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Copyright, Dr. John Martin
Vaccine Safety
Dr. John Martin
One of society's highest obligations is the protection of its children.
Vaccine programs provide a proven method for childhood disease prevention.
The safety of such programs has been entrusted to vaccine manufacturers and
to government. regulatory agencies. Although widely touted as the major
medical triumph of the 20th century, the development of viral vaccines has
elements of less than stellar performance. The discovery in 1960 of live
SV-40 virus contamination in formalin-treated poliovirus vaccine, produced in
kidney cells cultures from rhesus monkeys, did not lead to an immediate
recall of the contaminated vaccines. Rather the production method was
switched to the use of kidney cells from the much less well characterized
African green monkeys. This switch in monkey species was soon followed by the
decision to forgo formalin inactivation by using a weakened (attenuated) live
strain of poliovirus. Persisting concerns regarding contaminating viruses in
the live poliovaccine led in 1972 to a joint study between the vaccine
manufacturer and the United States Food and Drug Administration (FDA). Kidney
cultures from all 12 monkeys tested grew African green monkey simian
cytomegalovirus (SCMV). Only 4 of the SCMV isolates were detectable using the
regular methods for virus detection. No changes in testing methodology were imposed,
nor was the scientific community alerted to the findings. An excuse that was
subsequently offered was that all such information about the study was deemed
to be proprietary. The results of this earlier study were, however, not
conveyed to me in 1977 when, as an FDA scientist, I notified the Director of
the FDA's Bureau of Biologics that certain polio vaccine lots contained
unexplained non-cellular DNA; and were therefore potentially viral
contaminated.
The issue of SCMV contamination of poliovirus vaccines was again raised
with the FDA in May 1995. I was then working as a virologist at the
University of Southern California. I had developed tissue culture methods
which indicated the presence of atypical viruses in patients with complex
neurological diseases. The viruses were striking in that they failed to evoke
an inflammatory reaction in the patients from whom they were isolated. They
were termed stealth viruses on this basis and seemingly they lacked target
antigens for recognition by the body's cellular immune system. Sequencing
studies on a stealth virus indicated it had originated from SCMV. Several
meetings with FDA and Center for Disease Control and Prevention (CDC)
officials clearly pointed to their unwillingness to allow any outside review of
vaccine safety procedures. For example, a simple request to review
histological slides of neurological tissue of monkeys inoculated with polio vaccine
was refused, again on the basis that it was proprietary information.
Noteworthy was the admission that the vaccines were routinely tested in
rhesus monkeys because African green monkeys commonly show evidence of
neurological disease. Moreover, even in rhesus monkeys, the vaccine was said
to induce considerable damage, although less than that induced by non-attenuated
poliovirus.
The actual sequence data were published in a respected virology journal in
July 1995. The article aroused the interest of anti-vaccine consumer groups.
Through the efforts of one of these groups, I was invited to attend a vaccine
safety meeting of the Institute of Medicine, National Academy of Sciences.
The open meeting held on November 6, 1995 was followed the next day by an
"executive session." I was informed that several individuals at
this meeting were "furious" that I was allowed to speak. A very
much watered down account of what I said subsequently appeared in the
official report of the meeting.
Some insight into the lack luster nature of the existing system was
provided by several brief interchanges with Government and other officials
during the last several years. For example, I was asked whether formalin
treatment would inactivate stealth viruses. My response was that I did not
know. The chairman of the National Immunization Advisory Committee suggested
his advocacy of a split protocol in which both formalin inactivated and live
attenuated poliovaccine would provide the necessary time window for the
manufacturer of the inactivated vaccine to develop the stocks required for a
complete switch. True to his suggestion, the official switch to inactivated
vaccine is scheduled for January 2000. Of course, those "in the
know" would have already switched to the inactivated vaccine. An FDA
reform bill was being considered by Congress in 1997. I suggested that the
bill include the provision that "If a safety issue is identified in the
regulation of a biological product, then Industry will waive its proprietary
protection so that the information could be made available to the scientific
community." The suggestion was well received by the counsel for the
House Commerce Committee. It was soon dropped, however, when support was not
forthcoming from Industry, FDA or the American Medical Association (AMA). In
speaking with an AMA lobbyist, I understood they "would not want the
public to know that their doctors were not in the knowledge loop." I
once asked industry personnel involved in poliovaccine production whether
they were still encountering SCMV in poliovaccine production lots. After some
hesitation that disappeared as we all identified ourselves as parents, the
straightforward answer was "not infrequently." Armed with this
information I again requested of an FDA official to please use modern
techniques such as the polymerase chain reaction (PCR) to screen poliovaccine
lots for SCMV. "We would not know what to do with a positive
result" was his answer.
Continued sequencing of the prototype SCMV-derived stealth virus have
helped substantiate the original suggestion that stealth adapted viruses
simply lack the critical target antigens for cellular immune recognition.
More impressively, the virus has the capacity to assimilate genes from
infected cells and from bacteria. The cellular genes identified within the
stealth virus include a gene with potential oncogenic (cancer causing)
activity. The bacterial genes serve a wide range of metabolic functions that
could enhance bacterial growth. Human and animal viruses with bacterial
sequences represent a novel life form that has been christened viteria. The
recombination of viral, bacterial and cellular genes within broadly
infectious viteria is clearly of major medical and Public Health
significance. For instance, it could provide a viral explanation for positive
findings in clinical assays designed to detect various bacteria including the
Borrelia burgdorferi (the agent for Lyme disease), mycoplasma, and chlamydia.
FDA and CDC were informed of the publication of the results. It was
disheartening, yet challenging, that neither organization responded. NIH was
also notified but merely acknowledged that research is supportable by grants.
During the last decade, I have written several clinical articles
describing stealth virus infected patients with complex illnesses. The
patients have included children with autism, adults with psychotic disease
and several individuals with chronic fatigue/fibromyalgia syndrome. An
additional recent publication described a stealth virus infected child whose
illness began in 1997 as a behavioral problem. It took over seven months
before the illness was attributed to brain damage, as confirmed by magnetic
resonance imaging (MRI). Even then the neurologist was unable to detect
impaired motor or sensory functions. A brain biopsy performed shortly after
the essentially normal clinical examination showed marked
vacuolating/spongiform change. The child's clinical condition progressively
deteriorated. He was examined at several major medical centers where it was
wrongly concluded that he had a genetic disease from which he would soon die.
He was shown to be stealth virus infected by tissue culture and significantly
improved with anti-viral therapy, although he still has major residual
deficits.
Where is the Public Health concern that a childhood viral infection was
not recognized at major medical centers. Where is the interest in the many
other children who have tested positive for stealth viruses. Why the lack of
discussion about possible brain damage causing national tragedies such as
school shootings, and the increasing prevalence of autism, attention deficit,
asthma and sudden infant death syndrome. Are stealth virus infected patients
populating our psychiatric institutions, allergy clinics and even our cancer
wards.
The world and, in particular, its children appear to be at risk for
stealth adapted viruses. The contribution of vaccines to the formation and
dissemination of these viruses should be an open topic for scientific
discussion. This is not occurring with those presently in charge of
overseeing the safety of the Nation's immunization program.
W. John Martin, M.D., Ph.D.
Center for Complex Infectious Diseases
Rosemead CA 91770
www.ccid.org
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