Health Risks From Vaccine Cell Lines and Adventitious Contaminants Dr Sherri Tenpenny DO AOBNMM ABIHM Cleveland Ohio USA November 9 2019 DISCLAIMER This presentation is intended for educational purposes for course participants only ID: 930425
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Slide1
Vaccines and Cancer: The Health Risks From Vaccine Cell Lines and Adventitious Contaminants
Dr. Sherri Tenpenny, DO, AOBNMM, ABIHM
Cleveland, Ohio USA
November 9,
2019
Slide2DISCLAIMERThis
presentation is intended for educational purposes for course participants only.
The
information presented reflects the author’s opinions at the time
the presentation was created.
Some
information will change over time, as new research, data and information become available.
The
author assumes no responsibility for updating information that may modify any information presented
herein. All
rights
reserved. Copyright 2019.
Slide3What We Are Going To Discuss Today Cell lines and serum used to manufacture vaccines
The potential risks of cell lines and their viral contaminants
Why multiple benign viral contaminants can lead to virulent recombinants
Slide4Partial list of vaccine ingredients in commonly given vaccinesAluminum (4 forms)FormaldehydeGlutaraldehyde
2-phenoxyethanol
Polysorbate 80
Neomycin,
polymyxin
B
Lactose, casein
Sodium borateYeast proteins and Yeast DNABeta-propiolactone Triton X-100 Ethylene oxideThimerosal
Animal cellsBovine serum (several forms)Avian serum - chickentEgg protein – ovalbumin VERO cells – monkey Dog kidney cells (MDCK)Insect cells Human cellsWI-38MRC-5PER.C6
>NO TESTING FOR ANTIBODIES
>NO TESTING FOR SYNERGISTIC TOXICITY
Slide5Problematic Ingredients #1: COW PROTEINS
Slide6Bovine Ingredients in Vaccines Bovine casein (milk protein)Bovine extractBovine cassation acidsBovine serum albumen
Bovine calf serum
Bovine formula fed calf serum
Bovine calf serum protein
Fetal bovine serum (FBS)
Slide7What Cow Parts are in Vaccines? Casein and lactose – Cow’s milkGlycerol - Tallow (fat)
Gelatin
–
Connective tissue, bones, tendons
Galactose
–
Circulating red blood cells Serum – Blood minus cellsAccording to the FDA: “Cow components are often used
simply because cows are very large animals… and thus much material is available.” REFERENCE: FDA - https://www.fda.gov/vaccines-blood-biologics/questions-about-vaccines/bovine-derived-materials-used-vaccine-manufacturing-questions-and-answers
Slide8Cow SerumIndustry standards classify the serum according to the following guidelines:
Description of Age
Age Serum is obtained
Fetal bovine serum
Intra-uterine fetus
Newborn calf serum
Less than 21 days old
Formula-fed calf serum
Less than 22 weeks
old Calf bovine serum
21 days to 12 months old
Adult bovine serum
12 months or older
Slide9Fetal Bovine SerumSerum is a complex mixture and even after 50 years of use, the majority of subunits have not been fully identified. Fetal bovine serum
(FBS) is the most widely
used,
the most difficult to obtain and the most
expensive of all
cell culture
promoter
substnances used in drug manufacturing 2014: FBS was found to contain
approximately 1,800 different proteins and more than 4,000 metabolites. The proportions of each vary between different batches and vary by the health of the animal from which it is harvested REFERENCE: Tanga, Fen, et al. “Fetal bovine serum influences the stability and bioactivity of resveratrol analogues: A polyphenol-protein interaction approach.” Food Chemistry, Volume 219, 15 March 2017, Pages 321-328
Slide10WARNING: Disturbing ContentCows are occasionally sent to slaughter to thin the herd or because they are lame. If a cow is found to be pregnant during the removal of its internal organs, the uterus is quickly moved to a specialized extraction area where the fetal blood can be harvested within 30 minutes of the mother’s demise.
This
is done by inserting a sterile vacuum collection apparatus directly into the heart
of the fetal cow without
anesthetic. The fetus must be at least 3 months of age or the heart is too small for puncture
.
A 3-month fetus yields about 150ccs of serum while a near-term fetus (9 months) can yield up to 550ccs. The heart must be beating to ensure the blood remains uncoagulated and all blood can be extracted from the fetus; therefore, it is presumed that the fetus is alive at the time of the extraction.
After the blood is removed, the remains of the fetus are processed for animal feed.
REFERENCE: Carlo E. A. et al., “The use of fetal bovine serum: ethical or scientific problem?” ATLA 30, 219-227. 2013
Slide11Bovine Sera Contaminants
Nearly 100% of commercially available
of bovine sera
is contaminated with species from the family of
Pestiviruses
Known contaminants in Fetal Bovine Serum:
Bovine diarrhea
virus (BVDV-1 and BVDV-2)
Classic swine fever virus (CSFV) Border disease virus (BDV)Bovine herpesvirus-4 and herpesvirus-8Hobi-like viruses 2015
: Italian study found that all 26 batches of FBS tested were contaminated with at least one species of bovine Pestivirus
REFERENCE:
Giammarioli
, M,
Ridpath
JF, et al. “Genetic detection and characterization of emerging
HoBi
-like viruses in archival
foetal
bovine serum batches.”
Biologicals
43, 220-224.
2015
.
Slide12Bovine Sera ContaminantsAre
cow viruses
crossing
species
line
to cause
illness in humans?
BVDV-antigens were found in the stool of 30 out of 128 children with infantile gastroenteritis.
REFERENCE: Yolken, Robert, et al. “Infantile gastroenteritis associated with excretion of Pestivirus antigens.” Lancet (8637):517-20 · April 1989Microcephaly has been reported in infants born to mothers who were seropositive for BVDV.REFERENCE: Erickson GA, et al. “Viral contamination of fetal bovine serum used for tissue culture: risks and concerns.” Dev Biol Stand. 75:173-5. 1991
Slide13Vaccines with Bovine Products
Bovine Albumin
Calf Serum
Bovine Casein
Bovine Extract
Caseamino
Acids
Fetal
Bovine Serum (FBS)Vaqta PediarixPediarix
PediarixDaptacelAll
DTaP -
Tdap
Jap
Encep
Kinrix
Kinrix
Kinrix
Adacel
(teen)
Polio
Quadracel
Polio
Infanrix
Infanrix
Quadracel
MMR
Pentacel
Zostavax
Boostrix
Boostrix
Pentacel
ProQuad
–
MMR+
Varivax
RabAvert
DT
Td
Td
Rotateq
Typhoid
Menomune
Rabies
Menactra
Hepatitis
A
Prevnar
Varivax
-
Zostavax
Slide14Problematic Ingredients #2: EGGS and CHICKEN
Slide15EGGS as INCUBATORSEggs have been used to manufacture vaccines for more than 70 years. 11-day old chick embryos are injected with viral solutions.3-5 days later, the gooey viral suspension is removed and centrifuged several times.
Despite
all efforts, chicken blood,
chicken protein
and chicken proteins remain in
the final
product
Slide16Avian (chicken) sourcesUsed in the production of
Influenza
,Rabies
and Yellow
fever
vaccines; some MMR vaccines
Known avian contaminants
include:
Avian leukemia virus…AVL Avian sarcoma virus Avian myeloblastosis virus Avian erthroblastosis virus Avian
myelocytomatosis virus REFERENCE: S Johnson, Eric, et al. “Cancer mortality in poultry slaughtering/processing plant workers belonging to a union pension fund.
” Environmental
Research.
Vol
588. Issue 94. August 01,
2010
Both viruses have been assoc. with
breast cancer
Slide17Avian Viral contaminants
Both viruses have been assoc. with
breast cancer
“Considering that ALV
can
easily
capture the human oncogenes [called] “
erb-B” and “myc” and these two oncogenes are
strongly associated with common forms of human breast cancer, it seems that the issue of ALV vaccine contamination should deserve a high level of
attention.”
REFERENCE:
McRearden
, Benjamin. “What Is Coming Through That Needle? The Problem of Pathogenic Vaccine Contamination,” Townsend Letter, October (2003).
Slide1818
Why
Are Viral Contaminants
A
C
oncern
?
Slide19Recall: Bovine and Avian Contaminants Known Fetal
Bovine
Serum contaminants
Bovine diarrhea virus (BVDV-1 and BVDV-2)
Classic swine fever virus (CSFV)
Border disease virus (BDV)
Bovine herpesvirus-4 and herpesvirus-8
Hobi
-like viruses Known avian contaminants include: Avian leukemia virus… “parent virus” Avian sarcoma virus
Avian myeloblastosis virus Avian
erthroblastosis
virus
Avian
myelocytomatosis
virus
Slide2020
100
particles
Benign Herpes Virus
A
100
particles
Benign Herpes Virus
B
Mouse #1
Mouse #2
Mouse ok
Mouse ok
ONE
particle
Benign Herpes Virus
A
+
ONE
particle
Benign Herpes Virus
B
Mouse #3
62% of MICE DIE
11 new recombinant
Viruses isolated
3 LETHAL in 4
th
gen.
Javier, RT,
et.al
. Two
avirulent
herpes simplex viruses generate lethal
combinants
in vivo.
Science.
1986 Nov 7; 234(4777):746-8.
Slide2121
Conclusion:
Two
avirulent
viruses interact
in vivo to produce
virulent recombinants
that
can be
lethal to the next generation.
REFERENCE:
Javier
, R-T;
Sedarati
, F; Stevens, JG. Two
avirulent
herpes simplex viruses generate lethal recombinants in vivo.
Science.
1986 Nov 7; 234(4777): 746-8.
Slide22Problematic Ingredients #3:Monkey Kidneys
Slide23SV40 and CancerIn 1955
, Jonas Salk discovered how to mass produce polio vaccine by growing it in kidney tissues of African green monkeys.
By 1960:
R
esearchers had isolated simian viruses as a contaminant in vaccines. SV-40 is benign in monkeys, but was found to cause brain tumors in human tissue cultures.
1962:
The VERO cell line was derived by Japanese researchers from the kidney of adult African green monkey
VERO cell line is a continuous cell line which will grow indefinitely in cultureIt was estimated that between 1955 and 1963, 98 million Americans and millions of persons around the world received doses of live polio virus vaccines potentially tainted with SV-40.
Slide24SV40 and Cancer1990s: Michael Carbone, Asst. Professor of Pathology at Loyola University in Chicago, isolated fragments of the SV-40 virus in the following cancers
:
Human bone cancers
33% of osteosarcomas
40% of other bone cancers
Lung cancer
60% of mesotheliomas tested had SV-4050% of mesotheliomas are no longer associated with asbestosREFERENCE: The Virus and The Vaccine: The True Story of a Cancer-Causing Monkey Virus, Contaminated Polio Vaccine, and the Millions of Americans Exposed by Debbie Bookchin
and Jim Schumacher. St. Marrtin’s Press. 2005.
Slide25SV40 and Cancer1990s: An Italian research team, lead by Dr. Fernanda Martini, discovered SV-40 by reverse transcription PCR in:
other tumors, including a variety of brain tumors:
83% of
choriod
plexus
papillomas
73% of
ependymomas
50% of
glioblastomas
47
% of
astrocytomas
14
% of
meningiomas
None of the 13 normal brain tissue samples were positive for SV40 DNA
REFERENCE:
Martini
, Fernanda, et al. “SV4O Early Region and Large T Antigen in Human Brain Tumors, Peripheral Blood Cells, and Sperm Fluids from Healthy Individuals.”
iCancer
Research 56. 4820-4825. Oct 5, 1996.
Slide26SV40 and Cancer Martini’
s research team also found SV-40 in
23% of peripheral blood samples
and
45% of sperm samples
taken from disease-free individuals
SV-40 has appeared
in 61% of all cancer
in patients too young to have received the contaminated vaccine Conclusion: SV40 virus may be transmitted sexually, through cord blood and through blood transfusions, from parent to childREFERENCE: Martini, Fernanda, et al. “SV4O Early Region and Large T Antigen in Human Brain Tumors, Peripheral Blood Cells, and Sperm Fluids from Healthy Individuals.” iCancer Research 56. 4820-4825. Oct 5, 1996
.
Slide27Between 1997 and early 2002, more than 25 published studies found SV40 in human mesotheliomas; 16 others found the virus in brain and bone cancers, lymphomas, and other cancers and in kidneys and peripheral blood.
By
2003
, SV40 had been found in human
tumors
in 18 developed countries. T
he
rates of SV40-positive tumors seem highest in countries that used the greatest amount of contaminated Salk polio vaccine, including the UK, USA, and Italy.
REFERENCE: The Virus and The Vaccine: The True Story of a Cancer-Causing Monkey Virus, Contaminated Polio Vaccine, and the Millions of Americans Exposed by Debbie Bookchin and Jim Schumacher. St Maartin Press. 2005.
Slide28For Example:2002: Non-
Hodgkins
lymphoma
tumors
42%
of 154 non-Hodgkin lymphomas. No SV40 was detected in 186 non-malignant
samples
or in the 54 control cancers.
REFERNCE: Malkin, David. “Simian virus 40 and non-Hodgkin lymphoma.” Lancet. Vol. 359. Issue 9309. Pg. 812-13. March 9, 2002. 43% of 68 non-Hodgkin lymphomas, 9% Hodgkin’s lymphomas. Viral sequences were absent in 40 control tissues. REFERENCE: Vilchez, Regis et al. “Association between simian virus 40 and non-Hodgkin lymphoma.” Lancet. Vol. 359. Issue 9309. Pg 817-823. March 9, 2002
Slide29Then in 2004: “The SV40 virus is a known oncogenic DNA virus…
. Persuasive evidence now indicates that
SV40 is causing infections in humans today
and represents an emerging pathogen. A meta-analysis of data from 1,793 cancer patients indicates there is a significant excess risk of
SV40 association
with human primary
brain
cancers, primary
bone cancers, malignant mesothelioma, and non-Hodgkin's lymphoma.”REFERENCE: Vilchez
and Butel. “Emergent Human Pathogen Simian Virus 40 and Its Role in Cancer.” Clinical Microbiology Reviews. Jul; 17(3): 495–508
.
2004.
Slide30Most Recently, 2019: The association between SV40 and human tumors is based on results obtained by many investigators.
Most
of these studies detected SV40 DNA sequences, using qualitative PCR techniques, in tumor specimens.
REFERENCE
:
Rotondo
JC, et al. “Association Between Simian Virus 40 and Human Tumors.”
Front Oncology. 2019;9:670. July 25, 2019.
Slide31Problematic Ingredients #4: Dog Cells
Slide32MDCK Cells1958: Madin-Darby Canine Kidney
cell line
MDCK are kidney cells from
originally
derived from a
healthy female
cocker spaniel
Original line of MDCK cells was non-tumorigenic, but over time, some cells have been found to be highly
tumorigenicFDA: “Highly tumorigenic cell substrates pose significant regulatory challenges.”REFERENCE: FDA: Use of Madin-Darby Canine Kidney (MDCK) Cells for Manufacture of Inactivated Influenza Vaccines, Philip Krause, MD. (ppt presentation) 2017
Slide33Tumorigenic Cell Lines1998: Initial discussions regarding the use of cancer-causing cells to create vaccines 1999-2000 FDA Conclusions:
Unrecognized
adventitious agents
may be a
major concern
in
neoplastic cell substratesRisks from residual DNA were ‘perceived’
to be lowThe amount of foreign DNA is limited to 10ng per injection Residual DNA may be infectious and/or oncogenic KEY: “
Previously used assays testing for tumorigenicity
may
not
have adequately defined
the tumorigenic
risk
associated with
residual tumorigenic cell.”
REFERENCE:
FDA
Briefing Document: “Vaccines and Related Biological Products Advisory Committee Meeting. Cell Lines Derived from Human Tumors for Vaccine Manufacture.” September 19, 2012
Slide34Problematic Ingredients #4:Human Cells
Slide35Cell Lines
MDCK
1958
Dog
kidney
FluCelVax
(approved 2016)
VERO
1962African Green Monkey
Kidney
Polio
RA
27/3
1964
Human
Kidney
Rubella fraction of MMR
WI-38
1965
Human lung
Varivax
,
Rubella
MRC-5
1970
Human lung
Varivax
,
Havrix
,
Vaqta
,
Twinrix
, Rabies, Shingles, Smallpox, [
Pentacel
]
PER.C.6
1985
Human
–
retina cells
Experimental
–
Ebola and HIV
Baculo
-virus
2013
Spodoptera
frugiperda
,
Armyworm
FluBlok
(approved 2014)
Slide36MRC-5 Cells1966: The immortalized cell line, MRC-5,
was developed by British researchers at the Medical Research Council in England.
The
cells were derived from lung tissue of an aborted male at about 14-week gestation removed from a 27 year old woman for “psychiatric reasons.”
VACCINES:
Varivax, Havrix
, Vaqta, Twinrix, Rabies, Shingles, Smallpox, [Pentacel]
Slide37WI-38 Cells 1962: Cells were extracted
from the lungs of an aborted female baby at approximately the end of the third month of pregnancy.
Many aborted fetus cell lines and various organs were tested
The 38
th
cell line was
found to be the most
adequate for immortalizationThe line has always been free of adventitious agents
Developed by Dr. Leonard Hayflick at the Wistar Institute in Philadelphia, PA – hence the name, WI-381965: WI-38 became commercialized REFERENCE: Medical research: Cell division. Nature. Vol 498, Issue 7455. June 26, 2013VACCINES; Rubella, Hepatitis A, Chickenpox, Rabieshttps://www.nature.com/news/medical-research-cell-division-1.13273
Slide38WI-38 Cells 1961: “The Hayflick limit”
It was discovered
that
normal
fetal cells stop replicating after about 50 population doublings.
This became known as ‘The
Hayflick
limit.’These discoveries launched a new field: The study of cellular aging and the study of teleomeres. This 1961 paper became one of the most-ever cited publications in biology.
The full story of the development of the WI-38 cell line is part of medical history. It is quite interesting and even laced with intrigue. The full interview with Dr. Hayflick on YouTube: An Afternoon with Dr. Leonard Hayflick Discussing Aging Research, Telomeres, and Telomerase (Pt 1 and Pt 2)
REFERENCE: Medical research: Cell division. Nature.
Vol
498, Issue 7455. June 26, 2013
https
://www.nature.com/news/medical-research-cell-division-
1.13273
Slide39PER.C.6 Cells 1985: PER.C.6 cell lines
were obtained
from human embryonic
retinoblasts
and immortalized
While found to be only mildly
tumorgenic, the cells were found to form tumors if transferred to a recipient No current human vaccines are licensed with these cells, which are still considered to be experimental
Slide40Significant problems with the residual immortalized human cells found in vaccines
Slide41Open Letter from Dr. Theresa Deisher, PhD on Human DNA in Vaccines, April 2019
A little background on Dr.
Deisher
She is
President of the non-profit Sound Choice Pharmaceutical Institute.
Dr.
Deisher was the first person to discover adult cardiac derived stem cells, and has been a champion of
adult stem cell research, both professionally and privately for over two decades. Her research also focuses on the health risks of residual human fetal DNA contaminants and retroviruses found in pharmaceutical products, including some vaccines. She studies how these contaminants may be implicated in autism, autoimmune disease and cancer.
As the result of this work, her name is on 23 patents as the inventor.
Slide42Problem with Human Cell Lines“Vaccines manufactured
using human fetal cell
lines
are heavily contaminated with human fetal
DNA.
Levels in our children can reach up to
5
ng/ml after vaccination, depending on the age, weight and blood volume of the child. That level is known to activate Toll-like receptor 9 (TLR9), which can cause autoimmune attacks
.”“The rubella portion of the MMR vaccine contains human derived fetal DNA contaminants of about 175 ngs, more than 10x over the recommended WHO and FDA threshold of 10ng per vaccine doseREFERENCE: Theresa
Deisher, PhD. “Open Letter to Legislators Regarding Fetal Cell DNA in Vaccines.” April 8, 2019.
Slide43Problem with Human Cell Lines
Administration
of fragments of human, non-self DNA to a child
can
generate an immune response that
can
cross-react with the
child’s own DNA.Injecting children with human fetal DNA contaminants risks of causing
two well-established pathologies:Autoimmune disease: Foreign fetal human DNA triggers an immune response, leading the immune system to attack his/her own body.Insertional mutagenesis: fetal human DNA incorporates into the child’s DNA causing mutations. Gene therapy using as little as 1.9ng/ml of DNA fragments results 100% insertion into genomes of injected mice. The
levels of human fetal DNA fragments in the MMR, Varivax (chickenpox) and Hepatitis A
vaccines
contain much more than vaccines 1.9
ng
/ml.
Theresa
Deisher
, PhD
–
continued
…
Slide44Problem with Human Cell Lines
“The
presence of both the high level contaminating fetal DNA as well as the
the presence of Human
endogenous retrovirus K (HERVK)
in
the MMR vaccine is an unstudied risk with huge implications and dangers for individual and public
health.”To date there is evidence of HERV-K retrovirus activation in ovarian cancer, melanoma, breast, prostate, lymphomas, leukemia and sarcomas
.Threresa Deisher PhD - continued… Dr.
Deisher exposed HERV-K in MMRCorvelva
Laboratories exposed HERV-K in
Gardasil
Slide45Oct. 1967:
Science
Magazine
"
In point of fact, we are practicing biological engineering on a rather large scale by
using
live viruses in mass immunization campaigns…
Crude virus preparations are vulnerable to frightful mishaps of
contamination...
"
Joshua Lederberg
Dept. Human Genetics
Standford
School of Med.
1976:
Address at
the annual American Cancer Society
Science
Writers
Seminar
“
Immunization Programs against flu, measles, mumps, polio and so forth may actually be
seeding humans with RNA to form latent proviruses in cells throughout the body. “These latent proviruses could be molecules in search of diseases, including rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosus, Parkinson's disease, and perhaps cancer.”
Robert
W. Simpson, M.D.
,
Rutgers University
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