- In recent times mankind is experiencing a situation never
previously encountered, that being the threat of release of pathogens intended
to kill or disable large numbers of people. That danger has prompted certain
health agencies to prepare for possible mass vaccination of the populace.
The purpose of this report is to examine the existing scientific evidence
of pathogenic contaminants in vaccines. This summary, while making no claim
of being a complete review of the subject, will point out sufficient examples
and illustrations of contamination with bacteria, viruses, and their components,
so as to enable the reader to make a more informed decision regarding accepting
a vaccination (or forcing others to receive one). It is presented in a
format intended for the public, their physicians, and their agency or governmental
representatives, and may be freely copied in its entirety.
-
- If you as an individual are too busy to read this brief
summary in one sitting, please be aware there is ample evidence in the
scientific literature that serious viruses, bacteria; or components and
toxins therefrom; as well as foreign animal or cancer-related proteins
and DNA are finding their way into the commercial vaccines intended for
humans, pets, and agricultural animals. If you are interested in the short
and long-term health of yourself and those you care about, or serve as
a public servant or medic al advisor, you do owe it to yourself to be informed.
-
- In the production of viral vaccines on a commercial scale,
the virus of concern must be reproduced in large quantities. Viruses cannot
survive or reproduce without being introduced into cells that nourish them,
which enables the viral reproductive activity. In that sense all viruses
can be considered parasitic on other cells. Living cell types commonly
used to reproduce viruses in the lab include monkey kidney cells, chicken
embryos, as well as other animal and human cells. These cells must also
be nourished with food, and are most often fed with a nutrient mix containing
in large part, bovine (cow) calf serum (usually, serum extracted from fetal
calf blood). This product can carry many types of bovine blood-borne viruses,
and is one of the primary sources of vaccine contaminants. A journal article
states, "a potential risk associated with the production and use of
biological products is viral contamination. This contamination may be present
in the source material, e.g. human blood, human or animal tissues, cell
banks, or introduced in the manufacturing process through the use of animal
sera..."(1)
-
- Bovine Viruses
-
- The viruses and other agents that can contaminate bovine
calf serum are numerous. One of the most prominent is a pestivirus called
bovine viral diarrhea virus (2). More specifically, we see in several scientific
journal sources these types of statements: "contamination of a vaccine
as a consequence of infection of fetal calf serum"(3); "many
batches of commercially available serum are contaminated with viruses such
as BVD" [bovine viral diarrhea] (4); "virus was isolated from
332 of 1,608 (20.6%) lots of raw fetal calf serum obtained specifically
for the Center and 93 of 190 (49%) lots of commercially available fetal
calf serum (5); "agents most frequently detected in CCL's [continuous
cell lines] have been bovine viral diarrhea virus and mycoplasma. Our laboratory
has consistently found that the source of bovine viral diarrhea contamination
of CCLs has been the use of contaminated fetal bovine cell culture enrichment
serum"(6); and finally, "In conclusion, most commercially available
bovine sera are contaminated with BVDV and, although there is no evidence
that the virus is infectious, bovine sera should be screened for this virusfor
the development or production of vaccine."(7)
-
- Can this virus cause infection or disease in humans?
New evidence shows this is possible, as researchers have found a new strain
that was isolated from human cells, and it is very closely related to the
bovine strains (8). One study finds that an alarming 75% of all laboratory
cell lines examined were contaminated with pestivirus strains; of these,
all of the bovine cell lines were contaminated with one of three possible
BVDV strains; cell lines from other animal sources including primates,
sometimes contained one of these BVDV strains (9).
-
- There is now heightened concern that this virus and others
can cross species lines, creating new strains as they adapt to their new
hosts, and this would include passage of the virus to and from humans.
Whether the human strain of BVDV causes overt illness is uncertain, because
physicians may be uninformed and not even be looking for this virus. It
may be useful however, to compare the infection patterns in cattle. They
can be persistently infected at a low level for their entire life with
a non-pathogenic strain of the virus. Under these conditions, they consistently
create and shed virus into the surrounding environment, which then infects
other animals. The virus can nonetheless become lethal to the animal if
it mutates, with the new form also causing "visible cell damage and
death" in cultured conditions (10). The animal succumbs to gradual
or acute deterioration of the gastrointestinal mucous lining, which produces
diarrhea and its eventual demise. However, mutated virus is not always
necessary to provoke debilitating illness and death, and ordinary virus
can be isolated from the cow's pancreas, adrenal glands, and pituitary
glands (11); the virus has also been documented as causing serious pulmonary
illness (12). A study describes an outbreak of disease among goats due
to a vaccine contaminated with a bovine pestivirus; oddly, these animals
experienced reproductive failure and lesions to the central nervous system
(13). So, can these diseas symptoms in varied organs and tissues also occur
in humans when they carry this virus short or longterm?
-
- A cursory examination of the literature indicates this
may be occurring. One revealing study tells us "faeces from children
under 2 years old who had gastroenteritis that could not be attributed
to recognised enteric pathogens were examinedfor Pestivirus antigens. Such
antigens were detected in 30 of 128 episodes of gastroenteritisThe diarrhoeal
disease in children excreting Pestivirus antigens resembled that in other
children except that it was more commonly associated with signs and symptoms
of respiratory inflammation."(14) There are also concerns regarding
a pattern of pestivirus infection in infacts born with microcephaly, a
condition wherein the head or cranial capacity is unusually small (15,
16).
-
- Scientists from the USDA National Veterinary Services
Laboratory describe the situation quite clearly, and give an indication
of the seriousness of the problem: "The high frequency of virus and
antibody detection in individual animal or small pool samples suggests
that any large pool of unscreened sera will be contaminated. Infection
of cell cultures with BVDV can lead to interference with the growth of
other viruses. Vaccine produced on contaminated cells may in turn be contaminated,
leading to seroconversion or disease in the vaccine. The safety, purity,
and efficacy of viral vaccines require BVDV testing of ingredients, cell
substrates and final product."(17)
-
- And here is a similar statement from a New York Blood
Center: "Bovine viral diarrhea virus, whose small virion size does
not allow 100% assurance of its removal by filtration, may potentially
contaminate every lot of commercially produced fetal bovine serum."(18)
-
- In reality though, how much of this particular viral
contaminant has trickled into humans? Well, in spite of manufacturers and
regulatory agencies claiming efficacy of their testing procedures, one
2001 study found 13% of human MMR, polio, or Streptococcus pneumoniae vaccines
tested positive for pestivirus RNA (19). And another researcher observes,
"serum antibodies against BVDV have been detected in approximately
30% of human population who had no contact with potentially infected animals."(16)
Also, "pestiviruses adapted to human cell cultures may be harmful
because serious BVDV infections in humans have been frequently suggestedThe
BVDV persistently infected in cell cultures used for vaccine productions
have been shown to be a source of contamination in live virus vaccines.
It is, therefore, prerequisite to examine pestivirus contamination in cell
cultures to avoid secondary infections in humans as well as in animals."(20)
-
- Continuous Immortal Cell Lines
-
- This same scientist brings up another important issue.
Because many medical-use biological products (including vaccines) are now
being cultured or produced on what is called "continuous" cell
lines (i.e., these are cell cultures consisting of "immortal"
or cancerous types of cells because they have no limits on how many times
they can divide), there is concern that viral contamination of these cell
lines with a pathogen like bovine viral diarrhea virus, could spread cancer-promoting
material into the human recipient. How could this happen? Briefly, it works
like this. The virus (which in this case has a single strand of RNA for
its genome) is capable of incorporating RNA from the cells in which it
has been cultured, into its own genome. If any contaminant RNA virus is
present in a culture that contains immortal cancerous cells, this virus
can easily mutate to include unwanted oncogenic material, which can then
get passed into the biological product intended for human medical use (16).
-
- Were you aware that biological products, including some
common vaccines (for instance, polio and rabies), are being produced on
"continuous" immortal cell lines? Manufacturers, scientists,
and agencies will often assure us that these cells themselves are not "tumorigenic",
i.e., they do not cause tumors per se. A closer look however, shows this
is not always the case. While lab culturing may indicate that these types
of cells are not immediately changing to overt tumor cells, it is now well
known in the scientific community that after these cells have been repeatedly
cultured a certain number of times, something causes them to convert to
a cancerous state (21).
-
- This journal article summary addresses the issue in regards
to Vero cells, which is a continuous cell line coming from the African
green monkey, and is commonly used in vaccine production. It states, "One
of the current criteria for evaluating the acceptability of cell lines
for use in vaccine production is lack of tumorigenicity. Vero cells represent
an example of a class of cells known as continuous cell lines. They were
derived from African green monkey kidney, and their growth properties and
culture characteristics have many advantages over other cell substrates
for use in vaccine production. We have tested Vero cells for tumorigenicity
in nude mice and in a human muscle organ culture system, and found a significant
increase in their tumorigenic potential with increasing passage numbers.
Cells at passage 232 and higher produced nodules in all nude mice inoculated."(22)
[The term "passage" in this context means the number of times
a cell line has been cultured].
-
- There is another very important issue reported in studies
that is evidently being largely ignored as regards long-term vaccine effects
and safety. There is obvious evidence that in the lab, continuous immortal
cell lines react differently between one type of animal species and another
(21, 23). As an example, tissue from one species will allow the immortal
cell to induce a cancerous change more quickly, in comparison to tissue
from a different species. These results then beg the following questions.
How extensively have these continuous cell lines been tested on human tissues,
and would the results vary from one type of tissue to another? And what
happens over the long termif an immortal cell from a vaccine culture makes
its way into the final vaccine product, does it keep dividing in the human
body? Another scenario might suggest the tumor-promoting portion of its
DNA inserting into a viral genome, which then gets injected into the bodywhat
happens at that point?
-
- Furthermore, given the evidence that closely-related
animal species (as an example, various species of monkeys) react differently
to immortal cells, do we also need to consider that any one vaccine intended
for all humans might ultimately react differently among the various races,
ethnic groups, and sexes? And what are the effects of the vaccine contaminants
on persons with immune depression, on the elderly, or on infants?
-
- A letter from the FDA to vaccine manufacturers dated
as recently as March 2001 shows that this issue regarding immortal cell
lines is still of concern. It states, "In general, CBER [Center for
Biologics Evaluation and Research] currently views Vero cells as an acceptable
substrate for viral vaccines, but has residual concernsCBER recommends
that all products derived from Vero cells be free of residual intact Vero
cells. If your manufacturing process does not include a validated filtration
step or other validated procedure to clear residual intact Vero cells from
the product, please incorporate such a procedure into your manufacturing
process."(24) It is now 16 years after the WHO gave a go-ahead (in
1986) to use continuous cell lines for vaccine production (25), and yet
there are very basic safety questions not resolved by the manufacturers,
agencies, and scientific community, much less the finer details (26, 27).
One 1991 study reports: "Cell substrate DNA was shown to be an abundant
contaminant in the clarified preparations of the Sabin type 1, 2 and 3
poliovaccines produced on a continuous cell line"(28). Another indicates
that immortal cell lines showed 100-times greater number of DNA recombination
events compared to normal cells (29). As one researcher states, "Using
neoplastic cell lines as substrates for vaccine development could inadvertently
result in viral-viral or viral-cellula r interactions whose biological
consequences are unclearviral-viral and viral-cellular interactions can
result in the generation of new retroviruses with pathological consequences."(30).
We note the term "neoplastic" means the quality of having an
abnormal growth characteristic.
-
- There is an even stronger statement dating back to 1990.
A scientist in the field writes, "The present concern is for safety
of vaccines made using transformed or neoplastic mammalian cells that may
contain endogenous contaminating viruses or integrated gene sequences from
oncogenic viruses. There is also concern for use of plasmid vectors employing
promoter elements from oncogenic viruses. The principal concern for safety
lies with retention of residual DNA in the vaccine, especially since induction
of cancer is a single -cell phenomenon, and a single functional unit of
foreign DNA integrated into the host cell genome might serve to induce
cell transformation as a single event or part of a series of multifactorial
events. Current proposed standards for vaccines would permit contamination
with up to 100 pg [picograms] of heterologous DNA per dose. This is equivalent
to about 10(8) 'functional lengths' of DNA. Total safety would seem to
require complete absence of DNA from the product."(31)
-
- Please note that 10(8) means 10 to the power of 8, or
100,000,000 "functional lengths" of DNA are allowed per dose
of vaccine . Is there something wrong with this picture? How long will
the general public be subjected to these vaccine products that according
to this information, are nowhere near safe?
-
- It has taken, for instance, approximately forty years
for the scientific community to finally acknowledge that we have a serious
problem as a result of the contaminatio n of polio vaccines with simian
virus 40 (SV40) in the late 1950s-early 1960s. There has been previous
evidence of some human brain and other tumors containing this virus (32,
33), but the medical community has been slow to acknowledge a definitive
link between SV40 and cancer in humans. However, two independent research
teams have recently found this virus present in 43% of cases of non-Hodgkins
lymphoma (34, 35). Another study found it present in 36% of brain tumors,
16% of healthy blood cell samples, and 22% of healthy semen samples (36).
And strangely, SV40 has now been found to infect children (37). Considering
that children of this era, are not supposed to be receiving the virus via
the vaccine contamination route, this would therefore imply that SV40 is
being transmitted from one human to another, in ways not previously known.
-
- Other simian viruses may also be contaminating the (Vero)
monkey cell lines used for vaccine production. One example from the literature
cites the contamination presence of SV20, which is a oncogenic simian adenovirus
(38).
-
- Simply put, are we in a state of denial that vaccines
are ultimately transmitting viruses, DNA, and proteins into humans from
foreign animal sources (and possibly unhealthy human sources), and that
this may be strongly contributing to the incredible upsurge in cancers
and serious chronic diseases? Are these foreign animal genes altering your
DNA? Furthermore, given that viral presence can sometimes take years to
manifest actual disease symptoms, and then considering the tendencies of
health-related agencies and corporations towards short-term solutions and
profits, will we ever truly know the long-term consequences until it is
too late?
-
- Other Bovine Viruses
-
- Another contaminating virus found in the calf serum used
for vaccine production is bovine polyomavirus (polyomaviruses are strongly
associated with cancer); one pertinent article is titled "Bovine polyomavirus,
a frequent contaminant of calf serum"(39). Other contaminants include
a virus from the parvovirus family (40); another study cites "virus-like
particles" and "mycoplasma-like agents" in 68% and 20% of
the samples, respectively (41); and yet another mentions the presence of
infectious bovine rhinotracheitis virus (aka bovine herpesvirus 1), and
parainfluenza-3 virus in addition to the common BVDV (42). An interesting
report from 1975 not only affirms the presence of these viruses in calf
serum, and mentions the additional presence of bovine enterovirus-4, but
also tells us that 25% of serum lots that were pre-tested by the suppliers
and "considered to be free of known viral contaminants" were
actually contaminated with bovine viruses (43). It should be obvious that
any bovine blood-borne virus (including serious retroviruses such as bovine
leukemia virus, bovine visna virus, and bovine immunodeficiency virus)
could ultimately end up in human or animal vaccines via the use of calf
serum in the manufacturing process.
-
- Contamination of calf serum with certain bovine herpesviruses,
and the possible implication for human health, deserves a bit of scrutiny.
It is known that bovine herpesvirus-1 replicates easily in a human embryo
cell line called WI-38 (44). It is also known that bovine herpesvirus-4
is quite "persistent" in calf serum, and has a wide host range,
including human cells (45). In fact, this particular virus strongly replicates
in two human embryonic cell lines, WI-38 and MRC-5, enough so to prompt
one author to give these details and a warning: "PCR [polymerase chain
reaction] detected a 10,000-times-higher level of BHV-4 [bovine herpesvirus-4]
DNA the supernatant indicated a 100-fold increase of infectious particles.
Since this is the first bovine (human herpesvirus 8 and Epstein-Barr virus
rela ted) herpesvirus which replicates on human cells in vitro, the danger
of possible human BHV-4 infection should not be ignored." (46)
-
- The clincher to this possible contamination, is that
these same human cell lines WI-38 and MRC-5 are two of the most common
human cell lines used to manufacture viral vaccines, (for example - rubella,
chickenpox, smallpox) and these cell lines are of course, commonly nurtured
with calf serum.
-
- Contaminants From Chicken Sources
-
- Some viral vaccines are produced by growing the virus
in chicken eggs. Common human vaccines manufactured by this method include
influenza, mumps, measles, yellow fever, and others. Like the vaccines
that include bovine-source materials, those derived from chicken embryo
culture are plagued with some very serious viral contamination problems.
-
- Avian leukosis virus (aka avian leukemia virus or ALV)
is a retroviral pathogen that infects large segments of the modern poultry
industry, is present in commercial chickens and eggs, and thus exposes
humans on a consistent basis (47). An interesting virus in the sense that
it can be considered a "parent", it easily transforms into a
dizzying array of related viruses by hijacking one of numerous cancer-related
gene segments from its host, and inserting it into its own genome. Furthermore,
it has the additional capability of inserting itself into the host (including
human) genome, hiding out so to speak, and causing cancerous cell transformation
from that location. There is now much scientific literature available that
describes the various active mechanisms of this and other cancer-associated
viruses (48). Viruses that originate from the "parent" avian
leukosis virus, include the potent Rous sarcoma virus, Rous-associated
viruses, avian myeloblastosis virus, avian myelocytoma virus, avian erythroblastosis
virus, Fujinami sarcoma virus, etc. One group of researchers studying the
mechanism of ALV writes, "Serial passaging of a retrovirus that does
not carry an oncogene on such cultures leads with a high frequency to the
emergence of new viruses that have transduced oncogenes"(49). In other
words, given the right growth conditions, ALV can easily transform into
other closely related viruses that are known to be cancer-related.
-
- Just how common is this avian leukosis virus in viral
vaccines? The first evidence of contamination came to light in the 1960s
when yellow fever vaccine was found to contain it (50).
-
- Since that time, it is common knowledge in the industry
that this virus (or components thereof) still linger in human and animal
vaccines (51). Indeed, the respected Fields Virology text (year 2001 edition)
states, "At the present time, vaccines produced by some of the world's
12 manufacturing institutes are contaminated with avian leukosis virus"(52).
One point that researchers in this field do agree upon, are the presence
of ALV, avian endogenous virus, avian reticuloendotheliosis virus (another
poultry retrovirus), and also an enzyme called reverse transcriptase (a
component of retroviruses) in final vaccine products intended for human
use, especially the mumps, measles, yellow fever, and influenza vaccines
(53, 54, 55). What they do not agree upon are the effects on humans in
terms of transmission, infection, and possible subsequent disease. A recent
study coming out of the U.S. CDC (Centers for Disease Control), which analyzed
frozen blood serum samples from children that had received MMR vaccinations,
reports no avian viral presence in these samples (56).
-
- And yet, we see reports from other researchers that make
us question the results of that study.
-
- As is often the case with viruses, some strains will
show particular affinities for certain types of tissues or growth conditions,
and ALV is no exception (57). One researcher makes the effort to explain,
"Because of the difficulty in infecting mammalian cells in vitro with
these viruses, it is generally held that they do not infect humansOur results
show that exposed poultry workers and subjects with no occupational exposure
to these viruses have antibodies in their sera specifically directed against
ALSV [Avian leucosis/sarcoma viruses] Further investigation into whether
these findings mean that virus has been integrated into the human genome
is needed, to assess the public health implications of these results."(58).
He also explains in another article, that given the known behavior of these
viruses in mammalian cellular culture, a blood serum test will not always
provide the correct evidence of viral presence in the human body (47).
-
-
- In other words, does the virus (or viral antibodies)
need to be actively present in the blood stream at the time of the blood
draw? What if the viral particles have retreated into other tissues? Thus,
the CDC study mentioned above may not have presented an accurate assessment
of viral presence, or long-term effects from the numerous ALVassociated
"offspring" viruses. Considering that ALV can for example, easily
capture the human "erbB" oncogene (59), and that erbB as well
as the oncogene called myc are strongly associated with common forms of
human breast cancer, it seems that the issue of ALV vaccine contamination
would deserve a high level of attention! (By the way, the general reader
should not feel intimidated by the abbreviations associated with oncogeneserb
refers to "erythroblastosis", and myc refers to myelocytomatosis,
which are the names of two ALV-associated offspring viruses). A well-known
microbiology text reinforces these concepts by teaching, "Proto-oncogenes
become incorporated into retroviral genomes with surprising ease."
(60)
-
- Toxin Contamination
-
- The unintentional presence of bacterial-source toxins
(called "endotoxins" or "exotoxins") in human and veterinary
vaccines has been recognized for many years. Such toxins are originally
present in source materials, or are produced as a result of bacterial infection
during the manufacturing process (61, 62). The various methods used in
attempts to eliminate viruses and bacteria from vaccines are simply not
effective in the removal of these problematic toxic proteins (63). Several
observers have expressed concern that the presence of endotoxin may be
a source of severe adverse reactions seen in some individuals after receiving
a vaccine (61, 64). Some vaccines, such as those for diphtheria and tetanus,
are specifically created to induce a protective mechanism in the body against
the bacterial toxin; however, vaccines prepared from bacteria can contain
appreciable and potentially dangerous lingering amounts of toxin, despite
the steps used during manufacture to decrease the toxic potency, as described
in this comment: "Vaccines composed of gram-negative bacteria contain
endotoxin in considerable amounts. This may result in adverse effects after
vaccination of sensitive animals." (65). It has also been reported
that bacterial toxin contamination residing in calf serum, can cause breaks
in the DNA of human cells (66).
-
- Bacterial Contamination - Nanobacteria
-
- Nanobacteria is a recently discovered pathogen that infects
humans. Now considered to be the smallest existing bacterial form known
to science, it escapes through common filtering processes, and can easily
invade other cells and cause cell death. Nanobacteria also are classed
as "pleomorphic", that is, they have the ability the change physical
form. A human variety of this pathogen has been found to cause or be associated
with a host of disease conditions, only a few of which include atherosclerosis,
coronary artery / heart disease, kidney stones and kidney disease, arthritis,
MS, alzheimers, some cancers, and other conditions (67).
-
- Since this species of bacteria is specific to mammals,
and must be lab-cultured in mammalian blood or serum, it is not surprising
that this variety of nanobacterium has been isolated as a contaminant from
bovine calf serum, other mammaliam bio-products, and vaccines. One study
reports that 100% of serum of cattle in a US herd showed antigens to nanobacteria,
and cites another report from Europe that, "more than 80% of commercial
bovine serum lots contain Nanobacterium" (68). Obviously, any vaccines
that must incorporate mammalian products during production (which would
include cow, monkey, or human cells, blood or serum), will be prone to
nanobacterial contamination. This was indeed verified when a group of researchers
found that 2 out of 3 lots of inactivated polio vaccine, and 3 out of 6
lots of veterinary vaccines were contaminated with nanobacteria. They also
point out that the bacteria could be coming from calf serum and contaminated
culture cell lines (69). Any reasoning person with a basic knowledge of
vaccine production can deduce that nanobacteria have undoubtedly been infecting
humans in a fairly widespread manner via vaccination procedures. One might
also wonder whether it has contributed to the current prevalence of atherosclerosis
and generalized heart disease.
-
- Bacterial Contamination - Mycoplasmas And Related Forms
-
- If there is any one type of bacterial contamination in
vaccines that warrants particular attention, it would be mycoplasmas. These
small organisms have a structure not characteristic of most forms of bacteria,
i.e., they usually contain a thin outer membrane as compared to the more
complex walls of common bacterial forms. They are described as being capable
of slipping through filtration procedures, and can transfer to other media
through the air or via routine handling in the lab (70).
-
- One source states that "less than 10% of laboratories
actually test for infectio n/contamination regularly"that mycoplasmas
are "influencing almost every aspect of cell biology"and that
labs "which do not test for mycoplasma probably harbour contaminated
cell lines and may even have their entire stocks contaminated, as mycoplasma
spreads readily along cell lines via regents and media, the operator and
the work surface" (71). They are resistant to certain types of antibiotics
used to kill other bacteria (70, 72), and are subject to changing form
under varying physiological or biochemic al conditions (73).
-
- The journal and industry literature is filled with references
to the problems of mycoplasma contamination in cell cultures and vaccines.
Various studies cite corrupted cell lines ranging in occurrence from 5%
to 87% (71, 72, 74, 75, 76), and as we now know, once this pathogen is
in the cell culture being used to make the vaccine, it is liable to end
up in the final product (77, 78, 79,80).
-
- One author states, "Mycoplasma contaminants can
be considered important not only because of their role as pathogens but
also because they may indicate that insufficient care has been taken during
vaccine manufacture or quality control." (81). Species of mycoplasmas
that have polluted the cell cultures include Mycoplasma hominis, M. fermentans
(implicated in Gulf War illness), M. arginini, M. hyorhinis, M. orale,
M. pirum, M. pneumoniae, and Acholeplasma laidlawii (75, 76, 82). Any reputable
company that sells tissue or cell culture material, also must test for
and sell kits to detect mycoplasmas (72, 75, 76, 83, 84).
-
- Mycoplasmas and associated variant forms have long been
associated with many disease processes, including cancer, chronic illnesses
such as chronic fatigue syndrome, fibromyalgia, arthritis, Gulf War Illness,
and many others (73, 85, 86). It would be impossible to cite all the pertinent
references in this short report, on this vast arena of microbiology that
is often ignored by much of the medical community, sometimes with tragic
consequences. Mycoplasmas without question have the capability of altering
cell membranes and their antigens, disrupting DNA, and altering cellular
metabolism both in vitro and in vivo (70, 71, 72, 73, 86).
-
- Cross-Contamination Of Cell Lines
-
- As we recall that all viral vaccines can only be produced
with the use of cells, the purity of the cell lines an important issue.
The most famous example of many cell lines becoming contaminated from outside
sources, occurred when the famous and extremely fastidious HeLa cancer
cells started showing up in labs across the world in the 1960s. The phenomenon
is well-documented (87, 88, 89, 90), and is even the subject of an entire
book (91). One study from 1976 cited a litany of contamination in all primary
and continuous cell lines that were examined - many viruses were found,
as well as HeLa cells (92). As the years progress, the reports continue
to come in: one from 1984, for instance, tells of inter- and intra-species
cell cross-contamination, that 35% of all cell lines were corrupted, and
that most of these lines were (originally) cells of human origin (93).
-
- Let's fast-forward to 1999. A study in Germany finds
that the problem is continuing, if not worsening. In a survey of human
cell lines, the most common cross-contaminants came from "classic
tumor cell lines"; that these polluted lines had been unknowingly
used in "several hundred" projects which generated potentially
false reports; and that they considered it a "grave and chronic problem
demanding radical measures" (94).
-
- The situation is such that several scientists were prompted
to write a letter to the respected journal "Nature" in January
2000, calling for immediate action to institute procedures that would verify
the purity of cells used for research and production of biological products,
ensure freedom from mycoplasma, and include biohazard information (95).
(Did I hear that correctly - cells can be considered a biohazard)? Has
anything changed since then to remedy the situation? There is another report
from Jan. 2002, that two major cell lines used in research projects actually
turned out to be HeLa cells (96).
-
- I ask the reader to now recall information from earlier
in this report, that there are proposals being considered to produce vaccines
and other biological products using distinctly cancerous cell lines, including
HeLa (25). Does this seem reasonable, especially since the current lines
are already dangerously tainted with HeLa and possibly other cancerous
cells? Please remember the 100,000,000 allowable pieces of cell-source
DNA allowed per dose of vaccine (and this does not include the viral contaminants).
Anyone care for a small, under-the-skin serving of human cancer-cell-component
soup? With maybe a few monkey cell fragments for garnish, and viruses for
flavor?
-
- Additional Points To Consider
-
- There are several issues the public and medical community
may want to be aware of concerning safe administration of vaccines. The
human and animal body has normal barriers that help to protect against
infiltration by foreign agents, among them are the skin, the respiratory
and intestinal mucous linings, and the blood-brain barrier. The puncture
of skin by a needle breaches that barrier. A group of researchers states,
"Virus contamination of bioproducts such as vaccines, blood products
or biological material used in surgery and for transplantations also is
more hazardous because the application of contaminating virus usually occurs
by circumvention of the natural barrier systems of the bodyvirus contamination
of bioproducts should be considered as a hazard no matter which method
has been used for its detection." (97). Of even more concern, is the
administration of vaccines nasally (through the nose), or accidental passage
via that route (98). Fields Virology text (2001) says, "The olfactory
tract has long been recognized as an alternative pathway to the CNS [central
nervous system]olfactory neuronsare unprotected by the blood brain barrier."
While that writer particularly addresses the flavivirus family [i.e., "intranasal
inoculation of flaviviruses may result in lethal encephalitis" (99)],
this pattern of potential danger may deserve further attention than it
currently receives, especially if there ever is consideration to use a
method of nasal inoculation for mass vaccination of the public or military,
and there may be contaminating viruses or toxins in a vaccine that have
an affinity for nerve cells and tissues.
-
- Mass immunization programs often use jet injectors to
save the time and inconvenience associated with needles and syringes. However,
a study published in July 2001, found that the four injectors tested had
the capability of transferring tiny amounts of fluid and blood (and thus,
viruses such as hepatitis B and C, HIV, etc.) from one recipient to the
next (100). Numerous other articles confirm the danger, and question the
safety of these devices, including one study that reported an outbreak
of hepatitis B associated with use of a jet injector (101, 102).
-
- Some of the newest types of vaccines are called "subunit"
and "naked DNA" vaccines.
-
- Without going into the intricacies of their production,
they involve techniques used in genetic engineering. Subunit vaccines generally
will insert a viral or bacterial DNA section into the DNA from yeast, which
is allowed to reproduce in large quantities. The protein intended for inclusion
in the vaccine is then separated from the yeast cells. In the case of naked
DNA vaccines, the viral or DNA gene is first reproduced, then spliced into
a plasmid (which is essentially free DNA, widely used in recombinant technology),
reproduced in bacteria or cells, and then separated from them for inclusion
in the vaccine. Recombinant gene vaccines can also be produced via these
methods - for instance, hepatitis B is now an exclusively recombinant vaccine
(103, 104).
-
- One of the major concerns with these methods is the unpredictability
and interaction of the final vaccine product with the proteins or DNA of
the host. A document from the FDA states: "Genetic toxicity: Integration
of the plasmid DNA vaccine into the genome of the vaccinated subjects is
an important theoretical risk to consider in preclinical studies. The concern
is that an integrated vaccine may result in insertional mutagenesis through
the activation of oncogenes or inactivation of tumor suppressor genes.
In addition, an integrated plasmid DNA vaccine may result in chromosomal
instability through the induction of chromosomal breaks or rearrangements."
(105). Another group advises, "Research findings in gene therapy and
vaccine development show that naked/free nucleic acids constructs are readily
taken up by the cells of all species including human beings. These nucleic
acid constructs can become integrated into the cell's genome and such integration
may result in harmful biological effects, including cancers." (106).
And to reiterate the danger of tumorigenic cell lines, a researcher says,
"More recently, recombinant DNA technology has expanded beyond bacterial
cells to mammalian cells, some of which may also be tumorigenic."
(107).
-
- It seems obvious that there needs to be a new and open
dialog regarding vaccines among the regulatory agencies, manufacturers,
research and medical community, and the public. Many have been ridiculed
for refusing vaccination for themselves or their children, but considering
the occurrences of short-term adverse events and questionable efficacy
(108), possible long-term health damage, and now also facing the potential
of wide-ranging loss of civil liberties (109), is it so surprising that
many are questioning what the actual benefits are surrounding most vaccination
protocols? Are the cases of damaged children, non-functional adults, the
huge increases in cancer rates, immune and chronic diseases to be simply
and blindly accepted by the public as "tolerable losses"?
-
- As a citizen with a right to good health, please be advised
of the following issues. Vaccine quality in the U.S. relies for the most
part, on manufacturers reporting to the FDA. Here is a relevant statement
from the CDC: "Manufacturers are required to submit the results of
their own tests for potency, safety, and purity for each vaccine lot to
the FDA. They are also required to submit samples of each vaccine lot to
FDA for testing. However, if the sponsor describes an alternative procedure
which provides continued assurance of safety, purity and potency, CBER
may determine that routine submission of lot release protocols (showing
results of applicable tests) and samples is not necessary." (110)
Yes, this is the scope of the quality-control protocol that oversees a
market worth billions of dollars, yet allowing all these contaminants into
the vaccines.
-
- It may be helpful to have an idea of the scope of the
operation to understand what we are dealing with here. We are advised that
"Large-scale cell culture operations for biotechnology products use
millions of litres of complex media and gases as well as huge quantities
of organic and inorganic raw materials. These raw materials must always
be assumed to contain contamination by adventitious agents" (111).
And because there is a potentially large number of animal and human viruses
(or viral segments) that could be entering into the final vaccine products,
it would take a equally large bank of molecular probes, as well as frequent,
wide-spread testing, to screen for presence of these contaminating agents.
This would obviously add time and expense for the manufacturers. What needs
to be decided is this - is the effort and cost involved in cleaning up
these admittedly filthy medical products, worth the resultant benefit to
the public health? And since certain animal products are necessary for
the production of vaccines, it may also be necessary to clean house at
several levels, including the agricultural sector. It is no secret for
instance, that commercial chicken flocks raised for meat and eggs are often
carrying infectious avian leucosis virus, mentioned earlier in this report
(112, 113, 114)
-
- For the record, the smallpox vaccine ordered by the U.S.
government from Aventis is being produced on two types of continuous cell
lines, the human embryonic MRC-5 and the green monkey Vero cells (115).
We might also be advised of one researcher's thoughts, that "normal
embryo and foreskin cells presumably represent a state in development which
is genetically unstable, rendering them considerably more susceptible to
malignant transformation." (116). Are remnants of these types of cells
something we want injected into our bodies?
-
- The decision you make in accepting or refusing a vaccination
can be a very personal one, but whatever you decide, do try to be informed
of the true benefits and risks. Nobody should be forced to submit to any
medical procedure, especially one of questionable value.
-
-
- References / Notes
-
- [Items with a PMID number will usually have abstracts
available to read. Go to the PubMed website:
-
- http://www4.ncbi.nlm.nih.gov/entrez/query.fcgi and enter
the accession number into the search box.]
-
- 1. Trijzelaar B. Regulatory affairs and biotechnology
in Europe: III. Introduction into good regulatory practice--validation
of virus removal and inactivation. Biotherapy 1993; 6(2):93-102. PMID 8398576.
-
- 2. Vilcek S. Identification of pestiviruses contaminating
cell lines and fetal calf sera. Acta Virol 2001 Apr;45(2):81-6. PMID 11719986.
-
- 3. Barkema HW, Bartels CJ, van Wuijckhuise L, Hesselink
JW, Holzhauer M, Weber MF, Franken P, Kock PA, Bruschke CJ, Zimmer GM.
Outbreak of bovine virus diarrhea on Dutch dairy farms induced by a bovine
herpesvirus 1 marker vaccine contaminated with bovine virus diarrhea virus
type 2. Tijdschr Diergeneeskd 2001 Mar 15;126(6):158-65. PMID 11285633.
-
- 4. Rolleston WB. Bovine serum: reducing the variables
through the use of donor herds. Dev Biol Stand 1999;99:79-86. PMID 10404879.
-
- 5. Bolin SR, Matthews PJ, Ridpath JF. Methods for detection
and frequency of contamination of fetal calf serum with bovine viral diarrhea
virus and antibodies against bovine viral diarrhea virus. : J Vet Diagn
Invest 1991 Jul;3(3):199-203. PMID 1655059.
-
- 6. Erickson GA, Landgraf JG, Wessman SJ, Koski TA, Moss
LM. Detection and elimination of adventitious agents in continuous cell
lines. Dev Biol Stand 1989;70:59-66. PMID 2759356.
-
- 7. Yanagi M, Bukh J, Emerson SU, Purcell RH. Contamination
of commercially available fetal bovine sera with bovine viral diarrhea
virus genomes: implications for the study of hepatitis C virus in cell
cultures. J Infect Dis 1996 Dec;174(6):1324-7. PMID 8940226.
-
- 8. Giangaspero M, Harasawa R, Verhulst A. Genotypic analysis
of the 5'-untranslated region of a pestivirus strain isolated from human
leucocytes. Microbiol Immunol 1997;41(10):829-34. PMID 9403511.
-
- 9. Harasawa R, Mizusawa H. Demonstration and genotyping
of pestivirus RNA from mammalian cell lines. Microbiol Immunol 1995;39(12):979-85.
PMID 8789057.
-
- 10. Brock, KV. Pathogenesis of BVDV Infections. http://www.vetmed.auburn.edu/~brockkv/path.htm
and http://www.vetmed.auburn.edu/~brockkv/terms.htm
-
- 11. Stoffregen B, Bolin SR, Ridpath JF, Pohlenz J. Morphologic
lesions in type 2 BVDV infections experimentally induced by strain BVDV2-1373
recovered from a field case. Vet Microbiol 2000 Nov 15;77(1-2):157-62.
PMID 11042409.
-
- 12. Meehan JT, Lehmkuhl HD, Cutlip RC, Bolin SR. Acute
pulmonary lesions in sheep experimentally infected with bovine viral diarrhoea
virus. J Comp Pathol 1998 Oct;119(3):277-92. PMID 9807729.
-
- 13. Loken T, Krogsrud J, Bjerkas I. Outbreaks of border
disease in goats induced by a pestivirus-contaminated orf vaccine, with
virus transmission to sheep and cattle. J Comp Pathol 1991 Feb;104(2):195-209.
PMID 1650802.
-
- 14. Yolken R, Dubovi E, Leister F, Reid R, Almeido-Hill
J, Santosham M. Infantile gastroenteritis associated with excretion of
pestivirus antigens. Lancet 1989 Mar 11;1(8637):517-20. PMID 2564059.
-
- 15. Potts BJ, Sever JL, Tzan NR, Huddleston D, Elder
GA. Possible role of pestiviruses in microcephaly. Lancet 1987 Apr 25;1(8539):972-3.
-
- 16. Harasawa R. Latent Risk in Bovine Serums Used for
Biopharmaceutic Production. http://www.asmusa.org/pcsrc/sum02.htm
-
- 17. Levings RL, Wessman SJ. Bovine viral diarrhea virus
contamination of nutrient serum, cell cultures and viral vaccines. Dev
Biol Stand 1991;75:177-81. PMID 1665461.
-
- 18. http://www.nybloodcenter.org/PatentsAndLicensing/SDTechnology.htm
-
- 19. Giangaspero M, Vacirca G, Harasawa R, Buttner M,
Panuccio A, De Giuli Morghen C, Zanetti A, Belloli A, Verhulst A. Genotypes
of pestivirus RNA detected in live virus vaccines for human use. J Vet
Med Sci 2001 Jul;63(7):723-33. PMID 11503899.
-
- 20. Harasawa R, Mizusawa H. Detection of Pestiviruses
from Mammalian Cell Cultures by the Polymerase Chain Reaction. Proceedings
of 3rd Internet World Congress on Biomedical Sciences 1996.12.9-20 Riken,
Tsukuba, Japan. http://www.3iwc.riken.go.jp/CONGRESS/SYMPO/SBB0202/AK0111/TIT.HTM
-
- 21. Contreras G, Bather R, Furesz J, Becker BC. Activation
of metastatic potential in African green monkey kidney cell lines by prolonged
in vitro culture. In Vitro Cell Dev Biol 1985 Nov;21(11):649-52. PMID 4066602.
-
- 22. Levenbook IS, Petricciani JC, Elisberg BL. Tumorigenicity
of Vero cells. J Biol Stand 1984 Oct;12(4):391-8. PMID 6526826.
-
- 23. Furesz J, Fanok A, Contreras G, Becker B. Tumorigenicity
testing of various cell substrates for production of biologicals. Dev Biol
Stand 1989;70:233-43. PMID 2759351.
-
- 24. Letter to Sponsors Using Vero Cells as a Cell Substrate
for Investigational Vaccines. Department of Health and Human Services,
Public Health Service, Food and Drug Administration, Division of Vaccines
and Related Products Applications, March 12, 2001. www.fda.gov/cber/ltr/vero031301.htm
-
- 25. U.S. Dept. of Health and Human Services, Public Health
Service, Food and Drug Administration, Center for Biologics Evaluation
and Research. Evolving Scientific and Regulatory Perspectives on Cell Substrates
for Vaccine Development. http://www.fda.gov/cber/minutes/0907evolv.txt
-
- 26. Lewis AM Jr. Developing an approach to evaluate the
use of neoplastic cells as vaccine substrates. Dev Biol (Basel) 2001;106:37-42;
discussion 42-3. PMID 11761251.
-
- 27. Purcell DF. Pathogenesis of replication competent
retroviruses derived from mouse cells in immunosuppressed primates: implications
for use of neoplastic cells as vaccine substrates. Dev Biol (Basel) 2001;106:187-98;
discussion 199, 253-63. PMID 11761231.
-
- 28. Amosenko FA, Svitkin YV, Popova VD, Terletskaya EN,
Timofeev AV, Elbert LB, Lashkevich VA, Drozdov SG. Use of protamine sulphate
for elimination of substrate DNA in poliovaccines produced on continuous
cell lines. Vaccine 1991 Mar;9(3):207-9. PMID 1645900.
-
- 29. Thyagarajan B, McCormick-Graham M, Romero DP, Campbell
C. Characterization of homologous DNA recombination activity in normal
and immortal mammalian cells. Nucleic Acids Res 1996 Oct 15;24(20):4084-91.
PMID 8918816 (full text article available free at this link).
-
- 30. Ruscetti SK. Generation of mink cell focus-inducing
retroviruses: a model for understanding how viralviral and viral-cellular
interactions can result in biological consequences. Dev Biol (Basel) 2001;106:163-7;
discussion 167-8, 253-63. PMID 11761228.
-
- 31. Hilleman MR. History, precedent, and progress in
the development of mammalian cell culture systems for preparing vaccines:
safety considerations revisited. J Med Virol 1990 May;31(1):5-12. PMID
2198327.
-
- 32. Butel JS, Lednicky JA. Cell and molecular biology
of simian virus 40: implications for human infections and disease. J Natl
Cancer Inst 1999 Jan 20;91(2):119-34. PMID 9923853.
-
- 33. Arrington AS, Lednicky JA, Butel JS. Molecular characterization
of SV40 DNA in multiple samples from a human mesothelioma. Anticancer Res
2000 Mar-Apr;20(2A):879-84. PMID 10810370.
-
- 34. Vilchez RA, Madden CR, Kozinetz CA, Halvorson SJ,
White ZS, Jorgensen JL, Finch CJ, Butel JS. Association between simian
virus 40 and non-Hodgkin lymphoma. Lancet 2002 Mar9;359(9309):817-23.
PMID 11897278.
-
- 35. Shivapurkar N, Harada K, Reddy J, Scheuermann RH,
Xu Y, McKenna RW, Milchgrub S, Kroft SH, Feng Z, Gazdar AF. Presence of
simian virus 40 DNA sequences in human lymphomas. Lancet 2002 Mar 9;359(9309):851-2.
PMID 11897287.
-
- 36. Bu X, Zhang X, Zhang X, et Al. A study of simian
virus 40 infection and its origin in human brain tumors. Zhonghua Liu Xing
Bing Xue Za Zhi 2000 Feb;21(1):19-21. PMID 11860751.
-
- 37. Butel JS, Jafar S, Wong C, Arrington AS, Opekun AR,
Finegold MJ, Adam E. Evidence of SV40 infections in hospitalized children.
Hum Pathol 1999 Dec;30(12):1496-502. PMID 10667429.
-
- 38. von Mettenheim AE. Studies on simian viruses as possible
contaminants of inactivated virus vaccines. I. Direct and serologic detection
of simian adenovirus SV20. Zentralbl Bakteriol [Orig A] 1975 Jul;232(2-3):131-
-
- 40. PMID 1179876.
-
- 39. Schuurman R, van Steenis B, Sol C. Bovine polyomavirus,
a frequent contaminant of calf serum. Biologicals 1991 Oct;19(4):265-70.
PMID 1665699.
-
- 40. Nettleton PF, Rweyemamu MM. The association of calf
serum with the contamination of BHK21 clone 13 suspension cells by a parvovirus
serologically related to the minute virus of mice (MVM). Arch Virol 1980;64(4):359-74.
PMID 7396725.
-
- 41. Fong CK, Gross PA, Hsiung GD, Swack NS. Use of electron
microscopy for detection of viral and other microbial contaminants in bovine
sera. J Clin Microbiol 1975 Feb;1(2):219-24. PMID 51855.
-
- 42. Erickson GA, Bolin SR, Landgraf JG. Viral contamination
of fetal bovine serum used for tissue culture: risks and concerns. Dev
Biol Stand 1991;75:173-5. PMID 1665460.
-
- 43. Kniazeff AJ, Wopschall LJ, Hopps HE, Morris CS. Detection
of bovine viruses in fetal bovine serum use in cell culture. In Vitro 1975
Nov-Dec;11(6):400-3. PMID 172434.
-
- 44. Michalski FJ, Dietz A, Hsiung GD. Growth characteristics
of bovine herpesvirus 1 (infectious bovine rhinotracheitis) in human diploid
cell strain WI-38. Proc Soc Exp Biol Med 1976 Feb;151(2):407-10. PMID 175382.
-
- 45. Egyed L. Bovine herpesvirus type 4: a special herpesvirus
(review art icle). Acta Vet Hung 2000;48(4):501- 13. PMID 11402667.
-
- 46. Egyed L. Replication of bovine herpesvirus type 4
in human cells in vitro. J Clin Microbiol 1998 Jul;36(7):2109-11. PMID
9650976.
-
- 47. Johnson ES. Poultry oncogenic retroviruses and humans.
Cancer Detect Prev 1994;18(1):9-30. PMID 8162609.
-
- 48. For example, see Nevins JR, "Cell Transformation
by Viruses", in Knipe DM et al (ed.), 2001. Fields Virology (4th ed),
Vol. I, chapter 10, p.245-283. Lippincott. Also see Joklik WK, "Tumor
Viruses", in Joklik WK et al, 1992. Zinsser Microbiology (20th ed),
chapter 59, p.869-905. Appleton & Lange.
-
- 49. Felder MP, Eychene A, Laugier D, Marx M, Dezelee
P, Calothy G. Steps and mechanisms of oncogene transduction by retroviruses.
Folia Biol (Praha) 1994;40(5):225-35. PMID 7895853.
-
- 50. Harris RJ, Dougherty RM, Biggs PM, Payne LN, Goffe
AP, Churchill AE, Mortimer R. Contaminant viruses in two live virus vaccines
produced in chick cells. J Hyg (Lond) 1966 Mar;64(1):1-7. PMID 4286627.
-
- 51. Payne LN, Biggs PM, Chubb RC, Bowden RS. Contamination
of egg-adapted canine distemper vaccine by avian leukosis virus. Vet Rec
1966 Jan 8;78(2):45-8. PMID 4285488.
-
- 52. Knipe DM et al (ed.) 2001. Fields Virology (4th ed),
Vol. I, p.1103. Lippincott.
-
- 53. Johnson JA, Heneine W. Characterization of endogenous
avian leukosis viruses in chicken embryonic fibroblast substrates used
in production of measles and mumps vaccines. J Virol 2001 Apr;75(8):3605-12.
PMID 11264350.
-
- 54. Maudru T, Peden KW. Analysis of a coded panel of
licensed vaccines by polymerase chain reaction-based reverse transcriptase
assays: a collaborative study. J Clin Virol 1998 Jul 24;11(1):19-28. PMID
9784140.
-
- 55. Tsang SX, Switzer WM, Shanmugam V, Johnson JA, Goldsmith
C, Wright A, Fadly A, Thea D, Jaffe H, Folks TM, Heneine W. Evidence of
avian leukosis virus subgroup E and endogenous avian virus in measles and
mumps vaccines derived from chicken cells: investigation of transmission
to vaccine recipients. J Virol 1999 Jul;73(7):5843-51. PMID 10364336.
-
- 56. Hussain AI, Shanmugam V, Switzer WM, Tsang SX, Fadly
A, Thea D, Helfand R, Bellini WJ, Folks TM, Heneine W. Lack of evidence
of endogenous avian leukosis virus and endogenous avian retrovirus transmission
to measles, mumps, and rubella vaccine recipients. Emerg Infect Dis 2001
Jan-Feb;7(1):66-72. PMID 11266296. Full article text available at www.cdc.gov/ncidod/eid/vol7no1/hussain.htm
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