Mammography Revisited

Mammography Revisited

Febuary 7, 2020

Mammography Revisited

The goal of breast imaging is to reduce deaths due to breast cancer by detecting breast cancer early, when treatment is more effective and less harmful. Simply put, imaging diagnostics are designed to reduce the incidence of advanced disease. They do not prevent disease, but rather screen for pathology. However, because many types of breast imaging involve radiation exposure, their benefits must be balanced with their risks.

Despite what the medical media reports, breast cancers are rarely diagnosed at their very early stages. This is in part due to the fact that tumors smaller than 1 centimeter are not detectable by X-rays, mammography, X-ray computed tomography (CT), or ultrasound. (The exception to this size limitation is molecular breast imaging.)

Breast cancers found with high-quality, 2-D digital mammography are commonly within median size 1.0 to 1.5 cm (0.4 to 0.6 inches, or the size of a small marble).1 Approximately 10% of invasive cancers 1 cm in size or smaller have already spread to lymph nodes at the time of detection, compared to close to 35% of those 2 cm in size and 60% of those 4 cm or larger in size.2 It is true that imaging diagnostics generally detect tumors before they become palpable with breast exam. Breast cancers found by clinical breast examination, or by a woman herself, have a median size of 2 to 2.5 cm. Such cancers are more likely to be later stage breast cancers that are more likely to have already spread to the axillary lymph nodes and to be problematic.3

Despite their radiation risk, false positive, and false negative readings, mammograms are still the most commonly used breast imaging diagnostic in medicine today. Fierce debates about the benefits and harms of mammography have been played out in medical journals and the mainstream media for several decades. Many researchers believe that the benefits of screening outweigh the harms (e.g., over-diagnosis, radiation exposure), while others contend the opposite. Additionally, different organizations have considerably diverse recommendations as to frequency of mammography screening, particularly in relationship to age. Over the past few years, many organizations have changed their mammography recommendations and become more prudent and conservative. This is in part due to an independent review published in 2012 in The Lancet, which is recognized as one of the largest and longest studies of mammography to date.4 This study involved 90,000 women who were followed for a period of 25 years. The study concluded that mammograms have absolutely no impact on breast cancer mortality. These conclusions were widely publicized at the time and debated. They showed that the death rate from breast cancer was virtually identical between those who received an annual mammogram and those who did not, while 22% of screen-detected invasive breast cancers were over-diagnosed, leading to unnecessary treatment. Subsequently, several organizations changed their mammogram recommendation protocols.

The following are mammography recommendations of the United States Preventive Services Task Force5 (USPSTF) and the Canadian Task Force on Periodic Health Examination6 (CTFPHC). Both are independent scientific organizations whose volunteer panel members do not receive funding from the mammography industry or from other companies that would entail financial conflicts of interest.

The current United States Preventive Services Task Force mammography recommendations:7

  • Women, ages 75 years and older: The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening mammography.

  • Women, ages 50 to 74 years: biennial mammogram screening (every two years) is recommended;

  • Women, before the age of 50 years: The decision to start regular, biennial screening mammography should be an individual one and take patient context into account, including the patient’s values regarding specific benefits and harms.

The USPSTF further states on their website that

While screening mammography in women aged 40 to 49 years may reduce the risk for breast cancer death, the number of deaths averted is smaller than that in older women and the number of false-positive results and unnecessary biopsies is larger. The balance of benefits and harms is likely to improve as women move from their early to late 40s. In addition to false-positive results and unnecessary biopsies, all women undergoing regular screening mammography are at risk for the diagnosis and treatment of noninvasive and invasive breast cancer that would otherwise not have become a threat to their health, or even apparent, during their lifetime (known as “over-diagnosis”). Beginning mammography screening at a younger age and screening more frequently may increase the risk for over-diagnosis and subsequent overtreatment.

Meanwhile, the CTFPHC specifically “recommends against mammography screening of women aged 40 to 49.” They contend that “because women aged 40 to 49 are at lower risk of cancer, the absolute benefit is lower for this age group than for older women. Screening in women aged 40 to 49 reduces the absolute risk of dying from breast cancer by 0.05%.”8 In the judgment of the CTFPHC:

Most women 40 to 49 should not receive screening, but many could receive it. The risk of having a false positive mammogram requiring further screening is 1 in 3 (the risk of a false-positive result from mammography is higher for women younger than 50 years). The risk of having a biopsy is 1 in 28. The risk of having all or part of the breast removed unnecessarily is 1 in 20. For every 1000 women aged 39 years and older who are screened using mammography, 5 will have an unnecessary lumpectomy or mastectomy as a result of over diagnosis. Generally, the proportion of false positives is high when screening younger women, and there have even been suggestions that early screening may increase mortality.9

The CTFPHC recommends “for women aged 50 to 69 years routinely screening with mammography every 2 to 3 years.” They contend that “the absolute benefits of screening remain small among women aged 50–69 years but are greater than those seen in women aged 40–49. Screening in women aged 50–69 reduces the absolute risk of dying from breast cancer by 0.13%.”10

Lastly, the CTFPHC recommends “for women aged 70 to 74 years old screening with mammography every 2 to 3 years.” They contend “the reduction in relative risk of death from breast cancer associated with mammography for women 70–74 years old is statistically non-significant and similar to that seen for younger women.”11 Hence, according to CTFPHC, mammography confers less than 1% reduction of risk of dying from breast cancer from ages 40 to 69.

One factor that creates mammogram recommendation differences according to age is that women under 50 typically have denser breast tissue. On a mammogram, denser breast tissue appears white, the same color as cancer. In addition to breast tissue, all other components of the breast (glands, connective tissue, tumors, calcium deposits, etc.) also appear as shades of white on a mammogram. With menopause, the dense tissue in women’s breasts is replaced with fatty tissue, which looks gray on a mammogram. It is much easier to see the white cancer against this gray background. This has led to legislation, or “breast density laws”, to be passed in California, Connecticut, New York, Virginia, and Texas, which make it mandatory for radiologists to inform their patients who have dense breast tissue that mammograms are basically useless for them. A law is currently being considered at a federal level, which would inform all women across the country.

Mammography and X-ray Computed Tomography (CT) Scans: Balancing Benefits and Risks

Cancer induction is arguably the most important and the most feared radiation effect from medical imaging diagnostics. Radiation effects have a latency period between the time of exposure and the onset of the effect. For cancer induction, the latency period is on the order of years, with leukemia having the shortest latency period (5 to 15 years) and solid tumors having the longest latency period (10 to 60 years). However, it is not known how quickly low-level radiation can accelerate the growth of a precancerous lesion such as DCIS. Generally, it is very difficult to prove that a cancer is directly related to earlier radiation exposure, because other factors encountered during the latency period may be the actual cause of the cancer. This is particularly true when the exposures are at low radiation levels such as those received in diagnostic radiology studies.

Diagnostic X-rays including mammograms are the largest man-made source of radiation exposure to the general population, contributing about 14% of the total annual exposure worldwide from all sources. Although radiographic scans provide important diagnostic information, their use involves some small risk of developing cancer. Amy Berrington de González and colleagues at the Johns Hopkins Bloomberg School of Public Health in Baltimore examined the extent of this risk based on the annual number of diagnostic X-rays undertaken in the UK and in 14 other developed countries.

Their findings concluded:

There are no benefits for mammography in women under the age of 30, and only a marginal benefit for women between the ages of 30 and 34… Our results indicate that in the U.K. about 0.6% of the cumulative risk of cancer to age 75 years could be attributable to diagnostic X-rays. This percentage is equivalent to about 700 cases of cancer per year. In 13 other developed countries, estimates of the attributable risk ranged from 0.6% to 1.8%, whereas in Japan, which had the highest estimated annual exposure frequency in the world, it was more than 3%.12

In another study it was shown that breast cancer rates increased significantly in four Norwegian counties after women began getting mammograms every two years. In fact, according to background information in the study, the start of screening mammography programs throughout Europe has been associated with increased incidence of breast cancer.13

In general, radiation dose from all medical imaging has come under recent scrutiny in the medical and lay press. This is primarily the result of recent articles on the increased cancer risks associated with cumulative mammography exposure and CT scans.14, 15 In another study on cancer risks from CT scans, Berrington de González and colleagues estimated that 29,000 future cancers (approximately 2% of the cancers diagnosed annually in the U.S.) could be related to CT performed in the U.S. in 2007.16 This is comparable to recent estimates of 1.5% to 2.0% by Brenner and Hall.17

The late Dr. John W. Gofman, an authority on the health effects of ionizing radiation, estimated that 75% of breast cancer could be prevented by avoiding or minimizing exposure to ionizing radiation.18 This included mammography, X-rays, CTs, and other medical and dental sources. Often called the father of the antinuclear movement, Dr. Gofman and his colleague Arthur R. Tamplin at Lawrence Livermore National Laboratory, developed data in 1969 showing that the risk from low doses of radiation was 20 times higher than stated by the government.19 Their publication of the data, despite strong efforts to censor it, led them to lose virtually all their research funding and, eventually, their positions at the government laboratory. To this day, the cumulative risk of medical radiation exposure is considerably understated.

Ionizing radiation is a known cause of cancer and genetic mutation, and the effects of small amounts of radiation have a negative cumulative effect on the body. So, it seems amazing that mainstream medicine frequently dismisses the idea that medical imaging tests from mammograms to CT scans could play much of a role in causing breast cancer. This does not mean that an individual should never have X-rays or radiographic scans, but rather, that it is wise to be thoughtful about radiation exposure. The risk of harm from radiation is highest in tissue where cells are rapidly changing, such as the growing breast tissue of adolescent females. The chance of ionizing radiation causing genetic damage or increasing the risk of cancer is related to the total amount of radiation accumulated by a person.20 The greatest risk comes from:

  • larger doses of radiation21, such as CT scans;

  • cumulative exposure to radiation, such as over several years;

  • high-strength forms of radiation, as seen in radiation therapy.

False Positives and Over-diagnosis

When a mammogram shows an abnormal area that appears to look like cancer but turns out to be normal, it is called a false positive. Of course, the good news is this means no breast cancer, but the suspicious area, usually involving calcifications, requires follow-up with more than one doctor, extra tests involving more radiation exposure, and possibly an invasive biopsy.

In 2001, it was reported that as many as three quarters of all post-mammogram biopsy results are merely benign lesions.22 A 2012 study published in the New England Journal of Medicine analyzed the effects of mammogram screening in the U.S. over the past three decades, and concluded that 1.3 million women were misdiagnosed and mistreated as a result.23 The researchers found that the number of early-stage breast cancers detected have doubled over the past 30 years since the advent of mammography, from 112 to 234 cases per 100,000. The authors concluded:

After excluding the transient excess incidence associated with hormone-replacement therapy and adjusting for trends in the incidence of breast cancer among women younger than 40 years of age, we estimated that breast cancer was over-diagnosed (i.e., tumors were detected on screening that would never have led to clinical symptoms) in 1.3 million U.S. women in the past 30 years. We estimated that in 2008, breast cancer was over-diagnosed in more than 70,000 women; this accounted for 31% of all breast cancers diagnosed. Despite substantial increases in the number of cases of early-stage breast cancer detected, screening mammography has only marginally reduced the rate at which women present with advanced cancer. Although it is not certain which women have been affected, the imbalance suggests that there is substantial over-diagnosis, accounting for nearly a third of all newly diagnosed breast cancers, and that screening is having, at best, only a small effect on the rate of death from breast cancer.

This conclusion concurs with the Cochrane Collaboration Review, published in 2013, which also found no evidence that mammography screening influences overall mortality.24 These studies cast a shadow on mammography efficacy and calls into question whether mammography screening really benefits women. According to the authors of the Cochrane Review:

If we assume that screening reduces breast cancer mortality by 15% and that over-diagnosis and overtreatment is at 30%, it means that for every 2000 women invited for screening throughout 10 years, one will avoid dying of breast cancer and 10 healthy women, who would not have been diagnosed if there had not been screening, will be treated unnecessarily. Furthermore, more than 200 women will experience important psychological distress including anxiety and uncertainty for years because of false positive findings.

These studies are bringing mainstream attention to the possibility that mammography may have caused more harm than good in the millions of women who have employed it over the past 30 years as their primary strategy in detecting breast cancer. The adverse health effects associated with over-diagnosis and consequent invasive biopsies, and even overtreatment with lumpectomy, radiation, chemotherapy, and hormone-suppressive treatments, cannot be underestimated, especially when one considers the profound psychological trauma that follows each stage of diagnosis and treatment.

False Negatives

Mammograms detect tumors but can miss more than a quarter of all breast cancers.25 Dr. Samuel S. Epstein, in his book The Politics of Cancer,26 claims that in women ages 40 to 49, one in four instances of cancer are missed during each mammography. In general, breast screening with full-field digital mammography (FFDM) fails to detect 15-30% of cancers.27 This figure is higher for women with dense breasts. Hence, false negatives are twice as likely to occur in mammograms of premenopausal women.

Newer Mammography Machines

Digital cameras have replaced the older, film-based cameras for most North Americans. Mammography has also gone digital. Clinics now offer 2-D digital mammograms which replace X-ray film with solid-state detectors that convert X-rays into electric signals. As of October 2015, over 95% of accredited mammography machines in the U.S. were digital.28 The primary advantage of 2-D digital over film mammography is that the electrical signals used to produce images can be electronically manipulated. A radiologist or physician can zoom in to magnify and optimize different parts of breast tissue without having to take an additional image. The electronic images can also be readily shared with clinicians at other locations, which may particularly benefit rural and underserved communities using telemedicine for reading and interpreting these mammograms. 2-D digital mammograms have a slightly lower radiation dose than film. Hence, digital mammograms are also an improvement in clinical efforts to reduce women’s exposure to radiation, but they still carry risk of radiation exposure and false positive and negative results.

When digital imaging was first introduced as an alternative to analog film-screen radiography, technology enabled only small “spot views”. Larger digital detectors were then developed that permitted imaging an entire small breast, but multiple images were required for larger breasts, requiring added radiation and time. The latter limitation was partially overcome by mammographic equipment using fan-beam technology. Eventually, larger digital detectors became available, thus enabling full-field imaging or full-field digital mammography (FFDM).

Millions of women are now undergoing a newer type of mammography, known as digital breast tomosynthesis (DBT). Sometimes called 3-D mammography, DBT takes many X-rays at different angles to create a three-dimensional image of the breast. In both 3-D and 2-D mammograms, the breast is compressed between two plates. In 2-D mammograms, which take images only from the front and side, this may create images with overlapping breast tissue. Because 3-D mammography provides images of the breast in slices from many different angles, finding abnormalities and determining which abnormalities may be important may be easier with 3-D imaging. On the other hand, 3-D mammography is more expensive than 2-D. In one study it was concluded the radiation dose of patients undergoing a single-view DBT was comparable to a single-view full-field digital mammography (FFDM). For patients with thicker breasts, the radiation dose of DBT was slightly lower than FFDM.29 Basically, the negative issues with DBT as a screening tool include additional reading time, IT storage and connectivity limitations, over-diagnosis, and cost effectiveness.30

Cancer screening does not equal cancer prevention, and although early detection is important, using a screening method that in and of itself increases the risk of developing cancer is simply not good medicine. After advancements in MRI, ultrasound imaging, and thermography (infrared and contact), mammograms have become an antiquated and questionably appropriate cancer screening diagnostic. However, most clinics and hospitals are financially invested in mammographic equipment. It will take some time to change over to MRI in place of mammography, but it will eventually happen. In North America, women are still urged to get an annual mammogram starting at the age of 40, even though updated guidelines set forth by the U.S. Preventive Services Task Force in 2009 urge women to wait to get a mammogram until the age of 50, and to only get bi-annual screening thereafter. Unfortunately, many women are completely unaware that current research does not support the use of routine mammograms to prevent breast cancer mortality.

Often women can feel “guilt-tripped” into thinking that avoiding their annual mammogram appointment is hugely irresponsible. Additionally, some doctors are as confused and misinformed as their patients. This is directly due to misinformation and media propaganda in a powerful and profit-driven industry which often chooses to dismiss research that dramatically contradicts their profit-based agenda.

Peter C. Gøtzsche, MD of The Nordic Cochrane Centre31, 32 and author of Mammography Screening: Truth, Lies and Controversy sums it up thus:

Screening uses a test to check people who have no symptoms of a particular disease, to identify people who might have that disease and to allow it to be treated at an early stage when a cure is more likely. Mammography uses X-ray to try to find early breast cancers before a lump can be felt. Many countries have introduced mammography screening for women aged 50 to 69. The review includes seven trials involving a total of half a million women. The review found that mammography screening for breast cancer likely reduces breast cancer mortality, but the magnitude of the effect is uncertain and screening will also result in some women getting a cancer diagnosis even though their cancer would not have led to death or sickness. Currently, it is not possible to tell which women these are, and they are therefore likely to have breasts and lumps removed and to receive radiotherapy unnecessarily. Based on all trials, the reduction in breast cancer mortality is 20%, but as the effect is lower in the highest quality trials, a more reasonable estimate is a 15% relative risk reduction. Based on the risk level of women in these trials, the absolute risk reduction was 0.05%. Screening also leads to overdiagnosis and overtreatment, with an estimated 30% increase, or an absolute risk increase of 0.5%. This means that for every 2000 women invited for screening throughout 10 years, one will have her life prolonged. In addition, 10 healthy women, who would not have been diagnosed if there had not been screening, will be diagnosed as breast cancer patients and will be treated unnecessarily. It is thus not clear whether screening does more good than harm.

Decision making about mammography cancer screening has become difficult for the patient. There are always tradeoffs. It is essential to remember that the harms are just as real as any benefits. With other forms of screening diagnostics becoming available and affordable, i.e. ultrasound, contact regulation thermography, digital infrared thermal imaging, and breast MRI, the value of mammography will continue to be questioned. Thermography, both contact (CRT) and infrared provide physiological data that can be monitored for change and ultrasound’s anatomical data can help determine if a lump is a benign cyst or a potential cancer. Both technologies are completely safe and harmless, are very effective in providing important data for women of all ages with all breast types, including dense breasts, and for those with implants.

There have been numerous studies, books and articles written, exposing the Mammogram Scam, including writings from doctors John Goffman33, Gilbert Welch34, Peter Gøtzsche, Ben Johnson35, Christiane Northrup36, Christine Horner37, and Samuel Epstein38. Studies published by the US Preventative Services; New England Journal of Medicine39; The Lancet Medical Journal; Archives of Internal Medicine; British Medical Journal; and the Nordic Cochrane Center have also repeatedly challenged the validity of routine mammography and the dangerous protocols to which it leads.

In summary, here are 5 reasons to consider avoiding routine mammography in favor of thermography and ultrasound:

1. Mammograms are not prevention. Healthy changes in diet and lifestyle are truly preventative. Learning how to create and nurture healthy relationships and release and process psychoemotional traumas are also an important step in cancer prevention.

2. Mammograms lead to overdiagnosis and overtreatment due to false positives. A Danish study reveals that mammography screening leads to overdiagnosis and overtreatment at a rate of 48.3%. This is particularly true for women under 40, and possibly for all premenopausal women for whom mammograms are not very accurate due to denser breast tissue.40 In 2012, the New England Journal of Medicine reported that 1.3 million US women have been over-diagnosed and overtreated over the past 30 years.41

3. Mammograms do not reduce mortality rate. Studies demonstrate that for every 2,000 women screened over 10 years, only one will avoid dying of breast cancer, and 10 healthy women, who would not have been diagnosed if they had not been screened, will be treated unnecessarily.42

4. Mammograms expose women to ionizing radiation that IS carcinogenic. Radiation from a mammogram can be up to 1,000 times greater than a chest X-ray. In addition, some experts believe that ionizing radiation used in mammograms mutates breast cells. Plus, tight compression of the breasts can facilitate the spreading of already malignant cells (as can a biopsy). Premenopausal and pregnant women have breast tissue that is more sensitive to radiation. It is very possible that these high levels of radiation could potentially cause an epidemic of radiation-induced breast cancers.

5. Mammograms can cause increased anxiety. This is especially true when receiving a false positive comeback notice. Studies show a strong connection between stress, anxiety and cancer progression.43, 44 A 2013 study showed that false positive screenings can have negative, long-term psycho-social effects for up to 3 years after a false positive finding.45

Breast imaging is a multi-billion-dollar industry. And despite concerns over whether or not to undergo breast cancer screening, every year nearly 40 million mammograms are performed in the U.S. As long as the American College of Radiology, the American Medical Association, the American Cancer Society, and the FDA (with their unconscionable conflicts of interest) collude, the fox will continue to guard the treasured henhouse. For it is easier to deceive the masses than it is to convince the masses that they have been deceived.

As always, the information in this monograph is intended for informational purposes only and is meant to help users better understand health concerns. Information is based on review of scientific research data, historical practice patterns, and clinical experience. This information should not be interpreted as specific medical advice. Users should consult with a qualified healthcare provider for specific questions regarding therapies, diagnosis and/or health conditions, prior to making therapeutic decisions.

References

1. Guth U, Huang DJ, Huber M, et al. Tumor size and detection in breast cancer: Self-examination and clinical breast examination are at their limit. Cancer Detect Prev 2008;32:224-228.

2. Ries LAG, Eisner MP. Cancer of the Female Breast. In: Ries LAG, Young JL, Keel GE, Eisner MP, Lin YD, Horner M-J, eds.SEER Survival Monograph: Cancer Survival Among Adults: US SEER Program, 1988-2001, Patient and Tumor Characteristics Bethesda: National Cancer Institute, SEER Program, NIH Pub. No. 07-6215, 2007:101-110.

3. Tabar L, Dean PB, Tot T. Teaching Atlas of Mammography. Thieme. ISBN:3136408047.

4. Independent UK Panel on Breast Cancer Screening. The benefits and harms of breast cancer screening: an independent review. Lancet. 2012; 380: 1778–1786.

5. The U.S. Preventive Services Task Force (USPSTF) is an independent, volunteer panel of national experts in prevention and evidence-based medicine. The Task Force works to improve the health of all Americans by making evidence-based recommendations about clinical preventive services such as screenings, counseling services, and preventive medications. All recommendations are published on the Task Force’s Web site and/or in a peer-reviewed journal. – https://www.uspreventiveservicestaskforce.org

6. The Canadian Task Force on Preventive Health Care (CTFPHC) has been established by the Public Health Agency of Canada (PHAC) to develop clinical practice guidelines that support primary care providers in delivering preventive health care. Guideline development is based on systematic analysis of scientific evidence The CTFPHC is an independent body of fourteen primary care and prevention experts who recognize and support the need for evidence informed preventive activities in primary care in Canada. http://canadiantaskforce.ca/

7. http://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/breast-cancer-screening

8. https://canadiantaskforce.ca/guidelines/published-guidelines/breast-cancer/

9. https://canadiantaskforce.ca/guidelines/published-guidelines/breast-cancer/

10. https://canadiantaskforce.ca/guidelines/published-guidelines/breast-cancer/

11. https://canadiantaskforce.ca/guidelines/published-guidelines/breast-cancer/

12. Berrington de González A, Darby S. Risk of cancer from diagnostic X-rays: estimates for the UK and 14 other countries. Lancet 2004; 363: 345-51.

13. Zahl, PH, Mæhlen, Jan; Welch, H.G, The Natural History of Invasive Breast Cancers Detected by Screening Mammography Journal of the American Medical Association’s Archives of Internal Medicine (Arch Intern Med. 2008; 168[21]:2302-2303).

14. Brenner DJ, Hall EJ. Computed tomography: an increasing source of radiation exposure. N Engl J Med. 2007; 357(22): 2277-2284.

15. Smith-Bindman R, Lipson J, Marcus R, et al. Radiation dose associated with common computed tomography exams and the associated lifetime attributed risk of cancer. Arch Intern Med. 2009; 169(22):2078-2086.

16. Berrington de González A, Mahesh M, Kim KP, et al. Projected cancer risks from computed tomography scans performed in the United States in 2007. Arch Intern Med. 2009;169(22):2071-2077.

17. Brenner DJ, Hall EJ. Computed tomography: an increasing source of radiation exposure. N Engl J Med. 2007; 357(22): 2277-2284.

18. John W. Gofman, M.D., Ph.D. Preventing Breast-Cancer: The Story of a Major, Proven, Preventable Cause Of This Disease, 1996.

19. John Gofman and Arthur Tamplin, Population control through nuclear pollution, 1970, Nelson Hall co., p.65-68.

20. Although most radiation-induced damage is rapidly repaired, misrepair can lead to point mutations, chromosome translocations, and gene fusions that are linked to cancer induction. This effect is typically thought to be stochastic, ie, it can occur at any level of radiation exposure, with the likelihood increasing as the dose increases. The typical lag period between radiation exposure and cancer diagnosis is at least 5 years, and in most cases, the lag period may be 1 or 2 decades or longer. Amis ES, Butler PF, Applegate KE, et al. American College of Radiology white paper on radiation dose in medicine. J Am Coll Radiol. 2007;4:272-284.

21. Mammogram Radiation Dosage: The average breast radiation dose per mammogram view is 2.37 mGy for film or analog mammography and 1.86 mGy for digital (approximately 22% lower for digital than film mammography).

22. Institute of Medicine/National Resource Council (2001), Mammography and Beyond, National Academy Press: Washington DC. 2001; pg. 39.

23. Bleyer A., Welch HG. Effect of Three Decades of Screening Mammography on Breast-Cancer Incidence, N Engl J Med; 2012: 367:1998-2005.

24. Gøtzsche PC, Jørgensen KJ. Screening for breast cancer with mammography. Cochrane Database Syst Rev. 2013 Jun 4;(6):CD001877. doi: 10.1002/14651858.CD001877.pub5.

25. Yankansas, B et al., (2001) Association of Result Rates with Sensitivity and Positive Predictive Values of Screening Mammography. The Journal of the American Roentgen Ray Society, Sept. 2001;177[3]: 543-9.

26. Epstein, S. S., The Politics of Cancer. Revised and expanded edition, Anchor/Doubleday Press, New York, 1979.

27. Gilbert FJ, Tucker L, Young KC. Digital breast tomosynthesis (DBT): a review of the evidence for use as a screening tool. Clin Radiol 2016 Feb; 71(2):141-50. Epub 2015 Dec 23.

28. U.S. Food and Drug Administration. Radiation-Emitting Products.

https://www.fda.gov/Radiation-EmittingProducts/MammographyQualityStandardsActandProgram/FacilityScorecard/ucm113858.htm (Accessed October 12, 2015).

29. Paulis LE, Lobbes MB, Lalji UC, Gelissen N, Bouwman RW, Wildberger JE, Jeukens CR. Radiation exposure of digital breast tomosynthesis using an antiscatter grid compared with full-field digital mammography. Invest Radiol 2015 Oct; 50(10):679-85.

30. GurD, Abrams GS, Chough DM, et al. Digital breast tomosynthesis: observer performance study. AJR. 2009; 193:586-591.

31. https://nordic.cochrane.org/screening-breast-cancer-mammography

32. Gøtzsche, Peter C., and Margrethe Nielsen. Screening for breast cancer with mammography. Cochrane Database Syst Rev 4.1 (2009).

33. Dr. John W. Goffman, M.D., Ph.D. published that finding in a 1996 book called Preventing Breast-Cancer: The Story of a Major, Proven, Preventable Cause of this Disease. He was a retired Professor of Molecular and Cell Biology at the University of California, Berkeley.

34. Welch, H. G., Prorok, P. C., O’Malley, A. J., & Kramer, B. S. (2016). Breast-cancer tumor size, overdiagnosis, and mammography screening effectiveness. New England Journal of Medicine, 375(15), 1438-1447.

35. https://thetruthaboutcancer.com/video-mammograms-cause-breast-cancer/

36. https://www.drnorthrup.com/best-breast-cancer-screening-tests/

37. http://www.wellnesshour.com/early-detection-breast-cancer-christine-horner-md/

38. http://www.breastcancerchoices.org/epstein.html

39. Bleyer, A., & Welch, H. G. (2012). Effect of three decades of screening mammography on breast-cancer incidence. New England Journal of Medicine, 367(21), 1998-2005.

40. Jørgensen, K. J., Gøtzsche, P. C., Kalager, M., & Zahl, P. H. (2017). Breast cancer screening in Denmark: a cohort study of tumor size and overdiagnosis. Annals of internal medicine, 166(5), 313-323.

41. Bleyer, A., & Welch, H. G. (2012). Effect of three decades of screening mammography on breast-cancer incidence. New England Journal of Medicine, 367(21), 1998-2005.

42. https://www.cochrane.org/CD001877/BREASTCA_screening-for-breast-cancer-with-mammography

43. Moreno-Smith, M., Lutgendorf, S. K., & Sood, A. K. (2010). Impact of stress on cancer metastasis. Future oncology, 6(12), 1863-1881.

44. Sood, A. K., & Lutgendorf, S. K. (2011). Stress influences on anoikis. Cancer prevention research, 4(4), 481-485.

45. Brodersen, J., & Siersma, V. D. (2013). Long-term psychosocial consequences of false-positive screening mammography. The Annals of Family Medicine, 11(2), 106-115.

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Important Aspects of a Holistic Pain Therapy Concept

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Important Aspects of a Holistic Pain Therapy Concept

Dr. Ralf Oettmeier

Abstract

Modern pain therapy should follow causal and individualized principles. In concrete terms, this means the evaluation of the main causes of pain, which are often associated with inflammatory processes. In addition, if local or regional treatments fail, the focus should be on a holistic view using segment reflector complexes, knowledge from TCM and regulatory medicine. It is also important to supplement essential vital substances in the case of proven deficiencies, to include biological dentistry and to use naturopathic analgesics with few or no side effects. The holistic pain medicine is rounded off by psycho-emotional harmonization techniques, which take into account the nature of pain as an unpleasant emotional experience.

Introduction

The treatment of chronic pain is one of the greatest challenges of modern medicine and creates an enormous socio-economic burden potential. In Germany, Austria and Switzerland, for example, between 42 and 50 painkillers per head are consumed annually. More than half of them are bought over the counter in pharmacies. The remainder, for example, burdens the German health insurance funds with 7.3 billion euros (1). The associated side effects and deaths of regular use of non-steroidal anti-inflammatory drugs (NSAIDs) is serious. According to NOLTE et al, around 2,200 patients died in Germany in 2011 as a result of NSAID abuse. An additional € 750 million had to be raised for the treatment of NSAID side effects (2). A Swiss study was also able to show an increased rate of myocardial infarction and stroke with regular NSAID use when analyzing the data from 31 studies with a total of 120,000 people (3). In the United States, the official death rate from gastrointestinal bleeding due to NSAID abuse is around 16,500 annually (4).

This underlines the necessity of a paradigm shift in pain therapy: away from ostensible pharmaceutical intervention towards an individualized, causal and holistic concept. This article would like to dedicate itself to this premise.

 

To understand acute and chronic pain

According to the IASP, pain is an uncomfortable sensory and emotional experience that is associated with or described as real or potential tissue damage (5). It is therefore important to differentiate between physiological, biochemical and immaterial aspects at the various levels of pain processing. In the case of acute pain, the processing chain from the periphery to the brain up to the sensation of pain is easy (Fig. 1). Afferent nerve fibers in the periphery are stimulated by mechanical, chemical and physical noxae, which then set a stimulus conduction chain in motion. With the participation of mast cells, chemical substances such as histamine, substance P, bradykinin and prostaglandins are formed as stimulus intensifiers.

 

Figure 1: Model of the development of acute pain

 

The linear-mechanistic model is not sufficient to understand how chronic pain develops. To this end, practice-relevant models for defining receptive fields and neuroplasticity as the basis of pain memory were developed in the 1990s and are still valid today (6-9). As illustrated in Figures 2 and 3, there are both peripheral and central activating and inhibiting factors that modulate pain and ultimately influence its perception. Starting with the anamnesis, our attention should be paid to all of these components of the development of pain and the maintenance of its chronicity. This also makes it clear, that in complicated cases for an individual pain analysis a therapeutic team is necessary, taking the complexity of the topic as a whole into account.

 

Figure 2: Development of chronic pain (schematic)

 

Figure 3: Main components of the peripheral (left) and central (right) receptive field

 

In holistic medicine pain is also interpreted as being the tip of an iceberg, which is based on a multiple of its volume of potential causative factors “under the water surface” (Fig. 4). The deeper you go into the anamnestic and diagnostics, the more causal and long-term successful the pain therapy is. Of course, the best medicine would be to completely dissolve the “iceberg of pain”. In practice, for chronically ill patients, it can often only be reduced in size due to the increasing organic damage. Simple pain suppression with classic analgesics (NSAIDs, opioids) should only be reserved for situations where other, non-drug methods and natural painkillers fail. This should be the guideline for our actions.

Figure 4: Pain as the tip of a causal iceberg of functional and regulatory disorders as well as deep causal mechanisms

 

Local holistic pain therapy procedures

These procedures apply to the reduction of the nociceptive stimuli in the periphery of the area affected (felt) by the pain. Often, affected people instinctively take measures such as rest, warming, cooling or the use of ointments or compresses. Naturopathic pain therapy can also provide relief with ointments (frankincense, Traumeel®, Zeel®), local acupuncture or neural therapy, manual therapy, laser treatment or cupping. The classic method of cantharid plaster, Baunscheidtierens and leeches have proven themselves as drainage methods. But the more chronic the pain, the less helpful these methods will be. The Czech manual therapist LEWITT said: “Anyone treating chronic pain only where it is felt is lost.”

 

Segmental therapy for chronic pain

This consequently follows the assumption of the receptive field (see above) and has the reflex zones according to HEAD as well as the segment-reflective complex in the head and neck area as a physiological background (10-11). Non-drug procedures such as manual therapy, acupuncture, cupping, wraps and pads, locoregional magnetic field therapy and special massages are in the foreground. We favor superficial and possibly deep injections with neural therapy using procaine and naturopathic additives tailored to the problem (see table below). For example, a ventral injection is made into the liver-gallbladder segment both below the right costal arch and paravertebrally at the level of Th9-10 interspinal (Procain 1% plus Taraxacum comp. Injeel®, Hepar comp. Injeel® and Mucedokehl® SANUM).

 

Figure 5: Components of a vertebral segment as the basis of the peripheral receptive field (from v. D. Berg 2003)

 

Systemic approaches to holistic pain therapy

On the basis of holistic diagnostics, the processes affecting the entire human regulation system represent the focus of our work. These aim to free the system from permanently present neuro-modulative triggers (= interference fields), to have an anti-inflammatory and healing effect. For systematic reasons, we will consider the most important components separately in the following:

 

a) Detection and deactivation of neuro-modulative triggers

These previously called foci or interference fields are described as pathologically inflamed tissue, which in principle can occur in all areas of the body. They can be objectified through thorough examination, imaging, and functional measurements. We favor bio-thermology (also called regulation thermography) for diagnostics. Figure 6 shows the thermogram of a 62-year-old man who had been suffering from pronounced and previously therapy-resistant chronic lumbar pain for 6 years. However, the thermogram only showed abnormalities in the area of the maxillary sinuses, the tonsils and the upper cervical spine. Targeted neural therapy in these zones made the pain disappear within a few minutes.

 

Figure 6: Biothermology. The yellow and orange measuring points are noticeable (system thermolytics 3000-IR, SwissMedAnalytics AG), explanation in the text.)

 

The tooth and jaw region are of great importance in the impact of chronic inflammation sources on the body. In fact, every tooth socket (odontom) is connected with internal organs, joints and spinal column segments (Fig. 7). A routine component of holistic pain therapy is the presentation of the patient to a qualified, biologically thinking dentist. Through a thorough examination, imaging with OPT and possibly DVT, this objectively verifies the foci of inflammation in the tooth and jaw area (such as restostitides, inflammation of dead teeth, displaced teeth, scattered tooth germs, etc.) as well as disorders of the bite setting in the sense of a cranio-mandibular dysfunction. With adequate rehabilitation, sometimes the patients experience spectacular improvement in their pain problems. The OPT in Figure 8 shows a related case. Here, large pus granulomas can be seen in several root-treated teeth. Extraction of these with application of platelet-rich plasma (PRP) locally for wound care resulted in immediate relief from symptoms. The more chronic the problem, the more consistently one should eliminate such foci of inflammation.

Figure 7: Interrelationships between teeth and body (modified from R. VOLL)

 

Figure 8: Orthopantomogram (OPT) of a 64-year-old lady with migraines, headaches, back pain and upper abdominal pain

 

b) Detox instead of poison

It is logical, quasi “BIO-logical”, that toxic substances of all kinds also irritate nerves and thus foster pain. This has been clearly shown, for example, in fibromyalgia and exposure to cadmium, lead and mercury (12). Appropriate diagnostics using a chelate mobilization test or photometric element analysis using a SO-Check should be part of the routine. The adequate evacuation and detoxification is done using natural remedies for the liver, lymph and kidneys, antioxidants, zeolite and algae, with evacuation infusions (incl. DMPS, DMSO, EDTA), medical colon irrigation and whole-body hyperthermia. The main focus lies on avoiding new toxic loads through metal-free dental restoration, changing the diet, improving occupational safety and optimizing living and working conditions.

 

c) The special importance of orthomolecular medicine

Vitamins, minerals, trace elements, fatty acids and also essential amino acids are first examined for deficiencies in chronic pain patients and then adequately supplemented. For example, it was already possible to show in 1976 that a daily dose of 50 mg zinc for several weeks significantly reduces inflammation, swelling, morning stiffness and joint pain in rheumatoid patients (13). The importance of magnesium in pain therapy should also not be underestimated. For example, a 4-week administration of 500 mg magnesium a day produced a significant improvement lasting over 12 weeks of chronic back pain patients (14). Very good results have also been reported with high doses of glucosamine and chondroidin sulfate for osteoarthritis pain (15). Other antioxidants such as vitamin C, E or selenium are also part of a holistic orthomolecular therapy regimen (16). For inflammatory joint pain, we like to use 200-300 µg selenium as an additive to neural therapy. Finally, if there is a discrepancy, we should also systematically influence acid-base discrepancies. CSEUTS was able to show in 37 patients with inflammatory joint pain that this decreased significantly after 4 weeks of administration of base powder (twice daily) over four weeks with a simultaneous increase in the endorphin level. At the same time, the use of NSAIDs and cortisone could be significantly reduced (17). When it comes to unsaturated fatty acids, it is important to ensure a balanced ratio between omega 6 and omega 3 fatty acids, especially the ratio of arachidonic acid (ARA) and eicosapentaenoic acid (EPA). Alpha-linolenic acid EPA and DHA often have to be substituted for deficiencies. Too many animal fats and an excess of linoleic acid have a pro-inflammatory effect and thus aggravate pain.

 

d) Other proven systemic approaches to non-drug pain therapy

Patients with chronic pain should regularly benefit from the variety of effective non-medicinal procedures. These make use of the knowledge about the reflex zones such as manual therapy, chiropractic therapy, myoreflex techniques and neural therapy. Also somatotopias and complex inner connections are the basis of osteopathy, cranio-sacral therapy, foot reflexology and the Dorn-Breuss technique. On the basis of the meridian theory of TCM, acupuncture, acupressure and acupuncture massages as well as Shiatzu have meanwhile achieved a firm place in holistic pain therapy. Finally, we also like to use passively generated fever in the form of whole-body hyperthermia for systemic pain treatment as a therapeutic tool (18-20).

e) Systemic treatment with procaine and ProcCluster®

Procaine has anti-inflammatory and analgesic effects, promotes peripheral blood and lymph flow, reduces pro-inflammatory cytokines and is sympatholytic. The application as a short infusion and, according to the patient’s response, also by means of oral doses of 50-100 mg of the procaine salt ProcCluster® is standard for us in the treatment of chronic pain and inflammation. For further information, we refer to the extensive literature (21-23).

 

f) Effective pain therapy with naturopathic medicines

Before resorting to the side effect affected NSAIDs and opioids, the possibilities of naturopathic painkillers should be used and applied in the interests of the patient. We have an extensive range of phytotherapeutic, homeopathic and anthroposophic remedies at our disposal (10). The following tables show this as an example.

 

Table 1: Phytoanalgetics (used in Europe)

 

Table 2: Important pain problems and main proven homeopathic remedies used in Europe (Spl.® – Similaplex Fa. Pascoe, Opl. ® –Oligoplex Fa. Madaus, Pplx. ® – Plantaplex Fa. Steigerwald, Ptk. ® – Pentarkan Fa. DHU, cyl® – Ho Len Komplex Fa. Liebermann)

 

g.) Rounding off with psycho-emotional harmonization

Pain is ultimately an unpleasant emotional experience, a feeling, a sensation. Pain as such is difficult to objectify and cannot be measured in the blood: you have to believe the patient. According to neuroscience, the region of the thalamus, hippocampus and the limbic system play an essential neuro-modulative role. The psyche and its stability are the main components that need to be influenced in chronic pain patients (24-26). In some pain patients, the central receptive field is the main disturbance and trigger zone. It requires an empathetic therapist who can understand these relationships. Successful pain psychologists consistently take action here. Ultimately, there is a positive influence on all therapeutic interventions, especially when one “lends a hand” (= treatment). In neural therapy, we always combine the injection with an appropriate healing affirmation for the respective region. Incidentally, it is not a mistake to lay hands on therapeutically, as the specialist literature also describes (27). Let us give a final example to illustrate this: After neural therapy of the painful back of the head, the cervical spine and trapezius region, the patient speaks with the laying on of hands: “Your positive thoughts support this injection, which promotes blood and lymph flow in this region and improves the oxygen supply and ensures that everything that sits on the neck is transported away and frees itself. The heavy backpack, full of contaminated sites, worries and problems is emptied, becomes very light and leads to complete freedom from pain.”

 
 

Biblography

  1. Diener et al. PhZ online 37/2013

  2. Nolte et al: STK Zeitschrift 4/2012

  3. Institut Sozial- und Präventivmedizin Bern: Analyse des chronischen Gebrauchs von Naproxen, Ibuprofen, Diclofenac, Celecoxib, Etoricoxib, Rofecoxib und Lumiracoxib bei 120.000 Patienten (2013)

  4. Wolfe MM, Lichtenstein DR, Singh AG. Gastrointestinal Toxicity of Nonsteroidal Antiinflammatory Drugs, The New England Journal of Medicine 1999;340,24:1888–99

  5. Bonica JJ. The need of a taxonomy. International Association for the Study of Pain: Pain Definition. Pain 1979;6(3):247-8.

  6. T J Coderre 1J KatzA L VaccarinoR Melzack: Contribution of central neuroplasticity to pathological pain: review of clinical and experimental evidence. Pain (1993) Mar;52(3):259-85. doi: 10.1016/0304-3959(93)90161-h.

  7. K Okuse : Pain signalling pathways: from cytokines to ion channels. Int J Biochem Cell Biol (1997);39(3):490-6. doi: 10.1016/j.biocel.2006.11.016.

  8. S C Azad 1W Zieglgänsberger: What do we know about the state of chronic pain? Schmerz (2003) Dec;17(6):441-4. doi: 10.1007/s00482-003-0257-3.

  9. W Zieglgänsberger 1A BertheleT R Tölle: Understanding neuropathic pain. CNS Spectr (2005) Apr;10(4):298-308. doi: 10.1017/s1092852900022628.

  10. F. van den Berg (Hrsg.), Schmerztherapie in ärztlicher Hand. S. 229-240. In: Angewandte Physiologie, Teil 4, Thieme Verlag Stuttgart 2003

  11. Busch et al: „Der trigeminozervikale Komplex“, Schmerz 2004-18: 404-410

  12. G Bjørklund 1M Dadar 2S Chirumbolo 3J Aaseth : : Fibromyalgia and nutrition: Therapeutic possibilities? Pharmacother (2018) Jul;103:531-538.

  13. PA Simkin PA.: Oral zinc sulfate in rheumatoid arthritis., Lancet (1976);2: 539-542

  14. A A Yousef et al. A double-blinded randomised controlled study of the value of sequential intravenous and oral magnesium therapy in patients with chronic low back bain with a neuropathic component. Anaesthesia 2013;68:260-269

  15. J A Singh et al. Chondroitin and Glucosamine for osteoarthritis. Cochrane Database of systemic reviews. 2015;1. Art. No.CD005614

  16. T Edwards: Inflammation, pain, and chronic disease: an integrative approach to treatment and prevention. Ther Health Med Nov-Dec (2005) ;11(6):20-7; quiz 28, 75.

  17. R M Cseuz et al. Alkaline mineral supplementation decreases pain in rheumatoid arthritis patients. The Open Nutritional Journal. 2008;2:100-105

  18. I Stegemann, J Hinzmann , I Haase, T Witte: Ganzkörperhyperthermie mit wassergefilterter Infrarot-A-Strahlung bei Patienten mit axialer Spondyloarthritis.  OUP 2013; 10: 458–463. DOI 10.3238/oup.2013.0458–0463

  19. H. Wehner: Hyperthermie bei Fibromyalgie und Weichteilrheuma. Erfahrungsheilkunde 2019; 68(03): 154-157, DOI: 10.1055/a-0898-2288

  20. T Brockow, A Wagner, A Franke, M Offenbächer, KL Resch. Wirksamkeit einer seriellen Ganzkörperhyperthermie mittels wIRA als Zusatz zu einer Standard Rehabilitation bei Behandlung der Fibromyalgie. The Clinical Journal of Pain 2007;1:67-75

  21. U Reuter, R. Oettmeier, H Nazikül,: Procaine and Procaine-Base-Infusion: A Review of the Safety and Fields of Application after Twenty Years of Use. Clin Res Open Access 4(1): doi http://dx.doi.org/10.16966/2469-6714.127

  22. R Oettmeier, U Reuter: The Procaine-Base-Infusion: A Review after Twenty Years of Use. Med Clin Res & Rev, 2017, Volume 1 | Issue 3 | p. 1 – 8

  23. R Oettmeier, U Reuter and L B Pinilla Bonilla: The Procaine-Base-Infusion: 20 Years of Experience of an Alternative Use with Several Therapeutical Effects. J Altern Complement Integr Med 2019, 5: 061 DOI: 10.24966/ACIM-7562/100061

  24. B Giovanni: Pain and psycho-affective disorders. Neurosurgery 2008 Jun;62(6 Suppl 3):901-19; discussion 919-20. doi: 10.1227/01.neu.0000333760.53748.9e.

  25. T Esch, G Stephano: A bio-psycho-socio-molecular approach to pain and stress management. Forsch Komplementmed 2007 Aug;14(4):224-34. doi: 10.1159/000105671.Epub 2007 Aug 9.

  26. P Vercellini et al.: Chronic pelvic pain in women: etiology, pathogenesis and diagnostic approach. Gynecol Endocrinol 2009 Mar;25(3):149-58. doi: 10.1080/09513590802549858

  27. SM Wright: The use of therapeutic touch in the management of pain. Nurse Clin North Am. 1987 Sep;22(3):705-14.

Ralf Oettmeier

Alpstein Clinic AG,

Dorfplatz 5, CH-9056

Gais, Switzerland

www.alpstein-clinic.ch

Recent Posts

Messenger RNA (mRNA) SARS Coronavirus ‘Vaccines’ and their Potential Autoimmunity Part 2

Messenger RNA (mRNA) SARS Coronavirus ‘Vaccines’ and their Potential Autoimmunity Part 2

Febuary 24, 2021

Messenger RNA (mRNA) SARS Coronavirus ‘Vaccines’ and their Potential Autoimmunity Part 2

James Odell, OMD, ND, L.Ac.

Reference Commentary – The material published in this commentary is intended to foster scholarly inquiry and a rich discussion of the controversial topic of bioethics and health policy. The views expressed in this article are solely the authors and do not represent the policy or position of the Bioregulatory Medicine Institute (BRMI), nor any of its Board Advisors or contributors. The views expressed are not intended to malign any religious or ethnic group, organization, company, individual, or any other. Every effort has been made to attribute the sources of this article to the rightful authors listed in references.The content of this article is presented in summary form, is general, and is provided for informational purposes only: it is not advice, nor should it be treated as such. If you have any healthcare-related concerns, please call, or see your physician or other qualified healthcare providers. Never disregard medical advice or delay seeking it because of something you have read in this article.

 

In my last article entitled COVID 19 mRNA Vaccines, published in the 24th BRMI E-Journal, I reviewed many of the safety concerns about the experimental messenger RNA SARS coronavirus ‘vaccines’ not being discussed in the medical media. Because no long-term safety studies have had time to be performed to ensure that any of these products do not cause cancer, seizures, paralysis, heart disease, or autoimmune diseases, it is of paramount importance for the public to become informed as to any potential risk. Unfortunately, the medical media and pharmaceutical manufacturers have not provided adequate or complete information on the potential adverse effects these experimental mRNA ‘vaccines’ may cause. Partly, because much of this research is being gathered in real-time. In short, there is a gross lack of informed consent as much is still not known about their efficacy and safety. This commentary is an attempt to disclose pertinent information that potential recipients should know to make a truly informed decision as to whether to receive the injection.

 

After the last article, I received many inquiries about details of vaccine immunity in relation to this new mRNA platform. Many readers requested that information be simplified on vaccine immunology, whereas others asked that for more details about the technical aspects of vaccine immunity and their potential for autoimmunity. So, this part-two reference commentary is an attempt to compromise and further evaluate both how vaccines affect immunity and their potential for causing autoimmunity.

 

Emergency Use Authorization

 

The Pfizer-BioNTech and Moderna COVID-19 ‘vaccines’ have not been approved or licensed by the U.S. Food and Drug Administration (FDA), but instead have received authorized for emergency use by the FDA under an Emergency Use Authorization (EUA) for use in individuals 16 years of age and older. Thus, both products are experimental in that they have not been approved by the FDA for a biological license and were approved under EUA without long term safety data. The FDA has not fully evaluated the data and still has not decided if the potential risks outweigh the benefits of receiving it. Human trial data is not complete and published yet, and this is partly why it is considered ‘experimental’ and still unlicensed by the FDA as a biological drug.

 

According to the FDA website, medical products that may be considered for a EUA are those that “may be effective” to prevent, diagnose, or treat serious or life-threatening diseases or conditions that can be caused by a CBRN agent(s) (chemical, biological, radiological, and nuclear) identified in the HHS Secretary’s declaration of emergency or threat of emergency under section 564(b). The “maybe effective” standard for EUAs provides for a lower level of evidence than the “effectiveness” standard that the FDA uses for product approvals.

 

The World Health Organization announced on January 8th that Pfizer’s COVID-19 vaccine was not recommended for pregnant women unless they are at particularly high risk for the virus or a health care worker. They followed that recommendation with another on February 2nd advising against pregnant women taking the Moderna coronavirus vaccine unless they are health care workers or have preexisting conditions. Pregnant and lactating women were excluded from Pfizer/BioNTech and Moderna’s COVID-19 vaccine clinical trials, and they are not included in any ongoing trials for vaccines manufactured by other companies. That means there is no safety data available to know for sure whether these ‘vaccines’ are safe for people who are pregnant or breastfeeding. It is not known if or how these experimental drugs will affect fertility in the short or long term. What is known is that there have been several reports to Vaccine Adverse Event Reporting System (VAERS) of miscarriages following the shot.

 

Viral Messenger RNA as a Synthetic Pathogen of Unknown Risk

 

The central dogma of biology states that DNA makes RNA and RNA make proteins.However, there are many different types of RNAs, and only one of them, the messenger RNA (mRNA), gives rise to proteins. Messenger ribonucleic acids (mRNAs) transfer the information from DNA to the cell machinery that makes proteins. Specifically, mRNA delivers the information encoded in one or more genes from the DNA to the ribosome, a specialized cellular structure, or organelle, where that information is decoded into a protein. Ribosomes read the mRNA and translate the message into functional proteins in a process called ‘translation’. Depending on the newly synthesized protein’s structure and function, it will be further modified by the cell, exported to the extracellular space, or will remain inside the cell. The primary function of mRNA is to act as an intermediary between the genetic information in DNA and the amino acid sequence of proteins. Thus, messenger RNA is an intermediary between the gene, and the product, the protein.

 

In vaccines, it is the protein that ultimately elicits the immune response, not the RNA. Historically, vaccines are proteins, either viral, or bacterial, and it is the vaccine’s protein that, if all goes well, develops an immune response to elicit neutralizing antibodies. Vaccine-mediated immunity is often multifactorial, and the best protection is likely to be elicited by the combination of strong humoral and cell-mediated immune responses.

 

So, by definition, an mRNA ‘vaccine’ is not a true vaccine. First, because it is not a protein that directly elicits an immune response. It first must be decoded into protein, and it is then that protein that in turn creates the desired immune response. Secondly, by FDA definition, since it is a component used as a treatment to affect a body’s function, it is by legal definition a ‘medical device’ or a physical ‘device’ that comes in a molecular-sized package. Thus, strictly speaking, this messenger RNA device is a synthetic pathogen utilizing a genetic engineering process as a biological response modifier, not at all like a classical vaccine. In principle, biological response modifiers are biologically active agents including antibodies, small peptides, and/or other (small) molecules of mRNA, DNA, that can influence the immune response. Most importantly, this synthetic viral pathogen device is a new and different molecular platform, one that has never been injected into the public’s arm.

 

With these mRNA synthetic pathogens, what is injected into the body is not a weakened virus or even selected antigens, but rather protein-coding instructions that tell your body’s cells how to make the antigens on their own. Again, that process is called “translation.”

 

Erroneously referring to this intervention as a ‘vaccine’ exploits the public’s ingrained trust in previous vaccination programs. It keeps us in the illusion of vaccine safety in place of taking the necessary measures to investigate the impact of this new experimental device on our health. In studies of vaccination decision-making, risk perception is often intricately linked with ideas of trust in health professionals, in government, or public health institutions and the interplay between these actors. When medical professionals or institutions no longer fulfill their obligation of information transparency and disclosure of potential risks, this is a harmful violation of trust. Many people do not understand what FDA Emergency Use Authorization entails. It means it is still experimental and carries risk yet unknown. The public becomes the experiment.

 

Another wrinkle in information disclosure is the manufacturer’s complete lack of liability. As I described in the previous article, the Public Readiness and Emergency Preparedness Act of 2005 has now allowed vaccine manufacturers unlimited freedom to create, develop, and market COVID-19 vaccines without any liability whatsoever. All liability is protected by the PREP Act, which means if anyone has an adverse event or death caused by this vaccine there really is no recourse. This was put into the Federal Register in March of 2020 and does not expire till the end of 2024. So, anything that is developed over the next four years that has to do with a biological agent, such as a vaccine or drug or biotechnology, no matter how nefarious, is protected from liability under the umbrella of COVID-19.

 
 

Messenger RNA

 

This mRNA experimental synthetic pathogen carries mRNA genetic material from SARS-CoV-2 coronavirus into cells where that cellular machinery with the synthetic pathogen produces a protein to which the body mounts an immune response. In the case of COVID-19, inert spike (S) antigen proteins are produced. This then enables SARS-CoV-2 coronavirus particles to enter host cells and triggers humoral (antibody-mediated) acquired immunity. So, what could possibly go wrong with bodily cells that are artificially programmed to produce foreign viral proteins to which the immune system is going mount an immune response? Well, that biochemical reaction could create an autoimmune reaction. As this mRNA platform has never been used in humans before, the potential for this to go wrong and elicit widespread autoimmune diseases and deaths is enormous.

 

Pfizer, Moderna, Dr. Anthony Fauci, and Dr. Soumya Swaminathan, the WHO’s chief scientist, have now made it abundantly clear that the novel mRNA strand entering the cell is not intended to stop transmission but rather as a treatment. However, America’s Frontline Doctors and numerous other doctors have been censored from public discourse on the profoundly viable and formerly ubiquitous treatments such as hydroxychloroquine, ivermectin, zinc, vitamin C, and vitamin D3. If these effective treatments had not been denied us, both in access and scientific data, but disseminated to the global community, we might not have needed an ‘emergency use’ technology at all. Bear in mind for FDA to issue an emergency use authorization, there must be no adequate, approved, and available alternative to the candidate product for diagnosing, preventing, or treating the disease or condition. Could this be why these available and effective alternative products are constantly censored in the media and social media?

 

Antibodies and Vaccines

 

To understand how vaccines create immune responses it is necessary to briefly clarify and review the function of antibodies and both the adaptive and innate immune system. Antibodies, also known as immunoglobulins (Ig), are specialized proteins that bind to a uniquely shaped object – called an antigen – that is found on the surface of a pathogen. These pathogens can be things such as bacteria or viruses. Antibodies are produced by B lymphocytes, known as B cells, which are specialized white blood cells of the immune system. B cells have antibodies on their cell surface that allow them to recognize anything foreign. When they encounter a pathogen such as a virus, the B cells transform into plasma cells, which start producing antibodies that are designed to bind to an antigen that is specific to that pathogen.

 

B-plasma cells release large amounts of antibodies into the body’s circulation. This protects us in two main ways. First, antibodies can bind to antigens on the outside of the pathogen to stop it from entering our cells. This is particularly important for viruses, which enter human cells to replicate. Second, by binding to antigens on the pathogen, antibodies also signal other white blood cells known as phagocytic cells, which engulf and destroy the pathogen. So, in short, antibodies can both neutralize a virus and mark it for destruction.

 

Antibodies form part of our adaptive immune response, which is a refined, targeted response to a specific antigen. The first time we encounter a virus, some of our B cells become plasma cells, but others transform into memory B cells. The second time you are exposed to the same pathogen, these memory cells quickly transform into plasma cells that produce large amounts of antigen-specific antibodies to fight the infection.

 

There are many types of antibodies, each with different purposes, which are created in response to chemical signals. Different B cells in the body will produce multiple different antibodies that bind to different sites, but only binding to some of these sites will inactivate the virus. For a vaccine to work, it must produce a binding or neutralizing antibody. It is never certain that a vaccine will produce neutralizing antibodies. One important difference in antibodies produced from vaccines and antibodies from natural infections is that the immune system does not form as many different types of antibodies from a vaccination as it would in the course of a natural infection. Thus, natural infection often protects the individual for life, whereas artificial infection from a vaccine usually requires repeated boosters to maintain antibody levels.

 

However, in some circumstances, the binding of an antibody might worsen an infection. For example, antibodies might bind to a virus in such a way that helps the virus enter cells more easily. This might mean that a person re-infected after an initial mild infection might then have a more severe disease. Or it might mean that a person could have a worse response to a potential infection (like with COVID-19) if they have previously been vaccinated for the disease. This scenario has been called “antibody-dependent enhancement” (ADE) and will be discussed later in this article.

 

Three main types of antibodies are produced in response to infection: IgA, IgG, and IgM. IgM rises soonest and typically declines after infection. IgG and IgA persist and usually reflect longer-term immune responses. The detection of IgM antibodies is sometimes used as a test for recent infection. For example, an IgM antibody is commonly used to check for recent coronavirus infection. A particularly important type is IgG antibodies, which tend to be more long-lived than IgM antibodies. This subtype of antibodies is critical not just for controlling the initial disease but for preventing future disease if you are later re-exposed. It is observed that IgM levels increased during the first week after SARS-CoV-2 infection, peak 2 weeks later, and then they are reduced to near-background levels in most patients. IgG has been detectable after 1 week and may be maintained at a high level for a long period.

 

Some people make many high-quality antibodies that are good at recognizing the relevant antigen and binding to it. If this happens, the virus is rapidly bound by antibodies and eliminated before it can even cause an infection. Other people make antibodies, but they are not as effective at binding the pathogen. In this situation, the antibodies only provide partial protection at best. Then there are also those people who either produce little or no antibodies or poor-quality antibodies. Generally, many elderly fall into this category. In this case, vaccine immunity is not so effective, so they may experience a prolonged infection with more severe symptoms. They are also likely to be re-infected at a later point in time. This is part of the reason vaccines do not always confer immunity or confer only partial immunity for a limited period.

 

The adaptive immune system involves more than just B cells, plasma cells, and antibodies – it also includes T cells. T cells are another population of white blood cells that can develop into memory cells, just as B cells can. They can also differentiate into specialized cells that kill virus-infected cells. The functions of T cells and B cells are different. B cells develop into plasma cells that produce antibodies (T cells do not); T cells directly kill virus-infected cells (B cells do not). Sometimes individuals with a very vigorous T cell immune response will be protected from a pathogen even though they produce low amounts of antibody. The T cell immune response is much more difficult to measure than the antibody response and is usually only evaluated in a specialized laboratory or research setting. Our adaptive immune response is important because once developed, it is highly specific for the pathogen and provides us with immunologic memory.

 

We also have another type of immune system known as the innate immune system. The innate immune system is our frontline defense, the first system to respond to a new infection. This includes cells such as neutrophils, macrophages, and dendritic cells. Unlike the adaptive immune system, which includes antigen-specific antibodies that take time to develop, the innate immune system responds to antigens very quickly but in a non-specific way. It attacks anything that “looks” foreign to the body, like components of a bacterial cell wall, or viral RNA and DNA. Quite often, the innate immune response will take care of an infection before the adaptive immune system even has a chance to start manufacturing antibodies.

 

SARS-CoV-2 Antibody Blood Test

 

Many people are now taking the COVID-19 antibody blood test. This immune response test detects the immune proteins or antibodies that the body produces in response to the virus. It does not detect the virus itself; thus, an antibody test does not determine whether you are currently infected with the COVID-19 virus. Antibody testing is best undertaken at least two weeks after the onset of symptoms. Because SARS-CoV-2 belongs to a large family of coronaviruses, the test may inadvertently detect the antibody of related coronavirus strains (such as the HKU1, NL63, OC43, or 229E strains) and trigger a false-positive reading. False-negatives are even more common with SARS-CoV-2 antibody tests, due in part to the variable sensitivities of the tests. The sensitivity and specificity of antibody tests vary over time and results should be interpreted in the context of clinical history. Compared to venous blood tests, rapid finger-stick tests tend to be less reliable and more likely to return a false-negative result. In short, the evidence is currently insufficient to know whether individuals with SARS-CoV-2 antibodies have protective immunity.

 

Current SARS-CoV-2 ‘Vaccines’

 

At the time of this writing, there are 2 experimental mRNA SARS-CoV-2vaccines’ publicly available, one by Pfizer/BioNTech the other from Moderna, and one viral vector vaccine by Johnson and Johnson. As previously mentioned, mRNA-based ‘vaccines’ have never before been used on humans and these two are still not FDA licensed for human use, though they have been made publicly available through Emergency Use Authorization. These mRNA formulas contain a synthetic sequence of messenger RNA that is concealed within a patented lipid nanoparticle delivery system. After entering cellular ribosomes (that house the transcription machinery of the cells) of the muscle cells into which the synthetic pathogenic mRNA is injected, it then instructs cells to produce a copy of the spike protein of the virus. In essence, it means that the human body becomes the vaccine factory of the protein. This process is genetic engineering. Even more concerning, is that these synthetic pathogen devices place a novel molecule, spike protein, in/on the surface of host cells. This spike protein then becomes a potential receptor for another possibly novel pathogenic infectious agent.

 

Recently the Janssen Vaccines, a subsidiary of Johnson and Johnson has also received FDA Emergency Use Authorization for the company’s single-shot COVID-19 vaccine for adults 18 and older. Thus, it is now the third vaccine available in the U.S. This vaccine is based on an adenovirus vector Ad26 (not a mRNA vaccine like Pfizer or Moderna). Ad26.COV2.S expresses the full-length spike protein, stabilized by furin cleavage site mutations and two consecutive proline stabilizing mutations in the hinge region. It contains the wild-type signal peptide. The science behind recombinant adenoviral vector vaccines has been around for a long time, but the only commercially available adenovirus-based vaccine is a rabies vaccine for animals. Viral vector vaccines are more of a conventional vaccine platform, unlike mRNA vaccines. Viral vector vaccine work by carrying a DNA express or antigen(s) into host cells, thereby eliciting cell-mediated immunity in addition to the humoral immune responses. Adenovirus-based vaccines may also pose some problems in that the adenovirus is so common that the vaccine may not be as effective once booster doses are given, or that some people may already have immunity to the virus used in the vaccine. Additionally, incorporating a spike protein into the viral vector vaccine potentially creates this protein receptor to attract another novel pathogenic infectious agent.

 

Another frontrunner is the non-replicating viral vector vaccine by the AstraZeneca/Oxford University group. This also employs a genetically modified (non-replicating) chimpanzee viral vector vaccine, now designated AZD1222. The AstraZeneca/Oxford’s vaccine instead of utilizing a human adenovirus in its vaccine uses a genetically modified chimpanzee-derived adenovirus that encodes the spike protein of Middle East respiratory syndrome coronavirus (MERS-CoV).

 

According to the recent World Health Organization’s Draft landscape of COVID-19 candidate vaccines, there are currently 64 candidate vaccines in clinical development with a further 173 in pre-clinical development, these relying on 8 different vaccine platforms in addition to the two already relied on by the 3 frontrunners. Most (31%) rely on the more conventional protein subunit platform that has been widely used for seasonal influenza vaccines.

 

This article will continue to focus on mRNA vaccines, not viral vector vaccines.

 

SARS-CoV-2 Autoimmunity and Inflammatory Cytokines

 

Autoimmune disease occurs when the body’s immune system cannot discern the difference between its cells and foreign cells, and in turn, this causes the body to attack its normal cells. Simply speaking, in autoimmunity the patient’s immune system is activated against the body’s proteins. Molecular mimicry is an antigenic similarity between molecules found on some disease- causing microorganisms and specific previously healthy body cells or tissues. In short, molecular mimicry occurs when a pathogen expresses a protein that is remarkably similar in sequence or shape to a protein in the host. It has been suggested that molecular mimicry may contribute to a potential adverse reaction to the SARS-CoV-2 mRNA shot. Thus, antibodies to SARS-CoV-2 cross-reacting with structurally similar host protein sequences and raising an acute autoimmune response against them.

 

Cytokines are the hormonal messengers responsible for many of the biological effects in the immune system, such as cell-mediated immunity and allergic-type responses. Although they are numerous, cytokines can be functionally divided into two groups: those that are proinflammatory and those that are essentially anti-inflammatory but that promote allergic responses. As previously discussed, T cell lymphocytes play a central role in the adaptive immune response. T lymphocytes are also a major source of cytokines. These cells bear antigen-specific receptors on their cell surface to allow recognition of foreign pathogens. They can also recognize normal tissue during episodes of autoimmune diseases. There are two main subsets of T lymphocytes, distinguished by the presence of cell surface molecules known as CD4 and CD8. T lymphocytes expressing CD4 are also known as helper T cells, and these are regarded as being the most prolific cytokine producers. This subset can be further subdivided into Th1 and Th2, and the cytokines they produce are known as Th1-type cytokines and Th2-type cytokines.

 

Th1 or Th2 differ in a few important ways. The most apparent difference is that Th1 cytokines are produced by Th1 helper cells, as opposed to Th2 helper cells. Whether an attacking virus or bacteria invades inside or outside of cells is also important, as intracellular invaders tend to trigger Th1 cytokine responses, while outside agents call upon Th2 cytokine responses. As such, Th1 cytokines activate white blood cells called macrophages inside of tissues. In contrast, Th2 cytokines activate antibodies in what is known as a humoral immune response, and this type of response will most likely occur when the concentration of an invading substance (virus) is high.

 

Th1-type cytokines tend to produce the pro-inflammatory responses responsible for killing microorganisms and for perpetuating autoimmune responses. Interferon-gamma is the main Th1 cytokine. Excessive pro-inflammatory responses can lead to uncontrolled tissue damage, so there needs to be a mechanism to counteract this. The Th2-type cytokines include interleukins 4, 5, and 13, which are associated with the promotion of IgE and eosinophilic responses. Over-expression of IL-5 significantly increases eosinophil numbers and antibody levels. It has been proposed that IL-5 be used as a biomarker for antibody-dependent enhancement or pathogenic priming.

 

Regulatory T-cells (formerly called suppressor T cells) are a component of the immune system that suppresses the immune responses of other cells. Th1 assists in the activation of these regulatory T-cells which are meant to slow down B-cells and cytotoxic T-cells. If the regulatory T-cells are malfunctioning or deficient due to a decrease in Th1, the cytotoxic T-cells may take over and start killing healthy cells (autoimmune). This leads to increased immune stimulation, followed by an inflammatory cytokine storm and potential for autoimmune disorders. It is observed that some people find themselves with an autoimmune condition after a traumatic event or stressful event (e.g., a parent or sibling passing away). The physiological stress response caused Th1 to decrease, which lead to Th2 dominance.

 

Additionally, excess Th2 responses will counteract the Th1 mediated microbicidal action. The optimal scenario would therefore seem to be that humans should produce a well-balanced Th1 and Th2 response, suited to the immune challenge. Unfortunately, vaccines being an artificial induced immune response, historically have been implicated in creating an imbalance in this Th1 and Th2 response, resulting in pro-inflammatory Th2-type cytokines.

 

In chronic inflammatory autoimmune diseases, white cells such as neutrophils and other leukocytes are constitutively recruited by these proinflammatory cytokines and chemokines, resulting in tissue damage. This inflammatory reaction is called a ‘cytokine storm’. It is an overreaction of the immune system, in which an excess of certain proinflammatory cytokines trigger an onslaught of white blood cells that attack an area or organ of the body resulting in tissue damage, and in extreme cases, organ failure. An example of a cytokine storm in the lungs of a COVID-19 patient can draw inflammatory causing white blood cells into the spaces between air sacs, blocking oxygen from reaching the blood, which can prove fatal. Both genetic and environmental factors are thought to contribute both to the severity of viral infections and in determining who potentially develops an autoimmune condition.

 

Thus, it is observed that severe/fatal cases of COVID-19 are associated with immune hyperactivation and excessive cytokine release, leading to multiorgan failure. A broad range of mechanisms appears to be involved. However, it has been suggested that ‘molecular mimicry’ may contribute to this problem, with antibodies to SARS-CoV-2 spike glycoproteins cross-reacting with structurally similar host heptapeptide protein sequences (for example, in interleukin-7 and alveolar surfactant proteins), and raising an acute autoimmune response against them.1 Auto-inflammatory dysregulation in genetically susceptible individuals might also contribute to acute but also chronic autoimmunity during and after COVID-19.2

 

Though the exact etiology of many autoimmune diseases remain unknown, various factors are believed to contribute to the emergence of autoimmune disease in people including the genetic predisposition, corruption of the internal milieu resulting in microbe triggers such as bacterial, viral, fungal, and parasitic infections, including imbalances of the gut microbiota (dysbiosis of the intestinal microbiome), as well as numerous toxicological environmental agents, hormonal factors, and the host’s immune system dysregulation. All these factors interplay was coined by Shoenfeld et al., many years ago in “The Mosaic of Autoimmunity.”3

 

Certain viruses have long been implicated in the initiation of chronic inflammatory or autoimmune diseases such as rheumatoid arthritis, systemic lupus erythematosus, Sjogren’s syndrome, multiple sclerosis, polymyositis, uveitis, Henoch–Schönlein purpura, systemic juvenile idiopathic arthritis, and others.4 In May 2020 a German study entitled “COVID-19-induced acute respiratory failure: an exacerbation of organ-specific autoimmunity?”, examined a group of 22 patients for the possible role of autoimmunity in SARS-CoV-2 -associated respiratory failure. Based on serological, radiological, and histomorphology similarities between Covid-19-associated ARDS and acute exacerbation of connective tissue disease-induced interstitial lung disease, the authors suggest that SARS-CoV-2 infection might trigger or simulate a form of organ-specific autoimmunity in predisposed patients.5 In a similar retrospective study from China of 21 patients with critical SARS-CoV-2 pneumonia, the authors showed a prevalence of between 20 and 50% of autoimmune disease-related autoantibodies.6

 

Autopsies of Chinese citizens who have died from COVID-19 following SARS-CoV-19 infection show evidence of lung interstitial changes, suggesting the development of pulmonary fibrosis. This suggests, at least partly, an autoimmunology basis of the pathogenesis of COVID-19.

 

Vaccine Autoimmunity

 

In the past few decades, the study of autoimmune biology, the failure to recognize self-antigens as “self”, has grown immensely. One in five Americans has an autoimmune condition. Vaccines, particularly viral vaccines, have been observed playing a role in inducing autoimmune disease for a long time. Autoimmune reactions are among the most serious adverse events observed in vaccines. An example is Guillain-Barré syndrome (GBS), an autoimmune polyneuropathy. GBS has been attributed to certain vaccinations, particularly, with monovalent or combination measles, mumps, and rubella vaccines, influenza vaccine, oral polio vaccine, diphtheria, and tetanus toxoids. GBS has also been associated with the 1976 swine-influenza vaccine. 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 Some studies have shown an increased risk of GBS following receipt of seasonal H1N1 monovalent influenza vaccines.17,18 Bear in mind GBS is not the only autoimmune disease that has been documented as an adverse reaction to vaccination.

 

Vaccine autoimmunity reactions occur from several causes. One explanation is that they may be induced via “molecular mimicry”, and often, in specific families who happen to have a genomic mutation that makes one of their proteins more like the protein in the vaccine. It appears that in addition to molecular mimicry there are other mechanisms by which this SARS-CoV-2 mRNA “vaccine” could induce a hyperinflammatory autoimmune syndrome. One of the most documented is ‘pathogenic priming’ or ‘disease enhancement’, euphemistically called in literature ‘antibody-dependent enhancement or ADE’.

 

Pathogenic priming or disease enhancement occurs after vaccination or when an infection a person can experience more serious, enhanced disease when later being exposed to the pathogen against which that the vaccine was intended to protect. When the enhancement is specifically related to a vaccine, it is sometimes called vaccine-associated hypersensitivity (VAH). Pathogenic priming or disease enhancement has been demonstrated in SARS-CoV infection years ago, mediated by antibodies directed to the envelope spike proteins.19 Thus, a simple definition of pathogenic priming or ADE is increasing specific antibodies that do not protect, but instead, make a viral infection even worse. This unwanted antibody reaction has long been a thorn in the side of vaccine manufacturers. There are “neutralizing” antibodies as opposed to non-neutralizing ones – a neutralizing antibody, as the name implies, binds to its target in a way that shuts its function down. That is generally done by blocking the receptor of a given protein target or smothering the binding surface that it would need to function. For the coronavirus, a straightforward example of a neutralizing antibody would be one that binds to the tip of the spike protein, the receptor-binding domain that is the part that recognizes and binds to the human ACE2 protein on a cell surface. Block that thoroughly enough, and it would follow that you have blocked the virus’s ability to infect your cells.

 

More technically, in antibody-mediated viral neutralization, neutralizing antibodies binding to the receptor-binding domain of the viral spike protein, as well as other domains, prevent the virus from docking onto its entry receptor, ACE2. In antibody-dependent enhancement, low quality, low quantity, non-neutralizing antibodies bind to virus particles through the antigen-binding fragment or Fab domains. Fc receptors (FcRs) expressed on monocytes or macrophages bind to Fc domains of antibodies and facilitate viral entry and infection. (An Fc receptor is a protein found on the surface of certain cells – including, among others, B lymphocytes, follicular dendritic cells, natural killer cells, macrophages, neutrophils, eosinophils, basophils, human platelets, and mast cells – that contribute to the protective functions of the immune system.) Upon engagement by the Fc domains on antibodies, activating FcRs with ITAMs initiate signaling to upregulate pro-inflammatory cytokines and downregulate anti-inflammatory cytokines. This causes what is commonly described as a cytokine storm. Immune complexes and viral RNA in the endosomes can signal through Toll-like receptor 3 (TLR3), TLR7, and/or TLR8 to activate host cells, resulting in immunopathology.

 

(ITAM is an immunoreceptor tyrosine-based activation motif. A conserved sequence of four amino acids repeated twice in the cytoplasmic tails of non-catalytic tyrosine-phosphorylated receptors, cell-surface proteins found mainly on immune cells. Its major role is being an integral component for the initiation of a variety of signaling pathways and subsequently the activation of immune cells, although different functions have been described, for example, an osteoclast maturation.)

 

Thus, the concern about disease enhancement or ADE arises from the possibility that antibodies present at the time of infection may increase the severity of an illness. Uptake of SARS-CoV through ADE in macrophages led to elevated production of TNF and IL-6.20

 

In mice infected with SARS-CoV, ADE was associated with decreased levels of the anti-inflammatory cytokines IL-10 and TGFβ and increased levels of the pro-inflammatory chemokines CCL2 and CCL3. 21

 

Furthermore, immunization of non-human primates with a modified vaccinia Ankara (MVA) virus encoding the full-length S protein of SARS-CoV promoted activation of alveolar macrophages, leading to acute lung injury.22

 

The enhancement of disease by ADE or pathogenic priming has been described clinically in several studies such as children given formalin-inactivated respiratory syncytial virus (RSV) or measles vaccines in the 1960s, and in dengue hemorrhagic fever due to secondary infection with a heterologous dengue serotype.23, 24, 25, 26

 

ADE is a primary reason why vaccines for SARS-1 and MERS, were not previously manufactured commercially. Early researchers concluded coronavirus vaccines were too dangerous to proceed to human studies, as demonstrated in animal studies and were no longer necessary because SARS and MERS had waned naturally.

 

For example, previous vaccine studies in mice, with several whole-inactivated SARS-CoV candidates (with and without aluminum adjuvants) reduced lung viral titer and/or mortality upon viral challenge, but at the same time induced increased lung immunopathology in the form of eosinophilic infiltration (i.e., unusual presence of eosinophilic cells in the lung tissue) upon infection.27, 28, 29 Importantly, one study showed that in older mice, protection was lower and eosinophilic immune infiltration was exacerbated as compared to younger mice.30 Similarly, an inactivated MERS-CoV vaccine in aluminum adjuvant resulted in the production of neutralizing antibody and reduced lung viral titers (upon viral challenge), but induced increased eosinophil infiltration upon homologous coronavirus challenge, despite reducing lung viral titer and/or mortality.31

 

There has been expressed by many doctors a genuine concern over the risk of pathogenic priming or ADE with these new experimental viral mRNA synthetic pathogen platforms. The results from the fast-tracked human trials and subsequent emergency authorization are not sufficient to rigorously evaluate their true potential risk. The fact that only hundreds (not tens of thousands) of people for each vaccine who have been vaccinated have also been exposed to wild SARS-CoV-2 is not adequate to know if sub-groups of people could be susceptible to disease enhancement following exposure to the virus.

 

These concerns are sufficient enough for Drs Anne Arvin, Herbert Virgin, and colleagues from Vir Biotechnology in San Francisco and Stanford, writing in one of the world’s most prestigious journals, Nature, to have stated in July 2020 that ADE is “…a general concern for the development of vaccines and antibody therapies because the mechanisms that underlie antibody protection against any virus have a theoretical potential to amplify the infection or trigger harmful immunopathology. This possibility requires careful consideration at this critical point in the pandemic of coronavirus disease 2019”.32

 

Another concerned voice is, J. Patrick Whelan, MD, PhD, a pediatric rheumatologist, who has warned the FDA about the potential for mRNA vaccines designed to create immunity to the SARS-CoV-2 spike protein to instead cause injuries. Whelan’s training (at Harvard, Texas Children’s Hospital and Baylor College of Medicine) includes degrees in biochemistry, medicine, and rheumatology. For 20 years, he worked as a pediatric rheumatologist. Whelan warned that a recently infected patient who is subject to covid-19 vaccination is likely to suffer from autoimmune attacks along the ACE-2 receptors present in the heart, and in the microvasculature of the brain, liver, and kidney. The risk is doubled because two shots are required.

 

It is a well-documented fact that SARS-CoV-2 readily targets humans through the vascular endothelium. The virus is known to enter endothelial cells through the ACE-2 receptor on the endothelium. Because of this unique gain-of-function, one of the medical emergencies that may occur in covid-19 patients is thromboembolic complications (formation of a blood clot inside a blood vessel). If viral antigens are present in the endothelial lining of blood vessels, then the vaccine will cause an antigen-specific immune response that attacks those precious tissues, potentially causing cardiovascular events. Research warns that the vaccine may damage the vascular endothelium, especially in the elderly. Dr. Whelan claims that vaccine-induced endothelial inflammation is “certain to cause blood clot formation with the potential for major thromboembolic complications in a subset of such patients. The potential to cause microvascular injury (inflammation and small blood clots called microthrombi) to the brain, heart, liver and kidney … were not assessed in the safety trials.”

 

An essential stage in any vaccine licensing process should involve a careful analysis for potential of ADE/pathogenic priming, yet in the political and socioeconomic rush towards mass ‘vaccination’ this has been skipped as no longer-term safety testing has been conducted. At a minimum laboratory assessment of interleukin-5 should have been conducted in the human test trials to determine any evidence of eosinophilia autoimmune responses or pathogenic priming.

 

Current Adverse Reactions

 

Worldwide there have now been hundreds of deaths and thousands of serious adverse reactions reported after receiving the viral mRNA injection. The Vaccine Adverse Event Reporting System (VAERS), a co-managed program by the CDC and FDA, has accumulated an extensive list of these adverse reactions here in the U.S.

 

As of Feb. 12th, 929 deaths, 616 life-threatening adverse events, 316 cases of permanent disability, and more than 5,000 hospitalizations and emergency room visits after COVID vaccinations were reported to VAERS. 33 Fifty-three percent of those who died were male, forty-four percent were female, the remaining death reports did not include the gender of the deceased. The average age of those who died was 77, the youngest was a 23-year-old. The Pfizer shot was taken by 58% of those who died, while the Moderna shot was taken by 41%. As of February 4th, there had been 163 cases of Bell’s Palsy reported and 775 reports of anaphylaxis.34

 

According to the CDC VAERS website, “VAERS reports alone cannot be used to determine if a vaccine caused or contributed to an adverse event or illness.” Rather, it is considered to be a tool for detecting “signals” or patterns of significant problems with vaccines. While the VAERS database numbers are sobering, according to a U.S. Department of Health and Human Services study,35 the actual number of adverse events is likely significantly higher. VAERS is a passive surveillance system that relies on the willingness of individuals and professionals to submit reports voluntarily. Thus, we really do not know the full extent of adverse reactions to these products. Globally there are reports of hundreds of nursing home residents dying immediately of a day or two after the shot.

 

The medical establishment and its controlled media networks are downplaying the numerous severe adverse events caused by these mRNA products, either calling them coincidental, blaming them on a new viral variant, or claiming their “rare” occurrence is from the toxic additive known as polyethylene glycol (PEG). Though PEG reaction is real and widespread, the experimental mRNA synthetic pathogen technology will probably prove to be the real culprit.

 

Both the Moderna and Pfizer-BioNTech mRNA product contains polyethylene glycol. To be clear, we know that PEG is harmful and should not be injected into humans. It has never been used in other vaccines to date. Growing evidence suggests that a large percentage of people can generate allergic immune responses to PEG-modified therapeutics. The presence of anti-PEG antibodies has been associated with anaphylactic or hypersensitivity reactions after the administration of PEG- containing formulation.36, 37, 38.

 

A 2016 study reported an astonishing 72% of specimens possessed anti-PEG antibodies with 8% of those being extremely elevated more than 500 ng/mL. The authors concluded that the widespread prevalence of pre-existing anti-PEG antibodies underscores the importance of screening patients for anti-PEG Ab levels before the administration of PEG-containing products.39

 

In contrast to the popular assumption that PEG is biologically inert, PEG is both immunogenic and antigenic. While PEGylation of therapeutic agents have shown and will continue to show, a great value in medicine to address toxicity, immunogenicity, and rapid clearance of an unconjugated drug while maintaining efficacy in the treatment of many diseases, it is possible that a subset of patients with anti-PEG may not benefit from treatment with PEG-conjugated agents.

 

The PEG delivery system allows the mRNA spike protein to be expressed by any cell not just the cells with entry receptors like the wild-type viral sequence. Afterward the cell goes through programmed cell death. One question is what happens when cells like dopaminergic neurons go through this process and die? Instant Parkinson’s?

 

Conclusion

 

Currently, Pfizer/BioNTech and Moderna mRNA products have been approved by the FDA under an Emergency Use Authorization (EUA) but are still FDA unlicensed biologicals. This mRNA technology is being labeled as ‘vaccines’, when by legal definition they are viral mRNA synthetic-pathogen devices. These experimental products are presently being distributed to millions and eventually potentially billions of people worldwide. Both products were expedited or “fast-tracked” through human trials and have not had adequate evaluation or surveillance for any long-term side effects. The historic timeline for taking a vaccine from concept to licensed product is estimated at 10–15 years, though some licensed vaccines have taken up to 30 years.40

 

This extended timeline is due largely to the stringent pre-clinical and clinical testing that is required of human vaccine candidates. The extremely short duration human trials of these experimental products are unprecedented, and their performance and safety profiles are still largely unknown. The profit-motivated rush to deploy mRNA vaccines for treatment of the Wuhan coronavirus has caused regulators and researchers to skip (or accelerate) many critical steps in quality control and clinical trials.

 

Remembering that previous efforts to develop vaccines against human coronaviruses have faced challenges, with several preclinical studies demonstrating disease enhancement and death in vaccinated animals after viral challenge. This was characterized by eosinophilic infiltrates resulting in immunopathology, after the induction of a T helper cell type 2 (Th2)-biased response, or a weak neutralizing antibody response that might contribute to antibody-dependent enhancement of infection.41

 

Analyzing the induction of immune responses after vaccination is driven, in part, by concerns about enhanced disease from potentially immunopathologic Th2 responses, as seen in animal studies of vaccines against other coronaviruses.42, 43, 44, 45

 

Hence, one of the side effects of giving a mass vaccine could be an emergence of an epidemic of autoimmune diseases, especially in individuals who are genetically prone to autoimmunity. After many years, and considerable attention, the understanding of pathogenic priming or ADE of disease after vaccination is insufficient to confidently predict that a given immune intervention for a viral infection will not have certain negative and grave outcomes in humans.

 

The remaining elephant in the room is that of the greatest unknown, of tampering with the human genome. The possibility that synthetic viral mRNA fragments might, through some currently unknown process, permanently alter the genome of the host. mRNA ‘vaccine’ manufacturers currently claim this is impossible, but the history of medicine is full of examples of arrogant scientists making catastrophic assumptions about the human body that turned out to be overly optimistic. Using viral mRNA to create proteins has unknown long-term consequences. There is much we have yet to comprehend of the complexity of the human body and immune system. RNA expresses proteins but it has many other functions, specifically as an epigenetic modifier. RNA can modify genetics without being reverse transcribed into DNA.46 RNA has multiple mechanisms of modifying DNA expression including modifying DNA promoter regions.47 In short, the viral pathogen mRNA technology being used has many unknown long-term effects on the human genome.

 

If this human experiment does prove to cause adverse problems in time, it will already have been administered to millions worldwide and will be too late. This synthetic pathogenic genetic engineering cannot be removed, and it cannot be turned off. It will have been irretrievably unleashed into the cellular system of humankind.

 

There are many other potential adverse events that can be induced by the experimental mRNA based ‘vaccines’ against COVID-19 undisclosed here. These synthetic pathogen devices place a novel molecule to create a spike protein, in/on the surface of host cells. This spike protein can become a potential receptor for another possibly novel pathogenic infectious agent. Data is not publicly available to provide information on how long the mRNA is translated in the vaccine recipient and how long after translation the spike protein will be present in the recipient’s cells. Forever? What is done here genetically cannot be undone. Genetic diversity protects species from mass casualties caused by infectious agents. One individual may be killed by a virus while another may have no ill effects from the same virus. By placing the identical receptor, the spike protein, on cells of everyone in a population, the genetic diversity for at least one potential receptor disappears. Everyone in the population now becomes potentially susceptible to binding with the same infectious agent.

 

Research into mRNA vaccines is still in its infancy, even though various biotech pioneers have been working on ways to achieve mRNA vaccines for around two decades. Yet more decades of research will likely be required to achieve acceptable levels of safety and efficacy. Unfortunately, we have become the test animal.

 

For manufacturers mRNA “vaccines” offer economic advantages over traditional vaccines. They are cheaper and faster to manufacture. They typically require no adjuvants or other toxic additives to work as intended (aside from the potentially antigenic and toxic lipids that envelope the naked mRNA). Furthermore, they can direct the body to manufacture almost any protein imaginable. That is how it works in theory, of course.

 

But they also present enormous risks of which the results could be catastrophic and irreparable. mRNA “vaccines” could inadvertently trick the human body into attacking its critical functions such as fertility, neurological function, cell repair, and other indispensable processes. Additionally, mRNA “vaccines” could be maliciously exploited to weaponize vaccines to target essential physiological functions in humans. This is similar in effect to “RNA interference” technology which is a gene suppressing innovation that has been studied for use as an insect-killing pesticide technology in crops. Although the mechanisms of mRNA vaccines and RNA interference technology are vastly different, they can achieve many of the same outcomes such as induced infertility or death in targeted organisms, which could include humans. Technically, this could also be exploited to target specific genetic subgroups of humans – the elderly.

 

Any COVID ‘vaccine(s)’ approved for emergency use should be voluntary, since the ‘vaccine(s)’ are considered investigational and are held to a much lower standard for both efficacy and safety. For example, compared to the non-emergency approval process to get full licensure, an emergency approval allows for a vaccine that “may” be effective, compared to the non-emergency approval process where a vaccine must demonstrate “substantial” effectiveness. Emergency Use Authorization (EUA) law is clear: States are barred from mandating a vaccine approved for emergency usage. (See Section VI. Preemption.) It also should be illegal for private businesses, airlines, or your employer to mandate a vaccination while it is approved under a EUA.

 

Lastly, the manufacturers have been exempted from any liability that they may inflict on the public. In February, Health and Human Services Secretary Alex Azar invoked the Public Readiness and Emergency Preparedness Act. The 2005 law empowers the HHS secretary to provide legal protection to companies making or distributing critical medical supplies, such as vaccines and treatments unless there’s “willful misconduct” by the company. The protection lasts until 2024. That means that for the next four years, these companies “cannot be sued for money damages in court” over injuries related to the administration or use of products to treat or protect against SARS-CoV. Thus, there is not a manufacturer nor government in the world that will be held financially accountable when people succumb to grave harm.

References

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2. Caso F, Costa L, Ruscitti P. Could Sars-coronavirus-2 trigger autoimmune and / or autoinflammatory mechanisms in genetically predisposed subjects? Autoimmune Rev 2020;19:102524. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7271072/

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4. COHEN, ARNON DOV, and YEHUDA SHOENFELD. “The viral-autoimmunity relationship.” Viral immunology 8, no. 1 (1995): 1-9. https://www.liebertpub.com/doi/abs/10.1089/vim.1995.8.1?journalCode=vim

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6. Zhou, Yaqing, Tao Han, Jiaxin Chen, Can Hou, Lei Hua, Shu He, Yi Guo et al. “Clinical and Autoimmune Characteristics of Severe and Critical Cases of COVID‐19.” Clinical and Translational Science (2020). https://ascpt.onlinelibrary.wiley.com/doi/pdf/10.1111/cts.12805

7. Grose, Charles, and Ilya Spigland. “Guillain-Barré syndrome following administration of live measles vaccine.” The American journal of medicine 60, no. 3 (1976): 441-443. https://www.sciencedirect.com/science/article/abs/pii/0002934376907622

8. Schonberger, Lawrence B., Dennis J. Bregman, John Z. Sullivan-Bolyai, Richard A. Keenlyside, Donald W. Ziegler, Henry F. Retailliau, Donald L. Eddins, and John A. Bryan. “Guillain-Barré syndrome following vaccination in the national influenza immunization program, United States, 1976–1977.” American journal of epidemiology 110, no. 2 (1979): 105-123. https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.903.366&rep=rep1&type=pdf

9. Haber, Penina, Frank DeStefano, Fredrick J. Angulo, John Iskander, Sean V. Shadomy, Eric Weintraub, and Robert T. Chen. “Guillain-Barré syndrome following influenza vaccination.” Jama 292, no. 20 (2004): 2478-2481. https://jamanetwork.com/journals/jama/fullarticle/199859

10. Baxter, Roger, Ned Lewis, Nandini Bakshi, Claudia Vellozzi, Nicola P. Klein, and CISA Network. “Recurrent Guillain-Barre syndrome following vaccination.” Clinical infectious diseases 54, no. 6 (2012): 800-804. https://academic.oup.com/cid/article/54/6/800/290493?fbclid=IwAR3sAcwhLS-WMjPn8DyBGSPxtqbGJHTHGrnP4io9nYVroZQG5t0sJHtcMNc

11. Vellozzi, Claudia, Shahed Iqbal, and Karen Broder. “Guillain-Barre syndrome, influenza, and influenza vaccination: the epidemiologic evidence.” Clinical infectious diseases 58, no. 8 (2014): 1149-1155.

12. Haber, Penina, James Sejvar, Yann Mikaeloff, and Frank DeStefano. “Vaccines and guillain-barre syndrome.” Drug Safety 32, no. 4 (2009): 309-323. https://link.springer.com/article/10.2165/00002018-200932040-00005

13. Chen, Yong, Jinlin Zhang, Xuhua Chu, Yuanling Xu, and Fubao Ma. “Vaccines and the risk of Guillain-Barré syndrome.” European journal of epidemiology 35, no. 4 (2020): 363-370. https://encephalitis.by/wp-content/uploads/2020/02/vaccines-and-the-risk-of-guillain-barr-syndrome-2019.pdf

14. Evans, David, Simon Cauchemez, and Frederick G. Hayden. ““Prepandemic” immunization for novel influenza viruses,“swine flu” vaccine, Guillain-Barre syndrome, and the detection of rare severe adverse events.” Journal of Infectious Diseases 200, no. 3 (2009): 321-328. https://academic.oup.com/jid/article/200/3/321/900101

15. Lehmann, Helmar C., Hans-Peter Hartung, Bernd C. Kieseier, and Richard AC Hughes. “Guillain-Barré syndrome after exposure to influenza virus.” The Lancet infectious diseases 10, no. 9 (2010): 643-651. https://www.sciencedirect.com/science/article/abs/pii/S1473309910701407

16. Schonberger, Lawrence B., Dennis J. Bregman, John Z. Sullivan-Bolyai, Richard A. Keenlyside, Donald W. Ziegler, Henry F. Retailliau, Donald L. Eddins, and John A. Bryan. “Guillain-Barré syndrome following vaccination in the national influenza immunization program, United States, 1976–1977.” American journal of epidemiology 110, no. 2 (1979): 105-123. https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.903.366&rep=rep1&type=pdf

17. Vellozzi, Claudia, Karen R. Broder, Penina Haber, Alice Guh, Michael Nguyen, Maria Cano, Paige Lewis et al. “Adverse events following influenza A (H1N1) 2009 monovalent vaccines reported to the Vaccine Adverse Event Reporting System, United States, October 1, 2009–January 31, 2010.” Vaccine 28, no. 45 (2010): 7248-7255. https://www.sciencedirect.com/science/article/pii/S0264410X10013319

18. Greene, Sharon K., Melisa Rett, Eric S. Weintraub, Lingling Li, Ruihua Yin, Anthony A. Amato, Doreen T. Ho et al. “Risk of confirmed Guillain-Barré syndrome following receipt of monovalent inactivated influenza A (H1N1) and seasonal influenza vaccines in the Vaccine Safety Datalink Project, 2009–2010.” American journal of epidemiology 175, no. 11 (2012): 1100-1109. https://academic.oup.com/aje/article/175/11/1100/140453

19. Wang, Sheng-Fan, Sung-Pin Tseng, Chia-Hung Yen, Jyh-Yuan Yang, Ching-Han Tsao, Chun-Wei Shen, Kuan-Hsuan Chen et al. “Antibody-dependent SARS coronavirus infection is mediated by antibodies against spike proteins.” Biochemical and biophysical research communications 451, no. 2 (2014): 208-214. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7092860/

20. Wang, Sheng-Fan, Sung-Pin Tseng, Chia-Hung Yen, Jyh-Yuan Yang, Ching-Han Tsao, Chun-Wei Shen, Kuan-Hsuan Chen et al. “Antibody-dependent SARS coronavirus infection is mediated by antibodies against spike proteins.” Biochemical and biophysical research communications 451, no. 2 (2014): 208-214. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7092860/

21. Yasui, Fumihiko, Chieko Kai, Masahiro Kitabatake, Shingo Inoue, Misako Yoneda, Shoji Yokochi, Ryoichi Kase et al. “Prior immunization with severe acute respiratory syndrome (SARS)-associated coronavirus (SARS-CoV) nucleocapsid protein causes severe pneumonia in mice infected with SARS-CoV.” The Journal of Immunology 181, no. 9 (2008): 6337-6348. https://www.jimmunol.org/content/jimmunol/181/9/6337.full.pdf

22. Liu, Li, Qiang Wei, Qingqing Lin, Jun Fang, Haibo Wang, Hauyee Kwok, Hangying Tang et al. “Anti–spike IgG causes severe acute lung injury by skewing macrophage responses during acute SARS-CoV infection.” JCI insight 4, no. 4 (2019). https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6478436/

23. Kim, Hyun Wha, JOSE G. CANCHOLA, CARL D. BRANDT, GLORIA PYLES, ROBERT M. CHANOCK, KEITH JENSEN, and ROBERT H. PARROTT. “Respiratory syncytial virus disease in infants despite prior administration of antigenic inactivated vaccine.” American journal of epidemiology 89, no. 4 (1969): 422-434. http://sa.uploads.ru/SU2xL.pdf

24. Polack, Fernando P., Scott J. Hoffman, Gonzalo Crujeiras, and Diane E. Griffin. “A role for nonprotective complement-fixing antibodies with low avidity for measles virus in atypical measles.” Nature medicine 9, no. 9 (2003): 1209-1213. https://www.nature.com/articles/nm918

25. Katzelnick, Leah C., Lionel Gresh, M. Elizabeth Halloran, Juan Carlos Mercado, Guillermina Kuan, Aubree Gordon, Angel Balmaseda, and Eva Harris. “Antibody-dependent enhancement of severe dengue disease in humans.” Science 358, no. 6365 (2017): 929-932. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5858873/

26. Guzman, Maria G., Mayling Alvarez, and Scott B. Halstead. “Secondary infection as a risk factor for dengue hemorrhagic fever/dengue shock syndrome: an historical perspective and role of antibody-dependent enhancement of infection.” Archives of virology 158, no. 7 (2013): 1445-1459. https://link.springer.com/article/10.1007%2Fs00705-013-1645-3

27. Iwasaki, Akiko, and Yexin Yang. “The potential danger of suboptimal antibody responses in COVID-19.” Nature Reviews Immunology 20, no. 6 (2020): 339-341. https://www.nature.com/articles/s41577-020-0321-6?fbclid=IwAR2OHhAhzFzJpqZOEI_ifMLBpihW-beWYoGQ0L4XJ5cDQRpleOQ5kQ9lH28

28. Honda-Okubo, Yoshikazu, Dale Barnard, Chun Hao Ong, Bi-Hung Peng, Chien-Te Kent Tseng, and Nikolai Petrovsky. “Severe acute respiratory syndrome-associated coronavirus vaccines formulated with delta inulin adjuvants provide enhanced protection while ameliorating lung eosinophilic immunopathology.” Journal of virology 89, no. 6 (2015): 2995-3007. https://jvi.asm.org/content/jvi/89/6/2995.full.pdf

29. Tseng, Chien-Te, Elena Sbrana, Naoko Iwata-Yoshikawa, Patrick C. Newman, Tania Garron, Robert L. Atmar, Clarence J. Peters, and Robert B. Couch. “Immunization with SARS coronavirus vaccines leads to pulmonary immunopathology on challenge with the SARS virus.” PloS one 7, no. 4 (2012): e35421. https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0035421&fbclid=IwAR2uGSe8kP-_ceHlnwMqM-H-MvUksEdg80MS5lCrAIGvne00B08bIScOn-M

30. Iwata-Yoshikawa, Naoko, Akihiko Uda, Tadaki Suzuki, Yasuko Tsunetsugu-Yokota, Yuko Sato, Shigeru Morikawa, Masato Tashiro, Tetsutaro Sata, Hideki Hasegawa, and Noriyo Nagata. “Effects of Toll-like receptor stimulation on eosinophilic infiltration in lungs of BALB/c mice immunized with UV-inactivated severe acute respiratory syndrome-related coronavirus vaccine.” Journal of virology 88, no. 15 (2014): 8597-8614 https://jvi.asm.org/content/jvi/88/15/8597.full.pdf

31. Bolles, Meagan, Damon Deming, Kristin Long, Sudhakar Agnihothram, Alan Whitmore, Martin Ferris, William Funkhouser et al. “A double-inactivated severe acute respiratory syndrome coronavirus vaccine provides incomplete protection in mice and induces increased eosinophilic proinflammatory pulmonary response upon challenge.” Journal of virology 85, no. 23 (2011): 12201-12215. https://jvi.asm.org/content/jvi/85/23/12201.full.pdf

32. Arvin, Ann M., Katja Fink, Michael A. Schmid, Andrea Cathcart, Roberto Spreafico, Colin Havenar-Daughton, Antonio Lanzavecchia, Davide Corti, and Herbert W. Virgin. “A perspective on potential antibody-dependent enhancement of SARS-CoV-2.” Nature 584, no. 7821 (2020): 353-363. https://www.nature.com/articles/s41586-020-2538-8?ref=theprepping-com

33. Electronic Support for Public Health–Vaccine Adverse Event Reporting System (ESP:VAERS) (ahrq.gov)

34.https://www.medalerts.org/vaersdb/findfield.php?TABLE=ON&GROUP1=AGE&EVENTS=ON&SYMPTOMS[]=Anaphylactic+reaction+%2810002198%29&SYMPTOMS[]=Anaphylactic+shock+%2810002199%29&SYMPTOMS[]=Anaphylactoid+reaction+%2810002216%29&SYMPTOMS[]=Anaphylactoid+shock+%2810063119%29&SYMPTOMS[]=Swollen+tongue+%2810042727%29&SYMPTOMS[]=Tongue+paralysis+%2810043972%29&SYMPTOMS[]=Tongue+pruritus+%2810070072%29&SYMPTOMS[]=Urticaria+%2810046735%29&SYMPTOMS[]=Urticaria+aquagenic+%2810046739%29&SYMPTOMS[]=Urticaria+cholinergic+%2810046740%29&SYMPTOMS[]=Urticaria+chronic+%2810052568%29&SYMPTOMS[]=Urticaria+contact+%2810046742%29&SYMPTOMS[]=Urticaria+generalised+%2810052569%29&SYMPTOMS[]=Urticarial+vasculitis+%2810048820%29&SYMPTOMS[]=Urticaria+papular+%2810046750%29&SYMPTOMS[]=Urticaria+pigmentosa+%2810046752%29&SYMPTOMS[]=Urticaria+pressure+%2810052572%29&SYMPTOMS[]=Urticaria+thermal+%2810061399%29&SYMPTOMS[]=Urticaria+vesiculosa+%2810046755%29&VAX=COVID19

35.https://digital.ahrq.gov/sites/default/files/docs/publication/r18hs017045-lazarus-final-report-2011.pdf

36. Hershfield, Michael S., Nancy J. Ganson, Susan J. Kelly, Edna L. Scarlett, Denise A. Jaggers, and John S. Sundy. “Induced and pre-existing anti-polyethylene glycol antibody in a trial of every 3-week dosing of pegloticase for refractory gout, including in organ transplant recipients.” Arthritis research & therapy 16, no. 2 (2014): 1-11. https://arthritis-research.biomedcentral.com/articles/10.1186/ar4500

37. Armstrong, Jonathan K., Georg Hempel, Susanne Koling, Linda S. Chan, Timothy Fisher, Herbert J. Meiselman, and George Garratty. “Antibody against poly (ethylene glycol) adversely affects PEG‐asparaginase therapy in acute lymphoblastic leukemia patients.” Cancer 110, no. 1 (2007): 103-111. https://acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.22739

38. Garay, Ricardo P., Raafat El-Gewely, Jonathan K. Armstrong, George Garratty, and Pascal Richette. “Antibodies against polyethylene glycol in healthy subjects and in patients treated with PEG-conjugated agents.” Expert opinion on drug delivery 9, no. 11 (2012): 1319-1323. https://www.tandfonline.com/doi/pdf/10.1517/17425247.2012.720969

39. Yang, Qi, Timothy M. Jacobs, Justin D. McCallen, Dominic T. Moore, Justin T. Huckaby, Jasmine N. Edelstein, and Samuel K. Lai. “Analysis of pre-existing IgG and IgM antibodies against polyethylene glycol (PEG) in the general population.” Analytical chemistry 88, no. 23 (2016): 11804-11812. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6512330/

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Recent Posts

Twenty Edible Flowers

Twenty Edible Flowers

Febuary 7, 2020

Twenty Edible Flowers

Recent Posts

For centuries edible flowers have been an integral part of human nutrition and have been described in detail in ancient literature. In Central Europe for example, fried batter-coated black elder (Sambucus nigra) flowers were common, as well as dandelion flowers boiled with sugar. Furthermore, flowers were used as decorations in food prepared for the nobility, especially for feasts and banquets. Nowadays, sales of fresh, top-quality flowers for human consumption are increasing worldwide. These products, packed in bunches, boxes, etc. are sold either directly in farm shops or through various specialized outlets.

Edible flowers improve the appearance, taste and aesthetic value of food, aspects that consumers appreciate, justifying the increasing trend of fresh top-quality flowers’ sales worldwide. Beyond their culinary properties, edible flowers are receiving renewed medical interest. Some of these flowers contain phenolics and flavonoids that have been correlated with anti-inflammatory activity and a reduced risk of cardiovascular disease and certain cancers.1, 2, 3 Many contain valuable nutrients and exhibit functional qualities such as antioxidant and antimicrobial properties.4 Edible flowers can be used as an essential ingredient in recipes, provide seasoning to a dish, or simply be used as a garnish.

The contents of edible flowers (proteins, fats, saccharides, vitamins) are not very different from those in other culinary plants, e.g., in leaf vegetables. The main criteria for evaluation of edible flower quality are their sensory characteristics, i.e., appeal, size, shape, color, and (above all) taste and aroma. Their colors are predetermined by many chemical compounds, but the contents of carotenoids and flavonoids are the most important. A high antioxidant capacity of flowers is mostly correlated just with the level of flavonoids.

The renewed interest in the use of flowers in cooking and to improve the appearance and nutritive value of meals has prompted the interest of researchers to investigate chemical properties of numerous flowers. Research shows that many common flowers are rich in a great variety of natural antioxidants including flavonoids, anthocyanins, and many other phenolic compounds.5 Recently, the flavonoid profile of 10 common edible flowers from China was evaluated and it was shown that rutin and quercetin were the main compounds found.6

Anthocyanins too have been categorized as the largest group of water-soluble pigments present in flowers.7 Humans consume a considerable amount of anthocyanins from plant-based food sources in daily life. These natural pigments are of great interest in the food industry, due to their attractive colors and beneficial health effects, including anti-inflammatory, antiartherogenic, anticancer, antidiabetic, and antioxidant activities.8

Caution

• Never eat any plant if you aren’t 100 percent sure of what it is! Be sure you have identified the flower correctly and eat only the edible flowers and/or the edible parts of those flowers or plant. Best to eat flowers that you have grown yourself and know that they are safe for consumption.

• Be sure the plant hasn’t been sprayed with pesticides or herbicides. Do not eat flowers from florists, nurseries, or garden centers. In many cases these flowers have been treated with pesticides not labeled for food crops.

• Never harvest flowers growing by the roadside, they may be contaminated by exhaust fumes and any spraying done by government agencies.

• Generally, eat only the petals and remove the pistils and stamens before eating or cooking.

The following are descriptions of 20 of the most popular and medicinally valuable edible flowers:

Anise Hyssop, Blue Giant Hyssop (Agastache foeniculum)

Basil (Ocimum basilicum)

Borage (Borago officinalis)

Chamomile (Chamaemelum nobile)

Chrysanthemums

Dandelion (Taraxacum officinale)

English daisy (Bellis perennis)

Dianthus

Daylily (Hemerocallis fulva)

Elderberry (Sambucus Canadensis and Nigra)

Chinese Hibiscus (Hibiscus rosa-sinensisis)

Hollyhock (Alcea rosea)

Honeysuckle flower (Lonicera japonica)

Lavender (Lavandula)

Lilac (Syringa vulgaris)

Marigold (Tagetes)

Nasturtium (Tropaeolum majus)

Rose (Rosa Spp.)

Snapdragon (Antirrhinum majus)

Viola

Anise Hyssop, Blue Giant Hyssop (Agastache foeniculum)

Anise Hyssop, a member of the mint family (Lamiaceae), is native to prairies, dry upland forested areas, plains and fields in the upper Midwest and Great Plains into Canada from Ontario west to British Columbia.

The aromatic leaves and flowers have a licorice-like (anise) scent, and can be used in herbal teas, to flavor jellies or eaten fresh in small quantities, such as in a salad with other greens. Flower color varies from white to pale blue and lavender through blue purple, with the color more intense at the tip.

The plant was used medicinally by Native Americans to treat coughs, fevers, wounds, and diarrhea. The Cheyenne made a tea for a “dispirited heart” from the flowers. The Iroquois made a wash against poison ivy out of it. Other historic uses were as a protective charm, a poultice for burns, and as incense. The flower essence is said to “bring back sweetness after one has indulged in unwarranted guilt, to encourage honest communication, and to allay anxiety before exams or performances”.9

Culinary Tips

This perennial’s profusion of blossoms throughout a long growing season makes it an ideal edible flower. Use the flowers to garnish and sweeten tea, flavor sugar, bread, or honey. Separate the tiny flowers from the main stem to dot over the top of a fruit salad or garnish a summer cucumber soup. The flowers are also a perfect addition as a garnish to desserts and truly beautiful and tasty for tea parties.

The best time to harvest foliage to dry is when the flowers are just past full bloom, as the oil content in the leaves is the highest at that time, but they can be used at any time. Dried flower spikes retain their lovely lavender color and mild fragrance.

Basil (Ocimum basilicum)

Basil, also a member of the Lamiaceae family, is native to tropical regions from central Africa to Southeast Asia. It is now grown worldwide for its flavorful culinary properties. Depending on the species and cultivar, the leaves may taste somewhat like anise, with a strong, pungent, often sweet smell. The leaves are not the only part of basil used in culinary applications, the flower buds have a more subtle flavor and they are also edible. The various basils have such different scents because the herb has several different essential oils in different proportions for various cultivars.

Basil varieties to look for include:

  • Genovese basil

  • Thai basil

  • Cinnamon basil

  • African blue basil (perennial in warm climates, shown at top)

  • Holy basil

  • Lemon basil

Allowed to flower, the plants will go to seed and stop producing those fresh lovely leaves. Luckily, there’s an easy solution. Plant several extra basil plants. Once you have harvested the first batch of leaves, allow a few plants to go into flowering mode.

Culinary Tips

Basil leaves and flowers are an attractive and tasty addition as a garnish to salads and soups. However, basil produces less aromatic and flavorful oils after it begins to flower, which causes it to develop a slightly bitter flavor. Flowering also makes the stems become woody, rendering them inedible. An option is to pinch off the flower buds as soon as they emerge and use them as decoration atop foods. Removing the flowers also allows another harvest of leaves before the flavor begins to decline.

Borage (Borago officinalis)

Borage, or commonly known as star flower, originated from Syria but is now naturalized in many parts of Europe. It is a member of the Boraginaceae family along with comfrey and forget-me-nots. The flowers are star-like in shape and can be blue, lavender or purple in color. It is a favorite plant of honeybees, bumble bees and small, native bees.

It has served many purposes from the time of ancient Rome to the present. Pliny the Elder believed it to be an antidepressant, and it has long been thought to give courage and comfort to the heart. Traditionally, borage was used to relieve anxiety and stress and for lifting the spirits. It is also used to reduce high fevers taken hot because of its diaphoretic or sweat-inducing properties, making it a good remedy for colds, flu and infected lungs.10

The leaves and flowers are rich in potassium and calcium making it a good tonic and blood purifier. This herb is also one of the highest known plant sources of gamma-linolenic acid (an omega 6 fatty acid, also known as GLA), and the seed oil is often marketed as a GLA supplement. It is also a source of B vitamins, beta-carotene, fiber, choline, and trace minerals. In alternative medicine it is used for stimulating breast milk production and as an adrenal gland tonic, and as such, can be used to relieve stress.11

Borage ice cubes are the perfect way to chill lemonade.

Culinary Tips

Borage flowers have a mild, cucumber-like flavor and can be used to spice up salads, drinks, and savory dishes. The leaves too can be mixed into salad greens. The flowers are particularly fabulous with chicken and fish dishes. Overall, this herb and its flower can be used in soups, salads, borage-lemonade, strawberry-borage cocktails, preserves, borage jelly, various sauces, cooked as a stand-alone vegetable, or used in desserts in the form of fresh or candied flowers, to name a few.

Chamomile (Chamaemelum nobile)

Chamomile, also known as Roman chamomile, is a member of the Asteraceae, or daisy family. Before chamomile became a culinary staple and a famous tea, it was used mainly for medicinal reasons. The healing properties of chamomile were so prized in ancient Egypt that the plant was dedicated to the sun and worshipped. It is said that the god Ra used it as a symbol of his almighty power, while the Egyptian people offered it to the gods because of its healing properties in hopes it would cure acute fevers known at that time as “Ague”. You can also find evidence of chamomile’s medicinal uses in the Lacnunga, an Anglo-Saxon manuscript dating back to at least the first millennium. In it, the flower is referred to as the one of the “nine sacred herbs”.

In ancient Rome, Roman Chamomile was used to help soldiers take courage during times of war. It was also used during the Middle Ages in beer making due to its bitter taste, though it was later replaced by hops. The European cultivation of the plant started in England in the 16th century. The plant was listed first in the pharmacopoeia of Würtenberg as a carminative, painkiller, diuretic and digestive aid.12

Roman chamomile is used today as a top essential oil due to its healing properties as well as in many food dishes and drinks. As a medicinal herb, chamomile can be used for teas to aid digestion and act as a gentle sleep inducer. It is a powerful sedative and is commonly used for its calming and relaxing properties. It helps to soothe the body and mind while relaxing a person from within.

As an oil it can also be very beneficial for treating minor burns such as sunburn, as the oil contains skin-regenerating flavonoids, and anti-inflammatory and pain-relieving properties. It also has potent anti-inflammatory properties which make it a significant muscle and pain relaxer and healer. Used as a bath oil, chamomile oil may also help with teething in children and post pregnancy healing.13

Culinary Tips

Roman chamomile leaves and flowers are both edible but differ in taste. Chamomile flowers have a slight apple taste. Both can be tossed into a salad or a mug to make fresh chamomile herbal tea. Roman chamomile oil has many medicinal uses and may be used as flavoring in desserts, breads and pastries.

Chrysanthemums

Chrysanthemums are flowering plants of the genus Chrysanthemum in the family Asteraceae. They are native to Asia and northeastern Europe. Most species originate from East Asia and the center of diversity is in China. There are countless horticultural varieties and cultivars. Basically, all chrysanthemum flowers are edible, but the flavor varies widely from plant to plant, from sweet to tangy to bitter or peppery.

Chrysanthemum flower petals are often an ingredient in tea. The species Chrysanthemum coronarium is best for edible greens. Chrysanthemum greens have a slightly tangy taste and can be eaten raw or cooked. The leaves are steamed or boiled and used as greens in Chinese cuisine. Young leaves and stems are used in oriental stir-fries. When you cook Chrysanthemum greens, cook them very lightly. If overcooked they will become bitter. However, it is a delicious green, full of nutrition and particularly rich in potassium and antioxidants.

In traditional Chinese medicine (TCM) chrysanthemum flower petals (“Ju-hua”) are used in prescriptions for colds with “wind, and heat”, headache, inflamed eyes, swelling and pain in the throat, vertigo, tinnitus, sores such as boils, and tightness of the chest with anxiety.14, 15 In TCM, Chrysanthemum is often combined with Japanese honeysuckle in the treatment of high blood pressure.16

Culinary Tips

Asian chrysanthemum tea is typically made from the yellow or white flowers of Chrysanthemum morifolium or Chrysanthemum indicum. For salads and stir-fries, chrysanthemum flowers can be blanched, then the petals removed and added to your favorite dish. This is easiest with large petaled varieties of mums. Use only the petals, since the flower base is usually very bitter. In Korea, a rice wine flavored with chrysanthemum flowers is called gukhwaju.17

Caution: Pyrethrum, a plant-based insecticide, is made from the dried flowers of Chrysanthemum cinerariaefolium or Chrysanthemum coccineum. Although it takes a high concentration of flowers to make pyrethrum, it is best to avoid planting these types of mums in an edible garden.

Dandelion (Taraxacum officinale)

Dandelion derives its name from the French term “dent de lion” meaning “tooth of the lion”. Though the dandelion has been carried from place to place since before written history, it can at least be said that the plant is native to Europe and Asia. The earliest recordings can be found in Roman times and use has been noted by the Anglo-Saxon tribes of Britain and the Normans of France. In the 10th and 11th centuries there is mention of dandelions used for medicinal purposes in the works of Arabian physicians.18

Dandelion has been traditionally used for biliary disorders, gastrointestinal complaints such as a feeling of distension and flatulence, digestive complaints, and to stimulate diuresis.19 Dandelion is one of the most transformational, adaptive and vital plants. Almost overnight a field of dandelions can suddenly turn yellow, and then just as quickly the flowers can change to white and disappear. Psychoemotionally when consumed, it is thought to impart its unique transformational nature to help change and adapt one’s realm of ideas, beliefs and opinions. Hence, it empowers the mind with the capability of embracing new concepts and thoughts, and further stimulates a transformation of that information into action. It keeps the mental process from becoming stagnant through facilitating necessary belief changes relative to experience adjustments.

Dandelion contains a wide array of phytochemicals whose biological activities are actively being explored in various areas of human health. Evidence suggests that dandelion and its constituents have antioxidant and anti-inflammatory activities that result in diverse biological effects.20

Culinary Tips

The entire plant, including the leaves, stems, flowers, and roots, is edible, nutritious and medicinal. Many people relish the bitter flavor of dandelion greens in salads and soups, though few realize the flowers are also edible. The flowers are sweet and crunchy and can be eaten raw. Perhaps the best-known use for dandelion flowers is in dandelion wine, reputed to taste like sherry. The compilers of “Rodale’s Illustrated Encyclopedia of Herbs” advise adding ginger, sliced lemon and orange rind to enhance the flavor. They use a gallon of fresh dandelion flowers to a gallon of boiling water plus sugar. Other uses for dandelion flowers include as a garnish for salads, as a chopped addition for butter and other spreads to add color, and as an additive to flavored vinegars. They can also be made into jelly or dipped in batter and fried for dandelion fritters. The flavor is sweeter if picked immediately after the flowers open. The root of the dandelion can be dried and roasted and used as a coffee substitute or added to any recipe that calls for root vegetables.

English Daisy (Bellis perennis)

English daisy is a common European species of daisy, of the Asteraceae family. It is thought that the word “daisy” derives from the Anglo-Saxon “daes eage” which means “day’s eye”, as the flower opens at dawn and shuts at dusk. It has been used medicinally for centuries for eye problems, and Henry VIII of England ate daisies to treat stomach complaints. It is one of the plants mentioned by Ophelia in Shakespeare’s Hamlet. In ancient Rome, the surgeons who accompanied Roman legions into battle would order their slaves to pick sacks full of these daisies in order to extract their juice. Bellum, Latin for “war”, may be the origin of this plant’s scientific name. Bandages were soaked in this juice and would then be used to bind sword and spear cuts. Today, people take this daisy in tea for coughs, bronchitis, disorders of the liver and kidneys, and swelling (inflammation). They also use it as a drying agent (astringent) and as a “blood purifier.” 21, 22, 23

Also, Bellis perennis is commonly used in homeopathy, like arnica, for sprains and bruises. Homeopathic Bellis perennis is especially used for injuries from blows, falls and accidents and after certain surgical procedures.24, 25

Chewing the fresh leaves is said to be a cure for mouth ulcers, but even though leaves and flowers are edible raw they are not particularly tasty, thus the plant is mostly used as a medicinal herb in concoctions or infusions.

Culinary Tips

The flowers have a mildly bitter taste and are most commonly used for their looks rather than their flavor. However, English daisy flower buds and petals can be eaten raw in sandwiches, cooked in soups and eaten in salads. The open flowers are very decorative but can be slightly bitter or acrid. Flower buds can be pickled and used instead of capers. The leaves (think lamb’s lettuce) have an astringent or sour flavor. Young leaves can be eaten raw in salads or cooked, noting that the leaves become increasingly astringent with age.

Dianthus (Dianthus chinensis)

Dianthus is a genus of about 300 species of flowering plants in the family Caryophyllaceae, native mainly to Europe and Asia, with a few species extending south to north Africa, and one species (D. repens) in arctic North America. Dianthus has flowers in shades of white, pink, salmon and red.

The species Dianthus chinensis has long been a part of traditional Chinese herbal medicine (TCM), known as “Qumai” in Mandarin, where it is used to promote bladder and urinary tract health. In TCM, dianthus is considered “cold and bitter”, and is associated with the meridians of the bladder, heart, and small intestine. It unblocks the bowels, breaks up stasis, clears damp heat, and promotes urination.26, 27

In western herbal medicine, the entire plant is used as a bitter tonic herb that stimulates the urinary system, digestive system, and bowels. Dianthus chinensis is classified as antibacterial, anthelmintic, antiphlogistic, diuretic, diaphoretic, emmenagogue, febrifuge, and haemostatic. Internally it is used to treat cystitis. This herb is used to aid digestion and the urinary system. It is also used to treat urinary stones, constipation, and failure to menstruate. Externally a decoction is used to treat skin inflammations and swellings.28

Dianthus can stimulate the uterus, so it should not be taken in large quantities during pregnancy. Overdosage of dianthus can cause prolonged contractions of the uterus. Currently, there are no known drugs that interact with dianthus.29

Culinary Tips

Petals are sweet, once trimmed away from the base and their blossoms taste like their sweet, clove-scented perfumed aroma. Fresh dianthus petals can be used to liven up salads, sandwiches and pies. They are perfect as a garnish on iced drinks such as lemonade. The petals of the flowers make beautiful decorations for cakes and pastries. When using this herb for cooking be sure to remove the petal base, as it is quite bitter.

Daylily (Hemerocallis fulva)

Daylilies are native to Asia from the Caucasus east through the Himalaya to China, Japan, and Korea. They are known to have been cultivated in Chinese gardens 2,500 years ago. They were not originally ornamentals; rather, the young leaves and flowers were eaten as vegetables. The root and leaves were and still are used medicinally in traditional Chinese medicine where an extract of the flowers is used as a blood purifier and antidepressant.30, 31, 32 The rhizome has shown antimicrobial activity, it is also tuberculostatic and has an effect against the parasitic worms that cause filariasis.33

Daylilies are used in Korea to treat liver diseases, jaundice, constipation and pneumonia. This plant is quite nutritious, being a decent source of protein, fat, and carbs. It contains quite a bit of carotene, vitamin C, calcium, and potassium.34

Culinary Tips

Most types of lilies are mildly toxic when consumed, but not daylilies. (Though botanically speaking, daylilies are not a true lily.) Daylilies are not only edible, they are spectacular. The flowers, leaves, and tubers of the orange daylily are all edible. Daylily blossoms are meatier than most flower petals, with a succulent texture and a mildly sweet taste, like romaine lettuce. Leaves and shoots can be eaten raw or cooked when very young (or they become too fibrous). The flowers and young tubers can be also be eaten raw or cooked. The flowers can be dried and used as a thickener in soup. Add a few blooms to add color and flavor to a fresh green salad. Chop them up and add them to salads, but be sure to sample the flavor first, as some daylily varieties taste better than others. Try cooking them with scrambled eggs or adding them to a vegetable stir fry.

Elderberry (Sambucus Canadensis and Nigra)

The elder tree has been used for a variety of purposes throughout history ranging from musical instruments, to food, medicine, and magic. Elderberry fruit and its extract has been used in folk medicine for centuries to treat influenza, colds and sinusitis, and has been reported to have antiviral activity against influenza and herpes simplex.35, 36, 37, 38

The flower (known as an elderflower) is edible, as well as the ripe berries. Other parts of the plant, such as leaves, stems, roots, and unripe fruits, are toxic due to the presence of cyanogenic glycosides, and alkaloids. The flavor of the elderberry flowers does not come from the petals or nectar – it comes from the flowers’ pollen. It’s important to harvest the flower heads at the stage when the pollen is fresh, not before the flower buds open and not after the pollen is gone. So, if the flower buds haven’t opened yet, come back for them later. If the flowers have started turning brown, leave them alone. The aromatic flowers appear in the late spring or early summer, depending on where you live. They are creamy, white umbels, although some sources refer to them as corymbs. They can be as wide as eight inches across.

Elder Tree Folklore

The elder tree is one of those plants surrounded by mystery, magic, and superstition.

Anglo-Saxons, the Danish, and other old European societies (Celts) believed the elder tree was sacred. According to elder tree folklore, this sacredness came from the mother spirit or goddess believed to reside in the plant. The leaves were thought to protect a home or a person from evil spirits when dried and hung in a doorway or around the neck. It was a particularly good omen if an elder grew near a dwelling, as the tree’s proximity to the home would protect the household. Thus, it was often planted around homes for protection. Permission was always sought three times prior to cutting branches, but they were never to be used as firewood or for woodworking, since doing so would offend its mother spirit. Gifts of water, beer, milk, cake, or bread would often be found around elder. The Celts sometimes planted elder trees on the graves of their loved ones, believing that blossoms were evidence of happy souls.

Culinary Tips

Elderberry flowers have a light, honey-like aroma and taste, and they’re often used to flavor white wine, champagne, lemonade, iced tea, and other summery drinks. They can also be used to flavor cooked fruit and jam and make a sound match with gooseberries, which are in season at the same time as elderflower. Some culinary experts claim the white flowers from elderberry trees generally are best cooked before eating. However, you can sprinkle the tiny individual flowers in salads or fry the dome-shaped clusters whole to make elderberry fritters. Beware that elderberry foliage is mildly toxic, as is the uncooked fruit (the cooked fruit, however, is edible and delicious).

Chinese Hibiscus (Hibiscus rosa-sinensisis)

Chinese hibiscus a species of tropical hibiscus, a flowering plant in the Hibisceae tribe of the family Malvaceae. Hibiscus is a diverse genus made up of roughly 220 species of annuals, herbaceous perennials, shrubs, subshrubs, and trees. Hibiscus have been cultivated for centuries. The name “Hibiscus” comes from hibiskos, the old Greek name for the common marshmallow. One of the most commonly grown species and popular edible variety is Hibiscus rosa-sinensis, which means “China Rose”. However, there are numerous other edible species of hibiscus, such as the Jamaican Hibiscus sabdariffa. Many plants of this family are useful ornamentally, while some, like Chinese hibiscus, are also sources of fiber, food, and medicine, and commonly made into tea.39

Studies have showed that H. rosa sinensis possesses many biological activities, such as anticomplementary, antidiarrhetic and antiphlogistic activity.40 It has also been reported that the plant’s flower possesses antispermatogenic, androgenic41,antitumour and anticonvulsant properties. In addition, the leaves and flowers have been found to be hair growth promoters and aid in the healing of ulcers.42 Other reported biological activities of H. rosa sinensis include antiestrogenic, anti-implantation, abortifacient, antipyretic, antispasmodic, hypotensive, embryotoxic, insect attractant, analgesic, antifungal and anti-inflammatory properties.43

Chinese hibiscus tea is caffeine free, with a unique, delicious tart, cranberry-like flavor with tropical notes and can be consumed both hot and cold. It is rich in vitamin C and is known to be a natural body refrigerant in North Africa.44

Culinary Tips

Hibiscus flowers, though they are most often made into iced tea or infused into other cold drinks, may also be chopped and added to salads and desserts. Dried hibiscus flowers may be purchased in Asian and Latin groceries.

Hibiscus Tea

Tea Recipe Ingredients

2 quarts water

3/4 to 1 cup sugar or honey (depending on how sweet you would like it to be)

1 cup dried hibiscus flowers

1/2 cinnamon stick (optional)

A few thin slices ginger (optional)

Lime juice (optional)

Orange or lime slices for garnish

Hollyhock (Alcea rosea)

Hollyhocks are members of the Malvaceae or mallow family. They were imported into Europe from southwestern China during, or possibly before, the 15th century. The herbalist William Turner gave the plant the name “holyoke” from which the English name derives. Hollyhock is completely edible – leaves, roots, flowers, seeds.

It is a valuable medicinal plant, too. The flowers are harvested when they are open and are dried for later use. The shoots are used to ease a difficult labor. The root is astringent and demulcent. It is crushed and applied as a poultice for chapped skin, splinters, areas of painful inflammation and swellings. Because of the thickness of the leaves, it is most useful to lightly steam them first to make them more flexible. Apply to the area while still very warm, following with a towel for insulation then strips of cloth to hold the poultice in place.

Taken internally, Hollyhock is soothing to the gastrointestinal, respiratory and urinary tracts in the human body. It promotes urination, soothes ulcers and can help relieve a dry cough. Internally, it is also used in the treatment of dysentery.45, 46

The roots and the flowers have long been used in Tibetan medicine, primarily in the treatment of inflammations of the kidneys, uterus, and vagina. They are said to have a sweet, acrid taste and a neutral potency. The roots on their own are used to treat loss of appetite. The seed is demulcent, diuretic and febrifuge.47, 48

Culinary Tips

Young leaves have a mild flavor and may be eaten raw or cooked. They can also be finely chopped up and added to salads. Flower petals and buds may be eaten raw and added to salads or used as a colorful garnish. Flowers may be made into a refreshing tea.

Honeysuckle (Lonicera japonica)

Honeysuckles are arching shrubs or twining vines in the family Caprifoliaceae, native to the Northern Hemisphere. Honeysuckle is renowned for its colorful, fragrant flowers and possesses more than 150 complex phytochemicals – iridoids, anthocyanins, flavonols, flavanonols, flavones, and phenolic acids.

Many of the species have sweetly scented, bilaterally symmetrical flowers that produce a sweet, edible nectar, and most flowers are borne in clusters of two (leading to the common name of “twinberry” for certain North American species). The strongest odor is found to be emitted in the middle of the night.

The honeysuckle family is “iffy” for foragers. It has edible members and toxic members, edible parts, toxic parts, and they mix and match. Some species are medicinal and tasty, but some species are also toxic. So, it is important to know which species you are eating and make sure which part is usable. Thus, when making a tea it is best to purchase organic flowers of known species from a reputable supplier. Generally, Asian markets, health food stores or online herb suppliers are the best sources to find honeysuckle.

Among the edible species are: L. affinis, flowers and fruit; L. angustifolia, fruit; L. caprifolium, fruit, flowers to flavor tea; L. chrysantha, fruit; L. ciliosa, fruit, nectar; L. hispidula, fruit; L. involucrata, fruit; L. kamtchatica, fruit; L. Japonica, boiled leaves, nectar; L. periclymenum, nectar; L. utahensis, fruit; L. villosa, fruit; L. villosa solonis, fruit.

There are about 180 species of honeysuckle, most native to the northern hemisphere. The greatest number of species is in China with over 100. North America and Europe have only about 20 native species each, and the ones in Europe are usually toxic. Taste is not a measure of toxicity. Some Lonicera have delicious berries that are quite toxic, and some have unpalatable berries that are not toxic at all. This is one plant on which taste is not a measure of edibility. Again, to be safe, properly identify the species.

Two types of honeysuckle commonly used for medicinal purposes are Lonicera pericylmenum and Lonicera japonica. Herbalists use honeysuckle primarily for its anti-inflammatory, anti-bacterial and calming properties. In traditional Chinese medicine (TCM) the flowers and buds of Lonicera japonica are used for treatment of affection by exopathogenic “wind-heat” or epidemic febrile diseases at the early stage, sores, carbuncles, furuncles and swellings. The plant has been reported to possess properties of clearing “heat” from the blood and arresting dysentery.49, 50

Lonicera japonica

Lonicera pericylmenum

In TCM honeysuckle is commonly used as an expectorant. European honeysuckle flowers can be drunk as a tea to treat coughs and colds. Honeysuckle can also be used to treat upper respiratory tract infections and asthma. It is commonly combined with chrysanthemum flowers as a tea to treat a cold.51, 52

Culinary Tips

The tea can be made by pouring scalding water over the fresh or dried blossoms and letting it cool at room temperature. Then you can chill your infusion in the refrigerator. When iced, it makes a refreshing, cooling summer beverage.

Fresh flowers can also be added to stir-fries, rice dishes as well as salads or cooked into breads and pastries.

Lavender (Lavandula)

The genus Lavandula is native to the lands surrounding the Mediterranean Sea (including the Canary Islands and Madeira) as well as east through Ethiopia and the Middle East to India. It includes more than 30 species, dozens of subspecies, and hundreds of hybrids and selected cultivars. It belongs to the mint family, Lamiaceae. Lavenders fall into four main categories: Lavandula latifolia, a Mediterranean grass-like lavender; Lavandula angustifolia, a stockier plant with a fuller flower, commonly known as English lavender (formerly known as L. vera or L. officinalis); Lavandula stoechas, which has butterfly-like bracts on top of the flowers and is sometimes known as French lavender; and Lavandula x intermedia, which is a sterile cross between L. latifolia and L. angustifolia.

The various lavenders have similar ethnobotanical properties and major chemical constituents, however, there are some differences in the reported therapeutic uses for different species.

Documented evidence for the use of lavender as a therapeutic agent can be traced back to the ancient Romans and Greeks. Lavender oil was first cultivated in the high mountains of Persia and southern France. A hearty and robust plant, Lavender thrives in barren environments. This sharp environmental contrast has helped Lavender to evolve its natural power to heal.

Historically, lavender has been the source of drugs as well as perfumes, soaps, flavorings, and crafts. Lavender is traditionally believed to be anti-fungal, antibacterial, carminative, anti-depressive, sedative and effective for insect bites and burns. Lavender was also prescribed by some medieval physicians for treatment of epilepsy and migraine attacks. Furthermore, Lavender is considered beneficial in treatment of pain and tremors.53

Today, lavender is used as an oil predominantly in aromatherapy or massage. In addition to psychological effects, aromatherapy is thought to be therapeutically effective due to physiological effects of the inhaled volatile compounds. It is believed that inhaled lavender acts via the limbic system, particularly the amygdala and hippocampus.

Lavenders have carminative actions and the oils are commonly used as a nervine – to calm the nerves. L. stoechas has traditionally been used for headaches, and L. angustifolia has been used as a diuretic.54

While the exact cellular mechanism of action is unknown, some studies have suggested that lavender flower oil (based on studies of L. angustifolia) may have a similar action to the benzodiazepines and to enhance the effects of gammaaminobutyric acid in the amygdala.55, 56 Others have found that linalool inhibits acetylcholine release and alters ion channel function at the neuromuscular junction.57

Culinary Tips

Culinary lavender or the most commonly used species in cooking is L. angustifolia. As an aromatic, it has a sweet fragrance with a taste of lemon or citrus notes. It is used as a spice or condiment in pastas, salads and dressings, and desserts. Their buds and greens are used in teas, and their buds, processed by bees, are the essential ingredient of monofloral honey. Lavender flowers are often used in summer drinks, ice cream, chocolate, and other sweets. The flower buds can be rubbed between your fingers to separate the tiny individual flowers and then sprinkled into your dish.

The key to cooking with culinary lavender is to experiment; start out with a small amount of flowers and add more as you go. The lavender flowers add a beautiful color to salads. Lavender can also be substituted for rosemary in many bread recipes. The flowers can be put in sugar and sealed tightly for a couple of weeks; then the sugar can be substituted for ordinary sugar for a cake, buns or custards. Grind the lavender in an herb or coffee grinder or mash it with mortar and pestle. The flowers look beautiful (and taste good, too!) in a glass of champagne, with chocolate cake, or as a garnish for sorbets or ice creams. Lavender lends itself to savory dishes also, from hearty stews to wine-reduced sauces. Blooms add a mysterious scent to custards, flans or sorbets.

Lilac (Syringa vulgaris)

Lilac is a species of flowering plant in the olive family (Oleaceae), native to the Balkan Peninsula, where it grows on rocky hills. Grown for its scented pink flowers in spring, this large shrub or small tree is widely cultivated and has been naturalized in parts of Europe and North America.

According to Greek mythology, a beautiful nymph named Syringa (lilac’s genus name) had captivated, Pan, the god of the forests and fields, with her beauty. Pan chased Syringa through the forest. Syringa escaped Pan’s attention by turning herself into a lilac bush with the assistance of some nearby nymphs. Pan realized he was holding reeds instead of Syringa. His sighs combined with the wind and reeds made harmonious sounds. Hermes (aka Mercury) suggested that, seven reeds of different lengths bound together could make pan pipes, which were called Syrinx in honor of the nymph. Syringa also means “Hollow tube; tubular shape, pertaining to the shape of the flowers”. Although not hollow, lilac twigs can be easily drilled out to make flutes and pipe stems. Vulgaris, the species name, means common.

Culinary Tips

Lilac blossoms are edible, though they smell better than they taste, so use in small amounts. Probably the simplest way to enjoy lilacs is to make this beautiful lilac water. Simply fill a glass pitcher with fresh (unsprayed, of course) lilac blossoms. Fill to the top with spring water. Allow it to steep for an hour. Strain before serving in glasses. Scatter a few lilac blossoms on fresh green salads. The blossoms can be candied and preserved to decorate desserts later in the year. Cakes and cupcakes can be beautifully decorated with lilac blossoms as well. The unusual floral flavor of lilac pairs well with citrus.

Marigold (Tagetes)

Tagetes is a genus of annual or perennial, mostly herbaceous plants in the sunflower family (Asteraceae). It was described as a genus by Linnaeus in 1753. The common name in English, “marigold”, is derived from “Mary’s gold”. Marigolds have an extensive history. They were revered by the Aztecs and used medicinally, ornamentally and in religious rites. The Spanish and Portuguese explorers brought them back to Europe. There they were referred to as “Mary’s Gold” in deference to the Virgin Mary as well as a nod to their gilded hues. Marigolds are used in Pakistan and India to dye cloth and make flower garlands for harvest festivals. Here marigolds are used as food as well.

The use of marigolds is, for the most part, to add brilliant color, much like saffron threads impart a gorgeous golden hue to dishes. In fact, marigolds are sometimes referred to as the “poor man’s saffron”.

Flowers were used in ancient Greek, Roman, Middle Eastern, and Indian cultures as a medicinal herb, as well as a dye for fabrics, foods, and cosmetics. Many of these uses persist today. They are also used to make oil that protects the skin and the marigold leaves can also be made into a poultice that helps scratches and shallow cuts to heal faster and can help prevent infection.

The species Tagetes lucida, known as pericón, is used to prepare a sweetish, anise-flavored medicinal tea in Mexico. It is also used as a culinary herb in many warm climates, as a substitute for tarragon, and offered in the nursery as “Texas tarragon” or “Mexican mint marigold”.

Tagetes minuta, native to southern South America, is a tall, upright marigold plant with small flowers used as a culinary herb in Peru, Ecuador, and parts of Chile and Bolivia, where it is called by the Incan term huacatay. The paste is used to make the popular potato dish called ocopa. Having both “green” and “yellow/orange” notes, the taste and odor of fresh T. minuta is like a mixture of sweet basil, tarragon, mint and citrus. It is also used as a medicinal tea in some areas. It is commonly sold in Latin grocery stores in a bottled, paste format as black mint paste.

Both French marigolds (Tagetes patula) and African marigolds (T. erecta) produce flowers that are technically edible, but the pungent scent is probably worth avoiding. African marigold flowers are used as a food colorant in Europe but have only been approved for use as a poultry feed additive in the US.

Culinary Tips

Marigold flowers, especially T. tenuifolia, have a refreshing citrus, lemony flavor, and the petals work well torn into salads or sprinkled onto soups. They may also be added to hot tea or cold drinks.

Nasturtium (Tropaeolum majus)

Nasturtium, also called Indian Cress, is a species of flowering plant in the family Tropaeolaceae, originating in the Andes from Bolivia north to Colombia. All its parts are edible. It is very high in vitamin C along with iron, calcium, potassium and magnesium. The whole plant is considered a powerful antioxidant, so it may be used regularly and often. Moreover, nasturtiums contain up to 45 mg of lutein per 100 grams, being beneficial to the eyes, which is the highest amount found in any edible plant.

Culinary Tips

The nasturtium flower makes for an especially ornamental salad ingredient. It has a slightly peppery taste (reminiscent of watercress), to which the plant is closely related. It is primarily used in salads and as a garnish for hors d’oeuvres. (Though the tubular flowers are large and sturdy enough to stuff with cheese or tapenade.) Nasturtium flowers and foliage can also be used in stir-fries. Young seed pods may be eaten raw or cooked and are even hotter than the flowers or leaves. They can be harvested whilst immature and pickled for use as a caper substitute. The mature seed can be ground into a powder and used as a pepper substitute. The seed contains 26% protein and 10% oil.

Rose (Rosa spp.)

A rose is a woody perennial flowering plant of the genus Rosa, in the family Rosaceae, or the flower it bears. There are over 300 species and thousands of cultivars. They form a group of plants that can be erect shrubs, climbing, or trailing, with stems that are often armed with sharp prickles. Flowers vary in size and shape and are usually large and showy, in colors ranging from white through yellows and reds. Most species are native to Asia, with smaller numbers native to Europe, North America, and northwestern Africa. Species, cultivars and hybrids are all widely grown for their beauty and often are fragrant.

The rose hip, usually from R. canina, is used as a minor source of vitamin C. The fruits of many species have significant levels of vitamins and have been used as a food supplement. Many roses have been used in herbal and folk medicines. Rosa chinensis has long been used in traditional Chinese medicine. This and other species have been used for stomach problems and are being investigated for controlling cancer growth.58

Every variety of rose is edible, and each one offers a uniquely sweet and floral flavor. Roses taste much like they smell, but with a slightly bitter undertone. Rose petals resemble flavors of green apples and strawberries, with a soft scent that is a perfect addition to aromatic dishes.

Culinary Tips

Rose petals can add a subtle floral taste to lemonades, juices and iced tea. Simply muddle fresh rose petals to release the flavor, and stir them into a cool, fruity beverage. Rose petals can also be frozen into ice cubes for a beautiful and delicious punch.

Fresh rose petals make a great addition to fruit salads and mixed greens salads. Create a salad filled with other herbs and flowers from your garden for a refreshing summer lunch. Add dried rose petals to a sweet granola mix with dried cranberries, apricots and honey. This floral granola pairs well with vanilla yogurt or can be eaten plain as a healthy snack.

Rose-infused water offers a great way to incorporate the flavor of rose into an entire dish, such as a custard, sponge cake or other baked goods. Rose water can also be added to beverages or used as a perfume or toner. Spritzing rose water on your face and neck will refresh and tighten your skin. Rose water has a very distinctive flavor and is used heavily in Middle Eastern, Persian, and South Asian cuisine, especially in sweets such as barfi, baklava, halva, gulab jamun, kanafeh, and nougat.

In France, there is much use of rose syrup, most commonly made from an extract of rose petals. Mix equal parts sugar and water in a saucepan and bring it to a boil. Stir continuously until the sugar is completely dissolved. Reduce to a simmer and stir in dried or fresh rose petals. Remove the mixture from the heat and let it steep for about 10 minutes. Strain out the rose petals with a fine sifter and allow the syrup to cool. Rose simple syrup is delicious in cocktails, tea and lemonade.

In the Indian subcontinent, Rooh Afza, a concentrated squash made with roses, is popular, as are rose-flavored frozen desserts such as ice cream and kulfi.

Snapdragon (Antirrhinum majus)

Snapdragon, Antirrhinum majus, is native to parts of China and the US. Its name comes from the pinchable blossoms that open and close like the mouths of friendly dragons. It is a member of the Plantaginaceae, or plantain, family, a sub-group of the expansive Scrophulariaceae, or figwort.

It was used traditionally as a diuretic, for treatment of scurvy, liver disorders and tumors. The leaves and flowers were used as antiphlogistic, resolvent, stimulant and as poultices on tumors and ulcers. Antirrhinum majus contains amino acids, pigments, oils, anthocyanidins, flavonols, flavones, aurones, flavanones, cinnamic acids and many other compounds. Recent studies have shown that Antirrhinum majus possesses antimicrobial, insecticidal, cytotoxic, antioxidant, central and peripheral nervous system effects, and many other biological activities.59, 60

Snapdragons are on the edible flower lists, but they are usually prized more for their ornamental value than taste. Really, of all the edible flowers, snapdragon probably ranks last on the list because it is somewhat bitter.

Culinary Tips

Snapdragon flowers are a good source of vitamins and may be best used in green salads or infusion teas. Due to their bitter taste, snapdragon flowers are more commonly used for decorative purposes on cakes, tarts, pastries and other elegant dessert preparations. They can be used as a colorful garnish alongside salads, frittatas, crepes, spring rolls and fruit plates or on specialty cocktails.

Viola

Viola is a genus of flowering plants in the violet family Violaceae. Viola (violets, violas and pansies) are among the most popular edible flowers in North America, and with good reason. Viola are easy to grow and are among the few flowers that taste good, too. Violets and pansies come in every color under the rainbow. When eating pansies, you can break two of the cardinal rules of edible flowers: eat only the petals and remove the pistils and stamens before eating. In fact, you can eat the pansy sepals as well.

Consider the species listed here, as not all Viola species are safe to consume. Some of the plants mentioned here are often referred to as, or share the common name, pansy.

Viola cornuta is known as tufted pansy or horned violet. This pretty little spreading evergreen perennial is often treated as an annual. Its slightly scented flowers give a mild wintergreen flavor. The flowers appear from spring into early summer and sporadically after that. There are several different colored varieties available. A favorite is King Henry, with showy purple flowers and a yellow throat.

Viola x wittrockiana is the familiar pansy. Many different colored cultivars (often with two or three colors on the same flower) have been developed from this perennial that is often treated as an annual. It blooms from June to September. The flowers have a slightly glasslike flavor with a hint of wintergreen.

Viola tricolor is known as heartsease or Johnny-jump-up. Treated as an annual, it bears small flowers with three colors: deep violet, light blue or white, and gold. These have a wintergreen-like flavor and appear from June to September.

In purchasing edible violas, look for them at farmers’ markets or in the produce aisle of a specialty grocery store; order them from an edible-flower source; or even better, grow your own.

Culinary Tips

Culinary viola flowers may be used to decorate salads or in stuffing for poultry or fish. Soufflés, cream, and similar desserts can be flavored with the essence of Viola flowers. The young leaves are edible raw or cooked as a somewhat bland leaf vegetable.

Where to Buy

The best place to find edible flowers is your local farmers’ market. Not only are the options more interesting than what is available at grocery stores, but you can also talk to vendors to make sure their crops are safe for you to eat (always avoid flowers that have been sprayed with pesticides or other chemicals). If you don’t have a farmers’ market nearby, look for edible flowers in the produce section (not the florist section!) of your grocery store. You can also order them online. Shops like Gourmet Sweet Botanicals, Marx Foods, and Melissa’s will ship to you overnight so they are as fresh as possible.

Companies Selling Edible Flowers

References

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Silica: Bringing up and Healing the Past, Protecting the Future

Silica: Bringing up and Healing the Past, Protecting the Future

December 29, 2020

Silica: Bringing up and Healing the Past, Protecting the Future

Aric D. Cox, DC

Within most of the healing arts communities, silica most commonly draws thoughts towards homeopathic energy that supports skin, bone, and connective tissue health. Its elemental doppelganger, silicon, conjures thoughts of computer chips, processors, and an entire valley devoted to its innovation. However, it is in the human body that the substance of silicon and energy of silica converge. It is here that it outshines every technological advancement to come out of Silicon Valley and performs more profound functions than just structural support. Because of it our cell membranes act like supercomputers and each cell has its antenna-like network in which it sends and receive information. But in an age of rising autoimmunity (loss of self-recognition), hypersensitivity (stimulus overload), and increasing knowledge at our fingertips while simultaneously losing self-awareness, is there more need for this substance than ever?

 

One must wonder if the EMF-laden devices that are ever present in hour hands with their glass touch screens has any impact on the integrity of our body? As stated by James Oschman in Energy Medicine1:

 

Since organic molecules are being used in the electronics industry to manufacture microscopic molecular circuits, it is not a big leap to suggest that a molecular electronic network within the organism can communicate, storing, and processing information…(Oschman 2016).

 

Not enough attention is paid to the energetic interactions we have with our surroundings. The power of what we can’t see has yet to have its full significance on its influence on what we can see. Natural healthcare has the tools necessary to support vitality despite our toxic environment. Yet, its acceptance and application are not keeping up with the rate at which the modern world is tearing us down. Natural healthcare is still far behind with too much attention placed on assuring that patients get enough of the macro-minerals (magnesium, zinc, calcium) and the trace minerals tend to get lumped into one substance only to be considered as together versus appreciated individually.

 

From a bioregulatory medicine standpoint, we must maintain respect for the role of each nutrient and building block. Of particular importance is the role of silica. From cell physiology to homeopathy, silica is well known for its structural, energetic, and constitutional significance.

 

Silicon vs Silica

 

Clearing up the terminology can be most helpful going forward. Silicon is the elemental level of this substance. Silica can refer to the combination of silicon and oxygen. Quartz, as an example, is a silicate made from the pure combination of silicon and oxygen. Silica also is the designation given to the homeopathic potentized form of silicon dioxide (flint). Unless described otherwise, “silica” will refer to the homeopathic remedy.

 

Silicon is a chief element in earth’s crust in the mostly in the form of quartz, flint, or sand. The human body contains 7 grams of silicon and is founds in connective tissue, hair, and nails. Because of this role in bone health and connective tissue health, it has been determined to be an essential nutrient in our diet.

 

But taking a deeper look into silica, thanks to the discoveries and works compiled by James Oschman, we know silica plays a more fundamental and essential role. Silicon is found in its water-soluble form, orthosilic acid, in the blood and bound to glycoproteins in tissues. Silicon stabilizes the glycosaminoglycan network, which is the water containing aspect of connective tissue. Each cell is filled with a microtrabecular lattice that forms the ground substance within the cell and all organelles are suspended and interconnected. By stabilizing this connection, silicon allows efficient conveying and storage of current, charge, and vibrational information between cell and biological terrain.2 Therefore, it is reasonable to silicon allows a proper interface between the fluid-based soil of the biological terrain and the autonomic nervous system.

 

For Structure and Senses

 

With the mind-body-spirit awareness of anthroposophic medicine, potentized silica is essential for composing our physical and energetic framework. Much like quartz comprising the windows of our homes, anthroposophy posits that silica creates the “windows” into each sphere of our body. The presence of silica allows the imponderable (immeasurable) forces of the world to permeate into the body: light, sound, thought.3 It influences what is called the nerve-sense system. This is the cold, resting, low metabolism ying aspect of our function that helps us take in information. It is primarily represented by the brain and nervous system.

 

From our embryonic beginnings, silica establishes our formative forces. Being that the body is covered in a fine meshwork of silica is necessary to lay down boundaries. Just like the old proverb reminds us, “good fences make good neighbors”, silica helps organs establish their boundaries between each other. This delimiting effect not only helps organs sense each other and respect each other’s space, but also aides in bacterial colonization. For instance, silica is a component of the glycocalyx that lines the stomach and keeps Helicobater pylori at a proper distance.4

 

Silica also works within and establishes our boundaries from without via our sense organs. Therefore, silica deficiencies may arise from a lack of boundaries to outside influences. When we allow our “windows” to be too open, we allow too much of the wrong influences into our body. These may come from our choosing the wrong social influences and having fixed mindsets, thereby limiting our potential, and poisoning our mind. Or they may be forced upon us as in EMFs and creating discord in every level of our being, not just the integrity of our silica. Either way, this makes a way for hypersensitivities to occur. The stimuli around us overload the nerve-sense sytem.

 

Anthroposophic medicine understands that balance within the body comes because of polar opposites. In the case of silica, it is balanced out by the effects of sulphur. I’ve heard the interplay between these two forces described like that of a hot air balloon. In this picture the balloon refers to silica and sulphur is the hot air. While sulfur forces drive the metabolic fires of our cellular engines, silica gives it shape. It contains our metabolism so that no energy is lost so that we may rise.

 

Homeopathic roots

 

Taking the law of similars approach of homeopathy, the rigid nature and lengthy process of producing silica in nature play out in its potentized form. Just like how silica gets into the earth’s crust through erosion of rigid materials (i.e., flint), as a remedy, silica works well with chronic conditions that develop slowly over time. More than likely, chronic conditions appear as the result of the inflexibility (mentally, physically) of the individual.

 

Catherine R. Coulter, in her Portraits of Homeopathic Medicines books, describes the “silica” type beautifully through the metaphors of the grain of sand, the stalk of wheat, and the cricket.5 The grain of sand explains the silica type for their hardness and the way they more readily form fibroids, keloids, cysts, tumors, and swollen glands. Though they lack grit, silica exhibits grittiness in tissues and sandpaper like hands and cheeks. As in the silica that gives endurance to holding the grain until it ripens, so does this remedy give stamina to the mind when it is easily fatigued by thought. It gives strength and form to the body when overcome by overexertion. And finally, much like the cricket, when silica is full of energy, they can be fidgety and chirp away day and night. Their main limitation to continuing their song depends on warmth just as the cricket flourishes in the summer and diminishes in the winter’s cold.

 

A most helpful aspect to potentized silica is that it produces inflammation around deposits (thorns, needles, splinters). It also ripens cysts, abscesses, and helps old wounds to heal. This becomes advantageous both in the acute and chronic healing of the biological terrain. Through the bioregulatory medicine lens, silica can be pivotal when assisting a patient back through the disease evolution pathways.

 

Dr. Thomas Rau mentions in his Biological Medicine textbook, that silica should be used early in the treatment process for most chronic conditions to help detoxify the terrain.6 Especially in low potency or Schuessler cell salt potency (6X). Silica can also assist in clearing many of the disruptive fields seen in old infections and scar tissue.

 

Diet and Lifestyle

 

The biggest threat to silicon deficiency is a diet heavy in animal products. Not only is the excess protein deleterious to the biological terrain, eating more meat than plants severely limit our access to enough silicon. While classified as a trace mineral our daily needs are approximately 20-50mg.

Plants absorb orthosilic acid from soil and convert it to polymerized silicon for its mechanical/structural function within the plant. Thus, high fiber/high plant diets assure good, readily useable silicon amounts. However, silicon does require sufficient stomach acid iso that it may be absorbed directly through stomach and intestinal lining.

 

When silicon levels are sufficient it is best represented in the health of not only the brain of each cell (the membrane), but the brain as well. In a world of increasing amounts of neurotoxicity in our environment, our delicate nervous system needs all the support it can get. Many studies have been done on the degenerative presence of aluminum on the brain, but a French study showed what happens when silicon is used preventatively. They found the degenerative neurological effect of aluminum in drinking water when silicon was not present. But higher concentrations of silicon showed less likely impairments in cognitive function.7

 

Of course, no substance works alone in a vacuum. Silicon needs other elements and nutrients to perform its function and silica is facilitated by complementary energies. Herbs, orthomolecular nutrients, light, frequency, touch are all necessary to synergize the role of silicon in the body. Each patient’s need is different and yet foundationally, without this trace nutrient given its full due, energy medicine, functional medicine, western medicine, and bioregulatory medicine can only go so far.

 

Reference:

1. Oschman, James L. Energy Medicine: the Scientific Basis. Elsevier, 2016.

2. Monnier VM, Mustata GT, Biemel KL, Reihl O, Lederer MO, Zhenyu D, Sell DR. Cross-linking of the extracellular matrix by the maillard reaction in aging and diabetes: an update on “a puzzle nearing resolution”. Ann N Y Acad Sci. 2005 Jun;1043:533-44. doi: 10.1196/annals.1333.061. PMID: 16037276.

3. Husemann, Friedrich. “Silica (Quartz).” The Anthroposophic Approach to Medicine, by Friedrich Husemann and Otto Wolff, vol. 2, Mercury Press, 2014, pp. 118–119. 4. Ogata M, Araki K, Ogata T. An electron microscopic study of Helicobacter pylori in the surface mucous gel layer. Histol Histopathol. 1998 Apr;13(2):347-58. doi: 10.14670/HH 13.347. PMID: 9589892.

5. Coulter, C. Portraits of Homeopathic Medicines, by C. R. Coulter, vol. 2, Churchill Livingstone, 1997, pp. 63–96.

6. Rau, Thomas, and Thomas Rau. Biological Medicine. Semmelweis-Institut, Verl. für Naturheilkunde, 2011.

7. Jacqmin-Gadda H, Commenges D, Letenneur L, Dartigues JF. Silica and aluminum in drinking water and cognitive impairment in the elderly. Epidemiology. 1996 May;7(3):281-5. doi: 10.1097/00001648-199605000-00011. PMID: 8728442.

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Aric D. Cox, DC

Aric D. Cox, DC

drcox@irestorehealth.com

Is a Limbic System Impairment Hijacking Your Health?

Is a Limbic System Impairment Hijacking Your Health?

December 29, 2020

Is a Limbic System Impairment Hijacking Your Health?

Jonathan Streit, DC

Understanding the limbic system’s role in your health is pivotal to identifying whether or not you have a limbic system impairment. It can also equip you to recognize the types of trauma that create limbic system dysfunction. Knowing if a limbic system impairment is hijacking your health empowers you to put an end to suffering and usher in better health outcomes.

Your brain is made up of a 100 billion brain cells. Each cell is in constant communication with other cells. This allows the brain to adapt to countless stimuli. Using neuroplastic retraining2, we can change the brain’s way of processing. Read more…

Jonathan Streit, DC

drstreit@irestorehealth.com

Recent Posts

Nutrition: The most fundamental nutrient

Nutrition: The most fundamental nutrient

December 29, 2020

Nutrition: The most fundamental nutrient

Ian Kennedy

Nutrition is an unavoidable topic today within most complimentary, alternative, integrative, progressive and bioregulatory approaches to health and wellness. There is not a health care practice that you can walk into today and avoid the conversation of diet and nutrition. There is a vast array of information and opinion out there when it comes to nutrition, eating and diet. Minerals, vitamins, whole foods, organic foods, supplements, vegetarian, vegan, fruitarian, intermittent fasting and so on. Nutrition and diet is a multi-billion dollar industry and can be a very deep rabbit hole into which one can fall. An obsessiveness around food and diet can become an disorder all of its own. Personally, I advocate a diet that mirrors that of simians. This is a diet that consist primarily of a wide array of vegetables, fruits, berries, nuts, seeds, some egg, pure water and a little bit of meat once in a while. Our human DNA is 1.24 percent different then that of a chimpanzee. Not much of a difference at all when you think about it. Our anatomy is also very similar. This close resemblance between us is one of the reasons that monkeys and chimpanzees our used in pharmaceutical and other scientific laboratories for experimentation. Chimps and other simians however differ from us in that they possesses five to eight times the physical strength of a human. So, eating like a member of the great apes is not a bad idea and most likely mimics the diet of our ancestors.

Nevertheless, of all the nutrients that are vital to the proper function of the body and the life of a human being, one stands paramount and that is Oxygen. Oxygen is the most critical of nutrients. It is also the only one that we get with every breath we take. Deprived of the next in-breath you and your body fall apart. Today even conventional science suggests that 90% of our body energy comes from oxygen and only 10% comes from food. (https://sciencing.com/hunmans-oxygen-bodies-10018091.html)

 

This is because of oxygens role in the electron transport chain (ETC), which cannot function without oxygen. The ETC is by far the most efficient method of converting food into ATP, which chemically powers the body. This chain also produces byproducts that are used in other phases of ATP production. All this centers on the availability of electrons and oxygen. We all know that oxygen is critically important for appropriate brain function and though the brain makes up for only 2% of our body weight it consumes 20% of the body’s oxygen. Fact is, the best way to prevent brain deterioration and actually regenerate the brain is through oxygenation that occurs during deep breathing and low-impact exercise. Not diet. Not hormones. Not detoxification. Oxygen is the body’s number one most important nutrient for energy, proper function and regeneration. With little awareness one can see that many who find themselves in declining health have as a component to their deterioration poor sleep, poor posture and ultimately poor breathing.

Posture has much to do with breathing appropriately and many people sit, stand and sleep in unsupportive postures that inhibit correct breathing. Helping others just become more aware of their posture while standing, sitting and laying down will help the body to naturally beath better. It is easy to see why deep breathing is so important and why shallow breathing is so detrimental to the system when we consider the important of oxygen and its role in energy production and brain function. Those who suffer with fatigue, brain fog and general weakness you will find are also poor breathers. Another advantage to breathing properly and deliberately oxygenating the body is that cancer cells, fungi, and anaerobic bacteria thrive in an oxygen-absent or low oxygen environment, while cancer cells, fungi, and anaerobic bacteria do not survive an oxygen-rich environment.

For thousands of years great mystics, yogis, buddhas and spiritual practitioners have advocated conscience breathing techniques that range in results from increasing the heat within the body to stimulating the immune system and reaching higher states of awareness. Breathing and breath control practices have advantages and offers abilities to the adherent that not only offer immense health benefits but also the possibility of reaching deeper states of consciousness and being.

Ian Kennedy, True Wellness

BRMI Advisor Ian Kennedy

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Finding Balance with Time and Space

Finding Balance with Time and Space

December 29, 2020

Finding Balance with Time and Space

Ian kennedy

No one can ever occupy the same space that you now occupy

 

You were born into space and a time that is exclusively yours for the duration of time that you will occupy your body. Space and time are the most fundamental and monumental aspects of life. Without them, nothing exists. We are born at a certain time into an emptiness only we will fill at that moment. Many circumstances within the time-frame of the history one is living in may be largely out of one’s control, yet we still have authority over how we realize and utilize our time and what we do within the space we fill.

 

We are in fact all time travelers. There is no other way. Time waits for no man; it is like the darkness of space, eternal. If we have a physical body it must occupy space and move through a period of time. We may not really move through time as much as we may move with time, or time may move over us like a wave or a cloud, or maybe time moves right through us. Regardless, time ultimately wins out because at some point we can no longer hold onto the physical body, and without a body and its five senses there can be no sensation of time.

 

If you have ever been in a sensory deprivation tank (It’s a submersion in a mixture of dense saltwater creating high buoyancy within a chamber of complete darkness) When the sensation of the body and mind is limited in this way, there is a distorted perspective regarding time. It essentially disappears from one’s experience. This does not mean that time stops, just that our perception of it fades away. If you have ever used hallucinogens such as L.S.D. or plants like peyote or psilocybin mushrooms, (I am not advocating such use) one of the most noticeable reactions outside of hallucination, is the distortion of time. So, Einstein was right time is relative. Relative to your experience and your location within space. If you have ever been sedated for a medical procedure you have also experienced an absence of time. If you are able to allow meditativeness to over overtake you, you will find time also seems to dissolve from one’s perception.

 

Time is manifested in many ways

Cosmic time is set forth from the initial outpouring of cosmic material from out the void. Many researchers today looking into the origin of the universe are moving away from the “big bang” or instantaneous explosion theory and are coming to the concept of something more akin to a continuous cosmic roar. This roar is an outpouring of time, space, and cosmic material. Combined, these three create the geometry of the cosmos and even how the planets have been set in motion through space and time within our solar system.

 

There is also solar time. The fact we orbit around a sun creating what we call years, as well as the spin of the planet upon its own axis, creating our night and day together marks the lifespan for every creature on earth. What happens to time when we leave the rotation of the earth and the orbit of the sun? It has been noted that astronauts when in space and return to the earth have to missed a segment of solar/earth time.

 

Then there is the time within us set by the beating of our own heart and the respirations of our own breath. Regardless of where we are, time is inescapable. These are our most intimate personal timekeepers. With every breath and every heartbeat that leads to the next, the countdown to zero beats and breaths is on. Our very Bioregulatory fluctuation of parasympathetic and sympathetic is another timekeeper within the autonomic nervous system. Resting and burning energy is a continuous wave marking time within our physiology.

 

Cycles of time and space, macro and micro. are both unavoidable miracles of life. The great potential that lays within every human being however. is that we, unlike any other creature, have the capacity to realize this. By realizing that our time and our experience of the space we occupy are limited and finite and that these are irreplaceable committees afforded to us in this life can be enlightening. Working with time and space in a conscience way is purely a humanistic ability. What we do with our time and what we do in the space we occupy is truly the only legacy we can leave. It is our own karmic imprint that is left on the fabric of time and space that continues on forever. What actions you take externally and internally is all that remains.

 

How does this relate to our health and well being? How do space and time affect our Bioregulation? When we put our time and space in the proper place within our own lives we can go beyond the undercurrent of anxiety over illness, disease, old age, and death that can detract from the experience of life. We can endeavor to embrace every moment, as a lifetime, and every space we occupy as sacred space. Knowing that our body, mind, emotion, energy, and informational vibration are only held in place by space itself in the now of time, is a leap toward ultimate liberation.

 

With this in mind, it is a fine practice to bow down with gratefulness once in the morning, once in the middle of the day, and once at night with gratitude to the space that held you together for another twenty-four hours. Look up into the sky with gratefulness and gratitude not to a God or some geographical heaven but simply to the space that has held you for another day. If you consistently do this over a period of time you will see a sense of blissfulness will open up in your life in many different ways.

 

For me, living and helping others live a Bioregulatory lifestyle is more than using natural remedies and therapies to restore, maintain or advance our health. It is a commitment to maintaining a connection to the natural world while living in modern society. It is relying on the wisdom of the body and choosing to see everything in life as a miracle. A Bioregulatory lifestyle offers an ever-expanding awareness of self, including the time and space we presently have. A Bioregulatory lifestyle encourages an ever-deepening involvement in the natural processes of life and when there is deep involvement and a sharp awareness of the space we occupy and the continuous movement of time, the space we occupy becomes sacred and time has is spent wisely and never wasted.

 

Ian Kennedy

 
 
 
 
 
 
 

The True Wellness Center

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Thiomersal (C9H9HgNaO2S) in Vaccines

Thiomersal (C9H9HgNaO2S) in Vaccines

December 28, 2020

Thiomersal (C9H9HgNaO2S) in Vaccines

James Odell, OMD, ND, L.Ac.

Thimerosal (or Thiomersal) is a trade name for an organic mercurial compound (sodium ethyl-mercury (Hg) thiosalicylate) that is 49.55% mercury (Hg) by weight, which rapidly decomposes in aqueous saline solutions into ethyl-Hg hydroxide and ethyl-Hg chloride. It has been widely used since the 1930s as a preservative in certain vaccines cosmetics, tattoo inks, eye drops and contact lens solutions as well as a disinfectant (e.g. Merthiolate). Because of its application as a vaccine preservative, almost every human and animal (domestic and farmed) that has received Thimerosal-containing vaccines have been exposed to ethyl-mercury. Concerns have been voiced about its use in vaccines because ethyl-mercury is highly toxic to human cells and has been shown to be nephrotoxic (kidney) and neurotoxic (Geier, D 2015; Clarkson, T 1997). There are over 165 studies that have focused on Thimerosal used as a preservative in many childhood vaccines, and found it to be harmful.

Since there is insufficient data available regarding the toxic profile of ethylmercury, the FDA guidelines for methylmercury (MeHg) have been used to predict the potential toxicity of Thimerosal. This assumes that the toxicokinetic profile of the two organic mercury salts is similar. However, new studies prove that this is not the case. The main route of human exposure to MeHg is oral ingestion of seafood; for ethylmercury, human exposure is mainly by injection of thimerosal-containing vaccines. Compared with inorganic mercury salts, organic mercury (Thimerosal) is absorbed more effectively and thus has a greater toxic potential.

 

Specifically, Thimerosal is initially metabolized into ethyl-Hg compounds and thiosalicylate and rapidly binds onto thiol groups found on many proteins in human blood. It is then actively transported throughout the body and even across the blood-brain barrier into neuronal cells, where it significantly accumulates and may persist for months to years following exposure. There it damages neurons (brain cells), particularly in the dentate gyrus of the hippocampus and thalamus. Although Thimerosal-containing vaccines have been banned in several countries, it continues to be added to some vaccines in the US and many vaccines in the developing world.

 

Thiomersal – Not an Effective Antimicrobial

 

Mercury compounds have been used as disinfectants or antimicrobials since bacteriology began. For a long period of time mercurial compounds, such as mercury chloride, were thought to be useful in the killing of bacteria and other microorganisms. However, as early as 1943, it was reported that plasma preserved with 1:10,000 Thimerosal was still contaminated with viable microorganisms, and it was concluded that Thimerosal cannot be considered the ideal preservative. Morton et al. found that Thimerosal is not highly germicidal and does not possess high antimicrobial value in the presence of serum and other protein mediums. They further stated that the loss of antibacterial activity of mercurials in the presence of serum proves their incompatibility with serum. Furthermore, these investigators described that Thimerosal was 35-times more toxic to embryonic tissue cells than it was to bacteria, as well as more toxic to leukocytes (white blood cells) than bacteria (Morton, H 1948).

 

More recently, the effectiveness of Thimerosal as a preservative in Diphtheria–Tetanus–Pertussis (DTP) vaccine was evaluated by the US CDC. The CDC researchers reported that the choice and level of the preservative for inclusion in the DTP vaccine were limited because of possible harmful effects on the vaccine’s antigenicity, plus the need to ensure the safety of the preservative. These investigators reported that Thimerosal used in the production of the DPT vaccine as an organic-Hg bacteriostatic agent was only weakly bactericidal. These investigators concluded that at currently used concentrations, Thimerosal is not an ideal preservative (Stetler, H 1985). Higher concentrations were not recommended because it might reduce vaccine potency or pose a danger to individuals receiving the vaccine.

 

Other investigators have observed that Thimerosal failed to meet European Pharmacopoeia antimicrobial effectiveness acceptance criteria as a preservative due to lack of growth inhibition of Thimerosal on Staphylococcus aureus in both single and multi-challenge evaluations (Khandke, L 2011). These researchers have compared and described the toxicity levels of commonly used preservatives in vaccines and found that other non-mercurial, less toxic preservatives, such as 2-Phenoxyethanol, provided a superior antimicrobial effectiveness over Thimerosal for vaccine formulations.

 

Despite the evidence that Thimerosal is a potent biologically toxin (Geier, D 2010), is not an effective antimicrobial, and that there are other less toxic and more effective preservatives available, Thimerosal continues to be used as a preservative in several vaccines to date throughout the world. This compound is a considerable source of mercury exposure for children (Kern, J 2011).

 

Current use of Thimerosal in Vaccines

 

In the 1990s, an increasing number of different vaccines containing Thimerosal were introduced in vaccination schedules around the world, and thus, the average cumulative exposure to Thimerosal in infants has increased in recent years. In 1997, Frank Pallone, a U.S. congressman from New Jersey attached a simple, 133-word amendment to a Food and Drug Administration (FDA) reauthorization bill. This amendment gave the FDA 2 years to “compile a list of drugs and foods that contain intentionally introduced mercury compounds and [to] provide a quantitative and qualitative analysis of the mercury compounds in the list (21 USC 397 Section 413, 1997).” The bill — the FDA Modernization Act of 1997 — was signed into law on November 21, 1997. Neither the press nor the public took notice.

 

Eighteen months later, in May 1999, the FDA found that by 6 months of age, infants could receive as much as 75 μg of mercury from three doses of diphtheria–tetanus–pertussis vaccine, 75 μg from three doses of the Haemophilus influenzae type b vaccine, and 37.5 μg from three doses of the hepatitis B vaccine — a total of 187.5 μg of mercury. Thus, cumulative doses of Hg exposure from Thimerosal-containing vaccines can be as high as 187.5 μg Hg in the first six months of life (Bingham, M 2005). Although this degree of exposure in the first six months of life has been reduced in the US in recent years, it remains unchanged in developing countries.

 

In June 2000, a joint statement on Thimerosal in vaccines was prepared by the American Academy of Family Physicians (AAFP), the American Academy of Pediatrics (AAP), the Advisory Committee on Immunization Practices (ACIP), and the Public Health Service (PHS) in response to:

 

1) the progress in achieving the national goal declared in July 1999 to remove Thimerosal from vaccines in the recommended childhood vaccination schedule, and

2) results of recent studies that examined potential associations between exposure to mercury in thimerosal-containing vaccines and health effects.

 

In this statement, AAFP, AAP, ACIP, and PHS recommend “continuation of the current policy of moving to vaccines that are free of Thimerosal as a preservative. Until adequate supplies are available, use of vaccines that contain Thimerosal as a preservative is acceptable.”

 

However, starting in April of 2002, the US Center for Disease Control began to recommend that influenza vaccines are given to infants and children, who were 6-to-23 months of age, when the only approved influenza vaccine for that age group was preserved with Thimerosal (Sanofi Pasteur’s Fluzone®). In addition, the US CDC recommended influenza vaccines be given to women who were pregnant in their second and third trimesters, when the only available influenza vaccines were also Thimerosal preserved. In addition, through 2010, the US CDC progressively widened the age range for annual influenza vaccine such that very young children were supposed to get two doses of influenza vaccine initially (at 6 and 7 months of age) and then receive an additional dose every year. All these vaccines administered contained Thimerosal. By this time, the US CDC had also discontinued the “second-and-third-trimester” constraint on giving influenza vaccines to pregnant women.

 

Thus, even though the US FDA eventually approved the reduced-Thimerosal and no-Thimerosal formulations of the tetanus-containing vaccines and some other vaccines, exposure to Thimerosal through vaccination continued. In 2013, more than half of all the influenza vaccines were still preserved with Thimerosal.

 

To date, most routinely recommended pediatric vaccines manufactured for the U.S. market contain either no Thimerosal or trace amounts. Even though there are other more effective, non-toxic preservatives that could replace Thiomersal, it is still added particularly to multidose injectable vaccines, such as influenzas (flu). The cost-effectiveness of adding Thimerosal to multidose vaccines still overrides safety concerns. Thimerosal is still a preservative in some of the other US FDA-approved vaccines. Outside North America and Europe, many vaccines still contain Thiomersal. Clearly, Thimerosal should be banned and eliminated as a vaccine preservative throughout the world.

 

Thimerosal is still added to and present in these vaccines: (Source: Institute for Vaccine Safety, Johns Hopkins Bloomberg School of Public Health)

 

The culmination of the research that examines the effects of Thimerosal in humans indicates that it is a poison at minute levels with a plethora of deleterious consequences, and there is a clear cause for concern. To date, there are over 150 studies that show harm from Thimerosal including increased risk of neurodevelopmental disorders, such as autism, attention-deficit/hyperactivity disorder, and language and speech delay. The following selected articles describe Thimerosal as used in vaccines and its related biological toxic effects

Artices

 

Adams, J. B., M. Baral, E. Geis, J. Mitchell, J. Ingram, A. Hensley, I. Zappia et al. “The severity of autism is associated with toxic metal body burden and red blood cell glutathione levels.” Journal of Toxicology 2009 (2009).

http://downloads.hindawi.com/journals/jt/2009/532640.pdf

 

Abstract

This study investigated the relationship of children’s autism symptoms with their toxic metal body burden and red blood cell (RBC) glutathione levels. In children ages 3–8 years, the severity of autism was assessed using four tools: ADOS, PDD-BI, ATEC, and SAS. Toxic metal body burden was assessed by measuring urinary excretion of toxic metals, both before and after oral dimercaptosuccinic acid (DMSA). Multiple positive correlations were found between the severity of autism and the urinary excretion of toxic metals. Variations in the severity of autism measurements could be explained, in part, by regression analyses of urinary excretion of toxic metals before and after DMSA and the level of RBC glutathione.

 

Carneiro, Maria Fernanda Hornos, Juliana Maria Oliveira Souza, Denise Grotto, Bruno Lemos Batista, Vanessa Cristina de Oliveira Souza, and Fernando Barbosa Jr. “A systematic study of the disposition and metabolism of mercury species in mice after exposure to low levels of thimerosal (ethylmercury).” Environmental Research 134 (2014): 218-227.

https://d1wqtxts1xzle7.cloudfront.net/48859007/Identification_and_distribution_of_mercu20160915-15925-1wvmggx.pdf?1473951151=&response-content-disposition=inline%3B+filename%3DIdentification_and_distribution_of_mercu.pdf&Expires=1604530585&Signature=EoyMFFR4wtlMq08Lzb5VjsBPPMQTrrPMk7xj8-XHyDC1ra5QAeF0vDCxDl1J0igHGVNLR6e0BRvn4N2YcdK3cWhAKfFrE8TyhYeqEp7yYXfRiX25BhL492JO5e9MoVUCFD0E1OhTeXlWXJlLxkPhUg1z6CpwP–d9UlpRovmGqvqNZfD45BqJg6pBrspsW4SrHWkD20ACqNUbh0Ni5VHBzjga4zpUoPE~vctX2gcDRVnN-7OB3uKHCaGjWn3x3e3x6whQTAmaUl2h2YD5rEGOXK3XewCaPOswZd7weJpsdhMlZ8aO~I~079i2ToXJsQX2tz5AFuLQKNV31DUrXX7VQ__&Key-Pair-Id=APKAJLOHF5GGSLRBV4ZA

 

Abstract

Thimerosal (TM) is an ethylmercury (etHg)-containing preservative used in some vaccines despite very limited knowledge on the kinetics and direct interaction/effects in mammals’ tissues after exposure. Thus, this study aimed to evaluate the kinetics of Hg species in mice in a time course analysis after intramuscular injection of TM, by estimating Hg half-lives in blood and tissues. Mice were exposed to one single intramuscular dose of 20 mg of Hg as TM. Blood, brain, heart, kidney and liver were collected at 0.5 hour (h), 1 h, 8 h, 16 h, 144 h, 720 h and 1980 h after TM exposure (n¼4). Hg species in animal tissues were identified and quantified by speciation analysis via liquid chromatography hyphenated with inductively coupled mass spectrometry (LC–ICP-MS). It was found that the transport of etHg from muscle to tissues and its conversion to inorganic Hg (inoHg) occur rapidly. Moreover, the conversion extent is modulated in part by the partitioning between EtHg in plasma and in whole blood, since etHg is rapidly converted in red cells but not in a plasma compartment. Furthermore, the dealkylation mechanism in red cells appears to be mediated by the Fenton reaction (hydroxyl radical formation). Interestingly, after 0.5 h of TM exposure, the highest levels of both etHg and inoHg were found in kidneys (accounting for more than 70% of the total Hg in the animal body), whereas the brain contributed least to the Hg body burden (accounts for o1.0% of total body Hg). Thirty days after TM exposure, most Hg had been excreted while the liver presented the majority of the remaining Hg. Estimated half-lives (in days) were 8.8 for blood, 10.7 for brain, 7.8 for heart, 7.7 for liver and 45.2 for kidney. Taken together, our findings demonstrated that TM (etHg) kinetics more closely approximates Hg2þ than methylmercury (meHg) while the kidney must be considered a potential target for etHg toxicity.

Dorea, Jose. “Low-dose mercury exposure in early life: relevance of thimerosal to fetuses, newborns and infants.” Current Medicinal Chemistry 20, no. 32 (2013): 4060-4069.

https://www.ingentaconnect.com/content/ben/cmc/2013/00000020/00000032/art00006

Abstract

This review explores the different aspects of constitutional factors in early life that modulate toxicokinetics and toxicodynamics of low-dose mercury resulting from acute ethylmercury (etHg) exposure in Thimerosal-containing vaccines (TCV). Major databases were searched for human and experimental studies that addressed issues related to early life exposure to TCV. It can be concluded that: a) mercury load in fetuses, neonates, and infants resulting from TCVs remains in blood of neonates and infants at sufficient concentration and for enough time to penetrate the brain and to exert a neurologic impact and a probable influence on neurodevelopment of susceptible infants; b) etHg metabolism related to neurodevelopmental delays has been demonstrated experimentally and observed in population studies; c) unlike chronic Hg exposure during pregnancy, neurodevelopmental effects caused by acute (repeated/cumulative) early life exposure to TCV-etHg remain unrecognized; and d) the uncertainty surrounding low-dose toxicity of etHg is challenging but recent evidence indicates that avoiding cumulative insults by alkyl-mercury forms (which include Thimerosal) is warranted. It is important to a) maintain trust in vaccines while reinforcing current public health policies to abate mercury exposure in infancy; b) generally support WHO policies that recommend vaccination to prevent and control existing and impending infectious diseases; and c) not confuse the ‘need’ to use a specific ‘product’ (TCV) by accepting as ‘innocuous’ (or without consequences) the presence of a proven ‘toxic alkyl-mercury’ (etHg) at levels that have not been proven to be toxicologically safe.

Dórea, José G. “Integrating experimental (in vitro and in vivo) neurotoxicity studies of low-dose thimerosal relevant to vaccines.” Neurochemical research 36, no. 6 (2011): 927-938.

https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.668.6252&rep=rep1&type=pdf

Abstract

There is a need to interpret neurotoxic studies to help deal with uncertainties surrounding pregnant mothers, newborns and young children who must receive repeated doses of Thimerosal-containing vaccines (TCVs). This review integrates information derived from emerging experimental studies (in vitro and in vivo) of low-dose Thimerosal (sodium ethyl mercury thiosalicylate). Major databases (PubMed and Web-of-science) were searched for in vitro and in vivo experimental studies that addressed the effects of low-dose Thimerosal (or ethylmercury) on neural tissues and animal behaviour. Information extracted from studies indicates that: (a) activity of low doses of Thimerosal against isolated human and animal brain cells was found in all studies and is consistent with Hg neurotoxicity; (b) the neurotoxic effect of ethylmercury has not been studied with co-occurring adjuvant-Al in TCVs; (c) animal studies have shown that exposure to Thimerosal-Hg can lead to accumulation of inorganic Hg in brain, and that (d) doses relevant to TCV exposure possess the potential to affect human neuro-development. Thimerosal at concentrations relevant for infants’ exposure (in vaccines) is toxic to cultured human-brain cells and to laboratory animals. The persisting use of TCV (in developing countries) is counterintuitive to global efforts to lower Hg exposure and to ban Hg in medical products; its continued use in TCV requires evaluation of a sufficiently nontoxic level of ethylmercury compatible with repeated exposure (co-occurring with adjuvant-Al) during early life.

 

Dórea, José G. “Making sense of epidemiological studies of young children exposed to thimerosal in vaccines.” Clinica Chimica Acta 411, no. 21-22 (2010): 1580-1586.

https://www.sciencedirect.com/science/article/abs/pii/S0009898110004675

 

Abstract

Objective

To compare epidemiological studies dealing with neurological issues (compatible with Hg toxicity) linked to exposing newborns and infants to intramuscular doses of preservative-Hg resulting from vaccination with thimerosal-containing vaccines (TCV).

Methods

Major databases were searched for studies that addressed neurodevelopment outcomes other than autism. Eight studies were identified and compared.

Results

Information extracted from the studies done in the USA, the UK, and Italy is important in understanding the complex interplay of variables but insufficient to establish non-toxicity for infants and young children still receiving TCV: a) there is ambiguity in some studies reporting neurodevelopment outcomes that seem to depend on confounding variables; b) the risk of neurotoxicity due to low doses of thimerosal is plausible at least for susceptible infants; c) there is a need to address these issues in less developed countries still using TCV in pregnant mothers, newborns, and young children.

Conclusions

Since the use of TCV is still inevitable in many countries, this increases the need to protect vulnerable infants and promote actions that strengthen neurodevelopment. Developing countries should intensify campaigns that include breastfeeding among efforts to help prime the central nervous system to tolerate exposure to neurotoxic substances, especially thimerosal-Hg.

 
 

Fagan, D. G., J. S. Pritchard, Thomas W. Clarkson, and M. R. Greenwood. “Organ mercury levels in infants with omphaloceles treated with organic mercurial antiseptic.” Archives of Disease in Childhood 52, no. 12 (1977): 962-964.

https://adc.bmj.com/content/archdischild/52/12/962.full.pdf

Abstract

Samples of fresh and fixed tissues from infants with exomphalos treated by thiomersal application were analyzed for mercury content. The results showed that thiomersal can induce blood and organ levels of organic mercury which are well in excess of the minimum toxic level in adults and fetuses. The analysis of fresh and fixed tissues must be carefully controlled against normal tissues in order to interpret mercury levels accurately.

 

Gallagher, Carolyn M., and Melody S. Goodman. “Hepatitis B vaccination of male neonates and autism diagnosis, NHIS 1997–2002.” Journal of Toxicology and Environmental Health, Part A 73, no. 24 (2010): 1665-1677.

http://vaccinesafetycommission.org/pdfs/26-2010-Hep-B-Autism.pdf

 

Abstract

Universal hepatitis B vaccination was recommended for U.S. newborns in 1991; however, safety findings are mixed. The association between hepatitis B vaccination of male neonates and parental report of autism diagnosis was determined. This cross-sectional study used weighted probability samples obtained from National Health Interview Survey 1997–2002 data sets. Vaccination status was determined from the vaccination record. Logistic regression was used to estimate the odds for autism diagnosis associated with neonatal hepatitis B vaccination among boys age 3–17 years, born before 1999, adjusted for race, maternal education, and two-parent household. Boys vaccinated as neonates had threefold greater odds for autism diagnosis compared to boys never vaccinated or vaccinated after the first month of life. Non-Hispanic white boys were 64% less likely to have autism diagnosis relative to nonwhite boys. Findings suggest that U.S. male neonates vaccinated with the hepatitis B vaccine prior to 1999 (from vaccination record) had a threefold higher risk for parental report of autism diagnosis compared to boys not vaccinated as neonates during that same time period. Nonwhite boys bore a greater risk.

 

Geier, Mark R., and David A. Geier. “Neurodevelopmental disorders after thimerosal-containing vaccines: a brief communication.” Experimental biology and medicine 228, no. 6 (2003): 660-664.

http://schizophreniahelpforyou.com/EXPERT%20PAPER%20-%20Geier%20-%20Internet%20File.pdf

 

Abstract

We were initially highly skeptical that differences in the concentrations of thimerosal in vaccines would have any effect on the incidence rate of neurodevelopmental disorders after childhood immunization. This study presents the first epidemiologic evidence, based upon tens of millions of doses of vaccine administered in the United States, that associates increasing thimerosal from vaccines with neurodevelopmental disorders. Specifically, an analysis of the Vaccine Adverse Events Reporting System (VAERS) database showed statistical increases in the incidence rate of autism (relative risk [RR] = 6.0), mental retardation (RR = 6.1), and speech disorders (RR = 2.2) after thimerosal-containing diphtheria, tetanus, and acellular pertussis (DTaP) vaccines in comparison with thimerosal-free DTaP vaccines. The male/female ratio indicated that autism (17) and speech disorders (2.3) were reported more in males than females after thimerosal containing DTaP vaccines, whereas mental retardation (1.2) was more evenly reported among male and female vaccine recipients. Controls were employed to determine if biases were present in the data, but none were found. It was determined that overall adverse reactions were reported in similar-aged populations after thimerosal-containing DTaP (2.4 ± 3.2 years old) and thimerosal-free DTaP (2.1 ± 2.8 years old) vaccinations. Acute control adverse reactions such as deaths (RR = 1.0), vasculitis (RR = 1.2), seizures (RR = 1.6), ED visits (RR = 1.4), total adverse reactions (RR = 1.4), and gastroenteritis (RR = 1.1) were reported similarly after thimerosal containing and thimerosal-free DTaP vaccines. An association between neurodevelopmental disorders and thimerosal containing DTaP vaccines was found, but additional studies should be conducted to confirm and extend this study.

 

Geier, D. A., P. G. King, L. K. Sykes, and M. R. Geier. “A comprehensive review of mercury provoked autism.” Indian Journal of Medical Research 128, no. 4 (2008): 383.

http://w.toxcenter.org/artikel/Mercury-provoked-autism-review-mas.pdf

 

Abstract

Emerging evidence supports the theory that some autism spectrum disorders (ASDs) may result from a combination of genetic/biochemical susceptibility, specifically a reduced ability to excrete mercury (Hg), and exposure to Hg at critical developmental periods. Elemental/inorganic Hg is released into the air/water where it becomes methylated and accumulates in animal tissues. The US population is primarily exposed to methyl-Hg by fish consumption. In addition, many pharmaceuticals have been, and some continue to be, a ubiquitous source of danger because they contain mercurials. Mercurials may be found in drugs for the eye, ear, nose, throat, and skin; in bleaching creams; as preservatives in cosmetics, tooth pastes, lens solutions, vaccines, allergy test and immunotherapy solutions; in antiseptics, disinfectants, and contraceptives; in fungicides and herbicides; in dental fillings and thermometers; and many other products. Hg has been found to cause immune, sensory, neurological, motor, and behavioural dysfunctions similar to traits defining/associated with ASDs, and that these similarities extend to neuroanatomy, neurotransmitters, and biochemistry. Furthermore, a review of molecular mechanisms indicates that Hg exposure can induce death, disorganization and/or damage to selected neurons in the brain similar to that seen in recent ASD brain pathology studies, and this alteration may likely produce the symptoms by which ASDs are diagnosed. Finally, a review of treatments suggests that ASD patients who undergo protocols to reduce Hg and/or its effects show significant clinical improvements in some cases. In conclusion, the overwhelming preponderance of the evidence favours acceptance that Hg exposure is capable of causing some ASDs

 

Geier, David A., Paul G. King, Brian S. Hooker, José G. Dórea, Janet K. Kern, Lisa K. Sykes, and Mark R. Geier. “Thimerosal: clinical, epidemiologic and biochemical studies.” Clinica Chimica Acta 444 (2015): 212-220

https://www.sciencedirect.com/science/article/pii/S0009898115001023

 

Conclusion

The culmination of the research that examines the effects of Thimerosal in humans indicates that it is a poison at minute levels with a plethora of deleterious consequences, even at the levels currently administered in vaccines.

Geier, David A., Sarah K. Jordan, and Mark R. Geier. “The relative toxicity of compounds used as preservatives in vaccines and biologics.” Medical Science Monitor 16, no. 5 (2010): SR21-SR27.

https://www.researchgate.net/profile/David_Geier/publication/43348711_The_relative_toxicity_of_compounds_used_as_preservatives_in_vaccines_and_biologics/links/02bfe50ece52caa8b1000000.pdf

 

Abstract

We were initially highly skeptical that differences in the concentrations of thimerosal in vaccines would have any effect on the incidence rate of neurodevelopmental disorders after childhood immunization. This study presents the first epidemiologic evidence, based upon tens of millions of doses of vaccine administered in the United States, that associates increasing thimerosal from vaccines with neurodevelopmental disorders. Specifically, an analysis of the Vaccine Adverse Events Reporting System (VAERS) database showed statistical increases in the incidence rate of autism (relative risk [RR] = 6.0), mental retardation (RR = 6.1), and speech disorders (RR = 2.2) after thimerosal-containing diphtheria, tetanus, and acellular pertussis (DTaP) vaccines in comparison with thimerosal-free DTaP vaccines. The male/female ratio indicated that autism (17) and speech disorders (2.3) were reported more in males than females after thimerosal containing DTaP vaccines, whereas mental retardation (1.2) was more evenly reported among male and female vaccine recipients. Controls were employed to determine if biases were present in the data, but none were found. It was determined that overall adverse reactions were reported in similar-aged populations after thimerosal-containing DTaP (2.4 ± 3.2 years old) and thimerosal-free DTaP (2.1 ± 2.8 years old) vaccinations. Acute control adverse reactions such as deaths (RR = 1.0), vasculitis (RR = 1.2), seizures (RR = 1.6), ED visits (RR = 1.4), total adverse reactions (RR = 1.4), and gastroenteritis (RR = 1.1) were reported similarly after thimerosal containing and thimerosal-free DTaP vaccines. An association between neurodevelopmental disorders and thimerosal containing DTaP vaccines was found, but additional studies should be conducted to confirm and extend this study.

 
 

Geier, David A., Janet K. Kern, Paul G. King, Lisa K. Sykes, and Mark R. Geier. “A case-control study evaluating the relationship between Thimerosal-containing Haemophilus influenzae Type b vaccine administration and the risk for a pervasive developmental disorder diagnosis in the United States.” Biological trace element research 163, no. 1-2 (2015): 28-38.

https://link.springer.com/article/10.1007/s12011-014-0169-3

 

Abstract

Thimerosal is an organic mercury (Hg)-containing compound (49.55 % Hg by weight) historically added to many multi-dose vials of vaccine as a preservative. A hypothesis testing case-control study evaluated automated medical records in the Vaccine Safety Datalink (VSD) for organic Hg exposure from Thimerosal in Haemophilus influenzae type b (Hib)-containing vaccines administered at specific times within the first 15 months of life among subjects diagnosed with pervasive developmental disorder (PDD) (n = 534) in comparison to controls. The generally accepted biologically non-plausible linkage between Thimerosal exposure and subsequent diagnosis of febrile seizure (n = 5886) was examined as a control outcome. Cases diagnosed with PDD received significantly more organic Hg within the first 6 months of life (odds ratio (OR) = 1.97, p < 0.001) and first 15 months of life (OR = 3.94, p < 0.0001) than controls, whereas cases diagnosed with febrile seizure were no more likely than controls to have received increased organic Hg. On a per microgram of organic Hg basis, cases diagnosed with a PDD in comparison to controls were at significantly greater odds (OR = 1.0197, p < 0.0001) of receiving increasing organic Hg exposure within the first 15 months of life, whereas cases diagnosed febrile seizure were no more likely than controls (OR = 0.999, p > 0.20) to have received increasing organic Hg exposure within the first 15 months of life. Routine childhood vaccination is an important public health tool to reduce the morbidity and mortality associated with infectious diseases, but the present study provides new epidemiological evidence of a significant relationship between increasing organic Hg exposure from Thimerosal-containing vaccines and the subsequent risk of PDD diagnosis in males and females.

 
 
 
 

Geier, David A., Paul G. King, Brian S. Hooker, José G. Dórea, Janet K. Kern, Lisa K. Sykes, and Mark R. Geier. “Thimerosal: clinical, epidemiologic and biochemical studies.” Clinica Chimica Acta 444 (2015): 212-220.

 

https://www.sciencedirect.com/science/article/pii/S0009898115001023

Abstract – Conclusion

The culmination of the research that examines the effects of Thimerosal in humans indicates that it is a poison at minute levels with a plethora of deleterious consequences, even at the levels currently administered in vaccines.

 
 

Geier, David A., and Mark R. Geier. “A meta-analysis epidemiological assessment of neurodevelopmental disorders following vaccines administered from 1994 through 2000 in the United States.” Neuroendocrinology Letters 27, no. 4 (2006): 401-413.

 

https://www.researchgate.net/profile/Mark_Geier/publication/6976264_A_meta-analysis_epidemiological_assessment_of_neurodevelopmental_disorders_following_vaccines_administered_from_1994_through_2000_in_the_United_States/links/0912f50d1450b33df0000000/A-meta-analysis-epidemiological-assessment-of-neurodevelopmental-disorders-following-vaccines-administered-from-1994-through-2000-in-the-United-States.pdf

 

Abstract

BACKGROUND: Thimerosal is an ethylmercury-containing compound (49.6% mercury by weight) used as at the preservative level in vaccines (0.005% to 0.01%). METHODS: Statistical modeling in a meta-analysis epidemiological assessment of the Vaccine Adverse Event Reporting System (VAERS) for neurodevelopment disorders (NDs) reported following Diphtheria-Tetanus-whole-cell-Pertussis (DTP) vaccines in comparison to Diphtheria-Tetanus-whole-cell-Pertussis-Haemophilus Influenzae Type b (DTPH) vaccines (administered: 1994–1997) and following Thimerosal-containing Diphtheria-Tetanus-acellular-Pertussis (DTaP), vaccines in comparison to Thimerosal-free DTaP vaccines (administered: 1997–2000), was undertaken. RESULTS: Significantly increased adjusted (sex, age, vaccine type, vaccine manufacturer) risks of autism, speech disorders, mental retardation, personality disorders, thinking abnormalities, ataxia, and NDs in general, with minimal systematic error or confounding, were associated with TCV exposure. CONCLUSION: It is clear from the results of the present epidemiological study and other recently published data associating mercury exposure with childhood NDs, additional ND research should be undertaken in the context of evaluating mercury-associated exposures, especially from Thimerosal-containing vaccines.

Geier, David A., Janet K. Kern, Paul G. King, Lisa K. Sykes, and Mark R. Geier. “The risk of neurodevelopmental disorders following a Thimerosal-preserved DTaP formulation in comparison to its Thimerosal-reduced formulation in the Vaccine Adverse Event Reporting System (VAERS).” J Biochem Pharmacol Res 2, no. 2 (2014): 64-73.

https://www.researchgate.net/profile/Mark_Geier/publication/261474301_The_risk_of_neurodevelopmental_disorders_following_a_Thimerosal-preserved_DTaP_formulation_in_comparison_to_its_Thimerosal-reduced_formulation_in_the_vaccine_adverse_event_reporting_system_VAERS/links/0deec535678a12f9ff000000.pdf

 

Abstract

Mercury (Hg) exposure in human infants and fetuses has long been known to be significantly associated with neurodevelopmental disorders (NDs). Thimerosal (49.55% Hg by weight) is an ethyl-Hg containing compound added to many childhood vaccines as a preservative. A hypothesis testing case-control study was undertaken in the Vaccine Adverse Event Reporting System (VAERS) database (updated through September 2013) by examining 5,591 adverse event reports entered following Thimerosal-preserved Diphtheria-Tetanus-acellular-Pertussis (DTaP) (TripediaTM, Sanofi) administered from 1997-1999 (exposed) and following Thimerosal-reduced DTaP (TripediaTM, Sanofi) administered from 2004-2006 (unexposed). Cases were defined as individuals with adverse event reports with the outcomes of autism, speech disorder, mental retardation, or ND (at least of one these aforementioned specific outcomes being mentioned in the adverse event report). Controls were defined as individuals with adverse event reports without any mention of the specific case outcomes examined. Cases reported with the outcomes of autism (odds ratio = 7.67, p < 0.0001), speech disorders (odds ratio = 3.49, p < 0.02), mental retardation (odds ratio = 8.73, p < 0.0005), or ND (odds ratio = 4.82, p < 0.0001) were significantly more likely than controls to have received Thimerosalpreserved DTaP vaccine (exposed) in comparison to Thimerosal-reduced DTaP vaccine (unexposed). Though routine childhood vaccination is considered an important public health tool to reduce the morbidity and mortality associated with certain infectious diseases, this study supports a significant relationship between increased organic-Hg exposure from Thimerosal-preserved childhood vaccines and the child’s subsequent risk of a ND diagnosis.

 

Geier, David A., Brian S. Hooker, Janet K. Kern, Paul G. King, Lisa K. Sykes, and Mark R. Geier. “A two-phase study evaluating the relationship between Thimerosal-containing vaccine administration and the risk for an autism spectrum disorder diagnosis in the United States.” Translational Neurodegeneration 2, no. 1 (2013): 25.

https://www.mdpi.com/1660-4601/11/9/9156/htm

 

Abstract

A hypothesis testing case-control study evaluated concerns about the toxic effects of organic-mercury (Hg) exposure from thimerosal-containing (49.55% Hg by weight) vaccines on the risk of neurodevelopmental disorders (NDs). Automated medical records were examined to identify cases and controls enrolled from their date-of-birth (1991–2000) in the Vaccine Safety Datalink (VSD) project. ND cases were diagnosed with pervasive developmental disorder (PDD), specific developmental delay, tic disorder or hyperkinetic syndrome of childhood. In addition, putative non-thimerosal-related outcomes of febrile seizure, failure to thrive and cerebral degenerations were examined. The cumulative total dose of Hg exposure from thimerosal-containing hepatitis B vaccine (T-HBV) administered within the first six months of life was calculated. On a per microgram of organic-Hg basis, PDD (odds ratio (OR) = 1.054), specific developmental delay (OR = 1.035), tic disorder (OR = 1.034) and hyperkinetic syndrome of childhood (OR = 1.05) cases were significantly more likely than controls to receive increased organic-Hg exposure. By contrast, none of the non-thimerosal related outcomes were significantly more likely than the controls to have received increased organic-Hg exposure. Routine childhood vaccination may be an important public health tool to reduce infectious disease-associated morbidity/mortality, but the present study significantly associates organic-Hg exposure from T-HBV with an increased risk of an ND diagnosis.

 
 

Geier, David A., Lisa K. Sykes, and Mark R. Geier. “A review of Thimerosal (Merthiolate) and its ethylmercury breakdown product: specific historical considerations regarding safety and effectiveness.” Journal of Toxicology and Environmental Health, Part B 10, no. 8 (2007): 575-596.

http://ww.w.toxcenter.org/artikel/Thiomersal-schweres-Hirngift-Literaturstudie.pdf

 

Abstract

Thimerosal (Merthiolate) is an ethylmercury-containing pharmaceutical compound that is 49.55% mercury and that was developed in 1927. Thimerosal has been marketed as an antimicrobial agent in a range of products, including topical antiseptic solutions and antiseptic ointments for treating cuts, nasal sprays, eye solutions, vaginal spermicides, diaper rash treatments, and perhaps most importantly as a preservative in vaccines and other injectable biological products, including Rho(D)-immune globulin preparations, despite evidence, dating to the early 1930s, indicating Thimerosal to be potentially hazardous to humans and ineffective as an antimicrobial agent. Despite this, Thimerosal was not scrutinized as part of U.S. pharmaceutical products until the 1980s, when the U.S. Food and Drug Administration finally recognized its demonstrated ineffectiveness and toxicity in topical pharmaceutical products, and began to eliminate it from these. Ironically, while Thimerosal was being eliminated from topicals, it was becoming more and more ubiquitous in the recommended immunization schedule for infants and pregnant women. Furthermore, Thimerosal continues to be administered, as part of mandated immunizations and other pharmaceutical products, in the United States and globally. The ubiquitous and largely unchecked place of Thimerosal in pharmaceuticals, therefore, represents a medical crisis.

 

Guzzi, Gianpaolo, Paolo D. Pigatto, Francesco Spadari, and Caterina AM La Porta. “Effect of thimerosal, methylmercury, and mercuric chloride in Jurkat T Cell Line.” Interdisciplinary toxicology 5, no. 3 (2012): 159-161.

https://content.sciendo.com/view/journals/intox/5/3/article-p159.xml

 

Abstract

Mercury is a ubiquitous environmental toxicant that causes a wide range of adverse health effects in humans. Three forms of mercury exist: elemental, inorganic and organic. Each of them has its own profile of toxicity. The aim of the present study was to determine the effect of thimerosal, a topical antiseptic and preservative in vaccines routinely given to children, methyl mercury, and mercuric chloride on cellular viability measured by MTT in Jurkat T cells, a human T leukemia cell line. The treatment of Jurkat T cells with thimerosal caused a significant decrease in cellular viability at 1 μM (25%, p<0.05; IC50: 10 μM). Methyl mercury exhibited a significant decrease in cellular viability at 50 μM (33%, p<0.01; IC50: 65 μM). Mercuric chloride (HgCl2) did not show any significant change in cellular survival. Our findings showed that contrary to thimerosal and methyl mercury, mercuric chloride did not modify Jurkat T cell viability.

 

HEINONEN, OLLI P., SAMUEL SHAPIRO, RICHARD R. MONSON, STUART C. HARTZ, LYNN ROSENBERG, and DENNIS SLONE. “Immunization during pregnancy against poliomyelitis and influenza in relation to childhood malignancy.” International Journal of Epidemiology 2, no. 3 (1973): 229-236.

https://academic.oup.com/ije/article-abstract/2/3/229/649803

 

Abstract

In a follow-up study of 50,897 pregnancies, poliomyelitis and influenza immunizations, and viral infections were evaluated as possible risk factors for the development of malignancies in the offspring born between 1959 and 1966. Ascertainment of malignancies was based on clinical follow-up during the first year of life and on mortality experience covering the first four years of life. In 18, 342 children whose mothers were vaccinated during pregnancy with killed polio vaccine there were 14 malignancies (7.6 per 10,000) and in 32, 555 non-exposed children there were 10 (3.1 per 10,000). In the vaccinated group, nine malignancies occurred in children whose mothers were immunized during the first four lunar months of pregnancy (13.2 per 10,000). Time clustering of administration of the vaccine was evident in mothers whose children developed malignancies. There were seven tumours derived from neural tissue in the exposed children (3.8 per 10,000) and one in the non-exposed children (0.3 per 10,000). Elimination of three microscopic tumours reduced the overall rates in the exposed and non-exposed groups to 6.5 and 2.8 per 10,000, respectively. There was no evidence of an excess of malignancies in children exposed in utero to attenuated live polio vaccine, to influenza vaccine, or to spontaneous viral infections.

 
 

Hooker, Brian, Janet Kern, David Geier, Boyd Haley, Lisa Sykes, Paul King, and Mark Geier. “Methodological issues and evidence of malfeasance in research purporting to show Thimerosal in vaccines is safe.” BioMed research international 2014 (2014).

https://www.hindawi.com/journals/bmri/2014/247218/

Abstract

There are over 165 studies that have focused on Thimerosal, an organic-mercury (Hg) based compound, used as a preservative in many childhood vaccines, and found it to be harmful. Of these, 16 were conducted to specifically examine the effects of Thimerosal on human infants or children with reported outcomes of death; acrodynia; poisoning; allergic reaction; malformations; auto-immune reaction; Well’s syndrome; developmental delay; and neurodevelopmental disorders, including tics, speech delay, language delay, attention deficit disorder, and autism. In contrast, the United States Centers for Disease Control and Prevention states that Thimerosal is safe and there is “no relationship between Thimerosal containing vaccines and autism rates in children.” This is puzzling because, in a study conducted directly by CDC epidemiologists, a 7.6-fold increased risk of autism from exposure to Thimerosal during infancy was found. The CDC’s current stance that Thimerosal is safe and that there is no relationship between Thimerosal and autism is based on six specific published epidemiological studies coauthored and sponsored by the CDC. The purpose of this review is to examine these six publications and analyze possible reasons why their published outcomes are so different from the results of investigations by multiple independent research groups over the past 75+ years.

 

Kern, Janet K., Boyd E. Haley, David A. Geier, Lisa K. Sykes, Paul G. King, and Mark R. Geier. “Thimerosal exposure and the role of sulfation chemistry and thiol availability in autism.” International Journal of Environmental Research and Public Health 10, no. 8 (2013): 3771-3800.

https://www.mdpi.com/1660-4601/10/8/3771

Abstract

Autism spectrum disorder (ASD) is a neurological disorder in which a significant number of the children experience a developmental regression characterized by a loss of previously acquired skills and abilities. Typically reported are losses of verbal, nonverbal, and social abilities. Several recent studies suggest that children diagnosed with an ASD have abnormal sulfation chemistry, limited thiol availability, and decreased glutathione (GSH) reserve capacity, resulting in a compromised oxidation/reduction (redox) and detoxification capacity. Research indicates that the availability of thiols, particularly GSH, can influence the effects of thimerosal (TM) and other mercury (Hg) compounds. TM is an organomercurial compound (49.55% Hg by weight) that has been, and continues to be, used as a preservative in many childhood vaccines, particularly in developing countries. Thiol-modulating mechanisms affecting the cytotoxicity of TM have been identified. Importantly, the emergence of ASD symptoms post-6 months of age temporally follows the administration of many childhood vaccines. The purpose of the present critical review is provide mechanistic insight regarding how limited thiol availability, abnormal sulfation chemistry, and decreased GSH reserve capacity in children with an ASD could make them more susceptible to the toxic effects of TM routinely administered as part of mandated childhood immunization schedules

 

Khandke, Lakshmi, Cindy Yang, Ksenia Krylova, Kathrin U. Jansen, and Abbas Rashidbaigi. “Preservative of choice for Prev (e) nar 13™ in a multi-dose formulation.” Vaccine 29, no. 41 (2011): 7144-7153.

https://www.sciencedirect.com/science/article/pii/S0264410X11008218

Abstract

Development of a Prev(e)nar 13™ multi-dose vaccine, in support of vaccinating populations against pneumococcal disease, required the addition of a preservative to the vaccine formulation that met antimicrobial effectiveness tests based on the European Pharmacopoeia (EP) requirements, including deliberate multiple challenge studies and recommendation by the WHO Open Vial Policy. In this study, the antimicrobial effectiveness of several preservatives in Prev(e)nar 13™ formulations was evaluated. A Prev(e)nar 13™ formulation containing 2-Phenoxyethanol (2-PE) at a concentration of 5.0 mg/dose was stable and met EP recommended criteria for antimicrobial effectiveness tests when the formulation was kept over a 30-month period. In contrast, a recommended dose of Thimerosal, as a comparator, or other preservatives did not meet EP antimicrobial effectiveness acceptance criteria. The rate of growth inhibition of Thimerosal compared to 2-PE on Staphylococcus aureus, a resilient organism in these tests, was significantly slower in single and multi-challenge studies. These results indicate that 2-PE provides a superior antimicrobial effectiveness over Thimerosal for this vaccine formulation.

 

Koh, Karen J., Lachlan Warren, Lynette Moore, Craig James, and Geoffrey N. Thompson. “Wells’ syndrome following thiomersal‐containing vaccinations.” Australasian journal of dermatology 44, no. 3 (2003): 199-202.

https://onlinelibrary.wiley.com/doi/abs/10.1046/j.1440-0960.2003.00678.x

 

Summary

A 3½‐year‐old boy presented on three occasions with painful, itchy, oedematous plaques on his limbs. On two occasions he had received hepatitis B vaccination 11–13 days previously, and on the third occasion received triple antigen (DTP) vaccination 10 days earlier. Skin biopsy revealed a prominent infiltrate of eosinophils involving the entire thickness of the dermis. In addition, there were prominent ‘flame figures’ consisting of eosinophilic necrotic collagen surrounded by granular basophilic debris. The clinical and histological pictures were consistent with Wells’ syndrome. The eruption settled on the second and third occasions with 0.1% mometasone furoate cream. Subsequent patch testing showed 2+ reaction to preservative thiomersal at 96 hours. This is the first description of Wells’ syndrome with typical clinical and histopathological features associated with thiomersal in two different vaccines.

 

Marques, Rejane C., José G. Dórea, Márlon F. Fonseca, Wanderley R. Bastos, and Olaf Malm. “Hair mercury in breast-fed infants exposed to thimerosal-preserved vaccines.” european Journal of Pediatrics 166, no. 9 (2007): 935-941.

https://d1wqtxts1xzle7.cloudfront.net/45107045/Hair_mercury_in_breast-fed_infants_expos20160426-7877-1drid6w.pdf?1461691191=&response-content-disposition=inline%3B+filename%3DHair_mercury_in_breast_fed_infants_expos.pdf&Expires=1604604837&Signature=WfTUL6Vu7lPuS8ZgMuENkBPNRYFfFnzfCLz~WAMom5eZys2Zze-T5ja3G5tl8nTbjJJa6sKwDTeggoIgcJ4NfqKEOP4BtEb8Y7yVpgNiWJEzOWyEX7iz5Xvbtdg8SZnq5tm7eQEjyb6gExdjc8UTQg3-uE~r0UNlXBjxIbJGnvuxVASuAdpVu0TV1OE~gRyRDEOddgfdSCT1TCgVuQCsW32M5g-SjYQPhZuwqU2y4ucdV9GfZNMnkUnyy3AlX80QSWlpFEdykaVI2FIHX5-x~42GTyx31mi-N~Ri7AXzWyNa1l9PK4S5uWOrfjbSss-00SyElpqF~93KEVxqoLmNNw__&Key-Pair-Id=APKAJLOHF5GGSLRBV4ZA

 

Abstract

Because of uncertainties associated with a possible rise in neuro-developmental deficits among vaccinated children, thimerosal-preserved vaccines have not been used since 2004 in the USA (with the exception of thimerosalcontaining influenza vaccines which are routinely recommended for administration to pregnant women and children), and the EU but are widely produced and used in other countries. We investigated the impact of thimerosal on the total Hg in hair of 82 breast-fed infants during the first 6 months of life. The infants received three doses of the hepatitis-B vaccine (at birth, 1 and 6 months) and three DTP (diphtheria, tetanus, and pertussis) doses at 2, 4 and 6 months, according to the immunization schedule recommended by the Ministry of Health of Brazil. The thimerosal in vaccines provided an ethylmercury (EtHg) exposure of 25 μgHg at birth, 30, 60 and 120 days, and 50 μgHg at 180 days. The exposure to vaccine-EtHg represents 80% of that expected from total breast milk-Hg in the first month but only 40% of the expected exposure integrated in the 6 months of breastfeeding. However, the Hg exposure corrected for body weight at the day of immunization was much higher from thimerosal- EtHg (5.7 to 11.3 μgHg/kg b.w.) than from breastfeeding (0.266 μgHg/kg b.w.). While mothers showed a relative decrease (−57%) in total hair-Hg during the 6 months lactation there was substantial increase in the infant’s hair-Hg (446%). We speculate that dose and parenteral mode of thimerosal-EtHg exposure modulated the relative increase in hair-Hg of breast-fed infants at 6 months of age.

 

Morton, Harry E., Leon L. North, and Frank B. Engley. “The bacteriostatic and bactericidal actions of some mercurial compounds on hemolytic streptococci: in vivo and in vitro studies.” Journal of the American Medical Association 136, no. 1 (1948): 37-41.

https://jamanetwork.com/journals/jama/article-abstract/298167

 

Abstract

Two outbreaks of group A streptococcal abscesses following receipt of diphtheria-tetanus toxoid-pertussis (DTP) vaccine from different manufacturers were reported to the Centers for Disease Control (CDC) in 1982. The clustering of the immunization times of cases, the isolation of the same serotype of Streptococcus from all cases in each outbreak, and the absence of reported abscesses associated with receipt of the same lots of vaccine in other regions of the country, suggest that each outbreak was probably caused by contamination of a single 15-dose vial of vaccine. The preservative thimerosal was present within acceptable limits in unopened vials from the same lot of DTP vaccine in each outbreak. Challenge studies indicate that a strain of Streptococcus from one of the patients can survive up to 15 days in DTP vaccine at 4°C. Contamination of vials during manufacturing would have required survival of streptococci for a minimum of 8 months. Preservatives in multidose vaccine vials do not prevent short-term bacterial contamination. Options to prevent further clusters of streptococcal abscesses are discussed. The only feasible and cost-effective preventive measure now available is careful attention to sterile technique when administering vaccine from multidose vials.

Mrozek-Budzyn, Dorota, Renata Majewska, Agnieszka Kieltyka, and Malgorzata Augustyniak. “Neonatal exposure to Thimerosal from vaccines and child development in the first 3 years of life.” Neurotoxicology and Teratology 34, no. 6 (2012): 592-597.

https://www.sciencedirect.com/science/article/abs/pii/S0892036212001663

Abstract

Neonatal exposure to Thimerosal from vaccines and child development were examined. Neonatal exposure to Thimerosal affects psychomotor development. No association was found between Thimerosal exposure and mental tests scores.

Patrizi, Annalisa, Laura Rizzoli, Colombina Vincenzi, Pompilio Trevisi, and Antonella Tosti. “Sensitization to thimerosal in atopic children.” Contact Dermatitis 40, no. 2 (1999): 94-97.

https://onlinelibrary.wiley.com/doi/abs/10.1111/j.1600-0536.1999.tb05998.x

Abstract

Thimerosal is an organic mercurial compound widely used as a preservative in vaccines, eyedrops, and contact lens cleaning and storage solutions. 5 infants, 2 female and 3 male, ranging in age from 7 to 28 months and affected by atopic dermatitis (AD) diagnosed according to the Hanifin and Rajka criteria, experienced an exacerbation of their clinical condition 2–10 days after mandatory vaccinations with vaccines containing thimerosal. Cutaneous lesions of nummular eczema appeared on the trunk, limbs and face. All patients were patch tested with serial dilutions of thimerosal in petrolatum. A positive patch test reaction to thimerosal 0.1% pet. was observed in all 5 children. 3 of them also showed a positive reaction at 0.01% and 0.05% pet. Despite their thimerosal‐hypersensitivity, all children completed the entire series of mandatory vaccinations, care being taken to use different needles for injection and aspiration of the vaccine. The 2‐year follow‐up did not reveal other episodes of exacerbation of the AD after vaccination. The present study confirms the high frequency of sensitization to thimerosal in atopic children and suggests that vaccination can cause clinical symptoms in sensitized children. Nevertheless, sensitization to thimerosal does not prevent children from continuing with mandatory vaccinations.

Pichichero, Michael E., Angela Gentile, Norberto Giglio, Veronica Umido, Thomas Clarkson, Elsa Cernichiari, Grazyna Zareba et al. “Mercury levels in newborns and infants after receipt of thimerosal-containing vaccines.” Pediatrics 121, no. 2 (2008): e208-e214.

https://pediatrics.aappublications.org/content/121/2/e208.short

Abstract

The blood half-life of intramuscular ethyl mercury from thimerosal in vaccines in infants is substantially shorter than that of oral methyl mercury in adults. Increased mercury levels were detected in stools after vaccination, suggesting that the gastrointestinal tract is involved in ethyl mercury elimination. Because of the differing pharmacokinetics of ethyl and methyl mercury, exposure guidelines based on oral methyl mercury in adults may not be accurate for risk assessments in children who receive thimerosal-containing vaccines.

 

Rose, Shannon, Rebecca Wynne, Richard E. Frye, Stepan Melnyk, and S. Jill James. “Increased susceptibility to ethylmercury-induced mitochondrial dysfunction in a subset of autism lymphoblastoid cell lines.” Journal of toxicology 2015 (2015).

https://www.hindawi.com/journals/jt/2015/573701/

 

Abstract

The association of autism spectrum disorders with oxidative stress, redox imbalance, and mitochondrial dysfunction has become increasingly recognized. In this study, extracellular flux analysis was used to compare mitochondrial respiration in lymphoblastoid cell lines (LCLs) from individuals with autism and unaffected controls exposed to ethylmercury, an environmental toxin known to deplete glutathione and induce oxidative stress and mitochondrial dysfunction. We also tested whether pretreating the autism LCLs with N-acetyl cysteine (NAC) to increase glutathione concentrations conferred protection from ethylmercury. Examination of 16 autism/control LCL pairs revealed that a subgroup (31%) of autism LCLs exhibited a greater reduction in ATP-linked respiration, maximal respiratory capacity, and reserve capacity when exposed to ethylmercury, compared to control LCLs. These respiratory parameters were significantly elevated at baseline in the ethylmercury-sensitive autism subgroup as compared to control LCLs. NAC pretreatment of the sensitive subgroup reduced (normalized) baseline respiratory parameters and blunted the exaggerated ethylmercury-induced reserve capacity depletion. These findings suggest that the epidemiological link between environmental mercury exposure and an increased risk of developing autism may be mediated through mitochondrial dysfunction and support the notion that a subset of individuals with autism may be vulnerable to environmental influences with detrimental effects on development through mitochondrial dysfunction.

 
 

Sharpe, Martyn A., Taylor L. Gist, and David S. Baskin. “B-lymphocytes from a population of children with autism spectrum disorder and their unaffected siblings exhibit hypersensitivity to thimerosal.” Journal of Toxicology 2013 (2013).

https://www.hindawi.com/journals/jt/2013/801517/

 

Abstract

The role of thimerosal containing vaccines in the development of autism spectrum disorder (ASD) has been an area of intense debate, as has the presence of mercury dental amalgams and fish ingestion by pregnant mothers. We studied the effects of thimerosal on cell proliferation and mitochondrial function from B-lymphocytes taken from individuals with autism, their nonautistic twins, and their nontwin siblings. Eleven families were examined and compared to matched controls. B-cells were grown with increasing levels of thimerosal, and various assays (LDH, XTT, DCFH, etc.) were performed to examine the effects on cellular proliferation and mitochondrial function. A subpopulation of eight individuals (4 ASD, 2 twins, and 2 siblings) from four of the families showed thimerosal hypersensitivity, whereas none of the control individuals displayed this response. The thimerosal concentration required to inhibit cell proliferation in these individuals was only 40% of controls. Cells hypersensitive to thimerosal also had higher levels of oxidative stress markers, protein carbonyls, and oxidant generation. This suggests certain individuals with a mild mitochondrial defect may be highly susceptible to mitochondrial specific toxins like the vaccine preservative thimerosal.

 

Stetler, Harrison C., Paul L. Garbe, Diane M. Dwyer, Richard R. Facklam, Walter A. Orenstein, Gary R. West, K. Joyce Dudley, and Alan B. Bloch. “Outbreaks of group A streptococcal abscesses following diphtheria-tetanus toxoid-pertussis vaccination.” Pediatrics 75, no. 2 (1985): 299-303.

https://pediatrics.aappublications.org/content/75/2/299.short

 
 

Abstract

Two outbreaks of group A streptococcal abscesses following receipt of diphtheria-tetanus toxoid-pertussis (DTP) vaccine from different manufacturers were reported to the Centers for Disease Control (CDC) in 1982. The clustering of the immunization times of cases, the isolation of the same serotype of Streptococcus from all cases in each outbreak, and the absence of reported abscesses associated with receipt of the same lots of vaccine in other regions of the country, suggest that each outbreak was probably caused by contamination of a single 15-dose vial of vaccine. The preservative thimerosal was present within acceptable limits in unopened vials from the same lot of DTP vaccine in each outbreak. Challenge studies indicate that a strain of Streptococcus from one of the patients can survive up to 15 days in DTP vaccine at 4°C. Contamination of vials during manufacturing would have required survival of streptococci for a minimum of 8 months. Preservatives in multidose vaccine vials do not prevent short-term bacterial contamination. Options to prevent further clusters of streptococcal abscesses are discussed. The only feasible and cost-effective preventive measure now available is careful attention to sterile technique when administering vaccine from multidose vials.

 

Stratton, Kathleen, Alicia Gable, Marie C. McCormick, and Institute of Medicine (US) Immunization Safety Review Committee. “Thimerosal-containing vaccines and neurodevelopmental disorders.” In Immunization Safety Review: Thimerosal-Containing Vaccines and Neurodevelopmental Disorders. National Academies Press (US), 2001.

https://www.ncbi.nlm.nih.gov/books/NBK223724/

 

Conclusion

The committee sees significant reasons for continued public health attention to concerns about thimerosal exposure and neurodevelopmental disorders. The committee considered the burden of the potential adverse neurodevelopmental outcomes and of vaccine-preventable disorders, and it considered the extent of continued use of thimerosal-containing products. Therefore, the committee considers the presence of thimerosal in pediatric vaccines to be a significant issue, and it supports precautionary public health efforts to reduce mercury exposure. It is important to resolve whether or not children might have experienced neurodevelopmental disorders because of an unrecognized incremental mercury burden from thimerosal given the responsibility for assuring the safest vaccines possible.

 

Trümpler, Stefan, Wiebke Lohmann, Björn Meermann, Wolfgang Buscher, Michael Sperling, and Uwe Karst. “Interaction of thimerosal with proteins—ethylmercury adduct formation of human serum albumin and β-lactoglobulin A.” Metallomics 1, no. 1 (2009): 87-91.

https://pubs.rsc.org/lv/content/articlehtml/2009/mt/b815978e

 

Abstract

The interaction of thimerosal, an ethylmercury-containing bactericide and fungicide used as preservative in vaccines and other drugs, with free thiols in proteins has been investigated using gradient reversed phase liquid chromatography (LC) with inductively coupled plasma mass spectrometry (ICP-MS) and electrospray mass spectrometry (ESI-MS) detection. As model proteins, β-lactoglobulin A (18.4 kDa) from bovine milk and human serum albumin (66.5 kDa) have been used. Physiological conditions upon an intravenous injection of thimerosal-containing drugs were mimicked. The formation of ethylmercury–protein adducts was proved and the identification of the binding site of ethylmercury, a free thiol residue in the peptide T13 was achieved after tryptic digestion of β-lactoglobulin A.

 

Trümpler, Stefan, Björn Meermann, Sascha Nowak, Wolfgang Buscher, Uwe Karst, and Michael Sperling. “In vitro study of thimerosal reactions in human whole blood and plasma surrogate samples.” Journal of Trace Elements in Medicine and Biology 28, no. 2 (2014): 125-130.

https://www.sciencedirect.com/science/article/abs/pii/S0946672X14000091

 

Abstract

Because of its bactericidal and fungicidal properties, thimerosal is used as a preservative in drugs and vaccines and is thus deliberately injected into the human body. In aqueous environment, it decomposes into thiosalicylic acid and the ethylmercury cation. This organomercury fragment is a potent neurotoxin and is suspected to have similar toxicity and bioavailability like the methylmercury cation. In this work, human whole blood and physiological simulation solutions were incubated with thimerosal to investigate its behaviour and binding partners in the blood stream. Inductively coupled plasma with optical emission spectrometry (ICP-OES) was used for total mercury determination in different blood fractions, while liquid chromatography (LC) coupled to electrospray ionisation time-of-flight (ESI-TOF) and inductively coupled plasma-mass spectrometry (ICP-MS) provided information on the individual mercury species in plasma surrogate samples. Analogous behaviour of methylmercury and ethylmercury species in human blood was shown and an ethylmercury-glutathione adduct was identified.

 

Young, Heather A., David A. Geier, and Mark R. Geier. “Thimerosal exposure in infants and neurodevelopmental disorders: an assessment of computerized medical records in the Vaccine Safety Datalink.” Journal of the neurological sciences 271, no. 1-2 (2008): 110-118.

http://www.vaccinesafetycommission.org/pdfs/37-2008-Journal-Neuro-Young.pdf

 

Abstract

The study evaluated possible associations between neurodevelopmental disorders (NDs) and exposure to mercury (Hg) from Thimerosalcontaining vaccines (TCVs) by examining the automated Vaccine Safety Datalink (VSD). A total of 278,624 subjects were identified in birth cohorts from 1990–1996 that had received their first oral polio vaccination by 3 months of age in the VSD. The birth cohort prevalence rate of medically diagnosed International Classification of Disease, 9th revision (ICD-9) specific NDs and control outcomes were calculated. Exposures to Hg from TCVs were calculated by birth cohort for specific exposure windows from birth-7 months and birth-13 months of age. Poison regression analysis was used to model the association between the prevalence of outcomes and Hg doses from TCVs. Consistent significantly increased rate ratios were observed for autism, autism spectrum disorders, tics, attention deficit disorder, and emotional disturbances with Hg exposure from TCVs. By contrast, none of the control outcomes had significantly increased rate ratios with Hg exposure from TCVs. Routine childhood vaccination should be continued to help reduce the morbidity and mortality associated with infectious diseases, but efforts should be undertaken to remove Hg from vaccines. Additional studies should be conducted to further evaluate the relationship between Hg exposure and NDs.

 

Zimmermann, Luciana T., Danúbia B. Santos, Aline A. Naime, Rodrigo B. Leal, José G. Dórea, Fernando Barbosa Jr, Michael Aschner, João Batista T. Rocha, and Marcelo Farina. “Comparative study on methyl-and ethylmercury-induced toxicity in C6 glioma cells and the potential role of LAT-1 in mediating mercurial-thiol complexes uptake.” Neurotoxicology 38 (2013): 1-8.

https://www.sciencedirect.com/science/article/pii/S0161813X13000922

Abstract

Various forms of mercury possess different rates of absorption, metabolism and excretion, and consequently, toxicity. Methylmercury (MeHg) is a highly neurotoxic organic mercurial. Human exposure is mostly due to ingestion of contaminated fish. Ethylmercury (EtHg), another organic mercury compound, has received significant toxicological attention due to its presence in thimerosal-containing vaccines. This study was designed to compare the toxicities induced by MeHg and EtHg, as well as by their complexes with cysteine (MeHg-S-Cys and EtHg-S-Cys) in the C6 rat glioma cell line. MeHg and EtHg caused significant (p < 0.0001) decreases in cellular viability when cells were treated during 30 min with each mercurial following by a washing period of 24 h (EC50 values of 4.83 and 5.05 μM, respectively). Significant cytotoxicity (p < 0.0001) was also observed when cells were treated under the same conditions with MeHg-S-Cys and EtHg-S-Cys, but the respective EC50 values were significantly increased (11.2 and 9.37 μM). l-Methionine, a substrate for the l-type neutral amino acid carrier transport (LAT) system, significantly protected against the toxicities induced by both complexes (MeHg-S-Cys and EtHg-S-Cys). However, no protective effects of l-methionine were observed against MeHg and EtHg toxicities. Corroborating these findings, l-methionine significantly decreased mercurial uptake when cells were exposed to MeHg-S-Cys (p = 0.028) and EtHg-S-Cys (p = 0.023), but not to MeHg and EtHg. These results indicate that the uptake of MeHg-S-Cys and EtHg-S-Cys into C6 cells is mediated, at least in part, through the LAT system, but MeHg and EtHg enter C6 cells by mechanisms other than LAT system.

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COVID-19 mRNA Vaccines

COVID-19 mRNA Vaccines

December 28, 2020

COVID-19 mRNA Vaccines

James Odell, OMD, ND, L.Ac.

Editorial – The material published in this editorial is intended to foster scholarly inquiry and a rich discussion of the controversial topic of bioethics and health policy. The views expressed in this article are solely the authors and do not represent the policy or position of the Bioregulatory Medicine Institute (BRMI), nor any of its Board Advisors or contributors. The views expressed are not intended to malign any religious or ethnic group, organization, company, individual, or any other. Every effort has been made to attribute the sources of this article to the rightful authors listed in references.

With the recent licensing and roll out of COVID-19 vaccines in the U.K., Canada, the U.S. (Pfizer/ BioNTech and Moderna), and Russia (Sputnik) there are several serious safety concerns that have not been addressed or even mentioned in the medical media. In short, it is beyond reckless and totally unnecessary to administer these experimental vaccines to millions of people when there is only limited short term safety data. Absolutely no long-term safety studies have been done to ensure that any of these vaccines do not cause cancer, seizures, heart disease, allergies, and autoimmune diseases, as seen with other vaccines and observed in earlier coronavirus vaccine animal studies. Because animal studies were bypassed for these vaccines due to ‘fast-tracking’, millions of humans are now the primary test animal. Additionally, these vaccines were developed using a completely new mRNA technology that has never been licensed for human use. In essence, we have absolutely no knowledge of what to expect from these new mRNA vaccines. Since viruses mutate frequently, the chance of any vaccine working for more than a year is unlikely. That is why the influenza (flu) vaccine changes every year. This editorial comprehensively discloses current COVID-19 vaccine development, administration, and safety concerns in detail.

 

Ribonucleic acid (RNA) is a nucleic acid present in all living cells. Its principal role is to act as a messenger carrying instructions from DNA for controlling the synthesis of proteins. Although in some viruses’ RNA rather than DNA carries the genetic information. In each cell of a living organism, DNA is the molecule that contains the genetic information of the organism. It is composed of a series of four building blocks, whose sequence gives the instructions to fabricate proteins. This process requires a transient intermediary called messenger RNA that carries the genetic information to the cell machinery responsible for protein synthesis. RNA is the only molecule known to recapitulate all biochemical functions of life: definition, control, and transmission of genetic information, creation of defined three-dimensional structures, enzymatic activities, and storage of energy.

 

RNA became the focus of intense research in molecular medicine at the beginning of the millennium. Messenger viral RNA (mRNA) is now developed as a vaccine and this technology poses many questions and serious health concerns that have been left unanswered by the vaccine manufacturers. Unlike previous vaccines an mRNA vaccine is a new type of vaccine that inserts fragments of viral mRNA into human cells, which are reprogrammed to produce pathogen antigens, which then if all goes well, stimulate an adaptive immune response against the targeted pathogen. That seems straightforward, but what else is in the vaccines, and is this new technology truly proven safe and effective?

 

History of Coronavirus Vaccine Animal Studies and

Antibody Dependent Enhancement (ADE)

 

Researchers have been trying to develop a coronavirus vaccine since the Severe Acute Respiratory Syndrome (SARS-1) outbreak in 2002. Thus, over a span of 18 years there have been numerous coronavirus vaccine animal studies conducted, which unfortunately demonstrated significant and serious side-effects. Either the animals were not completely protected, became severely ill with accelerated autoimmune conditions, or died.1, 2, 3, 4, 5, 6, 7

 

Animal side effects and deaths were primarily attributed to what is called Antibody-Dependent Enhancement (ADE). In the 1960s, immunologists discovered ADE and since then have extensively researched and identified its mechanism. Virus ADE is a biochemical mechanism in which virus-specific antibodies (usually from a vaccine) promote the entry and/or the replication of another virus into white cells such as monocytes/macrophages and granulocytic cells. This then modulates an overly strong immune response (abnormally enhances it) and induces chronic inflammation, lymphopenia, and/or a ‘cytokine storm’, one or more of which have been reported to cause severe illness and even death. Essentially, ADE is a disease dissemination cycle causing individuals with secondary infection to be more immunologically upregulated than during their first infection (or prior vaccination) by a different strain. ADE of disease is always a concern for the development of vaccines and antibody therapies because the mechanisms that underlie antibody protection against any virus has a theoretical potential to amplify the infection or trigger harmful immunopathology.8, 9, 10 ADE of the viral entry has been observed and its mechanism described for many viruses including coronaviruses.11, 12, 13 Basically, it was shown that antibodies target one serotype of viruses but only sub neutralize another, leading to ADE of the latter exposed viruses. Thus, ADA of viral entry has been a major concern and stumbling block for vaccine development and antibody-based drug therapy. For example, it has been shown that when patients are infected by one serotype of dengue virus (i.e., primary infection), they produce neutralizing antibodies targeting the same serotype of the virus. However, if they are later infected by another serotype of dengue virus (i.e., secondary infection), the preexisting antibodies cannot fully neutralize the virus. Instead, the antibodies first bind to the virus and then bind to the IgG Fc receptors on immune cells and mediate viral entry into these cells.14 A similar mechanism has been observed for HIV, Ebola, and influenza viruses. Thus, sub neutralizing antibodies (or non-neutralizing antibodies in some cases) are responsible for ADE of these viruses.15, 16, 17, 18, 19, 20

 

Generally, the conclusion of some of those studies was that great caution needs to be exercised when moving forward to human trials primarily because of the potential of accelerated autoimmunity reaction. Because ADE has been demonstrated in animals21, coronavirus vaccine research never progressed to human trials, at least not till the recent SARS coronavirus-2 fast-track campaign.

 

More technical Understanding of SARS-CoV-2 ADE Mechanisms

 

As a forementioned, a potential barrier to the development of safe and efficacious COVID-19 vaccines is the risk that insufficient titers of neutralizing antibodies might trigger ADE of disease. Previous research in SARS-CoV infection demonstrated ADE is mediated by the engagement of Fc receptors (FcRs) expressed on different immune cells, including monocytes, macrophages and B cells.22, 23, 24 A Fc receptor is a protein found on the surface of certain cells – including, among others, B lymphocytes, follicular dendritic cells, natural killer cells, macrophages, neutrophils, eosinophils, basophils, human platelets, and mast cells – that contribute to the protective functions of the immune system.

 

Akiko Iwasaki and colleagues describe this coronavirus ADE mechanism in more detail in their 2020 research published in Nature Reviews Immunology.25 They confirm that pre-existing SARS-CoV-specific antibodies may thus promote viral entry into FcR-expressing cells. This process is independent of ACE2 expression and endosomal pH and proteases, suggesting distinct cellular pathways of ACE2-mediated and FcR-mediated viral entry.

In short, previous experience with veterinary coronavirus vaccines and animal models of SARS-CoV and MERS-CoV infection has raised safety concerns about the potential for ADE and/or vaccine-associated enhanced respiratory disease. These events were associated either with macrophage-tropic coronaviruses susceptible to antibody-dependent enhancement of replication or with vaccine antigens that induced antibodies with poor neutralizing activity and Th2-biased responses.

 

After two decades of failed animal trials, the question is posed as to why fast-tracking coronavirus vaccine will now result in a different outcome? Given that many of these fast-track trials have bypassed animal studies, are only performed on healthy volunteers and children (not the elderly or those with pre-morbidities), and that trials are conducted without an inert double-blind placebo-controlled environment, and are not given sufficient time to observe effects on the human trials, there is a serious safety concern. Many, many virologists, and epidemiologists feel this fast-track policy is a recipe for mass disaster. Microbiologist Dr. Sucharit Bhakdi and Dr. Karina Reiss in their new book Corona, False Alarm? give clarity to many of the issues surrounding the pandemic, especially the current coronavirus vaccines.26

 

Traditional vs. mRNA Vaccines

 

Historically, the manufacturing process for creating vaccines involves many trade secrets and numerous other ingredients as adjuvants and preservatives.27, 28 ‘Traditional or classical vaccines’ may contain attenuated or inactivated viruses and bacteria or proteins, as well as adjuvants, such as aluminum, to stimulate an immune response that produces artificial immunity, as well as a host of other ingredients called “excipients”. For example, older viral vaccines for smallpox and measles vaccine contain live attenuated viruses; injectable influenza vaccines contain inactivated viruses; the recombinant hepatitis B virus vaccine is a protein subunit vaccine, while the newer human papillomavirus (HPV) virus vaccine contains virus-like particles.

 

To date, there are several different types of potential vaccines for COVID-19 in development, including:

  • Inactivated or weakened virus vaccines, which use a form of the virus that has been inactivated or weakened, but still generates an artificial immune response.

  • Protein-based vaccines, which use fragments of proteins or protein shells that mimic the COVID-19 virus to generate an artificial immune response.

  • Viral vector vaccines, which use a virus that has been genetically engineered to generate an artificial immune response.

  • RNA and DNA vaccines, that uses genetically engineered RNA or DNA to generate a protein that itself prompts an artificial immune response.

For the past two decades, researchers have been experimenting with new technology platforms, notably ones that introduce foreign DNA and RNA into cells of the body, to develop experimental vaccines for SARS, MERS, HIV, and other diseases but, historically none have been proven effective and safe for humans.

 

Thus, for a traditional vaccine, the antigen is introduced in the body to produce an immune response. However, in the case of DNA- or RNA-based vaccines, no antigen is introduced, only the RNA or DNA containing the genetic information to produce the antigen. That is, for this specific class of vaccines, the introduction of DNA and RNA provides the instructions to the body to produce the antigen itself.29

 

mRNA vaccines differ greatly in their design and biochemical mechanisms from traditional vaccines. Traditional vaccines stimulate an antibody response by injecting a human with antigens (proteins or peptides), or an attenuated virus, or a recombinant antigen-encoding viral vector. These ingredients are prepared and grown outside of the human body, which takes time, and even when they are injected into the bloodstream, they do not enter the human cell.30

 

In contrast, mRNA vaccines insert a synthetically created fragment or snip of the virus RNA sequence directly into the human cells (known as transfection). This snip of viral RNA material then activates an enzyme called reverse transcriptase which replicates that RNA snip repeatedly. This then reprograms the cells to produce their own viral antigens, which, if all goes as planned, stimulates an adaptive immune response, resulting in the production of new antibodies that bind to the antigen and activate T-cells.31, 32, 33

 

Simply speaking, the new mRNA vaccines inject (transfects) molecules of synthetic genetic material from non-human sources (viral sequences) into our cells. Once in the cells, the genetic material interacts with our transfer RNA (tRNA) to make a foreign protein that supposedly teaches the body to destroy the virus being coded for. These created proteins are not regulated by our own DNA and are thus completely foreign to our cells. What they are fully capable of doing is completely unknown.

 

Till now, messenger-RNA vaccines have never been licensed for public use. In the last two decades, there has been deep-pocket funding for the development of mRNA vaccines against infectious diseases, particularly with the currently declared pandemic and vaccine fast track campaign. Historically, their application has until recently been restricted by the instability and inefficient in vivo delivery of mRNA. New technological advancements in RNA biology, chemistry, stability, and delivery systems have now accelerated the development of fully synthetic mRNA vaccines. The consensus is that mRNA vaccines are faster and cheaper to produce than traditional vaccines and for vaccine manufacturers, more cost-effectiveness translates to greater profits. Certainly, there are unique and unknown risks to messenger RNA vaccines, including local and systemic (ADE) inflammatory responses that could lead to autoimmune conditions.

 

mRNA Vaccines Mechanisms

 

mRNA vaccines have strands of genetic material called mRNA inside a special coating. That coating protects the mRNA from enzymes in the body that would otherwise break it down. It also helps the mRNA enter the muscle cells near the vaccination site. mRNA vaccines use a different approach that takes advantage of the process that cells use to make proteins: cells use DNA as the template to make messenger RNA (mRNA) molecules, which are then translated to build proteins. An RNA vaccine consists of an mRNA strand that codes for a disease-specific antigen. Once the mRNA is in the cell, human biology takes over. Ribosomes read the code and build the protein, and the cells express the protein in the body. Thus, cells use the genetic information to produce the disease-specific antigen. This antigen is then displayed on the cell surface, where it is recognized by the immune system.34

 

mRNA vaccines have been studied before for influenza, Zika, rabies, and cytomegalovirus. The concept for the development of an mRNA vaccine is rather straightforward. Once the antigen of choice from the pathogen target is identified, the gene is sequenced, synthesized, and cloned into the DNA template plasmid. mRNA is then transcribed in vitro, and the vaccine is delivered to the subject. The mRNA vaccine utilizes the host cell machinery for in vivo translation of mRNA into the corresponding antigen, thereby mimicking a viral infection to elicit potent humoral and cellular immune responses. The final cellular location of the antigen is determined by the signal peptide and transmembrane domain. This can be intrinsic to the natural protein sequence or engineered to direct the protein to the desired cellular compartment.35, 36

 

Once the viral mRNA is injected into the body, it faces immune responses that are programmed to destroy it. Our cells have evolved elaborate defense mechanisms intended to destroy foreign, unprotected, or “naked” RNA. However, the susceptibility of mRNA to degradation can be reduced by modifying the RNA during synthesis. One modification is to add in ‘nucleoside analogs’ that resemble the normal nucleosides found within RNA (A, U, C and G,) but have minor structural changes that make the RNA more resistant to enzyme degradation by the body’s ribonucleases. (Nucleosides are the structural subunit of nucleic acids such as DNA and RNA.)

 

Additional structural modifications and the inclusion of regulatory sequences can also improve the stability of mRNA.37 For example,the vaccine viral mRNA is delivered in the form of a complex with lipid nanoparticles, to stabilize the mRNA, making it easier to penetrate the cell, and increases the amount of antigen produced per cell.38 Lipid nanoparticle formulations also elicit a stronger immune response compared to naked mRNA.39This is where it gets tricky and potentially dangerous because some of the lipid nanoparticles developed for these mRNA vaccines can be strongly immunologically reactive and elicit an unwanted autoimmune reaction.

 

PEGylated Lipid Nanoparticles

 

Thus, mRNA is threatened by rapid degradation by ubiquitous extracellular ribonucleases before being taken up by cells.40 The mRNA molecule is also vulnerable to destruction from temperature changes as well as our immune system. Thus, the efficacy of mRNA vaccines requires ‘complexing agents’ which protect RNA from degradation. Complexation may also enhance uptake by cells and/or improve delivery to the translation machinery in the cytoplasm. To this end, mRNA is often complexed with either lipids or polymers. These mRNA vaccines are coated with PEGylated lipid nanoparticles (polyethylene glycol). This coating hides the mRNA from our immune system which ordinarily would attack and destroy kill any foreign material injected into the body. PEGylated lipid nanoparticles have been used in several different drugs for years. Unfortunately, PEGylated lipid nanoparticles have been shown to imbalance certain immune responses and can induce allergies and even autoimmune diseases.41, 42, 43, 44, 45, 46

 

A 2016 study in Analytical Chemistry reported detectable and sometimes high levels of anti-PEG antibodies (including first line-of-defense IgM antibodies and later stage IgG antibodies) in approximately 72% of contemporary human samples and about 56% of historical specimens from the 1970s through the 1990s. Of the 72% with PEG IgG antibodies, 8% had anti-PEG IgG antibodies > 500ng/ml., which is considered extremely elevated.47 Extrapolated to the U.S. population of 330 million who may receive this vaccine, 16.6 million may have anti-PEG antibody levels associated with adverse effects.The researchers confessed that the results were entirely unexpected. The authors concluded that:

 

“…sensitive detection and precise quantitation of anti-PEG Ab levels in a clinical setting will be essential to ensuring the safe use of PEGylated drugs in all target patient populations going forward.”

 

Multiple previous studies regarding the prevalence of anti-PEG antibodies in the population have stated that pre-screening should be done prior to any administration of a PEG-containing medication. Screening is likely to be even more important in the case of a vaccine intended for parenteral administration to as many people as possible that contains a substance to which a majority of the population unknowingly has anti-PEG antibodies.

 

Production of mRNA vaccines

 

To further understand PEGylated lipid nanoparticles and their role in vaccine delivery, it is helpful to understand a little more about how an mRNA vaccine is manufactured. A major manufacturing advantage of mRNA vaccines is that RNA can be produced in the laboratory from a DNA template using readily available materials, again less expensively and faster than conventional vaccine production, which utilize a variety of cell types such as chicken eggs or other mammalian cells such a fetal material.48 This all comes down to economics. It is faster and cheaper to make.

 

Traditional vaccines normally contain a strong adjuvant (often aluminum) supplying an enhanced signal for the initiation of the adaptive immune response. However, it is thought that mRNA vaccines sort of have their own adjuvant effect by themselves, partly by virtue of being foreign nucleic acids. It has not been disclosed if any of these candidates (from any company) have an adjuvant added to them. (More information on adjuvants later in this article.)

 

Moreover, according to Arcturus, the company manufacturing the Pfizer/BioNTech lipid delivery system, this involves a multi-component delivery system called LUNAR® (Lipid-enabled and Unlocked Nucleomonomer Agent modified RNA). “This system has access to over 150 proprietary lipids that have been utilized for mRNA-based COVID-19 vaccines.”49 Basically, all we know is this involves proprietary PEGylated lipid nanoparticles.

 

Current mRNA Vaccines and Potential Side-Effects

 

According to the WHO and the Milken Institute, as of August 2020, there were 202 companies and universities worldwide working on a coronavirus vaccine. The vaccine types vary from traditionally established vaccines (e.g., inactivated, and live attenuated) to vaccines that have only recently gained clinical approval (e.g., subunit) to those that have never been licensed for human use, till now (e.g., mRNA, DNA, non replicating viral vector, replicating viral vector). A striking feature of the vaccine development landscape for SARS coronavirus-2 is the range of technology platforms being evaluated, including nucleic acid (DNA and RNA), virus-like particle, peptide, viral vector (replicating and non-replicating), recombinant protein, live attenuated virus and inactivated virus approaches. Since November 9th, Moderna, the pharma giant Pfizer and its German collaborator BioNTech, and a Russian Institute have all offered “preliminary evidence that their mRNA spike-based vaccines can achieve greater than 90% protective efficacy.”

 

The vaccine pharmaceutical industry contends that an mRNA-based vaccine is “safer for the patient” than classical vaccines. But is that verified true? The manufacturer’s rationale is that mRNA is a non-infectious, non-integrating platform, there is no potential risk of infection or insertional mutagenesis. Since mRNA vaccines have never been licensed and have not undergone long-term testing, we cannot know this for certain. Additionally, there is also concern that these vaccine mRNA may have long-standing dire consequences on the body’s immunity, fertility, and DNA integrity.

 

According to researchers at the University of Pennsylvania and Duke University50, mRNA vaccines have these potential safety issues:

  • Local and systemic inflammation.

  • The biodistribution and persistence of expressed immunogen.

  • Stimulation of auto-reactive antibodies.

  • Induction of a potent type 1 interferon response, which has been associated with inflammation and potential autoimmunity. Thus, identification of individuals at an increased risk of autoimmune reactions before mRNA vaccination should be undertaken.

  • Presence of extracellular RNA, which may contribute to edema and pathogenic thrombus formation (blood clots). Extracellular naked RNA has been shown to increase the permeability of tightly packed endothelial cells and may thus contribute to edema.51 Another study showed that extracellular RNA promoted blood coagulation and pathological thrombus formation.52

  • Potential toxic effects of any non-native nucleotides and delivery system components (particularly those that have not been disclosed by manufacturers).

There is also concern about potential mRNA modifications to the genetics of the body. Once injected into the body mRNA vaccines take the RNA from the virus into the cell where it may create unwanted detrimental genetic modifications. Over the last five years, there has been an enormous increase in the amount of research into RNA modifications; this field is called epitranscriptomics. The role of DNA modification in gene regulation is well established, but much less is known about how mRNA modification influences the way genes are expressed. In fact, numerous studies have shown viral mRNAs to be implicated as a driver in some forms of cancer and autoimmune diseases.53, 54, 55, 56

 

Thus, long-term safety evaluation is essential and should precede the licensing of different mRNA modalities and delivery systems. Normally, vaccine development is a lengthy and complicated process, often lasting 10-15 years and involving a combination of public and private involvement. Unfortunately, the rapid worldwide competition between pharmaceutical companies to develop a COVID-19 vaccine has bypassed multiple safety controls, rendering the result both dubious and potentially dangerous for the public. Financial interests have taken precedence over the health and safety of the public. Hasty development of vaccines is always risky, and only thorough research employing all the safety precautions will lead to a safe and effective vaccine.

 

The current licensed COVID-19 vaccine is not being offered to pregnant women. This is because researchers do not know enough about how COVID-19 vaccination can affect children, pregnant women, or their babies. There is also no data on the safety of COVID-19 vaccines for breastfeeding women. The Pfizer/BioNTech vaccine is not available to children under age 16.

 

Moderna and Pfizer Vaccine Ingredients and Dosage

 

As unbelievable as it sounds, neither Pfizer/BioNTech nor Moderna have ‘completely’ disclosed everything in their vaccines. Apparently, to be licensed by the FDA they do not have to disclose to the public the entire composition of their vaccine. This is what we do know. Both Moderna and Pfizer/ BioNTech vaccines are mRNA vaccines and they are different in composition, delivery, and storage. They have different nucleoside analogs, and each has unique ways to essentially attenuate the capacity of messenger RNA to induce innate immunity. They each have a different complex liquid delivery system, and this is one reason why one is much more amenable to shipping and storing at minus 20º whereas the other requires shipping and storing at minus 70º.

 

Moderna’s vaccine uses 100 micrograms of RNA per dose, while Pfizer-BioNTech’s uses only 30 micrograms. In both the Moderna and Pfizer-BioNTech vaccines the mRNA is encapsulated in lipid nanoparticles (LPN). These microscopic droplets of oily liquid — about 0.1 micron in diameter — enclose and protect the mRNA as they are manufactured, transported, and injected into people.As previously mentioned, the composition of the lipid nanoparticles is different in the two vaccines.

 

Pfizer/BioNTech obtains their nanoparticles from Acuitas, a specialist Canadian company, while Moderna has developed its own lipid technology.

 

Listed ingredients of the Pfizer/BioNTech COVID-19 vaccine include:

  • 30 mcg of a nucleoside-modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2

  • lipids (0.43 mg (4-hydroxybutyl)azanediyl)bis (hexane-6,1-diyl) bis (2-hexyldecanoic)

  • .05 mg 2[polyethylene glycol)-2000]-N,N-ditetradecylacetamide

  • .09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.2 mg cholesterol)

  • .01 potassium chloride

  • .01 mg monobasic potassium phosphate

  • .36 mg sodium chloride

  • .07 mg dibasic sodium phosphate dehydrate

  • 6 mg sucrose

  • the diluent (.09 percent Sodium Chloride Injection) contributes an additional 2.16 mg sodium chloride per dose

So far as revealed in the public domain Moderna’s vaccine (mRNA-1273) specifically contains lipid nanoparticle dispersion containing an mRNA that encodes for the prefusion stabilized spike protein 2019-nCoV. mRNA-1273 consists of an mRNA drug substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, DSPC (1,2-distearoyl-sn-glycero-3-phosphocholine is a phosphatidylcholine with alkyl chain comprising 18 carbons), and PEG2000 DMG (1,2-dimyristoyl-rac-glycero-3-methoxypolyethylene glycol-2000). Adjuvants and other biotechnology if added have not been publicly disclosed. This vaccine requires two injections given 28 days apart.

 

For more information on clinical trials of all corona vaccines in development visit the Regulatory Affairs Professionals Society (RAPS).58

 

mRNA Vaccine Viral Shedding and Viral Vaccine Interference

 

Vaccine shedding is a term used for the release of virus following administration of a live-virus vaccine. This has been particularly observed in the administration of live polio vaccines. Neither of the vaccines in distribution or in development use the live virus that causes COVID-19. Thus, current consensus among vaccine developers is that vaccine viral shedding is not expected with mRNA vaccines. However, bear in mind mRNA viral vaccines is a new platform, and this issue is in unknown territory.

Viral interference describes the situation whereby infection or vaccine inoculation with one virus limits infection and replication of a second virus. For example, epidemiological studies show that following infection with influenza virus, there is a short period during which a host experiences a lower susceptibility to infection with other similar viruses. This viral interference appears to be independent of any antigenic similarities between the viruses. It certainly is possible that the mRNA vaccine may elicit vaccine viral interference and causes people to be more susceptible to other viruses, such as influenza.

 

SARS-CoV-2 Spike Protein Shares Sequence with a Human Protein Syncytin-1

 

Syncytin-1 is a protein that functions for placental development and therefore is essential for fertility. Fifteen years ago, it was proposed that a synthetic Syncytin-1 vaccine could be developed as a contraceptive that would work to produce antibodies against human Syncytin-1.59

 

It is proposed by some doctors that the Pfizer COVID vaccine may elicit an antibody response against Syncythin-1 and cause infertility because of a similar or shared amino acid sequence in the spike protein of SARS-CoV-2 and the Syncythin-1 placental protein. Pharmaceutically sponsored fact-checkers, and Pfizer employed virologists were quick to discount such an idea as “unlikely”. They claim that this amino acid sequence is too short for the immune system to meaningfully confuse it with this important placental protein. However unlikely, if this later proves true for some susceptible women, then that could cause infertility of an unspecified duration. Consider that scientific consensus is not 100 percent sure these similar amino acid sequences will cause Syncythin-1 antibodies to be produced. The role of retroviral proteins, especially syncytins, in the trophoblastic fusion process and placental morphogenesis were only identified and hypothesized about 20years ago.60 There is still much to learn, and much we still do not know about similar amino acid sequences and their effect on human physiology. Thus, this issue warrants further research, and until then we should proceed with caution and assume that it may possibly cause public harm.

 

Adjuvants

 

Adjuvants are immunostimulatory molecules administered together with the vaccine to help boost immune responses mainly by activating additional molecular receptors that predominantly recognize pathogens or danger signals. These pathways function primarily within the innate immune system, and each adjuvant generally has a different range of stimulation of these pathogen or danger receptors. While the vaccine goal is to stimulate recognition and response by lymphocytes, not innate cells, the activation of the innate immune cells is required to activate the lymphocytes to obtain both B and T-cell responses. Many adjuvants have previously failed in the clinic due to toxicity issues. These chemicals can have a wide range of compositions, including lipids, proteins, nucleic acids, and even inorganic material, such as aluminum salts. What they all have in common is that they hyper-stimulate receptors in immune cells and most do this through their cellular toxicity.

 

Pfizer/BioNTech and Moderna do not explicitly state the use of an adjuvant within their vaccines, but RNA already contains immunostimulatory properties and signals through pathogen recognition receptors. It remains to be seen whether the immunostimulation from RNA is strong enough to confer full protection against SARS-CoV-2. There is also a possibility that the lipid nanoparticle carriers they utilize confer adjuvant properties themselves. Or for that matter, elicit an abnormal autoimmune reaction.

 

It is unknown if any future licensed COVID-19 mRNA vaccines will contain aluminum or something else as an adjuvant, as commonly used in other viral vaccines. Despite almost 90 years of widespread use of aluminum adjuvants, medical science’s understanding of their mechanisms of action is still remarkably poor. There is also a concerning scarcity of data on toxicology and pharmacokinetics of these compounds. Despite this, the false notion that aluminium in vaccines is safe appears to be widely accepted. Experimental research clearly shows that aluminum adjuvants have a potential to induce serious immunological disorders in humans. Aluminum in adjuvant form carries a risk for autoimmunity, long-term brain inflammation, and associated neurological complications and may thus have profound and widespread adverse health consequences.61

 

Stability and Storage

 

These mRNA vaccines require cold storage to maintain the nanoparticles and to stop the mRNA from degrading. The Pfizer/BioNTech vaccine (BNT162b2) is to be stored at a temperature of -94 degrees Fahrenheit (-70 Celsius) and will last for only 24 hours at refrigerated temps between 35.6° and 46.4° Fahrenheit. It will be shipped on dry-ice (–80°C). The Moderna vaccine (mRNA-1273), must be stored at -4° Fahrenheit (-20 C) and shipped at this –20°C temperature using gel packs.62

Thus, preserving this constant cold temperature is a major hurdle for the implementation of its vaccine marketing campaign, particularly the Pfizer/BioNTech vaccine. Given those constraints, analysts argued that Pfizer’s vaccine could only be used at certain hospitals and clinics with the proper equipment, and would require intensive one-day vaccination events at such sites that would cover a fraction of the healthy population. Not only do most vaccination sites lack the freezing requirements needed, but also shipping companies are currently unable to ship mass quantities of ultracold vaccines. Pfizer has partnered with UPS to develop ultracold shipping containers that can hold the vaccine at the required temperature. The packages utilize cold-resistant glass vials to hold the vaccine and dry ice to maintain cold temperatures. Although this may seem like a sustainable solution, the US presently has a shortage of both dry-ice (due to a shortage in CO2) and cold-resistant glass.63 Mass shipping using these containers would cause a huge strain on the supply chain and likely would require investments of billions of dollars.64

 

Deployment

 

Pfizer-BioNTech has said that they will be able to supply 50 million doses by the end of this year and around 1.3 billion by the end of 2021. If licensed, Moderna has said it intends to provide the US government with 20 million doses by the end of this year, and manufacture between 500 million and one billion doses globally throughout 2021. There are currently more than 320 Covid-19 vaccine candidates in development. Several of them, including the Oxford/AstraZeneca vaccine, are emerging from phase III trials, so we can expect more announcements like this soon.

 

No Liability Due to the PREP Act

With the upcoming SARS coronavirus-2 vaccines the vaccine industry is completely liability-free (not legally liable). The governmental nonliability guarantee for vaccine the manufacturers of current mRNA vaccines being implemented, or any future vaccines chosen to fast-track, comes out of the Emergency Use Authorization Authority (EUA Authority) that originated out of Project Bioshield. The Project Bioshield Act was an act passed by the United States Congress in 2004 calling for $5 billion for purchasing vaccines that would be used in the event of a bioterrorist attack. This was further defined by the PREP Act of 2005, the Public Readiness and Emergency Preparedness Act, which further granted the non-liability of vaccine manufacturers previously outlined in the 1986 Injury Compensation Program for childhood vaccines. On March 10, 2020, the Secretary invoked the PREP Act and determined that COVID-19 constitutes a public health emergency. Therefore, the HHS declaration authorizes PREP Act immunity for the “manufacture, testing, development, distribution, administration, and use” of covered countermeasures. An amendment to the PREP Act, which was updated in April65, stipulates that companies “cannot be sued for money damages in court” over injuries caused by medical countermeasures for Covid-19. Such countermeasures include vaccines, therapeutics, and respiratory devices. The only exception to this immunity is if death or serious physical injury is caused by “willful misconduct.” And even then, the people who are harmed will have to meet heightened standards for “willful misconduct” that are favorable to defendants.66

 

While people harmed by vaccines for other diseases are able to file claims with the National Vaccine Injury Compensation Program, which was established in 1986, the PREP Act now bars anyone who feels they were harmed by a vaccine for the coronavirus from using that program.

 

The PREP Act has allowed vaccine manufacturers unlimited freedom to create, develop, and market vaccines without any liability whatsoever. Manufacturers have been allowed to bypass animal studies and go directly to human trials. They also can add anything they deem important to the vaccine formula they choose – whether it be a known toxin or carcinogen. All liability is protected by the PREP Act, which means if anyone has an adverse event, or death caused by this vaccine there really is no recourse. This was put into the Federal Register in March of 2020 and does not expire till the end of 2024. So, anything that is developed over the next four years that has to do with a biological agent, such as a vaccine or drug or biotechnology, no matter how nefarious, is protected from liability under the umbrella of COVID-19.

 

Conclusion

 

The world, pushed by the pharmaceutical owned media, is clamoring for a safe, effective COVID-19 vaccine. Many laboratories and companies have scrambled to rapidly develop these vaccines, resulting in more than 200 vaccine candidates. Without proceeding with animal studies, many of these companies have entered human phase I, II and III clinical trials within a short period of 6 months. Pfizer/BioNTech and Moderna ‘vaccines’ moved quickly through human testing, without giving time for proper evaluation of earlier phases. They have not been approved or licensed by the U.S. Food and Drug Administration (FDA) ,but instead have received authorization for emergency use by the FDA under an Emergency Use Authorization (EUA) for use in individuals 16 years of age and older and are being injected into millions of people. Dangers arise due to the fast-tracking process that limits the time available for large-scale studies. Owing to the accelerated development process, the interim data from ongoing clinical and preclinical vaccine studies are being published almost in real time. As a result, crucial information about the longevity and quality of vaccine-induced protective immunity is unavailable. Fast-tracking leads companies to push out the vaccine before the results of a large-scale study show the safety and efficacy of the vaccine. Scientists and epidemiologists emphatically confirm that the primary focus of vaccine research is to prove it safe for a large population or group before being unleashed. The trials should offer clear datasets before releasing the vaccine to the public (millions if not billions of people). Without clear time-tested datasets of a large population, it is not possible to ensure that the vaccine is safe for most people in the country.

Pfizer released a Peer Review study entitled Safety and Efficacy of the BNT162b2mRNA Covid-19 Vaccine, recently published in the New England Journal of Medicine.67 In the Pfizer/BioNTech COVID-19 vaccine trials conducted in the United States, there were more allergic reactions reported in the vaccine group than in the placebo control group.68 While allergic reactions occurred in less than one percent of those receiving the COVID vaccine, it is important to note that individuals with a “history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the study intervention(s)” were excluded from Pfizer’s clinical trials.69, 70

 

Further testing and adequate time-testing may also identify specific health conditions, allergies, or related concerns of individuals that may not be qualified to take the vaccine. By fast-tracking the vaccine, the possibility of harm due to allergic reactions, autoimmune reactions, complications with an existing health condition, interactions with certain medications or other related concerns may increase when compared to a longer time frame for trials. In short, tests must prove that the vaccine is safe, which in vaccine time usually requires years rather than months.

 

Numbers reveal the death rate from COVID resumed to the normal flu death rate in early September 2020. Many scientists now view that the coronavirus pandemic is over. Therefore, a vaccine is no longer needed; it is totally unnecessary and comes with a potential danger. Perhaps the saddest part of this worldwide rush to the vaccine is seeing how little faith people have in their own immune systems. Somehow the powers that should not be have managed to convince the majority of the people that the immune system is just a conspiracy theory, and rather than strengthening our own innate ability to heal and regenerate our bodies, we should give our faith into the hands of pharmaceutical corporations, who profit from sickness.

 

When we pause for just one moment to marvel the ability of your own skin to heal a wound or a bone to mend itself, we will realize that our bodies have their own bioregulatory intelligence. This organic living intelligence is far beyond the capacities of any nanotechnology or lab-created synthetic concoctions which merely try to mimic nature and its grand design. Our immune system and a healthy biological terrain are our best defense for pathogens and there are several proven ways to keep it active. The mineral zinc is important for numerous immunological enzymes and may be taken daily. Vitamin D3 has been shown to be low or deficient in individuals that develop a serious coronavirus infection. Thus, taking vitamin D3 is preventive and may be taken daily to keep body levels therapeutic. Also, vitamin C has been extensively proven effective for infection protection. Getting fresh air and sunlight, staying active and well hydrated, and enjoying joyous social activities are all helpful in staying well.

 

Lastly, mRNA vaccines have never been licensed before, and now they are being administered to millions of people with no manufacturer liability. The public has become the testing ground for this new technology. If these coronavirus mRNA vaccines later prove to be harmful to fragile genetic cellular structures, then that cannot be undone. Essentially, we need a much better understanding of their potential side effects, and more evidence of their long-term efficacy. Vaccine development takes time as the vaccines must not only be proven protective but also safe. Unlike other drugs that are delivered into sick patients, vaccines are administered into healthy patients and thus require very high safety margins. There is still a lot of research that should have been done around safety before mRNA vaccines become used on the public. Unfortunately, that is not what is happening now, and consequently this has a potential to turn into a disaster on a massive scale.

 

Note:

Vaccine providers are supposed to report adverse events that occur after vaccinations to VAERS but vaccinated persons who experienced the reaction or a family member also can file a report if a health care provider does not do it. According to one government funded study in 2011, fewer than one percent of all vaccine reactions are reported to VAERS. Report vaccine side effects to the FDA/CDC Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to https://vaers.hhs.gov/reportevent.html and include ‘Pfizer/BioNTech COVID-19 Vaccine EUA’ in the first line of box #18 of the report form.

 

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