were shown capable of forming spheroids, releasing EMT-like descendents and inducing tumours in vivo. These data refocus attention on the centuries-old embryological theory of cancer. This review attempts to reconcile seemingly conflicting data by viewing cancer as a pre-programmed phylogenetic life-cycle-like process. This cycle is apparently initiated by a meiosis-like process and driven as an alternative to accelerated senescence at the DNA damage checkpoint, followed by an asexual syngamy event and endopolyploid-type embryonal cleavage to provide germ-cell-like (EMT) cells. This cycle is augmented by genotoxic treatments, explaining why chemotherapy is rarely curative and drives resistance. The logical outcome of this viewpoint is that alternative treatments may be more efficacious – either those that suppress the endopolyploidy-associated ‘life cycle’ or, those that cause reversion of embryonal malignant cells into benign counterparts. Targets for these opposing strategies are components of the same molecular pathways and interact with regulators of accelerated senescence.
These observations and conclusions largely fit the embryonal theory of cancer. Its oncogerminative variant is proposed by Vladimir Vinnitsky
This consideration brings us to the c-myc protooncogene, whose overexpression uncouples DNA replication from mitosis, thus leading to endopolyploidy [110]. C-myc is one of the most ancient genes of early Metazoans [111], linked during evolution to the Warburg effect [112]. It is also the main oncogene imposing immortality to cancer cells and a master regulator of stemness [52]. Importantly, c-myc is a gene, whose suppression in in vivo models eliminates “oncogene addiction” and cures experimental cancer [113, 114]. Therefore, the targets for interrupting the cancer cell ‘life-cycle’ at its evolutionary root should likely focus around c-myc.
The best known and widely applied example of this treatment strategy is the differentiation inducer all-trans-retinoic acid (RA). Intriguing this is an old Chinese medicine against cancer and capable of curing acute myeloid leukemia
The post Anti-Cancer Vaccine with Embryonic Stem Cells appeared first on Jeffrey Dach MD.
February 18, 2018
Join Me at the ICIM Meeting in Cincinnati in April 2018
[image error] Come to the ICIM Meeting in Cincinnati !!
Join me, Phyllis Bronson PhD, Elizabeth Vaughan MD, Karen von Merveldt-Guevara MD and many others: What Works to Achieve Hormone Balance?
on April 17- 22, 2018 – ICIM International College of Integrative Medicine
at the Kingsgate Marriott Conference Center, Cincinnati, OH. 45219
Click here for details :https://www.eventbrite.com/e/what-works-in-clinical-medicin…
Main Congress: ICIM Cincinatti 2018
Resource people Jeffrey Dach MD, Karen von Merveldt-Guevara MD, Phyllis Bronson PhD, Hal Blatman MD, Barrie Tan PhD, Lou Diorio RPh, Dan Nelson MD, and Bryan J. Treacy, MD are on the agenda to present evidence about what works for hormone balance, manual medicine, controversies in nutritional supplementation, office compounding, and opioid addiction recovery.
Plus, we’ll hear updates on Ozone with Frank Shallenburger MD, cord blood live cells therapies with A.J Farshchian MD, and an exciting lecture from Joel E. Mortensen MD, Director Diagnostic Infectious Diseases Testing Laboratory, at the Cincinnati Children’s Hospital Medical Center: The future of flora analysis – culturomics to metagenomics.
Above quote and Header Image Courtesy of ICIM
The post Join Me at the ICIM Meeting in Cincinnati in April 2018 appeared first on Jeffrey Dach MD.
February 2, 2018
HPV Vaccine The Greatest Medical Scandal of Our Time
[image error] HPV Vaccine, The Greatest Medical Scandal of Our Time
HPV vaccine for your 11 year old son and daughter may soon be mandatory in your state thanks to the combination of two very bad things.
The first bad thing is criminal activity by drug makers Merck and Glaxo Smith Kline (GSK) that manufacture Gardasil and Cervarix. These criminal activities involve marketing a vaccine as a cancer preventive when no long term studies have been done to show this. The vaccines were approved without proper safety testing or long term safety monitoring. The HPV vaccines are in fact, causing harm to young women who have no recourse in the US since vaccine manufacturers are exempt from liability by Congressional mandate. However outside the US, criminal charges have been filed against the vaccine manufacturers in Spain.(18) Other countries have curtailed advertising and have reduced use of these vaccines.(21)(25,26)
The second very bad thing is the deplorable stupidity of your elected state representatives who after being spoon fed vaccine marketing propaganda have been deceived into proposing mandatory HPV vaccination for all 11 year old school girls and boys. The net result could very well be one of the greatest medical scandals in history.
Diane Harper MD on HPV Vaccine Efficacy
Diane Harper, the most authoritative expert on HPV Vaccine, was principle investigator for Merck’s Gardasil and GSK’s Cervarix Clinical trials used for FDA approval. She later became whistle blower and went public with information indicating the vaccines are dangerous and useless for prevention of cervical cancer. Diane Harper is a professor and chair of the department of Family and Geriatric Medicine at the University of Louisville.
HPV Vaccine only Temporary Immunity
In this video from 2011, Diane Harper MD expresses her concern that HPV vaccines provide only temporary immunity against selected HPV strains lasting 5-8 yrs, depending on vaccine. She says a full 15y years of immunity coverage is needed to prevent cervical cancer. There is no long term data to show prevention of cervical cancer. However, computer modeling projects that HPV vaccine programs reduces cervical cancer rates to 9-14 per 100,000. PAP Smear Cytology screening programs in the US have already reduced cervical cancer rates to 8 per 100,000, and in Dr Harpers opinion, HPV vaccine is unlikely to reduce this rate any further.
Video filmed at the American Association for the Advancement of Science Meeting in Washington, D.C., on February 18, 2011, Dr. Stan Maloy talks with Diane Harper, M.D., M.P.H,
The unethical and sleazy techniques used by vaccine makers Merck and GSK to push their agenda for mandatory vaccination is described by Sara Abiola, JD, PhD and Michelle M. Mello, JD, PhD in their 2012 article. (2) This is criminal behavior.
Merck promoted school-entry mandate legislation by serving as an information resource, lobbying legislators, drafting legislation, mobilizing female legislators and physician organizations, conducting consumer marketing campaigns, and filling gaps in access to the vaccine. Legislators relied heavily on Merck for scientific information. Most stakeholders found lobbying by vaccine manufacturers acceptable in principle, but perceived that Merck had acted too aggressively and nontransparently in this case.
Adverse Effects of HPV
The American College of Pediatricians has come out with a letter warning parents about POV (Premature Ovarian Failure) caused by HPV vaccines. (5,6)(22,23) See: Ovarian Failure After HPV Vaccine by Scott S. Field, MD January 2016.
Other serious adverse effects include cerebral vasculitis which can be fatal, or cause serious neurological disease.(11)
Politician Stupidity Award – Vote Them Out
In Florida, a bill was introduced January 4th by Sen. José Javier Rodríguez (Dem). This Senate Bill 1558, “Women’s Cancer Prevention Act” would take effect on July 1st, mandating HPV vaccination for all 11 and 12 year old children returning to school (males and females).
No long term studies have published (or even done) to show HPV vaccination in fact reduces the rate of women’s cancer.Left Image Courtesy of Patriots and Paulies.
Immediate Action Required
1) Contact Senator Jose Javier Rodriguez, sponsor of SB 1558 and ask him to withdraw his bill, SB 1558.
2) Contact Representative Amy Mercado, sponsor of HB 1343 and ask her to withdraw her bill, HB 1343.
Needless to say, these Mandatory HPV Vaccine bills must be stopped. Call your Congressman and voice your opposition now before any more harm can be done.
Still need more information? Read this article by Megan Heimer January 3, 2016 The HPV Vaccine: What You Need to Know About the Dumbest Vaccine Ever
Jeffrey Dach MD
7450 Griffin Road Suite 190
Davie, Florida 33314
954-792-4663
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Which is Greater Threat, Measles or measles Vaccine ?
Links and References
1) Harper, Diane M., and Leslie R. DeMars. “HPV vaccines–a review of the first decade.” Gynecologic oncology 146.1 (2017): 196-204.
Three dose efficacy preventing CIN 2 or worse by any HPV type is about 62% for both Cervarix and Gardsail9; the three dose efficacy preventing CIN 3 or worse by any HPV type is 93% for Cervarix and 43% for Gardasil, with no data for Gardasil9. All three vaccines lead to reduced numbers of colposcopies and excisional cervical therapies. Head to head trials indicate that Cervarix has superior immunogenicity compared to Gardasil for T-cell and B-cell functions for both HPV 16 and 18; there are no data for Gardasil9’s comparable immunogenicity. The immunogenicity data for HPV 18/45 induced by Gardasil and Gardasil9 indicates that long term surveillance for HPV 18/45 disease breakthrough must be in place.
Diane Medved Harper is a professor and chair of the department of Family and Geriatric Medicine at the University of Louisville.[3]
(2) Am J Public Health. 2012 May; 102(5): 893–898.
Pharmaceutical Companies’ Role in State Vaccination Policymaking: The Case of Human Papillomavirus Vaccination Michelle M. Mello, JD, PhD,corresponding author Sara Abiola, JD, PhD, and James Colgrove, PhD
Objectives. We sought to investigate roles that Merck & Co Inc played in state human papillomavirus (HPV) immunization policymaking, to elicit key stakeholders’ perceptions of the appropriateness of these activities, and to explore implications for relationships between health policymakers and industry.
Methods. We used a series of state case studies combining data from key informant interviews with analysis of media reports and archival materials. We interviewed 73 key informants in 6 states that were actively engaged in HPV vaccine policy deliberations.
Results. Merck promoted school-entry mandate legislation by serving as an information resource, lobbying legislators, drafting legislation, mobilizing female legislators and physician organizations, conducting consumer marketing campaigns, and filling gaps in access to the vaccine. Legislators relied heavily on Merck for scientific information. Most stakeholders found lobbying by vaccine manufacturers acceptable in principle, but perceived that Merck had acted too aggressively and nontransparently in this case.
Conclusions. Although policymakers acknowledge the utility of manufacturers’ involvement in vaccination policymaking, industry lobbying that is overly aggressive, not fully transparent, or not divorced from financial contributions to lawmakers risks undermining the prospects for legislation to foster uptake of new vaccines.
In June 2006, the Food and Drug Administration approved the first vaccine against human papillomavirus (HPV), the sexually transmitted virus implicated in three quarters of all cases of cervical cancer. Gardasil, produced by Merck & Co Inc, was licensed for vaccination of females aged 9 to 26 years for the prevention of cervical cancer and genital warts.1 The same month, the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention recommended routine vaccination of girls aged 11 to 12 years, with catch-up vaccination of females aged 13 to 26 years.2 A remarkable burst of legislative activity followed. Within a year, legislation relating to the vaccine was introduced in 41 states and the District of Columbia, including bills in 24 states that would mandate HPV vaccination for 6th-grade girls.3
Interest in the political forces behind HPV legislation remains high.4 Following media reports that Merck was heavily involved in promoting school-entry mandates, questions arose about the extent and appropriateness of industry involvement in vaccine policy. The presidential candidacy of Texas Governor Rick Perry recently prompted a new round of public and media scrutiny of the issue after opponent Representative Michele Bachmann accused the governor of ordering girls to receive the HPV vaccination because of his financial and political ties to Merck.5 We aimed to investigate these industry roles and elicit key stakeholders’ perceptions of their appropriateness and effects on policy outcomes.
3) Letters to the Editor Does the HPV Vaccine Prevent Cervical Cancer?
ln reply: Existing HPV vaccines provide protection against high-risk HPV types that are known to cause cervical dysplasia, which leads to cervical cancer. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices recommends routine HPV vaccination at 11 to 12 years of age1 based on randomized controlled trials that demonstrate effective prevention against precancerous cervical lesions (cervical intraepithelial neoplasia 2 and 3).2,3 Because invasive cervical cancer is rare in the United States, studies have not yet established an association between HPV vaccination and a lower incidence of cervical cancer. However, the intent of HPV vaccination is ultimately to prevent cervical cancer.
KENNETH W. LIN, MD, MPH Associate Deputy Editor for AFP Online
free pdf
3) Tomljenovic, L., J. P. Spinosa, and C. A. Shaw. “Human papillomavirus (HPV) vaccines as an option for preventing cervical malignancies:(how) effective and safe?.” Current pharmaceutical design 19.8 (2013): 1466.
4) Megan Heimer January 3, 2016 The HPV Vaccine: What You Need to Know About the Dumbest Vaccine Ever
Ovarian Failure
5) Colafrancesco, Serena, et al. “Human papilloma virus vaccine and primary ovarian failure: another facet of the autoimmune/inflammatory syndrome induced by adjuvants.” American Journal of Reproductive Immunology 70.4 (2013): 309-316.
PROBLEM:Post-vaccination autoimmune phenomena are a major facet of the autoimmune/inflammatory syndrome induced by adjuvants (ASIA) and different vaccines, including HPV, have been identified as possible causes.
METHOD OF STUDY:The medical history of three young women who presented with secondary amenorrhea following HPV vaccination was collected. Data regarding type of vaccine, number of vaccination, personal, clinical and serological features, as well as response to treatments were analyzed.
RESULTS:All three patients developed secondary amenorrhea following HPV vaccinations, which did not resolve upon treatment with hormone replacement therapies. In all three cases sexual development was normal and genetic screen revealed no pertinent abnormalities (i.e., Turner’s syndrome, Fragile X test were all negative). Serological evaluations showed low levels of estradiol and increased FSH and LH and in two cases, specific auto-antibodies were detected (antiovarian and anti thyroid), suggesting that the HPV vaccine triggered an autoimmune response. Pelvic ultrasound did not reveal any abnormalities in any of the three cases. All three patients experienced a range of common non-specific post-vaccine symptoms including nausea, headache, sleep disturbances, arthralgia and a range of cognitive and psychiatric disturbances. According to these clinical features, a diagnosis of primary ovarian failure (POF) was determined which also fulfilled the required criteria for the ASIA syndrome.
CONCLUSION:We documented here the evidence of the potential of the HPV vaccine to trigger a life-disabling autoimmune condition. The increasing number of similar reports of post HPV vaccine-linked autoimmunity and the uncertainty of long-term clinical benefits of HPV vaccination are a matter of public health that warrants further rigorous inquiry.
6) Little, Deirdre Therese, and Harvey Rodrick Grenville Ward. “Adolescent premature ovarian insufficiency following human papillomavirus vaccination: a case series seen in general practice.” Journal of investigative medicine high impact case reports 2.4 (2014): 2324709614556129.
Three young women who developed premature ovarian insufficiency following quadrivalent human papillomavirus (HPV) vaccination presented to a general practitioner in rural New South Wales, Australia. The unrelated girls were aged 16, 16, and 18 years at diagnosis. Each had received HPV vaccinations prior to the onset of ovarian decline. Vaccinations had been administered in different regions of the state of New South Wales and the 3 girls lived in different towns in that state. Each had been prescribed the oral contraceptive pill to treat menstrual cycle abnormalities prior to investigation and diagnosis. Vaccine research does not present an ovary histology report of tested rats but does present a testicular histology report. Enduring ovarian capacity and duration of function following vaccination is unresearched in preclinical studies, clinical and postlicensure studies. Postmarketing surveillance does not accurately represent diagnoses in adverse event notifications and can neither represent unnotified cases nor compare incident statistics with vaccine course administration rates. The potential significance of a case series of adolescents with idiopathic premature ovarian insufficiency following HPV vaccination presenting to a general practice warrants further research. Preservation of reproductive health is a primary concern in the recipient target group. Since this group includes all prepubertal and pubertal young women, demonstration of ongoing, uncompromised safety for the ovary is urgently required. This matter needs to be resolved for the purposes of population health and public vaccine confidence.
This second case series of adolescent POI/POF increases evidence suggesting that the hypothesis of an association between HPV vaccine and premature ovarian demise needs to be tested.
7) Tomljenovic, Lucija, et al. “HPV vaccines and cancer prevention, science versus activism.” Infectious Agents and Cancer 8.1 (2013): 6.
The rationale behind current worldwide human papilloma virus (HPV) vaccination programs starts from two basic premises, 1) that HPV vaccines will prevent cervical cancers and save lives and, 2) have no risk of serious side effects. Therefore, efforts should be made to get as many pre-adolescent girls vaccinated in order to decrease the burden of cervical cancer. Careful analysis of HPV vaccine pre- and post-licensure data shows however that both of these premises are at odds with factual evidence and are largely derived from significant misinterpretation of available data.
8) Nicol AF, Andrade CV, Russomano FB, Rodrigues LLS, Oliveira NS, Provance DW. HPV vaccines: a controversial issue? Brazilian Journal of Medical and Biological Research. 2016;49(5):e5060. doi:10.1590/1414-431X20155060.\
Controversy still exists over whether the benefits of the available HPV vaccines outweigh the risks and this has suppressed uptake of the HPV vaccines in comparison to other vaccines. Concerns about HPV vaccine safety have led some physicians, healthcare officials and parents to withhold the recommended vaccination from the target population. The most common reason for not administering the prophylactic HPV vaccines are concerns over adverse effects. The aim of this review is the assessment of peer-reviewed scientific data related to measurable outcomes from the use of HPV vaccines throughout the world with focused attention on the potential adverse effects. We found that the majority of studies continue to suggest a positive risk-benefit from vaccination against HPV, with minimal documented adverse effects, which is consistent with other vaccines. However, much of the published scientific data regarding the safety of HPV vaccines appears to originate from within the financially competitive HPV vaccine market. We advocate a more independent monitoring system for vaccine immunogenicity and adverse effects to address potential conflicts of interest with regular systematic literature reviews by qualified individuals to vigilantly assess and communicate adverse effects associated with HPV vaccination. Finally, our evaluation suggests that an expanded use of HPV vaccine into more diverse populations, particularly those living in low-resource settings, would provide numerous health and social benefits.
Since the quadrivalent HPV vaccine was approved by the FDA in the USA in June 2006, it will take at least another 15-20 years before the long-term efficacy of these vaccines becomes evident. In December 2014, the FDA approved the so-called HPV9 Gardasil¯ vaccine that includes direct protection against HPV types 31, 33, 45, 52 and 58 in addition to the HPV types 6, 11, 16 and 18 of the quadrivalent vaccine.
While the reduction in the occurrence of genital warts conferred by the HPV types present in the vaccines strongly suggests an ultimately lower incidence of HPV-positive cancers, the time period since the initial vaccinations has not been sufficient to determine the absolute reduction in cervical cancer, the major benefit expected.\\\
We also strongly believe that a regular systematic review of the literature by qualified individuals with no financial interests should be conducted. In many instances, financial resources originate from parties within the competitive HPV vaccine market, which certainly have economic interests, causing major complications in interpreting the results and conclusions from the various studies.
9) Aşkın, Özge. “Anogenital HPV.” Fundamentals of Sexually Transmitted Infections. InTech, 2017. Duration of efficacy is a key question when discussing the HPV vaccines. All three vaccines provide very high immunogenicity with antibody titers that are higher than the natural infections and remain high enough to prevent new infections. Booster doses’ necessity is still unknown. Up to now, it has been shown that the duration of vaccines may last 5–9 years. But more studies are needed about these important issues [35, 38].
The development of HPV vaccine is a milestone in the prevention of HPV-related infections and probably in the prevention of cervical cancer.
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Lucija Tomljenovic
10) Is There Objective Evidence that the Current HPV Vaccination Programs are not Justified?
Posted by Celeste McGovern on Mar 1, 2017 10:03:19 AM
In closing, Dr. Tomljenovic challenges her audience with a question: Is it ethical to put at risk of death or a disabling autoimmune disease at a pre-adolescent age for a vaccine that has not yet prevented a single case of cervical cancer, a disease that may develop 20-30 years after exposure to HPV, when the same can be prevented with regular PAP screening which carries no risks? Probably not.
Death after Quadrivalent Human Papillomavirus (HPV) Vaccination:Causal or Coincidental?
11) Death after Quadrivalent Human Papillomavirus (HPV) Vaccination:Causal or Coincidental? Tomljenovic L, Shaw CA (2012) Death after Quadrivalent Human Papillomavirus (HPV) Vaccination: Causal or Coincidental? Pharmaceut Reg Affairs S12:001.
Abstract Background: The proper understanding of a true risk from vaccines is crucial for avoiding unnecessary adverse reactions (ADRs). However, to this date no solid tests or criteria have been established to determine whether adverse events are causally linked to vaccinations. Objectives: This research was carried out to determine whether or not some serious autoimmune and neurological ADRs following HPV vaccination are causal or merely coincidental and to validate a biomarker-based immunohistochemical (IHC) protocol for assessing causality in case of vaccination-suspected serious adverse neurological outcomes. Methods: Post-mortem brain tissue specimens from two young women who suffered from cerebral vasculitistype symptoms following vaccination with the HPV vaccine Gardasil were analysed by IHC for various immunoinflammatory markers. Brain sections were also stained for antibodies recognizing HPV-16L1 and HPV-18L1 antigen which are present in Gardasil. Results: In both cases, the autopsy revealed no anatomical, microbiological nor toxicological findings that might have explained the death of the individuals. In contrast, our IHC analysis showed evidence of an autoimmune vasculitis potentially triggered by the cross-reactive HPV-16L1 antibodies binding to the wall of cerebral blood vessels in all examined brain samples. We also detected the presence of HPV-16L1 particles within the cerebral vasculature with some HPV-16L1 particles adhering to the blood vessel walls. HPV-18L1 antibodies did not bind to cerebral blood vessels nor any other neural tissues. IHC also showed increased T-cell signalling and marked activation of the classical antibody-dependent complement pathway in cerebral vascular tissues from both cases. This pattern of complement activation in the absence of an active brain infection indicates an abnormal triggering of the immune response in which the immune attack is directed towards self-tissue. Conclusions: Our study suggests that HPV vaccines containing HPV-16L1 antigens pose an inherent risk for triggering potentially fatal autoimmune vasculopathies. Practice implications: Cerebral vasculitis is a serious disease which typically results in fatal outcomes when undiagnosed and left untreated. The fact that many of the symptoms reported to vaccine safety surveillance databases following HPV vaccination are indicative of cerebral vasculitis, but are unrecognized as such (i.e., intense persistent migraines, syncope, seizures, tremors and tingling, myalgia, locomotor abnormalities, psychotic symptoms and cognitive deficits), is a serious concern in light of the present findings. It thus appears that in some cases vaccination may be the triggering factor of fatal autoimmune/neurological events. Physicians should be aware of this association.
13) video
Lucija Tomljenovic, PhD Session 7: 4th International Symposium on Vaccines in Leipzig, Germany April, 2016
Diane Harper researcher
90% of HPV cleared by immune system
HPV trials only 3 years in duration
efficacy of vaccine too short to prevent cervical cancer
Manitoba vaccine efficacy on preventing cervical dysplasia and in-situ CA -ineffective
!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
CArcinoma in situ less in non-vaccinated over 3 years observation.
14) Mahmud, Salaheddin M., et al. “Effectiveness of the quadrivalent human papillomavirus vaccine against cervical dysplasia in Manitoba, Canada.” Journal of Clinical Oncology 32.5 (2014): 438-443.
The median length of follow-up after enrollment was 3.1 years (range, 0.1 to 5.4). Overall, the 3-year cumulative probability of LSIL (3.7%) and HSIL (2.6%) was slightly higher in the nonvaccinated cohort compared with the vaccinated cohort (3.3% and 2.3%, respectively), whereas that of ASCUS was similar (2.8%). No invasive cancers were detected in either cohort, but 12 vaccinated females (0.3%) and 22 nonvaccinated females (0.2%) had CIS during follow-up.
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Pro-Vaccine Article
15) HPV Vaccine Controversy Ethics Economics Equality By Tanya Donahou
HPV Vaccine Controversy: Ethics, Economics, and Equality By Tanya Donahou, MD/MPH candidate, Boston University Schools of Medicine and Public Health, Class of 2013
Vaccine prevents CIN
16) Herweijer, Eva, et al. “Quadrivalent HPV vaccine effectiveness against high‐grade cervical lesions by age at vaccination: A population‐based study.” International journal of cancer 138.12 (2016): 2867-2874.
In conclusion, we show effectiveness of opportunistic qHPV vaccination for preventing CIN2+ and CIN3+ lesions, with greater effectiveness observed in girls younger at vaccination initiation.
Reply to above
17) Forced-Vaccinations-For-the-Greater-Good-Tomljenovic — By Lucija Tomljenovic, PhD
====================================
18) HPV (Gardasil) injury scandals worldwide, why is U.S. media silent? Parents beware.
BY J.B. HANDLEY December 7, 2016
19) Govt. Still Pushing HPV Vaccine on Kids a Decade after JW Exposed Deadly Side Effects MARCH 09, 2017
How Effective Is the HPV Vaccine at Preventing Cancer? A Closer Look…
How Effective Is the HPV Vaccine at Preventing Cancer? A Closer Look…
By Jeanne Lenzer | November 23, 2011 12:51 pm
Unfortunately, while the two HPV vaccines on the market may decrease the serious illness and death from cervical cancer, no study has proved that at this point, since no study has been conducted long enough to observe the development of cervical cancer or cervical cancer deaths.
Conclusive studies with the most important, clinically relevant end points should precede wide uptake of any intervention. The data currently rely on surrogate end points (markers of possible cancer) and are simply not conclusive. So we can’t truly say how effective the vaccine is.
Wake Forest medical researcher Curt Furberg, a former FDA advisor and co-author of the textbook Fundamentals of Clinical Trials, told me, “Getting data from markers is a first step. But we have burned our fingers too many times with surrogate markers. You should try to determine the real health benefit. Everything will be up in the air until we have the answer to the question: Will it prevent cancer? And until we have that answer, we should limit its use to girls enrolled in studies of the vaccine.”
Here are some other reasons why the HPV vaccines may not be as effective as advertised:
Duration of Protection:
An important issue raised by Diane Harper, an HPV researcher, is how long the vaccine will remain effective. She says the antibody titers in women who receive the vaccine fall off over time—i.e., the vaccine loses effectiveness. “One third of women lose antibody titers and hence protection from HPV by 5 years,” and “at 8.5 years, 15 percent have lost all detectable antibody titers to HPV-16, which leaves them completely unprotected from HPV-16 and -18, the only two cancer-causing strains that Gardasil was supposed to protect against.”
Harper says because of the vaccine’s limited duration, it likely won’t decrease the cervical cancer rate significantly below where it is with the routine Pap screening currently in use, although it may postpone cancer until later in life. Booster shots could presumably extend the effectiveness of the vaccine, she says, but we don’t yet have data on that. (Harper has received funding from Merck and GlaxoSmithKline for research on their HPV vaccines.)
=========================
20) Preventing Cervical Cancer Investigating costs, access, marketing, and effectiveness of vaccines By Donald W Light · Published 2017
While numerous studies that show the vaccines are cost-effective assume they prevent cancer, independent critics point out we don’t know and “the real impact of HPV vaccination on cervical cancer will not be observable for decades
Merck states that Gardasil 9 “does not eliminate the necessity for girls to undergo recommended cervical cancer screening later in life.
“The duration of immunity of Gardasil 9 has not been established” (MerckVaccines 2017).
To the extent that marketing lulls women into believing they are covered and no longer need routine screening, cancer rates could increase (Lenzer 2011).
Evidence that HPV vaccines prevent cancer is indirect because the latency period of fifteen to twenty years exceeds the time since use began.
We will not know for years how effectively HPV vaccines actually prevent cervical and related cancers or how the population of viral serotypes adapts.
=====================================================
21) Gardasil Shocker: Japan Withdraws Support for HPV Vaccine by Sarah Updated: January 25, 2018
Primary Ovarian Failure after HPV Vaccine
22) American College of Pediatricians Sounds Alarm About HPV Vaccine (Gardasil) by Sarah Updated: January 25, 2018
23) Ovarian Failure After HPV Vaccine Primary author: Scott S. Field, MD January 2016 The American College of Pediatricians
2. Little DT, and Ward HR. Adolescent premature ovarian insufficiency following human papillomavirus vaccination: a case series seen in general practice. J Inv Med High Imp Case Rep. 2014; doi: 10.1177/2324709614556129, pp 1-12.
3. Wise LD, Wolf JJ, Kaplanski CV, Pauley CJ, Ledwith BJ. Lack of effects on fertility and developemental toxicity of a quadrivalent HPV vaccine in Sprague-Dawley rats. Birth Defects Res B Dev. 2008; 83(6):561-572.
4. Segal L, Wilby OK, Willoughby CR, Veenstra S, Deschamps M. Evaluation of the intramuscular administration of CervarixTM vaccine on fertility, pre- and post-natal development in rats. Reprod Toxicol. 2011; 31:111-120.
5. Information available through http://wonder.cdc.gov/vaers.html.
6. http://www.cdc.gov/vaccines/pubs/pink....
7. http://www.fda.gov/downloads/Biologic..., p.373.
8. Vichnin M, Bonanni P, Klein NP, Garland SM, Block SL, Kjaer SK, et. al. An overview of quadrivalent human papillomavirus vaccine safety – 2006 to 2015. Pediatr Inf Dis J. 2015; doi: 10.1097/INF.0000000000000793, pp 1-48.
9. http://www.fda.gov/downloads/Biologic..., p.394,396.
24) Gardasil: Guarding or Gutting Our Youth? by Kelly Brogan MD
25) Gardasil Vaccine: Spain Joins Growing List of Countries to File Criminal Complaints
includes France, India, Japan, and many more.
26) Gardisal Vaccine FRANCE SAYS “NO” AS THEY BAN GARDASIL ADS
France says the award winning advertising campaign for Gardasil is false and misleading. The Sanevax Team wants to know – Where was the press coverage when this happened? Why did no one break the news to the public?
27) Colafrancesco S, Perricone C, Tomljenovic L, Shoenfeld Y. Human papilloma virus vaccine and primary ovarian failure: another facet of the autoimmune/inflammatory syndrome induced by adjuvants. Am J Reprod Immunol. 2013; 70:309-316.
The post HPV Vaccine The Greatest Medical Scandal of Our Time appeared first on Jeffrey Dach MD.
January 31, 2018
Interesting Algae Micro-Organisms on Electron Microscopy
Interesting Algae Micro-organisms on Electron Microscopy by Jeffrey Dach MD
[image error]Coccolithophore (phylum Plankton)
This is Plankton, a one-celled plant (using photosynthesis) living in the ocean. The outer “hubcaps” are called coccolithophores made of limestone (calcite or chalk). about 0.001 mm in diameter. courtesy of MArine Education Society.
Another one….this has Trumpets on the outer coating.Courtesy of nannotax.
Discosphaera tubifera; scalebar 1 micron.
……………..Another different ..courtesy of Mikrotax_Nannotax3
Courtesy of Paleocast Umbilicosphaera sibogae by ZEISS Microscopy, CC BY-NC-ND 2.0.
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January 10, 2018
Mitch Daniels Says AntiGMO is Immoral Perhaps the GMO Industry is Immoral
Mitch Daniels Says Anti-GMO is Immoral, Perhaps the GMO Industry is Immoral by Jeffrey Dach MD
Mitch Daniels, ex-governor of Indiana and President of Purdue University recently wrote a Pro-GMO editorial for the Washington Post declaring Anti-GMO arguments are “immoral” because GMO bio-technology prevents massive global starvation. His editorial went viral in all the major newsfeeds.(15,16) Left Image: Mitch Daniels Governor of Indiana Courtesy of Wikimedia Commons.
Like most politicians with a law degree and no science background, his editorial reveals lack of knowledge of GMO biotechnology. His editorial is essentially a cut and paste of pro-GMO propaganda directly from the public relations department of GMO giant, Monsanto.
Regarding GMO food, Mr Daniels claims:
“There has been no disruption of an ecosystem nor any adverse human health or even digestive problems, after 5 billion acres have been cultivated cumulatively and trillions of meals consumed.”
Regarding the impact of GMO plants on the environment:
Perhaps Mr Daniels has forgotten about the case of Liberty Link Corn and Liberty Link Rice by Aventis, both of which resulted in huge settlements for genetic contamination of the environment by the Aventis GMO products. Our judicial court system called GMO corn, a “public nuisance“. GMO contamination is far worse than chemical contamination of the environment which degrades over time. GMO contamination increases and magnifies over time as the GMO plants invade neighboring farms.
[image error]Regarding the impact of GMO food on human health:
Perhaps Mr. Daniels has forgotten about the first GMO nutritional supplement made with biotechnology, L-Tryptophan by a Japanese company called Showa Denko, which resulted in a disease called EMS, Eosinophia Myalgia Syndrome, which killed 37 people, affecting as many as 1500 people before the FDA banned the importation of the product in 1989. The reality is that tinkering with genetic information in plants may have unpredictable results, and has produced adverse effects on human health. Both animal and human studies over many years have documented adverse health effects. Left image: Round Up Ready Soy Beans courtesy of Washington Post
Mitch Daniels Says: “Trillions of GMO meals have been consumed“:
Yes this is true. GMO food has been consumed as a giant medical experiment on the population without the consent of the subjects, without preliminary safety testing, and without any followup observational studies to determine long term adverse health effects.
Outside the US in China, feeding children GMO food is considered unethical medical experimentation. A study done by Dr Guangwen Tang fed GMO Rice to 68 children. This GMO study was published, and then later retracted on ethical grounds when authorities discovered that Dr Tang failed to obtain parental consent or proper IRB approval. (4-6)
In his editorial, Mitch Daniels says:
“but it was the likes of the plant pathologist Norman Borlaug and wheat breeder Orville Vogel, whose Green Revolution, powered by modern plant science, saved the most lives.“
Yes, it is true that Orville Vogel and Norman Borlaug are national heroes who revolutionized agriculture, and saved a billion lives from starvation with high yield semi-dwarf wheat. Norman Borlaug received the Nobel Prize and Congressional Medal.
[image error]However, Borlaug’s work on semi-dwarf wheat was done with traditional breeding in the 1960’s, before the advent of GMO biotechnology. Since Borlaug’s wheat is not a GMO product, using the Borlaug example to praise GMO Food is deceptive and misleading. In fact, according to the USDA, “no GM wheat is commercially grown in the United States“. In view of this error, one might suspect the speaker has limited understanding of the subject matter or is being intentionally deceptive. Left Image Indiana Rally for the Right to Know GMO labeling courtesy of Alexis Baden-Mayer, Flickr, Creative Commons.
Mr Daniels says:
“And though the new technologies are awe-inspiring, they are just refinements of cruder techniques that have been used for centuries. ”
This is a false statement. Think about this. Traditional breeding techniques for centuries involves breeding plants and animals together naturally for the purpose of producing desirable traits. Recombinant genetic biotechnology now allows the “unnatural” combination of genetic material from different species which cannot reproduce together in the wild. A major GMO crop is Bt corn which has genetic material from a bacterial species, Bacillus thuringiensis, which produces a pesticide. Bacteria species cannot breed with corn species. Golden rice is the product of combining genetic material from rice plants with the sunflower plants which confers the ability to produce vitamin A. Rice and sunflowers are different plant species which cannot breed together normally.
GMO biotechnology is an entirely new way to modify the genome of plants which never existed before, and in no way can be considered “a refinement of cruder techniques used for centuries.” GMO biotechnology inserts genes from different species which cannot breed together naturally. This is not a “refinement of a centuries old technique” this is an entirely new form of genetic manipulation which does not occur in nature.
Lets say hypothetically our GMO scientists combine the Foxglove plant gene for Digitalis into corn. We now have corn which produces a cardiac, drug called digitalis and is highly toxic when eaten. Is this safe to eat? Of course not. The point here is that final food product may be healthy or it may be toxic depending on how it is made. As you can see from this example, to make a blanket statement that all GMO food is safe to eat is naive and misleading.
Mr Daniels says: The science is settled:
I would dispute this claim. The science is not settled and never has been. GMO food was FDA approved without safety studies based on “substantial equivalence“, thanks to Michael Taylor, a Monsanto lawyer at the FDA. This “legal wording” allows GMO plant food products to enter our food supply without any required safety testing. Outside the US rigorous safety testing is required.
For the next generation of GMO products, these FDA rules will no doubt be changed, as safety testing will be necessary and mandatory according to David R Schubert, in his article, “The Problem with nutritionally enhanced plants in Journal Medicinal food 2008″
“Among the next generation of genetically modified (GM) plants are those that are engineered to produce elevated levels of nutritional molecules such as vitamins, omega-3 fatty acids, and amino acids. Based upon the U.S. current regulatory scheme, the plants and their products may enter our food supply without any required safety testing. The potential risks of this type of GM plant are discussed in the context of human health, and it is argued that there should be very careful safety testing of plants designed to produce biologically active molecules before they are commercially grown and consumed. This will require a mandatory, scientifically rigorous review process.”
Mr Daniels says:
“Travel to Africa with any of Purdue University’s three recent World Food Prize winners, and you won’t find the conversation dominated by anti-GMO protesters. There, where more than half of the coming population increase will occur, consumers and farmers alike are eager to share in the life-saving and life-enhancing advances that modern science alone can bring. Efforts to persuade the Africans otherwise, or simply block their access to the next round of breakthroughs, are worse than anti-scientific. They’re immoral.“
Here, I would disagree with Mr Daniels and take the opposite viewpoint. I consider introducing (GMO) genetically modified plants into our food supply without labeling, without any preliminary or long term safety testing, and without environmental safety studies to be unethical and immoral medical experimentation on the population.
Failure to Yield
Although Borlaug’s work did increase wheat yield by a factor of 10, current efforts to make GMO products have No Concern with plant yield, rather Bt corn is modified to produce its own pesticide which we unwittingly consume. In fact, historically, GMO crops have not increase yield any more than traditional breeding techniques.
“according to Failure to Yield, a report by UCS expert Doug Gurian-Sherman released in March 2009…. Despite 20 years of research and 13 years of commercialization, genetic engineering has failed to significantly increase U.S. crop yields.” (UCS FAilure to Yield)
Glyphosate Usage Skyrocketing (Round-Up)
Monsanto’s Round-Up Ready Soy has been modified to resist the herbicide, Round-Up (Glyphosate), leaving a chemical residue which contaminates our food. Because of herbicide resistant weeds, glyphosate usage has skyrocketed, and government records show associated increase in human disease associated with glyphosate contamination of our food supply.
[image error] Above charts show increasing human disease as glyphosate usage increases, courtesy of (Swanson, 2014) Genetically engineered crops Glyphosate and the Deterioration of Health
How Does Glyphosate Cause Human Disease?
[image error]Glyphosate – The Elephant in the Room
The herbicide Roundup which contains glyphosate manufactured by Monsanto has received attention because animal studies show dysbiosis and disruption of gut flora in animals treated with glyphosate. (21-24) A series of animal studies by Dr. Kruger shows that glyphosate acts as an antimicrobial to gut bacteria preferentially killing beneficial bacteria while allowing pathogenic bacteria such as Clostridia and Salmonella to survive.(21-24) Dr Kruger says:
“evidence that the highly pathogenic bacteria as Salmonella Entritidis, Salmonella Gallinarum, Salmonella Typhimurium, Clostridium perfringens and Clostridium botulinum are highly resistant to glyphosate. However, most of beneficial bacteria as Enterococcus faecalis, Enterococcus faecium, Bacillus badius, Bifidobacterium adolescentis and Lactobacillus spp. were found to be moderate to highly susceptible. … A reduction of beneficial bacteria in the gastrointestinal tract microbiota by ingestion of glyphosate could disturb the normal gut bacterial community. “
Above left image courtesy of Dr Stephanie Seneff MIT Power Point Presentation: SeneffGlyphosateYale2014-2-Elephant in the Room
The Shikimate Pathway in Plants
Glyphosate was deemed safe for humans because it blocks an enzyme system in plants called the Shikimate pathway, a biochemical pathway which does not exist in humans. However, regulators forgot to consider the effect of glyphosate on friendly gut bacteria which do use the Shikimate pathway . The friendly gut bacteria are killed, and the pathogenic bacteria resistant to glyphosate survive. This produces gut dysbiosis similar to that found in autistic children. Which pathogenic bacteria are we left with? You guessed it, the Clostridia. Is it starting to make sense now?
Professor Don Huber Speaks Out
Here is a quote from Professor Don M. Huber:(3) from his document GMO Failed Promises Flawed Science Serious Health Safety Issue
”Future historians may well look back upon our time and write, not about how many pounds of pesticides we did or did not apply, but about how willing we are to sacrifice our children and jeopardize future generations for this massive experiment we call genetic engineering that is based on failed promises and flawed science, just to benefit the bottom line of a commercial enterprise.” Dr. Don M. Huber
In conclusion: Mitch Daniels’ editorial comes from a politician with close ties to GMO industry, with little or no understanding of GMO biotechnology, providing a cut and paste version of pro-GMO propaganda directly from the Monsanto PR department which is deceptive and misleading. Genetic tinkering by inserting genetic material from foreign species into a plant does not produce “substantially equivalent” food. Genetic tinkering creates a new drug with unpredictable adverse effects, and requires the same rigorous safety testing as any new drug submitted for FDA approval.
Rather than name-calling those questioning the GMO enterprise as immoral, perhaps Mr. Daniels should regard the GMO industry as immoral.
Articles With Related Interest:
GMO Food Fight From Senate Floor
Berberine Antidote to a Modern epidemic
by Jeffrey Dach MD
7450 Griffin Road Suite 190
Davie, Fl 33314
954-792-4663
Links and references:
1) Union of Concerned Scientists: Eight Ways Monsanto Fails at Sustainable Agriculture
In fact, Monsanto has held back the development of sustainable agriculture, and continues to do so, in several ways:
2) Response to “Avoiding GMOs isn’t just anti-science. It’s immoral” Jan 04, 2018 In “Avoiding GMOs isn’t just anti-science. It’s immoral”, an op-ed published in the Washington Post, Mitch Daniels would have you believe that scientific research finds only benefits and no downsides to genetically engineered (GE) crops. The reality is not so.
The National Academies of Sciences, Engineering and Medicine recently reviewed over 900 scientific research and publications studying the agronomic, environmental, social and economic effects of genetically modified crops.Significantly, the report finds that GE crops have no higher yield potential than varietals developed through traditional breeding.GE crops are not a silver bullet solution to feed our growing population. To suggest so is naïve, inaccurate…and may be immoral.
3) Don Huber GMO Failed Promises Flawed Science Serious Health Safety Issue Glyphosate ” Future historians may well look back upon our time and write, not about how many pounds of pesticides we did or did not apply, but about how willing we are to sacrifice our children and jeopardize future generations for this massive experiment we call genetic engineering that is based on failed promises and flawed science, just to benefit the bottom line of a commercial enterprise.” Dr. Don M. Huber is Emeritus Professor, Purdue University; COL AUS (Ret, Medical Intelligence); Former Chairman, USDA National Plant Disease Recovery Program; member, US Threat Pathogens Committee; former member of the Advisory Board, Office of Technology Assessment, US Congress; and OTSG Global Epidemiology Working Group.
4) Tang, Guangwen, et al. “β-Carotene in Golden Rice is as good as β-carotene in oil at providing vitamin A to children.” The American journal of clinical nutrition 96.3 (2012): 658-664.
5) Golden rice paper retracted after legal bid fails By Erik StokstadJul. 31, 2015 , 3:00 PM SCience Magazine
6) Retraction of Tang G, Hu Y, Yin S-a, Wang Y, Dallal GE, Grusak MA, and Russell RM. b-Carotene in Golden Rice is as good as
b-carotene in oil at providing vitamin A to children. Am J Clin Nutr 2012;96:658–64.Committee).
7) Washington Post Publishes Hit Piece Declaring Non-GMO Movement “Immoral,” Here’s What They Got So Blatantly Wrong
By Nick Meyer On January 4, 2018
8) Monsanto’s Four Tactics for Undermining Glyphosate Science Review
Genna Reed, science and policy analyst, Center for Science and Democracy | March 23, 2017, 1:58 pm
9) Food Industry Enlisted Academics in G.M.O. Lobbying War, Emails Show By ERIC LIPTONSEPT. 5, 2015 New York Times
Monsanto and its industry partners have also passed out an undisclosed amount in special grants to scientists like Kevin Folta, the chairman of the horticultural sciences department at the University of Florida, to help with “biotechnology outreach” and to travel around the country to defend genetically modified foods.
10) Monsanto’s Monopoly on Agricultural Research by Big Universities
by Yelena Sukhoterina | November 20, 2015
11) Monsanto pledges $3 million for corn rootworm research
12) May 5, 2017 Collaborating With Academics and Universities Monsanto
13) Suppressing Research 8 Ways Monsanto Fails at Sustainable Agriculture: #7 multibillion-dollar agricultural corporations, including Monsanto, have fought independent research on their genetically engineered crops. They have often refused to provide independent scientists with seeds, or they’ve set restrictive conditions that severely limit research options. In 2009, 26 academic entomologists wrote to the U.S. Environmental Protection Agency that because patents on engineered genes do not provide for independent non-commercial research, they could not perform adequate research on these crops. “No truly independent research can be legally conducted on many critical questions involving these crops,” they wrote. A Purdue University entomologist who signed the letter put it more succinctly to a reporter for a scientific journal: “Industry is completely driving the bus.”
14) Forum, Jan. 5: Follow the GMO Money
Thursday, January 04, 2018
15) Avoiding GMOs isn’t just anti-science. It’s immoral.
By Mitch Daniels December 27, 2017
16) Avoiding GMOs isn’t just anti-science. It’s immoral
By Mitch Daniels The Washington Post Published December 29, 2017
2016
17) Anti-GMO Activists: ‘Heartless, Callous and Cruel’
by Bruce Edward Walker • March 22, 2016
18) Purdue President Calls To End Of “Morally Irresponsible” Attacks On GMO’s amidst mass rejection by Isiah Holmes • March 1, 2016
19-20) left blank
glyphosate
21) http://www.ncbi.nlm.nih.gov/pubmed/23224412
Curr Microbiol. 2013 Apr;66(4):350-8. doi: 10.1007/s00284-012-0277-2. Epub 2012 Dec 9. The effect of glyphosate on potential pathogens and beneficial members of poultry microbiota in vitro. Shehata AA1, Schrödl W, Aldin AA, Hafez HM, Krüger M.
The use of glyphosate modifies the environment which stresses the living microorganisms. The aim of the present study was to determine the real impact of glyphosate on potential pathogens and beneficial members of poultry microbiota in vitro.
The presented results evidence that the highly pathogenic bacteria as Salmonella Entritidis, Salmonella Gallinarum, Salmonella Typhimurium, Clostridium perfringens and Clostridium botulinum are highly resistant to glyphosate. However, most of beneficial bacteria as Enterococcus faecalis, Enterococcus faecium, Bacillus badius, Bifidobacterium adolescentis and Lactobacillus spp. were found to be moderate to highly susceptible. Also Campylobacter spp. were found to be susceptible to glyphosate. A reduction of beneficial bacteria in the gastrointestinal tract microbiota by ingestion of glyphosate could disturb the normal gut bacterial community. Also, the toxicity of glyphosate to the most prevalent Enterococcus spp. could be a significant predisposing factor that is associated with the increase in C. botulinum-mediated diseases by suppressing the antagonistic effect of these bacteria on clostridia.
Glyphosate linked to botulism and other animal health problems
Three very interesting papers from Monika Kruger and her team in Leipzig on the effect glyphosate has on the gut micro-organisma in animals by damaging the beneficial bacteria
“A reduction of beneficial bacteria in the gastrointestinal tract microbiota by ingestion of glyphosate could disturb the normal gut bacterial community.”
There is now a strong probability that glyphosate residues in animal feeds result in botulism in the cattle and also in related ailments in poultry.
22) Visceral botulism at dairy farms in Schleswig Holstein, Germany – Prevalence of Clostridium botulinum in feces of cows, in animal feeds, in feces of the farmers, and in house dust by Monika Krüger, Anke Große-Herrenthey, Wieland Schrödl, Achim Gerlach, Arne Rodloff Anaerobe 18 (2012) 221e223 Accepted 11 December 2011 Available online 21 December 2011
From 41 dairy farms in Schleswig Holstein, Germany, 196 fecal specimens of diseased cows, 77 fecal specimens of farmers and family members from 26 of these farms, 35 animal feed specimens and 7 house dust specimens were investigated for Clostridium botulinum and its antigens, respectively. Four of the humans under study (one child, 8 month, and three adults) showed symptoms of infant/visceral botulism. Specimens were cultivated in reinforced clostridial medium (RCM). C. botulinum antigens were detected by ELISA. The aim of the study was to obtain information on the relationship of detected C. botulinum toxin-types in cows, in the feces of attending humans, and in the immediate environment. The results revealed that C. botulinum toxin-types were different for cows and humans. Toxin-type A was dominant in cow feces while type E was found in humans. Type E was also present in some animal feed specimens. Conversely, toxin-type A was prevalent in the house dust of farms. It may be assumed that the feeds were the source of human colonization with C. botulinum.
23) Effect Glyphosate Pathogens Poultry Microbiota In Vitro Krueger Shehata Curr Microbiol 2012
The Effect of Glyphosate on Potential Pathogens and Beneficial Members of Poultry Microbiota In Vitro by Awad A. Shehata, Wieland Schro¨dl, Alaa. A. Aldin, Hafez M. Hafez , and Monika Kru¨ger Curr Microbiol 2012 Springer
The use of glyphosate modifies the environment which stresses the living microorganisms. The aim of the present study was to determine the real impact of glyphosate on potential pathogens and beneficial members of poultry microbiota in vitro. The presented results evidence that the highly pathogenic bacteria as Salmonella Entritidis, Salmonella Gallinarum, Salmonella Typhimurium, Clostridium perfringens and Clostridium botulinum are highly resistant to glyphosate. However, most of beneficial bacteria as Enterococcus faecalis, Enterococcus faecium, Bacillus badius, Bifidobacterium adolescentis and Lactobacillus spp. were found to be moderate to highly susceptible. Also Campylobacter spp. were found to be susceptible to glyphosate. A reduction of beneficial bacteria in the gastrointestinal tract microbiota by ingestion of glyphosate could disturb the normal gut bacterial community. Also, the toxicity of glyphosate to the most prevalent Enterococcus spp. could be a significant predisposing factor that is associated with the increase in C. botulinum-mediated diseases by suppressing the antagonistic effect of these bacteria on clostridia.
24) Glyphosate suppresses the antagonistic effect of Enterococcus on Clostridia Kruger 2013 by Monika Krüger, Awad Ali Shehata, Wieland Schrödl, Arne Rodloff. Anaerobe 20 (2013) 74e78
25) GMO Opposition Is About Culture and Economics, Not Morals
Henry Homeyer For the Valley News Friday, January 12, 2018
26) The science is still out on GMO food safety David Schubert Professor The Salk Institute for Biological Studies May 13 2018 San Diego Tribune Opinion Letter.
Jeffrey Dach MD
7450 Griffin Road, Suite 190
Davie, Fl 33314
954-792-4663
www.jeffreydachmd.com
www.drdach.com
www.naturalmedicine101.com
www.bioidenticalhormones101.com
www.truemedmd.com
Disclaimer click here: www.drdach.com/wst_page20.html
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) 2017 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.
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.
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The post Mitch Daniels Says AntiGMO is Immoral Perhaps the GMO Industry is Immoral appeared first on Jeffrey Dach MD.
Mitch Daniels Says Anti-GMO is Immoral – Perhaps the GMO Industry is Immoral
[image error]Mitch Daniels Says Anti-GMO is Immoral – Perhaps the GMO Industry is Immoral by Jeffrey Dach MD
Mitch Daniels, ex-governor of Indiana and President of Purdue University recently wrote a Pro-GMO editorial for the Washington Post declaring Anti-GMO arguments are “immoral” because GMO bio-technology prevents massive global starvation. His editorial went viral in all the major newsfeeds.(15,16) Left Image: Mitch Daniels Governor of Indiana Courtesy of Wikimedia Commons.
Like most politicians with a law degree and no science background, his editorial reveals lack of knowledge of GMO biotechnology. His editorial is essentially a cut and paste of pro-GMO propaganda directly from the public relations department of GMO giant, Monsanto.
Regarding GMO food, Mr Daniels claims:
“There has been no disruption of an ecosystem nor any adverse human health or even digestive problems, after 5 billion acres have been cultivated cumulatively and trillions of meals consumed.”
Regarding the impact of GMO plants on the environment:
Perhaps Mr Daniels has forgotten about the case of Liberty Link Corn and Liberty Link Rice by Aventis, both of which resulted in huge settlements for genetic contamination of the environment by the Aventis GMO products. Our judicial court system called GMO corn, a “public nuisance“. GMO contamination is far worse than chemical contamination of the environment which degrades over time. GMO contamination increases and magnifies over time as the GMO plants invade neighboring farms.
[image error]Regarding the impact of GMO food on human health:
Perhaps Mr. Daniels has forgotten about the first GMO nutritional supplement made with biotechnology, L-Tryptophan by a Japanese company called Showa Denko, which resulted in a disease called EMS, Eosinophia Myalgia Syndrome, which killed 37 people, affecting as many as 1500 people before the FDA banned the importation of the product in 1989. The reality is that tinkering with genetic information in plants may have unpredictable results, and has produced adverse effects on human health. Both animal and human studies over many years have documented adverse health effects. Left image: Round Up Ready Soy Beans courtesy of Washington Post
Mitch Daniels Says: “Trillions of GMO meals have been consumed“:
Yes this is true. GMO food has been consumed as a giant medical experiment on the population without the consent of the subjects, without preliminary safety testing, and without any followup observational studies to determine long term adverse health effects.
Outside the US in China, feeding children GMO food is considered unethical medical experimentation. A study done by Dr Guangwen Tang fed GMO Rice to 68 children. This GMO study was published, and then later retracted on ethical grounds when authorities discovered that Dr Tang failed to obtain parental consent or proper IRB approval. (4-6)
In his editorial, Mitch Daniels says:
“but it was the likes of the plant pathologist Norman Borlaug and wheat breeder Orville Vogel, whose Green Revolution, powered by modern plant science, saved the most lives.“
Yes, it is true that Orville Vogel and Norman Borlaug are national heroes who revolutionized agriculture, and saved a billion lives from starvation with high yield semi-dwarf wheat. Norman Borlaug received the Nobel Prize and Congressional Medal.
[image error]However, Borlaug’s work on semi-dwarf wheat was done with traditional breeding in the 1960’s, before the advent of GMO biotechnology. Since Borlaug’s wheat is not a GMO product, using the Borlaug example to praise GMO Food is deceptive and misleading. In fact, according to the USDA, “no GM wheat is commercially grown in the United States“. In view of this error, one might suspect the speaker has limited understanding of the subject matter or is being intentionally deceptive. Left Image Indiana Rally for the Right to Know GMO labeling courtesy of Alexis Baden-Mayer, Flickr, Creative Commons.
Mr Daniels says:
“And though the new technologies are awe-inspiring, they are just refinements of cruder techniques that have been used for centuries. ”
This is a false statement. Think about this. Traditional breeding techniques for centuries involves breeding plants and animals together naturally for the purpose of producing desirable traits. Recombinant genetic biotechnology now allows the “unnatural” combination of genetic material from different species which cannot reproduce together in the wild. A major GMO crop is Bt corn which has genetic material from a bacterial species, Bacillus thuringiensis, which produces a pesticide. Bacteria species cannot breed with corn species. Golden rice is the product of combining genetic material from rice plants with the sunflower plants which confers the ability to produce vitamin A. Rice and sunflowers are different plant species which cannot breed together normally.
GMO biotechnology is an entirely new way to modify the genome of plants which never existed before, and in no way can be considered “a refinement of cruder techniques used for centuries.” GMO biotechnology inserts genes from different species which cannot breed together naturally. This is not a “refinement of a centuries old technique” this is an entirely new form of genetic manipulation which does not occur in nature.
Lets say hypothetically our GMO scientists combine the Foxglove plant gene for Digitalis into corn. We now have corn which produces a cardiac, drug called digitalis and is highly toxic when eaten. Is this safe to eat? Of course not. The point here is that final food product may be healthy or it may be toxic depending on how it is made. As you can see from this example, to make a blanket statement that all GMO food is safe to eat is naive and misleading.
Mr Daniels says: The science is settled:
I would dispute this claim. The science is not settled and never has been. GMO food was FDA approved without safety studies based on “substantial equivalence“, thanks to Michael Taylor, a Monsanto lawyer at the FDA. This “legal wording” allows GMO plant food products to enter our food supply without any required safety testing. Outside the US rigorous safety testing is required.
For the next generation of GMO products, these FDA rules will no doubt be changed, as safety testing will be necessary and mandatory according to David R Schubert, in his article, “The Problem with nutritionally enhanced plants in Journal Medicinal food 2008″
“Among the next generation of genetically modified (GM) plants are those that are engineered to produce elevated levels of nutritional molecules such as vitamins, omega-3 fatty acids, and amino acids. Based upon the U.S. current regulatory scheme, the plants and their products may enter our food supply without any required safety testing. The potential risks of this type of GM plant are discussed in the context of human health, and it is argued that there should be very careful safety testing of plants designed to produce biologically active molecules before they are commercially grown and consumed. This will require a mandatory, scientifically rigorous review process.”
Mr Daniels says:
“Travel to Africa with any of Purdue University’s three recent World Food Prize winners, and you won’t find the conversation dominated by anti-GMO protesters. There, where more than half of the coming population increase will occur, consumers and farmers alike are eager to share in the life-saving and life-enhancing advances that modern science alone can bring. Efforts to persuade the Africans otherwise, or simply block their access to the next round of breakthroughs, are worse than anti-scientific. They’re immoral.“
Here, I would disagree with Mr Daniels and take the opposite viewpoint. I consider introducing (GMO) genetically modified plants into our food supply without labeling, without any preliminary or long term safety testing, and without environmental safety studies to be unethical and immoral medical experimentation on the population.
Failure to Yield
Although Borlaug’s work did increase wheat yield by a factor of 10, current efforts to make GMO products have No Concern with plant yield, rather Bt corn is modified to produce its own pesticide which we unwittingly consume. In fact, historically, GMO crops have not increase yield any more than traditional breeding techniques.
“according to Failure to Yield, a report by UCS expert Doug Gurian-Sherman released in March 2009…. Despite 20 years of research and 13 years of commercialization, genetic engineering has failed to significantly increase U.S. crop yields.” (UCS FAilure to Yield)
Glyphosate Usage Skyrocketing (Round-Up)
Monsanto’s Round-Up Ready Soy has been modified to resist the herbicide, Round-Up (Glyphosate), leaving a chemical residue which contaminates our food. Because of herbicide resistant weeds, glyphosate usage has skyrocketed, and government records show associated increase in human disease associated with glyphosate contamination of our food supply.
[image error] Above charts show increasing human disease as glyphosate usage increases, courtesy of (Swanson, 2014) Genetically engineered crops Glyphosate and the Deterioration of Health
How Does Glyphosate Cause Human Disease?
[image error]Glyphosate – The Elephant in the Room
The herbicide Roundup which contains glyphosate manufactured by Monsanto has received attention because animal studies show dysbiosis and disruption of gut flora in animals treated with glyphosate. (21-24) A series of animal studies by Dr. Kruger shows that glyphosate acts as an antimicrobial to gut bacteria preferentially killing beneficial bacteria while allowing pathogenic bacteria such as Clostridia and Salmonella to survive.(21-24) Dr Kruger says:
“evidence that the highly pathogenic bacteria as Salmonella Entritidis, Salmonella Gallinarum, Salmonella Typhimurium, Clostridium perfringens and Clostridium botulinum are highly resistant to glyphosate. However, most of beneficial bacteria as Enterococcus faecalis, Enterococcus faecium, Bacillus badius, Bifidobacterium adolescentis and Lactobacillus spp. were found to be moderate to highly susceptible. … A reduction of beneficial bacteria in the gastrointestinal tract microbiota by ingestion of glyphosate could disturb the normal gut bacterial community. “
Above left image courtesy of Dr Stephanie Seneff MIT Power Point Presentation: SeneffGlyphosateYale2014-2-Elephant in the Room
The Shikimate Pathway in Plants
Glyphosate was deemed safe for humans because it blocks an enzyme system in plants called the Shikimate pathway, a biochemical pathway which does not exist in humans. However, regulators forgot to consider the effect of glyphosate on friendly gut bacteria which do use the Shikimate pathway . The friendly gut bacteria are killed, and the pathogenic bacteria resistant to glyphosate survive. This produces gut dysbiosis similar to that found in autistic children. Which pathogenic bacteria are we left with? You guessed it, the Clostridia. Is it starting to make sense now?
Professor Don Huber Speaks Out
Here is a quote from Professor Don M. Huber:(3) from his document GMO Failed Promises Flawed Science Serious Health Safety Issue
”Future historians may well look back upon our time and write, not about how many pounds of pesticides we did or did not apply, but about how willing we are to sacrifice our children and jeopardize future generations for this massive experiment we call genetic engineering that is based on failed promises and flawed science, just to benefit the bottom line of a commercial enterprise.” Dr. Don M. Huber
In conclusion: Mitch Daniels’ editorial comes from a politician with close ties to GMO industry, with little or no understanding of GMO biotechnology, providing a cut and paste version of pro-GMO propaganda directly from the Monsanto PR department which is deceptive and misleading. Genetic tinkering by inserting genetic material from foreign species into a plant does not produce “substantially equivalent” food. Genetic tinkering creates a new drug with unpredictable adverse effects, and requires the same rigorous safety testing as any new drug submitted for FDA approval.
Rather than name-calling those questioning the GMO enterprise as immoral, perhaps Mr. Daniels should regard the GMO industry as immoral.
Articles With Related Interest:
GMO Food Fight From Senate Floor
Berberine Antidote to a Modern epidemic
by Jeffrey Dach MD
7450 Griffin Road Suite 190
Davie, Fl 33314
954-792-4663
Links and references:
1) Union of Concerned Scientists: Eight Ways Monsanto Fails at Sustainable Agriculture
In fact, Monsanto has held back the development of sustainable agriculture, and continues to do so, in several ways:
2) Response to “Avoiding GMOs isn’t just anti-science. It’s immoral” Jan 04, 2018 In “Avoiding GMOs isn’t just anti-science. It’s immoral”, an op-ed published in the Washington Post, Mitch Daniels would have you believe that scientific research finds only benefits and no downsides to genetically engineered (GE) crops. The reality is not so.
The National Academies of Sciences, Engineering and Medicine recently reviewed over 900 scientific research and publications studying the agronomic, environmental, social and economic effects of genetically modified crops.Significantly, the report finds that GE crops have no higher yield potential than varietals developed through traditional breeding.GE crops are not a silver bullet solution to feed our growing population. To suggest so is naïve, inaccurate…and may be immoral.
3) Don Huber GMO Failed Promises Flawed Science Serious Health Safety Issue Glyphosate ” Future historians may well look back upon our time and write, not about how many pounds of pesticides we did or did not apply, but about how willing we are to sacrifice our children and jeopardize future generations for this massive experiment we call genetic engineering that is based on failed promises and flawed science, just to benefit the bottom line of a commercial enterprise.” Dr. Don M. Huber is Emeritus Professor, Purdue University; COL AUS (Ret, Medical Intelligence); Former Chairman, USDA National Plant Disease Recovery Program; member, US Threat Pathogens Committee; former member of the Advisory Board, Office of Technology Assessment, US Congress; and OTSG Global Epidemiology Working Group.
4) Tang, Guangwen, et al. “β-Carotene in Golden Rice is as good as β-carotene in oil at providing vitamin A to children.” The American journal of clinical nutrition 96.3 (2012): 658-664.
5) Golden rice paper retracted after legal bid fails By Erik StokstadJul. 31, 2015 , 3:00 PM SCience Magazine
6) Retraction of Tang G, Hu Y, Yin S-a, Wang Y, Dallal GE, Grusak MA, and Russell RM. b-Carotene in Golden Rice is as good as
b-carotene in oil at providing vitamin A to children. Am J Clin Nutr 2012;96:658–64.Committee).
7) Washington Post Publishes Hit Piece Declaring Non-GMO Movement “Immoral,” Here’s What They Got So Blatantly Wrong
By Nick Meyer On January 4, 2018
8) Monsanto’s Four Tactics for Undermining Glyphosate Science Review
Genna Reed, science and policy analyst, Center for Science and Democracy | March 23, 2017, 1:58 pm
9) Food Industry Enlisted Academics in G.M.O. Lobbying War, Emails Show By ERIC LIPTONSEPT. 5, 2015 New York Times
Monsanto and its industry partners have also passed out an undisclosed amount in special grants to scientists like Kevin Folta, the chairman of the horticultural sciences department at the University of Florida, to help with “biotechnology outreach” and to travel around the country to defend genetically modified foods.
10) Monsanto’s Monopoly on Agricultural Research by Big Universities
by Yelena Sukhoterina | November 20, 2015
11) Monsanto pledges $3 million for corn rootworm research
12) May 5, 2017 Collaborating With Academics and Universities Monsanto
13) Suppressing Research 8 Ways Monsanto Fails at Sustainable Agriculture: #7 multibillion-dollar agricultural corporations, including Monsanto, have fought independent research on their genetically engineered crops. They have often refused to provide independent scientists with seeds, or they’ve set restrictive conditions that severely limit research options. In 2009, 26 academic entomologists wrote to the U.S. Environmental Protection Agency that because patents on engineered genes do not provide for independent non-commercial research, they could not perform adequate research on these crops. “No truly independent research can be legally conducted on many critical questions involving these crops,” they wrote. A Purdue University entomologist who signed the letter put it more succinctly to a reporter for a scientific journal: “Industry is completely driving the bus.”
14) Forum, Jan. 5: Follow the GMO Money
Thursday, January 04, 2018
15) Avoiding GMOs isn’t just anti-science. It’s immoral.
By Mitch Daniels December 27, 2017
16) Avoiding GMOs isn’t just anti-science. It’s immoral
By Mitch Daniels The Washington Post Published December 29, 2017
2016
17) Anti-GMO Activists: ‘Heartless, Callous and Cruel’
by Bruce Edward Walker • March 22, 2016
18) Purdue President Calls To End Of “Morally Irresponsible” Attacks On GMO’s amidst mass rejection by Isiah Holmes • March 1, 2016
19-20) left blank
glyphosate
21) http://www.ncbi.nlm.nih.gov/pubmed/23224412
Curr Microbiol. 2013 Apr;66(4):350-8. doi: 10.1007/s00284-012-0277-2. Epub 2012 Dec 9. The effect of glyphosate on potential pathogens and beneficial members of poultry microbiota in vitro. Shehata AA1, Schrödl W, Aldin AA, Hafez HM, Krüger M.
The use of glyphosate modifies the environment which stresses the living microorganisms. The aim of the present study was to determine the real impact of glyphosate on potential pathogens and beneficial members of poultry microbiota in vitro.
The presented results evidence that the highly pathogenic bacteria as Salmonella Entritidis, Salmonella Gallinarum, Salmonella Typhimurium, Clostridium perfringens and Clostridium botulinum are highly resistant to glyphosate. However, most of beneficial bacteria as Enterococcus faecalis, Enterococcus faecium, Bacillus badius, Bifidobacterium adolescentis and Lactobacillus spp. were found to be moderate to highly susceptible. Also Campylobacter spp. were found to be susceptible to glyphosate. A reduction of beneficial bacteria in the gastrointestinal tract microbiota by ingestion of glyphosate could disturb the normal gut bacterial community. Also, the toxicity of glyphosate to the most prevalent Enterococcus spp. could be a significant predisposing factor that is associated with the increase in C. botulinum-mediated diseases by suppressing the antagonistic effect of these bacteria on clostridia.
Glyphosate linked to botulism and other animal health problems
Three very interesting papers from Monika Kruger and her team in Leipzig on the effect glyphosate has on the gut micro-organisma in animals by damaging the beneficial bacteria
“A reduction of beneficial bacteria in the gastrointestinal tract microbiota by ingestion of glyphosate could disturb the normal gut bacterial community.”
There is now a strong probability that glyphosate residues in animal feeds result in botulism in the cattle and also in related ailments in poultry.
22) Visceral botulism at dairy farms in Schleswig Holstein, Germany – Prevalence of Clostridium botulinum in feces of cows, in animal feeds, in feces of the farmers, and in house dust by Monika Krüger, Anke Große-Herrenthey, Wieland Schrödl, Achim Gerlach, Arne Rodloff Anaerobe 18 (2012) 221e223 Accepted 11 December 2011 Available online 21 December 2011
From 41 dairy farms in Schleswig Holstein, Germany, 196 fecal specimens of diseased cows, 77 fecal specimens of farmers and family members from 26 of these farms, 35 animal feed specimens and 7 house dust specimens were investigated for Clostridium botulinum and its antigens, respectively. Four of the humans under study (one child, 8 month, and three adults) showed symptoms of infant/visceral botulism. Specimens were cultivated in reinforced clostridial medium (RCM). C. botulinum antigens were detected by ELISA. The aim of the study was to obtain information on the relationship of detected C. botulinum toxin-types in cows, in the feces of attending humans, and in the immediate environment. The results revealed that C. botulinum toxin-types were different for cows and humans. Toxin-type A was dominant in cow feces while type E was found in humans. Type E was also present in some animal feed specimens. Conversely, toxin-type A was prevalent in the house dust of farms. It may be assumed that the feeds were the source of human colonization with C. botulinum.
23) Effect Glyphosate Pathogens Poultry Microbiota In Vitro Krueger Shehata Curr Microbiol 2012
The Effect of Glyphosate on Potential Pathogens and Beneficial Members of Poultry Microbiota In Vitro by Awad A. Shehata, Wieland Schro¨dl, Alaa. A. Aldin, Hafez M. Hafez , and Monika Kru¨ger Curr Microbiol 2012 Springer
The use of glyphosate modifies the environment which stresses the living microorganisms. The aim of the present study was to determine the real impact of glyphosate on potential pathogens and beneficial members of poultry microbiota in vitro. The presented results evidence that the highly pathogenic bacteria as Salmonella Entritidis, Salmonella Gallinarum, Salmonella Typhimurium, Clostridium perfringens and Clostridium botulinum are highly resistant to glyphosate. However, most of beneficial bacteria as Enterococcus faecalis, Enterococcus faecium, Bacillus badius, Bifidobacterium adolescentis and Lactobacillus spp. were found to be moderate to highly susceptible. Also Campylobacter spp. were found to be susceptible to glyphosate. A reduction of beneficial bacteria in the gastrointestinal tract microbiota by ingestion of glyphosate could disturb the normal gut bacterial community. Also, the toxicity of glyphosate to the most prevalent Enterococcus spp. could be a significant predisposing factor that is associated with the increase in C. botulinum-mediated diseases by suppressing the antagonistic effect of these bacteria on clostridia.
24) Glyphosate suppresses the antagonistic effect of Enterococcus on Clostridia Kruger 2013 by Monika Krüger, Awad Ali Shehata, Wieland Schrödl, Arne Rodloff. Anaerobe 20 (2013) 74e78
25) GMO Opposition Is About Culture and Economics, Not Morals
Henry Homeyer For the Valley News Friday, January 12, 2018
Jeffrey Dach MD
7450 Griffin Road, Suite 190
Davie, Fl 33314
954-792-4663
www.jeffreydachmd.com
www.drdach.com
www.naturalmedicine101.com
www.bioidenticalhormones101.com
www.truemedmd.com
Disclaimer click here: www.drdach.com/wst_page20.html
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) 2017 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.
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
The post Mitch Daniels Says Anti-GMO is Immoral – Perhaps the GMO Industry is Immoral appeared first on Jeffrey Dach MD.
December 27, 2017
Understanding SIBO Small Intestinal Bacterial Overgrowth
[image error] Understanding SIBO – Small Intestinal Bacterial Overgrowth
Causes, Diagnosis, and Treatment by Jeffrey Dach MD
Alfred, a 57 year old CEO of a high tech company, flew in from Europe to see me for symptoms of abdominal gas, bloating, pain and food sensitivities. Alfred also has frequent migraines triggered by foods. His local doctors have prescribed anti-fungal drugs thinking Alfred had Candida overgrowth in the small bowel. Alfred’s SIBO Breath Test was indeed positive, showing increased production of both hydrogen and methane gas. In this article we will discuss the diagnosis, causes and treatment of SIBO.
Header image: A schematic diagram that shows principle of hydrogen breath test. SIBO, small intestinal bacterial overgrowth; ppm, parts per million. Fig 1 courtesy of J Neurogastroenterol Motil. 2011 Jul; 17(3): 312–317. How to Interpret Hydrogen Breath Tests by Uday C Ghoshal
What is SIBO ?
SIBO stands for small intestinal bacterial overgrowth, and is commonly associated with underlying Achlorhydria (lack of gastric acid) and/or impaired gastric motility.
1) Achlorhydria (gastric atrophy or long term PPI antacid use).
2) Gastric Motility Disorder (autonomic dysfunction related to mitochondrial dysfunction) . Here, it is useful to check for the MTHFR gene mutation, and B12 deficiency, (and thiamine deficiency) which may cause autonomic dysfunction. Parkinson’s Disease is known to be associated with autonomic dysfunction and leaky gut, and has a high association with SIBO. Diagnosis is made by Hydrogen and Methane breath testing, now widely available.
SIBO is essentially a dysbiosis related to loss of gastric sterile barrier to passage of microbes from stomach to small bowel. It is frequently associated with other small bowel disorders such as leaky gut which may cause low level endotoxemia (as in Cirrhosis), and malabsorption of fat and fat soluble vitamins.
Treatment involves replacing gastric acid levels which restores the sterile barrier to passage of bacteria from stomach to small bowel. Discontinuing PPI Anti-Acid suppressing drugs, adding in Digestive Enzymes with Betain HCL, and replacing the vitamin and mineral deficiencies is a good first step in treatment.
Restoring healthy gut bacteria flora with gut-antibiotics (Rifaximin) and probiotics is described in the protocol sheet for treating SIBO which can be found HERE. Herbal alternatives are also listed for those wishing to avoid the antibiotics. Autonomic Dysfunction may be caused by underlying MTHFR mutation in which case methyl-folate, Benfo-thiamine and methyl-B12 may be useful.
Conclusion: The wide availability of SIBO Breath testing has made SIBO the popular “Diagnosis Du Jour”. Understanding SIBO association with underlying gastric achlorhydria and/or autonomic dysfunction is important for successful management.
Jeffrey Dach MD
7450 Griffin Road
Suite 190
Davie, Florida 33314
954-792-4663
Articles With Related Interest:
NSAIDS Small Bowel and Leaky GUT
Hair Loss from Low Stomach Acid
HeartBurn GE Reflux and Acid Blocker Drugs
Anti-Acids Associated with B12 deficiency
Links and References
Nice overview three part series
SIBO 101: A Comprehensive Guide to Small Intestinal Bacterial Overgrowth by Admin – Cynthia Perkins on February 13, 2015
part two
SIBO Treatment, Diet and Maintenance – Cynthia Perkins on February 24, 2015
part three
Candida, SIBO or H. Pylori? – Cynthia Perkins on March 6, 2015
=================================================
!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!Best
Townsend Letter February/March 2015
SIBO: Dysbiosis Has A New Name by Steven Sandberg-Lewis, ND, DHANP and Allison Siebecker, ND, MSOM
Antibiotics
The most studied and successful prescription antibiotic for SIBO is rifaximin (brand name Xifaxan). It has a broad spectrum of activity and is nonabsorbable. Its luminal status allows it to act locally, and it is therefore less likely to cause systemic side effects common to other antibiotics.90
Rifaximin has up to a 91% success rate and is given at
550 mg t.i.d. × 14 days.
!!! Best !!!!!!!!!!!!!!!!!!!!!!!!!!
SIBO Treatment Protocol Pimentel Siebecker Sandberg Lewis 2014 From Townsend Letter Feb/March 2015 SIBO treatment
=======================================================
Dr. Allison Siebecker Web Site
Dr. Allison Siebecker Handouts for your use
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Small Intestinal Bacterial Overgrowth (SIBO)
by Well Balanced – Food – Life – Travel on January 22, 2014 kate scarlata
Okay, I am about to get all science-y on you. Are you ready? Thinking cap on? I attended a great conference last weekend, a SIBO symposium sponsored by the National College of Natural Medicine in Portland, Oregon. Top SIBO specialists that presented most of the information at the symposium included: Mark Pimentel, MD, FRCPC, Allison Siebecker, ND, MSOM, LAc, Leonard Weinstock, MD, FACG and Steven Sandberg-Lewis,
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BOOKS
The Gut Health Protocol: A Nutritional Approach To Healing SIBO, Intestinal Candida, GERD, Gastritis, and other Gut Health Issues July 1, 2016 by John Herron
The SIBO Solution: Your Comprehensive Guide to Eliminating Small Intestinal Bacterial Overgrowth Jun 14, 2015 by Sylvie McCracken
A New IBS Solution: Bacteria-The Missing Link in Treating Irritable Bowel Syndrome Paperback – May 15, 2006 by Mark Pimentel (Author)
According to Dr. Mark Pimentel, Director of the Gastrointestinal Motility Program at Cedars-Sinai Medical Center, the majority of IBS cases can be treated successfully.Dr. Mark Pimentel believes that the “missing link,” or root cause of most IBS symptoms can be attributed to an overgrowth of bacteria in the small intestine. A New IBS Solution takes you through the historical evolution of conventional medicine’s views on IBS in a way that can be easily understood. In addition, Dr. Pimentel presents a simple treatment protocol that will not only help you resolve your IBS symptoms, but will also prevent their recurrence.
The Low-FODMAP Diet for Beginners: A 7-Day Plan to Beat Bloat and Soothe Your Gut with Recipes for Fast IBS Relief Paperback – October 10, 2017 by Mollie Tunitsky (Author)
The Complete Low-FODMAP Diet: A Revolutionary Plan for Managing IBS and Other Digestive Disorders Paperback – August 13, 2013
by Sue Shepherd PhD (Author), Peter Gibson MD (Author)
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Autonomic Dysfunction ZZZ
Small Intestine Bacterial Overgrowth (SIBO) by Autonomic Specialists
Small intestine bacterial overgrowth (SIBO) is commonly found in patients with dysautonomia. Of the patients we treat for autonomic dysfunction at Autonomic Specialists, most test positive for SIBO. Because it is so prevalent in our patients, we’ve had to establish a treatment program specifically to address this problem.
SIBO – Symptoms and Complications
small intestine bacterial overgrowth sibo
SIBO is chronic infection of the small intestine. It can be seen with a number of conditions but is most strongly associated with irritable bowel syndrome (IBS). In fact according to Dr. Pimentel, SIBO is the cause of IBS. It is not necessarily an infection in the sense of a build up of pathogens, rather it is simply a build of bacteria in an area of the body that is normally free from bacteria.
SIBO can lead to IBS symptoms such as bloating, pain, constipation, diarrhea or both. Malabsorption may also occur in the presence of SIBO. Perhaps the biggest issue caused by SIBO is intestinal permeability, otherwise known as leaky gut. Intestinal permeability may lead to activation of the immune system which can result in food sensitivities. Fatigue, altered cognition, pain and other neurologic symptoms may also occur as a result of intestinal permeability.
Risk Factors for SIBO
Achlorhydria is a predisposing factor for SIBO as is extended antibiotic use. Dysautonomia is also a risk factor for SIBO. In fact in our practice most patients with dysautonomia are found to also suffer from SIBO. Several publications demonstrate a strong connection between SIBO and fibromyalgia.
Testing for SIBO
Diagnosis of SIBO is often confirmed by breath test. This involves the ingestion of a sugar solution followed by collection of the gases breathed out of the lungs over time. A rise in hydrogen or methane gas shortly after eating, indicating fermentation occurring in the small intestine, is indicative of SIBO.
SIBO Treatment at Autonomic Specialists
Successful treatment of SIBO can be challenging. However, treatment is important for more than just relief of IBS symptoms. SIBO is often present with other conditions, some of which are autoimmune or chronic inflammatory illnesses. Correction of intestinal permeability in those circumstances is particularly important.
We take a multi-pronged approach to treating SIBO using :
1) antimicrobials,
2) pro kinetic agents such as low dose naltraxone (LDN), and
3) low FODMAPS or elemental diets.
Dysautonomia SIBO Mito Action Webcast 2011 Richard G Boles Too Hot, Too Cold, Too High, Too Low -Blame it on Dysautonomia! MitoAction Webcast 6-May, 2011 Richard G. Boles, M.D. Medical Genetics Childrens Hospital Los Angeles Associate Professor of Pediatrics Keck School of Medicine at USC. Slides.
Mitochndrial Dysfunction causes Dysautonomy and SIBO MTHFR ? Methylfolate Rx
Parkinsons Disease Autonomic Dysfunction and SIBO
SIBO Small intestinal bacterial overgrowth in Parkinson’s disease Tan Parkinsonism 2014 Tan, Ai Huey, et al. “Small intestinal bacterial overgrowth in Parkinson’s disease.” Parkinsonism & related disorders 20.5 (2014): 535-540.
BACKGROUND: Recent studies reported a high prevalence of small intestinal bacterial overgrowth (SIBO) in Parkinson’s disease (PD), and a possible association with gastrointestinal symptoms and worse motor function. We aimed to study the prevalence and the potential impact of SIBO on gastrointestinal symptoms, motor function, and quality of life in a large cohort of PD patients.
METHODS: 103 Consecutive PD patients were assessed using the lactulose-hydrogen breath test; questionnaires of gastrointestinal symptoms and quality of life (PDQ-39); the Unified PD Rating Scale (UPDRS) including “on”-medication Part III (motor severity) score; and objective and quantitative measures of bradykinesia (Purdue Pegboard and timed test of gait). Patients and evaluating investigators were blind to SIBO status.
RESULTS: 25.3% of PD patients were SIBO-positive. SIBO-positive patients had a shorter mean duration of PD (5.2 ± 4.1 vs. 8.1 ± 5.5 years, P = 0.007). After adjusting for disease duration, SIBO was significantly associated with lower constipation and tenesmus severity scores, but worse scores across a range of “on”-medication motor assessments (accounting for 4.2-9.0% of the variance in motor scores). There was no association between SIBO and motor fluctuations or PDQ-39 Summary Index scores.
CONCLUSIONS: This is the largest study to date on SIBO in PD. SIBO was detected in one quarter of patients, including patients recently diagnosed with the disease. SIBO was not associated with worse gastrointestinal symptoms, but independently predicted worse motor function. Properly designed treatment trials are needed to confirm a causal link between SIBO and worse motor function in PD.
Breath Testing
de Lacy Costello, B. P. J., M. Ledochowski, and Norman M. Ratcliffe. “The importance of methane breath testing: a review.” Journal of breath research 7.2 (2013): 024001.
In conclusion, the combined measurement of hydrogen and methane should offer considerable improvement in the diagnosis of malabsorption syndromes and SIBO when compared with a single hydrogen breath test.
Saad, Richard J., and William D. Chey. “Breath testing for small intestinal bacterial overgrowth: maximizing test accuracy.” Clinical Gastroenterology and Hepatology 12.12 (2014): 1964-1972.
The diagnosis of small intestinal bacterial overgrowth (SIBO) has increased considerably owing to a growing recognition of its association with common bowel symptoms including chronic diarrhea, bloating, abdominal distention, and the irritable bowel syndrome. . The measurement of methane in addition to hydrogen can increase the sensitivity of breath testing for SIBO.
Am J Gastroenterol. 1996 Sep;91(9):1795-803.
The lactulose breath hydrogen test and small intestinal bacterial overgrowth.Riordan SM1, McIver CJ, Walker BM, Duncombe VM, Bolin TD, Thomas MC.
To i) document the sensitivity and specificity of a combined scintigraphic/lactulose breath hydrogen test for small intestinal bacterial overgrowth and ii) investigate the validity of currently accepted definitions of an abnormal lactulose breath hydrogen test based on “double peaks” in breath hydrogen concentrations.
METHODS:Twenty-eight subjects were investigated with culture of proximal small intestinal aspirate and a 10-g lactulose breath hydrogen test combined with scintigraphy. Gastroduodenal pH, the presence or absence of gastric bacterial overgrowth, and the in vitro capability of overgrowth flora to ferment lactulose were determined.
RESULTS:Sensitivity (16.7%) and specificity (70.0%) of the lactulose breath hydrogen test alone for small intestinal bacterial overgrowth were poor. Combination with scintigraphy resulted in 100% specificity, because double peaks in serial breath hydrogen concentrations may occur as a result of lactulose fermentation by cecal bacteria. Sensitivity increased to 38.9% with scintigraphy, because a single rise in breath hydrogen concentrations, commencing before the test meal reaches the cecum, may occur in this disorder. Sensitivity remained suboptimal irrespective of the definition of small intestinal bacterial overgrowth used, the nature of the overgrowth flora, favorable luminal pH, the presence of concurrent gastric bacterial overgrowth, or the in vitro ability of the overgrowth flora to ferment lactulose.
CONCLUSIONS:Definitions of an abnormal lactulose breath hydrogen test based on the occurrence of double peaks in breath hydrogen concentrations are inappropriate. Not even the addition of scintigraphy renders this test a clinically useful alternative to culture of aspirate for diagnosing small intestinal bacterial overgrowth.
Rifaxinin- Antibiotics
Gatta, L., and C. Scarpignato. “Systematic review with meta‐analysis: rifaximin is effective and safe for the treatment of small intestine bacterial overgrowth.” Alimentary pharmacology & therapeutics 45.5 (2017): 604-616.
Schwartz, Emily, Luigi Brunetti, and Jane Ziegler. “Antibiotic Treatment of Small Intestinal Bacterial Overgrowth: What Is the Evidence?.” Topics in Clinical Nutrition 31.4 (2016): 296-313.
The analysis of the available data suggests that antibiotics, particularly rifaximin, may be effective in normalizing breath tests and improving gastrointestinal symptoms in patients with SIBO.
Reviews
2010
Bures, Jan, et al. “Small intestinal bacterial overgrowth syndrome.” World journal of gastroenterology: WJG 16.24 (2010): 2978.
The greatest experience for treatment of SIBO was acquired with rifaximin[43,148-154]. Rifaximin is a semi-synthetic rifamycin-based non-systemic antibiotic, with a low gastrointestinal absorption and good bactericidal activity. The antibacterial action covers Gram-positive and Gram-negative organisms, both aerobes and anaerobes[155]. According to different studies, rifaximin improves symptoms in 33%-92% and eradicates small intestinal bacterial overgrowth in up to 80% of patients[151,152]. Most authors recommend administering rifaximin for 7-10 d as one treatment course or as a cyclic therapy. Higher doses (1200 or 1600 mg/d) are more effective than standard doses (600 or 800 mg/d)[148,154]. Rifaximin is probably the only antibiotic that is capable of achieving a long-term favourable clinical effect in patients with irritable bowel and SIBO[43].
The relapse rate of SIBO after successful treatment is high. Lauritano et al[165] found recurrence of SIBO in 44% (35/80) of patients nine months after successful treatment with rifaximin. Apart from the basic underlying disease, further risk factors for recurrence of SIBO have been identified including older age (OR 1.1), appendectomy in the patient’s history (OR 5.9) and long-term treatment with proton pump inhibitors (OR 3.5)[165].
2014 excellent !!!!!!!
free pdf Small Intestinal Bacterial Overgrowth SIBO Salem J Gastroint Dig Syst 2014 Salem, A., and B. C. Ronald. “Small Intestinal Bacterial Overgrowth (SIBO).” J Gastroint Dig Syst 4.225 (2014): 2.
Rifaximin has been reported in several studies to improve symptoms in up to 92% of patients and additionally to eradicate bacterial overgrowth in up to 80% based on normalization of breath testing [39,40]. The recommendation regarding dosing and duration of treatment varies widely from one study to the next; however, it has been reported that higher dosing (1200 or 1600 mg daily) is more effective as a treatment course as compared to conventional dosing [38,41].
Tetracyclin has also been suggested as an initial therapy for SIBO (1000 mg daily for a 7 day course) and has been shown to result in both normalization of hydrogen breath testing and resolution of symptoms [42]. In another study by Castiglione et al., patients with Crohn’s disease and concomitant SIBO were found to be effectively treated with a combination of Ciprofloxacin and Metronidazole [43].
Due to the malabsorptive nature of SIBO; vitamin A, B12, D and E levels should be routinely obtained and replaced if indicated.
Pancreatic enzyme supplementation should also be considered in those patients with severe bacterial overgrowth and evidence of fat
malabsorption.
As carbohydrates are the primary source for bacteria, a low (FODMAP) diet, which refer to low intake of carbohydrates in the form of (fermentable Olig-Di-Monosaccharaides And Polyps), has been shown to significantly relieve symptoms, particularly in those with IBS [46].
Probiotics, herbals, and certain diet may also play a significant role
for relieving and treating SIBO. Chedid et al recently reported that
herbal therapies appear to be as effective as antibiotic therapy in the
treatment of SIBO based on resolution of hydrogen breath testing [47].
Probiotics are bacterial preparations that alter the bacteria in the bowel
to cause beneficial effect. The primary role for probiotics is to
strengthen the barrier function of the gut, to modify the inflammatory response of the bowel, and to potentially decrease visceral hypersensitivity as well [48,49]. Recent studies have also shown
beneficial effects in the setting of treating SIBO patients with enteric- coated peppermint oil [50].
Lastly, long term use of proton pump inhibitors (PPIS); have been
postulated to predispose to an increase in the number of bacteria in
the stomach and the small bowel. Therefore, stopping unnecessary
acid suppressive therapy (which is often prescribed erroneously) may play a significant role in relieving the symptoms for SIBO.
Probiotics
Khalighi, A. R., et al. “Evaluating the efficacy of probiotic on treatment in patients with small intestinal bacterial overgrowth (SIBO)-A pilot study.” The Indian journal of medical research 140.5 (2014): 604.
Lactol contains a combination of probiotic(Lactobacillus sporogenes) and prebiotic (fructo-oligosaccharides)
Background objectives: Small intestinal bacterial overgrowth (SIBO) leads to several gastrointestinal (GI) problems and complications leading to malabsorption. The effectiveness of probiotics in the treatment of SIBO syndrome has not been well studied. This pilot study was aimed to assess the efficacy of a probiotic consisting of lactobacilli in the treatment of SIBO.
Methods: In this study, 30 cases suffering from chronic abdominal pain or diarrhoea and with a positive hydrogen breath test were randomized in a double-blind manner into two groups: probiotic drug user and control group. After an initial 3-week aggressive therapy with broad-spectrum antibiotics, a 15-day maintenance antibiotic therapy with lactol was administered for the study group and the same regimen without lactol for the control group. After six months the HBT result and the GI symptoms were analyzed and compared between the two groups.
Results: The result of hydrogen breath test and the clinical symptoms in patients receiving the maintenance regimen with lactol probiotic showed a better response. The hydrogen breath test turned negative in 93.3 per cent of those receiving lactol compared to 66.7 per cent of the controls. In all the cases receiving lactol, the abdominal pain disappeared completely (P=0.002). In addition, other GI problems including flatulence, belching and diarrhoea significantly improved in the study group (P
Interpretation & conclusions: Based on the preliminary data it seems that adding lactol probiotic to the maintenance therapy of small intestinal bacterial overgrowth patients on routine antibiotic therapy will be beneficial in preventing the complications of this syndrome.
Quigley, Eamonn MM, and Rodrigo Quera. “Small intestinal bacterial overgrowth: roles of antibiotics, prebiotics, and probiotics.” Gastroenterology 130.2 (2006): S78-S90.
Small intestinal bacterial overgrowth is common in intestinal failure. Its occurrence relates to alterations in intestinal anatomy, motility, and gastric acid secretion. Its presence may contribute to symptoms, mucosal injury, and malnutrition. Relationships between bacterial overgrowth and systemic sepsis are of potential importance in the intestinal failure patient because the direct translocation of bacteria across the intestinal epithelium may contribute to systemic sepsis: a phenomenon that has been well established in experimental animal models. The accurate diagnosis of bacterial overgrowth continues to present a number of challenges in clinical practice and especially so among patients with intestinal failure. The management of patients with bacterial overgrowth remains, for the most part, primarily empiric and comprises antibiotic therapy and correction of any associated nutritional deficiencies. Although evidence from experimental animal studies consistently indicates that probiotics exert barrier-enhancing, antibacterial, immune-modulating, and anti-inflammatory effects, which all could be benefits in small intestinal bacterial overgrowth and intestinal failure, their role in human beings remains to be evaluated adequately.
SIBO Cirrhosis and Endotoxemia (leaky Gut)- acid suppressive therapy.
Bauer, Tilman M., et al. “Small intestinal bacterial overgrowth in human cirrhosis is associated with systemic endotoxemia.” The American journal of gastroenterology 97.9 (2002): 2364-2370.
Systemic endotoxemia has been implicated in various pathophysiological sequelae of chronic liver disease. One of its potential causes is increased intestinal absorption of endotoxin. We therefore examined the association of small intestinal bacterial overgrowth with systemic endotoxemia in patients with cirrhosis.
METHODS:Fifty-three consecutive patients with cirrhosis (Child-Pugh group A, 23; group B, 18; group C, 12) were included. Jejunal secretions were cultivated quantitatively and systemic endotoxemia determined by the chromogenic Limulus amoebocyte assay. Patients were followed up for 1 yr.
RESULTS:Small intestinal bacterial overgrowth, defined as > or = 10(5) total colony forming units per milliliter of jejunal secretions, was present in 59% of patients and strongly associated with acid suppressive therapy. The mean plasma endotoxin level was 0.86 +/- 0.48 endotoxin units/ml (range = 0.03-1.44) and was significantly associated with small intestinal bacterial overgrowth (0.99 vs 0.60 endotoxin units/ml, p = 0.03). During the 1-yr follow-up, seven patients were lost to follow up or underwent liver transplantation and 12 patients died. Multivariate Cox regression showed Child-Pugh group to be the only predictor for survival.
CONCLUSIONS:Small intestinal bacterial overgrowth in cirrhotic patients is common and associated with systemic endotoxemia. The clinical relevance of this association remains to be defined.
Jeffrey Dach MD
7450 Griffin Road, Suite 190
Davie, Fl 33314
954-792-4663
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December 20, 2017
Unexplained Infertility Linked to Low Thyroid Function
[image error] Unexplained Infertility Linked to Low Thyroid Function
by Jeffrey Dach MD
A new study in Endocrinology, found that women with unexplained infertility had higher TSH levels than aged matched controls, indicating lower thyroid function may be responsible. Nearly twice as many women with Unexplained Infertility had TSH level above 2.5 compared to controls.(1)
My previous article, Low Thyroid, Hashimotos and Pregnancy, discussed the association between low thyroid function and poor pregnancy outcomes.
Broda Barnes and Hypothyroidism, The Unexpected Illness
Dr. Broda Barnes in his famous 1976 thyroid classic, “Hypothyroidism, the Unexpected Illness“, discusses the association between low thyroid function and infertility, menstrual irregularities, excessive menstrual bleeding, and ovarian dysfunction in general.(3) Dr Barnes treated many such low thyroid women with thyroid hormone with good results. Here is a quote from Dr Broda Barnes from 1972:
“The medical literature is full of reports going back many years that provide evidence that thyroid medication, used when indicated, is one of the most helpful measures in the treatment of infertility in both men and women. And not infrequently it may be needed by both partners in an infertile marriage.”
Hashimotos and Pregnancy
Similarly the presence of Hashimotos’ antibodies is associated with poor pregnancy outcomes. Ten to twenty per cent of reproductive age women have elevated thyroid antibodies. Dr. Roberto Negro from Italy published a study in 2006 of women who had Hashimotos with Elevated thyroid antibodies. Treatment of these women with thyroid hormone resulted in a dramatic reduction of stillbirths and preterm deliveries.(2)
Conclusion: Many cases of Unexplained Infertility and menstrual irregularities are related to low thyroid function. Administration of thyroid hormone often resolves the issue.
Jeffrey Dach MD
7450 Griffin Road suite 190
Davie, Fl 33314
954-792-4663
Articles with Related Interest:
Low Thyroid, Hashimotos and Pregnancy
Links and References:
Header image: courtesy of : Dalene at Natural Fertility Info.com , see You Tube Video: Thyroid Problems and How They Affect Fertility
1) Women with Unexplained Infertility found to have lower thyroid function than Control Patients, (higher TSH values) . See: Tahereh Orouji Jokar, Lindsay T Fourman, Hang Lee, Katherine Mentzinger, Pouneh K Fazeli. Higher TSH levels within the normal range are associated with unexplained infertility. The Journal of Clinical Endocrinology & Metabolism, 2017; “Women with Unexplained Infertlity (UI) had significantly higher TSH levels than controls. Nearly twice as many women with UI (26.9%) had a TSH >2.5mIU/L compared to controls (13.5%; p
2) https://www.ncbi.nlm.nih.gov/pubmed/16621910
J Clin Endocrinol Metab. 2006 Jul;91(7):2587-91.
Levothyroxine treatment in euthyroid pregnant women with autoimmune thyroid disease: effects on obstetrical complications. Negro R1, Formoso G, Mangieri T, Pezzarossa A, Dazzi D, Hassan H.
Euthyroid women with autoimmune thyroid disease show impairment of thyroid function during gestation and seem to suffer from a higher rate of obstetrical complications.
OBJECTIVE:We sought to determine whether these women suffer from a higher rate of obstetrical complications and whether levothyroxine (LT(4)) treatment exerts beneficial effects.
DESIGN:This was a prospective study.
SETTING:The study was conducted in the Department of Obstetrics and Gynecology.
PATIENTS:A total of 984 pregnant women were studied from November 2002 to October 2004; 11.7% were thyroid peroxidase antibody positive (TPOAb(+)).
INTERVENTION:TPOAb(+) patients were divided into two groups: group A (n = 57) was treated with LT(4), and group B (n = 58) was not treated. The 869 TPOAb(-) patients (group C) served as a normal population control group.
MAIN OUTCOME MEASURES:Rates of obstetrical complications in treated and untreated groups were measured.
RESULTS:At baseline, TPOAb(+) had higher TSH compared with TPOAb(-); TSH remained higher in group B compared with groups A and C throughout gestation. Free T(4) values were lower in group B than groups A and C after 30 wk and after parturition. Groups A and C showed a similar miscarriage rate (3.5 and 2.4%, respectively), which was lower than group B (13.8%) [P < 0.05; relative risk (RR), 1.72; 95% confidence interval (CI), 1.13-2.25; and P < 0.01; RR = 4.95; 95% CI = 2.59-9.48, respectively]. Group B displayed a 22.4% rate of premature deliveries, which was higher than group A (7%) (P < 0.05; RR = 1.66; 95% CI = 1.18-2.34) and group C (8.2%) (P < 0.01; RR = 12.18; 95% CI = 7.93-18.7).
CONCLUSIONS:Euthyroid pregnant women who are positive for TPOAb develop impaired thyroid function, which is associated with an increased risk of miscarriage and premature deliveries. Substitutive treatment with LT(4) is able to lower the chance of miscarriage and premature delivery.
3) Barnes, Broda Otto, and Lawrence Galton. Hypothyroidism: The unsuspected illness. New York: Harper & Row, 1976.
The post Unexplained Infertility Linked to Low Thyroid Function appeared first on Jeffrey Dach MD.
December 12, 2017
Cholesterol Levels and Atherosclerosis: Autopsy Studies Show No Correlation
[image error] Cholesterol Levels and Atherosclerosis: Autopsy Studies Show No Correlation
By Jeffrey Dach MD
Drs William Ware (25) and Uffe Ravnskov(1) have both pointed out an inconvenient truth. Many autopsy studies dating back to 1936 all show the same finding: cholesterol levels do not correlate with the amount of atherosclerosis found on autopsy studies.(1)(25) If accepted as true, this would indeed disprove the cholesterol theory of atherosclerotic heart disease. Left Image: CAT scan of atherosclerotic disease in coronary artery (white arrow). Courtesy of Pathology Outlines.com
Drs Landé and Sperry conducted an autopsy study published in the 1936 Archives of Pathology. They say:
“In fresh autopsy material in 123 cases of violent death they compared the serum cholesterol content with the lipid content of the aorta. No relationship was present in any age group. It is concluded that the incidence and severity of atherosclerosis in man is not directly correlated with the blood serum cholesterol content.”(2)
Dr KS Mathur did another autopsy study published in 1962 in Circulation.
Two hundred cases were selected from medicolegal autopsies for a study of the relationship of serum cholesterol to the amount and severity of atherosclerosis in the aorta and the coronary and cerebral arteries… No correlation could be observed between the serum cholesterol level and the amount and severity of atherosclerosis in the arteries.(3)
A more recent study of 51 autopsies, by Dr Braz in the 2007 J Med Biol Res showed:
“that in patients with severe atherosclerosis blood cholesterol and triglyceride levels seem to have little influence on coronary lipid content, indicating that other factors may contribute to arterial lipid deposition and plaque formation.”(4)
Dr Paterson published two studies in 1960 and 1963 (Circulation) evaluating “Serum lipid levels and the severity of coronary and cerebral atherosclerosis in adequately nourished men, 60 to 69 years of age.” He says:
“No significant relationships,nor any trend toward such relationships,were found in 18 individual analyses concerning the coronary arteries. Furthermore, the mean serum lipid levels were consistently (but not significantly) higher in persons who did not have demonstrable sequelae of coronary sclerosis at autopsy than in persons who had sequelae. We conclude from these results that the validity of the “lipid theory” of atherosclerosis remains unproved, as far as the coronarv arteries are concerned.“(5-6)
Many other have reported similar findings (7,8)
Mainstream Cardiology Has Rejected This Information
Of course, as Dr William Ware has pointed out, mainstream cardiology has ignored and rejected the information that autopsy studies showing no correlation between serum cholesterol and extent and severity of coronary artery disease.(25) Another inconvenient fact ignored by conventional cardiology is that modern imaging studies with Calcium Scoring have falsified the cholesterol theory of heart disease.(25) This was discussed in my previous article.
My Neighbor Bill
Last week I was having a beer in the back yard with my neighbor, Bill who is recovering from a triple bypass operation. Bill said:
“It was my darn cholesterol that caused it….I’m taking Lipitor (statin drug) and my cholesterol is a lot lower now.“
I said “that’s great, Bill”. People believe that cholesterol causes heart disease thanks to drug company television advertising. I didn’t have the heart to tell Bill the theory cholesterol causes heart disease has been disproved by numerous autopsy studies. I knew that Bill believed in the cholesterol theory of heart disease, and any information to the contrary would induce a state of shock and disbelief. The benefit from statin drugs is not solely from reduction of LDL cholesterol. Rather, the benefit of statin drugs, if any, arises from the pleotrophic effects as anti-inflammatory drugs.(17-18)
Pleiotropic Effects Explain Clinical Benefit of Statins (if any)
This is a quote from Dr Kavalipati(17):
“Over the years, analyses of several clinical studies, including the landmark HPS and ASCOT-LLA trial, reported findings with statins that were inexplicable with the lipid-lowering mechanism alone.”(17)
At the same time the statin drug reduces serum cholesterol, there is a simultaneous pleiotrophic effect (anti-inflammatory) which is completely independent from the cholesterol lowering effect. How much clinical benefit is due to cholesterol lowering, and how much benefit is due to pleiotrophic effects is a matter of debate. According to Dr Oesterle in Circulation Research 2017:
“Statins may exert cardiovascular protective effects that are independent of LDL-cholesterol lowering called pleiotropic effects…..The relative contributions of statin pleiotropy to clinical outcomes, however, remain a matter of debate and are hard to quantify because the degree of isoprenoid inhibition by statins correlates to some extent with the amount of LDL-cholesterol reduction.”(18)
All the Benefits of Statin Drugs Are Due to Pleiotrophic Effects
My best guess is that all the benefits of statins are due to pleiotrophic effects. This is supported by the fact that other lipid lowering drugs using a different mechanism from statins failed to prevent heart attacks or strokes. (23,24) A perfect example is the new drug, evacetrapib, which lowers LDL and increases HDL cholesterol using a different mechanism from statins. After the evacetrapib failed to prevent heart attacks or strokes in a huge randomized placebo controlled trial published in 2017 NEJM, the drug was abandoned. (23,24) The drugs lowered cholesterol, but had no clinical benefit in preventing cardiac events.
Statin Drug Studies Before and After 2005
Dr Michel de Lorgeril in his two articles from 2015 and 2016 reveals an unpleasant fact.(22,23) Because of the Vioxx Scandal, Congress tightened rules for clinical drug trials in 2005. Statin drug studies before 2005 are of questionable validity, and after 2005 are more “transparent”, “honest” and of greater validity.(22,23) This is Dr Michel de Lorgeril’s conclusion:
“In conclusion, this review strongly suggests that statins are not effective for cardiovascular prevention. The studies published before 2005/2006 were probably flawed, and this concerned in particular the safety issue. A complete reassessment is mandatory. Until then, physicians should be aware that the present claims about the efficacy and safety of statins are not evidence based.”(22)
Statins Not Beneficial In Primary Prevention
Regarding primary prevention of heart disease by statin drugs in healthy patients with only elevated cholesterol and no known underlying heart disease, Dr Michel de Lorgeril says that Statin drugs have no benefit, and their discontinuation might even save lives:
“We conclude that (1) despite the recent hype raised by HOPE-3, the cholesterol-lowering rosuvastatin is likely not beneficial in intermediate-risk individuals without cardiovascular disease (primary prevention). This trial may even represent a typical example of how evidence-based medicine has been flawed in commercial studies. (2) Statin discontinuation does not lead to increased (Ischemic Heart Disease) IHD and overall mortality, at least in the months following interruption of treatment. On the contrary, one might even conclude that statin discontinuation could save lives.“(23)
Conclusion: Many autopsy studies dating back to 1936 show no correlation between cholesterol level and severity of atherosclerotic disease. The clinical benefit of statin drugs, if any, is entirely due to the pleiotrophic effects. Reduction of cholesterol with non-statin drugs do not prevent heart attacks or strokes.(19-25) For more information on what really causes heart disease and how to prevent it see my previous article on this topic.
Jeffrey Dach MD
7450 Griffin Road
Suite 190
Davie, Florida 33314
954-792-4663
Articles With Related Interest:
The LPS Theory of Heart Disease
Aged Garlic for Treating Calcium Score
The Art of the Curbside Cholesterol Consult
Statin Denialism On the Internet
Statin Drugs and Botanicals Anti-Inflammatory Effects
Statins Reduce Perioperative Mortality, Surely you Are Joking?
Statin Choir Boy Turns Disbeliever
Getting Off Statin Drug Stories
Statin Drugs for Women, Just Say No
Links and References
Serum lipid levels and atherosclerosis
1) Is atherosclerosis caused by high cholesterol?
U. Ravnskov QJM: An International Journal of Medicine, Volume 95, Issue 6, 1 June 2002, Pages 397–403,
1936
2) Landé, K. E., and W. M. Sperry. “Human atherosclerosis in relation to the cholesterol content of the blood serum.” Arch. Pathol. 22 (1936): 301-312.
Abstract : The authors accepted the finding of previous workers that a correlation exists between the degree of arteriosclerosis in man and the lipoid content of the aorta. In fresh autopsy material in 123 cases of violent death they compared the serum cholesterol content with the lipid content of the aorta. No relationship was present in any age group. It is concluded that the incidence and severity of atherosclerosis in man is not directly correlated with the blood serum cholesterol content.-A. Lyall.
3) Mathur, K. S., et al. “Serum cholesterol and atherosclerosis in man.” Circulation 23.6 (1961): 847-852.
Two hundred cases were selected from medicolegal autopsies for a study of the relationship of serum cholesterol to the amount and severity of atherosclerosis in the aorta and the coronary and cerebral arteries. A preliminary study of cholesterol before and after death in 20 cases showed a close parallel between the two when the sample of blood was taken within 16 hours of death.
The mean serum total cholesterol showed a tendency to rise from 122 mg. per cent ±16 in the first decade to 176 mg. per cent ±28 in the fifth decade. A statistically significant correlation was found between serum total cholesterol levels and age up to the fifth decade.
No correlation could be observed between the serum cholesterol level and the amount and severity of atherosclerosis in the arteries. When all the cases were divided into arbitrary groups according to the amount of atherosclerosis, a rise in the levels of mean serum total cholesterol was seen in the first six successive groups of aortic atherosclerosis. But when age was excluded from the correlation between atherosclerosis and serum cholesterol, the interrelationship between the two was found to be statistically insignificant.
4) Braz J Med Biol Res. 2007 Apr;40(4):467-73.
Coronary fat content evaluated by morphometry in patients with severe atherosclerosis has no relation with serum lipid levels.
Braz DJ Jr1, Gutierrez PS, da Luz PL.
The relationship between lipid serum levels and coronary atherosclerotic plaque fat content was studied in 51 necropsy patients. Serum lipids were measured by standard techniques, during life, in the absence of lipid-lowering drugs. Intima, intimal fat and media areas were measured using a computerized system in cryosections of the odd segments of the right, anterior descending and circumflex coronary arteries stained with Sudan-IV. Mean intimal and lipid areas were 5.74 /- 1.98 and 1.22 /- 0.55 mm2 (22.12 /- 8.48%) in 26 cases with high cholesterol (>or=200 mg/dL) and 4.98 /- 1.94 and 1.16 /- 0.66 mm2 (22.75 /- 9.06%) in 25 cases with normal cholesterol ( 0.05). Patients with high levels of low-density lipoprotein (>or=130 mg/dL, N = 15) had a higher intima/media area ratio than those with normal levels of low-density lipoprotein (< 0.01). No significant difference in the morphometrical variables was found in groups with high or low serum levels of triglycerides (>or=200 mg/dL, N = 13 vs or=35 mg/dL, N = 11 vs we show here that in patients with severe atherosclerosis blood cholesterol and triglyceride levels seem to have little influence on coronary lipid content, indicating that other factors may contribute to arterial lipid deposition and plaque formation.
Paterson
5) Paterson, J. C., Lucy Dyer, and E. C. Armstrong. “Serum cholesterol levels in human atherosclerosis.” Canadian Medical Association Journal 82.1 (1960): 6.
The results lend little support to the contention that the severity of atherosclerosis is related to the level of serum cholesterol, except perhaps when it exceeds 300 mg. %. In 58 cases in the age group 60-69 years, significant relationships between the level of serum cholesterol and the severity of disease were found only once in 40 statistical analyses, and the complictions of atherosclerosis were just as frequent in cases with low serum cholesterol levels (150-199 mg. %) as in cases with moderately high ones (250-299mg.%).
6) Paterson, J. C., Rosemary Armstrong, and E. C. Armstrong. “Serum lipid levels and the severity of coronary and cerebral atherosclerosis in adequately nourished men, 60 to 69 years of age.” Circulation 27.2 (1963): 229-236.
No significant relationships,nor any trend toward such relationships,were found in 18 individual analyses concerning the coronary arteries. Furthermore, the mean serum lipid levels were consistently (but not significantly) higher in persons who did not have demonstrable sequelae of coronary sclerosis at autopsy than in persons who had sequelae. We conclude from these results that the validity of the lipid theory” of atherosclerosis remains unproved, as far as the coronarv arteries are concerned.
7) Am J Med. 1982 Aug;73(2):227-34. Cabin HS, Roberts WC.
Relation of serum total cholesterol and triglyceride levels to the amount and extent of coronary arterial narrowing by atherosclerotic plaque in coronary heart disease. Quantitative analysis of 2,037 five mm segments of 160 major epicardial coronary arteries in 40 necropsy patients.
The amount of cross-sectional area narrowing by atherosclerotic plaques was determined histologically in each 5 mm segment of the entire lengths of the right, left main, left anterior descending, and left circumflex coronary arteries in 40 patients with fatal coronary heart disease and known fasting serum total cholesterol and triglyceride levels. The patients were divided into four groups based upon the serum total cholesterol and triglyceride levels: group I, total cholesterol of 250 mg/dl or less, triglyceride of 170 mg/dl or less; group II, total cholesterol of 250 or less, triglyceride of more than 170; group III, total cholesterol of more than 250, triglyceride of 170 or less; group IV, total cholesterol of more than 250, triglyceride of more than 170. The number of 5 mm segments of coronary artery narrowed severely (76 to 100 percent in cross-sectional area) by atherosclerotic plaques in each group was as follows: 172 of 505 (34 percent) 5 mm segments from group I; 242 of 353 (69 percent) segments from group II; 120 of 295 (41 percent) from group III and 425 of 884 (48 percent) segments from group IV. The mean percentage of 5 mm segments narrowed severely was significantly greater in group II than in group I (p less than 0.005) or group III (p less than 0.01). Additionally, the mean number of four coronary arteries per subject severely narrowed and the number of subjects with severe narrowing of the left main coronary artery were significantly greater in groups II and III than in group I. The percentages of 5 mm segments narrowed severely correlated significantly with the serum triglyceride level (p less than 0.03). Although it correlated with the number of severely narrowed coronary arteries per subject, the serum total cholesterol level did not correlate with the percentage of 5 mm segments of coronary artery with severe narrowing.
8) MÉNDEZ, JOSÉ, and CARLOS TEJADA. “Relationship between serum lipids and aortic atherosclerotic lesions in sudden accidental deaths in Guatemala City.” The American journal of clinical nutrition 20.10 (1967): 1113-1117.
Postmortem blood samples were collected from 43 individuals, who died suddenly in accidents in Guatemala City, within 2-5 hr after death. Aortas and coronary arteries were obtained for staining and grading.
No significant correlation was found between the extent of the lipid streak or fibrous plaque lesions in the aorta and either serum cholesterol or lipid phosphorus concentration, or serum cholesterol-to-lipid phosphorus ratio. Correlation with the coronary lesions could not be calculated due to the small number of cases presenting such lesions. Although there was no correlation between serum lipid levels at death and aortic atherosclerotic lesions, it is recognized that the lipid levels of an earlier period in the subject’s life might have had a more significant influence.
The postmortem serum cholesterol levels of nine patients dying in the hospital were abnormally low in some cases, because of the specific cause of death, time of prior hospitalization and, in particular, of the agonal period suffered before death. These cases need to be eliminated from any study of the relationship between serum lipid levels and atherosclerosis.
9) Solberg, Lars A., and Jack P. Strong. “Risk factors and atherosclerotic lesions. A review of autopsy studies.” Arteriosclerosis, Thrombosis, and Vascular Biology 3.3 (1983): 187-198.
angiography
pdf
10) Nitter-Hauge, Sigurd, and Ivar Enge. “Relation between blood lipid levels and angiographically evaluated obstructions in coronary arteries.” British heart journal 35.8 (1973): 791.
We were unable to find any significant correlation between the serum lipids and the severity of the obstructive disease.
11) Johnson, K. M., D. A. Dowe, and J. A. Brink. “Traditional clinical risk assessment tools do not accurately predict coronary atherosclerotic plaque burden: a CT angiography study.” AJR. American journal of roentgenology 192.1 (2009): 235. OBJECTIVE: The objective of our study was to determine the degree to which Framingham risk estimates and the National Cholesterol Education Program (NCEP) Adult Treatment Panel III core risk categories correlate with total coronary atherosclerotic plaque burden (calcified and noncalcified) as estimated on coronary CT angiograms.
MATERIALS AND METHODS: Coronary CT angiography was performed in 1,653 patients (1,089 men, 564 women) without a history of coronary heart disease (mean age /-SD: men, 51.6 /-9.7 years; women, 56.9 /-10.5 years). The most common reasons for the examination were hypercholesterolemia, family history, hypertension, smoking, and atypical chest pain. The coronary tree was divided into 16 segments; four different methods were used to quantify the amount of atherosclerotic plaque or the degree of stenosis in each segment, and segment scores were combined to give total scores. Framingham risk estimates and NCEP risk categories were calculated for each patient.
RESULTS: Correlation of plaque scores with the Framingham 10-year risk estimates were modest: Spearman’s rho was 0.49-0.55. For all comparisons of NCEP risk categories to plaque score categories, the proportion of raw agreement, p(0), was less than 0.50. Cohen’s kappa ranged from 0.18 to 0.20. Overall, 21% of the patients would have their perceived need for statins changed by using the coronary CTA plaque estimates in place of the NCEP core risk categories; 26% of the patients on statins had no detectable plaque.
CONCLUSION: Coronary risk stratification using a risk factor only-based scheme is a weak discriminator of the overall atherosclerotic plaque burden in individual patients. Patients with little or no plaque might be subjected to lifelong drug therapy, whereas many others with substantial plaque might be undertreated or not treated at all.
12) Circulation. 1985 May;71(5):881-8.
Lipoprotein predictors of the severity of coronary artery disease in men and women. Reardon MF, Nestel PJ, Craig IH, Harper RW.
In this study we examined the relationships between levels of several components of plasma lipoproteins and severity of coronary artery disease in 65 men and 42 women who underwent coronary arteriography for suspected coronary disease. Severity of coronary atherosclerosis was scored as the extent of disease seen at arteriography. Univariate analyses of the relationships between the plasma lipoprotein parameters and score for severity of atherosclerosis revealed a marked difference between men and women. In men, the score for severity of atherosclerosis was strongly related to the low-density lipoprotein (LDL) cholesterol and apolipoprotein B concentrations, whereas in women it was related to the triglyceride concentrations in plasma intermediate-density lipoprotein (IDL) and LDL and to the cholesterol and apolipoprotein B concentrations in IDL. The significance of these correlations was not negated by possible confounding factors such as alcohol intake, diabetes, and treatment with thiazides and beta-adrenergic blockers. Stepwise regression analyses of data adjusted for weight and age indicated that 22% of the variation in the score for severity of atherosclerosis could be accounted for by levels of LDL cholesterol in men. No other lipoprotein parameter could account for any further variation. In contrast, cholesterol did not account for any variation in the score for severity of atherosclerosis in women, whereas plasma triglyceride accounted for 16% of the observed variation in this group. No relationships were found between score for severity of atherosclerosis and high-density lipoprotein cholesterol or plasma apolipoprotein A-I concentrations in either group.(ABSTRACT TRUNCATED AT 250 WORDS).
13) Am J Cardiol. 1991 Mar 1;67(6):479-83.
Relation of serum lipoprotein cholesterol levels to presence and severity of angiographic coronary artery disease. Romm PA1, Green CE, Reagan K, Rackley CE.
To assess the relation of lipid levels to angiographic coronary artery disease (CAD), lipid profiles were obtained on 125 men and 72 women undergoing diagnostic coronary angiography. CAD, defined as greater than or equal to 25% diameter narrowing in a major coronary artery, was present in 106 men (85%) and 54 women (75%). Multiple regression analyses revealed that only high-density lipoprotein (HDL) cholesterol level in men, and age and total/HDL cholesterol ratio in women, were independently associated with the presence of CAD after adjustment for other risk factors. HDL cholesterol level and age were significantly correlated with both extent (number of diseased vessels) and severity (percent maximum stenosis) of CAD in men. In women, age was the only independent variable related to severity, whereas age and total/HDL cholesterol ratio were related to extent. Of 71 patients with total cholesterol less than 200 mg/dl, 79% had CAD. With multiple regression analyses, HDL cholesterol was the only variable independently related to the presence and severity of CAD in these patients after adjustment for age and gender; extent was significantly associated with age and male gender, and was unrelated to any of the lipid parameters. With use of multiple logistic and linear regression analyses of the group of 197 patients, HDL cholesterol was the most powerful independent variable associated with the presence and severity of CAD after adjustment for age and gender. HDL cholesterol was also an independent predictor of extent. Age was independently associated with each of the end points examined, and was the variable most significantly related to extent. These data add to the growing body of information demonstrating an important association between HDL and CAD.
14) Am J Epidemiol. 1981 Apr;113(4):396-403.
Community pathology of atherosclerosis and coronary heart disease: post mortem serum cholesterol and extent of coronary atherosclerosis.
Oalmann MC, Malcom GT, Toca VT, Guzmán MA, Strong JP.
Abstract
Little is known about the direct relationship between serum cholesterol and the extent of coronary atherosclerosis in human populations even though the association of serum cholesterol levels with risk of developing coronary heart disease (CHD) is well documented. The results of this study of men 25-44 years of age, residents of Orleans Parish, Louisiana, show a significant relationship between post mortem serum cholesterol levels and extent of more advanced lesions (raised lesions) in the coronary arteries in 110 autopsied white men, but not in the cases of 221 autopsied black men. When disease categories comprising CHD cases and non-CHD cases (basal group) were evaluated, the racial difference in the cholesterol-lesion associations persisted. The reason for the racial difference in the observed cholesterol-lesion association is not clear. Additional research, where younger age groups are included, and considering earlier lesions and other risk factors in different environments may help in clearing this question.
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intravascular ultrasound
Statin Pleomorphic effect?
15) Relation Between Progression and Regression of Atherosclerotic Left Main Coronary Artery Disease and Serum Cholesterol Levels as Assessed With Serial Long-Term (≥12 Months) Follow-Up Intravascular Ultrasound Clemens von Birgelen, Marc Hartmann, Gary S. Mintz, Dietrich Baumgart, Axel Schmermund, Raimund Erbel
Circulation. 2003;108:2757-2762
Background— The relation between serum lipids and risk of coronary events has been established, but there are no data demonstrating directly the relation between serum low-density lipoprotein (LDL) cholesterol and high-density lipoprotein (HDL) cholesterol versus serial changes in coronary plaque dimensions.
Methods and Results— We performed standard analyses of serial intravascular ultrasound (IVUS) studies of 60 left main coronary arteries obtained 18.3±9.4 months apart to evaluate progression and regression of mild atherosclerotic plaques in relation to serum cholesterol levels. Overall, there was (1) a positive linear relation between LDL cholesterol and the annual changes in plaque plus media (P&M) cross-sectional area (CSA) (r=0.41, P
Conclusions— There is a positive linear relation between LDL cholesterol and annual changes in plaque size, with an LDL value of 75 mg/dL predicting, on average, no plaque progression. HDL cholesterol shows an inverse relation with annual changes in plaque size.
16) Noakes, T. D. “The 2012 University of Cape Town Faculty of Health Sciences centenary debate: “Cholesterol is not an important risk factor for heart disease, and the current dietary recommendations do more harm than good”.” South African Journal of Clinical Nutrition 28.1 (2015): 19-33.
https://www.ncbi.nlm.nih.gov/pubmed/1...
Exp Mol Pathol. 2001 Apr;70(2):103-19.
Coronary heart disease, hypercholesterolemia, and atherosclerosis. I. False premises.
Stehbens WE1. Department of Pathology and Molecular Medicine, Wellington School of Medicine, Wellington, New Zealand.
Lipid-rich caseous debris of advanced lesions stimulated interest in the role of cholesterol and lipids in atherosclerosis. Lipid-containing arterial lesions in cholesterol-overfed animals (cholesterolosis) and xanthomatous vascular lesions in subjects with familial hypercholesterolemia were then misrepresented as being atherosclerotic and led to the development of the hypercholesterolemic/lipid hypothesis. It is untenable that cholesterol, an essential multifunctional metabolite, is pathogenic at all blood levels and hypercholesterolemia is not prerequisite for human or experimental atherosclerosis. Serum cholesterol levels display a poor correlation with atherosclerosis at autopsy and with unreliable national coronary heart disease (CHD) mortality in each sex. Atherosclerosis topography and its iatrogenic production in humans and experimentally in herbivores by hemodynamic means both support a biomechanical causation and preclude causality by any circulating humoral factor. CHD, not a specific disease, is a nonspecific complication of many diseases including atherosclerosis and cannot be equated with coronary atherosclerosis due to differences in pathology and pathogenesis. Thus, extrapolations from CHD risk factors or correlations with fallacious vital statistics to atherosclerosis are invalid. It follows that the hypercholesterolemic/lipid hypothesis evolving from false premises, misuse of CHD, scientific misrepresentation, and fallacious data has no legitimate basis.
17) Kavalipati, Narasaraju, et al. “Pleiotropic effects of statins.” Indian journal of endocrinology and metabolism 19.5 (2015): 554.
18) Oesterle, Adam, Ulrich Laufs, and James K. Liao. “Pleiotropic Effects of Statins on the Cardiovascular System.” Circulation Research (2017).
The statins have been used for 30 years to prevent coronary artery disease and stroke. Their primary mechanism of action is the lowering of serum cholesterol through inhibiting hepatic cholesterol biosynthesis thereby upregulating the hepatic low-density lipoprotein (LDL) receptors and increasing the clearance of LDL-cholesterol. Statins may exert cardiovascular protective effects that are independent of LDL-cholesterol lowering called pleiotropic effects. Because statins inhibit the production of isoprenoid intermediates in the cholesterol biosynthetic pathway, the post-translational prenylation of small GTP-binding proteins such as Rho and Rac, and their downstream effectors such as Rho kinase and nicotinamide adenine dinucleotide phosphate oxidases are also inhibited. In cell culture and animal studies, these effects alter the expression of endothelial nitric oxide synthase, the stability of atherosclerotic plaques, the production of proinflammatory cytokines and reactive oxygen species, the reactivity of platelets, and the development of cardiac hypertrophy and fibrosis. The relative contributions of statin pleiotropy to clinical outcomes, however, remain a matter of debate and are hard to quantify because the degree of isoprenoid inhibition by statins correlates to some extent with the amount of LDL-cholesterol reduction. This review examines some of the currently proposed molecular mechanisms for statin pleiotropy and discusses whether they could have any clinical relevance in cardiovascular disease.
19) DuBroff, Robert, and Michel de Lorgeril. “Cholesterol confusion and statin controversy.” World journal of cardiology 7.7 (2015): 404.
The role of blood cholesterol levels in coronary heart disease (CHD) and the true effect of cholesterol-lowering statin drugs are debatable. In particular, whether statins actually decrease cardiac mortality and increase life expectancy is controversial. Concurrently, the Mediterranean diet model has been shown to prolong life and reduce the risk of diabetes, cancer, and CHD. We herein review current data related to both statins and the Mediterranean diet. We conclude that the expectation that CHD could be prevented or eliminated by simply reducing cholesterol appears unfounded. On the contrary, we should acknowledge the inconsistencies of the cholesterol theory and recognize the proven benefits of a healthy lifestyle incorporating a Mediterranean diet to prevent CHD.
Core tip: Traditional efforts to prevent cardiovascular disease have emphasized the benefits of cholesterol lowering and statin drugs. Often overlooked is the fact that numerous studies of cholesterol lowering have failed to demonstrate a mortality benefit and the benefits of statins may have been overstated. The Mediterranean diet has consistently lowered cardiovascular events and mortality in numerous studies and does not typically lower cholesterol levels. Alternative theories of atherosclerosis are independent of cholesterol metabolism and may provide the key to future preventive strategies.
Nearly twenty years ago two landmark randomized clinical trials appeared in The Lancet which forever changed the course of medicine for patients with coronary heart disease (CHD). The 4S study employed a cholesterol-lowering statin drug and reported a 30% mortality reduction[1]. The Lyon Diet Heart Study utilized the Mediterranean diet and reported a 70% mortality reduction[2]. Subsequent studies of the Mediterranean diet have confirmed these findings and also shown a reduced risk of cancer, diabetes, and Alzheimer’s disease[3-6]. Subsequent statin studies have led the United States Food and Drug Administration to issue warnings regarding the increased risk of diabetes and decreased cognition with statin drugs. Paradoxically, statins have gone on to become a multi-billion dollar industry and the foundation of many cardiovascular disease prevention guidelines while the Mediterranean diet has often been ignored. We believe this statin-centric cholesterol-lowering approach to preventing CHD may be misguided.
20)Okuyama, Harumi, et al. “Statins stimulate atherosclerosis and heart failure: pharmacological mechanisms.” Expert review of clinical pharmacology 8.2 (2015): 189-199. Statins stimulate atherosclerosis and heart failure Okuyama Harumi Expert review clin pharm 2015
In contrast to the current belief that cholesterol reduction with statins decreases atherosclerosis, we present a perspective that statins may be causative in coronary artery calcification and can function as mitochondrial toxins that impair muscle function in the heart and blood vessels through the depletion of coenzyme Q10 and‘heme A’ , and thereby ATP generation. Statins inhibit the synthesis of vitamin K2, the cofactor for matrix Gla-protein activation, which in turn protects arteries from calcification. Statins inhibit the biosynthesis of selenium containing proteins, one of which is glutathione peroxidase serving to suppress peroxidative stress. An impairment of selenoprotein biosynthesis may be a factor in congestive heart failure, reminiscent of the dilated cardiomyopathies seen with selenium deficiency. Thus, the epidemic of heart failure and atherosclerosis that plagues the modern world may paradoxically be aggravated by the pervasive use of statin drugs. We propose that current statin treatment guidelines be critically reevaluated.
21) de Lorgeril, Michel, and Mikael Rabaeus. “Beyond confusion and controversy, Can we evaluate the real efficacy and safety of cholesterol-lowering with statins?.” Journal of Controversies in Biomedical Research 1.1 (2016): 67-92.
A strong controversy has emerged about the reality of safety and efficacy of statins as stated by company-sponsored reports. However, physicians need credible data to make medical decisions, in particular about the benefit/harm balance of any prescription. This study aimed to test the validity of data on the company-sponsored statin trial by comparing them over time and then comparing statins with each other. Around the years 2005/2006, new stricter Regulations were introduced in the conduct and publication of randomized controlled trials (RCTs). This would imply that RCTs were less reliable before 2006 than they were later on. To evaluate this, we first reviewed RCTs testing the efficacy of statins versus placebo in preventing cardiovascular complications and published after 2006. Our systematic review thereby identified four major RCTs, all testing rosuvastatin. They unambiguously showed that rosuvastatin is not effective in secondary prevention, while the results are highly debatable in primary prevention. Because of the striking clinical heterogeneity and the inconsistency of the published data in certain RCTs, meta-analysis was not feasible. We then examined the most recent RCTs comparing statins to each other: all showed that no statin is more effective than any other, including rosuvastatin. Furthermore, recent RCTs clearly indicate that intense cholesterol-lowering (including those with statins) does not protect high-risk patients any better than less-intense statin regimens. As for specific patient subgroups, statins appear ineffective in chronic heart failure and chronic kidney failure patients. We also conducted a MEDLINE search to identify all the RCTs testing a statin against a placebo in diabetic patients, and we found that once secondary analyses and subgroup analyses are excluded, statins do not appear to protect diabetics. As for the safety of statin treatment – a major issue for medical doctors – it is quite worrisome to realize that it took 30 years to bring to light the triggering effect of statins on new-onset diabetes, manifestly reflecting a high level of bias in reporting harmful outcomes in commercial trials, as has been admitted by the recent confession of prominent experts in statin treatment. In conclusion, this review strongly suggests that statins are not effective for cardiovascular prevention. The studies published before 2005/2006 were probably flawed, and this concerned in particular the safety issue. A complete reassessment is mandatory. Until then, physicians should be aware that the present claims about the efficacy and safety of statins are not evidence based.
22) Rabaeus, Mikael, Paul V. Nguyen, and Michel de Lorgeril. “Recent flaws in Evidence Based Medicine: statin effects in primary prevention and consequences of suspending the treatment.” Journal of Controversies in Biomedical Research 3.1 (2017): 1-10.
Statin therapy is presented as a protection against ischemic heart disease (IHD) complications. As IHD is often a fatal disease, statins are thereby supposed to decrease cardiovascular mortality and increase life expectancy. However, these benefits are increasingly challenged in the medical community, the controversy being particularly intense when discussing the effects of statins in primary prevention and the consequences of statin discontinuation. Both primary prevention and treatment discontinuation have been recently used by investigators linked to the pharmaceutical industry to justify and boost prescription and consumption of statins and other cholesterol-lowering medications. We herein review some recent commercial data related to primary prevention with rosuvastatin and statin discontinuation and their respective effects on IHD and overall mortality rate. We conclude that (1) despite the recent hype raised by HOPE-3, the cholesterol-lowering rosuvastatin is likely not beneficial in intermediate-risk individuals without cardiovascular disease (primary prevention). This trial may even represent a typical example of how evidence-based medicine has been flawed in commercial studies. (2) Statin discontinuation does not lead to increased IHD and overall mortality, at least in the months following interruption of treatment. On the contrary, one might even conclude that statin discontinuation could save lives. One possible explanation of this apparently paradoxical finding is that statin discontinuers, in the same time they stop statin therapy, likely try to adopt a healthy lifestyle. Further studies are needed to confirm the real effects of statin discontinuation in various clinical conditions. In the meantime, it is not evidence based to claim that statin discontinuation increases mortality or saves lives.
Non-Statin Lipid Lowering Drug Fails
23) Lincoff, A. Michael, et al. “Evacetrapib and cardiovascular outcomes in high-risk vascular disease.” New England Journal of Medicine 376.20 (2017): 1933-1942.
Abstract BACKGROUND: The cholesteryl ester transfer protein inhibitor evacetrapib substantially raises the high-density lipoprotein (HDL) cholesterol level, reduces the low-density lipoprotein (LDL) cholesterol level, and enhances cellular cholesterol efflux capacity. We sought to determine the effect of evacetrapib on major adverse cardiovascular outcomes in patients with high-risk vascular disease.
METHODS:
In a multicenter, randomized, double-blind, placebo-controlled phase 3 trial, we enrolled 12,092 patients who had at least one of the following conditions: an acute coronary syndrome within the previous 30 to 365 days, cerebrovascular atherosclerotic disease, peripheral vascular arterial disease, or diabetes mellitus with coronary artery disease. Patients were randomly assigned to receive either evacetrapib at a dose of 130 mg or matching placebo, administered daily, in addition to standard medical therapy. The primary efficacy end point was the first occurrence of any component of the composite of death from cardiovascular causes, myocardial infarction, stroke, coronary revascularization, or hospitalization for unstable angina.
RESULTS:
At 3 months, a 31.1% decrease in the mean LDL cholesterol level was observed with evacetrapib versus a 6.0% increase with placebo, and a 133.2% increase in the mean HDL cholesterol level was seen with evacetrapib versus a 1.6% increase with placebo. After 1363 of the planned 1670 primary end-point events had occurred, the data and safety monitoring board recommended that the trial be terminated early because of a lack of efficacy. After a median of 26 months of evacetrapib or placebo, a primary end-point event occurred in 12.9% of the patients in the evacetrapib group and in 12.8% of those in the placebo group (hazard ratio, 1.01; 95% confidence interval, 0.91 to 1.11; P=0.91).
CONCLUSIONS:
Although the cholesteryl ester transfer protein inhibitor evacetrapib had favorable effects on established lipid biomarkers, treatment with evacetrapib did not result in a lower rate of cardiovascular events than placebo among patients with high-risk vascular disease.
24) Dashing Hopes, Study Shows a Cholesterol Drug Had No Effect on Heart Health By GINA KOLATAAPRIL 3, 2016 New York Times
25) cholesterol atherosclerosis falsified coronary artery plaque Ware Medical Hypotheses 2009 Ware, William R. “The mainstream hypothesis that LDL cholesterol drives atherosclerosis may have been falsified by non-invasive imaging of coronary artery plaque burden and progression.” Medical hypotheses 73.4 (2009): 596-600.
The post Cholesterol Levels and Atherosclerosis: Autopsy Studies Show No Correlation appeared first on Jeffrey Dach MD.
November 30, 2017
Flu Shot Only Ten Per Cent Effective
[image error]Flu Shot Only Ten Per Cent Effective by Jeffrey Dach MD
The Australian Department of Health reported the Flu Vaccine is only 10% effective against the predominant strain of Influenza A (H3N2). (1-2) This doesn’t exactly inspire confidence in our Flu vaccine, which is the same one as Australia’s.
Twenty Two Thousand Nurses Refused Flu Shot
Twenty Two thousand nurses refused mandatory flu vaccination as precondition for hospital employment.(6)
Suing the Hospital
The nurses union at Harvard’s Women and Brigham’s hospital is suing the hospital to overturn mandatory Flu Shots for nurses.(5)
David Brownstein says: FUGETABOUTIT !!
As Dr David Brownstein has said many times, “why would anyone want a Flu Shot that fails most people who get them?”(3-4)
Why Influenza Vaccines Fail (7-8)
Influenza A is an RNA virus present in birds and pigs, which mutates and changes rapidly.(7-8) The situation is made worse by overcrowding of animals by “modern industrial farming practices also called “Factory farming”. “The stress and unsanitary conditions…weaken animals’ immune systems, making them more susceptible to infection.“(Quote from The Week) The influenza virus may breed and mutate in animals, and then transmitted back to humans.(reference the CDC)
Dr Stephen Harrod Buhner has a nice description of what happens in his book: Herbal Antivirals:Natural Remedies for Emerging Resistant and Epidemic Viral Infections by Stephen Harrod Buhner.
“While DNA viruses make billions more of themselves, RNA viruses make billions of similar but not identical viruses. It is something like a swarm of honeybees — all similar but all different. In fact it is much more accurate to think of an RNA infection as infection by a viral swarm.”
The virus is a not a static genome. Rather, it is a rapidly mutating genome. As you can well imagine, it is virtually impossible to come up with an effective vaccine against such a moving target. This is especially true if last years viral strain is used as a template for a new vaccine. The virus has already changed.
Above header image Flu shot sign in front of Walgreens courtesy of Coronado Times.
Articles with related reference:
Antiviral Herbals Stephen Buhner
Jeffrey Dach MD
7450 Griffin Road Suite 190
Davie Florida 33314
954-792-4663
Links and References:
1) Perspective Chasing Seasonal Influenza — The Need for a Universal Influenza Vaccine Catharine I. Paules, M.D., Sheena G. Sullivan, M.P.H., Ph.D., Kanta Subbarao, M.B., B.S., M.P.H., and Anthony S. Fauci, M.D. November 29, 2017DOI: 10.1056/NEJMp1714916
according to the Australian Government Department of Health. Influenza A (H3N2) viruses predominated, and the preliminary estimate of vaccine effectiveness against influenza A (H3N2) was only 10%.
2) Australia’s flu season has U.S. health officials bracing for a bad winter — and wishing for a new vaccine. LA Times
The most common flu strain there was the influenza A virus known as H3N2, and the vaccine given to Australians had an effectiveness of only 10%, according to preliminary estimates.
The vaccine now being administered to Americans uses the same formulation. Even worse, nearly three-quarters of the 1,544 laboratory-confirmed cases of flu seen in the U.S. since Oct. 1 were of the H3N2 variety, according to the Centers for Disease Control and Prevention.
3) Time For A Flu Vaccine? Fugetaboutit! By Dr. David Brownstein
Dr. Brownstein’s Holistic Medicine September 25, 2017
4) Dr. Brownstein: Flu Vaccines Fail Nearly all Who Get Them
Flu vaccines fail nearly all who get them. It is a ludicrous argument to mandate flu vaccines for health care workers and others. The Big Pharma Cartel wants all 350 million of us to get vaccinated yearly in order to prevent the flu. That might be reasonable if the flu vaccine is beneficial to most who receive it. It is not.
5) Brigham and Women’s mandatory flu shot policy prompts nursing suit: 7 things to know Written by Kelly Gooch | September 27, 2017 |
A union representing nurses at Boston-based Brigham and Women’s Hospital is standing up against the facility’s new policy mandating flu vaccines for employees, reports The Boston Globe.
6) 22,000 Nurses Refuse *Mandatory* Vaccinations Fighting for the right to choose Christina Sarich by Christina Sarich January 9, 2016
7) Why flu vaccines so often fail By Jon CohenSep. 20, 2017 , 2:30 PM
8) Resa-Infante, Patricia, et al. “The influenza virus RNA synthesis machine: advances in its structure and function.” RNA biology 8.2 (2011): 207-215.
The post Flu Shot Only Ten Per Cent Effective appeared first on Jeffrey Dach MD.
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